SISTEMA PARA A LIBERAÇÃO DE FÁRMACO AO TECIDO OCULAR

Description

1 / 57 “SYSTEM FOR DRUG DELIVERY TO OCULAR TISSUE” DIVIDED FROM ORDER BR112023002465-0, FILED ON AUGUST 11, 2021 CROSS-REFERENCE TO RELATED REQUESTS

[0001] This application claims priority over U.S. Conditional Application No. 63 / 064658, filed August 12, 2020, the entirety of which is incorporated herein by reference. TECHNICAL FIELD

[0002] Several aspects of this disclosure generally relate to drug delivery to ocular tissue. More specifically, this disclosure relates to instruments and methods for drug delivery to the suprachoroidal space of an eye. INTRODUCTION

[0003] Eye conditions and diseases lead to optic nerve damage and visual field loss. Medications, laser surgery, and / or incisional surgery are interventions that can be used to help lower intraocular pressure, preserve existing vision, and delay further progression of the condition and / or disease. With respect to incisional surgery, the instruments for performing surgical procedures, devices for delivering drug therapies, and methods made possible by such instruments are highly sought after to provide better outcomes for users and subjects. SUMMARY OF THE DISCLOSURE

[0004] According to one aspect of the disclosure, it is a system for delivering medication to the suprachoroidal space of an eye comprising a needle having a passage through it and a sharp, more distal tip and an apparatus configured to manipulate the sclera to facilitate the delivery of the medication to the suprachoroidal space of the eye.

[0005] Various system modalities may include one or more of the following aspects: the needle may be configured to deliver the medication to the suprachoroidal space of the eye; the most distal sharp tip may include a plurality of Petition 870260057113, dated 12 / 06 / 2026, p. 11 / 171 2 / 57 openings, wherein the openings may include a circular configuration or slits or wherein the plurality of openings is present in at least a portion of a circumference and a length of the most distal sharp tip; the device may be configured to release the medication to the suprachoroidal space of the eye; the device may be disposed within the needle passage and longitudinally translatable with respect to the needle; the device may include a tubular rod having a distal end, wherein the tubular rod comprises a rigid material, a semi-rigid material or a flexible material; the distal end may include an atraumatic distal tip, wherein the atraumatic distal tip may include a plurality of openings, additionally wherein the openings may include a circular configuration or slits or wherein the plurality of openings is present in at least a portion of a circumference and a length of the atraumatic distal tip;The distal end may include an expandable limb, wherein the expandable limb may include a stent; the tubular shaft may include an expandable portion, wherein the expandable portion may include a pair of curved limbs positioned proximally to the atraumatic distal tip; the tubular shaft may include a cross-sectional dimension smaller than a cross-sectional dimension of the passage; an outer surface of the tubular shaft may include one or more channels; the distal end of the tubular shaft may include at least two legs configured to selectively diverge from the distal end of the tubular shaft used from the needle passage; the needle may be curved; the needle may be U-shaped; the needle may include a curve positioned proximally to the most distal sharp tip;The needle may include an outer surface having a plurality of geometric features configured to provide tactile feedback to the user, or the distal end may include an anchor, wherein the anchor may have a curved, planar, or atraumatic shape.

[0006] In another aspect, a system of the present disclosure may comprise a planar surface having a projection for deforming one or more sclera or choroid, wherein the projection may be a round surface. In another aspect, a system of the present disclosure may include a chamber for Petition 870260057113, dated 12 / 06 / 2026, page 12 / 171 3 / 57 remove a portion of the sclera from this, where the device can be configured to apply suction to the sclera; the needle can be disposed within the chamber; the chamber can include a stop configured to limit the proximal advancement of the sclera into the chamber; the stop can be configured to encircle the needle; the stop can include a plurality of extensions that extend from the lateral wall of the chamber towards a center of the chamber; the stop can include a plurality of openings configured to facilitate the application of suction to the sclera; the chamber can include a circular cross-section or the chamber can include a semicircular cross-section configuration.

[0007] The present disclosure includes an apparatus for manipulating a sclera to facilitate the release of a drug to a suprachoroidal space of an eye, the apparatus comprising a tubular shaft having a distal end, wherein the tubular shaft comprises a rigid, semi-rigid or flexible material and a needle having a passage through thereto and a sharp more distal tip, wherein the apparatus is disposed within the needle. Various embodiments of the apparatus may include one or more of the following aspects: the needle may be configured to release the drug to the suprachoroidal space of the eye; the sharp more distal tip may include a plurality of openings, wherein the openings may include a circular configuration or slits or wherein the plurality of openings is present in at least a portion of a circumference and a length of the sharp more distal tip; the apparatus may be configured to release the drug to the suprachoroidal space of the eye;The device may be longitudinally translatable relative to the needle; the distal end may include an atraumatic distal tip, wherein the atraumatic distal tip may include a plurality of openings, wherein the openings may include a circular configuration or slits, or wherein the plurality of openings is present in at least a portion of a circumference and a length of the atraumatic distal tip; the distal end may include an expandable limb, wherein the expandable limb may include a stent; the tubular stem may include an expandable portion, wherein the expandable portion may include a pair of proximally positioned curved limbs; Petition 870260057113, dated 12 / 06 / 2026, p. 13 / 171 4 / 57 of the distal end; the tubular shaft may include a cross-sectional dimension smaller than a cross-sectional dimension of the passage; an outer surface of the tubular shaft may include one or more channels; the distal end of the tubular shaft may include at least two legs configured to diverge selectively when the distal end of the tubular shaft is used from the needle passage; the needle may be curved or the distal end may include an anchor, wherein the anchor has a planar or atraumatic shape.

[0008] In another aspect, the present disclosure includes an apparatus for manipulating a sclera to facilitate the release of a drug to a suprachoroidal space of an eye, the apparatus comprising a planar surface having a projection for deforming one or more sclera or choroid, wherein the projection may be a round surface.

[0009] In another aspect, the present disclosure includes an apparatus for manipulating a sclera to facilitate the release of a drug into a suprachoroidal space of an eye, the apparatus comprising a chamber for withdrawing a portion of the sclera thereof. Various embodiments of the apparatus may include one or more of the following aspects: the apparatus may be configured to apply suction to the sclera; a needle may be disposed within the chamber; the chamber may include a stop configured for proximal advancement of the sclera into the chamber; the stop may be configured to encircle the needle; the stop may include a plurality of extensions extending from the lateral wall of the chamber toward a center of the chamber; the stop may include a plurality of openings configured to facilitate the application of suction to the sclera; the chamber may include a circular cross-section or the chamber may include a semicircular cross-section configuration.

[0010] In another aspect, the present disclosure includes an apparatus for manipulating a sclera to facilitate the release of a drug to a suprachoroidal space of an eye, the apparatus comprising a needle tubing having a cylindrical shape and a serrated needle tip, wherein the serrated needle can oscillate to cut through a portion of the sclera. Petition 870260057113, dated 12 / 06 / 2026, page 14 / 171 5 / 57

[0011] In another aspect, the present disclosure includes an apparatus for manipulating a sclera to facilitate the release of a drug into a suprachoroidal space of an eye, the apparatus comprising a needle with a sharp distal tip; a needle hub connected to a proximal end of the needle and a housing that encircles the needle hub and does not extend from a proximal end of the needle hub. Various embodiments of the apparatus may include one or more of the following aspects: the housing may be cylindrical in shape; the housing may comprise an additional component chosen from a syringe, a spring, a piston, a plunger rod, an indicator, a feedback mechanism or combinations thereof or a rod that encircles a portion of the needle and extends from the distal end of the needle hub, wherein the distal end of the rod is angled, allowing the needle to be inserted at an angle.

[0012] In another aspect, the present disclosure is designed for a method for delivering a drug to a suprachoroidal space of an eye, the method comprising manipulating a sclera and a choroid layer of the eye to increase a dimension of the suprachoroidal space; advancing the distal end of a drug delivery device into the suprachoroidal space; positioning the most distal tip of the drug delivery device in the suprachoroidal space and delivering a volume of the drug to the suprachoroidal space.Various modalities of the method may include one or more of the following aspects: advancing the distal end of the drug delivery device into the suprachoroidal space may include penetrating the sclera; positioning the most distal tip of the drug delivery device may include placing the most distal tip in the suprachoroidal space without contacting the choroid; positioning the most distal tip of the drug delivery device may include placing the most distal tip in the suprachoroidal space without perforating an outer surface of the choroid; positioning the most distal tip of the drug may include placing the most distal tip in the suprachoroidal space without penetrating a thickness of the choroid; a volume of drug delivered to the suprachoroidal space may be... Petition 870260057113, dated 12 / 06 / 2026, p. 15 / 171 6 / 57 approximately 50 uL to 500 uL; the release of the drug volume into the suprachoroidal space can be controlled by pressure; manipulation of the sclera and choroid layer may include rotating the drug delivery device; manipulation of the sclera and choroid layer may include pulling the sclera layer to increase the size of the suprachoroidal space; releasing the drug volume into the suprachoroidal space may include releasing the volume from the most distal tip of the drug delivery device or releasing a volume of drug into the suprachoroidal space may include releasing the drug from a location proximal to the most distal tip of the drug delivery device.

[0013] In another aspect, the present disclosure includes an apparatus for facilitating the targeted release of a drug into a human organ of a patient.The apparatus may include a container for a fluid-connected drug, the needle comprising a needle shaft and a sharp, distal tip with a bevel, wherein the needle is connected to a distal end of the container, and an adapter that encircles a portion of the needle shaft along its longitudinal axis, but not including the sharp, distal tip of the needle, the adapter including an outermost oblique surface configured to direct a trajectory of the sharp, distal tip to a predetermined depth and location within the human organ, wherein the outermost oblique surface faces an identical direction as the bevel of the sharp, distal tip, wherein an angle of the outermost oblique surface dictates the trajectory of the needle, and wherein a length of the needle extending from the outermost oblique surface determines the depth or location of drug release.Various embodiments of the device may include one or more of the following aspects: the most distal sharp tip may be a portion of the needle extending from the distal end of the adapter; a needle shaft hub connected to a proximal end of the needle, such as a rigid needle; a hub disposed between the container and the needle; the needle is removablely connected to the hub; the needle is a first needle and the device additionally comprises a... Petition 870260057113, dated 12 / 06 / 2026, p. 16 / 171 7 / 57 second needle; the first and second needles are interchangeable; the needle is replaceable; the angle varies from about 25 degrees to about 75 degrees; the angle varies from about 40 degrees to about 60 degrees; the angle is about 45 degrees; the adapter is connected to a portion of the needle shaft by means of a fastener or screw; the adapter is translatable with respect to an axial path of the needle shaft; the adapter is attached to the needle shaft by means of an adhesive;The adapter may include: a proximal end having a surface extending in a first plane perpendicular to the needle, an angled distal side, an intermediate surface extending between the proximal end and the angled distal side, wherein the intermediate surface extends in a second plane perpendicular to the first plane, and a distal end, wherein the distal end includes a substantially flat surface extending in a third plane parallel to the first plane; at least a portion of the adapter includes a substantially cylindrically formed cross-section; the outermost oblique surface is angled with respect to a longitudinal axis of the adapter; a portion of the most distal sharp point of the needle extends beyond the distal end of the adapter; the most distal sharp point of the needle has a length ranging from about 600 µm to about 800 µm;The outermost oblique surface is a planar surface, and the outermost oblique surface is a convex surface configured to match the outer surface of an eye.

[0014] In another aspect, the present disclosure includes a system for delivering medication to a patient's ocular space. The system may include a syringe with a nominal maximum filling volume between about 0.5 ml and about 1.0 ml; a needle comprising a needle shaft and a sharp, distal tip with a bevel and an adapter that encircles a portion of the needle shaft along its longitudinal axis, the adapter including an outer oblique surface angled with respect to a longitudinal axis of the adapter and wherein the adapter is configured to direct a trajectory from the sharp, distal tip to predetermined ocular depth and location; wherein the Petition 870260057113, dated 12 / 06 / 2026, page 17 / 171 The 8 / 57 syringe, needle, and adapter are sterilized and contained in a blister pack. Various embodiments of the system may still include one or more of the following features: the adapter is configured to limit the advancement of the most distal tip into the suprachoroidal space of the eye; the most distal sharp tip is a portion of the needle extending from the outermost oblique surface; an angle of the outermost oblique surface ranges from about 25 degrees to about 75 degrees; an angle of the outermost oblique surface ranges from about 40 degrees to about 60 degrees; an angle of the outermost oblique surface is about 45 degrees; and the most distal sharp tip of the needle has a length ranging from about 600 µm to about 800 µm.

[0015] In another aspect, the present disclosure includes a kit for treating a patient suffering from an eye disease. The kit may include: a syringe with a maximum nominal filling volume between about 0.5 ml and about 1.0 ml; a needle having a needle shaft and a sharp, more distal tip; an adapter that encircles a portion of the needle shaft along its longitudinal axis, but not including the sharp, more distal tip of the needle, the adapter including an outer oblique surface configured to direct the trajectory of the sharp, more distal tip to a predetermined ocular depth and location; and an ophthalmic drug.

[0016] In another aspect, the present disclosure includes a kit for treating a patient suffering from an eye disease. The kit may include: a syringe filled with an ophthalmic drug, wherein a volume of the ophthalmic drug ranges between about 0.5 ml and about 1.0 ml; a needle having a needle shaft, a passage through it and a sharp more distal tip and an adapter that encircles a portion of the needle shaft along the longitudinal axis of the needle shaft, the portion excluding the sharp more distal tip of the needle, the adapter including an outermost oblique surface configured to direct a trajectory of the sharp more distal tip to a predetermined depth and location.

[0017] In another aspect, the present disclosure includes a method for releasing Petition 870260057113, dated 12 / 06 / 2026, p. 18 / 171 9 / 57 administering medication to a patient's eye. The method may include: positioning a more distal tip of a medication delivery device into a suprachoroidal space of the eye at a predetermined depth and location, wherein the medication delivery device may comprise: a container for a fluid-connected medication, the needle comprising a needle shaft and a sharp more distal tip with a bevel, wherein the needle is connected to a distal end of the container, and an adapter encircling a portion of the needle shaft along its longitudinal axis, the portion not including the sharp more distal tip of the needle, the adapter including an outermost oblique surface configured to direct the trajectory of the sharp more distal tip to a predetermined ocular depth and location and deliver a volume of medication into the suprachoroidal space.

[0018] In another aspect, the present disclosure includes a method for delivering a medication to a suprachoroidal space of an eye using a medication device. The medication device may include: a container for a medication fluidly connected to the needle, the needle comprising a needle shaft and a sharp distal tip with a bevel and an adapter that encircles a portion of the needle shaft along its longitudinal axis, the adapter including an outer oblique surface angled with respect to the longitudinal axis. The method may include: penetrating the sclera of the eye with the sharp distal tip; inserting the needle through the sclera into the suprachoroidal space until the outer oblique surface contacts the sclera and, on the outer oblique surface contacting the sclera, delivering a volume of medication to the suprachoroidal space.

[0019] In another aspect, the present disclosure includes a method for delivering a drug to the suprachoroidal space of an eye. The method may include: manipulating a part of the sclera or choroid layer of the eye to increase the dimension of the suprachoroidal space; advancing the distal end of a drug delivery device into the suprachoroidal space; positioning the most distal tip of the drug delivery device in the suprachoroidal space and releasing the drug. Petition 870260057113, dated 12 / 06 / 2026, p. 19 / 171 10 / 57 a volume of medication into the suprachoroidal space. Various embodiments of the method may additionally include one or more of the following aspects: advancing the distal end of the drug delivery device into the suprachoroidal space includes penetrating the sclera; positioning the most distal tip of the drug delivery device including placing the most distal tip in the suprachoroidal space without contacting the choroid; positioning the most distal tip of the drug delivery device including placing the most distal tip in the suprachoroidal space without perforating an outer surface of the choroid; positioning the most distal tip of the medication including placing the most distal tip in the suprachoroidal space without penetrating a thickness of the choroid and a volume of medication delivered to the suprachoroidal space is approximately 50 µL to 500 µL. BRIEF DESCRIPTION OF THE FIGURES

[0020] The attached drawings, which are incorporated into and form part of this descriptive report, illustrate various examples and, together with the description, serve to explain the principles of the examples and embodiments described.

[0021] The disclosure aspects may be implemented in connection with embodiments illustrated in the accompanying drawings. These drawings show different aspects of the present disclosure and, where appropriate, reference numbers illustrating structures, components, materials and / or elements in different figures are similarly labeled. It is understood that various combinations of structures, components and / or elements, other than those specifically shown, are considered and are within the scope of the present disclosure.

[0022] In addition, there are many modalities described and illustrated herein. This disclosure is not limited to any single aspect or modality, nor is it limited to any combinations and / or exchanges of such aspects and / or modalities. Furthermore, each of the aspects of this disclosure and / or modalities thereof may be used alone or in combination with one or more of the other aspects of this disclosure and / or modalities thereof. For the sake of brevity, certain exchanges and combinations are not discussed herein and / or Petition 870260057113, dated 12 / 06 / 2026, p. 20 / 171 11 / 57 illustrated separately. Notably, an embodiment or implementation described here as exemplary should not be interpreted as preferred or advantageous, for example, over other embodiments or implementations; rather, these are intended to reflect or indicate that the embodiment(s) is / are exemplary embodiment(s).

[0023] FIGS. 1A and 1B are cross-sectional views of an exemplary instrument that treats ocular tissue, according to an embodiment of the present disclosure.

[0024] FIG. 2 is a cross-sectional view of an exemplary instrument that treats ocular tissue, according to an embodiment of the present disclosure.

[0025] FIGS. 3A and 3B are cross-sectional views of an exemplary instrument, according to an embodiment of the present disclosure.

[0026] FIGS. 4A and 4B are cross-sectional views of an exemplary instrument that treats ocular tissue, according to an embodiment of the present disclosure.

[0027] FIGS. 5A and 5B are cross-sectional views of an exemplary instrument according to an embodiment of the present disclosure.

[0028] FIG. 6A is a cross-sectional view of an exemplary instrument, and FIG. 6B is a top view of the instrument of FIG. 6A, according to an embodiment of the present disclosure.

[0029] FIGS. 7A to 7C depict an exemplary instrument for treating eye tissue, according to an embodiment of the present disclosure.

[0030] FIGS. 8A to 8F describe another exemplary instrument that treats ocular tissue, according to an embodiment of the present disclosure.

[0031] FIG. 9 depicts another exemplary instrument that treats ocular tissue, according to an embodiment of the present disclosure.

[0032] FIG. 10 depicts a further exemplary instrument that treats ocular tissue, according to an embodiment of the present disclosure.

[0033] FIGS. 11A and 11B describe another exemplary instrument, according to an embodiment of the present disclosure. Petition 870260057113, dated 12 / 06 / 2026, p. 21 / 171 12 / 57

[0034] FIGS. 12A and 12B are cross-sectional views of an exemplary tubular rod of an exemplary instrument, according to an embodiment of the present disclosure.

[0035] FIG. 13 is a side view of another exemplary instrument, according to an embodiment of the present disclosure.

[0036] FIGS. 14 to 19 are views of cross-sections of a further exemplary instrument that treats ocular tissue, according to an embodiment of the present disclosure.

[0037] FIG. 20 is a top view of an exemplary instrument that treats ocular tissue, according to an embodiment of the present disclosure.

[0038] FIGS. 21A and 21B are viewed in perspective of another exemplary instrument, according to an embodiment of the present disclosure.

[0039] FIGS. 22A and 22B are viewed in perspective of an exemplary additional instrument, according to an embodiment of the present disclosure.

[0040] FIGS. 23A and 23C are cross-sectional views of yet another exemplary instrument, according to an embodiment of the present disclosure. FIG. 23B is a cross-sectional view showing the exemplary instrument of FIGS. 23A and 23C that treats ocular tissue, according to an embodiment of the present disclosure.

[0041] FIG. 24 is a partially transparent view of an exemplary instrument, according to an embodiment of the present disclosure.

[0042] FIG. 25 is a partially transparent view of another exemplary instrument, according to an embodiment of the present disclosure.

[0043] FIGS. 26A and 26B are partially transparent views of an exemplary instrument, according to an embodiment of the present disclosure.

[0044] FIGS. 27A and 27B are cross-sectional views showing a further embodiment of an instrument being used to deliver a drug to ocular tissue, according to an embodiment of the present disclosure.

[0045] FIG. 28 is a perspective view of an exemplary instrument, according to an embodiment of the present disclosure. Petition 870260057113, dated 12 / 06 / 2026, p. 22 / 171 13 / 57

[0046] FIG. 29 is a cross-sectional view of an exemplary instrument according to an embodiment of the present disclosure.

[0047] FIG. 30 depicts an exemplary instrument that treats ocular tissue, according to an embodiment of the present disclosure.

[0048] As used herein, the terms “comprises,” “comprising,” “includes,” “including,” or any other variation thereof, are intended to encompass a non-exclusive inclusion, such that a process, method, article, or apparatus comprising a list of elements does not include only those elements, but may include other elements not expressly listed or inherent in such process, method, article, or apparatus. “Exemplar” is used in the sense of “example,” rather than “ideal.” Furthermore, the terms “first,” “second,” and the like, herein, do not indicate any order, quantity, or importance, but instead are used to distinguish one element or structure from another. Additionally, the terms “a” and “an” herein do not indicate a limitation of quantity, but instead indicate the presence of one or more of the items referred to.

[0049] Notably, for simplicity and clarity of illustration, certain aspects of the figures describe the overall structure and / or manner of construction of the various embodiments. Descriptions and details of well-known features and techniques may be omitted to avoid unnecessarily obscuring other features. The elements in the figures are not necessarily drawn to scale; the dimensions of some features may be exaggerated relative to other elements to improve understanding of the embodiments in the example. For example, a person skilled in the art would consider that side views are not drawn to scale and should not be seen as representing proportional relationships between different components. Side views are provided to help illustrate the various components of the described assembly and to show their position relative to each other. DETAILED DESCRIPTION

[0050] Reference will now be made in detail to examples from the present disclosure, which are illustrated in the attached drawings. Whenever possible, the Petition 870260057113, dated 12 / 06 / 2026, p. 23 / 171 14 / 57 The same reference numbers will be used by all designs to refer to the same or similar parts. The term “distal” refers to a portion further away from a user when introducing a device into a subject. Conversely, the term “proximal” refers to a portion closer to the user when placing the device on the subject. In the discussion that follows, relative terms such as “about”, “substantially”, “approximately”, etc. are used to indicate a possible variation of ±10% in an established numerical value.

[0051] The disclosure aspects relate, among other things, to instruments and methods for delivering drugs to ocular tissues. Each of the aspects described herein may include one or more of the features described in connection with any of the other aspects described. It may be understood that both the preceding general description and the following detailed description are exemplary and explanatory only and are not restrictive of any claimed inventions.

[0052] The suprachoroidal space (SCS) is a potential space between the sclera and choroid that runs around the circumference of the posterior segment of the eye. It is a useful site for drug delivery because it targets the choroid, retinal pigment epithelium, and retina with high bioavailability, while maintaining low levels in other parts of the eye. Under physiological conditions, primarily due to intraocular pressure (IOP), the SCS is primarily in a collapsed state. The SCS plays a role in maintaining IOP through uveoscleral outflow, which is an alternative drainage pathway for aqueous humor and is a natural flow path from the front to the back 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 different volumes, for example, up to about 3.0 mm, depending on the injection volumes.Injecting high volumes of drugs can have adverse effects, for example, elevated IOP, which can cause localized serous retinal elevation, choroidal hemorrhage from the needle entry point, and choroidal edema and potential choroidal displacement; backflow from the needle entry point and fluid reflux that can cause subconjunctival hemorrhage. Petition 870260057113, dated 12 / 06 / 2026, page 24 / 171 15 / 57 Additionally, large volumes of fluid may not be injected into the eye until a needle from an injection device has fully penetrated the sclera.

[0053] To expand the SCS, for example, by mechanically separating the sclera and choroid and breaking the fibers that hold the sclera and choroid together, instruments can be inserted through the sclera and placed at the correct depth between the sclera and choroid layers, such that optimal volumes of fluids, for example, drugs, can be injected into the SCS. Any drugs inserted into the SCS can allow direct drug delivery to the posterior section of the eye to specifically target, for example, the retina and / or macula. The instruments and methods for insertion and injection into the eye can only allow extension to a certain depth of the ocular layers. For example, the sclera layer ranges from about 500 µm to about 1100 µm, the SCS has a thickness of about 35 µm, and the choroid layer ranges from about 50 µm to about 300 µm.The insertion depth of a drug delivery instrument into the ocular layers can vary from about 1 mm to about 10 mm. However, such an insertion depth can penetrate and / or impact additional layers of ocular tissue, for example, the choroid, retinal pigment epithelium (RPE), and retina. Penetration of these layers should be minimized as much as possible so that the desired drug can be targeted to the intended area of ​​the eye via a minimally invasive procedure. For example, injection procedures can be performed as an outpatient procedure. The instruments and methods discussed in this disclosure address the disadvantages described above and can increase the ability of the SCS to maintain and diffuse optimal drug volumes, for example, 50 pl to 500 pl.

[0054] The exemplary modalities described herein may be used in the treatment of a variety of conditions, including ocular conditions. For example, modalities of the present disclosure may be used in the treatment of refractive errors, macular degeneration, cataracts, retinopathy, retinal detachments, glaucoma, amblyopia, strabismus, any other ocular condition or Petition 870260057113, dated 12 / 06 / 2026, page 25 / 171 16 / 57 any other condition suitable for treatment via tissue in the eye.

[0055] The above description and examples are illustrative and are not intended to be restrictive. A person of ordinary skill in the art may make numerous modifications and / or changes without departing from the overall scope of the invention. For example, and as mentioned above, aspects of the above-described embodiments may be used in any suitable combination with one another. Additionally, portions of the above-described embodiments may be removed without departing from the scope of the invention. Furthermore, modifications may be made to adapt a particular situation or aspect to the explanations of the various embodiments without departing from their scope. Many other embodiments will be apparent to those skilled in the art upon reviewing the above description.

[0056] Referring to FIGS. 1A and 1B, the different tissues and layers of the eye are represented, for example, sclera 2, SOS 4 and choroid 6. FIGS. 1A to 4B show various views of an instrument 10 for manipulating the layers of ocular tissue to facilitate the release of a drug to a suprachoroidal space of an eye. Instrument 10 may include a needle 12 and a tubular rod 14. The needle 12 may have a passage 16 and a more distal tip 18. The tubular rod 14 may be disposed on the needle 12 and may be longitudinally translatable relative to the needle 12, such that instrument 10 may be inserted into a subject's eye to create a separation between different tissues in the eye (e.g., separating tissues from each other, breaking fibers and / or connections in different tissues) and / or remove tissue within the eye, while at least a portion of instrument 10 may remain outside the eye where it can be held by a user.A drug, that is, a medication, may be contained within the needle 12, tubular rod 14, or both the needle 12 and the tubular rod 14. In examples where the instrument 10 can be inserted into a subject's eye and the tubular rod 14 can be positioned to create and / or augment SOS 4 (FIG. 1B), the medication can flow more easily beyond an instrument insertion site 24 and spread into an area of ​​the tissues and / or an expanded area 26. Petition 870260057113, dated 12 / 06 / 2026, p. 26 / 171 17 / 57 of SCS 4 to help avoid adverse reactions associated with drug injection. Spreading the drug over the tissue area may also prevent reflux of the drug from the instrument insertion site 24 and improve bioavailability to a posterior section of the eye.

[0057] The most distal tip 18 may be a sharp point or needle configured to penetrate a layer of eye tissue, for example, the sclera 2. The distal end 20 may have a substantially atraumatic or blunt tip 22 resistant to choroidal penetration 6 (FIG. 1A). Once the instrument 10 is inserted into a subject's eye, the tubular rod 14 may be longitudinally pushed through the passage 16 to separate the sclera 2 and choroid 6 (for example, by pushing and / or otherwise deforming the sclera 2 and / or choroid 6), which may form an expanded portion 26 of SCS 4 (FIG. 1B). Instrument 10 may include a plurality of openings 150 allowing the drug to flow from instrument 10 into SCS 4. For example, the openings 150 may be circular, slits, or combinations thereof (FIGS. 11A and 11B).The openings 150 may be arranged in the needle 12, tubular rod 14, or both the needle 12 and the tubular rod 14, in any configuration appropriate to allow a drug to flow from the instrument 10. For example, the openings 150 may be positioned along a length of and / or radially around a circumference of the needle 12 (e.g., on a side wall of the needle 12), tubular rod 14, or both the needle 12 and the tubular rod 14. In some examples, the instrument 10 may include from 2 to 30 openings or more than 30 openings. Referring to FIGS. 11A and 11B, the instrument 10 may be inserted into a patient's eye, parallel to the plane of SCS 4, such that a drug may flow from the instrument 10 into an area of ​​SCS 4 to help prevent adverse reactions associated with a drug in SCS 4.

[0058] The tubular shaft 14 may be solid, that is, containing no opening, such that a drug may flow from the needle 12 and flow around the tubular shaft 14. In such an example, the tubular shaft 14 may include a transverse dimension smaller than the transverse dimension of the passage 16, so that the drug may flow around Petition 870260057113, dated 12 / 06 / 2026, p. 27 / 171 18 / 57 of the tubular shaft 14. The tubular shaft 14 may have various configurations to facilitate drug flow around the tubular shaft 14 and beyond the insertion site 24 (FIG. 1B). FIGS. 12A and 12B show exemplary geometries of the tubular shaft 14. For example, the tubular shaft 14 may have a star shape (FIG. 12A) with a plurality of members 160 extending from and connected to a radial center 162 allowing the tubular shaft 14 containing the channels 164 to slightly separate the sclera 2 and choroid 6. The channels 164 may allow a drug to flow from the needle 12, around the tubular shaft 14 and beyond the injection site 24. Drug flow 166 around the members 160 of the tubular shaft 14 is shown in FIG. 12A. In another example, the tubular rod 14 may include at least one pair of channels 164 (FIG. 12B), such that needle 12 can be inserted in a specific orientation so that channels 164 are oriented within the SOS plane 4.When a drug is injected through the needle 12, the drug can flow through the channels 164 and be pushed out / beyond the tubular rod 14. Such configurations of the tubular rod 14 can be beneficial during the instrument 10 manufacturing process, as the channels 164 can be formed on an outer surface of the tubular rod 14, as opposed to an inner area of ​​the tubular rod 14. The drug flow 166 through the channels 164 of the tubular rod 14 is shown in FIG. 12B. Such configurations of the tubular rod 14 can also be useful for injecting substances of different viscosities into the SOS 4. For example, a low viscosity fluid can be injected through the channels 164, advantageously causing the low viscosity fluid to spread throughout the SOS 4. The tubular rod 14 can subsequently be removed from the needle 12, effectively increasing the size of the flow path. A viscous fluid, such as a gel, can then be injected through the needle 12.The tubular rod 14 can therefore promote the diffusion of lower viscosity fluids without permanently obstructing the flow path for higher viscosity fluids.

[0059] In yet another example, different substances can be made to flow through each of the channels 164 of the tubular rod 14. For example, a drug can be made to flow through one of the channels 164 and another substance can be. Petition 870260057113, dated 12 / 06 / 2026, p. 28 / 171 19 / 57 made to flow through another of the channels 164. Substances can be made to flow through the channels 164 and injected into the patient's eye sequentially or in parallel. Such a configuration can be useful in situations, for example, where a drug is in granular form and requires hydration to be released from the granules into the tissue. The drug granules can be injected through one of the channels 164 and a hydrating fluid can be made to flow through another of the channels 164. At the exit of the channels 164, the granules and the hydrating fluid can mix to allow the drug to be released from the granules into the tissue. As another example, substances of varying viscosities can be injected into the eye, each through separate channels 164. Yet another example, substances that polymerize when mixed can be injected into the eye, each through separate channels 164.By injecting the substances through separate channels 164, the separation of the substances can be maintained and polymerization can be avoided until the substances enter the target space of the eye.

[0060] In some embodiments, the tubular rod 14 can be formed wholly or partially of an absorbent material, such as a sponge, for example. In such configurations, the tubular rod 14 can be used to absorb fluid that accumulates in SCS 4 or other proteins of a patient's eye. Fluid accumulation can occur due to instrument 10 insertion into a patient's eye, with hemorrhage, bleeding, or general accumulation. Upon insertion of instrument 10 into SCS 4, the tubular rod 14 can be selectively translated relative to the needle 12 in the direction of SCS 4 to absorb fluid located near the most distal tip 18 in SCS 4. In embodiments where the tubular rod 14 is partially formed of an absorbent material, the blunt tip 22 (as shown in FIGS.1A and 1B) of the tubular rod 14 may be formed from absorbent material. The blunt tip 22 may itself be similarly formed wholly or partially from absorbent material.

[0061] In some embodiments, the tubular rod 14 may alternatively be formed from a drug or medicine. For example, the tubular rod 14 may be formed from a solidified drug, such as a lyophilized drug. Upon insertion of the Petition 870260057113, dated 12 / 06 / 2026, p. 29 / 171 20 / 57 instrument 10 in SCS 4, the tubular rod 14 can be translated relative to the needle 12 in the direction of SCS 4. When the tubular rod 14 is extended in SCS 4, the tubular rod 14 or a portion thereof may break off or otherwise disconnect from the instrument 10, thereby allowing the drug to be applied in SCS 4.

[0062] The distal end 20 may include an expandable member 28 (FIG. 2). The expandable member 28 may be any expandable member, for example, a stent or balloon. The expandable member 28 may expand in a vertical direction to separate the sclera 2 and choroid 6 to increase the thickness of the SCS 4 and / or a horizontal direction to expand into an area of ​​SCS 4. For example, the expandable member 28 may expand the sclera 2 in an upward direction, i.e., beyond the choroid 6, to increase the SCS 4. In other words, the expandable member 28 may expand to allow an increased amount of a drug to flow more easily from the instrument 10 into the SCS 4. Referring to FIG. 3A, the tubular rod 14 may include an expandable portion 30. The expandable portion 30 may expand in a vertical direction and / or a horizontal direction to expand into an area of ​​SCS 4.For example, the expandable portion 30 may include a pair of curved members positioned proximally to the distal tip 20 (FIG. 3A), such that a drug may flow from the expandable portion 30 to the injection site 24 and into an expanded area 26 of SCS 4. In some examples, the drug may flow from a plurality of openings 150 in the tubular shaft 14 and / or expandable portion 30. In other examples, the expandable portion 30 may include a plurality of sutures 32 (FIG. 3B). The sutures 32 may attach to the sclera 2 when the expandable portion 30 expands in a vertical and / or horizontal direction.

[0063] The components of instrument 10 may be made of any suitable metal, polymer and / or combination of suitable metals and / or polymers. Exemplary metallic materials may include stainless steel, nitinol, titanium, and / or alloys thereof. Exemplary polymeric materials may include polyetheretherketone (PEEK), polyimide and polyethersulfone (PES). In some examples, the tubular rod 14 may be made of a rigid material, a semi-rigid material or Petition 870260057113, dated 12 / 06 / 2026, page 30 / 171 21 / 57 flexible material, wherein such material may be expandable and / or may allow various configurations as discussed herein. The materials of instrument 10 may be any biocompatible material that can be sterilized.

[0064] Referring to figures FIGS. 4A and 4B, instrument 10 may have a curved or hook shape. The curvature of instrument 10 may allow insertion of instrument 10 at a desired depth between sclera 2 and choroid 6, such that the user may rotate and / or raise instrument 10 to pull a portion of sclera 2 beyond SCS 4, creating an expanded portion 26. As shown in FIG. 4B, SCS 4 may expand outward, i.e., beyond choroid 6, rather than inward, which may help to avoid adverse effects when injecting a drug into ocular tissue. The tubular shaft 14 can be advanced to further separate the sclera 2 and the choroid 6 (FIG. 4B), allowing the injected drug to spread more evenly between the sclera 2 and the choroid 6. A bevel or needle opening 12 can be positioned in any direction relative to the curvature of the instrument 10, including towards the center of the curvature, beyond the center of the curvature, or in any direction between these.Furthermore, instrument 10 may include a magnetic element or may be formed wholly or partly of a magnetic material. When inserted into SCS 4 and while positioned between the sclera 2 and the choroid 6, a magnet external to the patient's eye may be used to guide instrument 10 by acting on the magnetic element or magnetic material. For example, the external magnet may be positioned outside the patient's eye near a surface outside the sclera 2. The external magnet may exert a magnetic force on the needle 12, thereby impelling the needle 12 toward the sclera 2 and keeping the portion of the needle 12 located within SCS 4 in an orientation that is parallel or nearly parallel to the sclera 2 to avoid inadvertently penetrating the choroid 6.

[0065] Various configurations of instrument 10, as well as the components of instrument 10, are described herein. FIGS. 5A and 5B represent an alternative embodiment wherein instrument 50 may include a needle 52 and a rod 54 (e.g., a tubular shaft). The needle 52 may include a passage 56 and the Petition 870260057113, dated 12 / 06 / 2026, p. 31 / 171 22 / 57 distal end 57 and the tubular shaft 54 ​​may include the most distal tip 58. The most distal tip 58 may be a sharp or piercing tip configured to penetrate a layer of eye tissue. The distal end 57 may have a substantially atraumatic or blunt tip 59. As shown in FIGS. 5A and 5B, the most distal tip 58 may include a plurality of angled / curved surfaces such that a needle 52 is inserted into the sclera, the tubular shaft 54 ​​can be pulled back through the passage 56. While the tubular shaft 54 ​​is pulled through the passage 56, the angled / curved surfaces of the most distal tip 58 may force a portion of the distal end 57 to enlarge (FIG. 5B), which in turn may separate the sclera and choroid layers, allowing a drug to flow more easily from the injection site. The tubular rod 54 can also be pushed through 56 to its original orientation, as shown in FIG. 5A.The drug may be released from one or more openings at the distal tip 58, as described by the arrows in FIG. 5B. The instrument 50 may include a locking / unlocking mechanism to prevent the tubular shaft 54 ​​from being pushed back through the passage 56 while the instrument 50 is inserted into a sclera. In other examples, the needle portions 52 may be shaped or curved to resemble an eye shape or curvature.

[0066] FIGS. 6A and 6B represent an alternative embodiment, in which the instrument 60 may include a needle 61 and a tubular shaft 62. The needle 61 may include a passage 63 and the most distal tip 64 and the tubular shaft 62 may include the distal end 65. The most distal tip 64 may be a sharp or needle-like tip configured to penetrate a layer of eye tissue. The distal end 65 may have a substantially atraumatic or blunt tip 66. As shown in FIGS. 6A, the tubular rod 62 can be configured such that a wedge 67 of the instrument 60 can engage with the tubular rod 62 once the instrument 60 is inserted into the sclera of the eye, the wedge 67 forcing a portion of the tubular rod 62 to spread (FIG. 6B) within the plane of the SCS to separate the sclera and choroid layers and allow a drug to flow and spread more easily from the injection site. For example, the tubular rod 62 may include a slit 68 Petition 870260057113, dated 12 / 06 / 2026, p. 32 / 171 23 / 57 allowing a portion of the tubular rod to expand, as shown in FIG. 6B. FIG. 6B is a top view of the instrument 60 showing the expanded distal end 65 of the tubular rod 62. The wedge 67 may be any suitable shape configured to engage with and force apart a portion of the tubular rod 62. In some embodiments, the wedge 67 may be omitted and the distal end 65 may be configured to be self-expanding to form the slot 68 once the distal end 65 is advanced out of the passage 63.

[0067] FIGS. 7A-7C show exemplary components for a distal end of the tubular rod 76 extending outward from the needle 70. The needle 70 may include at least one opening 74. The distal end of the tubular rod 76 may include an anchor 72. The anchor 72 may have a concave curvature. The user may insert the needle 70 into the sclera 2 and choroid 6 (FIG. 7A) and then pull the needle 70 back toward the user, away from the choroid 6 of the eye. During needle 70 retraction, anchor 72 is activated and engages with an inner surface of the sclera 2 (FIG. 7B), which can stop needle 70 at a desired depth within SOS 4. Anchor 72 is able to stop once it reaches sclera 2 because of the different mechanical properties between sclera 2 and other softer layers of eye tissue. Anchor 72 can also pull sclera 2 away from the choroid 6, thereby increasing a portion of SOS 4.

[0068] In some embodiments, anchor 72 may be formed wholly or partly of a magnetic material, such that a magnet external to the patient's eye may be used to pull the sclera 2 from the choroid 6. While this embodiment may require penetration of the choroid 6, it may allow the user to easily achieve a correct depth of insertion without the use of precise device geometries. In another embodiment, as shown in FIG. 7C, anchor 72 may be configured to avoid penetration of the choroid 6. For example, anchor 72 may have a flat or atraumatic shape or configuration to abut the choroid 6 without penetrating the tissue layer. Anchor 72 may be pushed out of the needle 70 manually or anchor 72 may automatically extend from the needle 70 after a decrease in penetration force. In some examples, the Petition 870260057113, dated 12 / 06 / 2026, page 33 / 171 24 / 57 anchor 72 can be made of a flexible or semi-flexible material, such that portions of anchor 72 can bend. For example, portions of anchor 72 can bend towards the choroid 6 when needle 70 is retracted / removed from the tissue layers once the injection is complete.

[0069] In some embodiments, anchor 72 can be configured to engage with an inner surface of the choroid 6. In such embodiments, the user can insert needle 70 into the sclera 2 and choroid 6 (FIG. 7A) and then pull needle 70 back towards the user. Upon retraction of needle 70, anchor 72 can activate and engage with an inner surface of choroid 6, thereby separating choroid 6 from the retina below. Because choroid 6 is formed of soft tissue, anchor 72 can be configured to separate choroid 6 from the retina without tearing or rupturing choroid 6. Such a configuration can be particularly useful for performing treatments such as gene therapy in a subretinal space to treat various conditions such as retinal detachments and the like.

[0070] FIGS. 8A to 8F show exemplary embodiments of instrument 10 and methods of delivering a drug to the SCS 4 of the eye. Instrument 10 may include all or some of the features as discussed above. As shown in FIG. 8A, instrument 10 may have a curved or hook shape. The curvature of instrument 10 may allow insertion of instrument 10 to a desired depth between the sclera 2 and the choroid 6, such that the user may rotate and / or elevate instrument 10 to pull a portion of the sclera 2 away from the SCS 4, creating the expanded portion 26. As shown in FIG. 8B, the SCS 4 may expand outward, i.e., beyond the choroid 6, rather than inward, which may help to avoid adverse effects when injecting a drug into the tissue. In some examples, a needle 80 may be inserted into the expanded portion 26.The use of instrument 10 in conjunction with needle 80 may require less precision from the user because of the increased distance, i.e., the expanded portion 26, between the sclera 2 and the choroid 6. However, the use of instrument 10 in conjunction with needle 80 may need to be precisely controlled, since this method uses two insertion sites, one for instrument 10 and a second for needle 80. Petition 870260057113, dated 12 / 06 / 2026, p. 34 / 171 25 / 57

[0071] FIG. 8C shows a second alternative instrument, stabilizing leg 82, for use in conjunction with instrument 10. A user can attach a stabilizing leg 82 to instrument 10, such that the use of both components can control how deeply instrument 10 is inserted through sclera 2 and SOS 4. Compared to the systems and methods shown in FIG. 8B, the use of the stabilizing leg 82 utilizes an insertion site, which can reduce the risk of infection, discomfort, and / or trauma to a patient. The stabilizing leg 82 additionally provides additional user control.

[0072] FIGS. 8D and 8E show an alternative embodiment of instrument 10 including a curve 84 positioned proximally to the most distal tip 18. The curve 84 can control how deep instrument 10 can be inserted through the sclera 2 and SOS 4. Once instrument 10 is inserted, a user can rotate instrument 10 to simultaneously pull a portion of the sclera 2 out of the choroid 6 while injecting a volume of drug into the expanded portion 26. FIG. Figure 8F shows an alternative embodiment of instrument 10 configured substantially in a U-shape. The U-shape of instrument 10 can control how deeply instrument 10 can be inserted into sclera 2, SOS 4, and choroid 6. Once instrument 10 is inserted, a user can push / rotate instrument 10 causing the most distal tip 18 to point upwards towards sclera 2, without performing a second insertion into sclera 2.The differences in mechanical properties between the sclera and other softer layers can give the user tactile feedback indicating that the user may need to stop advancing the needle before penetrating the sclera layer again from the inside. While the U-shape may allow the user to find a correct injection depth without the need for ultra-precise device geometries, the use of the instrument in the U-shape penetrates the choroid in some modalities.

[0073] In some examples, needle 12 may include more than one more distal tip 18. Referring to FIG. 9, the more distal tip(s) 18 of needle 12 may form a Y shape, allowing needle 12 to have 2 sets of injections into the sclera 2. The more distal tip(s) 18 may extend over a Petition 870260057113, dated 12 / 06 / 2026, p. 35 / 171 26 / 57 scleral area 2, allowing the drug to spread to a larger area of ​​SOS 4. The openings in the most distal tip(s) 18 can be oriented in various directions, including outward from a main axis of the needle 12, inward toward the main shaft, or in various directions between them. The openings can be oriented to maximize the flow of a drug from the needle 12 and the surface area over which the drug flows. Additionally, although the most distal tip(s) 18 is / are shown in FIG. 9 as extending directly from the needle 12, the most distal tip(s) 18 can collectively form a semicircular shape that resembles the shape of the outer surface of the patient's eye. Such a configuration may allow the insertion of the most distal tip(s) 18 close to a limbus of the eye and after injection of the drug through the needle 12, the drug flows towards the back of the eye.

[0074] When using a device or system as described herein, differences in the mechanical and / or chemical properties between the vitreous, choroid, and sclera may allow the user to feel tactile feedback when the device, system, or its components reach the terminal surface of the sclera. In other words, based on the properties of the tissue layers, the user can know once the device, system, or its components are inserted at the correct depth. For example, the sclera may be about 10 times harder than the choroid. While a standard needle can be inserted at an angle into the eye, following a curvature of the eye, and the user can use tactile feedback as described above, such a method may increase the risk of trauma to the eye. Referring to FIG. 13, needle 12 may include geometric features 170 configured to provide tactile feedback to the user.Geometric features 170 can be notches or ribs and can be placed at defined intervals, for example, every 100 pm (represented by A in FIG. 13). In addition to providing tactile feedback to the user, geometric features 170 can also provide audible feedback to the user. For example, geometric features 170 can produce clicking sounds upon insertion at one or more depths in the eye in one or more eye spaces. In some modalities, geometric features 170 may include... Petition 870260057113, dated 12 / 06 / 2026, page 36 / 171 27 / 57 one or more sensors configured to detect a needle insertion depth 12. Based on signals generated by one or more sensors indicating insertion at one or more depths in the eye, audio can be generated to alert the user of an insertion depth. The audio can be generated by any audio-generating device, such as a small electronic speaker or similar, located on the needle 12, in a needle hub in a syringe housing, or positioned close to and separate from the needle 12. The geometric characteristics 170, therefore, allow the user to use the needle 12 for injections into any of the various spaces of the eye, such as the suprachoroidal space, vitreous humor, or other spaces.

[0075] Differences in tissue layer properties can also aid in controlling drug flow. For example, needle 12 may have a plurality of openings 150 as shown in FIGS. 11A and 11B. In some examples, the openings 150 may be configured around a circumference and / or below a length of needle 12. Since needle 12 can be inserted into tissue layers, the different chemical and / or mechanical properties of the tissue layers can block the openings 150 and prevent a volume of the drug from flowing out of needle 12 and into areas of the other tissue layers other than the SOS.

[0076] Referring to FIG. 10, an external portion 100 can be used together with the needle 12. The external portion 100 can comprise a flat surface having a projection to deform one or more of the sclera 2 or choroid 4. For example, the projection can be a round surface. The external portion 100 can be applied to the external surface of the eye to create a deformation in one or more of the sclera 2 or choroid 4. As shown in FIG. 10, since the outer portion 100 is applied to the outer surface of the eye, the needle 12 can be inserted at an appropriate angle and / or distance from the deformed area of ​​the sclera 2 and / or choroid 4, such that the needle 12 can become trapped between the sclera 2 and the choroid 4. While the use of the outer portion 100 can assist in inserting the needle 12 to the correct depth, the outer portion 100 does not necessarily increase a Petition 870260057113, dated 12 / 06 / 2026, page 37 / 171 28 / 57 area of ​​SCS 4 for medication dispensing.

[0077] FIGS. 14-17 show exemplary embodiments of the present disclosure utilizing a chamber 110 together with the needle 12. The chamber 110 can be configured to pull, drag, or pinch a portion of the sclera 2. For example, the chamber 110 may have a circular chamber and / or components that can drag a portion of the sclera 2 and pull such portion of the sclera 2 out of this chamber 110. Referring to FIG. 14, the chamber 110 may include a portion 110A and a shield 110b extending from the distal surface of portion 110a. Portion 110a may be a fixed table, tray, or forehead support. Needle 12 can be connected to chamber 110 by means of appropriate means, for example, a needle hub 112. Chamber 110 can be activated automatically or manually by the user, such that chamber 110 can pinch a portion of the sclera 2 and pull it into chamber 110, i.e., beyond the choroid 6 (as shown in FIG. 15).In some examples, chamber 110 can be configured to apply suction to sclera 2. For example, chamber 110 may include a vacuum, such as a dynamic vacuum traction or a static vacuum traction. Referring to FIG. 15, chamber 110 may include a vacuum to apply suction to a portion of sclera 2. Once a portion of sclera 2 is pulled into this chamber 110 and away from the choroid 6, the needle 12 can be inserted into that portion of sclera 2. FIG. 16 shows another embodiment where chamber 110 can be applied to a portion of sclera 2. Chamber 110 may include a vacuum to pull a portion of sclera 2 upward into chamber 110. The needle 12 can be inserted into a base of chamber 110, for example, in a distal position of shield 110b. In another embodiment, chamber 110 may include a stop component 114 configured to limit proximal advancement of the sclera 2 in chamber 110 (FIG. 17).For example, the stop component 114 may encircle a needle portion 12. The stop component 114 may include a plurality of extensions 116 that extend from the side wall of the chamber 110 toward a chamber center 110. The stop component 114 may also include a plurality of openings 117 configured to facilitate the application of suction, for example. Petition 870260057113, dated 12 / 06 / 2026, p. 38 / 171 29 / 57 of a vacuum, to the sclera 2. The stop component 114 can still be configured to allow a user to adjust an angle of injection. For example, by rotating the stop component 114 and / or chamber 110 around a longitudinal axis of the needle 12, the angle of penetration of the sclera 2 by the needle 12 can be adjusted. In some embodiments, a user can adjust the angle of penetration from about 90° relative to the surface of the sclera 2 (as shown in FIG. 17) to about 45° by rotating the stop component 114 and / or chamber 110. The stop component 114 can cause adjustments in the angle of penetration, for example, by deflecting the needle 12 when the needle 12 has a flexible construction or is formed of a flexible material.

[0078] As described above, the shield 110b of chamber 110 may include a circular cross-section. Referring to FIG. 20, instead of applying suction across the entire circular section of the sclera 142 enclosed by the shield 110b, suction may be applied in a horseshoe or semicircular shape 140. In such a case, the shield 110b of chamber 110 may include a semicircular cross-sectional configuration. By applying suction in a horseshoe shape 140, a portion of the sclera 142 can be raised upwards in section 144. The user can then insert needle 12 horizontally (into the sclera 142 and tangent to the natural surface of the eye) in a center and between the two sides in a horseshoe shape 140. Additionally, posterior insertion of needle 12 can wedge needle 12 between a sclera and choroid layer. The systems and methods of use described here, for example, in FIGS.14 to 17 and 20, can be minimally invasive to the patient, while creating additional space within SCS 4 without disturbing the choroid 6. Needle insertion accuracy may be less important because the SCS 4 area has been increased through the use of vacuum.

[0079] Systems and methods as described herein, which may comprise chamber 110, may be used to prevent a drug from being pushed out of the needle or apparatus. For example, referring to FIG. 15, needle 12 may be partially inserted into a portion of the eye. Chamber 110 may suction a portion of the sclera 2 and may pull such portion of the sclera 2 until it covers the tip. Petition 870260057113, dated 12 / 06 / 2026, p. 39 / 171 30 / 57 more distal 18. In another example, a delivery system and / or apparatus according to the present disclosure may have a frictional force greater than chamber 110, such that chamber 110 can pull a portion of the sclera 2 while allowing a drug to exit the needle 12 and without SCS 4. In other examples, a valve, for example, a shut-off valve, may be present in the needle 12, the needle hub 112, or any component of a device or apparatus according to this disclosure. The valve can be used to block and unblock the flow of medication from needle 12. For example, after chamber 110 is applied to sclera 2 and a portion of sclera 2 can be suctioned and pulled into chamber 110, needle 12 can be inserted and that valve can be used to unblock the flow of medication from needle 12 without SCS 4 and then blocked to stop the flow of medication from needle 12.

[0080] In some embodiments, the chamber 110 may rest against the outer surface of the eye to act as a guide for the user (FIG. 19). The user may rest the shield 110b of the chamber 110 against the outer surface of the eye and then advance the needle 12 out of the needle hub 112 and into the sclera 2. As shown in FIG. 19, the chamber 110 may include a dial or crank 220 for advancing the needle 12. The apparatus and method described herein, for example, in FIG. 19, may closely control the depth of needle insertion.

[0081] In another example, as shown in FIG. 18, the needle hub 112 may house a portion of the needle 12, wherein the needle hub 112 may be fixed to a holder 210. The holder 210 may be fixed to a table, tray or forehead support, which may be fixed to a stable external surface, to assist the user. The holder 210 may include a dial or crank 220 for advancing the needle 12.The needle hub 112 may include a feedback mechanism, for example, a force sensor, to prevent the needle 12 from extending from the holder 210 when it senses a decrease in resistance to penetration. As discussed above, resistance to penetration may refer to the mechanical and / or chemical properties of the ocular tissue layers. The dial 220 may be used to insert the needle 12 into the eye in a controlled manner, until the mechanism... Petition 870260057113, dated 12 / 06 / 2026, page 40 / 171 31 / 57 feedback warns the user to stop due to decreased force and / or resistance to penetration. The feedback mechanism may be a feedback loop so that needle insertion 12 can stop automatically.

[0082] Referring to FIGS. 21A and 21B, the systems and methods described herein may include a microneedle cube 180. The microneedle cube 180 may be substantially rectangular and include a plurality of curved surfaces. The microneedle cube 180 may include a plurality of microneedles 182. As shown in FIGS. 21A and 21B, the microneedles 182 may be of varying lengths and thicknesses. In another example, the microneedles 182 may be of varying angles, wherein the microneedles 182 may be of varying angles relative to a surface of the microneedle cube 180. In some embodiments, the microneedles 182 may have angles of approximately 45° relative to a microneedle cube 180. In some embodiments, each of the microneedles 182 may be angled in the same direction. In some modalities, one or more of the 182 microneedles may be angled in different directions.The microneedle hub 180 can provide staged firing of different sets of microneedles, similar to a tattoo needle. This staged firing can spread a drug over a large area of ​​ocular tissue. The variable lengths of microneedles 182 (FIG. 21B) can provide the user with flexibility in handling varying thicknesses of ocular tissue layers, for example, the sclera. In some embodiments, the microneedles 182 may include an opening (not shown) at a distal end of each microneedle 182. The openings of the microneedles 182 may be oriented in varying directions, such as a drug flowing in multiple directions relative to the microneedle hub 180. In some embodiments, the microneedles 182 may be formed from such a lyophilized drug that upon insertion into a patient, the microneedles 182 may dissolve, thereby releasing a drug.The 180 microneedle cube can be used alone or in conjunction with any of the devices, systems, and methods described here.

[0083] In some modalities, the 180 microneedle cube and / or microneedles Petition 870260057113, dated 12 / 06 / 2026, p. 41 / 171 32 / 57 182 may include a spring-loaded mechanism. When the microneedles 182 are pressed against an eye, the spring-loaded mechanism may cause the microneedles 182 to deviate angularly relative to the microneedle hub 180. In some embodiments, the microneedles 182 may be arranged in a circular or semicircular formation and may deviate in an outward direction relative to the formation. The deviation of the microneedles 182 may allow the microneedles 182 to penetrate the eye at sufficiently shallow angles, separate the sclera 2 and choroid layers 6 to allow for better and increased drug flow, and may further maximize the area over which a drug is distributed.

[0084] Another embodiment, as shown in FIGS. 22A and 22B, includes a needle tubing 190 with a needle tip 192. The needle tubing 190 may have a cylindrical shape and the needle tip 192 may be a serrated needle tip. The needle tip 192 oscillates on the outer surface of the eye, allowing the needle tip 192 to cut through the sclera 2 without penetrating the choroid 6. In some examples, the needle tubing 190 with the needle tip 192 may be surrounded by a chamber 194 as described above, where the chamber 194 may include a vacuum. The chamber 194 may be applied in a circular shape around the needle tubing 190 to pinch and grasp the sclera 2 and lift a portion of the sclera 2 upwards. The vacuum from chamber 194 can create a seal on the outer surface of sclera 2, potentially allowing chamber 194 to grip a portion of sclera 2.

[0085] FIGS. 23A to 23C represent another embodiment in which the needle 12 can be connected to the needle hub 112. The tubular rod 14 may include a lever 200 and a stop 202. The lever 200 and the stop 202 may be positioned at a proximal end of the tubular rod 14. A distal end of the tubular rod 14 may include a pair of arms 204. The most distal tip 18 of the needle 12 may be sharpened to penetrate the sclera 2. FIG. 23A shows the device before injection. During injection (FIG. 23B), the lever 200 can be activated to push the tubular rod 14 through the needle 12 and into the SCS 4. A Petition 870260057113, dated 12 / 06 / 2026, page 42 / 171 Lever 200 can push the tubular rod until stop 202 is level with needle hub 112 to seal the device during release. Once inserted, arms 204 can mechanically separate the sclera 2 and choroid 6, and in turn, guide the drug out without the SCS 4 from the injection site. When the injection is complete (FIG. 23C), lever 200 can be pulled up to remove arms 204 from the ocular tissue layers. In some examples, arms 204 may be formed of a donut-like hydrogel and may be configured to detach from the tubular rod 14 when positioned in the SCS 4. Arms 204 may be loaded with a drug that is released upon hydration. Arms 204 can be hydrated by injecting a hydrating solution into a vicinity of arms 204, or they can be hydrated naturally over time due to exposure to fluid that occurs naturally in the eye.

[0086] FIGS. 24 to 27 represent embodiments of the present disclosure in which the needle 12 can be connected to the needle hub 112. The device includes a housing 240. The housing 240 may have a cylindrical shape and may contain the needle hub 112, and any additional components, for example, a syringe, the hub 260 (e.g., a luer lock adapter on a syringe) or spring 250 that can be connected to the needle hub 112. Referring to FIG. 24, the housing 240 may contain a piston 252, plunger rod 242 at a proximal end of the housing 240, an indicator 246, and feedback mechanism 248. The spring 250 may be in line with the needle 12, such that the spring 250 offers resistance as the user is inserting the needle 12 through the sclera. Once needle 12 is inserted through the sclera, the spring force drops and can provide a signal to the user indicating that the user should stop inserting needle 12.The signal can be indicator 246 or any suitable signal. For example, indicator 246 can be an LED light or a noise. Feedback mechanism 248 can be a stop or a brake that prevents spring 250 from pushing needle hub 112 past a pre-set limit in housing 240. In some examples, needle hub 112 can be configured not to move in the direction of... Petition 870260057113, dated 12 / 06 / 2026, page 43 / 171 34 / 57 distal end of housing 240 and only moves back to a proximal end of housing 240. The device may also include an external rod 280 (FIGS. 26A and 26B) that can fit into the needle hub 112. Alternatively, the external rod 280 may be attached directly to the needle hub. 12. The external rod 280 may have a cylindrical shape that encloses at least a portion of the needle 12. In some embodiments, the external rod 280 may be formed of a transparent material, allowing the user to see the needle 12 through the external rod 280. This may allow the user to more easily observe needle 12 placement during an injection. The distance between a distal end of the external rod 280 and the most distal tip of the needle 12, represented by B in FIG. 26A, may be used to control the depth of needle insertion. The distance B may be adjustable.For example, the outer rod 280 may have a screw-on component that defines Distance B, the outer rod 280 may include a mechanism that makes Distance B adjustable, the outer rod 280 may have markings, for example, color codes, indicating the length of Distance B to the user, or the outer rod 280 may be a disposable component. In some examples, several outer rods 280 may be provided to a user, wherein each of the outer rods 280 may provide a different Distance B, such that the user may choose the correct rod component based on an estimate of the patient's scleral thickness. In another example, the outer rod 280 may have an angled edge (FIG. 26B) to allow needle insertion at a desired angle. In another example, the device may operate automatically such that needle 12 is inserted into the eye until the feedback mechanism 248 (as shown in FIG. 24) prevents needle 12 from being inserted further.Such automatic operation can improve needle control 12 and can additionally control a total injection rate. In yet another example, the outer rod 280 can be shaped similarly to the adapter 290 (shown in FIGS. 28 to 30 and described in further detail below), such that it includes a surface that can be placed against and joined with the sclera of a patient's eye. In yet another example, the outer rod 280 can rotate relative to... Petition 870260057113, dated 12 / 06 / 2026, p. 44 / 171 35 / 57 to the needle hub 112 and the needle 12 and can provide audible feedback to a user. For example, rotation of the outer shaft 280 can produce an audible clicking sound to the user when the rotation reaches a predetermined limit. The predetermined limit can be, for example, a point where the needle hub 112 approaches the distal end of the outer shaft 280. In yet another example, the modalities shown in FIGS. 24 to 27 can be combined with any of the feedback features described herein previously, providing the user with indications as to whether the needle 12 has been inserted at the target location.

[0087] Various methods of delivering a drug to a patient's eye's suprachoroidal space (SCS) are described here throughout the discussion of devices and systems. An example of delivering a drug to a patient's eye's suprachoroidal space using instrument 10 is shown in FIGS. 27A and 27B. Instrument 10 can be inserted through injection site 24, such that the most distal tip 18 of the needle 12 can cut a portion of the sclera 2. Once instrument 10 is in SCS 4, the tubular rod 14 can be inserted into SCS 4 until it reaches a certain distance from insertion site 24 and expands a portion of the sclera 2 and / or choroid 6, thereby increasing an area of ​​SCS 4 (FIG. 27A). Once the tubular rod 14 is inserted into SCS 4, a volume of drug can be injected into the SCS 4 area. The tubular rod 14 can be retractable, as shown in FIG. 27B.As the tubular rod 14 is retracted, a volume of a drug can be simultaneously injected from the tubular rod 14 into the SCS 4, such that the drug can fill the space left by the tubular rod 14. The instrument 10, needle 12, and tubular rod 14 may include any of the components as discussed above.

[0088] The methods described herein may be pressure-controlled. For example, an injection or infusion rate may be based on pressure feedback. Pressure in the SCS may be limited to avoid increased pressure levels that could cause damage to the eye's tissues. A pressure-controlled injection may also allow for a longer duration of drug release outside the injection site within the SCS. In other examples, the apparatus and / or devices discussed herein may be connected to a pump / device. Petition 870260057113, dated 12 / 06 / 2026, p. 45 / 171 36 / 57 electromechanical devices that can monitor pressure throughout the system. A pressure-controlled injection can also control a drug flow rate in the SCS such that the flow rate pressure cannot exceed a certain pressure, for example, the IOL pressure.

[0089] Referring to FIGS. 28 to 30, the systems and methods described herein may include an adapter 290. The adapter 290 may be a component configured to encircle a needle shaft 12. The adapter 290 may be positioned toward the most distal tip 18 relative to the needle connector 112 to which the needle 12 may be connected. In another configuration, the needle 12 is connected to a container (not shown) for a medication, for example, a syringe. In some examples, the needle 12 may be a rigid needle. In other examples, the needle connector 112 may be disposed between the container (not shown) and the needle 12. The adapter 290 may include an intermediate surface 292 that defines a substantially cylindrical portion of the adapter 290. When the adapter 290 is positioned to encircle a portion of the needle 12, a longitudinal axis of the substantially cylindrical portion of the adapter 290 may extend parallel to a longitudinal axis of the needle 12.For the purposes of this disclosure, the longitudinal axis of the substantially cylindrical portion should be understood to be a longitudinal axis of adapter 290.

[0090] Adjacent to intermediate surface 292, the adapter 290 may include an angled distal surface 294 disposed toward a distal end of the adapter 290 relative to intermediate surface 292. The angled distal surface 294 may define a substantially frustoconical portion or a partially frustoconical portion of the adapter 290. The angled 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, for example.

[0091] Adapter 290 may additionally include a larger oblique surface Petition 870260057113, dated 12 / 06 / 2026, p. 46 / 171 37 / 57 outer 298. The outermost oblique surface 298 may be a flat surface adjacent to the intermediate surface 292 and / or angled distal surface 294. Alternatively, the outermost oblique surface 298 may be a convex surface configured to be placed against and correspond with the sclera of a patient's eye. As shown in FIG. 29, the outermost oblique surface 298 can be oriented at an angle Θ relative to the longitudinal axis of the adapter 290. The angle Θ can vary from about 25 degrees to about 75 degrees relative to the longitudinal axis of the adapter 290, from about 40 degrees to about 65 degrees relative to the longitudinal axis of the adapter 290, or from about 30 degrees to about 60 degrees relative to the longitudinal axis of the adapter 290. In an exemplary embodiment, the angle θ can be about 45 degrees relative to the longitudinal axis of the adapter 290.

[0092] The outermost oblique surface 298 can be configured in various ways for contact with the sclera of a patient's eye. For example, the outermost oblique surface 298 can be smooth or polished to minimize scleral abrasion. Alternatively, the outermost oblique surface 298 can be rough to minimize movement of the adapter 290 relative to the sclera. In some embodiments, the outermost oblique surface 298 can include geometric features such as protrusions, indented cavities, waves, other geometric features, or any combination thereof. Additionally, a coating can be applied to the outermost oblique surface 298. The coating can be therapeutic, antibacterial, and / or stabilizing. As another example, the outermost oblique surface 298 can be formed by overmolding a material onto the adapter 290.The overmolded material can be selected, for example, based on its surface properties (e.g., rough, smooth, etc.) or its suitability for surface finishing, such as polishing. The outermost oblique surface 298 can additionally incorporate various combinations of the aforementioned characteristics, such as a polished surface with geometric features, a rough surface with geometric features, an overmolded material with a coating, etc. Although the... Petition 870260057113, dated 12 / 06 / 2026, page 47 / 171 38 / 57 exemplary combinations of the characteristics described here, these combinations are not intended to be limiting and other combinations are considered.

[0093] The adapter 290 may include visual indications of a position of the adapter 290 and / or the outermost oblique surface 298. For example, the outermost oblique surface 298 may be colored differently from other surfaces of the adapter 290 to distinguish the outermost oblique surface 298 from other surfaces. The adapter 290 may also include visible markings to indicate a position of the adapter 290 and / or the outermost oblique surface 298. Such visible markings may include contrasting color markings, textured markings, or markings similar to the outermost oblique surface 298 and / or other surfaces of the adapter 290. The visible markings may be applied to the adapter 290 using screen printing, overmolding, engraving, or various other suitable techniques. The visible markings may be of any geometric shape, including circles, ovals, polygons, irregular shapes, or any combination thereof.

[0094] 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 existing 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 angular distal surface 294 and exist in a perpendicular plane separate from the longitudinal axis of the adapter 290. Thus, the proximal surface 295 may be parallel to the distal surface 296.

[0095] The adapter 290 may include a needle perforation 302 in which the needle 12 may be positioned. The needle perforation 302 may extend parallel or substantially parallel to the longitudinal axis of the adapter 290. When positioned in the needle perforation 302, the needle 12 may traverse the entire proximal surface 295 and distal surface 296. When positioned in the needle perforation, the most distal tip 18 of the needle 12 may extend into a Petition 870260057113, dated 12 / 06 / 2026, page 48 / 171 39 / 57 distance C from the distal surface 296. A length of distance C may be such as a bevel 18a from the most distal tip 18 extending from the distal surface 296. The length of distance C may additionally be such as a portion of a needle shaft 12 proximal to the most distal tip 18 extending from the distal surface 296. Distance C may be, for example, between 200 pm and 1200 pm, between 400 pm and 1000 pm, between 600 pm and 800 pm, or approximately 700 pm. In some implementations, the bevel 18a and the outermost oblique surface 298 may be oriented at the same angle relative to the longitudinal axis of the adapter 290.

[0096] Adapter 290 can be selectively translated relative to needle 12 along the longitudinal axis of needle 12. Translation of adapter 290 may be desirable by adjusting distance C, for example. For use, adapter 290 can be fixed to needle 12. Adapter 290 can be connected to needle 12 by any suitable means, including by a thread, a fastener, a nut, a screw or adhesive. As an example, and as shown in FIGS. From 28 to 30, the adapter 290 can be fixed to the needle 12 using a thread 288. The thread 288 can be inserted into a threaded hole 304 inside the adapter 290. When tightened, the thread 288 can exert a force on the needle 12 perpendicular to the longitudinal axis of the needle 12. The force can result in friction in a longitudinal direction between the needle 12 and the thread 288 as well as between the needle 12 and the hole for the needle 302, thus preventing the adapter 290 from shifting relative to the needle 12.If the user wishes to adjust the distance C, for example, to extend a distance from the most distal tip 18 to the distal surface 296, the user can loosen the screw to allow displacement of the adapter 290 relative to the needle 12. As shown in FIG. 30, the adapter 290 can be used to guide a trajectory of the most distal tip 18 of the needle 12 through the sclera 2 in SCS 4. To inject a medication into SCS 4, a user can, for example, penetrate the sclera 2 with the most distal tip 18 and insert the needle 12 through the sclera 2. The user can angle the needle 12 such that the outermost oblique surface 298 is oriented parallel to a plane tangential to it. Petition 870260057113, dated 12 / 06 / 2026, page 49 / 171 40 / 57 outer surface of the sclera 2. The user can then continue to insert the needle 12 until the outermost oblique surface 298 contacts the sclera surface 2. In an exemplary method where the outermost oblique surface 298 is a flat surface, the user can insert the needle 12 until the outermost oblique surface 298 is tangential with the sclera surface 2. In an exemplary method where the outermost oblique surface 298 is a convex surface, the user can insert the needle 12 until the outermost oblique surface 298 engages with the sclera surface 2. When the outermost oblique surface 298 contacts the sclera 2, the needle 12 can be prevented from being inserted further and can be prevented from potentially penetrating the choroid 6.

[0097] In some implementations, the user may be able to adjust the distance C to a desired length by passing the adapter 290 along the needle 12. When the user adjusts the distance C and / or angle θ as desired, the user can use the adapter 290 to guide a trajectory of the needle 12 in SOS 4 as it penetrates the sclera 2 to a substantially predetermined depth. In this way, the user may have the ability to inject the medication into the suprachoroidal space 4 with relative precision without penetrating the choroid 6.

[0098] As shown in FIGS. 28 to 30, the adapter 290 can be positioned around the needle 12. Alternatively, the adapter 290 can be attached to one or both connectors 112 and a medication container (e.g., a syringe) connected to the needle 12. For example, the adapter 290 can be attached to connector 112 in a similar manner as the external rod 280 as shown in FIGS. 26A and 26B. Furthermore, the adapter 290 can be spring-loaded, such that a spring propels the adapter 290 towards the more distal tip 18. In use, the user can place the adapter 290 against the patient's sclera and exert sufficient force to compress the spring, thereby exposing the needle 12. The spring can be configured to control the depth of penetration of the needle 12 into the patient's eye.

[0099] The 290 adapter can be made of any metal, polymer, and / or Petition 870260057113, dated 12 / 06 / 2026, page 50 / 171 41 / 57 combination of suitable metals and / or polymers, exemplary metallic materials may include stainless steel, nitinol, titanium, and / or alloys of these metals. Exemplary polymeric materials may include polyetheretherketone (PEEK), polyimide, and polyethersulfone (PES). In some examples, adapter 290 may be made of a rigid, semi-rigid, or flexible material. Adapter 290 may additionally be formed of any biocompatible material that can be sterilized. In some examples, adapter 290 may be made of a transparent material to allow easy identification of, and / or relative navigation of, blood vessels in a patient's eye.

[0100] It should be understood that the dimensions of adapter 290 are not intended to be limiting and may in fact vary. For example, the length of adapter 290 (i.e., the distance between the proximal surface 295 and the distal surface 296) may vary to accommodate needles of different lengths. Furthermore, the puncture diameter for needle 302 may vary to accommodate needles having different diameters. Additionally, the diameters of the proximal surface 295 and / or the distal surface 296 may vary.

[0101] As described herein, the 290 adapter can be useful in reducing human error in ocular injection procedures. In addition to being useful for injections into the suprachoroidal space, the 290 adapter can be useful for injections into other spaces in the eye, such as the subretinal space. Current methods for subretinal drug delivery can be invasive and may additionally require surgery. Surgical procedures for subretinal drug delivery may involve creating tears on the surface of the retina and / or total vitrectomies to allow a cannula to access the subretinal space. Alternatively, the 290 adapter can allow access to the subretinal space through the sclera, thus decreasing the invasiveness of the procedure. Using eye imaging techniques such as optical coherence tomography (OCT) and / or ultrasound, an exact distance between the surface of the sclera and the subretinal space can be calculated.A distance between the most distal tip 18 of the needle 12 and the distal surface 296 or the most external oblique surface 298 of. Petition 870260057113, dated 12 / 06 / 2026, page 51 / 171 The 42 / 57 adapter 290 can be configured to match the distance between the sclera and the subretinal space. In such a configuration, the adapter 290 can prevent the needle 12 from extending beyond the subretinal space into the vitreous. The outermost oblique surface 298 can further control the angle at which the subretinal injection is performed.

[0102] Adapter 290 can be formed by any suitable manufacturing process, including but not limited to milling, CNC machining, polymer casting, rotational molding, vacuum forming, injection molding, extrusion, blow molding, or any combination thereof.

[0103] The various devices and components described herein may be provided in a kit for practicing one or more of the methods described herein. For example, a syringe, a needle, an adapter, and a quantity of ophthalmic drug may be provided in a blister pack. Each syringe, needle, adapter, and ophthalmic drug may be sealed within the blister pack after sterilization. In some embodiments, a kit may include multiple adapters. The multiple adapters may have varying dimensions, such as a user selecting a best adapter appropriate to a patient's anatomy and / or to control the angle of penetration or depth of the needle. The multiple adapters may also be formed from varying materials, such as a user choosing an adapter having a material appropriate for a particular procedure and / or patient. In some embodiments, the syringe may contain the ophthalmic drug.A maximum nominal filling volume of the syringe can be between approximately 0.5 mL and approximately 1.0 mL. In several methods described herein, the volume of medication, for example, an ophthalmic drug, delivered to the patient can vary from approximately 50 µL to approximately 500 µL.

[0104] Various drugs and drug formulations can be used with the embodiments of the present disclosure. As an example, the embodiments described herein can be used to inject a drug in slow-release tablet form. The drug can be released from the tablets when the tablets are Petition 870260057113, dated 12 / 06 / 2026, p. 52 / 171 43 / 57 hydrated, which can also be achieved by exposing the pellets to the eye fluids, by injecting a separate hydrating fluid, or by a combination of the foregoing. The separate hydrating fluid, such as saline solution, can be injected either before, after, or simultaneously with the pellets. As another example, the modalities described here can be used to inject multiple substances sequentially. A first substance can be injected to expand a target space of the eye, such as the suprachoroidal space, and a second substance can subsequently be injected into the expanded suprachoroidal space. The first substance can be, for example, saline, and the second substance can be, for example, a drug in a viscous gel form. As yet another example, a sponge-like material can first be injected or inserted into a target space of the eye.Sponge-like material can be configured to release a drug over time. The sponge-like material can also be refilled or re-soaked with the drug for subsequent injections.

[0105] The embodiments of this disclosure may additionally include features to improve the accuracy of the injections. As an example, the embodiments described herein may include a light, such as an LED light, configured to illuminate an injection site. As another example, the embodiments described herein may include a needle formed wholly or partly of a magnetic material or otherwise including a magnetic element. A magnet positioned externally to the patient's eye, for example, held by the user, may be used to guide the needle to the target injection site. The magnet may additionally be used to pull, i.e., exert a magnetic force, on the needle to prevent the needle from penetrating beyond a desired depth. As yet another example, the embodiments described herein may include a mechanism configured to sense an angle of the needle relative to the eye.The mechanism may include a sensor that can be calibrated according to the patient's sclera thickness. Sclera thickness can be measured using optical coherence topography (OCT), ultrasound, or any other suitable technique. The mechanism... Petition 870260057113, dated 12 / 06 / 2026, page 53 / 171 44 / 57 can be configured to provide feedback to the user such that if the needle is oriented at an appropriate angle relative to the eye, the user can be alerted to continue advancing the needle. If the needle is not oriented at an appropriate angle relative to the eye, the user can be alerted to stop advancing the needle and adjust the needle orientation.

[0106] In the embodiments of this disclosure, needle 12 may be a first needle and the devices, apparatus, and / or kits described herein may include a second needle. The first needle and the second needle may be interchangeable. Thus, needle 12 may be replaceable.

[0107] Additional illustrative modalities are listed below in accordance with this disclosure: (1) A system for delivering medication to a suprachoroidal space of an eye, the system comprising: a needle having a passage through it and a sharp distal tip; and an apparatus configured to manipulate a sclera to facilitate the delivery of medication to the suprachoroidal space of the eye. (2)0 system of (1), in which the needle is configured to release the medication into the suprachoroidal space of the eye. (3)0 system of (1), in which the sharpest distal tip includes a plurality of openings. (4) The system in (3), in which the openings include a circular configuration. (5) The system in (3), in which the openings include slots. (6) The system of (3), in which the plurality of openings is present in at least one portion of a circumference and a length of the sharpest distal point. (7)0 system of (1), in which the device is configured to release the medication into the suprachoroidal space of the eye. (8)0 system of (1), in which the apparatus is arranged within the needle passage and longitudinally translatable in relation to Petition 870260057113, dated 12 / 06 / 2026, page 54 / 171 45 / 57 needle. (9) The system of (8), wherein the apparatus includes a tubular rod having a distal end, wherein the tubular rod comprises a rigid material, a semi-rigid material or a flexible material. (10)0 system of (9), wherein the distal end includes a non-traumatic distal tip. (11)0 system of (10), in which the non-traumatic distal tip includes a plurality of openings. (12)0 system of (11), in which the openings include a circular configuration. (13)0 system of (11), in which the openings include slots. (14)0 system of (11), in which the plurality of openings is present in at least one portion of a circumference and a non-traumatic distal tip length. (15)0 system of (9), in which the distal end includes an expandable limb. (16)0 system of (15), in which the expandable member includes a stent. (17)0 system of (10), in which the tubular rod includes an expandable portion. (18)0 system of (17), in which the expandable portion includes a pair of curved arms positioned proximally to the non-traumatic distal tip. (19)0 system of (9), in which the tubular rod includes a cross-sectional dimension smaller than a cross-sectional dimension of the passage. (20)0 system of (9), in which an outer surface of the tubular rod includes one or more channels. (21)0 system of (9), wherein the distal end of the tubular rod includes at least two legs configured to selectively diverge when the distal end of the tubular rod is implanted from Petition 870260057113, dated 12 / 06 / 2026, page 55 / 171 46 / 57 of the needle passage. (22)0 system of (1), in which the needle is curved. (23)0 system of (1), in which the needle is in the shape of a U. (24)0 system of (1), wherein the apparatus comprises a flat surface having a projection for deforming one or more of the sclera or choroid. (25)0 system of (24), in which the projection is a rounded surface. (26)0 system of (1), in which the apparatus includes a camera configured to draw a portion of the sclera on it. (27)0 system of (26), in which the device is configured to apply suction to the sclera. (28)0 system of (27), in which the needle is arranged inside the chamber. (29)0 system of (27), in which the chamber includes a stop configured to limit the proximal advancement of the sclera into the chamber. (30)0 system of (29), in which the stop is configured to encircle the needle. (31)0 system of (29), in which the stop includes a plurality of extensions extending from a side wall of the chamber towards a center of the chamber. (32)0 system of (29), in which the stop includes a plurality of openings configured to facilitate the application of suction to the sclera. (33)0 system of (26), in which the chamber includes a circular cross-section configuration. (34)0 system of (26), in which the chamber includes a semicircular cross-section configuration. (35)0 system of (1), in which the needle includes a curve positioned proximally to the sharpest distal tip. (36)0 system of (1), in which the needle includes an outer surface having a plurality of geometric features configured to provide tactile feedback to a user. Petition 870260057113, dated 12 / 06 / 2026, page 56 / 171 47 / 57 (37)0 system of (9), wherein the distal end includes an anchor. (38)0 system of (37), in which the anchor has a curved, flat or non-traumatic shape. (39) An apparatus for manipulating a sclera to facilitate the release of a drug into a suprachoroidal space of an eye, the apparatus comprising: a tubular rod having a distal end, wherein the tubular rod comprises a rigid, semi-rigid or flexible material; and a needle having a passage through it and a sharp distal tip, wherein the apparatus is disposed within the needle. (40)0 device of (39), in which the needle is configured to release the medication into the suprachoroidal space of the eye. (41)0 apparatus of (39), in which the sharpest distal tip includes a plurality of openings. (42)0 device of (41), where the openings include a circular configuration. (43)0 device of (41), in which the openings include slots. (44)0 apparatus of (41), in which the plurality of openings is present in at least one portion of a circumference and a length of the sharpest distal tip. (45)0 device of (39), in which the device is configured to release the medication into the suprachoroidal space of the eye. (46)0 device of (39), in which the device is translatable longitudinally in relation to the needle. (47)0 device of (39), in which the distal end includes a non-traumatic distal tip. (48)0 device of (47), in which the non-traumatic distal tip includes a plurality of openings. (49)0 device of (48), where the openings include a circular configuration. (50)0 device of (48), where the openings include slots. Petition 870260057113, dated 12 / 06 / 2026, p. 57 / 171 48 / 57 (51)0 device of (48), in which the plurality of openings is present in at least one portion of a circumference and a non-traumatic distal tip length. (52)0 apparatus of (39), in which the distal end includes an expandable member. (53)0 device of (52), in which the expandable member includes a stent. (54)0 apparatus of (39), in which the tubular rod includes an expandable portion. (55)0 device of (54), wherein the expandable portion includes a pair of curved arms positioned proximally to the distal end. (56)0 apparatus of (39), wherein the tubular rod includes a cross-sectional dimension smaller than a cross-sectional dimension of the passage. (57)0 apparatus of (39), in which an outer surface of the tubular rod includes one or more channels. (58)0 device of (39), wherein the distal end of the tubular rod includes at least two legs configured to selectively diverge when the distal end of the tubular rod is implanted from the needle passage. (59)0 device of (39), in which the needle is curved. (60)0 device of (39), in which the distal end includes an anchor. (61)0 device of (60), in which the anchor has a curved, flat or non-traumatic shape. (62) An apparatus for manipulating a sclera to facilitate the release of a drug to a suprachoroidal space of an eye, the apparatus comprising a flat surface having a projection for deforming one or more of the sclera or choroid. (63)0 apparatus of (62), in which the projection is a rounded surface. (64) An apparatus for manipulating a sclera to facilitate the release of a drug into a suprachoroidal space of an eye, the apparatus Petition 870260057113, dated 12 / 06 / 2026, p. 58 / 171 49 / 57 comprising a chamber configured to draw a portion of the sclera into it. (65)0 device of (64), in which the device is configured to apply suction to the sclera. (66)0 device of (64), in which a needle is placed inside the chamber. (67)0 device of (66), in which the chamber includes a stop configured for proximal advancement of the sclera into the chamber. (68)0 device of (67), in which the stop is configured to encircle the needle. (69)0 apparatus of (67), wherein the stop includes a plurality of extensions extending from a side wall of the chamber towards a center of the chamber. (70)0 device of (67), in which the stop includes a plurality of openings configured to facilitate the application of suction to the sclera. (71)0 apparatus of (67), in which the chamber includes a circular cross-section configuration. (72)0 apparatus of (67), in which the chamber includes a semicircular cross-section configuration. (73) An apparatus for manipulating a sclera to facilitate the release of a drug into a suprachoroidal space of an eye, the apparatus comprising a needle tubing having a cylindrical shape and a serrated needle tip. (74)0 apparatus of (73), in which the serrated needle tip oscillates to cut through a portion of the sclera. (75) An apparatus for manipulating a sclera to facilitate the release of a drug into a suprachoroidal space of an eye, the apparatus comprising: a needle with a sharp distal tip; a needle connector connected to a proximal end of the needle; and a housing surrounding the needle connector and extending to Petition 870260057113, dated 12 / 06 / 2026, page 59 / 171 50 / 57 starting from a proximal end of the needle connector. (76)0 device of (75), in which the housing is of cylindrical shape. (77)0 apparatus of (75), wherein the housing comprises an additional component chosen from a syringe, a spring, a piston, a plunger rod, an indicator, a response mechanism or combinations thereof. (78)0 apparatus of (75), additionally comprising a rod encircling a portion of the needle and extending from a distal end of the needle connector. (79)0 device of (78), in which a distal end of the shaft is angled, allowing the needle to be inserted at an angle. (80) A method for delivering a drug to a suprachoroidal space of an eye, the method comprising: manipulating one of a sclera and one choroid layer of the eye to increase one dimension of the suprachoroidal space; advancing a distal end of a drug delivery device into the suprachoroidal space; positioning a more distal tip of the drug delivery device in the suprachoroidal space; and delivering a volume of the drug to the suprachoroidal space. (81)0 method of (80), in which advancing the distal end of the drug delivery device into the suprachoroidal space includes penetration of the sclera. (82)0 method of (80), in which positioning the most distal tip of the drug delivery device includes placing the most distal tip in the suprachoroidal space without coming into contact with the choroid. (83)0 method of (80), in which positioning the most distal tip of the drug delivery device includes placing the most distal tip in the suprachoroidal space without perforating an outer choroidal surface. (84)0 method of (80), in which positioning the most distal tip of Petition 870260057113, dated 12 / 06 / 2026, page 60 / 171 51 / 57 The medication involves placing the most distal tip in the suprachoroidal space without penetrating a thickness of the choroid. (85)0 method of (80), wherein a volume of the drug delivered to the suprachoroidal space is approximately 50 uL to 500 uL. (86)0 method of (80), in which the release of the drug volume into the suprachoroidal space is controlled by pressure. (87)0 method of (80), in which manipulation of one of the sclera and choroid layer includes rotating the drug delivery device. (88)0 method of (80), in which the manipulation of one of the sclera and choroid layers includes pulling the sclera layer to increase the dimension of the suprachoroidal space. (89)0 method of (80), in which the release of the drug volume into the suprachoroidal space includes the release of the volume from the most distal tip of the drug delivery device. (90)0 method of (80), wherein the release of a volume of the drug into the suprachoroidal space includes releasing the drug from a location proximal to the most distal tip of the drug delivery device. (91) An apparatus for facilitating the targeted delivery of a drug into a human organ of a patient, the apparatus comprising: a fluidically connected drug container attached to a needle, the needle comprising a needle shaft and a sharp distal tip with a bevel, wherein the needle is connected to a distal end of the container, and an adapter encircling a portion of the needle shaft along its longitudinal axis, but not including the sharp distal tip of the needle, the adapter including an outer oblique surface configured to direct a trajectory of the sharp distal tip to a predetermined depth and location within the human organ, Petition 870260057113, dated 12 / 06 / 2026, page 61 / 171 52 / 57 where the outermost oblique surface faces an identical direction as the bevel of the sharpest distal tip, wherein an angle of the outermost oblique surface determines the trajectory of the needle, and wherein a length of the needle extending from the outermost oblique surface determines the depth and location of drug release. (92)0 device of (91), wherein the sharpest distal tip is a portion of the needle extending from a distal end of the adapter. (93)0 apparatus of (91), further comprising a needle shaft connector connected to a proximal end of the needle, such as a rigid needle. (94)0 apparatus of (91), additionally comprising a connector disposed between the container and the needle. (95)0 device of (94), in which the needle is connected in a removable manner to the connector. (96)0 apparatus of (95), wherein the needle is a first needle, and the apparatus additionally comprises a second needle. (97)0 device of (96), in which the first needle and the second needle are interchangeable. (98)0 device of (91), in which the needle is replaceable. (99)0 device of (91), in which the angle varies from about 25 degrees to about 75 degrees. (100)0 device of (91), in which the angle varies from about 40 degrees to about 60 degrees. (101)0 device of (91), where the angle is about 45 degrees. (102)0 device of (91), in which the adapter is connected to a portion of the needle shaft by means of a fastener or thread. (103)0 device of (102), in which the adapter is translatable in relation to an axial path of the needle rod. Petition 870260057113, dated 12 / 06 / 2026, p. 62 / 171 53 / 57 (104)0 device (91), in which the adapter is attached to the needle shaft by means of an adhesive. (105)0 apparatus of (91), wherein the adapter includes: a proximal end having a surface extending in a first plane perpendicular to the needle; an angled distal side; an intermediate surface extending between the proximal end and the angled distal side, wherein the intermediate surface extends in a second plane perpendicular to the first plane; and a distal end, wherein the distal end includes a substantially flat surface extending in a third plane parallel to the first plane. (106)0 apparatus of (91), wherein at least a portion of the adapter includes a cross-section substantially in cylindrical form. (107)0 device of (91), in which the outermost oblique surface is angled relative to a longitudinal axis of the adapter. (108)0 apparatus of (91), wherein the sharpest distal tip of the needle has a length ranging from about 600 pm to about 800 pm. (109)0 apparatus of (91), in which the outermost oblique surface is a flat surface. (110)0 apparatus of (91), wherein the outermost oblique surface is a convex surface configured to couple with an outer surface of an eye. (111) A system for delivering medication to a patient's eye space, the system comprising: a syringe with a maximum nominal filling volume of between about 0.5 mL and about 1.0 mL; a needle comprising a needle shaft and a sharp distal tip with a bevel; and an adapter encircling a portion of the needle shaft along its longitudinal axis, the adapter including an outermost oblique surface angled relative to a longitudinal axis of the adapter and in Petition 870260057113, dated 12 / 06 / 2026, page 63 / 171 54 / 57 where the adapter is configured to direct a trajectory from the sharpest distal tip to a predetermined ocular depth and location; wherein the syringe, needle, and adapter are sterilized and included in a blister pack. (112) The system of (111), in which the adapter is configured to limit the advancement of the sharpest distal tip into a suprachoroidal space of an eye. (113)0 system of (111), wherein the sharpest distal tip is a portion of the needle extending from the outermost oblique surface. (114)0 system of (111), in which an angle of the outermost oblique surface varies from about 25 degrees to about 75 degrees. (115)0 system of (111), in which an angle of the outermost oblique surface varies from about 40 degrees to about 60 degrees. (116)0 system of (111), in which an angle of the outermost oblique surface is about 45 degrees. (117)0 system of (111), wherein the sharpest distal tip of the needle has a length ranging from about 600 pm to about 800 pm. (118) A kit for treating a patient suffering from an eye disease, the kit comprising: a syringe with a nominal maximum filling volume between about 0.5 ml and about 1.0 ml; a needle having a needle shaft and a sharp distal tip; an adapter encircling a portion of the needle shaft along its longitudinal axis, but not including the sharp distal tip of the needle, the adapter including an outer oblique surface configured to direct a trajectory of the sharp distal tip to a predetermined ocular depth and location; and an ophthalmic drug. (119) A kit for treating a patient suffering from an eye disease, the kit comprising: a syringe pre-filled with an ophthalmic drug, Petition 870260057113, dated 12 / 06 / 2026, page 64 / 171 55 / 57 wherein a volume of ophthalmic drug ranges from about 0.5 ml to about 1.0 ml; a needle having a needle shaft, a passage through it, and a sharp distal tip; and an adapter encircling a portion of the needle shaft along a longitudinal axis of the needle shaft, the portion excluding the sharp distal tip of the needle, the adapter including an outermost oblique surface configured to direct a trajectory of the sharp distal tip to a predetermined ocular depth and location. (120) A method for delivering a drug to a patient's eye, the method comprising: positioning a more distal tip of a drug delivery device in a suprachoroidal space of the eye at a predetermined ocular depth and location, wherein the drug delivery device comprises: a container for a drug fluidically connected to a needle, the needle comprising a needle shaft and a sharp more distal tip with a bevel, wherein the needle is connected to a distal end of the container, and an adapter encircling a portion of the needle shaft along its longitudinal axis, the portion not including the sharp more distal tip of the needle, the adapter including an outermost oblique surface configured to direct a trajectory of the sharp more distal tip to a predetermined ocular depth and location; and delivering a volume of the drug to the suprachoroidal space. (121) A method for delivering a drug to a suprachoroidal space of an eye using a drug delivery device, the drug delivery device comprising: a container for a drug fluidly connected to a needle, the needle comprising a needle shaft and a sharp distal tip with a bevel; and an adapter encircling a portion of the needle shaft. Petition 870260057113, dated 12 / 06 / 2026, page 65 / 171 56 / 57 needle along its longitudinal axis, the adapter including an outermost oblique surface angled with respect to the longitudinal axis; the method comprising: penetrating the sclera of the eye with the sharp, distal tip; inserting the needle through the sclera into the suprachoroidal space until the outermost oblique surface contacts the sclera; and upon the outermost oblique surface contacting the sclera, releasing a volume of medication into the suprachoroidal space. (122) A method for delivering a drug to a suprachoroidal space of an eye, the method comprising: manipulating a sclera or choroid layer of the eye to increase a dimension of the suprachoroidal space; advancing a distal end of a drug delivery device into the suprachoroidal space; positioning a more distal tip of the drug delivery device in the suprachoroidal space; and delivering a volume of the drug to the suprachoroidal space. (123)0 method of (122), in which advancing the distal end of the drug delivery device into the suprachoroidal space includes penetration of the sclera. (124)0 method of (122), in which positioning the most distal tip of the drug delivery device includes placing the most distal tip in the suprachoroidal space without coming into contact with the choroid. (125)0 method of (122), in which positioning the most distal tip of the drug delivery device includes placing the most distal tip in the suprachoroidal space without perforating an outer choroidal surface. (126)0 method of (122), in which positioning the most distal tip of the medicine includes placing the most distal tip in the suprachoroidal space without penetrating a thickness of the choroid. (127)0 method of (122), in which a volume of the medicine supplied Petition 870260057113, dated 12 / 06 / 2026, p. 66 / 171 57 / 57 to the suprachoroidal space is approximately 50 uL to 500 uL.

[0108] It will be evident to those skilled in the art that various modifications and variations can be made to the devices and methods described without departing from the scope of the disclosure. Other aspects of the disclosure will be evident to those skilled in the art from considerations of the descriptive report and practice of the features described herein. It is intended that the descriptive report and examples be considered only as exemplary. Petition 870260057113, dated 12 / 06 / 2026, page 67 / 171

Claims

1 / 3 CLAIMS 1. System for delivering medication into the suprachoroidal space of an eye, the system characterized in that it comprises: a needle with a passage and a sharp distal tip; and an apparatus configured to manipulate the sclera in order to facilitate the delivery of medication into the suprachoroidal space of the eye.

2. System according to claim 1, characterized in that the apparatus includes a rod having an atraumatic tip and the rod is translatable through the needle passage to expand the suprachoroidal space; wherein the passage and the rod are configured so that, while the atraumatic tip is positioned within the suprachoroidal space, a fluid pathway is formed between the suprachoroidal space and the passage, so that the medication is permitted to flow through the passage.

3. System according to claim 2, characterized in that the rod comprises a tubular rod disposed within the needle passage.

4. System according to claim 2, characterized in that the stem includes a plurality of openings configured to facilitate the flow of the drug.

5. System according to claim 4, characterized in that the plurality of openings are circular.

6. System according to claim 4, characterized in that one or more of the plurality of openings are arranged radially around a circumference of the rod.

7. System according to claim 2, characterized in that the rod comprises a rigid material, a semi-rigid material or a flexible material.

8. System according to claim 2, characterized in that the rod has a first cross-sectional dimension, the passage has a second cross-sectional dimension, and the first cross-sectional dimension is smaller than the second cross-sectional dimension. Petition 870260057113, dated 12 / 06 / 2026, p. 68 / 171 2 / 3 9. System according to claim 2, characterized in that an outer surface of the rod includes one or more channels configured to allow the medication to flow around the rod.

10. System according to claim 2, characterized in that a distal end of the rod includes an expandable element.

11. System according to claim 10, characterized in that the expandable element includes a stent or a balloon.

12. System according to claim 2, characterized in that the shaft includes an expandable portion comprising a pair of arms positioned proximally in relation to a distal end of the atraumatic tip.

13. System according to claim 12, characterized in that the expandable portion includes a plurality of sutures configured to secure a sclera.

14. System according to claim 1, characterized in that the needle is curved or hook-shaped.

15. System according to claim 2, characterized in that it further comprises a first magnetic element positioned on the rod.

16. System according to claim 15, characterized in that it further comprises a second magnetic element external to the needle and configured to guide the first magnetic element.

17. System according to claim 2, characterized in that a distal end of the rod includes an anchor that has a concave curvature configured to engage with an inner surface of a sclera.

18. System according to claim 17, characterized in that the anchor is configured to rest against a choroid without penetrating the choroid.

19. System according to claim 17, characterized in that the anchor is formed from a flexible or semi-flexible material. Petition 870260057113, dated 12 / 06 / 2026, page 69 / 171 3 / 3 20. System according to claim 2, characterized in that a distal end of the rod includes at least two legs configured to diverge when the distal end of the rod is implanted from the needle passage.

21. System according to claim 20, characterized in that at least two legs are formed from a hydrogel and configured to detach from the rod when positioned in the suprachoroidal space.

22. System according to claim 2, characterized in that it further comprises a lever and a stop positioned at a proximal end of the rod, wherein the lever is configured to push the rod through the needle and the stop is configured to seal the system during drug administration.

23. System according to claim 2, characterized in that the rod is retractable, and wherein the system is configured to administer the medication while the rod is retracted or is being retracted.

24. System according to claim 1, characterized in that it further comprises: a needle hub connected to a proximal end of the needle; and an enclosure surrounding the needle hub and extending from a proximal end of the needle hub. Petition 870260057113, dated 12 / 06 / 2026, pp. 70 / 171

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