Hydraulic delivery of surgical implants
The hydraulic delivery system addresses the challenges of delivering ophthalmic implants by using a plunger and fluid flow mechanism to advance implants through small incisions, ensuring controlled and efficient delivery of intraocular lenses.
Patent Information
- Application Number
- JP2025158187
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2020-06-02
- Filing Date
- 2025-09-24
- Publication Date
- 2025-12-11
AI Technical Summary
Existing delivery systems for ophthalmic implants, particularly intraocular lenses, face challenges in efficiently delivering implants through small incisions while managing fluid-induced distortions and maintaining controlled delivery processes.
A hydraulic delivery system using a plunger and fluid flow mechanism, where an implant is advanced through a sealed position and then delivered via hydraulic pressure, minimizing incision size and reducing system complexity by employing a bypass channel for fluid management.
The system enables predictable and controlled delivery of intraocular lenses, including accommodative lenses, through small incisions, reducing fluid requirements and maintaining consistent protrusion positions, thus improving surgical outcomes.
Smart Images

Figure 2025181991000001_ABST
Abstract
Description
[Technical Field]
[0001] Priority claims This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 033,258, entitled "HYDRAULIC DELIVERY OF SURGICAL IMPLANTS," filed June 2, 2020, the inventors of which are Todd Taber, Kathryn Jensen, Michael Piazza, Jestwin Edwin Lee, IV, Saumya Dilip Yadav, Austin Xavier Rodeheaver, and Pradeep Magadum, which is incorporated by reference in its entirety as if fully and particularly set forth herein.
[0002] The present invention as recited in the accompanying claims relates generally to ophthalmic surgery. More particularly, but not by way of limitation, the claimed subject matter relates to systems, devices and methods for inserting implants into the eye. [Background technology]
[0003] The human eye can suffer from many diseases that cause anything from mild deterioration to complete loss of vision. Contact lenses and eyeglasses can compensate for some ailments, but in other cases, eye surgery may be necessary. In some instances, implants may be beneficial or desirable. For example, intraocular lenses can replace the cloudy natural lens in the eye to improve vision.
[0004] While the benefits of intraocular lenses and other implants are known, improvements in delivery systems, components and processes continue to improve outcomes and benefit patients. Summary of the Invention [Means for solving the problem]
[0005] Novel and useful systems, devices, and methods for ophthalmic surgery are set forth in the appended claims. Illustrative embodiments are also provided to enable one of ordinary skill in the art to make and use the claimed subject matter.
[0006] For example, some embodiments provide an apparatus 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 through a hollow advancement plunger. The plunger can rigidly advance the implant to a sealed position in a first stage, and then the implant can be advanced into the eye via hydraulic pressure or fluid flow in a second stage. For example, the plunger can first be used to advance the implant to a point where a seal is formed around the implant within the delivery channel. The implant can then be hydraulically advanced and delivered. For example, delivery fluid can be passed through the bore of the plunger to advance the implant. In some embodiments, an implant interface associated with the plunger can be configured to engage a shoulder of the implant for advancement.
[0007] Such embodiments may be particularly advantageous for the delivery of intraocular lenses, including accommodative lenses, which can present unique delivery challenges. For example, accommodative lenses may contain a fluid that can be manipulated by ciliary muscle movement to change the lens's power. Some embodiments can compress a relatively large lens for advancement through an acceptably small incision, manage distortions caused by fluid transfer during compression and exit from the nozzle, and manage the fluid within the accommodative lens to perform delivery in a predictable and controlled manner. The intraocular lens may further include one or more protrusions that can expand radially to secure the lens within the eye. Some embodiments can reduce system complexity and the number of delivery steps while maintaining consistency in protrusion position. Some embodiments may also reduce the amount of working fluid required for delivery.
[0008] More generally, some embodiments may provide an apparatus for advancing a lens in an implant delivery system. The apparatus 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 the plunger may have a first end adjacent the plunger interface, a second end, and a bore extending therethrough between the first and second ends. A plunger seal may be disposed within the housing and coupled to the 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 are movable within the housing in a fixed relationship to one another between a first position and a second position. Generally, 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 bore from the fluid chamber. In the second position, the bypass channel can fluidly couple the bore to the fluid chamber around the plunger seal. In more particular embodiments, the drive seal can be movable to a third position to move fluid from the fluid chamber through the bypass channel and the bore.
[0009] Some embodiments may further include a nozzle seal and a bypass seal, the nozzle seal being disposed proximate the first end of the plunger and the bypass seal being configured to be disposed between the nozzle seal and the bypass channel in the second position.
[0010] Some exemplary embodiments further include an implant interface coupled to the first end of the plunger, which may be configured to engage a portion of the implant for advancement.
[0011] Some embodiments may further include at least one priming channel configured to fluidly couple the bore to the fluid chamber between the first position and the second position. The priming channel may have a lower flow rate than the bypass channel.
[0012] Another embodiment may provide a device for implanting a lens in an eye. Such an embodiment may include a nozzle having a delivery lumen, an implanter section coupled to the nozzle, and an actuator. The actuator may include, for example, a housing, a plunger disposed within the housing, a bore fluidly coupled to the delivery lumen through the plunger and the implanter section, a fluid chamber, and a bypass channel. The plunger may be operable to move from a first position to a second position within the housing to advance the lens from the implanter section to the delivery lumen. The bore may be fluidly isolated from the fluid chamber in the first position and fluidly coupled to the fluid chamber through the bypass channel in the second position. In the second position, the actuator may be further configured to move fluid from the fluid chamber to the delivery lumen through the bypass channel and the bore.
[0013] Other embodiments may provide methods of using a surgical delivery system. In some examples, the fluid and hydraulic plunger may be stored and transported within an actuator. The actuator may be connected to other components for storage and transport or may be assembled with other components to form a surgical delivery system in a surgical environment. 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 the implant through an incision. The surgical delivery system may further include an implant management system configured to orient or manipulate the implant for advancement and delivery. In some examples, the drive system may push the hydraulic plunger to advance the implant into the delivery lumen of the nozzle, while a seal prevents movement of fluid through the hydraulic plunger. The drive system may then advance the seal to allow fluid to move through a bypass channel around the seal to the hydraulic plunger. The bore of the hydraulic plunger may carry fluid into the delivery lumen, and hydraulic pressure of the fluid may push the implant out of the delivery lumen.
[0014] More generally, some embodiments of a method for ejecting a lens from a surgical delivery system may include providing a lens in an implant compartment, advancing the lens from the implant compartment into the delivery system with a rigid plunger, and then fluidly coupling a fluid chamber to a bore of the rigid plunger through a bypass channel. Fluid in the bypass channel may then be pressed to move fluid through the bypass channel and bore to a delivery lumen, and the fluid may advance the lens through the delivery lumen.
[0015] Features, elements, and aspects described in connection with some embodiments may be omitted, combined, or substituted with alternative features. Other features, objects, 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.
[0016] The accompanying drawings illustrate some objects, advantages and preferred modes of making and using certain embodiments of the claimed subject matter, in which like reference numerals represent like parts. [Brief explanation of the drawings]
[0017] [Figure 1] FIG. 1 is a schematic diagram of an exemplary system for inserting an implant into the eye. [Figure 2] FIG. 2 is a schematic diagram of an example of the system of FIG. [Figure 3] FIG. 3 is a detailed diagram of an actuator that may be associated with the system of FIG. [Figure 4] FIG. 4 is an assembly diagram of another example of the system of FIG. [Figure 5] FIG. 5 is an isometric view of the actuator shown in FIG. [Figure 6] FIG. 6 is an isometric view of the system of FIG. 4 in an assembled state. [Figure 7] FIG. 7 is a side view of the system of FIG. [Figure 8] FIG. 8 is a front view of the system of FIG. [Figure 9] FIG. 9 is a cross-sectional view of the system of FIG. [Figure 10] FIG. 10 is an isometric view of another example of an actuator that may be associated with the system of FIG. [Figure 11] FIG. 11 is a rear view of the actuator of FIG. [Figure 12] FIG. 12 is a cross-sectional view of the actuator of FIG. [Figures 13A-13B] 13A-13B are schematic diagrams illustrating an exemplary method for ejecting an implant from the system of FIG. [Figures 13C-13D] 13C-13D are schematic diagrams illustrating an exemplary method for ejecting an implant from the system of FIG. [Figures 14A-14B]14A-14B are schematic diagrams illustrating an exemplary application of the system of FIG. 1 for inserting an implant into the eye. DETAILED DESCRIPTION OF THE INVENTION
[0018] The following description of exemplary embodiments provides information to enable one skilled in the art to make and use the claimed subject matter, but may omit certain details already known in the art. Thus, the following detailed description is to be taken as illustrative and not limiting.
[0019] Exemplary embodiments may be described herein with reference to spatial relationships between or spatial orientations of various elements depicted in the accompanying drawings. Generally, such relationships or orientations assume a frame of reference that coincides with or is associated with a patient in a position to receive an implant. However, as will be recognized by those skilled in the art, this frame of reference is merely for descriptive convenience, rather than a strict requirement.
[0020] 1 is a schematic diagram of a system 100 capable of inserting an implant into an eye. In some embodiments, system 100 may include two or more modules, which may be configured to be appropriately coupled and uncoupled for storage, assembly, use, and disposal. For example, as shown in FIG. 1 , some embodiments of system 100 may include a nozzle 105, an implant section 110 coupled to nozzle 105, and an actuator 115 coupled to implant section 110. In some embodiments, system 100 may further include a drive module 120 configured to engage actuator 115.
[0021] 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 surgical requirements and technique as needed. For example, small incisions are generally preferred to reduce or minimize healing time. Incisions of less than 3 millimeters may be preferred in some instances, and the tip of the nozzle 105 may have a width of less than 3 millimeters in some embodiments.
[0022] Implant compartment 110 generally represents a variety of devices suitable for storing an implant prior to delivery into the eye. In some embodiments, implant compartment 110 may additionally or alternatively be 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 by subsequent actuation of actuator 115. In some examples, implant compartment 110 may be configured to actively deform, stretch, expand, or otherwise manipulate features of the implant before the implant is advanced into nozzle 105. For example, implant compartment 110 may be configured to expand or widen one or more features of an intraocular lens, such as a protrusion.
[0023] The actuator 115 is generally configured to advance the implant from the implant compartment 110 to the nozzle 105 and then from the nozzle 105 through the incision and into the eye.
[0024] The drive module 120 is generally operable to operate the actuator 115. In some examples, the drive module 120 may be electrically, mechanically, hydraulically, pneumatically, or by a combination thereof, or in some other manner. In some examples, the drive module 120 may be manually operated. According to other implementations, the drive module 120 may be an automated system.
[0025] In general, components of system 100 may be directly or indirectly coupled. For example, nozzle 105 may be directly coupled to implant section 110 and indirectly coupled to actuator 115 through implant section 110. Coupling may include fluid, mechanical, thermal, electrical, or chemical coupling (such as chemical adhesion), or in some circumstances, some combination of coupling. For example, actuator 115 may be mechanically coupled to drive module 120 and mechanically and fluidly coupled to implant section 110. In some embodiments, components may also be coupled by being physically close, integrated into a single structure, or formed from the same piece of material.
[0026] 2 is a schematic diagram of an example of the system 100 showing additional details that may be relevant to some embodiments. In the example of FIG. 2, the nozzle 105 has a delivery lumen 205 and the implant 210 is disposed within the implant compartment 110.
[0027] 2 generally includes a housing 215, a plunger 220 disposed within the housing 215, a bore 225 through the plunger 220, and a drive interface 230 configured to couple to the drive module 120. The plunger 220 is generally constructed from a substantially rigid material, such as a medical-grade polymeric material. A plunger seal 235 may be disposed within the housing 215 and coupled 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 through the drive interface 230. For example, the drive interface 230 may include an aperture configured to receive the push rod 245.
[0028] 2, drive seal 240 may be disposed between plunger seal 235 and drive interface 230, and fluid chamber 250 may be defined within housing 215 between plunger seal 235 and drive seal 240. In the exemplary configuration of FIG. 2, plunger seal 235 is configured to provide a fluid seal across housing 215 and substantially prevent movement of fluid from fluid chamber 250 to bore 225. Drive seal 240 may also be configured to provide a fluid seal across housing 215 and substantially prevent movement of fluid from fluid chamber 250 to drive interface 230.
[0029] FIG. 3 is a detailed view of the actuator 115 of FIG. 2 and illustrates additional details that may be relevant to some embodiments. For example, the housing 215 of FIG. 3 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 may take a variety of forms. For example, the bypass channel 310 may include a protrusion on the housing 215, as shown in FIG. 3. In other examples, the bypass channel 310 may include a groove or recess in the interior surface of the housing 215. In some embodiments, the bypass channel 310 may include multiple channels. For example, multiple channels may be disposed circumferentially around the housing 215 in some embodiments.
[0030] Plunger 220 generally has a first end 315 and a second end 320, with first end 315 generally disposed adjacent plunger interface 305. A bore 225 generally extends longitudinally through plunger 220 from first end 315 to second end 320.
[0031] In some embodiments, the actuator 115 may further 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 migration past the seal. As shown in the example of FIG. 3 , one or both of the nozzle seal 325 and the bypass seal 330 may be a ring seal, such as an O-ring, disposed circumferentially around a portion of the plunger 220. In other examples, an umbrella seal may be suitable. In more particular embodiments, the nozzle seal 325 may be disposed proximate the first end 315 of the plunger 220, and the bypass seal 330 may be disposed proximate the second end 320 of the plunger 220.
[0032] 3 includes a cap 335 and an aperture 340. The cap 335 may be coupled to an end of the housing 215 to retain the drive seal 240 and other components within the housing 215.
[0033] 4 is an assembly diagram of another example of the system 100. As shown in the example of FIG. 4, the implant compartment 110 can include an implant management system 405, a base 410, and a cover 415. In various embodiments, the implant management system 405 can be any of a variety of systems, devices, components, or cartridges configured to prepare an implant for delivery. The base 410 and the cover 415 can be configured to substantially enclose the implant management system 405. The base 410 and the cover 415 can also be configured to be mechanically coupled to the nozzle 105 and the actuator 115.
[0034] 4 includes a hollow cylinder that can receive plunger 220, plunger seal 235, and drive seal 240. Figure 4 also shows an example of an implant interface 420 that can be coupled to first end 315 of plunger 220 in some embodiments. In the example of Figure 4, plunger 220 and plunger seal 235 can be inserted into housing 215, after which an appropriate working fluid can be added before inserting drive seal 240 and attaching cap 335 to housing 215.
[0035] In some examples, an implant (not shown) may be pre-loaded into the implant management system 405. The implant management system 405 is generally configured to store and manipulate the implant. For example, some embodiments of the implant management system 405 may be configured to orient or fold the implant. In some particular examples, the implant management system 405 may be configured to fold, unfold, or straighten the protrusions of an intraocular lens. In the example of FIG. 4, the implant management system 405 includes an arm 425 that may be operable to manipulate the 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. In the example of FIG. 4, the arm 425 is configured to be actuated by a user of the implant management system 405.
[0036] FIG. 5 is an isometric view of the actuator 115 of FIG. 4 in an assembled state. As shown in the example of FIG. 5, some embodiments of the plunger interface 305 can 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 can extend through the plunger interface 305. The nozzle seal 325 of FIG. 5 includes an O-ring disposed around the plunger 220 adjacent the first end 315. As seen in the example of FIG. 5, the bore 225 can define an opening in the first end 315. In some embodiments, the opening can be centrally disposed through the first end 315, and the implant interface 420 can be coupled to the plunger 220 adjacent the opening in the first end 315. The implant interface 420 can include a notch 510, which can be configured to engage an implant.
[0037] 6 is an isometric view of the assembled system 100 of FIG. 4 , illustrating additional details that may be relevant to some embodiments. As shown in the example of FIG. 6 , the system 100 may have an elongated, slender shape. In some examples, the actuator 115 may be at least partially inserted into the implant section 110 and secured in place by a locking mechanism 605 adapted to engage an interlocking feature on the actuator 115, such as a locking tab 505. In other examples, the actuator 115 may be secured by other suitable fasteners, an interference fit, or thermal or chemical attachment.
[0038] As shown in the example of FIG. 6, some embodiments of the nozzle 105 can include an insertion tip 610 and an incision guard 615. The insertion tip 610 can be adapted to minimize shear forces on the incision. In some examples, the insertion tip 610 can be chamfered or angled. The incision guard 615 can include a flared portion adapted to contact the eye around the incision to limit the penetration depth of the insertion tip 610.
[0039] Some embodiments of the system 100 may additionally include various ergonomic features. In Figure 6, for example, the cover 415 of the implant management system 405 includes a relief 620. The relief 620 in Figure 6 may include, for example, a shallow recess formed in the cover 415 to accommodate one or more fingers of an operator. The relief 620 may further include a patterned surface that may improve grip and control of the system 100.
[0040] Figure 7 is a side view of the system 100 of Figure 6, showing additional details that may be relevant to some embodiments. As shown in the example of Figure 7, the base 410 may include a relief 705 that is the same as or similar to the relief 620.
[0041] Figure 8 is a front view of the system 100 of Figure 6. As illustrated in Figure 8, the insertion tip 610 can have a circular profile and the incision guard 615 can have an oval profile. The insertion tip 610 and incision guard 615 can be concentric in some embodiments, as shown in the example of Figure 8.
[0042] Figure 9 is a cross-sectional view of the system 100 of Figure 8 taken along line 9-9 and shows additional details that may be relevant to some embodiments. In the example of Figure 9, the nozzle 105 is coupled to the implant section 110, and the actuator 115 is coupled to the implant section 110. The plunger 220 is disposed within the housing 215, and the bore 225 extends through the plunger 220 between the first end 315 and the second end 320. The plunger seal 235 may be disposed within the housing 215 and coupled to the second end 320 of the plunger 220.
[0043] Drive seal 240 may be disposed between plunger seal 235 and drive interface 230, and fluid chamber 250 may be defined within housing 215 between plunger seal 235 and drive seal 240. In the exemplary configuration of FIG. 9 , plunger seal 235 provides a fluid seal across housing 215 and is configured to substantially prevent movement of fluid from fluid chamber 250 to bore 225. Drive seal 240 may also provide a fluid seal across housing 215 and be configured to substantially prevent movement of fluid from fluid chamber 250 to drive interface 230.
[0044] The bypass channel 310 can be disposed between the plunger interface 305 and the drive interface 230. The bypass channel 310 of FIG.
[0045] 9, the implant chamber 430 can provide a fluid pathway between the bore 225 and the delivery lumen 205. The implant chamber 430 can also be configured to receive a portion of the plunger 220, including the implant interface 420, in some embodiments.
[0046] 9 is generally suitable for storing an implant (not shown) prior to delivery. More specifically, plunger seal 235 and drive seal 240 may be disposed in a first position, with plunger seal 235 fluidly isolating bore 225 and bypass channel 310 from fluid chamber 250, allowing a suitable working fluid to be stored in fluid chamber 250. Suitable working fluids may include, but are not limited to, liquids such as saline or viscous lubricants having non-Newtonian properties.
[0047] FIG. 10 is an isometric view of another example of an actuator 115, illustrating additional details that may be relevant to some embodiments. The actuator 115 of FIG. 10 is similar to the actuator 115 of FIG. 5. For example, the plunger interface 305 of FIG. 10 may include an opening in the housing 215, and at least a portion of the implant interface 420 and the plunger 220 may extend through the plunger interface 305. The nozzle seal 325 of FIG. 10 includes an O-ring disposed around the plunger 220 adjacent the first end 315. As seen in the example of FIG. 10, the bore 225 may define an opening in the first end 315. In some embodiments, the opening may be centrally disposed through the first end 315, and the implant interface 420 may be coupled to the plunger 220 adjacent the opening in the first end 315. The actuator 115 of FIG. 10 further includes a fluid coupling 1005.
[0048] FIG. 11 is a rear view of the actuator 115 of FIG. 10 showing additional details that may be associated with some embodiments of the fluid coupling 1005. In the example of FIG. 11, at least a portion of the fluid coupling 1005 may be integral with the housing 215. The fluid coupling 1005 may be a luer lock, luer slip, or similar coupling configured to receive a syringe or other device. For example, the fluid coupling 1005 of FIG. 11 includes a female luer lock 1105 having at least one locking tab 1110 configured to engage the threads of a compatible male luer lock coupling. A port 1115 may be disposed in the actuation seal 240 of the female luer lock 1105.
[0049] Figure 12 is a cross-sectional view of the actuator 115 of Figure 11 taken along line 12-12. In the example of Figure 12, a plunger 220 is disposed within a housing 215, and a bore 225 extends through the plunger 220 between a first end 315 and a second end 320. A plunger seal 235 may be disposed within the housing 215 and coupled to the second end 320 of the plunger 220. An implant interface 420 may be coupled to the first end 315 in some embodiments of the plunger 220.
[0050] Drive seal 240 may be integral with or coupled to fluid coupling 1005, and fluid chamber 250 may be defined within housing 215 between plunger seal 235 and drive seal 240. In the exemplary configuration of FIG. 12 , plunger seal 235 provides a fluid seal across housing 215 and is configured to substantially prevent movement of fluid between bore 225 and fluid chamber 250. Drive seal 240 may also provide a fluid seal across housing 215 and be configured to substantially prevent movement of fluid between drive interface 230 and fluid chamber 250.
[0051] The bypass channel 310 may be disposed between the plunger interface 305 and the drive seal 240. In more particular embodiments, the bypass channel 310 may be disposed between the plunger interface 305 and the plunger seal 235. The bypass channel 310 of FIG. 12 comprises a recess in the inner surface of the housing 215. In some examples, the bypass channel 310 may have a width that increases with distance from the plunger seal 235.
[0052] As shown in the example of FIG. 12, some embodiments of actuator 115 may optionally include at least one priming channel 1205. Priming channel 1205 may take a variety of forms. For example, priming channel 1205 may include a groove or recess in the inner surface of housing 215, as shown in the example of FIG. 12. In other examples, priming channel 1205 may include a protrusion on housing 215. In some embodiments, priming channel 1205 may include multiple channels. For example, multiple channels may be arranged circumferentially around housing 215 in some embodiments.
[0053] In the example of FIG. 12, the nozzle seal 325 is positioned proximate the first end 315 of the plunger 220 and the bypass seal 330 is positioned proximate the second end 320 of the plunger 220 .
[0054] As shown in FIG. 12 , the port 1115 can include a fill seal 1210. The fill seal 1210 can include a self-sealing material adapted to allow fluid penetration while sealing upon removal. For example, the actuator 115 of FIG. 12 can be shipped and stored without fluid in the fluid chamber 250. A syringe or other suitable fluid source (not shown) can then be coupled to the fluid fitting 1105 through the port 1115 and the fill seal 1210 to add an appropriate actuating fluid to the fluid chamber 250. Additionally or alternatively, a check valve or umbrella valve can be configured to allow fluid to pass into the fluid chamber 250 and prevent backflow.
[0055] 13A-13D are schematic diagrams illustrating an exemplary method of ejecting an implant 210 from the system 100. Initially, the various components of the system may be assembled as needed. For example, the nozzle 105, implant section 110, and actuator 115 may be coupled to one another as shown in FIG. 13A. The drive system 120 may also be coupled to the actuator 115 through a drive interface 230. For example, a push rod 245 may engage a driven seal 240 through the drive interface 230 as shown in FIG. 13A.
[0056] The implant 210 can be provided to the implant management system 405 in the implant compartment 110, as shown in the example of FIG. 13A . In some embodiments, the implant 210 can include an intraocular lens having an optic 1305, a leading projection 1310, and a trailing projection 1315. The intraocular lens can have a shape similar to the eye's natural lens and can be made from a number of materials. Examples of suitable materials can include silicone, acrylic, and combinations of such suitable materials. In some examples, the implant 210 can include a fluid-filled intraocular lens, such as a fluid-filled accommodative intraocular lens.
[0057] In some examples, the actuating fluid 1320 may be stored in the fluid chamber 250. In other examples, such as the embodiment of Figure 10, the actuating fluid 1320 may be added to the fluid chamber 250 at any time before use.
[0058] Plunger 220, plunger seal 235 and drive seal 240 are generally movable within the housing between a first position as illustrated in the example of FIG. 13A and other positions as illustrated in FIGS. 13B-13D.
[0059] 13A , the plunger seal 235 fluidly isolates the bore 225 from the actuating fluid 1320 in the fluid chamber 250, which may allow the actuating fluid 1320 to be stored in the fluid chamber 250 in the first position. In some examples, the nozzle seal 325 and the first end 315 of the plunger 220 may protrude into the implant section 110 in the first position, as shown in FIG. 13A , which may form a seal within the implant section 110 behind the implant 210. The first end 315 of the plunger 220 may also engage the implant 210 in the first position. In other examples, the nozzle seal 325 and the first end 315 may be contained within the housing 215 in the first position.
[0060] In some embodiments, the implant management system 405 can be actuated to configure the implant 210 for delivery. For example, the implant management system 405 can straighten one or more of the leading protrusion 1310 and the trailing protrusion 1315.
[0061] In some embodiments, drive system 120 can move push rod 245 relative to drive seal 240. In response to the force of push rod 245 against drive seal 240, plunger 220, plunger seal 235, drive seal 240, and actuating fluid 1320 can rigidly move to a second position while maintaining a fixed relationship as illustrated in FIG. 13B . In the example of FIG. 13B , implant 210 is also partially advanced into delivery lumen 205 of nozzle 105 by first end 315 of plunger 220. For example, first end 315 can engage optical element 1305 in some embodiments. Advancement can passively straighten trailing protrusion 1315 in some embodiments. In the second position of FIG. 13B , plunger seal 235 is advanced to a position adjacent to priming channel 1205. Priming channel 1205 fluidly couples fluid chamber 250 to bore 225 around plunger seal 235. When push rod 245 and drive seal 240 apply pressure to actuating fluid 1320 in fluid chamber 250, actuating fluid 1320 may move through priming channel 1205 and into bore 225.
[0062] Generally, the rate of fluid flow through the priming channel 1205 is low enough and short enough to minimize bubble formation in the fluid and maintain sufficient pressure in the actuating fluid 1320 to continue the advancement of the plunger seal 235 and plunger 220 to the third position, as shown in FIG. 13C , in response to pressure applied to the actuated seal 240 by the push rod 245. In the position of FIG. 13C , the implant 210 is further advanced into the delivery lumen 205, which may form a fluid seal between the implant 210 and the delivery lumen 205. In some examples, the implant 210 may be fully positioned within the delivery lumen 205. In the third position, the bypass channel 310 fluidly couples the bore 225 to the fluid chamber 250 around the plunger seal 235. As the push rod 245 and drive seal 240 apply pressure to the actuating fluid 1320 in the fluid chamber 250, the actuating fluid 1320 may move unimpeded through the bypass channel 310 and into the bore 225 at a higher flow rate.
[0063] 13C against further force being applied to the drive seal 240. For example, in some embodiments, the second end 320 of the plunger 220 can be flared, and the plunger interface 305 can be configured to engage the second end 320 to limit advancement. Additionally or alternatively, the implant section 110 or the nozzle 105 can include a plunger stopper 1325 configured to engage a portion or feature of the plunger 220, such as the second end 320 of the plunger 220, and prevent further advancement. In yet another example, some embodiments of the delivery lumen 205 can be tapered, which can block further advancement of the plunger 220 toward the insertion tip 615. For example, the diameter of the delivery lumen 205 can decrease as it approaches the insertion tip 615.
[0064] With plunger 220 held, additional pressure applied to actuating fluid 1320 by drive seal 240 can move actuating fluid 1320 through bypass channel 310 and bore 225, as shown in the example of Figure 13D. Movement of actuating fluid 1320 from bore 225 to delivery lumen 205 under pressure from drive seal 240 increases the pressure and flow rate of actuating fluid 1320 in delivery lumen 205 behind implant 210, which can advance implant 210 further through delivery lumen 205 until implant 210 is expelled.
[0065] 14A-14B are schematic diagrams further illustrating an exemplary use of the system 100 for delivering an implant 210 to an eye 1400. As shown, an incision 1405 can be formed in the eye 1400, for example, by a surgeon. In some examples, the incision 1405 can be formed through the sclera 1410 of the eye 1400. In other examples, the incision can be formed in the cornea 1415 of the eye 1400. The incision 1405 can be sized to allow for insertion of a portion of the nozzle 105 to deliver the implant 210 into the capsule 1420. For example, in some examples, the size of the incision 1405 can have a length of less than about 3000 microns (3 millimeters). In other examples, the incision 1405 can have a length of about 1000 microns to about 1500 microns, about 1500 microns to about 2000 microns, about 2000 microns to about 2500 microns, or about 2500 microns to about 3000 microns.
[0066] After forming the incision 1405, the nozzle 105 can be inserted through the incision 1405 into the interior portion 1425 of the eye 1400. The system 100 can then eject the implant 210 through the nozzle 105 and into the capsule 1420 of the eye 1400. In some applications, the implant 210 can be delivered in a folded configuration and can return to an initial, expanded state within the capsule 1420, as shown in FIG. 14B . In the example of FIG. 14B , the implant 210 is an example of an intraocular lens having an optic 1430 and protrusions 1435. For example, the implant 210 can be in the form of an accommodative intraocular lens having a fluid-filled optic 1430 and / or protrusions 1435. The capsule 1420 can hold the implant 210 within the eye 1400 in a relationship relative to the eye 1400 such that the optic 1430 refracts light directed toward the retina (not shown). The protrusions 1435 can engage the capsule 1420 to secure the implant 210 therein. After the implant 210 is provided within the capsule 1420, the nozzle 105 can be removed from the eye 1400 through the incision 1405, and the eye 1400 is allowed a period of time to heal.
[0067] The systems, devices, and methods described herein may offer significant advantages. For example, some embodiments may be particularly advantageous for delivering intraocular lenses, including fluid-filled accommodative lenses, which can present unique challenges for delivery. Some embodiments can compress relatively large lenses to fit through acceptably small incisions, manage deformations caused by fluid transfer during compression and during exit from the nozzle, and perform delivery in a predictable and controlled manner. Furthermore, some embodiments can reduce system complexity and the number of delivery steps while maintaining consistency in protrusion position. Some embodiments may also reduce the amount of working fluid required for delivery.
[0068] While shown in several illustrative embodiments, those skilled in the art will recognize that the systems, devices, and methods described herein are capable of various modifications and variations that fall within the scope of the appended claims. Furthermore, the use of terms such as "or" to describe various alternatives does not require mutual exclusivity unless the context clearly requires otherwise, and the indefinite articles "a" or "an" do not limit subject matter to a single example unless the context clearly requires otherwise. Components may also be combined or excluded in various configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations, the nozzle 105, implant segment 110, actuator 115, and drive system 120 may each be separate from one another for manufacture or sale, or may be combined in various ways.
[0069] The claims may encompass additional subject matter not specifically described in detail. For example, certain features, elements, or aspects may be omitted from the claims if they are not necessary to distinguish new and inventive features from those already known to those skilled in the art. Features, elements, and aspects described in connection with some embodiments may also be omitted, combined, or replaced by alternative features serving the same, equivalent, or similar purpose without departing from the scope of the invention as defined by the appended claims.
Claims
1. 1. An apparatus for advancing a lens within an implant delivery system, comprising: a 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 adjacent the plunger interface, a second end, and a bore between the first end and the second end; a plunger seal disposed within the housing and coupled to the second end of the plunger; a drive seal disposed within the housing between the plunger seal and the drive interface; a fluid chamber defined within the housing between the plunger seal and the drive seal; wherein the plunger, the plunger seal, and the drive seal are movable within the housing between a first position in which the plunger seal fluidly isolates the bore from the fluid chamber, and a second position in which the bypass channel fluidly couples the bore to the fluid chamber around the plunger seal.
2. The apparatus of claim 1 , wherein the driven seal is movable to a third position to displace fluid from the fluid chamber through the bypass channel and the bore.
3. a nozzle seal disposed adjacent the first end of the plunger; a bypass seal configured to be disposed between the nozzle seal and the bypass channel in the second position; The apparatus of claim 1 further comprising:
4. The apparatus of claim 2 , wherein the nozzle seal comprises a first ring seal and the bypass seal comprises a second ring seal.
5. The apparatus of claim 2 , wherein the nozzle seal comprises an umbrella seal.
6. The device of any one of claims 1 to 5, further comprising a lens interface coupled to the first end of the plunger.
7. The device of any one of claims 1 to 6, wherein the first end of the plunger is configured to move through the plunger interface.
8. The apparatus of any preceding claim, wherein the bypass channel comprises a plurality of channels arranged circumferentially around the housing.
9. The device of any one of claims 1 to 8, wherein the housing further comprises a priming channel configured to fluidly couple the bore to the fluid chamber between the first position and the second position.
10. The device of claim 9 , wherein the priming channel has a lower flow rate than the bypass channel.
11. The apparatus of any preceding claim, wherein the drive interface is configured to receive a push rod for engaging the drive seal within the housing.
12. The device of any one of claims 1 to 11, further comprising a fluid disposed in the fluid chamber.
13. The apparatus of any one of claims 1 to 12, further comprising a push rod configured to engage the drive seal through the drive interface.
14. 1. A device for implanting a lens in an eye, comprising: a nozzle having a delivery lumen; an implant segment coupled to the nozzle; a housing; a plunger disposed within the housing and operable to move from a first position to a second position to advance the lens from the implant section into the delivery lumen; an actuator including a bore fluidly coupled to the delivery lumen through the plunger and the implant section, a fluid chamber, and a bypass channel; wherein the bore is fluidly isolated from the fluid chamber in the first position and fluidly coupled to the fluid chamber through the bypass channel in the second position.
15. 15. The device of claim 14, wherein the actuator is configured to move fluid from the fluid chamber through the bypass channel and the bore to the delivery lumen in the second position.
16. The apparatus of claim 14 , wherein the actuator further comprises a driven seal configured to displace fluid from the fluid chamber through the bypass channel and the bore in the second position.
17. 17. The device of claim 14, wherein the actuator further comprises a priming channel configured to fluidly couple the bore to the fluid chamber between the first position and the second position.
18. the bypass channel has a first flow rate; the priming channel has a second flow rate; and 18. The apparatus of claim 17, wherein the second flow rate is less than the first flow rate.
19. the implant compartment includes an implant management system having an implant chamber; and The apparatus of any one of claims 14 to 18, wherein the plunger is operable to move at least partially through the implant chamber to advance the lens.