RU2783788C2 - Devices for eye surgery - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: surgical device for cutting the lens inside the capsule bag of the eye contains: a rod extending from a case along the longitudinal axis of the device, wherein the rod has lumen and a distal end; a cutting element moved along lumen of the rod, wherein the cutting element contains at least the first dissecting element having the first end, the second end, and a distal loop formed between the first and the second ends; a motor having a working connection to the cutting element and moved along the longitudinal axis of the case; and a move counting mechanism connected to the motor and enclosed inside the case. The cutting element is made with the possibility of transfer from the first removed configuration towards the second unfolded configuration, when the motor is distally extended. When being in the second unfolded configuration, the distal loop of at least the first dissecting element forms an enlarged open area located outside the distal end of the rod, wherein the enlarged open area has the first side distally extended relatively to the distal end of the rod and the second side proximally located relatively to the distal end of the rod. The move counting mechanism is made with the possibility of tracking distal extensions and/or proximal extensions of the motor and calling an act of locking, which prevents distal extension of the motor.

EFFECT: use of this invention will allow for extraction of tissue from the anterior chamber without damage to other eye structures.

15 cl, 33 dwg

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority over concurrent U.S. Provisional Applications Nos. 62/598,857, filed December 14, 2017, titled "Devices and Methods for Ocular Surgery", and 62/696,769, filed July 11, 2018. and titled "Devices and Methods for Ocular Surgery", the disclosures of which are incorporated herein by reference in their entirety in all respects.

FIELD OF THE INVENTION

[0002] The proposed technology refers, in General, to devices and methods for eye surgery in the case where one such procedure is the removal of the lens from the human eye. In particular, the technology relates to the capture, fragmentation and extraction of lens or other tissue during ophthalmic surgery.

BACKGROUND OF THE INVENTION

[0003] Some types of conventional ophthalmic surgery require the lens tissue and solid intraocular objects, such as an intraocular lens, to be ground into pieces so that they can be removed from the eye. For example, lens extraction for cataract surgery is one of the most common areas of outpatient surgery, with over 3 million cases performed annually in the US alone. During cataract surgery, the most common method of removing the lens is phacoemulsification, which involves the use of ultrasonic energy to grind the lens and then aspiration to remove the lens fragments with an instrument. Other methods for fragmenting and extracting the lens may include using tools such as hooks, knives, or a laser to grind the lens into fragments and then extract it through an incision in the cornea from the inside. Intraocular fragmentation of the lens tissue with an inside approach is very important in cataract surgery in order to allow removal of cataracts from incisions in the eye, which usually do not exceed 2.8-3.0 mm.

[0004] However, existing tools and methods do not provide full-thickness lens fragmentation. These methods approach the lens from the anterior surface of the eye, and therefore the cutting forces applied by mechanical instruments are limited so that they are often insufficient to provide full-thickness segmentation. In addition, due to surgical access through an incision at the edge of the cornea, a mechanical instrument is advanced at an angle substantially parallel to the plane defined by the capsulorhexis. As a result, a conventional lasso, loop, or wire extraction surgical instrument is not in an orientation in which the device can wrap around the lens to allow for fragmentation or extraction. Furthermore, even if a conventional instrument could wrap around the lens, which it cannot, the lasso wire would run the risk of applying excessive damaging force to the capsular bag when moved to a predetermined position.

[0005] Energizing instruments are limited in their ability to cut sections of the lens that are physically close to other sensitive anatomical structures, such as the capsular bag. For example, a laser is not usually used to cut the posterior edge of the lens because it is in close proximity to the posterior edge of the capsular bag, leaving the lens incompletely fragmented and requiring careful fragmentation using ancillary techniques.

[0006] For the reasons given, phacoemulsification has become the most common method of lens removal. However, phacoemulsification has its drawbacks. As fluid and substances are aspirated from the capsular bag and anterior chamber, other fluids such as saline are injected to maintain a constant volume or pressure. The flow of fluids in the eye during pumping and aspiration can create a turbulent flow that can adversely affect tissue within the eye, such as the corneal endothelium. The ultrasonic energy used in phacoemulsification can have a negative effect on the eye tissue. In addition, phacoemulsification requires expensive and bulky capital equipment, limiting the places where phacoemulsification can be performed.

[0007] Additionally, some suction and pump configurations require large units of capital equipment, as in the case of phacoemulsification, or may require certain facilities, such as a wall-mounted vacuum source, which may not be available in all surgical facilities, especially in underdeveloped regions. A desirable alternative would also be an inexpensive alternative with the same or better performance, eg without the need for an expensive control panel and electronic control system.

SUMMARY OF THE INVENTION

[0008] In one aspect, a surgical device is described, a surgical device for cutting the lens within the capsular bag of the eye. The device includes a rod extending from the housing along the longitudinal axis of the device. The rod has a lumen and a distal end. The device includes a cutting element that moves along the lumen of the rod. The cutting element includes a first cutting element and a second cutting element. Each of the first and second dissecting elements has a first end, a second end and a distal loop formed between the first and second ends. The device includes an actuator having a working connection with the cutting element. The cutting element is configured to move from the first retracted configuration towards the second deployed configuration upon first actuation of the actuator. When in the second deployed configuration, the distal loop of each of the first and second dissecting elements forms an enlarged open area located outside the distal end of the rod, while the enlarged open area has a first leg extended distally relative to the distal end of the rod, and a second leg located proximally relative to distal end of the rod.

[0009] When the cutting element is in the second deployed configuration, the distal loops forming the enlarged open areas of each of the first and second dissecting elements may be aligned generally in a plane parallel to each other. The second actuation of the actuator or a second, different actuator may force the distal loop, forming an enlarged open area of one of the first and second dissecting elements, to move in an angular direction relative to the plane, with the transfer of the cutting element into a third, deflected configuration. The second actuation of the actuator or a second, different actuator may force the distal loop forming the enlarged open area of both the first and second dissecting elements to move in an angular direction away from each other, with the cutting element being transferred to a third, deflected configuration.

[0010] The device may further include an intermediate splitting element located between the first and second splitting elements. The intermediate sever may also have a first end, a second end, and a distal loop formed between the first and second ends. When the cutting element is in the second deployed configuration, the distal loop of the intermediate transversal element may form an enlarged open area located outside the distal end of the rod. The enlarged open area of the intermediate dissecting element may have a first leg extended distally relative to the distal end of the rod and a second leg located proximally relative to the distal end of the rod. When the cutting element is in the second deployed configuration, the distal loops defining the enlarged open areas of each of the first, second, and intermediate dividing elements may be aligned generally in a plane parallel to each other. The second activation of the actuator or a second, different actuator may force the distal loops forming the enlarged open areas of both the first and second dissecting elements to move in the angular direction from the intermediate dissecting element, with the transfer of the cutting element into a third, deflected configuration. The first and second transverse elements can move in the range from about 15 degrees to about 45 degrees relative to the plane, while the plane is essentially a vertical plane.

[0011] The first ends and the second ends of each of the first and second dissecting elements can be moved relative to the rod. The first ends may be axially movable along the longitudinal axis of the device. The second ends may be movable in an angular direction relative to the longitudinal axis of the device. The first ends of each of the first and second dividing elements can be movable relative to the longitudinal axis of the device, and the second ends of each of the first and second dividing elements can be fixed relative to the longitudinal axis of the device. The first ends may be axially movable along the longitudinal axis of the device and movable in an angular direction relative to the longitudinal axis of the device.

[0012] The actuator may be a slider movable along the longitudinal axis of the body. The device may further include a movable assembly located inside the housing and connected to move with the engine relative to the housing. The movable assembly may include a first loop holder connected to the first cutting element and a second loop holder connected to the second cutting element. Moving the slider a first distance distally with respect to the body can translate the slider assembly distally, which causes the distal loops of the first and second splitters to form enlarged open areas and move the cutter toward the second deployed configuration. Moving the slider a second distance in the distal direction, greater than the first distance, may force the distal loops forming the enlarged open areas of the first and second dissecting elements to move in an angular direction from each other, with the cutting element being transferred to a third, deflected configuration. The first hinge holder may be rotatable about a first axis of rotation in a first direction, and the second hinge holder may be rotatable about a second axis of rotation in a second direction opposite the first direction. Rotation of the first loop holder about the first axis of rotation may cause the distal loop of the first transcending element to deflect in the first direction, and rotation of the second loop holder about the second axis of rotation may cause the distal loop of the second transverse element to deflect in the second, opposite direction. Moving the slider a second distance in a distal direction greater than the first distance may rotate the first and second stitch holders about their axes of rotation, moving the cutting element towards a third, deflected configuration. The device may further include a wedge located within the distal end region of the housing. Moving the slider a second distance in a distal direction greater than the first distance may force the first and second stitch holders against the wedge, which forces the first loop holder to rotate about the first axis of rotation in the first direction, and causes the second loop holder to rotate about the second axis of rotation in the second, in the opposite direction, with the reduction of the distal loops, forming an enlarged open area of the first and second dissecting elements, to a deviation in different directions. The wedge may be stationary, or may be movable in a proximal direction by actuating a second, different actuator. Proximal movement of the wedge may force the wedge against the first and second loop holders, which causes the first loop holder to rotate about the first axis of rotation in the first direction and causes the second loop holder to rotate about the second axis of rotation in the second, opposite direction, adducting the distal loops forming enlarged open areas of the first and second dissecting elements, to deviation in different directions. The wedge can be movable in the proximal direction to cause deflection of the first and second loop holders regardless of the relative location of the movable assembly along the longitudinal axis of the device.

[0013] When the cutting element is in the second, expanded configuration, the distal loops defining the enlarged open areas of the first and second transcending elements may be generally oval in shape and have a maximum width of about 4.0 mm to about 20 mm and a maximum height from about 1.0 mm to about 15 mm. The distal loops forming the enlarged open areas of the first and second cutting elements can be made with the possibility of deviating in the angular direction from each other, with the transfer of the cutting element into a third, deviated configuration, regardless of the size of the enlarged open areas. The size of the enlarged open areas of the first and second transverse elements before deflection may be selectable. The device may further include a regulator configured to change the relative distance between the wedge and the movable assembly. A smaller relative distance may provide a smaller open area of the first and second transverse elements in the second, deployed configuration before deflection, and a larger relative distance may provide a larger open area of the first and second transverse elements before deflection.

[0014] In a related embodiment, a surgical device for cutting the lens within the capsular bag of the eye is described, which includes a shaft extending from the housing along the longitudinal axis of the device. The rod has a lumen and a distal end. The device includes a cutting element that moves along the lumen of the rod. The cutting element includes at least a first cutting element having a first end, a second end and a distal loop formed between the first and second ends. The device includes a slider having a working connection with the cutting element and moving along the longitudinal axis of the body. The device includes a stroke counting mechanism connected to the engine and enclosed inside the housing. The cutting element is made with the possibility of transition from the first, retracted configuration in the direction to the second, deployed configuration, when the slider is extended distally. When in the second, deployed configuration, the distal loop of at least the first dissecting element forms an enlarged open area located outside the distal end of the rod, while the enlarged open area has a first leg extended distally relative to the distal end of the rod, and a second leg located proximal to the distal end of the nail. The stroke counting mechanism is configured to track distal extensions and/or proximal extensions of the slider.

[0015] The stroke counting mechanism may be configured to trigger a lockout act that prevents the slider from extending distally after the lockout act. The stroke counting mechanism may include a cylindrical counting drum containing a plurality of inclined cams; hard stopper; and a pair of inclined slider guides shaped and arranged to engage with a plurality of inclined cams on the counting drum, which cause the counting drum to rotate about the longitudinal axis of the device. Each distal extension of the slider can rotate the cylindrical counting drum a fraction of a full turn around the longitudinal axis of the device. The cylindrical counting drum may be rotatable up to about 24 beats before the blocking act occurs. The locking act can block distal extension of the slider and allow proximal retraction of the slider. The slider may be configured to perform from about 3 to about 30 distal extension strokes before the locking act occurs and the slider is locked in the rear position.

[0016] The device may include a lock signaling element. The lock signal element may include a lock signal window extending through the housing and providing a visual indication of the position of the counting drum in the housing relative to the hard stop of the stroke counting mechanism. The counting drum may be axially movable within the housing and have an outer surface having a color that contrasts with that of the housing. When the counting drum is positioned near the lock signal window, the color of the count wheel can be observed through the lock signal window, providing an indication of the distal slider advances available before the lock event occurs. The counting drum may contain a series of marks on the outer surface and be fixed with respect to the block signaling window. The sequence of marks may indicate the number of distal advances made by the engine.

[0017] The engine may further include a shutter window. When the slider is moved towards the distal end region of the body, the slider shutter window and the body lock signaling window can be aligned, revealing a sequence of marks on the drum. When the slider is moved proximally from the distal end region of the body, the slider shutter window and the body lock signaling window cannot be aligned, and the sequence of marks on the drum is not visible.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] These and other aspects are described in detail in the following with reference to the following drawings. Generally speaking, the figures are not drawn to scale in an absolute or relative sense, but are intended to be illustrative. In addition, the relative placement of features or elements may be modified for the purpose of image clarity.

[0019] FIG. 1 is a schematic side view of the anatomy of the eye, showing the insertion of a rod and dissecting element through an incision in the lateral surface of the cornea.

[0020] FIG. 2 is a plan view of the transversal element in the expanded position.

[0021] FIG. 3 is a perspective view of a capsulorhexis bag with the dissecting element in the first retracted insertion configuration.

[0022] FIG. 4 is a perspective view of a capsulorhexis bag with a dissecting member in a second, unfolded gripping configuration.

[0023] FIG. 5 is a perspective view of a capsular sac with a capsulorhexis made, with the dissecting element in the third fragmentation position.

[0024] FIG. 6 is a perspective view of the lens shown in FIG. 5, with the transversal element omitted for clarity.

[0025] FIG. 7 is a perspective view of the lens shown in FIG. 5, with the dissecting member and capsular bag omitted for clarity.

[0026] FIG. 8 is a perspective view of a surgical device including a handle, a shaft, and several dissecting members.

[0027] FIG. 9 is a perspective view of the surgical device shown in FIG. 8 with the dissecting elements in the first retracted configuration.

[0028] FIG. 10 is a perspective view of the surgical device shown in FIG. 8 with the left slider pushed forward to deploy the left transversal element towards the second deployed configuration.

[0029] FIG. 11 is a perspective view of the surgical device shown in FIG. 8 with the left slider fully advanced to deploy the left transversal element into a second, deployed configuration.

[0030] FIG. 12 is a perspective view of the surgical device shown in FIG. 8 with the right slider pushed forward to deploy the right transversal element towards the second deployed configuration.

[0031] FIG. 13 is a perspective view of the surgical device shown in FIG. 8 with the right slider fully extended forward to deploy the right transversal element into a second, deployed configuration.

[0032] FIG. 14 is a perspective view similar to FIG. 13 showing the dissecting elements with respect to the lens.

[0033] FIG. 15 is a detailed perspective view of the distal end of the surgical device shown in FIG. eight.

[0034] FIG. 16 is a sectional perspective view of the handle, with the right slider in its original position.

[0035] FIG. 17 is a detailed perspective view of a portion of the handle shown in FIG. 16.

[0036] FIG. 18 is a detailed perspective view of another portion of the handle shown in FIG. 16.

[0037] FIG. 19 is a detailed perspective view of the handle shown in FIG. 16-18, with the right engine partially advanced forward.

[0038] FIG. 20 is a detailed perspective view of the handle shown in FIG. 16-18 with the right slider advanced further distally forward than in its position in FIG. 19.

[0039] FIG. 21 is a detailed perspective view of the handle shown in FIG. 16-18 with the right slider returned towards its original position.

[0040] FIG. 22 is a detailed perspective view of the handle shown in FIG. 16-18, with the right slider returned to its original position.

[0041] FIG. 23 is a side view of another embodiment of two dissecting members extending from the lens enclosing shaft.

[0042] FIG. 24A is a perspective view of another embodiment of a surgical device including a handle, a shaft, and several dissecting members prior to deployment.

[0043] FIG. 24B is a perspective view of the device shown in FIG. 24A in a second, deployed configuration.

[0044] FIG. 24C is a perspective view of the device shown in FIG. 24B, in a third, rejected configuration.

[0045] FIG. 24D is an exploded view of the device shown in FIG. 24A containing three transverse elements.

[0046] FIG. 24E is an exploded view of another embodiment of the device shown in FIG. 24A containing two transverse elements.

[0047] FIG. 25A is a detailed perspective view of the device shown in FIG. 24A enclosing the lens.

[0048] FIG. 25B-25C are detailed perspective views of the device shown in FIG. 25A, after stretching and cutting the lens.

[0049] FIG. 26A is an exploded view of the device shown in FIG. 24A including a two-phase placement mechanism.

[0050] FIG. 26B is a partial perspective view of the device shown in FIG. 24A showing the movable assembly and loop holders.

[0051] FIG. 26C is a partial end view of the device shown in FIG. 24A.

[0052] FIG. 26D is a partial perspective view showing the loop holder of the device shown in FIG. 24A, before deflection.

[0053] FIG. 26E is a partial perspective view showing the loop holder of the device shown in FIG. 24A after rejection.

[0054] FIG. 26F is a top plan view of the wedge of the device shown in FIG. 24A.

[0055] FIG. 26G-26H are views of the deployment adjustment mechanism of the device shown in FIG. 24A.

[0056] FIG. 26I-26L are various views of the deployment adjustment mechanism.

[0057] FIG. 26M is a partial perspective view of the loop holder of the device shown in FIG. 24A, before rejection, showing the user feedback element.

[0058] FIG. 26N is a top plan view of the user feedback element shown in FIG. 26M.

[0059] FIG. 27A-27C are views of an embodiment of the stroke counting mechanism.

[0060] FIG. 28A-28B are views of another embodiment of the stroke counting mechanism.

[0061] FIG. 29A-29B are views of another embodiment of the stroke counting mechanism.

[0062] FIG. 30A-30E are views of another embodiment of the stroke counting mechanism.

[0063] FIG. 31A is a perspective view of another embodiment of the apparatus including a stroke counting mechanism.

[0064] FIG. 31B is a partial sectional view of the device shown in FIG. 31A.

[0065] FIG. 31C is an embodiment of the counting drum.

[0066] FIG. 31D is a view of the inclined slide rails adapted to engage with the counting drum shown in FIG. 31c.

[0067] FIG. 31E is a view of the counting drum shown in FIG. 31C regarding the engine.

[0068] FIG. 31F is an illustration of an embodiment of the blocking signaling for the device shown in FIG. 31A.

[0069] FIG. 32A-32B are views of another embodiment of the stroke counting mechanism.

[0070] FIG. 33A-33C are illustrations of embodiments of transversal elements formed from a long, narrow strip of material.

[0071] It should be understood that the drawings are by way of example only and are not intended to be drawn to scale. It should be understood that the devices described in this application may include features not necessarily depicted in each figure.

DETAILED DESCRIPTION

[0072] This application describes methods and devices for intraocular fragmentation and removal of the lens and other tissues during intraocular surgery. The devices described in this application allow the extraction of tissue from the anterior chamber without damaging other structures of the eye. In various embodiments, an ophthalmic surgical device is described that uses cutting strings, loops, threads, lasso, and the like that are designed to engage and fragment lens tissue and assist in removing it from the eye with a minimally invasive approach from the inside. In one aspect, a hand-held device is provided that can also be operated (manually) by a user and does not require an electronic control system. The devices described in this application are designed for finely adjustable and individual installation, which can occur in two stages (i.e. deployment and rotation or deployment and deflection) or in three stages (i.e. deployment, rotation and deflection) .

[0073] Further in the figures, FIG. 1 shows the normal anatomy of eye 1, including the cornea 2, the capsular sac 6 and the lens 8 within the capsular sac 6. During a cataract procedure, an incision 4 can be made at the edge of the cornea 2 to gain access to the capsular sac 6. The surgeon creates capsulorhexis 10 on the anterior surface of the capsular bag 6. The capsulorhexis 10 may be performed by any suitable method, such as cutting with a scalpel, energizing with a femtosecond laser or other energetic cutting tool, robotic or automated cutting, or any other suitable method. The capsulorhexis 10 may be resected or excised with a diameter of approximately 2.0 mm to 8.0 mm. The capsulorhexis 10 can be made with a diameter less than 2.0 mm, in particular when the lens fragments 8 (as described in more detail below) are small enough to be removed through the capsulorhexis 10 of a smaller diameter. Capsulorhexis 10 can be performed with a separate set of instruments, such as microscissors, as is done in most cases. It is desirable to ensure the minimum size of the corneal incision. For example, corneal incisions that are self-sealing and do not require sutures for closure are optimal for minimally invasive surgery with the lowest risk of complications. The devices described in this application are designed to minimize the size of the incision required to perform fragmentation and removal of the lens.

[0074] As also shown in FIG. 3, then the rod 12 is inserted through the incision 4 into the cornea 2. As seen in FIG. 3, the distal end of the shaft 12 is located above (ie, in front of) the capsulorhexis 10, at a distance from the capsulorhexis 10, but is located within the circumference of the capsulorhexis 10 as viewed from outside the eye 1. As seen in FIG. 1, the rod 12 is typically parallel to the plane defined by the edges of the capsulorhexis 10 after it has been inserted through the incision 4 in the cornea 2. assigned configuration. In such embodiments, the small radius bend 24 may be outside the shaft 12 already bent at least partially in the proximal direction. Thus, even in embodiments in which the transversal member 16 is made of a superelastic material, the angle at which sections of the transversal member 16 flex during the transition from the first retracted configuration to the second deployed configuration is reduced. In addition, less space is required inside the lumen 14 of the rod 12 to hold part of the transversal element 16 than to hold it in its entirety, which allows the production of a rod 12 of a smaller diameter. In accordance with some embodiments, the shaft 12 is a tube with an ovular cross-section, with a rounded tip. The ovular cross section complements the possibility of inserting the rod 12 into the eye 1 through the corneal incision 4. Also, if there are several dissecting elements, they can be more easily placed side by side in the lumen 14 of the rod 12 with an ovular cross section. Alternatively, the rod 12 may have a circular cross section or any other suitable cross section shape. The proximal end of the transversal element 16 extends through the lumen 14 of the rod 12. Alternatively, the entire transversal element 16 is located within the lumen 14 of the rod 12 in a first retracted configuration. Alternatively, at least two dividing elements 16 are used, with each dividing element 16 initially in the first retracted configuration. Although one transect element 16 is described with respect to this particular embodiment for the sake of clarity, in light of the following disclosure, it will be apparent that any suitable number of transect elements 16 can be provided and used in a single lens removal procedure, and that the devices and methods described herein are not are limited to the use of any particular number of severing elements 16. Related devices having severing elements similar to those described in this application are described in US patent No. 9,775,743 and US patent No. 9,629,747, each of which is fully incorporated by reference in this application.

[0075] In accordance with some embodiments, the transversal member 16 includes a first end 18 and a second end 20. As detailed below with reference to FIG. 16-22, one of the ends 18, 20 of the transversal element 16 may be movable relative to the rod 12, while the other of the ends 18, 20 of the transversal element 16 may be fixed relative to the rod 12. For example, the second end 20 of the transversal element 16 may be fixed relative to rod 12, and the first end 18 of the splitting element 16 may be movable relative to the rod 12. The second end 20 can be connected to the rod 12 or other structure by crimping, welding, gluing, mechanical locking devices, or any other suitable(th) his) design or method. In some embodiments, the transversal element 16 is of a circular, oval, or other atraumatic cross section. In other embodiments, the implementation, the dissecting element 16 is a tape. As used herein, the term tape means a structure that is wider than it is thick when viewed in the longitudinal direction.

[0076] In a first, retracted configuration, in which the distal end of the transversal member 16 extends distally from the stem 12, the transversal member 16 is sized and shaped to pass through a standard corneal incision 4 without damaging the eye 1. The corneal incision 4 is typically no larger than 3, 5 mm wide and is done with a small knife. Therefore, the outer diameter of the rod 12 preferably does not exceed 3.5 mm. When a cut 4 with a different size is used, a rod 12 with a different outer diameter can be used, considering that it is most desirable to form the cut 4 in the form of a line no more than 5 mm in length. In other embodiments, the transversal member 16 is positioned entirely within the lumen 14 of the shaft 12 such that it is within the inner diameter of the shaft 12 when the shaft 12 is inserted through the incision 4 and then protrudes from the shaft 12 upon placement in the eye. Alternatively, additional components may be used to shelter the transversal member 16 during insertion through the corneal incision 4. The device may include a thin-walled, retractable sleeve or sheath that restricts movement of the transversal member 16 away from the longitudinal axis A of the device at certain times of use (i.e., e. during insertion, deployment, and/or before deflection of the plurality of transversal elements relative to each other). In some embodiments, the distal end of the shaft 12 may have a tapered piece that gradually tapers from the end of the shaft 12 to a cross section so smaller that it can facilitate insertion through the corneal incision 4. The tapered piece may also cover the dissecting member 16 to compress it. during the introduction. The tapering piece may additionally have a slit in front through which the severing element 16 can continue, or be opened after it has passed through the slit 4.

[0077] According to some embodiments, the transversal element 16 is made of a flexible or superelastic material, such as a nickel-titanium alloy, which allows the transversal element 16 to flex and deform when it is inserted into the eye 1 through the corneal incision 4. The transversal element 16 may also be formed from other materials, such as polymers, instead of metal. In these embodiments, the compressed shape of the transversal element 16 may be larger in one or more directions than the corneal incision 4 and deform to pass through the incision 4 as the shaft 12 moves toward the capsulorhexis 10. Alternatively, the transversal element 16 may not have retracted configuration and can be inserted through the incision 4 in the same configuration that is later used to engage the lens 8. In such embodiments, the transversal member 16 contracts as it passes through the corneal incision 4 and then deploys again after it extends into the eye 1. In still other embodiments, the transversal element 16 may not have a first, retracted configuration and may be inserted through the incision 4 in a larger configuration than the configuration subsequently used to engage the lens 8. In still other embodiments, implementation, the dissecting element 16 can be bent, rotated or otherwise inserted through corneal incision 4 in many ways.

[0078] As seen in FIG. 4, the transversal element 16 or elements is pushed distally relative to the lumen 14 of the shaft 12. As described above, one end 20 of the transversal element 16 can be fixed so that the other end 18 of the transversal element 16 is pushed distally relative to the lumen 14 of the shaft 12. As a result, the transversal element 16 moves from the first retracted configuration to the second gripping configuration.

[0079] The dissecting element 16 may be made of any suitable material. For example, as described above, shape memory materials such as nickel-titanium alloy can be used to allow the transversal member 16 to transition to its predetermined shape in the second deployed configuration, with a high degree of resilience. In one embodiment, the nickel-titanium alloy can be used in its superelastic state, where the nickel-titanium alloy transforms its crystal structure from a first, retracted configuration to a second, unfolded configuration. In other embodiments, the transversal member 16 is made from a nickel-titanium alloy that is pre-compressed to transition from a first retracted configuration to a second gripping configuration after reaching a transition temperature that is above room temperature but below body temperature. Thus, the transversal member 16 made of nickel-titanium alloy can enter the eye at room temperature below its transition temperature at which it will retain its compressed shape. When the transversal member 16 is placed in the eye 1 and warmed to body temperature, the nickel-titanium alloy may warm above its transition temperature and begin to return to its predetermined second deployed configuration. This reshaping may take place over a period of time which allows the surgeon to place the dissecting member in the capsular bag 6 and orient it while the reshaping occurs so that the loop can define a cutting plane through the lens. Alternatively, any number of other biocompatible materials may be considered, such as stainless steel or non-metallic polymeric materials. In some embodiments, the nickel-titanium alloy may be the actively heated surgical device 40, in which case the transition temperature of the transversal member 16 may be selected above room temperature, but below a temperature that would damage capsular bag tissue 6 or other eye tissue 1. Instead of nickel -Titanium alloy can apply other shape memory materials, shape memory plastics. As an alternative, any number of other biocompatible materials may be considered, such as stainless steel, titanium, silicone, polyimide, PEBAX® grade polyester blockamide, nylon, polycarbonate, or any other suitable material. In addition, multiple materials can be used butted along their length or in plane-parallel layers, or concentric tubes of materials.

[0080] As also shown in FIG. 1 and 4, in the second deployed configuration, the transversal member 16 is shaped specifically to capture the lens. In accordance with some embodiments, the second, deployed configuration is a predetermined shape of the transversal element 16, for example, through the use of elastic or superelastic materials for the manufacture of the transversal element.

[0081] As most clearly seen in FIG. 4, in a second unfolded configuration, the dissecting member 16 approximately corresponds to an irregularly shaped loop which has a shape generally similar to the cross section of the lens 8 and which is shaped and sized to enclose the lens 8 within the capsular bag 6. As described above, in In some embodiments, the transversal element 16 is made from a piece of round wire. The second, deployed configuration of the transversal element 16 has a point 22 of convergence at which the first end 18 and the second end 20 of the transversal element 16 converge back, forming a shape with such a perimeter that the device 40 approximately corresponds to the closed loop 21. "Convergence" means the location of the first end 18 and the second end 20 of the cutting element 16 in close proximity to each other. Convergence point 22 may be located at or near the distal end of shaft 12. In the second deployed configuration, the dissecting member includes a distal portion 28 that extends distally from the convergence point 22 and a proximal portion 26 that extends proximally from the convergence point 22. Convergence point 22 in this exemplary embodiment is at a point above the surface of the lens and within the circle defined by the capsulorhexis 10 at the top of the capsular bag 6. In some embodiments, the proximal portion 26 of the dissecting member 16 may include a small radius bend 24 as shown in fig. 1. A small radius bend 24 bends the second end 20 of the transversal element 16 in the proximal direction so that the second end 20 extends proximally from the convergence point 22. Alternatively, the transversal element 16 may follow a different trajectory in order to provide a transition to this trajectory without such a small radius of curvature. For example, trajectories that are outside the normal plane in FIG. 1, for example, curves or oscillating lines can be applied to reduce the overall bending radius of the proximal portion 26 of the transversal member 16. This may improve the ability of the transversal member 16 to reshape to other smaller compressed configurations, as described below.

[0082] The first end 18 and/or the second end 20 is pushed out of the lumen 14 of the shaft 12 while the other end is fixed relative to the shaft 12, as described above. Alternatively, both ends 18, 20 of the splitting element 16 are movable relative to the rod 12 and are movable relative to the lumen 14 of the rod 12. Alternatively, the rod 12 may be a sliding component, and the splitting element 16 remains stationary. When the end or ends 18, 20 (sometimes referred to as "legs") are pushed outward from the lumen 14, the transversal member 16 transitions into a second deployed configuration. As the transversal member 16 transitions, the small radius bend 24 allows the proximal section of the transversal member to extend proximally from the distal end of the stem 12 to a location away from and one lateral (i.e., displaced) from the longitudinal centerline of the lumen 12, toward capsular bag 6. In this way, the dissecting member 16 is able to extend downward towards the capsulorhexis 10 and expand in length within the capsular bag 6, which is larger than the diameter of the capsulorhexis 10, as seen in FIG. 1. In accordance with some embodiments, the small radius bend 24 causes the second end 20 to form an angle of at least 120 degrees with respect to the longitudinal centerline of the stem 12 and with respect to the distal direction, as seen in FIG. 1. Both the distal portion 28 and the proximal portion 26 of the transversal member 16 in the second deployed configuration are slightly curved and generally approach the size and shape of the sides of the capsular bag 6 to fit into the capsular bag 6 without causing damage (e.g., rupture or puncture of the capsular bag, excessive stretching of the capsular bag, or damage to the inner surface of the tissue of the capsular bag).

[0083] As also shown in FIG. 2, the shape of the transversal member 16 in the second deployed configuration forms a plane that is generally flat or horizontal with respect to the upper surface of the lens, in accordance with some embodiments. As also shown in FIG. 1 and 3, when properly oriented, the transversal element 16 is held so that it opens through the capsulorhexis 10 into the capsular bag 6. bag and crystal. The plane includes the longitudinal axis of the lumen 14 of the stem 12. Alternatively, the shape of the transversal member 16 in the second deployed configuration is also a three-dimensional shape that does not lie in a single plane. For example, the transversal element 16 may alternately fit in and out of the plane, or may bulge significantly out of the plane in one direction or the other. Rotation may be provided by manual rotation of the shaft 12 of the surgical device 40 by the user, or may be provided by mechanisms built into the surgical device 40, as described in more detail below. As also shown in FIG. 4, the transversal element 16 has traveled most of the way from the first retracted configuration to the second deployed configuration and is partially rotated relative to the lens 8. The transversal element 16 can be rotated so that the shape plane is generally vertical or at any of numerous other numerous angles. Mechanisms and methods for performing such a rotation are described in more detail below. In addition, it is possible to use several cutting elements 16, which rotate at many different angles. In other embodiments, rotation does not occur until the transversal member 16 transitions to the second deployed configuration. In accordance with some embodiments, the rotation begins at the time when the transversal element 16 moves into the second deployed configuration. For example, turning may begin after the loop opening 46 and within the transversal member 16 is expanded to a size where a 5-6 mm chord extends through the open area 46 between two points in the proximal portion 26 and the distal portion 28. In another example, the turn may begin when the chord is longer or shorter than 5-6 mm.

[0084] The second, deployed configuration of the transversal member 16 may have a generally ovular shape, as shown in FIG. 1, with a width of 7.0-15 mm and a height of 3.0-10 mm, in accordance with some embodiments. In accordance with other embodiments, the width of the transversal element 16 may be 4.0-20 mm, with a height of 1.0-15 mm. In some embodiments, the size of the second deployed configuration of the transversal element 16 may be intentionally smaller than the size of the lens in some places or throughout the profile. This may improve the ability of the transversal member 16 to remain close to the lens 8 and reduce interaction with the capsular bag 6. For example, the second, deployed configuration of the transversal member 16 may have a width of 12 and a height of 4.0 mm. This may allow clearance between the transversal member 16 and the lens 8 across the width of the oval while maintaining contact along the height of the oval, which may reduce the likelihood of injury to the posterior surface of the capsular bag 6. That is, by shaping the second deployed configuration of the transversing member 16 to engage the site lens 8, instead of moving to a position where it wraps around the thickest part of the lens 8, the transversal element 16 is reduced to a smaller size and engages a smaller portion of the capsular bag 6 than in a configuration in which the second, deployed configuration of the transversal element 16 is capable of encircle the thickest part of the lens 8. In other embodiments, the second, deployed configuration of the transversal element 16 is predefined to have, in general, a particular lumen around the lens 8. In accordance with some embodiments, the second, expanded configuration of the transversal element 16 and has a different shape than, in general, an oval.

[0085] The dissecting element 16 may have features or geometry that further prevents damage to the capsular bag by the element. For example, the dissecting member 16 is a round wire of sufficient diameter to reduce the chance of rupture or damage to the capsular bag 6, in accordance with some embodiments. The diameter of such a round wire may be 0.004-0.012 inches (0.1-0.3 mm), but may also be any other that prevents excessive stress when placed in the capsule bag 6, for example, a diameter of 0.001-0.030 inches (0.25 -076 mm). Alternatively, the profile of the transversal member 16 may be ovular with greater width or height, or may be a band to further distribute the force applied by the transversal member 16 to the capsular bag 6 over a larger surface area, which reduces or eliminates high pressure zones applied by the transversal element to the capsular bag 6.

[0086] In some embodiments, portions of the outer surface of the transversal member 16 may be coated to improve certain aspects of the device. For example, as described in more detail below, the transversal element 16 traverses the gap between the capsular bag 6 and the lens 8. As the transversal element 16 moves between these anatomical structures, it may be beneficial to have a more hydrophilic or hydrophobic surface so that the transversal element 16 rotates and moves more freely. . In one embodiment, the transversal element 16 may be coated with a hydrophobic material, such as a fluoropolymer; such as polytetrafluoroethylene (PTFE). The coating may be applied by dipping, by plasma vapor deposition, by heat-shrink wraps, or by any other suitable method. The coating may reduce friction between the transversal member 16 and the lens 8 and/or capsular bag 6 to allow the transversal member 16 to move more freely. Alternatively, the transversal member 16 may be coated with other materials, such as active pharmaceutical agents, that are intended to be released into the eye during the procedure. For example, a steroid such as triamcinolone can be applied to the surface of the transversal member 16 so that it is released into the eye during the procedure. Any number of other coatings and drugs may be considered.

[0087] The dissecting element 16 can be manufactured using any other suitable geometries or materials. In an exemplary embodiment, the dissecting element 16 is a round wire. The wire is configured to pass in a so-called blunt path between the lens 8 and the capsular bag 6. The wire may have different sizes or diameters along the length of the transversal element 16. Alternatively, the transversal element 16 may have any number of other profiles. For example, the transversal member 16 may be a tube, a narrow strip, a ribbon, a hex wire, or many other suitable shapes. In addition, the profile of the transversal element 16 may vary along its length. For example, the transversal element 16 may include one or more soft zones along its profile, in which damage to the capsular bag 4 is of particular concern. The soft zones can include various materials, such as, but not limited to, soft elastomeric materials such as silicone, which are bonded or coated to the corresponding zones of the transversal member 16. The soft zones can distribute force over a larger area and provide a softer and more atraumatic contact. with a capsular bag 6. In other embodiments, soft zones are changes in the geometric profile of the transversal element in some zones. For example, zones that are flattened or expanded, even if made of the same material, distribute the force over a larger area. In addition, the rigidity or flexibility of the transversal element can be changed along the transversal element 16 by changing the thickness of the material or the diameter of the wire in some areas. Alternatively, the dividing element 16 can be supplemented with bushings or other materials to locally increase the rigidity in some areas. In yet other embodiments, the transversal member 16 may have cutouts or ribs along its length that alter its flexibility or rigidity in certain areas.

[0088] In other embodiments, the shape of the splitter 16 in the second deployed configuration is not predetermined. Instead, the shape of the transversal element 16 in the second deployed configuration is determined by the material or geometry of the transversal element 16 engaged with the lens 8. The transversal element 16 may be sufficiently flexible, resilient, soft, or rounded along its length, while maintaining sufficient rigidity to allow rotation to engage the lens 8 so that a minimum force is exerted on the capsular bag 6 even when the dissecting member 16 is inside the capsular bag 4 and fully opened. In other embodiments, the transversal member 16 may be a soft elastomer, such as silicone, which may be soft enough and of a large enough diameter that the transversal member 16 does not exert excessive force on the capsular bag 6. In still other embodiments, the transversal member 16 may be sufficiently rounded along some portions and edges so that the force applied to the capsular bag 6 is distributed over a larger area and therefore the bursting pressure can be reduced. In still other embodiments, the transversal element 16 may consist of a combination of several elements, for example in a chain structure, which allows flexible movement between several elements. In still other embodiments, the transversal member 16 may have slits along portions of its length, which may locally increase its flexibility. For example, the divider 16 may include a tube with cuts along its length in areas where the capsular bag 6 may come into contact with the divider 16 so that said areas are more flexible and therefore less likely to be subjected to excessive force on the capsular bag 6 In still other embodiments, portions of the transversal member 16 in the second deployed configuration are not pre-shaped, and other portions of the transversal member 16 are pre-shaped. For example, the portion of the transversal element 16 in front of the lens may be made of a round wire with a shape memory and has a shape compressed to a predetermined shape, which facilitates the conduction of the transversal element 16 into the eye. For example, such a portion may include a small radius bend 24 of the proximal portion 26. The portion of the transversal element 16 behind the lens 8 may be made from a different, more flexible material that conforms more easily to the shape of the eye. Thus, the portion of the transversal element 16 in the second deployed configuration, which allows the insertion of the transversal element through the capsulorhexis and includes a small radius bend, is in front of the lens 8, and the portion of the transversal element 16 in the second deployed configuration, which contacts the capsular bag 6, consists made of a more flexible material, even less capable of damaging the capsular bag 6.

[0089] In accordance with some embodiments, additional guide tubes or components may align or guide the path of the transversal element 16 through the capsulorhexis 10 and/or around the lens 8. For example, in embodiments in which the transversal element 16 in the second deployed configuration does not have predetermined shape, along the areas of the distal section 28 or the proximal section 26 of the dissecting element 16 may be a guide element to limit it to a particular shape. The tube may extend from the convergence point 22 towards the distal portion 28, and the tube may concentrically define the flexible transversal member 16 so that it more or less follows the desired trajectory during insertion into the capsular bag 6 and placement around the lens 8. Then the guide tube can be retracted, leaving the flexible dissecting element 16 in place around the lens 8.

[0090] In yet other embodiments, the predetermined shape of the transversal member 16 in the second deployed configuration may be created during any part of the surgical procedure. For example, the surgeon may use imaging techniques to measure the anatomical features of the eye, such as the lens 8 or the capsular bag 6. In such a case, the surgeon may use this information to form or reshape the transcending element 16. Alternatively, to reshape the dissecting element 16, in the second deployed configuration, equipment such as a forming die or an automatic wire shaper can be used in combination with the measured data. In one embodiment, the surgeon uses an imaging tool, such as an optical computed tomography (OCT) scanner, to take a measurement of the lens 8, and this information is then fed into an automated wire shaper that forms a custom dissecting member 16 for the patient. In still other embodiments, the surgeon may add to or reshape the transversal element 16 while at least a portion of the transversal element 16 is within the eye. For example, the surgeon may begin placing the dissecting member 16 in the capsular bag 6 and determine that its shape can be improved. The surgeon may then insert a separate instrument, such as forceps, into the eye, or use the built-in instrument associated with the stem 12 to complement or reshape the dissecting member 16.

[0091] According to some embodiments, fluid is introduced between the capsular bag 6 and the lens 8 after the capsulorhexis 10 has been made so that a gap is created between the lens 8 and the capsular bag 6 in at least some areas. This can be called fluid separation or gap creation. In accordance with some embodiments, the fluid creates a gap in order to rotate the dissecting member 16 in a second deployed configuration within the capsular bag 6 and around the lens 8. In an exemplary embodiment, fluids such as viscoelastic hyaluronic acid or saline, since these materials are widely used during eye surgery, are well tolerated within the eye and readily available. One or more other or additional fluids may be administered, for example, colored fluids, steroid-type pharmaceutical fluids, medicated fluids, bioabsorbable fluids, lubricants, hydrogels, microspheres, powders, fluorescent contrast agents, liquid foams, or any other suitable fluids. In addition, one or more gases, such as air, oxygen, argon, ozone, or the like, can be introduced in addition or instead. Alternatively, in other embodiments, a fluid gap may not be required between the lens 8 and the capsular bag 6, and the dissecting member 16 may mechanically or bluntly separate the lens 8 and the capsular bag 6 as the member rotates around the lens 8. Fluid separation and blunt separation can be performed in combination with each other or separately. The fluid can be introduced by cannula or needle into the capsular bag 6 using a separate instrument. In accordance with other embodiments, the elements of the surgical device 40, for example, the dissecting element 16, may be integrated with means for separating the fluid. For example, the transversal element 16 may be made in the form of a flexible tube with a plurality of holes along its length, which allow the flow of fluid through them. In such an embodiment, fluid may be supplied into the lumen of the transversal member 16 and then flow out of the plurality of openings. This can improve the ability of the transversal element 16 to pass between the capsular bag 6 and the lens 8 because the fluid can be injected through the transversal element 16 continuously or at separate times when separation is required. In still other embodiments, fluid administration may be included in other aspects of surgical device 40. For example, fluid may be delivered through lumen 14 of stem 12. Alternatively, a component separate from stem 12, such as a telescopic tube or other tube to allow the introduction of fluid. In some embodiments, the fluid that is supplied through a component of the device, such as the shaft 12 or the dissecting element 16, can be used for other surgical purposes. For example, fluid may be infused through shaft 12 to support eye chamber 1 without the need for a separate cannula or the need for a viscoelastic agent. Irrigation and aspiration can be provided by a single component or by several separate components. For example, fluids such as saline may be infused into the eye through the lumen of the transversal 16 embodiment described above and aspirated through the lumen of the rod 12. Other irrigation or aspiration techniques may be performed in some embodiments.

[0092] FIG. 5, the dissecting member 16 is shown already fully extended into the second deployed configuration and rotated about the longitudinal axis of the shaft 12 and/or otherwise rotated or moved into some orientation within the capsular bag 6, in which the dissecting member 16 encloses the lens 8 without exerting excessive force on the capsular bag 6. After that, the dissecting element 16 is used to cut the lens 8 by pulling one or both ends 18, 20 of the dissecting element 16, for example, by pulling one or both ends 18, 20 through the lumen 14 of the rod 12. The dissecting element 16 can be moved otherwise in a manner opposite to that described above, to deploy the transversal element 16 from the first to the second configuration in order to compress and cut the lens 8. When the transversal element 16 is pulled, it exerts an inward force on the lens 8 and begins to cut and/or fragment it due to the force applied to lens 8 for a small p the area of the surface of the dissecting element 16 of small diameter. The dissecting element 16 continues to be pulled until the lens 8 is partially or completely dissected. In some embodiments, the implementation of the dissecting element 16 is pulled until the lens 8 is not dissected completely. In other embodiments, tension on the transversal element 16 only partially fragments the lens 8, and the remainder of the lens 8 can be fragmented by reuse of the transversal element or additional instruments. In FIG. 6 shows a fragmented lens 8 within the capsular bag 6. The plane of transection is generally vertical, but it should be understood that there are many possible angles and orientations for the trajectory of the transversing element 16. FIG. 7 shows the lens without the capsular bag.

[0093] In some embodiments, surgical device 40 may include multiple dissecting elements 16, as described below, to create multiple lens fragments at a time. For example, several dissecting elements 16 may form a mesh that is capable of cutting the lens 8 into a large number of fragments; while the cutting elements 16 can be at oblique or acute angles relative to each other in such a way that they form a cross pattern of the location. In other embodiments, the surgical device 40 may be used sequentially on the lens 8. For example, after making one cut, the lens 8 (or the cutter 16) can be rotated 90 degrees so that the plane of the first cut is then perpendicular to the plane of delivery of the device. The dissecting member 16 can then be reintroduced into the capsular bag 6 as described above and used to create a new cut through two lens fragments, resulting in a total of four fragments. The process can be repeated as many times as necessary to form any number of lens fragments of any desired size. The final required size of the lens fragments may depend on the method of extraction from the eye 1. In some embodiments, phacoemulsification may additionally be used in the capsular bag 6 to remove the lens fragments. This may be particularly useful in severe or nuclear cataracts where complete fragmentation of the lens increases surface area and reduces the size of the fragments that need to be emulsified by phacoemulsification. In other embodiments, the lens fragments can be removed as described below.

[0094] In some embodiments, the lens fragments can be expelled from the capsular bag 6 by introducing fluid into the capsular bag 6 under slight pressure. Fluid flow and/or pressure may move the lens fragments into the anterior chamber of the eye 1 so that other tools and methods can be used to remove the lens. For example, tweezers or a grasping tool can be used to grasp the lens fragments and pull them out of the eye 1 through the corneal incision 4. In some embodiments, the dissecting element 16 can be used to capture the lens fragments and pull them out of the eye 1. The dissecting element 16 can be returned into the second deployed configuration and placed around the lens fragment. The dissecting element 16 can then be pulled or otherwise closed until the lens 8 is secured within the dissecting element, but the lens fragment is not cut. The lens fragment can then be pulled by the dissecting element 16 from the eye 1. To ensure that the lens 8 is not cut by the dissecting element 16, additional components can be used, such as pads, tapes or strips with a larger surface area, which grasp but do not cut the lens fragment. . These components may continue from the rod 12 or may be separate components that are introduced into the eye 1 through the incision 4 and attached to the dissecting element 16.

[0095] As shown in FIG. 8-9, one embodiment of surgical device 40 includes two dissecting members 16 extending from the distal end of shaft 12 with a handle mechanism 42 attached to the proximal end of shaft 12. In FIG. 15 also shows two transverse members 16 in a first, retracted configuration at the distal end of shaft 12. Handle 42 includes two longitudinally movable sliders 44a, 44b that are connected to two transversal members 16 as described below. The sliders 44a, 44b are in their retracted proximal position in this initial configuration. The rod 12 and the dissecting elements 16 in a first retracted configuration are inserted through the incision 4 in the cornea 2 to the capsulorhexis 10 as described above. As used herein, the term "handle" includes both handles designed to be manually gripped and actuated by a surgeon and a robotic arm that is connected to a surgical robot and intended to be robotically controlled and actuated.

[0096] FIG. 16-17 also shows one embodiment of the handle 42 of the surgical device 40, shown in sectional view in a configuration corresponding to the first retracted configuration of the dissecting elements 16. The slider 44 is movable along the upper surface of the handle 42. The finger 48 extends from the slider 44 into the handle 42 through a groove in the upper surface of the handle 42. The pin 48 is connected to a helical cam 50 or other cam structure located proximal to the pin 48, which is longitudinally (i.e., without the possibility of longitudinal movement) fixed (a) to the finger 48, but can freely rotate about its own axis relative to the pin 48. This can be achieved mechanically, by means of a coupling pin, bushing or other suitable mechanism. A curved cam groove 52 is defined in the surface of the scroll cam 50. The scroll cam 50 is enclosed in a chamber within the handle 42 which allows the scroll cam 50 to move longitudinally, but essentially prevents radial movement. Anterior portion 56 extends distally from finger 48 and is rotatable relative to finger 48. Anterior portion 56 is preferably rotatably (i.e., non-rotatable) fixed to helical cam 50. In some embodiments, anterior portion 56 is simply the distal end of the helical cam. cam 50. Between the finger 48 and the anterior passage 60 of the handle 42 is a return spring 58, working to repel the finger 48 in the direction of the first retracted configuration. The proximal end of the return spring 58 may be centered on and engaged with the anterior portion 56. The proximal end of the first end 18 of the transversal member 16 may be fixed to the anterior portion 56 in any suitable manner, such as by screwing onto the anterior portion, by a friction fit, by welding, by soldering, or by an interference fit. Alternatively, the proximal end of the first end 18 may be locked to the pin 48. A cam pin 62 is formed in and/or fixed relative to the handle 42 and engages with the cam groove 52. When the scroll cam 50 moves relative to the rest of the handle 42, the cam pin 62 remains there on the handle 42. front portion 56, return spring 58, and connection to first end 18 of splitter 16) are used in a parallel arrangement within handle 42. Such assemblies may be identical to each other, may be side mirror images of each other, or may differ from each other in other ways that allow essentially the same node to control two separate transverse elements 16 in the manner described below. The description of the movement of the sliders 44a, 44b and the transverse elements 16 is the same for both sliders 44 and the transverse elements 16, unless otherwise indicated, and the descriptions of both are equivalent unless otherwise indicated.

[0097] FIG. 10 shows that one of the transversing elements 16 is moved into a second deployed configuration by sliding the corresponding slider 44b in the distal direction. One end 20 of the splitting element 16 can be attached to the rod 12, the handle 42 or other structure, fixed relative to the handle 42, and maintained in a fixed position while the first end 18 is made with the possibility of translational movement and rotation, when moving elements inside the handle 42. As discussed above, first end 18 is attached to front portion 56. As also shown in FIG. 18, as slider 44 moves distally, finger 48 compresses return spring 58, distally moves anterior portion 56, and distally pushes volute cam 50. Return spring 58 compresses and transmits proximal force to finger 48. If the user releases slider 44, then slider 44, finger 48 and the gears that are translationally (i.e., non-translatably) fixed to the pin 48 are pushed distally toward the home position of the slider 44. As the slider 44 extends distally, the scroll cam 50 translates within the handle 42. The cam groove 52 can be substantially longitudinal during this first segment of motion of the slider 44 such that engagement between the cam groove 52 and the cam pin 62 does not cause the helical cam 50 to rotate. relative to the longitudinal axis of the rod 12. When the slider 44 is extended distal, it distally pushes the first end 18 of the transversal element 16. As a result, the transversal element 16 changes shape to the second deployed configuration in the same manner as described above with respect to FIG. 1-4.

[0098] As also shown in FIG. 11, the slider 44 can be further extended distally after the transversal member 16 has reshaped to the second deployed configuration. The cam groove 52 is engaged with the cam pin 62 to rotate the scroll cam 50 as seen in FIG. 18-20. The amount of distal movement of the slider 44 controls the amount of rotation of the scroll cam 50. Thus, the linear movement of the slider 44 is converted into a rotational movement of the slicing member 16. 56 and hence the rotation of the transversal member 16 in the second deployed configuration. The cutting element 16 is rotated, and the plane defined by the shape of the cutting element 16 is rotated accordingly. 0-40 degrees from vertical orientation. During this rotation, the dissecting element 16 moves between the capsular bag 6 and the lens 8, engaging the lens 8 in the open area 46 within the perimeter of the dissecting element 16. The dissecting element 16 may not substantially engage the capsular bag 6 and/or the lens 8 or may be configured to engage either the lens 8 or the capsular bag 6. Alternatively, the dissecting member 16 may cause a blunt separation between the capsular bag 6 and the lens 8.

[0099] FIG. 20 also shows that the slider 44 has been fully moved forward and the rotation of the scroll cam 50 and the splitter 16 has been completed. The cutting member 16 encloses the lens 8 within the capsular bag 6 and is configured to apply an inward cutting force with respect to the lens 8 in the manner described above with respect to FIG. 4-5.

[0100] As also shown in FIG. 12-13, the second transversal member 16 can then be deployed into a second deployed configuration and rotated into position to enclose the lens 8 in the same manner as described above with respect to FIGS. 9-11 and 16-20. As shown also in FIG. 14, both transversal elements 16 engage the lens 8 so that when the transversal elements 16 are pulled or otherwise closed, the transversal elements 16 will cut the lens 8 into three partially or completely separate fragments. As shown also in FIG. 21, tension can be provided by proximal shifting of the sliders 44, thereby pulling the first end 18 of each transverse element 16 in the proximal direction and tensioning it. In some embodiments, the proximal force applied to the finger 48 by the return spring 58 may be large enough to cut the lens 8 without additional force being applied by the user. In other embodiments, the user provides additional force that fragments the lens 8. This may be necessary in particular for nuclear or severe cataracts. Each transversal element 16 engages the posterior surface of the lens 8 along a line spaced from the other transversal element 16 and engages the anterior surface of the lens 8 along substantially the same line, in accordance with some embodiments.

[0101] In FIG. 22, the slider 44 moves proximally to return to its original position. The cutting member 16 is rotated back to its original insertion plane and then retracted towards the stem 12. As also shown in FIG. 15, the transversing elements 16 may return to substantially their original configuration after the lens has been transected. The cam groove 52 of the helical cam 50 may be a closed loop as shown. Alternatively, the cam groove 52 may have a unidirectional path, with the slider 44 being translated fully distally and then proximally to move it to its original position. In some embodiments, unidirectional latches or levers may be incorporated into the cam groove 52 that block the rotation or movement of the helical cam 50 in certain directions, and which may be contained in particular positions of the cam groove 52 or along the entire cam groove 52.

[0102] In accordance with some embodiments, the transversal elements 16 can be configured to move synchronously, upon actuation of a single slider 44, instead of connecting each transversal element 16 to another slider 44a, 44b, as described above. In such a case, the dividing elements 16 can be configured to deploy, open and/or rotate at the same time. Alternatively, the rotation of the transversal elements 16 may be time-shifted such that one transversal element 16 opens first and rotates first, before the other transversal element 16. splitting element 16. In still other embodiments, the two sliders 44a, 44b can be configured such that the left slider 44b will move both sliders 44 forward, and the right slider 44a will move only the right slider 44a forward (or vice versa). The right slider 44a can be configured to move back both sliders 44a, 44b, and the left slider can only move the left slider 44b back. Thus, the user can decide whether to move the sliders 44a, 44b independently or synchronously.

[0103] In accordance with some elements, the dissecting elements 16 rotate in one direction. For example, the first dissecting element 16 opens and then rotates into the capsular bag 6 in a clockwise direction. Then the second dissecting element is opened and also rotated into the capsular bag 6 in a clockwise direction. In this embodiment, the first transversal element 16 may rotate to an angle 10-40 degrees beyond the vertical plane, and the second transversal element 16 may rotate to an angle 10-40 degrees below the vertical plane.

[0104] In still other embodiments, one or more additional or different mechanisms may be used to deploy the transversal members 16. For example, a scroll wheel or other pivot mechanism may be used to deploy one or both of the transversal members 16. In some embodiments, the movement made by the user corresponds to moving the splitting element 16 at a greater or lesser speed, so that the specified amount of movement of the interface components with the user moves the splitting element 16 by a greater or lesser amount due to the use of gears of different scale pulleys or any other number of components . In some embodiments, certain parts of the surgical device 40 may be mechanically driven by components such as electric motors, linear reluctance motors, pneumatic devices, hydraulic devices, magnets, or the like. The surgical device 40 may be included with one or more larger robotic assemblies. For example, a robotic device that is designed to perform a cataract procedure may include an embodiment of a surgical device 40. This may allow surgeons to perform portions of the described method with a robot. In some embodiments, this may include the possibility of alternative methods and methods, for example, the implementation of the approach to the capsular bag 4 through the sclera. In accordance with some embodiments, at least inserting a rod 12 having a through lumen 14 through the corneal incision 4 towards the capsulorhexis 10 and advancing the transcending element 16 from the distal end of the lumen 14 so that, as a result, the dissecting element 16 is bent away from axis of the rod 12 through the capsulorhexis 10 unfolded to a size exceeding the size of the capsulorhexis 10, and captured at least part of the lens 8, are performed with robotic control.

[0105] In some embodiments, the transversal element 16 does not have to approximate the loop initially when it is placed in the capsular bag 6. For example, the transversal element 16 may be a single piece of round wire that is fed into the capsule bag 6 from the rod 12, without bending back on itself to form a loop. In such an embodiment, the distal end of the transversal element 16 is blunt to prevent puncturing or tissue damage within the eye 1. The distal end of the transversal element 16 may be configured such that, upon approaching the wall of the capsular bag 6, it may flex with either a predetermined by a bend in its design, or by passing along the inner surface of the capsular bag 6. The dissecting element 16 can then cross the gap between the lens 8 and the capsular bag 6 in such a way that it passes around the circumference of the lens 8. The dissecting element 16 can then return back into the field of view of the user into the top portion of the capsular bag 6 where the user can grip the dissecting member 16 with elements on the handle 42, such as grips or a completely separate instrument. At this point, the dissecting member 16 encloses the lens 8 within the capsular bag 6 and approximates the loop. When one or both ends of the dissecting member 16 is pulled and/or pulled out, an inwardly directed cutting force is applied to the lens 8 such that it fragments. The transversal member 16 of this embodiment may have a cross-section that allows it to flex, preferably more easily in some directions than other directions, so that the transversal member 16 can flex as desired to pass around the lens 8, but nonetheless , follow a suitable trajectory around the lens 8 without leaving the trajectory into the tissue. This solution may include the use of a cross section with a preferred bending moment, such as an "I" profile, which bends preferably in some planes. As an alternative, a tube with cutouts capable of bending can be made to bend in certain planes by placing the cutouts in that plane. Therefore, the transversal member 16 can flex around the lens 8 in a generally distal-proximal manner. This may improve the ability of the transversal element 16 to follow the desired main path relative to the capsular bag 6 and the lens 8. In some embodiments, the transversal element 16 may be completely flexible so that its distal end is not limited to passing along any predetermined trajectory. The distal end may be configured to include a magnet or electromagnetic components that can be subjected to force by an external electromagnetic field. In such a case, an external device can be used to control the location of the distal end of the transversal element 16 so that it can be guided around the capsular bag 6 along the desired trajectory. In this embodiment, any number of different trajectories or fragmentation planes may be considered. The surgical device 40 may include various visualization means to create a desired trajectory for the distal end of the transversal element 16 that does not damage the capsular bag 6.

[0106] In some embodiments, the transversal element 16 may branch into multiple sections and/or multiple loops. For example, in the original configuration, the dividing element 16 may have such a shape or profile, as described above. However, when converted to a second deployed configuration, the transversal element 16 may branch along its length into two elements, which may have the same or similar shapes, or different shapes, each of which encloses the entire lens 8 or part of it. This may allow the dissecting element 16 to cut the lens 8 into several fragments without using two separate dissecting elements 16.

[0107] In some embodiments, one or both of the dissecting elements 16 may be configured to deliver one or more types of energy to promote blunt separation or fragmentation of the lens 8. For example, one or both of the dissecting elements 16 may include one or more areas configured to include one or more areas made with the possibility of heating through the use of a resistive electrical wire that heats up when a current passes through it. Elevated temperature can improve separation of the capsular bag 6 and lens 8, as well as help to cut the lens 8. Alternatively, any number of other methods can be used, such as radiofrequency ablation, electric cauterization, ultrasonic vibration energy, or the like.

[0108] The energy of ultraviolet (UV) radiation can kill cells, which may be one of the causes of secondary opacification of the capsule after primary cataract extraction. Irradiation of the capsule with UV energy while the lens is being separated from the lens capsule and dissected can reduce the rate of secondary secondary opacification. The energy of UV radiation can be supplied through one or more dissecting elements 16 of the device. In some embodiments, transversal member 16 may be a non-metallic filament that can be used to transmit UV radiation along transversal member 16. For example, transversal member 16 may be formed from a transparent, flexible polymer or other material that can transmit UV radiation. Thus, the transversal element 16 may act as a light guide for transmitting UV radiation energy during capture and transection of the lens 8. In other embodiments, the transversal elements 16 may be formed from metal, such as nitinol wire, and sheathed in a transparent polymeric material. , which can be used as a light guide to transmit UV energy through the shell to irradiate the capsule.

[0109] In some embodiments, the handle 42 may include fluid delivery elements. For example, as described above, the dividing element 16 or rod 12 may be capable of injecting fluids using appropriate components. The handle 42 may include passages and fluid paths that connect said components to external sources of fluid via tubing, integral connectors, or the like. Alternatively, handle 42 may include internal pressure injection systems that force fluid to flow over stem 12. Fluid may be stored in a cylinder with a piston, with the piston pushed forward by actuating components in handle 42. For example, a separate slider or the button may be connected to the piston and positioned such that when the engine is moved by the user, the piston translates and forces fluid from the cylinder into the injection system. This may allow the user to control the delivery of fluid through the dissecting member 16, shaft 12, or any other component of the component handle 42 at certain times during the procedure, such as creating a gap between the capsular bag 6 and the lens 8. Alternatively, the surgical device 40 may be arranged so that the fluid is automatically injected by the surgical device 40 during certain periods as part of the normal actuation of the device. For example, the spring may be configured to force the rod such that as the scroll cam 50 moves along its groove, the piston will displace some fluid.

[0110] In FIG. 23 is a side view of an alternative embodiment of the transversal elements 16. The two transversal elements 16 extend from the distal end of the shaft 12. In this embodiment, the transversal elements 16 are arranged to wrap around the lens 8 starting from the distal end 8a of the lens 8 rather than around the sides of lens 8 as described above. The dissecting elements 16 can be advanced one at a time from the distal end of the shaft 12 in a distal direction to the distal end 8a of the lens 8 and into the capsular bag. The dissecting member 16 may approximate a wire loop that is pre-shaped and curved to allow it to pass around the lens 8 without applying excessive force to the capsular bag. Such an implementation may include transverse bends, as well as forward and reverse curvatures, which form various three-dimensional geometries when the transversal element 16 is moved apart from the delivery device. To enter the capsular bag and capture the lens 8, the dissecting elements 16 are configured to form different shapes when they are deployed. Instead of being in a plane, these transversal elements 16 are folded down from the stem 12 in a second configuration, as seen in FIG. 23. When multiple transversal elements 16 are used, each can be configured to fold to a different angle than the other or other elements. One end of the splitter 16 can be pulled out while the other remains relatively fixed to the delivery device, or both ends can be pulled out simultaneously, as described above. As described above, the transversal element may have different profiles, materials, or flexibilities along its length.

[0111] One of the dissecting elements 16 can be extended to traverse the gap between the capsular bag and the lens 8 and then can be moved down and proximally around the lens 8. The second dissecting element 16 can be extended as shown, and any number of other dissecting elements 16 can be applied. In some embodiments, the forward retractable transversal element 16 can be used in combination with the side retractable transversal element 16 described above to create intersecting fragmentation planes such that the two transversal elements 16 can cut the lens into 4 separate fragments. In addition, the fragmentation planes may be at any number of angles relative to each other, and the slicing members 16 may extend around the lens 8 from any number of directions, such as in embodiments combining forward and sideward advance.

[0112] FIG. 24A-24E, FIGS. 25A-25C, FIG. 26A-26N, FIG. 27A-27C, FIG. 28A-28B, FIG. 29A-29B, FIG. 30A-30E, FIG. 31A-31F depict interrelated embodiments of a device 2440 for fragmenting the lens 8 within the capsular bag 6 and for removing the lens tissue from the eye 1. The same or similar reference numbers may refer to the same or similar designs. Aspects described with respect to the same or similar structures may be equally applicable to structures described elsewhere in this application. The features, aspects, and uses of each of the devices and methods described herein may equally apply to embodiments of the devices and methods described below.

[0113] As with the other embodiments described elsewhere in this application and shown in FIG. 24A-24E, the device 2440 may include a body 2442 having an anterior cone 2443. A distal shaft 2412 may extend from the body 2442 along the longitudinal axis of the device, with the shaft 2412 having a lumen and a distal end. The device may include a cutting element 2416 movable through the lumen of the shaft 2412. The cutting element and the shaft 2412 are configured to be inserted through the incision 4 in the cornea 2. For example, the distal shaft 2412 may have an outer diameter sized to extend through a self-sealing incision into cornea 2. The shaft 2412 may have an external diameter, configured to be inserted into the anterior chamber, which is from about 0.5 mm to about 2.5 mm. In some embodiments, the shaft 2412 may have a constant outer diameter along its length from the anterior cone 2443 to the distal end of the shaft 2412. The outer diameter of the shaft 2412 may also be a non-constant outer diameter along the length of the shaft. For example, in some embodiments, shaft 2412 may taper toward distal exit 2405 such that the outer diameter near the distal tip is smaller than the outer diameter near front cone 2443. In still other embodiments, shaft 2412 may have a beveled edge near the distal exit. 2405. A corrugated tube 2445 may be attached to the forward-facing, distal end of housing 2442 (see FIG. 24E). The corrugated tube 2445 may be cylindrical and enclose the proximal end of the distal shaft 2412 extending through the anterior cone 2443. The corrugated tube 2445 may be a relatively soft member. The distal end of the corrugated tube 2445 is configured to engage and seal with the outer surface of the eye surrounding the incision 4 after the rod 2412 has been inserted through the incision 4. The corrugated tube 2445 may provide a visual indication of the depth of penetration. The rod 2412 reaches the proper penetration depth after the distal end of the corrugated tube 2445 comes into contact with the outer surface of the eye. The corrugated tube 2445 can thus further prevent the rod 2412 from being inserted too deeply into the eye beyond a certain desired depth. In some embodiments, a plurality of grooves 2447 may be formed in the outer surface of the corrugated tube 2445 to give the tube an annular appearance. The grooves 2447 allow the corrugated tube 2445 to contract along the longitudinal axis when force is applied, and to expand along the longitudinal axis to elongate when the force is removed.

[0114] The cutting element of the device 2440 includes one or more dissecting elements 2416 that extend through the lumen of the distal shaft 2412. Each dissecting element 2416 may include a first end, a second end, and a distal loop formed between the first and second ends, as more described below. At least a portion of each transverse element 2416 may fit within a respective one or more secondary tubular elements or shells, or bushings 2415 (see Fig. 24E or 26A), which, in turn, fit into the lumen of the distal rod 2412. The cutting element is made with the ability to move from the first, retracted configuration towards the second deployed configuration, when actuating the actuator on the device 2440. In the second deployed configuration, the distal loop of each of the dissecting elements forms an enlarged open area. The enlarged open areas may be outside the distal end of the shaft 2412 and have a first leg extending distally from the distal end of the shaft and a second leg located proximal to the distal end of the shaft. The distal loops defining the enlarged open areas of each of the transversal elements 2416 may be aligned generally parallel to each other in a plane (eg, vertical plane) when the cutting element is in the second deployed configuration. The second actuation of the actuator or a second, different actuator may cause the distal loops, forming enlarged open areas of at least one or more dissecting elements, to make an angular movement relative to the plane, thereby transferring the cutting element to a third, deflected configuration. A second actuation of the actuator, or a second, different actuator, may cause the distal loops of the enlarged open areas of each transversal element to make an angular movement away from each other, for example, moving two transversal elements into a position at an angle to each other, which translates the cutting element into a third, rejected configuration.

[0115] The dissecting elements 2416 are configured to deploy within the eye so that loops or open areas increase at the distal end of the dissecting elements 2416 and reach a size to cover at least a portion of the lens 8 located inside the capsular bag 6. Opened areas, formed by the distal loops of the transversing members 2416 are deployable from a first, retracted insertion configuration (FIG. 24A) to a second deployed configuration (FIG. 24B) and a third, deflected configuration (FIG. 24C). When moving from a contracted position (FIG. 24A) to a relaxed form of a deployed position (FIG. 24B), each of the one or more transverse elements 2416 can form a distal loop having a relaxed (free) shape, which forms an open area 2446, given in the orientation , which maximizes the open area 2446. It should be understood that the use of the term "loop" in relation to the cutting end of the non-stressed, free-form dissecting elements 2416 does not limit the presence of a particular, for example, round shape at the open area 2446. The shape of the loop can be oval, elliptical, or another irregular shape, non-geometric shape. The loop does not need to be completely closed either.

[0116] The devices are described as being suitable for cutting the entire lens within the capsular bag, but may be used for other purposes without departing from various aspects of the devices and methods described. The dissecting elements described in this application can be located and continue between the capsular bag and the anterior side of the lens, due to the natural deployment of the loop towards the expanded form. When cutting the lens, the loops may continue around the posterior and anterior surfaces to form a complete section of the lens. The loops can also be moved between the posterior surface of the lens and the capsular bag to separate the lens from the capsular bag before cutting the lens into fragments. The devices described in this application are particularly useful for atraumatic pulling between the bag and the lens when the lens is still intact.

[0117] In an embodiment, the splitter 2416 may include three splitters 2416a, 2416b, 2416c, of which an intermediate loop or splitter 2416b is located generally between the first and second splitters 2416a, 2416c (see FIG. 24D ). The intermediate cleaver may likewise include a first end, a second end, and a distal loop formed between the first and second ends. When the cutting element is translated towards the second deployed configuration, the distal loop of the intermediate transversal element may form an enlarged opening located outside the distal end of the shaft 2412. The enlarged opening may have a first leg extended distally relative to the distal end of the shaft and a second leg located proximally. relative to the distal end of the rod. In this embodiment, the transverse members 2416a, 2416b, 2416c are deployable from a first, retracted configuration (FIG. 24A) to a second deployed configuration (FIG. 24B) and a third, deflected configuration (FIG. 24C). The enlarged open areas of each of the first, second and intermediate dividing elements may be aligned generally parallel to each other in a plane while in the second deployed configuration. In a third, deviated configuration, the outer two transverse elements 2416a, 2416c can be moved at an angle from the intermediate transversal element 2416b. A second actuation of the actuator, or a second, different actuator, may cause the enlarged open areas of both the first and second transverse elements to make an angular movement away from the intermediate transversal element, which brings the cutting element into a third, deflected configuration. The splitting elements 2416a, 2416b, 2416c can be driven to move from the contracted position to the relaxed form of the deflected position, for example, by means of a slider 2444 or other actuator located on the housing 2442. The splitting elements 2416a, 2416b, 2416c can also be driven to moving towards a third, rejected configuration via a slider 2444 and/or other actuator located on the body 2442. As described in more detail below, the device 2440 may include a two-phase deployment, during which the deployment of the loops into the second deployed configuration can be performed independently of deflection to a third, rejected configuration.

[0118] As described elsewhere in this application, the dissecting elements 2416 may be formed from a superelastic metal and/or polymer material. Housing 2442 device 2440 may be formed from relatively rigid(their), lightweight(s) material(s). The stem 2412 connected to the distal end region of the housing 2442 may have a lumen extending through it to the distal outlet 2405. The stem 2412 may have an oval cross-section with a rounded tip. The oval cross section improves the possibility of inserting the rod 2412 into the eye 1 through the corneal incision 4. The oval cross section also allows for a plurality of dissecting elements 2416a, 2416b, 2416c to be parallel within the lumen. Alternatively, the stem 2412 may have a circular cross section or any other suitable cross section shape.

[0119] The distal end of the transversal elements 2416 may extend out of the lumen outlet 2405 while in a first, retracted configuration (see FIG. 24A). In such embodiments, the small radius bend 24 may be located outside the shaft 2412, already bent at least partially in the proximal direction (see Fig. 24B). Thus, even in embodiments in which the transversal member 2416 is made from a superelastic material, the angle at which the portion of the transversal member 2416 flexes during transition from the first retracted configuration to the second deployed configuration is reduced. In addition, within the lumen of the stem 2412, holding a portion of the splitter 2416 may require less space than holding it in its entirety, allowing the stem 2412 to be made smaller in diameter. Alternatively, the dissecting members 2416 may be entirely within the lumen of the shaft 2412 in a first, retracted configuration. The distal end of the transversal member 2416, whether inside or outside the lumen in the first retracted configuration, is sized and shaped to pass through a pure corneal incision 4 without damaging the eye 1. In general, pure corneal incisions 4 are smaller than about 3 .5 mm, although this size may vary. The maximum outer diameter of the distal end region of the shaft 2412, including the dissecting elements 2416 in the first retracted configuration, may be less than about 3.5 mm, so that they can be inserted through a purely corneal incision, for example, with a size of approximately 1.5mm to 3.5mm.

[0120] As described elsewhere in this application, and as shown in FIG. 26A, each of the transverse members 2416 may include a first end 2418 and a second end 2420, at least one of which is movable relative to the stem 2412. 2412 and the other end (e.g., second end 2420) of the transverse elements 2416 may be movable relative to the shaft 2412. side of the second deployed configuration. When the movable end is retracted proximally, if possible, the transversal elements 2416 are translated from the second deployed configuration to the first retracted configuration. It should be understood that both ends 2418, 2420 may be movable relative to the rod 2412, as described elsewhere in this application, and as described in more detail below. The terms "first", "second" or "third" as used are not intended to be limiting and may be used interchangeably in this application unless expressly stated otherwise.

[0121] The dissecting elements 2416, upon extension from the lumen of the shaft 2412, may have a distal end region or a distal loop that approximately corresponds to the open area or forms it, in general, in the form of an irregularly shaped loop having a cross section of the natural lens 8. This allows an increased open areas 2446 of the dissecting elements 2416 surround the lens 8 within the capsular bag 6. When the end or ends 2418, 2420 are pushed distally out of the lumen, the dissecting elements 2416 transition to a second deployed configuration. As the transverse members 2416 exit the shaft 2412, a small radius bend 24 allows the proximal section of the transversal members 2416 to extend proximally from the distal end of the shaft 2412 to a location spaced from and one lateral side of the longitudinal centerline of the lumen 2412 (i.e., longitudinal axis A device 2440), towards the capsular bag 6. Thus, the transversal elements 2416 are able to extend downward through the capsulorhexis 10 and stretch in length within the capsular bag 6, which is greater than the diameter of the capsulorhexis 10. retracted configuration towards a second deployed configuration in which a larger portion of each transverse element 2416 is extended from the distal end of the lumen 2450. At least portions of the transversal elements 2416 are located within the lumen when in the first, retracted configuration. It should be understood that some of the transversal elements 2416 may extend outside the lumen, but that the transversal elements 2416 and shaft 2412 are still sized for insertion into the anterior chamber of the eye through a small corneal incision (eg, a pure corneal incision). Movement from the first retracted configuration towards the second deployed configuration may cause at least one of the ends 2418, 2420 to extend distally relative to the distal end of the rod 2412 to form an open region 2446, with the open regions 2446 delimited by their respective transverse members 2416 and the distal end 2405 of the shaft 2412. At least a portion of the transverse elements 2416 that define the open area 2446 extends proximally relative to the distal end 2405 of the shaft 2412. capsular bag 6 and the lens 8 of the eye while the lens remains in the capsular bag 6 to capture a portion of the lens 8 within the open area 2446. As the dissecting elements 2416 continue to deploy, the plane formed by the dissecting elements 2416 but rotated so that the dissecting members intersect the gap between the capsular bag 6 and the lens 8. The mold plane can be rotated to a generally vertical position or any number of other angles relative to the vertical. Rotation can be performed by the user by manually rotating the shaft 2412 of the surgical device 2440. Rotation can be performed by mechanisms built into the surgical device 2440, as described elsewhere in this application.

[0122] As mentioned above, the device 2440 includes an actuator for tensioning the dissecting elements 2416 to reduce the size of the disclosed regions 2446 and cut the lens 8. The actuator may be a slider 2444 movable relative to the housing 2442, for example, along the longitudinal axis of the housing. The slider 2444 is movable on the top surface of the housing 2442. It should be understood that the use of the term "slider" is not intended to be limiting, and other actuator configurations are contemplated throughout this application. For example, the actuating mechanism may be a button, switch, knob, or other interface. As best shown in FIG. 26A-26C, the slider 2444 may be operatively connected to a mobile assembly 2472 located within the interior of the housing 2442 via one or more pins 2448 that extend upward through a slot 2474 in the upper surface of the housing 2442. The pin(s) 2448 may be connected to the bottom the surface of the slider 2444. The slider 2444 and the movable assembly 2472 are movable within the interior of the housing 2442 along the longitudinal axis A of the housing 2442. As shown in FIG. 26A, a plurality of loop holders 2476 may be attached to the mobile assembly 2472, which includes a lead 2482 and a proximal pin 2478. The lead 2482 may extend outwardly from the proximal pin 2478. The proximal pin 2478 may be generally cylindrical and configured to be received through a respective channel 2480 of the slide assembly 2472 (see FIG. 26B), and pivotable about its respective axis of rotation internally. channel 2480.

[0123] As mentioned, the proximal pin 2478 is rotatable about its respective axis of rotation within its respective channel 2480. The movable assembly 2472 may be connected to first and second loop holders 2476a, 2476c located on each side of the longitudinal axis A of the device 2440 ( see Fig. 26C-26E). The rotation of the hinge holders 2476a, 2476c about their respective axes R ₁ , R ₂ of rotation and hence the rotational movement of the arms 2482a, 2482c may be a mirror image. Fig. 26D shows the hinge holders 2476a, 2476c prior to deflection. The arms 2482a, 2482c of the hinge holders 2476a, 2476c are arranged in a substantially vertical position such that they are substantially parallel to each other. During deflection, the hinge holder 2476a located on one side of the longitudinal axis A rotates in the first direction about its rotation axis R ₁ (for example, clockwise), and the hinge holder 2476c located on the opposite side of the longitudinal axis A rotates in the second direction about its axis R ₂ of rotation (for example, counterclockwise). The tabs 2482a, 2482c swing outward from a substantially vertical home position (eg, orthogonal to longitudinal axis A) to a substantially non-vertical position. The amount of rotation achieved by each of the fingers 2482a, 2482c may vary, but typically ranges from about 15 degrees to about 45 degrees relative to the vertical home position.

[0124] Rotation of the hinge holders 2476 causes a corresponding rotation of the distal hinges forming the enlarged open areas 2446 of the transversal elements 2416, and thereby brings the cutting element into a deflected configuration. The deflected cutting element configuration may vary. As described herein, the distal loops forming the enlarged open areas can move in an angular direction away from each other, placing the cutting element in a deflected configuration, with the angular movement occurring relative to the plane of the longitudinal axis of the device (or the longitudinal axis of the rod or the longitudinal axis of the lumen, through which the cutting element continues). When the cutting element is in a deployed configuration such that the open regions formed by the distal loops are expanded or otherwise enlarged from their original insertion configuration (commonly referred to as the retracted configuration), the distal loops forming the open regions may be substantially parallel to each other. in a plane, for example, a vertical plane, relative to the longitudinal axis of the rod. It should be understood that when the distal loops and their enlarged open areas are generally aligned with the plane parallel to each other, one or more portions of such a distal loop may extend outward from the plane. This means that the enlarged open areas formed by the distal loops may take on a shape that is not planar (see, for example, the transversal element 16 shown in Fig. 2), but the enlarged open areas of the dissecting elements may be located essentially parallel to each other. to each other and substantially in a plane with respect to the device while in the second deployed configuration. It should also be understood that the enlarged open areas need not be fully enlarged in order to be deflected relative to each other. Thus, when a second, deployed configuration is referred to herein, the distal loops do not need to be deployed to their maximum deployed configuration. The second, deployed configuration may include an enlarged configuration in which the enlarged open areas formed by the distal loops are deployed less than the maximum deployment before they are deflected relative to each other. Fig. 24B shows transverse elements 2416 having enlarged open areas 2446 that have already been deployed in generally two directions (i.e., along the X and Y axes) and have not yet been deflected so that they are still generally pressed against each other. friend (i.e. along the Z axis). Fig. 24C shows the transverse elements 2416 in a deviated configuration in which one or more of the distal loops defining the enlarged open areas are moved angularly away from each other (eg, along the z-axis). In some embodiments, the cutting element comprises two transversal elements, and the distal loops forming the enlarged open areas of the two transversal elements deviate a distance in the Z-axis direction. shaft 2412 lumen axis) may remain generally pressed against the adjacent distal loop, while another portion of the enlarged open area (i.e., the portion below the longitudinal axis of the shaft 2412 lumen) may be deviated from the adjacent distal loop. This section of the hinge, which is rotated and thus deflected, can be angled relative to the plane of the longitudinal axis of the rod. The angle may vary, for example, from about 15 degrees relative to the plane to about 45 degrees relative to the plane.

[0125] One or more transverse elements 2416 may have a fixed first end 2418 and a movable second end 2420. deployed configuration (see FIGS. 26B-26C). The movable second ends 2420a, 2420c of the two outer dividers 2416a, 2416c are further capable of angular movement about longitudinal axis A. The second end 2420b of the intermediate divider 2416b (shown in FIG. direction relative to the longitudinal axis A. For example, the fixed first end 2418a of the first transverse element 2416a can be fixed so that it remains stationary during actuation, and the movable second end 2420a of the first transverse element 2416a can be configured to move relative to the longitudinal axis A device 2440 along at least two planes. Similarly, the fixed first end 2418c of the second transverse element 2416c can be fixed can be fixed so that it remains stationary during actuation, and the movable second end 2420c of the second transverse element 2416c can be configured to move relative to the longitudinal axis A of the device 2440 along at least two planes. The fixed first end 2418b of the intermediate splitter 2416b can be fixed so that it remains stationary during actuation, and the movable second end 2420b of the intermediate splitter 2416b can be configured to move about the longitudinal axis A of the device 2440. However, the intermediate splitter 2416b may be movable along a single plane and may not be capable of rotational or angular movement about the longitudinal axis A. Essentially, all three transversal elements 2416a, 2416b, 2416c can be configured to deploy when the engine 2444 is actuated , for example, by moving their respective movable second ends 2420a, 2420b, 2420c along the longitudinal axis A of the device 2440. relative to the longitudinal axis A. The movable second end 2420b of the intermediate transversal member 2416b can be fixed so that it does not move. It should be understood that the relative deflecting movements of the plurality of transverse elements 2416 may vary, and this case is an example of how deflection may occur. Each of the plurality of dividing elements 2416 may have an end capable of translational movement along the longitudinal axis A of the device, as well as rotational and/or angular movements relative to the longitudinal axis A.

[0126] As shown in FIG. 26B-26E, rotational movement of the hinge holders 2476 about their respective axes of rotation R ₁ , R ₂ provides a rotational angular displacement that forces the outer transverse members 2416a, 2416c to deviate from the intermediate transversal member 2416b. One or more dissecting elements may not be represented in the figures for clarity. In an embodiment, the fixed first ends 2418a, 2418b, 2418c of each of the three dividers 2416a, 2416b, 2416c may be attached to an area of the body 2442 or other fixed component of the device 2440. The movable second ends 2420a, 2420c of the outer two dividers 2416a, 2416c may be attached to the distally facing surfaces of their respective loop holders 2476. For example, the first of the loop holders, 2476a, may be connected to the movable second end 2420a of the first transversal element 2416a, and the second loop holder 2476c may be connected to the movable second end 2420c of the second transversal element 2416c (see Fig. 26C). When the hinge holders 2476a, 2476c rotate about their rotation axes R ₁ , R ₂ , the ends 2420a, 2420c translate with them about the rotation axes R ₁ , R ₂ towards the third, deflected configuration. Fig. 26C depicts a third, deflected configuration in which the first loop holder 2476a is rotated clockwise (arrow C) such that the lead 2482a leans to the left of vertical and the second loop holder 2476c is rotated counterclockwise (arrow CC) such that that the 2482c branch deviates to the right from the vertical. The movable ends 2420a, 2420c of the splitters 2416a, 2416c move with the hinge holders 2476a, 2476c in the direction of the longitudinal axis A of the device 2440, causing the loops to diverge outward from the longitudinal axis A. The movable second end 2420b of the intermediate splitter 2416b (not shown in FIG. 26C) ) can be attached to the movable assembly 2472 in such a way that movements of the hinge holders 2476 do not affect its position relative to the longitudinal axis A.

[0127] In some embodiments, the device 2440 may further include a thin-walled sleeve 2415 of small diameter that is movable about the longitudinal axis of the device (see FIG. 24E). At least a portion of the plurality of transversal elements 2416 may extend through the sleeve 2415. When the sleeve 2415 is extended distally along the greater length of the transversal elements 2416, the sleeve 2415 prevents the transversal elements 2416 from deviating from each other and/or from the longitudinal axis A of the device 2440, even when they are loops unfolded. When the sleeve 2415 is retracted towards the proximal end of the device 2440, the transversing elements 2416 are free to deflect. The withdrawal of the sleeve 2415 can be performed manually by the user. Alternatively, retraction of the sleeve 2415 may occur automatically during the deployment phases of the transversal elements 2416. The transversal elements 2416 are configured to deploy from a first retracted configuration to a second deployed configuration. Sleeve 2415 may be positioned around a length of the dividers 2416 in a manner that allows their respective loops to reach an enlarged state, but prevents deflection or angular movement of the dividers 2416 relative to the longitudinal axis. Driving the transversal elements 2416 from the second, deployed configuration towards the third, deviated configuration may also retract the sleeve 2415. The retraction of the sleeve 2415 may occur in stages (retraction, then deflection) in such a way that the transversal elements 2416 can be deflected relative to the longitudinal axis. Each transversal element 2416 may be rigidly attached to its respective sleeve 2415. In the case where the device includes a single transversal element 2416, then there may be a single sleeve 2415. In the case where the device includes two transversal elements 2416, there may be two bushings 2415, one for each transverse element 2416, and so on. Each sleeve 2415 allows longitudinal, lateral, and rotational movement of its transversal member 2416. Longitudinal movement allows the distal loops to extend and deploy beyond the distal opening 2405 of the stem 2412. Lateral and rotational movement allows the distal loops to deviate or fan out. Sleeves 2415 for each splitter 2416 help prevent "twisting" of the wires when the splitters 2416 are manipulated and provide sufficient torsional rigidity to pull and deflect.

[0128] The taps 2482 of the hinge holders 2476 can be pressed into a deflected configuration by a wedge 2490 located on the movable wedge assembly 2492. The wedge 2490 may be located in the distal end region of the housing and have an inclined surface 2494 facing the proximal end of the device 2440. Movement of the arms 2482 towards the wedge 2490 causes the arms 2482 to expand apart and lean outward (see FIGS. 26D-26F). As described above, the hinge holders 2476 may be attached to a movable assembly 2472, which may be slid along the longitudinal axis A of the device 2440 by means of a slider 2444. Distal movement of the movable assembly 2472 may cause the arms 2482 of the hinge holders 2476 to abut the wedge 2490 and slide along sloped surfaces. 2494. The arms 2482 can rotate about their respective axes of rotation such that they skew away from each other as they slide along the sloped surface 2494 in a distal direction towards the thicker portion of the wedge 2490. In some embodiments, the wedge 2490 is proximal movable. direction and can move close to the mobile node 2472 to deflect the branches 2482 holders 2476 loops.

[0129] The deployment may be a phased deployment, including a deployment step followed by a rejection step. The deployment may also be a staged deployment, including a deploy phase followed by a pivot phase followed by a deflection phase. If the device includes a retractable collar 2415 that controls deflection of the transversal elements, then the staged placement may further include a retraction of the collar prior to or combined with a deflection stage. Sliding movement of the slider 2444 relative to the housing 2442 moves the movable assembly 2472 a first distance to allow the loops to be deployed from the first retracted configuration towards the second, deployed configuration. Sliding movement of the slider 2444 relative to the body 2442 moves the movable assembly 2472 a second distance beyond the first distance to allow loop deflection (ie, a third, deflected configuration). The rotation of the deployed hinges is described elsewhere in this application as being performed by a mechanical element within the device itself, or may be performed by the user.

[0130] The deflection mechanism may further include an element configured to provide feedback to the user as to where the slider 2444 is located in the first placement phase. For example, as best shown in FIG. 26M and 26N, the user feedback element 2493 may be a deflection detent spring configured to contact the loop holders 2476 just before the fingers 2482 begin to deflect. The user feedback element 2493 may be attached near the distal end region of the body 2442, somewhat proximal to the sloped surface 2494 facing towards the proximal end of the device 2440. The user feedback element 2493 may include two springs 2491 biased towards the central lines of the sliding wedge assembly 2492, with the distal ends of the springs 2491 located somewhat proximal to the inclined surface 2494 of the wedge 2490. The distal ends of the springs 2491 may be spaced closer together than the proximal ends of the springs 2491 such that the springs 2491 fold away from the centerline of the wedge slide assembly 2492 and away from each other as the arms 2482 have passed distally therebetween. Each spring 2491 may include a locking recess 2501 near the inner surface of their distal end region. The locking recess 2501 forms a concavity sized and shaped to accommodate the outer diameter of its respective elbow 2482. Upon reaching the location of the locking recess 2501, the arms 2482 snap into their locking recesses 2501, which provides tactile and/or audible feedback that indicates to the user that the leads 2482 will soon come into contact with the ramps 2494 of the wedge 2490 if the slider 2444 is moved further distally. Upon further distal extension of the slider 2444, the legs 2482 extend beyond the locking recesses 2501 of the springs 2491 and abut against the proximally facing sloped surfaces 2494 of the wedge 2490 to initiate their rotation.

[0131] In some configurations, an initial, extended distally directional movement of the slider 2444 provides a second, deployed configuration and a final, short, distally directional movement of the slider 2444 furthermore provides a third, deflected configuration. This staggered placement can deploy the loops on first actuation (i.e., moving the slider 2444 a first distance), and can deflect the loops, on a second actuation (i.e., moving the slider 2444 a second distance greater than the first distance) . In some configurations, a third, deflected configuration is provided by moving the wedge 2490 proximally in the direction of the arms 2482. In this configuration, relative to the position of the sliding slider assembly 2472 and hence the arms 2482 of the hinge holders 2476 can remain fixed along the longitudinal axis A, and the wedge 2490 on the movable node 2492, the wedge can move in the proximal direction to the elbows 2482. For example, loops or open areas 2446 can be deployed upon first actuation (i.e., sliding the slider 2444 a first distance in the distal direction), and loops or open areas 2446 may deviate on second actuation (ie, moving wedge 2490 proximally). It should be understood that the second actuation may be performed using the engine 2444 or an actuator independent of the engine 2444, as described in more detail below. This allows a rejected configuration to be achieved despite full deployment of the loops, while still providing a two-stage, two-phase placement. As such, even when the deployment size is limited to a size smaller than the maximum deployment, the individual loops of the cleaving elements 2416 may still deviate from each other. Thus, the distal loops of the dissecting elements are configured to deviate in an angular direction from each other, with the translation of the cutting element into a third, deviated configuration, regardless of the size of the enlarged open areas.

[0132] The device 2440 allows the user to fully control and select at what point during the extension of the wires, the loops will begin to separate in the angular direction from each other. As described elsewhere in this application, the second, deployed configuration of the transversal elements 2416 may be generally oval in shape with a maximum width of about 4.0 mm to about 20 mm and a height of about 1.0 mm to about 15 mm. In some embodiments, the second, deployed configuration of the transversal elements 2416 may be manually adjustable by the user such that the size of the disclosed region 2446 that can be achieved after full placement is less than the maximum size of the disclosed region 2446 when the transversal element 2416 is not limited. The second, deployed configuration of the dissecting elements 2416 can be limited to an intentionally smaller size than the lens 8 in some areas or along the entire profile. This can improve the ability of the transversing elements 2416 to remain close to the lens 8 and reduce interaction with the capsular bag 6. Limiting the size of the open area 2446 of the transversing elements 2416 to a size that is smaller than the maximum dimension also allows the transversing elements 2416 to be used as tissue manipulators to capture small fragments of the lens material and remove them from the capsular bag. This may eliminate the need for a second removal device.

[0133] The maximum size of the open area 2446 achievable by the splitting elements 2416, when the slider 2444 is actuated and before deflection, can be manually adjusted by the user. Fig. 26G-26L depict a deployment adjustment mechanism including a knob 2470 located on a housing 2442. In some embodiments, knob 2470 may be a rotary knob, button, switch, slider, or other element configured to be actuated by a user. It should be understood that the use of the terms "head" or "slider" is not intended to be limiting, and that, in this application, any of a variety of user input devices that can be actuated by the user to provide extension and/or deflection of the dissecting elements 2416 are considered possible. The size of the enlarged open areas of the dividing elements before deflection can be user selectable, for example, by using a regulator configured to change the relative distance between the wedge and the movable assembly. A smaller relative distance between the wedge and the movable assembly may result in a smaller open area of the dividing elements, when forced into a second deployed configuration prior to deflection, and a larger relative distance between the wedge and the movable assembly may result in a larger open area. dissecting elements, with a forced transfer to the second deployed configuration before deflection.

[0134] In an embodiment, the controller 2470 is pivotally connected to the proximal end of the cam 2495 such that turning the controller 2470 causes the cam 2495 to rotate. The regulator 2470 may be coupled directly to the proximal end of the cam 2495 or to a locating pin 2499 extending through the cam 2495 (see FIG. 26J). The proximal end of the cam 2495 may include a mechanism that provides incremental rotation with a sequence of tactile or audible clicks providing feedback to the user to perform some degree of rotation. In some embodiments, the mechanism may include a plurality of locking recesses 2484 located near the proximal end of the cam 2495 and configured to interact with a spring 2486, such as a flat spring. The spring 2486 may have an end configured to flex upward from the longitudinal axis so that it slides over the proximal end of the rotating cam 2495 and flex downward to insert into each locking recess 2484. The spring 2486 may provide a locking force when the user turns the threads. The cam 2495 may have a cam helical groove 2496 on the outer surface that is configured to engage a cam pin 2497 located at the proximal end of the sliding wedge assembly 2492. When the adjuster 2470 is rotated in the first direction, the cam pin 2497 of the wedge slider 2492 moves along the cam helical groove 2496 around the cam 2495, thereby shifting the wedge slider 2492 along the longitudinal axis A of the device 2440. The wedge 2490 at the distal end of the wedge slider 2492 moves toward the proximal end of the device 2440. When the wedge 2490 is retracted to a more proximal location along the longitudinal axis A of the device, the hinges or open areas 2446 of the dissecting elements 2416 will deviate earlier during the deployment stroke. This means that the open area 2446 of the respective transverse elements 2416 will be smaller during deflection. The opposite movement may occur when the knob 2470 is rotated in the second, opposite direction. The wedge 2490 can be extended to a more distal location along the longitudinal axis A of the device such that the cleaver loops 2416 will deflect later during the deployment stroke, resulting in a larger open area 2446 during deflection. The slider movable assembly 2472 may further include a deployment stop 2498 configured to abut against the wedge 2490, thereby preventing additional relative shift between the movable assembly 2472 and the wedge 2490 (see FIG. 26K). Thus, the position of the wedge 2490 may ultimately limit the total deployment achieved due to the impossibility of moving past the deployment stop 2498.

[0135] As described above, one or more retractable bushings 2415 (see FIG. 24E) can be included in the design, which support the transverse members 2416 in such a limited configuration that they do not deviate from the longitudinal axis of the device until the user wishes, for a deviation to occur. The retractable sleeve 2415 can be rigidly connected to each dissecting element 2416, as described elsewhere in this application, and facilitate the longitudinal and rotational movement of the elements 2416. The retractable sleeve 2415 thus prevents multiple wires from creating unnecessary stretching of the lens during positioning. The retractable sleeve 2415 may be used in conjunction with a separate expansion member (eg wedge 2490) to allow adjustment of the amount of deflection as detailed above. Alternatively, the retractable sleeve 2415 may be used in conjunction with a plurality of transverse elements 2416 that are pre-shaped to deflect when the sleeve 2415 is retracted and released from the restraining force. In this embodiment, no separate expansion element (eg wedge 2490) is included in the design. Each of the plurality of dividing elements 2416 may be preformed into a third, deflected configuration. During the deployment of the loops towards the second, deployed configuration, the sleeve 2415 may be positioned in a distally extended position to keep the plurality of transversal members 2416 constrained towards the longitudinal axis A of the device. The sleeve 2415 can then be retracted to allow the plurality of transverse members 2416 to automatically deflect towards a relaxed deflected configuration.

[0136] As described elsewhere in this application, the dissecting elements 2416 may be a wire having a circular or oval cross section. For example, the device may include a plurality of transverse elements 2416 formed from three separate wires (eg, 0.006 inch (0.15 mm) nitinol wire). The severing elements 2416 may also be a tape or a long narrow sheet of material. For example, the device may include a plurality of dividing elements 2416 formed from a narrow strip 2905 of material (see FIGS. 33A-33C). In the embodiment shown in FIG. 33A, the distal end region of the narrow strip 2905 may have a plurality of compressed elements 2910 formed therein, each of which is shaped to form a cutting loop when in the free state, as described elsewhere in this application. The proximal end region of the narrow band 2905 may remain as a single narrow band of material. In another embodiment shown in FIG. 33B-33C, a plurality of compressed elements 2910 may be formed in the middle region of the narrow band 2905 such that both the proximal end region and the distal end region are flat, adjacent narrow bands of material interspersed with compressed elements 2810 extending therebetween. The narrow strip of material partially eliminates the entanglement of individual wires during placement moves. The narrow band 2905 may be formed from nitinol or other biocompatible shape memory material. In the embodiment shown in FIG. 33A-33C, the narrow strip 2905 has two notches 2915 creating three compressed members 2910. The narrow strip 2905 is about 0.006 inches (0.15 mm) thick and may be about 0.022 inches (0.56 mm) wide. The narrow strip 2905 may be laser cut to form two notches 2915 resulting in three compressed elements 2910. inches (0.15 mm). The three compressed elements 2910 can then be electropolished to remove corners, converting the shape of the compressed elements 2910 into a plurality of dissecting elements 2416. 0.006 inch (0.15 mm) 2416 transversal elements that nearly match 0.006 inch (0.15 mm) diameter nitinol wire. It should be understood that the number of compressed elements 2910 created may vary, as well as their sizes, depending on the number of dissecting elements 2416 required for the device. For example, the width of the narrow strip 2905 may depend on the number of transverse elements 2416 to be formed. In some embodiments, the narrow strip 2905 may be converted into two, three, four or more compressed elements 2910. It should also be understood that the width and thickness of the narrow strip 2905 may, but need not, be constant and may vary along their length.

[0137] Again, as shown in FIG. 25A-25C, as well as in FIG. 26A-26D, after the transverse elements 2416 have been advanced into a second, deployed configuration (which, as described above, may have a fully deployed maximum size of the disclosed area, or a size that is less than the maximum), rotated and/or deflected into a third, deflected configuration within the capsular bag 6, in which the dissecting elements 2416 cover at least a portion of the lens 8, the dissecting elements 2416 are used to cut the lens 8 by pulling the movable ends 2420 of the dissecting elements 2416. set forth above to fold the dissecting elements 2416 from the second, deployed configuration back towards the first configuration to compress and cut the lens 8. When the dissecting elements 2416 are pulled, they apply an inward force to the lens 8 and begin cutting and/or fragmenting the lens, thanks to the effort at the lens 8 along the small surface of the dissecting elements 2416 of small diameter. Tension can be provided by moving the slider 2444 in the proximal direction, thereby pulling the movable ends of each transverse element 2416 in the proximal direction and straining it. Tension may also be provided, at least in part, by the user applying additional force, as described elsewhere in this application.

[0138] With a single tension procedure, the lens 8 can be divided into two, three or more fragments, depending on the number of dissecting elements 2416 included in the design. The process can be repeated at a different angle of rotation (i.e., 90 degrees, to create a cross alignment with the first fragmentation), and the deployment and tension is performed again to fragment the lens 8 into even smaller fragments (e.g., four, six or more). In FIG. 25C, the cutting plane is shown as being generally vertical, but it should be understood that there may be any number of angles and orientations for the cutting path of the cutting elements 2416. The process can be repeated as many times as necessary to create any number of lens fragments of any desired size. The final size of the lens fragments sought may depend on the method of extraction from the eye 1. In some embodiments, phacoemulsification in the capsular bag 6 may be additionally applied to remove the lens fragments. This may be particularly useful in severe or nuclear cataracts where complete fragmentation of the lens increases surface area and reduces the size of the fragments that need to be emulsified by phacoemulsification. In other embodiments, the implementation, fragments of the lens can be removed, as described in this application. In some embodiments, lens fragments can be recovered as described in U.S. Publication No. 2018/0318132 entitled "Devices and Methods for Ocular Surgery" published Nov. 8, 2018, which is incorporated herein by reference.

[0139] With the proximal movement of the slider 2444, the movable node can return to its original position to safely remove the dissecting elements 2416 from the eye. The transversal elements 2416 can be rotated back to their original insertion plane and then retracted into the shaft 2412. When the slider 2444 is fully retracted in the proximal direction, the transversal elements 2416 may be in an excessively deformed position, which, over time, can compromise the shape memory characteristics of the transversal elements 2416 The device may include a spring 2458 that, when the loops of the transverse members 2416 are retracted into the lumen of the shaft 2412, prevents the loops from retracting to a size that adversely affects the shape memory of the nitinol. For example, a spring 2458 (see FIG. 24D) may be placed on the proximal-facing front portion 2456 and extend proximally from the slider 2472 such that the slider 2444 and slider 2472 are compressed into a slightly more distal position relative to the body 2442 after the slider 2444 is released ( see Fig. 26A-26B). If the user retracts the transverse members 2416 too far with the slider 2444, then the spring 2458 may compress the slide assembly 2472 a short distance distally after the slider 2444 is released by the user. This allows the loops of the transversing elements 2416 to extend slightly from the distal end 2405 of the stem 2412 and maintain, at rest, the open area 2446 slightly enlarged compared to the fully retracted state (see FIG. 24A). The size of the distal end 2405 of the shaft 2412 and the slightly enlarged open areas 2446 located outside the distal end 2405 of the shaft 2412 may be small enough for insertion through a purely corneal incision (i.e., the maximum outer diameter is less than about 3.5 mm), so that the distal loops of the transversing elements 2416 do not always need to be fully retracted into the lumen of the rod 2412 for insertion into the anterior chamber of the eye.

[0140] Actuation of the slider may be limited such that the device is blocked from being used for more than one medical procedure. For example, non-disengaging latches, levers, ratchets, pawls, gear racks, and other mechanical elements can be built into the housing to engage with the slider, preventing the cutting element from being extended by distal movements of the slider and the slide assembly attached to the slider. The move counting mechanisms described herein can make the device a single use device or a limited use device. "Single use" or "limited use" means in this application that the devices described in this application are intended for use with one patient and are not intended for re-sterilization and use with another patient. The stroke counting mechanisms described herein may provide a low cost method for limiting the use of a device that can be manufactured as a low cost disposable device. It should be understood that stroke counting mechanisms configured to track distal and/or proximal slider advances can be used with a device having any number of transversal elements, including 1, 2, 3 or more transversal elements.

[0141] Even with a disposable device, it is advisable to provide that the slider 2444 (or other retractable/retractable mechanism) is actuated for at least two reciprocating strokes. For example, the user may wish to move the slider 2444 back and forth several times to become familiar with the device before using it on a patient. In some embodiments, the device 2440 may include a stroke counting mechanism that allows multiple actuations or distal advances/proximal advances of the slider (or other input device configured to extend and retract the dissecting elements 2416) a discrete number of times before the extension is blocked. slider 2444, movable assembly 2472, and/or dissecting elements 2416. Thus, the stroke counting mechanism may limit the suitability of the device after clinical use for a single patient. The stroke counting mechanism may monitor distal advances and/or proximal advances of the slider and cause a blocking act that prevents further distal advances of the slider after the locking act occurs. It should be understood that limitation on the use of the term "slider" is not intended, and other types of input devices are provided in this application, made with the possibility of extension/retraction of the dissecting elements 2416.

[0142] In some embodiments, the slider 2444 may be attached to the move counting mechanism 2701. Fig. 27A-27C represent the move counting mechanism 2701, which may include a ratchet counting system. A ratchet or gear 2705 located within the handle 2442 may include a plurality of teeth 2710 in engagement with the primary stop 2715 and the secondary stop 2720. The main stop 2715 may be attached to the interior of the housing 2442 and the secondary stop 2720 may be attached to the slider 2444. During the forward movement of the slider 2444 (i.e., towards the distal end of the body 2442 in the direction of arrow A), the tooth 2710 of the gear 2705 is pressed against the main stop 2715, which causes the gear 2705 to rotate forward one tooth 2710 in the direction of the arrow B. In reverse, as the slider 2444 moves toward the proximal end of the housing 2442, the secondary stop 2720 prevents the gear wheel 2705 from being pushed in the opposite direction as the teeth 2710 slide back over the main stop 2715. The gear 2705 also includes a locking tooth 2725 configured with the possibility of locking stop 2730. After the gear wheel 2705 has advanced moving forward a number of strokes, which can be set by the number of teeth 2710 on the gear 2705, the locking tooth 2725 is locked by the stop 2730 preventing the gear 2705 from turning further in any direction (see FIG. 27C). This prevents the slider 2444 from reaching the distal end of its movement and thereby prevents the transversal elements 2416 from fully deploying. The number of teeth 2710 may vary, including 2, 3, 4, 5, 6, 7, 8, 9, 10 or more teeth. Once locked, the slider 2444 is still free to move at the proximal portion of its stroke, allowing further compression of the distal loop and safe removal of the transversing elements 2416 from the eye. The main stop 2715 may be formed from a sheet of metal material having a shape that will bend upward if the user attempts to overcome the main stop 2715 by pushing the slider forward. Likewise, the auxiliary stop 2720 may be formed from sheet metal material. Alternatively, one or both of the stops 2715, 2720 may be formed as flexible molded plastic pieces that can deviate from the path when the gear 2705 rotates in direction B, but will not deviate from the path when the gear 2705 rotates in direction B. opposite direction.

[0143] The stroke counting mechanisms described herein can be configured to count the number of distal advances, proximal advances (ie, leads), or both distal advances and proximal advances of the slider. The stroke counting mechanisms described in this application can block distal extensions after a certain number of actuations of the engine have been completed. In general, the stroke counting mechanisms described herein do not interfere with the proximal movement of the slider so that the device does not snag in an extended configuration with the loops deployed held outside the shaft.

[0144] The configuration of the stroke counting mechanism can be changed. Fig. 28A-28B show another embodiment of the stroke counting mechanism 2701. The move counting mechanism 2701 may include a ratchet counting system. The gear 2705, located inside the handle or housing 2442, may have a plurality of teeth 2710 in engagement with the main stop 2715 and the secondary stop 2720. In this embodiment, the gear 2705 can be fixed to the body 2442 of the device in such a way that it remains stationary along the longitudinal axis of the device during movement of the slider 2444. The slider 2444 may have a proximally extending cantilever 2735 containing a main stop 2715 at its proximal end. In contrast to the embodiment in FIG. 27A-27C, in which gear 2705 advances during each forward stroke of motor 2444, gear 2705 in this embodiment advances one tooth 2710 at the proximal end of each reverse stroke of motor 2444 (arrow A in FIG. 28A). The main stop 2715 on the proximally extending console 2735 engages with the tooth 2710 of the gear 2705 and rotates the gear 2705 in the opposite direction by one tooth 2710 (arrow B in Fig. 28A). The gear wheel 2705 is blocked from turning in the opposite direction due to the presence of the auxiliary stop 2720 engaging with the tooth 2710 on the gear wheel 2705. The auxiliary stop 2720 may be located on the inner surface of the housing 2442. After the gear wheel 2705 has been advanced as a result of a discrete number of strokes, set by the number of teeth 2710 on the gear wheel 2705, the stop tooth 2740 is captured by the main stop 2715 on the console 2735, which, in turn, cannot be moved forward, since the gear wheel 2705 is blocked from turning in the forward direction due to the auxiliary stop 2720 (see Fig. .28B). This locks the slider 2444 in its most proximal position and the dissecting members 2416 in their most compressed form. The counting ratchet system may have any of a variety of configurations that allow a limited number of retract/extend cycles of the slider before mechanical lockout occurs.

[0145] FIG. 29A-29B show another configuration of the stroke counting mechanism 2701. As in the embodiments described above, the gear wheel 2705 is located inside the handle and has a plurality of teeth 2710 in working engagement with the main stop 2715 and the auxiliary stop 2720. The gear wheel 2705 can be fixed to the inner surface of the body 2442 of the device and is made with the possibility of rotation around an axis, located perpendicular to the longitudinal axis of the housing 2442, extending from the distal end to the proximal end. The gear 2705 is fixed along the longitudinal axis so that when the slider 2444 is extended and retracted axially along the longitudinal axis of the housing 2442, it engages with the teeth 2710 of the gear 2705. The slider 2444 may have a proximally extending cantilever 2735 having a main stop 2715 at its proximal end. areas. The main stop 2715 extends from the proximal end region of the cantilever 2735 such that the end of the main stop 2715 faces the distal end of the body 2442. The teeth 2710 of the gear 2705 protrude sideways towards the proximal end of the body 2442. This relative positioning of the main stop 2715 and the teeth 2710 allows, so that the gear wheel 2705 moves forward during each forward stroke of the slider 2444 (i.e., towards the distal end of the housing 2442) and remains stationary during each reverse stroke of the slider 2444 (i.e., towards the proximal end of the housing 2442), when the main stop 2715 overrides the teeth 2710 of the gear 2705. During the forward movement of the slider 2444, the tooth 2710 of the gear 2705 is pressed against the main stop 2715, forcing the gear 2705 to rotate one tooth 2710 in arrow B. In reverse, when the slider 2444 is moved towards the proximal end of the body 2442, the auxiliary stop 2720 prevents pushing the gear 2705 in the opposite direction as the teeth 2710 slide back over the main stop 2715. The gear 2705 may also include a locking tooth (similar to tooth 2725 in FIG. 27A-27C) configured to be locked with a stop as described elsewhere in this application.

[0146] The above-described versions of the counters provide for the rotation of the gear about an axis that is perpendicular to the longitudinal axis A of the housing 2442. The counter mechanism 2701 may also include a member configured to rotate about the longitudinal axis A of the housing 2442. FIG. 30A-30D depict another embodiment of the stroke counting mechanism 2701 including a cylindrical counting drum 3005 disposed within a housing 2442 such that the central axis of the drum 3005 is aligned coaxially with the longitudinal axis A of the housing 2442. The counting drum 3005 may include a plurality of inclined cams 3010 projecting upward from and located radially along the periphery of the outer surface of this drum. The underside of the slider 2444 may have a first slider ramp 3025 and a second slider ramp 3030 (see FIG. 30D) shaped and positioned to engage with the tilt cams 3010, respectively, when the slider 2444 is retracted and extended. The shape of each tilt cam 3010 and the shape of the ramps 3025, 3030 of the slider can vary, but are usually responsive to each other. The mutually reciprocal shapes of the tilt cams 3010 and the slider ramps 3025, 3030 allow the slider ramps 3025, 3030 to abut against and slide on the ramps 3010. Axial movement of the ramps 3025, 3030 along the longitudinal axis A causes the drum 3005 to rotate in the direction of arrow B due to interaction with the ramps 3010 (see FIG. 30A). Each distal slider extension can rotate the cylindrical counting drum a fraction of a full drum revolution, as described in more detail below. The drum is configured to rotate up to a certain number of beats before the blocking act occurs. The locking act can block distal advances of the slider while allowing proximal retraction of the slider to prevent locking of the slider when the cutting element is in a deployed configuration within the patient's eye.

[0147] In some embodiments, the cams 3010 may be polygonal in shape with at least two inclined surfaces relative to the longitudinal axis of the drum 3005, including a front slope 3015 configured to engage with a mating ramp on the first slider ramp 3025, and a rear ramp 3020 configured to engage with the mating ramp of the second slider ramp 3030. In some embodiments, the front slope 3015 faces the distal end of the body 2442 and the back slope 3020 faces the proximal end of the body 2442. As such, the first slider ramp 3025, configured to engage with the front slope 3015, faces the proximal end of the body. 2442 and a second slider ramp 3025, configured to engage with the rear ramp 3020, faces the distal end of the housing 2442 (see FIG. 30B). When reversing (i.e., toward the proximal end of housing 2442), the first slider ramp 3025 abuts the forward tilt 3015 of the first tilt cam 3010a of the drum 3005. The drum 3005, in turn, rotates about the longitudinal axis A of the device in the first direction arrow B. The drum 3005 rotates a fraction of a full rotation of the drum 3005. After the drum 3005 completes its share of rotation and the slider 2444 continues to move backward, the rotation of the drum 3005 is blocked by the cantilever portion 3027 of the second slider ramp 3030 (see Fig. 30E) . The cantilever portion 3027 is positioned between two of the inclined cams 3010a, 3010b on the drum 3005 such that rotation of the drum 3005 is blocked even if, for example, the device is shaken or dropped. The slider 2444 can block the rotation of the drum 3005 when the slider ramps 3010 are not aligned with the ramps 3010 on the drum 3005. As the slider 2444 moves forward, the second slider ramp 3030 abuts the rear ramp 3020 of the next ramp 3010b and rotates the drum 3005 about longitudinal axis A. body 2442 for another fraction of a full turn of the drum 3005 in arrow B. For example, the drum 3005 can turn 1/24 of a full turn when in reverse, and another 1/24 of a full turn when moving forward. Thus, during each cycle of forward and backward movement of the slider 2444, the drum 3005 may rotate 1/12 of a full turn.

[0148] The number of tilt cams 3010 may vary depending on how many actuation cycles of the engine 2444 are required (eg, 3, 4, 5, 6, up to about 19, 20, or more). The slider can be advanced distally for about 3 to about 30 strokes before the act of locking occurs and the slider is locked in the rear position. Each reel 3005 may further include a locking cam 3032 (see FIG. 30C). The locking cam 3032 may be positioned on the outer surface of the drum 3005 after this last tilted cam 3010. The locking cam 3032 may have a forward slope 3015. However, the locking cam 3032 may not have a rear slope 3020. with the ability to prevent translational movement of the slider 2444 forward or in the distal direction (see Fig. 30C). The locking cam 3032 may limit the number of rotations of the drum 3005 to a certain number. The locking cam 3032 may be positioned to engage with the slider ramps when the slider 2444 is moved forward or when the slider 2444 is moved back.

[0149] The position of the slider 2444 when it engages the detent cam 3032 can be anywhere along its range of motion. For example, the slider 2444 may engage with the detent cam 3032 when the slider 2444 is in the full forward position, the rearmost position, or anywhere in between the two. In some embodiments, the slider 2444 engages the detent cam 3032 approximately midway through the range of motion, in the forward stroke. This configuration offers several potential benefits associated with the shape of the splitter 2416 at the front of the device. For example, the transversal element 2416 can be brought to its smallest configuration even if the stroke counting mechanism has reached its limit and a blocking act has occurred. This is useful because the device can always be removed from the eye through the corneal incision by fully retracting the slider.

[0150] In some embodiments, the counting drum 3005 includes a plurality of inclined cams 3010 within an internal passageway 3035 (shown in FIGS. 31C and 31E). A plurality of inclined cams 3010 may be disposed radially along the inner surface of the internal passage 3035. As with the embodiment described above, each inclined cam 3010 may have a front slope 3015 and a rear slope 3020, configured to be placed in engagement with the first slider slide 3025 and the second slider ramp 3030 as the slider 2444 retracts and extends. In this embodiment, the proximal end region of the slider 2444 may extend through the inner passage 3035 of the counting drum 3005 such that the slider ramps 3025, 3030 can engage with the tilt cams 3010 The outer surface of the drum 3005 may include a helical thread 3040 (noticeable in FIG. 31B) configured to engage with a corresponding female thread on the inner surface of the housing 2442. As the drum 3005 rotates, the drum 3005 is screwed along the length of the housing 2442 in the axial direction. Eventually, the drum 3005 reaches a hard stop which blocks the movement of the drum 3005 further in the axial direction and the device is locked. Thus, the drum 3005 may complete several revolutions before the blocking act occurs and reaches the hard stop. The rigid stopper may include a female thread ending on the inner surface of the body 2442. The helical thread 3040 may limit the number of rotations of the drum 3005 to a certain number, such as 2.5 turns of travel. The drum 3005 can rotate 2.5 revolutions, at a rate of 12 strokes/revolution, or a total of 30 strokes, before hitting the hard stop. On a hard stop, the slider 2444 can be caught at the rear of the travel length and the device is blocked from being reused.

[0151] In some embodiments, the device may include a mechanism to provide a warning before an actuation lock occurs (see FIG. 31F). The lock signaling element may be mechanical, such as a window 3042 extending through the housing 2442, providing a visual indicator or indication of the position of the drum 3005 within the housing 2442, such as relative to a hard stop. The window 3042 may be located near a location where the user can easily see it during use (eg, on top of the device, near where the user can hold the device). A window 3042 allows the user to see a contrast color when the index drum 3005 is translated backward. When the drum 3005 is positioned near the window 3042 of the housing 2442, the color of the drum 3005 may be visible through the window 3042, providing an indication of the number of distal extensions still possible before the blocking act occurs. For example, the outer surface of the drum 3005 may be visible through the window 3042 during use. When drum 3005 is in a more distal position within housing 2442 and there are still very few moves that can be made, drum 3005 can be positioned distally from window 3042 such that it is not visible through window 3042 and window 3042 appears dark or has a first color. Drum 3005 may remain distal to window 3042 for a number of strokes until drum 3005 reaches a stop (eg, cam 3032 or other stop as described elsewhere in this application). At this stage, when a few more strokes can be made, the outer surface of the drum 3005 can be seen through the window 3042. The color of the outer surface of the drum 3005 can be easily identifiable through the window 3042. The drum 3005 can have a particular color that is easily identifiable compared to the color of the handle 2442 (for example, orange or red when the handle 2442 is white or gray) and signals to the user the position of the drum 3005 before blocking occurs. Alternatively, the outer surface of the drum 3005 may be visible through the window 3042 before and during use. The outer surface of the drum 3005 may have at least two contrasting colors that let the user know where the drum 3005 is as it moves. For example, the proximal end region of the drum 3005 can be seen through the window 3042 prior to use. The outer surface of the proximal end region of the drum 3005 may have a first color (eg, black or blue). With each cycle of movement of the slider 2444, the drum 3005 is forced proximally within the housing 2442 until the distal end region of the outer surface of the drum 3005 is visible through the window 3042. The outer surface of the distal end region of the drum 3005 may have a different color (for example, orange or red ). Thus, when the drum 3005 reaches the stop inside the housing 2442, a different color can be seen through the window 3042, warning the user that the drum 3005 is nearing the end of its life.

[0152] In some embodiments, the drum 3005 includes a sequence of marks 3007 on its outer surface. For example, FIG. 30A-30E show that the drum 3005 contains the numbers "1" through "20" marked on the outer surface. The marks 3007 may be in line with the window 3042 at the top of the housing such that the marks 3007 on the drum 3005 aligned with the window 3042 are visible to the user. The marks 3007 may be numbers corresponding to the number of cycles remaining, the number of cycles completed, etc., so that the user is informed of the state of the stroke counting mechanism. In addition, the slider 2444 may also have a window 3009 along its length (see FIG. 30D). The window 3009 of the slider 2444 may be positioned in line with the window 3042 through the top of the housing 2442 such that the mark(s) 3007 on the drum 3005 at a particular position of the slider 2444 is(are) aligned with the windows 3009, 3042 and visible to the user. For example, when the slider 2444 is fully advanced distally forward and the dissector 2416 of the device is fully deployed, then the window 3009 of the slider 2444 may be in line with the upper body window 3042 so that the user can see the corresponding number at that time. When the slider 2444 is retracted proximally, the window 3009 of the slider 2444 moves and the slider 2444 blocks the view of the marks 3007 on the drum 3005 through the top of the housing 2442. Thus, the slider 2444 can function as a shutter that opens only at a predetermined slider position. In some embodiments of the apparatus, this may be useful to prevent users from mishandling the drum 3005 or attempting to turn it back to "reset" the stroke counter mechanism 2701. Such a shutter mechanism can be incorporated into any of the embodiments described herein, and it is contemplated that any number of other shutter designs are possible.

[0153] In still other, additional implementations, the counter mechanism 2701 does not necessarily use the rotation of the drum or gear wheel in the same way as in the above embodiments, and may use linear actuators instead. Fig. 32A-32B depict an embodiment of the counter mechanism 2701 that includes an axially sliding rack 3050. The rack 3050 may include a plurality of teeth 2710 configured to engage with a corresponding element, such as cam lugs 3052 on a proximally extending console 2735 of the engine. 2444. The proximally extending console 2735 is configured so that it does not normally contact the rack 3050 during most of its travel. As best shown in FIG. 32A, proximally extending arm 2735 in a relaxed, straight position may be aligned with longitudinal axis A. When slider 2444 is retracted proximally, proximally extending arm 2735 may fold away from longitudinal axis A in a downward direction away from teeth 2710 of rack 3050. When slider 2444 is extended distally , the proximally extending cantilever 2735 can expand back to longitudinal axis A in an upward direction towards the teeth 2710 of the rack 3050. One or more cam lugs 3052 at the extreme proximal end of the cantilever 2735 are configured to engage with one or more cam profiles 3054 on the inner surface of the housing 2442 when the slider 2444 is moved proximally and distally. When the slider 2444 is retracted proximally, the cam lugs 3052 on the proximally extending arm 2735 engage the cam profile 3054 on the body 2442 and cause the proximally extending arm 2735 to be pressed downward (see arrow A in FIG. 32A). The proximally extending arm 2735 resiliently flexes downward relative to the thruster 2444 and housing 2442. After the cam lugs 3054 are slid proximally along the cam profile 3054, the proximally extending arm 2735 may return upwards back to its relaxed, straight-ahead position aligned with longitudinal axis A. When the slider 2444 extends distally, for example, to extend the transversing element once more, the cam lugs 3052 engage with the cam profile 3054 on the housing 2442. engages with the teeth 2710 on the rack 3050 causing the rack 3050 to move forward with the slider 2444 while the proximally extending cantilever 2735 is folded upward. As the cam lugs 3052 advance distally past the cam profile 3054, the proximally extending cantilever 2735 unclenches downward from the teeth 2710 and into its neutral unstressed state aligned with longitudinal axis A. along the cam profiles 3054, and the rack 3050 advances a predetermined distance. During the proximal movement of the slider 2444, the cam lugs 3052 descend below the cam profile 3054 and the element 3056 moves away from the teeth 2710 of the rack 3050. During the distal movement of the slider 2444, the cam lobes 3052 rise back above the cam profile 3054 and the element 3056 is pressed against the teeth 2710 of the rack 3050, thereby causing the rack 3050 to move a certain distance forward. The rack 3050 is configured to, after a predetermined number of cycles, engage with a rigid stop on the body such that it cannot be advanced any further. In this state, the slider 2444 is blocked from moving forward.

[0154] Devices and methods may be described in connection with the preferred embodiments, and it will be understood that numerous modifications may be made to the preferred embodiments. For example, the tissue handlers may comprise additional threads of the transverse threads, without departing from the numerous aspects described.

[0155] In various implementations, the description is given with reference to the figures. However, some embodiments may be practiced without one or more of the specific details provided, or in combination with other known methods and configurations. The description sets forth numerous specific details, such as specific configurations, dimensions, and processes, to provide a thorough understanding of the embodiments. In other examples, well-known manufacturing processes and methods are not described specifically and in detail so as not to obfuscate the description unnecessarily. Reference in this specification to “one embodiment”, “an embodiment”, “one embodiment”, “an embodiment”, or the like, means that the particular feature, construction, configuration or characteristic described is contained in , at least one embodiment or embodiment. Thus, the expression "one embodiment", "an embodiment", "one embodiment", "an embodiment", or a similar expression, in various places in the present description, does not necessarily refer to the same embodiment or embodiment. In addition, particular features, structures, configurations, or characteristics may be combined in any suitable manner in one or more embodiments.

[0156] The use of relative terms in the description may denote a relative position or direction. For example, the definition "distal" may mean the first direction from the origin. Likewise, the term "proximal" may mean a location in a second direction opposite the first direction. However, such terms are provided to establish relative coordinate systems and are not intended to limit the application or orientation of the fixed delivery system to the particular configuration described in the various embodiments.

[0157] Although the present description contains many specific details, they can be interpreted not in the sense of limiting the scope of the invention that is claimed, or that can be claimed, but only in the sense of descriptions of features that characterize specific embodiments. Some of the features that are described herein in the context of separate embodiments may also be implemented in combination in one embodiment. Conversely, various features that are described in the context of one embodiment may also be implemented in multiple embodiments individually or in any suitable subcombination. Moreover, although the features may be described above as being operable in some combinations and even initially claimed as such, one or more features from the claimed combination may, in some cases, be omitted from the combination and the claimed combination may be made into a subcombination or subcombination variant. Likewise, although the operations are shown in the drawings in a particular order, this should not be understood as a requirement that, in order to achieve the desired results, such operations be performed in the particular order shown or in sequential order, or that all the operations depicted be performed. Only a few examples and embodiments are disclosed. Based on the above disclosure, you can create variations, modifications and improvements to the described examples and embodiments and create other options.

[0158] In the above descriptions and in the claims, expressions such as "at least one of" or "one or more of" followed by a connecting list of elements or features may occur. The "and/or" expression may also occur in a list of two or more elements or features. Unless otherwise implied or expressly refuted by the context in which the said expression is used, such expression provides for the designation of any of the listed elements or features separately or any of the listed elements or features in combination with any of the other listed elements or features. For example, the expressions "at least one of A and B", "one or more of A and B"; and "A and/or B" each assume the meaning of "one A, one B, or both A and B". A similar interpretation is also provided for lists containing three or more items. For example, the expressions "at least one of A, B and C", "one or more of A, B and C"; and "A, B and/or C" are each intended to mean "one A, one B, one C, A and B together, A and C together, B and C together, or A and B and C together."

[0159] The use of the expression "based on" above in the description and claims is intended to mean "based on at least in part", so that an unspecified feature or element is also allowed.

Claims (25)

1. Surgical device for cutting the lens inside the capsular bag of the eye, while the device contains: a rod extending from the housing along the longitudinal axis of the device, and the rod has a lumen and a distal end; a cutting element movable through the lumen of the rod, the cutting element comprising at least a first cutting element having a first end, a second end and a distal loop formed between the first and second ends; an engine having a working connection with the cutting element and moving along the longitudinal axis of the body; and a stroke counting mechanism connected to the engine and enclosed inside the case, moreover, the cutting element is made with the possibility of transition from the first, retracted, configuration in the direction to the second, deployed, configuration with the distal extension of the engine, and moreover, when in the second, deployed, configuration, the distal loop of at least the first dissecting element forms an enlarged open area located outside the distal end of the rod, and the enlarged open area has a first side extended distally relative to the distal end of the rod, and a second side located proximally relative to distal end of the rod, and moreover, the stroke counting mechanism is configured to monitor the distal extensions and/or proximal extensions of the slider and cause a blocking act that prevents the distal extension of the slider. 2. The device according to claim 1, in which the stroke counting mechanism comprises: a cylindrical counting drum containing inclined cams; hard stopper; and a pair of inclined guides of the slider, made in shape and location with the possibility of engaging with inclined cams on the counting drum, which causes the counting drum to rotate around the longitudinal axis of the device. 3. The apparatus of claim 2, wherein each distal extension of the slide rotates the cylindrical counting drum a fraction of a full turn about the longitudinal axis of the apparatus. 4. The apparatus of claim 3, wherein the cylindrical counting drum is rotatable by up to 24 beats before the blocking act occurs. 5. The device according to claim. 1, in which the act of blocking allows proximal abduction of the slider after the act of blocking. 6. The device of claim. 1, in which the slider is configured to perform from 3 to 30 extension strokes in the distal direction before the blocking act occurs and the slider is locked in the rear position. 7. The device according to claim. 2, additionally containing a lock signaling element. 8. The apparatus of claim 7, wherein the lock signal element comprises a lock signal window extending through the housing and providing a visual indication of the position of the counting drum in the housing relative to the stroke counter rigid stopper. 9. The apparatus of claim. 8, wherein the counting drum contains a series of marks on the outer surface and is axially fixed with respect to the block signaling window. 10. The apparatus of claim 9, wherein the sequence of marks indicates the number of distal advances made by the slider. 11. The apparatus of claim 8, wherein the slider further comprises a shutter window in which, when the slider is moved toward the distal end region of the body, the slider shutter window and the body lock signaling window are aligned to reveal a series of marks on the drum, and wherein, when the slider is moved proximally from the distal end region of the housing, the slider shutter window and the housing lock signaling window do not align, and the sequence of marks on the drum is not noticeable. 12. The device according to claim 1, in which the stroke counting mechanism comprises a cylindrical counting drum, the central axis of which is aligned coaxially with the longitudinal axis of the device, and a spiral thread engaged with the corresponding thread so that with each distal extension of the engine, the drum rotates around the central axis. 13. The device according to claim 12, further comprising a rigid stop containing the end of the corresponding thread. 14. The apparatus of claim 12 wherein the position of the counting drum inside the housing is visible through a window in the housing. 15. The apparatus of claim 14, wherein at least a portion of the outer surface of the counting drum has a color that is visible through the window, providing an indication of the distal advances of the slider that are possible before the blocking act occurs.

Images