The present disclosure generally relates to surgical devices and, in particular, relates to cataract extraction devices.
Cataracts often cause loss of vision by clouding the lens of the eye. Cataract surgery is often performed, in which the lens is removed from the eye and replaced with a synthetic lens. However, if care is not taken, it can be difficult to remove the lens.
The accompanying drawings, which are included to provide further understanding of the subject technology and are incorporated in and constitute a part of this description, illustrate aspects of the subject technology and, together with the specification, serve to explain principles of the subject technology.
In the following detailed description, specific details are set forth to provide an understanding of the subject technology. It will be apparent, however, to one ordinarily skilled in the art that the subject technology may be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the subject technology.
A handheld device, sometimes referred to herein as a cataract extraction device or an extraction device, is provided that can be used to break the lens of the eye of a patient into a desired number of pieces and remove the resulting pieces from the eye through an incision. For example, after a hydrodissection of the lens has been performed to displace the lens from its capsule, the extraction device can be moved into the eye through a corneal incision and be utilized to encapsulate or partially surround the lens and remove it in a controlled manner in one or more pieces. As another example, the extraction device can be utilized to encircle and cut the lens into smaller pieces while the lens is within the lens capsule. A second device can be used to flush the eye of any lens remnants.
The extraction device may include additional mechanisms or components to control the motion of lens elements out of the anterior chamber of the eye. The devices can be provided together as a kit. In some embodiments, the extraction device can contain at least a part of the lens during and/or after hydrodissection. If the lens is undesirably displaced during hydrodissection, the device can be used to recapture the lens or a portion thereof.
In accordance with various embodiments described in further detail below, an extraction device may be provided with a delivery shaft and a manipulator having one or more components or features that can be extended from a lumen of the delivery shaft to cut, grab, encapsulate, and/or otherwise manipulate the lens of a patient's eye for extraction.
According to some embodiments, for example as shown in
The first wire 130 can form a first arc portion (e.g., loop) distal to the distal end of the delivery shaft 110, and the second wire 140 can form a second arc portion (e.g., loop) distal to the distal end of the delivery shaft 110. Each of the first wire 130 and the second wire 140 can be separately retractable relative to the delivery shaft 110. As shown in
The first wire 130 and the second wire 140 can be rings of metal (e.g., nitinol), plastic, and/or a shape memory material. The capture region 120 may also include other materials, such as a suture or polymer that acts to encircle the lens once deployed from the lumen. The rings can be closed by retraction to cut a lens of a patient into smaller pieces. Alternatively, or in combination, other mechanisms could be employed to dissect the lens, including scissors, forceps, or blades. Such tools can dissect the lens as the lens is held in position or move (e.g., rotate) the lens against a mechanism to cut the lens. Alternatively, or in combination, any number of wires can be provided. For example, wires in addition to the first wire 130 and the second wire 140 can be provided in a nested formation, such that each wire is deployed within a region bounded by an adjacent wire.
According to some embodiments, for example as shown in
According to some embodiments, for example as shown in
The cover 150 can include polyethylene or similar compliant polymer. The cover 150 can include polyethylene and nitinol, PTFE and nitinol, a flexible polymer and/or nitinol, a substantially inflexible material and/or nitinol, a substantially inflexible material and/or a material that acts as a platform for the inflexible or flexible material membranes so that the membrane may be advanced efficiently over the capture region 120. Additional structures that can accompany a cover are discussed in greater detail herein. The cover 150 can be a molded piece of elastomeric material that is everted. The cover 150 can have a natural tendency to return to its original shape. A device that is controllable by a user can be brought into contact with the cover 150 to urge the cover 150 into a shape for which the cover 150 has a bias.
According to some embodiments, the capture region 120 can be introduced prior to the cover 150 and the cover 150 is deployed second over the capture region 120 which has already been positioned to hold the natural lens. According to some embodiments, the cover 150 can be introduced prior to the capture region 120 and the capture region 120 is deployed second over the cover 150 which has already been positioned to hold the natural lens. The cover 150 can be deployed to capture a lens before, during, or after the lens has been cut and/or dissected (e.g., hydrodissected from the lens capsule and/or divided into pieces) by a tool (e.g., the wires 130, 140 of the capture region 120). The cover 150 can be deployed from a proximal end of the capture region 120 and a distal direction or from a distal end of the capture region 120 in a proximal direction.
The capture region 120 and/or the cover 150 can be retracted in stages or in one movement into the lumen of the introducer. According to some embodiments, the material that forms the lumen used to introduce the capture region 120 and cover 150 is composed of flexible material that may expand when the capture region 120 and cover 150 are retracted and then returns to previous form.
According to some embodiments, the capture region 120 and cover 150 are maneuvered in and out of the eye with a screw type mechanism to control linear motion. According to some embodiments, the capture region 120 and cover 150 are maneuvered in and out of the eye with a hydraulic system to control linear motion. According to some embodiments, the capture region 120 and cover 150 are maneuvered in and out of the eye with a mechanical mechanism to control linear motion, such as a pneumatic control.
According to some embodiments, the capture region 120 and cover 150 are maneuvered in and out of the eye after the lens has been completely removed from the natural bag and positioned at the iris plane or above.
According to some embodiments, the capture region 120 and cover 150 are maneuvered to feed the lens into a cutting membrane that is present at the lumen of the device so as to cause further segmentation of the lens prior to retracting into the lumen. According to some embodiments, the capture region 120 and cover 150 are maneuvered to feed the lens using a twisting action so as to cause further segmentation of the lens prior to retracting into the lumen. According to some embodiments, a third structure is introduced that contains a second lumen that “punches a hole” within the body of the contained lens material so as to core out the central nucleus prior to being retracted into the lumen of the main device. According to some embodiments, the device lumen is connected to an inflow and outflow lumen that allows for fluid to enter and exit the eye and to maintain the anterior chamber. According to some embodiments, the device lumen is connected to an inflow and outflow lumen that allows for lens material to enter and exit the eye and to maintain the anterior chamber.
According to some embodiments, the cover 150 surrounds the lens which has been dissected out of the lens bag, and a cover 150 that contains a second lumen “punches a hole” within the body of the contained lens material so as to core out the central nucleus prior to being retracted into the lumen of the main device (no capture region 120 is used).
According to some embodiments, the extraction device is devoid of electronic components. According to some embodiments, the extraction device is operated using finger and hand controls. According to some embodiments, the extraction device is operated with foot pedal controls. According to some embodiments, the extraction device is operated using robotic controls.
According to some embodiments, the capture region 120 is used independently to segment the lens into smaller pieces and a second device, commonly known as phacoemulsification hand piece or irrigation/aspiration hand piece, is used to remove the segmented lens pieces.
According to some embodiments, the capture region 120 and/or the cover 150 are manufactured from materials that are substantially transparent to optical coherence tomography (OCT) imaging so as to not interfere or substantially not interfere with intraoperative OCT imaging. According to some embodiments, the structures of the extraction device are colored so the operator may easily differentiate between the parts.
According to some embodiments, the entire extraction device is disposable. According to some embodiments, some parts of the extraction device are disposable. For example, the capture region 120 and the cover 150 are designed so that removing them for cleaning will disallow further adjoining with the lumen shaft.
According to some embodiments, the extraction device, including capture region 120 and/or secondary component are designed to contain a plurality of holes that are 50 microns to 1 mm in size. The holes are designed to allow for segmentation of the lens into pieces equal to or smaller than 1 mm once the distal components are retracted back into the lumen. The segmented pieces, which remain in the anterior chamber, are then removed from the eye by an irrigation/aspiration extraction device.
According to some embodiments, the capture region 120 is discontinuous, with only partial surrounding of the lens prior to manipulation of the lens.
According to some embodiments, for example as shown in
According to some embodiments, for example as shown in
According to some embodiments, for example as shown in
According to some embodiments, for example as shown in
According to some embodiments, for example as shown in
According to some embodiments, a method for using extraction devices described herein includes making an incision (e.g., an incision of less than 4 millimeters (mm)) to enter an anterior chamber of an eye. A capsulorhexis is performed. The lens is hydrodissected and/or hydrodelineated so that the lens changes position from being entirely within the natural capsular bag to being partially or completely displaced from the capsular bag. Viscoelastic may be used to further position the lens for optimum approach by an extraction device. The extraction device is introduced through the incision and advanced forward. An encircling structure (e.g., capture region 120) is introduced through the lumen of the device and advanced towards the lens. The encircling structure is positioned so that it surrounds the lens. Further deployment of the encircling structure may allow for multiple elements to expand and further encompass the lens. A second structure (e.g., cover 150) is advanced from the lumen of the device distally. The second structure covers the encircling structure from proximal to distal and substantially conforms to the encircling structure geometry. The encircling structure is retracted back into the lumen and may or may not twist as it is being retracted so that the lens is segmented into pieces smaller than the original whole lens. The encircling structure may or may not be advanced and retracted several times to further segment the lens. The second structure is then retracted in whole or in segments so that any remaining lens material within the structure is retracted into the lumen. The second structure can expand distally to allow for all the lens material to fit into the lumen. The entire device is removed from the anterior chamber of the eye. A second suction device is used to remove any remaining lens materials. The lens bag is reformed with viscoelastic to receive an artificial intraocular lens for reversal of aphakia and refractive correction.
According to some embodiments, for example as shown in
According to some embodiments, for example as shown in
According to some embodiments, for example as shown in
According to some embodiments, for example as shown in
As shown in
Following encapsulation of the sample, a mesh cover or bag 1050 as discussed herein may be extended over rings 1020 (e.g., using guides similar to guides 160 above) to substantially surround and encapsulate the sample 1024 within bag 1050. In some embodiments, once sample 1024 is encapsulated within rings 1020 and bag 1050, rings 1020 may be pulled back into lumen 1012. As rings 1020 are withdrawn into lumen 1012, rings 1020 may cut sample 1024 into fragments to aid in withdrawing the sample into lumen 1012. After cutting of sample 1024 with rings 1020, bag (or cover) 1050 may be withdrawn into lumen 1012 to retrieve and extract the sample.
According to some embodiments, for example as shown in
According to some embodiments, for example as shown in
According to some embodiments, for example as shown in
In some embodiments, one or more of leaves 1314 may have a cutting edge 1318 thereon that, when that leaf 1314 is rotated about the axis of, for example, shaft 1312, cuts through and excises the tissue to be encapsulated. In other embodiments, edges of leaves 1314 may be blunt edges that slide between the lens and its surrounding tissue to encapsulate substantially the entire lens prior to removal. In some embodiments, a cutting and/or suction mechanism can be applied within the encapsulated region formed by leaves 1314 (e.g., via an inner lumen of shaft 1312 into the encapsulated region to break up the encapsulated lens and suction out the broken up lens before re-stacking or re-layering leaves 1314 for withdrawal of device 1300.
According to some embodiments, for example as shown in
As shown in
According to some embodiments, for example as shown in
As shown, a mesh cover or bag 1550 may be deployed from shaft 1510 (in a manner similar to the cover extension operations as discussed above in accordance with one or more embodiments) to encapsulate the sample to be removed.
In the example of
According to some embodiments, for example as shown in
Once in the eye, tip 1601 of device 1600 may be forced to change shape by sliding segment 1630A to make it deform into a bow shape. This deformation may open the mouth of a basket formed to scoop up the lens. Segment 1630F may be fixed from moving in relation to segment 1630A. In addition to opening the mouth of the basket by deforming segment 1630A, the length of the basket may extended by sliding segment 1630B (see, e.g.,
As segment 1600B is deformed, segment 1600B may stretch open a bag or net-like cover structure 1650 as shown in
The top view of
According to some embodiments, for example as shown in
In the embodiment of
In the example of
According to some embodiments, for example as shown in
Device 1800 may also include an additional (e.g., nitinol) frame 2002 (see, e.g.,
Device 1800 may also include a third frame 1900 (e.g., a nitinol frame) with a covering 1902 that forms a lid 1806 for basket 1804 when third frame 1900 is deployed. Covering 1902 may be a polymer or mesh covering or, in some embodiments, may contain relatively more rigid or solid material to provide additional strength and structure to frame 1900 for cutting of lens tissue as discussed in further detail hereinafter. In use, one or more of the following tasks may be performed.
In a first task, after a capsulorhexis has been performed and a lens of a patient's eye has been hydrodissected out of the natural position (e.g., so that the lens is sitting on the equator and partially in the iris plane), an introducer such as shaft 1810 may be inserted into the patient's eye (e.g., via an incision). In a second task, frame 1802 with bag 1804 and frame 2002 may be deployed into the anterior chamber of the eye. In a third task, the lens may be approached and guided partially into the bag 1804 so that, for example, half the lens is in this artificial bag 1804. In a fourth task, lid 1806 on frame 1900 may then be introduced such that lid 1806 and frame 1900 transect (e.g., bisect) the lens so that a portion (e.g., substantially half) of the lens is in encapsulated within a cavity defined by the bag 1804 and lid 1806 and a remaining portion (e.g., a remaining half) is outside of the cavity. In a fifth task, frame 2002 that was introduced into the eye along with frame 1802 may be withdrawn or retracted from within the cavity into the lumen 1812 of the introducer 1810 to further segment the portion of the lens that is sitting in the cavity between artificial bag 1804 and lid 1806. In a sixth task, the entire complex of all pieces in bag 1804 (e.g., in the cavity defined by bag 1804 and lid 1806) may then be retracted into the introducer 1810 to remove the portion of lens that is encapsulated therein. Introducer 1810 may then be removed from the eye and the segmented pieces are removed from the bag. The first through sixth tasks may be repeated for, for example, the other half lens that remains in the eye. Although the example tasks above have been described with a portion of the lens being encapsulated in the cavity defined by bag 1804 and lid 1806, in some scenarios, the entirety of a lens may be encapsulated within the cavity, transected by one or more frames 2002, and removed by withdrawing frames 1802 and 1900 into introducer 1810 (e.g., without transecting the lens with lid frame 1900 while extending the lid frame 1900).
As shown in the cross-sectional view of
In some embodiments, frame 2002 that is retracted after bagging the lens might be one of many such intermediate frames that are deployable and retractable such that the half lens that is bagged can be segmented multiple times with the multiple intermediate frames. For example, a plurality of frames 2002 may be stacked on top or next to each other for independent deployment and retraction for cutting actions. Although nitinol is often mentioned herein as an example material for frames and/or other components, frames 1802, 1900, and/or 2000 may be formed from nitinol or other metals or polymers in various embodiments.
Bag 1804 and/or lid 1806 can contain elastic or inelastic polymer or mesh materials. Shaft 1810 (sometimes referred to as an introducer or an injector) may be composed of metal, polymer or glass materials. The distal end of the introducer, in one or more embodiments, may contain flexible materials that expand when the bag is retracted back into the introducer. Shafts such as shaft 110 etc. described herein may be formed from sections of hypodermic tubing, sometimes referred to as a hypotube, according to some embodiments.
Although bag 1804 and lid 1806 are shown in various examples as continuous sheets of material attached to their respective frames, this is merely illustrative. In some implementations, bag 1804 and/or lid 1806 may be provided with one or more openings (not explicitly shown). The openings may be cutouts from a continuous sheet implemented bag or lid or may be openings in mesh sheets attached to the respective frames that form bag 1804 and/or lid 1806.
In configurations in which bag 1804 and/or lid 1806 are provided with one or more openings, after some or all of a lens of a patient's eye has been secured between bag 1804 and lid 1806 within the anterior chamber of the patient's eye, frames 1802 and/or 1900 may be withdrawn into delivery shaft 1810 such that parts of the secured lens (or portion thereof) are forced to exit the bag and/or lid through the openings into the anterior chamber as the bag and/or lid is being withdrawn into the distal end of the tube. In this way, bag 1804 and/or lid 1806 may be configured to act as a strainer for the lens (or portion thereof) that, upon withdrawal of frames 1802 and/or 1900 into the distal end of delivery shaft 1810, cause some or all of the lens come out through the openings as a ground or strained material that can be later removed (e.g., via suction) from the anterior chamber.
In configurations in which bag 1804 and/or lid 1806 are provided with one or more openings, a method of removing some or all of the lens of a patient's eye may include extending a first frame (e.g., frame 1802) having an attached flexible bag structure (e.g., bag 1804) with a plurality of openings from a distal end of a delivery shaft (e.g., shaft 1810) into an anterior chamber of an eye of a patient such that the flexible bag structure at least partially surrounds at least a portion of a lens of the eye of the patient; extending a second frame (e.g., frame 1900) having an attached lid structure (e.g., lid 1806) along the first frame to secure the at least the portion of the lens between the flexible bag structure and the lid structure; and withdrawing the first and second frames into the distal end of the delivery shaft to strain the at least the portion of the lens through the plurality of openings in the flexible bag structure into the anterior chamber.
The method may also include extending a third frame (e.g., frame 2002) into the eye of the patient together with the first frame; and, prior to withdrawing the first and second frames, withdrawing the third frame to transect the secured at least the portion of the lens, in one or more embodiments.
The method may also include suctioning the strained at least the portion of the lens from the anterior chamber, in one or more embodiments.
According to some embodiments, for example as shown in
First wire 2420, second wire 2430, and third wire 2440 may be extended from distal end 2415 of delivery shaft 2410 and positioned to lasso or surround lens 2424 (e.g., within the eye following hydrodissection or hydrodelineation of the lens). Once first wire 2420, second wire 2430, and third wire 2440 are positioned around the lens as shown in
As shown in
For example, in one implementation, delivery shaft 2410 may include one or more features such as feature 2450 (e.g., an integral or attached extension from the inner surface of delivery shaft 2410 in lumen 2413) that causes first wire 2420, second wire 2430, and third wire 2440 to separate from each other as they are extended from distal end 2415 (e.g., as adjacent wires slide along opposing sides of feature 2450). Feature 2450 may be a protrusion extending from an inner surface of the delivery shaft in the lumen that causes the first, second, and third wire loops to separate upon extension from within the lumen.
As another example, after extension of first wire 2420, second wire 2430, and third wire 2440 together (e.g., in contact with each other in a substantially flattened configuration) from lumen 2413, one or more slidable separators 2451 may be actuated within or extended from lumen 2413 between adjacent wires to cause the adjacent wires to separate into the position shown in
As another example, first wire 2420, second wire 2430, and third wire 2440 may be heat set wires such as nitinol heat set wires that are conditioned to separate after being extended a predetermined distance from within lumen 2413. For example, first, second, and third wire loops 2420, 2430, and 2430 may be heat set wire loops configured to self separate upon extension to a predetermined distance from the distal end of the delivery shaft.
In various implementations, first wire 2420, second wire 2430, and third wire 2440 may be extended from lumen 2413 at the same time or at different times (e.g., using a common extension mechanism or separate extension mechanisms to push the wires out of the lumen).
Although a single slider tab 2502 is shown in
One or more slider tabs such as slider tab 2502 may each be attached to one or both ends of the wire loops that form wires 2420, 2430, and 2440. For example, one end of each wire loop may be fixed within shaft 2410 and an opposing end attached to a slider tab so that extending the wire from lumen 2413 is performed by moving one side of the wire out of the lumen while the other side remains fixed. As another example, both ends of each wire loop may be attached to a slider tab so that extending the wire from lumen 2413 is performed by moving the entire loop. Wires 2420, 2430, and 2440 may be manipulated around lens 2424 together, prior to separation, or may be sequentially manipulated around lens 2424 after separation.
It should be appreciated that, although wires 2420, 2430, and 2440 are shown to be linearly separated in the implementation shown in
As shown in
Wire-guide structure 2800 may include a cylindrical main body 2806 (e.g., a portion of shaft 2410) and one or more protrusions 2808 (e.g., on the inner surface of shaft 2410 or on an outer surface of structure 2810) that guide the position of wire 2420. For example, a portion of wire 2420 may be positioned between two of protrusions 2808 and between the outer surface of cylindrical main body 2810 and the inner surface of delivery shaft 2410 so that the position of wire 2420 can be controlled by protrusions 2808.
Wire-guide structure 2802 may include a cylindrical main body 2810 that is at least partially nested within cylindrical main body 2806 of wire-guide structure 2800. Wire-guide structure 2802 may include a notch 2812 that allows wire 2440 to pass into an internal recess within wire-guide structure 2802 so that the rotational position of wire 2440 can be controlled by rotation of wire-guide structure 2802 (e.g., relative to wire-guide structures 2800 and 2804).
Wire-guide structure 2804 may include a cylindrical main body 2814 that is at least partially nested within cylindrical main body 2810 of wire-guide structure 2802. Wire-guide structure 2804 may include a notch 2816 that allows wire 2430 to pass into an internal recess within wire-guide structure 2804 so that the rotational position of wire 2430 can be controlled by rotation of wire-guide structure 2804 (e.g., relative to wire-guide structures 2800 and 2802).
In the implementations of
As shown in
It should be appreciated that, although three wires are shown in the implementations of
Wire-guide structures such as wire-guide structures 2800 and 2802 may be provided within delivery shaft 2410 to control the relative rotation of wire loops 2420 and 2430. Once in the configuration shown in
Although wires 2420 and 2430 are rotated in the implementation of
Once in the configuration shown in
As another example,
For further clarity, face-on views of various implementations of extraction device 2400 (e.g. views facing the distalmost end of device 2400 along the central longitudinal axis of device 2400) are shown in
The various implementations of extraction device 2400 described in connection with
Device 2400 may also include a spiral compaction wire 4108 wrapped in spiral windings around bag 4102. After wires 2420, 2430, and 2440 and stent 4100 have been retracted to cut and cube lens 2424 within bag 4102, spiral compaction wire 4108 may be retracted to further compact the pieces of lens 2424 within encapsulation bag 4102 for extraction from the eye (e.g., by extracting bag 4102 and wire 4108 into lumen 2413 or by withdrawing device 2400 from the eye without extracting bag 4102 back into lumen 2413).
According to some embodiments, for example as shown in
The wire 5330 may be slidable or otherwise movable relative to the delivery shaft to allow for extension or withdrawal of the wire loop, as desired. According to some embodiments, the wire 5330 may be actuated by a manually or automatically controlled mechanism based on mechanical or electronic activation. The divergence of the channels 5335a and 5335b may facilitate expansion and contraction of a diameter of the wire loop with sliding engagement of the wire 5330 relative to the delivery shaft. A capture region 5320 can be defined, at least in part, by the loop of the wire 5330. Extension (deployment) of the wire 5330 in a distal direction may increase the diameter of the wire loop, causing the size of the capture region 5320 to expand. Retraction (withdrawal) of the wire 5330 in a proximal direction may decrease the diameter of the wire loop, causing the size of the capture region 5320 to shrink.
According to some embodiments, the wire 5330 may be shape set so that it has a preformed, natural shape that forms a closed loop. For example, the wire 5330 may be made from a nitinol wire or shape memory material that has a natural shape forming a closed loop like that shown in
According to some embodiments, the wire 5330 may be a freely flexible wire that is not shape set to form any well-defined natural shape. For example, the wire 5330 may be made from a freely flexible material in which the delivery shaft 5310 or other components of the extraction device 5300 are entirely responsible for constraining or orienting portions of the wire 5330 to form a desired shape such as the closed loop shown in
According to some embodiments, for example as shown in
As seen in
The wire 5330 can be formed into a loop in the device by constraining end portions 5341 of the wire 5330 within the delivery shaft, as shown for example in
According to some embodiments, the wire may have a constant cross-section along its entire length. According to other embodiments, the wire may have a cross-section that varies along its length. The varying cross-section may vary in at least one of shape or area. Such variations in cross-section may be designed to achieve certain beneficial effects. For example, the cross-section may vary based on curvature of the wire loop (e.g., to facilitate a lenticular shape), to enhance cutting ability of the wire, to mitigate kinking, and/or to enhance structural stability of the deployed wire loop.
According to some embodiments, the wire may have a cross-section that varies based on the degree of curvature of the wire 5330 at a particular location along the length of the wire. Varying the cross-section in accordance with the degree of curvature may, for example, facilitate formation of a substantially lenticular shape for the wire loop when the wire loop is in the deployed, expanded configuration.
In the example shown in
According to some embodiments, varying the cross-section between alternating shapes such as alternating round regions, which may be more conducive to bending or curving, and flat regions, which may be less conducive to bending or curving, may allow specific regions to either bend or not bend when the wire is extended. It is contemplated that such alternating cross-sectional shapes can be useful for cataract surgery or for other procedures, where it is desirable to steer a tube or wire across turns and not just straight. For example, the round segment can make a turn from one vessel branch to another for vascular surgery, or the round segment can urge a loop to bend into the capsule, while the straight segment can urge portions of the wire or the loop to go straight.
According to some embodiments, the cross-section may vary based on desired cutting ability. Such variations may involve smaller areas and/or sharper cross-sectional shapes (e.g., rectangular, square, or triangular) in regions of the wire where enhanced cutting ability is desired. For example with reference to
According to some embodiments, the cross-section may vary based on regions of stress in the wire to mitigate kinking. For example, the exit regions 5553 of the wire 5330 can be susceptible to kinking due to a sharp bend or small radius curvature upon shaft exit. The exit regions 5553 of the wire can correspond to locations where the wire exits the delivery shaft 5310 and is adjacent to portions of the delivery shaft in the fully extended position. According to some embodiments, such regions can have a larger cross-sectional area or diameter than regions of the wire adjacent to the exit regions 5553 or other remaining regions of the wire 5330. For example, with reference to
According to some embodiments, the cross-section may vary to provide structural stability of the wire. For example, the exit regions 5553 of the wire 5330 may have an oblong cross-sectional shape with a long axis oriented transverse to the plane of the loop. Such a cross-sectional shape at the exit regions 5553 may provide structural stability by minimizing a tendency for the extended loop to bend out-of-plane, in a direction perpendicular or otherwise transverse to the plane of the loop, while permitting the wire to bend in-plane, in a direction along the plane of the loop. Alternatively, or in combination, the exit regions 5553 of the wire may have increased area relative to other regions of the wire to provide for enhanced structural stability for the extended loop.
According to some embodiments, for example, as shown in
According to some embodiments, the deployed wire 5330 may be arranged in a single plane prior to deployment, during deployment, and upon full deployment from the delivery shaft. According to some embodiments, the wire may be arranged in multiple planes prior to deployment, during deployment, and/or upon full deployment from the delivery shaft. For example, as shown in
According to some embodiments, the wire 5330 is configured to extend from the delivery shaft straight, without forming any bend angle θ relative to the axis of the delivery shaft 5310.
According to some embodiments, the wire 5330 may be configured to vibrate in and/or out of the lumen. For example, the extraction device 5300 may be configured to induce vibration in the wire 5330 in the X, Y, and/or Z-plane to induce it to slide between tissue planes of the sample, such as between a lens and a capsular bag of a patient.
According to some embodiments, the wire 5330 may be colored or color-coded to enhance visualization once positioned in the eye. For example, the wire 5330 may be yellow, red, blue, or multicolored.
While one wire 5330 is pictured, in some embodiments paired wires, or more generally multiple wires may be utilized. The paired or multiple wires may each have the same size and shape, or the paired or distinct wires may differ in one or more of a size and shape when fully deployed from the lumen.
According to some embodiments, the bend angle θ may additionally or alternatively be provided in the lumen of the delivery shaft 5310. In such embodiments, the wire 5330 may or may not have the bend angle noted previously, and the bend angle of the lumen may be provided before or after the transition to the diverging channels or branching arms of the lumen. In such embodiments, the bend angle θ may be a non-zero angle relative to an axis of the handle 5500, and may be within any of the ranges for the bend angle θ mentioned above. The bend angle may enhance positioning of the wire relative to the lens once the wire is deployed.
According to some embodiments, the handle 5500 may be equipped with an actuator that can be activated by a user to deploy and/or retract the wire 5330. According to some embodiments, the actuator of the handle 5500 may include a slider tab 5502, moveable by a user within a groove, for deployment (or “extension”) and retraction (or “withdrawal”) of wire 5330 within delivery shaft 5310. Slider tab 5502 may be coupled to one or more portions of the wire 5330 such that sliding the slider tab 5502 away from shaft 5310, in a proximal direction, pulls wire 5330 back into shaft 5410, while sliding slider tab 5502 towards shaft 5310, in a distal direction, pushes wire 5330 through the shaft 5410. As described above, sliding motion of the slider tab 5502 may also serve to expand or contract the wire loop like a lasso. Although a single slider tab 5302 is shown in
As shown in
According to some embodiments, for example, as shown in
According to some embodiments, for example as shown in
In some embodiments in which the manipulator includes a wire loop, the articulating arm 5650 can be configured to cause rotation of the wire 5330 in a direction transverse to a plane defined by the wire loop. Such movement can facilitate movement of the wire loop around a lens of a patent to, for example, facilitate subsequent cutting of the lens encircled by the wire loop via retraction of the wire. In various embodiments, the articulating arm can be configured to rotate the wire loop relative to the handle 5500 or another component proximal to the wire in any direction transverse to the loop.
According to some embodiments, for example as seen in
The extraction device 5300 may employ an actuator for operating the articulating arm to cause the rotation of the distal segment 5675 relative to the proximal segment 5665. According to some embodiments, the actuator may include or be coupled to a pull cable 5680 that is operable to rotate the distal segment 5675 relative to the proximal segment 5665. The actuator may include a control component (such as a slider, roller, switch, button, etc.) on the handle 5500 that a user may manipulate to tension or pull on the pull cable 5680. A distal end portion of the pull cable can be coupled distal segment 5675 so that tension on the pull cable is converted to rotation of the distal segment. For example, the distal end portion of the pull cable can be welded or otherwise fixedly attached to the distal segment 5675. Although a single pull cable is shown, it is contemplated that other types of mechanisms may be employed to drive movement of the articulating arm, instead of or in combination with the pull cable. For example, the articulating arm may employ motors, linear actuators, bar linkages, cams, or other mechanisms for controlling motion of the articulating arm, or for converting movements of a control component on the handle to the desired rotational movement of the articulating arm. Further, it is contemplated that multiple pull cables may be used in some embodiments to drive rotation of the distal segment in different directions or to provide multiple degrees of freedom for the distal segment. Alternatively, or in combination with the actuator, in some embodiments the arm may be rotated about the articulating joint 5690 using preformed regions of the wire as the wire loop is deployed and extended through the wire. For example, the wire may have a preformed bent region that applies force to the articulating arm as the wire is extended therethrough, such that the wire urges rotation of the distal segment 5675 relative to the proximal segment 5665 about the articulating joint as the preformed bent region passes over the articulating joint.
The articulating arm 5650 may be configured with substantially any range of motion or degrees of freedom as desired. According to some embodiments, articulation of the articulating arm 5650 may be configured to cause bending rotation of the distal segment 5675 relative to the proximal segment 5665 about the joint 5690, such that a bend angle φ between a longitudinal axis of the distal segment 5675 and a longitudinal axis of the proximal segment 5665 changes with the rotation. Such a bending rotation may, for example, be used to move a wire loop extending from the distal segment down and around a lens of the eye.
According to some embodiments, the articulating arm 5650 may have a range of motion that permits the angle φ to be varied up to +/−180 degrees, where an angle φ of zero degrees corresponds to a straight arrangement in which the axis of the proximal segment 5665 and the distal segment 5675 are aligned with each other. According to some embodiments, the articulating arm may have a range of motion that permits the angle φ to be varied up to +/−90 degrees. According to some embodiments, the control component of the actuator is disposed on one side of the handle, and the articulating arm is configured to bend the distal segment 5675 toward the same side as the control component. According to other embodiments, the articulating arm is configured to bend the distal segment 5675 away from the side of the control component. According to some embodiments, the articulating arm is configured to bend the distal segment in either direction toward or away from the side of the control component as desired. According to some embodiments, the articulating arm 5650 may have a default or non-actuated position, in which the proximal segment 5665 and the distal segment 5675 are in a straight arrangement aligned with each other (angle φ=0), and an actuated position, in which the proximal and distal segments are bent relative to each other to form a non-zero angle φ. The control component can be biased to the non-actuated position such that the non-actuated position corresponds to a position of the articulating arm in the absence of any user interaction with a control component, while the actuated position corresponds to a position upon user interaction with the control component.
Alternatively, or in combination, articulation of the articulating arm 5650 may be configured to cause twisting rotation of the distal segment 5675 relative to the proximal segment 5665 about the joint 5690. In such embodiments, the distal segment can be configured to rotate about the longitudinal axis of the distal segment and/or the longitudinal axis of the proximal segment. In some embodiments employing a twisting rotation, the loop may extend to one side of the shaft, and the twisting rotation may be configured to swing the loop down and around a lens of the eye.
According to some embodiments, the range of motion of the articulating arm 5650 can be selected to facilitate interaction with a lens 5324. For example, and as further discussed herein, the manipulator can include a wire 5330 forming a wire loop when the wire 5330 is in a deployed position. The loop of the wire may define a plane, and as seen for example in
According to some embodiments, the articulating arm 5650 can facilitate a procedure in which the arm is inserted into the eye, such as through a cornea and into the anterior chamber of the aye. The articulating arm 5650 can be configured to articulate in various ways depending on, for example, the anatomy of the eye or the preference of the surgeon operating the device. For example, the articulating arm 5650 may be inserted through a corneal incision with the bend angle φ of the articulating arm at a first angle. Next, the wire loop may be deployed with the bend angle φ of the articulating arm at a second angle. Then, the wire loop may be placed around the lens at a third angle. In various embodiments, each of the first, second, and third angle may be the same, or any two or more of the first, second, and third angles may be different than one another.
According to some embodiments in which the wire loop has a non-zero bend angle θ, as described previously, the articulating arm may be configured to rotate the distal segment 5675 in a direction opposite to the bend angle θ. An example of this motion is shown in
According to some embodiments, dimensions of the articulating arm 5650 may be selected to facilitate articulation of the arm while at least a portion of the arm is maintained within the eye. For example, the articulating arm 5650 may be dimensioned to permit rotation of the distal segment while the articulating joint 5690 is held within the eye, and while the arm is inserted through the eye through a small corneal or other eye incision. The articulating portion of the articulating arm may have a length L, which can be defined from the most proximal portion of the articulating joint to the distalmost end of the delivery shaft. As described further below with respect to
According to some embodiments, the roller 5730 may be configured for direct interaction therewith by a user. For example, a surgeon may slide their thumb or other finger over the roller to spin the roller and thereby articulate the articulating arm 5650. According some embodiments, the roller 5730 may be configured to indirect interaction therewith by a user. For example, the roller 5730 may be coupled to another control component, such as a slider or a button, which is configured to interface with the roller 5730 to operate the roller for tensioning the pull cable 5680 or otherwise operating the articulating arm 5650. According to some embodiments, the roller 5730 may be configured for both of the aforementioned modes of operation depending on the user's preference (e.g., the surgeon may be able to operate the roller directly or indirectly, depending on their preference or the situation).
The slider tab 5502 can be coupled to the wire 5330 in any suitable fashion.
According to some embodiments, the actuator for operating the articulating arm may be separate from the actuator for extension and retraction of the wire. According to some embodiments, a combined actuator may be used for both articulation of the articulating arm and for extension/retraction of the wire. For example a single lever or other control component may be operable for both rotation of the articulating arm and movement of the wire within the lumen of the delivery shaft.
In the example shown, the articulating arm 5650 has a substantially tubular construction. Each of the proximal segment 5665 and the distal segment 5675 are constructed as tubular members that may be substantially rigid sections of the tubular arm. Internal components of the actuator mechanism such as the pull cable 5680 and inner shaft 5672 can extend through a lumen of the tubular articulating arm. The joint 5690 is a flexible tubular section between the proximal and distal segment that is bendable to provide a joint that permits articulation thereabout. Such a flexible tubular section may, for example, be constructed as a laser cut section of a nitinol tube or other metal tube that extends the length of the articulating arm, where the laser cut section forms a series of ribs (e.g., circumferential ribs) arranged along the length of the flexible section as seen for example in
It is contemplated that various components coupled to each other can be separate components attached to each other or can be integrally formed as a unitary construction. For example, the delivery shaft 5310 can be a separate component that is fixedly attached to the distal segment 5675 of the articulating arm or can be an integral part thereof. Additionally or alternatively, the proximal segment 5665 can be a separate component that is fixedly attached to the handle 5500 of the extraction device 5300 or can be an integral part thereof. Additionally or alternatively, the proximal segment 5665, distal segment, 5675, and articulating joint 5690 can be separate components attached to each other or can be integrally formed with flexibility at the articulating joint 5690 to permit the desired articulation.
According to some embodiments, for example as shown in
According to some embodiments, for example as shown in
According to some embodiments, for example, as shown in
According to some embodiments, for example, as shown in
It is contemplated that the cutting face may be formed using any suitable construction between the channels at the distal end of the delivery shaft 5310, such as rigid plastics, metals, or the like.
According to some embodiments there may be notches on the inner surfaces of the branching arms of the hub 5390 to allow for more complete retraction of the wires into a common lumen proximal to where the two branching arms of the Y-lumen start.
According to some embodiments, for example, as shown in
According to some embodiments, for example, as shown in
According to some embodiments, a method for using the extraction device 5300 includes making an incision (e.g., a corneal incision of less than 4 millimeters (mm)) to enter an anterior chamber of an eye of a patient. A capsulorhexis may be performed to form a capsulorhexis. Forming the capsulorhexis may remove a portion of a capsular bag of the eye. A lens 5324 of the eye may be hydrodissected and/or hydrodelineated so that the lens changes position from being entirely within the natural capsular bag to being partially or completely displaced from the capsular bag. Alternatively, this step may be omitted as the design of the extraction device 5300 may allow for the wire 5330 to be deployed between the lens and the capsular bag while the lens is still in the capsular bag. A viscoelastic may be used to further position the lens 5324 for optimum approach by the extraction device 5300.
After forming the capsulorhexis, a delivery shaft 5310 of extraction device 5300 may be inserted into the eye. The delivery shaft 5310 may be introduced to the anterior chamber of the eye through the incision and advanced forward. In some embodiments employing an extendable wire 5330, the wire may be in a proximal or retracted position during the insertion through the incision. In some embodiments employing an articulating arm 5650, the articulating arm may be in a straight or non-articulated configuration during the insertion through the incision. A wire loop of a wire 5330 may be advanced distally and expanded by extending the wire through either or both of channels 5335a and 5335b of a lumen of the delivery shaft using an actuator (e.g., slider tab 5502 or button 5503), to bring the wire to an extended and expanded configuration. The wire 5330 may be deployed between the lens and the capsular bag while the lens is still in the capsular bag. The wire loop may be lassoed around the lens 5324 so that it at least partially surrounds the lens 5324. In some embodiments employing an articulating arm 5650, the arm may be articulated during and/or after extension of the wire to move the wire loop down (in a posterior direction) and around the lens, so that the expanded wire loop encircles the lens. Articulation of the arm may be accomplished using an actuator (e.g., roller 5730). The arm may be articulated about the articulating joint 5690 while the articulating joint is maintained within the eye or within the anterior chamber. The lens may be fixated against a Y-shaped hub and/or cutting face of the delivery shaft 5310, such that the Y-shaped hub or cutting face contacts the lens. The wire loop may be retracted proximally using the actuator so that the lens is cut or segmented into pieces smaller than the original whole lens. To segment the lens, the lens may be dissected and/or bisected in situ (within the bag). The lens may be segmented by retracting the wire against the cutting face to cut tissue of the lens. In some embodiments, the actuator may retract both ends of the wire loop simultaneously to prevent rotation of the lens. The wire or encircling structure may or may not be advanced and retracted several times to further segment the lens. For example, after segmenting the lens in situ, the lens may be rotated using another instrument and the lens may be further segmented using a similar process.
After retracting the wire and cutting the lens, the delivery shaft 5310 may be removed from the anterior chamber of the eye. In some embodiments employing an extendable wire loop, the wire may be in a retracted positioned during the removal from the eye. In some embodiments employing an articulating arm 5650, the articulating arm may be in a straight or non-articulated configuration during the removal from the eye. A device such as a second suction device may be used to remove any remaining lens tissue. An intraocular lens (IOL) may be delivered into the lens capsule after removal of the cut lens tissue. The lens bag may be reformed with viscoelastic to receive an artificial intraocular lens for reversal of aphakia and refractive correction.
One or more features of any one of the extraction devices 100, 200, 300, 400, 600, 705, 805, 905, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 2400, and 5300 can be combined with one or more features of any other one of the extraction devices 100, 200, 300, 400, 600, 705, 805, 905, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 2400, and 5300. One or more features of any one of the covers and/or bags discussed herein can apply to any other one of the covers and/or bags and the deployment mechanisms such as guides associated therewith.
The subject technology is illustrated, for example, according to various aspects described above. Various examples of these aspects are described as numbered concepts or clauses (1, 2, 3, etc.) for convenience. These concepts or clauses are provided as examples and do not limit the subject technology. It is noted that any of the dependent concepts may be combined in any combination with each other or one or more other independent concepts, to form an independent concept. The following is a non-limiting summary of some concepts presented herein:
Concept 1. An extraction device, comprising:
a delivery shaft having a lumen and a distal end;
a first wire forming a first arc and being positionable distal to the distal end of the delivery shaft while ends of the first arc are at a distalmost end of the delivery shaft; and
a second wire forming a second arc and being positionable distal to the distal end of the delivery shaft while ends of the second arc are at the distalmost end of the delivery shaft,
wherein a distalmost extent of the first wire is distal to a distalmost extent of the second wire, wherein the first wire and the second wire are separately retractable relative to the delivery shaft.
Concept 2. The extraction device of Concept 1 or any other Concept, further comprising:
a first guide and a second guide moveable along the first wire toward the distalmost extent of the first wire from a first position to a second position more distal than the first position; and
a cover attached to the first guide and the second guide, wherein, while in the second position, the cover encompasses an outer cross-sectional dimension of each of (i) the first wire and (ii) the second wire.
Concept 3. The extraction device of Concept 1 or any other Concept, further comprising:
a first ring extending about the first wire and the second wire;
a first cover extending from the first ring to the delivery shaft;
a second ring extending about the first wire and the second wire; and
a second cover extending from the second ring to the distalmost end of the first wire.
Concept 4. An extraction device, comprising:
a delivery shaft having a lumen and a distal end;
a dissection tool distal to the distal end of the delivery shaft;
a first capture portion positionable on a first side of an axis of the delivery shaft and comprising a first cover; and
a second capture portion positionable on a second side of the axis, opposite the first side, and comprising a second cover,
wherein the first capture portion and the second capture portion are configured to move toward the axis upon actuation and define an enclosed space between the first cover and the second cover.
Concept 5. An extraction device, comprising:
a delivery shaft having a distal end;
an irrigation port at the distal end;
a loop having a fluid permeable cover; and
a blade being moveable from a retracted position to an actuated position across at least a portion of the loop.
Concept 6. An extraction device, comprising:
a delivery shaft having:
an inner cylindrical shaft structure with a distal end; and
an outer cylindrical shaft structure having a distal end with a sharp cutting edge, wherein the sharp cutting edge of the outer cylindrical shaft structure is deployable beyond the distal end of the inner cylindrical shaft structure.
Concept 7. An extraction device, comprising:
a delivery shaft having a distal end with a sharp cutting edge; and
a gripping apparatus that is extendible from within a lumen of the delivery shaft and operable to grip and pull tissue against the sharp cutting edge.
Concept 8. An extraction device, comprising:
a delivery shaft having a distal end; and
an excision member that is extendible from within a lumen of the delivery shaft, wherein the excision member comprises a control shaft and a plurality of layered cutting and encapsulation leaves.
Concept 9. The extraction device of Concept 8 or any other Concept, wherein, the layered cutting and encapsulation leaves are configured to be reticulated relative to each other about an axis to create an enclosure for a lens or portion thereof.
Concept 10. An extraction device, comprising:
a delivery shaft having a distal end;
a first frame extendible from the distal end of the delivery shaft and having a flexible bag structure attached thereto; and
a second frame extendible from the distal end of the delivery shaft and having a lid structure attached thereto, wherein, in an extended configuration for the first frame and the second frame, the flexible bag structure and the lid structure are configured to define and enclose a cavity within which at least a portion of a lens of a patient's eye is encapsulated.
Concept 11. The extraction device of Concept 10 or any other Concept, wherein the second frame is configured, upon extension from the distal end of the delivery shaft, to transect the encapsulated at least the portion of the lens of the patient's eye.
Concept 12. The extraction device of Concept 11 or any other Concept, further comprising one or more additional frames, each extendible from the distal end of the delivery shaft with the first frame and retractable from within the cavity into the distal end of the delivery shaft to dissect the at least the portion of the lens of the patient's eye held therein.
Concept 13. A method, comprising:
extending a first frame, having an attached flexible bag structure, and a second frame into an eye of a patient such that the flexible bag structure at least partially surrounds at least a portion of a lens of the eye of the patient;
extending a third frame having an attached lid structure along the first frame to encapsulate the at least the portion of the lens between the flexible bag structure and the lid structure; and
withdrawing the second frame to transect the encapsulated at least the portion of the lens.
Concept 14. The method of Concept 13 or any other Concept, further comprising, prior to extending the first frame with the attached flexible bag structure and the second frame into the eye of the patient, performing a hydrodissection and/or a hydrodelineation procedure to change a position of the lens from being entirely within a natural capsular bag of the lens to being partially or completely displaced from the natural capsular bag.
Concept 15. The method of Concept 13 or any other Concept, further comprising withdrawing the first frame and the third frame from the eye of the patient to remove the transected, encapsulated at least the portion of the lens from the eye.
Concept 16. An extraction device, comprising:
a delivery shaft having a distal end;
a first frame extendible from the distal end of the delivery shaft and having a flexible bag structure attached thereto, wherein the flexible bag structure includes a plurality of openings; and
a second frame extendible from the distal end of the delivery shaft and having a lid structure attached thereto, wherein, in an extended configuration for the first frame and the second frame, the flexible bag structure and the lid structure are configured to secure at least a portion of a lens of a patient's eye therebetween.
Concept 17. The extraction device of Concept 16 or any other Concept, wherein, upon withdrawal of the first frame and the second frame into the distal end of the delivery shaft while the at least the portion of the lens is secured between the flexible bag structure and the lid structure, the flexible bag structure is configured to strain the at least the portion of the lens through the plurality of openings.
Concept 18. The extraction device of Concept 16 or any other Concept, wherein the second frame is configured, upon extension from the distal end of the delivery shaft, to transect the lens.
Concept 19. The extraction device of Concept 16 or any other Concept, further comprising one or more additional frames, each extendible from the distal end of the delivery shaft with the first frame and retractable into the distal end of the delivery shaft to dissect the at least the portion of the lens of the patient's eye held therein.
Concept 20. The extraction device of Concept 16 or any other Concept, wherein the lid structure comprises a plurality of openings.
Concept 21. A method, comprising:
extending a first frame having an attached flexible bag structure with a plurality of openings from a distal end of a delivery shaft into an anterior chamber of an eye of a patient such that the flexible bag structure at least partially surrounds at least a portion of a lens of the eye of the patient;
extending a second frame having an attached lid structure along the first frame to secure the at least the portion of the lens between the flexible bag structure and the lid structure; and
withdrawing the first and second frames into the distal end of the delivery shaft to strain the at least the portion of the lens through the plurality of openings in the flexible bag structure into the anterior chamber.
Concept 22. The method of Concept 21 or any other Concept, further comprising:
extending a third frame into the eye of the patient together with the first frame; and
prior to withdrawing the first and second frames, withdrawing the third frame to transect the secured at least the portion of the lens.
Concept 23. The method of Concept 22 or any other Concept, further comprising suctioning the strained at least the portion of the lens from the anterior chamber.
Concept 24. An extraction device, comprising:
a delivery shaft having a lumen and a distal end; and
first, second, and third wire loops extendible from within the lumen at the distal end, wherein the first, second, and third wire loops are configured to separate upon extension from within the lumen to at least partially surround a lens of a patient's eye, and wherein the separated first, second, and third wire loops are configured to be withdrawn into the lumen to pass through and dissect the lens.
Concept 25. The extraction device of Concept 24 or any other Concept, further comprising:
a handle, wherein a proximal end of the delivery shaft is attached to the handle; and
a slider tab in the handle and attached to the first, second, and third wire loops, wherein the slider tab is slidable to extend and withdraw the first, second, and third wire loops.
Concept 26. The extraction device of Concept 24 or any other Concept, wherein the second wire loop comprises a middle wire loop disposed between the first and third loops, and wherein the first, second, and third wire loops are configured to linearly separate in a direction substantially perpendicular to a plane defined by the middle wire loop.
Concept 27. The extraction device of Concept 26 or any other Concept, further comprising a plurality of interconnecting wires that extend from the first wire loop to the middle wire loop and from the middle wire loop to the third wire loop.
Concept 28. The extraction device of Concept 24 or any other Concept, wherein the first, second, and third wire loops are configured to separate by a rotation of the second and third wire loops relative to the first wire loop.
Concept 29. The extraction device of Concept 28 or any other Concept, further comprising first, second, and third nested wire-guide structures within the delivery shaft and configured to control a rotational position of the first, second, and third wire loops.
Concept 30. The extraction device of Concept 29 or any other Concept, wherein the first wire-guide structure comprises:
a cylindrical main body; and
a plurality of protrusions on an outer surface of the cylindrical main body.
Concept 31. The extraction device of Concept 30 or any other Concept, wherein the second wire-guide structure comprises:
a cylindrical main body at least partially nested within the cylindrical main body of the first wire-guide structure; and
at least one slot for the second wire loop.
Concept 32. The extraction device of Concept 31 or any other Concept, wherein the third wire-guide structure comprises:
a cylindrical main body at least partially nested within the cylindrical main body of the second wire-guide structure; and
at least one slot for the third wire loop.
Concept 33. The extraction device of Concept 32 or any other Concept, wherein the second and third wire-guide structures are rotatable relative to the first wire-guide structure.
Concept 34. The extraction device of Concept 33 or any other Concept, wherein the first, second, and third wire-guide structures are slidable within the delivery shaft for extension and retraction of the first, second, and third wire loops.
Concept 35. An extraction device, comprising:
a delivery shaft having a lumen and a distal end;
first and second wire loops extendible from within the lumen at the distal end; and
a plurality of interconnecting wires that extend from the first wire loop to the second wire loop, wherein the first and second wire loops are configured to separate upon extension from within the lumen to at least partially surround a lens of a patient's eye, and wherein the separated first and second wire loops and the plurality of interconnecting wires are configured to be withdrawn into the lumen to pass through and dissect the lens.
Concept 36. The extraction device of Concept 35 or any other Concept, wherein the first and second wire loops are configured to linearly separate to a separated configuration in which the first wire loop is substantially parallel to the second wire loop.
Concept 37. The extraction device of Concept 35 or any other Concept, wherein the first and second wire loops are configured to separate by a rotation of the first or second wire loop.
Concept 38. The extraction device of Concept 37 or any other Concept, wherein the plurality of interconnecting wires comprises two relatively shorter interconnecting wires that extend between the first and second wire loops near a distal end of the loops and two relatively longer interconnecting wires that extend between the first and second wire loops nearer the distal end of the delivery shaft than the two relatively shorter interconnecting wires.
Concept 39. An extraction device, comprising:
a delivery shaft having a lumen and a distal end;
first, second, and third wire loops extendible from within the lumen at the distal end, wherein the first, second, and third wire loops are configured to separate upon extension from within the lumen and are maneuverable to at least partially surround a lens of a patient's eye;
a stent extendible from within the lumen around the extended first, second, and third wire loops; and
an encapsulation bag extendible from within the lumen around the extended stent and the extended first, second, and third wire loops.
Concept 40. The extraction device of Concept 39 or any other Concept, wherein the stent comprises an opening and the encapsulation bag comprises an opening configured to be coaligned with the opening in the stent in an extended configuration for the stent and the encapsulation bag.
Concept 41. The extraction device of Concept 39 or any other Concept, further comprising a spiral compaction wire configured to radially compress the encapsulation bag.
Concept 42. The extraction device of Concept 41 or any other Concept, wherein the first, second, and third wire loops are configured to be retracted into the lumen to pass through and cut the lens into pieces.
Concept 43. The extraction device of Concept 42 or any other Concept, wherein the stent is configured to be retracted into the lumen following retraction of the first, second, and third wire loops to cut the pieces into smaller pieces within the encapsulation bag.
Concept 44. The extraction device of Concept 43 or any other Concept, wherein the spiral compaction wire is configured to radially compress the encapsulation bag following retraction of the first, second, and third wire loops and the stent.
Concept 45. An extraction device, comprising:
a delivery shaft having a lumen and a distal end, wherein the lumen comprises a first channel and a second channel diverging at the distal end; and
a wire forming a wire loop and extending from the first channel and the second channel, wherein the wire is movable within the lumen.
Concept 46. The extraction device of Concept 45 or any other Concept, further comprising:
a handle coupled to the delivery shaft; and
an actuator coupled to the wire, wherein the actuator is operable to extend and withdraw the wire loop.
Concept 47. The extraction device of Concept 46 or any other Concept, wherein the actuator comprises a slider tab, wherein sliding motion of the slider tab relative to the handle is configured to extend and withdraw the wire loop.
Concept 48. The extraction device of Concept 46 or any other Concept, wherein the actuator comprises a push button, wherein depression of the push button is configured to extend the wire loop, and wherein release of the push button is configured to withdraw the wire loop.
Concept 49. The extraction device of Concept 46 or any other Concept, wherein a proximal end of the delivery shaft is fixedly coupled to a distal end of the handle.
Concept 50. The extraction device of Concept 46 or any other Concept, wherein the actuator is at least partially disposed in a groove of the handle.
Concept 51. The extraction device of Concept 46 or any other Concept, further comprising:
an inner shaft disposed in the handle, wherein the actuator is operatively coupled to the wire through the inner shaft.
Concept 52. The extraction device of Concept 45 or any other Concept, wherein the delivery shaft has a Y-shaped hub at the distal end.
Concept 53. The extraction device of Concept 52 or any other Concept, wherein the wire loop is configured to be retracted into the lumen to pass through a lens of a patient's eye and cut the lens into pieces while the lens is supported against the Y-shaped hub.
Concept 54. The extraction device of Concept 52 or any other Concept, further comprising:
a sleeve, disposed around the delivery shaft and slidable relative to the delivery shaft,
wherein the first channel extends through a first arm of the Y-shaped hub and the second channel extends through a second arm of the Y-shaped hub,
wherein motion of the sleeve in a distal direction relative to the delivery shaft is configured to compress the first arm and the second arm.
Concept 55. The extraction device of Concept 45 or any other Concept, wherein the loop of the wire has a non-zero bend angle relative to an axis of the delivery shaft.
Concept 56. The extraction device of Concept 55 or any other Concept, wherein the non-zero bend angle is in a range of 10-30 degrees relative to the axis of the delivery shaft.
Concept 57. The extraction device of Concept 45 or any other Concept, wherein the delivery shaft has a non-zero bend angle relative to an axis of a handle.
Concept 58. The extraction device of Concept 57 or any other Concept, wherein the non-zero bend angle is in a range of 10-30 degrees relative to the axis of the handle.
Concept 59. A method, comprising:
inserting a delivery shaft into an anterior chamber of an eye of a patient, the delivery shaft having a lumen and a distal end, the lumen having a first channel and a second channel diverging at the distal end; and
at least partially surrounding a lens of the eye with a wire forming a loop and extending from the a first channel and a second channel, wherein the wire is movable within the lumen.
Concept 60. The method of Concept 59 or any other Concept, further comprising:
cutting the lens into pieces by retracting the wire using an actuator of a handle, wherein the handle is coupled to the delivery shaft and the actuator is coupled to the wire.
Concept 61. The method of Concept 60 or any other Concept, further comprising:
supporting the lens against a Y-shaped hub while cutting the lens into pieces.
Concept 62. The method of Concept 60 or any other Concept, further comprising:
wherein cutting the lens into pieces is performed while the lens is still in a capsular bag.
Concept 63. The method of Concept 60 or any other Concept, further comprising:
forming a capsulorhexis in a capsular bag prior to inserting the delivery shaft; and
inserting a distal portion of the wire below the lens and above a posterior part of a capsular bag, wherein a proximal portion of the wire is disposed above the capsulorhexis when the distal portion of the wire is disposed below the lens.
Concept 64. An extraction device, comprising:
a delivery shaft having a lumen and a distal end, the lumen comprising a first channel and a second channel at the distal end;
a wire forming a wire loop and extending from the first channel and the second channel, the wire being extendable and retractable within the lumen; and
a cutting face positioned between the first channel and the second channel, the cutting face being configured to contact the wire upon retraction of the wire.
Concept 65. The extraction device of Concept 64 or any other Concept, wherein the cutting face comprises a surface positioned distal to a distal end of each of the first and second channels.
Concept 66. The extraction device of Concept 64 or any other Concept, wherein the cutting face comprises a convex surface extending distally and spanning across a region between the first and second channels.
Concept 67. The extraction device of Concept 66 or any other Concept, wherein the convex surface is a smooth arcuate surface.
Concept 68. The extraction device of Concept 66 or any other Concept, wherein the delivery shaft comprises a tubular member having a first end portion forming the first channel, a second end portion forming the second channel, and cutaway region between the first and second end portions that forms the cutting face.
Concept 69. The extraction device of Concept 64 or any other Concept, wherein the cutting face comprises a flat surface extending transverse to the first and second channels.
Concept 70. The extraction device of Concept 64 or any other Concept, wherein the cutting face comprises a surface at a distal end of a protrusion that extends through a gap between the first and second channels.
Concept 71. The extraction device of Concept 64 or any other Concept, further comprising:
a handle coupled to the delivery shaft; and
an actuator on the handle operable to retract the wire towards the cutting face.
Concept 72. The extraction device of Concept 71 or any other Concept, wherein the actuator comprises a push button, wherein depression of the push button is configured to extend the wire through the lumen, and wherein release of the push button is configured to retract the wire towards the cutting face.
Concept 73. The extraction device of Concept 64 or any other Concept, further comprising:
a handle coupled to the delivery shaft, wherein the distal end of the delivery shaft is rotatable relative to the handle about an articulating joint.
Concept 74. A method of cataract extraction, comprising:
inserting a delivery shaft of an extraction device into an eye of a patient;
extending a wire from the inserted delivery shaft to expand a loop of the wire, the wire being positioned in a pair of channels of the delivery shaft;
encircling a lens of the eye with the expanded loop of the wire;
contacting the encircled lens with a cutting face between the pair of channels; and
retracting the wire through the encircled lens and against the cutting face to cut tissue of the lens.
Concept 75. The method of Concept 74 or any other Concept, further comprising removing delivery shaft from the eye after retracting the wire, wherein the wire is in a retracted position during the inserting and the removing of the delivery shaft.
Concept 76. The method of Concept 74 or any other Concept, further comprising:
prior to inserting the delivery shaft, forming a capsulorhexis to remove a portion of a capsular bag of the eye;
after cutting the tissue of the lens, removing the cut tissue from the eye; and
after removing the cut tissue, delivering an intraocular lens into the capsular bag.
Concept 77. The method of Concept 74 or any other Concept, wherein the lens is encircled by rotating the delivery shaft about an articulating joint of the extraction device to move the expanded loop around the lens.
Concept 78. An extraction device, comprising:
a handle;
an articulating arm coupled to the handle, the articulating arm having a distal segment, a proximal segment, and an articulating joint between the distal segment and the proximal segment;
a manipulator configured to extend from the distal segment of the articulating arm to manipulate a lens of an eye; and
an actuator on the handle operable to rotate of the distal segment relative to the proximal segment about the articulating joint.
Concept 79. The extraction device of Concept 78 or any other Concept, wherein the manipulator comprises a wire configured to extend from the distal segment to form a loop, and to retract into the distal segment to cut a lens encircled by the loop.
Concept 80. The extraction device of Concept 79 or any other Concept, wherein rotation of the distal segment relative to the proximal segment about the articulating joint is configured to move the loop in a direction transverse to a plane defined by the loop.
Concept 81. The extraction device of Concept 79 or any other Concept, wherein the distal segment is fixed to a pair of channels that each accommodate a portion of the wire, and wherein the proximal segment is fixed to the handle.
Concept 82. The extraction device of Concept 81 or any other Concept, further comprising a cutting face positioned between the pair of channels, wherein the cutting face is configured to contact the wire upon retraction of the wire.
Concept 83. The extraction device of Concept 78 or any other Concept, wherein the actuator is a first actuator, and the extraction device further comprises a second actuator on the handle separate from the first actuator, wherein the second actuator is operable to extend and retract the manipulator from the distal segment of the articulating arm.
Concept 84. The extraction device of Concept 78 or any other Concept, wherein the actuator is a combined actuator configured to extend and retract the manipulator within the distal segment of the articulating arm in concert with rotation of the distal segment.
Concept 85. The extraction device of Concept 78 or any other Concept, wherein the actuator includes a roller operable to rotate the distal segment, wherein the extraction device further comprises a slider operable to extend and retract the manipulator within the distal segment of the articulating arm.
Concept 86. The extraction device of Concept 85 or any other Concept, wherein the slider is coupled to the roller so that operation of the slider is further configured to operate the roller to rotate the distal segment.
Concept 87. The extraction device of Concept 78 or any other Concept, further comprising:
a pull cable having a first end portion fixedly coupled to the distal segment, wherein operation of the actuator is configured to pull on the pull cable to rotate the distal segment.
Concept 88. The extraction device of Concept 78 or any other Concept, wherein the articulating arm comprises a bendable tubular member in which the articulating joint is formed of a flexible portion of the bendable tubular member.
Concept 89. The extraction device of Concept 88 or any other Concept, wherein the bendable tubular member is a nitinol tube, and the flexible portion is a laser cut segment of the nitinol tube, the laser cut segment forming a series of ribs.
Concept 90. The extraction device of Concept 78 or any other Concept, wherein the actuator is operable from a non-actuated state, in which an axis of the distal segment and an axis of the proximal segment are aligned with each other, to an actuated state, in which the axis of the distal segment and the axis of the proximal segment form a non-zero angle relative to each other.
Concept 91. The extraction device of Concept 78 or any other Concept, wherein the actuator comprises a control component on a side of the handle, and the actuator is configured to rotate the distal segment in a direction towards the control component.
Concept 92. The extraction device of Concept 78 or any other Concept, wherein the actuator comprises a control component on a side of the handle, and the actuator is configured to rotate the distal segment in a direction away from the control component.
Concept 93. An extraction device, comprising:
an articulating arm having a distal segment, a proximal segment, and an articulating joint between the distal segment and the proximal segment;
a wire configured to extend out of the distal segment of the articulating arm to form a loop around lens of an eye; and
an actuator configured to operate the articulating arm to rotate the distal segment relative to the proximal segment about the articulating joint.
Concept 94. The extraction device of Concept 93 or any other Concept, wherein the rotation of the distal segment relative to the proximal segment is configured to move the loop in a direction transverse to a plane defined by the loop.
Concept 95. A method of cataract extraction, comprising:
inserting an articulating arm of a device into an eye of a patient;
rotating a distal segment of the articulating arm relative to a proximal segment of the articulating arm about a joint therebetween to move a wire extending out from the distal segment around a lens of the eye; and
while the wire is around the lens, retracting the wire to cut the lens.
Concept 96. The method of Concept 95 or any other Concept, wherein the articulating arm is in a straight configuration during the inserting the articulating arm, wherein the rotating of the distal segment moves the articulating arm from a straight configuration to a bent configuration.
Concept 97. The method of Concept 96 or any other Concept, further comprising:
returning the articulating arm to the straight configuration; and
removing the articulating arm from the eye with the articulating arm in the straight configuration.
Concept 98. The method of Concept 95 or any other Concept, further comprising:
extending the wire through the articulating arm to expand a loop of the wire, wherein the rotating of the distal segment moves the wire in a direction transverse to a plane of the loop.
Concept 99. The method of Concept 95 or any other Concept, wherein the joint is positioned within the eye during the rotating of the distal segment.
Concept 100. The method of Concept 95 or any other Concept, wherein the rotating of the distal segment and the retracting of the wire are each performed by operating an actuator in a handle coupled to the proximal segment.
Concept 101. The method of Concept 95 or any other Concept, wherein the distal segment is rotated by operating a roller to tension a pull cable coupled to the distal segment.
Concept 102. An extraction device, comprising:
a delivery shaft defining a shaft axis, the delivery shaft having a lumen and a distal end; and
a wire movable within the lumen between a retracted position and an extended position, wherein in the extended position the wire forms an oblong loop having a longitudinal dimension and a lateral dimension greater than the longitudinal dimensional, and wherein the wire has a natural shape that is expanded relative to the loop so that the delivery shaft applies a force to the wire to constrain the wire in the loop when in the extended position.
Concept 103. The extraction device of Concept 102 or any other Concept, wherein the natural shape of the wire is an open configuration.
Concept 104. The extraction device of Concept 102 or any other Concept, wherein the natural shape of the wire has preformed curved regions that urge the loop into a lenticular shape when the wire is in the extended configuration.
Concept 105. The extraction device of Concept 10 or any other Concept 2, wherein the wire loop has a first region of higher curvature than a second region, and the wire has a smaller cross-sectional area at the first region than the second region.
Concept 106. The extraction device of Concept 102 or any other Concept, further comprising a cutting face configured to contact a portion of the wire when the wire is in the retracted position, wherein the portion has a sharper cross-sectional shape than another portion of the wire.
Concept 107. The extraction device of Concept 102 or any other Concept, further comprising a cutting face configured to contact a portion of the wire when the wire is in the retracted position, wherein the portion has a reduced cross-sectional area than another portion of the wire.
Concept 108. The extraction device of Concept 102 or any other Concept, wherein the wire comprises a segment having a flat cross-section and another segment having a round cross-section.
Concept 109. The extraction device of Concept 108 or any other Concept, wherein the segment having a flat cross-section is configured to minimize out of plane bending of the wire.
Concept 110. The extraction device of Concept 109 or any other Concept, wherein the flat section has a long axis oriented in a direction transverse to a plane defined by the loop.
Concept 111. The extraction device of Concept 102 or any other Concept, wherein, when in the extended position, an exit region of the wire located proximal to the delivery shaft has a different cross-sectional shape than a distal region of the wire.
The foregoing description is provided to enable a person skilled in the art to practice the various configurations described herein. While the subject technology has been particularly described with reference to the various figures and configurations, it should be understood that these are for illustration purposes only and should not be taken as limiting the scope of the subject technology.
There may be many other ways to implement the subject technology. Various functions and elements described herein may be partitioned differently from those shown without departing from the scope of the subject technology. Various modifications to these configurations will be readily apparent to those skilled in the art, and generic principles defined herein may be applied to other configurations. Thus, many changes and modifications may be made to the subject technology, by one having ordinary skill in the art, without departing from the scope of the subject technology.
It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the processes may be rearranged. Some of the steps may be performed simultaneously. The accompanying method claims present elements of the various steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented.
A phrase such as “an aspect” does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. A disclosure relating to an aspect may apply to all configurations, or one or more configurations. An aspect may provide one or more examples of the disclosure. A phrase such as “an aspect” may refer to one or more aspects and vice versa. A phrase such as “an embodiment” does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. A disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples of the disclosure. A phrase such “an embodiment” may refer to one or more embodiments and vice versa. A phrase such as “a configuration” does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. A disclosure relating to a configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples of the disclosure. A phrase such as “a configuration” may refer to one or more configurations and vice versa.
As used herein, the phrase “at least one of” preceding a series of items, with the term “and” or “or” to separate any of the items, modifies the list as a whole, rather than each member of the list (i.e., each item). The phrase “at least one of” does not require selection of at least one of each item listed; rather, the phrase allows a meaning that includes at least one of any one of the items, and/or at least one of any combination of the items, and/or at least one of each of the items. By way of example, the phrases “at least one of A, B, and C” or “at least one of A, B, or C” each refer to only A, only B, or only C; any combination of A, B, and C; and/or at least one of each of A, B, and C.
Terms such as “top,” “bottom,” “front,” “rear” and the like as used in this disclosure should be understood as referring to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, a top surface, a bottom surface, a front surface, and a rear surface may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference.
Furthermore, to the extent that the term “include,” “have,” or the like is used in the description or the claims, such term is intended to be inclusive in a manner similar to the term “comprise” as “comprise” is interpreted when employed as a transitional word in a claim.
The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments.
A reference to an element in the singular is not intended to mean “one and only one” unless specifically stated, but rather “one or more.” Pronouns in the masculine (e.g., his) include the feminine and neuter gender (e.g., her and its) and vice versa. The term “some” refers to one or more. Underlined and/or italicized headings and subheadings are used for convenience only, do not limit the subject technology, and are not referred to in connection with the interpretation of the description of the subject technology. All structural and functional equivalents to the elements of the various configurations described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and intended to be encompassed by the subject technology. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the above description.
While certain aspects and embodiments of the subject technology have been described, these have been presented by way of example only, and are not intended to limit the scope of the subject technology. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms without departing from the spirit thereof. The accompanying claims and their equivalents are intended to cover such forms or modifications as would fall within the scope and spirit of the subject technology.
This application is the national stage of International Patent Application No. PCT/US2019/029206, entitled “APPARATUS AND METHOD FOR CATARACT EXTRACTION,” filed Apr. 25, 2019, which claims the benefit of U.S. Provisional Application No. 62/666,640, entitled “APPARATUS AND METHOD FOR CATARACT EXTRACTION,” filed May 3, 2018, the entirety of which is incorporated herein by reference.
Filing Document | Filing Date | Country | Kind |
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PCT/US2019/029206 | 4/25/2019 | WO | 00 |
Number | Date | Country | |
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62666640 | May 2018 | US |