Patent Description:
Various aspects of the present disclosure relate generally to ocular tissue treatment. More specifically, the present disclosure relates to instruments and related methods for reducing intraocular eye pressure.

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

Prior treatments to reduce IOP may include application of eye drops and other medications. Application of such medications may be required multiple times a day, and may interfere with a patient's quality of life. Additionally, laser treatments and other surgical applications may be used to reduce IOP, however, such treatments may be invasive and often provide only temporary reduction of IOP.

The systems, devices, and methods of the current disclosure may rectify some of the deficiencies described above or address other aspects of the prior art.

<CIT> relates to a method and a device for the treatment of glaucoma, in which a tube-shaped implant is inserted and released in the Schlemm's canal, which is exposed by an incision and a folded up scleral flap with two opposite openings, by means of a catheter, which is provided with a distal and a proximal portion and which is connected to a pressure source for injecting a gaseous or fluid medium. <CIT> relates to pain management systems, and more specifically to catheter-based infusion systems for the administration of fluids. More specifically, it relates to an apparatus and system for performing a nerve block procedure. <CIT> relates generally to methods and devices for use in delivering devices for treating glaucoma.

At least one aspect is directed to a medical device. The medical device includes a microcannula having a proximal end, a distal end, a cavity, and a central longitudinal axis. The medical device includes a handled, coupled to the proximal end of the microcannula. The microcannula includes multiple orifices, extending circumferentially about the microcannula distal end. Each orifice defines a channel extending transverse to the central longitudinal axis, and one or more grooves about a circumference of the microcannula.

In some implementations, an outer diameter of the microcannula varies along a length of the microcannula.

In some implementations, an inner diameter of the microcannula varies along a length of the microcannula.

In some implementations, a first orifice among the orifices is spaced <NUM> degrees apart from a second orifice among the multiple of orifices.

In some implementations, each of the one or more grooves have a depth between <NUM> and <NUM>.

In some implementations, each of the one or more grooves are formed proximal to the orifices.

In some implementations, each of the one or more grooves is spaced apart from another groove by a distance between <NUM> and <NUM>.

At least one aspect is directed to a medical device that includes a first cannula having a distal end, and a cavity, the first cannula having a central longitudinal axis, and protrusions. The protrusions of the first cannula extend circumferentially at the distal end of the first cannula and are located in the cavity of the first cannula. The medical device includes a second cannula having a distal end, and a cavity. The second cannula is moveably housed within the first cannula and has a central longitudinal axis, protrusions, and a plurality of orifices extending circumferentially about the distal end of the second cannula. The protrusions of the second cannula extend circumferentially at the distal end of the second cannula and are located on an outer circumferential surface of the second cannula. A first orifice among the plurality of orifices is positioned parallel to a second orifice among the plurality of orifices.

In some implementations, the second cannula includes one or more grooves about a circumference of the second cannula.

In some implementations, the one or grooves of the second cannula are located at the distal end of the second cannula.

In some implementations, the one or more grooves are equidistantly spaced apart.

In some implementations, each of the protrusions of the first cannula are equidistantly spaced apart.

In some implementations, the protrusions of the second cannula are proximal to a user than the protrusions of the first cannula when the distal end of the second cannula is within the first cannula.

In some implementations, the protrusions of the second cannula are distal to a user than the protrusions of the second cannula when at least a portion of the distal end of the second cannula is moved outside of the distal end of the first cannula.

At least one aspect is directed to a method of delivering fluid into the eye. The method includes inserting a microcannula through an incision in an anterior chamber of an eye. The microcannula including a proximal end, a distal end, and a cavity, the microcannula having a central longitudinal axis. Advancing the microcannula distal end through a trabecular meshwork of an eye and into Schlemm's canal of an eye. Delivering fluid through a plurality of orifices each of which being positioned within Schlemm's canal, each orifice defining a channel extending circumferentially about the microcannula distal end.

In some implementations, the channel of the orifice of the plurality of orifices extends transverse to the central longitudinal axis.

In some implementations, the microcannula includes one or more grooves about a circumference of the microcannula at the distal end of the microcannula.

In some implementations, the microcannula includes one or more protrusions extending circumferentially at the distal end of the microcannula and located on an outer circumferential surface of the microcannula. The microcannula is movably housed within a second cannula, the second cannula having one or more protrusions extending circumferentially at a distal end of the second cannula and located a cavity of the second cannula.

In some implementations, the step of advancing the microcannula distal end further includes applying a force to the microcannula to move the one or more protrusions of the microcannula distal to a user and past the one or more protrusions of the second cannula.

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

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

As shown in <FIG>, an exemplary device <NUM> includes a handle <NUM> coupled to a microcannula <NUM> via a connector <NUM>. For example, a proximal end <NUM> or region of microcannula <NUM> is coupled to a distal end <NUM> or region of handle <NUM> via connector <NUM>. Connector <NUM> includes a lumen <NUM> (<FIG>) extending through a reinforcement shaft or tube <NUM> and a connector body <NUM>. A proximal end of connector <NUM> may be threadably or otherwise fixedly coupled to distal end <NUM> of handle <NUM>, while proximal end <NUM> of microcannula <NUM> extends through lumen <NUM> of connector <NUM> and is fixedly coupled (e.g., glued, welded, or otherwise secured) to connector <NUM>. In such a manner, microcannula <NUM> is fixedly coupled to handle <NUM>.

A radially outer circumferential surface of connector body <NUM> may be knurled, ribbed, or otherwise textured to enhance a medical professional's grasp of handle <NUM>. In some arrangements, at least one of connector <NUM> and distal end <NUM> includes a fluid luer port (not shown). The fluid luer port may extend radially away from connector <NUM> and/or distal end <NUM>, and may be configured for connection to interchangeable external reservoirs. In such a manner, a reservoir <NUM> (<FIG>) positioned within handle <NUM>, may be selectively refilled as needed or desired by a medical professional, as will be described in further detail below.

As shown in <FIG>, microcannula <NUM> includes a working length L, e.g., a length extending between a proximal end of tube <NUM> and a distal-most end of microcannula <NUM> between about <NUM> and about <NUM>. In some implementations, working length L may be about <NUM>. In some implementations, the working length L may be about <NUM>. As shown in <FIG>, in some implementations, a diameter D of microcannula <NUM> may be between about <NUM> and about <NUM>. A distal end <NUM> of microcannula <NUM> is rounded or otherwise atraumatic (e.g., blunt, unsharpened, etc.) and includes a plurality of orifices <NUM>. For example, distal end <NUM> of microcannula <NUM> includes four orifices <NUM> (only two orifices <NUM> being visible in <FIG>) equidistantly spaced about a circumference of distal end <NUM>. Each orifice <NUM> may have an orifice diameter O, between <NUM> and <NUM>. In some implementations, diameter O of each orifice <NUM> is about <NUM>. In some implementations, diameter O of each orifice <NUM> is about <NUM> While four equidistantly spaced orifices <NUM> are illustrated and described, in other arrangements, more or less orifices <NUM> may be positioned about the circumference of distal end <NUM> and may be equidistantly or non-equidistantly spaced. For example, as shown in <FIG>, the distal end <NUM> includes two orifices <NUM>. In some implementations, orifices <NUM> are positioned about <NUM> degrees apart from each other about the circumference of distal end <NUM>, as shown in <FIG> (only one of the two orifices <NUM> being visible in <FIG>). Additionally, in some arrangements, orifices <NUM> may be positioned at varying axial locations along distal end <NUM>. In some implementations, orifices <NUM> are arranged for delivery of a fluid (e.g., liquid or gas) or other substance from a reservoir <NUM> (<FIG>) and extend at an angle non-perpendicular to a central axis C of microcannula <NUM>, as will be described in further detail below. In some implementations, orifices <NUM> are arranged for delivery of a fluid or other substance from the reservoir <NUM> and extend at an angle perpendicular to the central axis C of microcannula <NUM>.

In some implementations, microcannula <NUM> may have an outer diameter with varying sizes along the length of the microcannula <NUM>. For example, as shown in <FIG>, outer diameter OD1 near the proximal end of microcannula <NUM> may be between about <NUM> and about <NUM>, such as about <NUM>, and outer diameter OD2 near the distal end of microcannula <NUM> may be between about <NUM> and about <NUM>, such as about <NUM>. The outer diameter of microcannula <NUM> may taper down near a terminal end of microcannula <NUM>. For example, in <FIG>, the outer diameter OD1 of micro cannula <NUM> is tapered down to OD2 near the terminal end <NUM> of microcannula <NUM>. A first outer diameter of microcannula <NUM> may taper down starting from a certain distance away from a terminal end of microcannula <NUM>. For example, in <FIG>, the outer diameter OD1 may be tapered down starting from <NUM> away from the terminal end <NUM> of microcannula <NUM>. A first outer diameter of microcannula <NUM> may be gradually tapered down to a second outer diameter. For example, in <FIG>, starting from <NUM> away from the terminal end <NUM> of microcannula <NUM>, the outer diameter OD1 is tapered down gradually from <NUM> to the outer diameter OD2 of <NUM> near the terminal end <NUM>.

Microcannula <NUM> may have an inner diameter with varying sizes along the length of the microcannula <NUM>. For example, an inner diameter near the proximal end of microcannula <NUM> may be between about <NUM> and <NUM>, such as <NUM>, and an inner diameter near the distal end of the microcannula <NUM> may be of a different size than the inner diameter near the proximal end. In some implementations, the inner diameter of microcannula <NUM> may be tapered down from the inner diameter near the proximal end to the inner diameter near the distal end starting from a certain distance away from the terminal end of microcannula <NUM>. In some implementations, the inner diameter of microcannula <NUM> may be tapered down starting from the location of a circumferential groove on the microcannula <NUM>, for example, a circumferential groove closest to the proximal end of microcannula <NUM>, such as circumferential groove 99a in <FIG>. In some implementations, the inner diameter of microcannula <NUM> is tapered down at the same rate as the outer diameter of microcannula <NUM> is tapered down, 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 implementations, inner diameter of microcannula <NUM> is tapered down starting from the same location on the microcannula <NUM> as outer diameter of microcannula <NUM> is tapered down. For example, as described above, outer diameter of microcannula <NUM> may be tapered down from OD1 starting from a location on microcannula <NUM> that is <NUM> away from terminal end <NUM> of microcannula <NUM>, and similarly, inner diameter of microcannula <NUM> may be tapered down from a first size starting from a location that is <NUM> away from the terminal end <NUM> of microcannula <NUM>.

Microcannula <NUM> may include one or more grooves about the circumference of microcannula <NUM> (referred to herein as "circumferential grooves"), such as circumferential grooves 99a, 99b, 99c. In some implementations, as shown in <FIG>, microcannula <NUM> include three such circumferential grooves. Each circumferential groove may be spaced apart from another circumferential groove on microcannula <NUM> by a distance gd, as shown in <FIG>. The distance gd may be between about <NUM> and about <NUM>. For example, the distance gd between circumferential grooves 99a, 99b, and 99c in <FIG> may be about <NUM>. Each circumferential groove may be of depth gDe, as shown in <FIG>. The depth gDe may be between about <NUM> and <NUM>. In some implementations, circumferential grooves have depth gDe of <NUM>. As shown in <FIG>, circumferential grooves may be formed near the distal end of microcannula <NUM>. In some implementations, circumferential grooves may be formed starting from a location on microcannula <NUM> that is between about about <NUM> away and <NUM> away from the terminal end <NUM> of microcannula <NUM>, for example, starting from about <NUM> away from the terminal end <NUM> of microcannula <NUM>. In some implementations, the distal portion of the microcannula <NUM>, starting from a location on microcannula <NUM> that is between about <NUM> away and <NUM> away from terminal end <NUM> of microcannula <NUM>, is configured to be a rough shaft.

In some implementations, microcannula <NUM> may include one or more protrusions about the circumference of microcannula <NUM> (referred to herein as "circumferential protrusions"). Each circumferential protrusion may be spaced apart from another circumferential protrusion on microcannula <NUM> by a certain distance, such as a distance between about <NUM> and about <NUM>. In some implementations, each circumferential protrusion may be about <NUM>. Each circumferential protrusion may be of a certain height between about <NUM> and <NUM>. In some implementations, circumferential protrusions have height of <NUM>. Circumferential protrusions may be formed near the distal end of microcannula <NUM>. In some implementations, circumferential protrusions may be formed starting from a location on microcannula <NUM> that is between about about <NUM> away and <NUM> away from the terminal end <NUM> of microcannula <NUM>, for example, starting from about <NUM> away from the terminal end <NUM> of microcannula <NUM>. Microcannula <NUM> may be formed of various materials including, but not limited to, polymethyl methacrylate (PMMA), polyimide, various types of silicones, such as high durometer silicone, and the like. Microcannula <NUM> may include or be coupled to a fastening mechanism. An example of such a fastening mechanism is a luer lock, such as luer lock <NUM>, shown in <FIG>. In some implementations, the fastening mechanism may be configured with an external thread profile, such as the external thread profile <NUM> of luer lock <NUM> shown in <FIG>. In some implementations, microcannula <NUM> is attached or coupled to a fastening mechanism, such as a luer lock <NUM>, at the proximal end of microcannula <NUM>. In some implementations, connector body <NUM> may be configured to accept the fastening mechanism. For example, if the fastening mechanism includes an external thread profile, connector body <NUM> may be configured with an internal thread profile (not shown) near the distal end of connector body <NUM> to accept the fastening mechanism.

In some implementations, exemplary device <NUM> may include multiple cannula and/or microcannula, such as outer cannula <NUM>, inner cannula <NUM>, as shown in <FIG>. Inner cannula <NUM> may be housed within outer cannula, as shown in <FIG>. In <FIG>, outer cannula <NUM> may have an outer diameter between <NUM> and <NUM>, such as about <NUM>, <NUM>, or <NUM>. In some implementations, outer cannula <NUM> has an inner diameter between <NUM> and <NUM>. Outer cannula <NUM> includes one or more protrusions, such as protrusions 220a, 220b, collectively protrusions <NUM>. Protrusions <NUM> are located on the inside of the outer cannula <NUM>, such as on the inner circumferential surface of the outer cannula <NUM>. Protrusions <NUM> may be equidistantly or non-equidistantly spaced apart from each other. Protrusions <NUM> may be protruding notches, extensions, and the like. In some implementations, protrusions <NUM> extend towards each other. Outer cannula <NUM> is coupled to a distal end of handle <NUM>, such as distal end <NUM> via connector <NUM>. As described above, inner cannula <NUM> is housed within outer cannula <NUM>. Inner cannula <NUM> is also housed within handle <NUM> and is configured to extend out from handle <NUM> and retract into handle <NUM>. A control unit, such as actuator <NUM>, is configured to control the extension and retraction of inner cannula <NUM>.

Inner cannula <NUM> includes one or more protrusions, such as protrusions 240a, 240b, collectively referred to herein as protrusions <NUM>, as shown in <FIG>. Protrusions <NUM> may be equidistantly or non-equidistantly spaced apart from each other and located on the outer circumferential surface of inner cannula <NUM>. Protrusions <NUM> may be located on the inner cannula <NUM> at locations that align with protrusions <NUM> such that protrusions <NUM> engage protrusions <NUM> when inner cannula <NUM> is extended out a certain distance from distal end of handle <NUM>, such as distal end <NUM>, and prevent inner cannula <NUM> from extending any further until a threshold amount of force is applied to an actuator to further extend the inner cannula <NUM>. Application of threshold amount of force to the actuator extends the inner cannula <NUM> by causing protrusions <NUM> to depress protrusions <NUM>. Protrusions <NUM> may be configured to be depressed into the outer cannula <NUM>. Application of the threshold amount of force causes the inner cannula <NUM> to quickly penetrate trabecular meshwork <NUM>, as shown in <FIG>. In some implementations, inner cannula <NUM> may include circumferential grooves, such as circumferential grooves 99a, 99b, and 99c, as shown in <FIG>. In some implementations, inner cannula <NUM> may include one or more orifices, such as orifices <NUM>, positioned about the circumference of a distal end of inner cannula <NUM>. The orifices of inner cannula <NUM> may be equidistantly or non-equidistantly spaced. In some implementations, orifices of inner cannula <NUM> are positioned about <NUM> degrees apart from each other about the circumference of distal end of inner cannula <NUM>, similar to position of orifices <NUM>, described above, and as shown in <FIG>. In some implementations, orifices of inner cannula <NUM> may be positioned at varying axial locations along distal end of inner cannula <NUM> and orifices of inner cannula <NUM> are arranged for delivery of a fluid (e.g., liquid or gas) or other substance from a reservoir, such as reservoir <NUM>, as shown in <FIG>. In some implementations, the orifices of inner cannula <NUM> extend at an angle non-perpendicular or transverse to a central axis of inner cannula <NUM>.

Handle <NUM> may have an ergonomic shape designed to be held comfortably in the hand, e.g., the palm of the dominate hand of a medical professional. Handle <NUM> may have a length between about <NUM> (<NUM> inches) and about <NUM> (<NUM> inches). Handle <NUM> may include a proximal end <NUM>, distal end <NUM>, and a channel or track <NUM> extending there between, as will be descried in further detail below. Proximal end <NUM> and distal end <NUM> have a generally circular cross-sectional shape. Alternatively, proximal end <NUM> and distal end <NUM> may have any other cross-sectional shape (e.g., oval, polygonal, irregular, etc.) without departing from the scope of this disclosure. In some arrangements, the cross-sectional shape of proximal end <NUM> and/or distal end <NUM> may vary along the length of handle <NUM> and/or be different from each other. Optionally, proximal end <NUM> may be tapered or narrowed in a proximal direction, as shown.

Handle <NUM> includes an actuator <NUM>. Actuator <NUM> includes a button or slide <NUM> received within track <NUM> of handle <NUM>. In some arrangements, slide <NUM> may be at least partially bent or folded, as shown in <FIG> and <FIG>. Alternatively, slide <NUM> may have any appropriate shape. A first end <NUM> (e.g., a distal end) of slide <NUM> may be fixedly (e.g., permanently fixed, non-separable, fixed throughout use, welded, glued, and/or heat staked, etc.) to a sled, carriage, and/or actuator body <NUM> movably positioned (e.g., slidably, translatable, etc.) within handle <NUM>. For example, actuator body <NUM> may move, slide, or translate along an axis (e.g., a central longitudinal axis of handle <NUM> or an axis parallel thereto) with respect to handle <NUM>, as will be described in further detail below. Additionally, a second end <NUM> (e.g., proximal end) of slide <NUM> includes a protrusion or projection sized to be received within track <NUM>, as will be described in further detail below. As shown, second end <NUM> is angled, tapered, or slanted to facilitate movement along track <NUM>, as will be described in further detail below. In some implementations, actuator <NUM> may be a push button, such as push button <NUM>, as shown in <FIG>, a scroll wheel <NUM>, as shown in <FIG>, a slider <NUM>, as shown in <FIG> and the like. In some implementations, actuator <NUM> may be configured to be squeezed, such as actuator <NUM>, as shown in <FIG>, to control delivery of fluid via microcannula <NUM>.

In some implementations, microcannula <NUM> is housed within an outer tube, such as outer tube <NUM>, as shown in <FIG>. The outer tube <NUM> includes an opening or cut out such as opening <NUM>. In some implementations, the opening or cutout <NUM> is located at the distal end of outer tube <NUM>, as shown in <FIG>. The outer tube <NUM> extends to the handle <NUM> and is configured to be rotated by a control mechanism located proximal to the handle <NUM>. Rotating the outer tube <NUM> may expose or hide one or more orifices on the microcannula <NUM>, such as orifices <NUM> at the distal end. For example, as shown in <FIG>, rotating the outer tube <NUM>, such that the opening <NUM> is moved from the position in <FIG> to the position in <FIG>, the orifices <NUM> exposed in <FIG> are now hidden in <FIG>.

In some implementations, microcannula <NUM> is movably housed within an outer sheath, such as outer sheath <NUM>, as shown in <FIG>. Microcannula <NUM> is configured to extend out of a distal end of outer sheath <NUM> in response to a user interaction with a control mechanism configured to extend and retract at least a portion of microcannula <NUM>, such as the tip of microcannula <NUM>, out of and in to outer sheath <NUM>, respectively. For example, a user may apply a threshold amount of force to an actuator coupled to the microcannula <NUM>, in the direction configured to cause the microcannula <NUM> to extend outside of the outer sheath <NUM>, in order to extend the microcannula <NUM> outside of the outer sheath <NUM>, as shown in <FIG>. In some implementations, the outer sheath <NUM> is configured to move in the direction proximal to a user of medical device <NUM> causing at least a portion of the microcannula <NUM>, such as the tip of the microcannula <NUM>, to be exposed outside of the outer sheath <NUM>, as shown in <FIG>. The outer sheath <NUM> may move in the direction proximal to the user in response to pressing the distal portion of the outer sheath <NUM> against the trabecular meshwork of a patient.

The application of the threshold amount of force to an actuator coupled to the microcannula <NUM>, causing at least a portion of the microcannula <NUM> to extend outside of the outer sheath <NUM>, causes at least that portion of the microcannula <NUM> to penetrate the trabecular meshwork of a patient, such as trabecular meshwork <NUM> (shown in <FIG>), when the microcannula <NUM> is advanced near the trabecular meshwork of the patient. Similarly, in implementations where the outer sheath <NUM> is configured to move in the direction proximal to a user of the medical device <NUM> in response to pressing the distal portion of the outer sheath <NUM> against the trabecular meshwork, the exposed portion of the microcannula <NUM> or a portion of the exposed portion of the microcannula <NUM> may penetrate the trabecular meshwork.

Track <NUM> extends through a radially outer wall of handle <NUM> with respect to the central longitudinal axis of handle <NUM>. Accordingly, slide <NUM> may extend radially outwardly of the center axis through track <NUM>. As shown, track <NUM> may be notched such that pairs of inwardly protruding notches, extensions, or flanges <NUM> extend towards each other to narrow a width of track <NUM> at a plurality of axially spaced locations along the length of track <NUM>. In other words, track <NUM> extends longitudinally along handle <NUM> and has a width, extending in a direction perpendicular the longitudinal length of track <NUM>. The width of track <NUM> varies along the length of the track <NUM> such that each location of track <NUM> having a pair of flanges <NUM> has a smaller or more narrow width than a width of track <NUM> at a location devoid of one or more flanges <NUM>. An axial spacing between adjacent pairs of flanges <NUM> may directly correlate to an amount of a single dose or quantity of a substance (e.g., a fluid or gas) for injection via microcannula <NUM>, as will be described in further detail below. Additionally, it is understood that slide <NUM> may be replaced with any appropriate actuator, e.g., wheel, button, toggle, or the like, without departing from the scope of this disclosure.

Turning to <FIG> and <FIG>, as noted above, connector <NUM> facilitates coupling between microcannula <NUM> and handle <NUM>. For example, a proximal end <NUM> of connector <NUM> may be received radially within a cavity <NUM> of distal end <NUM> of handle <NUM>. Proximal end <NUM> and cavity <NUM> may be correspondingly threaded to facilitate secure engagement therebetween. As noted above, proximal end <NUM> of microcannula <NUM> extends through lumen <NUM> of connector <NUM> and may be fixedly coupled (e.g., glued, welded, or otherwise secured) to connector <NUM>. Additionally, connector <NUM> includes a tube, shaft, or other such support <NUM> received within lumen <NUM> of connector <NUM>, and within a lumen <NUM> of distal end <NUM> of handle <NUM>.

A piston assembly including a piston rod <NUM> extends proximally through a central lumen <NUM> of microcannula <NUM>, through lumen <NUM> of connector <NUM>, through lumen <NUM> of distal end <NUM> of handle <NUM>, and towards actuator body <NUM> housed within a cavity <NUM> of handle <NUM>. Piston rod <NUM> may be reciprocally disposed within central lumen <NUM>. A proximal end of piston rod <NUM> is fixedly coupled to actuator body <NUM> such that distal advancement of actuator body <NUM> will result in likewise distal advancement of piston rod <NUM>. As shown in <FIG>, piston rod <NUM> is coupled to a piston head <NUM> and is axially moveable relative to central lumen <NUM> of microcannula <NUM>. A piston passage <NUM> extends through piston rod <NUM>, through piston head <NUM>, and terminates distally in a piston orifice <NUM>. A one-way or other suitable valve <NUM> may be arranged within the piston passage <NUM> to prevent, inhibit, or block backflow of fluid or other substances, e.g., proximally directed flow.

In order to deliver fluid or other substances from reservoir <NUM>, a medical professional may advance slide <NUM> distally towards microcannula <NUM>. Due to the connection between first end <NUM> and actuator body <NUM>, and the connection between actuator body <NUM> and piston rod <NUM>, distal advancement of slide <NUM> advances piston head <NUM> towards orifices <NUM> to deliver fluid or other substances within central lumen <NUM> through orifices <NUM>. Any appropriate mechanism may be used to urge fluid or substances within reservoir <NUM> through the piston passage <NUM>, through the one-way valve <NUM> within the piston passage <NUM>, and into the cavity <NUM>. For example, reservoir <NUM> may be compressed thereby pushing fluid or other substances into and through the piston passage <NUM>. Alternatively, fluid or other substances may be drawn through piston passage <NUM> via capillary action, via a micro pump (e.g., a MEMS pump) or any other suitable pump (not shown).

In some implementations, as shown in <FIG>, a fill port <NUM> may be in fluid communication with reservoir <NUM> and visco may be injected into the reservoir <NUM> via the fill port. A one-way valve <NUM> may be attached to a distal end of the reservoir <NUM> and a plunger <NUM> may be attached to a proximal end of reservoir <NUM>. A valve spring <NUM> is coupled to plunger <NUM> and one-way valve and <NUM>. Actuation or compression of plunger <NUM> compresses visco and opens the one-way valve <NUM>, causing visco to eject through an orifice <NUM> on the distal end <NUM> of microcannula <NUM>. Plunger <NUM> may be actuated mechanically or electrically. In some implementations, plunger <NUM> may be actuated by a gas, such as carbon dioxide, CO2. In some implementations plunger <NUM> may be coupled to a phaco system and actuated by the phaco system.

In some implementations, handle <NUM> may include a visco bag and a button communicatively coupled to the visco bag with the visco bag in communication with an orifice <NUM> on the distal end <NUM>. Depression of the button compresses visco bag and causes visco fluid to eject through the orifice <NUM> on the distal end <NUM>. In some implementations, as shown in <FIG> handle <NUM> includes a flexible bulb <NUM> 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 <NUM> to be directed to an orifice <NUM> at the distal end <NUM>.

As shown in <FIG>, each orifice <NUM> may be a channel angled relative to an axis of the microcannula <NUM>, such as the central axis C of the microcannula <NUM>. As described above, an orifice <NUM> may extend at an angle perpendicular or non-perpendicular to an axis of the microcannula <NUM>, such that the channel is angled perpendicularly or non-perpendicularly to the axis of the microcannula <NUM>. In addition, each orifice may have one or more openings having a tapered configuration. For example, a first end (e.g., a radially inner end) of each orifice <NUM> may be positioned at a first axial location along the length L of microcannula <NUM> while a second end (e.g., a radially outer end) of each orifice <NUM> may be positioned at a second axial location along the length L of microcannula <NUM>. In some embodiments, the second axial location may be proximal of the first axial location. In other embodiments, the second axial location may be distal to the first axial location. In such a manner, a channel defined by each orifice <NUM> may be angled relative to central longitudinal axis C. In other words, the first end of each orifice <NUM> is positioned radially closer to the central longitudinal axis C (and distally or proximally of the second end of each orifice <NUM> along an axis parallel to central longitudinal axis C), while the second end of each orifice <NUM> is positioned radially farther away from central longitudinal axis C (and proximally or distally of the first end of each orifice <NUM> along an axis parallel to central longitudinal axis C). For example, a channel defined by orifice <NUM> may extend at an angle α relative to central longitudinal axis C of between about <NUM>° and about <NUM>° degrees. Accordingly, during delivery of fluid or other substance from central lumen <NUM> through orifices <NUM>, the fluid or other substance will necessarily flow proximally (e.g., from a distal location towards a proximal location) or distally and radially away from microcannula <NUM>.

As noted above, axial spacing between adjacent pairs of flanges <NUM> of track <NUM> correlates to an amount of a single dose or quantity of fluid or other substance for injection via microcannula <NUM>. For example, before advancement of slide <NUM>, second end <NUM> of slide <NUM> is positioned between two adjacent first pairs of flanges <NUM>, thus preventing inadvertent advancement (or retraction) of slide <NUM> and injection of fluid or other substances through orifices <NUM>. To advance slide <NUM> and inject fluid or other substances via orifices <NUM>, a medical professional must first overcome the resistance provided by the two adjacent first pairs of flanges <NUM> against the second end <NUM> of slide <NUM>, and then continue advancing slide <NUM> to push or urge fluid or other substances in central lumen <NUM> distal of piston head <NUM> through orifices <NUM>. That is, as slide <NUM> is urged distally forward, the angled or slanted surface of second end <NUM> will slide or move along surfaces of flanges <NUM> until second end <NUM> deflects radially inwardly towards the central axis of handle <NUM> and is positioned underneath flanges <NUM>, at which point slide <NUM> can continue advancement distally.

As slide <NUM> continues distal advancement, second end <NUM> may be received between two adjacent second pairs of flanges <NUM> and retained therein, thus preventing further inadvertent advancement. For example, second end <NUM> may deflect radially outwardly away from the central axis of handle <NUM> (returning towards an undeflected orientation). It is understood, second end <NUM> may be biased radially outwardly toward the undeflected orientation. The two second adjacent pairs of flanges <NUM> may be adjacent (e.g., next to) the two adjacent first pairs of flanges <NUM>. In other words, as slide <NUM> is advanced distally, interaction between second end <NUM> and each two adjacent pairs of flanges <NUM> will cause an increase of resistance exerted to the medical professional, thereby resulting in a tactile indication that a specified dose or amount of fluid or substance has been delivered through orifices <NUM>.

In some implementations, as shown in the exploded view of <FIG>, the tip of microcannula <NUM> includes a machined cap <NUM> that may be laser welded on to the tip of microcannula <NUM>, as shown in <FIG>. In some implementations, as shown in the exploded view of <FIG>, wire <NUM> may be adhered to the tip of the microcannula <NUM> using an adhesive material, such as epoxy. The resulting tip shown in <FIG>. In some implementations, wire may be laser welded on to the tip of microcannula <NUM>. Tip of microcannula <NUM> may be encapsulated with silicone over mold <NUM>, in some implementations, as shown in <FIG> and in the rotated view of <FIG>. The silicon overmold <NUM> may include one more slits <NUM> in some implementations, as shown in <FIG>. In some implementations, as shown in the exploded view of <FIG>, polyimide overmold 406a and 406b, and a core pin <NUM> may be used to encapsulate the tip of the microcannula <NUM>, resulting in the microcannula <NUM> and tip configuration, as shown in the <NUM> degrees rotated view of <FIG>. In some implementations, tip of microcannula <NUM> is configured with soft polymer material to prevent penetration into certain portions of the patient, such as sclera. In some implementations, tip of microcannula <NUM> includes a light source, such as a light emitting diode, which is configured to produce light at the trabecular meshwork in response to receiving an input to produce light, such as powering on the light source.

In some implementations, microcannula <NUM> includes a nitinol (NiTi) tube at the distal end of microcannula <NUM>. The NiTi tube may be configured to the The NiTi tube at the distal end is configured to one bend in a certain direction after the NiTi tube travels a certain distance. In some implementations, handle <NUM> includes a control mechanism coupled to the NiTi tube and the control mechanism is configured to rotate NiTi tube <NUM> degrees in response to receiving an input or a user interacting with the control mechanism.

<FIG> illustrate an exemplary method of using device <NUM> to deliver a substance (e.g., a fluid or gas) into, e.g., Schlemm's canal <NUM> or any other suitable portion of a patient's eye. As noted above, in a healthy eye, a stream of aqueous humor <NUM> drains out of the anterior chamber <NUM> of the eye, through the trabecular meshwork <NUM> and then into Schlemm's canal <NUM> and distal collector channels. The aqueous humor <NUM> then exits through Schlemm's canal <NUM> into the collector channels and distal venous system. When this flow path of aqueous humor <NUM> is interrupted (e.g., due to diseased or damaged tissue in the trabecular meshwork <NUM> and/or Schlemm's canal <NUM>), the IOP of an eye may rise, potentially resulting in a variety of medical concerns (e.g., glaucoma, loss of vision, optic nerve damage, etc.). In order to improve the flow path of aqueous humor <NUM>, a medical professional may insert microcannula <NUM> through an incision <NUM> made in the anterior chamber <NUM> and advance distal end <NUM> of microcannula <NUM> through the trabecular meshwork <NUM> and into Schlemm's canal <NUM>, as shown in <FIG>. Optionally, distal end <NUM> may be curved such that insertion of microcannula <NUM> into Schlemm's canal <NUM> may be accomplished by inserting distal end <NUM> tangentially to Schlemm's canal <NUM> (e.g., in a manner similar to that of insertion of an IV needle into a vein) rather than directly pushing into Schlemm's canal <NUM> via the distal-most end of microcannula <NUM>.

Turning now to <FIG>, once distal end <NUM> of microcannula <NUM> is inserted into Schlemm's canal <NUM> such that each orifice <NUM> is fully housed within Schlemm's canal <NUM>, the medical professional may inject a pre-defined dose or amount of fluid or other substance from reservoir <NUM> via actuation of slide <NUM> (<FIG>, <FIG>, and <FIG>) as discussed above. Further, since advancement of slide <NUM> is limited due to the interaction of second end <NUM> and flanges <NUM>, each pre-defined dose or amount of fluid or substance to be injected upon each incremental advancement of slide <NUM> is accurate and precise. For example, each "dose" may be <NUM> microliters +/- <NUM> microliters.

After injection of a pre-defined dose or amount of fluid or other substance through orifices <NUM> (<FIG> and <FIG>), microcannula <NUM> may be rotated between about <NUM>° and about <NUM>°, e.g., between about <NUM>° and about <NUM>° about central axis C (<FIG>) of microcannula <NUM>. Once rotated, the medical professional may inject an additional pre-defined dose or amount of fluid or other substance from reservoir <NUM> via actuation of slide <NUM> (<FIG>, <FIG>, and <FIG>) as discussed above. This process may be repeated any appropriate number of times, e.g., about six times, and then microcannula <NUM> may be removed from incision <NUM>.

Optionally, after the injection of one or more pre-defined doses of fluid or other substance at a certain location within Schlemm's canal <NUM> (e.g., without relocating (other than rotating) distal end <NUM> of microcannula <NUM>), distal end <NUM> may be retracted and repositioned within the eye. In some arrangements, such repositioning may occur via withdrawal of microcannula <NUM> from incision <NUM> (e.g., a first incision <NUM>), and reinsertion through an additional incision <NUM>, spaced from the first incision <NUM>. In some implementations, fluid may be delivered into the Schlemm's canal <NUM> and trabecular meshwork <NUM> simultaneously, causing the Schlemm's canal <NUM> to open and deliver the fluid into the various layers of the trabecular meshwork <NUM>. Alternatively, such repositioning may include retraction of distal end <NUM> from Schlemm's canal <NUM> and/or trabecular meshwork <NUM> and then relocation into a new portion of Schlemm's canal <NUM> without removal of microcannula <NUM> from the first incision <NUM>. In either case, distal end <NUM> of microcannula <NUM> may be positioned approximately <NUM>-<NUM>° away from the original insertion site.

The substance located within reservoir <NUM>, and injected via orifices <NUM> may be any appropriate substance. For example, the substance may comprise viscoelastic fluid such as, e.g., sodium hyaluronate and chondroitin sulfate. Viscoelastic fluid is a highly pliable, gel-like material which helps provide enough space for adequate drainage and eye pressure relief by expanding tissue structures away from one another, to re-open or expand a flow path of aqueous humor <NUM>. Viscoelastic fluid also may clear an obstructed view by expanding bleeding structures away from one another to improve visualization.

In another arrangement, reservoir <NUM> may be filled with stem cells, medicaments, a gas (e.g., SF6 or C3F8), and/or dyes (e.g., trypan blue dye). Injected dye, for example, will flow through the trabecular meshwork <NUM>, enhancing visualization of aqueous humor <NUM> fluid flow to determine which areas, if any, of the trabecular meshwork <NUM> remain blocked, collapsed, or otherwise impede flow of aqueous humor <NUM>. Injected stem cells, on the other hand, may initiate growth of healthy tissues within the eye (e.g., to develop healthy trabecular meshwork <NUM> to enhance drainage of aqueous humor <NUM> there through).

In some arrangements, a first substance is injected into one or more locations of the eye, the reservoir <NUM> is refilled with a second substance different than the first substance, and then the second substance is injected into one or more locations of the eye. Additionally, this process may be repeated as necessary to deliver each selected substance. For example, as noted above one or both of connector <NUM> and distal end <NUM> may include a fluid luer port (not shown), through which reservoir <NUM> may be selectively refilled. Accordingly, a plurality of substances, e.g., viscoelastic, medicament, stem cells, and dye, may be injected into the eye of a patient to achieve a desired result (e.g., visualize the flow path of aqueous humor <NUM>, expand Schlemm's canal <NUM>, promote tissue regrowth, or to otherwise medicinally treat diseased tissue). Accordingly, during a procedure, a single (e.g., only one) incision <NUM> may be needed to deliver a variety of substances as deemed necessary and/or beneficial by the medical professional, thus reducing trauma, recovery time, medical professional time, and associated fees, etc..

It is to be understood that while the foregoing description describes devices and methods for injection of a fluid or other substance through orifices <NUM>, the disclosure is not so limited. Indeed, device <NUM> described herein may be arranged for precision-controlled aspiration of fluid or other substances away from the eye. For example, rather than distal advancement of slide <NUM> to incrementally inject a pre-defined "dose" or quantity of a substance or fluid radially outwardly of microcannula <NUM> via orifices <NUM>, proximal retraction of slide <NUM> may incrementally draw (e.g., suction, pull, etc.) fluid or other substances (e.g., tissue, blood, aqueous humor <NUM>, etc.) out of Schlemm's canal <NUM> for removal from the eye. In other words, device <NUM> may be actuated in a reverse manner from that described above to achieve a removal of fluid or other substances from the eye. In arrangements in which device <NUM> is positioned for removal of fluid or other substances from the eye, one or more components of device <NUM> may be reversed (e.g., one-way valve <NUM> may be oriented to permit proximal flow of fluid or other substance while preventing distal flow of fluid or other substance along piston passage <NUM>, etc.). In some embodiments, microcannula <NUM> may be operably coupled to a suitable vacuum source for the generation of suction.

Device <NUM> may be comprised of any appropriate materials. For example, microcannula <NUM> may include one or more of metals (e.g., stainless steel, titanium, nitinol, etc.) or a rigid (e.g., sufficiently rigid to push through trabecular meshwork <NUM> and Schlemm's canal <NUM> without bending or otherwise deforming) polymer (e.g., PEEK, Polyimide, etc.). Exemplary materials also may include polymers transparent to optical coherence tomography (OCT) (e.g., glycol modified polyethylene terephthalate, polyvinal chloride, polymethyl methacrylate, and/or polyphenylsulfone, etc.) such that imaging via OCT can be done simultaneously with positioning of microcannula <NUM> and/or injection of a substance via orifices <NUM> while minimally disrupting the images obtained via OCT.

Additionally, any one or more portions of microcannula <NUM>, e.g., distal end <NUM>, may be radiopaque to enhance visualization by a medical professional during a procedure. Likewise, handle <NUM> may include any one or more metals or polymers, as appropriate. Additionally or alternatively, distal end <NUM> may include a light-emitting diode (LED) (not shown). When the LED is lit, the medical professional may be able to see the light through the sclera of the eye, giving the user an indication of the position of microcannula <NUM> in the eye. In some arrangements, one or more radiopaque indicia or other markings may be located at distal end <NUM> of microcannula <NUM> to facilitate visualization of the depth of microcannula <NUM> into the eye of the patient. Additionally, microcannula <NUM> may include a cutting device (e.g., knife, blade, point tip, etc.) (not shown) adjacent distal end <NUM>. In use, such a cutting device may enable a medical professional to cut tissue (e.g., trabecular meshwork <NUM> and/or Schlemm's canal <NUM>) prior to or following injection of a substance via orifices <NUM>. For example, microcannula <NUM>. including the cutting device may be moved side-to-side to cut the tissue lifted due to injection of the substance via orifices <NUM>.

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

A phrase "at least one of" preceding a series of items, with the terms "and" or "or" to separate any of the items, modifies the list as a whole, rather than each member of the list. By way of example, each of the phrases "at least one of A, B, and C" or "at least one of A, B, or C" refers to only A, only B, or only C; any combination of A, B, and C; and/or at least one of each of A, B, and C.

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

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

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

Claim 1:
A medical device (<NUM>) comprising:
a microcannula (<NUM>) configured for insertion into an eye, the microcannula (<NUM>) having a proximal end (<NUM>), a distal tip (<NUM>), a cavity (<NUM>), and a central longitudinal axis (C);
a handle (<NUM>) coupled to the proximal end (<NUM>) of the microcannula (<NUM>);
multiple orifices (<NUM>) extending circumferentially about the distal tip (<NUM>) of the microcannula (<NUM>), each of the orifices (<NUM>) defining a channel angled relative to the central longitudinal axis (C), each of the orifices (<NUM>) having a radially inner end, and a radially outer end positioned radially farther away from the central longitudinal axis (C) than the radially inner end, each of the orifices (<NUM>) being configured to deliver a substance radially outwardly from the distal tip (<NUM>) of the microcannula (<NUM>); and
a plurality of grooves (99a, 99b, 99c) about a circumference of the distal tip (<NUM>) of the microcannula (<NUM>),
wherein an inner diameter of the microcannula (<NUM>) tapers down from a first position of the microcannula (<NUM>) to a second position of the microcannula (<NUM>), wherein the second position is closer to the distal tip (<NUM>) than the first position, and
characterized by wherein the radially outer end is positioned distal to the radially inner end, such that each of the orifices (<NUM>) is configured to deliver the substance distally and radially outwardly from the microcannula (<NUM>).