Ophthalmic devices

Abstract

To provide a medical device configured for use in the treatment of glaucoma or other eye conditions.SOLUTION: An ophthalmic device is provided, comprising: a cannula having a cannula distal end, a lumen, and one or more orifices coupled to the lumen, the cannula configured to deliver a fluid; a sleeve disposed around the cannula and having a sleeve distal end; a handle coupled to the sleeve and 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, an inlet port, a drive member, a plunger, a rear seal, a bore tube, and a front tube.SELECTED DRAWING: Figure 12A

Description

[Technical Field]

[0001] This disclosure relates generally to medical devices and medical procedures, and more specifically to ophthalmic devices. [Background technology]

[0002] Glaucoma is a disease resulting from elevated intraocular pressure (IOP). IOP can rise when the eye's natural drainage (e.g., drainage of ocular fluid) is obstructed, reduced, or otherwise blocked. The cavity in front of the lens of the eye (e.g., directly above) is filled with a viscous fluid called aqueous humor. The continuous flow of aqueous humor in the eye nourishes the non-vascular parts of the eye (e.g., the cornea and lens). This flow of aqueous humor also removes waste products (e.g., fragments of foreign bodies) from these tissues. In a healthy eye, when new aqueous humor is secreted from the epithelial cells of the ciliary body, the aqueous humor flows from the anterior chamber through the trabecular meshwork into Schlemm's canal. The drained aqueous humor enters the venous flow from Schlemm's canal and is carried away with the venous blood leaving the eye. When the eye's natural drainage mechanism (e.g., Schlemm's canal and / or trabecular meshwork) malfunctions, IOP begins to rise.

[0003] The accompanying drawings incorporated herein and forming part thereof illustrate exemplary embodiments of the Disclosure and serve to illustrate the principles of the Disclosure together with this Description. [Brief explanation of the drawing]

[0004] [Figure 1] This is a perspective view showing an example of an ophthalmic device. [Figure 2A] This is a perspective view showing the distal end of an example of an ophthalmic device having an internal cannula surrounded by a sleeve, illustrating the internal cannula covered by the sleeve. [Figure 2B] This is a perspective view showing the distal end of an example of an ophthalmic device having an internal cannula surrounded by a sleeve, with the internal cannula protruding from the sleeve. [Figure 3A] This is a longitudinal section showing a retractable sleeve that interacts with ocular tissue, with the distal sleeve being shown. [Figure 3B] This is a longitudinal section showing a retractable sleeve interacting with ocular tissue, with the sleeve shown in its retracted, proximal position. [Figure 4A] This is a side view showing an example of a sleeve that interacts with ocular tissue, specifically a sleeve sized to contact the trabecular meshwork covering Schlemm's canal and the more rigid anatomical structures near Schlemm's canal. [Figure 4B] This is a side view showing an example of a sleeve that interacts with ocular tissue, specifically one sized to compress the trabecular meshwork into Schlemm's canal. [Figure 5A] These are various diagrams illustrating examples of sleeves that can be included in ophthalmic devices, and are perspective views of the sleeves. [Figure 5B] These are various diagrams illustrating examples of sleeves that can be included in ophthalmic devices, and are top views of the sleeves. [Figure 5C] These are various diagrams illustrating examples of sleeves that can be included in ophthalmic devices, and are side views of the sleeves. [Figure 6A] These are various diagrams illustrating examples of sleeves that can be included in ophthalmic devices, and are perspective views of the sleeves. [Figure 6B] These are various diagrams illustrating examples of sleeves that can be included in ophthalmic devices, and are top views of the sleeves. [Figure 6C] These are various diagrams illustrating examples of sleeves that can be included in ophthalmic devices, and are side views of the sleeves. [Figure 7A] These are various diagrams illustrating examples of cannulas that can be included in ophthalmic devices, and are perspective views of cannulas. [Figure 7B] These are various diagrams illustrating examples of cannulas that can be included in ophthalmic devices, with Figure 7A being a top view of a cannula being used. [Figure 7C]Various diagrams of examples of cannulas that can be included in an ophthalmic device, and a side view of the cannula implemented in FIG. 7A. [Figure 8] A longitudinal cross-sectional view showing an example of a sleeve that can be included in an ophthalmic device. [Figure 9A] A side view showing an example of a mechanism configured to retract a sleeve in an ophthalmic device, showing the mechanism in the starting position. [Figure 9B] A side view showing an example of a mechanism configured to retract a sleeve in an ophthalmic device, showing the mechanism in an intermediate position. [Figure 9C] A side view showing an example of a mechanism configured to retract a sleeve in an ophthalmic device, showing the mechanism in the release position. [Figure 10] A longitudinal cross-sectional view showing an example of an ophthalmic device. [Figure 11A] A cutaway view showing an example of a mechanism configured to inject fluid, showing the nut and pump of the mechanism with the link mechanism removed. [Figure 11B] A cutaway view showing an example of a mechanism configured to inject fluid, showing the link mechanism in the initial position. [Figure 11C] A cutaway view showing an example of a mechanism configured to inject fluid, showing the link mechanism in the actuated position. [Figure 12A] A perspective view of an example of an ophthalmic device. [Figure 12B] A perspective view of the internal components of the ophthalmic device of FIG. 12A. [Figure 12C] A cross-sectional view of the internal components of the ophthalmic device of FIG. 12A. [Figure 12D] Various partial views of the internal components of the ophthalmic device of FIG. 12A showing the action of the components, showing the operation of the components during operation. [Figure 12E] Various partial views of the internal components of the ophthalmic device of FIG. 12A showing the action of the components, showing the operation of the components during operation. [Figure 12F]Various partial views of the internal components of the ophthalmic device of FIG. 12A showing the operation of the components, showing the operation of the components during operation. [Figure 13A] A longitudinal sectional view showing an example of an ophthalmic device. [Figure 13B] A perspective view of the internal components of the ophthalmic device of FIG. 13A. [Figure 13C] A sectional view of the internal components of the ophthalmic device of FIG. 13A. [Figure 13D] A partial sectional view of the internal components of the ophthalmic device of FIG. 13A showing the operation of the components, showing the operation of the components during operation. [Figure 13E] A partial sectional view of the internal components of the ophthalmic device of FIG. 13A showing the operation of the components, showing the operation of the components during operation. [Figure 13F] A partial sectional view of the internal components of the ophthalmic device of FIG. 13A showing the operation of the components, showing the operation of the components during operation. [Figure 13G] A partial sectional view of the internal components of the ophthalmic device of FIG. 13A showing the operation of the components, showing the operation of the components during operation. [Figure 14A] A perspective view of an example of an assembly of an ophthalmic device and a priming syringe. [Figure 14B] A partial view of the internal components of FIG. 14A, showing the operation of the components during priming. [Figure 14C] A partial view of the internal components of FIG. 14A, showing the operation of the components during priming. [Figure 15A] A cutaway view showing an example of an ophthalmic procedure that can be performed using the ophthalmic device, showing the ophthalmic device entering the anterior chamber. [Figure 15B] A cutaway view showing an example of an ophthalmic procedure that can be performed using the ophthalmic device, showing the ophthalmic device injecting fluid into Schlemm's canal.

Mode for Carrying Out the Invention

[0005] The following detailed descriptions are illustrative and not intended to limit the features claimed. As used herein, the terms “comprises,” “comprising,” or other variations thereof are intended to include non-exclusive inclusion, in which a process, method, article, or apparatus comprising the enumerated elements may include not only those elements but also other elements not expressly enumerated or inherent in such process, method, article, or apparatus. Furthermore, the term “exemplary” is used herein in the sense of “example” and not “ideal.” As used herein, the terms “about,” “substantially,” and “nearly” indicate a range of values ​​within + / - 5% of the stated value. The term “distal” refers to the part of the device furthest from the user when the device is introduced into the subject’s body. In contrast, the term “proximal” refers to the part of the device closest to the user when the device is placed into the subject’s body.

[0006] The embodiments described below relate to medical devices, such as ophthalmic devices, configured for use in the treatment of glaucoma or other eye conditions, and related methods of use. According to some embodiments, the ophthalmic device may have a distal end including a cannula. The cannula may include an internal lumen and one or more outflow orifices configured to deliver a viscoelastic fluid or other substance into a patient target site, such as Schlemm's canal.

[0007] According to some embodiments, the tip of the cannula may include a collar disposed around the outer surface of the cannula. The collar may be configured to interact with intraocular tissue in the aqueous humor outflow pathway of the patient's eye to facilitate the positioning of the cannula or to facilitate fluid transport related to the eye. For example, the collar may include a radially projecting lip that is fixed or movable to a position proximal to the orifice, to provide a structure that facilitates positioning the cannula's orifice in or near Schlemm's canal.

[0008] According to some embodiments, the collar may be implemented as part of a retractable sleeve. The sleeve may be positioned around the cannula and configured to pull patient tissue by a suction effect when retracted relative to the cannula. For example, operation of a button or other actuator component positioned on the device handle may be configured to pull the sleeve back, thereby pulling the trabecular meshwork along the periphery of the cannula, allowing the cannula to penetrate the trabecular meshwork, and opening Schlemm's tube to facilitate fluid delivery within it.

[0009] According to some embodiments, the mechanism may be configured to retract the sleeve or otherwise move components of the ophthalmic device with a relatively quick and sharp snapping motion. Such motion can facilitate, for example, the aspiration and penetration of patient tissue by a cannula. Additionally or alternatively, the mechanism may be configured to operate a pump to inject fluid or substance through the cannula in coordination with the retraction of the sleeve.

[0010] These and other embodiments are discussed below in relation to the specific examples shown in Figures 1 to 9B. However, those skilled in the art will recognize various modifications and alternative uses. Therefore, the detailed descriptions provided with respect to these figures and the descriptions provided above should not be construed as limiting, but rather serve to illustrate the various concepts associated with this disclosure.

[0011] Figure 1 shows an example of a medical device, and more specifically, 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 the injection of a substance into Schlemm's canal or other internal parts of the patient's eye. However, although the examples described herein refer to ophthalmic instruments and procedures, it should be understood that the teachings for the ophthalmic device 10 can be readily applied or adapted to a variety of other medical and non-medical uses. These may include, for example, other medical procedures involving interaction with patient tissue other than the patient's eye, and other non-medical uses involving the injection or transport of fluids.

[0012] Referring to Figure 1, the ophthalmic device 10 may include a handle 12 connected to an ocular component 21. The ocular component 21 is generally configured to interact with ocular tissue and / or to be inserted into an intraocular cavity, for example, into the anterior chamber of the patient's eye. The ocular component 21 may be configured to facilitate fluid delivery, tissue manipulation, and / or other interactions with the patient's eye.

[0013] As shown in the example in Figure 1, the eyepiece component 21 may include a long tubular member protruding from the distal end of the handle 12 and defining the longitudinal central axis C. The eyepiece component 21 may have an operating length L and a diameter that allows insertion into the anterior chamber through a corneal incision or other incision on the surface of the patient's eye. As described herein, the operating length L can be defined as the exposed length or distance of the eyepiece component 21 protruding from the handle 12, extending from the distal end of the handle 12 to the distal end of the eyepiece component 21. The operating length L may be, for example, in the range of about 16 millimeters (mm) to 40 mm, or more specifically about 18 mm, but it is intended that other dimensions outside of these examples may be preferred in various implementations. The diameter may vary along the working length L or remain constant throughout the working length L, for example, in the range of about 100 micrometers (μm) to 1000 μm, or more specifically, about 700 μm, although other dimensions outside these examples may be preferable in various mounting configurations. As shown in the example in Figure 1, the eyepiece component 21 may be mounted in a linear geometry (defining a linear central axis C), or the eyepiece component 21 may be mounted in a curved and / or bent geometry.

[0014] Continuing to refer to Figure 1, the handle 12 can be implemented as the body of the ophthalmic device 10 and may be configured to be operated by the user or another operator. For example, as shown in Figure 1, the handle 12 may be implemented as a long, tubular member having a distal end and a proximal end opposite the distal end. This may facilitate the grasping or operation of the handle 12 by, for example, a surgeon gripping it like a pencil, although the handle 12 may be implemented with a pistol-shaped configuration and / or other shapes and configurations such as a finger loop. The outer surface of the handle 12 may include a grip 13 having a surface with a ridged shape and / or texture (e.g., jagged, ribbed, or other surface texture) to allow the user to easily grasp the handle 12. Implementation forms in which the outer surface of the handle 12 has a flat, straight shape and / or a smooth outer surface are also conceivable.

[0015] The handle 12 may include or be connected to an actuator 38. The actuator 38 may be connected to one or more moving parts of the ophthalmic device 10 to provide one or more operating functions that facilitate the performance of ophthalmic procedures using the device. For example, the actuator 38 may be configured to move one or more parts of the eyepiece component 21 independently of the handle 12, and / or to move two or more moving parts of the eyepiece component 21 independently of each other. Additionally or alternatively, the actuator 38 may be configured to actuate pumps, plungers, and / or compression mechanisms for transporting fluid through the eyepiece component 21. The actuator 38 may be configured, for example, to move such parts directly or via internal mechanisms disposed within the handle 12.

[0016] In the example shown in Figure 1, the actuator 38 is implemented as, or includes, a mechanical push button mounted on the handle 12, which is movable between an unpressed position and a pressed position. The push button is shown mounted on the side of the handle 12, which may facilitate, for example, operation by a surgeon or other user when their hand grasps the handle 12 during a procedure, using their thumb and / or index finger. Additional or alternative implementations are envisioned in which the push button is mounted in another location, such as the proximal end of the handle. Instead of or in addition to the push button, the actuator 38 is also envisioned to include any other suitable mechanism that can be operated by a user or other operator to actuate a slider, roller wheel, squeeze valve, and / or moving parts of the ophthalmic device 10.

[0017] Figures 2A and 2B are enlarged views showing examples of eyepiece components 21 that can be included in the ophthalmic device 10. Figures 2A and 2B show the distal portion 27 of the eyepiece component 21 as shown in Figure 1.

[0018] In the examples shown in Figures 2A and 2B, the eyepiece component 21 includes a cannula 14 and a sleeve 260 (which may also be referred to herein as a “sheath”). The sleeve 260 is arranged around the cannula 14, and the cannula 14 is arranged inside the sleeve 260. The cannula 14 and the sleeve 260 can each be implemented, for example, as substantially tubular components, in which case the cannula 14 is arranged coaxially with the sleeve 260, and both the cannula 14 and the sleeve 260 are arranged around a central axis C. The cannula 14 and / or the sleeve 260 may each have an operating length equal to the operating length L of the eyepiece component 21, for example.

[0019] The cannula 14 and sleeve 260 may be configured to move relative to each other. For example, as shown in Figures 2A and 2B, the cannula 14 and sleeve 260 may be movable relative to each other between a first configuration (shown in Figure 2A) in which the distal end of the cannula 14 is substantially covered or surrounded by the sleeve 260, and a second configuration (shown in Figure 2B) in which the distal end of the cannula 14 protrudes distally from the distal end of the sleeve 260. Relative movement may be achieved, for example, by retracting the sleeve 260 proximally, independently of the cannula 14 and handle 12, and / or by deploying the cannula 14 distally, independently of the sleeve 260 and handle 12. The actuator 38 may be operationally coupled to the cannula 14 and / or sleeve 260 to move the cannula 14 and / or sleeve 260 relative to a fixed component of the handle 12.

[0020] The cannula 14 may be configured to transport fluids or other substances. For example, the cannula 14 may be configured to inject a viscoelastic fluid, such as sodium hyaluronate or chondroitin sulfate. Viscoelastic fluids are highly flexible, gel-like substances that help provide sufficient space for proper drainage and intraocular pressure relief by expanding and separating tissue structures, thereby reopening or expanding the pathways for aqueous humor. Viscoelastic fluids can also improve visualization by clearing visual field obstructions by expanding and separating bleeding structures. It is also intended that the cannula 14 may be used to deliver stem cells, drugs, gases (e.g., SF6 or C3F8), and / or dyes (e.g., trypan blue dye). Injected stem cells may, for example, initiate the growth of healthy tissue within the eye (e.g., thereby developing a healthy trabecular meshwork to improve the drainage of aqueous humor through it). The injected dye can, for example, flow through the trabecular meshwork, improving the visualization of aqueous humor fluid flow so that it is possible to determine which areas remain obstructed, compressed, or otherwise impede the flow of aqueous humor within the trabecular meshwork. Furthermore, although examples of substance injection are described, it is intended that the cannula 14 may be used additionally or alternatively to draw out substances, such as tissue, blood, aqueous humor, or other substances from Schlemm's canal or other parts of the eye.

[0021] As shown in Figure 2B, the cannula 14 may be implemented as a non-sharp microcannula, having a rounded, non-sharp, or otherwise non-traumatic tip at its distal end. While implementations in which the cannula 14 has a sharp needle or trauma-causing tip at its distal end are also considered, a non-sharp cannula can facilitate penetration of porous patient tissues such as the trabecular meshwork while reducing the risk of undesirable trauma to surrounding tissues.

[0022] The cannula 14 may include one or more orifices 32 disposed on the distal portion of the cannula 14, for example, on or near the distal end of the cannula. One or more orifices 32 may provide one or more fluid transport ports configured to transport fluid or other substances. For example, one or more orifices 32 may be configured to provide an outflow port for delivering a viscoelastic substance to Schlemm's canal of the patient's eye. As shown in the example in Figure 2B, one or more orifices 32 may be disposed on the side of the cannula 14, and these orifices 32 may provide one or more fluid channels penetrating the side wall of the cannula 14 in a direction transverse to the central axis C. Alternatively, other implementations are conceivable in which the orifices are disposed along the central axis C and / or at any other one or more locations suitable for transporting fluid from and to an intended target site. Each orifice may have a diameter between 30 μm and 70 μm, or, for example, about 50 μm or about 60 μm, but it is intended that other orifice diameters outside these ranges can be suitably used in various implementation configurations. The cannula 14 may include one or more grooves 34 disposed on the distal portion of the cannula 14.

[0023] For example, as shown in Figures 2A and 2B, the relative movement between the sleeve 260 and the cannula 14 may be configured such that the sleeve 260 selectively covers and exposes one or more of the orifices 32. For example, in the first configuration shown in Figure 2A, the distal end of the sleeve 260 can be positioned at a first axial position distal to the orifice 32 so as to cover or surround the orifice 32, and in the second configuration shown in Figure 2B, the distal end of the sleeve 260 can be positioned at a second axial position proximal to the orifice 32 so as to expose the orifice 32 outside the distal end of the sleeve 260.

[0024] The ophthalmic device 10 may further include a collar 299 disposed around the tip of the cannula 14, either at or near the distal end of the cannula. For example, as shown in Figures 2A and 2B, the collar 299 may be an integral part of the sleeve 260, or it may be fixedly connected to the sleeve 260 at the distal end of the sleeve, in which case the collar 299 may move together with the sleeve 260 so that the collar 299 and the cannula 14 are movable relative to each other. The collar 299 may provide a structure disposed around the cannula 14 (for example, on or along the outer diameter of the cannula 14) that is configured to interact with patient tissue to facilitate the placement of the cannula 14. For example, a surface 451 of the collar 299 at the distal end of the collar may be configured to provide a guide constraint that manipulates the trabecular meshwork and / or contacts other tissue near the trabecular meshwork and / or Schlemm's canal. This guiding constraint makes it easier, for example, to install the orifice 32 at a desired penetration depth within the Schlemm tube.

[0025] In the examples shown in Figures 2A and 2B, the collar 299 is included as part of the distal portion of the sleeve 260. When the sleeve 260 and cannula 14 are in the second configuration shown in Figure 2B, the surface 451 of the collar 299 provides a lip that projects radially outward away from the outer diameter of the cannula 14. The lip may contact other tissue near the trabecular meshwork or Schlemm's canal so that, when the device is in the second configuration, the penetration depth of the cannula 14 is constrained or guided by a predetermined distance between the distal end of the cannula 14 and the lip (or surface 451 or the distal end of the collar 299).

[0026] Figures 3A and 3B are longitudinal cross-sectional views showing the distal portion 27 of an example of an eyepiece component 21 that interacts with ocular tissue. Figure 3A shows the sleeve 260 in the distal position, and Figure 3B shows the sleeve 260 in the retracted position, where the sleeve 260 is retracted in the proximal direction 99 as indicated by the arrow.

[0027] As shown in Figures 3A and 3B, the collar 299 at the distal end of the sleeve 260 can be configured to contact patient tissue, and the sleeve 260 can be configured to retract proximally so that patient tissue is pulled along the cannula 14. For example, the sleeve 260 may be configured to retract proximally 99 with a snapping motion (i.e., a sharp, rapid motion) when the sleeve 260 and / or collar 299 are pressed against the trabecular meshwork 86, thereby creating an aspirating microenvironment for the trabecular meshwork 86 of the patient's eye. The sleeve 260 can pull and expand the trabecular meshwork 86 proximally through its snapping motion, which may also serve to expand Schlemm's canal 80 as the trabecular meshwork 86 springs up from the anterior wall of Schlemm's canal. When the trabecular meshwork 86 is pulled, the distal end of the cannula 14 remains in place, resulting in the trabecular meshwork 86 moving along the cannula 14, the cannula 14 perforating or penetrating the trabecular meshwork 86, and the orifice 32 remaining in place inside the Schlemm's canal 80. When the trabecular meshwork 86 is pulled and the orifice 32 is positioned within the Schlemm's canal 80, the ophthalmic device 10 may be configured to deliver material into the Schlemm's canal 80 via the lumen 95 in the cannula 14, which is fluid-connected to the orifice 32. Pulling back the sleeve 260 proximal can be advantageous in expanding the Schlemm's canal 80 and / or otherwise facilitating fluid delivery and / or treatment via penetration by the cannula 14. It is also intended that, in some implementations, the injection of the substance may be performed by positioning the cannula 14 distally while the sleeve 260 remains in place, by moving the cannula 14 proximal or distally together with the sleeve 260, and / or by other techniques.

[0028] Figures 4A and 4B are longitudinal lateral views showing examples of sleeve 260 interacting with ocular tissue. Figure 4A shows a first example of sizing that can be implemented at the distal end of sleeve 260, and Figure 4B shows a second example of sizing that can be implemented at the distal end of sleeve 260. Figures 4A and 4B show the trabecular meshwork 86 and Schlemm's canal 80, as well as other nearby ocular anatomical structures, such as the scleral promontory 71, ciliary muscle 69, and Schwalbe's line 67.

[0029] As shown in both Figures 4A and 4B, the size of the distal end of the sleeve 260 (or the size of the distal end of the surface 451 or collar 299) can be made small enough so that the distal end can be inserted into the iris-corneal angle using an ab interno approach (an approach from within the anterior chamber) and abut and contact the trabecular meshwork 86. In the example shown in Figure 4A, the size of the distal end of the sleeve 260 is made large enough so that the distal end abuts both the trabecular meshwork 86 and nearby anatomical structures that are more rigid than the trabecular meshwork 86, such as the scleral promontory 71, so as the distal end is advanced to push against the trabecular meshwork 86, substantially preventing the trabecular meshwork 86 from being crushed within Schlemm's canal 80. In the example shown in Figure 4B, the size of the distal end of the sleeve 260 is sufficiently small so that when the distal end is pressed against the trabecular meshwork 86, for example, in the region between the scleral promontory 71 and the Schwalbe line 67, the distal end is configured to compress the trabecular meshwork 86 within the Schlemm's canal 80. In any example, when in contact with the trabecular meshwork 86, the distal end may be configured to form a complete or partial seal to the trabecular meshwork 86 and / or other ocular tissues, as well as to surrounding fluids, such as aqueous humor and / or viscoelastic substances (e.g., ophthalmic viscoelastic devices (OVDs)). The ophthalmic device 10 may then be configured to pull the sleeve 260 back to pull the trabecular meshwork 86, as described above with respect to Figures 3A and 3B. Furthermore, it is intended that the distal end may have an elongated cross-sectional shape, with the long side being the size shown in Figure 4A and the short side being the size shown in Figure 4B. The long side can be configured to advance in a way that pushes the trabecular meshwork 86 into contact with a rigid anatomical structure when the long side is oriented so as to cross the direction in which the trabecular meshwork 86 extends around the lens of the eye, and the short side can be configured to compress the trabecular meshwork 86 within Schlemm's canal 80 when the long side is aligned with the direction in which the trabecular meshwork 86 extends.

[0030] Figures 5A to 5C show various views of the distal portion of an example of sleeve 260 including color 299. Figure 5A is a perspective view of sleeve 260, Figure 5B is a top view of sleeve 260 as implemented in Figure 5A, and Figure 5C is a side view of sleeve 260 as implemented in Figure 5A.

[0031] For example, as shown in Figures 5A to 5C, the collar 299 (e.g., face 451) and the distal end of the sleeve 260 may have an elongated cross-sectional shape (e.g., oval, elliptical, rounded rectangle, or other elongated shape). The elongated shape has a pair of opposing long sides 93 and a pair of opposing short sides 96. The long sides 93 define the major axis 85 of the elongated cross-section, and the elongated cross-section has a long outer diameter D along the major axis 85. LONG It has the following characteristics: The short side 96 defines the short axis 89 of the elongated cross-section, and the elongated cross-section has a long outer diameter D along the short axis 89. LONG Smaller outer diameter D SHORT The distal ends of the collar 299 and sleeve 260 may include a pair of expanding outer surfaces 79 on both sides of the sleeve 260 that expand toward the opposing short sides of the distal end of the sleeve 260 (or flares radially outward). For example, as shown in Figure 5C, the distal ends of the collar 299 and sleeve 260 may also include a pair of converging outer surfaces 75 on both sides of the sleeve 260 that converge toward the opposing long sides of the distal end of the sleeve 260 (or taper radially inward). This results in a long outer diameter D LONG The outer diameter D of the proximal portion sleeve 260 is PROX It can become larger than, while the outer diameter D is short. SHORT The outer diameter D of the proximal portion PROX It may be smaller than this. The distal end of the sleeve 260 may be sized to fit within the iris-corneal angle (the angle formed between the iris and the cornea) so that the distal tip can contact or press against the trabecular meshwork and / or scleral promontory of the eye, and the above-described orientation with respect to the flared base configuration along the long axis 85 may be useful, for example, to indicate a preferred orientation of the sleeve tip so that the surgeon can properly position the tip so that overcompression of the trabecular meshwork and / or Schlemm's canal is avoided.

[0032] The color 299 and / or sleeve 260 may further be configured as light conductors to improve visibility when placed in the eye. For example, one or more light-emitting diodes (LEDs) or other light sources may be placed within the handle 12 or otherwise positioned proximal to the distal end of the sleeve 260 on the ophthalmic device 10. The light sources may be configured to couple visible light into the sidewall of the sleeve 260 and propagate that light through the sidewall of the sleeve 260 by total internal reflection (TIR) ​​outward from the distal end or distal portion of the sleeve 260 (e.g., outward from surface 451). Additionally or alternatively, the sleeve 260 may be made transparent or include one or more transparent windows to facilitate visualization of the sleeve 260 and / or cannula 14, although in other implementations, the sleeve 260 is intended to be completely opaque to visible light.

[0033] Figures 6A to 6C show various views of the distal portion of an example of a sleeve 260 including a collar 299. Figure 6A is a perspective view of the sleeve 260, Figure 6B is a top view of the sleeve 260 as implemented in Figure 6A, and Figure 6C is a side view of the sleeve 260 as implemented in Figure 6A. For example, as shown in Figures 6A to 6C, the outer surface of the collar 299 and the outer surface of the distal portion of the sleeve 260 may further include grooves 101. The grooves 101 can improve the attraction effect when the sleeve 260 and collar 299 are pulled back proximal by increasing the surface area of ​​the outer surface that comes into contact with fluids such as the OVD or other ambient fluids that may be disposed in the anterior chamber of the eye. In Figures 6A to 6C, the grooves 101 are shown as multiple circumferential grooves extending along the outer circumference of the sleeve 260 and located within the converging region of the collar 299 at the distal portion of the sleeve 260. However, it is intended that the grooves 101 may be implemented as other types of surface area increasing textures and / or positioned at other locations along the axial length of the sleeve.

[0034] For example, as shown in FIGS. 7A-7C, it is also contemplated that color 299 can be fixedly coupled to cannula 14. FIG. 7A is a perspective view of cannula 14, FIG. 7B is a top view of cannula 14 as implemented in FIG. 7A, and FIG. 7C is a side view of cannula 14 as implemented in FIG. 7A.

[0035] In this example, the independently movable sleeve may be omitted from the ophthalmic device 10. For example, color 299 may be integrally formed as part of an outer portion of cannula 14, or color 299 may be welded or otherwise fixedly attached to cannula 14 such that color 299 moves with cannula 14. The fixedly coupled color 299 may have any of the other features described above with respect to color 299 when mounted on a sleeve or an elongated cross-sectional shape. For example, as shown in FIGS. 7A and 7B, a lip can be provided by a surface of color 299, and this lip can project radially outward from the distal portion of cannula 14. The lip can thus provide a structure for interacting with tissue as described above. For example, as shown in FIG. 7B, the radial length L R of the lip can be made substantially equal to the axial length L A of the protruding portion of cannula 14, although it is contemplated that other dimensions may be suitably used. In this example, the lip length L R is defined by the distance between the radially outermost surface of the lip and the radially outermost surface of the axially protruding region of cannula 14 from which the lip extends. The cannula tip length L AThis is determined by the axial length from the lip (or from the distal end of face 451 or collar 299) to the distal end of the cannula 14. The diameter of the cannula 14 proximal to the collar 299 may be larger than that of the portion distal to the collar 299. This allows for an advantageous increase in the rigidity or structural integrity of the cannula 14 along its working length, while keeping the diameter of the distal end of the cannula 14 sufficiently small to allow insertion into Schlemm's canal or another preferred target site in the patient. It is also intended that any of these dimensions or geometric features described with respect to the fixed collar shown in Figures 7A to 7C may be suitably used in a mounting configuration in which the collar is part of the sleeve 260 or otherwise movable relative to the cannula 14 and arranged in a second configuration such as that shown in Figure 2B.

[0036] Figure 8 is a longitudinal cross-sectional view showing the distal portion of an example of an eyepiece component 21 that can be included in the ophthalmic device 10. In the example shown in Figure 8, the cannula 14 is shown in a position protruding from the sleeve 260 (for example, in a second configuration as shown in Figure 2B). The cannula 14 is composed of multiple segments, including an apical segment 151 and a proximal shaft segment 153. The apical segment 151 can be attached to the proximal shaft segment 153, for example, by laser welding or any other suitable fastening mechanism. The apical segment 151 has an inner diameter D SMALL The proximal shaft 153 has an inner diameter D of the tip segment 151. SMALL Larger inner diameter D LARGE Therefore, the lumen 95 extending through the cannula 14 is segmented such that it has a proximal portion 163 with a larger diameter than the distal portion 161. This can, for example, reduce back pressure within the device, but implementations in which the cannula 14 consists of a single piece or a single structure, and / or the lumen 96 has a substantially constant diameter across the cannula 14 are also contemplated.

[0037] Figure 8 also shows a collar 299 configured as shown in the examples in Figures 5A-5C, where the collar 299 is mounted on the distal end of the sleeve 260, and the distal tip of the sleeve 260 has an elongated cross section with flared, expanding outer surfaces 79 on both sides of the sleeve 260. As shown in the example in Figure 8, one or more orifices 32 may include a pair of orifices on both sides of the cannula 14 (for example, oriented approximately 180 degrees apart from each other along the circumference of the cannula 14). The pair of opposing orifices may be aligned along the long axis 85 of the distal tip (aligned along the long axis of the elongated cross section of the collar 299) such that the orifices 32 face the short side 96 of the distal end of the sleeve and the expanding outer surface 79. This allows, for example, a flared or expanding surface to act as an indicator for directing the orifice of the cannula 14 into the Schlemm's tube in the direction in which the injected fluid extends. Although shown in an implementation where the collar 299 is fixedly connected to a movable sleeve 260, it is also intended that this orientation of the orifice 32 can be applied to an implementation where the collar 299 is fixed to the cannula 14, as in the examples in Figures 7A and 7C.

[0038] Figures 9A to 9C are side views showing an example of an internal mechanism 301 that can be incorporated into the ophthalmic device 10 and used to retract the sleeve 260. The internal mechanism 301 can be, for example, installed within the internal volume of the handle 12 and connected to the actuator 38.

[0039] Figure 9A shows the internal mechanism 301 in its initial loaded state, Figure 9B shows the internal mechanism 301 in an intermediate state, and Figure 9C shows the internal mechanism 301 in a released state during or after the retraction of the sleeve 260. The internal mechanism 301 shown in Figures 9A to 9C utilizes a cam and follower system to retract the sleeve 260 proximal 99 relative to the cannula 14 and the handle 12 (the sleeve 260, cannula 14, and handle 12 are not visible in Figures 9A to 9C). More specifically, the internal mechanism 301 includes a cam 311 connected to the capture section 321 and a spring-driven follower 331. The follower 331 may be fixedly connected to the sleeve 260 so that the sleeve 260 moves together with the follower 331. The capture unit 321 is configured to hold the follower 331 in a distal position, and the cam 311 is configured to move the capture unit 321 and release the follower 331 in the proximal direction 99. The cam 311 can be connected to a push button (as shown in Figure 1) so that the cam 311 can be moved or activated by this push button.

[0040] In Figure 9A, the internal mechanism 301 is shown in its initial state. In this state, the follower 331 (and sleeve 260) is in the distal position. The capture unit 321 is in the first position, in which position the capture unit 321 holds the follower in the distal position by, for example, contacting the proximal surface of the follower 331 to prevent or limit the proximal movement of the follower 331. While the capture unit is in the first position and the follower is in the distal position, the spring 335 applies a spring force to the follower 331 in the proximal direction 99. Although the spring 335 is shown as an axial compression spring in Figures 9A to 9C, it will be understood that various other springs may be suitably used. A push button (not visible in Figure 9A) can be connected to the cam 311 and is in the unpressed position (e.g., the upper position) when the internal mechanism 301 is in its initial state. By applying force to the push button, the user can bias the cam 311 to rotate in a first cam rotation direction 355 around the pivot point 343. When the cam 311 rotates in the first cam rotation direction 355, the cam 311 rotates in opposition to the capture part 321, biasing the movement of the capture part 321 such that it bends, for example, in a direction 373 toward a second position of the capture part, away from its first position.

[0041] In Figure 9B, the internal mechanism 301 is shown in an intermediate state when the above forces are applied. As shown in Figure 9B, when the cam 311 rotates in the first rotational direction 355, a gap 381 may be formed between the cam 311 and the follower 331. For example, when the cam 311 rotates against the trap 321, the trap 321 can continue to hold the follower 331 in a distal position while the cam 311 rotates in the first cam rotational direction 355 so that it moves away from the follower 331. The gap 381 can provide clearance for the follower 331 to move freely with the sleeve 260, and as a result, when the trap 321 releases the follower 331, the latent energy held by the spring 335 can cause a quick and sharp snapping motion.

[0042] In Figure 9C, the internal mechanism 301 is shown in a retracted or retracted state, with the capture unit 321 releasing the follower 331. As shown in Figure 9C, when the cam 311 has rotated sufficiently against the capture unit 321, the cam 311 can release the follower 331 by moving the capture unit 321 to a second position where the capture unit 321 releases the follower 331, for example by removing a limiting portion that is in contact with the distal surface of the capture unit 321 against the proximal surface of the follower 331. When the follower is released, the latent energy stored in the spring 335 is released, biasing the follower 331 (and therefore the sleeve 260) to move proximal 99. The follower 331 can move freely through the gap 381 to the proximal position until it is stopped by the limiting portion. For example, the proximal movement of the follower 331 may end when the follower 331 contacts the cam 311, when it contacts a stop (not visible in Figure 9C) contained within the housing of the handle 12, and / or when it contacts a stop (contained on the capture portion 321). The surface providing the stop for the follower 331 may, for example, have relatively high rigidity or may include cushioning or energy-absorbing members to mitigate impact and prevent the shock from being transmitted through the device to the surgeon's hand.

[0043] In Figure 9C, the capture unit 321 is shown in the second position (release position). For example, when the push button is released by the user, the capture unit 321 can be biased to the first position (the contact position shown in Figure 9A), and as a result, the internal mechanism 301 can be reset to its initial state. For example, when the push button is released after the follower 331 has been pulled back, the biasing of the capture unit 321 toward the first position moves the capture unit 321 upward, thereby biasing the cam 311 to rotate in a second cam rotation direction opposite to the first cam rotation direction 355. When the capture unit 321 biases the cam 311 to rotate in the opposite direction, the cam 311 biases the follower 331 distally (or the capture unit 321 biases the follower via the cam 311), thereby moving the follower 331 from the follower proximal position to the follower distal position, and applying load to the spring 335 again. When the capture unit 321 biases the rotation of the cam 311 and moves the follower 331 in this manner, the capture unit 321 can also return to a first position in which it contacts the follower 331 and holds the follower 331 in a distal position. The internal mechanism 301 can then operate again in a similar manner for one or more repeated retractions of the sleeve.

[0044] The mechanism is described in relation to an implementation in which the internal mechanism 301 is used to pull back the sleeve 260 (for example, to pull the trabecular mesh via a snapping motion, as described above with respect to the examples in Figures 3A and 3B), but it will be understood that this mechanism may be suitably used for other modes of operation. For example, the snapping motion produced by the mechanism can be used to snap the cannula 14 and / or sleeve 260 in the proximal and / or distal directions, generating vibration (for example, when the follower 331 collides with the stopper), which facilitates penetration of the trabecular mesh without requiring an suction effect. In this case, the follower 331 may be fixedly connected to the cannula 14 or any other suitable component for which movement is desired. It will also be understood that various parts and operations of the mechanism can be reversed when the mechanism is employed for distal movement of the sleeve 260, cannula 14, or any other component. It is further intended that other mechanisms, such as a magnetic actuator or another type of spring-driven actuator, may be employed to pull back the sleeve 260.

[0045] Figure 10 is a longitudinal cross-sectional view showing an example of an ophthalmic device 10. Figure 10 shows an example of a structure relating to a fluid delivery mechanism for facilitating the delivery of substances through a handle 12 and an eyepiece component 21 that can be included within the handle 12.

[0046] As shown in Figure 10, the handle 12 may include a housing 513 that encloses and defines an internal volume 517. A lumen 525 (sometimes referred to herein as the “handle lumen”) may be disposed within the handle 12, and this may be fluid-coupled to a lumen 95 (sometimes referred to herein as the “cannula lumen”) protruding from the distal end of the handle 12. The handle lumen 525 may extend, for example, through the internal volume 517 and may 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 outside of the handle.

[0047] For example, as shown in Figure 10, the handle 12 may include an inlet port 531 configured to connect to a fluid source and to receive an incoming fluid. Examples of the inlet port 531 include a Luer-lock connector, or any other suitable connector configured to connect to a syringe for viscoelastic materials or any other suitable fluid reservoir. In Figure 10, the inlet port 531 is shown located at the proximal end of the handle 12 and is configured to provide an inlet channel extending through an opening at the proximal end of the handle housing 513. Additionally or alternatively, the inlet port 531 may be located on another part of the surface of the handle 12, for example, on a lateral side wall of the handle 12. In the example shown in Figure 10, the handle 12 holds a reservoir 599, which can be filled with an initial volume of fluid or other material via the inlet port 531.

[0048] The handle 12 shown in Figure 10 further includes a pump 611 which may be configured to move fluid through the handle lumen 525 and / or through the cannula lumen 95. For example, as shown in Figure 10, the pump 611 may include, or be connected to, a piston 598 which is disposed within the internal volume 517 of the handle 12 and configured to translate axially proximal and / or distal. The piston pump may be configured to move distally from a proximal pump position to a distal pump position in order to draw fluid from the inlet port 531 and / or to bias or push the fluid outward through the distal end of the cannula lumen 95 and outward through the orifice 32. In this case, the pump 611 may be configured to perform positive and / or negative volumetric transfer of fluid. The piston 598 may also be configured to reciprocate within the housing and to reset to move proximal from a distal pump position to a proximal pump position to deliver the next dose of fluid. Alternatively, the piston 598 can be configured to move gradually in the distal direction, in which case each increment of movement in the distal direction corresponds to the amount of fluid or other substance.

[0049] Pump 611 may include or be connected to a valve 639 that can be positioned within the fluid path of the handle lumen 525, and may be fixedly connected to pump 611 so as to move with pump 611. Valve 639 may be implemented, or otherwise include, a one-way valve (or "check valve") that allows fluid movement distally through it and restricts fluid movement proximal through it, thereby generating an suction force from the inlet port 531, and also pushes fluid out of the orifice when valve 639 moves distally with handle 12. It will be understood that, additionally or alternatively, various other types of pumps and / or fluid transport mechanisms may be configured to move fluid through the ophthalmic device 10.

[0050] The pump 611 may be further coupled to the actuator 38 to enable the pump to operate for the delivery of a certain dose or amount of fluid when the actuator 38 is operated. The pump 611 may be coupled, for example, to the same actuator that moves the sleeve 260 or other parts of the eyepiece component 21, or the pump 611 may be coupled to a separate actuator different from the one used to move the eyepiece component 21. In the example shown in Figure 10, the actuator 38 is coupled to the pump 611 and includes a push button configured to trigger the delivery of fluid in individual doses when the user presses the push button.

[0051] Figures 11A to 11C are cross-sectional views of the handle 12 of the eyepiece component 10, in which the actuator 38 is configured to coordinate the operation of the distal eyepiece component and the pump 611. Figure 11A is a cross-sectional view showing the internal mechanism with the linkage mechanism and cam removed for clarity. Figures 11B and 11C are cross-sectional views showing the internal mechanism with the linkage mechanism 723 and cam 311, shown in the initial position before pressing the button and the activated position after pressing the button, respectively.

[0052] The mechanism shown in Figures 11A to 11C can be used such that pressing the button on the actuator 38 triggers both the retraction of the sleeve 260 (for example, to pull the trabecular mesh 86 along the cannula 14 as shown in Figures 3A to 3B) and the delivery of a fluid dose through the cannula 14 while the sleeve 260 is retracted (for example, while the trabecular mesh 86 is pulled along the cannula 14 and the orifice 32 is positioned within the Schlemm tube 80 as shown in Figures 3A to 3B). For example, as shown in Figure 11A, the mechanism may include a nut 779 connected to a threaded portion 781 that is contained within or fixedly connected to the pump 611. By engaging the nut 779 with the threaded portion 781, the rotation of the nut 779 can drive the axial movement of the pump 611 (for example, distal translation), thereby causing the pump 611 to move fluid in the handle 12.

[0053] As shown in Figures 11B and 11C, the actuator 38 may be implemented as a push button connected to a nut 779 via a linkage mechanism 723. As shown in Figures 11B and 11C, the same push button that drives the nut 779 can also be connected to a cam 311, either directly or via the linkage mechanism 723. When the button is pressed by user force from the unpressed position shown in Figure 11B to the pressed position shown in Figure 11C, this push button drives the cam to rotate in a first rotational direction 355 (for example, to pull back the sleeve 260) and drives the nut 779 via the linkage mechanism 723, causing the piston 598 to move progressively distally forward to move the fluid through the handle 12 by volumetric transfer. Simultaneously, the rotation of the cam 311 causes the sleeve 260 to be pulled back, and as a result, the material is delivered by the pump 611 while the sleeve 260 is in the proximal position.

[0054] Figures 12A to 12F show an ophthalmic device 110 in which actuators are configured to coordinate the operation of the distal eyepiece component and the pump. Figure 12A shows a perspective view of the ophthalmic device 110. Figures 12B and 12C show perspective and cross-sectional views of the internal components of the ophthalmic device 110. Figures 12D to 12F show various views of the internal components of the ophthalmic device 110 in operation.

[0055] Referring to Figure 12A, the ophthalmic device 110 has many components that are the same as those of the ophthalmic device 10, and these components are given the same numbering for consistency. The ophthalmic device 110 may include a handle 112 connected to the eyepiece component 21. The handle 112 may be sized and shaped so that it can be easily grasped by a healthcare professional (e.g., an ophthalmic surgeon) and the stress on the healthcare professional's hand is minimized. The outer surface of the handle 112 includes a grip 113 having a ridged shape and ribbed surface so that the user can easily grasp the handle 112. The actuator 38 is a mechanical push button disposed on the handle 112 that is movable between an unpressed position and a pressed position. The handle 112 may include a visual port 114 (e.g., a dispensing volume indicator), or the handle 112 may not have a visual port and may be essentially opaque. The handle 112 may include an inlet port 831 configured to connect to a fluid source and to receive an incoming fluid. Inlet port 831 may include any of the configurations and / or features of inlet port 531.

[0056] The internal components shown in Figures 12B and 12C can be used to trigger, each time the button on the actuator 38 is pressed, both the retraction of the sleeve 260 (for example, to pull the trabecular mesh 86 along the cannula 14 as shown in Figures 3A-3B) and the delivery of a fluid dose through the cannula 14 while the sleeve 260 is retracted (for example, while the trabecular mesh 86 is being pulled along the cannula 14 and the orifice 32 is positioned within the Schlemm tube 80 as shown in Figures 3A-3B). For example, as shown in Figures 12B and 12C, the internal components may include a drive nut 879 connected to a threaded portion 881 which is contained within or fixedly connected to a plunger 811 (e.g., a pump). By engaging the drive nut 879 with the threaded portion 881, the rotation of the drive nut 879 drives the axial movement of the plunger 811 (for example, translation distally), thereby causing the plunger 811 to move fluid within the handle 112.

[0057] As shown in Figures 12B to 12F, the actuator 38 may be implemented as a push button connected to a drive nut 879 via a link mechanism arm 823. The drive nut 879 may have multiple teeth 875, each tooth 875 having a flat portion 876 and an inclined portion 877. The link mechanism arm 823 may have an engaging portion 827 that is sized and shaped to grasp the flat portion 876 of the teeth 875 from above. The same push button 38 that drives the drive nut 879 can also be connected to a cam 311 via a projection 824. When the button 38 is pressed down by a user force 850 from the unpressed position shown in Figure 12D, the button 38 can rotate around the actuator shaft 39, thereby pushing the projection 824 down onto the cam 311 and pulling the link mechanism arm 823 up onto the teeth 875 of the drive nut 879 with which the link mechanism arm 823 is engaged. Therefore, the button 38 can bias the cam 311 to rotate in a first rotational direction 355 via the projection 824 (for example, to pull back the sleeve 260), and drive the drive nut 879 to rotate in a drive rotational direction 855 (for example, counterclockwise) via the link mechanism arm 823, thereby moving the plunger tube 898 forward (for example, distally) by an increasing stroke length 870 to move the fluid through the handle 112 by volumetric transfer. The plunger tube 898 may have a plunger seal 899 (for example, a corrugated seal) to prevent backflow of the material. Simultaneously with the rotation of the drive nut 879, the rotation of the cam 311 causes the sleeve 260 to be pulled back, and as a result the material is delivered by the plunger 811 while the sleeve 260 is in the proximal position when pulled back.

[0058] As shown in Figure 12F, the side panel shim 890 can engage with the teeth 875 of the drive nut 879 in a ratcheting process. For example, when the drive nut 879 rotates in the drive rotation direction 855, the engaging portion 891 of the side panel shim 890 can ride up onto the inclined portion 877 of the teeth 875 and then drop down along the flat portion 876 of the trailing edge of the teeth 875, thus allowing the drive nut 879 to rotate in the drive rotation direction 855 with little or no resistance. However, when the engaging portion 891 of the side panel shim 890 is engaged with the flat portion 876 of the teeth 875, the side panel shim 890 resists rotation of the drive nut 879 in the opposite direction (e.g., clockwise).

[0059] Figures 13A to 13G show an ophthalmic device 210 in which actuators are configured to coordinate the operation of the distal eyepiece component and the pump. Figure 13A shows a perspective view of the ophthalmic device 210. Figures 13B and 13C show perspective and cross-sectional views of the internal components of the ophthalmic device 210. Figures 13D to 13G show diagrams of parts of the internal components of the ophthalmic device 210 in operation.

[0060] Referring to Figure 13A, the ophthalmic device 210 has many components that are the same as those of the ophthalmic device 10, and these components are given the same numbering for consistency. The ophthalmic device 210 may include a handle 212 connected to the eyepiece component 21. The handle 212 may be sized and shaped so that it can be easily grasped by a medical professional (e.g., an ophthalmic surgeon) and the stress on the medical professional's hand is minimized. The outer surface of the handle 212 may include a grip 213 having a ridged shape and ribbed surface so that the user can easily grasp the handle 212. The actuator 38 is a mechanical push button disposed on the handle 212 that is movable between an unpressed position and a pressed position. The handle 212 may include a viewing port (not shown), or the handle 212 may not have a viewing port and may be essentially opaque. The handle 212 may include an inlet port 931 configured to connect to a fluid source and to receive an incoming fluid. Inlet port 931 may include any of the configurations and / or features of inlet port 531.

[0061] The internal components shown in Figures 13B and 13C can be used to trigger, each time the button on the actuator 38 is pressed, both the retraction of the sleeve 260 (for example, to pull the trabecular mesh 86 along the cannula 14 as shown in Figures 3A-3B) and the delivery of a fluid dose through the cannula 14 while the sleeve 260 is retracted (for example, while the trabecular mesh 86 is pulled along the cannula 14 and the orifice 32 is positioned within the Schlemm tube 80 as shown in Figures 3A-3B). For example, as shown in Figures 13B and 13C, the internal components may include a drive gear 979 connected to a rack portion 981, which is contained within or fixedly connected to a plunger 911 (e.g., a pump). By engaging the drive gear teeth 977 with the rack portion teeth 983, the rotation of the drive gear 979 drives the axial movement of the plunger 911 (e.g., distal translation), thereby causing the plunger 911 to move fluid in the handle 212.

[0062] As shown in Figures 13B to 13G, the actuator 38 may be implemented as a push button connected to a trigger gear 969. The trigger gear teeth 967 can be engaged with the actuator teeth 37, and the trigger gear 969 can be rotated by pushing down the actuator 38. The trigger gear 969 may be connected to a drive gear 979 via a drive shaft 923. The trigger gear 969 may also be connected to a sleeve follower 971 via a cam portion 31. When the button 38 is pressed down by a user force 850 from the unpressed position shown in Figure 13D, the button 38 can rotate the sleeve follower 971 to the cam portion 31, causing the convex portion 972 of the sleeve follower 971 to rotate to the valley portion 973 of the sleeve follower 971, snapping the sleeve 260 backward (for example, in the proximal direction) and pulling the sleeve 260 back. By pressing the button 38 from the unpressed position shown in Figure 13D, the drive shaft 923 can be rotated by the trigger gear 969, which in turn rotates the drive gear 979. Thus, the button 38 drives the drive gear 979 to rotate in the drive rotation direction 955 via the drive shaft 923, which drives the movement of the rack portion 981, thereby moving the plunger 911 forward (e.g., distally) by an increasing stroke length 970 to move the fluid through the handle 212 by volumetric transfer. The plunger 911 may have a rear seal 999 (e.g., an O-ring seal). Simultaneously with the rotation of the drive gear 979, the movement of the cam portion 31 causes the sleeve 260 to be retracted. The material is delivered by the plunger 911, which is initiated by the operation of the actuator 38 and is done via the retraction of the sleeve 260 in the proximal position.

[0063] As shown in Figure 13F, the one-way clutch 990 can enable the drive gear teeth 977 of the drive gear 979 to engage with the rack portion teeth 983 of the rack portion 981 in a ratchet process and / or index process. For example, after the drive gear 979 has rotated in the drive rotation direction 955 to move the rack portion by a stroke length 970, the one-way clutch 990 can rotate the trigger gear 969 in the opposite direction without further rotating the drive gear 979 or the drive shaft 923 in either direction. As a result, the rack portion 981 is maintained in place, while the button 38 is reset (for example, when the button 38 moves back to the unpressed position shown in Figure 13D). Thus, the one-way clutch 990 allows the drive gear 979 to rotate only in the drive rotation direction 955, so that when the button 38 is reset, the drive gear 979 and the rack portion 981 remain in the same position. When the user's force 850 is removed (for example, when the user stops pressing down on button 38), button 38 may move via spring 984 (for example, a torsion spring) to return to the unpressed position, in which case the biasing force 960 pushes button 38 back to the initial unpressed or reset position. Once button 38 is reset, it can be pressed again to restart the process.

[0064] Each time button 38 is triggered, the button 38 may be swung a certain distance (e.g., 20 degrees) to move the rack portion 981 forward by a set number of rack portion teeth 983 (e.g., two teeth). In this case, the distance the rack portion 981 moves may be the stroke length 970 of one tooth of the rack portion 981 encompassing the rack portion teeth 983, thereby limiting the use of the ophthalmic device 210 to 10 operations (e.g., 10 pumps). For example, as shown in Figure 13C, the rear seal 999 at the rear end of the plunger 911 (e.g., the end closest to the inlet port 931) may be configured to pop out and become free after a set number of operations (e.g., 3 operations). This prevents additional material added through the inlet port 931 from being retained in the bore tube 913 (e.g., material reservoir) of the ophthalmic device 210. Furthermore, the front end of the plunger 911 (e.g., the end closest to the tip segment 151) may include a one-way valve 915 (e.g., a duck valve), a valve retainer 917, and a front seal 919 (e.g., an O-ring seal). The one-way valve 915 can enable priming of the ophthalmic device 210 and prevent backflow of material during the priming and pumping processes. In this case, the one-way valve 915 seals the plunger 911 and enables further operations (e.g., seven or more) after the rear seal 999 pops out after the first three operations, thereby enabling the maximum number of operations for which the ophthalmic device 210 can be used. Accordingly, for health and safety reasons and to optimize the integrity of the device by minimizing wear of components, the ophthalmic device 210 may be rendered unusable after 10 operations (e.g., pumping operations). For example, by configuring the ophthalmic device 210 to be discardable after a set number of uses, the need to clean / sterilize the device is eliminated, and the problem of either seal 919 or 999 drying out and causing a malfunction is avoided.

[0065] Figures 14A–14C illustrate the priming process of ophthalmic devices 10, 110, and 210 for filling with an appropriate volume of material (e.g., viscoelastic fluid) and for removing air from the fluid pathways of ophthalmic devices 10, 110, and 210. As shown in Figure 14A, a syringe 1000 (e.g., a standard Luer port syringe) containing the desired material can be connected to the inlet ports 531, 831, and 931, and the material can then be pushed through the entire fluid pathway of ophthalmic devices 10, 110, and 210 until the material exits the tip segment 151. The one-way valve 915 allows the material to flow toward the tip segment 151 while preventing any backflow of material returning through the one-way valve 915. Once priming is complete, the cannula 14 and bore tube 913 can be filled with the desired volume of material, such as a volume sufficient for, for example, 10 pumping operations.

[0066] As shown in Figure 14B, the rear end of the plunger 911 is sealedly engaged in the inlet ports 531, 831, and 931 via a rear seal 999. In Figure 14B, the rear end of the plunger 911 is shown in the starting position 950 (e.g., before or after priming, but before any operation). During each operation of the ophthalmic devices 10, 110, and 210 (e.g., a pumping operation), the plunger 911 moves forward by a stroke length 970 with each pumping cycle, moving away from the inlet ports 531, 831, and 931. After a set number of operations (e.g., three operations), the rear end of the plunger 911 has moved forward enough to separate from or disengage from the cylinder 995 of the ophthalmic devices 10, 110, and 210, as shown in Figure 14C. For example, the rear seal 999 can pop out from its sealing engagement with the inside of the cylinder 995, thereby preventing the ophthalmic devices 10, 110, and 210 from becoming primed again. At this point, the material flow path can contain just enough material for the remaining portion of the desired operation (e.g., 7 pumping operations). In this case, the ophthalmic devices 10, 110, and 210 cannot be primed, refilled, or used again beyond the total number of acceptable pumping cycles (e.g., a total of 10 pumping cycles).

[0067] Figures 15A and 15B illustrate an exemplary method of performing an ophthalmic procedure using the ophthalmic device 10. This method can be used to deliver a substance (e.g., a fluid or gas) into, for example, a Schlemm's tube 80 or any other suitable part of the patient's eye.

[0068] As noted above, in a healthy eye, the aqueous humor 82 flows out of the anterior chamber 84 of the eye, through the trabecular meshwork 86, and then into Schlemm's canal 80 and the distal collector channel. The aqueous humor 82 then flows through Schlemm's canal 80 into the collector channel and the distal venous system. If this pathway of aqueous humor 82 is interrupted (for example, due to lesions or damaged tissue in the trabecular meshwork 86 and / or Schlemm's canal 80), the IOP of the eye increases, which can result in various medical problems (e.g., glaucoma, vision loss, optic nerve damage, etc.).

[0069] To improve the flow path of aqueous humor 82, a medical professional can insert the eyepiece component 21 through an incision 88 made in the anterior chamber 84 and advance the distal end of the sleeve 260 of the eyepiece component 21 to the trabecular meshwork 86 so that it abuts against or contacts the trabecular meshwork 86. The sleeve 260 (not visible in Figure 15B) can then be withdrawn, as further described above, using any mechanism or component shown in Figure 15B and described herein, so that the distal end of the cannula 14 including the orifice 32 enters Schlemm's canal 80.

[0070] Referring to Figure 15B, once the distal end of the cannula 14 is inserted into the Schlemm's canal 80 and each of the one or more orifices 32 is fully housed within the Schlemm's canal 80, a medical professional can inject a predetermined dose or amount of fluid or other substance through the actions described above. After the injection of the predetermined dose or amount of fluid or other substance through the orifices 32, this process may be repeated any appropriate number of times, with the cannula 14 held in the same position and / or by moving the cannula 14 to one or more different positions to inject the fluid at different locations and / or from different angles. Optionally, after one or more injections of the predetermined dose of fluid or other substance at a particular location within the Schlemm's canal 80, the distal end of the cannula 14 may be withdrawn and repositioned within the eye. In some configurations, such repositioning may be performed by withdrawing the cannula 14 from the incision 88 (e.g., the first incision) and reinserting it through an additional incision spaced apart from the first incision. Additionally or alternatively, such repositioning may include withdrawing the distal end 30 from the Schlemm's canal 80 and / or the trabecular meshwork 86 and then repositioning it within the new portion of the Schlemm's canal 80 without removing the cannula 14 from the first incision 88. In some implementations, fluid can be delivered simultaneously into the Schlemm's canal 80 and the trabecular meshwork 86, thereby opening the Schlemm's canal 80 and delivering the fluid into the various layers of the trabecular meshwork 86.

[0071] While the above description concerns devices and methods for injecting fluids or other substances through the orifice 32, it should be understood that the ophthalmic device 10 described herein may be configured to aspirate and remove fluids or other substances from the eye with precise control. For example, to achieve the removal of fluids or other substances from the eye, the ophthalmic device 10 may be operated in the reverse manner described above.

[0072] One or more embodiments of the subject technology may include an ophthalmic device comprising: a cannula having a distal end, a lumen, and one or more orifices connected to the lumen, configured to deliver fluid; a sleeve disposed around the cannula and having a distal end; a handle connected to the sleeve and the cannula, having an actuator; and an internal mechanism connected to the actuator and configured to pull the sleeve back relative to the cannula. The internal mechanism may include a follower fixedly connected to the sleeve and movable between a distal and proximal position; and a release member movable between an operating position and a release position, connected to the actuator, and configured to release a force biasing the follower from the distal to the proximal position when the release member moves from the operating position to the release position.

[0073] One or more embodiments of the subject technology may include the following: the actuator includes a push button located on the side of the handle and movable from an unpressed position to a pressed position when force is applied by the user, and when the push button moves from the unpressed position to the pressed position, the push button is configured to bias the release member to rotate in a first rotational direction.

[0074] One or more embodiments of the subject technology may include a reset spring connected to an actuator, configured to bias a push button to return from a pressed position to an unpressed position, thereby biasing a release member to rotate in a second rotational direction opposite to a first rotational direction.

[0075] One or more embodiments of the subject technology may include the following: a cannula comprising a proximal shaft segment and an end segment attached to the proximal shaft segment, wherein one or more orifices are disposed on the end segment.

[0076] One or more embodiments of the subject technology may include a spring connected to a follower and configured to apply a spring force to bias the follower proximal when the follower is in a distal position; a capture portion movable between a first position and a second position, configured to hold the follower in a distal position when the capture portion is in the first position and to release the follower when the capture portion is in the second position; and a release member connected to the capture portion, configured to rotate in a first rotational direction opposite to the capture portion to bias the capture portion from the first position to the second position.

[0077] One or more embodiments of the subject technology may include the following: the cam is further coupled to a follower, the capture unit is biased toward a second position, and when the user's force is released, the capture unit is configured to bias the follower from a proximal position to a distal position by biasing the cam toward a second rotational direction opposite to a first rotational direction, opposite to the follower.

[0078] One or more embodiments of the subject technology may include a sliding housing having one or more first magnets and one or more second magnets, the release member comprising a rotatable housing having one or more third magnets, the sliding housing configured to hold a follower in a distal position when one or more third magnets are aligned with one or more first magnets, and to bias the follower in a proximal position when one or more third magnets are aligned with one or more second magnets.

[0079] One or more embodiments of the subject technology may include the following: two first magnets are arranged within a sliding housing at 180 degrees apart on a first plane that bisects the central axis of the sliding housing; two second magnets are arranged within a sliding housing at 180 degrees apart on a second plane that bisects the central axis of the sliding housing; and two third magnets are arranged within a rotatable housing at 180 degrees apart on a third plane that bisects the central axis of the rotatable housing.

[0080] One or more embodiments of the subject technology may include the following: a rotatable housing is configured to align one or more third magnets with one or more first magnets when the release member is in the operating position, and the rotatable housing is configured to align one or more third magnets with one or more second magnets when the release member is in the released position.

[0081] One or more embodiments of the subject technology may include a release member comprising: a spring connected to a follower and configured to apply a spring force to bias the follower proximal when the follower is in a distal position; a dowel pin movable between a first position and a second position, configured to hold the follower in a distal position when the dowel pin is in the first position and to release the follower when the dowel pin is in the second position; and an arm connected to the dowel pin and configured to rotate the dowel pin so as to bias the dowel pin from the first position to the second position.

[0082] One or more embodiments of the subject technology may include the following: a dowel pin comprising two curved portions and two flat portions, one of which is configured to abut the proximal surface of a follower in a first position, and the other of which is configured to abut the proximal surface of a follower in a second position.

[0083] One or more embodiments of the subject technology may include the following: a dowel pin having an opening configured to receive a cannula, the opening being configured to prevent the dowel pin from coming into contact with the cannula during rotation of the dowel pin.

[0084] One or more embodiments of the subject technology may further include an internal mechanism having a sliding housing having a proximal surface comprising a first raised portion and a first recessed portion, wherein the release member comprises a rotatable housing having a distal surface comprising a second raised portion and a second recessed portion, the sliding housing being configured to allow a follower to be positioned distally when the first raised portion is engaged with the second raised portion, and to allow the follower to be biased proximal when the first raised portion is engaged with the first recessed portion and the second raised portion is engaged with the second recessed portion.

[0085] One or more embodiments of the subject technology may include a first inclined portion disposed between a first raised portion and a first recessed portion, the second raised portion being configured to slide along the first inclined portion from the first raised portion to the first recessed portion as the rotatable housing is moved from the operating position to the released position.

[0086] One or more embodiments of the subject technology may include a second inclined portion disposed between a second raised portion and a second recessed portion, wherein the first raised portion is configured to slide along the second inclined portion from the second raised portion to the second recessed portion as the rotatable housing is moved from an operating position to a released position.

[0087] One or more embodiments of the subject technology may further include an internal mechanism comprising: a gap disposed between the distal surface of a follower and the proximal surface of a sliding housing when the follower is positioned distally; and a spring connected to the sliding housing and configured to apply a spring force to bias the sliding housing proximal when the follower is in the distal position, wherein the spring force is configured to accelerate the distal surface of the follower in the gap and bring it into contact with the proximal surface of the sliding housing with a collision force.

[0088] One or more embodiments of the subject technology may include the following: a spring force is configured to move the sleeve backward at a speed of 0.762 to 1.27 centimeters / second (0.3 to 0.5 inches / second).

[0089] One or more embodiments of the subject technology may include a damper spring positioned proximal to the follower, which is configured to dampen the impact force from the follower when the follower is moved to a proximal position and to bias the follower toward a distal position when the follower is in a proximal position.

[0090] One or more embodiments of the subject technology may include the following: a rotatable housing is configured to rotate 45 degrees in a first rotational direction about the longitudinal central axis of the cannula as the rotatable housing moves from the operating position to the release position.

[0091] One or more embodiments of the subject technology are internal mechanisms for an ophthalmic device, comprising: a slidable follower configured to be fixedly connected to a sleeve disposed around a cannula, the slidable follower being movable between a distal and proximal position along a longitudinal central axis; a slidable housing having a proximal surface with a first raised portion and a first recessed portion; and a rotatable housing having a distal surface with a second raised portion and a second recessed portion, configured to be connected to an actuator and movable between an operating position and a release position, wherein the first raised portion engages with the second raised portion in the operating position. The rotatable housing includes a second protruding portion which engages with a first recessed portion in an open position; a gap provided between the distal surface of the follower and the proximal surface of the slidable housing when the follower is positioned distally; a spring connected to the slidable housing and configured to apply a spring force to bias the slidable housing proximal when the follower is in a distal position; and an internal mechanism, the spring force configured to accelerate the distal surface of the follower within the gap, causing it to contact the proximal surface of the slidable housing with a collision force.

[0092] While this specification describes the principles of the disclosure with reference to exemplary examples relating to specific uses, it should be understood that the disclosure is not limited thereto. Those skilled in the art who can utilize the teachings provided herein will recognize that further modifications, uses, examples, and substitutions of equivalents are all within the scope of the examples described herein. Therefore, the present invention should not be considered limited by the foregoing description.

[0093] References to singular elements are not intended to mean just one unless explicitly stated so, but rather to mean one or more. For example, the module “a” can refer to one or more modules. Elements beginning with “a,” “an,” “the,” or “said” do not preclude the existence of additional identical elements unless further constraints are imposed.

[0094] Where headings and subheadings exist, they are used for convenience only and do not limit the invention. The word "exemplary" is used to mean that it serves as an example or illustration. To the extent that terms such as "include" and "have" are used, such terms are intended to be comprehensive, as is the case when the term "comprise" is used as a transitional clause in a claim. Terms indicating relationships, such as "first" and "second," may be used to distinguish one entity or action from another entity or action without necessarily requiring or suggesting any actual relationship or order between such entities or actions.

[0095] The phrases such as "one aspect," "that aspect," "another aspect," "several aspects," "one or more aspects," "one implementation," "that implementation," "another implementation," "several implementations," "one or more implementations," "one example," "that example," "another example," "several examples," "one or more examples," "one configuration," "that configuration," "another configuration," "several configurations," "one or more configurations," "the subject art," "the disclosure," "the present disclosure," and other variations thereof are for convenience only and do not imply that the disclosures relating to such phrases are essential to the subject art or that such disclosures apply to all configurations of the subject art. The disclosures relating to such phrases may apply to all configurations or to one or more configurations. The disclosures relating to such phrases may provide one or more examples. The phrases "one aspect" or "several aspects" may refer to one or more aspects, and vice versa, and this is also true for the other phrases mentioned above.

[0096] The phrase "at least one of" preceding a series of items modifies the list as a whole, rather than each individual component of the list, although the terms "and" or "or" separate all of those items. The phrase "at least one of" does not require you to select at least one item. Rather, it allows for meanings that include at least one of any one of the items, and / or at least one of any combination of items, and / or at least one of each of the items. For example, the phrases "at least one of A, B, and C" or "at least one of A, B, or C" refer to A only, B only, or C only, any combination of A, B, and C, and / or at least one of each of A, B, and C, respectively.

[0097] The specific order or hierarchy of the disclosed steps, actions, or processes is to be understood as illustrating an exemplary method. Unless expressly stated otherwise, the specific order or hierarchy of the steps, actions, or processes may be performed in a different order. Some of the steps, actions, or processes may be performed simultaneously. Where present, the appended method claims present various elements of steps, actions, or processes in an exemplary order and are not intended to be limited to this specific order or hierarchy. They may be performed sequentially, linearly, in parallel, or in a different order. The instructions, actions, and systems described can generally be integrated into a single software / hardware product or packaged into multiple software / hardware products.

[0098] In one aspect, the term "connected" or similar may refer to direct connection. In another aspect, the term "connected" or similar may refer to indirect connection.

[0099] Terms such as top, bottom, front, back, side, horizontal, vertical, and similar refer to arbitrary reference frames rather than general reference frames based on gravity. Therefore, in a gravity-based reference frame, such terms may extend upward, downward, diagonally, or horizontally.

[0100] This disclosure is provided so that any person skilled in the art can implement the various embodiments described herein. In some cases, well-known structures and components are shown in the form of block diagrams to avoid obscuring the concepts of the subject art. This disclosure provides various examples of the subject art, and the subject art is not limited to these examples. Various modifications of these embodiments will be readily apparent to a person skilled in the art, and the principles described herein may be applied to other embodiments.

[0101] Any structural and functional equivalents of the elements of various aspects described throughout this disclosure, which are known to those skilled in the art or will become known in the future, are expressly incorporated by reference herein and are intended to be included in the claims. Furthermore, nothing disclosed herein is intended to be open to the public, whether such disclosure is expressly included in the claims or not. No element of any claim should be construed under Section 112(f) of the U.S. Patent Act unless that element is expressly described using the phrase “means for” or, in the case of a method claim, using the phrase “step for.”

[0102] The title of the invention, the technical field and background art, a brief description of the drawings, the abstract, and the drawings are incorporated herein by reference, but are provided not as restrictive statements, but as exemplary examples of the disclosure. This specification is presented with the understanding that they are not used to limit the scope or meaning of the claims. Furthermore, it can be understood that in the detailed description, the description provides exemplary examples, and various features are grouped together in various implementations for the purpose of streamlining the disclosure. The method of disclosure should not be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly described in each claim. Rather, as reflected in the claims, inventive subject matter consists of features that do not constitute all of the single configuration or operation disclosed. The claims are incorporated herein by reference in the detailed description, and each claim stands on its own as claimed subject matter.

[0103] The claims are not intended to be limited to the embodiments described herein, but rather to encompass the entire scope consistent with the language of the claims and to include all legal equivalents. Nevertheless, no claim is intended to include, and no claim should be interpreted as, including subject matter that does not meet the requirements of applicable patent law.

Claims

1. It is an ophthalmic device, A cannula having a distal end, a lumen, and one or more orifices connected to the lumen, configured to deliver fluid, A sleeve is disposed around the cannula and has a sleeve distal end, A handle having an actuator, the handle being connected to the sleeve and the cannula at the distal end of the handle, An internal mechanism connected to the actuator and configured to pump the fluid, An inlet port located on the proximal end of the handle, A drive member connected to the actuator, comprising a drive gear having a plurality of drive teeth, A plunger connected to the drive member, comprising a rack portion having a plurality of plunger teeth that engage with the plurality of drive teeth of the drive member, configured to provide a force that moves the plunger distally along the longitudinal axis of the handle when the rotation of the drive member moves the actuator from an unpressed position to a pressed position, wherein the movement of the plunger causes the fluid to move distally within the handle and the cannula, and a portion of the fluid is discharged from the one or more orifices, A rear seal coupled to the proximal end of the plunger and disposed within the inlet port, configured to prevent the fluid from leaking from the plunger during priming of the device, A bore tube slidably coupled to the distal end of the plunger, and An internal mechanism comprising a forward seal coupled to the distal end of the plunger and fully disposed within the bore tube, the forward seal being configured to continuously prevent backflow of the fluid in the proximal direction through the bore tube, Ophthalmic devices.

2. The actuator includes a push button positioned on the handle and movable from the unpressed position to the pressed position when force is applied by the user. When the push button moves from the unpressed position to the pressed position, the push button is configured to bias the drive member in the direction of rotation. The ophthalmic device according to claim 1.

3. The ophthalmic device according to claim 2, further comprising a reset spring connected to the actuator, wherein the reset spring is configured to bias the push button to return from the pressed position to the unpressed position.

4. The ophthalmic device according to claim 2, wherein the drive member is connected to a part of the plunger, and the plunger is advanced distally by the rotation of the drive member in the driving rotation direction.

5. The internal mechanism further comprises a trigger gear connected to the drive member via a drive shaft, The trigger gear has multiple trigger teeth, The actuator comprises a plurality of actuator teeth, The movement of the push button to the pressed position includes rotating the push button about the actuator shaft, thereby moving the actuator teeth along the trigger teeth, and moving the trigger gear in the drive rotation direction, and the movement of the trigger gear also moves the drive member via the drive shaft in the drive rotation direction. The ophthalmic device according to claim 2.

6. The sleeve is operably connected to the actuator, The rotation of the push button around the actuator axis pulls the sleeve back from the distal end of the cannula, and as a result, the fluid is delivered to the distal end of the cannula while the sleeve is in the retracted proximal position. The ophthalmic device according to claim 5.

7. The ophthalmic device according to claim 5, wherein the internal mechanism further comprises a one-way clutch connected to the trigger gear and configured to provide indexing configuration engagement between the trigger gear and the drive shaft, the one-way clutch being configured to disengage the trigger gear from the drive shaft so that the trigger gear rotates in the opposite direction to the drive rotation direction without further movement of the drive shaft and the drive member.

8. The ophthalmic device according to claim 1, wherein the internal mechanism further comprises a one-way valve connected to the distal end of the plunger, the one-way valve being configured to allow fluid flow distally during priming and to prevent backflow of the fluid proximal beyond the distal end of the plunger.

9. The ophthalmic device according to claim 1, wherein the internal mechanism further comprises a cylinder connected to the inlet port, the cylinder configured to slidably receive the proximal end of the plunger.

10. The proximal end of the plunger is configured to slide distally within the cylinder each time the actuator is pressed. The rear seal is configured to engage and disengage from the sealing engagement portion with the cylinder after the actuator has been pressed a set number of times, thereby preventing the ophthalmic device from becoming primed again. The ophthalmic device according to claim 9.

11. The ophthalmic device according to claim 10, wherein the ophthalmic device is configured to maintain a fluid volume after the rear seal is engaged with and disengaged from the cylinder, and the maintained fluid volume is dispensed after the actuator is pressed a set number of remaining times.

12. The ophthalmic device according to claim 1, wherein the rear seal is configured to detach from the injection port after a predetermined number of operations of the ophthalmic device, thereby preventing the fluid added through the injection port from being retained in the bore tube.

13. The ophthalmic device according to claim 12, wherein the internal mechanism further comprises a one-way valve coupled to the distal end of the plunger, the one-way valve configured to allow the fluid to flow distally during priming and to prevent backflow of the fluid proximal beyond the distal end of the plunger, and the one-way valve configured to seal the plunger after the rear seal disengages from the inlet port, thereby providing further operation of the ophthalmic device.

Images