Ophthalmic device

Abstract

Ophthalmic devices (100) are provided, including a cannula (121) having a cannula distal end and a lumen, the cannula configured to deliver a fluid, a handle (112) coupled to the cannula at a handle distal end, the handle having an actuator (138) and an internal mechanism coupled to the actuator and configured to pump the fluid. The internal mechanism includes a first pump assembly (111) coupled to the actuator and configured to trigger delivery of a discrete dosage of fluid via operation of the actuator and a second pump assembly (140) coupled to the actuator and configured to trigger delivery of a discrete dosage of fluid via operation of the actuator. External priming reservoirs for ophthalmic devices are also provided.

Description

OPHTHALMIC DEVICECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 671,912 filed on July 16, 2024, the entirety of which is incorporated herein by reference.TECHNICAL FIELD

[0002] The present disclosure generally relates to medical devices and procedures, and more particularly, to ophthalmic devices with fluid delivery.BACKGROUND

[0003] Glaucoma is a disease resulting from an increase in intraocular eye pressure (IOP). IOP may increase when natural drainage of the eye (e.g., drainage of the humus of the eye) is prevented, reduced, or otherwise blocked. Cavities in front of (e.g., on top of) the lens of the eye are filled with a viscous fluid called aqueous humor. A continuous flow of aqueous humor through the eye provides nutrition to portions of the eye (e.g., the cornea and the lens) that have no blood vessels. This flow of aqueous humor also removes waste (e.g., foreign object debris) from these tissues. In a healthy eye, a stream of aqueous humor drains out of the anterior chamber of the eye through the trabecular meshwork and into Schlemm’s canal as new aqueous humor is secreted by the epithelial cells of the ciliary body. The drained aqueous humor enters the venous blood stream from Schlemm’s canal and is carried along with the venous blood leaving the eye. When the natural drainage mechanisms of the eye (e.g., Schlemm’s canal and / or the trabecular meshwork) stop functioning properly, the IOP begins to increase.BRIEF DESCRIPTION OF THE DRAWINGS

[0004] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the present disclosure and together with the description, serve to explain the principles of the disclosure.

[0005] FIG. 1 A is a perspective view showing an example of an ophthalmic device.

[0006] FIG. IB is a side section view of the ophthalmic device of FIG. 1 A.

[0007] FIG. 1C is a perspective view showing an example of an ophthalmic device.

[0008] FIG. ID is a perspective view showing an example of an ophthalmic device.

[0009] FIG. IE is a perspective view showing an example of an ophthalmic device.

[0010] FIG. 2 is a side section view showing an example of an ophthalmic device.

[0011] FIG. 3 is a side section view showing an example of a pump mechanism of an ophthalmic device.

[0012] FIG. 4 is a side section view showing an example of a pump mechanism of an ophthalmic device.

[0013] FIG. 5 is a side section view showing an example of an ophthalmic device.

[0014] FIG. 6 is a side section view of the ophthalmic device of FIG. 5 with some elements removed.

[0015] FIG. 7 is a side section view showing an example of an ophthalmic device.

[0016] FIG. 8 is another side section view of the ophthalmic device of FIG. 7.

[0017] FIG. 9 is a perspective view showing an example of an external priming reservoir for an ophthalmic device.

[0018] FIG. 10 is an exploded perspective view of the priming reservoir of FIG. 9.

[0019] FIG. 11 is an exploded perspective view of portions of the priming reservoir of FIG. 9.

[0020] FIG. 12 is an exploded perspective view of portions of the priming reservoir of FIG. 9.

[0021] FIG. 13 is an exploded perspective view of portions of the priming reservoir of FIG. 9.

[0022] FIG. 14 is side section view of the priming reservoir of FIG. 9.

[0023] FIG. 15 is a side view of the priming reservoir of FIG. 9.

[0024] FIG. 16 is a perspective view of a portion of the priming reservoir of FIG.9.

[0025] FIGS. 17A-17B are cutaway views showing an example of an ophthalmic procedure that can be performed with an ophthalmic device. FIG. 17A shows the ophthalmic device entering an anterior chamber and FIG. 17B shows the ophthalmic device injecting a fluid into a Schlemm’s canal.DETAILED DESCRIPTION

[0026] The following detailed description is exemplary and explanatory only and is not restrictive of the features, as claimed. As used herein, the terms “comprises,” “comprising,” or other variations thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such a process, method, article, or apparatus. Additionally, the term “exemplary” is used herein in the sense of “example,” rather than “ideal.” As used herein, the terms “about,” “substantially,” and “approximately,” indicate a range of values within + / - 5% of a stated value. The term “distal” refers to a portion farthest away from a user when introducing a device into a subject. By contrast, the term “proximal” refers to a portion closest to the user when placing the device into the subject.

[0027] Embodiments discussed below relate to a medical device, such as an ophthalmic device configured for use in the treatment of glaucoma or other eye conditions, and related methods of use. According to some embodiments, the ophthalmic device can have a distal end including a cannula, a microcannula, or a microcatheter (collectively a cannula), for example. The cannula can include an inner lumen and one or more outflow orifices configured for delivery of viscoelastic fluid or other substance (e.g., materials, energy, gases, suction, surgical tools and implants to a distal surgical site for a variety of surgical tasks) into a target site of a patient, such as Schlemm’s Canal, aqueous humor collector channels, aqueous veins, retinal veins and the suprachoroidal space. According to some embodiments, an external priming reservoir may also be coupled to the ophthalmic device to both prime and deliver fluid to the ophthalmic device.

[0028] These and other embodiments are discussed below in relation to particular examples illustrated in FIGS. 1-16. However, various modifications and alternativeapplications will be appreciated by those skilled in the art. Thus, the detailed description provided with respect to these figures as well as the description provided above should not be construed as limiting but rather serves to explain various concepts associated with this disclosure.

[0029] FIG. 1A shows an example of a medical device, and more particularly, shows an example of an ophthalmic device 10. In the example shown, the ophthalmic device 10 is configured as a medical instrument or minimally invasive surgical instrument configured to interact with ocular tissue to facilitate injection of a substance into a Schl emm’s canal or other intraocular site of an eye of a patient. However, while examples herein are described with reference to ophthalmic instruments and procedures, it will be appreciated that teachings of the ophthalmic device 10 can be readily applied to or adapted for any of a variety of other medical and non-medical applications. These can include, for example, other medical procedures involving interactions with patient tissue other than in the patient’s eye, and other non-medical applications involving fluid injection or transfer.

[0030] Referring to FIG. 1A, the ophthalmic device 10 can include a handle 12 coupled to an ocular component 21. The ocular component 21 is generally configured for interacting with ocular tissue and / or insertion into an intraocular cavity, such as the anterior chamber of an eye of a patient. The ocular component 21 can be configured to facilitate fluid delivery, tissue manipulation, and / or other interactions with the eye of the patient.

[0031] As shown in the example of FIG. 1A, the ocular component 21 can include an elongated tubular member protruding from a distal end of the handle 12 and defining a central longitudinal axis C. The ocular component 21 can have a working length L and a diameter that permits insertion into the anterior chamber through a corneal incision or other incision on an eye of a patient. The working length L described herein can be defined as the exposed length or distance of the ocular component 21 protruding from the handle 12, extending from the distal end of the handle 12 to the distal end of the ocular component 21. The working length L can be, for example, in the range of between about 16 millimeters (mm) and 40 mm, or more particularly about 18 mm, although it contemplated that other dimensions outside of these examples may be suitable in various implementations. The diameter may vary across the working length L or be constant throughout the working length L and can be, for example, in the range of about 100 micrometers (pm) to 1000 pm, or more particularly about 700 pm, although it is contemplated that other dimensions outside of these example may besuitable in various implementations. As shown in the example of FIG. 1A, the ocular component 21 can be implemented with a straight geometry (defining a straight central axis C), or the ocular component 21 can be implemented with a curved and / or bent geometry.

[0032] With continued reference to FIG. 1 A, the handle 12 can be implemented as a main body of the ophthalmic device 10 and can be configured to be manipulated by the hand of a user or other operator. For example as shown in FIG. 1A, the handle 12 can be implemented as an elongated tubular member having a distal end and a proximal end opposite to the distal end. This can, for example, facilitate gripping or manipulation of the handle 12 using a pencil-grip by a surgeon, although it is contemplated that handle 12 can be implemented with other shapes and configurations, such as pistol-shaped arrangements and / or finger loops. An outer surface of the handle 12 can include finger grips 13 having a contoured shape and / or textured surface (e.g., knurled, ribbed, or other surface textures) to facilitate grasping of the handle 12 by the user. Implementations are also contemplated in which the outer surface of the handle 12 has a straight non-contoured shape and / or a smooth outer surface.

[0033] The handle 12 can include or be coupled to an actuator 38. The actuator 38 can be coupled to one or more moving parts of the ophthalmic device 10 to provide one or more operative functions that facilitate performance of an ophthalmic procedure using the device. For example, the actuator 38 can be configured to move one or more parts of the ocular component 21 independently of the handle 12 and / or move two or more moving parts of the ocular component 21 independently of each other. Additionally or alternatively, the actuator 38 can be configured to actuate a pump, plunger, and / or squeeze mechanism for fluid transfer through the ocular component 21. The actuator 38 can, for example, be configured to move the part(s) directly or via an internal mechanism disposed in the handle 12.

[0034] In the example shown in FIG. 1A, the actuator 38 is implemented as or otherwise includes a mechanical push button disposed on the handle 12 and movable between an un-pressed and pressed position. The push button is shown disposed on a lateral side of the handle 12 which can, for example, facilitate actuation by a surgeon or other user using their thumb and / or index finger when the handle 12 is grasped in the hand of the user during a procedure. Additionally or alternatively, implementations are contemplated in which the push button is disposed in other locations, such as a proximal end of the handle, for example. Implementations are also contemplated in which, instead of or in addition to the push button, the actuator 38 includes a slider, roller wheel, squeeze bulb, and / or any other suitablemechanism that can be manipulated by a user or other operator to actuate a moving part of the ophthalmic device 10.

[0035] Referring to FIG. IB, the handle 12 can include a housing 15 that encloses and defines an internal volume 17. A lumen 25 (sometimes referred to herein as “handle lumen”) can be disposed in the handle 12 and be fluidly coupled to a lumen 95 (sometimes referred to herein as “cannula lumen”) protruding from the distal end of the handle 12. The handle lumen 25 can, for example, extend through the internal volume 17 and be configured to deliver fluid to the cannula lumen 95 from a fluid source, such as a fluid reservoir disposed within the internal volume or coupled to the handle externally.

[0036] As shown for example in FIG. IB, the handle 12 can include an inlet port 31 configured to couple to a fluid source and to receive an inlet fluid. The inlet port 31 can, for example, include a luer lock connector or any other suitable connector configured to connect to a viscoelastic syringe or any other suitable fluid reservoir. The inlet port 31 is shown in FIG. IB disposed on a proximal end of the handle 12 so as to provide an inlet channel extending through an opening in a proximal end of the handle housing 15. Additionally or alternatively, the inlet port 31 can be disposed on another location on the handle 12, such as on a lateral sidewall of the handle 12. In the example shown in FIG. IB, the handle 12 holds a reservoir 99 that can be filled with an initial volume of fluid or other substance via the inlet port 31.

[0037] The handle 12 shown in FIG. IB further includes a pump 11 which can be configured to move fluid through the handle lumen 25 and / or through the cannula lumen 95. For example, as shown in FIG. IB, the pump 11 can include or be coupled to a piston 98 disposed within the internal volume 17 of the handle 12 and configured to translate in an axial direction proximally and / or distally. The piston pump can be configured to move in the distal direction from a proximal pump position to a distal pump position to draw fluid from the inlet port 31 and / or to urge or push fluid out through the distal end of the cannula lumen 95. Thus, the pump 11 can be configured for positive and / or negative displacement of fluid. The piston 98 can also, for example, be reciprocal in the housing and configured to move in a proximal direction, from the distal pump position to the proximal pump position, so as to reset for delivering a subsequent dosage of fluid. Alternatively, the piston 98 can be configured to move incrementally in a distal direction in which each increment of distal motion corresponds to a dosage of fluid or other substance.

[0038] The pump 11 can include or be coupled to a valve 39 which can be disposed in the fluidic pathway of the handle lumen 25 and be fixedly coupled to the pump 11 so as to move together with the pump 11. The valve 39 can, for example, be implemented as or otherwise include a one-way valve (e.g., check valve) that permits fluid motion there through in a distal direction and restricts fluid motion there through in a proximal direction so as to create suction from the inlet port 31 and to force fluid out the distal end of the cannula lumen 95 upon distal motion of the valve 39 together with the handle 12. Additionally or alternatively, it will be appreciated that various other types of pumps and / or fluid transfer mechanisms can be configured to move the fluid through the ophthalmic device 10.

[0039] The pump 11 can further be coupled to actuator 38 so as to permit actuation of the pump for delivery of a dosage or amount of fluid upon actuation of the actuator 38. The pump 11 can, for example, be coupled to the same actuator that moves a sleeve or other part of the ocular component 21, or the pump 11 can be coupled to a separate actuator from that used to move the ocular component 21. In the example shown in FIG. IB, the actuator 38 includes a push button coupled to the pump 11 and configured to trigger delivery of a discrete dosage of fluid upon user depression of the push button.

[0040] Another exemplary ophthalmic device 10a (e.g., ocular delivery system) is depicted in FIG. 1C. In the figure, ophthalmic device 10a includes a universal handle 12a having a grip portion 14a and a housing 15a. The housing 15a has a proximal end 16a and a distal end 17a. A cannula 21a is coupled to and extends from the housing distal end 17a. A drive assembly 38a is substantially contained within the housing 15a that actuates movement of a positioning element (not shown). Port 18a is provided on the distal end 17a of the housing 15a for removable connection to a source of irrigation fluid.

[0041] With reference to FIG. ID, an example of another ophthalmic device 10b (e.g., cannula adapter, fluid delivery device) is disclosed. The ophthalmic device 10b can include a housing 15b having two portions, a first slider 38b, a second slider 38c, a stopper 37b and a distal end 17b having two portions. The distal end 17b can include an opening sized to receive a cannula 21b. The first slider 38b can be mechanically and / or operably coupled to a reservoir. The first slider 38b and the second slider 38c can together move distally (e.g., towards the distal end 17b), where the distal movement of the second slider 38c can cause a catheter to move distally and out of the cannula 21b.

[0042] As shown in FIG. IE, an ophthalmic device 10c has a housing 15c and a cannula 21c extending from the housing 15c. An activation assembly 38d may be disposed on and / or within the housing 15c. The activation assembly 38d may include a wheel 37c (e.g., scroll wheel) configured to rotate around in place within the housing 15c. A movable housing ring 39c may be disposed on the housing 15c around some or all of the wheel 37c. The movable housing ring 39c may be coupled to the wheel 37c so that the movable housing ring 39c and the wheel 37c move in tandem when the wheel 37c is pushed inward into the housing 15c.

[0043] A fixed housing ring 40c may be disposed on the housing 15c around some or all of the movable housing ring 39c. The fixed housing ring 40c remains fixed to the housing 15c and thus remains in a fixed position as the moveable housing ring 39c moves inward and outward. For example, when the wheel 37c is pushed inward or is biased outward (e.g., springs out) when pressure on the wheel 37c is released. In aspects of the disclosure, the housing 15c itself may be disposed on the around some or all of the movable housing ring 39c instead of a fixed housing ring 40c. A tactile portion 43c may be disposed on the housing 15c or may be formed as a part of the housing 15c.

[0044] In use, the ophthalmic device 10c may be gripped by a user’s hand, where rotation of the wheel 37c may cause extension or retraction of a wire, a guidewire or a catheter from or into the cannula 21c. For example, the user’s finger or thumb may be used to scroll the wheel 37c forward to extend a guidewire and / or a catheter. Similarly, the wheel 37c may be scrolled backwards in order to retract the guidewire and / or catheter, for example. In addition, the user may push inward on the wheel 37c, causing the wheel 37c and the moveable housing ring 39c to displace inwards into the housing 15c, which may cause a pumping action to eject fluid through the cannula 21c, for example. In aspects of the disclosure, the above described use of ophthalmic device 10c may be performed for any suitable reason unrelated to medical processes or treatment of a person, such as maintenance or testing of the ophthalmic device 10c. Accordingly, the ophthalmic device 10c is not limited to medical treatment of a person, such as for medical treatment of a person’s eye.

[0045] As shown in FIG. 2, an ophthalmic device 100 includes a handle 112 with a handle housing 115 coupled to an ocular component 121. The handle 112 includes an inlet port 131 configured to couple to a fluid source and to receive an inlet fluid.

[0046] A first pump 111 may be a manual pump coupled to an actuator 138 having a push button 136 and configured to trigger delivery of a discrete dosage of fluid upon depression of the push button 136 similarly to pump 11 described above.

[0047] A second pump 140 may be an automatic pump that drives fluid forward (e.g., distally) due to rotation of a scroll wheel 137 of the actuator 138. Here, forward actuation of the scroll wheel 137 drives a pump slider 142 into a plunger 144 and displaces an ophthalmic viscoelastic device (OVD). A reload step at some regular interval would refill the pump 140 and output would pause. The pump slider 142 is in line with the fluid travel direction and has a mechanical linkage 146 to the scroll wheel 137.

[0048] In aspects of the disclosure, the scroll wheel may be independent of the actuator. For example, an independent scroll wheel may provide the fluid delivery structure / functionality of the scroll wheel 137, while a separate push button actuator may be used for movement of a sleeve, a cannula or a catheter within a cannula. In aspects of the disclosure, the actuation and fluid delivery mechanisms may be one or more sliders instead of a push button and / or a scroll wheel.

[0049] As shown in FIG. 3, the pump 140 operates via the plunger 144 that is advanced into the fluid volume and thereby displaces the OVD during its forward stroke. In the back stroke, the OVD will pull to fill the volume. The pump 140 may have two one-way valves. The automatic pump 140 is connected to the manual pump 111 in the fluid pathway, so it can share one valve (e.g., valve 139) with the manual pump 111 and then has one valve of its own (e.g., valve 149). The valves 139, 149 ensure fluid cannot traverse backward on either the pumping or refill stages.

[0050] An optional valve 159 may be coupled to the outlet 118 to act as a one-way valve to prevent the refill stage of the manual pump 111 from applying force against the plunger valve 149 and inadvertently actuating the automatic pump 140. In aspects of the disclosure, a biasing force of a spring 155 (see FIG. 5) may replace the functionality of the valve 159.

[0051] In the example shown in FIG. 3, the fluid path travels through an inner lumen 145 of the stationary plunger 144. A hypotube 143 on the slider 142 seals to the plunger 144 via a sealing member 148 (e.g., via O-ring) and actuates in a reciprocal manner to push and pull fluid. The valve 149 (e.g., one-way duckbill) is located within the slider 142.Alternatively, the plunger 144 position could be swapped with the plunger 144 placed on the slider 142 and the hypotube 143 then fixed to an outlet 118 of the manual pump 111.

[0052] In the example shown in FIG. 4, a plunger 144a does not have an internal fluid path and instead the fluid is routed through a connector 147 (e.g., t-connector). This arrangement may offer space savings within the housing 115.

[0053] As shown in FIGS. 5 and 6, the linkage 146 may reciprocate the slider 142 by mechanical linkage to the rotation of the scroll wheel 137. The linkage 146 includes a cam 150 coupled to a gear 151 (e.g., mounted to the gear shaft 153) that is directly or indirectly coupled to the scroll wheel 137. A one-way clutch mechanism 154 located at the interface of the cam 150 to the shaft 153 ensures that the cam 150 is rotated on forward scrolling of the scroll wheel 137, while the cam 150 slips and does not rotate on backward scrolling of the scroll wheel 137. The linkage 146 also includes a follower 141 coupled to the slider 142.

[0054] Here, the cam-follower approach shown in FIGS. 5 and 6 can enable consistent and near-linear pumping output while scrolling the scroll wheel 137 forward, with only a quick downtime for refill. Refill action is spring driven via a spring 155, which biases the follower 141 against the cam 150 and moves the slider 142 back in the distal direction to pull fluid through the manual pump 111. A pump volume rate per catheter travel can be tailored based on any of the diameter of the plunger 144, the gear 151 ratio and the cam 150 profile.

[0055] One or more embodiments may have a single combined pump chamber rather than two independent pump chambers. For example, a plunger pump (e.g., pump 111) typically has a fixed side and an actuating side. However, for a combined pump both sides actuate, one side activated by scrolling the scroll wheel 137 and the other side activated by pressing the button 136. The interior space of the combined pump has volume for both pumping operations so that the manual pump can fully activate even if the automatic pump is at the minimum stroke. Also, mechanisms for both sides of the combined pump are fixed unless activated, i.e. they don’t move under pressure of the combined pump.

[0056] As shown in FIGS. 7 and 8, a combined pump 160 has the automatic pump 140 that remains the same as described above with the cam 150 and follower 141 mechanism. Here, pumping forces acting on the follower 141 do not rotate the cam 150 based on the pump forces being approximately aligned to the center of the cam 150 and hence do not apply force onto the scroll wheel 137. Thus, the slider 142 slides proximally when activated by the scrollwheel 137 and the slider 142 slides distally to reset after the profile of the cam 150 drops due to the biasing force from the spring 155.

[0057] The combined pump 160 also has a manual pump portion 161 that replaces the manual pump 111 described above. Here, the manual pump portion 161 has coupling 162 coupled on one side to the automatic pump 140 and a bell crank 163 operatively coupled to the other side of the coupling 162 to operate movement within the manual pump portion 161. The proximal end of a chamber 165 is coupled to a priming port 166 having a valve 167 (e.g., one way valve) that prevents backwards fluid flow from the chamber 165 to the priming port 166.

[0058] Actuating the button 136 pushes on the bell crank 163, which translates the rotational motion of the bell crank 163 to slide a plunger 164 within the chamber 165 of the manual pump portion 161. When the button 136 is not being actively pressed, the manual pump portion 161 is in a fully back position (e.g., proximal position) and does not move under pumping forces from the automatic pump 140. Thus, the plunger 164 slides distally when activated by the button 136 and the plunger 164 slides proximally when the button 136 is not activated due to the biasing force from the spring 155.

[0059] In aspects of the disclosure, the ophthalmic device 100 is configured to deliver fluid variably. For example, fluid may be delivered to and / or out of the ocular component 121 as the scroll wheel 137 is advanced or rotated forward. As another example, fluid may be delivered to and / or out of the ocular component 121 as the button 136 is pressed.

[0060] In aspects of the disclosure, fluid may be delivered from the ophthalmic device 100 at any given time, selectively, on retraction of a sleeve on the ocular component 121 or retraction of the ocular component 121 and / or on advancement of the ocular component 121.

[0061] In aspects of the disclosure, fluid may be delivered from the ophthalmic device 100 both automatically and manually. For example, fluid may be delivered automatically by via forward and / or reverse movement of the scroll wheel 137, while fluid may be delivered manually as desired by pressing the button 136 at any time.

[0062] In aspects of the disclosure, the ophthalmic device 100 may include indicator markings to indicate a measure of travel (e.g., % or ’A clock hours).

[0063] Referring to FIGS. 9-16, an external priming reservoir 200 is configured to couple to an ophthalmic device (e.g., ophthalmic device 10, 100) to allow for priming the ophthalmic device and / or delivery of fluid to the ophthalmic device.

[0064] The external priming reservoir 200 includes a body 210 having a housing 212 defining an internal cavity 214. An outlet end 216 may include internal threads 218 for mating with threads of the inlet end of the ophthalmic device (e.g., inlet port 131, priming port 166). The outside surface of the body 210 may include gripping features 211 configured to provide ergonomic handling of the external priming reservoir 200, such as when connecting or disconnecting the external priming reservoir 200 to / from the ophthalmic device.

[0065] A vessel 220 is disposed within the cavity 214 such that an outlet port 222 extends out past the outlet end 216 of the body 210. For example, the outlet port 222 and outlet end 216 / intemal threads 218 may form a male Luer connector for connection to a female Luer connector of the ophthalmic device. Alternatively, the outlet port 222 may be disposed entirely within the cavity 214 such that the outlet port 222 and outlet end 216 / intemal threads 218 form a female Luer connector for connection to a male Luer connector of the ophthalmic device.

[0066] A plunger assembly 230 is coupled to both the vessel 220 and an inlet end 217 of the body 210. The plunger assembly 230 includes a plunger 232 coupled to an end portion 234 (e.g., Luer top), such as sealing coupled by ultrasonic weld for example. The plunger 232 is configured to receive a sealing member 236 (e.g., X-ring). A valve 238 (e.g., duckbill valve, check valve) may be disposed between a lumen 235 of the end portion 234 and a plunger lumen 233. A lead portion 231 of the plunger 232 is disposed within a chamber 225 of the vessel 220 such that the sealing member 236 is sealingly engaged with an interior surface 227 of the chamber 225. A cap 239 of the end portion 234 is sealingly coupled to the inlet end 217 of the body 210 via any suitable sealing, such as an ultrasonic weld or adhesive for example.

[0067] Vessel lugs 228 are disposed on the vessel 220 adjacent an inlet port 221 of the vessel 220. For example, two vessel lugs 228 may be positioned 180 degrees apart on the exterior of the vessel 220. Similarly, bosses 219 are disposed in the housing 212 of the body 210, the bosses 219 sized and shaped to receive the vessel lugs 228. For example, the two bosses 219 may be positioned 180 degrees apart on the housing 212 to match the positioningof the two vessel lugs 228 described above. The bosses 219 are non-linear to provide a camming and / or stop element effect on the corresponding vessel lugs 228.

[0068] In a sealing engagement position between the vessel lug 228 and the boss 219, a stop surface 229a of the vessel lug 228 is engaged with a cam surface 215 of the boss 219. This prevents further movement of the vessel lug 228 along an internal ridge 213 of the housing 212 in a direction past the cam surface 215, thus trapping the vessel lug 228 against the boss 219 to provide a tight seal. The boss 219 includes a window that extends through the housing 212, thus providing a visual indication when the vessel lug 228 is engaged against the cam surface 215 of the boss 219.

[0069] As the body 210 is rotated in a priming direction, the vessel lug 228 moves away from the cam surface 215 of the boss 219 and rides along the internal ridge 213 until a lead surface 229b of the vessel lug 228 engages and is stopped by the opposing boss 219. Upon commencing rotation of the body 210, the plunger 232 moves linearly within the chamber 225 of the vessel 220 and pushes fluid in the chamber 225 out through the outlet port 222 (e.g., begins dispensing fluid).

[0070] In aspects of the disclosure, the interaction between the vessel lug 228 and the boss 219 provides a tactile sensation of a click and a release. In aspects of the disclosure, once the tactile sensation of click and release is obtained, the external priming reservoir 200 cannot be reset or reused with another ophthalmic device. In aspects of the disclosure, the internal threads 218 of the body 210 engage with the ophthalmic device and force the external priming reservoir 200 and the ophthalmic device to lock together as the external priming reservoir 200 is threaded onto the ophthalmic device, thus eliminating the need for a user to push the external priming reservoir 200 and the ophthalmic device together using a subjective amount of force.

[0071] FIGS. 17A and 17B illustrate an exemplary method of performing an ophthalmic procedure using the ophthalmic device 10. The method can be used to deliver a substance (e.g., a fluid or gas) into, e.g., Schlemm’s canal 80 or any other suitable portion of a patient’s eye.

[0072] As noted above, in a healthy eye, a stream of aqueous humor 82 drains out of the anterior chamber 84 of the eye, through the trabecular meshwork 86 and then into Schlemm’s canal 80 and distal collector channels. The aqueous humor 82 then exits throughSchl emm’s canal 80 into the collector channels and distal venous system. When this flow path of aqueous humor 82 is interrupted (e.g., due to diseased or damaged tissue in the trabecular meshwork 86 and / or Schlemm’s canal 80), the IOP of an eye may rise, potentially resulting in a variety of medical concerns (e.g., glaucoma, loss of vision, optic nerve damage, etc.).

[0073] In order to improve the flow path of aqueous humor 82, a medical professional may insert ocular component 21 through an incision 88 made in the anterior chamber 84 and advance the distal end of sleeve 260 of the ocular component 21 to the trabecular meshwork 86 so that it abuts against or contacts the trabecular meshwork 86. The sleeve 260 (not visible in FIG. 17B) can then be retracted so that distal end of the cannula 14 including orifice(s) 32 enter the Schlemm’s canal 80, as shown in FIG. 17B and as further described above using any of the mechanisms or components described herein.

[0074] With reference to FIG. 17B, once distal end of cannula 14 is inserted into Schlemm’s canal 80 such that each of the one or more orifices 32 is fully housed within Schlemm’s canal 80, the medical professional may inject a pre-defined dose or amount of fluid or other substance via actuation as discussed above. After injection of a pre-defined dose or amount of fluid or other substance through orifices 32, this process may be repeated any appropriate number of times, with the cannula 14 held in the same position and / or with the cannula 14 moved to one or more different positions to inject fluid in different locations and / or from different angles. Optionally, after the injection of one or more pre-defined doses of fluid or other substance at a certain location within Schlemm’s canal 80, distal end of the cannula 14 may be retracted and repositioned within the eye. In some arrangements, such repositioning may occur via withdrawal of cannula 14 from incision 88 (e.g., a first incision), and reinsertion through an additional incision, spaced from the first incision. Additionally or alternatively, such repositioning may include retraction of distal end 30 from Schlemm’s canal 80 and / or trabecular meshwork 86 and then relocation into a new portion of Schlemm’s canal 80 without removal of cannula 14 from the first incision 88. In some implementations, fluid may be delivered into the Schlemm’s canal 80 and trabecular meshwork 86 simultaneously, causing the Schlemm’s canal 80 to open and deliver the fluid into the various layers of the trabecular meshwork 86.

[0075] It is to be understood that while the foregoing description describes devices and methods for injection of a fluid or other substance through orifices 32, the ophthalmic device 10 described herein may be arranged for precision-controlled aspiration of fluid or othersubstances away from the eye. For example, ophthalmic device 10 may be actuated in a reverse manner from that described above to achieve a removal of fluid or other substances from the eye.

[0076] One or more embodiments of the subject technology may include an ophthalmic device including a cannula having a cannula distal end and a lumen, the cannula configured to deliver a fluid; a handle coupled to the cannula at a handle distal end, the handle having an actuator; and an internal mechanism coupled to the actuator and configured to pump the fluid, the internal mechanism comprising: a first pump assembly coupled to the actuator and configured to trigger delivery of a discrete dosage of fluid via operation of the actuator; and a second pump assembly coupled to the actuator and configured to trigger delivery of a discrete dosage of fluid via operation of the actuator.

[0077] One or more aspects of the subject technology may include wherein the first pump assembly comprises: an inlet port disposed on a handle proximal end; a drive member coupled to the actuator; and a plunger coupled to the drive member, wherein the drive member is configured to provide a force that moves the plunger in a distal direction along a longitudinal axis of the handle when the actuator moves from a first position to a second position, the movement of the plunger causing the fluid to move distally through the handle and the cannula, and a portion of the fluid to exit a distal portion of the cannula.

[0078] One or more aspects of the subject technology may include wherein: the actuator includes a push button positioned on the handle and is moveable from the first position to the second position upon application of a force; and upon movement of the push button from the first position to the second position, the push button is configured to urge movement of the drive member so that the discrete dosage of fluid is delivered via manual operation of the push button.

[0079] One or more aspects of the subject technology may include a reset spring coupled to the actuator, the reset spring configured to urge the push button from the second position back to the first position.

[0080] One or more aspects of the subject technology may include wherein the second pump assembly comprises: a plunger having an inner lumen, the plunger fluidly coupled to a fluid outlet of the first pump assembly; and a pump slider coupled to the plunger and to the actuator, wherein the actuator is configured to cause the pump slider and the plungerto move with respect to each other along a longitudinal axis of the handle to cause the fluid to move distally through the handle and the cannula and a portion of the fluid to exit a distal portion of the cannula.

[0081] One or more aspects of the subject technology may include wherein: the actuator includes a scroll wheel positioned on the handle and is rotatably moveable forward upon application of a forward force and backward upon application of a backward force; and upon forward rotatable movement of the scroll wheel, the scroll wheel is configured to urge movement of one of the pump slider and the plunger so that fluid is delivered via manual operation of the scroll wheel.

[0082] One or more aspects of the subject technology may include wherein the plunger is stationary and the pump slider is reciprocally moveable via forward and backward rotation of the scroll wheel.

[0083] One or more aspects of the subject technology may include wherein the pump slider comprises a hypotube slidingly coupled to an exterior of the plunger and a sealing member is disposed between the hypotube and the plunger.

[0084] One or more aspects of the subject technology may include wherein movement of the hypotube towards the first pump assembly pushes fluid out of a fluid outlet of the second pump assembly, and wherein movement of the hypotube away the first pump assembly pulls fluid out of the fluid outlet of the first pump assembly.

[0085] One or more aspects of the subject technology may include wherein a hypotube of the pump slider is stationarily coupled to the fluid outlet of the first pump assembly and the plunger is reciprocally moveable via forward and backward rotation of the scroll wheel.

[0086] One or more aspects of the subject technology may include a linkage between the scroll wheel and the pump slider, the linkage comprising: a gear mounted on a shaft and coupled to the scroll wheel; a cam coupled to the gear; a follower coupled to the pump slider and engaged by the cam; and a one-way clutch disposed at an interface of the cam and the shaft, wherein the one-way clutch is configured to rotate the cam on forward rotation of the scroll wheel and to slip so that the cam does not rotate on backward rotation of the scroll wheel, wherein the engagement between the cam and follower causes continuous fluid pumping during forward rotation of the scroll wheel.

[0087] One or more aspects of the subject technology may include a spring having a first end coupled to the first pump assembly and a second end coupled to the pump slider, wherein the spring biases the follower against the cam and moves the pump slider in the distal direction to pull fluid through the first pump assembly to refill the second pump assembly.

[0088] One or more aspects of the subject technology may include wherein the first pump assembly and the second pump assembly comprise a combined pump assembly comprising a coupling having a first side coupled to the second pump assembly and a second side coupled to a plunger of the first pump assembly slidingly disposed within a chamber of the first pump assembly, the ophthalmic device further comprising: a bell crank operatively coupled to the second side of the coupling and coupled to a push button of the actuator, wherein the bell crank is configured to move the coupling and the plunger of the first pump assembly distally when the push button is pressed, wherein the spring is configured to one of: move the coupling and the plunger of the first pump assembly proximally when the push button ceases being pressed; and hold the coupling and the plunger of the first pump assembly in a proximal most position when the push button is not being pressed.

[0089] One or more aspects of the subject technology may include wherein a proximal end of a chamber of the first pump assembly is coupled to a priming port, and wherein a one-way valve is disposed at a distal end of the priming port, the one-way valve configured to prevent fluid flow in a proximal direction from the chamber into the priming port.

[0090] One or more aspects of the subject technology may include wherein the second pump assembly comprises: a connector, wherein a first port of the connector is coupled to a fluid outlet of the first pump assembly; a plunger with no inner lumen, the plunger slidingly coupled to a second port of the connector; and a pump slider coupled to the plunger and to the actuator, wherein the actuator is configured to cause the pump slider and the plunger to move with respect to each other along a longitudinal axis of the handle to cause the fluid to move out of a third port of the connector.

[0091] One or more aspects of the subject technology may include wherein: the first pump assembly comprises a first one-way valve disposed in a distal portion of the first pump assembly, the first one-way valve configured to prevent fluid flow in a proximal direction into the first pump assembly past the first one-way valve; and the second pump assembly comprises a second one-way valve disposed in a distal portion of the second pump assembly,the second one-way valve configured to prevent fluid flow in a proximal direction into the second pump assembly past the second one-way valve.

[0092] One or more embodiments of the subject technology may include an external priming reservoir for an ophthalmic device, the external priming reservoir comprising: a body comprising: an outlet end; an inlet end; a cavity disposed between the inlet end and the outlet end; an internal ridge; and one or more bosses disposed adjacent the internal ridge, each boss having a window extending through a housing of the body; a vessel disposed within the cavity, the vessel comprising: an outlet port extending past the outlet end of the cavity; an inlet port disposed within the cavity; a chamber disposed between the inlet port and the outlet port; and one or more vessel lugs disposed adjacent the inlet port; and a plunger assembly coupled to the inlet end of the body and having a portion slidingly disposed within the chamber of the vessel.

[0093] One or more aspects of the subject technology may include wherein a first boss has a cam surface configured to engage a stop surface of a first vessel lug to provide a tight seal and to prevent movement of the first vessel lug along the internal ridge in a first direction past the cam surface, and wherein the first vessel lug has a lead surface configured to engage a second boss to prevent movement of the first vessel lug along the internal ridge in a second direction opposite the first direction past the second boss.

[0094] One or more aspects of the subject technology may include wherein the plunger assembly comprises: an end portion; a plunger coupled to the end portion; a one-way valve disposed between a lumen of the end portion and a plunger lumen of the plunger; and an X-ring configured to sealing engage with an interior surface of the chamber of the vessel.

[0095] One or more aspects of the subject technology may include wherein the outlet end of the body comprises internal threads, wherein the internal threads and the outlet port of the vessel form a Luer connector configured to sealingly mate with an opposing Luer connector of the ophthalmic device.

[0096] While principles of the present disclosure are described herein with reference to illustrative embodiments for particular applications, it should be understood that the disclosure is not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, embodiments,and substitution of equivalents all fall within the scope of the embodiments described herein.Accordingly, the invention is not to be considered as limited by the foregoing description.

[0097] A reference to an element in the singular is not intended to mean one and only one unless specifically so stated, but rather one or more. For example, “a” module may refer to one or more modules. An element proceeded by “a,” “an,” “the,” or “said” does not, without further constraints, preclude the existence of additional same elements.

[0098] Headings and subheadings, if any, are used for convenience only and do not limit the invention. The word exemplary is used to mean serving as an example or illustration. To the extent that the term include, have, or the like is used, such term is intended to be inclusive in a manner similar to the term comprise as comprise is interpreted when employed as a transitional word in a claim. Relational terms such as first and second and the like may be used to distinguish one entity or action from another without necessarily requiring or implying any actual such relationship or order between such entities or actions.

[0099] Phrases such as an aspect, the aspect, another aspect, some aspects, one or more aspects, an implementation, the implementation, another implementation, some implementations, one or more implementations, an embodiment, the embodiment, another embodiment, some embodiments, one or more embodiments, a configuration, the configuration, another configuration, some configurations, one or more configurations, the subject technology, the disclosure, the present disclosure, other variations thereof and alike are for convenience and do not imply that a disclosure relating to such phrase(s) is essential to the subject technology or that such disclosure applies to all configurations of the subject technology. A disclosure relating to such phrase(s) may apply to all configurations, or one or more configurations. A disclosure relating to such phrase(s) may provide one or more examples. A phrase such as an aspect or some aspects may refer to one or more aspects and vice versa, and this applies similarly to other foregoing phrases.

[0100] A phrase “at least one of’ preceding a series of items, with the terms “and” or “or” to separate any of the items, modifies the list as a whole, rather than each member of the list. The phrase “at least one of’ does not require selection of at least one item; rather, the phrase allows a meaning that includes at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. By way of example, each of the phrases “at least one of A, B, and C” or “at least one of A, B, or C” refers to onlyA, only B, or only C; any combination of A, B, and C; and / or at least one of each of A, B, and C.

[0101] It is understood that the specific order or hierarchy of steps, operations, or processes disclosed is an illustration of exemplary approaches. Unless explicitly stated otherwise, it is understood that the specific order or hierarchy of steps, operations, or processes may be performed in different order. Some of the steps, operations, or processes may be performed simultaneously. The accompanying method claims, if any, present elements of the various steps, operations or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented. These may be performed in serial, linearly, in parallel or in different order. It should be understood that the described instructions, operations, and systems can generally be integrated together in a single software / hardware product or packaged into multiple software / hardware products.

[0102] In one aspect, a term coupled or the like may refer to being directly coupled. In another aspect, a term coupled or the like may refer to being indirectly coupled.

[0103] Terms such as top, bottom, front, rear, side, horizontal, vertical, and the like refer to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, such a term may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference.

[0104] The disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. In some instances, well-known structures and components are shown in block diagram form in order to avoid obscuring the concepts of the subject technology. The disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the principles described herein may be applied to other aspects.

[0105] All structural and functional equivalents to the elements of the various aspects described throughout the disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. §112(f), unless the element isexpressly recited using the phrase “means for” or, in the case of a method claim, the element is recited using the phrase “step for”.

[0106] The title, background, brief description of the drawings, abstract, and drawings are hereby incorporated into the disclosure and are provided as illustrative examples of the disclosure, not as restrictive descriptions. It is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the detailed description, it can be seen that the description provides illustrative examples and the various features are grouped together in various implementations for the purpose of streamlining the disclosure. The method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the claims reflect, inventive subject matter lies in less than all features of a single disclosed configuration or operation. The claims are hereby incorporated into the detailed description, with each claim standing on its own as a separately claimed subject matter.

[0107] The claims are not intended to be limited to the aspects described herein, but are to be accorded the full scope consistent with the language of the claims and to encompass all legal equivalents. Notwithstanding, none of the claims are intended to embrace subject matter that fails to satisfy the requirements of the applicable patent law, nor should they be interpreted in such a way.

Claims

CLAIMSWHAT IS CLAIMED IS:

1. An ophthalmic device comprising: a cannula having a cannula distal end and a lumen, the cannula configured to deliver a fluid; a handle having an actuator; and an internal mechanism coupled to the actuator and configured to pump the fluid, the internal mechanism comprising: a first pump assembly coupled to the actuator and configured to trigger delivery of a discrete dosage of fluid via operation of the actuator; and a second pump assembly coupled to the actuator and configured to trigger delivery of a discrete dosage of fluid via operation of the actuator.

2. The ophthalmic device of Claim 1, wherein the first pump assembly comprises: an inlet port disposed on a handle proximal end; a drive member coupled to the actuator; and a plunger coupled to the drive member, wherein the drive member is configured to provide a force that moves the plunger in a distal direction along a longitudinal axis of the handle when the actuator moves from a first position to a second position, the movement of the plunger causing the fluid to move distally through the handle and the cannula, and a portion of the fluid to exit a distal portion of the cannula.

3. The ophthalmic device of Claim 2, wherein: the actuator includes a push button positioned on the handle and is moveable from the first position to the second position upon application of a force; and upon movement of the push button from the first position to the second position, the push button is configured to urge movement of the drive member so that the discrete dosage of fluid is delivered via manual operation of the push button.

4. The ophthalmic device of Claim 3, further comprising: a reset spring coupled to the actuator, the reset spring configured to urge the push button from the second position back to the first position.

5. The ophthalmic device of Claim 1, wherein the second pump assembly comprises: a plunger having an inner lumen, the plunger fluidly coupled to a fluid outlet of the first pump assembly; and a pump slider coupled to the plunger and to the actuator, wherein the actuator is configured to cause the pump slider and the plunger to move with respect to each other along a longitudinal axis of the handle to cause the fluid to move distally through the handle and the cannula and a portion of the fluid to exit a distal portion of the cannula.

6. The ophthalmic device of Claim 5, wherein: the actuator includes a scroll wheel positioned on the handle and is rotatably moveable forward upon application of a forward force and backward upon application of a backward force; and upon forward rotatable movement of the scroll wheel, the scroll wheel is configured to urge movement of one of the pump slider and the plunger so that fluid is delivered via manual operation of the scroll wheel.

7. The ophthalmic device of Claim 6, wherein the plunger is stationary and the pump slider is reciprocally moveable via forward and backward rotation of the scroll wheel.

8. The ophthalmic device of Claim 7, wherein the pump slider comprises a hypotube slidingly coupled to an exterior of the plunger and a sealing member is disposed between the hypotube and the plunger.

9. The ophthalmic device of Claim 8, wherein movement of the hypotube towards the first pump assembly pushes fluid out of a fluid outlet of the second pump assembly, and wherein movement of the hypotube away the first pump assembly pulls fluid out of the fluid outlet of the first pump assembly.

10. The ophthalmic device of Claim 6, wherein a hypotube of the pump slider is stationarily coupled to the fluid outlet of the first pump assembly and the plunger is reciprocally moveable via forward and backward rotation of the scroll wheel.

11. The ophthalmic device of Claim 6, further comprising a linkage between the scroll wheel and the pump slider, the linkage comprising: a gear mounted on a shaft and coupled to the scroll wheel; a cam coupled to the gear; a follower coupled to the pump slider and engaged by the cam; and a one-way clutch disposed at an interface of the cam and the shaft, wherein the one-way clutch is configured to rotate the cam on forward rotation of the scroll wheel and to slip so that the cam does not rotate on backward rotation of the scroll wheel, wherein the engagement between the cam and follower causes continuous fluid pumping during forward rotation of the scroll wheel.

12. The ophthalmic device of Claim 11, further comprising a spring having a first end coupled to the first pump assembly and a second end coupled to the pump slider, wherein the spring biases the follower against the cam and moves the pump slider in the distal direction to pull fluid through the first pump assembly to refill the second pump assembly.

13. The ophthalmic device of Claim 12, wherein the first pump assembly and the second pump assembly comprise a combined pump assembly comprising a coupling having a first side coupled to the second pump assembly and a second side coupled to a plunger of the first pump assembly slidingly disposed within a chamber of the first pump assembly, the ophthalmic device further comprising: a bell crank operatively coupled to the second side of the coupling and coupled to a push button of the actuator, wherein the bell crank is configured to move the coupling and the plunger of the first pump assembly distally when the push button is pressed, wherein the spring is configured to one of: move the coupling and the plunger of the first pump assembly proximally when the push button ceases being pressed; and hold the coupling and the plunger of the first pump assembly in a proximal most position when the push button is not being pressed.

14. The ophthalmic device of Claim 12, wherein a proximal end of a chamber of the first pump assembly is coupled to a priming port, and wherein a one-way valve is disposed at a distal end of the priming port, the one-way valve configured to prevent fluid flow in a proximal direction from the chamber into the priming port.

15. The ophthalmic device of Claim 1, wherein the second pump assembly comprises: a connector, wherein a first port of the connector is coupled to a fluid outlet of the first pump assembly; a plunger with no inner lumen, the plunger slidingly coupled to a second port of the connector; and a pump slider coupled to the plunger and to the actuator, wherein the actuator is configured to cause the pump slider and the plunger to move with respect to each other along a longitudinal axis of the handle to cause the fluid to move out of a third port of the connector.

16. The ophthalmic device of Claim 1, wherein: the first pump assembly comprises a first one-way valve disposed in a distal portion of the first pump assembly, the first one-way valve configured to prevent fluid flow in a proximal direction into the first pump assembly past the first one-way valve; and the second pump assembly comprises a second one-way valve disposed in a distal portion of the second pump assembly, the second one-way valve configured to prevent fluid flow in a proximal direction into the second pump assembly past the second one-way valve.

17. An external priming reservoir for an ophthalmic device, the external priming reservoir comprising: a body comprising: an outlet end; an inlet end; a cavity disposed between the inlet end and the outlet end; an internal ridge; and one or more bosses disposed adjacent the internal ridge, each boss having a window extending through a housing of the body; a vessel disposed within the cavity, the vessel comprising:an outlet port extending past the outlet end of the cavity; an inlet port disposed within the cavity; a chamber disposed between the inlet port and the outlet port; and one or more vessel lugs disposed adjacent the inlet port; and a plunger assembly coupled to the inlet end of the body and having a portion slidingly disposed within the chamber of the vessel.

18. The external priming reservoir of Claim 17, wherein a first boss has a cam surface configured to engage a stop surface of a first vessel lug to provide a tight seal and to prevent movement of the first vessel lug along the internal ridge in a first direction past the cam surface, and wherein the first vessel lug has a lead surface configured to engage a second boss to prevent movement of the first vessel lug along the internal ridge in a second direction opposite the first direction past the second boss.

19. The external priming reservoir of Claim 17, wherein the plunger assembly comprises: an end portion; a plunger coupled to the end portion; a one-way valve disposed between a lumen of the end portion and a plunger lumen of the plunger; and an X-ring configured to sealing engage with an interior surface of the chamber of the vessel.

20. The external priming reservoir of Claim 17, wherein the outlet end of the body comprises internal threads, wherein the internal threads and the outlet port of the vessel form a Luer connector configured to sealingly mate with an opposing Luer connector of the ophthalmic device.

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