RU2785416C2 - Surgical device for dissection of eye lens - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: invention relates to medical equipment, namely to surgical devices, and, in particular, to dissection of lens tissue for removal of lens or another tissue in eye surgery. A surgical device for dissection of the lens inside the eye capsule bag contains a case, a rod, a dissecting element, and an actuator. The rod is connected to the case, and it has a longitudinal axis passing from a proximal end of the rod to an outlet at a distal end of the rod. The rod contains the first lumen and the second lumen passing through it. The dissecting element is made with the possibility of movement relatively to the rod from the first introduction configuration to the second capture configuration, in which at least a section of the dissecting element passes outside from the rod. Both the dissecting element in the first introduction configuration and the distal end of the rod have a size for introduction into the anterior eye chamber through a cutout for being placed above the anterior surface of the lens inside the capsule bag. The section of the dissecting element is located inside the first lumen, and at least a section of the dissecting element is located inside the second lumen, when the dissecting element is in the first introduction configuration. The second capture configuration contains a loop formed by the complete dissecting element. The loop contains an open area. A distal section of the open area is located distally relatively to the outlet, and a proximal section of the open area is located proximally relatively to the outlet. The second capture configuration of the dissecting element is made of such a size and shape so that to allow movement of the dissecting element between the capsule bag and the lens, whereas the lens remains in the capsule bag, for capture of a section of the lens in the open area. The actuator is functionally connected to the dissecting element. The actuator is made with the possibility of stretching the dissecting element for decrease in the open area and cutting of the lens.

EFFECT: use of the invention allows for provision of reduction in the risk of damage to eye tissue, as well as more efficient operation of a surgeon.

20 cl, 53 dwg

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority from U.S. Patent Application No. 15/073,177, filed March 17, 2016, and is related to U.S. Patent Application No. 14/857,518, filed September 17, 2015, which are hereby incorporated by reference.

FIELD OF TECHNOLOGY TO WHICH THE INVENTION RELATES

[0002] The present invention relates generally to surgical devices, and in particular to dissection of lens tissue to remove lens or other tissue in ophthalmic surgery.

BACKGROUND OF THE INVENTION

[0003] Some types of traditional eye surgery require the destruction of lens tissue and solid intraocular objects, such as an artificial lens, into fragments so that the tissue can be removed from the eye. Lens removal for cataract surgery is one of the most common areas of ambulatory surgery, with more than 3 million surgeries performed annually in the US alone. The lens is inside an anatomical structure called the capsular sac that separates the vitreous cavity from the anterior chamber (located between the capsular sac and the cornea). Fluid communication between the vitreous cavity and the anterior chamber is undesirable, and therefore, during the removal of the lens, care must be taken to maintain the integrity of the posterior surface of the capsular bag. Still, the capsular bag consists of a thin fragile fabric. As a result, the clinician must be careful when removing lens tissue to avoid damage to the capsular bag. Further complicating the procedure is that the lens is usually removed from the anterior surface of the capsular bag through a usually round incision. The procedure and the incision resulting from the procedure is called a capsulorhexis. Usually, capsulorhexis does not exceed 2.8-3 mm in diameter. Typically, cataract surgery and other surgical procedures that affect the lenses are performed by making a small incision in the edge of the cornea, providing access to the anterior chamber and to the posterior surface of the capsular bag. The capsulorhexis is then performed, in which case this hole can be used for surgical access to the lens.

[0004] During cataract extraction surgery, a commonly used method for removing the lens is phacoemulsification, in which ultrasonic energy is used to destroy the lens, after which the lens fragments are aspirated. Other methods of fragmentation and removal of the lens have included the use of mechanical instruments such as hooks or knives, or energy-delivery instruments such as a laser, to break the lens into fragments and then remove it through an incision in the cornea from the inside.

[0005] However, existing tools and methods do not provide full-thickness fragmentation of the lens. With these methods, access to the lens is achieved from the anterior surface of the eye, and therefore the cutting forces applied by mechanical instruments are limited so that they are often not sufficient to provide full-thickness fragmentation. In addition, due to surgical access through an incision at the edge of the cornea, the mechanical instrument is advanced at an angle substantially parallel to the plane defined by the capsulorhexis. As a result, the traditional loop, bow or wire extraction surgical instrument is not given an orientation in which the device can be wrapped around the lens to allow for fragmentation or removal. Furthermore, even if such a conventional instrument could be wrapped around the lens, which is not possible, the loop wire would risk applying excessive, damaging force to the capsular bag when moved into position. The ability of energy-delivery instruments is limited when cutting sections of the lens that are physically close to other vulnerable anatomical structures, such as the capsular bag. For example, the 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 a lens that is not completely fragmented and needs to be carefully fragmented 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 masses are aspirated from the capsular bag and anterior chamber, other fluids such as saline are forced inward 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 damage tissue within the eye, such as the corneal endothelium. The ultrasonic energy used in phacoemulsification can lead to its negative effects on the ocular tissue. In addition, phacoemulsification requires expensive and bulky capital equipment, which limits the number of locations where phacoemulsifications can be performed.

SUMMARY OF THE INVENTION

[0007] The present invention is based on the realization that existing methods for removing lens tissue are generally laborious and inefficient. In addition, to eliminate the risks of damage to the capsular bag due to the use of existing methods, the lens is destroyed or does not dissolve completely, leaving one or more fragments with dimensions larger than desirable in the clinical aspect.

[0008] Therefore, the present invention provides devices and methods that effectively break the lens into small fragments and capture these fragments. Such devices and methods, if desired, complement or replace other devices or methods for eye surgery. Such devices and adapters reduce the risk of damage to ocular tissue, such as the capsular bag, and allow the surgeon to work more efficiently.

[0009] In some embodiments, the implementation of the surgical device includes a rod with a lumen formed through the entire rod; and an element moved from a storage position to a deployed position in which a larger portion of the element extends from the outlet at the distal end of the lumen; while moving from the storage position to the deployed position forces the first element arm to extend distally relative to the distal end of the rod and forces the second element arm to move proximally relative to the distal end of the rod.

[0010] In some embodiments, a human eye surgical device (which includes a capsular bag, a lens within the capsular bag, and a cornea) includes a tube with a lumen formed through the entire tube; and a dissecting element configured to change between at least the first shape and the second shape, wherein the second shape has a perimeter, and the dissecting element extends from the distal end of the lumen; wherein the first shape is sized for insertion through the capsulorhexis on the anterior surface of the capsular bag, and the diameter of the capsulorhexis is less than that of the lens; moreover, the dissecting element is movable from the first form to the second form for moving between the lens and the capsular bag such that when the dissecting element has a second form, the dissecting element contains at least a portion of the lens within its perimeter; and wherein the cutting member is movable to the third mold from the second mold to apply a cutting force to the lens.

[0011] In some embodiments, the implementation of the device for eye surgery includes a shaft with a lumen formed through the entire shaft; an internal rotary element located at least partially in the lumen; the outer rotary element located at least partially in the lumen and located radially between the inner rotary element and the rod; a first plurality of ribbons extending distally from a distal end of the outer pivot member, each of the first plurality of ribbons being circumferentially spaced from one another; a second plurality of ribbons extending distally from the distal end of the inner pivot member, each of the second plurality of ribbons being circumferentially spaced from one another; and a tip connected to the distal end of each of the tapes; moreover, the first set of tapes and the second set of tapes are movable from a closed position to an open position; and moreover, at least one of the first set of tapes and the second set of tapes can be rotated relative to the other in the open position.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] FIG. 1 is a schematic side view of the anatomy of the eye, showing the insertion of a rod and a dissecting element through an incision in the lateral side of the cornea.

[0013] FIG. 2 is a plan view of the transversal element in the expanded position.

[0014] FIG. 3 is a perspective view of a capsulorhexis-formed capsular bag with a dissecting member in a first insertion configuration.

[0015] FIG. 4 is a perspective view of a capsulorhexis bag with a dissecting member in a second gripping configuration.

[0016] FIG. 5 is a perspective view of a capsular sac with a capsulorhexis made, with the dissecting element in the third fragmentation position.

[0017] FIG. 6 is a perspective view of the lens shown in FIG. 5 with the cutting element not shown for clarity.

[0018] FIG. 7 is a perspective view of the lens shown in FIG. 5 with the dissecting member and capsular bag not shown for clarity.

[0019] FIG. 8 is a perspective view of a surgical device including a handle, a shaft, and several dissecting elements.

[0020] FIG. 9 is a perspective view of the surgical device shown in FIG. 8 with the cutting elements in the first insertion configuration.

[0021] FIG. 10 is a perspective view of the surgical device shown in FIG. 8 with the left slider extended to deploy the left transversal element into the second grip configuration.

[0022] FIG. 11 is a perspective view of the surgical device shown in FIG. 8 with the left slider fully extended to deploy the left transversal element into the second grip configuration.

[0023] FIG. 12 is a perspective view of the surgical device shown in FIG. 8 with the right slider extended to deploy the right transversal element into the second grip configuration.

[0024] FIG. 13 is a perspective view of the surgical device shown in FIG. 8 with the right slider fully extended to deploy the right splitter into the second grip configuration.

[0025] FIG. 14 is a perspective view of FIG. 13, showing the dissecting elements relative to the lens.

[0026] FIG. 15 is a detailed perspective view of the distal end of the surgical device shown in FIG. eight.

[0027] FIG. 16 is a sectional perspective view of the handle with the right slider in its original position.

[0028] FIG. 17 is a detailed perspective view of a portion of the handle shown in FIG. 16.

[0029] FIG. 18 is a detailed perspective view of another portion of the handle shown in FIG. 16.

[0030] FIG. 19 is a detailed perspective view of the handle shown in FIG. 16-18, with the right slider partially extended.

[0031] FIG. 20 is a detailed perspective view of the handle shown in FIG. 16-18 with the right slider extended further distally than in its position in FIG. 19.

[0032] FIG. 21 is a detailed perspective view of the handle shown in FIG. 16-18, with the right slider returned to its original position.

[0033] FIG. 22 is a detailed perspective view of the handle shown in FIG. 16-18, with the right slider returned to its original position.

[0034] FIG. 23 is a side view of another embodiment of two dissecting members extending from the shaft to enclose the lens.

[0035] FIG. 24 is a plan view of another embodiment of two dissecting members extending from a shaft to enclose the lens and a holding bag.

[0036] FIG. 25 is a perspective view of the distal end of another embodiment of a surgical instrument in a first insertion configuration.

[0037] FIG. 26 is a perspective view of the distal end of the surgical instrument shown in FIG. 25 in a second deployed configuration.

[0038] FIG. 27 is a perspective view of the distal end of the surgical instrument shown in FIG. 25 in a second unfolded configuration covering the lens fragment.

[0039] FIG. 28 is a perspective view of the distal end of the surgical instrument shown in FIG. 25 in a third cage configuration.

[0040] FIG. 29 is a perspective view of the distal end of the surgical instrument shown in FIG. 25 in a fourth extraction configuration.

[0041] FIG. 30A is a side view of an alternative embodiment of a surgical instrument.

[0042] FIG. 30B is a side view of the device shown in FIG. 30A with inner tubes extending from both lumens.

[0043] FIG. 31 shows another device for dissecting the lens.

[0044] FIG. 32 is another view of the device shown in FIG. 31.

[0045] FIG. 33 is the device shown in FIG. 31 with the element in the first configuration.

[0046] FIG. 34 is an image of an element protruding further from the rod.

[0047] FIG. 35 - image of the element in an intermediate position.

[0048] FIG. 36 is an image of the element in the second configuration.

[0049] FIG. 37 shows the element in the second configuration above the lens, with the capsular bag removed for clarity.

[0050] FIG. 38 - section of the element that has circled the circumference of the lens to a position behind the lens.

[0051] FIG. 39 is an image of the element rotated so that the lens moves through a closed loop.

[0052] FIG. 40 shows an inner tube extended over the element to change the shape of the element.

[0053] FIG. 41 is another lens dissection device positioned above the lens, with the capsular bag removed for clarity.

[0054] FIG. 42 shows the device shown in FIG. 41, in another view.

[0055] FIG. 43 - inner tube, curved back.

[0056] FIG. 44 - the inner tube, continuing relative to the circumference of the lens.

[0057] FIG. 45 - an element continuing further from the inner tube around the back of the lens.

[0058] FIG. 46 - an element advanced around the lens.

[0059] FIG. 47 - element engaged to form a loop.

[0060] FIG. 48 - another device for dissecting the lens inside the capsular bag.

[0061] FIG. 49 is the device shown in FIG. 48 with the closed loop extended.

[0062] FIG. 50 shows the device shown in FIG. 48 with the closed loop extended further.

[0063] FIG. 51 is the device shown in FIG. 48 with a closed loop deployed to move about the circumference towards the back of the lens.

[0064] FIG. 52 is the device shown in FIG. 48 with the closed loop deployed and placed to form a dissection in the lens.

[0065] FIG. 53 is the device shown in FIG. 52, with inner tubes extended from both arms.

DETAILED DESCRIPTION OF THE INVENTION

[0066] As shown in FIG. 1, the normal anatomy of eye 1 includes the cornea 2, the capsular bag 6, and the lens 8 within the capsular bag 6. An incision 4 is made at the margin of the cornea 2 and the surgeon performs a capsulorhexis procedure on the capsular bag 6 resulting in capsulorhexis 10 in the anterior surface of the capsular bag 6. The capsulorhexis 10 may be performed by any suitable method, for example, cutting with a scalpel, energizing with a femtosecond laser or other energy-supplying cutting tool, robotic or automatic cutting, or any other suitable method. The capsulorhexis 10 may be torn or cut with a diameter of approximately 2.0 mm to 8.0 mm. According to other embodiments, the capsulorhexis 10 can be made smaller than 2.0 mm in diameter, particularly when the lens fragments 8 (as described in more detail below) are small enough to be retrieved through the smaller diameter capsulorhexis 10. Capsulorhexis 10 can be performed with a separate set of tools, such as micronippers, as usual. Alternatively, the surgical device 40 described herein may include features and tools to facilitate or complete capsulorhexis. For example, micronippers can be attached to the distal end of the shaft 12 to enable the tool 40 to perform capsulorhexis. As other examples, one or more of a blade, a keratome, a hook, a laser, an ablative energy applicator, or the like for use during a surgical operation may be embedded in or associated with the distal end of the rod 12. For example, a protruding tip can be attached to the shaft 12 and used to rotate the lens 8 between fragmentation steps as described herein. The protruding tip may be a sharp tip that can cut into the lens 8 so that the user can rotate the lens 8 to a new orientation and dissect the lens 8 at a different angle. In accordance with some embodiments, any separate instruments used by the surgeon to perform the capsulorhexis are removed from the incision 4 in the cornea 2. As also shown in FIG. 3, the rod 12 is then inserted through the incision 3 in the cornea 2. As seen in FIG. 3, the distal end of the nail 12 is positioned above (ie, anterior to) the capsulorhexis 10, at a distance from the capsulorhexis 10, but at a position within the circumference of the capsulorhexis 10 as viewed from outside the eye 1. As seen in FIG. 1, the rod 12 is generally parallel to the plane defined by the edges of the capsulorhexis 10 after it has been inserted through the incision 3 in the cornea 2. injection configurations. In such embodiments, the small radius bend 24 may be outside the shaft 12 and already be bent in at least the proximal direction. However, even in embodiments in which the transversal member 16 is made of a superelastic material, the angle by which the second arm 20 of the transversal member 16 bends during the transition from the first insertion configuration to the second gripping configuration is reduced. In addition, within the lumen 14 of the shaft 12, a portion of the transversal element 16 requires less space than the entire element, which allows the shaft 12 to be made smaller in diameter. In accordance with some embodiments, the rod 12 is a tube of oval cross-section with a rounded tip. The oval cross section is more conducive to the introduction of the rod 12 into the eye 1 through the incision 4 of the cornea. Additionally, if there are several dissecting elements, they can be more easily placed side by side in the lumen 14 of the rod 12 of oval 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 the first insertion configuration. Alternatively, at least two transversal elements 16 are used, with each transversal element 16 initially in the first insertion configuration. Although, in connection with this particular embodiment, a single transversal element 16 is described for clarity, in light of the following disclosure, it will be apparent that any suitable number of transversal elements 16 can be provided and used in a single lens removal procedure, and that the devices and methods described in of the present application are not limited to the use of any particular number of cleaving elements 16.

[0067] In accordance with some embodiments, the transversal element 16 has a first arm 18 and a second arm 20. As described in more detail below with reference to FIG. 16-22, one of the arms 18, 20 of the transversal element 16 may be movable relative to the rod 12, while the other of the arms 18, 20 of the transversal element 16 may be fixed relative to the rod 12. For example, the second arm 20 of the transversal element 16 may be fixed relative to rod 12, and the first arm 18 of the splitting element 16 may be movable relative to the rod 12. The second arm 20 may be connected to the rod 12 or other structure by crimping, welding, adhesives, mechanical connections, or any other suitable design or method. In some embodiments, the implementation of the dissecting element 16 is a wire with a round, oval or other atraumatic cross section. In other embodiments, the implementation of the dissecting element 16 is a tape. In the context of this document, a tape is a structure that has a width greater than its thickness, when viewed in the longitudinal direction.

[0068] In the first insertion 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 has a width typically no more than 3.5 mm and is performed with a small knife. Thus, the outer diameter of the rod 12 is preferably not more than 3.5 mm. If a cut 4 of a different size is used, a rod 12 with a different outer diameter can be used, taking into account that the cut 4 is most desirable to be formed in the form of a line no longer than 5 mm. 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 withdrawn from the shaft 12 already in the eye. Alternatively, it is possible to use additional components to cover the sheath of the dissecting element 16 during insertion through the incision 4 of the cornea. For example, at the distal end of the rod 12 may be a tapering piece that gradually tapers from the end of the rod 12 to a smaller cross section so that it can facilitate insertion through the incision 4 of the cornea. The tapering piece may also cover the dissecting member 16 to hold it during insertion. The tapered part may additionally have a slot, in front of which the cutting element 16 can be extended through this slot or with its break, after it has passed through the slot 4.

[0069] According to some embodiments, the transversal member 16 is made from a flexible or superelastic material, such as a nickel-titanium alloy, which allows the transversal member 16 to flex and flex when it is inserted into the eye 1 through the corneal incision 4. In these embodiments, the contracted shape of the transversal member 16 may be larger in one or more dimensions than the corneal incision 4 and bend to pass through the incision 4 when the shaft 12 is moved toward the capsulorhexis 10. Alternatively, the transversal member 16 may not have a first insertion configuration and can be inserted through the incision 4 in the same configuration later used to capture the lens 8. In such embodiments, the transversal member 16 is compressed as it passes through the corneal incision 4 and then deploys again after it enters the eye 1. In yet other embodiments, the transversal element 16 may not have the first insertion configuration and may be inserted through the incision 4 in a configuration larger than the configuration used later to capture the lens 8. In still other embodiments, the transversal element 16 may be captured hook, turn or otherwise enter through the incision 4 of the cornea at any time explore ways.

[0070] As shown in FIG. 4, the transversal element(s) 16 or elements are (are) pushed distally relative to the lumen 14 of the rod 12. As discussed above, one arm 20 of the transversal element 16 can be fixed so that the other arm 18 of the transversal element 16 is pushed distally relative to the lumen 14 of the rod 12. As a result, the transversal member 16 moves from the first insertion configuration to the second gripping configuration.

[0071] The dissecting element 16 may be made from any suitable material. For example, as described above, shape memory materials, such as a nickel-titanium alloy, can be used to allow the transversal member 16 to move to its predetermined shape in the second grip configuration, with a high degree of resilience. In one embodiment, the nickel-titanium alloy can be used in its superelastic state, in which the nickel-titanium alloy transforms through the crystal structure to move from a first insertion configuration to a second capture configuration. In other embodiments, the transversal member 16 is made from a nickel-titanium alloy that is shaped to transition from a first insertion configuration to a second capture configuration after reaching a phase transition temperature that is above room temperature but below body temperature. Thus, the transversal element 16 made of nickel-titanium alloy can enter the eye at room temperature below its phase transition temperature, so that it will hold a contracted shape. When the transversal element 16 is placed in the eye 1 and allowed to warm to body temperature, the nickel-titanium alloy may warm above its phase transition temperature and begin to return to its predetermined second grip configuration. This reshaping can occur over a period of time, which allows the surgeon to place the dissecting element in the capsular bag 6 and orient it while the shape changes, so that the loop can define the lens transection plane. As an alternative, any number of other biocompatible materials can be considered, such as stainless steel. In some embodiments, the nickel-titanium alloy can be actively heated by the surgical device 40, in which case the phase transition temperature of the transversal member 16 can be selected to be above room temperature, but less than a temperature that would damage the tissue of the capsular bag 6 or other tissue of the eye 1. Instead nickel-titanium alloy, other shape memory materials such as shape memory plastics can be used. Alternatively, any number of biocompatible materials may be considered, such as stainless steel, titanium, silicone, polyimide, PEBAX® polyether blockamide, nylon, polycarbonate, or any other suitable material. In addition, multiple materials can be used end-to-end or as glued layers or concentric tubes of material.

[0072] As also shown in FIG. 1 and 4, in the second gripping configuration, the transversal member 16 is specially shaped to grip the lens. In accordance with some embodiments, the second grip configuration is the shape of the transversal element 16, predetermined, for example, by using resilient or superelastic materials to manufacture the transversal element.

[0073] As most evident in FIG. 4, in the second gripping configuration, the dissecting member 16 is approximately similar to an irregular loop that has a general shape similar to the section of the lens 8 and that is shaped and sized to enclose the lens 8 within the capsular bag 6. As discussed above, in some embodiments, the dissecting element 16 is made from a piece of round wire. The second gripping configuration of the transversal member 16 has a merging point 22 at which the first arm 18 and the second arm 20 of the transversal member 16 converge back together to form a perimeter shape such that the device 40 is approximately identical to the closed loop 21. The expression "merge" means the location of the first arm 18 and the second arm 20 of the cutting element 16 in close proximity to each other. The point 22 merge may be at the distal end of the rod 12 or in close proximity to it. In the second grip configuration, the dissecting member comprises a distal portion 28 that extends distally from the fusion point 22 and a proximal portion 26 that extends proximally from the fusion point 22. Confluence 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 comprise a small radius bend 24 as shown in FIG. 1. A small radius bend 24 folds the second arm 20 of the transversal member 16 in a proximal direction such that the second arm 20 extends proximally from the fusion point 22. Alternatively, the transversal member 16 may follow a different path to provide a given path transition, without such a small radius bend. For example, it is possible to provide trajectories that are outside the normal plane in FIG. 1, for example, bending or wobbling to reduce the overall radius of bending of the proximal portion 26 of the transversal member 16. This may optimize the ability of the transversal member 16 to reshape to other smaller contracted configurations, as explained hereinafter.

[0074] The first arm 18 and/or the second arm 20 are pushed out of the lumen 14 of the stem 12 while the other arm is locked to the stem as described above. Alternatively, both arms 18, 20 of the splitting element 16 are movable relative to the stem 12 and are movable relative to the lumen 14 of the stem 12. Alternatively, the stem 12 may be a sliding component and the splitting member 16 remains stationary. When the arm or arms 18, 20 are pushed outward from the lumen 14, the transversal member 16 changes into a second grip configuration. When 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, at a location spaced and to one side from the longitudinal centerline of the lumen 12, towards the capsular bag 6. , the dissecting member 16 may extend downward through the capsulorhexis 10 and deploy within the capsular bag 6 to a length that is greater than the diameter of the capsulorhexis 10 as seen in FIG. 1. In some embodiments, the small radius bend 24 results in a second arm 20 at an angle of at least 120 degrees with respect to the longitudinal centerline of the shaft 12 and with respect to the distal direction, as seen in FIG. 1. Both the distal portion 28 and the proximal portion of the transversal member 16 in the second grip configuration are slightly curved and generally approximate the size and shape of the sides of the capsular bag 6 in order to enter the capsular bag 6 without causing damage (such as tearing or making a hole in the capsular bag, excessive stretching of the capsular bag, or damage to the inner surface of the tissue of the capsular bag).

[0075] As also shown in FIG. 2, the shape of the transversal member 16 in the second grip 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, in the correct orientation, the splitter 16 is held so that it opens through the capsulorhexis 10 into the capsular bag 6. As the splitter 16 continues to deploy, the plane formed by the splitter 16 can be rotated so that the splitter passes through the space bag and crystal. The plane contains the longitudinal axis of the lumen 14 of the rod 12. Alternatively, the shape of the transversal member 16 in the second grip configuration is a more three-dimensional shape that does not lie in a single plane. For example, the transversal member 16 may oscillate in and out of the horizontal plane, or bulge significantly out of the horizontal plane in one direction or the other. Rotation may be provided by manual rotation of the rod 12 or 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 member 16 has gone through most of the transition from the first insertion configuration to the second gripping configuration and has partially rotated relative to the lens 8. The transversal member 16 can be rotated such that the shape plane is predominantly vertical or at a variety of other angles. Mechanisms and methods for performing such a rotation are described in detail below. In addition, a plurality of dividing members 16 can be used, which rotate through a plurality of different angles. In other embodiments, rotation does not occur until the transversal member 16 transitions into the second grip configuration. In accordance with some options for implementation, the rotation begins when the dissecting element 16 moves into the second configuration of the capture. For example, turning may begin after the loop opening 46 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 on the proximal section 26 and the distal section 28. As another example, the turn may begin when the chord becomes longer than or shorter than 5-6 mm.

[0076] The second configuration of the gripping element 16 may be generally oval, as shown in FIG. 1, with a width of 7.0-15.0 mm and a height of 3.0-10.0 mm, in accordance with some embodiments. In accordance with other embodiments, the width of the transversal element 16 may be 4.0-20.0 mm, with a height of 1.0-15.0 mm. In some embodiments, the size of the second grip configuration of the transversal element 16 may be intentionally smaller than the size of the lens in some areas or throughout the profile. This may complement the ability of the transversal member 16 to stay close to the lens 8 and reduce the impact on the capsular bag 6. For example, the second grip configuration of the transversal member 16 may be 12.0 mm wide and 4.0 mm high. This makes it possible to provide a gap between the dissecting element 16 and the lens 8 at the width of the oval, while maintaining an interference along the height of the oval, which can reduce the likelihood of damage to the back surface of the capsular bag 6. 8, instead of moving to a position where this element encircles the thickest part of the lens 8, the transversal element 16 is smaller and captures a smaller portion of the capsular bag 6 than in the configuration in which the second configuration of the capture of the transversal element 16 can encircle the thickest part of the lens. 8. In other embodiments, the second grip configuration of the transversal element 16 is predetermined such as to have a generally defined lumen around the lens 8. In accordance with some embodiments, the second grip configuration of the transversal element 16 has a shape other than, in o anyway, oval.

[0077] The dissecting element 16 may have features or geometry that further prevent the element from damaging the capsular bag. 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 this round wire may be 0.004 inch - 0.012 inch (0.102 mm - 0.305 mm), but may also be any size that prevents excessive stress from being applied to the capsular bag 6, for example, a diameter of 0.001 inch - 0.030 inch (0.025 mm - 0.076 mm). Alternatively, the profile of the splitter 16 may be oval, with a greater width or height, or may be tapered to further spread the force of the splitter 16 against the capsular bag 6 over a larger surface area and thereby reduce or eliminate high pressure areas. applied by the dissecting element to the capsular bag 6.

[0078] In some embodiments, portions of the outer surface of the transversal element 16 may be coated to optimize certain aspects of the device. For example, as explained in detail below, the transversal element 16 traverses the space between the capsular bag 6 and the lens 8. element 16 rotated and moved more freely. In one embodiment, the transversal element 16 may be coated with a hydrophobic material, such as a fluoropolymer; e.g. PTFE (polytetrafluoroethylene). The coating can be applied by dipping, vapor phase plasma spraying, heat shrink sleeves, or 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 more free movement of the transversal member 16. Other means of reducing friction may include the use of mechanical grinding, plasma treatment, or any other suitable method. Alternatively, the transversal member 16 may be coated with other materials, such as active pharmaceutical agents, which are designed to be released into the eye during the procedure. For example, a steroid like triamcinolone can be applied to the surface of the transversal member 16 so that it is released into the eye during the procedure. Any other number of coatings and drugs are contemplated.

[0079] The dissecting element 16 may be of any other suitable geometry or materials. In an exemplary embodiment, the cutting element 16 is a round wire. The wire is configured to pass directly through the space between the lens 8 and the capsular bag 6. The wire may have various 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 tape, a hexagonal wire, or any other number of suitable shapes. In addition, the profile of the transversal element 16 may vary along its length. For example, the transversal member 16 may include one or more cushioned regions along its profile when it is particularly important to prevent damage to the capsular bag 4. The cushioned regions may include various materials, such as, but not limited to, soft elastometric materials such as silicone, which glued or coated onto the respective areas of the transversal element 16. The softened regions can spread the force over a larger area and provide a softer and more atraumatic contact surface with the capsular bag 6. In other embodiments, the softened regions are changes in the geometric profile of the transversal element in some areas. For example, areas that are flattened or expanded, even if they are made of the same material, distribute the force over a larger area. Additionally, the stiffness or flexibility of the transversal element may vary along the transversal element 16 by changing the thickness of the material or the diameter of the wire in some areas. Alternatively, bushings or other material may be added to the splitter 16 to locally increase stiffness in some areas. In yet other embodiments, the transversal member 16 may have cuts or ribs along its length that alter its flexibility or rigidity in certain areas.

[0080] In other embodiments, the shape of the splitter 16 in the second grip configuration is not predetermined. Instead, the shape of the transversal member 16 in the second grip configuration is determined by the properties of the material or geometry of the transversal member 16 when the lens 8 is engaged. to grip the lens 8 so that the capsular bag 6 is subjected to minimal force even when the dissecting member 16 is inside the capsular bag 4 and fully opened. In other embodiments, the splitter 16 may be of a soft elastomer, such as silicone, which may be soft enough and large enough in diameter that the splitter 16 does not exert excessive force on the capsule bag 6. In still other embodiments, the splitter 16 may be sufficiently rounded along certain areas and edges so that the force applied to the capsular bag 6 is distributed over a larger area, and thus the burst pressure can be reduced. In still other embodiments, the implementation of the dissecting element 16 may consist of several interlocking elements, for example, a chain structure, allowing flexible movement between several elements. In still other embodiments, the transversal member 16 may have slots along portions of its length, which may locally increase the flexibility of the member. For example, the splitter 16 may include a tube with cuts along its length in areas where the capsular bag 6 may come into contact with the splitter 16 so that these areas are more flexible and therefore less prone to applying excessive force to the capsular bag 6. In In yet other embodiments, portions of the transversal element 16 in the second grip configuration are not pre-shaped, but other portions of the transversal element 16 are pre-shaped. For example, the portion of the transversal element 16 anterior to the lens may be made from a round shape memory wire that is shaped to a predetermined shape that facilitates the passage 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 member 16 posterior to the lens 8 may be made of a different, more flexible material that conforms much more easily to the shape of the eye. At the same time, the section of the dissecting element 16 in the second grip configuration, which allows the insertion of the dissecting element through the capsulorhexis, which includes a small radius bend, is anterior relative to the lens 8, and the section of the dissecting element 16 in the second grip configuration, which is in contact with the capsular bag 6, consists from a more flexible material, less likely to damage the capsular bag 6.

[0081] 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 grip configuration does not have predetermined shape, the guide element may be along the areas of the distal section 28 or the proximal section 26 of the dissecting element 16 to force it to take a particular shape. From the fusion point 22, a tube may extend towards the distal portion 28, and the tube may concentrically hold the flexible dissecting element 16 in such a way that it follows the desired path to a greater or lesser extent during insertion into the capsular bag 6 and placement around the lens 4. Then the guide the tube can be withdrawn and, at the same time, leave the flexible dissecting element 16 in a given place around the lens 4.

[0082] In still other embodiments, the implementation of the predetermined shape of the dissecting element 16 in the second grip configuration can be created during any part of the surgical operation. 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 4. The surgeon may then use this information to change the shape of the dissecting element. Alternatively, some equipment, such as a shaping die or an automatic wire bender, can be used in conjunction with the measured data to reshape the transversal member 16 in the second grip configuration. In one embodiment, the surgeon uses an imaging technique such as optical coherence tomography (OCT) to take a measurement of the lens 8 and then this information is passed to an automatic wire bender which creates a dissecting element 16 custom made for the patient. In still other embodiments, the implementation of the surgeon can complement or change the shape of the transversal element 16 at a time when at least a portion of the dissecting element 16 is inside 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. In such a case, the surgeon may 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.

[0083] According to some embodiments, after the capsulorhexis 10 is made, fluid is injected between the capsular bag 6 and the lens 8 so that space is created between the lens 8 and the capsular bag 6 in at least some areas. This action can be called liquid separation, hydro separation or space creation. In accordance with some embodiments, the fluid creates space for the transversal member 16 in the second grip configuration to pivot within the capsular bag 6 and encircle the lens 8. In an exemplary embodiment, fluids such as viscoelastic hyaluronic acid or saline may be administered because these materials commonly used in ophthalmic surgery, well tolerated in the eye and readily available. One or more other liquids or additional liquids may be administered, for example, colored liquids, pharmaceutical liquids such as steroids, liquids containing drugs, bioabsorbable liquids, lubricants, hydrogels, microspheres, powdered substances, fluorescent contrast agents, liquid foams, or any other suitable liquid. In addition to or instead of liquids, one or more gases, such as air, oxygen, argon, nitrogen, or the like, can be supplied. Alternatively, in other embodiments, a fluid-filled space between the lens 8 and capsular bag 6 may not be required, and the dissecting member 16 may mechanically separate or bluntly dissect the lens 8 and capsular bag 4 as it is rotated around the lens 8. Fluid Separation and blunt dissection can be performed in combination with each other or separately. The liquid can be injected by cannula or needle into the capsular bag 6 using a separate instrument. According to other embodiments, fluid separation means may be incorporated into elements of the surgical device 40, such as the transversal member 16. For example, the transversal member 16 may be in the form of a flexible tube with a plurality of openings along its length that allow fluid to flow through him. 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. Such a solution can optimize the ability of the transversal element 16 to pass between the capsular bag 6 and the lens 8, since the liquid can be injected along the transversal element 16 continuously or at discrete times when separation is required. In yet other embodiments, fluid injection capability may be incorporated into 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 retractable tube, may be connected to stem 12. or other tube to provide fluid. In some embodiments, the fluid that is infused through a component of the device, such as shaft 12 or element 16, may serve other surgical purposes. For example, fluid can be infused over stem 12 to support eye chamber 1 without the need for a separate cannula or without the need for a viscoelastic agent. Irrigation and aspiration can be performed with a single component or with several separate components. For example, fluids such as saline may be infused into the eye through the lumen of the transversal 16 embodiment as described above and aspirated through the lumen of the rod 12. Other irrigation or aspiration techniques may be used, in accordance with some embodiments.

[0084] As shown in FIG. 5, the transversal member 16 has already been fully extended into the second grip configuration and rotated about the longitudinal axis of the shaft 12 and/or, in other words, rotated or moved into an orientation within the capsular bag 6 in which the transversal member 16 encloses the lens 8 without applying excessive force to the capsular bag 6. Then the dissecting element 16 is used to dissect the lens 8 by tensioning one or both arms 18, 20 of the dissecting element 16, for example, by pulling back one or both arms 18, 20 along the lumen 14 of the rod 12. The dissecting element 16 can move in the opposite direction. , as described above for deploying the transversing member 16 from the first to the second configuration to contract and transect the lens 8. When the transversing member 16 is pulled, it exerts an inward force on the lens 8 and begins to transect and/or fragment it due to the force applied to the lens 8. lens 8 over a small surface area of a thin dissecting diameter element 16. 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, pulling on the transversal member 16 only partially fragments the lens 8, and the remaining portion of the lens 8 can be fragmented by repeated use of the transversal member 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 may be any multiple angles and orientations of the transection path of the transversing member 16. FIG. 7 shows the lens with the capsular bag removed.

[0085] In some embodiments, the implementation of the surgical device 40 may contain several dissecting elements 16, as described below, to form several fragments of the lens at the same time. For example, several dissecting elements 16 may form a mesh that is capable of dissecting the lens 8 into multiple fragments; the splitting elements 16 may be at oblique or acute angles with respect to each other in such a way that they form a crisscross pattern. In other embodiments, the implementation of the surgical device 40 can be applied to the lens 8 sequentially. For example, after one cut has been made, the lens 8 (or the cutter 16) can be rotated 90 degrees so that the first cut plane becomes perpendicular to the plane of the delivery device. The dissecting member 16 can then be reintroduced into the capsular bag 6 as described above and used to make a new incision through two lens fragments, making 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, phacoemulsifications in the capsular bag 6 may be additionally applied to remove the lens fragments. Phacoemulsification may be particularly useful in complex or nuclear cataracts where complete fragmentation of the lens increases the surface area and reduces the size of the fragments that need to be emulsified by phacoemulsification. In other embodiments, lens fragments can be removed as described below.

[0086] In some embodiments, the implementation of the lens fragments can be forced out of the capsular bag 6 by introducing liquid into the capsular bag 6 under slight pressure. Fluid flow and/or pressure can move 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, forceps or grasping instruments 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 may be used to capture the lens fragments and remove them from the eye 1. The dissecting element 16 may be returned to the second gripping configuration and placed around the lens fragment. The dissecting element 16 can then be pulled or otherwise closed until the lens 8 is locked within the dissecting element, but the lens fragment is not dissected. The lens fragment can then be pulled out of the eye 1 by the dissecting element 16. To ensure that the lens 8 is not dissected by the dissecting element 16, additional components can be used, such as soft pads, tapes or strips with a larger surface area that captures the lens fragment rather than cuts it. Said components may extend from the shaft 12 or may be separate components that are introduced into the eye 1 through the incision 4 and attached to the dissecting element 16.

[0087] 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 shows two transverse members 16 in a first insertion configuration, at the distal end of the shaft 12. Handle 42 includes two longitudinally sliding sliders that are connected to two transversal members 16 as described below. The sliders in this initial configuration are in their allotted proximal location. The rod 12 and the dissecting elements 16 in the first insertion configuration are inserted through the incision 4 in the cornea to the capsulorhexis 10 as described above. As used herein, the term "handle" includes both handles designed to be grasped and actuated by a surgeon's hand, as well as a robotic arm that is associated with a surgical robot and is intended to be robotically controlled and actuated.

[0088] As also seen in FIG. 16-17, one embodiment of the handle 42 of the surgical device 40 is shown in section in a configuration corresponding to the first insertion 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 slot in the upper surface. handle 42. Finger 48 is connected to a scroll cam 50 or other cam structure located proximally relative to finger 48, which is fixed longitudinally relative to finger 48, but which is free to rotate about its axis relative to the finger. 48. This design can be provided mechanically by means of an engaging pin, collar, or other suitable mechanism. A cam groove 52 is formed in the surface of the scroll cam 50. The scroll cam 50 is held in a chamber within the handle 42, which allows the scroll cam 50 to move longitudinally but not move substantially radially. Front lip 56 extends distally from pin 48 and is rotatable with respect to pin 48. Preferably, front lip 56 is fixed against rotation relative to scroll cam 50; in some embodiments, front lug 56 is simply the distal end of helical cam 50. Between finger 48 and anterior passage 60 from handle 42 is a return spring 58 that functions to push finger 48 into the first insertion configuration. The proximal end of the return spring 58 may be centered on and engaged with the front shoulder 56. The proximal end of the first arm 18 of the transversal member 16 may be secured to the front shoulder 56 in any suitable manner, such as winding around the front shoulder, friction fit, welding, soldering, or press fit. Alternatively, the proximal end of the first arm 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 in the same place on the handle 42. , return spring 58, and connection to the first arm 18 of the splitter 16) located side by side within the handle 42. These assemblies may be identical to each other, may be side mirror images of each other, or may differ from each other in another way that allows, essentially one node to control two separate transverse elements 16 in the manner described below. Descriptions of movement of sliders 44a, 44b and transverse members 16 are the same for both sliders 44 and transverse members 16 unless otherwise noted, and descriptions for both are interchangeable unless otherwise noted.

[0089] As shown in FIG. 10, one of the transversing elements 16 is moved into the second gripping configuration by sliding the corresponding slider 44b in the distal direction. One arm 20 of the splitting element 16 may be connected to the rod 12, the handle 42 or other structure fixed relative to the handle 42, and can be held in a fixed position, and the first arm 18 is made with the possibility of translation and rotation with movable elements inside the handle 42. As set forth above, the first arm 18 is attached to the front ledge 56. As also shown in FIG. 18, when the slider 44 is moved distally, the pin 48 compresses the return spring 58, moves the front lug 56 distally, and advances the helical cam 50 distally. The return spring 58 compresses and exerts a proximally directed force on the finger 48. If the user releases the slider 44, the slider 44, the finger 48, and the mechanisms locked against translational movement relative to the finger 48 are pushed distally in the direction of the original position of the slider 44. When the slider 44 extends distally , the scroll cam 50 translates within the handle 42. The cam groove 52 may be substantially longitudinal on this first travel segment of the slider 44 such that engagement between the cam groove 52 and the cam pin 62 does not cause the scroll cam 50 to rotate; therefore, the transversal member 16 remains in substantially the same rotational orientation with respect to the longitudinal axis of the shaft 12. As the slider 44 advances distally, it pushes the first transversal arm 18 distally. As a result, the transversal member 16 changes shape to the second gripping configuration in the same manner as described above with reference to FIG. 1-4.

[0090] As also shown in FIG. 11, the slider 44 can be extended further distally after the transversal member 16 is reshaped to the second grip configuration. The cam groove 52 engages 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 4 is translated into a rotational movement of the splitter 16. the protrusion 56 and hence the pivoting of the transversal member 16 in the second grip 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 relative to vertical orientation. During this rotation, the dissecting element 16 moves between the capsular bag 6 and the lens 8, trapping the lens 8 in the open area 46 within the perimeter of the dissecting element 16. The dissecting element 16 may not substantially capture the capsular bag 6 and/or the lens 8 or may be configured to capture either the lens 8 or the capsular bag 6. Alternatively, the dissecting member 16 may produce a blunt dissection between the capsular bag 6 and the lens 8.

[0091] As also shown in FIG. 20, the slider 44 has been moved fully forward and the rotation of the scroll cam 50 and the splitter 16 has been completed. The severing member 16 encloses the lens 8 within the capsular bag 6 and is configured to apply an inwardly severing force to the lens 8 in the manner described above with reference to FIG. 4-5.

[0092] As also shown in FIG. 12-13, then the second transversal member 16 can be deployed into the second gripping configuration and rotated into position to enclose the lens 8 in the manner described above with reference to FIG. 9-11 and 16-20. As shown also in FIG. 14, both transversal elements 16 engage the lens 8 in such a way that, when the transversal elements 16 are pulled or otherwise closed, the transversal elements 16 will dissect the lens 8 into three partially or completely separate fragments. As shown also in FIG. 21, tension can be produced by shifting the sliders 44 in the proximal direction, thereby extending the first arm 18 of each transversal 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 dissect 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 required in particular for nuclear or difficult 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 substantially along the same line, in accordance with some embodiments.

[0093] FIG. 22 shows that slider 44 has been moved proximally to return to its original position. The transversing member 16 is rotated back to its original insertion plane and furthermore retracted to the stem 12. As also shown in FIG. 15, the dissecting elements 16 can return to substantially their original configuration after the lens has been dissected. The cam groove 52 of the scroll cam 50 may form a closed loop as shown. Alternatively, the cam groove 52 may have a one-way path, with the slider 44 being fully translated distally and then proximally to move it to its original position. In some embodiments, latches or one-sided locking levers may be incorporated into the cam groove 52 that lock the scroll cam 50 from rotating or moving in certain directions and may be contained in discrete positions in the cam groove 52 throughout the cam groove 52.

[0094] In accordance with some embodiments, the transversal elements 16 may be configured to move in synchronism with actuation of a single slider 44, instead of each transversal element 16 being associated with a different slider 44a, 44b as described above. In such a case, the dividing elements 16 can be configured to open and 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. This can be achieved by associating different cam grooves 52 and cam pins 62 with each transversal element 16 In yet other embodiments, the two sliders 44a, 44b may be configured such that the left slider 44b moves both sliders 44 forward and the right slider 44a moves only the right slider 44a forward (or vice versa). The right slider 44a may be configured to move back both sliders 44a, 44b, and the left slider may be configured to move back only the left slider 44b. Thus, the user can decide whether to move the sliders 44a, 44b independently or synchronously.

[0095] In accordance with some variants of implementation, the dissecting elements 16 rotate in the same 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 opens and also rotates into the capsular bag 6 in a clockwise direction. In this embodiment, the first transversal element 16 may be rotated 10-40 degrees off the vertical plane, and the second transversal element 16 may be rotated 10-40 degrees off the vertical plane.

[0096] In yet other embodiments, one or more additional or different mechanisms may be used to deploy the transversal elements 16. For example, a scroll wheel feeder or other pivoting mechanism may be used to deploy one or both of the transversal elements 16. In some embodiments, the movement made by the user is accelerated or decelerated through transmission to the movement of the transversal element 16 such that a given amount of movement of the user interface components moves the transversal element 16 by a greater or lesser amount through the use of gears, scaled 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 motors, pneumatic components, hydraulic components, magnets, or the like. The surgical device 40 may be incorporated into one or more large robotic assemblies. For example, a robotic device that is configured to perform cataract surgery may include an embodiment of a surgical device 40. This solution may allow surgeons to robotically perform portions of the described method. In some embodiments, this solution may provide alternative methods and methods, for example, gaining access to the capsular bag 4 through the sclera. In accordance with some embodiments, at least inserting a rod 12, having a lumen 14 through the entire rod, through the corneal incision 4 to the capsulorhexis 10 and extending the transcending element 16 from the distal end of the lumen 14 to cause the transversing element 16 to bend away from the axis of the rod 12 through the capsulorhexis 10, deploy to a size larger than the capsulorhexis 10 and capture at least a portion of the lens 8, are robotically controlled.

[0097] In some embodiments, the transversal element 16 does not need to approximately correspond to the loop at the very beginning when it is placed in the capsular bag 6. For example, the transversal element 16 may be a solid round wire that is introduced into the capsule bag 6 from the rod 12, without wrapping on itself to form a loop. In such an embodiment, the distal tip of the dissecting member 16 is blunted to prevent puncturing or damaging the tissue within the eye 1. The distal tip can be flexed either by adopting a flex predetermined in its design or by deflection along the inner surface of the capsular bag. 6, when the distal tip of the transversal element 16 reaches the wall of the capsular bag 6. The transversal element 16 can then pass the space between the lens 8 and the capsular bag 6 in such a way that it bypasses the circumference of the lens 8. The transversal element 16 can then return to the user's field of view in the upper a portion of the capsular bag 6 where the user can grasp the dissecting element 16 with structural elements on the handle 42, such as grippers or a completely separate tool. At the moment, the dissecting element 16 encloses the lens 8 inside the capsular bag 6 and almost corresponds to the loop. When one or both ends of the transversal member 16 is pulled and/or pulled out, an inwardly directed shear force is applied to the lens 8 such that it fragments. The transversal member 16 in 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 required to bypass the lens 8 but still maintain a suitable trajectory around lens 8, without leaving the trajectory into the tissue. This solution may include the use of a cross section with a selective bending moment, as for the "I" beam, which bends selectively about some planes. Alternatively, a tube with cutouts that allow bending can be made bendable in certain planes by locating the cutouts in that plane. Therefore, the transversal element 16 can bend around the lens 8, mainly in the distal-proximal directions. This may optimize the ability of the transversal member 16 to follow a desired common trajectory relative to the capsular bag 6 and the lens 8. In some embodiments, the transversal member 16 may be perfectly flexible such that its distal tip is not restricted to travel along any predetermined trajectory. The distal tip may be configured to contain magnetic or electromagnetic components that can be subjected to force by an external electromagnetic field. An external device can then be used to control the location of the distal tip of the transversing element 16 so that it can be passed around the capsular bag 6 along the desired trajectory. With this embodiment, any number of different paths or fragmentation planes can be provided. The surgical device 40 may include a variety of imaging tools to design a desired trajectory for the distal tip of the transversal member 16 that will not damage the capsular bag 6.

[0098] In some embodiments, the implementation of the dissecting element 16 may branch into multiple sections and/or multiple loops. For example, in the initial configuration, the dividing element 16 may have a shape and profile similar to those described above. However, upon transition to the second gripping configuration, the transversal element 16 may branch along its length into two elements, which may have identical or similar shapes or different shapes, each enclosing the lens 8 in whole or in part. This may allow the dissecting element 16 to dissect the lens 8 into several fragments without using two separate dissecting elements 16.

[0099] In some embodiments, one or both of the dissecting elements 16 may be configured to deliver one or more types of energy to assist in blunt dissection or fragmentation of the lens 8. For example, one or both of the dissecting elements 16 may include one or more more areas made with the possibility of heating by using an electrically resistive wire that heats up when a current is passed through it. Elevated temperature can optimize the separation of the capsular bag 6 and the lens 8, as well as promote the dissection of the lens 8. Alternatively, many other means can be used, such as radiofrequency ablation, electrosurgery, ultrasonic energy, or the like.

[00100] In some embodiments, handle 42 may include fluid delivery features. For example, as described above, the dividing element 16 or rod 12 may allow the introduction of liquids through the appropriate components. Handle 42 may include fluid passages and paths that connect these components to external sources of fluid via tubing, integral connectors, or the like. Alternatively, handle 42 may include internal pressurization systems that pump fluid through stem 12. Fluid may be stored in a cylinder with a piston while the piston is pushed forward by actuating components in handle 42. For example, a separate slider or button may have connection to the piston and positioned so that when the slider is moved by the user, the piston translates and forces fluid out of the cylinder into the injection system. This may allow the user to control the flow of fluid through the dissecting member 16, shaft 12, or any other component of the handle 42 for periods of time during surgery, such as to create space between the capsular bag 6 and the lens 8. Alternatively, the surgical device 40 it may be arranged that the fluid is automatically injected by the surgical device 40 for certain periods as part of the normal operation of the device. For example, the spring may be configured to apply force to the piston such that as the scroll cam 50 moves along its path, the suitably configured piston displaces some fluid.

[00101] FIG. 23 shows an alternative embodiment of the transversal elements 16 in side view. Extending from the distal end of the shaft 12 are two dissecting elements 16. In this embodiment, the dissecting elements 16 are arranged to wrap around the lens 8 starting from the distal end 8a of the lens 8, instead of wrapping around the sides of the lens 8 as described above. The dissecting elements 16 can be advanced one by one from the distal end of the rod 12 in a distal direction, towards the distal end 8a of the lens 8 and into the capsular bag. The dissecting member 16 may nearly conform to a loop of wire that is configured to take a predetermined shape and bend to allow the loop to bypass the lens 8 without undue force being applied to the capsular bag. Said loop may comprise transverse bends, as well as back and forth bends, which form different three-dimensional geometries when the transversal element 16 is pulled out of the supply device. To enter the capsular bag and capture the lens 8, the dissecting elements 16 are configured to assume different shapes when they are deployed. Instead of being in a plane, said splitting elements 16 bend downward from the stem 12 in a second configuration, as seen in FIG. 23. When multiple transverse members 16 are used, each may be configured to bend at a different angle than the other or others. One end of the splitter 16 may extend while the others remain relatively fixed to the inlet, or both ends may extend simultaneously, as described above. As described above, the transversal element may have different profiles, materials, or flexibility along its length.

[00102] One of the dissecting elements 16 can extend through the space between the capsular bag and the lens 8 and then can move 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 used. In some embodiments, the forwardly extending transversal element 16 can be used in combination with the laterally extending transversal element 16, as described above, to create intersecting fragmentation planes such that two transversal elements 16 can transect the lens into 4 discrete pieces. In addition, the fragmentation planes may be at multiple angles to each other and the slicing members 16 may extend around the lens 8 from multiple directions, such as a combination of forward and sideward extension embodiments.

[00103] FIG. 24 shows another alternative embodiment in plan view. In this embodiment, one of the dissecting elements 16 is secured to the holding bag 70 along at least a portion of its open length. The holding bag 70 may be made from a thin polymeric material such as polyester, high density polyethylene, low density polyethylene, or any other suitable plastic. Alternatively, the containment bag may be composed of a fine mesh type of stainless steel wire braid, nickel-titanium alloy braid, or any other suitable material. The retention bag 70 is connected to a portion of the transversal element 16 and forms a cavity, whereby the transversal element 16 can change its configuration between open and contracted, which opens and closes the retention bag 70. In one embodiment, the transversal element 16 with the retention bag 70 can be brought into tightened shape and placed in the eye 1 of the patient through the incision 4. The holding bag 70 can be hidden in the lumen 14 of the rod 12 during insertion into the eye 1 through the incision. The dissecting member 16 can then be placed near the capsulorhexis 10 and inserted into the capsular bag 6 around the lens 8 as described above. In some embodiments, the implementation of the holding bag 70 may have a predetermined shape, such as the profile of the lens 8 or a fragment of the lens. As the dissecting member 16 wraps around the lens 8, the retaining bag 70 follows the dissecting member 16 and the lens 8 enters the cavity formed by the retaining bag 70. The dissecting member 16 can be moved so that the entire lens 8 is captured in the retaining bag 70 from all sides. lens 8, according to some embodiments. The dissecting member 16 is then changed to a contracted shape which closes the retaining bag 70 and surrounds the lens 8 with a sheath. The retaining bag 70 is then withdrawn from the eye 1 through the incision 4. The lens 8 can be folded and compressed to pass along the length of the corneal incision 4 when it is withdrawn. The retrieval bag 70 may be coated in any suitable manner to enhance its removal from the incision 4, such as by reducing the coefficient of friction of the retrieval bag 70. In other embodiments, additional tools or components may be used to further fragment the lens 8, depending on from the rigidity of the lens 8. For example, as shown in FIG. 24, a plurality of dissecting elements 16 may be inserted into the capsular bag to fragment the lens 8 within the retention bag 70. These additional dissecting elements 16 may be placed at the same time that the retention bag 70 is placed or may be inserted after the retention bag 70 has been removed. lens 8 from the capsular bag, but before lens 8 is removed from eye 1.

[00104] In other embodiments, other means of fragmentation can be applied after the lens 8 is placed inside the retention bag 70. For example, after the lens 8 is captured in the retention bag 70, ultrasonic energy or phacoemulsification can be applied inside the retention bag 70 to fragment the lens 8. This approach may involve the use of sensors retractable into the holding bag 70 from the distal end of the shaft 12. Alternatively, mechanical instruments such as foreign body tools, drills, or the like can be used to sufficiently fragment the lens 8 so that it can be pulled out of the eye 1 through a narrow incision 4 in the cornea.

[00105] In still other embodiments, the holding bag 70 described herein can be used as a retrieval device used after the lens 8 is fragmented to remove lens fragments from the eye 1. For example, the device shown in FIG. 1 can be used to dissect the lens 8 into any number of fragments. One or more of the fragments may be large enough to be difficult to remove through the corneal incision with normal instruments. The holding bag 70 can be used to grab lens fragments inside the capsular bag or floating in the anterior chamber and pull them out of the corneal incision 4. In addition, the holding bag 70 may be provided with cutouts or openings that allow the passage of liquid or small objects. For example, the containment bag 70 may be a mesh or braid that allows intraocular fluid or viscoelastic fluid to pass through the holes while holding the lens fragment.

[00106] FIG. 25-29 show another embodiment of a surgical device 80 for removing lens fragments 8f from eye 1. The surgical device 80 includes an external pivot 82a and an internal pivot 82b. Elements 82a, 82b are arranged concentrically along a central axis, which may also define the longitudinal axis of the rod 12. As shown in FIG. 25, the surgical device 80 is initially in a first configuration with a device profile small enough to allow the device to be inserted through a standard corneal incision 4 as shown in FIG. 1. The outer pivot 82a and the inner pivot 82b may be tubes that are cut along their length to form bands 82 circumferentially separated by windows 84. The outer pivot 82a may have an outer diameter that is sized to a suitable size to be able to corneal incision inserts, ideally 0.015 inch (0.38 mm) to 0.060 inch (1.52 mm) outer diameter, although any outer diameter may be considered, depending on the intended length of the incision. The inner pivot member 82b may have an outer diameter that is sized to fit concentrically within the inner diameter of the outer pivot member 82a. The tubes of the outer pivot 82a and the inner pivot 82b may be laser cut, machined, chemically etched, welded, or fabricated in any suitable manner to form the bands 82 and windows 84. The bands 82 may be sized to any suitable width that does not dissect the lens 8f when a force is applied to contract the members 82a, 82b as described below. The width of the tapes 82 may be in the range of 0.004 inches (0.10 mm) to 0.050 inches (1.27 mm), however, the tapes 82 may have a width outside the range shown.

[00107] The outer pivot 82a and the inner pivot 82b can be pulled into a second gripping configuration, for example by pushing the distal tip of the surgical device 80 forward with a separate push rod type component, or by holding the outer pivot 82a with an additional outer tube, which serves as a casing for the surgical device 80 during insertion into the eye. Alternatively, the surgical device 80 is flexible enough that no tension member is required and the surgical device 80 flexes when it is inserted through the corneal incision 4. The distal tip 86 may be coupled to the distal end of each of the outer pivot 82a and the inner pivot 82b and provide a smooth entry into the corneal incision and a blunt surface for contact with ocular structures. The distal tip 86 may be composed of a soft polymer such as PEBAX® polyester blockamide, polyurethane, thermoplastic elastomer, or the like. Alternatively, the distal tip 86 may be composed of a hard material such as metal such as stainless steel or titanium, or a biocompatible non-metallic material. Alternatively, the distal tip 86 may be sharp and allow insertion of the surgical device 80 into the eye 1 without first making an incision 4, with the sharp distal tip 86 forming the incision. When the outer pivot member 82a and the inner pivot member 82b are composed of a superelastic material, the transition from the first configuration to the second configuration may include a phase change of the material.

[00108] In the preferred embodiment, the tape 82 is configured to have a predetermined expanded shape such that after the surgical device 80 is placed inside the anterior chamber of the eye 1, it is deployed so that the elements return to their predetermined shape. This can be achieved by using a shape memory material, such as a nickel-titanium alloy in its superelastic state, which takes shape to return to the open profile shown in FIG. 26 after the tightening element is separated. Alternatively, the nickel-titanium alloy may return each tape 82 to its expanded form after the device is inserted into the eye and allowed time to warm to a body temperature that is above the nickel-titanium alloy's phase transition temperature. Alternatively, heating elements may be coupled to the surgical device 80 to heat the surgical device 80 above even the phase change temperature after the surgical device 80 is placed in a location where the second configuration is desired to be opened. In other embodiments, the outer pivot 82a and the inner pivot 82b may be composed of a variety of materials. For example, resilient materials such as stainless steel, titanium, plastic, or the like can be used while the strain is less than the ultimate strain for elastic recovery. Alternatively, sections or entire belts 82 may be composed of several materials, which may further differ from sections of the rotary elements 82a, 82b. For example, the bands 82 may be made from a nickel-titanium alloy and attached to pivot members that are made of stainless steel. In the embodiments shown in FIG. 25-29, each of the two pivot members 82a, 82b includes two bands 82. However, any other suitable number of bands 82 may be included in the construction of each pivot member 82a, 82b, and any suitable number of pivot members 82a, 82b may be provided. . For example, the device may include four pivots 82a, 82b stacked concentrically, each containing only one band 82. In this embodiment, the bands 82 can be rotated so that they are all grouped together, further reducing the sectional profile of the device in section. 4 corneas. In some embodiments, the predetermined shape of the ribbons 82 is the initial configuration and the ribbons are bent outward into a second configuration.

[00109] As shown in FIG. 26, in the second configuration, the pivot members 82a, 82b define a plane and encompass a central region that is open to allow the lens fragments to be received and covered by the loop of the device. In FIG. 27 shows the surgical device 80 moved to enclose the lens fragment 8f. As shown in FIG. 28, the inner pivot 82a and the outer pivot 82b are already rotated by approximately 90 degrees relative to each other. The surgical device 80 is now in a third, rotated configuration. To obtain the third configuration, one or both rotary elements 82a, 82b can be rotated. For example, the tube 88 attached to the proximal end of the outer pivot 82b and/or the tube 90 attached to the proximal end of the inner pivot 82a are rotated to rotate the pivots 82a, 82b to the third configuration. In other embodiments, the implementation of the rotary elements 82a, 82b can be rotated to any suitable angle relative to each other. In the third configuration, the inner pivot 82a and the outer pivot 82b nearly correspond to the cage that encloses the lens fragment 8f.

[00110] As shown in FIG. 29, the bands 82 are moved to tighten around the lens fragment 8f. In some embodiments, a tightening element, such as an outer shell or push-pull type rod, may be used to tighten the tapes 82. In other embodiments, the mechanism or method for deploying the tapes into the second configuration is reversible. For example, if the tapes 82 are superelastic, the tapes 82 may be cooled or may be mechanically forced through a phase change to their original shape. In other embodiments, the implementation of the rotary elements 82a, 82b are pulled together when they are pulled through the cut 4 of the cornea. The incision 4 compresses and compresses the bands 82 and the lens 8 so that the bands 82 and the lens 8 conform to the size of the incision 4 when they are pulled out. In addition, other components and mechanisms may be included in the design to assist in the removal of the lens fragment 8f from the eye 1. For example, compression springs, pneumatic mechanisms, motorized mechanisms, and the like may be combined or used with the surgical device 80 to pull the lens fragments 8f out of the eye. 1. In some embodiments, the tapes 82 may cut into the lens fragment 8f or further fragment the lens.

[00111] In some embodiments, the tapes 82 may include or be connected to extraction bags as described above. The bag may be present between two or more belts 82 on one or more of the pivot members 82a, 82b. In the disclosed configuration, the lens fragment 8f can be similarly placed in the central region of the inner pivot 82a and the outer pivot 82b. When the inner pivot 82a and the outer pivot 82b move to the third configuration, the bag moves similarly and captures the lens fragment.

[00112] In other embodiments, the device shown in FIG. 25-29 may be constructed in any other suitable manner. For example, the pivot elements 82a, 82b may not be connected at their distal end, and may instead form an open cage. In some embodiments, pivot members 82a, 82b may not be concentrically aligned, or may be non-tubular structures such as wires or rulers or the like.

[00113] FIG. 30A and 30B show an alternate embodiment. Instead of a single lumen rod 12, a double lumen rod contains a first inlet tube 12a and a second inlet tube 12b. Each has a gap through the entire tube, and the cutting element 16 extends through the free end of each inlet tube 12a, 12b and forms a closed loop or shape. The cutting element 16 may have the same characteristics as described above with respect to any of the embodiments. The second inlet tube 12b is bent back in the proximal direction (to the right, as shown in Fig. 30), so that the proximal segment of the dissecting element 16 can rotate around the proximal end of the lens 8 in use. The free ends of the two lead-in tubes 12a, 12b can be separated from one another by a distance that is less than the diameter of the capsulorhexis 10. Therefore, the lead-in tubes 12a, 12b can lead the flexible transversing element 16 to the lens and ensure that this dissecting element 16 rotates relative to the lens 8 and covered at least part of the lens, as described above. The use of a simple flexible transversal element 16 instead of a superelastic transversal element 16 can simplify the design of the device. One or both of the inlet tubes 12a, 12b may be shaped in the same shape as at least parts of a different embodiment of the transversal member 16 shown in FIG. one; for example, the second supply tube 12b may include a small radius bend 24 which is created by the transversal elements 16 itself in the embodiment of FIG. 1. As described above, the dissecting element 16 can be deployable from a less open initial shape to a more open grip shape. For example, as an initial shape, the transversal element 16 may extend at least linearly between the ends of the inlet tubes 12a, 12b, after which an additional section of the transversal element 16 may be pushed out of the end of one or both inlet tubes 12a, 12b to form a curved shape. capture shown in Fig. 30. The embodiment shown in FIG. 30A is applied essentially as described above.

[00114] As shown in FIG. 30B, a first inner tube 180A is located in one of the lumen and a second inner tube 180B is located in the other lumen. The first and second inner tubes 180A, 180B may be used in any manner described in connection with the inner tubes described herein. The first and second inner tubes 180A, 180B can be extended from both ends of the element 16 to shape the element 16, move the element 16 around the circumference, or use any other method described in this application. The first and second tubes 180A, 180B are useful in that they can be used to substantially shape the element 16 so that 16 can be very flexible and staggered by the inner tubes 180A, 180B, as described below.

[00115] In any of the above embodiments, some elements of the device 40, 80, such as the lumen 14 of the stem 12 or the inner pivot member 82a, may have vacuum suction means incorporated. Vacuum suction can be used to aspirate small lens fragments or to hold the lens fragment in place during transfer.

[00116] FIG. 31-33 show another device 140 for dissecting/segmenting the lens. The device 140 contains a cutting or dissecting element 116, which can be used in any way described in this application. In addition, all devices described in this application can be used in any way described in this application, and all such methods are explicitly included for each device. Element 116 is movable from the first configuration shown in FIG. 33 to the second configuration shown in FIG. 31. Member 116 has a first arm 118 and a second arm 120. The first arm 118 may extend through a gap 114 in stem 112 as shown in FIG. 33-36. Lumen 114 has an outlet 115 at its distal end 123, wherein lumen 114 defines a longitudinal center line LC at outlet 115 which also defines the general orientation of member 16 as it emerges from lumen 114. Stem 112 may also have a second lumen (see FIG. . 30), in which the second arm 120 is located such that both ends of the element 116 can be shifted relative to the rod 112 and allow control, as explained in this application. Alternatively, the second arm 120 may be connected to the stem 112 such that only the first arm 118 can be moved relative to the stem 112.

[00117] The device 140 forms a closed loop 121 that increases in size as the element 116 transitions from the first configuration to the second configuration. As described herein, element 116 advances between the anterior surface of the lens and the capsular bag as element 116 moves from the first configuration to the second configuration. The closed loop 121 forms an open area 146 defined by an orientation that maximizes the open area 146 of the closed loop 121. After the device 140 is in the second configuration, the device 140 is controlled to move the open area 146 around the lens to the desired location for dissection of the lens. Device 140 may also be used to separate the posterior surface of the lens from the capsular bag via member 116 as described above. Element 116 can be moved in any suitable manner, such as by rotating element 116 and/or rod 112. Closed loop 121 can be of a fixed size when moved, for example, during separation. The closed loop 121 increases in size when the element 116 is moved into the second configuration, with the closed loop 121 advancing between the lens and the capsular bag due to the increase in the size of the closed loop 121 and the elastic properties of the closed loop 121. The stiffness of the closed loop 121 requires an optimal balance between the softness and compliance of the element 116 to reduce and prevent injury to the capsular bag while still providing sufficient rigidity to move through the space between the capsular bag and the anterior surface of the lens when the closed loop 121 is deployed. Conventional loops made from fine fibers are not able to advance in this manner, as the fibers cannot exert an outward force sufficient to advance between the lens and the capsular bag. A rigid loop, on the other hand, may be able to move between the lens and the capsular bag, however, an excessively rigid loop increases the likelihood of damage to the capsular bag.

[00118] The length of the element 116, which extends from the rod 112, increases when the element 116 moves into the second configuration. In one aspect of the invention, the first arm 118 may extend from the clearance of the shank 112 for a first length that is equal to at least 85% or at least 95% of the total length increase as member 116 moves from the first configuration to the second configuration. Of course, when the second arm 120 is not movable with respect to the shaft 112, the first arm 118 creates all the increase in length.

[00119] When element 116 is in the first configuration shown in FIG. 33, a portion of element 116 may be positioned between the capsular bag and the anterior surface of the lens (capsular bag shown exaggerated for clarity) before moving element 116 from the first configuration to the second configuration. For example, part or all of the closed loop 121 shown in FIG. 34 may be positioned or tucked between the capsular bag and the lens prior to moving element 116 into the second configuration. Element 116 can be placed in the eye in a position above/anterior relative to the lens in any suitable manner. For example, element 116 may be fully enclosed within stem 112 and extended from stem 112 into the first configuration shown in FIG. 34 after injection into the eye. Alternatively, the element 116 may be in the first configuration when it is inserted into the eye and positioned over the lens in the first configuration. The element 116 can be extended through another cannula or tube to hold the element during insertion into the eye. Device 140 may be inserted into the eye using any suitable access method.

[00120] Element 116 may form an intermediate position before reaching the second configuration, as shown in FIG. 35. The device 140 forms an intermediate closed loop 130 in an intermediate position. The intermediate closed loop 130 has an IA area limited in this case to 30% of the open area 146 in the second configuration. The intermediate position may alternatively be formed when the maximum cross-sectional dimension of the closed loop 121 approaches or equals 5 mm.

[00121] An intermediate position represents an intermediate state in which the closed loop 121 has reached or nearly reached the size of the lens. In accordance with the present invention, element 116 extends from lumen 114 in a manner that tends to deploy element 116 on top of the lens, as opposed to pushing closed loop 121 toward the capsular bag. The intermediate region IA formed by the open region 146 has a geometric center GC. The longitudinal center line LC forms an angle A with line L extending between the outlet 115 and the geometric center GC of at least 60 degrees or at least 80 degrees. By orienting the element 116 and the longitudinal center line LC in this manner while in the intermediate position, further extension of the element 116 from the intermediate position tends to deploy the element 116 over the lens, instead of moving the intermediate closed loop 121 towards the capsular wall, which would occur at a slight angle . In other words, the closed loop 121 and the element 116 deploy over the lens instead of protruding outward because the second arm 120 moves proximally relative to the distal end 123 of the rod 112 when the element 116 moves to an intermediate position, while the first arm 118 moves distally . In other words, the intermediate position has a proximal region PA located proximal to the distal end 123 of the shaft 112, which is at least 30% of the intermediate region IA.

[00122] As shown in FIG. 31, when the element 116 is in the second configuration, the element 116 may generally extend at least 85% or completely on one side of the longitudinal center line LC, which similarly facilitates the deployment of the closed loop 121. The disclosed area 146 in the second configuration has a proximal portion 143 located proximal to the distal end 123 of the stem 112 and a distal portion 145 located distal to the distal end 123 of the stem 112. The position of the distal end 123 of the stem 112 (not shown) is indicated in FIG. 31 for clarity. The proximal portion 143 has an area that is at least 10% of the open area 146 in the second configuration. In other words, at least 10% of the length L of the element 116 is located proximal to the distal end 123 of the shaft 112 in the second configuration, when measured along the longitudinal center line LC.

[00123] Element 116 may also include an advancing portion 150 that moves toward the circumference of the lens when element 116 transitions from the first configuration to the second configuration. The advancing portion 150 includes a section 152 that flips in concert to the back of the lens. The advancing portion 150 may have a radius of curvature in the second configuration that is greater, for example, by 20% or 40%, than the radius of curvature of the lens circumference. The increased radius of curvature along the advancing portion 150 may help prevent element 116 from protruding excessively into the capsular bag, which can occur with a more curved shape. The advancing portion 150 may have a variable radius of curvature, of course, within the scope of the invention. In the context of the present description, the straight section should be considered to have an infinite radius of curvature and therefore greater than the radius of the lens, by virtue of the present definition.

[00124] The section 152 of the advancing portion 150, which is inverted about the circumference, moves to a position between the posterior surface of the lens and the capsular bag, instead of moving outward after moving around the circumference. The section can be flipped about the circumference of the lens by simply moving element 116 into the second configuration, without the need for further manipulation of element 116 (eg, rotation of element 116 and/or rod 112). Alternatively, device 140 can be manipulated to flip section 152 onto the posterior side of the lens during or after element 116 is moved into the second configuration.

[00125] Section 152 may have a critical length that flips to the back of the lens. In one aspect, section 152 flips to the back, at a critical length of at least 2 mm, or at least 4 mm, when the lens circumference has a radius of 5 mm. The section 152 of the advancing portion 150 that flips to the back of the lens forms an angle of at least 20 degrees or at least 45 degrees with the lens axis 154. The advancing portion 150 may also be at least 6 mm long.

[00126] The advancing section 150 also defines an envelope line 156 in a second configuration that delimits the element 116 such that no portions of the element 116 extend beyond the envelope line 156. The envelope line 156 is formed by the symmetrical extension of the advancing section 150 to an angle of 180 degrees. Element 116 may be located entirely within the envelope line 156 in the second configuration. The advancing portion 150 may be the first portion of the element 116 reaching the circumference of the lens, when viewed along the axis 154 of the lens. The open area 146 in the second configuration may have a width in a direction transverse to the longitudinal centerline that is no greater than 0.7 of the radius of curvature of the advancing portion 150. The advancing portion 150 may also have a length that is at least 25% of length L of element 116 in the second configuration (see Fig. 31). The advancing portion 150 may also be located on the posterior portion 160 of the member 116 when the lens is in the open area 146 prior to dissection of the lens. The back section 160 has a back length PL and the advancing section 150 has a length that is at least 70% of the back length PL.

[00127] The apparatus 140 is described in detail below with reference to FIG. 31 and 32. The posterior portion 160 of element 116 includes approximately half of the proximal fold 162 and approximately half of the distal fold 164. The proximal fold 162 and the distal fold 164 are located near the circumference of the lens, and each fold 162, 164 spans anterior and posterior sides. lens. The anterior portion 166 of member 116 includes a straight segment 168 extending from lumen 114 of shank 112 and leading to distal curvature 170. Distal curvature 170 has a radius of curvature of 0.2143 inches (5.443 mm), a proximal bend radius of 0.0394 inches (1.001 mm) , the radius of the distal bend is 0.0689 inches (1.75 mm), the radius of the advancing section 150 is 0.3176 inches (8.067 mm), and the radius of the sharp bend 172 is 0.0059 inches (0.15 mm). The small radius bend 172 may have any of the features described herein for a small radius bend, such as an angle of at least 120 degrees. As shown in FIG. 32, the distal round 170 and the proximal round 174 are bent with a radius of 0.414 inches (10.5 mm) of the distal round and a radius of 0.186 inches (4.72 mm) of the proximal round. Element 116 may be nitinol wire shaped as described above, although other cross sections and shapes may be used within numerous aspects of the invention. The wire may have a diameter of 0.004 inch (0.102 mm) to 0.008 inch (0.104 mm), although other sizes may be used and the size and cross section may vary within the scope of the invention. Element 116 has a concave shape as shown in FIG. 32 which faces the convex anterior surface of the lens to assist in the smooth advancement of element 116 between the convex anterior surface of the lens and the capsular bag.

[00128] The device 140 and other devices described in this application can be made with the possibility of soft advancement between the lens and the capsular bag due mainly to the elastic deployment of a closed loop. To this end, the closed loop when folded is smaller than the free form of the closed loop when the element is extended. The closed loop unfolds into a free form as more of the element moves out of the shaft, which naturally advances the loop between the capsular bag and the lens. The free closed loop shape is larger than the intermediate shape and may have the closed loop shape formed when the element is in the second configuration. Of course, the free form may be smaller or larger than the second configuration, within numerous aspects of the invention. In other words, the closed loop formed by the device advances between the capsular bag and the lens due to the natural deployment of the closed loop. The length of the element extending from the lumen is increased to increase the size of the closed loop.

[00129] FIG. 40 shows a device 140 with a shaft 112 having an inner tube 180. The inner tube 180 is located in the lumen 114 and is slidable within the lumen 114 and moved to an extended position in which the inner tube 180 extends from the outlet 115 of the lumen 114. The inner tube 180 has a lumen 182 and a tube outlet 184 through which member 116 extends. This inner tube 180 may be configured to work with other embodiments described herein, such as those shown in FIG. 30. In particular, if the inner tube 180 can move within the tube 12a, then the wire 16 can be made from a much softer material, such as suture thread or thinner metal wire, and still provide the described coverage of the lens.

[00130] Inner tube 180 can be extended over member 116 to reshape member 116 and closed loop 121 as shown in FIG. 40. For example, inner tube 180 may have a shape that folds back as inner tube 180 moves out of the lumen. The inner tube 180 can change the shape of the element 116 to flip the section 160 (see Fig. 38) around the circle, as described above. Fig. 40 shows a slight separation 161 between the element 116 and the lens, which will allow the section 160 of the closed loop 121 (and in particular the advancing portion) to move to the back of the lens as shown in FIG. 38. As such, the inner tube 180 can be extended over the member 116 to move the closed loop section 121 to the back of the lens. The inner tube 180 can be extended in steps and can be coordinated with the stepped extension of the element 116 and the deployment of the closed loop 121. For example, the element 116 can be extended to deploy the closed loop 121, with the inner tube 180 extending in two stages; one before and one after the extension of element 116.

[00131] In another use of inner tube 180, element 116 can be extended from shaft 112 to increase the open length and size of closed loop 121 by sliding back the shaft 112 relative to inner tube 180 so that closed loop 121 unfolds proximally. All applicable aspects of the invention, such as those pertaining to supporting the unfolding of the closed loop 121 over the lens, are equally applicable here as mentioned above. The element 116 has a first end extending from the outlet of the inner tube 180 and a second end attached to the rod 112. The inner tube 180 may also help move the element 116 so that the lens moves through the closed loop 121. In other words, the element 116 moves so that the closed loop 121 bypasses the portion of the anterior surface and the posterior surface of the lens. For example, element 116 can be rotated to separate the posterior surface of the lens from the capsular bag in the position shown in FIG. 39. When the shaft 112 includes an inner tube 180, in the context of the present description, the outlet of the shaft 112 and the longitudinal center line LC of the shaft 112 must be defined by the more distal lumen outlet 115 and the inner tube outlet 184, since the element 116 is free from retention, when exiting the extreme distal outlet. In other words, the outlet 184 of the inner tube equates to the outlet of the stem 112 and defines the longitudinal centerline LC as the inner tube 180 extends from the lumen 114 of the stem 112.

[00132] FIG. 41-47 show another device 200 for dissecting the lens within the capsular bag. The device 200 includes an element 116A having a distal end 202, which may be a free end. Element 116A is extended around the lens and a location on element 116, such as the distal end 202, is captured as shown in FIG. 47. The element 116A is then pulled so that the lens is located in the loop 121A, which is reduced in size to dissect the lens. Element 116A has a connector that engages to apply tension to element 116A. The connector may be any suitable connector, such as an eye 208 that can be engaged with hook 210. Any other suitable engagement element, such as tongs or a loop, may be used. In addition, the engagement element may be connected to the rod or independent of the rod. Element 116A may also be gripped by a slot or tab on stem 112 or inner tube 180. Tension may be applied to member 116A by any suitable method, including pulling on one or both ends of member 116A, or pulling on stem 112, inner tube 180, or any other suitable construction on element 116A (while holding element 116A in a fixed position), or any combination of these methods.

[00133] Element 116A is located in stem 112, which may also include inner tube 180. FIG. 41 and 42 show a shaft 112 proximate the lens within the capsular bag with element 116A and inner tube 180 extended from outlet 115 in lumen 114. Member 116A can be extended to pass between the capsular bag and lens, and without inner tube 180, in within the scope of the invention. Fig. 43-45 show both inner tube 180 and element 116A advancing from the front to the back of the lens.

[00134] Element 116A may have a predetermined shape, wherein element 116A is collapsed within lumen 114 and expands to a predetermined shape when element 116A extends from shaft 112. Inner tube 180 may be advanced over element 116A to change the shape of element 116A. For example, inner tube 180 may be shaped to curve back as inner tube 180 is extended out of lumen 114. Inner tube 180 may also be extended along the circumference of the lens and back behind the lens.

[00135] The inner tube 180 can be extended over the element 116A to move the element 116A to the back of the lens. The inner tube 180 and the element 116A can also be pulled out in several steps. For example, element 116A may be advanced before the tube, then the tube may be advanced over element 116A, after which element 116A may be extended further.

[00136] Inner tube 180 has a deployable shape that curves back as shown in FIG. 44-47. The inner tube 180 is held in a folded shape by the stem and unfolds to a curved, unfolded shape when extended from the stem. Element 116A is movable to separate the posterior surface of the lens from the capsular bag, as described above.

[00137] The pulling step may be performed with the loop 121A formed before the start of the pulling step, as shown in FIG. 46. Alternatively, the loop 121A may be formed after the element 116A is tensioned if the tab of the element 116A is engaged before the loop 121A is fully formed. When tension is applied, loop 121A is formed following the reduction in size of loop 121A to cut the lens. Loop 121A can be formed primarily by the element (to optimize dissection) by retracting inner tube 180 before tensioning element 116A. Loop 121A may also be formed by element 116A and shaft 112. Element 116A, of course, continues along loop 121A, even when located in shaft 112.

[00138] FIG. 48-53 show another device 220 for dissecting the lens within the capsular bag. The device 220 includes an element 116B that extends distally from the stem 112. The element 116B has a first arm 222 and a second arm 224 that extend simultaneously. Device 220 forms a closed loop 226 that changes orientation by at least 60 degrees or at least 75 degrees as element 116B moves from the first configuration shown in FIG. 48 to the second configuration shown in FIG. 52. The orientation of the closed loop 226 changes about an axis that is perpendicular to the longitudinal axis line LC of the rod as viewed along the lens axis 154. The closed loop 226 may include an advancing portion 230 having a radius of curvature of at least 6 mm, with the advancing portion 230 being the most distal portion of the loop 226 and extending through an angle of at least 45 degrees when the element 116B is in the second configuration. . The orientation of the closed loop 226 changes without the need to change the orientation of the rod 112. This behavior can be supported by predefined shapes in the element 116B. In some embodiments, element 116B may vary in size along its length and, for example, thickened portions may be present at the proximal base where the orientation change occurs, which may provide more force to achieve the second configuration. In addition, the change may be supported by internal tubes, which may or may not extend from the lumen of the stem 112. FIG. 53 represents inner tubes 180 extending along the first arm 222 and the second arm 124 of member 116B. The inner tubes 180 can be used in any way, for example, to shape the element 116B or move the element 116 along the circumference of the lens. In addition, the inner tubes 180 can help reorient the closed loop 226 in the manner described herein.

[00139] The element 116B is extended from the rod 112 for a certain length, when moving from the first configuration to the second configuration. The length may be divided into a first half and a second half advanced during the first half and second half of the advance, respectively. Element 116B is shaped so that the orientation during the second half of the length changes at least twice as much as the first half of the length. In other words, at least 40% of the change in orientation occurs during the final 20% of the length extending from the rod. The closed loop 226 is fully distal to the outlet 115 of the lumen 114 when the element is in the second configuration. Element 116B can be pulled to cut the lens after it reaches the position shown in FIG. 52. Element 116B may be used in combination with another device, such as device 140, to make cross cuts as mentioned above.

[00140] Although embodiments of various methods and devices are described in detail in this application with reference to some modifications, it should be understood that other modifications, embodiments, methods of application, and combinations thereof are also possible. Therefore, the essence and scope of the invention should not be limited to the description of the embodiments included in the present application. Furthermore, while the various embodiments and description may indicate certain anatomical locations, types, or surgical procedures, it should be understood that these embodiments are applicable to other locations, types, and surgical procedures.

Claims (28)

1. Surgical device for dissection of the lens inside the capsular bag of the eye, containing: frame; a rod (12, 112) connected to the body and having a longitudinal axis extending from the proximal end of the rod to the outlet (115) at the distal end (123) of the rod, the rod containing the first lumen (14, 114) and the second lumen passing through him; a dissecting element (16, 116), made with the possibility of moving relative to the rod from the first insertion configuration to the second gripping configuration, in which at least a section of the dissecting element extends outward from the rod, and both the dissecting element, in the first insertion configuration, and the distal end the rods are sized for insertion into the anterior chamber of the eye (1) through the incision (4) to be placed over the anterior surface of the lens (8) inside the capsular bag (6), and moreover, the section of the cutting element is located inside the first lumen, and at least the section of the cutting element is located inside the second lumen, when the cutting element is in the first insertion configuration, and moreover, the second grip configuration contains a loop (121) formed by a completely dissecting element, and the loop contains an open area (46, 146), moreover, the distal section (145) of the open area is located distally relative to the outlet, and the proximal section (143) of the open area is located proximally relative to the outlet, and wherein the second configuration of the transversal gripper is sized and shaped to allow the transversal element to advance between the capsular bag and the lens while the lens remains in the capsular bag to grip a portion of the lens in the open area; and actuator (44) functionally connected to the dissecting element, wherein the actuator is configured to tension the dissecting element to reduce the open area and cut the lens. 2. The surgical device of claim 1, wherein the transversal member has a first arm (18, 118) and a second arm (120), wherein movement of the transversal member from the first insertion configuration towards the second grip configuration results in advancing the first arm distally relative to the nail and leads to the movement of the second arm proximally relative to the distal end of the rod. 3. The surgical device of claim 1, wherein the transversal element undergoes a shape change during the transition of the transversal element from the first insertion configuration towards the second grip configuration as a result of the transversal element extending past the first and second lumen, the second grip configuration having a predetermined shape. 4. The surgical device of claim 3, wherein the predetermined shape is freeform. 5. The surgical device of claim 3, wherein the predetermined shape of the second grip configuration comprises a kink such that at least a portion of the transversal member extends outwardly from the lumen and proximal to the distal portion of the shaft. 6. The surgical device of claim 3, wherein the predetermined shape comprises a closed flat or non-planar loop. 7. The surgical device of claim 1, wherein the loop has a diameter greater than the diameter of the capsulorhexis in the capsular bag. 8. The surgical instrument of claim 1, wherein the dissecting member is a nickel-titanium alloy wire. 9. The surgical device of claim 1, wherein the dissecting member has a first arm (18, 118) and a second arm (120), and wherein the second arm in the second grip configuration flexes back more than 120 degrees relative to the longitudinal axis of the shaft. 10. The surgical device according to claim 1, further comprising a handle (42) attached to the proximal end of the rod, and the dissecting element is subject to rotational movement in response to the action of the actuating element on the handle, and the rotational movement occurs relative to the longitudinal axis of the rod. 11. The surgical device of claim 10, wherein the actuating element is a slider operatively connected to both the transversing element and a cam (50) that converts the linear movement of the slider into a rotary movement of the transversing element. 12. The surgical device of claim 1, wherein the loop is curved and non-planar. 13. The surgical device of claim 1, wherein the first insertion configuration of the dissecting element is sized for insertion through the capsulorhexis (10) on the anterior surface of the capsular bag of the eye, wherein the dissecting element is movable from the first insertion configuration to the second grip configuration, to move between the lens and the capsular bag, so that when the dissecting element has a second gripping configuration, the dissecting element is shaped and sized to surround the lens within the capsular bag; and wherein the dissecting member is movable to a third configuration from the second gripping configuration to apply a shearing force to the lens, with the lens remaining inside the capsular bag. 14. The surgical device of claim 1, wherein the dissecting member is movable from the first insertion configuration to the second gripping configuration to move between the lens and the capsular sac when a force is applied to the capsular sac below a threshold corresponding to damage to the capsular sac. 15. The surgical device of claim 1, wherein the dissecting member has a first arm (18, 118) and a second arm (120), and wherein the dissecting member in the second grip configuration comprises a first arm portion within the first lumen and a second arm portion within the second lumen. 16. The surgical device of claim 1, wherein the dissecting member has a first arm (18, 118) and a second arm (120), and wherein the first arm is connected to the shaft such that only the first arm is slidable relative to the shaft. 17. The surgical device of claim 1, wherein the open area of the dissecting member, when in the second grip configuration, has a diameter greater than the diameter of the capsulorhexis in the capsular bag. 18. The surgical device of claim 1, wherein the transversal member comprises a first arm (18, 118) and a second arm (120), wherein the first arm and the second arm of the transversal member converge together to form a loop. 19. The surgical device of claim 18, wherein the fusion point (22) is formed between the first arm and the second arm, the fusion point being located in the region of the distal end of the nail. 20. The surgical device of claim 19 wherein the distal portion of the open area extends distally to the fusion point and the proximal portion of the open area extends proximal to the fusion point.

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