Ocular treatment device and related methods of use

By designing a miniature cannula, the problems of frequent use and high invasiveness in existing glaucoma treatments have been solved, achieving a continuous, non-invasive reduction in intraocular pressure, thus improving treatment effectiveness and quality of life.

CN114848286BActive Publication Date: 2026-03-24NEW WORLD MEDICAL INC
View PDF 2 Cites 0 Cited by

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2017-12-18
Publication Date
2026-03-24

AI Technical Summary

Technical Problem

Existing glaucoma treatments such as eye drops and laser therapy may require frequent use and are highly invasive, and only provide a temporary reduction in intraocular pressure.

Method used

A miniature cannulation device with multiple orifices and grooves is designed for insertion through the anterior chamber of the eye and into the Schlem's canal. Fluid is delivered through the orifices to reduce intraocular pressure. The cannula has a variable diameter and can be movably accommodated as a second cannula to enhance insertion and delivery.

Benefits of technology

It provides a continuous, non-invasive method for lowering intraocular pressure, reducing the frequency of treatment and improving treatment effectiveness and patients' quality of life.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure CN114848286B_ABST
    Figure CN114848286B_ABST
Patent Text Reader

Abstract

Devices and methods for ocular treatment are provided. The devices can include a microcannula having a proximal end, a distal end, a cavity, and a central longitudinal axis. The devices can include a handle coupled to the proximal end of the microcannula. The devices can include a plurality of apertures extending circumferentially around the distal end of the microcannula, each aperture defining a passage extending transverse to the central longitudinal axis, and one or more grooves around the circumference of the microcannula.
Need to check novelty before this filing date? Find Prior Art

Description

[0001] This application is a continuation-in-part of patent application number 2017800782689, filed December 18, 2017, entitled "Ocular Treatment Devices and Related Methods of Use."

[0002] Related Applications

[0003] This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62 / 436,099, filed December 19, 2016, entitled "Ocular Treatment Devices and Related Methods of Use," the entire contents of which are incorporated herein by reference. TECHNICAL FIELD

[0004] Various aspects of the present disclosure generally relate to ocular tissue treatment. More particularly, the present disclosure relates to devices and related methods for reducing intraocular pressure. BACKGROUND

[0005] Glaucoma is a disease caused by an increase in intraocular pressure (IOP). IOP can increase when the natural drainage of the eye (e.g., drainage of the humor vitreous of the eye) is prevented, reduced, or otherwise obstructed. The cavity in the anterior portion of the eye lens (e.g., the top portion) is filled with a viscous fluid called aqueous humor. Aqueous humor continuously flows through the eye to provide nutrition to the portions of the eye that are not vascularized (e.g., the cornea and the lens). This flow of aqueous humor also removes waste (e.g., foreign debris) from these tissues. In a healthy eye, as new aqueous humor is secreted by the epithelial cells of the ciliary body, the aqueous humor flows out of the anterior chamber of the eye through the trabecular meshwork and into Schlemm's canal. The drained aqueous humor enters the venous blood flow from Schlemm's canal and leaves the eye with the venous blood. When the natural drainage mechanisms of the eye (e.g., Schlemm's canal and / or the trabecular meshwork) stop working properly, IOP begins to increase.

[0006] Existing treatments to reduce IOP can include the application of eye drops and other medications. The application of these medications can be required multiple times per day and can impact the quality of life of the patient. Additionally, laser treatments and other surgical applications can be used to reduce IOP, however, such treatments can be invasive and generally only provide a temporary reduction in IOP.

[0007] The systems, devices, and methods of the present disclosure can correct some of the deficiencies described above or address other aspects of the prior art. SUMMARY

[0008] At least one aspect is directed to a medical device. The medical device includes a microcannula having a proximal end, a distal end, a lumen, and a central longitudinal axis. The medical device includes a handle coupled to the proximal end of the microcannula. The microcannula includes a plurality of apertures extending circumferentially around the distal end of the microcannula and one or more grooves around a circumference of the microcannula. Each aperture defines a passage extending transverse to the central longitudinal axis.

[0009] In some embodiments, an outer diameter of the microcannula varies along a length of the microcannula.

[0010] In some embodiments, an inner diameter of the microcannula varies along a length of the microcannula.

[0011] In some embodiments, a first aperture of the plurality of apertures is spaced 180 degrees from a second aperture of the plurality of apertures.

[0012] In some embodiments, each groove of the one or more grooves has a depth of between 15 pm and 35 pm.

[0013] In some embodiments, each groove of the one or more grooves is formed proximally of the plurality of apertures.

[0014] In some embodiments, each groove of the one or more grooves is spaced a distance of between 40 pm and 60 pm from another groove.

[0015] At least one aspect is directed to a medical device including a first cannula having a distal end, a lumen, a central longitudinal axis, and a protrusion. The protrusion of the first cannula extends circumferentially around the distal end of the first cannula and is located in the lumen of the first cannula. The medical device includes a second cannula having a distal end and a lumen. The second cannula is movably housed within the first cannula and has a central longitudinal axis, a protrusion, and a plurality of apertures extending circumferentially around the distal end of the second cannula. The protrusion of the second cannula extends circumferentially around the distal end of the second cannula and is located on an outer peripheral surface of the second cannula. A first aperture of the plurality of apertures is positioned parallel to a second aperture of the plurality of apertures.

[0016] In some embodiments, the second cannula includes one or more grooves around a circumference of the second cannula.

[0017] In some embodiments, the one or more grooves of the second cannula are located at the distal end of the second cannula.

[0018] In some embodiments, the one or more grooves are equally spaced.

[0019] In some embodiments, each protrusion of the first cannula is equally spaced apart.

[0020] In some embodiments, when the distal end of the second cannula is within the first cannula, the protrusions of the second cannula are closer to the user than the protrusions of the first cannula.

[0021] In some embodiments, when at least a portion of the distal end of the second cannula moves outside of the distal end of the first cannula, the protrusions of the second cannula are farther from the user than the protrusions of the second cannula.

[0022] At least one aspect is directed to a method of delivering fluid into an eye. The method includes inserting a microcannula through an incision in an anterior chamber of the eye. The microcannula has a proximal end, a distal end, and a lumen, the microcannula having a central longitudinal axis. The distal end of the microcannula is advanced through a trabecular meshwork of the eye and into a Schlemm’s canal of the eye. Fluid is delivered through a plurality of orifices, each orifice being located within the Schlemm’s canal, each orifice defining a channel extending circumferentially around the distal end of the microcannula.

[0023] In some embodiments, the channel of each orifice of the plurality of orifices extends transverse to the central longitudinal axis.

[0024] In some embodiments, the microcannula includes one or more grooves around a circumference of the microcannula at the distal end of the microcannula.

[0025] In some embodiments, the microcannula includes one or more protrusions extending circumferentially around the distal end of the microcannula and located on an outer peripheral surface of the microcannula. The microcannula is movably housed within a second cannula having one or more protrusions extending circumferentially around a distal end of the second cannula and located within a lumen of the second cannula.

[0026] In some embodiments, the step of advancing the distal end of the microcannula further includes applying a force to the microcannula to move the one or more protrusions of the microcannula away from the user and past the one or more protrusions of the second cannula. BRIEF DESCRIPTION OF DRAWINGS

[0027] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the disclosure and together with the description, serve to explain the principles of the disclosure.

[0028] Figure 1 An exemplary device having a handle and a microcannula is shown in accordance with some aspects of the present disclosure;

[0029] Figure 2A is in accordance with an illustrative embodiment Figure 1enlarged view of a micro cannula of the device of

[0030] Figure 2B is according to an illustrative embodiment Figure 1 enlarged view of a micro cannula of the device of

[0031] Figure 2C is according to an illustrative embodiment Figure 2B enlarged view of a distal end of a micro cannula of the device of

[0032] Figure 2D is according to an illustrative embodiment Figure 2B enlarged view of a securing mechanism of a micro cannula of the device of

[0033] Figure 2E and Figure 2F shows an exemplary device having a plurality of cannulas according to an illustrative embodiment;

[0034] Figures 2G-2J shows various actuators included in an exemplary device according to an illustrative embodiment;

[0035] Figure 2K and Figure 2L shows an exemplary device having an outer tube according to an illustrative embodiment;

[0036] Figure 2M and Figure 2N shows Figure 1 enlarged cross-sectional view of a micro cannula and an outer sheath of the device of

[0037] Figure 3A shows a cross-sectional view of an exemplary device of Figure 1 according to an illustrative embodiment;

[0038] Figure 3B shows a cross-sectional view of a reservoir of an exemplary device of Figure 1 according to an illustrative embodiment;

[0039] Figure 3C shows a cross-sectional view of another embodiment of an exemplary device of Figure 1 according to an illustrative embodiment;

[0040] Figure 4A shows a perspective view of a micro cannula of the device of Figure 1 according to an illustrative embodiment;

[0041] Figures 4B-4J shows a cross-sectional view of a distal end of a micro cannula of the device of Figure 1 according to an illustrative embodiment; and

[0042] Figure 5A andFigure 5B The use according to the illustrative embodiment is shown. Figure 1 An exemplary method of the apparatus. Detailed Implementation

[0043] The following detailed description is exemplary and illustrative only and is not intended to limit the claimed features. As used herein, the terms “comprising,” “including,” or other variations are intended to cover non-exclusive inclusions, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but may also include other elements not expressly listed or other elements inherent to such a process, method, article, or apparatus. Additionally, the term “exemplary” is used herein in the sense of “example” rather than “ideal.” As used herein, the terms “about,” “substantially,” and “approximately” indicate a range of values ​​within + / - 5% of the stated value. The term “distal” refers to the portion furthest from the user when the device is introduced into the subject. Conversely, the term “proximal” refers to the portion closest to the user when the device is placed into the subject.

[0044] like Figure 1 As shown, the exemplary medical device 10 includes a handle 12, which is coupled to a microcannula 14 via a connector 16. For example, the proximal end 18 or region of the microcannula 14 is coupled to the distal end 20 or region of the handle 12 via the connector 16. The connector 16 includes an inner lumen 22 extending through a reinforcing shaft or tube 24. Figure 3A The connector 16 and connector body 26. The proximal end of connector 16 may be threaded or otherwise securely coupled to the distal end 20 of handle 12, while the proximal end 18 of miniature cannula 14 extends through the inner cavity 22 of connector 16 and is securely coupled (e.g., glued, soldered or otherwise secured) to connector 16. In this way, miniature cannula 14 is securely coupled to handle 12.

[0045] The radially outer peripheral surface of the connector body 26 may be knurled, ribbed, or otherwise textured to enhance the grip of the handle 12 by a medical professional. In some arrangements, at least one of the connector 16 and the distal end 20 includes a fluid Luer port (not shown). The fluid Luer port may extend radially away from the connector 16 and / or the distal end 20 and may be configured to connect to an interchangeable external reservoir. In this way, the reservoir 28 located within the handle 12 ( Figure 3A It can be selectively refilled according to the needs or expectations of medical professionals, which will be described in further detail below.

[0046] like Figure 1As shown, the mini-cannula 14 includes a working length L, for example, a length extending between the proximal end of tube 24 and the distal end of the mini-cannula 14 between about 30 mm and about 40 mm. In some embodiments, the working length L may be about 36.150 mm. In some embodiments, the working length L may be about 20 mm. Figure 2A As shown, in some embodiments, the diameter D of the microcannula 14 can be between about 500 μm and about 600 μm. The distal end 30 of the microcannula 14 is circular or non-invasive (e.g., blunt, unsharpened, etc.) and includes a plurality of orifices 32. For example, the distal end 30 of the microcannula 14 includes four orifices 32 equidistantly spaced around the circumference of the distal end 30 (in... Figure 2A Only two orifices 32 are visible in the image. Each orifice 32 may have an orifice diameter O between 30 μm and 70 μm. In some embodiments, the diameter O of each orifice 32 is about 50 μm. In some embodiments, the diameter O of each orifice 32 is about 60 μm. Although four equally spaced orifices 32 are shown and described, in other arrangements, more or fewer orifices 32 may be positioned around the circumference of the distal end 30 and may be equally or unequally spaced. For example, as shown... Figure 2B As shown, the distal end 30 includes two apertures 32. In some embodiments, such as Figure 2B As shown (in) Figure 2B Only one of the two orifices 32 is visible in the middle, and the orifices 32 are positioned approximately 180 degrees apart from each other around the circumference of the distal end 30. Additionally, in some arrangements, the orifices 32 may be positioned at varying axial locations along the distal end 30. In some embodiments, the orifices 32 are arranged for access from the storage container 28 ( Figure 3A The orifice 32 is used to deliver fluids (e.g., liquids or gases) or other substances and extends at an angle not perpendicular to the central axis C of the microcannula 14, as will be described in further detail below. In some embodiments, the orifice 32 is arranged for delivering fluids or other substances from the reservoir 28 and extends at an angle perpendicular to the central axis C of the microcannula 14.

[0047] In some embodiments, the microcannula 14 may have different outer diameters along its length. For example, as Figure 2B As shown, the outer diameter OD1 near the proximal end of the microcannula 14 can be between approximately 500 μm and approximately 700 μm, for example, approximately 600 μm, and the outer diameter OD2 near the distal end of the microcannula 14 can be between approximately 100 μm and approximately 200 μm, for example, approximately 150 μm. The outer diameter of the microcannula 14 can gradually taper near the distal end of the microcannula 14. For example, in Figure 2BIn some embodiments, the outer diameter OD1 of the micro cannula 14 tapers to an OD2 near the terminal end 98 of the micro cannula 14. The first outer diameter of the micro cannula 14 can taper from a location a distance from the terminal end of the micro cannula 14. For example, in some embodiments, the outer diameter OD1 can taper from 600 pm to an outer diameter OD2 of 150 pm near the terminal end 98 of the micro cannula 14, starting from a location 350 pm from the terminal end 98 of the micro cannula 14. Figure 2B In some embodiments, the outer diameter OD1 can taper from 600 pm to an outer diameter OD2 of 150 pm near the terminal end 98 of the micro cannula 14, starting from a location 350 pm from the terminal end 98 of the micro cannula 14. Figure 2B In some embodiments, the outer diameter OD1 can taper from 600 pm to an outer diameter OD2 of 150 pm near the terminal end 98 of the micro cannula 14, starting from a location 350 pm from the terminal end 98 of the micro cannula 14.

[0048] Along the length of the micro cannula 14, the micro cannula 14 can have different sizes of inner diameter. For example, the inner diameter near the proximal end of the micro cannula 14 can be between about 300 pm and 500 pm, e.g., 400 pm, and the inner diameter near the distal end of the micro cannula 14 can have a different size than the inner diameter near the proximal end. In some embodiments, the inner diameter of the micro cannula 14 can taper from the inner diameter near the proximal end to the inner diameter near the distal end, starting from a location a distance from the terminal end of the micro cannula 14. In some embodiments, the inner diameter of the micro cannula 14 can taper from a location on the micro cannula 14, e.g., a circumferential groove nearest the proximal end of the micro cannula 14, e.g., circumferential groove 99a in Figure 2B some embodiments, the inner diameter of the micro cannula 14 tapers at the same rate of change as the outer diameter of the micro cannula 14 tapers, such that the ratio between the size of the outer diameter and the size of the inner diameter is constant or near constant. In some embodiments, the inner diameter of the micro cannula 14 tapers starting from the same location on the micro cannula 14 as the outer diameter of the micro cannula 14 tapers, as the outer diameter of the micro cannula 14 tapers. For example, as described above, the outer diameter of the micro cannula 14 can taper from OD1 starting from a location 350 pm from the terminal end 98 of the micro cannula 14, and similarly, the inner diameter of the micro cannula 14 can taper from a first size starting from a location 350 pm from the terminal end 98 of the micro cannula 14.

[0049] The micro cannula 14 can include one or more grooves around the circumference of the micro cannula 14 (referred to herein as “circumferential grooves”), e.g., circumferential grooves 99a, 99b, 99c. In some embodiments, as shown in Figure 2B and Figure 2C shown, the micro cannula 14 includes three such circumferential grooves. As shown in Figure 2B each circumferential groove can be spaced apart from another circumferential groove on the micro cannula 14 by a distance gd. The distance gdmay be between about 40 pm and about 60 pm. For example,Figure 2B The distance gd between the circumferential grooves 99a, 99b, and 99c in the micro cannula 14 can be about 50 pm. As shown in FIG. 1, each circumferential groove can have a depth gDe. The depth gDe can be between about 15 pm and 35 pm. In some embodiments, the circumferential grooves have a depth gDe of 25 pm. As shown in FIG. 1, the circumferential grooves can be formed near the distal end of the micro cannula 14. In some embodiments, the circumferential grooves can be formed on the micro cannula 14 starting at a location that is between about 500 pm and 250 pm from the terminal end 98 of the micro cannula 14, for example, starting at a location that is about 350 pm from the terminal end 98 of the micro cannula 14. In some embodiments, the distal portion of the micro cannula 14 (on the micro cannula 14 starting at a location that is between about 500 pm and 250 pm from the terminal end 98 of the micro cannula 14) is configured as a rough shaft. Figure 2C Figure 2B

[0050] In some embodiments, the micro cannula 14 can include one or more protrusions (referred to herein as "circumferential protrusions") around the circumference of the micro cannula 14. Each circumferential protrusion can be spaced apart from another circumferential protrusion on the micro cannula 14 by a distance, for example, a distance between about 40 pm and about 60 pm. In some embodiments, each circumferential protrusion can be about 50 pm. Each circumferential protrusion can have a particular height that is between about 15 pm and 35 pm. In some embodiments, the circumferential protrusions have a height of 25 pm. The circumferential protrusions can be formed near the distal end of the micro cannula 14. In some embodiments, the circumferential protrusions can be formed on the micro cannula 14 starting at a location that is between about 500 pm and 250 pm from the terminal end 98 of the micro cannula 14, for example, starting at a location that is about 350 pm from the terminal end 98 of the micro cannula 14. The micro cannula 14 can be formed from various materials, including but not limited to polymethyl methacrylate (PMMA), polyimide, various types of silicone, for example, high durometer silicone, and the like. The micro cannula 14 can include or be coupled to a fastening mechanism. One example of such a fastening mechanism is a luer lock, for example, the luer lock 102 shown in FIG. 1. In some embodiments, the fastening mechanism can be configured with an external threaded profile, for example, the external threaded profile 103 of the luer lock 102 shown in FIG. 1. In some embodiments, the micro cannula 14 is attached or coupled to a fastening mechanism, such as the luer lock 102, at the proximal end of the micro cannula 14. In some embodiments, the connector body 26 can be configured to accommodate the fastening mechanism. For example, if the fastening mechanism includes an external threaded profile, the connector body 26 can be configured with an internal threaded profile (not shown) near the distal end of the connector body 26 to accommodate the fastening mechanism. Figure 2D Figure 2D

[0051] ​​​​In some implementations, such as Figure 2E As shown, the exemplary medical device 10 may include multiple cannulas and / or micro-cannulas, such as external cannula 210 and internal cannula 230. Figure 2E As shown, the inner cannula 230 can be accommodated within the outer cannula. Figure 2E In this embodiment, the outer diameter of the external cannula 210 may be between 200 μm and 400 μm, for example, approximately 250 μm, 300 μm, or 350 μm. In some embodiments, the inner diameter of the external cannula 210 is between 100 μm and 200 μm. The external cannula 210 includes one or more protrusions, for example, protrusions 220a and 220b, collectively referred to as protrusions 220. The protrusions 220 are located inside the external cannula 210, for example, on the inner circumferential surface of the external cannula 210. The protrusions 220 may be equidistant or unequally spaced from each other. The protrusions 220 may be protruding notches, extensions, etc. In some embodiments, the protrusions 220 extend toward each other. The external cannula 210 is connected to the distal end of the handle 12, for example, the distal end 20, via connector 16. As described above, the inner cannula 230 is accommodated within the external cannula 210. The inner cannula 230 is also housed within the handle 12 and configured to extend from and retract into the handle 12. A control unit, such as an actuator 38, is configured to control the extension and retraction of the inner cannula 230.

[0052] like Figure 2E As shown, the endoscope 230 includes one or more protrusions, such as protrusions 240a and 240b, collectively referred to herein as protrusion 240. Protrusions 240 may be spaced equidistantly or unequally apart and located on the outer peripheral surface of the endoscope 230. Protrusions 240 may be positioned on the endoscope 230 at a location aligned with protrusion 220 such that protrusion 220 engages protrusion 240 when the endoscope 230 extends a distance from the distal end (e.g., distal end 20) of handle 12, and prevents the endoscope 230 from extending further until a threshold amount of force is applied to the actuator to further extend the endoscope 230. The threshold amount of force is applied to the actuator by pressing protrusion 240 against protrusion 220, causing the endoscope 230 to extend. Protrusion 220 may be configured to be pressed into the external endoscope 210. Figure 2F As shown, the application of a threshold force causes the insertion cannula 230 to rapidly penetrate the trabecular mesh 86. In some embodiments, such as Figure 2B As shown, the insertor 230 may include circumferential grooves, such as circumferential grooves 99a, 99b, and 99c. In some embodiments, the insertor 230 may include one or more orifices, such as orifice 32, located around the circumference of the distal end of the insertor 230. The orifices of the insertor 230 may be equidistant or unequally spaced. In some embodiments, the position is similar to that of orifice 32 described above, and as... Figure 2BAs shown, the orifices of the inner cannula 230 are positioned approximately 180 degrees apart from one another around the circumference of the distal end of the inner cannula 230. In some embodiments, the orifices of the inner cannula 230 can be positioned at varying axial positions along the distal end of the inner cannula 230, and the orifices of the inner cannula 230 are arranged for delivery of fluid (e.g., liquid or gas) or other substances from a reservoir (e.g., as shown Figure 3A As shown, the orifices of the inner cannula 230 are positioned approximately 180 degrees apart from one another around the circumference of the distal end of the inner cannula 230. In some embodiments, the orifices of the inner cannula 230 can be positioned at varying axial positions along the distal end of the inner cannula 230, and the orifices of the inner cannula 230 are arranged for delivery of fluid (e.g., liquid or gas) or other substances from a reservoir (e.g., as shown

[0053] The handle 12 can have an ergonomic shape designed to be comfortably held in a hand, e.g., the palm of a dominant hand of a medical professional. The handle 12 can have a length of between about 5 inches (12.7 cm) and about 10 inches (25.4 cm). The handle 12 can include a proximal end 34, a distal end 20, and a channel or track 36 extending between the proximal end 34 and the distal end 20, which will be described in further detail below. The proximal end 34 and the distal end 20 have a generally circular cross-sectional shape. Alternatively, the proximal end 34 and the distal end 20 can have any other cross-sectional shape (e.g., oval, polygonal, irregular, etc.), without departing from the scope of the present disclosure. In some arrangements, the cross-sectional shape of the proximal end 34 and / or the distal end 20 can vary along the length of the handle 12 and / or differ from one another. Optionally, as shown, the proximal end 34 can taper or narrow in a proximal direction.

[0054] The handle 12 includes an actuator 38. The actuator 38 includes a button or slider 40 housed within the track 36 of the handle 12. In some arrangements, as shown in Figure 1 and FIG. 3, the slider 40 can be at least partially curved or folded. Alternatively, the slider 40 can have any suitable shape. A first end 42 (e.g., a distal end) of the slider 40 can be fixed (e.g., permanently, inseparable, throughout use, welded, glued, and / or heat staked, etc.) to the slide plate, carriage, and / or actuator body 44 is movably positioned (e.g., slidable, translatable, etc.) within the handle 12. For example, the actuator body 44 can move, slide, or translate along an axis (e.g., a central longitudinal axis of the handle 12 or an axis parallel thereto) relative to the handle 12, which will be described in further detail below. Additionally, a second end 46 (e.g., a proximal end) of the slider 40 includes a protrusion or tab sized to be housed within the track 36, which will be described in further detail below. As shown, the second end 46 is angled, tapered, or inclined to facilitate movement along the track 36, which will be described in further detail below. In some embodiments, the actuator 38 can be a button (e.g., as shown Figure 2G as shown in FIG. 3), a roller 251 as shown in Figure 2H as shown in FIG. 3), a roller 251 as shown in Figure 2IThe slider 252 shown is an example. In some embodiments, the actuator 38 may be configured to be compressed (e.g., as shown in the figure). Figure 2J The actuator 253 shown is used to control the delivery of fluid via the micro-cannula 14.

[0055] In some embodiments, the microcannula 14 is housed within an outer tube, for example, as... Figure 2K The outer tube 254 is shown. The outer tube 254 includes an opening or cutout, for example, an opening 255. In some embodiments, such as... Figure 2K As shown, the opening 255 or slit is located at the distal end of the outer tube 254. The outer tube 254 extends to the handle 12 and is configured to be rotated by a control mechanism located proximal to the handle 12. Rotating the outer tube 254 can expose or conceal one or more openings on the microcannula 14, such as the distal opening 32. For example, as... Figure 2L As shown, the outer tube 254 is rotated so that the opening 255 is... Figure 2K Move the position in the middle to Figure 2L The position in the middle, in Figure 2K The exposed orifice 32 is now in Figure 2L It is hidden in the middle.

[0056] In some embodiments, the microcannula 14 is movably housed within an outer sheath, for example, as... Figure 2M The outer sheath 260 is shown. The microcannula 14 is configured to extend from the distal end of the outer sheath 260 in response to interaction between a user and a control mechanism configured to extend and retract at least a portion of the microcannula 14 (e.g., the distal end of the microcannula 14) from and into the outer sheath 260, respectively. For example, in a direction configured to extend the microcannula 14 outside the outer sheath 260, a user can apply a threshold amount of force to an actuator coupled to the microcannula 14 so as... Figure 2N The microcannula 14 is extended outside the outer sheath 260 as shown. In some embodiments, the outer sheath 260 is configured to move proximally to the user of the medical device 10, such that at least a portion of the microcannula 14 (e.g., the tip of the microcannula 14) is as shown. Figure 2N As shown, it is exposed outside the outer sheath 260. The outer sheath 260 can move in the proximal direction of the user in response to pressing the distal portion of the outer sheath 260 against the patient's trabecular meshwork.

[0057] A threshold force is applied to the actuator coupled to the microcannula 14 such that at least a portion of the microcannula 14 extends beyond the outer sheath 260, resulting in at least that portion of the microcannula 14 penetrating the patient's trabecular meshwork, for example, trabecular meshwork 86 (e.g., ...). Figure 5A and Figure 5BSimilarly, in embodiments where the outer sheath 260 is configured to move in a proximal direction toward a user of the medical device 10 in response to pressing a distal portion of the outer sheath 260 against the trabecular meshwork, the exposed portion of the microcannula 14 or a portion of the exposed portion of the microcannula 14 can penetrate the trabecular meshwork.

[0058] The track 36 extends through a radially outer wall of the handle 12 relative to a central longitudinal axis of the handle 12. Thus, the slider 40 can extend radially outward from the central axis through the track 36. As shown, the track 36 can be notched such that pairs of inwardly projecting notches, extensions, or flanges 48 extend toward one another to narrow a width of the track 36 at a plurality of axially spaced-apart locations along a length of the track 36. In other words, the track 36 extends longitudinally along the handle 12 and has a width that extends in a direction perpendicular to a longitudinal length of the track 36. The width of the track 36 varies along the length of the track 36 such that the width of the track 36 at each location having a pair of flanges 48 is less than or narrower than the width of the track 36 at locations without one or more flanges 48. The axial spacing between adjacent pairs of flanges 48 can be directly related to the amount of a single dose or quantity of a substance (e.g., fluid or gas) injected via the microcannula 14, which will be described in further detail below. Additionally, it should be appreciated that the slider 40 can be replaced with any appropriate actuator, e.g., a wheel, button, switch, etc., without departing from the scope of the present disclosure.

[0059] Turning to Figure 3A and Figure 4A As described above, the connector 16 facilitates coupling between the microcannula 14 and the handle 12. For example, a proximal end 50 of the connector 16 can be radially received within a cavity 52 of the distal end 20 of the handle 12. The proximal end 50 and the cavity 52 can be correspondingly threaded to facilitate secure engagement therebetween. As described above, the proximal end 18 of the microcannula 14 extends through the inner lumen 22 of the connector 16 and can be fixedly coupled (e.g., glued, welded, or otherwise fixed) to the connector 16. Additionally, the connector 16 includes a tube, shaft, or other such support 54 that is received within the inner lumen 22 of the connector 16 and within an inner lumen 56 of the distal end 20 of the handle 12.

[0060] A plunger assembly including a plunger rod 58 extends proximally through a central inner lumen 60 of the microcannula 14, through the inner lumen 22 of the connector 16, through the inner lumen 56 of the distal end 20 of the handle 12, and toward the actuator body 44 that is received within a cavity 62 of the handle 12. The plunger rod 58 can be reciprocally disposed within the central inner lumen 60. A proximal end of the plunger rod 58 is fixedly coupled to the actuator body 44 such that distal advancement of the actuator body 44 will cause like distal advancement of the plunger rod 58. As Figure 4AAs shown, the piston rod 58 is coupled to the piston head 64 and is axially movable relative to the central lumen 60 of the microcannula 14. A piston channel 66 extends through the piston rod 58, through the piston head 64, and distally terminates at a piston orifice 68. A one-way valve 70 or other suitable valve can be disposed within the piston channel 66 to prevent, inhibit, or block backflow of fluid or other substances, e.g., proximally.

[0061] To deliver fluid or other substances from the reservoir 28, a medical professional can push the slider 40 distally toward the microcannula 14. Due to the connection between the first end 42 and the actuator body 44, and the connection between the actuator body 44 and the piston rod 58, distal advancement of the slider 40 advances the piston head 64 toward the orifice 32 to deliver fluid or other substances within the central lumen 60 through the orifice 32. Any suitable mechanism can be used to push the fluid or substances within the reservoir 28 through the piston channel 66, through the one-way valve 70 within the piston channel 66, and into the cavity 62. For example, the reservoir 28 can be compressed, thereby pushing the fluid or other substances into and through the piston channel 66. Alternatively, the fluid or other substances can be drawn through the piston channel 66 via capillary action, via a micro-pump (e.g., a MEMS pump), or any other suitable pump (not shown).

[0062] In some embodiments, as Figure 3B shown, a fill port 350 can be in fluid communication with the reservoir 28, and a visco can be injected into the reservoir 28 via the fill port. A one-way valve 351 can be attached to a distal end of the reservoir 28, and a plunger 352 can be attached to a proximal end of the reservoir 28. A valve spring 353 is coupled to the plunger 352 and the one-way valve 351. Actuation or compression of the plunger 352 compresses the visco and opens the one-way valve 351, such that the visco is ejected through the orifice 32 on the distal end 30 of the microcannula 14. The plunger 352 can be mechanically or electrically actuated. In some embodiments, the plunger 352 can be actuated by a gas, such as carbon dioxide CO2. In some embodiments, the plunger 352 can be coupled to and actuated by an ultrasonic phacoemulsification system.

[0063] In some embodiments, the handle 12 can include a visco bag and a button communicatively coupled to the visco bag, where the visco bag is in communication with the orifice 32 on the distal end 30. Depression of the button compresses the visco bag and causes the viscoelastic fluid to be ejected through the orifice 32 on the distal end 30. In some embodiments, as Figure 3C shown, the handle 12 includes a flexible bulb 360 in communication with one-way valves 361a, 361b. Compression of the flexible bulb causes the one-way valves to open, and visco in the handle 12 is directed to the orifice 32 at the distal end 30.

[0064] AsFigure 4A As shown, each aperture 32 can be a channel that is angled relative to an axis of the microcannula 14 (e.g., a central axis C of the microcannula 14). As noted above, the aperture 32 can extend at an angle that is perpendicular or non-perpendicular to the axis of the microcannula 14, such that the channel is angled perpendicular or non-perpendicular to the axis of the microcannula 14. Additionally, each aperture can have one or more openings that have a tapered configuration. For example, a first end (e.g., a radially inner end) of each aperture 32 can be positioned at a first axial location along the length L of the microcannula 14, while a second end (e.g., a radially outer end) of each aperture 32 can be positioned at a second axial location along the length L of the microcannula 14. In some embodiments, the second axial location can be proximal to the first axial location. In other embodiments, the second axial location can be distal to the first axial location. In this manner, the channel defined by each aperture 32 can be angled relative to the central longitudinal axis C. In other words, the first end of each aperture 32 is positioned radially closer to the central longitudinal axis C (and distal or proximal to the second end of each aperture 32 along an axis parallel to the central longitudinal axis C), while the second end of each aperture 32 is positioned radially further from the central longitudinal axis C (and proximal or distal to the first end of each aperture 32 along an axis parallel to the central longitudinal axis C). For example, the channel defined by the aperture 32 can extend at an angle a relative to the central longitudinal axis C of between about 5° and about 45°. Thus, during delivery of fluid or other substance from the central lumen 60 through the aperture 32, the fluid or other substance will have to flow proximally (e.g., from a distal location toward a proximal location) or distally and radially away from the microcannula 14.

[0065] As noted above, the axial spacing between adjacent pairs of flanges 48 of the track 36 is related to the amount of fluid or other substance that is injected via the microcannula 14 in a single dose or quantity. For example, prior to advancement of the sled 40, the second end 46 of the sled 40 is positioned between two adjacent pairs of first flanges 48, thereby preventing inadvertent advancement (or retraction) of the sled 40 and injection of fluid or other substance through the aperture 32. In order to advance the sled 40 and inject fluid or other substance via the aperture 32, the medical professional must first overcome the resistance provided by the two adjacent pairs of first flanges 48 abutting the second end 46 of the sled 40, and then continue to advance the sled 40 to push or facilitate the fluid or other substance in the central lumen 60 distal of the piston head 64 through the aperture 32. That is, when the sled 40 is pushed distally forward, the angled or beveled surface of the second end 46 will slide or move along the surface of the flanges 48 until the second end 46 deflects radially inward toward the central axis of the handle 12 and is positioned below the flanges 48, at which point the sled 40 can continue to be advanced distally.

[0066] As the slider 40 continues to advance distally, the second end 46 can be received and held between and within two adjacent pairs of second flanges 48, thereby preventing further unintentional advance. For example, the second end 46 can be radially outwardly offset from the central axis of the handle 12 (returning towards the undeflected orientation). It should be understood that the second end 46 can be radially outwardly offset towards the undeflected orientation. Two adjacent pairs of second flanges 48 can be adjacent to (e.g., adjacent to) two adjacent pairs of first flanges 48. In other words, as the slider 40 advances distally, the interaction between the second end 46 and each pair of adjacent flanges 48 will result in an increased resistance applied to a medical professional, resulting in a tactile indication that a specified dose or amount of fluid or substance has been delivered through the orifice 32.

[0067] In some implementations, such as Figure 4B As shown in the exploded view, the end of the microcannula 14 includes a machined cap 401, as... Figure 4C As shown, the cap 401 can be laser-welded to the end of the microcannula 14. In some embodiments, such as Figure 4D As shown in the exploded view, wire 402 can be adhered to the end of microcannula 14 using an adhesive material such as epoxy resin. The resulting end is as follows. Figure 4E As shown. In some embodiments, the wire can be laser-welded to the end of the microcannula 14. In some embodiments, such as Figure 4F and Figure 4G As shown in the rotated view, the tip of the microcannula 14 can be encapsulated with a silicone molding 403. In some embodiments, such as Figure 4H As shown, the silicone molded part 403 may include one or more slits 404. In some embodiments, such as Figure 4I As shown in the exploded view, polyimide molded parts 406a and 406b and the core pin 405 can be used to encapsulate the end of the microcannula 14, thereby... Figure 4J As shown in the 90-degree rotated view, the microcannula 14 and its distal end configuration are created. In some embodiments, the distal end configuration of the microcannula 14 has a soft polymer material to prevent penetration into parts of the patient, such as the sclera. In some embodiments, the distal end of the microcannula 14 includes a light source, such as a light-emitting diode, configured to generate light at the trabecular meshwork in response to receiving an input that generates light (e.g., powering the light source).

[0068] In some embodiments, the microcannula 14 includes a nickel-titanium alloy (NiTi) tube at its distal end. The NiTi tube at the distal end may be configured to bend once in a certain direction after traveling a certain distance. In some embodiments, the handle 12 includes a control mechanism coupled to the NiTi tube, and the control mechanism is configured to rotate the NiTi tube 180 degrees in response to receiving input or user interaction with the control mechanism.

[0069] Figure 5A and Figure 5B An exemplary method of using the medical device 10 to deliver a substance (e.g., a fluid or gas) to, for example, the Schlemm’s canal 80 or any other suitable portion of a patient’s eye is shown. As described above, in a healthy eye, the flow of aqueous humor 82 exits the anterior chamber 84 of the eye, passes through the trabecular meshwork 86, and then enters the Schlemm’s canal 80 and the distal collector channel. The aqueous humor 82 then exits through the Schlemm’s canal 80 into the collector channel and the distal venous system. When this flow path of aqueous humor 82 is interrupted (e.g., due to diseased or damaged tissue in the trabecular meshwork 86 and / or the Schlemm’s canal 80), the IOP of the eye can rise, potentially leading to various medical problems (e.g., glaucoma, vision loss, optic nerve damage, etc.). To improve the flow path of the aqueous humor 82, as Figure 5A shown, a medical professional can insert the microcannula 14 through an incision 88 made in the anterior chamber 84 and advance the distal end 30 of the microcannula 14 through the trabecular meshwork 86 and into the Schlemm’s canal 80. Optionally, the distal end 30 can be curved such that insertion of the microcannula 14 into the Schlemm’s canal 80 can be achieved by inserting the distal end 30 tangentially into the Schlemm’s canal 80 (e.g., in a manner similar to how an IV needle is inserted into a vein) rather than directly pushing into the Schlemm’s canal 80 via the distal-most end of the microcannula 14.

[0070] Turning now to Figure 5B , once the distal end 30 of the microcannula 14 is inserted into the Schlemm’s canal 80 such that each orifice 32 is fully contained within the Schlemm’s canal 80, the medical professional can inject a predetermined dose or amount of fluid or other substance from the reservoir 28 via actuation of the slide 40 (as described above). Figure 1 , Figure 3A and Figure 4A Further, because advancement of the slide 40 is limited by the interaction of the second end 46 and the flange 48, each predetermined dose or amount of fluid or substance to be injected is accurate and precise with each incremental advancement of the slide 40. For example, each “dose” can be 200 microliters + / - 50 microliters.

[0071] After injection of the predetermined dose or amount of fluid or other substance through the orifices 32 (and Figure 2A and Figure 4A ), the microcannula 14 can be rotated about the central axis C (and Figure 4A ) between about 50° and about 120°, for example, between about 60° and about 90°. Once rotated, the medical professional can inject a predetermined dose or amount of fluid or other substance from the reservoir 28 via actuation of the slide 40 (as described above). Figure 1The additional predetermined dose or amount of fluid or other substance is injected from the reservoir 28 (e.g., as shown in FIGS. 3 and 4). This process can be repeated any appropriate number of times, e.g., about six times, after which the microcannula 14 can be removed from the incision 88.

[0072] Optionally, after injecting one or more predetermined doses of fluid or other substance at a location within the Schlemm's canal 80 (e.g., without repositioning (except rotation) the distal end 30 of the microcannula 14), the distal end 30 can be retracted and repositioned within the eye. In some arrangements, such repositioning can occur by withdrawing the microcannula 14 from the incision 88 (e.g., the first incision) and reinserting through another incision spaced apart from the first incision. In some embodiments, fluid can be simultaneously delivered into the Schlemm's canal 80 and the trabecular meshwork 86, thereby causing the Schlemm's canal 80 to open and deliver fluid into various layers of the trabecular meshwork 86. Alternatively, such repositioning can include retracting the distal end 30 from the Schlemm's canal 80 and / or the trabecular meshwork 86 and then repositioning to a new portion of the Schlemm's canal 80 without removing the microcannula 14 from the first incision. In either case, the distal end 30 of the microcannula 14 can be positioned at a location about 30-90° from the original insertion site.

[0073] The substance located within the reservoir 28 and injected via the orifice 32 can be any appropriate substance. For example, the substance can include a viscoelastic fluid, e.g., sodium hyaluronate and chondroitin sulfate. The viscoelastic fluid is a highly flexible, gel-like material that helps provide sufficient space for adequate drainage and intraocular pressure relief by expanding the flow paths of the aqueous humor 82 away from one another. The viscoelastic fluid can also clear obstructed visual fields by expanding the bleeding structures away from one another to improve visibility.

[0074] In another arrangement, the reservoir 28 can be filled with stem cells, drugs, gases (e.g., SF6 or C3F8), and / or dyes (e.g., trypan blue dye). The injected dye, for example, will flow through the trabecular meshwork 86, thereby enhancing the visibility of the aqueous humor 82 fluid flow to determine which areas, if any, of the trabecular meshwork 86 remain obstructed, collapsed, or otherwise impede the flow of the aqueous humor 82. On the other hand, the injected stem cells can initiate the growth of healthy tissue within the eye (e.g., forming a healthy trabecular meshwork 86 to enhance drainage of the aqueous humor 82 through the trabecular meshwork 86).

[0075] In some arrangements, a first substance is injected into one or more locations of the eye, the reservoir 28 is refilled with a second substance different from the first substance, and then the second substance is injected into one or more locations of the eye. Additionally, this process can be repeated as necessary to deliver each of the selected substances. For example, as described above, one or both of the connector 16 and the distal end 20 can include a fluid luer port (not shown) through which the reservoir 28 can be selectively refilled. Thus, a variety of substances (e.g., viscoelastic substances, drugs, stem cells, and dyes) can be injected into the patient's eye to achieve a desired result (e.g., visualize the flow path of the aqueous humor 82, expand the Schlemm's canal 80, promote tissue regeneration, or otherwise medicate diseased tissue). Thus, during the procedure, a single (e.g., only one) incision 88 can be required to deliver the various substances deemed necessary and / or beneficial by the medical professional, thus reducing trauma, recovery time, time of the medical professional, and associated costs, among other things.

[0076] It should be appreciated that while the foregoing description describes devices and methods for injecting fluid or other substances through the orifice 32, the present disclosure is not so limited. Indeed, the medical device 10 described herein can be arranged for precise control of withdrawal of fluid or other substances from the eye. For example, rather than distal advancement of the slide 40 to incrementally inject a predetermined "dose" or amount of a substance or fluid radially outward from the microcannula 14 via the orifice 32, proximal retraction of the slide 40 can incrementally withdraw (e.g., suction, pull) fluid or other substances (e.g., tissue, blood, aqueous humor 82, etc.) from the Schlemm's canal 80 to remove from the eye. In other words, the medical device 10 can be actuated in a manner opposite that described above to effect removal of fluid or other substances from the eye. In arrangements in which the medical device 10 is positioned for removal of fluid or other substances from the eye, one or more components of the medical device 10 can be reversed (e.g., the one-way valve 70 can be oriented to allow proximal flow of fluid or other substances along the piston channel 66 while preventing distal flow of fluid or other substances along the piston channel 66, etc.). In some embodiments, the microcannula 14 can be operably coupled to a suitable vacuum source to create suction.

[0077] The medical device 10 can be constructed from any suitable material. For example, the microcannula 14 can include one or more metals (e.g., stainless steel, titanium, nitinol, etc.) or rigid (e.g., rigid enough to pass through the trabecular meshwork 86 and Schlemm’s canal 80 without bending or otherwise deforming) polymers (e.g., PEEK, polyimide, etc.). Exemplary materials can also include polymers that are transparent to optical coherence tomography (OCT) (e.g., glycol-modified polyethylene terephthalate, polyvinyl chloride, polymethyl methacrylate, and / or polyphenylsulfone, etc.) such that imaging via OCT can be performed simultaneously with the positioning of the microcannula 14 and / or injection of a substance via the orifice 32, while minimally disrupting the images obtained via OCT.

[0078] Additionally, any one or more portions of the microcannula 14 (e.g., the distal end 30) can be radiopaque to enhance visualization by the medical professional during the procedure. Likewise, the handle 12 can suitably include any one or more metals or polymers. Additionally or alternatively, the distal end 30 can include a light-emitting diode (LED) (not shown). When the LED is illuminated, the medical professional is able to see a light ray through the sclera of the eye, thereby providing the user with an indication of the position of the microcannula 14 in the eye. In some arrangements, one or more radiopaque markers or other indicia can be located at the distal end 30 of the microcannula 14 to facilitate visualization of the depth of the microcannula 14 in the patient’s eye. Additionally, the microcannula 14 can include a cutting device (e.g., a knife, blade, tip, etc.) (not shown) adjacent the distal end 30. In use, such a cutting device can enable the medical professional to cut tissue (e.g., the trabecular meshwork 86 and / or Schlemm’s canal 80) before or after injection of a substance via the orifice 32. For example, the microcannula 14 including the cutting device can be moved left and right to cut tissue that is lifted as a result of the injection of the substance via the orifice 32.

[0079] While the principles of the disclosure have been described herein with reference to illustrative embodiments for particular applications, it is to be understood that the disclosure is not limited to the foregoing descriptions. Those skilled in the art and having access to the teachings provided herein will realize additional modifications, applications, embodiments and equivalents thereof within the scope of the embodiments described herein. Therefore, the application is not to be construed as limited to the foregoing description.

[0080] Reference to a singular item includes one or more such items unless specifically stated otherwise. E.g., a reference to “one” module can mean one or more modules. The term “based on” does not mean “based only on” unless otherwise expressly specified. Except as otherwise indicated, the use of “or” is to be treated as an “and / or”, unless otherwise indicated.

[0081] Headings and subheadings, if any, are used for convenience only and do not limit the application. Exemplary is used to mean serving as an example or illustration. As used in the use of the term "including" "containing" "having" or the like, such term is intended to be equivalent to the term "comprising" as if that term were explicitly used in the definition. As used in the use of the term "or" as it can be used in the "either-or" sense, such term is intended to be equivalent to the term "and / or" as if that term were explicitly used in the definition. As used in the use of the term "a" or "an" as it can be used in the as-taking definition, such term is intended to be equivalent to the term "one" or "at least one" as if that term were explicitly used in the definition.

[0082] Phrases such as one aspect, the aspect, another aspect, some aspects, one or more aspects, an implementation, the implementation, another implementation, some implementations, one or more implementations, one embodiment, the embodiment, another embodiment, some embodiments, one or more embodiments, one configuration, the configuration, another configuration, some configurations, one or more configurations, the subject technology, the disclosure, the present disclosure, other variations, and the like are presented for the purpose of conveying concepts related to the subject technology and are not intended to limit the scope of the subject technology to a particular disclosure presented. The disclosure related to such phrases can apply to all configurations or one or more configurations. The disclosure related to such phrases can provide one or more examples. Phrases such as aspect or aspects and the like can refer to one or more aspects and vice versa, and this applies similarly to other aforementioned phrases.

[0083] The phrase "at least one of followed by a series of items, and the terms "and / or" or "or" as used in a list of items, does not require selection of at least one of each item in the list; rather, only one of any of the items in the list is required. The phrase at least one of permits inclusion of at least one, but not each, of an item in the list; for example, a list of items consisting of at least one of A, B, and C, covers A only, B only, C only, as well as any combination of A, B, and C. The phrase at least one of permits inclusion of at least one, but not each, of an item in the list; for example, a list of items consisting of at least one of A, B, and C, covers A only, B only, C only, as well as any combination of A, B, and C.

[0084] It should be understood that a specific order or hierarchy of steps, operations or processes disclosed are merely examples of implementing the exemplary methods. Unless explicitly stated otherwise, it should be understood that a specific order or hierarchy of steps, operations or processes can be performed in different order. Some of the steps, operations or processes can be performed simultaneously. The accompanying method claims, if any, present elements of the various steps, operations or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0085] In one aspect, the term "coupled" and the like can mean directly coupled. In another aspect, the term "coupled" and the like can mean indirectly coupled.

[0086] Terms such as top, bottom, front, back, side, horizontal, vertical, and the like refer to an arbitrary frame of reference, not a normal gravity reference frame. Accordingly, such terms can extend upward, downward, diagonally, or horizontally in a gravity reference frame.

[0087] The present disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. In some instances, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject technology. The present disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the principles described herein can be applied to other aspects.

[0088] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether these disclosure is explicitly recited in the above description. The claims are not to be interpreted under the provisions of 35 U.S.C. § 112, sixth paragraph, unless the language in a claim expressly recites an "means for" plus function claim element. With respect to the methods disclosed, the steps presented are exemplary. The methods can be practiced in an order other than that presented and / or at the same time. It is intended that each step be performed by a corresponding step in the method.

[0089] The title, background, brief description of drawings, abstract, and drawings are hereby incorporated into this disclosure and provided as illustrative examples of the disclosure and are not provided as limitations on the scope of or support for the claims. It is to be understood that they do not serve as limitations of the scope or support of the claims. In addition, in the detailed description, it is to be understood that all features that are permutations of other features are presented as illustrative examples only and are not meant to limit the scope or support of the claims. The methods of the disclosure are not to be construed as reflecting the intention that the claimed subject matter is limited to the features explicitly stated in each claim. Rather, as is reflected in the claims, the inventive subject matter is limited only by the elements and steps expressed in each claim. The claims are hereby incorporated into the detailed description, with each claim standing on its own as separately claimed subject matter.

[0090] The claims are not intended to be limited to the aspects described herein, but are to be accorded the full scope consistent with the language of the claims, and to cover all legal equivalents thereof. However, no claim is intended to be construed as including any feature beyond the essential character of the claimed subject matter, or should be interpreted as so doing.

Claims

1. An eye treatment device, comprising: A microcannula having a proximal end, a distal end, and a cavity, and having a central longitudinal axis; A handle, the handle being attached to the proximal end of the microcannula; A plurality of orifices extending circumferentially around the distal end of the microcannula, each of the plurality of orifices defining a channel extending transversely to the central longitudinal axis and having a radially outer end positioned further radially away from the central longitudinal axis than the radially inner end, each of the plurality of orifices being configured to deliver material radially outward from the distal end of the microcannula. An outer tube, wherein the microcannula is housed within the outer tube, the outer tube including an opening at its distal end; as well as A control mechanism, located near the handle, is configured to rotate the outer tube such that the opening moves from a first position to a second position, wherein the first orifice is hidden in the first position and exposed in the second position.

2. The eye treatment device according to claim 1, wherein, The outer diameter of the microcannula varies along its length.

3. The eye treatment device according to claim 1, wherein, The first outer diameter of the microcannula gradually tapers to a second outer diameter at the distal end of the microcannula.

4. The eye treatment device according to claim 3, wherein, The first outer diameter is between 500 μm and 700 μm, and the second outer diameter is between 100 μm and 200 μm.

5. The eye treatment device according to claim 1, wherein, The first orifice and the second orifice of the plurality of orifices are spaced 180 degrees apart.

6. The eye treatment device according to claim 1, wherein, The plurality of orifices are positioned around the circumference of the distal end and are equidistant from each other.

7. The ocular treatment device of claim 1 further includes one or more grooves surrounding the circumference of the microcannula and located at the distal end of the microcannula.

8. The eye treatment device according to claim 7, wherein, Each of the one or more grooves has a depth between 15 μm and 35 μm.

9. The eye treatment device according to claim 7, wherein, Each of the one or more grooves is formed on the proximal side of the plurality of orifices.

10. The eye treatment device according to claim 7, wherein, The one or more grooves include three grooves that are equidistant from each other.

11. The eye treatment device according to claim 1, wherein, The substance is a viscoelastic fluid, and the handle includes: a reservoir containing the viscoelastic fluid, and an actuator configured to eject the viscoelastic fluid radially outward through the plurality of orifices.

12. The eye treatment device according to claim 1, wherein, The radially outer end is positioned distal to the radially inner end, such that each of the orifices is configured to deliver the substance distally and radially outward from the microcannula.

13. The eye treatment device according to claim 1, further comprising: An external cannula having a distal end and a cavity, the external cannula having a central longitudinal axis and one or more protrusions, the one or more protrusions of the external cannula extending circumferentially at the distal end of the external cannula and located in the cavity of the external cannula.

14. The eye treatment device according to claim 13, wherein, The microcannula is movably accommodated within the external cannula, and the one or more protrusions are located on the outer peripheral surface of the microcannula.

15. The eye treatment device according to claim 14, wherein, The one or more protrusions of one of the external cannula and the micro cannula include a plurality of protrusions spaced at equal intervals.

16. An eye treatment device, comprising: Outer sheath; A microcannula, which is movably accommodated within the outer sheath and has a proximal end, a distal end, a cavity, and a central longitudinal axis; A handle, the handle being coupled to the proximal end of the microcannula, and the handle including a proximal end, a distal end, and a track extending between the proximal end and the distal end of the handle; An actuator, coupled to the microcannula and including a slider disposed within the track, the slider being configured to slide linearly along the track, the actuator being configured to cause the distal end of the microcannula to extend from the distal end of the outer sheath; as well as A plurality of orifices extend circumferentially around the distal end of the microcannula, each orifice defining a channel extending to the central longitudinal axis, and each orifice being configured to deliver material radially outward from the distal end of the microcannula. The track extends longitudinally along the handle, and when the microcannula is in the extended position, the distal end of the microcannula is configured to extend from the distal end of the outer sheath, and when the microcannula is in the retracted position, the distal end of the microcannula is fully contained within the outer sheath. The track has a width perpendicular to the central longitudinal axis and multiple narrowing portions defined by opposing flange pairs projecting inward toward the central longitudinal axis, wherein the axial spacing between adjacent flange pairs is related to the amount of a single dose or quantity of substance injected via the microcannula.

17. The eye treatment device of claim 16, further comprising a control mechanism located proximal to the handle, the control mechanism being configured to extend and retract the distal end of the microcannula into the distal end of the outer sheath, respectively.

18. The eye treatment device according to claim 16, wherein, The actuator is configured to extend the distal end of the microcannula from the distal end of the outer sheath once it receives a threshold amount of force.

19. The eye treatment device according to claim 16, wherein, The distal end is configured to extend into a trabecular mesh that penetrates the eye, while keeping the outer sheath outside the trabecular mesh.

20. The eye treatment device according to claim 16, wherein, The first portion of the slider is bent or folded, and the first portion of the slider extends radially outward from the central longitudinal axis through the track.

21. The eye treatment device according to claim 16, wherein, The first orifice and the second orifice of the plurality of orifices are spaced 180 degrees apart.

22. The eye treatment device according to claim 16, wherein, The plurality of orifices are positioned around the circumference of the distal end and are equidistant from each other.

23. The eye treatment device according to claim 16, wherein, The substance is a viscoelastic fluid, and the handle includes: a reservoir containing the viscoelastic fluid, and an actuator configured to eject the viscoelastic fluid radially outward through the plurality of orifices.

24. The eye treatment device according to claim 16, wherein, For each of the plurality of orifices, the radially outer end is positioned distal to the radially inner end, such that each orifice is configured to deliver material distally and radially outward from the microcannula.

25. The eye treatment device according to claim 16, further comprising: One or more first protrusions extend circumferentially inward from the distal end of the outer sheath and are located in the cavity of the outer sheath; as well as One or more second protrusions extend circumferentially from the distal end of the microcannula and are located on the outer peripheral surface of the microcannula.

26. The eye treatment device according to claim 25, wherein both the first protrusion and the second protrusion comprise a plurality of protrusions spaced equidistantly.

27. An eye treatment device, comprising: A microcannula having a proximal end, a distal end, a cavity, and a central longitudinal axis; An outer sheath, which is movably positioned around the microcannula; A handle, which is coupled to the proximal end of the microcannula and includes a track, wherein the track has a width perpendicular to the central longitudinal axis and a plurality of narrowing portions defined by opposing flange pairs projecting inward toward the central longitudinal axis, and the handle includes a proximal end, a distal end, and a track extending between the proximal end and the distal end of the handle. as well as A plurality of orifices extend circumferentially around the distal end of the microcannula, each orifice defining a channel extending to the central longitudinal axis, and each orifice being configured to deliver material radially outward from the distal end of the microcannula. The track extends longitudinally along the handle, and when the outer sheath is in the retracted position, the distal end of the microcannula is configured to extend from the distal end of the outer sheath, and when the outer sheath is in the extended position, the distal end of the microcannula is fully contained within the outer sheath. The outer sheath is configured to move in the proximal direction when the distal portion of the outer sheath presses against the trabecular mesh of the eye.

28. The eye treatment device according to claim 27, comprising one of the following: The first orifice and the second orifice of the plurality of orifices are spaced 180 degrees apart; The plurality of orifices are positioned around the circumference of the distal end and are equidistant from each other; and For each of the plurality of orifices, the radially outer end is positioned distal to the radially inner end, such that each orifice is configured to deliver material distally and radially outward from the microcannula.

29. The eye treatment device according to claim 27, wherein, The substance is a viscoelastic fluid, and the handle includes: a reservoir containing the viscoelastic fluid, and an actuator configured to eject the viscoelastic fluid radially outward through the plurality of orifices.

30. An eye treatment device, comprising: Outer sheath; One or more first protrusions, the one or more first protrusions extending circumferentially inward at the distal end of the outer sheath and located in the cavity of the outer sheath; A microcannula, which is movably accommodated within the outer sheath and has a proximal end, a distal end, a cavity, and a central longitudinal axis; One or more second protrusions extend circumferentially at the distal end of the microcannula and are located on the outer peripheral surface of the microcannula; as well as A plurality of orifices are disposed on the distal end of the microcannula, each orifice defining a channel extending to the central longitudinal axis, and each orifice being configured to deliver material radially outward from the distal end of the microcannula. When the microcannula is in the extended position, the distal end of the microcannula is configured to extend from the distal end of the outer sheath, and when the microcannula is in the retracted position, the distal end of the microcannula is configured to be received within the outer sheath.

31. The eye treatment device according to claim 30, further comprising: A handle, the handle being attached to the proximal end of the microcannula; as well as A control mechanism located near the handle is configured to extend and retract the distal end of the microcannula into the distal end of the outer sheath, respectively.

32. The ocular treatment device of claim 31, further comprising an actuator coupled to the microcannula, the actuator being configured to cause the distal end of the microcannula to extend from the distal end of the outer sheath.

33. The eye treatment device according to claim 32, wherein, The actuator is configured to extend the distal end of the microcannula from the distal end of the outer sheath once it receives a threshold amount of force.

34. The eye treatment device according to claim 32, wherein, The distal end is configured to extend into a trabecular mesh that penetrates the eye, while keeping the outer sheath outside the trabecular mesh.

35. The eye treatment device according to claim 32, wherein, The handle includes a track, and the actuator includes a slider disposed within the track, the slider being configured to slide in a straight line along the track.

36. The eye treatment device according to claim 35, wherein, The first portion of the slider is bent or folded, and the first portion of the slider extends radially outward from the central longitudinal axis through the track.

37. The eye treatment device according to claim 35, wherein, The track has a width perpendicular to the central longitudinal axis and a plurality of narrowing portions, the plurality of narrowing portions being defined by opposing flanges projecting inward toward the central longitudinal axis.

38. The eye treatment device according to claim 37, wherein, The axial spacing between adjacent flange pairs is related to the amount of a single dose or quantity of substance injected via the microcannula.

39. The eye treatment device according to claim 30, wherein, The first orifice and the second orifice of the plurality of orifices are spaced 180 degrees apart.

40. The eye treatment device according to claim 30, wherein, The plurality of orifices are positioned around the circumference of the distal end and are equidistant from each other.

41. The eye treatment device according to claim 31, wherein, The substance is a viscoelastic fluid, and the handle includes: a reservoir containing the viscoelastic fluid, and an actuator configured to eject the viscoelastic fluid radially outward through the plurality of orifices.

42. The eye treatment device according to claim 30, wherein, For each of the plurality of orifices, the radially outer end is positioned distal to the radially inner end, such that each orifice is configured to deliver material distally and radially outward from the microcannula.

43. The eye treatment device according to claim 30, wherein both the first protrusion and the second protrusion comprise a plurality of protrusions spaced equidistantly.

44. An eye treatment device, comprising: A microcannula having a proximal end, a distal end, a cavity, and a central longitudinal axis; An outer sheath, which is movably positioned around the microcannula; A first protrusion extends circumferentially inward at the distal end of the outer sheath; The second protrusion is located on the outer peripheral surface of the microcannula; A handle, the handle being attached to the proximal end of the microcannula; as well as A plurality of orifices are disposed at the distal end of the microcannula, each orifice defining a channel extending to the central longitudinal axis, and each orifice being configured to deliver material outward from the distal end of the microcannula. When the outer sheath is in the retracted position, the distal end of the microcannula is configured to extend from the distal end of the outer sheath, and when the outer sheath is in the extended position, the distal end of the microcannula is configured to be received within the outer sheath.

45. The eye treatment device of claim 44, wherein the outer sheath is configured to move in a proximal direction when the distal portion of the outer sheath is pressed against the trabecular mesh of the eye.

46. ​​The eye treatment device according to claim 44, comprising one of the following: The first orifice and the second orifice of the plurality of orifices are spaced 180 degrees apart; The plurality of orifices are positioned around the circumference of the distal end and are equidistant from each other; and For each of the plurality of orifices, the radially outer end is positioned distal to the radially inner end, such that each orifice is configured to deliver material distally and radially outward from the microcannula.

47. The eye treatment device according to claim 44, wherein, The substance is a viscoelastic fluid, and the handle includes: a reservoir containing the viscoelastic fluid, and an actuator configured to eject the viscoelastic fluid radially outward through the plurality of orifices.

Citation Information

Patent Citations

  • Drug delivery device

    CN101132819A

  • Medical Device with Cannula Inserter

    US20090012472A1