Hydraulic delivery of surgical implants

Abstract

An apparatus for delivering an implant to an eye using a flow or pressure of hydraulic fluid. The implant can be stored, advanced, and delivered to the eye using hydraulic fluid stored in a sterile container through a hollow advancement plunger. The plunger can rigidly advance the implant to a sealed position in a first stage and then can advance the implant into the eye via hydraulic pressure or fluid flow in a second stage.

Description

[0001] Priority Statement

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 033,258, filed June 2, 2020, entitled “HYDRAULIC DELIVERY OF SURGICAL IMPLANTS”, inventors Todd Taber, Kathryn Jensen, Michael Piazza, Jestwin Edwin Lee, IV, Saumya Dilip Yadav, Austin Xavier Rodeheaver, and Pradeep Magadum, 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 processes continue to improve outcomes and benefit patients. Summary of the Invention

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

[0007] For example, some embodiments provide a device for delivering an implant using hydraulic pressure or fluid flow. In a more specific example, an implant can be stored, advanced, and delivered to the eye using hydraulic fluid stored in a sterile container via a hollow advance plunger. The plunger can rigidly advance the implant to a sealed position in a first stage, and then in a second stage, the implant can be advanced into the eye via hydraulic pressure or fluid flow. For example, the plunger can first be used to advance the implant to a point within a delivery channel that forms a seal around the implant. The implant can then be advanced hydraulically for delivery. For example, delivery fluid can pass through a hole in the plunger to advance the implant. In some embodiments, the implant interface associated with the plunger can be shaped to engage with the shoulder of the implant for advancement.

[0008] This embodiment may be particularly advantageous for delivering intraocular lenses, including adjustable lenses, which can present unique delivery challenges. For example, the adjustable lens may contain a fluid that can be manipulated by ciliary muscle movement to alter the lens's refractive power. Some embodiments can handle the fluid in the adjustable lens compressing a relatively large lens to advance it through an acceptable small incision, manage deformation caused by the moving fluid during compression and exit from the nozzle, and perform delivery in a predictable and controlled manner. The intraocular lens may additionally include one or more loops that can extend radially to hold the lens within the eye. Some embodiments can reduce system complexity and the number of delivery steps while maintaining loop positional consistency. Some embodiments can also reduce the amount of working fluid used for delivery.

[0009] More generally, some embodiments may provide a device for advancing a lens in an implant delivery system. The device may include a housing having a plunger interface, a drive interface, and a bypass channel disposed between the plunger interface and the drive interface. A plunger may be disposed within the housing and may have a first end adjacent to the plunger interface, a second end, and an orifice through the plunger between the first and second ends. A plunger seal may be disposed within the housing and coupled to a second end of the plunger, and a drive seal may be disposed within the housing between the plunger seal and the drive interface. A fluid chamber may be defined within the housing between the plunger seal and the drive seal. The plunger, plunger seal, and drive seal may be movable within the housing between a first position and a second position in a fixed relationship to each other. Typically, the first end of the plunger may be configured to move through the plunger interface. In the first position, the plunger seal may fluidly isolate the orifice from the fluid chamber. In the second position, the bypass channel may fluidly connect the orifice to the fluid chamber, bypassing the plunger seal. In a more specific embodiment, the drive seal can be moved to a third position to allow fluid to pass from the fluid chamber through the bypass channel and orifice.

[0010] Some embodiments may further include a nozzle seal and a bypass seal. The nozzle seal may be disposed near a first end of the plunger, and the bypass seal may be configured to be disposed in a second position between the nozzle seal and the bypass passage.

[0011] Some example embodiments may additionally include an implant interface coupled to a first end of the plunger, which may be configured to engage with a portion of the implant for advancement.

[0012] Some embodiments may additionally include at least one activation channel configured to fluidly connect the orifice to a fluid chamber between a first position and a second position. The activation channel may have a lower flow rate than the bypass channel.

[0013] Other embodiments may provide a device for implanting a lens into the eye. Such embodiments may include a nozzle having a delivery lumen, an implant capsule coupled to the nozzle, and an actuator. The actuator may include, for example, a housing, a plunger disposed within the housing, an orifice fluidly connected to the implant capsule and the delivery lumen via the plunger, a fluid chamber, and a bypass channel. The plunger is operable to move within the housing from a first position to a second position to advance the lens from the implant capsule into the delivery lumen. The orifice may be fluidly isolated from the fluid chamber in the first position and fluidly coupled to the fluid chamber via the bypass channel in the second position. In the second position, the actuator may be further configured to allow fluid to move from the fluid chamber to the delivery lumen through the bypass channel and the orifice.

[0014] Other embodiments may provide a method of using a surgical delivery system. In some examples, fluid and a hydraulic plunger may be stored and delivered in an actuator. The actuator may be connected to other components for storage and delivery, or it may be assembled with other components in an operating environment to form a surgical delivery system. For example, in some embodiments, the actuator may be connected to a drive system configured to drive the actuator. The actuator may also be connected to a nozzle configured to deliver an implant through an incision. The surgical delivery system may additionally include an implant handling system configured to orient or manipulate the implant for advancement and delivery. In some examples, the drive system may actuate a hydraulic plunger to advance the implant into a delivery lumen of the nozzle while a seal prevents fluid from passing through the hydraulic plunger. The drive system may then advance the seal to allow fluid to pass through a bypass passage around the seal and into the hydraulic plunger. Orifices in the hydraulic plunger may carry fluid into the delivery lumen, and the hydraulic pressure of the fluid may force the implant out of the delivery lumen.

[0015] More generally, some embodiments of a method for ejecting a lens from a surgical delivery system may include: placing the lens in an implant chamber, advancing the lens from the implant chamber into the delivery system using a rigid plunger, and then fluidly connecting a fluid chamber to an orifice in the rigid plunger via a bypass channel. Fluid in the bypass channel can then be squeezed to allow fluid to pass through the bypass channel and the orifice to the delivery lumen, and the fluid may advance the lens through the delivery lumen.

[0016] Features, elements, and aspects described in the context of some embodiments may be omitted, combined, or replaced by alternative features. Further features, purposes, advantages, and preferred modes of making and using the claimed subject matter are described in more detail below with reference to the accompanying drawings of illustrative embodiments. Attached Figure Description

[0017] The accompanying drawings illustrate some objects, advantages, and preferred modes of manufacture and use of the claimed subject matter. In the examples, the same reference numerals denote the same parts.

[0018] Figure 1 This is a schematic diagram of an example system for inserting an implant into the eye.

[0019] Figure 2 yes Figure 1 A schematic diagram illustrating an example of a system.

[0020] Figure 3 It is possible to be with Figure 2 A detailed view of the actuators associated with the system.

[0021] Figure 4 yes Figure 1 An assembly diagram of another example of the system.

[0022] Figure 5 yes Figure 4 An isometric view of the actuator.

[0023] Figure 6 It is the assembled Figure 4 An isometric view of the system.

[0024] Figure 7 yes Figure 6 A side view of the system.

[0025] Figure 8 yes Figure 6 The front view of the system.

[0026] Figure 9 yes Figure 8 A cross-sectional view of the system.

[0027] Figure 10 It is possible to be with Figure 1An isometric view of another example of the actuators associated with the system.

[0028] Figure 11 yes Figure 10 Rear view of the actuator.

[0029] Figure 12 yes Figure 11 A cross-sectional view of the actuator.

[0030] Figures 13A to 13D It demonstrates the insertion of implants from Figure 1 A schematic diagram of the example methods that are pushed out of the system.

[0031] Figures 14A to 14B 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

[0032] The following description of exemplary embodiments provides information that enables those skilled in the art to make and use 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.

[0033] 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. Generally, such relationships or orientations employ a frame of reference consistent with or relevant to the patient in the appropriate position to receive the implant. However, as those skilled in the art will recognize, this frame of reference is merely a descriptive expedient and not a strict specification.

[0034] 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.

[0035] The nozzle 105 typically 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. Incisions less than 3 mm may be preferred in some cases, and in some embodiments, the width of the tip of the nozzle 105 may be less than 3 mm.

[0036] 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 unfold or open one or more features of an intraocular lens, such as a loop.

[0037] Actuator 115 is typically configured to advance the implant from implant compartment 110 into nozzle 105, and then from nozzle 105 into the eye through an incision.

[0038] Drive module 120 is typically operable to energize actuator 115. In some examples, drive module 120 may be operated electrically, mechanically, hydraulically, or pneumatically, or a combination thereof, or in some other manner. In some cases, drive module 120 may be manually operated. Depending on other implementations, drive module 120 may be an automated system.

[0039] Typically, 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 or chemical connections (such as chemical bonds), or in some cases, a combination of these connections. For example, actuator 115 can be mechanically connected to drive module 120 and 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.

[0040] Figure 2 This is a schematic diagram of an example of system 100, illustrating additional details that may 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.

[0041] Figure 2The 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 engage 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 engaged with 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.

[0042] 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 2 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.

[0043] Figure 3 yes Figure 2 A detailed view of actuator 115 shows additional details that may 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.

[0044] The plunger 220 typically has a first end 315 and a second end 320, wherein the first end 315 is typically positioned adjacent to the plunger interface 305. A bore 225 generally extends longitudinally through the plunger 220 from the first end 315 to the second end 320.

[0045] 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 typically 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 suitable. 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.

[0046] 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.

[0047] Figure 4 This is another example assembly diagram of System 100. (See diagram below.) Figure 4 As illustrated in the examples, the implant compartment 110 may include an implant handling system 405, a base 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 base 410 and cap 415 may be configured to substantially enclose the implant handling system 405. The base 410 and cap 415 may also be configured to be mechanically coupled to the nozzle 105 and actuator 115.

[0048] 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.

[0049] 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 specific 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 an arm 425 operable for manipulating an implant within the implant chamber 430. Other examples may additionally or alternatively include other suitable mechanisms for manipulating the arm 425, such as a rotary dial, cap, or wheel. Figure 4 In the example, arm 425 is configured to receive user actuation of implant processing system 405.

[0050] 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 5 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. The implant interface 420 may include a notch 510 that may be configured to engage an implant.

[0051] Figure 6 It is the assembled Figure 4 An isometric view of system 100 shows additional details that may 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.

[0052] like Figure 6 As illustrated in the examples, some embodiments of the nozzle 105 may include an insertion tip 610 and a cut protection member 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 cut protection member 615 may include an opening portion adapted to contact the eye around the cut to limit the penetration depth of the insertion tip 610.

[0053] Some embodiments of system 100 may additionally include a variety of different ergonomic features. For example, in Figure 6In the implant handling system 405, the cover 415 includes a raised portion 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.

[0054] Figure 7 yes Figure 6 A side view of system 100 shows additional details that may be associated with some embodiments. For example... Figure 7 As shown in the example, the base 410 may include a raised portion 705 similar to or similar to the raised portion 620.

[0055] Figure 8 yes Figure 6 The front view of system 100. (See example) Figure 8 As shown, the insertion tip 610 may have a circular profile, and the cut-out guard 615 may have an elliptical profile. In some embodiments, the insertion tip 610 and the cut-out guard 615 may be concentric, such as... Figure 8 The example shown is as follows.

[0056] Figure 9 yes Figure 8 A cross-sectional view of system 100 taken along line 9-9 shows additional details that may 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.

[0057] 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.

[0058] 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.

[0059] In such Figure 9 In the assembled configuration shown, the implant chamber 430 can provide a fluid path between the orifice 225 and the delivery lumen 205. In some embodiments, the implant chamber 430 can also be configured to receive a portion of the plunger 220 that includes the implant interface 420.

[0060] Figure 9 The example configuration is typically suitable for storing the implant (not shown) prior to delivery. More specifically, the plunger seal 235 and the drive seal 240 may be positioned in a first location, wherein 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 may include, but is not limited to, liquids such as saline or viscous lubricants with non-Newtonian properties.

[0061] 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.

[0062] Figure 11 yes Figure 10 The rear view of actuator 115 shows additional details that may 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.

[0063] Figure 12 yes Figure 11 A cross-sectional view of actuator 115 taken along line 12-12. Figure 12 In 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.

[0064] 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.

[0065] 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.

[0066] 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.

[0067] 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.

[0068] like Figure 12As 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 12 The 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.

[0069] Figures 13A to 13D This is a schematic diagram illustrating an example method of ejecting implant 210 from system 100. First, the various components of the system can be assembled as needed. For example, nozzle 105, implant compartment 110, and actuator 115 can be interconnected, such as... Figure 13A As 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 13A What is shown.

[0070] Implant 210 can be disposed in implant handling system 405 of implant compartment 110, such as Figure 13A As illustrated in the examples. In some embodiments, implant 210 may include an intraocular lens having an optic 1305, an anterior loop 1310, and a posterior loop 1315. The shape of the intraocular lens 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 intraocular lens, such as a fluid-filled adjustable intraocular lens.

[0071] In some examples, the working fluid 1320 can be stored in the fluid chamber 250. In other examples, such as in... Figure 10 In one embodiment, the working fluid 1320 can be added to the fluid chamber 250 at any time before use.

[0072] The plunger 220, plunger seal 235, and drive seal 240 are typically located within the housing, such as Figure 13A The example shows the first position and Figures 13B to 13D Move between the other locations shown.

[0073] exist Figure 13AIn the first position, the plunger seal 235 isolates the orifice 225 from the working fluid 1320 in the fluid chamber 250, thus allowing the working fluid 1320 to remain within the fluid chamber 250 in the first position. In some embodiments, such as Figure 13A 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.

[0074] In some embodiments, the implant handling system 405 may be actuated to configure the implant 210 for delivery. For example, the implant handling system 405 may straighten one or more of the anterior loop 1310 and the posterior loop 1315.

[0075] 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 1320 can be rigidly moved to a second position, thereby maintaining... Figure 13B The fixed relationship shown. Figure 13B In the example, the implant 210 is also partially advanced into the delivery lumen 205 of the nozzle 105 via the first end 315 of the plunger 220. For example, in some embodiments, the first end 315 may engage the optic 1305. In some embodiments, advancement may also cause the posterior loop 1315 to be passively straightened. Figure 13B 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 1320 in the fluid chamber 250, the working fluid 1320 can move through the actuation channel 1205 into the orifice 225.

[0076] 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 1320 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 13C As shown. In Figure 13CIn 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 be fluidly connected to the fluid chamber 250, bypassing the plunger seal 235. When the push rod 245 and the drive seal 240 apply pressure to the working fluid 1320 in the fluid chamber 250, the working fluid 1320 can move freely through the bypass channel 310 into the orifice 225 at a higher flow rate.

[0077] The plunger 220 can resist further forces applied to the drive seal 240 and remain in place. Figure 13C The 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 1325 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 other examples, 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.

[0078] With the plunger 220 held in place, the additional pressure applied to the working fluid 1320 by the drive seal 240 can cause the working fluid 1320 to pass through the bypass passage 310 and the orifice 225, such as Figure 13D As illustrated in the example, the movement of the working fluid 1320 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 1320 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.

[0079] Figures 14A to 14BThis is a schematic diagram further illustrating an example of delivering an implant 210 to an eye 1400 using system 100. As shown, for example, a surgeon may create an incision 1405 in the eye 1400. In some cases, the incision 1405 may extend through the sclera 1410 of the eye 1400. In other cases, an incision may be created in the cornea 1415 of the eye 1400. The size of the incision 1405 may be configured to allow a portion of the nozzle 105 to be inserted to deliver the implant 210 into the capsular bag 1420. For example, in some cases, the size of the incision 1405 may have a length of less than about 3000 micrometers (3 millimeters). In other cases, the length of the incision 1405 may range 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.

[0080] After incision 1405 is made, nozzle 105 can be inserted through incision 1405 into the internal portion 1425 of eye 1400. System 100 can then push implant 210 into the capsular pouch 1420 of eye 1400 through nozzle 105. In some applications, implant 210 can be delivered in a folded configuration and can return to its initial unfolded state within capsular pouch 1420, such as... Figure 14B As shown. In Figure 14B In the example, implant 210 is an example of an intraocular lens having an optic 1430 and a loop 1435. For example, implant 210 may be in the form of a fluid-filled adjustable intraocular lens having an optic 1430 and / or a loop 1435. Capsule 1420 holds implant 210 within eye 1400, its relationship to eye 1400 such that optic 1430 refracts light to the retina (not shown). Loop 1435 may engage capsule 1420 to secure implant 210 therein. After implant 210 is dispensed into capsule 1420, nozzle 105 can be removed from eye 1400 through incision 1405, allowing eye 1400 to heal over time.

[0081] The systems, apparatus, and methods described herein can offer significant advantages. For example, some embodiments may be particularly advantageous for delivering intraocular lenses, including fluid-filled adjustable lenses, which can present unique delivery challenges. Some embodiments can compress relatively large lenses to accommodate deformation caused by moving fluid during compression and exit from the nozzle through an acceptable small incision, and perform delivery in a predictable and controlled manner. Additionally, some embodiments can reduce system complexity and the number of delivery steps while maintaining loop positional consistency. Some embodiments can also reduce the amount of working fluid used for delivery.

[0082] Although shown only in a few illustrative embodiments, those skilled in the art will recognize that the systems, apparatus, and methods described herein are readily adaptable to various changes and modifications falling within the scope of the appended claims. Furthermore, descriptions of various 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 various 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.

[0083] 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 advancing a lens in an implant delivery system, the device comprising: A housing, the housing including a plunger interface, a drive interface, and a bypass channel disposed between the plunger interface and the drive interface; A plunger disposed within the housing, the plunger having a first end, a second end adjacent to the plunger interface, and a hole between the first end and the second end; A plunger seal is disposed within the housing and connected to the second end of the plunger; A drive seal is disposed within the housing and between the plunger seal and the drive interface; as well as A fluid chamber, defined within the housing and between the plunger seal and the drive seal. The plunger, the plunger seal, and the drive seal are movable within the housing between a first position and a second position. In the first position, the plunger seal fluidly isolates the orifice from the fluid chamber. In the second position, the bypass channel allows the orifice to bypass the plunger seal and fluidly connect with the fluid chamber.

2. The device as claimed in claim 1, wherein, The drive seal can be moved to a third position, allowing fluid to pass from the fluid chamber through the bypass channel and the orifice.

3. The device as claimed in claim 1, further comprising: A nozzle seal is disposed near the first end of the plunger; as well as A bypass seal is configured to be disposed at the second position between the nozzle seal and the bypass channel.

4. The device as described in claim 3, wherein, The nozzle seal includes a first annular seal, and the bypass seal includes a second annular seal.

5. The device as described in claim 3, wherein, The nozzle seal includes an umbrella-shaped seal.

6. The device according to any one of claims 1-5, further comprising a lens interface connected to a first end of the plunger.

7. The device according to any one of claims 1-5, wherein, The first end of the plunger is configured to move through the plunger interface.

8. The device according to any one of claims 1-5, wherein, The bypass channel includes multiple channels arranged circumferentially around the housing.

9. The device according to any one of claims 1-5, wherein, The housing further includes an activation channel configured to fluidly connect the orifice to the fluid chamber between the first position and the second position.

10. The device as claimed in claim 9, wherein, The starting channel has a lower flow rate than the bypass channel.

11. The device according to any one of claims 1-5, wherein, The drive interface is configured to receive a push rod for engaging with the drive seal within the housing.

12. The device according to any one of claims 1-5, further comprising fluid disposed in the fluid chamber.

13. The device according to any one of claims 1-5, further comprising: A push rod configured to engage the drive seal via the drive interface.

14. A device for implanting a lens into the eye, the device comprising: A nozzle having a delivery lumen; An implant capsule, which is connected to the nozzle; as well as An actuator, comprising a housing, a plunger, an orifice, a fluid chamber, and a bypass channel, wherein the plunger is disposed within the housing and operable to move from a first position to a second position to advance the lens from the implant capsule into the delivery lumen, and the orifice is fluidly connected to the delivery lumen through the plunger and the implant capsule. The orifice is fluidly isolated from the fluid chamber at the first position and fluidly connected to the fluid chamber through the bypass channel at the second position.

15. The device as claimed in claim 14, 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.

16. The device as claimed in claim 14, wherein, The actuator further includes a drive seal configured to allow fluid to pass from the fluid chamber through the bypass channel and the orifice in the second position.

17. The device as claimed in any one of claims 14-16, 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.

18. The device as claimed in claim 17, 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.

19. The device as claimed in any one of claims 14-16, wherein, The implant capsule includes an implant handling system having an implant chamber; and The plunger is operable to move at least partially through the implant chamber to advance the lens.

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