Eyeball needle guide and method for facilitating access to the eye

Abstract

An eyeball needle guide for access into the space under the sclera of an eye comprises a housing. The housing has a contact surface and a needle guide surface. The contact surface defines a cavity within the housing. The contact surface extends at least partially along a contact plane. The needle guide surface extends around a needle axis to define a needle guide channel. The needle guide channel extends through the housing to an opening defined by the contact surface, whereby the needle guide channel communicates with the cavity through the opening. The needle axis is substantially parallel to the contact plane. The contact surface is shaped such that when the eyeball needle guide is positioned on the eye, a portion of the sclera is positioned within the cavity, the surface of the eye contacts the contact surface, and takes the shape of the contact surface.

Description

Technical Field

[0001] The present disclosure generally relates to pharmaceutical devices and related methods for delivering therapeutic agents, and more particularly to an eyeball guide and related methods for facilitating needle access to the interior of the eye.

Background Art

[0002] The eye is a complex organ with various specialized tissues that provide the optical and neurological processes for vision. Accessing the eye for drug therapy is hampered by the small size and delicate nature of the tissues. The posterior region of the eye (including the retina, macula, choroid, and optic nerve) is particularly difficult to access due to its recessed position within the eye socket cavity. In addition, topical eye drops have difficulty penetrating into the posterior region, further limiting treatment options.

[0003] The suprachoroidal space and the subchoroidal space are intraocular spaces that may be available for treatment options. The suprachoroidal space is located between the choroid, which is an inner vascular membrane, and the sclera, which is the outer layer of the eye. The subchoroidal space is located beneath the choroid and above the retina. The choroidal space extends from the anterior portion of the eye near the ciliary body to the posterior end of the eye near the optic nerve. Normally, the suprachoroidal space is not distinct because the choroid is juxtaposed close to the sclera by the intraocular pressure of the eye. Since there is no substantial attachment of the choroid to the sclera, when a fluid accumulation or other condition occurs, the tissues separate to form the suprachoroidal space. The suprachoroidal space provides a potential pathway for access from the anterior region of the eye to treat the posterior region.

[0004] Accessing the suprachoroidal or subchoroidal space of the eye is a delicate procedure that requires considerable skill and time. There are several methods for accessing this space to deliver therapeutic agents, but the complexity and time required have been barriers to widespread adoption. Any attempt to pierce the sclera with a needle to access a specific depth (and thus a specific interlaminar space) faces the challenge of providing enough force to penetrate the relatively tough scleral tissue without over-penetrating. This challenge is exacerbated by the flexible nature of the eye and the lack of means to support the opposite side of the tissue being penetrated.

[0005] The foregoing background discussion is intended solely to assist the reader. It is not intended to limit the technological innovations described herein. Thus, the foregoing discussion should not be construed as indicating that any particular element of a conventional system is not suitable for use with the technological innovations described herein, nor is it intended to indicate that any element is essential to the practice of the technological innovations described herein. SUMMARY OF THE INVENTION

[0006] One aspect of the present disclosure provides an eye needle guide for access into a space beneath the sclera of an eye. The eye needle guide comprises a housing having a contact surface and a needle guide surface. The contact surface defines a cavity within the housing. The contact surface extends at least partially along a contact plane. The needle guide surface extends around a needle axis to define a needle guide channel. The needle guide channel extends through the housing to an opening defined by the contact surface, whereby the needle guide channel communicates with the cavity through the opening. The needle axis is substantially parallel to the contact plane. The contact surface is shaped such that when the eye needle guide is positioned on the eye, a portion of the sclera is positioned within the cavity and the surface of the eye contacts the contact surface.

[0007] Another aspect of the present disclosure provides a pharmaceutical kit comprising an eye needle guide and a needle. The eye needle guide comprises a housing having a contact surface and a needle guide surface. The contact surface defines a cavity within the housing. The contact surface extends at least partially along a contact plane. The needle guide surface extends around a needle axis to define a needle guide channel. The needle guide channel extends through the housing to an opening defined by the contact surface, whereby the needle guide channel communicates with the cavity through the opening. The needle axis is substantially parallel to the contact plane. The contact surface is shaped such that when the eye needle guide is positioned over the eye, a portion of the sclera is positioned within the cavity and the surface of the eye contacts the contact surface. A needle configured to be inserted through the needle guide channel along the needle axis

[0008] Another aspect of the present disclosure provides an eye needle guide for access into the space beneath the sclera of an eye. The eye needle guide comprises a first body portion and a second body portion. The first body portion has a first contact surface and a needle guide surface. The needle guide surface extends around a needle axis to define a needle guide channel. The needle guide channel extends through the housing to an opening defined by the first contact surface. The second body portion has a second contact surface. The second contact surface extends at least partially along a contact plane. The first body portion is movable relative to the second body portion such that the eye needle guide is movable between an aligned position and an open position. In the aligned position, the first contact surface and the second contact surface define a cavity. The needle guide channel communicates with the cavity through the opening and the needle axis is substantially parallel to the contact plane. In the open position, the needle axis is angularly offset from the contact plane.

[0009] Another aspect of the present disclosure provides a method of delivering a therapeutic agent to an eye using an eye needle guide. The method includes positioning an eye needle guide over the eye, the eye needle guide comprising a housing having a contact surface and a needle guide surface, the contact surface defining a cavity within the housing, the contact surface extending at least partially along a contact plane, the needle guide surface extending around a needle axis to define a needle guide channel, the needle guide channel extending through the housing to an opening defined by the contact surface, whereby the needle guide channel communicates with the cavity through the opening, the needle axis being substantially parallel to the contact plane, and when the eye needle guide is positioned over the eye, a portion of the sclera of the eye is positioned within the cavity and the surface of the eye contacts the contact surface; and inserting a needle through the sclera and through the needle guide channel after positioning the eye needle guide over the eye.

[0010] Another aspect of the present disclosure provides an eye needle guide for access to a space beneath the sclera of an eye. The eye needle guide includes a housing and a post. The housing has a first contact surface and a post guide surface. The first contact surface defines a cavity within the housing, and the post guide surface defines a post channel within the housing. The post is at least partially positioned within the post channel. The post has a second contact surface and a needle guide surface. The needle guide surface extends around a needle axis through the post to define a needle guide channel. The needle guide channel has an opening defined by the second contact surface. The needle axis has a distal axis portion that extends substantially linearly from a location within the needle guide channel through the opening. The distal axis portion of the needle axis is substantially parallel to at least a portion of the first contact surface. The post is movable within the post channel to define a first depth position within the cavity and a second depth position within the cavity. At the first depth position, the distal axis portion of the needle axis is spaced from the substantially parallel portion of the first contact surface by a first depth distance. At the second depth position, the distal axis portion of the needle axis is spaced from the substantially parallel portion of the first contact surface by a second depth distance different from the first depth distance.

[0011] The summary of the present invention is provided to introduce a series of concepts in a simplified form, and these concepts will be further described in the following "Detailed Description of the Invention" section. The summary of the present invention is not intended to identify the important features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. Furthermore, the claimed subject matter is not restricted by limitations that solve any or all of the drawbacks described in any part of the present disclosure.

Brief Description of the Drawings

[0012] The foregoing summary and the following detailed description of the exemplary embodiments of the present application will be better understood when read in conjunction with the accompanying drawings. For the purpose of illustrating the present application, exemplary embodiments of the present disclosure are shown in the drawings. However, it should be understood that the present application is not limited to the exact arrangements and means shown in the drawings. In the drawings, it is as follows.

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DETAILED DESCRIPTION OF THE INVENTION

[0013] The specific terms used herein are for convenience only and are not limiting. The terms "axial", "radial", "circumferential", "outward", "inward", "upper", "lower", "top", and "bottom" refer to the directions in the referenced drawings. As used herein, the terms "substantially", "approximately", their derivatives, and words of similar meaning, when used to describe a size, shape, orientation, distance, spatial relationship, or other parameter, include the stated size, shape, orientation, distance, spatial relationship, or other parameter, and can also include ranges that are more than 10% and less than 10% of the stated parameter, which can include ranges of 5% or more and 5% or less, 3% or more and 3% or less, 1% or more and 1% or less. The terms "substantially", "approximately", etc. are intended to mean a significant degree or majority of the specified thing, but not necessarily all (but can include all). All ranges disclosed herein include the recited endpoints and can be combined independently (e.g., the range of "2 grams to 10 grams" includes the endpoints 2 grams and 10 grams, as well as all intermediate values). The terms include the words listed above, their derivatives, and words having similar meanings.

[0014] FIG. 1 shows an eye needle guide 100 positioned over an eye 10, and FIGS. 2 and 3 show cross-sectional views of the eye needle guide 100 positioned over the eye 10 taken along line 2-2 shown in FIG. 1. The eye 10 has a spherical shape and a layer having physical properties that present challenges when attempting to access a space either above or below, for example, the choroidal layer 12 of the eye 10. The eye needle guide described herein employs a molding surface to temporarily reconstruct the shape of the eye 10 so as to align a lower layer target space (e.g., the subchoroidal space or the suprachoroidal space) beneath the sclera 14 of the eye 10 with the needle 20.

[0015] The eye needle guide 100 includes a housing 102. The housing 102 is shaped to be positioned on the outer surface of the eye 10. The housing 102 is configured to receive the needle 20 therethrough for accessing the eye 10. The housing 102 may be further configured to connect to a negative pressure source 22. The negative pressure source is configured to provide negative pressure to the eye needle guide 100 via a pressure conduit 103. The negative pressure may provide a holding force between the housing 102 and the eye 10 to maintain attachment of the eye needle guide 100 to the eye 10.

[0016] Figure 4 shows a close-up view of the eye needle guide 100 shown in Figure 2. The housing 102 has a contact surface 104 configured to face and contact the exposed portion of the eye 10, and an outer surface 105 on the opposite side of the contact surface 104 in the outward direction away from the eye 10 as well. As described below, the contact surface is configured to contact the eye 10 so as to separate the exposed portion of the sclera 14 from the choroid 12 and form a landing zone therebetween. The housing 102 further defines a needle guide channel 124 extending from the outer surface 105 to the contact surface 104 and is configured to guide a needle into the eye within the landing zone along a direction that is substantially tangential to the exposed surface of the eye. The contact surface 104 has an outer peripheral edge portion 110 extending around the housing 102. The outer peripheral edge portion 110 is curved and may extend circumferentially around the housing 102. In one aspect, the peripheral edge portion 110 extends continuously around the housing 102. The contact surface 104 radially defines a cavity 108 within the outer peripheral edge portion 110. The cavity 108 is sized to receive at least a portion of the eye 10 therein.

[0017] The contact surface 104 includes a first surface portion 112, a second surface portion 114, and a third surface portion 116. The third surface portion 116 may be referred to as a base surface portion configured to contact an undeformed portion of the undeformed sclera 14, which means that the third surface portion 116 does not separate the sclera 14 from the choroid 12 when the third surface portion 116 contacts the sclera. The second surface portion 114 may define an eye deformation surface portion configured to define a seat for the deformed portion of the sclera 14 displaced under the suction force provided by the negative pressure source 22. In some embodiments, the sclera 14 may be displaced away from the choroid 12 to define a suprachoroidal landing zone. In other embodiments, the choroid 12 may be displaced together with the sclera 14s to define a subchoroidal landing zone. In one embodiment, the first or outer region of the second surface portion 114 may contact the undeformed sclera 14, and the second or inner region of the second surface portion 114 may define a seat for the deformed portion of the sclera 14 (see FIG. 5). The landing zone may be defined by a portion of the sclera 14 (alone or in combination with a portion of the choroid 12) that is deformed relative to the second region of the second surface portion 114. The first surface portion 112 may be referred to as a spacer surface portion that spaces the second surface portion 114 from the third surface portion in an outward direction, and thus away from the eye 10. The first surface portion 112 may also define an inner opening into the needle guide channel 124.

[0018] The second surface portion 114 may extend at least partially along the contact plane 120. The contact plane 120 defines a plane that extends inside and outside the page of FIG. 4. The second surface portion 114 may extend radially inwards from the outer peripheral edge 110 towards the first surface portion 112, substantially along the contact plane 120. In one aspect, the entire second surface portion 114 extends substantially along the contact plane 120 from the outer peripheral edge 110 to the first surface portion 112. In some embodiments, the second surface portion 114 may be planar or curved as required.

[0019] The eye needle guide 100 can define a landing zone for the needle 20 when the contact surface 104 is disposed in contact with the eye 10. As used herein, the term "landing zone" can refer to a zone disposed between the choroid 12 and the deformed portion of the sclera 14 after the sclera 14 has been repositioned relative to the eye needle guard 100 and configured to receive the injection end of the needle 20. Thus, the landing zone can be partially defined by either or both of the outer peripheral edge portion 110 and the second surface portion 114. Specifically, either or both of the second surface portion 114 and the outer peripheral edge portion 110 in the second surface portion 114 can face the landing zone. More specifically, when the third surface portion 116 of the contact surface 104 is disposed in contact with the eye, the deformed portion of the sclera 14 is applied to the second surface portion 114, while the non-deformed portion of the sclera 14 remains applied to the third surface portion 116. Thus, the landing zone can have a thickness that extends between a first distance and a second distance. The first distance can be defined from the second surface portion 114 to the choroid facing the surface of the deformed sclera 14. The second distance can be defined from the second surface portion 114 to the sclera 14. Thus, in one embodiment, the landing zone can be on the choroid. In other embodiments, the landing zone can be defined under the choroid 12 and can be referred to as subchoroidal. The subchoroidal landing zone can provide subchoroidal access for the needle. The landing zone can have a length that extends along at least a portion of the circumferential length of the second surface portion 114 that extends from the first surface portion 112 to the outer peripheral edge portion 110 along the second surface portion 114. In one embodiment, the length of the landing zone can extend between the second surface portion 114 and the outer peripheral edge portion 110. For example, the length of the landing zone can extend from the second surface portion 114 toward the outer peripheral edge portion 110 and can terminate inside the outer peripheral edge portion 110. In some embodiments, the length of the landing zone can extend from the second surface portion 114 to the outer peripheral edge portion 110.

[0020] The first surface portion 112 is angularly offset from the second surface portion 114 such that the cavity 108 is defined by the first surface portion 112 and the second surface portion 114. The first surface portion 112 may be curved or straight, as desired. In one aspect, the first surface portion 112 may define an angle with the needle axis 122, as described below. The angle may be in the range of approximately 30 degrees to approximately 90 degrees, such as, for example, approximately 45 degrees to approximately 90 degrees, such as, for example, approximately 60 degrees to approximately 90 degrees, such as, for example, approximately 70 degrees to approximately 90 degrees, such as, for example, approximately 80 degrees to approximately 90 degrees. The angle may be defined by a straight line and the needle axis 122. In some embodiments where the first surface 112 is a flat surface, the straight line may extend along the first surface portion 112. In other embodiments, for example, where the first surface 112 is curved, the straight line may extend through a first point defined by the intersection of the first surface portion 112 and the third surface portion 116 and a second point defined by the intersection of the first surface portion 112 and the second surface portion 114.

[0021] The third surface portion 116 extends from the first surface portion 112 to the outer peripheral edge 110. The third surface portion 116 may be curved such that the third surface portion 116 approximates the curvature of the eye 10. The curvature of the third surface portion 116 may facilitate positioning of the housing 102 over the eye 10. In one embodiment, the housing 102 may be positioned over the eye 10 such that the eye extends along the third surface portion 116. The first surface portion 112 may define a standoff surface that extends outwardly from the third surface portion 116 to the second surface portion 114. As a result, the needle may enter the landing zone along a trajectory that is tangential to the eye or angularly offset from a direction that is tangential to the eye. Thus, when the third surface portion 116 contacts the eye, at least the inner portion of the second surface portion 114 may be spaced apart from the eye 10. In this regard, it can be said that the first surface portion 112 spaces the second surface portion 114 from the third surface portion 116 and thus away from the eye during use to define the landing zone described above. During use, the shape of the eye 10 may be reconstructed by bringing a portion of the sclera 14 against the second surface portion 114 so as to define the landing zone described above. It should be understood that when the shape of the eye 10 is reconstructed, the portion of the sclera 14 brought against the second surface portion 112 takes the shape of the second surface portion 112. Another portion of the sclera 14 may extend along the third surface portion 116. Yet another portion of the sclera 14 may extend along the first surface portion 112 so as to define the landing of the landing zone where the needle is received when the needle is driven to a location between the choroid 12 and the sclera 14. It will be appreciated that all embodiments of the eye needle guide described herein may be configured to reposition at least a portion of the sclera 14 by moving a portion of the sclera 14 away from the choroid 12 and towards the surface, thereby repositioning the sclera 14 and thus the eye 10. In particular, the portion of the sclera 14 may extend along at least a portion of the surface and thus may define the shape of the surface. Thus, the needle 20 may be inserted between the portion of the choroid 12 within the landing zone and the sclera 14.

[0022] It will be understood that the third surface portion 116 may be optional such that the housing 102 includes the first surface portion 112 and the second surface portion 114 but does not include the third surface portion 116. For example, the first surface portion 112 may define a contact surface 104 that contacts the eye 10, and the second surface portion 114 extends outwardly and away from the contact surface 104 and thus away from the eye during use, from the first surface portion 112. As described above, during use, the shape of the eye 10 can be reconstructed by bringing a portion of the sclera 14 against the second surface portion 112 so as to define the landing zone described above. It should be understood that when the shape of the eye 10 is reconstructed, the portion of the sclera 14 brought against the second surface portion 112 takes the shape of the second surface portion 112.

[0023] The housing 102 defines a needle guide surface 106 that extends around the needle shaft 122 and defines a needle guide channel 124. The needle guide channel 124 extends through the housing 102 to an opening 126 (e.g., a first opening) defined by the contact surface 104. The opening 126 of the needle guide channel 124 communicates with the cavity 108 of the housing 102. In one aspect, a first surface portion 112 of the contact surface 104 defines the opening 126. The needle guide axis 122 may extend substantially parallel to the contact plane 120 at a location adjacent to the contact plane and may also extend along the contact plane 120. Thus, the needle guide axis 122 does not intersect the contact plane 120 within the outermost footprint of the eye needle guide 100. In one embodiment, the needle guide axis 122 may be parallel to the contact plane 120 or may be slightly angularly offset from the contact plane 120 but still be substantially parallel to the contact plane 120, whereby the needle 20 can be easily inserted through the sclera 14 into the landing zone without penetrating the choroid 12. As used herein, the term substantially parallel may include an angle of less than approximately 20 degrees, e.g., less than approximately 10 degrees, e.g., less than approximately 5 degrees. Alignment of the needle guide axis 122 with the contact plane 120 facilitates alignment of the needle 20 with the landing zone of the second surface portion 114 of the contact surface 104. Alignment of the needle 20 with the landing zone may provide a predictable depth of penetration of the needle 20 into the eye 10.

[0024] In one aspect, the needle shaft 122 is substantially straight such that the needle guide channel 124 extends linearly through the housing 102. Alternatively, the needle shaft 122 may include a curved portion such that a portion of the needle guide channel 124 is curved. For example, the needle guide channel 124 extends from an outer opening 228 defined by the outer surface 230 of the housing 102. The needle shaft 122 may include a curved portion and a straight portion. The curved portion extends from the outer opening 128 to the straight portion, and the straight portion extends from the curved portion to the opening 126. The straight portion of the shaft 122 may extend along the contact plane 120. The curved needle shaft 122 may facilitate alignment with a landing zone of a flexible needle (e.g., a nitinol needle) inserted through the needle guide channel 124 such that the flexible needle is substantially parallel to the elongation direction of the landing zone.

[0025] The housing 102 may also include a pressure surface 232 that defines a pressure channel 234 that extends through the housing 102 from the outer surface 230 to a pressure opening 236 (e.g., a second opening) defined by the contact surface 104. The pressure opening 236 communicates with the cavity 108 to fluidly connect the exterior of the housing 102 to the cavity 108. In one aspect, the pressure opening 236 is defined by a second surface portion 114 of the contact surface 104. The pressure channel 234 may be sized and configured to receive a pressure tube therein. In one aspect, the pressure channel 234 may include a threaded region for threaded connection to a pressure conduit 103. Alternatively, the pressure conduit 103 may be connected to the housing 102 via an adhesive, glue, interference fit, snap fit, or yet other fastening or connecting means to fluidly connect the negative pressure source 22 to the pressure channel 234.

[0026] Referring to FIGS. 2 and 4, the pressure conduit is connected to the housing 102 such that the negative pressure source 22 is in fluid communication with the pressure channel 234. During an eye treatment procedure, the eye needle guide 100 can be positioned over the eye 10 by a medical professional. The location of the eye needle guide 100 can be selected based on the desired treatment location on the eye 10. After the placement of the eye needle guide 100, a negative pressure can be applied to the cavity 108 by the negative pressure source 22. The negative pressure can draw the sclera 14 into the cavity 108. When the sclera 14 is drawn into the cavity 108, the outer surface of the eye 10 contacts the contact surface 104 of the housing 102 and takes substantially the same shape as the contact surface 104. The contact surface 104 defines a specific profile for deforming the surface of the eye 10. The portion of the outer surface of the eye 10 or the sclera 14 that contacts the second surface portion 114 extends substantially parallel to the contact plane 120. The shaped surface of the second surface portion 114 can effectively flatten at least a small portion of the sclera 14 such that the flattened portion of the sclera 14 is substantially parallel to the needle axis 122.

[0027] It will be appreciated that the eye needle guide 100 may further include a handle (not shown). The handle extends from the body 102 and can be operated by a user to adjust and position the body 102 over the eye 10. The handle can be removable from the body 102 such that the handle can be removed prior to the treatment procedure when the body 102 is positioned over the eye 10. Alternatively, the handle can be fixed to the body 102 to assist in maintaining the position of the body 102 over the eye 10 during the procedure.

[0028] Referring to FIGS. 3 and 4, when the eye 10 contacts the contact surface 104 of the eye needle guide 100 and the sclera is positioned within the cavity 108, the needle 20 can be inserted directly into the landing zone through the needle guide channel 124 within the housing 102. The configuration of the second surface portion 114 and the shaped surface of the needle guide channel 124 can make the depth of needle penetration less critical than conventional needle access. The needle 20 can include a needle stop 24 for controlling the insertion depth such that the needle 20 does not extend beyond the landing zone and thus does not penetrate the choroid 12.

[0029] The needle shaft 122 can be offset from the contact plane 120 by a distance that substantially corresponds to the thickness of the sclera 14 for suprachoroidal access or the thickness of the sclera 14 and the thickness of the choroid 12 for subchoroidal access. It will be appreciated that other distances can be used to offset the needle 20 to access other locations within the eye.

[0030] In one aspect, the needle 20 can benefit from a high-speed firing mechanism such as those used in biopsy needles. The rapid operation can reduce the problem of penetrating the tough sclera without losing the attachment of the eye needle guide 100 to the eye 10. A biopsy-type firing mechanism can also provide a predictable depth of penetration.

[0031] The needle 20 can have a needle tip with a conical or trocar-type symmetric shape that can facilitate alignment of the needle 20 within the eye 10 as the needle 20 advances. The needle 20 can include side holes for injection. In one aspect, when the needle 20 accesses the target location, a sheath or catheter (not shown) can be quickly left in place and negative pressure can be removed from the cavity 108. This can provide access to the interlayer space for further blunt dissection and / or delivery of therapeutic agents.

[0032] A relatively rapid procedure for using the above-described method to deliver a therapeutic agent to the inner layer space of the eye 10 can include placing the eye needle guide 100 at the desired location of the eye 10, applying a vacuum from the negative pressure source 22, firing the needle 20, delivering the agent, removing the needle 20 from the eye 10, releasing the vacuum, and removing the eye needle guide 100 from the eye 10. In one aspect, the step of "delivering the agent" can be replaced by a catheter insertion step to leave an access channel for additional delivery to the target space or navigation of the target space.

[0033] Figures 5 - 7 show cross-sectional views of alternative embodiments of the eye needle guide 200 according to aspects of the present disclosure. The portions of the alternative embodiments of the eye needle guide 200 disclosed in Figures 5 - 7 are similar to the embodiments of the eye needle guide 100 described above in Figures 1 - 4, and these portions function in the same manner as those described above. The eye needle guide 200 includes a housing 202. The housing 202 is shaped to be positioned on the outer surface of the eye 10. The housing 202 is configured to receive the needle 20 therethrough for accessing the eye 10.

[0034] The housing 202 has a contact surface 204, an outer surface 205 opposite the contact surface 204, and a needle guide channel 224 extending from the outer surface 205 to the contact surface 204 as described above. The contact surface 204 defines a cavity 208 within the housing 202. The cavity 208 is sized to receive at least a portion of the eye 10 therein.

[0035] The housing 202 includes a first housing portion 209 and a second housing portion 211. The contact surface 204 of the first housing portion 209 includes a first surface portion 212 and a third surface portion 216. The contact surface 204 of the second housing portion 211 includes a second surface portion 214. The second surface portion 214 extends at least partially along a contact plane 220. The contact surface 204 may define a landing zone as described above. The third surface portion 216 may be referred to as a base surface portion configured to contact an undeformed portion of the undeformed sclera 14, which means that the third surface portion 216 does not separate the sclera 14 from the choroid 12. The second surface portion 214 may be referred to as an eye deformation surface portion configured to define a seat for a deformed portion of the sclera 14 separated from the choroid 12 under the suction force provided by the negative pressure source 22. In this regard, the second surface portion 214 may be offset in an outward direction from the third surface portion 216. The first surface portion 212 may extend in an outward direction from the third surface portion 216 so as to define an inner opening to the needle guide channel 224 extending from the outer surface 205 to the first surface portion 212.

[0036] The housing 202 defines a needle guide surface 206 that extends around the needle shaft 222 so as to define a needle guide channel 224. The needle guide channel 224 extends through the housing 202 to the contact surface 204 and communicates with the cavity 208 of the housing 202. The needle guide shaft 222 is substantially parallel to the contact plane 220. The alignment of the needle guide shaft 222 and the contact plane 220 facilitates alignment with the landing zone of the needle 20.

[0037] The housing 202 may further include a first holding member 217 and a second holding member 219. The first holding member 217 may be positioned on the first housing portion 209. The second holding member 219 may be positioned on the second housing portion 211. The first holding member 217 and the second holding member 219 may include, for example, opposing returns, serrations, edges, protrusions, teeth, combinations thereof, or other members that extend from the contact surface 204 and can grip the surface of the eye 10. It will be appreciated that the first holding member 217 and the second holding member 219 may be formed as part of their respective first housing portion 209 and second housing portion 211. Alternatively, the first holding member 217 and the second holding member 219 may be separately attached to the contact surface 204 of their respective first housing portion 209 and second housing portion 211. Each of the first holding member 217 and the second holding member 219 may include a single respective holding member. Alternatively, each of the first holding member 217 and the second holding member 219 may include a plurality of holding members. The first holding member 217 and the second holding member 219 can stabilize and hold the eye 10 so as to resist movement between the eye 10 and the eye needle guide 100 when the eye needle guide 100 is positioned on the eye 10.

[0038] Referring to FIGS. 5 and 6, the first housing portion 209 may be movable relative to the second housing portion 211 such that the housing 202 is movable between a holding position (FIG. 6) and an open position (FIG. 5). In the holding position, the first housing portion 209 is at a first distance D 1is spaced only from the second housing portion 211. In the open position, the first housing portion 209 is at a first distance D 1 greater than a second distance D 2 and is spaced only from the second housing portion 211. In one aspect, the needle guide channel 224 is spaced from the second surface portion 214 of the contact surface by a first distance in the holding position. In the open position, the needle guide channel 224 is spaced from the second surface portion 214 of the contact surface by a second distance greater than the first position. In one aspect, the first housing portion 209 and the second housing portion 211 may be in contact with each other in the holding position, and the first housing portion 209 and the second housing portion 211 are spaced apart from each other in the open position.

[0039] In one embodiment, the first housing portion 209 and the second housing portion 211 may be linearly movable relative to each other between the holding position and the open position. In particular, the eye needle guide 200 may include a guide member 203 received by either or both of the first housing portion 209 and the second housing portion 211. Accordingly, either or both of the first housing portion 209 and the second housing portion 211 may selectively slide along the guide member 203 toward and away from the other of the first housing portion 209 and the second housing portion 211. The guide member 203 may extend along a central axis that may be linear or curved as desired. Either or both of the first housing portion 209 and the second housing portion 211 may move along the central axis of the guide member 203 between the holding position and the open position. Accordingly, either or both of the first housing portion 209 and the second housing portion 211 may move along the central axis of the guide member 203 along a linear or curved path between the holding position and the open position. The guide member 203 may be configured as a guide rod having a cross-section of any suitable shape as desired.

[0040] When the eye needle guide 200 is in the open position, the eye needle guide 200 can be positioned on the eye 10 such that the contact surface 204 contacts the surface of the eye 10. After the eye needle guide 200 is positioned on the eye 10, the housing 204 can be shifted from the open position to the holding position, which can draw the sclera 14 into the cavity 208 of the housing 204 and against the second surface portion 214. For example, the first holding member 217 and the second holding member 219 can engage the sclera 14 when the eye needle guide 200 is positioned on the eye 10. When the distance between the first housing portion 209 and the second housing portion 211 transitions from a second distance D 2 to a first distance D 1 , the first holding member 217 and the second holding member 219 can draw the sclera 14 into the cavity 208, bring the surface of the eye 10 or the sclera 14 into contact with the contact surface 204, and cause the second surface portion 214 to take shape. The portion of the outer surface of the eye 10 that contacts the second portion 214 can extend substantially parallel to the contact plane 220. The shaped surface of the second surface portion 214 can effectively flatten at least a small portion of the sclera 14 such that the flattened portion of the sclera 14 is substantially parallel to the needle axis 222. This can reconstruct the tissue of the eye 10 by drawing the sclera into the cavity 208 and cause the second surface portion 214 to take shape for shallow angle injection. The needle 20 can be inserted directly into the target space under the sclera 14 through the needle guide channel 224 in the housing 202 and in a substantially similar manner as described above with respect to the eye needle guide 100.

[0041] Figures 8 and 9 show cross-sectional views of alternative embodiments of the eye needle guide 300 according to aspects of the present disclosure. The portions of the alternative embodiments of the eye needle guide 300 disclosed in Figures 8 and 9 are similar to the embodiments of the eye needle guides 100 and 200 described above in Figures 1-7, and these portions function in the same manner as those described above. The eye needle guide 300 includes a housing 302. The housing 302 is shaped to be positioned on the outer surface of the eye 10. The housing 302 is configured to receive the needle 20 therethrough for accessing the eye 10. The housing 302 has a contact surface 304, an outer surface on the opposite side of the contact surface in the outward direction, and a needle guide surface 306 that defines a needle guide channel 324 as described above. The contact surface 304 defines a cavity 308 within the housing 302. The cavity 308 is sized to receive at least a portion of the eye 10 therein.

[0042] The housing 302 includes a first housing portion 309 and a second housing portion 311. The contact surface 304 of the first housing portion 309 includes a first surface portion 312 and a third surface portion 316. The contact surface 304 of the second housing portion 311 includes a second surface portion 314. The third surface portion 316 can be referred to as a base surface portion configured to contact an undeformed portion of the undeformed sclera 14, which means that the third surface portion 316 does not separate the sclera 14 from the choroid 12. The second surface portion 314 can be referred to as an eye deformation surface portion configured to define a seat for a deformed portion of the sclera 14 that is separated from the choroid 12 under the suction force provided by the negative pressure source 22. In this regard, the second surface portion 314 can be offset in the outward direction from the first surface portion 312. The first surface portion 312 can extend in the outward direction from the third surface portion 316 so as to define an inner opening to the needle guide channel 324 that extends from the outer surface 305 to the first surface portion 312. The second surface portion 314 extends at least partially along a contact plane 320. The contact surface 304, particularly the second surface portion 314, can define a landing zone as described above.

[0043] The first housing portion 309 can be movable relative to the second housing portion 311 such that the housing 302 can be shifted between a holding position (FIG. 9) and an open position (FIG. 8). In one aspect, the first housing portion 309 can be rotationally movable relative to the second housing portion 311 so as to selectively move closer to or farther from each other about a pivot member 313 between the holding position and the open position, respectively. The second surface portion 314 and the third surface portion 316 are more spaced apart from each other in the open position than in the holding position. The pivot member 313 can include, for example, a pin, a rod, a ball, or any other member that can facilitate rotation between components. In the open position, the needle guide shaft 322 that defines the needle guide channel 324 is angularly offset from the contact plane 320. In the holding position, the needle guide shaft 322 can be substantially parallel to the contact plane 320.

[0044] When the eye needle guide 300 is in the open position, the eye needle guide 300 can be positioned on the eye 10 such that the contact surface 304 contacts the surface of the eye 10. After the eye needle guide 300 is positioned on the eye 10, the housing 304 can be shifted from the open position to the holding position, which can draw the sclera 14 into the cavity 308 of the housing 304. For example, when the housing 304 is shifted to the holding position, the first holding member 317 and the second holding member 319 can engage the sclera 14 and draw the sclera 14 into the cavity 308. The force applied by the first holding member 317 and the second holding member 319 can contact the sclera 14 of the eye 10 against the contact surface 304 and define a landing zone in the manner described above. The portion of the sclera 14 of the eye 10 that contacts the second surface portion 314 extends substantially parallel to the contact plane 320. The needle 20 can be inserted directly into the target space under the sclera 14 through the needle guide channel 324 in the housing 302 and in a manner substantially similar to that described above with respect to the eye needle guide 100.

[0045] It will be appreciated that the eye needle guides 200 and 300 may also include other immobilization components or additional immobilization components. For example, the eye needle guides 200 and 300 may include a vacuum (e.g., a negative pressure source 22) to maintain contact between the eye needle guides 200 and 300 and the eye 10.

[0046] Figures 10-12 show, respectively, a cross-sectional view, a perspective view, and a bottom view of an alternative embodiment of an eye needle guide 400 according to an aspect of the present disclosure. The portions of the alternative embodiment of the eye needle guide 400 disclosed in Figures 10-12 are similar to the embodiments of the eye needle guides 100, 200, and 300 described above in Figures 1-9, and these portions function in a similar manner to those described above. The eye needle guide 400 includes a housing 402. The housing 402 is shaped to be positioned on the outer surface of the eye 10. The housing 402 is configured to receive the needle 20 therethrough for accessing the eye 10.

[0047] The housing 402 has a contact surface 404 and an outer surface 405 that is on the opposite side of the contact surface in the outward direction. The housing 402 further defines a needle guide channel 424 that extends from the outer surface 405 to the contact surface 405 in the manner described above. The contact surface 404 may further include a first surface portion 412, a second surface portion 414, and a third surface portion 416. The third surface portion 416 may be referred to as a base surface portion configured to contact an undeformed portion of the undeformed sclera 14, which means that the third surface portion 416 does not separate the sclera 14 from the choroid 12. The second surface portion 414 may be referred to as an eye deformation surface portion configured to define a seat for a deformed portion of the sclera 14 that is separated from the choroid 12 under the suction force provided by the negative pressure source 22. In this regard, the second surface portion 414 may be offset in the outward direction from the first surface portion 412. The first surface portion 412 may extend in the outward direction from the third surface portion 416 to the second surface portion 14. The needle guard channel 424 may extend from the outer surface 405 to the first surface portion 412 such that an inner opening to the needle guide channel 424 is disposed in the first surface portion 412. The contact surface 404 defines a cavity 408 within the housing 402. The cavity 408 is sized to receive at least a portion of the eye 10 therein. The housing 402 defines a needle guide surface 406, and the needle guide surface 406 defines a needle guide channel 424 that communicates with the cavity 408. The needle guide channel 424 extends around a needle guide axis 422. The needle guide axis 422 is substantially parallel to the extension direction of a landing zone that may be defined by the contact surface 404 in the manner described above.

[0048] The housing 402 may also include a plurality of pressure channels 434 that extend through the housing 402 from the outer surface 405 to the contact surface 404, particularly to the second surface portion 414. The plurality of pressure channels 434 define a corresponding plurality of pressure openings 436 at the second surface portion 414. Thus, the pressure channels 434 communicate with the cavity 408 of the housing 402. The pressure openings 436 may be spaced apart around the contact surface 404. In some embodiments, each of the plurality of pressure openings 436 may be spaced substantially equidistant from each of the other pressure openings 436 or may be variably spaced as desired.

[0049] The eye needle guide 400 may further include a gasket 437 that extends around the outer peripheral edge 410 of the housing 402. The gasket 437 is positioned to contact the eye 10 when the eye needle guide is attached to the eye 10. The gasket 437 may assist in creating a seal between the housing 402 and the eye 10 when a suction force is applied to the cavity 408. In this regard, the gasket 437 may define both the third surface portion 416. The gasket 437 may further define a first surface portion 412 that extends from the third surface portion 416 to the second surface portion 414.

[0050] Once the eye needle guide 400 is positioned over the eye 10, the non-deformed portion of the sclera 14 can contact the third contact surface 416. The negative pressure source 22 can define a suction force within the cavity 408. In particular, the negative pressure source 22 can induce a negative pressure within the cavity 408, which in turn creates a suction force that separates a portion of the sclera 14 from the choroid 12 and draws it into the cavity 408, contacting the contact surface 404, particularly the second surface portion 414. The portion of the sclera 14 that contacts the second surface portion 414 can take the shape of the second surface portion 414, and thus defines the deformed portion of the sclera 14. Accordingly, the deformed portion of the sclera 14 can be in a plane that is substantially parallel to the needle guide axis 422. The needle 20 can be inserted through the needle guide channel 424 within the housing 402, through the sclera 14, into the target space 439 that defines a landing zone in an orientation that is substantially parallel to the second surface portion 414. The needle guide channel 424 can guide the entry of the needle into the suprachoroidal space. The needle 20 can include a needle stop 24 for controlling the insertion depth so that the needle 20 does not extend beyond the landing zone and / or does not return into the sclera 14 through the target space 439.

[0051] 13-16 illustrate cross-sectional views of alternative embodiments of an eye needle guide 500, according to aspects of the present disclosure. Portions of the alternative embodiments of the eye needle guide 500 disclosed in FIGS. 13-16 are similar to the embodiments of the eye needle guides 100, 200, 300, and 400 described above in FIGS. 1-12, and these portions function in a similar manner as described above. The eye needle guide 500 includes a housing 502 and a post 503 that is at least partially positioned within the housing 502. The housing 502 is shaped to be positioned on the outer surface of the eye 10. The post 503 is configured to receive the needle 20 therethrough for accessing the eye 10.

[0052] The housing 502 has a first contact surface 504 and a post guide surface 505. The first contact surface 504 defines a cavity 508 within the housing 502. The cavity 508 is sized to receive at least a portion of the eye 10 therein. In one aspect, the first contact surface 504 extends circumferentially within the housing 502 to define a substantially conical shape that tapers radially outward from the post guide surface 505 to the outer peripheral edge 510 of the housing 502. The first contact surface 504 can extend continuously around the housing 502 defining a 360-degree conical shape. In an alternative aspect, the first contact surface 504 at least partially defines a conical shape. The partial conical shape defines a conical shape of less than 360 degrees. The shape of the first contact surface 504 facilitates positioning of the eyelet needle guide 500 onto the eye 10 and alignment of the needle 20 with the first contact surface 504.

[0053] The post guide surface 505 defines a post channel 508 within the housing 502. The post channel 509 is sized to receive at least a portion of the post 503 therein. The post channel 509 extends through the housing 502 to an opening defined by the first contact surface 504 such that the post channel 509 communicates with the cavity 508.

[0054] The housing 502 can also include a plurality of pressure channels 534 that extend through the housing 502 to a plurality of pressure openings 536. The plurality of pressure openings 536 are defined by the first contact surface 504.

[0055] The post 503 is positioned at least partially within the post channel 507. The post 503 has a second contact surface 509 and a needle guide surface 506. The needle guide surface 506 extends around the needle axis 522 through the post 503 to define a needle guide channel 524. The needle guide channel 524 has an opening 538 defined by the second contact surface 509. The needle axis 522 has a distal axis portion 523 that extends substantially linearly from a location within the necessary guide channel 524 through the opening 538 defined by the second contact surface 509. When the post 503 is positioned within the post channel 507, the distal axis portion 523 of the needle axis 522 is substantially parallel to at least a portion of the first contact surface 504 of the housing 502.

[0056] The post 503 is movable within the post channel 509. In one aspect, the post 503 is threadedly coupled within the post channel 509 such that rotation of the post 503 relative to the housing linearly translates the post 503 through the post channel 509. The post 503 can be retracted to a position within the post channel 509 such that the second contact surface 509 is positioned within the post channel 509. The post 503 can be translated relative to its position within the post channel 509 such that the post 503 extends through the opening of the post channel 509 within the first contact surface 504 and the second contact surface 509 is positioned within the cavity 508. The post 503 can be translated to different positions within the post channel 509 to define different depth positions and define the needle depth position. For example, the post 503 can be translated to a first depth position within the cavity 508 and a second depth position within the cavity 508. At the first depth position, the distal shaft portion 523 of the needle shaft 522 is spaced a first depth distance from a portion of the first contact surface 504 that is substantially parallel. The first depth distance can define a target depth within the eye 10. For example, the first depth distance can define an approximate thickness of the sclera 14 of a particular eye 10 such that a needle inserted through the needle guide channel 524 can be inserted into the eye 10 to a position between the sclera 14 and the choroid 12. The post 503 can be adjusted to different depth distances to accommodate different eye 10 sizes and configurations and to change the depth of injection. For example, the post 503 can be translated to a second depth position within the cavity 508 that is different from the first depth distance. The second depth position can define another target depth within the eye 10, such as a subchoroidal location, or the second depth position can define a target depth for an eye having a different size and / or configuration than the eye 10.

[0057] When the post 503 is positioned within the cavity 508, the distal shaft portion 523 of the needle shaft 522 is spaced a depth distance from a portion of the first contact surface 504 that is substantially parallel. As described above, the depth distance can be adjusted by moving the position of the second contact surface 509 of the post 503 within the cavity 508.

[0058] The post 503 may also include a direction indicator 540 positioned on the proximal end of the post. The direction indicator 540 may provide an indication to the user regarding the direction in which the needle guide channel 524 communicates within the cavity 508. The direction indicator 540 may include, for example, a particular shape (e.g., a cam shape) of the end of the post, a direction indication (e.g., an arrow), a combination thereof, or some other indicator indicating the direction through which the needle guide channel 524 communicates.

[0059] When the eye needle guide 500 is positioned over the eye 10, a suction force can be applied to the pressure channel 534 by the negative pressure source 22 to draw the sclera 12 into the cavity 508 and into contact with the first contact surface 504 of the housing 502. The sclera 14 can assume the shape of the first contact surface 504. The post 503 can move from a retracted position (FIG. 13) to an extended position (FIG. 14) such that the second contact surface 509 of the post 503 is positioned within the cavity 508. After the post 503 is inserted into the cavity 508 to a desired depth position, the needle 20 can be directly inserted into the target space 539 within the eye 10 in an orientation substantially parallel to the first contact surface 504 through the needle guide channel 524 within the post 503. The needle 20 may include a needle stop 24 for controlling the insertion depth such that the needle 20 does not extend beyond the landing zone and / or does not pass through the target space 439 and return into the sclera 14.

[0060] FIG. 17 shows a cross-sectional view of an alternative embodiment of an eye needle guide 600 according to one aspect of the present disclosure. The portions of the alternative embodiment of the eye needle guide 600 disclosed in FIG. 17 are similar to the embodiments of the eye needle guides 100, 200, 300, 400, and 500 described above in FIGS. 1 - 16, and these portions function in a similar manner as those described above. The eye needle guide 600 includes a housing 602 and a pressure post 603. The housing 602 is shaped to be positioned on the outer surface of the eye 10. The housing 602 is configured to receive the needle 20 therethrough for access to the eye 10.

[0061] The housing 602 has a contact surface 604 and a needle guide channel 624. The needle guide channel 624 can be substantially parallel to the contact surface 604. The pressure post 603 can be positioned within a pressure channel 608 defined by the housing 602. The pressure channel 608 communicates with the contact surface 604. The pressure post 603 is translatable within the pressure channel 608 and affects the pressure applied to the eye 10 when the eye 10 engages the contact surface 604. For example, when the contact surface 604 engages the eye 10 and the pressure post 603 moves proximally away from the eye 10, a negative pressure (e.g., a vacuum) is created within the pressure channel 608 relative to the surface of the eye 10. The negative pressure can maintain the engagement between the eye 10 and the housing 602 during a treatment procedure. The negative pressure also helps to achieve deformation of the eye 10, create a target space 639 (e.g., the suprachoroidal space) within the eye 10, and release a therapeutic agent. To release the eye 10 from the housing 602, the pressure post 603 can be translated distally toward the eye 10 to reduce the vacuum force within the pressure channel 608. After the vacuum force is reduced, the housing 602 can be removed from the eye 10.

[0062] Figures 18 - 20 show cross-sectional views of alternative embodiments of an eye needle guide 700 according to aspects of the present disclosure. Portions of the alternative embodiments of the eye needle guide 700 disclosed in Figures 18 - 20 are similar to the embodiments of the eye needle guides 100, 200, 300, 400, 500, and 600 described above in Figures 1 - 17, and these portions function in a similar manner as those described above. The eye needle guide 700 includes a housing 702. The housing 702 is shaped to be positioned on the outer surface of the eye 10. The housing 702 is configured to receive the needle 20 therethrough for access to the eye 10.

[0063] The housing 702 has a contact surface 704 and a plurality of needle guide surfaces 706. The contact surface 704 defines a cavity 708 within the housing 702. The cavity 708 is sized to receive at least a portion of the eye 10 therein. The plurality of needle guide surfaces 706 define a plurality of needle guide channels 724 that communicate into the cavity 708 through a plurality of openings 726. Each needle guide channel 724 extends around a needle guide axis that is substantially parallel to the elongation direction of the landing zone. For example, the contact surface 704 may extend circumferentially around the housing axis 745 of the housing 702. The housing axis 745 may extend through the center of the cavity 708. The contact surface 704 may taper outwardly in a forward-rearward direction. Further, the contact surface 704 may define a substantially frustoconical shape that tapers radially outwardly from a position adjacent the needle guide surface 706 to the outer peripheral edge 710 of the housing 702. In other embodiments, the contact surface 704 may define any suitable shape other than frustoconical configured to reconstruct the eye 10, particularly by repositioning the sclera 14 in a location proximate the peripheral edge 710, so as to define a region where the needle is inserted into the landing zone. Each needle guide channel 724 may extend toward the cavity 708 in a direction that is substantially parallel to a portion of the contact surface 704 that is directly adjacent to the respective opening 726 of the needle guide channel 724. Each needle guide channel 724 may extend in a direction that is offset from each of the other needle guide channels 724 while still being substantially parallel to the portion of the contact surface 704 that is directly adjacent to the respective opening 726. In one aspect, each needle guide channel 724 may be equidistantly spaced circumferentially around the housing 704. It will be appreciated that the housing 704 may include a single needle guide channel 724. In one aspect, the housing 702 includes a retention ring.

[0064] The housing 702 may also include at least one pressure channel 734 that extends through the housing 702 to a plurality of pressure openings 736. The plurality of pressure openings 736 are defined by the first contact surface 704.

[0065] Once the eye needle guide 700 is positioned over the eye 10, a suction force can be applied by the negative pressure source 22 to draw the sclera 12 into the cavity 708 and bring it into contact with the contact surface 704. The sclera 14 can be shaped to conform to the shape of the contact surface 704 such that the sclera 14 is substantially parallel to the direction in which the needle guide channel 724 extends toward the cavity 708. The needle 20 can be inserted directly into the target space 739 beneath the sclera 14 through one of the needle guide channels 724 within the housing 702 and in an orientation substantially parallel to the contact surface 704. The needle guide channel 724 can guide the entry of the needle into the suprachoroidal space. The needle 20 can include a needle stop 24 for controlling the insertion depth such that the needle 20 does not extend beyond the contact surface 704 and / or does not pass through the target space 739 and return into the sclera 14.

[0066] Figures 21 and 22 show cross-sectional views of alternative embodiments of an eye needle guide 800 according to aspects of the present disclosure. Portions of the alternative embodiments of the eye needle guide 800 disclosed in Figures 21 and 22 are similar to the embodiments of the eye needle guides 100, 200, 300, 400, 500, 600, and 700 described above in Figures 1-19, and these portions function in a similar manner as described above. The eye needle guide 800 includes a first handle 802 and a second handle 803. The first handle 802 and the second handle 803 can be rotatably coupled together, for example, so as to define a pair of forceps. The first handle 802 and the second handle 803 are sized to be grasped and manipulated by a user during a treatment procedure.

[0067] Each of the first handle 802 and the second handle 803 includes a respective first contact surface 804 and second contact surface 805. The first contact surface 804 and the second contact surface 805 are shaped to be positioned on the outer surface of the eye 10. Each of the first contact surface 804 and the second contact surface 805 can include at least one retention member 817. The retention member 817 is configured to maintain the engagement between the eye needle guide 800 and the eye 10 during a treatment procedure. In one aspect, each of the first contact surface 804 and the second contact surface 805 includes a plurality of exclusion members 817.

[0068] The second handle 803 defines a needle guide channel that extends through the second handle 803 to an opening defined by the second contact surface 805. The needle guide channel 824 is sized to receive the needle 20 therethrough and access the eye 10.

[0069] The eye needle guide 800 is movable between a holding position and an open position. In the holding position, the needle guide channel 824 is substantially parallel to at least a portion of the first contact surface 804. The first contact surface 804 and the second contact surface 805 define a cavity 808 sized to receive a portion of the sclera 14 therein.

[0070] When the eye needle guide 800 is in the open position, the eye needle guide 800 can be positioned on the eye 10 such that the contact surfaces 804 and 805 contact the surface of the eye 10. After the eye needle guide 800 is positioned on the eye 10, the eye needle guide 800 can be moved from the open position to the holding position, whereby the holding member 817 can draw the sclera 14 into the cavity 808. The force applied by the holding member 817 can cause the surface of the eye 10 to conform to the shape of the first contact surface 804 and the second contact surface 805. The portion of the outer surface of the eye 10 that contacts the first contact surface 804 extends substantially parallel to the needle guide channel 824. The needle 20 can be inserted directly into the target space 839 under the sclera 14 through the needle guide channel 824 and in a substantially similar manner as described above with respect to the eye needle guide 100.

[0071] FIG. 23 shows a cross-sectional view of an alternative embodiment of the eye needle guide 900 according to an aspect of the present disclosure. The portion of the alternative embodiment of the eye needle guide 900 disclosed in FIG. 23 is similar to the embodiments of the eye needle guides 100, 200, 300, 400, 500, 600, and 700 described above in FIGS. 1-21, and these portions function in the same manner as those described above. The eye needle guide 900 includes a housing 902. The housing 902 is shaped to be positioned on the outer surface of the eye 10. The housing 902 is configured to receive the needle 20 therethrough for accessing the eye 10. The eye needle guide 900 may include a handle 907 that may extend from the body 902. The handle 907 can be operated by the user to adjust and position the body 102 on the eye 10.

[0072] The housing 902 has a contact surface 904 and a needle guide channel 924 that communicates into a cavity 908 defined by the contact surface 904. The needle guide channel 924 is substantially parallel to at least a portion of the contact surface 904.

[0073] When the eye needle guide 900 is positioned on the eye 10, a force F can be applied by the user in a direction toward the eye 10. The applied force F can push the sclera 12 into the cavity 908 and take the shape of the contact surface 904. The shape of the sclera 14 that contacts the contact surface 904 is substantially parallel to the needle guide channel 924. The needle 20 can be directly inserted into the target space 939 under the sclera 14 through the needle guide channel 924 and in an orientation substantially parallel to the contact surface 904. The needle guide channel 924 can guide the entry of the needle 20 into the suprachoroidal space.

[0074] The eyeball needle guide 900 can be referred to as a "press-fit type" eyeball needle guide. FIGS. 24A to 24F show alternative embodiments of the press-fit type eyeball needle guides 900', 900'', 900''', 900'''', 900''''' and 900''''''. The portions of the alternative embodiments of the eyeball needle guide disclosed in FIGS. 24A to 24F are the same as those of the eyeball needle guide 900 described above in FIG. 23, and these portions function in the same manner as those described above. It will be appreciated that other configurations of the press-fit type eyeball needle guide may include a needle guide channel and a contact surface that at least partially defines a landing zone of the aforementioned type configured to receive a needle for injecting a therapeutic agent into the eye 10. For example, the mirror press may include a needle guide channel and may be shaped to define a landing zone having an elongation direction that is substantially parallel to the needle guide channel.

[0075] FIGS. 25 and 26 show cross-sectional views of alternative embodiments of the eyeball needle guide 1000 according to aspects of the present disclosure. The portions of the alternative embodiments of the eyeball needle guide 1000 disclosed in FIGS. 25 and 26 are the same as those of the eyeball needle guides 100, 200, 300, 400, 500, 600, 700, and 900 described above in FIGS. 1 to 20, FIG. 23, and FIGS. 24A to 24F, and these portions function in the same manner as those described above. The eyeball needle guide 1000 includes a housing 1002 shaped to be positioned on the outer surface of the eye 10.

[0076] The housing 1002 has a contact surface 1004, a needle guide channel 1024, and an injection fluid channel 1028. The needle guide channel 1024 is substantially parallel to the extension direction of the landing zone partially defined by the contact surface 1004. The contact surface 1004 defines a cavity 1008 within the housing 1002. The cavity 1008 is sized to receive at least a portion of the eye 10 therein. The needle guide channel 1024 communicates with the cavity 1008. The needle guide channel 1024 is substantially parallel to the extension direction of the landing zone 1005 partially defined by the contact surface 1004. The injection fluid channel 1028 extends through the housing 1002 and communicates with the cavity 1008. The injection fluid channel 1028 has an opening defined by the contact surface 1004 radially between the needle guide channel 1024 and a portion of the contact surface 1004 that draws the sclera 14 away from the choroid 12. The injection fluid channel 1028 is sized to receive a drug injection device therein for injecting a drug into the eye 10.

[0077] When the eye needle guide 1000 is positioned over the eye 10, a first injection device 1050 can be inserted into the injection fluid channel 1028. A bleb 1052 can be created by injecting a drug 1048 into the eye 10 to deform the choroid 12 and push the surface of the eye 10 into the cavity 1008 of the body 1002. The sclera 14 can take the shape of the contact surface 1004 such that the sclera 14 is substantially parallel to the direction toward the needle guide channel 1024. The needle 20 can be inserted directly through the needle guide channel 1024 and through the bleb 1052 of the drug 1048 in the eye 10 and into the target space 1039 under the sclera 14 in an orientation substantially parallel to the extension direction of the landing zone. The needle guide channel 1024 can guide the entry of the needle into the suprachoroidal space. The needle 20 can include a needle stop 24 for controlling the insertion depth such that the needle 20 does not extend beyond the landing zone and / or does not pass through the target space 1039 and return into the sclera 14.

[0078] It will be understood that the foregoing description provides examples of the disclosed systems and methods. However, other implementations of the present disclosure are contemplated in which the details may differ from the foregoing examples. For example, any of the aspects disclosed herein may incorporate features disclosed with respect to any of the other aspects disclosed herein. References to the present disclosure or its embodiments are all intended to refer to the particular embodiments being discussed at that time and are not intended to suggest any limitation as to the broader scope of the present disclosure in general. All statements of distinction and negation with respect to specific features are intended to indicate a lack of preference for those features, but are not intended to exclude such from the scope of the present disclosure entirely, unless otherwise indicated.

[0079] As will be readily appreciated by those of ordinary skill in the art, machines, products, compositions of matter, means, methods, or steps that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein, whether currently existing or later developed, may be utilized in accordance with the present disclosure.

Claims

1. An eye needle guide configured to access the subchoroidal space under the choroid of the eye or the suprachoroidal space between the sclera of the eye and the choroid of the eye, the eye needle guide comprising: a housing having a contact surface and a needle guide surface; the contact surface defining a cavity within the housing, the contact surface extending at least partially along a contact plane; the needle guide surface extending around a needle axis to define a needle guide channel, the needle guide channel extending through the housing to an opening defined by the contact surface, whereby the needle guide channel communicates with the cavity through the opening, the needle axis being substantially parallel to the contact plane; the eye needle guide being positioned on the eye and configured to draw a portion of the sclera toward a surface portion of the contact surface.

2. The eye needle guide according to claim 1, wherein the housing further comprises a pressure surface defining a pressure channel extending through the housing to a second opening defined by the contact surface, whereby the pressure channel communicates with the cavity through the second opening.

3. The eye needle guide according to claim 2, wherein the pressure channel extends through the housing to a plurality of openings, the plurality of openings including the second opening and at least one other opening, the pressure channel communicating with the cavity through the plurality of openings.

4. The eye needle guide according to claim 2, wherein the contact surface has a first surface portion and a second surface portion, the second surface portion extending along the contact plane, the first surface portion being angularly offset from the contact plane such that the cavity is defined by the first surface portion and the second surface portion, a first opening being defined by the first surface portion, and the second opening being defined by the second surface portion.

5. The eye needle guide according to claim 4, wherein an angle between the first portion and the second portion is less than 90 degrees.

6. The eye needle guide according to claim 4, wherein the contact surface further has a third portion extending from the first portion, the third portion being curved such that the third portion approximates the curvature of the eye.

7. The contact surface extends between an end portion that is outermost in a first radial direction and an end portion that is outermost in a second radial direction, the cavity is positioned between the end portion that is outermost in the first radial direction and the end portion that is outermost in the second radial direction, the housing includes a first retaining element positioned adjacent to the end portion that is outermost in the first radial direction and a second retaining element positioned adjacent to the end portion that is outermost in the second radial direction, and when the surface of the eye contacts the contact surface, the first and second retaining elements provide a retaining force for retaining the sclera within the cavity. The eye needle guide according to claim 1.

8. The housing includes a first housing portion and a second housing portion, the first housing portion includes the first retaining element, the second housing portion includes the second surface portion of the contact surface and the second retaining element, the first housing portion is movable relative to the second housing portion such that the housing is movable between a retaining position and an open position, in the retaining position, a first retaining member is spaced apart from a second retaining member by a first distance, and in the open position, the first retaining member is spaced apart from the second retaining member by a second distance that is greater than the first distance. The eye needle guide according to claim 7.

9. The first housing portion is linearly movable relative to the second housing portion. The eye needle guide according to claim 8.

10. The housing includes a first housing portion and a second housing portion, the first housing portion includes the needle guide channel, and the second housing portion includes a portion of the contact surface that extends along the contact plane. The needle axis extends through the opening of the contact surface and faces the contact plane. The first housing portion is movable relative to the second housing portion such that the housing is movable between a first depth position and a second depth position, in the first depth position, the needle axis is spaced apart from the contact plane by a first depth distance, and in the second depth position, the needle axis is spaced apart from the contact plane by a second depth distance that is different from the first depth distance. The eye needle guide according to claim 1.

11. The contact surface has an outer peripheral edge extending around the contact surface, and the eye needle guide is coupled to the housing and further includes a gasket extending radially outward from the outer peripheral edge of the contact surface, the gasket including a flexible material, the eye needle guide according to claim 1. **Claim 12** The housing extends at least partially circumferentially around a housing axis, and the contact surface extends at least partially in a conical shape, the eye needle guide according to claim 1. **Claim 13** The housing includes a resilient ring, the eye needle guide according to claim 12. **Claim 14** The needle guide surface is a first needle guide surface, the needle guide channel is a first needle guide channel, the needle axis is a first needle axis, the opening is a first needle opening, the contact plane is a first contact plane, the contact surface extends at least partially along a second contact plane, the housing further includes a second needle guide surface extending around a second needle guide axis and defining a second needle guide channel, the second needle guide channel extending through the housing to the second needle opening such that the second needle guide channel communicates with the cavity through a second needle opening defined by the contact surface, the needle axis being substantially parallel to the second contact plane, the eye needle guide according to claim 12. **Claim 15** Positioned on the eye and configured to pull a portion of the sclera away from the choroid into the cavity and toward the surface portion of the contact surface, the eye needle guide according to claim 1. **Claim 16** A pharmaceutical kit, the eye needle guide according to claim 1, and a needle configured to be inserted along the needle axis through the needle guide channel, the pharmaceutical kit. **Claim 17** The distal tip of the needle is conical, the pharmaceutical kit according to 16. **Claim 18** The needle further includes a stop coupled to the needle, the needle being insertable into the cavity of the housing to a predetermined distance, the stop being positioned to substantially prevent the needle from extending into the cavity a distance greater than the predetermined distance, the kit according to claim 16. **Claim 19** An eye needle guide for access to a space under the sclera of an eye, the eye needle guide being A first contact surface and a needle guide surface that defines a needle guide channel extending around the needle axis and through the housing to an opening defined by the first contact surface. A first body portion having the needle guide surface. A second body portion having a second contact surface, wherein the second contact surface extends at least partially along a contact plane. The second body portion is provided. The first body portion is movable relative to the second body portion such that the eye needle guide is movable between an alignment position and an open position. In the alignment position, the first contact surface and the second contact surface define a cavity, the needle guide channel communicates with the cavity through the opening, the needle axis is substantially parallel to the contact plane, and in the open position, the needle axis is angularly offset from the contact plane. An eye needle guide.

20. The eye needle guide according to claim 19, wherein the first body portion is rotatably movable relative to the second body portion.

21. The first contact surface includes at least one first retaining element, the second contact surface includes at least one second retaining element, and when the eye needle guide is in the alignment position and the first and second contact surfaces are in contact with the eye, the at least one first retaining member and the at least one second retaining member provide a retaining force for retaining the sclera in the cavity. The eye needle guide according to claim 19.

22. The first contact surface and the second contact surface are shaped such that when the eye needle guide is in the alignment position and the eye needle guide is positioned on the eye, a portion of the sclera is positioned within the cavity and the surface of the eye contacts the first contact surface and the second contact surface. The eye needle guide according to claim 19.

23. A method of delivering a therapeutic agent to the eye, the method comprising: Positioning an eyeball needle guide over the eye, the eyeball needle guide comprising a housing having a contact surface and a needle guide surface, the contact surface defining a cavity within the housing, the contact surface extending at least partially along a contact plane, the needle guide surface extending around a needle axis to define a needle guide channel, the needle guide channel extending through the housing to an opening defined by the contact surface, whereby the needle guide channel communicates with the cavity through the opening, the needle axis being substantially parallel to the contact plane, Positioning the eyeball needle guide such that when the eyeball needle guide is positioned over the eye, a portion of the sclera of the eye is positioned within the cavity and the surface of the eye contacts the contact surface, Inserting a needle through the sclera and through the needle guide channel after positioning the eyeball needle guide over the eye. A method comprising: Claim 24 The housing further comprising a pressure surface defining a pressure channel extending through the housing to a second opening defined by the contact surface, the method further comprising: Providing the negative pressure to the pressure channel such that the negative pressure provides a holding force for holding the sclera within the cavity. The method according to claim 23, Claim 25 The housing including a first housing portion and a second housing portion, the first housing portion including the needle guide channel, the second housing portion including the contact surface extending along the contact plane, the first housing portion being movable relative to the second housing portion, the method further comprising: After positioning the eyeball needle guide over the eye, moving the housing from an open position to a holding position, in the holding position, the needle guide channel being spaced from the contact surface on the second housing portion by a first distance, in the open position, the needle guide channel being spaced from the contact surface of the second housing portion by a second distance greater than the first distance. The method according to claim 23, Claim 26 An eyeball needle guide for access to a space beneath the sclera of an eye, the eyeball needle guide comprising: A housing having a first contact surface and a post guide surface, wherein the first contact surface defines a cavity within the housing, and the post guide surface defines a post channel within the housing. A post at least partially positioned within the post channel, the post having a second contact surface and a needle guide surface, the needle guide surface extending around a needle axis through the post to define a needle guide channel, the needle guide channel having an opening defined by the second contact surface, the needle axis having a distal axis portion extending substantially linearly through the opening from a location within the required guide channel, the distal axis portion of the needle axis being substantially parallel to at least a portion of the first contact surface. An eye needle guide, wherein the post is movable within the post channel to define a first depth position within the cavity and a second depth position within the cavity, and at the first depth position, the distal axis portion of the needle axis is spaced from the substantially parallel portion of the first contact surface by a first depth distance, and at the second depth position, the distal axis portion of the needle axis is spaced from the substantially parallel portion of the first contact surface by a second depth distance different from the first depth distance.

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