Looping for delivery of intraocular implants

By using a combination of anterior and posterior opening arms in the ophthalmic implant delivery system, the problem of inflexible loop handling in existing technologies is solved, and accurate and safe delivery of implants is achieved.

CN116528797BActive Publication Date: 2026-04-14ALCON INC
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
ALCON INC
Filing Date
2021-12-02
Publication Date
2026-04-14

AI Technical Summary

Technical Problem

Existing ophthalmic implant delivery systems suffer from a lack of flexibility and effectiveness in manipulation and delivery, particularly in handling loops, which affects the accuracy and safety of implants.

Method used

The fixation device, which includes anterior and posterior opening arms, straightens the anterior and posterior loops by active or passive means to form a straight-to-straight loop configuration. The lens is advanced by a plunger, and the actuation of the arm is coordinated by a cam system to ensure accurate delivery of the implant.

Benefits of technology

It improves the flexibility and accuracy of the implant delivery process, reduces the risk of implant rotation, and enhances the controllability and safety of the delivery system.

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Abstract

An apparatus for eye surgery can include a nozzle having a delivery lumen, an implant capsule coupled with the nozzle, and an implant (210) disposed in the implant capsule. The implant can include an optical body (1420), an anterior haptic (1425), and a posterior haptic (1430). In some examples, the implant can be an intraocular lens. The apparatus can further include an actuator including a housing and a plunger disposed within the housing, and an anterior opening arm operable to open the anterior haptic within the implant capsule. The plunger can be operable to advance the optical body from the implant capsule to the delivery lumen after the anterior opening arm straightens the anterior haptic.
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Description

[0001] Priority Statement

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 120,955, filed December 3, 2020, entitled “HAPTIC MANAGEMENT FOR DELIVERY OF INTRAOCULAR IMPLANTS”, inventors Jestwin Edwin Lee, IV, Kate Jensen, Anubhav Chauhan, Todd Taber, Yinghui Wu, and Saumya Dilip Yadav, which is incorporated herein by reference in its entirety as if fully and completely set forth herein. Technical Field

[0003] The invention set forth in the appended claims generally relates to eye surgery. More specifically, but not limitingly, the claimed subject matter relates to systems, devices, and methods for inserting implants into the eye. Background Technology

[0004] The human eye can be affected by a variety of conditions, ranging from mild vision loss to complete blindness. While contact lenses and eyeglasses can compensate for some conditions, others may require eye surgery. In some cases, implants can be beneficial or necessary. For example, an artificial lens can replace the cloudy natural lens inside the eye to improve vision.

[0005] While the benefits of intraocular lenses and other implants are well-known, improvements in delivery systems, components, and manufacturing processes will continue to enhance efficacy and benefit patients. Summary of the Invention

[0006] The appended claims set forth novel and useful systems, apparatus, and methods for eye surgery. Illustrative embodiments are also provided to enable those skilled in the art to implement and apply the claimed subject matter.

[0007] For example, some embodiments may include or be substantially constituted by a device for delivering an intraocular lens, the device including at least one fixation device configured to actively manipulate at least one loop associated with the lens prior to delivery. In more specific embodiments, one or more fixation devices may be configured to actively straighten anterior loop, posterior loop, or both.

[0008] In some embodiments, the fixation device may include a front flare arm configured to actively straighten the anterior loop. For example, the front flare arm may advance forward to engage and push the anterior loop forward, placing it in a straightened orientation. In some embodiments, the front flare arm may form the lower wall of a delivery channel. A plunger may then engage the optical portion of the lens and advance the lens forward. As the plunger advances the lens, a second fixation device may interact with the posterior loop to passively straighten it. For example, the second fixation device may include a portion of a sidewall that may be formed as a substantially rigid arm configured to engage the posterior loop. In some embodiments, the front flare arm and the plunger may be advanced forward together by a single actuator. In other embodiments, the front flare arm and the plunger may be actuated independently.

[0009] Some embodiments may include two movable opening arms, each of which can engage one of the loops. The two arms can extend or move in opposite directions to orient, straighten, or otherwise manipulate the loop. For example, one arm can move forward to straighten the anterior loop, while the other arm can move in the opposite direction to straighten the posterior loop, resulting in a straight-loop configuration suitable for delivery. In some examples, the arms may additionally form sidewalls that help maintain the loop configuration, prevent optical body rotation, or both. The sidewalls may also define smaller lumens to maintain lens alignment as the lens is advanced.

[0010] In some examples, the arm may be actuated by a separate joystick, dial, or similar feature. Some embodiments may additionally or alternatively include a cam system configured to coordinate the actuation of the arm.

[0011] In some embodiments, two securing devices may be formed as part of the inner wall of the delivery device for orienting the loop prior to advancement. The first securing device may be in the form of an arm with a Y-shaped end for pushing or straightening the front loop. The second securing device may include a cam with a hook-shaped end that can slide in the opposite direction to the first securing device to straighten the rear loop.

[0012] More generally, some embodiments of a device for ocular surgery may include a nozzle having a delivery lumen, an implant capsule coupled to the nozzle, and an implant disposed within the implant capsule. The implant may include an optical body, an anterior loop, and a posterior loop. In some examples, the implant may be an intraocular lens. The device may further include: an actuator including a housing, a plunger disposed within the housing; and an anterior flaring arm operable to flare the anterior loop within the implant capsule. The plunger may be operable to advance the optical body from the implant capsule into the delivery lumen after the anterior flaring arm straightens the anterior loop.

[0013] In a more specific embodiment, the implant capsule may include a posterior vasator arm operable for opening the posterior loop of the lens. In some embodiments, the posterior vasator arm may passively open the posterior loop as the plunger advances the lens. In other embodiments, the posterior vasator arm may be actuated to actively open the posterior loop. For example, in some embodiments, the posterior vasator arm may actively open the posterior loop before the plunger advances the lens. In some embodiments, the anterior and posterior vasators may be operable for movement in opposite directions.

[0014] Additionally or alternatively, in some embodiments, after the anterior loop is opened, the anterior opening arm, the posterior opening arm, or both may form a wall adjacent to the optical body within the implant capsule. In some embodiments, the anterior opening arm, the posterior opening arm, or both may include ends configured to facilitate engagement with the loop. For example, several different embodiments of the anterior and posterior opening arms may include notched ends, tapered ends, rounded ends, curved ends, or some combination thereof.

[0015] In some example embodiments, the device for ocular surgery may include an implant chamber and an implant disposed within the implant chamber. The implant may include an optical body, an anterior loop, and a posterior loop. An anterior opening arm may be operable to open the anterior loop, and a posterior opening arm may be operable to open the posterior loop.

[0016] In a more specific example, the implant chamber may include a delivery port, an anterior opening arm operable to move the free end of the anterior loop toward the delivery port, and a posterior opening arm operable to move the free end of the posterior loop away from the delivery port. Some embodiments may additionally include a cam configured to translate the anterior and posterior opening arms.

[0017] Methods for ejecting a lens from a surgical delivery system may include: placing the lens in an implantation chamber; straightening the anterior loop of the lens with an anterior pleuritic arm; advancing the lens from the implantation chamber into a delivery lumen using a rigid plunger; fluidly connecting a fluid chamber to an orifice in the rigid plunger via a bypass channel; squeezing fluid in the fluid chamber to move fluid through the bypass channel and orifice into the delivery lumen; and using the fluid to advance the lens through the delivery lumen.

[0018] The features, elements, and aspects described in the context of some embodiments may be omitted, combined, or replaced by alternative features. Other features, objects, advantages, and preferred modes for implementing and applying the claimed subject matter are described in more detail below with reference to the accompanying drawings of illustrative embodiments. Attached Figure Description

[0019] The accompanying drawings illustrate some objectives, advantages, and preferred modes of implementing and applying the claimed subject matter. In the examples, the same reference numerals denote the same parts.

[0020] Figure 1 This is a schematic diagram of an example system for inserting an implant into the eye.

[0021] Figure 2 yes Figure 1 A schematic diagram illustrating an example of a system.

[0022] Figure 3 It is possible to be with Figure 2 A detailed view of the actuators associated with the system.

[0023] Figure 4 yes Figure 1 An assembly diagram of another example of the system.

[0024] Figure 5 yes Figure 4 A detailed view of the actuator is shown.

[0025] Figure 6 It is the assembled Figure 4 An isometric view of the system.

[0026] Figure 7 yes Figure 6 A side view of the system.

[0027] Figure 8 yes Figure 6 The front view of the system.

[0028] Figure 9 yes Figure 8 A cross-sectional view of the system.

[0029] Figure 10 It is possible to be with Figure 1 An isometric view of another example of the actuators associated with the system.

[0030] Figure 11 yes Figure 10 Rear view of the actuator.

[0031] Figure 12 yes Figure 11 A cross-sectional view of the actuator.

[0032] Figure 13 yes Figure 4 An assembly diagram of the implant processing system is shown.

[0033] Figure 14 yes Figure 13 A top view of the implant processing system.

[0034] Figure 15 This is an isometric view of another example of an implant handling system.

[0035] Figure 16 yes Figure 15 Assembly diagram of the implant treatment system.

[0036] Figure 17 It is possible to be with Figure 16 A bottom view of the base associated with some embodiments of the implant handling system.

[0037] Figure 18 yes Figure 15 A top view of the implant processing system.

[0038] Figure 19 This is an isometric view of another example of an implant handling system.

[0039] Figure 20 This is an isometric view of another example of an implant handling system.

[0040] Figure 21 yes Figure 20 Assembly diagram of the implant treatment system.

[0041] Figure 22 yes Figure 21 A top view of the implant processing system.

[0042] Figure 23 This is an isometric view of another example of an implant handling system.

[0043] Figure 24 yes Figure 23 Assembly diagram of the implant treatment system.

[0044] Figure 25 yes Figure 23 A top view of the implant processing system.

[0045] Figures 26A to 26D It demonstrates the insertion of implants from Figure 1 A diagram illustrating the example methods that are pushed out of the system.

[0046] Figures 27A to 27B It is a demonstration Figure 1 A schematic diagram illustrating an example application of the system that inserts an implant into the eye. Detailed Implementation

[0047] The following description of exemplary embodiments provides information that enables those skilled in the art to implement and apply the subject matter set forth in the appended claims, but some details well known in the art may be omitted. Therefore, the following detailed description should be regarded as illustrative rather than restrictive.

[0048] This document may also describe exemplary embodiments with reference to the spatial relationships or spatial orientations of the various elements depicted in the accompanying drawings. Typically, such relationships or orientations employ a frame of reference consistent with or relevant to a patient in the appropriate position to receive the implant. However, as those skilled in the art will recognize, such a frame of reference is merely descriptive and not a strict specification.

[0049] Figure 1 This is a schematic diagram of a system 100 for inserting an implant into the eye. In some embodiments, system 100 may include two or more modules that can be configured to be coupled and disengaged as needed for storage, assembly, use, and disposal. For example, as Figure 1 As shown, some embodiments of system 100 may include a nozzle 105, an implantation capsule 110 coupled to the nozzle 105, and an actuator 115 coupled to the implantation capsule 110. In some embodiments, system 100 may additionally include a drive module 120 configured to engage the actuator 115.

[0050] The nozzle 105 generally includes a tip adapted for insertion into the eye through an incision. The size of the tip can be adapted to the requirements and techniques of the surgical procedure. For example, small incisions are generally preferred to reduce or minimize healing time. In some cases, an incision of less than 3 mm may be preferred, and in some embodiments, the width of the tip of the nozzle 105 may be less than 3 mm.

[0051] Implant compartment 110 generally represents a variety of different devices suitable for storing implants prior to delivery into the eye. In some embodiments, implant compartment 110 may be additionally or alternatively configured to prepare the implant for delivery. For example, some embodiments of implant compartment 110 may be configured to be actuated by a surgeon or other operator to prepare the implant for delivery via subsequent action of actuator 115. In some cases, implant compartment 110 may be configured to actively deform, elongate, extend, or otherwise manipulate features of the implant prior to its advancement into nozzle 105. For example, implant compartment 110 may be configured to extend or open one or more features of an intraocular lens, such as a loop.

[0052] The actuator 115 is generally configured to advance the implant from the implant compartment 110 into the nozzle 105, and then from the nozzle 105 into the eye through an incision.

[0053] The drive module 120 is generally operable to energize the actuator 115. In some examples, the drive module 120 can be operated electrically, mechanically, hydraulically, or pneumatically, or a combination thereof, or in some other way. In some cases, the drive module 120 can be manually operated. Depending on other implementations, the drive module 120 can be an automated system.

[0054] Typically, the components of system 100 can be directly or indirectly connected. For example, nozzle 105 can be directly connected to implant capsule 110 and indirectly connected to actuator 115 via implant capsule 110. Connections can include fluid connections, mechanical connections, thermal connections, electrical connections, or chemical connections (such as chemical bonds), or a combination of connections in certain situations. For example, actuator 115 can be mechanically connected to drive module 120 and can be mechanically fluidly connected to implant capsule 110. In some embodiments, components can also be connected by physical proximity, integration into a single structure, or formation from the same material.

[0055] Figure 2 This is a schematic diagram of an example of system 100, illustrating additional details that can be associated with some embodiments. Figure 2 In the example, the nozzle 105 has a delivery lumen 205, and the implant 210 is disposed within the implant compartment 110.

[0056] Figure 2 The actuator 115 typically includes a housing 215, a plunger 220 disposed within the housing 215, an orifice 225 through the plunger 220, and a drive interface 230 configured to connect with the drive module 120. The plunger 220 is typically made of a substantially rigid material, such as a medical-grade polymer. A plunger seal 235 may be disposed within the housing 215 and connected to the plunger 220. A drive seal 240 may also be disposed within the housing 215. In some embodiments, the drive module 120 may include a push rod 245 configured to engage the drive seal 240 via the drive interface 230. For example, the drive interface 230 may include an orifice configured to receive the push rod 245.

[0057] like Figure 2 As shown in the example, the drive seal 240 can be disposed between the plunger seal 235 and the drive interface 230, and the fluid chamber 250 can be defined within the housing 215, between the plunger seal 235 and the drive seal 240. Figure 2In the example configuration, the plunger seal 235 is configured to provide a fluid seal across the housing 215 and substantially prevent fluid from moving from the fluid chamber 250 to the orifice 225. The drive seal 240 can also be configured to provide a fluid seal across the housing 215 and substantially prevent fluid from moving from the fluid chamber 250 to the drive interface 230.

[0058] Figure 3 yes Figure 2 A detailed view of actuator 115 shows additional details that can be associated with some embodiments. For example, Figure 3 The housing 215 further includes a plunger interface 305 and a bypass channel 310 disposed between the plunger interface 305 and the drive interface 230. The bypass channel 310 can take various forms. For example, the bypass channel 310 may include a protrusion in the housing 215, such as... Figure 3 As shown. In other examples, bypass channel 310 may include a groove or recess in the inner surface of housing 215. In some embodiments, bypass channel 310 may include multiple channels. For example, in some embodiments, multiple channels may be arranged circumferentially around housing 215.

[0059] The plunger 220 generally has a first end 315 and a second end 320, wherein the first end 315 is generally positioned adjacent to the plunger interface 305. The bore 225 generally extends longitudinally through the plunger 220 from the first end 315 to the second end 320.

[0060] In some embodiments, the actuator 115 may additionally include a nozzle seal 325 and a bypass seal 330. Each of the nozzle seal 325 and the bypass seal 330 is generally configured to form a seal between a portion of the plunger 220 and the housing 215 to substantially prevent fluid movement through the seal. Figure 3 As illustrated in the examples, one or both of the nozzle seal 325 and the bypass seal 330 may be an annular seal, such as an O-ring, circumferentially disposed around a portion of the plunger 220. In other examples, an umbrella-shaped seal may be applicable. In a more specific embodiment, the nozzle seal 325 may be disposed near a first end 315 of the plunger 220, and the bypass seal 330 may be disposed near a second end 320 of the plunger 220.

[0061] Figure 3 The drive interface 230 includes a cap 335 and an orifice 340. The cap 335 can be engaged with one end of the housing 215 to retain the drive seal 240 and other components within the housing 215.

[0062] Figure 4 This is another example assembly diagram of System 100. (See diagram below.) Figure 4As illustrated in the example, the implant compartment 110 may include an implant handling system 405, a carrier 410, and a cap 415. In several different embodiments, the implant handling system 405 may be any of a variety of different systems, devices, components, or cartridges configured to prepare the implant for delivery. The carrier 410 and cap 415 may be configured to substantially enclose the implant handling system 405. The carrier 410 and cap 415 may also be configured to be mechanically coupled to the nozzle 105 and actuator 115.

[0063] Figure 4 The housing 215 includes a hollow cylinder that can accommodate a plunger 220, a plunger seal 235, and a drive seal 240. Figure 4 An example of an implant interface 420 is also shown, which in some embodiments can be coupled to the first end 315 of the plunger 220. Figure 4 In the example, plunger 220 and plunger seal 235 can be inserted into housing 215, and then applicable working fluid can be added before inserting drive seal 240 and attaching cap 335 to housing 215.

[0064] In some examples, an implant (not shown) may be pre-loaded into the implant handling system 405. The implant handling system 405 is typically configured to store and manipulate implants. For example, some embodiments of the implant handling system 405 may be configured to orient or fold the implant. In some cases, the implant handling system 405 may be configured to fold, open, or straighten the loop of an intraocular lens. Figure 4 In one example, the implant handling system 405 includes a front opening arm 425 operable for manipulating an implant within the implant chamber 430 of the implant handling system 405. Other examples may additionally or alternatively include other suitable mechanisms for manipulating the front opening arm 425, such as a rotary dial, cap, or wheel. Figure 4 In the example, the anterior open arm 425 is configured to receive manual actuation of the implant handling system 405.

[0065] Figure 5 It is the assembled Figure 4 An isometric view of actuator 115. (See image.) Figure 5 As illustrated in the examples, some embodiments of the plunger interface 305 may include an opening in the housing 215 and one or more locking tabs 505. The implant interface 420 and at least a portion of the plunger 220 may extend through the plunger interface 305. Figure 5 The nozzle seal 325 includes an O-ring disposed adjacent to the first end 315 around the plunger 220. For example... Figure 5As seen in the example, the hole 225 may define an opening in the first end 315. In some embodiments, the opening may be centrally located through the first end 315, and the implant interface 420 may be coupled to the plunger 220 adjacent to the opening in the first end 315. The implant interface 420 may include a notch 510 that may be configured to engage an implant.

[0066] Figure 6 It is the assembled Figure 4 An isometric view of system 100 shows additional details that can be associated with some embodiments. For example... Figure 6 As illustrated in the examples, system 100 can have an elongated shape. In some cases, actuator 115 can be at least partially inserted into implant capsule 110 and secured in place by locking mechanism 605, which is adapted to engage interlocking features of actuator 115 such as locking tab 505. In other examples, actuator 115 can be secured by other suitable fasteners, interference fits, or thermal or chemical bonding.

[0067] like Figure 6 As illustrated in the examples, some embodiments of the nozzle 105 may include an insertion tip 610 and a depth guard 615. The insertion tip 610 may be adapted to minimize shear forces on the cut. In some examples, the insertion tip 610 may be beveled or angled. The depth guard 615 may include an opening portion adapted to contact the eye around the cut to limit the penetration depth of the insertion tip 610.

[0068] Some embodiments of system 100 may additionally include a variety of different ergonomic features. For example, in Figure 6 In the implant compartment 110, the cover 415 includes a levitation protrusion 620. Figure 6 The raised portion 620 includes a shallow recess formed in the cover 415 for accommodating one or more fingers, such as those of an operator. The raised portion 620 may additionally include a textured surface that can improve grip and control of the system 100.

[0069] Figure 7 yes Figure 6 The side view of system 100 illustrates additional details that can be associated with some embodiments. For example... Figure 7 As shown in the example, the carrier 410 may include a raised portion 705 similar to or similar to the raised portion 620.

[0070] Figure 8 yes Figure 6 The front view of system 100. (See example) Figure 8As shown, the insertion tip 610 may have a circular profile, and the depth guard 615 may have an elliptical profile. In some embodiments, the insertion tip 610 and the depth guard 615 may be concentric, such as... Figure 8 The example shown is as follows.

[0071] Figure 9 yes Figure 8 A cross-sectional view of system 100 taken along line 9-9 shows additional details that can be associated with some embodiments. Figure 9 In this example, nozzle 105 is coupled to implant chamber 110, and actuator 115 is coupled to implant chamber 110. A plunger 220 is disposed within housing 215, and a hole 225 extends through the plunger 220 between a first end 315 and a second end 320. A plunger seal 235 may be disposed within housing 215 and coupled to the second end 320 of plunger 220.

[0072] The drive seal 240 can be disposed between the plunger seal 235 and the drive interface 230, and the fluid chamber 250 can be defined within the housing 215, between the plunger seal 235 and the drive seal 240. Figure 9 In the example configuration, the plunger seal 235 is configured to provide a fluid seal across the housing 215 and substantially prevent fluid from moving from the fluid chamber 250 to the orifice 225. The drive seal 240 can also be configured to provide a fluid seal across the housing 215 and substantially prevent fluid from moving from the fluid chamber 250 to the drive interface 230.

[0073] The bypass channel 310 can be located between the plunger interface 305 and the drive interface 230. Figure 9 The bypass channel 310 includes a recess in the inner surface of the housing 215.

[0074] like Figure 9 As shown, some embodiments of the implant handling system 405 may include an implant chamber 905 that provides a fluid path between the orifice 225 and the delivery lumen 205. In some embodiments, the implant chamber 905 may also be configured to receive a portion of the plunger 220 that includes the implant interface 420.

[0075] Figure 9The example configuration is typically suitable for storing the implant (not shown) prior to delivery. More specifically, the implant can be stored in the implant chamber 905. The plunger seal 235 and the drive seal 240 can be positioned in a first location where the plunger seal 235 fluidly isolates the orifice 225 and bypass passage 310 from the fluid chamber 250, thereby allowing the applicable working fluid to be stored in the fluid chamber 250. The applicable working fluid can include, but is not limited to, liquids such as saline or viscous lubricants with non-Newtonian properties.

[0076] Figure 10 This is an isometric view of another example of actuator 115, showing additional details that may be associated with some embodiments. Figure 10 The actuator 115 is similar to Figure 5 Actuator 115. For example. Figure 10 The plunger interface 305 may include an opening in the housing 215, and the implant interface 420 and at least a portion of the plunger 220 may extend through the plunger interface 305. Figure 10 The nozzle seal 325 includes an O-ring disposed adjacent to the first end 315 around the plunger 220. For example... Figure 10 As seen in the example, the hole 225 may define an opening in the first end 315. In some embodiments, the opening may be centrally located through the first end 315, and the implant interface 420 may be coupled to the plunger 220 adjacent to the opening in the first end 315. Figure 10 The actuator 115 further includes a fluid fitting 1005.

[0077] Figure 11 yes Figure 10 The rear view of actuator 115 shows additional details that can be associated with some embodiments of fluid fitting 1005. Figure 11 In the example, at least a portion of the fluid fitting 1005 may be integral with the housing 215. The fluid fitting 1005 may be a Luer lock, a Luer slider, or a similar fitting configured to receive a syringe or other device. For example, Figure 11 The fluid fitting 1005 includes a female Luer lock 1105 having at least one locking tab 1110 configured to engage threads on a compatible male Luer lock fitting. A port 1115 may be located in the drive seal 240 of the female Luer lock 1105.

[0078] Figure 12 yes Figure 11 A cross-sectional view of actuator 115 taken along line 12-12. Figure 12In one example, plunger 220 is disposed within housing 215, and orifice 225 extends through plunger 220 between first end 315 and second end 320. Plunger seal 235 may be disposed within housing 215 and coupled to the second end 320 of plunger 220. In some embodiments of plunger 220, implant interface 420 may be coupled to first end 315.

[0079] The drive seal 240 can be integral with or coupled to the fluid fitting 1005, and the fluid chamber 250 can be defined within the housing 215, between the plunger seal 235 and the drive seal 240. Figure 12 In the example configuration, plunger seal 235 is configured to provide a fluid seal across housing 215 and substantially prevent fluid movement between orifice 225 and fluid chamber 250. Drive seal 240 can also be configured to provide a fluid seal across housing 215 and substantially prevent fluid movement between drive port 230 and fluid chamber 250.

[0080] The bypass channel 310 can be disposed between the plunger interface 305 and the drive seal 240. In a more specific embodiment, the bypass channel 310 can be disposed between the plunger interface 305 and the plunger seal 235. Figure 12 The bypass channel 310 includes a recess in the inner surface of the housing 215. In some examples, the width of the bypass channel 310 may increase with the distance from the plunger seal 235.

[0081] like Figure 12 As illustrated in the examples, some embodiments of actuator 115 may optionally have at least one actuation channel 1205. The actuation channel 1205 can take many different forms. For example, the actuation channel 1205 may include a groove or recess in the inner surface of the housing 215, such as... Figure 12 The example illustrates this. In other examples, the activation channel 1205 may include a protrusion in the housing 215. In some embodiments, the activation channel 1205 may include multiple channels. For example, in some embodiments, the multiple channels may be arranged circumferentially around the housing 215.

[0082] exist Figure 12 In the example, the nozzle seal 325 is located near the first end 315 of the plunger 220, and the bypass seal 330 is located near the second end 320 of the plunger 220.

[0083] like Figure 12 As shown, port 1115 may include a filler seal 1210. The filler seal 1210 may include a self-sealing material adapted to allow fluid penetration while providing a seal upon removal. For example, Figure 12The actuator 115 can deliver and store fluid even when there is no fluid in the fluid chamber 250. A syringe or other suitable fluid source (not shown) can then be connected to the fluid fitting 1105 via port 1115 and filling seal 1210 to add suitable working fluid to the fluid chamber 250. Additionally or alternatively, a check valve or umbrella valve can be configured to allow fluid to enter the fluid chamber 250 and prevent backflow.

[0084] Figure 13 yes Figure 4 An assembly diagram of the implant handling system 405 shows additional details that can be associated with some examples. For example... Figure 13 As illustrated in the example, the implant 210 and the anterior flare arm 425 can be disposed between the cap 1305 and the base 1310. The cap 1305 may additionally include a through channel 1315 and a guide channel 1320. The cap 1305 and the base 1310 can be configured to be joined together to enclose the implant 210 and the anterior flare arm 425. For example, the cap 1305 may include one or more locking tabs 1325 configured to snap onto the base 1310. In some embodiments, one or more of the cap 1305 and the base 1310 may be transparent to allow the implant 210 to be visible.

[0085] Figure 14 yes Figure 13 A top view of the implant handling system 405, with the cap 1305 removed to further reveal the implant 210, the anterior opening arm 425, and the base 1310. (See attached image.) Figure 14 As shown in the examples, some embodiments of the implant handling system 405 may include a posterior opening arm 1405, a guide channel 1410, and a through channel 1415. Figure 14 The implant 210 includes an optical body 1420, an anterior loop 1425, and a posterior loop 1430.

[0086] Guide channel 1410 can be configured to interact with guide channel 1320 (see guide channel 1320). Figure 13 Alignment is performed to constrain the front opening arm 425 to a linear movement substantially parallel to the through channel 1415. The through channel 1415 can be configured to align with the through channel 1315 (see...). Figure 13 Alignment to form implant chamber 905 (see example) Figure 9 The implant chamber can constrain the optical body 1420 to linear movement between the plunger port 1435 and the delivery port 1440.

[0087] Figure 14 The anterior opening arm 425 is movable to open the anterior loop within the implant capsule. For example, Figure 14The front opening arm 425 can be configured to engage the free end 1445 of the front loop 1425, and advancing the front opening arm 425 toward the delivery port 1440 can actively open the front loop 1425 toward the delivery port 1440. Figure 14 In one example, the anterior flare arm 425 includes a rounded end to facilitate engagement with the free end 1445 of the anterior loop 1425. In other examples, the anterior flare arm 425 may include other configurations for engaging the free end 1445, such as a tapered end or a notched end. In some embodiments, the anterior loop 1425 may be moved into a straight configuration before the optical body 1420 is advanced. As it advances toward the delivery port 1440, the anterior flare arm 425 may additionally form a wall along the through channel 1415, which may help prevent rotation of the optical body 1420 and maintain alignment of the implant 210.

[0088] exist Figure 14 In the example, the rear opening arm 1405 is configured as a substantially rigid extension fixed to the base 1310. The rear opening arm 1405 can be configured to engage the free end 1450 of the rear loop 1430, which can passively open the rear loop 1430 as the optical body 1420 is advanced toward the delivery port 1440. In some examples, the rear loop 1430 can be moved into a straight configuration before the optical body 1420 is advanced through the delivery port 1440.

[0089] Figure 15 This is an isometric view of another example of the implant handling system 405, showing additional details that can be associated with some embodiments. For example, as Figure 15 As shown, each of the front open arm 425 and the rear open arm 1405 may include at least one actuator 1505. Each of the actuators 1505 is configured to be accessible via a guide rail 1510, which is configured to constrain the movement of the actuator 1505 to a substantially linear motion. Figure 15 As shown in the example, guide rails 1510 can be parallel to each other.

[0090] Figure 16 yes Figure 15 Assembly diagram of implant processing system 405. (See diagram for example.) Figure 16 As illustrated in the example, implant 210, anterior opening arm 425, and posterior opening arm 1405 may be disposed between cap 1305 and base 1310. In some embodiments, guide rail 1510 may be disposed in cap 1305. Base 1310 may additionally include one or more guide channels 1410, which may be configured to align with guide rail 1510 to constrain anterior opening arm 425 and posterior opening arm 1405 to a substantially linear movement parallel to the through channel 1415.

[0091] Figure 17 yes Figure 16 The bottom view of the cover 1305 shows additional details that can be associated with some embodiments. For example, as Figure 17 As shown, the guide rails 1510 can be parallel to each other and parallel to the through channel 1315. The front opening arm 425 and the rear opening arm 1405 can be slidably received within the guide rails 1510 and are operable for linear movement within the respective guide rails 1510. Figure 17 The front flare arm 425 includes a notched end, and the rear flare arm 1405 includes a tapered end. In other examples, one or both of the rear flare arm 1405 and the rear flare arm may include other configurations, such as a tapered end, a notched end, a curved end, or a combination thereof.

[0092] Figure 18 yes Figure 15 A top view of the implant handling system 405, wherein the cover 1305 is removed to further display the implant 210. (See attached image.) Figure 18 As shown in the example, the front opening arm 425 and the rear opening arm 1405 are operable to move in opposite directions to open the front loop 1425 and the rear loop 1430, respectively. More specifically, in Figure 18 In the example, the anterior opening arm 425 is operable to move the free end 1445 of the anterior loop 1425 toward the delivery port 1440, and the posterior opening arm 1405 is operable to move the free end 1450 of the posterior loop 1430 away from the delivery port 1440. Additionally, in some embodiments, after opening the anterior loop 1425 and the posterior loop 1430, the anterior opening arm 425 and the posterior opening arm 1405 may form a wall adjacent to the optical body 1420, which helps prevent rotation of the optical body 1420 and maintains the alignment of the implant 210.

[0093] Figure 19 This is an isometric view of another example of the implant handling system 405, showing additional details that can be associated with some embodiments. For example, Figure 19 The implant processing system 405 is basically similar to Figure 15 The implant handling system 405 further includes a cam 1905 configured to translate the front opening arm 425 and the rear opening arm 1405. For example, the cam 1905 may include a dial 1910 and two connecting arms 1915 that can be coupled to an actuator 1505. In some embodiments, the cam 1905 can translate the front opening arm 425 (not visible) and the rear opening arm 1405 simultaneously.

[0094] Figure 20 This is an isometric view of another example of the implant handling system 405, showing additional details that can be associated with some embodiments. (See also...) Figure 20As shown in the example, the front opening arm 425 can be positioned between the cover 1305 and the base 1310, adjacent to the plunger port 1435. Figure 20 Examples of fluid ports 2005 that can be associated with some embodiments of the implant handling system 405 are also shown.

[0095] Figure 21 yes Figure 20 Assembly diagram of implant processing system 405. (See diagram for example.) Figure 21 As shown in the example, implant 210, anterior opening arm 425, and posterior opening arm 1405 can be disposed between cap 1305 and base 1310. Base 1310 may additionally include one or more guide channels 1410, which can be configured to constrain anterior opening arm 425 to a substantially linear movement parallel to the through channel 1415.

[0096] Figure 22 yes Figure 21 A top view of the implant handling system 405, wherein the cover 1305 is removed to further display the implant 210. (See attached image.) Figure 22 As shown in the example, the front opening arm 425 and the rear opening arm 1405 can be operated to move in opposite directions to open the front loop 1425 and the rear loop 1430, respectively. Figure 22 The implant handling system 405 includes a guide rail 1510, and an actuator 1505 can be configured to move within the guide rail 1510 to constrain the actuator 1505 to linear movement parallel to the through-channel 1415. More specifically, in Figure 22 In the example, the front opening arm 425 is operable to move the free end 1445 of the front loop 1425 toward the delivery port 1440, and the rear opening arm 1405 is operable to move the free end 1450 of the rear loop 1430 away from the delivery port 1440. Figure 22 In one example, the anterior opening arm 425 includes a notched end 2205 that facilitates engagement with the free end 1445, and the posterior opening arm 1405 includes a curved end 2210 that facilitates engagement with the free end 1450. Additionally, in some embodiments, after the anterior loop 1425 and the posterior loop 1430 are opened, at least one of the anterior opening arm 425 and the posterior opening arm 1405 may form a wall adjacent to the optical body 1420, which may help prevent rotation of the optical body 1420 and maintain the alignment of the implant 210. In some embodiments, the fluid port 2005 may be fluidly connected to the through channel 1415.

[0097] Figure 23 This is an isometric view of another example of the implant handling system 405, showing additional details that can be associated with some embodiments. Figure 23The implant processing system 405 can be similar in many ways to Figure 20 Implant handling system 405. Figure 23 The front opening arm 425 can be positioned between the cover 1305 and the base 1310, adjacent to the plunger port 1435. For example... Figure 23 As shown, some embodiments of the actuator 1505 can be constrained in the base 1310 by the guide rail 1510. Additionally or alternatively, in some examples, the guide rail 1510 may be curved.

[0098] Figure 24 yes Figure 23 Assembly diagram of implant processing system 405. (See diagram for example.) Figure 24 As shown in the example, implant 210, anterior opening arm 425, and posterior opening arm 1405 can be disposed between cap 1305 and base 1310. Base 1310 may additionally include guide channel 1410, which can be configured to constrain anterior opening arm 425 to a substantially linear movement parallel to the through channel 1415.

[0099] Figure 25 yes Figure 23 A top view of the implant handling system 405, where the cap 1305 has been removed to further reveal additional features. (See attached image.) Figure 25 As shown in the example, the front opening arm 425 and the rear opening arm 1405 are operable to open the front loop 1425 and the rear loop 1430 in opposite directions. More specifically, in Figure 25 In the example, the front opening arm 425 is operable to move the free end 1445 of the front loop 1425 toward the delivery port 1440, and the rear opening arm 1405 is operable to move the free end 1450 of the rear loop 1430 away from the delivery port 1440. Figure 25 In one example, the anterior opening arm 425 includes a notched end 2205 that facilitates engagement with the free end 1445, and the posterior opening arm 1405 includes a curved end 2210 that facilitates engagement with the free end 1450. Additionally, in some embodiments, after the anterior loop 1425 and the posterior loop 1430 are opened, at least one of the anterior opening arm 425 and the posterior opening arm 1405 may form a wall adjacent to the optical body 1420, which can help prevent rotation of the optical body 1420 and maintain the alignment of the implant 210.

[0100] Figures 26A to 26D This is a schematic diagram illustrating an example method of ejecting implant 210 from system 100. Initially, multiple different components of system 100 can be assembled if needed. For example, nozzle 105, implant capsule 110, and actuator 115 can be interconnected, such as... Figure 26AAs shown. The drive system 120 can also be connected to the actuator 115 via the drive interface 230. For example, the push rod 245 can engage the drive seal 240 via the drive interface 230, such as Figure 26A What is shown.

[0101] The implant 210 can be placed in the implant handling system 405 of the implant compartment 110, such as Figure 26A As illustrated in the examples. In some embodiments, implant 210 may include an artificial lens whose shape may resemble the natural lens of the eye, and may be made of a variety of materials. Examples of suitable materials may include silicone, acrylic materials, and combinations of these suitable materials. In some cases, implant 210 may include a fluid-filled artificial lens, such as a fluid-filled adjustable artificial lens.

[0102] In some examples, the working fluid 2605 can be stored in the fluid chamber 250. In other examples, such as in... Figure 10 In one embodiment, the working fluid 2605 can be added to the fluid chamber 250 at any time before use.

[0103] The plunger 220, plunger seal 235, and drive seal 240 can generally be located within the housing, such as Figure 26A The example shows the first position and Figures 26B to 26D Movement between the other positions shown.

[0104] exist Figure 26A In the first position, the plunger seal 235 fluidly isolates the orifice 225 from the working fluid 2605 in the fluid chamber 250, thus allowing the working fluid 2605 to remain within the fluid chamber 250 in the first position. In some embodiments, such as Figure 26A As shown, the first position nozzle seal 325 and the first end 315 of the plunger 220 can protrude into the implant chamber 110, thus forming a seal behind the implant 210 within the implant chamber 110. In some examples, the first end 315 of the first position plunger 220 can also engage the implant 210. In other examples, the first position nozzle seal 325 and the first end 315 can be housed within the housing 215.

[0105] In some embodiments, the implant handling system 405 can be actuated to configure the implant 210 for delivery. For example, the implant handling system 405 can straighten one or more of the anterior loop 1425 and the posterior loop 1430. In some embodiments, the anterior loop 1425 can be actively opened, and the posterior loop 1430 can be passively opened, such as in… Figure 14 In the example above. In other examples, both can open actively, such as in... Figure 18 In the example.

[0106] In some embodiments, the drive system 120 can move the push rod 245 against the drive seal 240. In response to the force of the push rod 245 on the drive seal 240, the plunger 220, plunger seal 235, drive seal 240, and working fluid 2605 can be rigidly moved to a second position, thereby maintaining... Figure 26B The fixed relationship shown. Figure 26B In the example, implant 210 is also partially advanced into the delivery lumen 205 of nozzle 105 via the first end 315 of plunger 220. For example, in some embodiments, the first end 315 may engage optical body 1420. In some embodiments, advancement may also cause the rear loop 1430 to be passively straightened. Figure 26B In the second position, the plunger seal 235 is advanced to a position adjacent to the actuation channel 1205. The actuation channel 1205 allows the fluid chamber 250 to be fluidly connected to the orifice 225, bypassing the plunger seal 235. When the push rod 245 and the drive seal 240 apply pressure to the working fluid 2605 in the fluid chamber 250, the working fluid 2605 can move through the actuation channel 1205 into the orifice 225.

[0107] Typically, the fluid flow rate through the initiation channel 1205 is low and brief enough to minimize bubble formation in the fluid and maintain sufficient pressure in the working fluid 2605 to continue advancing the plunger seal 235 and plunger 220 to the third position in response to the pressure applied to the drive seal 240 by the push rod 245. Figure 26C As shown. In Figure 26C In the third position, the implant 210 is further advanced into the delivery lumen 205, thus forming a fluid seal between the implant 210 and the delivery lumen 205. In some examples, the implant 210 may be completely positioned within the delivery lumen 205. In the third position, the bypass channel 310 allows the orifice 225 to bypass the plunger seal 235 and fluidly connect to the fluid chamber 250. When the push rod 245 and the drive seal 240 apply pressure to the working fluid 2605 in the fluid chamber 250, the working fluid 2605 can move freely through the bypass channel 310 into the orifice 225 at a higher flow rate.

[0108] The plunger 220 can resist further forces applied to the drive seal 240 and remain in place. Figure 26CThe third position. For example, in some embodiments, the second end 320 of the plunger 220 may be flared outwards, and the plunger interface 305 may be configured to engage the second end 320 to limit advance. Additionally or alternatively, the implant capsule 110 or nozzle 105 may include a plunger stop 2610 configured to engage a portion or feature of the plunger 220 (such as the second end 320 of the plunger 220) to prevent further advance. In yet another example, some embodiments of the delivery lumen 205 may be tapered to prevent the plunger 220 from advancing further toward the insertion tip 615. For example, the diameter of the delivery lumen 205 may decrease as it gets closer to the insertion tip 615.

[0109] With the plunger 220 held in place, the additional pressure applied to the working fluid 2605 by the drive seal 240 can cause the working fluid 2605 to move through the bypass passage 310 and the orifice 225, such as Figure 26D As illustrated in the example, the movement of the working fluid 2605 into the delivery lumen 205 from the orifice 225 under the pressure of the drive seal 240 can increase the pressure and flow rate of the working fluid 2605 in the delivery lumen 205 behind the implant 210, thus further propelling the implant 210 through the delivery lumen 205 until the implant 210 is ejected.

[0110] Figures 27A to 27B This is a schematic diagram further illustrating an example application of system 100 delivering implant 210 to eye 2700. As shown, for example, a surgeon may form an incision 2705 in eye 2700. In some cases, incision 2705 may penetrate the sclera 2710 of eye 2700. In other cases, an incision may be formed in the cornea 2715 of eye 2700. The size of incision 2705 may be set to allow a portion of nozzle 105 to be inserted to deliver implant 210 into capsular bag 2720. For example, in some cases, the length of incision 2705 may be less than about 3000 micrometers (3 millimeters). In other cases, the length of incision 2705 may be from about 1000 micrometers to about 1500 micrometers, from about 1500 micrometers to about 2000 micrometers, from about 2000 micrometers to about 2500 micrometers, or from about 2500 micrometers to about 3000 micrometers.

[0111] After making incision 2705, nozzle 105 can be inserted through incision 2705 into the internal portion 2725 of eye 2700. Then, system 100 can use nozzle 105 to push implant 210 into the capsular bag 2720 of eye 2700. Figure 27BIn the example, implant 210 is an example of an intraocular lens having an optical body 1420, an anterior loop 1425, and a posterior loop 1430. For example, implant 210 may be in the form of a fluid-filled adjustable intraocular lens having one or more of the optical body 1420, anterior loop 1425, and posterior loop 1430. In some applications, implant 210 may be delivered in a straightened configuration, wherein one or both of the anterior loop 1425 and posterior loop 1430 are in an open configuration, and may return to an initial resting state, wherein the anterior loop 1425 and posterior loop 1430 are at least partially bent around the optical body 1420 within the capsular bag 2720, as... Figure 27B As shown. The capsule 2720 holds the implant 210 within the eye 2700, and its relationship to the eye 2700 allows the optical body 1420 to refract light onto the retina (not shown). Anterior loop 1425 and posterior loop 1430 can engage with the capsule 2720 to secure the implant 210 therein. After the implant 210 is dispensed into the capsule 2720, the nozzle 105 can be removed from the eye 2700 through the incision 2705, allowing the eye 2700 to heal over time.

[0112] The systems, apparatus, and methods described herein can offer significant advantages. For example, some embodiments may be particularly advantageous for the delivery of intraocular lenses, including fluid-filled adjustable lenses, which can present unique challenges for delivery. Some embodiments can straighten and / or compress relatively large lenses to accommodate deformation caused by transferred fluid during compression and exit from the nozzle via an acceptable small incision, and deliver the lenses in a predictable and controlled manner. Additionally, some embodiments can reduce system complexity and the number of delivery steps while maintaining loop position consistency. Some embodiments can also reduce the amount of working fluid used for delivery.

[0113] Although shown only in a few illustrative embodiments, those skilled in the art will recognize that the systems, devices, and methods described herein are readily adaptable to a variety of different changes and modifications falling within the scope of the appended claims. Furthermore, descriptions of multiple different alternatives using terms such as “or” are not required to be mutually exclusive unless the context explicitly requires it, and the indefinite article “a / an” does not limit the subject matter to a single instance unless the context explicitly requires it. Components may also be combined or removed in a variety of different configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations, nozzle 105, implant capsule 110, actuator 115, and drive system 120 may each be separate from each other or combined in a variety of different ways for manufacture or sale.

[0114] The claims may also cover additional subject matter not specifically detailed. For example, certain features, elements, or aspects may be omitted from the claims if it is not necessary to distinguish novel and inventive features from those known to a person skilled in the art. Features, elements, and aspects described in the context of some embodiments may also be omitted, combined, or replaced by alternative features for the same, equivalent, or similar purposes without departing from the scope of the invention as defined by the appended claims.

Claims

1. A device for eye surgery, the device comprising: A nozzle having a delivery lumen; An implant capsule, which is connected to the nozzle; An implant disposed in the implant capsule, the implant comprising an optical body, an anterior loop, and a posterior loop; An actuator, the actuator comprising a housing and a plunger disposed within the housing, a fluid chamber, and an orifice passing through the plunger and fluidly connected to the delivery lumen via the implant compartment; as well as An anterior opening arm, operable to open the anterior loop within the implant compartment; The plunger is movable from a first position to a second position so as to advance the optical body from the implant compartment into the delivery lumen after the anterior opening arm opens the anterior loop; The actuator is configured to move fluid through the orifice to advance the implant from the implant chamber through the delivery lumen; and The orifice is fluidly isolated from the fluid chamber in a first position and fluidly connected to the fluid chamber in a second position.

2. The device as claimed in claim 1, wherein, The implant compartment includes a rear opening arm operable to passively open the rear loop of the implant as the plunger advances the implant.

3. The device as claimed in claim 1 or claim 2, wherein, After the anterior loop is opened, the anterior opening arm forms a wall adjacent to the optical body within the implant chamber.

4. The device as claimed in claim 1, wherein, The implant capsule further includes a rear-opening arm; and The posterior opening arm is operable to open the posterior loop of the implant.

5. The device as claimed in claim 4, wherein, The front opening arm and the rear opening arm are operable to move in opposite directions.

6. The device as claimed in claim 4, wherein, The front opening arm is operable to move the free end of the front loop toward the delivery lumen; and The rear opening arm is operable to move the free end of the rear loop away from the delivery lumen.

7. The device as claimed in claim 1 or 2, wherein, The orifice is fluidly isolated from the fluid chamber in a first position and fluidly connected to the fluid chamber via a bypass channel in a second position.

8. The device as claimed in claim 7, wherein, The actuator is configured to move fluid from the fluid chamber through the bypass channel and the orifice to the delivery lumen in the second position.

9. The device as claimed in claim 7, wherein, The actuator further includes a drive seal configured to move fluid from the fluid chamber through the bypass channel and the orifice in the second position.

10. The device as claimed in claim 7, wherein, The actuator further includes an activation channel configured to fluidly connect the orifice to the fluid chamber between the first position and the second position.

11. The device as claimed in claim 10, wherein, The bypass channel has a first flow velocity; The starting channel has a second flow rate; and The second flow velocity is less than the first flow velocity.

12. An apparatus for eye surgery, the apparatus comprising: Delivery lumen; Implant chamber; An implant disposed in the implant chamber, the implant comprising an optical body, an anterior loop, and a posterior loop; A front opening arm, which is movable to open the front loop; The rear opening arm is movable to open the rear loop; A plunger having a first end, a second end, and an orifice between the first end and the second end; A fluid chamber for storing the working fluid, and Putter; The plunger is movable between a first position and a second position to advance the implant from the implant chamber into the delivery lumen; The push rod is configured in a second position to move working fluid from the fluid chamber through the orifice in order to advance the implant through the delivery lumen.

13. The device as claimed in claim 12, wherein, After the front loop is opened, the front opening arm forms a wall adjacent to the optical body.

14. The device as claimed in claim 13, wherein, After the rear loop is opened, the rear opening arm forms a second wall adjacent to the optical body.

15. The device as claimed in any one of claims 12-14, wherein, The front opening arm includes a front recessed end; and The rear opening arm includes a rear recessed end.

16. The device as claimed in any one of claims 12-14, wherein, The front opening arm includes a notched end; and The rear-opening arm includes a curved end.

17. The device as claimed in any one of claims 12-14, wherein, The front opening arm and the rear opening arm are operable to move in opposite directions.

18. The device of any one of claims 12-14, further comprising a cam configured to translate the front opening arm and the rear opening arm.

Citation Information

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