A medical device for sectioning an intraocular lens

Abstract

A medical device for sectioning an intraocular lens comprises a delivery element 220 having a lumen and a distal opening, and a sectioning element 400 configured to be housed within the lumen in a com

Description

[0001] This application generally relates to the field of a medical device for ophthalmic surgeries and, more specifically, to a medical device configured to fragment an intraocular lens into a multitude of pieces, notably with a single mechanical sectioning operation. COPYRIGHT

[0002] A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever. BACKGROUND

[0003] Conventional ophthalmic surgeries often necessitate the disintegration of lenticular tissue and solid intraocular objects, such as the intraocular lens, into pieces to facilitate their extraction from the eye. For instance, cataract surgery, a prevalent outpatient procedure, involves more than 3 million cases annually in the United States alone.

[0004] The lens resides within an anatomical structure referred to as the capsular bag, which separates the vitreous cavity from the anterior chamber (located between the capsular bag and the cornea). It is undesirable to allow fluid communication between the vitreous cavity and the anterior chamber, so during the process of extraction of the lens, care is taken to maintain the integrity of the posterior surface of the capsular bag. However, the capsular bag is composed of thin, delicate tissue. As a result, the physician must exercise extreme care in removing lens tissue to avoid unintended damage to the capsular bag. Further complicating the procedure, the lens is typically removed from the anterior surface of the capsular bag through a generally circular incision.

[0005] During cataract surgery a commonly used method for lens extraction is phacoemulsification, which uses ultrasonic energy to break up the lens, after which the lens fragments are aspirated. A significant disadvantage is the potential for complications arising from the aspiration of the lens. Ultrasonic energy and high-volume fluid flow during phacoemulsification may create turbulent conditions, which can adversely affect ocular tissues such as the corneal endothelium. However, phacoemulsification has its own drawbacks. As fluid and substances are aspirated from the capsular bag and the anterior chamber, saline or other fluids are introduced to maintain a constant volume or pressure. The flow of the fluids in the eye during inspiration and aspiration may create turbulent flow, which may have a deleterious effect on the tissue within the eye, such as the corneal endothelium. The ultrasonic energy used in phacoemulsification can have its own negative consequences on ocular tissue. Further, phacoemulsification requires expensive and bulky capital equipment, limiting the locations in which phacoemulsification can be performed.

[0006] US10478334B2 proposes a medical device that includes an element positionable within a element having a lumen defined there through with the element movable from a stored position to a deployed position in which a larger portion of the element extends out of the distal end of the lumen. The element forms a closed loop, which is positioned around the lens while the lens is within a capsular bag. The closed loop is then reduced in size to form a transection cut in the lens in half. A device that meets such description is commercialized by Zeiss (miLoop™) and is designed for mechanically fragmenting the lens nucleus without the need for ultrasound energy. While it has several advantages, it also comes with some notable disadvantages. For example, the miLoop requires surgeons to become familiar with handling its unique mechanism, which involves a retractable nitinol loop that encircles and bisects the lens. This can be challenging forthose who are more accustomed to traditional phacoemulsification techniques. Proper deployment and use of the nitinol loop require precise handling and technique. Inconsistent or improper use can lead to incomplete fragmentation or potential damage to the lens capsule. There is a risk of inadvertently damaging the capsular bag during the procedure, especially if the loop is not correctly positioned or if excessive force is applied.

[0007] In view of the above, there remains a need to provide improved devices and procedures for ophthalmic surgeries that necessitate the disintegration of lenticular tissue and solid intraocular objects, such as the intraocular lens. SUMMARY

[0008] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key aspects or essential aspects of the claimed subject matter.

[0009] As embodied and broadly described herein, the present disclosure relates to a medical device for sectioning an intraocular lens, comprising a delivery element having a lumen and a distal opening; and a sectioning element configured to be housed within the lumen in a compact delivery configuration and to be advanced through the delivery element toward the distal opening, wherein the sectioning element is further configured to transition between the compact delivery configuration to an expanded operational configuration upon deployment, the expanded operational configuration defining a working area adapted to receive and retain at least a portion of the intraocular lens, wherein the sectioning element comprises a deformable support structure and a cutting interface operatively associated with the support structure and spanning at least part of the working area, and wherein the sectioning element is configured to apply one or more forces to the retained intraocular lens to divide the intraocular lens into a multitude of discrete segments during, or in coordination with, reconfiguration from the expanded operational configuration to the compact delivery configuration

[0010] As embodied and broadly described herein, the present disclosure relates to a method for sectioning an intraocular lens, comprising (a) providing a medical device comprising a delivery element having a lumen and a distal opening, and a sectioning element housed within the lumen in a compact delivery configuration; (b) advancing the sectioning element through the delivery element and transitioning it from the compact delivery configuration to an expanded operational configuration upon deployment from the distal opening, the expanded configuration defining an working area; (c) capturing at least a portion of the intraocular lens within the working area, the sectioning element comprising a deformable support structure and a cutting interface operatively associated with the support structure and extending across at least part of the working area; (d) applying one or more forces to the retained intraocular lens by reconfiguring the sectioning element from the expanded operational configuration toward the compact delivery configuration, thereby sectioning the intraocular lens into a multitude of discrete segments.

[0011] As embodied and broadly described herein, the present disclosure relates to a method of sectioning an intraocular lens of a patient, comprising: (a) inserting a distal portion of a delivery element into the eye of the patient, the delivery element comprising a lumen and a distal opening; (b) advancing a sectioning element in a compact delivery configuration through the lumen of the delivery element; (c) deploying the sectioning element from the distal opening, the sectioning element transitioning to an expanded operational configuration that defines a working area adapted to receive and retain at least a portion of the intraocular lens, the sectioning element comprising a deformable support structure and a cutting interface operatively associated with the support structure and extending across at least part of the working area; (d) capturing the intraocular lens within the working area of the deployed sectioning element; (e) reconfiguring the sectioning element from the expanded operational configuration toward the compact delivery configuration while maintaining retention of the intraocular lens; and (f) applying one or more mechanical, tensile, compressive, or shearing forces to the retained intraocular lens during the reconfiguration to divide the lens into a multitude of discrete segments.

[0012] All features of exemplary embodiments which are described in this disclosure and are not mutually exclusive can be combined with one another. Elements of one embodiment can be utilized in the other embodiments without further mention. Other aspects and features of the present invention will become apparent to those ordinarily skilled in the art upon review of the following description of specific embodiments in conjunction with the accompanying FIG.s. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] For a better understanding of the various embodiments described herein, and to show more clearly how these various embodiments may be carried into effect, reference will be made, by way of example, to the accompanying drawings which show at least one example embodiment, and which are now described. The drawings are not intended to limit the scope of the teachings described herein. In the drawings:

[0014] FIG. 1 is a side schematic view of the ocular anatomy;

[0015] FIG. 2 is an illustration of a medical device that can be used to fragment an intraocular lens, in accordance with non-limiting embodiments of the present disclosure;

[0016] FIG. 3A and FIG. 3B are cross-sectional views of the medical device shown in FIG. 2 or of a distal portion thereof, which include an implementation of an actuation assembly to deliver a sectioning element into the eye, in accordance with non-limiting embodiments of the present disclosure;

[0017] FIG. 4A is an illustration of the sectioning element in a compact delivery configuration, in accordance with non-limiting embodiments of the present disclosure;

[0018] FIG. 4B is an illustration of a variant of the sectioning element of FIG. 4A that includes an additional internal element to section the intraocular lens, in accordance with non-limiting embodiments of the present disclosure;

[0019] FIG. 4C is an illustration of the sectioning element of FIG. 4A in an expanded operational configuration forming a working area (e.g., an enclosure) configured to capture an eye lens, in accordance with non-limiting embodiments of the present disclosure;

[0020] FIG. 4D is a cross-sectional view of a distal end of the medical device shown in FIG. 2, where the sectioning element is in the expanded operational configuration of FIG. 4C, in accordance with non-limiting embodiments of the present disclosure;

[0021] FIG. 5A is a cross-sectional view of a distal end of the medical device shown in FIG. 2, where the sectioning element is in the compact delivery configuration, housed within the lumen of the delivery element, in accordance with non-limiting embodiments of the present disclosure;

[0022] FIG. 5B is a cross-sectional view of a distal end of the medical device shown in FIG. 2, where the sectioning element is in the expanded operational configuration of FIG. 4B, in accordance with non-limiting embodiments of the present disclosure;

[0023] FIG. 6 is a non-limiting perspective view of a distal end of the device of FIG. 2, showing the flexible support structure which defines an internal area specifically shaped and sized to accommodate, lasso, surround or receive there through lens, in accordance with non-limiting embodiments of the present disclosure;

[0024] FIG. 7A is a non-limiting perspective view of a deployment element for coupling legs of the flexible support structure, in accordance with non-limiting embodiments of the present disclosure;

[0025] FIG. 7B is a non-limiting elevated view of the deployment element of FIG. 7A which is coupled to legs of the flexible support structure, in accordance with non-limiting embodiments of the present disclosure;

[0026] FIG. 8 illustrates a lens having been sectioned into a multitude of pieces by the sectioning element, in accordance with non-limiting embodiments of the present disclosure;

[0027] FIG. 9 is a non-limiting flowchart of a method of using the medical device of FIG. 2 for fragmenting a lens into a multitude of pieces within a capsular bag of an eye, in accordance with non-limiting embodiments of the present disclosure.

[0028] In the drawings, exemplary embodiments are illustrated by way of example. It is to be expressly understood that the description and drawings are only for the purpose of illustrating certain embodiments and are an aid for understanding. They are not intended to be a definition of the limits of the invention. DETAILED DESCRIPTION

[0029] The present technology is explained in greater detail below. This description is not intended to be a detailed catalog of all the different ways in which the technology may be implemented, or all the features that may be added to the instant technology. For example, features illustrated with respect to one embodiment may be incorporated into other embodiments, and features illustrated with respect to a particular embodiment may be deleted from that embodiment. In addition, numerous variations and additions to the various 5 embodiments suggested herein will be apparent to those skilled in the art considering the instant disclosure which variations and additions do not depart from the present technology. Hence, the following description is intended to illustrate some embodiments of the technology, and not to exhaustively specify all permutations, combinations, and variations thereof.

[0030] The present inventors have through R&D work designed a medical device designed to fragment an intraocular lens, within the eye. For example, the eye can be a human eye. The device is configured to mechanically fragment the intraocular lens into a multitude of discrete pieces, for example, several dozen small fragments, in a single mechanical sectioning motion and while the lens remains in situ.

[0031] As used herein, the term "multitude" refers to more than two discrete pieces or segments. The term is intended to distinguish from devices or methods that merely divide an intraocular lens into two parts (e.g., bisecting or transecting devices). A "multitude" may include three or more pieces resulting from the sectioning process, thereby facilitating more efficient removal or manipulation of lens fragments within the eye

[0032] The device can include a delivery element having a lumen and a distal opening, and a sectioning element operably associated with the delivery element. The sectioning element comprises a flexible support structure defining an internal area and a cutting interface spanning the internal area and coupled to the frame. The sectioning element is configured to transition from a stored position within the delivery element to a deployed position external to the distal opening. In the deployed position, the sectioning element expands to define an working area (e.g., having an internal cavity) sized to receive at least a portion of the lens.

[0033] The working area can be defined by a three-dimensional geometry formed by the expanded flexible support structure and the cutting interface spanning the internal area of the frame. When deployed, the flexible support structure assumes an open configuration, and the cutting interface expands across the frame to form the working area. The working area may define a cavity with sufficient volume to receive and enclose at least a portion of the lens. As the user operates the device, the cutting interface can be pressed against the lens to expand the working area internal volume to receive and hold the complete eye lens within its boundaries.

[0034] The sectioning element is further configured to transition from the expanded operational configuration to a compact delivery configuration while the lens is held within the working area, where the cutting interface applies a cutting or fragmenting action to the lens during the collapse, thereby sectioning the lens into a multitude of fragments in a single mechanical sectioning motion, and without requiring removal of the lens from the eye.

[0035] Advantageously, the disclosed device and method can enable fragmentation of the intraocular lens into sufficiently small pieces to permit removal via irrigation and aspiration alone, thereby significantly reducing, or potentially eliminating, the need for ultrasound energy (i.e., phacoemulsification). This reduction or elimination of phacoemulsification can offer several benefits. Indeed, since the use of ultrasound energy can cause collateral thermal and mechanical stress to adjacent ocular tissues, potentially leading to postoperative complications such as corneal edema and inflammation - therefore, reduction or elimination of phacoemulsification with the use of the disclosed device and method provides notable advantages. In addition, phacoemulsification procedures require substantial technical proficiency, often necessitating years of training to perform safely and effectively - which can be reduced or eliminated with the disclosed device and method. The associated equipment also represents a significant capital investment, with recurring per-procedure costs due to consumables, which may limit access to this technology in low-resource or developing regions - in contrast, the disclosed device and method typically require less associated equipment and may thus represent an easier access alternative. Eye structure

[0036] FIG. 1 is a stylized depiction of a normal human eye 10. Certain anatomical details, well known to those skilled in the art, have been omitted for clarity and convenience. The anterior chamber 100 is a fluid-filled cavity situated between the cornea 102 and the iris 104. The cornea 102 is connected on its periphery to the sclera 106, which is a tough fibrous tissue forming the white shell of the eye. The lens 108 is the second refracting surface in the eye, after the cornea 102. The lens 108 is within a capsular bag 110 and has a posterior surface, an anterior surface and an axis, the lens 108 also has a circumference that separates the anterior surface from the posterior surface. By changing its shape, the lens 108 allows for accommodation (i.e. the process of focusing from distance to near, and at all distances in between). The capsular bag 110 is the structure that holds the lens 108 in a central position within the eye 10. Attached to the periphery of the capsular bag 110 are tiny string-like structures called zonules 112 that help maintain the appropriate orientation of the lens 108 inside the eye, and allow for the process of accommodation to occur. The capsular bag 110 is anterior (closer to the front) to the vitreous cavity 114. The vitreous cavity contains vitreous fluid, a clear gel-like substance that is located in the eye. Medical device

[0037] FIG. 2 illustrates a non-limiting implementation of a medical device that is arranged and configured in accordance with certain features, aspects, and advantages of the present disclosure. The illustrated medical device can be used to section an intraocular lens into a 7 multitude of pieces. Advantagesouly, this sectioning is performed while the intraocular lens is within the eye and with a single mechanical sectionning step.

[0038] In non-limiting practical implementations, the medical device 200 includes a body 210 for grasping by a user. For example, the user can grasp the body 210 with a single hand. The body 210 may have at least a segment of the surface thereof which is raised, depressed, grooved, or textured to improve hold by the user or to improve comfort of the user.

[0039] In non-limiting practical implementations, the body 210 may be formed of a single segment, as shown in FIG. 2. Alternatively, the medical device 200 may include a plurality of segments connected to each other.

[0040] The user may be a medical practitioner, such as an eye surgeon (ophthalmologist), or a surgical robot which is configured for robotic control and actuation by an eye surgeon.

[0041] In non-limiting practical implementations, the body 210 can be formed with first and second housing portions 270, 280 (the second housing portion 280 is shown alone in FIG. 3A and FIG. 3B). For example, first and second housing portions 270, 280 may be configured to assemble one onto another through suitable coupling means. For example, the second housing portion 280 may include a plurality of peripherally spaced projections 360. Correspondingly, the first housing portion 270 may, accordingly, include a plurality of peripherally spaced notches that receive the corresponding projections 360, so as to assemble the first and second housing portions 270, 280, thus forming the body 210.

[0042] In non-limiting practical implementations, the body 210 and / or any components thereof is capable of being autoclaved or sterilized in some other manner. For example, the body 210 and / or any components thereof may be made from any suitable material, such as, but not limited to, polyethylene (PE) including low-density PE, high-density PE, ultra-high molecular weight PE; polypropylene (PP); polytetrafluoroethylene; thermoplastic polyurethane; polycarbonate; polyphtalic acid; acrylic; acrylonitrile butadiene styrene (ABS); silicon; and the like.

[0043] In non-limiting practical implementations, the medical device 200 may have a suitable length, which is convenient for the intended ophthalmologic procedure. For example, the medical device 200 may have a length L from a proximal end to a distal end thereof of from about 100 mm to about 300 mm, including any values or ranges therein. For example, a length L of about 120 mm, about 130 mm, about 140 mm, about 150 mm, about 160 mm, about 170 mm, about 180 mm, about 190 mm, about 200 mm, about 210 mm, or about 220 mm. For example, a length Lof about 140 mm, about 145 mm, or about 150 mm. For example, a length L of about 145 mm.

[0044] In non-limiting practical implementations, the medical device 200 may have a suitable thickness, which is convenient for the intended ophthalmologic procedure. For example, the medical device 200 may have a thickness H of from 6.0 mm to about 9.0 mm, including any values or ranges therein. For example, a thickness H of about 6.5 mm, about 7.0 mm, about 7.5 mm, or about 8.0 mm, preferably a thickness H of about 7.4 mm.

[0045] In non-limiting practical implementations, the medical device 200 may have a suitable width, which is also convenient for the intended ophthalmologic procedure. For example, the medical device 200 may have a width W of from 10.0 mm to about 20.0 mm, including any values or ranges therein. For example, a width W of about 12.0 mm, about 14.0 mm, about 14.5 mm, about 15.0 mm, about 15.5 mm, about 16.0 mm, about 17.0 mm, preferably a width W of about 15.4 mm. Delivery element

[0046] In non-limiting practical implementations, the medical device 200 described herein can be configured to deliver and position a sectioning element through a delivery element in an eye of a patient in order to fragment the intraocular lens into a multitude of pieces.

[0047] FIG. 3A and FIG. 3B each depict a cross-sectional view of the medical device 200, which includes delivery element 220. For example, the delivery element 220 can couple to and extend from a distal end of the body 210.

[0048] In non-limiting practical implementations, the delivery element 220 has an elongated shape that extends from the distal end of the body 210 along a longitudinal axis Q. In nonlimiting practical implementations, the delivery element 220 and the body 210 can both extend along the same longitudinal axis Q, as shown in FIG. 3A.

[0049] In non-limiting practical implementations, the delivery element 220 includes an internal wall 225 which defines internal lumen 370, and includes distal opening 390. The distal opening 390 can be in fluid communication with the lumen 370.

[0050] As mentioned above, the medical device 200 is particularly useful to fragment the intraocular lens in the eye. As such, the delivery element 220 advantageously may be sized for introductions of a distal portion of the delivery element 220 into the eye, for example through an ocular incision having a size which is sufficient to fit at least the distal portion of the sectioning element there through. The corneal incision can be generally about 5 mm or less in width, such as about 3.5 mm, and can be made with a small knife. Thus, the outer diameter of the delivery element 220 advantageously can be 3.5 mm or less. Where a differently-sized incision is used, a different outer diameter of delivery element 220 may be used, keeping in mind that it is most desirable to form the incision as a line about 5 mm or less in length.

[0051] In non-limiting practical implementations, the delivery element 220 may be an ovular cross-section tube with a rounded tip. The ovular cross-section may enhance the ability of the delivery element 220 to be inserted into the eye 10 through the corneal incision, without damaging the eye 10. Additionally, in the event that there are multiple elements contained within the delivery element 220, they may be arranged side-by-side more easily in the lumen 370 of the ovular cross-section delivery element 220. Alternately, the delivery element 220 may have a circular cross-section or a cross-section of any other suitable shape.

[0052] In non-limiting practical implementations, the delivery element 220 may further include guiding elements 215 which distally extends from a distal end of the delivery element 220. These guiding elements 215 can take the form of guiding posts that facilitate, align and / or guide delivery of the sectioning element within the eye 10, as will be discussed later in this text. Sectioning element

[0053] In non-limiting practical implementations, the medical device 200 includes sectioning element 400. The sectioning element 400 is configured to fragment the intraocular lens within the eye into a multitude of pieces, with a single sectioning operation.

[0054] In non-limiting practical implementations, the delivery element 220 houses the sectioning element 400 in a compact delivery configuration (shown in FIG. 4A). The sectioning element 400 is configured to coaxially displace through the lumen 370 out the distal opening 390. For example, the coaxial displacement can occur through the lumen 370 along the longitudinal axis Q relative to the delivery element 220. When exiting the distal opening 390, the sectioning element 400 is configured to expand into an expanded operational configuration (shown in FIG. 4C and FIG. 5A).

[0055] In some embodiments, the sectioning element 400 expansion to the expanded operational configuration occurs passively due to the material from which is composed the sectioning element 400, as will be discussed elsewhere in this text.

[0056] In non-limiting practical implementations, portions of the outer surface of the sectioning element 400 may be coated to improve certain aspects of the device. For example, as discussed in greater detail below, the sectioning element 400 traverses a space between the capsular bag 110 and the lens 108. As the sectioning element 400 moves between these anatomical structures it may be advantageous to have a more hydrophilic or hydrophobic surface so the sectioning element 400 rotates and moves more freely. In one embodiment, at least a portion 10 of the sectioning element 400 may be coated with a hydrophobic material such as a fluoropolymer; for example, PTFE. A coating can be added through dip coating, plasma vapor deposition process, heat shrink sleeves, or any other suitable method. The coating can reduce the friction between the sectioning element 400, and the lens 108 and / or capsular bag 110, to allow the sectioning element 400 to move more freely. Other methods of reducing the friction may include using mechanical abrasion, plasma treatments, or any other suitable method. Alternatively, the sectioning element 400 may be coated with other materials such as active pharmaceutical agents which are configured to release into they during the procedure. For example, a steroid like triamcinolone may be added to the surface of the sectioning element 400 such that during the procedure it releases into the eye. Any other number of coatings and drugs may be contemplated.

[0057] Several components of the sectioning element 400 will now be described with reference to FIGs 4A, 4B, 5A and 5B. Flexible support structure

[0058] In non-limiting practical implementations, the sectioning element 400 includes a flexible support structure 410.

[0059] In non-limiting practical implementations, the flexible support structure 410 is configured to reversibly transition from a compact delivery configuration (shown in FIG. 4A) to an expanded operational configuration (shown in FIG. 4C).

[0060] In non-limiting practical implementations, the flexible support structure 410 may be composed of a single wire-structure capable of expanding into a deployed loop. Alternatively, the flexible support structure 410 may be composed of first and second wire legs that couple to deployment element 700 shown in FIG. 7A, forming a shape with a perimeter so that the flexible support structure 410 can expand and form the deployed loop. The deployment element 700 will be discussed in further details later in this text.

[0061] In non-limiting practical implementations, the flexible support structure 410 can be a wire having a round cross section of sufficient diameter to reduce the likelihood of tearing or damaging the capsular bag 110. The diameter of that round cross section wire may be of from about 0.02 mm to about 0.7 mm, but may also be any size that prevents excessive stress from being placed on the capsular bag. Alternatively, the profile of the flexible support structure 410 may be ovular with a larger width or height, or may be a strap, to further distribute the force of the flexible support structure 410 on the capsular bag 110 over a larger surface area, thereby reducing or eliminating areas of high pressure exerted on the capsular bag 110 by the sectioning element 400.

[0062] In non-limiting practical implementations, when the sectioning element 400 is in the compact delivery configuration, the flexible support structure 410 forms a collapsed loop with a reduced internal area. For example, the collapsed loop may have an ellipse shape which is elongated compared to that one of the deployed loop. In use, the collapsed loop may have at least two functions. First, the collapsed loop may have a size and shape that allows it to be contained (housed) within the delivery element 220. Second, once the sectioning element 400 has been positioned to secure lens 108 therein, transitioning the sectioning element 400 from the expanded operational configuration to the compact delivery configuration causes a fragmentation of the lens 108, as will be further explained later in this text.

[0063] In non-limiting practical implementations, when the sectioning element 400 is in the compact delivery configuration, the flexible support structure 410 defines an internal area having a longer first diameter size D? and a shorter second diameter size D2’. For example, the first diameter size D? of the collapsed loop internal area may be longer than the first diameter Di of the deployed loop internal area, i.e., D? >Di, and the second diameter size D2’ of the collapsed loop internal area may be shorter than the second diameter D2 of the deployed loop internal area, i.e., D2’ <D2.

[0064] In non-limiting practical implementations, the collapsed loop internal area may have a first diameter Di’of from about 4.0 mm to about 12.5 mm, including any ranges or values therein. For example, the diameter D? may be of about 4.0 mm, about 4.5 mm, about 5.0 mm, about 5.5 mm, about 6.0 mm, about 6.5 mm, about 7.0 mm, about 7.5 mm, about 8.0 mm, about 8.5 mm, about 9.0 mm, about 9.5 mm, about 10.0 mm, about 10.5 mm, about 11.0 mm, about 11.5 mm, about 12.0 mm, or about 12.5 mm. For example, the collapsed loop internal area may have a second diameter D2’ of from about 1.0 mm to about 4.5 mm, including any ranges or values therein. For example, the diameter D2’ may be of about 1.0 mm, about 1.5 mm, about 2.0 mm, about 2.5 mm, about 3.0 mm, about 3.5 mm, about 4.0 mm, or about 4.5 mm.

[0065] In non-limiting practical implementations, when the sectioning element 400 is in the expanded operational configuration, the flexible support structure 410 forms a deployed loop, which defines an internal area specifically shaped and sized to accommodate, lasso, surround or receive there through lens 108, as shown in FIG. 4C and FIG. 6.

[0066] In non-limiting practical implementations, the deployed loop has a perimeter defining a circular, oval or other atraumatic cross-section internal area. In use, the deployed loop may be positioned within the capsular bag 110 of eye 10 to accommodate, lasso, surround or receive there through lens 108. The deployed loop open area may thus have a perimeter defining a cross-section with a size that is suitable to capture the lens 108.

[0067] In non-limiting practical implementations, the deployed loop internal area can have a first diameter Di, which is the longest line segment that passes through the center of the circumference cross-section and has two endpoints at the circumference, at the broad part of the ellipse, which is large enough to accommodate, lasso, surround or receive there through the equatorial diameter of lens 108. Further, the deployed loop internal area can also have a second diameter D2, which is the shortest line segment that passes through the center of the circumference cross-section and has two endpoints at the circumference, crossing through the center at the narrowest part, which is large enough to accommodate, lasso, surround or receive there through the sagittal thickness of lens 108. In other words, D2 <Di.

[0068] Typically, the diameter of an adult human eye lens 108 is of from about 8.0 mm to about 10.0 mm (equatorial diameter), with a thickness of lens of from about 4.0 to about 5.0 mm (sagittal thickness).

[0069] In non-limiting practical implementations, the first diameter Di may be of from about 7.5 mm to about 11.0 mm, including any ranges or values therein. For example, the first diameter Di may be of about 7.5 mm, about 8.0 mm, about 8.5 mm, about 9.0 mm, about 9.5 mm, about 10.0 mm, about 10.5 mm, or about 11.0 mm. The second diameter D2 may be of from about 3.5 mm to about 5.5 mm, including any ranges or values therein. For example, the second diameter D2 may be of about 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm, or 5.5 mm.

[0070] In non-limiting practical implementations, the flexible support structure 410 is composed of a medical grade material suitable for use in the eye. For example, the flexible support structure 410 can include a shape memory material allowing it to transition from the compact delivery configuration to the expanded operational configuration, with a high amount of elasticity. For example, the flexible support structure 410 can be made of stainless steel, nickel-titanium alloy, titanium, titanium alloys, silicone, polyimide, PEBAX® polyether block amide, nylon, polycarbonate, Cobalt-Chromium Alloys, MP35N (a nickel-cobalt alloy), tantalum, or any other suitable material. Furthermore, multiple materials joined end to end or in laminated layers or concentric tubes of material may be used. Cutting interface

[0071] In non-limiting practical implementations, the sectioning element 400 further includes a cutting interface 415, which is coupled to the flexible support structure 410.

[0072] Preferably, the cutting interface 415 spans the internal area.

[0073] In non-limiting practical implementations, when the sectioning element 400 is in the compact delivery configuration, the cutting interface 415 is compressed allowing the sectioning 13 element 400 to be contained (housed) within the delivery element 220, as shown in FIG. 5A In other words, the cutting interface 415 can substantially form a compacted structure with the flexible support structure 410 to enable for the sectioning element 400 to be contained (housed) within the lumen 370 of the delivery element 220.

[0074] In non-limiting practical implementations, when the sectioning element 400 transitions to the expanded operational configuration, the cutting interface 415 spans the internal area and extends along a plane formed by the flexible support structure 410, as shown in FIG. 4B. Alternatively, when the sectioning element 400 transitions to the expanded operational configuration, the cutting interface 415 can partially deploy in the form of a slightly concave cutting interface structure which can extend on one side of the plane formed by the flexible support structure 410 (not shown).

[0075] In non-limiting practical implementations, the cutting interface 415 is configured for placement over the anterior surface of lens 108 to initiate the lens 108 capture procedure.

[0076] In some embodiments, the concave cutting interface structure is defined by the three-dimensional geometry formed by the interaction of the flexible support structure 410 and the cutting interface 415 spanning its internal area. In the deployed position, the flexible support structure 410 assumes an open configuration that supports the cutting interface 415 peripherally. Upon positioning the sectioning element 400 over the eye lens 108, the user may operate the device to press the cutting interface 415 against the anterior surface of the lens 108. As a result, the cutting interface 415 deforms and progressively conforms to the curvature of the lens 108, forming a concave structure that extends away from the plane of the flexible support structure 410. This deformation creates a three-dimensional cavity, bounded laterally by the flexible support structure 410 and volumetrically shaped by the tensioned cutting interface 415, which captures and secures the lens 108 in a manner corresponding to its geometry. The working area thus formed serves both to contain the lens 108 during manipulation and to facilitate mechanical sectioning as the sectioning element 400 transitions from the deployed to the compact delivery configuration.

[0077] In non-limiting practical implementations, the cutting interface 415 is made from a material having bidirectional elasticity properties allowing the cutting interface 415 to extend and conform to the lens 108 shape. For example, the cutting interface 415 can be made of a medical grade material suitable for use in the eye. For example, the cutting interface 415 can be made with flexible or super elastic material, plastics materials, or metal materials. For example, the cutting interface 415 can be made with nylon (e.g., known for its strength and flexibility), polypropylene, nickel-titanium alloy, HDPE (High-Density Polyethylene) (e.g., which offers high abrasion resistance and durability), polyester (e.g., which provides softness and higher strength 14 compared to nylon and polyethylene, UHMWPE (Ultra-High-Molecular-Weight Polyethylene) (e.g., which is known for its high strength and lightweight properties), biopolymers such as chitosan, alginate, and collagen (e.g., which can offer biocompatibility and biodegradability), vicryl, Gore-Tex (expanded polytetrafluoroethylene or “ePTFE”), Prolene which is a brand of synthetic polypropylene and more specifically composed of an isotactic crystalline stereoisomer of polypropylene (manufactured by Ethicon Inc., a subsidiary of Johnson &Johnson), nitinol, or any feasible composites thereof. For example, the cutting interface 415 can be made of knitted filaments of extruded polypropylene, where each fiber junction is interlinked to provide elasticity in both directions.

[0078] In non-limiting practical implementations, the shape of the working area cavity 430 is defined by the material or geometric properties of the cutting interface 415 engaging with the lens 108.

[0079] In non-limiting practical implementations, the cutting interface 415 contains multiple small openings afforded by one or more possible cutting interface patterns. For example, the cutting interface 415 can have a closely spaced grid or lattice pattern, allowing the device to apply pressure evenly across the lens 108. For example, the cutting interface 415 can have a radial pattern, where the plurality of wire elements radiate from a central point, allowing for efficient cutting of the lens 108 in all directions. For example, the cutting interface 415 can have an intersecting line pattern, where the plurality of wire elements intersect at various angles, similar to a crisscross, but with different angles and spacing. For example, the cutting interface 415 can have a triangular or diamond pattern, which may provide sharp points that can penetrate the lens 108.

[0080] In non-limiting practical implementations, the cutting interface 415 contains a multitude of wire elements 420 each having respective ends coupled to the periphery of the flexible support structure 410. For example, the cutting interface 415 may take the form of a mesh, as shown in FIG. 4B.

[0081] In non-limiting practical implementations, the multitude of wire elements 420 are intersecting wire elements.

[0082] In non-limiting practical implementations, each of the multitude of wire elements 420 have a wire diameter of from about 0.050 mm to about 0.200 mm, including any ranges or values therein. For example, a wire diameter of about 0.050 mm, about 0.100 mm, about 0.150 mm, about 0.200 mm.

[0083] In non-limiting practical implementations, the cutting interface 415 is capable of forming a dome-like structure that captures the lens 108, as shown in FIG. 4C and FIG. 4D. For example, 15 the dome-like structure can have a height H’ at the apex, which is suitable to capture the entire lens 108 within the cavity 430 defined by the cutting interface 415.

[0084] In non-limiting practical implementations, the height H’ at the apex may be of from about 3.5 mm to about 5.5 mm, including any ranges or values therein. For example, the height H’ at the apex may be of about 3.5 mm, about 4.0 mm, about 4.5 mm, about 5.0 mm, or about 5.5 mm.

[0085] In non-limiting practical implementations, when the cutting interface 415 containing the captured lens 108 transitions from the expanded operational configuration to the compact delivery configuration, the cutting interface 415 sections the whole lens 108 into a multitude of pieces. For example, the multitude of pieces can correspond to the cutting interface 415 openings.

[0086] In non-limiting practical implementations, the openings have a diameter of from about 50 microns to about 2.5 mm in size, including any value or ranges therein. For example, a diameter of about 50 microns, about 100 microns, about 150 microns, about 200 microns, about 250 microns, about 300 microns, about 350 microns, about 400 microns, about 450 microns, about 500 microns, about 550 microns, about 600 microns, about 650 microns, about 700 microns, about 750 microns, about 800 microns, about 850 microns, about 900 microns, about 950 microns, about 1000 microns, about 1100 microns, about 1200 microns, about 1300 microns, about 1400 microns, about 1500 microns, about 1600 microns, about 1700 microns, about 1800 microns, about 1900 microns, about 2000 microns, about 2100 microns, about 2200 microns, about 2300 microns, about 2400 microns, about 2500 microns, including any values therein between. For example, the multiple openings may each have a size of about 1.0 mm x about 1.0 mm. The reader will readily understand that 1000 microns = 1 mm.

[0087] In non-limiting practical implementations, the sectioning element 400 may include additional one or more internal flexible support structures 410’, as shown in FIG. 4B and FIG. 4D. Such additional one or more internal flexible support structures 410’ may be located at a distance from the flexible support structure 410, within the cavity 430. Such additional one or more internal flexible support structures 410’ may constitute additional pressure points against the captured lens 108 which can further contribute to the sectioning action upon transitioning the sectioning element 400 from the expanded operational configuration to the compact delivery configuration. Such additional one or more internal flexible support structures 410’ can be made with flexible or super elastic material, plastics materials, or metal materials.

[0088] In non-limiting practical implementations, additional components may be used to sheath sectioning element 400 during insertion through the corneal incision. For example, a tapered piece may be positioned on the distal end of the delivery element 220, which gradually tapers from the end of the delivery element 220 down to a smaller cross section such that it can aid insertion through the corneal incision. The tapered piece can also cover the sectioning element 400 to constrain it during insertion. The tapered piece can further have a slit in the front which the sectioning element 400 can extend through or tear open once it has passed through the incision.

[0089] In operation, once the lens is securely captured within the cavity formed by the deployed cutting interface 415 and flexible support structure 410, the sectioning element 400 is actuated to transition from the expanded operational configuration to the compact delivery configuration. During this transition, the cutting interface 415 contracts and applies distributed mechanical forces across the surface of the lens. As the cutting interface 415 collapses inwardly, its filaments or strands, which may be under tension and / or possess sharpened or rigid characteristics, exert localized pressure that shears, slices, or otherwise mechanically divides the lens material along multiple intersecting paths, as shown in FIG. 8. This coordinated collapse results in the fragmentation of the lens into a multitude of discrete pieces, typically numbering in the dozens, with a single mechanical movement. The sectioning action occurs entirely within the eye 10, without requiring prior phacoemulsification, thereby enabling efficient in situ fragmentation of the lens suitable for removal by irrigation and aspiration. Actuator assembly

[0090] In non-limiting practical implementations, the medical device 200 includes an actuator assembly configured to control the sectioning element 400. While the following text describes a particular implementation of an actuation assembly with reference to the enclosed Figures, the reader will nevertheless understand that variations may be used to achieve a similar result.

[0091] FIG. 3A depicts a non-limiting practical implementation of actuation assembly 300, which includes suitable component or combination of components capable of providing the functionality described herein (also some of which are shown in FIG. 3B).

[0092] In non-limiting practical implementations, the actuation assembly 300 includes one or more actuators configured to control a translational movement of the sectioning element 400 into and out of the delivery element. For example, the one or more actuators configured to control the translational movement can be manually engaged by the user to control the sectioning element 400.

[0093] For example, the one or more actuators configured to control the translational movement can take the form of actuator 240. The actuator 240 can be manually controlled or can be motor driven, for example.

[0094] For example, the actuator 240 can be conveniently located with at least a portion thereof being above an external surface of the body 210. For example, the actuator 240 can be located at a proximal portion of the body 210 for ease of access and actuation with a finger.

[0095] In non-limiting practical implementations, the actuator 240 may be a slider, trigger, wheel, or any other form that can be easily engaged, preferably with only one finger. FIG. 2 and FIG. 3A illustrate the case where the actuator 240 is a slider.

[0096] In non-limiting practical implementations, the actuator 240 may include grooves, or some otherform that is capable of providing friction, along an edge thereof to improve the user’s ability to confidently engage and release the actuator 240, even when moisture is present or when the user is wearing gloves. Furthermore, to improve the safety of using the medical device 200, the actuator 240 may include a locking mechanism or a means of preventing the unintended engagement or release of said actuator.

[0097] In non-limiting practical implementations, the actuator 240 may be made of the same or different material as the body 210.

[0098] In non-limiting practical implementations, the body 210 has an internal surface 50 defining an internal cavity 390, which is configured to accommodate internal components of the actuation assembly 300. The internal components of the actuator assembly 300 are configured to at least operatively connect the actuator 240 to the sectioning element 400.

[0099] In non-limiting practical implementations, the actuation assembly 300 may include a delivery stem or rod, which includes proximal and distal portions 350A, 350B. The distal portion 350B operatively couples to a distal end thereof to the sectioning element 400. For example, such coupling can be direct by crimping, welding, adhesives, mechanical interlocks, or any other suitable structure or method, or can be indirect through deployment element 700 (which will be discussed later in this text).

[00100] For example, the distal portion 350B can have a size and shape suitable for coaxial displacement within the delivery element 220, whereas the proximal portion 350A can have a size and shape which impedes coaxial displacement within the delivery element 220. For example, the proximal portion 350A can have a size and shape such that a distal end thereof abuts against an internal transverse wall 375 which stops the coaxial displacement of the proximal portion 350A. In such embodiments, the internal transverse wall 375 includes a central aperture 395 through which travels the distal portions 350B along a distance which is sufficient to allow the sectioning element 400 operatively coupled to the distal end of the distal portions 350B to exit the delivery element 220 through the opening 390.

[00101] In non-limiting practical implementations, engaging the actuator 240 from a first position to a second position causes the coaxial movement of the proximal and distal portions 350A, 350B. For example, when the actuator 240 is a slider as shown in FIG. 2 and FIG. 3A, advancing the actuator 240 from a first position to a second position as shown with arrow 290, causes a coaxial movement of the proximal and distal portions 350A, 350B, until the distal end of the proximal portion 350A abuts against the internal transverse wall 375 which stops the coaxial displacement of the proximal portion 350A. Meanwhile, the distal portion 350B having a size and shape suitable for coaxial movement through the central aperture 395 and within the delivery element 220, has advanced the sectioning element 400 to exit the delivery element 220 through the opening 390. At this point, as the internal wall 225 of the delivery element 220 no longer compresses the sectioning element 400, the sectioning element 400 expands to the expanded operational configuration. Optionally, the actuator 240 may include a snapping mechanism to retain the actuator 240 at its second position to avoid unintended return of the sectioning element 400 within the delivery element 220.

[00102] In non-limiting practical implementations, the coupling between the actuator 240 and the proximal I distal portions 350A1350B can be permanent or transient.

[00103] A non-limiting implementation of a transient coupling will now be discussed. In this implementation, the actuation assembly 300 includes connecting stem 320 which operatively couples the proximal I distal portions 350A I 350B with the actuator 240. For example, the connecting stem 320 can include an engaging element located at a proximal portion thereof, which is configured to engage with corresponding and complementary engaging element on the actuator 240 (not shown) upon actuation of the actuator 240. For example, actuating the actuator 240 from the first position to the second position causes a distal movement of the proximal I distal portions 350A I 350B through the forced engagement of the connecting stem 320 engaging element with the corresponding engaging element on the actuator 240, allowing a solidary movement between the actuator 240 and the proximal I distal portions 350A1350B.

[00104] A non-limiting implementation of a permanent coupling will now be discussed. In this implementation, the actuation assembly 300 includes connecting stem 320 which operatively couples the proximal I distal portions 350A I 350B with the actuator 240. For example, the connecting stem 320 can include an engaging element located at a proximal portion thereof, which is configured to permanently engage with corresponding and complementary engaging element on the actuator 240. For example, actuating the actuator 240 from the first position to the second position causes a distal displacement of the proximal I distal portions 350A / 350B through the permanent engagement of the connecting stem 320 engaging element with the corresponding engaging element on the actuator 240 (not shown), allowing a solidary movement between the actuator 240 and the proximal I distal portions 350AI 350B.

[00105] In non-limiting practical implementations, the actuation assembly 300 can provide haptic or audible feedback to the operator (and others working with the operator), for example in the form ofclicking sounds or vibration corresponding to engagement of engaging elements.

[00106] In non-limiting practical implementations, one of the connecting stem 320 engaging element and the corresponding and complementary engaging element on the actuator 240 may be a protrusion or pin while the other one may be a slot configured for engaging with the protrusion or pin. Of course, many other forms of complementary engaging elements may be devised that functionally couple the actuator 240 to the proximal I distal portions 350A1350B.

[00107] In non-limiting practical implementations, actuating the actuator 240 from a first position to a second position (movement shown with arrow 290 in FIG. 2 and FIG. 3A) effectively engages the internal components of the actuation assembly 300 to cause the coaxial movement of the sectioning element 400 to exit the element 220. In a reverse manner, actuating the actuator 240 from the second position to the first position effectively engages the internal components of the actuation assembly 300 to cause the coaxial movement of the sectioning element 400 to reintegrate the element 220.

[00108] In non-limiting practical implementations, the actuation assembly 300 can further include one or more actuators configured to control the transition from the expanded operational configuration to the compact delivery configuration of the sectioning element. For example, the one or more actuators configured to control the transition from the expanded operational configuration to the compact delivery configuration of the sectioning element can be manually engaged by the user to control the sectioning element 400.

[00109] For example, the one or more actuators configured to control the transition from the expanded operational configuration to the compact delivery configuration of the sectioning element can take the form of actuator 310. The actuator 310 can be manually controlled or can be motor driven, for example.

[00110] In non-limiting practical implementations, the actuator 310 may be a slider, trigger, wheel, or any other form that can be easily engaged, preferably with only one finger. FIG. 2 and FIG. 3A illustrates the case where the second actuator 310 is a wheel.

[00111] In non-limiting practical implementations, the actuator 310 may include grooves, or some otherform that is capable of providing friction, along an edge thereof to improve the user’s ability to confidently engage and release the second actuator 310, even when moisture is 20 present or when the user is wearing gloves. Furthermore, to improve the safety of using the medical device 200, the second actuator 310 may include a locking mechanism or a means of preventing the unintended engagement or release of said actuator.

[00112] In non-limiting practical implementations, both the actuator 240 and the actuator 310 can be conveniently located on an external surface of the body 210, next to each other.

[00113] In non-limiting practical implementations, the medical device 200 may optionally include one or more actuators configured to control a rotational movement of the sectioning element 400 about longitudinal axis Q of the delivery element. For example, the one or more actuators configured to control the rotational movement can be manually engaged by the user to control a rotational movement of the sectioning element 400.

[00114] For example, the one or more actuators configured to control the rotational optional movement can take the form of actuator 365. The actuator 365 can be manually controlled or can be motor driven, for example.

[00115] For example, the actuator 365 can be located at a distal portion of the body 210 for ease of access and actuation with a finger.

[00116] In non-limiting practical implementations, the actuator 365 may be a slider, trigger, wheel, or any other form that can be easily engaged, preferably with only one finger. FIG. 3A and FIG. 3B illustrate the case where the actuator 365 is a wheel.

[00117] In non-limiting practical implementations, the actuator 365 may include grooves, or some otherform that is capable of providing friction, along an edge thereof to improve the user’s ability to confidently engage and release the actuator 365, even when moisture is present or when the user is wearing gloves. Furthermore, to improve the safety of using the medical device 200, the actuator 365 may include a locking mechanism or a means of preventing the unintended engagement or release of said actuator.

[00118] In non-limiting practical implementations, the actuator 365 may be made of the same or different material as the body 210.

[00119] In non-limiting practical implementations, the actuator 365 may be operatively coupled to at least the proximal portion 350A such that actuation of the actuator 365 causes a rotation of the proximal portion 350A which induces a corresponding rotation of the sectioning element 400. When actuator 365 is a wheel, turning the wheel left or right causes a corresponding rotation of the proximal portion 350A which induces a corresponding rotation of the sectioning element 400. For example, such rotation may involve rotating the plane formed by the sectioning element 400 so that the sectioning element traverses a space between the capsular bag and the lens. The plane includes the longitudinal axis Q of the delivery element 220.

[00120] In non-limiting practical implementations, as shown in FIG. 3B, the actuator wheel 365 may be rotatably mounted to the body 210 and positioned adjacent to a gear or interfacing feature of the proximal portion 350A and / or distal portion 350B. The interface between the actuator wheel 365 and the proximal portion 350A and / or distal portion 350B may include teeth or other mating structures that allow torque applied to the wheel to be transmitted to the proximal portion 350A and / or distal portion 350B. As the user rotates the actuator wheel 365, the interlocking teeth or mechanical interface cause the proximal portion 350A and / or distal portion 350B to rotate about the longitudinal axis Q. This rotational movement is transmitted along the length of the delivery stem or rod to induce a corresponding rotation of the sectioning element 400, which is positioned outside and near the distal end of the delivery element 220.

[00121] In some non-limiting implementations, the delivery stem or rod may be a torsionally rigid member configured to transmit rotational force without substantial lag or torsional deformation, ensuring accurate and responsive control of the sectioning element 400 by the user. The configuration shown in FIG. 3A and FIG. 3B enables intuitive and ergonomic control of the sectioning element 400, as the wheel 365 can be accessed with a finger while holding the device. This allows the operator to dynamically and precisely adjust the angular orientation of the sectioning element during a medical procedure without requiring repositioning or use of the other hand.

[00122] In further non-limiting implementations, the actuator wheel 365 may include detents or tactile feedback features that provide resistance or indexing at defined angular positions. Such features may help the user maintain a desired orientation of the sectioning element 400 and reduce the risk of unintentional movement during use.

[00123] In non-limiting practical implementations, the sectioning element 400 can further include a collapsing wire 22 having first end 18 and second end 20. In some embodiments, the collapsing wire 22 can be coupled to the collapsible frame 410 over its entire perimeter. In other embodiments, the collapsing wire 22 can be coupled to the collapsible frame 410 over discrete regions of the perimeter thereof.

[00124] In non-limiting practical implementations, and as shown in FIG. 7B, each of the ends 18, 20 may be connected to respective coupling elements 718, 720 of deployment element 700. The deployment element 700 is connected to the distal portion 350B of the delivery stem or rod and includes flexible arms 750A, 750B that extend distally and are biased radially outward. Upon actuation of the sectioning element 400 to move through the element 220 and exit the distal opening 390, the deployment element 700 also at least partially exits the element 220, causing each of the flexible arms 750A, 750B to extend radially outward. This radial expansion drives the separation of ends 18, 20, thereby facilitating the expansion of the collapsible frame 410 into its expanded operational configuration. When the sectioning element 400 is actuated to transition from the expanded operational configuration back to the compact delivery configuration, the deployment element 700 is retracted into the element 220, drawing the flexible arms 750A, 750B and the corresponding coupled ends 18, 20 towards each other thus forcing the collapsible frame 410 to collapse and the transition of the sectioning element 400 from the expanded operational configuration to the compact delivery configuration.

[00125] In non-limiting practical implementations, and as shown in the zoomed view in FIG. 3A, one of the ends 18, 20 may be movable relative to the element 220 while the other may remain fixed. For example, the second end 20 may be fixed relative to the element 220, while the first end 18 is slidable relative to the element 220 and is connected to the actuator 310. The fixed end 20 may be secured to the element 220 or another structure using crimping, welding, adhesives, mechanical interlocks, or any other suitable structure or method. Actuation of the actuator 310 can cause tensioning of one or both ends 18, 20 such as by retracting one or both ends 18, 20 through the lumen 370 of the element 220. This tensioning action causes the collapsible frame 410 to collapse and the transition of the sectioning element 400 from the deployed to the compact delivery configuration.

[00126] During the transition towards the compact delivery configuration, the constricted cutting interface 410 applies increasing pressure to the lens 108 secured within the working area cavity 430, thus compressing and sectioning the lens 108 into the multitude of pieces 710, as shown in FIG. 8. Referring to FIG. 8, the lens 108 is shown with the capsular bag removed.

[00127] Once the lens 108 has been sectioned into the multitude of pieces 710, the sectioning element 400 can be totally retracted through the opening 390 and reintegrated into the lumen 370 of the element 220. For example, this reintegration may be achieved by actuating the actuator 290 from the second position back to the first position. Such actuation causes coaxial movement of the proximal I distal portions 350A I 350B relative to the element 220 and away from the eye, thereby drawing the sectioning element 400 back into the lumen 370 through the distal opening 390 of the element 220.

[00128] The medical device 200 can include other components such as casings, screws, flanges, bolts, and the like. These elements are believed to be self-explanatory and are not described further herein. The precise configuration of the various components illustrated on the accompanying Figures do not limit the present disclosure.

[00129] In non-limiting practical implementations, one or more additional or alternative mechanisms may be employed to deploy the sectioning element 400. For example, a scroll wheel advancing mechanism or other rotating mechanism may be utilized to deploy the sectioning element 400. In some embodiments, the movement of one or more actuators may be geared up ordown relative to the movement of the sectioning element 400, such that a given movement of the one or more actuators results in a proportionally greater or lesser movement of the sectioning element 400 through the use of gears, scaled pulleys, or other suitable components. Furthermore, certain parts of the medical device 200 may be mechanically powered using components such as motors, linear motors, pneumatics, hydraulics, magnets, or similar mechanisms. The medical device 200 may also be integrated into one or more larger robotic assemblies. For example, a robotic system configured for cataract procedures may incorporate the medical device 200, enabling surgeons to perform portions of the herein described method robotically. Practical implementation

[00130] A practical non-limiting implementation of a method for operating the disclosed device will now be described with reference to method 800 illustrated in FIG. 9.

[00131] At step 810, the method may optionally include performing an incision in the eye with a suitable tool, e.g., a capsulorhexis. This step may further include positioning the medical device 200 at a first point with respect to the eye 10 and advancing the medical device 200 along the longitudinal axis until a delivery element 220 of the medical device 200 has reach a desired depth in the eye 10.

[00132] For example, an incision can be made in the edge of the cornea 102, and the eye surgeon performs a capsulorhexis procedure on the capsular bag 110, resulting in a capsulorhexis in the anterior surface of the capsular bag 110. The capsulorhexis may be performed in any suitable manner, such as incising with a scalpel, applying energy with a femtosecond laser or other energy-based cutter, incising under robotic or automated control, or in any other suitable manner. The capsulorhexis can be torn or cut in a diameter of approximately 2.0 mm to 8.0 mm. According to other embodiments, the capsulorhexis may be made smaller in diameter than 2.0 mm, particularly where fragments of the lens 108 (as described in greater detail below) are small enough in size to be extracted through a smaller-diameter capsulorhexis. The capsulorhexis can be made with a separate set of instruments such as micro-forceps, as is commonly done.

[00133] Typically, a fluid can be introduced between the capsular bag 110 after the capsulorhexis is made, such that a space is created between the lens 108 and capsular bag 110 in at least some areas. This may be referred to as fluid dissection, hydro dissection or space creation. According to some embodiments, the fluid creates a space for the sectioning element 400 in the deployed, capture configuration to be rotated within the capsular bag 110 and surround the lens 108. In an exemplary embodiment, fluids such as viscoelastic hyaluronic acid or saline may be injected since these materials are commonly used during ocular surgery, well tolerated within the eye, and readily available. One or more other or additional fluids may be introduced, such as dyed fluids, pharmaceutical liquids like steroids, drug loaded fluids, bio absorbable fluids, lubricants, hydro gels, microspheres, powdered substances, fluorescent contrast, liquid foams, or any other suitable fluid. Additionally, one or more gases additionally or instead may be introduced, such as air, oxygen, argon, nitrogen, or the like.

[00134] Alternatively, in other embodiments, a fluid space may not be required between the lens 108 and the capsular bag 110, and the sectioning element 400 may perform a mechanical sectioning of the lens 108 as it is rotated about the lens 108.

[00135] According to other embodiments, provisions for fluid dissection may be incorporated into elements of the medical device 200, such as the delivery element 220. For example, the delivery element 220 may be fabricated as a flexible tube with a plurality of holes along its length that allow forthe passage of fluid there through. In such an embodiment, fluid may be introduced into the lumen 370 of the delivery element 220 and then flow out of the plurality of holes. This may improve the ability of the sectioning element 400 to pass between the capsular bag 110 and the lens 108 because the fluid may be introduced through the delivery element 220 continuously or at discrete points in time when dissection is needed. In still other embodiments, the fluid injection may be incorporated in other aspects of the medical device 200. For example, a component separate from the delivery element 220, such as a telescoping tube or other tube, may be connected to the delivery element 220 to provide for fluid introduction. In some embodiments, the fluid which is infused through a component of the device, such as the delivery element 220, may be used for other surgical purposes. For example, fluid may be infused through the delivery element 220 to maintain the chamber of the eye 10 without the need for a separate cannula or without the need fora viscoelastic substance. Irrigation and aspiration may be accomplished through a single component or through multiple separate components. Other irrigation or aspiration techniques may be performed, according to some embodiments.

[00136] At step 820, the method may further include causing delivery of sectioning element 400 overthe lens 108 in the capsular bag.

[00137] For example, this step may include positioning a distal end of the delivery element 220 of the medical device 200 within the eye 10. Advantageously, the delivery element 220 houses the sectioning element 400 in a compact delivery configuration, as shown in FIG. 5A.

[00138] Delivery of the sectioning element 400 in the capsular bag can be performed by engaging a manually operable actuator, which controls a coaxial displacement of the sectioning element 400 through the lumen 370 out the distal opening 390. At this point, the sectioning element 400 expands into the deployed loop, as shown in FIG. 5B.

[00139] At step 830, the method includes capturing the lens 108 with the sectioning element 400.

[00140] As the deployed loop is positioned over the lens to accommodate, lasso, surround or receive there through the lens 108, the cutting interface 415 is pressed against the lens 108. Doing such pressing against the eye lens 108 causes the cutting interface 415 to extend away from the loop plane, thus forming a structure defining cavity 430 that conforms to a shape of the eye lens 108. Subsequently or concomitantly, the sectioning element 400 is rotated around the lens 108 by about 180°, preferably while applying some pressure against the lens 108, to capture the lens 108. The plane formed by the sectioning element 400 can thus be rotated so that the sectioning element traverses a space between the capsular bag and the lens. The plane includes the longitudinal axis Q of the delivery element 220. The rotation may be accomplished by manual rotation of the element 220 or medical device 200 by the user, or may be accomplished by integrated mechanisms within the medical device 200, as described in greater detail elsewhere in this text.

[00141] At step 840, the method includes fragmenting the lens 108 into a multitude of pieces 710 (e.g., several dozens of small pieces), preferably with a single sectioning movement of the sectioning element 400.

[00142] For example, the sectioning element 400 sections the lens into corresponding pieces when transitioning from the deployed to the compact delivery configuration. For example, the transitioning can cause the cutting interface 415 wire elements 420 to apply increasing compressive forces to the eye lens 108, thus resulting in the eye lens 108 being sectioned into the multitude of pieces 710, preferably with a single sectioning movement of the sectioning element 400.

[00143] Advantageously, the resulting multitude of pieces (e.g., several dozens) are of a small size that corresponds to the size of the cutting interface openings.

[00144] At step 850, the multitude of pieces can be removed with any convenient method.

[00145] The multitude of pieces can be removed, for example using an irrigation aspiration, advantageously without phacoemulsification. The reader will readily understand that when removing the multitude of pieces 710 by aspiration with a tip, the tip is selected with an aperture 26 which is larger than the largest size of the multitude of pieces 710. For example, the multitude of pieces 710 may be pushed out of the capsular bag 110 by introducing fluid into the capsular bag 110 under slight pressure. The fluid flow and / or pressure may move the lens 108 multitude of pieces 710 into the anterior chamber 100 of the eye 10, such that other tools and methods for extracting the 108 multitude of pieces 710 may be utilized. For example, forceps or grasping tools may be used to grab the 108 multitude of pieces 710 and pull them out of the eye 10 through the corneal incision.

[00146] For example, the multitude of pieces 710 may be removed with an irrigation and aspiration device, as will be described later in this text.

[00147] The medical device 200 can thus be used to fragment lens 108 within capsular bag 110 of an eye 10 into a multitude of pieces 710 (e.g., typically several dozens of small pieces), with a single sectioning movement of the sectionning element 400. Irrigation and aspiration device

[00148] In some implementation, there is provided an irrigation and aspiration device.

[00149] For example, the device may include a hand piece for holding by the user. The hand piece may include an elongate tip extending distally from the hand piece distal end. The elongate piece may include a plurality of aspiration ports and of irrigation ports positioned at different locations on the tip. The device may further include a pump system capable of independently controlling aspiration and irrigation rates at each port. The device may further include a pressure sensor to monitor intraocular pressure (IOP) in real-time. The device may further include a control unit that adjusts fluid flow rates based on IOP readings to maintain anterior chamber stability.

[00150] In some practical implementation, the aspiration ports may have a size that is suitable to remove multitude of lens fragment pieces having a size of about 1.0 mm or even smaller.

[00151] In some practical implementation, the device may further include a closed-loop feedback system that automatically adjusts fluid flow rates to maintain a target IOP.

[00152] In some practical implementation, the hand piece tip is interchangeable to allow for different port configurations.

[00153] In some practical implementation, the device may further include a pulsed aspiration mode to enhance removal efficiency.

[00154] In some practical implementation, the hand piece tip can be a circular tip with evenly spaced irrigation and aspiration ports around the circumference; or the hand piece tip can be a linear tip with alternating irrigation and aspiration ports along its length; or the hand piece tip can be a curved tip with irrigation ports on the convex side and aspiration ports on the concave side.

[00155] In some practical implementation, the device may have a port configuration allowing for selectively selecting between aspiration ports and irrigation ports. For example, the device may have a port configuration including a first set of aspiration ports and a second set of irrigation ports. In some embodiments, the first set and second set include the same number of ports. In other embodiments, the first set and second set include different number of ports. For example, in a first option, the device may have a port configuration including 4 aspiration ports and 4 irrigation ports. For example, in a second option, the device may have a port configuration including 6 aspiration ports and 3 irrigation ports. For example, in a third option, the device may have a port configuration including 3 aspiration ports and 6 irrigation ports.

[00156] In some practical implementation, the pump system can have a configuration selected from dual peristaltic pumps (one for irrigation, one for aspiration), a venturi pump for aspiration and a gravity-fed irrigation, and a hybrid system with a peristaltic pump for irrigation and a venturi pump for aspiration.

[00157] In some practical implementation, the device may further include a control mechanism for controlling the aspiration and irrigation rates. For example, the control mechanism may include a foot pedal with linear control of aspiration and irrigation rates; or a touchscreen interface for precise flow rate adjustments; or voice-activated commands for hands-free operation; and the like.

[00158] In some practical implementation, the device can operate taking into account hemodynamic formulations. For example with balanced fluidics, which maintains a 1:1 ratio of irrigation to aspiration flow rates, and automatically adjust flow rates based on IOP readings to keep anterior chamber volume constant. For example, with pulsed aspiration, which alternate between high and low aspiration rates at a frequency of 10-20 Hz, and maintain constant irrigation to ensure chamber stability during aspiration pulses. For example, with pressurebased flow control, which can set a target IOP (e.g., 18-22 mmHg), continuously monitor IOP using integrated pressure sensor, and adjusts irrigation and aspiration rates independently to maintain target IOP. For example, with adaptive flow rates, which start with low flow rates and gradually increase based on detected fragment size and density, and reduces flow rates when approaching sensitive structures (e.g., posterior capsule). For example, with multi-port synchronization, which coordinate aspiration and irrigation across multiple ports to create a 28 circular flow pattern within the anterior chamber, and alternate active ports to prevent localized chamber collapse.

[00159] These design options and hemodynamic formulations aim to provide efficient cataract fragment removal while maintaining anterior chamber stability. The multiple ports and adaptive flow control should allow for more precise and safer cataract removal compared to traditional irrigation and aspiration systems.

[00160] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by a person of ordinary skill in the art to which the present invention pertains. As used herein, and unless stated otherwise or required otherwise by context, each of the following terms shall have the definition set forth below.

[00161] Other examples of implementations will become apparent to the reader in view of the teachings of the present description and as such, will not be further described here.

[00162] All references cited throughout the specification are hereby incorporated by reference in their entirety for all purposes.

[00163] Note that titles or subtitles may be used throughout the present disclosure for convenience of a reader, but in no way these should limit the scope of the invention. Moreover, certain theories may be proposed and disclosed herein; however, in no way they, whether they are right or wrong, should limit the scope of the invention so long as the invention is practiced according to the present disclosure without regard for any particular theory or scheme of action.

[00164] As used herein, the wording “independently selected” in reference to a group of specified items refers to the fact that when more than one item is selected from the group of items, the decision of selecting a specific item is not influenced by the decision of selecting any of the previous or following item(s).

[00165] Reference throughout the specification to “some embodiments”, and so forth, means that a particular element (e.g., feature, structure, and / or characteristic) described in connection with the invention is included in at least one embodiment described herein, and may or may not be present in other embodiments. In addition, it is to be understood that the described inventive features may be combined in any suitable manner in the various embodiments.

[00166] It will be understood by those of skill in the art that throughout the present specification, the term “a” used before a term encompasses embodiments containing one or more to what the term refers. It will also be understood by those of skill in the art that throughout the present specification, the term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, un-recited elements or method steps.

[00167] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. In the case of conflict, the present document, including definitions will control.

[00168] As used in the present disclosure, when the terms “around”, “about” or “approximately” are before a quantitative value, the present disclosure also includes the specific quantitative value itself, unless specifically stated otherwise. As used herein, the terms “around”, “about” or “approximately” refer to a ±10% variation from the nominal value unless otherwise indicated or inferred.

[00169] Unless otherwise noted, the expression “at least” or “at least one of’ as used herein includes individually each of the recited objects after the expression and the various combinations of two or more of the recited objects unless otherwise understood from the context and use. The expression “and / or” in connection with three or more recited objects should be understood to have the same meaning unless otherwise understood from the context.

[00170] The use of the term “include,” “includes,” “including,” “have,” “has,” “having,” “contain,” “contains,” or “containing,” including grammatical equivalents thereof, should be understood generally as open-ended and non-limiting, for example, not excluding additional unrecited elements or steps, unless otherwise specifically stated or understood from the context.

[00171] Unless otherwise noted, the order of steps or order for performing certain actions is immaterial so long as the present invention remain operable. Moreover, two or more steps or actions may be conducted simultaneously.

[00172] Unless otherwise noted, the use of any and all examples, or exemplary language herein, for example, “such as” or “including,” is intended merely to illustrate better the present invention and does not pose a limitation on the scope of the invention. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the present invention.

[00173] Furthermore, although the various embodiments and description may specify certain anatomical locations, species, or surgical procedures, it should be appreciated that these embodiments apply to other locations, species, and surgical procedures.

[00174] Although various embodiments of the disclosure have been described and illustrated, it will be apparent to those skilled in the art considering the present description that numerous modifications and variations can be made. The scope of the invention is defined more particularly in the appended claims.

Claims

1. A medical device for sectioning an intraocular lens, comprisinga) a delivery element having a lumen and a distal opening; andb) a sectioning element configured to be housed within the lumen in a compact delivery configuration and to be advanced through the delivery element toward the distal opening,wherein the sectioning element is further configured to transition between the compact delivery configuration to an expanded operational configuration upon deployment, the expanded operational configuration defining a working area adapted to receive and retain at least a portion of the intraocular lens,wherein the sectioning element comprises a deformable support structure and a cutting interface operatively associated with the support structure and spanning at least part of the working area, andwherein the sectioning element is configured to apply one or more forces to the retained intraocular lens to divide the intraocular lens into a multitude of discrete segments during, or in coordination with, reconfiguration from the expanded operational configuration to the compact delivery configuration.

2. The medical device of claim 1, wherein the sectioning element is further configured to reciprocate into and out of the delivery element.

3. The medical device of claim 1 or 2, comprising a body shaped for grasping with a user’s hand, wherein the delivery element is coupled with and extends from a distal end of the body.

4. The medical device of any one of claims 1 to 3, wherein the cutting interface compresses and sections the lens into the multitude of discrete pieces as the sectioning element transitions from the expanded operational configuration to the compact delivery configuration with the lens retained within the working area.

5. The medical device of any one of claims 1 to 4, wherein the cutting interface is configured to conform to a shape of the intraocular lens when pressed against the intraocular lens.

6. The medical device of any one of claims 1 to 5, wherein the cutting interface contains multiple openings, such that the multitude of discrete pieces corresponds to the cutting interface openings.

7. The medical device of claim 6, wherein the openings have a diameter ranging from about 50 microns to about 2.5 mm.

8. The medical device of any one of claims 1 to 7, wherein the cutting interface comprises wire elements having a wire diameter ranging from about 0.050 mm to about 0.200 mm.

9. The medical device of claim 8, wherein the wire elements are composed of a medicalgrade material capable of cutting through the intraocular lens while exhibiting bidirectional elasticity.

10. The medical device of any one of claims 1 to 9, wherein the internal area defined by the frame has a cross-section with a first diameter ranging from about 5 mm to about 10 mm, and a second diameter ranging from about 3.5 mm to about 5.5 mm.

11. The medical device of any one of claims 1 to 10, wherein the sectioning element further comprises one or more internal flexible support structures positioned radially within the flexible support structure, the internal flexible support structures being substantially concentric with the flexible support structure when the sectioning element is in the compact delivery configuration.

12. The medical device of claim 11, wherein, when the sectioning element is in the expanded operational configuration, the one or more internal flexible support structures are axially spaced from the flexible support structure and disposed toward an apical region of the cutting interface defining the working area.

13. The medical device of claim 11 or 12, wherein the one or more internal flexible support structures are configured to contact the intraocular lens at one or more locations distinct from the flexible support structure to apply localized pressure to the lens during the transition of the sectioning element from the expanded operational configuration to the compact delivery configuration to facilitate sectioning of the lens into the multitude of discrete pieces.

14. The medical device of any one of claims 1 to 13, further comprising one or more actuators configured to control a translational movement of the sectioning element into and out of the delivery element.

15. The medical device of claim 14, wherein the one or more actuators further controls a rotational movement of the sectioning element about a longitudinal axis of the delivery element.

16. A method for sectioning an intraocular lens, comprising:a) providing a medical device comprising a delivery element having a lumen and a distal opening, and a sectioning element housed within the lumen in a compact delivery configuration;b) advancing the sectioning element through the delivery element and transitioning it from the compact delivery configuration to an expanded operational configuration upon deployment from the distal opening, the expanded configuration defining an working area;c) capturing at least a portion of the intraocular lens within the working area, the sectioning element comprising a deformable support structure and a cutting interface operatively associated with the support structure and extending across at least part of the working area;d) applying one or more forces to the retained intraocular lens by reconfiguring the sectioning element from the expanded operational configuration toward the compact delivery configuration, thereby sectioning the intraocular lens into a multitude of discrete segments.

17. The method of claim 16, wherein the device comprises a body shaped for grasping with a user’s hand, wherein the delivery element is coupled with and extends from a distal end of the body.

18. The method of claim 16 or 17, wherein the cutting interface compresses the intraocular lens during the transition from the expanded operational configuration to the compact delivery configuration to section the lens into the multitude of discrete pieces.

19. The method of any one of claims 16 to 18, further comprising conforming the cutting interface to a shape of the intraocular lens prior to sectioning.

20. The method of any one of claims 16 to 19, wherein the cutting interface includes multiple openings, and the lens is sectioned along those openings.

21. The method of claim 20, wherein the openings have a diameter ranging from about 50 microns to about 2.5 mm.

22. The method of any one of claims 16 to 21, wherein the cutting interface comprises wire elements having a wire diameter ranging from about 0.050 mm to about 0.200 mm.

23. The method of claim 22, wherein the wire elements are composed of a medical-grade material capable of cutting through the intraocular lens while exhibiting bidirectional elasticity.

24. The method of any one of claims 16 to 23, wherein the internal area has a cross-section defined by a first diameter ranging from about 5 mm to about 10 mm, and a second diameter ranging from about 3.5 mm to about 5.5 mm.

25. The method of any one of claims 16 to 24, wherein the sectioning element further comprises one or more internal flexible support structures positioned within the flexible support structure, the internal flexible support structures being substantially concentric with the flexible support structure in the compact delivery configuration.

26. The method of claim 25, wherein the one or more internal flexible support structures, in the expanded operational configuration, are located axially toward an apical region of the working area relative to the flexible support structure.

27. The method of claim 25 or 26, further comprising pressing the one or more internal flexible support structures against the intraocular lens at one or more locations distinct from the flexible support structure during transition to the compact delivery configuration to assist in sectioning.

28. The method of any one of claims 16 to 27, further comprising actuating one or more control elements to move the sectioning element into and out of the delivery element.

29. The method of claim 28, wherein the one or more control elements further control a rotational movement of the sectioning element about a longitudinal axis of the delivery element.

30. The method of any one of claims 16 to 29, wherein the sectioning occurs in a single continuous transition from the expanded operational configuration to the compact delivery configuration.

31. A method of sectioning an intraocular lens of a patient, comprising:a) inserting a distal portion of a delivery element into the eye of the patient, the delivery element comprising a lumen and a distal opening;b) advancing a sectioning element in a compact delivery configuration through the lumen of the delivery element;c) deploying the sectioning element from the distal opening, the sectioning element transitioning to an expanded operational configuration that defines a working5 area adapted to receive and retain at least a portion of the intraocular lens, thesectioning element comprising a deformable support structure and a cutting interface operatively associated with the support structure and extending across at least part of the working area;d) capturing the intraocular lens within the working area of the deployed sectioning 10 element;e) reconfiguring the sectioning element from the expanded operational configuration toward the compact delivery configuration while maintaining retention of the intraocular lens; andf) applying one or more mechanical, tensile, compressive, or shearing forces to the15 retained intraocular lens during the reconfiguration to divide the lens into amultitude of discrete segments.CLAIMS1. A medical device for sectioning an intraocular lens, comprisinga) a delivery element having a lumen and a distal opening; andb) a sectioning element configured to be housed within the lumen in a compact delivery configuration and to be advanced through the delivery element toward the distal opening,wherein the sectioning element is further configured to transition between the compact delivery configuration to an expanded operational configuration upon deployment, the expanded operational configuration defining a working area adapted to receive and retain at least a portion of the intraocular lens,wherein the sectioning element comprises a deformable support structure and a cutting interface operatively associated with the support structure and spanning at least part of the working area, andwherein the sectioning element is configured to apply one or more forces to the retained intraocular lens to divide the intraocular lens into a multitude of discrete segments during, or in coordination with, reconfiguration from the expanded operational configuration to the compact delivery configuration.

2. The medical device of claim 1, wherein the sectioning element is further configured to reciprocate into and out of the delivery element.

3. The medical device of claim 1 or 2, comprising a body shaped for grasping with a user’s hand, wherein the delivery element is coupled with and extends from a distal end of the body.

4. The medical device of any one of claims 1 to 3, wherein the cutting interface contains multiple openings, such that the multitude of discrete pieces corresponds to the cutting interface openings.

5. The medical device of claim 4, wherein the openings have a diameter ranging from 50 microns to 2.5 mm.

6. The medical device of any one of claims 1 to 5, wherein the cutting interface comprises wire elements having a wire diameter ranging from 0.050 mm to 0.200 mm.

7. The medical device of claim 6, wherein the wire elements are composed of a medicalgrade material capable of cutting through the intraocular lens while exhibiting bidirectional elasticity.

8. The medical device of any one of claims 1 to 7, wherein the internal area defined by the frame has a cross-section with a first diameter ranging from 5 mm to 10 mm, and a second diameter ranging from 3.5 mm to 5.5 mm.

9. The medical device of any one of claims 1 to 8, wherein the sectioning element further comprises one or more internal flexible support structures positioned radially within the flexible support structure, the internal flexible support structures being substantially concentric with the flexible support structure when the sectioning element is in the compact delivery configuration.

10. The medical device of claim 9, wherein, when the sectioning element is in the expanded operational configuration, the one or more internal flexible support structures are axially spaced from the flexible support structure and disposed toward an apical region of the cutting interface defining the working area.

11. The medical device of any one of claims 1 to 10, further comprising one or more actuators configured to control a translational movement of the sectioning element into and out of the delivery element.

12. The medical device of claim 11, wherein the one or more actuators further controls a rotational movement of the sectioning element about a longitudinal axis of the delivery element.A

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