Systems and methods for drug delivery to ocular tissue

Abstract

Apparatuses and methods for facilitating the guided delivery of a drug into a patient's body organ are disclosed. An apparatus (2500) for facilitating the guided delivery of a drug into a patient's body organ can include a container (2504) configured to package a drug, a needle (2502) having a passage therethrough and a sharp distal tip, and a needle sheath (2506) at least partially surrounding a shaft of the needle. The needle sheath can include a distal surface, wherein the sharp distal tip of the needle can be configured to extend through an opening in the distal surface. The needle sheath can be movable relative to the needle along an axis of the needle to control a distance from the distal surface to the distal tip of the needle.

Description

Cross-reference to related applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 596,998, filed November 8, 2023, and U.S. Provisional Patent Application No. 63 / 600,071, filed November 17, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] Various aspects of this disclosure generally relate to the delivery of drugs to ocular tissues. More specifically, this disclosure relates to instruments and related methods for delivering drugs to, for example, the suprachoroidal space of the eye. introduction

[0003] Eye conditions and diseases can lead to optic nerve damage and visual field loss. Medications, laser surgery, and / or incisional surgery are interventions that can help lower intraocular pressure, salvage existing vision in subjects, and slow the further progression of the aforementioned conditions and / or diseases. Regarding incisional surgery, instruments used to perform the surgical procedure, devices for delivering drug therapy, and methods feasible through such instruments are highly desirable, offering improved outcomes for both users and subjects. Summary of the Invention

[0004] According to an aspect of this disclosure, an apparatus for delivering a drug to ocular tissue may include: a container configured to contain the drug; a needle having a shaft defining a needle axis, a channel through the needle, and a sharp distal tip, wherein the channel is configured to deliver the drug through the needle; and a needle sheath at least partially surrounding the shaft of the needle, wherein the needle sheath may include a distal surface, wherein the sharp distal tip of the needle is configured to extend through an opening in the distal surface; wherein the needle sheath is movable relative to the needle along the needle axis to control the distance from the distal surface to the distal tip of the needle.

[0005] According to another aspect of this disclosure, a device for delivering a drug to ocular tissue may include: a needle having a shaft defining a needle axis and a sharp distal tip, and a needle sheath at least partially surrounding the shaft of the needle. The needle sheath may include a distal surface, wherein the sharp distal tip of the needle is configured to extend through an opening in the distal surface. The needle sheath is movable relative to the needle along the needle axis. The device may further include a dial coupled to one or more of the needle and the needle sheath, wherein rotation of the dial is configured to change the distance from the distal surface to the sharp distal tip.

[0006] In another aspect of this disclosure, a method for delivering a drug to ocular tissue using a delivery device comprising a container configured to package the drug, a needle having a sharp distal tip, and a needle sheath at least partially surrounding a shaft of the needle, the method comprising: adjusting a distance from a distal surface of the needle sheath to the distal tip of the needle; after adjusting the distance, inserting the distal tip of the needle into the ocular tissue; positioning the distal surface of the needle sheath against the outermost surface of the ocular tissue; and delivering a volume of the drug to the ocular tissue via the needle. Attached Figure Description

[0007] The accompanying drawings are incorporated in and form part of this specification, illustrating various examples and, together with the specification, serving to explain the principles of the disclosed examples and embodiments.

[0008] Various aspects of this disclosure can be implemented in conjunction with the embodiments shown in the accompanying drawings. These drawings illustrate different aspects of this disclosure and, where appropriate, reference numerals for similar structures, components, materials, and / or elements are labeled in a similar manner in different figures. It should be understood that various combinations of the structures, components, and / or elements, except those specifically shown, are contemplated and are within the scope of this disclosure.

[0009] Furthermore, numerous embodiments are described and illustrated herein. This disclosure is neither limited to any single aspect or embodiment thereof, nor to any combination and / or substitution of such aspects and / or embodiments. Moreover, each aspect of this disclosure and / or its embodiments may be used alone or in combination with other aspects of this disclosure and / or its embodiments. For the sake of brevity, certain substitutions and combinations are not discussed and / or described separately herein. It is important to note that embodiments or implementations described herein as “exemplary” should not be construed as being superior or better than, for example, other embodiments or implementations; rather, it is intended to reflect or indicate that the embodiments are “example” embodiments.

[0010] Figure 1 This is a perspective view of an exemplary device for treating ocular tissue according to an embodiment of this disclosure.

[0011] Figure 2 This is a cross-sectional view of an exemplary device for treating ocular tissue according to an embodiment of the present disclosure.

[0012] Figure 3 This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0013] Figure 4 This is a cross-sectional view of an exemplary device for treating ocular tissue according to a further embodiment of this disclosure.

[0014] Figure 5 This is a perspective view of an exemplary device for treating ocular tissue according to another embodiment of this disclosure.

[0015] Figure 6A and Figure 6B This is a perspective view of an exemplary device for treating ocular tissue according to yet another embodiment of this disclosure.

[0016] Figure 7 This is a perspective view of an exemplary device for treating ocular tissue according to an embodiment of this disclosure.

[0017] Figure 8 This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0018] Figure 9 This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0019] Figure 10 This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0020] Figure 11A and Figure 11B This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0021] Figure 12 This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0022] Figure 13A , Figure 13B and Figure 13C This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0023] Figure 14A , Figure 14B and Figure 14C Describes the relationship between the quantities related to ocular tissue treatment according to the embodiments of this disclosure.

[0024] Figure 15A , Figure 15B and Figure 15C This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0025] Figure 16A and Figure 16B This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0026] Figure 17A and Figure 17B This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0027] Figure 18A and Figure 18B This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0028] Figure 19 This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0029] Figure 20A and Figure 20B This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0030] Figure 21A , Figure 21B and Figure 21C This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0031] Figure 22A , Figure 22B and Figure 22C This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0032] Figure 23 This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0033] Figure 24A and Figure 24B This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0034] Figure 25A and Figure 25B This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0035] Figure 26A and Figure 26B This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0036] Figure 27 This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0037] Figure 28A and Figure 28B This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0038] Figure 29 This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0039] Figure 30This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0040] Figure 31A and Figure 31B This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0041] Figure 32A and Figure 32B This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0042] Figure 33 This disclosure describes an exemplary device for treating ocular tissues according to embodiments thereof.

[0043] It is worth noting that, for the sake of simplicity and clarity, certain aspects of the accompanying drawings describe the general structure and / or construction of the various embodiments. Descriptions and details of known features and techniques may be omitted to avoid unnecessarily obscuring other features. Elements in the drawings are not necessarily drawn to scale; the dimensions of some features may be enlarged relative to other elements to improve understanding of the exemplary embodiments. For example, those skilled in the art will understand that side views are not drawn to scale and should not be considered as representations of proportional relationships between different components. Side views are provided to aid in illustrating the various parts of the illustrated components and to show their relative positions to each other. Detailed Implementation

[0044] Reference will now be made in detail to the examples of this disclosure shown in the accompanying drawings. Where possible, the same reference numerals will be used throughout the drawings to refer to the same or similar parts. The term "distal" refers to the part furthest from the user when the device is introduced to the subject. In contrast, the term "proximal" refers to the part closest to the user when the device is placed inside the subject. In the following discussion, relative terms such as "about," "substantially," "approximately," etc., are used to indicate possible variations of ±10% in the set values.

[0045] As used herein, the terms “comprises,” “comprising,” “includes,” “including,” or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of components includes not only those components but may also include other components not expressly listed or inherent to such process, method, article, or apparatus. The term “exemplary” is used to mean “example,” not “ideal.” Furthermore, the terms “first,” “second,” etc., used herein do not indicate any order, quantity, or importance, but are used to distinguish an element or structure from another element or structure. Additionally, the terms “a” and “an” used herein do not indicate a limitation of quantity but rather indicate the presence of one or more of the referenced items.

[0046] Various aspects of this disclosure relate to instruments and methods for delivering drugs to ocular tissues. Each aspect disclosed herein may include one or more features described in connection with any other disclosed aspect. It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and do not limit any of the claimed inventions.

[0047] While this disclosure describes certain instruments and methods, additional descriptions relating to the instruments and methods described herein can be found in U.S. Application No. 17 / 444,897 (published as US 2022 / 0047420 A1) and U.S. Application No. 18 / 336,148 (published as US 2023 / 0405238 A1), the entire contents of which are incorporated herein by reference.

[0048] The suprachoroidal space (SCS) is the potential space between the sclera and choroid, traversing the periphery of the posterior segment of the eye. The SCS is a useful site for drug delivery because it targets the choroid, retinal pigment epithelium, and / or the retina with high bioavailability, while remaining at low levels elsewhere in the eye. Under normal physiological conditions, the SCS is primarily in a collapsed state due to intraocular pressure (IOP). The SCS plays a role in maintaining IOP via the uveal-scleral outflow pathway, which is another drainage route for aqueous fluid and a natural flow path from the anterior to the posterior segment of the eye. Due to its role in maintaining IOP, the SCS has the potential to expand and contract in response to the presence of fluid. The SCS can expand to accommodate varying volumes, for example, up to approximately 3.0 mm, depending on the injection volume. Injecting large amounts of medication can produce adverse effects such as increased intraocular pressure, retinal elevation, choroidal hemorrhage and choroidal edema and potential choroidal detachment away from the needle insertion site; needle reflux; and fluid backflow that can lead to subconjunctival hemorrhage. In addition, large amounts of fluid must not be injected into the eye before the needle of the injection device has fully penetrated the sclera.

[0049] To expand the sclera-choroid (SCS), for example by mechanically separating the sclera and choroid and breaking down the fibers holding them together, an instrument can be inserted through the sclera and positioned at the correct depth between the scleral and choroidal layers to inject an optimal volume of fluid (e.g., a drug or other suitable therapeutic agent) into the SCS. Any drug inserted into the SCS allows for direct delivery of medication to the posterior segment of the eye, specifically targeting, for example, the retina and / or the macula. The SCS can also be a useful destination for sustained-release formulations such as long-acting medications. For example, a long-acting medication inserted into the SCS can help treat portions of the posterior segment of the eye, such as the retina, retinal pigment epithelium (RPE), choroid, or other parts. From within the SCS, the long-acting medication can effectively target portions of the posterior segment of the eye without affecting the visual axis. The instruments and methods used for insertion and injection into the eye may only allow extension to a specific depth within the ocular layers. For example, under physiological conditions, the sclera ranges from about 300 µm to about 1100 µm, the SCS has a thickness of about 35 µm, and the choroid ranges from about 50 µm to about 300 µm. The insertion depth of the device used to deliver the drug into the ocular layers can range from about 0.5 mm to about 1.1 mm. However, such insertion depths can penetrate and / or affect other layers of ocular tissue, such as the choroid, retinal pigment epithelium (RPE), and retina. Penetration of these layers should be minimized so that the desired drug can be delivered to the target area of ​​the eye via a minimally invasive procedure. For example, the injection procedure can be performed as an outpatient procedure. The devices and methods discussed in this disclosure address the aforementioned drawbacks and can increase the SCS's ability to contain and diffuse an optimal volume of drug, for example, from about 50 µL to about 500 µL.

[0050] The example embodiments described herein can be used to treat a variety of diseases, including eye diseases. For example, embodiments of this disclosure can be used to treat refractive errors, macular degeneration, cataracts, retinopathy, retinal detachment, glaucoma, amblyopia, strabismus, any other eye disease, or any other disease suitable for treatment via tissues in the eye.

[0051] The descriptions and examples herein are illustrative only and not intended to be restrictive. Many modifications and / or alterations can be made by those skilled in the art without departing from the general scope of the invention. For example, as discussed, aspects of the above embodiments can be used with each other in any suitable combination. Furthermore, portions of the above embodiments can be omitted without departing from the scope of the invention. Additionally, modifications can be made to adapt particular situations or aspects to the teachings of the various embodiments without departing from their scope. Many other embodiments will also be apparent to those skilled in the art upon reviewing the foregoing description.

[0052] Figure 1 and Figure 2 An example of device 10 according to this disclosure is described. Device 10 may include a needle 12 having a channel therethrough configured to serve as a conduit for a drug. The needle 12 may further include a distal tip 18. The distal tip 18 may be a sharp point or a needle configured to penetrate a tissue layer of the eye (e.g., the sclera). The needle 12 may be coupled to a needle hub 112, which may be further coupled to a container (not shown). A drug may be included within the needle 12, the needle hub 112, the container, or any combination thereof. In some examples, the needle 12 may be a posted needle. In other examples, the needle hub 112 may be disposed between the container and the needle 12.

[0053] The components of device 10 may be made of any suitable metal, polymer, and / or combination of metal and / or polymer. Exemplary metallic materials may include stainless steel, nickel-titanium alloys, titanium, and / or alloys of these metals. Exemplary polymeric materials may include polyetheretherketone (PEEK), polyimide, and polyethersulfone (PES). In some examples, the components of device 10 may be made of rigid, semi-rigid, or flexible materials, wherein such materials may be scalable and / or allow for various configurations as discussed herein. The materials of device 10 may be any sterilizable biocompatible material.

[0054] The device 10 may further include an adapter 290. The adapter 290 may be an assembly configured to surround a shaft of the needle 12. The adapter 290 may be positioned relative to the needle seat 112 toward its distal tip 18, to which the needle 12 may be connected. The adapter 290 may include an intermediate surface 292 defining a substantially cylindrical portion of the adapter 290. When the adapter 290 is positioned as part of the needle 12, the longitudinal axis of the substantially cylindrical portion of the adapter 290 may extend parallel to the longitudinal axis of the needle 12. For the purposes of this disclosure, the longitudinal axis of the substantially cylindrical portion should be understood as the longitudinal axis of the adapter 290.

[0055] Adjacent to the intermediate surface 292, the adapter 290 may include a beveled distal surface 294, which is disposed relative to the intermediate surface 292 toward the distal end of the adapter 290. The beveled distal surface 294 may define a substantially truncated conical portion or a partially truncated conical portion of the adapter 290. For example, the beveled distal surface 294 may be oriented at an angle ranging from about 30 degrees to about 60 degrees relative to the longitudinal axis of the adapter 290, at an angle ranging from about 40 degrees to about 50 degrees relative to the longitudinal axis of the adapter 290, or at an angle of about 45 degrees relative to the longitudinal axis of the adapter 290.

[0056] The adapter 290 may further include an outermost inclined surface 298. The outermost inclined surface 298 may be a planar surface adjacent to the intermediate surface 292 and / or the inclined distal surface 294. Alternatively, the outermost inclined surface 298 may be a convex surface configured to abut and overlap the sclera of the patient's eye. Figure 2 As shown, the outermost inclined surface 298 can be oriented at an angle θ relative to the longitudinal axis of the adapter 290. The angle θ can range from approximately 25 degrees to approximately 75 degrees, from approximately 40 degrees to approximately 65 degrees, or from approximately 30 degrees to approximately 60 degrees relative to the longitudinal axis of the adapter 290. In an exemplary embodiment, the angle θ can be approximately 45 degrees relative to the longitudinal axis of the adapter 290.

[0057] The outermost inclined surface 298 can be configured to contact the sclera of the patient's eye in various ways. For example, the outermost inclined surface 298 can be smooth or polished to minimize abrasion of the sclera. Alternatively, the outermost inclined surface 298 can be rough to minimize movement of the adapter 290 relative to the sclera. In some embodiments, the outermost inclined surface 298 may include geometric features such as dimples, recessed dimples, waves, other geometric features, or any combination thereof. Furthermore, a coating may be applied to the outermost inclined surface 298. The coating may be therapeutic, antibacterial, and / or sterile. In some embodiments, a local anesthetic may be applied as a coating to the outermost inclined surface 298. As another example, the outermost inclined surface 298 may be formed on the adapter 290 by an overmolding material. The overmolding material may be selected based on, for example, its surface properties (e.g., roughness, smoothness, etc.) or the suitability of its surface processing (e.g., polishing). The outermost inclined surface 298 may further incorporate various combinations of the above features, such as a polished surface with geometric features, a rough surface with geometric features, an overmolded material with a coating, etc. Although exemplary combinations of features are described herein, these combinations are not intended to be limiting and other combinations may be considered.

[0058] The adapter 290 may include a visible indication of the position of the adapter 290 and / or the outermost inclined surface 298. For example, the outermost inclined surface 298 may be colored differently from the other surfaces of the adapter 290 to distinguish it from the other surfaces. The adapter 290 may also include visible markings to indicate the position of the adapter 290 and / or the outermost inclined surface 298. Such visible markings may include contrasting color markings, texture markings, etc., on the outermost inclined surface 298 and / or the other surfaces of the adapter 290. The visible markings may be applied to the adapter 290 using screen printing, overmolding, etching, or various other suitable techniques. The visible markings may be of any geometry, including circular, elliptical, polygonal, irregular shapes, or any combination thereof.

[0059] The adapter 290 may include a proximal surface 295 and a distal surface 296. The proximal surface 295 may be a substantially circular surface adjacent to the intermediate surface 292 and exist in a plane perpendicular to the longitudinal axis of the adapter 290. The distal surface 296 may also be a substantially circular surface. The distal surface 296 may be adjacent to the inclined distal surface 294 and exist in a different plane perpendicular to the longitudinal axis of the adapter 290. Therefore, the proximal surface 295 may be parallel to the distal surface 296.

[0060] The adapter 290 may include a pinhole 302 in which a pin 12 may be placed. The pinhole 302 may extend parallel or substantially parallel to the longitudinal axis of the adapter 290. When placed in the pinhole 302, the pin 12 may intersect each of the proximal surface 295 and the distal surface 296. When placed in the pinhole, the distal tip 18 of the pin 12 may extend a distance C from the distal surface 296. The length of the distance C may be such that the bevel 18a of the distal tip 18 may extend from the distal surface 296. The length of the distance C may further be such that a portion of the axis of the pin 12 near the distal tip 18 may extend from the distal surface 296. The distance C may be, for example, between 200 µm and 1200 µm, between 400 µm and 1000 µm, between 600 µm and 800 µm, or about 700 µm. In some examples, ramp 18a and the outermost ramp 298 may be oriented at the same angle relative to the longitudinal axis of adapter 290.

[0061] The adapter 290 can be selectively translated relative to the needle 12 along its longitudinal axis. For example, translation of the adapter 290 may be necessary to adjust the distance C. In some embodiments, the adapter 290 may be fixed to the needle 12. The adapter 290 can be connected to the needle 12 by any suitable means, including by screws, fasteners, nuts, bolts, or adhesives. As an example, and as... Figure 1 and Figure 2 As shown, the adapter 290 can be secured to the needle 12 using a screw 288. The screw 288 can be inserted into a threaded hole 304 within the adapter 290. When tightened, the screw 288 applies a force to the needle 12 perpendicular to its longitudinal axis. This force causes longitudinal friction between the needle 12 and the screw 288, and between the needle 12 and the hole 302, thereby preventing translation of the adapter 290 relative to the needle 12. If the user wishes to adjust the distance C, for example, the distance extending from the distal surface 296 to the farthest tip 18, the user can loosen the screw 288, thus allowing translation of the adapter 290 relative to the needle 12.

[0062] Figure 3Exemplary use cases of device 10 are described, with device 10 shown relative to the layers of the eye, namely the sclera 2, SCS 4, and choroid 6. As shown, adapter 290 can be used to guide the trajectory of the distal tip 18 of needle 12 through the sclera 2 into the SCS 4. To inject medication into the SCS 4, the user can, for example, penetrate the sclera 2 with the distal tip 18 and insert needle 12 through the sclera 2. The user can rotate the angle of needle 12 such that the outermost inclined surface 298 is positioned parallel to a plane tangent to the outer surface of the sclera 2. The user can then continue inserting needle 12 until the outermost inclined surface 298 contacts the surface of the sclera 2. In an exemplary method where the outermost inclined surface 298 is a planar surface, the user can insert needle 12 until the outermost inclined surface 298 is tangent to the surface of the sclera 2. In an exemplary method where the outermost inclined surface 298 is a convex surface, the user can insert needle 12 until the outermost inclined surface 298 engages with the surface of the sclera 2. When the outermost inclined surface 298 contacts the sclera 2, it prevents the needle 12 from being inserted further and prevents potential penetration of the choroid 6.

[0063] In some implementations, the user can adjust the distance C to the desired length by translating the adapter 290 along the needle 12. Once the user has adjusted the distance C and / or angle θ as needed, the user can use the adapter 290 to guide the trajectory of the needle 12 into the SCS 4, allowing it to penetrate the sclera 2 to a substantially predetermined depth. Thus, the user can inject medication into the suprachoroidal space 4 with relative precision without penetrating the choroid 6.

[0064] like Figures 1 to 3 As shown, the adapter 290 can be placed near the needle 12. The adapter 290 can alternatively be attached to either or both of the needle hub 112 and a medication container (e.g., a syringe) connected to the needle 12. In some embodiments, the adapter 290 can be spring-loaded, such that the spring pushes the adapter 290 towards the distal tip 18. In use, the user can press the adapter 290 against the patient's sclera and apply a force sufficient to depress the spring, thereby exposing the needle 12. The spring can be configured to control the depth to which the needle 12 penetrates the patient's eye.

[0065] The adapter 290 can be made of any suitable material, such as a suitable metal, polymer, and / or combination of metals and / or polymers. Exemplary metallic materials may include stainless steel, nickel-titanium alloys, titanium, and / or alloys of these metals. Exemplary polymeric materials may include polyetheretherketone (PEEK), polyimide, and polyethersulfone (PES). In some examples, the adapter 290 may be made of a rigid, semi-rigid, or flexible material. The adapter 290 may further be made of any sterilizable biocompatible material. In some examples, the adapter 290 may be made of a transparent material to allow for easier identification of blood vessels in the patient's eye and / or relative navigation.

[0066] In some implementations, the needle 12 and / or the distal tip 18 may be retractable. Specifically, the distal tip 18 may move between a retracted position (where the distal tip 18 is housed within the adapter 290) and an extended position (where the distal tip 18 protrudes from the adapter 290). For example, as Figure 4 and Figure 5 As shown, before using the instrument 10, the distal tip 18 can be in a retracted position within the needle hole 302 of the adapter 290 to prevent accidental insertion of the distal tip 18 or intentional injury therefrom. During injection, the distal tip 18 can be moved to an extended position, which can be similar to... Figure 1 , Figure 2 and Figure 3 The position shown is such that the farthest tip 18 extends at least partially from the pinhole 302, across the distal surface 296.

[0067] The device 10 may include a mechanism for moving the distal tip 18 from a retracted position to an deployed position. The mechanism may be of any suitable type, such as a manually powered mechanism, an electric mechanism, a motor-driven mechanism, a spring-driven mechanism, a compressed gas mechanism, etc., or any combination thereof. In some embodiments, the mechanism may be user-actuated, allowing the user to selectively deploy and retract the distal tip 18. In other embodiments, deployment of the distal tip 18 may be user-actuated, but retraction of the distal tip 18 may occur automatically at the end of the dose delivery event. In an example, such as... Figure 5 As shown, the mechanism may include a resilient member 310. The resilient member 310 may be, for example, a spring, and may deflect the needle 12 and / or the distal tip 18 toward a retracted position. When the user wishes to move the distal tip 18 from the retracted position to the extended position, the user may depress the resilient member 310, thereby allowing the distal tip 18 to extend beyond the distal surface 296. The user may use a button, switch, slider, or any other suitable mechanism to depress the resilient member 310. In some embodiments, the distal tip 18 may be configured to remain in the extended position once moved from the retracted position until the user takes further action to move the distal tip 18 back to the retracted position. In some embodiments, the distal tip 18 may be configured to move to the retracted position unless the user continues to actively depress the resilient member 310.

[0068] In some embodiments, the mechanism for moving the distal tip 18 from the retracted position to the deployed position may respond to signals transmitted by one or more sensors. For example, the device 10 may include a microprocessor. The microprocessor may be configured to receive signals from one or more sensors and may be further configured to control the mechanism for moving the distal tip 18 from the retracted position to the deployed position in response to the signals.

[0069] In some implementation schemes, such as Figure 6A and Figure 6B As shown, the device 10 may include a capacitance sensor 306. The capacitance sensor 306 may be located on the outermost inclined surface 298 of the adapter 290. When the capacitance sensor 306 is placed in contact with the sclera of the eye, for example, the capacitance sensor 306 may be configured to transmit a signal to a microprocessor indicating contact with the sclera. In response to receiving said signal, the microprocessor may cause the mechanism to move the distal tip 18 from a retracted position to an extended position. In some embodiments, the capacitance sensor 306 may be configured to transmit a signal to the microprocessor indicating the thickness of the sclera and choroid. In response to said signal, the microprocessor may calculate the distance at which the distal tip 18 can safely travel forward to the eye. The microprocessor may then cause the mechanism to move the distal tip 18 forward by the calculated distance.

[0070] In practice, such as Figure 6A As shown, the distal tip 18 can initially be in a retracted position before injection. When the user is ready to inject, the user can press the outermost inclined surface 298 against the sclera of the eye. When the outermost inclined surface 298 presses against the sclera, the capacitance sensor 306 can contact the sclera and detect its capacitance. Upon detecting the capacitance of the sclera, the capacitance sensor 306 can transmit a signal to the microprocessor indicating contact with the sclera. In response to the received signal, the microprocessor can move the distal tip 18 from the retracted position to the extended position, as... Figure 6B As shown. Because the position of the instrument 10 relative to the eye when the capacitive sensor 306 detects the sclera, the distal tip 18 can penetrate the sclera as it moves from the retracted position to the extended position.

[0071] In some implementations, when the distal tip 18 is in the deployed position, the capacitive sensor 306 may continue to transmit signals to the microprocessor. As long as the capacitive sensor 306 continues to transmit signals indicating that it is still in contact with the sclera, the mechanism can maintain the distal tip 18 in the deployed position. On the other hand, if the capacitive sensor 306 disengages from the sclera, a signal indicating that the capacitive sensor 306 is no longer in contact with the sclera is transmitted to the microprocessor. In response, the microprocessor can cause the mechanism to move the distal tip 18 to the retracted position.

[0072] In some implementations, the microprocessor may be configured to determine that the medication has been completely administered from device 10, or additionally, that the required amount of medication has been administered from device 10. In response to determining that the medication has been completely administered or the required amount has been administered, the microprocessor may cause the device to move the distal tip 18 to a retracted position. This retraction may be initiated by the microprocessor while the capacitive sensor 306 remains in contact with the sclera to ensure safe removal of device 10 from the patient.

[0073] Alternatively, in an embodiment of the manual operating mechanism, a signal from the capacitive sensor 306 indicating contact with the sclera can generate one or more visual, auditory, or tactile cues to be communicated to the user. For example, upon contact with the sclera, a light on the instrument 10 may illuminate, indicating to the user that the instrument 10 is in a suitable position for injection. In another example, an audible signal may be emitted from the instrument 10 to indicate to the user that the instrument 10 is in a suitable position for injection. In yet another example, the instrument 10 may vibrate to indicate to the user that the instrument 10 is in a suitable position for injection. While examples of visual, auditory, and tactile feedback are provided, it should be understood that any appropriate indication may be provided to alert the user to the placement of the instrument 10.

[0074] In some implementation schemes, such as Figure 7 As shown, the device 10 may include one or more pressure sensors 308 (as an additional or alternative to the capacitive sensor 306). Similar to the capacitive sensor 306, the pressure sensor 308 may be located on the outermost inclined surface 298 of the adapter 290. When the pressure sensor 308 is positioned to contact the sclera of the eye, for example, each of the pressure sensors 308 may be configured to transmit a signal indicating pressure applied to the sclera. In response to receiving a signal from the pressure sensor 308 indicating contact with the sclera, the microprocessor may cause the mechanism to move the distal tip 18 from a retracted position (not shown) to an extended position (as shown). Figure 7 (As shown). In some embodiments, the microprocessor may cause the mechanism to move the farthest tip 18 from a retracted position to an extended position in response to a signal indicating uniform or near-uniform pressure applied to the pressure sensor 308. An indication of uniform or near-uniform pressure applied to the pressure sensor 308 may indicate that the outermost inclined surface 298 is pressed uniformly against the sclera, rather than at an angle, loosely positioned, or in a similar situation.

[0075] In practice, the distal tip 18 may initially be in the retracted position before injection. When ready to inject, the user places the outermost inclined surface 298 against the sclera of the eye. While the outermost inclined surface 298 is placed against the sclera, one or more pressure sensors 308 may contact the sclera and detect the pressure applied to it. Upon detecting pressure indicating contact with the sclera, the one or more pressure sensors 308 may transmit a signal indicating contact with the sclera to the microprocessor. Figure 7 As shown, in response to receiving the signal, the microprocessor can move the distal tip 18 from the retracted position to the extended position. Because the pressure sensor 308 detects pressure applied by the sclera relative to the eye, the distal tip 18 can penetrate the sclera when moving from the retracted position to the extended position.

[0076] In some implementations, when the distal tip 18 is in the deployed position, the pressure sensor 308 can continue to transmit signals to the microprocessor. As long as the pressure sensor 308 continues to transmit signals indicating contact between the sensor and the sclera, the mechanism can maintain the distal tip 18 in the deployed position. Conversely, if the pressure sensor 308 has disengaged from the sclera, it can transmit a signal to the microprocessor indicating that the pressure sensor 308 is no longer in contact with the sclera. In response, the microprocessor can cause the mechanism to move the distal tip 18 back to the retracted position.

[0077] In some implementations, the microprocessor may be configured to determine that the medication has been completely administered from the device 10, or additionally, that the required amount of medication has been administered from the device 10. In response to determining that the medication has been completely administered or the required amount has been administered, the microprocessor may cause the mechanism to move the distal tip 18 to a retracted position. This retraction may be initiated by the microprocessor while the pressure sensor 308 remains in contact with the sclera to ensure safe removal of the device 10 from the patient.

[0078] Alternatively, as previously described herein, in embodiments of the manual operating mechanism, a signal from pressure sensor 308 indicating contact with the sclera can generate one or more visual, auditory, or tactile indications to be conveyed to the user.

[0079] In some implementation schemes, such as Figure 8 and Figure 9 As shown, the device 10 can be configured to detect and / or operate based on its angular position. For example, as Figure 8 As shown, the device 10 may include one or more sensors (e.g., position or gyroscope sensors) configured to detect an angle β of the axis BB extending through the needle 12 relative to the axis AA extending tangentially to the sclera 2. The one or more sensors may include an image sensor, a gyroscope sensor, an accelerometer, a combination thereof, or any other suitable sensor. Each of the sensors may be configured to transmit a signal to a microprocessor, which may in turn be configured to calculate the angle β based on the signal. In response to determining that the angle β is a suitable angle for injection, the microprocessor may cause the mechanism to move the distal tip 18 from a retracted position to an extended position.

[0080] In another example, such as Figure 9As shown, the device 10 may include a level 312 or any other suitable mechanical, electromechanical, or electronic positioning mechanism. In some embodiments, the level 312 may be, for example, a bubble level. The level 312 may be angularly offset from the needle 12 such that when the level 312 is horizontal, the needle 12 is at a desired angle relative to the horizontal plane. In use, the device 10 may be oriented such that the level 312 is placed horizontally (e.g., the bubble is centered). When the level 312 is horizontal, the needle 12 can be positioned at the desired angle to penetrate the SCS 4. In some embodiments, in response to being positioned in a horizontal orientation, the level 312 may transmit a signal indicating the horizontal orientation to a microprocessor. In response to said signal, the microprocessor may cause the mechanism to move the farthest tip 18 from a retracted position to an extended position.

[0081] In some implementations, the microprocessor may be configured to determine that the drug has been completely administered from the device 10, or to additionally determine that the required amount of drug has been administered from the device 10. In response to determining that the drug has been completely administered or the required amount has been administered, the microprocessor may cause the mechanism to move the farthest tip 18 to the retracted position.

[0082] Figure 8 and Figure 9 The embodiment shown can alternatively be operated manually. In such an embodiment, signals from the sensor and / or level 312 can generate one or more visual, auditory, or tactile indications to be conveyed to the user, as previously described herein. The user can then selectively extend and retract the needle 12 as needed or clinically necessary.

[0083] In some implementations, the device 10 may be configured to alert the user if the distal tip 18 has been inserted too deeply into the subject's eye. In such an example, the device 10 may include a microneedle 314 placed thereon, such as Figure 10 As shown. The microneedle 314 can be located at various locations on the device 10, including on the adapter 290, on the needle hub 112, along the axis of the needle 12, on the syringe, or at any other suitable location. In some embodiments, the microneedle 314 may be coupled to, for example, the outermost inclined surface 298. In such embodiments, both the microneedle 314 and the needle 12 may be formed of a conductive material and may be electrically connected to each other on a low-voltage circuit. The microneedle 314 may extend a fixed length from the rest of the device 10 and may be configured to be inserted into the outermost surface of the choroid 6. If the distal tip 18 is inserted into the choroid 6 through the SCS 4, an increased current flows through the low-voltage circuit. The microprocessor may detect the increased current, and in response to detecting the increased current, the microprocessor may generate one or more visual, auditory, or tactile indications to communicate to the user. One or more visual, auditory, or tactile indications may alert the user that the distal tip 18 has been inserted too deeply.

[0084] In some embodiments, the microneedle 314 may be configured to deploy and retract from the instrument 10. For example, as previously described herein, the capacitive sensor 306 may be configured to transmit a signal to the microprocessor indicating the thickness of the sclera and choroid. In response to the signal, the microprocessor may calculate the distance at which the microneedle 314 can safely travel to the outermost surface of the choroid 6. The microprocessor may then cause the deployment mechanism to move the microneedle 314 the calculated distance into the eye for insertion into the outermost surface of the choroid 6.

[0085] In some embodiments, in addition to or instead of the microneedle 314, the device 10 may also include electrodes. In some embodiments, the electrodes may be located on the microneedle 314, and in some embodiments, the electrodes may be located on the outermost inclined surface 298. The electrodes may be electrically connected to the electrode located on a low-voltage circuit near the distal tip 18. Based on the detected conductivity between the electrodes, the microprocessor may determine whether the electrode on the distal tip 18 is in contact with the sclera 2, within the SCS 4, or in contact with the choroid 6. The microprocessor may be configured to generate one or more visual, auditory, or tactile indications to be conveyed to the user, wherein the indications vary according to the position of the distal tip 18. The indications may alert the user whether the distal tip 18 has been inserted to the required depth within the eye (e.g., into the SCS), or whether the distal tip 18 has been inserted too shallowly or too deeply.

[0086] While the device 10 is described herein and shown in the relevant figures as including a needle 12 extending through the adapter 290, it should be understood that such a needle is not necessarily required. For example, the device 10 may alternatively include a microneedle positioned toward the distal surface 296, which does not extend completely through the adapter 290. In such an embodiment, the adapter 290 may include a fluid conduit therein, which is in fluid communication with the microneedle. The device 10 may be configured such that medication flows through the fluid conduit to the microneedle and into the patient. As previously described herein, such a microneedle may be movable, moving from a retracted position within the adapter 290 to an extended position where the microneedle protrudes beyond the distal surface 296.

[0087] It should be understood that any dimensions of the adapter 290 as seen in the accompanying drawings are not intended to be limited and are indeed variable. For example, the length of the adapter 290 (i.e., the distance between the proximal surface 295 and the distal surface 296) can be varied to accommodate needles of different lengths. Furthermore, the diameter of the pinhole 302 can be varied to accommodate needles of different diameters. Additionally, the diameters of the proximal surface 295 and / or the distal surface 296 can be varied.

[0088] As described herein, the adapter 290 can be used to reduce human error in ocular injection procedures. In addition to injection into the suprachoroidal space, the adapter 290 can be used for injection into other spaces of the eye, such as the subretinal space. Current methods for subretinal drug delivery can be invasive and may require surgery. Surgical procedures for subretinal drug delivery may involve creating a tear on the retinal surface and / or total vitrectomy to allow the cannula to enter the subretinal space. Alternatively, the adapter 290 can allow access to the subretinal space through the sclera, thus reducing the invasiveness of the procedure. Using ocular imaging techniques such as optical coherence tomography (OCT) and / or ultrasound, the accurate distance between the scleral surface and the subretinal space can be calculated. The distance between the distal tip 18 of the needle 12 and the distal surface 296 or the outermost inclined surface 298 of the adapter 290 can be configured to match the distance between the sclera and the subretinal space. In such a configuration, the adapter 290 prevents the needle 12 from extending beyond the subretinal space into the vitreous body. The outermost inclined surface 298 can also control the angle at which subretinal injection is performed.

[0089] The adapter 290 can be formed by any suitable process, including but not limited to milling, CNC machining, polymer casting, rotary molding, vacuum forming, injection molding, extrusion, blow molding, or any combination thereof.

[0090] The various devices and components described herein are available as kits for implementing one or more of the methods described herein. For example, syringes, needles, adapters, and a quantity of ophthalmic medication may be provided in blister packs. Each of the syringe, needle, adapter, and ophthalmic medication may be sealed within the blister pack after sterilization. In some embodiments, the kit may include multiple adapters. The multiple adapters may have different sizes, allowing the user to select an adapter best suited to the patient's anatomy and / or to control the penetration angle or depth of the needle. The multiple adapters may also be made of different materials, allowing the user to select an adapter with a suitable material for a specific procedure and / or patient. In some embodiments, the syringe may contain ophthalmic medication. The nominal maximum fill capacity of the syringe may be between about 0.5 mL and about 1.0 mL. In the various methods described herein, the volume of medication (e.g., ophthalmic medication) delivered to the patient may range from about 50 µL to about 500 µL.

[0091] Various drugs and formulations of drugs can be used in embodiments of this disclosure. As an example, the embodiments described herein can be used to inject drugs in the form of extended-release pellets. Upon hydration of the pellet, the drug can be released from the pellet, which can be achieved by exposing the pellet to a fluid in the eye, by injecting a separate rehydration solution, or by any combination thereof. The separate rehydration solution, such as saline, can be injected before, after, or simultaneously with the pellet. As another example, the embodiments described herein can be used to sequentially inject multiple substances. A first substance can be injected to dilate a target space in the eye, such as the suprachoroidal space, and a second substance can then be injected into the dilated suprachoroidal space. The first substance can be, for example, saline, while the second substance can be, for example, a drug in the form of a viscous gel. As yet another example, a sponge-like material can be injected or inserted into the target space in the eye first. The sponge-like material can be configured to release the drug over time. With subsequent drug injections, the sponge-like material can be further refilled or re-soaked with the drug.

[0092] Pharmaceuticals that can be used in embodiments of this disclosure include: aflibercept (EYLEA®), acetone-concentrated cortisol suspension (ZUPRATA®), bevacizumab (AVASTIN®), and gene therapy drugs (including adeno-associated virus serotype 8 (AAV8) vectors for ocular gene transfer). While examples are provided herein, these examples are not intended to be limiting, and any suitable pharmaceutical can be used in embodiments of this disclosure.

[0093] In embodiments of this disclosure, needle 12 may be a first needle, and the devices, apparatuses, and / or kits disclosed herein may include a second needle. The first and second needles are interchangeable. Therefore, needle 12 may be replaceable.

[0094] Embodiments of this disclosure may further include variations of the previously described devices and / or additional devices for treating ocular tissues and / or delivering drugs to ocular tissues. For example, the previously described devices may be further incorporated into and / or modified according to the following aspects. Alternatively, the following exemplary devices may be considered separately from the previously described devices. It should be understood that various combinations of structures, components, and / or elements described herein are contemplated and are within the scope of this disclosure.

[0095] according to Figure 11A and Figure 11BAn exemplary drug delivery device 1100 for delivering drugs to ocular tissue may include a needle 1102 attached to a syringe 1104. The syringe 1104 may be located within a channel 1114 of a sleeve 1110. Similar to adapter 290, the sleeve 1110 may be configured to surround the syringe 1104 and / or the needle 1102. The syringe 1104 and the needle 1102 may be coupled to the sleeve 1110 via a lock 1106. The lock 1106 may be selectively adjustable by a user to hold the syringe 1104 and the needle 1102 in place relative to the sleeve 1110, or, as needed, to release the syringe 1104 and the needle 1102 to allow movement relative to the sleeve 1110. In some embodiments, the lock 1106 may be a screw extending from the outer surface of the sleeve 1110 into the channel 1114, and the screw may be tightened or loosened as needed to secure or release the syringe 1104 and the needle 1102, respectively. Figure 11A The retracted configuration of pin 1102 is shown, while Figure 11B The expanded configuration of pin 1102 is shown.

[0096] The sleeve 1110 may include a curved surface 1112 configured to rest against the sclera 2 of a patient's eye. The sleeve 1110 and the curved surface 1112 may be configured to control the depth and angle at which the needle 1102 is inserted into the patient's eye. In some embodiments, the channel 1114 may be tilted (i.e., oblique) relative to the curved surface 1112, such that the needle 1102 enters the patient's eye at the desired angle upon insertion and facilitates placement within the SCS 6. Furthermore, in some embodiments, the sleeve 1110 may define the maximum distance the needle 1102 can be inserted into the patient's eye. For example, as... Figure 11B As shown, the sleeve 1110 can be configured to allow the needle 1102 to penetrate only the sclera 2 of the patient's eye, without penetrating the choroid 4.

[0097] Figure 12An exemplary drug delivery device 1200 is described. The drug delivery device 1200 may include a needle 1202 attached to a syringe 1204 and an adapter 1210 surrounding the needle 1202. Similar to adapter 290, adapter 1210 may be configured to surround the needle 1202 and may include an oblique distal surface 1212 for placement on the sclera. Adapter 1210 may include a shank 1206 bonded to the syringe 1204 to prevent rotation of adapter 1210 relative to the syringe 1204. The needle 1202 may also have a fixed position relative to the syringe 1204. The drug delivery device 1200 may further include a dial 1222 having a threaded connection to either or both of the syringe 1204 and the shank 1206. When the dial 1222 is rotated, the adapter 1210 can be configured to move along the axis of the needle 1202, thereby increasing or decreasing the distance by which the needle 1202 protrudes from the adapter 1210. Therefore, to obtain the desired needle insertion depth, the user can rotate the dial 1222 to expose the needle 1202 of the corresponding length.

[0098] Figure 13A , Figure 13B and Figure 13C Another exemplary drug delivery device 1300 for delivering medication to ocular tissue is shown. The drug delivery device 1300 may take the form of a wearable pair of glasses or a face mask 1310 configured to fit the patient's face. The drug delivery device 1300 may include a port 1312 configured near the patient's eye, through which a syringe 1320 with a needle can be inserted. The port 1312 may be tilted at an angle θ relative to the outer surface of the face mask 1310 to guide the needle into the patient's eye at a desired angle. The drug delivery device 1300 may include one or more earpieces 1314 attached to the side via a hinge 1316 so that the device can be supported by the patient's ears and may be adjustable to accommodate different patient anatomy.

[0099] In some implementation schemes, such as Figure 13CAs shown, syringe 1320 may include a plunger 1324, which may be driven by a spring 1322. In other embodiments, plunger 1324 may be driven by a motor or any other suitable biasing mechanism. Plunger 1324 may be axially movable through syringe 1320 to force medication through needle 1328. In some embodiments, a pressure sensor may be included to detect pressure within syringe 1320, and the detected pressure may be used to determine the desired depth of needle 1328 insertion. For example, region 7, including the SCS, between sclera 2 and retinal pigment epithelium (RPE) 8 may have pressure P1. Region 9 below RPE 8 may have pressure P2, which is greater than P1. To inject medication into region 7, a pressure sensor may be used to detect pressure P3 within the syringe during medication diffusion. If P3 is a value between P1 and P2, P3 may indicate that needle 1328 has penetrated sclera 2 but has not yet penetrated RPE 8.

[0100] Furthermore, in some embodiments, a force sensor may be included to detect the force applied to advance the needle 1328 into the eye. For example, the detected peak force as a function of distance may indicate the penetration depth of different layers of the eye (e.g., the sclera, choroid, or RPE, which are located at different distances from the outer surface of the eye). In some embodiments, a pressure sensor may be used instead of or as a supplement to a force sensor. In some embodiments, portions of the device responsible for pressure sensing and / or force sensing may be reusable.

[0101] Figure 14A , Figure 14B and Figure 14C Several graphs are presented to further illustrate the relationship between pressure, force, and distance as a function of time when the needle is inserted into the eye. Therefore, Figure 14A , Figure 14B and Figure 14C This is enlightening for incorporating pressure sensors and / or force sensors into the devices described herein. Figure 14A In this diagram, the fluid pressure within the syringe and the distance the needle travels into the eye are illustrated as a function of time as the needle is advanced into the eye. In some embodiments, the needle can be advanced in small, intermittent distances as the measurement progresses. For example... Figure 14A As shown, the pressure within the syringe remains stable as the needle advances through one or more layers of the eye. When the needle enters a space (e.g., the SCS), the pressure then decreases. To prevent unintentional further penetration into the eye, the device can stop needle advancement upon detecting a pressure drop and / or alert the user to the pressure decrease. Pressure measurement can further be used to trigger a dose-ending action and / or automatically retract the needle from the eye.

[0102] Figure 14BThe relationship between the force applied to the needle and the distance the needle is inserted is illustrated as a function of time stages as the needle is advanced into the eye. In some embodiments, the needle can be advanced in small, intermittent distances as the measurement progresses. As shown, the force applied to the needle spikes with each advancement. Larger force peaks may indicate that the needle is within a layer of the eye, such as the sclera, while lower force peaks or flattening forces may indicate that the needle has penetrated one or more layers into a space, such as the SCS. Once the peak force decreases below a predetermined threshold, the device can stop advancing the needle and / or alert the user. The force measurement can be further used to trigger a dose-ending action and / or automatically retract the needle from the eye.

[0103] In some implementations, continuous feedback can be used instead of phased feedback. Figure 14C A graph depicting force and distance as a continuous function of time is provided, illustrating how a force threshold A can be achieved to reach the desired insertion depth. For example, the device can be configured to automatically stop advancing the needle when the insertion force decreases below a certain threshold. This threshold can be calibrated to indicate that the distal end of the needle has reached the desired depth, such as to the SCS. Alternatively, or additionally, a change in the needle's velocity rate (i.e., acceleration) can be used. For example, needle acceleration can indicate that the needle has penetrated a layer of the eye into a space (e.g., the SCS) and can trigger the device to stop advancing the needle.

[0104] Figure 15A , Figure 15B and Figure 15C A drug delivery device 1400 for delivering medication to ocular tissue is described. The drug delivery device 1400 may include a needle 1402, a spool 1404, an adapter 1406, and a spring 1408. The spool 1404 may be located within the needle 1402, and the spool 1404 is movable between a first position (where the passage through the needle 1402 is unobstructed) and a second position (where the passage is obstructed). When the spool 1404 is in the first position, medication may flow through the needle 1402. The spool 1404 may be biased towards the first position (where the passage is unobstructed) by the spring 1408.

[0105] like Figure 15A As shown, under ambient pressure, spring 1408 can position spool 1404 in the first position. Figure 15B As shown, when needle 1402 is inserted into the eye, the increased pressure compresses spring 1408 and / or spool 1404, causing spool 1404 to move to a second position. Spring 1408 can be calibrated such that the increased pressure on sclera 2 causes spool 1404 to move to the second position, thereby preventing medication from diffusing into sclera 2. When needle 1402 moves to a lower pressure, for example, into the eye... Figure 15CAs shown in SCS 6, spool 1404 can return to a first position where the drug can flow through needle 1402. If needle 1402 is further advanced into another layer, such as choroid 4, the increased pressure can force spool 1404 into a second position, thereby preventing the drug from diffusing into choroid 4.

[0106] In some embodiments, a motor or other similar actuator (e.g., an electromagnetic coil) may be used to advance the needle 1402 and / or drive the plunger within the syringe. As the needle 1402 is advanced and / or the plunger is driven, the resistance and / or current of the motor can be monitored. A higher current may indicate that the needle 1402 is facing increased advance resistance and may cause the device to stop advancing the needle 1402. Similarly, a higher current may indicate that the fluid passage from the syringe is blocked, suggesting that the needle 1402 is not within the desired space (e.g., SCS) for dispersing the drug.

[0107] Figure 16A and Figure 16B A similar drug delivery device 1600 for delivering drugs to ocular tissue is described. The drug delivery device 1600 may include a needle 1602, a syringe 1604, a flow control mechanism 1610, and a biasing mechanism 1608. The syringe 1604 may be configured to contain a liquid drug, and the flow control mechanism 1610 may be configured to control conditions allowing the drug to flow through the needle 1602.

[0108] An exemplary configuration of the flow control mechanism 1610 is as follows: Figure 16B As shown. The flow control mechanism 1610 may include a spool 1612 biased to a first position by a biasing mechanism 1608. Depending on the pressure applied to the spool 1612, the spool 1612 may seal or open the fluid passage from the syringe 1604 to the needle 1602. Figure 16B As shown, the fluid passage can be initially closed by valve 1616 and spool 1612 can be initially biased away from valve 1616 by biasing mechanism 1608. When needle 1602 is inserted into the eye and pressure applied to spool 1612 increases, spool 1612 can be forced upward, causing biasing mechanism 1608 to be compressed, and protrusion 1618 moves valve 1616 to the open position. As needle 1602 is further advanced into a lower pressure region of the eye, such as SCS, spool 1612 can be moved downward away from valve 1616 due to the force applied by biasing mechanism 1608. When valve 1616 is in the open position and spool 1612 is in the downward position, liquid medication can be allowed to flow from syringe 1604 through needle 1602. In some embodiments, movement of spool 1612 can provide a visual indication to the user. For example, when the needle 1602 is inserted into the eye to the desired depth, the spool 1612 can generate a corresponding visual indication to the user, indicating that drug delivery should continue.

[0109] Figure 17Aand Figure 17B An exemplary drug delivery device 1700 for delivering medication to ocular tissue is described. The drug delivery device 1700 may include a guide 1708, and in some embodiments, the guide 1708 may include a handle 1706. The guide 1708 may be configured to rest against the sclera 2 of a patient's eye and may define the angle and / or depth of needle insertion. For example, the guide 1708 may first be placed against the desired location in the patient's eye. A syringe 1704 and / or a needle 1702 may then be inserted into the guide 1708 and advanced within the guide 1708 such that the needle 1702 penetrates the sclera 2. Once the needle 1702 has penetrated to the desired depth within the eye, such as to the SCS 6, the guide 1708 may inhibit further insertion of the needle 1702.

[0110] like Figure 17B As shown, guide 1708 may include lock 1710 to selectively secure syringe 1704 and / or needle 1702 within the guide. Lock 1710 can be toggled between securing and releasing syringe 1704 and / or needle 1702 using a switch. In some embodiments, a force applied to needle 1702 during insertion can be detected. When the force decreases below a certain threshold, needle 1702 can be indicated to enter a space (e.g., SCS 6) and the device can stop advancing needle 1702. In some embodiments, feedback can be provided to the user when needle 1702 is inserted to a specific depth. For example, the feedback may include tactile, auditory, visual, or any other suitable type of feedback. In some embodiments, needle 1702 can be automatically inserted and retracted via electromechanical means. In some embodiments, injection can be similarly automatically generated electromechanically when the needle is inserted to the desired depth.

[0111] Figure 18A and Figure 18B An exemplary drug delivery device 1800 for delivering medication to ocular tissue is described. The drug delivery device 1800 may include a needle 1802 and a probe sensor 1804. The probe sensor 1804 may be initially located within the needle 1802 and may be configured to extend outward from the distal end of the needle 1802. In some embodiments, the probe sensor 1804 may be pushed outward from the needle 1802 by a spring, motor, or other suitable mechanism. In some embodiments, the probe sensor 1804 may be, for example, a capacitive sensor or a conductive sensor.

[0112] When needle 1802 is inserted into a patient's eye, probe sensor 1804 can contact the eye's tissues and detect the capacitance and / or conductivity of said tissues. For example, upon detecting capacitance and / or conductivity indicating that probe sensor 1804 should contact the choroid 4 rather than the sclera 2, probe sensor 1804 can extend from needle 1802. This extension can prevent further insertion of needle 1802 into the eye. The extension of probe sensor 1804 can further create space between the sclera 2 and the choroid 4 for the medication to be injected. In some embodiments, contact between probe sensor 1804 and choroid 4 can automatically stop the advancement of needle 1802. In some embodiments, an indication of this contact can be provided to the user.

[0113] Figure 19 An exemplary drug delivery device 1900 for delivering medication to ocular tissue is described. The drug delivery device 1900 may include a needle 1902 and a capacitive electrode 1904. Once the needle 1902 has penetrated the sclera 2 and the medication 1906 has been injected into the SCS 6, the capacitive electrode 1904 can be used to detect the distribution profile of the medication 1906 within the SCS 6. For example, the capacitive electrode 1904 may detect the conductivity of the medication 1906. In some embodiments, saline solution may be added to the medication 1906 to enhance conductivity. Based on the values ​​detected by the capacitive electrode 1904, the user can determine whether the medication 1906 has adequately diffused within the SCS 6.

[0114] Figure 20A and Figure 20B An exemplary drug delivery device 2000 for delivering medication to ocular tissue is described. The drug delivery device 2000 may include a needle 2002 provided within a guide 2008. The guide 2008 may be configured to be positioned against the sclera 2 of a patient's eye. The needle 2002 may be coupled to a drive 2006 for extending the needle 2002 into the eye. In some embodiments, a syringe 2004 filled with medication may be located within the guide 2008. A slot 2010 may be located between the needle 2002 and the syringe 2004. The slot 2010 may close until the needle 2002 is in the desired position for medication delivery, thereby preventing fluid communication between the syringe 2004 and the needle 2002. When the needle 2002 is positioned in the desired position for medication delivery, the slot 2010 may then be opened to allow fluid communication between the syringe 2004 and the needle 2002 to deliver the medication to the eye.

[0115] Figure 21A and Figure 21BAn exemplary drug delivery device 2100 for delivering medication to ocular tissue is described. The drug delivery device 2100 may include a needle 2102 made of a non-conductive material and having a conductive overlay 2104 thereon. In some embodiments, the conductive overlay 2104 may typically be triangular. An electrical signal generated by the conductive overlay 2104 can be measured, and said electrical signal can provide an indication of needle insertion depth. When the desired insertion depth is reached, the advancement of the needle 2102 may be automatically stopped and / or an indication may be provided to the user. In some embodiments, such as Figure 21C As shown, the device 2110 may include a plurality of needles 2112, each extending a different length from the needle hub 2114. Electrical signals from each needle 2112 can be used to determine the depth at which the device is inserted into the eye.

[0116] Figure 22A , Figure 22B and Figure 22C Further exemplary drug delivery devices and techniques for delivering drugs to ocular tissues are described. In some embodiments, multiple injections can be performed to ensure accurate drug delivery to a desired location within the eye, such as to the SCS. First, needle 2202 can be inserted into the desired location within the eye, such as... Figure 22A As shown. Once it is confirmed that the needle 2202 is in the desired position, the first fluid 2204 can be injected. In some embodiments, the first fluid 2204 may include a colored dye visible from outside the eye. In some embodiments, the first fluid 2204 may be viscous, such that upon injection it forms a spherical shape and spreads out the layers of the eye to create space for the drug.

[0117] like Figure 22B As shown, a second injection can then be performed. With the first fluid 2204 already injected, the layers of the eye can be separated, thereby creating space for the second injection and facilitating partial injection and diffusion throughout the eye. The second injection can be performed using the same needle 2202 held in the same position or using a different needle. During the second injection, the drug can be injected into the sphere and / or space formed by the first fluid 2204.

[0118] In some implementation schemes, such as Figure 22C As shown, a guide 2206 may be included to guide the needle 2202 into the eye at a desired angle. The guide 2206 may include a curved surface configured to rest against the outer surface of the eye. The guide 2206 may further include a groove configured to receive the needle 2202 and angled relative to the curved surface. During the injection procedure, the needle 2202 may be positioned through the groove to penetrate the eye at the desired angle.

[0119] Figure 23An exemplary drug delivery device 2300 for delivering medication to ocular tissue is described. The drug delivery device 2300 may include a needle 2302, a guide 2304, and a pressure measuring device 2306. The pressure measuring device 2306 may be a mechanical or electromechanical device. In use, the needle 2302 is inserted into the eye at the desired location. The user can then use the pressure measuring device 2306 to test the pressure in the eye at the distal end of the needle 2302. If the measured pressure is at the desired level for receiving medication in the desired area of ​​the eye (e.g., the SCS), the user can proceed with administering the medication through the needle 2302.

[0120] Figure 24A and Figure 24B Exemplary drug delivery devices 2400 and 2410 for delivering medication to ocular tissue are described. Device 2400 may include a syringe 2404 and a retractable needle 2402. The syringe 2404 may include a distal surface 2408 configured to rest against a patient's eye. Device 2400 may further include a mechanism for adjusting the length of the needle for penetration. In some embodiments, the mechanism may include a movable shield 2406 located around the syringe. Axial movement of the shield 2406 may extend and / or retract the needle.

[0121] like Figure 24B As shown, instead of the shield 2406, the drug delivery device 2410 may include a rotating dial 2416 located on the syringe 2414. The syringe 2414 may include a distal surface 2418 configured to rest against a patient's eye. The dial 2416 is rotatable to extend and / or retract the syringe 2414 and / or the needle 2412. For example, the dial 2416 may be threaded to the outer surface of the syringe 2414. In some embodiments, the mechanisms of the drug delivery devices 2400 and 2410 allow needles 2402 and 2412 to extend and / or retract incrementally. In some embodiments, the mechanisms allow needles 2402 and 2412 to extend and / or retract continuously.

[0122] Similar to Figure 24A and Figure 24B The device shown, Figure 25A and Figure 25BThe exemplary drug delivery devices 2500 and 2550 shown may include an adjustable dial configured to allow a user to adjust the length of the needle and / or the insertion depth of the needle. For example, drug delivery device 2500 may include a needle 2502, a syringe 2504, a needle sheath 2506, and a dial 2508. In some embodiments, the needle 2502 may be a Luer needle. The needle 2502 and syringe 2504 may be coupled together to inhibit translation of the needle 2502 relative to syringe 2504. The dial 2508 and needle sheath 2506 may be coupled together to inhibit translation of the needle sheath 2506 relative to dial 2508. To adjust the distance by which the needle 2502 protrudes from the needle sheath 2506, the user may rotate the dial 2508 relative to syringe 2504. This rotation may cause a change in the axial position of the needle sheath 2506 relative to the needle 2502, thereby extending or retracting the needle 2502 as needed.

[0123] Similarly, the drug delivery device 2550 may include a needle 2552, a needle sheath 2556, and a dial 2558. In some embodiments, the needle sheath 2556 may have an angled contact surface configured to rest against the patient's eye and configured to control the angle at which the needle 2552 is inserted into the eye. The needle 2552 may further include a needle hub 2560. The needle hub 2560 is connected to the dial 2558 via a threaded interface. Through this threading, rotation of the dial 2558 relative to the syringe and / or the needle 2552 can cause translation of the needle hub 2560 and the needle 2552 relative to the needle sheath 2556. Such rotation allows the needle 2552 to extend or retract from the needle sheath 2556 as needed.

[0124] In some embodiments, dials 2508 and 2558 can advance needle 2502 or needle 2552 manually or automatically. Needle 2502 or needle 2552 can be advanced in small increments (e.g., 50 µm) by rotating the corresponding dial. Advancing needle 2502 or needle 2552 in small increments allows for enhanced control during insertion. In some embodiments, drug delivery device 2500 or drug delivery device 2550 may include one or more sensors to detect resistance exerted by the eye on needle 2502 or needle 2552 as needle 2502 or needle 2552 is advanced. For example, needle 2502 or needle 2552 experiences substantially constant resistance as it passes through the sclera and lower force upon reaching the SCS. Once a lower force is detected, the device may automatically stop advancing the needle to avoid penetrating the choroid. In some embodiments, the device may provide feedback to the user indicating that needle 2502 or needle 2552 has reached the SCS.

[0125] Figure 26A and Figure 26BExemplary drug delivery devices 2600 and 2650 for delivering medication to ocular tissue are described. For example, drug delivery device 2600 may include a needle 2602 having a port 2604 on one side through which medication can be dispensed. The needle 2602 may further have a plurality of sensors 2606. In some embodiments, the plurality of sensors 2606 may be capacitive sensors, and the capacitive sensors may be positioned on both the distal and proximal sides of the port 2604. During the injection procedure, the needle 2602 may be advanced into the patient's eye until the sensor 2606 on the distal side of the port 2604 indicates contact with the choroid 4, and the sensor 2606 on the proximal side of the port 2604 indicates contact with the sclera 2. When the sensor 2606 indicates this, the user can infer that the port 2604 is located in the SCS 6 and can continue dispensing medication into the SCS 6 via the needle 2602. In some implementations, a pressure sensor may be used in place of or as a supplement to a capacitive sensor, and may detect the unique pressure characteristics of the sclera 2 and / or choroid 4.

[0126] As another example, see Figure 26B The drug delivery device 2650 may include a needle 2652, a wire 2654 connected to the needle 2652, and a grounding probe 2656. The grounding probe 2656 may be inserted into the patient's eye to contact the choroid 4. The needle 2652 may then be inserted into the patient's eye to the desired depth above the choroid 4. To ensure that the needle 2652 has not penetrated the choroid 4, the resistance between the grounding probe 2656 and the needle 2652 may be measured. If the resistance indicates that the needle 2652 has not penetrated the choroid 4, the injection procedure may continue and the drug may diffuse into the eye.

[0127] Figure 27An exemplary drug delivery device 2700 for delivering medication to ocular tissue is described. The drug delivery device 2700 may include a needle 2702, a syringe 2704, a plunger 2706, and one or more sensors 2712. Sensors 2712 may be configured to detect forces and / or pressures applied to the shoulder 2708 of the syringe 2704 via a finger-like flange 2710. During insertion of the needle 2702 into a patient's eye, as the user applies pressure to the finger-like flange 2710 to advance the needle 2702, the one or more sensors 2712 may detect forces and / or pressures occurring between the finger-like flange 2710 and the shoulder 2708. The forces and / or pressures detected by the sensors 2712 may remain relatively constant as the needle 2702 passes through the sclera of the eye. As the needle 2702 passes through the sclera and enters the SCS, the forces and / or pressures may decrease significantly. Upon the decrease in forces and / or pressures, the advancement of the needle 2702 may cease, and the medication may continue to diffuse into the SCS. In some implementations, when the force and / or pressure decreases, the drug delivery device 2700 may provide feedback to the user to alert the user to stop advancing the needle 2702.

[0128] Figure 28A and Figure 28B An exemplary drug delivery device 2800 for delivering medication to ocular tissue is described. In some embodiments, the drug delivery device 2800 may include a syringe 2804 and a probe 2806 configured to create space for the medication within a patient's eye. For example, as... Figure 28A As shown, during the injection procedure, needle 2802 can be inserted into the patient's eye and through the sclera 2. Probe 2806 can then extend from needle 2802 into the SCS 6 to dilate the SCS 6. Probe 2806 can be a solid material, a flexible material, or a fluid material. In some embodiments, probe 2806 can be in the form of a catheter, a balloon, or a stent. In some embodiments, the catheter may include a guide wire having a thickness of about 50 µm to facilitate placement of the catheter in the desired layer of the eye. In some embodiments, probe 2806 can be extended into the SCS 6 by a biasing mechanism such as a spring, motor, etc.

[0129] The probe 2806 extends into the SCS 6, distancing the sclera 2 from the choroid 4, thereby increasing the capacity of the SCS 6. Once the SCS 6 expands, medication can be delivered via the needle 2802. Expanding the SCS 6 via the probe 2806 facilitates drug diffusion through the SCS 6. In some embodiments, a force sensor may be included to detect the force applied to the needle 2802 by ocular tissue. A decrease in the force applied to the needle 2802 indicates that the SCS 6 has been properly expanded via the probe 2806. In some embodiments, this decrease in force may trigger drug delivery.

[0130] like Figure 28BAs shown, the drug delivery device 2800 may include a mechanism 2810 for extending a probe 2806 through a needle. In some embodiments, the mechanism 2810 may be located within a chamber within the syringe 2804. The mechanism 2810 may include any suitable biasing device, including a spring, motor, pump, etc. In some examples, the mechanism 2810 may operate by applying fluid pressure to the proximal end of the probe 2806, thereby causing the probe 2806 to extend from the needle 2802. The drug to be injected may be contained outside the chamber within the syringe 2804. Alternatively, the mechanism 2810 for extending the probe 2806 through the needle 2802 may be located outside the syringe 2804. For example, the mechanism 2810 may be located at the interface between the syringe 2804 and the needle 2802.

[0131] like Figure 29 As shown, in some embodiments, probe 2906 may be integrated with needle 2902. For example, exemplary drug delivery device 2900 may include needle 2902 having a semi-blunt distal tip that is sharp enough to pierce the sclera 2 and blunt enough to not pierce the choroid 4. Thus, upon insertion of needle 2902, the distal tip can pierce the sclera 2 and then displace the choroid 4 to increase the capacity of SCS 6. Needle 2902 may further include a port or opening 2904 located on the proximal side of the distal tip, through which drug can be dispensed into SCS 6.

[0132] Figure 30 An exemplary drug delivery device 3000 is described, wherein a probe 3006 serves as part of a needle insertion system. The drug delivery device 3000 may include a needle 3002, a probe 3006, and a protective element 3008. The drug delivery device 3000 may also include an anchor 3010 configured to couple the needle 3002 to the protective element 3008. The probe 3006 may be spring-loaded, such that during insertion of the needle 3002 into a patient's eye and during penetration of the sclera, the probe 3006 may extend from the needle 3002 into the SCS. When a user advances the needle 3002 into the patient's eye by applying pressure to the protective element 3008, the needle 3002 may enter the relatively depressurized SCS. As the needle 3002 enters the SCS, the probe 3006 may extend into the SCS, thereby decoupling the needle 3002 from the protective element 3008 by the anchor 3010. Once decoupled, applying force to the protective element 3008 no longer advances the needle 3002. In some embodiments, the extension of probe 3006 can automatically stop the advance of needle 3002. In some embodiments, the extension of probe 3006 can place needle 3002 in a configuration where it cannot be manually advanced further. This effect can prevent the choroid from being unintentionally penetrated by needle 3002.

[0133] Figure 31A and Figure 31BAn exemplary drug delivery device 3100 for delivering medication to ocular tissue is described. The drug delivery device 3100 may include a needle 3102, a block 3104, and a finger 3106. The needle 3102 may be coupled to the block 3104 via the finger 3106, the finger 3106 being responsive to a force applied to the needle 3102. For example, during insertion of the needle 3102 into a patient's eye, the sclera may apply a force to the needle 3102 to hold the finger 3106 in a first configuration in which the finger 3106 couples the needle 3102 to the block 3104. The first configuration is as follows: Figure 31A As shown. The finger 3106 can be deflected to allow clockwise rotation without interference from the lug 3108, which can be fixed to the needle 3102. Because in the first configuration, the needle 3102 is coupled to the block 3104 via the finger 3106 and the lug 3108, the user can advance the needle 3102 by pushing the block 3104.

[0134] As the needle 3102 is advanced into the SCS, the force applied to the needle 3102 can be substantially reduced, thereby allowing the finger 3106 to rotate through the lug 3108 and the gate 3110. In this second configuration, the needle 3102 can become functionally decoupled from the block 3104, so that the needle 3102 no longer advances in response to pushing the block 3104. This action can prevent the needle 3102 from accidentally penetrating the choroid plexus.

[0135] Figure 32A and Figure 32B Exemplary drug delivery devices 3200 and 3250 for delivering medication to ocular tissue are described. Drug delivery device 3200 may include a needle 3202, a needle hub 3208, a syringe 3204, and a shield 3206. Shield 3206 may be configured to couple with syringe 3204, needle 3202, and / or needle hub 3208. Shield 3206 may surround needle 3202 such that it defines a maximum distance D that needle 3202 can be inserted into a patient's eye. Shield 3206 may be interchangeable with shields of different sizes to allow variation in the distance D that needle 3202 can be inserted. In some embodiments, each of a plurality of shields may define a discontinuous needle length and may not be adjustable. For an injection procedure, a user may determine an appropriate needle length and may select a corresponding shield based on said appropriate needle length. In some embodiments, each shield may engage and / or disengage the syringe and / or needle.

[0136] In some embodiments, the shield may be adjustable. For example, the drug delivery device 3250 may include a needle 3252, a syringe 3254, and a shield 3256. The shield 3256 may be coupled to the syringe 3254 via a threaded interface 3258. By rotating the shield 3256 about the syringe 3254 and / or the needle 3252, threading allows the shield 3256 to be axially translated relative to the needle 3252, thereby adjusting the distance by which the needle 3252 protrudes relative to the shield 3256. In some embodiments, the shield 3256 may include a rotatable dial configured to allow axial adjustment of the shield 3256. In some embodiments, the shield 3256 may be coupled to the syringe 3204, needle hub 3208, or needle 3202 via, for example, a retaining screw 3260, to maintain the distance by which the needle protrudes.

[0137] Figure 33 An exemplary drug delivery device 3300 for delivering medication to ocular tissue is described. The drug delivery device 3300 may include a sleeve 3306 configured to couple to a syringe. In some embodiments, the sleeve 3306 may include a sensor 3310 configured to measure the thickness of the sclera of the eye. The sensor 3310 may be a blow sensor, a light sensor, etc. Before inserting the syringe into the sleeve 3306, a user may place the sleeve 3306 against the eye to measure the sclera. After obtaining the scleral thickness measurement, the syringe may be loaded into the sleeve 3306. The sleeve 3306 may include a stop 3304 configured to control the axial position of the syringe within the sleeve 3306. The axial position of the syringe within the sleeve 3306 may be adjustable such that the length of the needle protruding from the sleeve 3306 through the opening 3312 is adjustable. Based on the thickness measurement, the user may select an appropriate needle length and adjust the stop 3304 within the sleeve 3306 accordingly to set the syringe in an appropriate position. The user can then place the device on the eye so that the needle penetrates the eye, and the sleeve 3306 is positioned to contact the outer surface of the eye. The user can then inject medication through the needle.

[0138] The following are further illustrative embodiments based on this disclosure:

[0139] (1) A drug delivery device comprising: a needle having a sharp distal tip; a needle hub connected to a proximal end of the needle; and an adapter surrounding a portion of the needle; wherein the sharp distal tip is configured to move from a retracted position in which the sharp distal tip is located within the adapter to an extended position in which the sharp distal tip protrudes from the adapter.

[0140] (2) The device as described in (1) further includes a user-actuated mechanism configured to selectively move the farthest tip of the sharp point between the retracted position and the extended position.

[0141] (3) The device as described in (2) further includes a biasing member configured to push the sharp, farthest tip toward the retracted position.

[0142] (4) The device as described in (1) further includes one or more sensors; and a microprocessor configured to receive signals from the one or more sensors and, based on the signals, move the sharp, farthest tip from the retracted position to the unfolded position.

[0143] (5) The device as described in (4), wherein the one or more sensors include a capacitive sensor located on the adapter.

[0144] (6) The device as described in (4), wherein the one or more sensors include a pressure sensor located on the adapter.

[0145] (7) A drug delivery device comprising: a needle having a sharp distal tip; a needle hub connected to a proximal end of the needle; an adapter surrounding a portion of the needle; one or more sensors; and a microprocessor configured to receive signals from the one or more sensors and, based on the signals, determine the position of the sharp distal tip or the adapter relative to a human organ.

[0146] (8) The device as described in (7), wherein the one or more sensors include a capacitive sensor located on the adapter.

[0147] (9) The device as described in (7), wherein the one or more sensors include a plurality of pressure sensors located on the adapter.

[0148] (10) The device as described in (7) further includes a microneedle; wherein the needle and the microneedle are electrically connected via a low-voltage circuit.

[0149] (11) The device as described in (7), wherein the one or more sensors include a first electrode located on the adapter and the microneedle and a second electrode located near the farthest tip.

[0150] (12) The device as described in (7), wherein the one or more sensors include a level configured to determine the angular position of the needle and the adapter.

[0151] (13) The device as described in (7) further includes: a mechanism configured to move the sharp farthest tip from a retracted position in which the sharp farthest tip is located within the adapter to an extended position; wherein the microprocessor is further configured to, in response to determining the position of the sharp farthest tip or the adapter, cause the mechanism to move the sharp farthest tip from the retracted position to the extended position.

[0152] (14) The device as described in (13), wherein the microprocessor is further configured to: determine, based on the signals from the one or more sensors, that the distal tip of the sharp point or the adapter has disengaged from the human organ; and in response to the distal tip of the sharp point or the adapter disengaging from the human organ, cause the mechanism to move the distal tip of the sharp point from the deployed position to the retracted position.

[0153] (15) The device as described in (7), wherein the one or more sensors include a sensor configured to detect the angular position of the needle relative to the tangent of the human organ; wherein the microprocessor is further configured to determine that the angular position of the needle is a predetermined angular position.

[0154] (16) The device as described in (15) further includes: a mechanism configured to move the sharp farthest tip from a retracted position in which the sharp farthest tip is located within the adapter to an extended position; wherein the microprocessor is further configured to cause the mechanism to move the sharp farthest tip from the retracted position to the extended position in response to determining that the angular position of the needle is a predetermined angular position.

[0155] (17) The device as described in (15), wherein the microprocessor is further configured to issue one or more visual, auditory or tactile indications in response to determining that the angular position of the needle is a predetermined angular position.

[0156] (18) The device as described in (10), wherein the microprocessor is further configured to: determine that the current of the low-voltage circuit exceeds a predetermined current; and in response to determining that the current of the low-voltage circuit exceeds the predetermined current, cause one or more visual, auditory or tactile indications to be issued.

[0157] (19) The device as described in (7) further includes: a first electrode located near the farthest tip of the sharp point, and a second electrode; wherein the microprocessor is further configured to: determine the position of the farthest tip of the sharp point based on the conductivity between the first electrode and the second electrode; and in response to determining the position of the farthest tip of the sharp point, cause one or more visual, auditory or tactile indications to be issued.

[0158] (20) A kit comprising: a needle having a sharp distal tip; a container for packaging an ophthalmic drug; and an adapter configured to couple to the needle such that the sharp distal tip is movable from a retracted position in which the sharp distal tip is located within the adapter to an extended position in which the sharp distal tip protrudes from the adapter.

[0159] (21) An apparatus for delivering a drug to ocular tissue, the apparatus comprising: a container configured to package the drug; a needle having a shaft defining a needle axis, a channel through the needle, and a sharp distal tip, wherein the channel is configured to deliver the drug through the needle; and a needle sheath at least partially surrounding the shaft of the needle, wherein the needle sheath includes a distal surface, wherein the sharp distal tip of the needle is configured to extend through an opening in the distal surface; wherein the needle sheath is movable relative to the needle along the needle axis to control the distance from the distal surface to the distal tip of the needle.

[0160] (22) The device as described in (21), wherein the distal surface is configured to be positioned against the outer surface of the eye, and the needle sheath is configured to limit the depth of insertion of the needle into the eye.

[0161] (23) The device as described in (21) further includes: a dial coupled to one or more of the needle, the needle sheath and the container, wherein rotation of the dial is configured to move the needle sheath relative to the needle.

[0162] (24) The device as described in (23), wherein the dial is coupled to one or more of the needle, the needle sleeve and the container via a threaded connection.

[0163] (25) The device as described in (23), wherein the rotation of the dial is configured such that the needle sleeve moves relative to the needle in discontinuous increments.

[0164] (26) The device as described in (23), wherein the needle is suppressed from rotating relative to the container.

[0165] (27) The device as described in (26), wherein the needle is bonded to the container.

[0166] (28) The device as described in (21) further includes: a shield coupled to one or more of the needle, the needle sheath and the container, wherein movement of the shield along the needle axis is configured to cause the needle sheath to move relative to the needle.

[0167] (29) The device as described in (21), wherein the distal surface is at an angle relative to the needle shaft.

[0168] (30) The device as described in (21) further includes: a sensor configured to measure the thickness of the sclera of the eye.

[0169] (31) The device as described in (21) further includes: a lock configured to selectively inhibit movement of the needle sleeve relative to the needle.

[0170] (32) A device for delivering a drug to ocular tissue, the device comprising: a needle having a shaft defining a needle axis and a sharp distal tip; a needle sheath at least partially surrounding the shaft of the needle, wherein the needle sheath includes a distal surface, wherein the sharp distal tip of the needle is configured to extend through an opening in the distal surface; wherein the needle sheath is movable relative to the needle along the needle axis; and a dial coupled to one or more of the needle and the needle sheath, wherein rotation of the dial is configured to change the distance from the distal surface to the sharp distal tip.

[0171] (33) The device as described in (32), wherein the distal surface is configured to be positioned against the outer surface of the eye, and the needle sheath is configured to limit the depth of insertion of the needle into the eye.

[0172] (34) The device as described in (32), wherein the dial is coupled to one or more of the needle and the needle sleeve via a threaded connection.

[0173] (35) The device as described in (32), wherein the rotation of the dial is configured such that the needle sleeve moves relative to the needle in discontinuous increments.

[0174] (36) The device as described in (32), wherein the rotation of the dial is configured such that the needle sleeve moves continuously relative to the needle.

[0175] (37) The device as described in (32) further includes: a sensor configured to measure the thickness of the sclera of the eye.

[0176] (38) The device as described in (32) further includes: a lock configured to selectively inhibit movement of the needle sleeve relative to the needle.

[0177] (39) A method of delivering a drug to ocular tissue using a delivery device, the delivery device comprising a container configured to package the drug, a needle having a sharp distal tip, and a needle sheath at least partially surrounding a shaft of the needle, the method comprising: adjusting a distance from a distal surface of the needle sheath to the distal tip of the needle; after adjusting the distance, inserting the distal tip of the needle into the ocular tissue; positioning the distal surface of the needle sheath against the outermost surface of the ocular tissue; and delivering a volume of the drug to the ocular tissue via the needle.

[0178] (40) The method of (39), wherein the delivery device further includes a sensor configured to measure the thickness of the sclera, and the method further includes: measuring the thickness of the sclera using the sensor; and adjusting the distance from the distal surface of the needle sheath to the farthest tip of the needle based on the measured thickness.

[0179] Those skilled in the art will understand that various modifications and changes can be made to the disclosed apparatus and methods without departing from the scope of this disclosure. Other aspects of this disclosure will be apparent to those skilled in the art through practice of the specification and features disclosed herein. The specification and examples are intended to be illustrative only.

Claims

1. A device for delivering a drug to ocular tissue, the device comprising: A container configured to package the drug; A needle having a shaft defining a needle axis, a channel passing through the needle, and a sharp distal tip, wherein the channel is configured to deliver the drug through the needle; and A needle sheath, which at least partially surrounds the shaft of the needle, wherein the needle sheath includes a distal surface, wherein the sharp, distal tip of the needle is configured to extend through an opening in the distal surface; The needle sleeve is movable relative to the needle along the needle axis to control the distance from the distal surface to the farthest tip of the needle.

2. The device as claimed in claim 1, wherein, The distal surface is configured to be positioned against the outer surface of the eye, and the needle sheath is configured to limit the depth to which the needle is inserted into the eye.

3. The device as claimed in claim 1, further comprising: A dial coupled to one or more of the needle, the needle sheath, and the container, wherein rotation of the dial is configured to cause the needle sheath to move relative to the needle.

4. The device as described in claim 3, wherein, The dial is coupled to one or more of the needle, the needle sheath, and the container via a threaded connection.

5. The device as described in claim 3, wherein, The rotation of the dial is configured to cause the needle sleeve to move relative to the needle in discontinuous increments.

6. The device as claimed in claim 3, wherein, The needle is prevented from rotating relative to the container.

7. The device as claimed in claim 6, wherein, The needle is bonded to the container.

8. The device of claim 1, further comprising: A shield coupled to one or more of the needle, the needle sheath, and the container, wherein movement of the shield along the needle axis is configured to cause movement of the needle sheath relative to the needle.

9. The device as claimed in claim 1, wherein, The distal surface is at an angle relative to the needle axis.

10. The device of claim 1, further comprising: A sensor configured to measure the thickness of the sclera of the eye.

11. The device of claim 1, further comprising: A lock is configured to selectively inhibit movement of the needle sheath relative to the needle.

12. A device for delivering a drug to ocular tissue, the device comprising: A needle, which has a shaft that defines the needle axis and a sharp, farthest point; A needle sheath, at least partially surrounding the shaft of the needle, wherein the needle sheath includes a distal surface, wherein the distal tip of the needle is configured to extend through an opening in the distal surface, and wherein the needle sheath is movable relative to the needle along the needle axis; and A dial coupled to one or more of the needle and the needle sheath, wherein rotation of the dial is configured to change the distance from the distal surface to the farthest tip of the sharp point.

13. The device as claimed in claim 12, wherein, The distal surface is configured to be positioned against the outer surface of the eye, and the needle sheath is configured to limit the depth of insertion of the needle into the eye.

14. The device as claimed in claim 12, wherein, The dial is coupled to one or more of the needle and the needle sheath via a threaded connection.

15. The device as claimed in claim 12, wherein, The rotation of the dial is configured to cause the needle sleeve to move relative to the needle in discontinuous increments.

16. The device as claimed in claim 12, wherein, The rotation of the dial is configured to cause the needle sleeve to move continuously relative to the needle.

17. The apparatus of claim 12, further comprising: A sensor configured to measure the thickness of the sclera of the eye.

18. The apparatus of claim 12, further comprising: A lock is configured to selectively inhibit movement of the needle sheath relative to the needle.

19. A method of delivering a drug to ocular tissue using a delivery device, said delivery device comprising a container configured to package the drug, a needle having a sharp distal tip, and a needle sheath at least partially surrounding a shaft of said needle, the method comprising: Adjust the distance from the distal surface of the needle sheath to the farthest tip of the needle; After adjusting the distance, insert the farthest tip of the needle into the eye tissue; Position the distal surface of the needle sheath against the outermost surface of the eye tissue; as well as A certain volume of the drug is delivered to the ocular tissue via the needle.

20. The method of claim 19, wherein, The delivery device further includes a sensor configured to measure the thickness of the sclera, and the method further includes: The thickness of the sclera is measured using the sensor; and Based on the measured thickness, the distance from the distal surface of the needle sheath to the farthest tip of the needle is adjusted.

Images