Eye needle guide and method of facilitating access to eye

Abstract

An ophthalmic needle guide for entry into a space below a sclera of an eye includes 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 about 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 such that the needle guide channel leads to the cavity via 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 a surface of the eye contacts the contact surface and assumes the shape of the contact surface.

Description

Technical Field

[0001] The present disclosure relates generally to medical devices and related methods for delivering therapeutic agents, and more particularly to ocular guides and related methods for facilitating needle entry into the interior of an eye. Background Art

[0002] The eye is a complex organ with a variety of specialized tissues that provide optical and neurological processes for vision. The small size and delicate nature of the tissues hinder access to the eye for medical treatment. Due to the sunken position of the eye within the orbit, the posterior region of the eye (including the retina, macula, choroid and optic nerve) is particularly difficult to access. In addition, topical eye drops have difficulty penetrating into the posterior region, further limiting treatment options.

[0003] The suprachoroidal space and subchoroidal space are potential spaces in the eye for treatment options. The suprachoroidal space is located between the choroid (inner vascular membrane) and the sclera (outer layer of the eye). The subchoroidal space is located below the choroid and above the retina. The choroidal space extends from the front of the eye near the ciliary body to the back of the eye near the optic nerve. Usually, the suprachoroidal space is not obvious, because the choroid and sclera are closely juxtaposed due to the intraocular pressure of the eye. Since the choroid is essentially not attached to the sclera, when fluid accumulation or other conditions occur, the tissue separates to form the suprachoroidal space. The suprachoroidal space provides a potential path for entry 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 a great deal of skill and time. There are several methods for accessing this space to deliver therapeutic agents, but the complexity and time required hinder the widespread use of these methods. The challenge faced by any attempt to pierce the sclera with a needle in an attempt to enter a specific depth (and therefore a specific interlaminar space) is to provide enough force to penetrate the relatively tough scleral tissue without over-penetration. This challenge is magnified by the compliant nature of the eye, and there is no means to provide support to the opposite side of the tissue being penetrated.

[0005] The foregoing background discussion is intended only to assist the reader. It is not intended to limit the innovations described herein. Therefore, the foregoing discussion should not be taken to indicate that any particular element of a previous system is not suitable for use with the innovations described herein, nor is it intended to indicate that any element is essential in implementing the innovations described herein. Summary of the invention

[0006] One aspect of the present disclosure provides an ocular needle guide for accessing a space beneath the sclera of an eye. The ocular needle guide includes 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 about 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 such that the needle guide channel leads to the cavity via the opening. The needle axis is substantially parallel to the contact plane. The contact surface is shaped such that when the ocular needle guide is positioned on the eye, a portion of the sclera is positioned within the cavity and a surface of the eye contacts the contact surface.

[0007] Another aspect of the present disclosure provides a pharmaceutical kit comprising an ocular needle guide and a needle. The ocular 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 such that the needle guide channel leads to the cavity via the opening. The needle axis is substantially parallel to the contact plane. The contact surface is shaped such that when the ocular needle guide is positioned on the eye, a portion of the sclera is positioned within the cavity and a surface of the eye contacts the contact surface. The needle is configured to be inserted through the needle guide channel along the needle axis.

[0008] Another aspect of the present disclosure provides an ocular needle guide for accessing a space below the sclera of an eye. The ocular needle guide includes 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 so that the ocular needle guide can be switched 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 leads to the cavity via 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 for delivering a therapeutic agent to an eye using an ocular needle guide, the method comprising: positioning the ocular needle guide on the eye, the ocular needle guide comprising a shell having a contact surface and a needle guiding surface, the contact surface defining a cavity within the shell, the contact surface extending at least partially along a contact plane, the needle guiding surface extending around a needle axis to define a needle guiding channel, the needle guiding channel extending through the shell to an opening defined by the contact surface such that the needle guiding channel leads to the cavity via the opening, the needle axis being substantially parallel to the contact plane, wherein when the ocular needle guide is positioned on the eye, a portion of the sclera of the eye is positioned within the cavity and a surface of the eye contacts the contact surface; and after positioning the ocular needle guide on the eye, inserting a needle through the needle guiding channel through the sclera.

[0010] Another aspect of the present disclosure provides an ocular needle guide for accessing a space below the sclera of an eye. The ocular needle guide includes a housing and a column. The housing has a first contact surface and a column guide surface. The first contact surface defines a cavity within the housing, and the column guide surface defines a column channel within the housing. The column is at least partially positioned within the column channel. The column has a second contact surface and a needle guide surface. The needle guide surface extends through the column around a needle axis 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 position 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 column is movable within the column channel to define a first depth position within the cavity and a second depth position within the cavity. In the first depth position, the distal axis portion of the needle axis is spaced apart from a substantially parallel portion of the first contact surface by a first depth distance. In the second depth position, the distal axis portion of the needle axis is spaced apart from a substantially parallel portion of the first contact surface by a second depth distance different from the first depth distance.

[0011] This summary is provided in a simplified form to introduce some concepts that are further described in the detailed description section below. This summary is not intended to identify key 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 limited to limitations that solve any or all disadvantages described in any part of this disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The foregoing summary of the invention and the following detailed description of 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, illustrated in the accompanying drawings are exemplary embodiments of the present disclosure. However, it should be understood that the present application is not limited to the precise arrangements and instrumentalities shown. In the accompanying drawings:

[0013] Figure 1 Illustrated is a side view of an ocular needle guide positioned on an eye according to one aspect of the present disclosure.

[0014] Figure 2 Example along Figure 1 A cross-sectional view of the eye needle guide positioned on the eye in a first orientation is shown taken along line 2-2.

[0015] Figure 3 Example along Figure 1 A cross-sectional view of the eye needle guide positioned on the eye in a second orientation is shown taken along line 2-2.

[0016] Figure 4 Illustrated Figure 2 A close up view of the eye needle guide is shown.

[0017] Figure 5 Illustrated is a cross-sectional view of an ocular needle guide positioned on an eye in a first orientation according to another aspect of the present disclosure.

[0018] Figure 6 Illustrated is a second orientation positioned on the eye Figure 5 Cross-sectional view of an illustrated eye needle guide.

[0019] Figure 7 Illustrated Figure 5 A close up view of the eye needle guide is shown.

[0020] Figure 8 A cross-sectional view of an eye needle guide in a first orientation according to another aspect of the present disclosure is illustrated.

[0021] Fig. 9 The second orientation is illustrated Figure 8 Cross-sectional view of an illustrated eye needle guide.

[0022] Fig.10 Illustrated is a cross-sectional view of an ocular needle guide positioned on an eye according to another aspect of the present disclosure.

[0023] Fig.11 Illustrated Fig.10 A top perspective view of the eye needle guide is shown.

[0024] Fig.12 Illustrated Fig.10 Bottom view of the eye needle guide shown.

[0025] Fig.13 Illustrated is a cross-sectional view of an ocular needle guide positioned on an eye in a first orientation according to another aspect of the present disclosure.

[0026] Fig.14 The second orientation is illustrated Fig.13 Cross-sectional view of an illustrated eye needle guide.

[0027] Fig.15 Illustrated Fig.13 A top perspective view of the eye needle guide is shown.

[0028] Fig.16 Illustrated Fig.13 Bottom view of the eye needle guide shown.

[0029] Fig.17 Illustrated is a cross-sectional view of an ocular needle guide positioned on an eye according to another aspect of the present disclosure.

[0030] Fig.18 Illustrated is a cross-sectional view of an ocular needle guide positioned on an eye according to another aspect of the present disclosure.

[0031] Fig.19 Illustrated Fig.18 A top perspective view of the eye needle guide is shown.

[0032] Fig. 20 Illustrated Fig.18 Bottom view of the eye needle guide shown.

[0033] Fig.21 Illustrated is a cross-sectional view of an ocular needle guide positioned on an eye according to another aspect of the present disclosure.

[0034] Fig. 22 Illustrated Fig.21 A top perspective view of the eye needle guide is shown.

[0035] Fig.23 Illustrated is a cross-sectional view of an ocular needle guide positioned on an eye according to another aspect of the present disclosure.

[0036] FIG. 24A to FIG. 24F A top perspective view of an eye needle guide is illustrated according to other aspects of the present disclosure.

[0037] Fig.25 Illustrated is a cross-sectional view of an ocular needle guide positioned on an eye in a first orientation according to another aspect of the present disclosure.

[0038] Fig.26 The second orientation is illustrated Fig.25 Cross-sectional view of an illustrated eye needle guide. DETAILED DESCRIPTION

[0039] Certain terms used in this specification are for convenience only and are not limiting. The words "axial", "radial", "circumferential", "outward", "inward", "upper", "lower", "top" and "bottom" refer to directions in the referenced drawings. As used herein, when used to describe a size, shape, orientation, distance, spatial relationship or other parameter, the terms "substantially", "approximately" and their derivatives and words of similar meaning include the size, shape, orientation, distance, spatial relationship or other parameter, and may also include ranges of more than 10% and less than 10% of the parameter, including more than 5% and less than 5%, including more than 3% and less than 3%, including more than 1% and less than 1%. The terms "substantially", "approximately" and the like are intended to indicate that the specified is quite large or largely to a certain extent but not necessarily completely (but may be completely included). All ranges disclosed herein include the endpoints and can be independently combined (for example, the range of "2 grams to 10 grams" includes the endpoints 2 grams and 10 grams, and all intermediate values). The terms include the words listed above, their derivatives and words with similar meanings.

[0040] Figure 1 An eye needle guide 100 is illustrated positioned on an eye 10, and Figure 2 and Figure 3 Example along Figure 1 A cross-sectional view of an ocular needle guide 100 positioned on an eye 10, taken along line 2-2, is shown. The eye 10 has a spherical shape and layers with physical properties that present challenges when attempting to access spaces above or below, for example, the choroid 12 layer of the eye 10. The ocular needle guide described herein employs a shaped surface to temporarily reshape the eye 10 to align an underlying target space (e.g., the suprachoroidal space or the subchoroidal space) below the sclera 14 of the eye 10 with the needle 20.

[0041] 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 to enter the eye 10. The housing 102 may also be configured to be connected 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 the attachment of the eye needle guide 100 to the eye 10.

[0042] Figure 4 Illustrated Figure 2A close up view of the illustrated eye needle guide 100. The housing 102 has a contact surface 104 configured to face and contact an exposed portion of the eye 10, and an outer surface 105 opposite the contact surface 104 in an outward direction, which is also away from the eye 10. As will be described below, the contact surface is configured to contact the eye 10 so as to space the exposed portion of the sclera 14 from the choroid 12 to form a landing zone between the exposed portion and the choroid. The housing 102 also defines a needle guide channel 124 extending from the outer surface 105 to the contact surface 104, and is configured to guide the needle into the eye and into the landing zone along a direction substantially tangential to the surface of the exposed eye. The contact surface 104 has an outer peripheral edge 110 extending around the housing 102. The outer peripheral edge 110 can be curved and extend circumferentially around the housing 102. In one aspect, the peripheral edge 110 extends continuously around the housing 102. The contact surface 104 defines a cavity 108 located radially within the outer peripheral edge 110. The cavity 108 is sized to receive at least a portion of the eye 10 therein.

[0043] 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 that is 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 is in contact with the sclera. The second surface portion 114 may define an eye-deformed surface portion that is configured to define a seat for a deformed portion of the sclera 14 that has been displaced under the suction provided by the negative pressure source 22. In some examples, the sclera 14 may be displaced from the choroid 12 to define a suprachoroidal landing zone. In other examples, the choroid 12 may be displaced with the sclera 14 to define a subchoroidal landing zone. In one example, a first area or outer area of ​​the second surface portion 114 may contact the undeformed sclera 14, and a second area or inner area of ​​the second surface portion 114 may define a seat for a deformed portion of the sclera 14 (see Figure 5 ). The landing zone can be defined by a portion of the sclera 14 (alone or in combination with a portion of the choroid 12) that is deformed against the second region of the second surface portion 114. The first surface portion 112 can be referred to as a spacing surface portion that spaces the second surface portion 114 from the third surface portion in an outward direction, and therefore from the eye 10. The first surface portion 112 can also define an interior opening to the needle guide channel 124.

[0044] The second surface portion 114 can extend at least partially along a contact plane 120. The contact plane 120 defines a region extending into and out of the contact plane 120. Figure 4The second surface portion 114 can extend radially inward from the outer peripheral edge 110 toward 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 examples, the second surface portion 114 can be planar or curved as desired.

[0045] When the contact surface 104 is placed against the eye 10, the ocular needle guide 100 can define a landing zone for the needle 20. As used herein, the term "landing zone" can refer to a zone that is disposed between the choroid 12 and the deformed portion of the sclera 14 and is configured to receive the injection end of the needle 20 once the sclera 14 has been repositioned against the ocular needle guard 100. Thus, the landing zone can be defined in part by either or both of the outer peripheral edge 110 and the second surface portion 114. Specifically, either or both of the second surface portion 114 and the outer peripheral edge 110 at the second surface portion 114 can face the landing zone. More specifically, when the third surface portion 116 of the contact surface 104 is placed against the eye, the deformed portion of the sclera 14 abuts the second surface portion 114, while the undeformed portion of the sclera 14 remains against the third surface portion 116. Thus, the landing zone can have a thickness that extends between the first distance and the second distance. The first distance may be defined as from the second surface portion 114 to the choroid-facing surface of the deformed sclera 14. The second distance may be defined as from the second surface portion 114 to the sclera 14. Thus, in one example, the landing zone may be suprachoroidal. In other examples, the landing zone may be defined below the choroid 12 and may be referred to as subchoroidal. The subchoroidal landing zone may provide a subchoroidal passage for the needle. The landing zone may have a length extending along at least a portion of the circumferential length of the second surface portion 114, which extends from the first surface portion 112 to the outer peripheral edge 110 along the second surface portion 114. In one example, the length of the landing zone may extend between the second surface portion 114 and the outer peripheral edge 110. For example, the length of the landing zone may extend from the second surface portion 114 toward the outer peripheral edge 110 and may terminate inside the outer peripheral edge 110. In some examples, the length of the landing zone may extend from the second surface portion 114 to the outer peripheral edge 110.

[0046] The first surface portion 112 is offset at an angle from the second surface portion 114 so that the cavity 108 is defined by the first surface portion 112 and the second surface portion 114. The first surface portion 112 can be curved or straight as required. In one aspect, the first surface portion 112 can define an angle with the needle axis 122, as described below. The angle can be in the range of from about 30 degrees to about 90 degrees, such as from about 45 degrees to about 90 degrees, such as from about 60 degrees to about 90 degrees, such as from about 70 degrees to about 90 degrees, such as about 80 degrees to about 90 degrees. The angle can be defined by a straight line and the needle axis 122. In some examples where the first surface 112 is a flat surface, the straight line can extend along the first surface portion 112. In other examples, for example, when the first surface 112 is curved, the straight line can 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.

[0047] The third surface portion 116 extends from the first surface portion 112 to the outer peripheral edge 110. The third surface portion 116 can be curved so that the third surface portion 116 approximates the curvature of the eye 10. The curvature of the third surface portion 116 can facilitate positioning the housing 102 on the eye 10. In one example, the housing 102 can be positioned on the eye 10 so that the eye extends along the third surface portion 116. The first surface portion 112 can define a support surface that extends outward from the third surface portion 116 to the second surface portion 114. Thus, the needle can enter the landing zone along a trajectory that is tangential to the eye or a trajectory that is angularly offset from a direction tangential to the eye. Thus, when the third surface portion 116 contacts the eye, at least an inner portion of the second surface portion 114 can be spaced apart from the eye 10. In this regard, the first surface portion 112 can be said to space the second surface portion 114 apart from the third surface portion 116, and thereby spaced apart from the eye during use, so as to define the above-mentioned landing zone. During use, the shape of the eye 10 can be reshaped by abutting a portion of the sclera 14 against the second surface portion 114 to define the above-mentioned landing zone. It should be understood that when the shape of the eye 10 is reshaped, the portion of the sclera 14 abutting the second surface portion 112 takes on the shape of the second surface portion 112. Another portion of the sclera 14 can extend along the third surface portion 116. Still another portion of the sclera 14 can extend along the first surface portion 112 so as to define the landing of the landing zone. Still another portion of the sclera 14 can define the landing of the landing zone when the needle 20 is driven to a position between the choroid 12 and the sclera 14, which receives the needle. It should be understood that all embodiments of the eye needle guide described herein can be configured to reposition at least a portion of the sclera 14 by moving at least a portion of the sclera 14 away from the choroid 12 against the surface, thereby repositioning the sclera 14 and thereby repositioning the eye 10. Specifically, the portion of the sclera 14 can extend along at least a portion of the surface and thereby can define the shape of the surface. Thus, the needle 20 may be inserted between the portion of the choroid 12 and the sclera 14 in the landing zone.

[0048] It should be understood that the third surface portion 116 can 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 can define a contact surface 104 that contacts the eye 10, and the second surface portion 114 extends a distance from the first surface portion 112 that is outwardly away from the contact surface 104 and thereby spaced away from the eye during use. As described above, the shape of the eye 10 can be reshaped by abutting a portion of the sclera 14 against the second surface portion 112 to define the above-mentioned landing zone. It should be understood that when the shape of the eye 10 is reshaped, the portion of the sclera 14 abutting the second surface portion 112 takes on the shape of the second surface portion 112.

[0049] The housing 102 defines a needle guide surface 106 extending around a needle axis 122 to define 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 leads to the cavity 108 of the housing 102. In one aspect, the first surface portion 112 of the contact surface 104 defines the opening 126. The needle guide axis 122 can extend substantially parallel to the contact plane 120 at a location adjacent to the contact plane, and can 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 example, the needle guide axis 122 can be parallel to the contact plane 120, or can be slightly angularly offset from the contact plane 120 but still substantially parallel to the contact plane 120, so that the needle 20 can be easily inserted through the sclera 14 and into the landing zone without penetrating the choroid 12. As used herein, the term substantially parallel may include an angle of less than about twenty degrees, such as less than about ten degrees, such as less than about five 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 penetration depth of the needle 20 into the eye 10.

[0050] In one aspect, the needle axis 122 is substantially linear, such that the needle guide channel 124 extends linearly through the housing 102. Alternatively, the needle axis 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 external opening 228 defined by an outer surface 230 of the housing 102. The needle axis 122 may include a curved portion and a straight portion. The curved portion extends from the external opening 128 to the straight portion, and the straight portion extends from the curved portion to the opening 126. The straight portion of the axis 122 may extend along the contact plane 120. The curved needle axis 122 may facilitate alignment of a flexible needle (e.g., a nitinol needle) inserted through the needle guide channel 124 with the landing zone, such that the flexible needle is substantially parallel to the elongation direction of the landing zone.

[0051] The housing 102 may also include a pressure surface 232 that defines a pressure channel 234 that extends from the outer surface 230 through the housing 102 to a pressure opening 236 (e.g., a second opening) defined by the contact surface 104. The pressure opening 236 leads to the cavity 108, thereby fluidly connecting the exterior of the housing 102 to the cavity 108. In one aspect, the pressure opening 236 is defined by the second surface portion 114 of the contact surface 104. The size and configuration of the pressure channel 234 can be designed to receive a pressure tube therein. In one aspect, the pressure channel 234 can include a threaded area to be threadedly connected to the pressure conduit 103. Alternatively, the pressure conduit 103 can be connected to the housing 102 via an adhesive, glue, interference fit, snap fit, or some other fastener or connection device so as to fluidly connect the negative pressure source 22 to the pressure channel 234.

[0052] refer to Figure 2 and Figure 4 , the pressure conduit is connected to the housing 102 such that the negative pressure source 22 is fluidly connected to the pressure channel 234. During an eye treatment procedure, the ocular needle guide 100 can be positioned on the eye 10 by a medical professional. The location of the ocular needle guide 100 can be selected based on the desired treatment location on the eye 10. After the ocular needle guide 100 is placed, negative pressure can be applied to the cavity 108 by the negative pressure source 22. The negative pressure can pull the sclera 14 into the cavity 108. When the sclera 14 is pulled into the cavity 108, the outer surface of the eye 10 contacts the contact surface 104 of the housing 102, assuming an approximate shape of the contact surface 104. The contact surface 104 defines a specific contour to deform 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 so that the flattened portion of the sclera 14 is substantially parallel to the needle axis 122.

[0053] It should be understood that the eye needle guide 100 may also include a handle (not shown). The handle may extend from the body 102 and be manipulated by the user to adjust and position the body 102 on the eye 10. The handle may be detachable from the body 102 so that when the body 102 is positioned on the eye 10, the handle may be removed prior to a treatment procedure. Alternatively, the handle may be fixed to the body 102 to help maintain the position of the body 102 on the eye 10 during the procedure.

[0054] refer to Figure 3 and Figure 4Once the eye 10 is in contact with the contact surface 104 of the ocular needle guide 100 and the sclera is positioned within the cavity 108, the needle 20 can be inserted through the needle guide channel 124 in the housing 102 and directly into the landing zone. The shaped surface of the second surface portion 114 and the configuration of the needle guide channel 124 can make the depth of needle penetration less critical than conventional needle entry. The needle 20 can include a needle stop 24 to control the insertion depth so that the needle 20 does not extend beyond the landing zone and therefore does not penetrate the choroid 12.

[0055] Needle axis 122 may be offset from contact plane 120 by a distance that substantially matches the thickness of sclera 14 for a suprachoroidal pathway, or matches the thickness of sclera 14 and choroid 12 for a subchoroidal pathway. It should be appreciated that other distances for offsetting needle 20 may also be used to access other locations within the eye.

[0056] In one aspect, the needle 20 may benefit from a fast firing mechanism, such as that used for a biopsy needle. The fast action may alleviate the challenge of penetrating the tough sclera without losing the attachment of the eye needle guide 100 to the eye 10. The biopsy type firing mechanism may also provide a predictable penetration depth.

[0057] The needle 20 may have a conical or trocar-type symmetrically shaped needle tip, which may facilitate alignment of the needle 20 within the eye 10 as the needle 20 is advanced. The needle 20 may include a side hole for injection. In one aspect, once the needle 20 has entered the target location, a sheath or catheter (not shown) may be quickly left in place and the negative pressure may be removed from the cavity 108. This may provide access to the interlaminar space for further blunt dissection and / or delivery of a therapeutic agent.

[0058] A relatively quick procedure for delivering a therapeutic agent to the inner space of the eye 10 using the above-described method may involve placing the ocular needle guide 100 at a desired location in 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 ocular needle guide 100 from the eye 10. In one aspect, the "delivering agent" step may be replaced with a catheter insertion step to leave an access channel for additional delivery to or guidance of the target space.

[0059] Figures 5 to 7 A cross-sectional view illustrating an alternative aspect of an eye needle guide 200 in accordance with aspects of the present disclosure. Figures 5 to 7 The various portions of the alternative aspects of the eye needle guide 200 disclosed in Figures 1 to 4The eye needle guide 200 includes aspects of the eye needle guide 100 described in , and the functions of these parts are similar to 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 to enter the eye 10.

[0060] The housing 202 has a contact surface 204 and 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.

[0061] The shell 202 includes a first shell portion 209 and a second shell portion 211. The contact surface 204 of the first shell portion 209 includes a first surface portion 212 and a third surface portion 216. The contact surface 204 of the second shell portion 211 includes a second surface portion 214. The second surface portion 214 extends at least partially along the contact plane 220. The contact surface 204 can define a landing area as described above. The third surface portion 216 can be referred to as a base surface portion, which is 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 can be referred to as an eye deformation surface portion, which is configured to define a seat for a deformed portion of the sclera 14 that has been separated from the choroid 12 under the suction provided by the negative pressure source 22. In this regard, the second surface portion 214 can be offset from the third surface portion 216 in an outward direction. The first surface portion 212 may extend in an outward direction from the third surface portion 216 so as to define an interior opening to the needle guide channel 224 that extends from the outer surface 205 to the first surface portion 212 .

[0062] The housing 202 defines a needle guide surface 206 extending about a needle axis 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 opens into the cavity 208 of the housing 202. The needle guide axis 222 is substantially parallel to the contact plane 220. Alignment of the needle guide axis 222 with the contact plane 220 facilitates alignment of the needle 20 with the landing zone.

[0063] The housing 202 may also include a first retaining member 217 and a second retaining member 219. The first retaining member 217 may be positioned on the first housing portion 209. The second retaining member 219 may be positioned on the second housing portion 211. The first retaining member 217 and the second retaining member 219 may include, for example, opposing barbs, serrations, edges, protrusions, teeth, combinations thereof, or other members extending from the contact surface 204 and capable of gripping the surface of the eye 10. It should be understood that the first retaining member 217 and the second retaining member 219 may be formed as part of the respective first housing portion 209 and the second housing portion 211. Alternatively, the first retaining member 217 and the second retaining member 219 may be separately attached to the contact surface 204 of the respective first housing portion 209 and the second housing portion 211. The first retaining member 217 and the second retaining member 219 may each include a single respective retaining member. Alternatively, the first retaining member 217 and the second retaining member 219 may each include a plurality of retaining members. When the eye needle guide 100 is positioned on the eye 10 , the first retaining member 217 and the second retaining member 219 may stabilize and hold the eye 10 against movement between the eye 10 and the eye needle guide 100 .

[0064] refer to Figure 5 and Figure 6 , the first housing portion 209 is movable relative to the second housing portion 211, so that the housing 202 can be in the holding position ( Figure 6 ) and the open position ( Figure 5 ). In the holding position, the first housing portion 209 and the second housing portion 211 are spaced apart by a first distance D1. In the open position, the first housing portion 209 and the second housing portion 211 are spaced apart by a second distance D2, which is greater than the first distance D1. In one aspect, the needle guide channel 224 is spaced apart by a first distance from the second surface portion 214 of the contact surface in the holding position. In the open position, the needle guide channel 224 is spaced apart by a second distance from the second surface portion 214 of the contact surface that is greater than the first position. In one aspect, the first housing portion 209 and the second housing portion 211 may contact 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.

[0065] In one example, the first housing portion 209 and the second housing portion 211 can be linearly movable relative to each other between the holding position and the open position. Specifically, 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. Therefore, either or both of the first housing portion 209 and the second housing portion 211 can selectively slide toward and away from the other of the first housing portion 209 and the second housing portion 211 along the guide member 203. The guide member 203 can extend along a central axis, which can be straight or curved as desired. Either or both of the first housing portion 209 and the second housing portion 211 can travel along the central axis of the guide member 203 between the holding position and the open position. Therefore, either or both of the first housing portion 209 and the second housing portion 211 can travel along a straight path or a curved path along the central axis of the guide member 203 between the holding position and the open position. The guide member 203 can be configured as a guide rod having a cross-section of any suitable shape as desired.

[0066] When the eye needle guide 200 is in the open position, the eye needle guide 200 may 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 may be converted from the open position to the retaining position, which may pull the sclera 14 into the cavity 208 of the housing 204 and against the second surface portion 214. For example, when the eye needle guide 200 is positioned on the eye 10, the first retaining member 217 and the second retaining member 219 may engage the sclera 14. When the distance between the first housing portion 209 and the second housing portion 211 is converted from the second distance D2 to the first distance D1, the first retaining member 217 and the second retaining member 219 may pull the sclera 14 into the cavity 208, so that the surface of the eye 10 or the sclera 14 contacts the contact surface 204 and assumes the shape of the second surface portion 214. The portion of the outer surface of the eye 10 that contacts the second portion 214 may 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 so that the flattened portion of the sclera 14 is substantially parallel to the needle axis 222. This can reshape the tissue of the eye 10 by pulling the sclera into the cavity 208 to assume the shape of the second surface portion 214 for shallow angle injection. The needle 20 can be inserted through the needle guide channel 224 in the housing 202 and directly into the target space below the sclera 14 in a manner substantially similar to that described above with respect to the ocular needle guide 100.

[0067] Figure 8 and Fig. 9 A cross-sectional view illustrating an alternative aspect of an eye needle guide 300 in accordance with aspects of the present disclosure. Figure 8 and Fig. 9 The portions of the alternative aspects of the eye needle guide 300 disclosed in Figures 1 to 7 1 and 2, and the functions of these parts are similar to 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 to enter the eye 10. The housing 302 has a contact surface 304 and an outer surface opposite the contact surface in an outward direction, and a needle guide surface 306 that defines a needle guide channel 324 in the manner 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.

[0068] 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 may be referred to as a base surface portion, which is 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 may be referred to as an eye-deformed surface portion, which is configured to define a seat for a deformed portion of the sclera 14 that has been separated from the choroid 12 under the suction provided by the negative pressure source 22. In this regard, the second surface portion 314 may be offset from the first surface portion 312 in an outward direction. The first surface portion 312 may extend in an outward direction from the third surface portion 316 so as to define an inner opening to the needle guide channel 324, which extends from the outer surface 305 to the first surface portion 312. The second surface portion 314 extends at least partially along the contact plane 320. The contact surface 304, and in particular the second surface portion 314, may define a landing zone as described above.

[0069] The first housing portion 309 is movable relative to the second housing portion 311 so that the housing 302 can be in a holding position ( Fig. 9 ) and the open position ( Figure 8) between the retaining position and the open position. In one aspect, the first housing portion 309 can be selectively rotationally moved toward and away from each other about the pivot member 313 between the retaining position and the open position relative to the second housing portion 311. The second surface portion 314 and the third surface portion 316 are spaced farther from each other in the open position than in the retaining position. The pivot member 313 may include, for example, a pin, a rod, a ball, or other members that can facilitate rotation between the components. In the open position, the needle guide axis 322 defining the needle guide channel 324 is angularly offset from the contact plane 320. In the retaining position, the needle guide axis 322 may be substantially parallel to the contact plane 320.

[0070] When the eye needle guide 300 is in the open position, the eye needle guide 300 can be positioned on the eye 10 so 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 transitioned from the open position to the holding position, which can pull the sclera 14 into the cavity 308 of the housing 304. For example, when the housing 304 is transitioned to the holding position, the first retaining member 317 and the second retaining member 319 can engage the sclera 14 and can pull the sclera 14 into the cavity 308. The force applied by the first retaining member 317 and the second retaining member 319 can cause the sclera 14 of the eye 10 to contact the contact surface 304 so as to 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 may be inserted through the needle guide channel 324 in the housing 302 and directly into the target space beneath the sclera 14 in a manner substantially similar to that described above with respect to the ocular needle guide 100 .

[0071] It should be understood that the eye needle guides 200 and 300 may also include other retaining components or additional retaining components. For example, the eye needle guides 200 and 300 may include a vacuum (eg, negative pressure source 22) to maintain contact between the eye needle guides 200 and 300 and the eye 10.

[0072] Figures 10 to 12 A cross-sectional view, a perspective view, and a bottom plan view, respectively, illustrate alternative aspects of an eye needle guide 400 in accordance with aspects of the present disclosure. Figures 10 to 12 The portions of the alternative aspects of the eye needle guide 400 disclosed in Figures 1 to 9 The eye needle guide 400 includes aspects of the eye needle guides 100, 200, and 300 described in detail above, and the functions of these parts are similar 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 to enter the eye 10.

[0073] The housing 402 has a contact surface 404 and an outer surface 405 opposite to the contact surface in an outward direction. The housing 402 further defines a needle guide channel 424 extending from the outer surface 405 to the contact surface 405 in the manner described above. The contact surface 404 may also 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, which is 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, which is configured to define a seat for a deformed portion of the sclera 14 that has been separated from the choroid 12 under the suction provided by the negative pressure source 22. In this regard, the second surface portion 414 may be offset from the first surface portion 412 in an outward direction. The first surface portion 412 may extend from the third surface portion 416 to the second surface portion 14 in an outward direction. The needle guard channel 424 can extend from the outer surface 405 to the first surface portion 412 such that the interior opening of the needle guide channel 424 is disposed at 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, which in turn defines a needle guide channel 424 leading to the cavity 408. The needle guide channel 424 extends about a needle guide axis 422. The needle guide axis 422 is substantially parallel to the elongated direction of a landing zone, which can be defined by the contact surface 404 in the manner described above.

[0074] The housing 402 may also include a plurality of pressure channels 434 extending through the housing 402 from the outer surface 405 to the contact surface 404, and specifically 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 lead to the cavity 408 of the housing 402. The pressure openings 436 may be spaced around the contact surface 404. In one aspect, each of the plurality of pressure openings 436 may be spaced approximately equidistant from each of the other pressure openings 436, or may be variably spaced as desired.

[0075] The eye needle guide 400 may further include a gasket 437 extending 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 help form a seal between the housing 402 and the eye 10 when suction is applied to the cavity 408. In this regard, the gasket 437 may define both of the third surface portion 416. The gasket 437 may also define a first surface portion 412 extending from the third surface portion 416 to the second surface portion 414.

[0076] When the ocular needle guide 400 is positioned on the eye 10, the undeformed portion of the sclera 14 can contact the third contact surface 416. The negative pressure source 22 can define a suction force in the cavity 408. Specifically, the negative pressure source 22 can cause a negative pressure in the cavity 408, which in turn creates a suction force that pulls a portion of the sclera 14 from the choroid 12 into the cavity 408 and into contact with the contact surface 404, specifically the second surface portion 414. The portion of the sclera 14 that contacts the second surface portion 414 can take on the shape of the second surface portion 414 and thereby define a deformed portion of the sclera 14. The deformed portion of the sclera 14 can thereby 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 in the housing 402, through the sclera 14, and into the target space 439, which 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 needle into the suprachoroidal space. The needle 20 can include a needle stop 24 to control the insertion depth so that the needle 20 does not extend beyond the landing zone and / or through the target space 439 and back into the sclera 14.

[0077] Figures 13 to 16 A cross-sectional view illustrating an alternative aspect of an eye needle guide 500 in accordance with aspects of the present disclosure. Figures 13 to 16 The portions of the alternative aspects of the eye needle guide 500 disclosed in Figures 1 to 12 The eye needle guide 500 includes aspects of the eye needle guides 100, 200, 300, and 400 described in the foregoing, and the functions of these parts are similar to those described above. The eye needle guide 500 includes a housing 502 and a post 503 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 to enter the eye 10.

[0078] 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 toward an outer peripheral edge 510 of the housing 502. The first contact surface 504 may extend continuously around the housing 502, defining a 360 degree conical shape. In an alternative aspect, the first contact surface 504 defines at least a partial conical shape. The partial conical shape defines a conical shape that is less than 360 degrees. The shape of the first contact surface 504 facilitates positioning the eye needle guide 500 on the eye 10 and aligning the needle 20 with the first contact surface 504.

[0079] The post guide surface 505 defines a post passage 508 within the housing 502. The post passage 509 is sized to receive at least a portion of the post 503 therein. The post passage 509 extends through the housing 502 to the opening defined by the first contact surface 504 such that the post passage 509 opens into the cavity 508.

[0080] The housing 502 may also include a plurality of pressure passages 534 extending 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.

[0081] The post 503 is at least partially positioned 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 through the post 503 around the needle axis 522 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 position within the needle 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.

[0082] 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 causes the post 503 to linearly translate 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 to a position within the post channel 509 such that the post 503 extends through the opening of the post channel 509 in 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, thereby defining a 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. In the first depth position, the distal axis portion 523 of the needle axis 522 is spaced apart from the substantially parallel portion of the first contact surface 504 by a first depth distance. The first depth distance can define a target depth within the eye 10. For example, the first depth distance can define the approximate thickness of the sclera 14 of a particular eye 10, so 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 column 503 can be adjusted to different depth distances to accommodate various eye 10 sizes and structures, and can be adjusted to modify the injection depth. For example, the column 503 can be translated within the cavity 508 to a second depth position that is different from the first depth distance. The second depth position can define another target depth within the eye 10, for example, a subchoroidal position, or the second depth position can define a target depth for an eye having a size and / or structure different from the eye 10.

[0083] When post 503 is positioned within lumen 508, distal axis portion 523 of needle axis 522 is spaced a depth distance from the substantially parallel portion of first contact surface 504. As described above, the depth distance can be adjusted by moving the position of second contact surface 509 of post 503 within lumen 508.

[0084] Post 503 may also include a direction indicator 540 positioned on the proximal end of the post. Direction indicator 540 may provide an indication to the user regarding the direction in which needle guide passage 524 opens into cavity 508. Direction indicator 540 may include, for example, a particular shape of the end of the post (e.g., a cam shape), a direction indication (e.g., an arrow), a combination thereof, or some other indicator indicating the direction in which needle guide passage 524 opens.

[0085] When the ocular needle guide 500 is positioned over the eye 10, suction can be applied by the negative pressure source 22 to the pressure channel 534 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 be moved from the retracted position ( Fig.13) moves to the expanded 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 inserted through the needle guide channel 524 in the post 503 and directly into the target space 539 within the eye 10 in an orientation substantially parallel to the first contact surface 504. The needle 20 may include a needle stop 24 to control the insertion depth so that the needle 20 does not extend beyond the landing zone and / or through the target space 439 and back into the sclera 14.

[0086] Fig.17 A cross-sectional view illustrating an alternative aspect of an eye needle guide 600 according to one aspect of the present disclosure. Fig.17 The various parts of the alternative aspects of the eye needle guide 600 disclosed in Figures 1 to 16 The eye needle guide 600 is similar to the aspects of the eye needle guides 100, 200, 300, 400 and 500 described in the previous description, and the functions of these parts are similar to those described above. The eye needle guide 600 includes a housing 602 and a pressure column 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 to enter the eye 10.

[0087] 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 column 603 can be positioned within a pressure channel 608 defined by the housing 602. The pressure channel 608 leads to the contact surface 604. When the eye 10 engages the contact surface 604, the pressure column 603 can translate within the pressure channel 608 to affect the pressure applied to the eye 10. For example, when the contact surface 604 engages the eye 10 and the pressure column 603 moves in a proximal direction away from the eye 10, a negative pressure (e.g., a vacuum) is generated within the pressure channel 608 against the surface of the eye 10. During the treatment protocol, the negative pressure can maintain the engagement between the eye 10 and the housing 602. The negative pressure also helps to achieve deformation of the eye 10, thereby creating a target space 639 (e.g., a suprachoroidal space) within the eye 10 to release the therapeutic agent. To release the housing 602 from the eye 10, the pressure post 603 can be translated in a distal direction 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.

[0088] Figures 18 to 20 A cross-sectional view illustrating an alternative aspect of an eye needle guide 700 in accordance with aspects of the present disclosure. Figures 18 to 20 The various portions of the alternative aspects of the eye needle guide 700 disclosed in Figures 1 to 17The eye needle guide 700 includes aspects of the eye needle guides 100, 200, 300, 400, 500 and 600 described in the foregoing, and the functions of these parts are similar to 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 to enter the eye 10.

[0089] 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 pass through a plurality of openings 726 into the cavity 708. Each needle guide channel 724 extends around a needle guide axis that is substantially parallel to the elongated direction of the landing zone. For example, the contact surface 704 may extend circumferentially around a 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 an anterior-posterior direction. In addition, the contact surface 704 may define a substantially frustoconical shape that tapers radially outwardly from a position adjacent to the needle guide surface 706 to an outer peripheral edge 710 of the housing 702. In other examples, the contact surface 704 can define any suitable shape other than a frustoconical shape that is configured to reshape the eye 10 by repositioning the sclera 14, specifically repositioning it at a location proximate to the peripheral edge 710, so as to define an area through which the needle will be inserted into the landing zone. Each needle guide channel 724 can extend toward the cavity 708 in a direction substantially parallel to a portion of the contact surface 704 proximate to the corresponding opening 726 of the needle guide channel 724. Each needle guide channel 724 can extend in a direction offset from each of the other needle guide channels 724 while still being substantially parallel to the portion of the contact surface 704 proximate to the corresponding opening 726. In one aspect, each needle guide channel 724 can be equally spaced around the circumference of the housing 704. It should be understood that the housing 704 can include a single needle guide channel 724. In one aspect, the housing 702 includes a laser vision correction surgical ring.

[0090] The housing 702 may also include at least one pressure channel 734 extending 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.

[0091] When the ocular needle guide 700 is positioned on the eye 10, suction can be applied by the negative pressure source 22 to pull the sclera 12 into the cavity 708 and into contact with the contact surface 704. The sclera 14 can assume the shape of the contact surface 704 so 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 through one of the needle guide channels 724 in the housing 702 and directly into the target space 739 below the sclera 14 in an orientation substantially parallel to the contact surface 704. The needle guide channel 724 can guide the needle into the suprachoroidal space. The needle 20 can include a needle stop 24 to control the insertion depth so that the needle 20 does not extend beyond the contact surface 704 and / or through the target space 739 and back into the sclera 14.

[0092] Fig.21 and Fig. 22 A cross-sectional view illustrating an alternative aspect of an eye needle guide 800 in accordance with aspects of the present disclosure. Fig.21 and Fig. 22 The various portions of the alternative aspects of the eye needle guide 800 disclosed in Figures 1 to 19 The eye needle guide 800 is similar to the aspects of the eye needle guides 100, 200, 300, 400, 500, 600 and 700 described in the foregoing, and the functions of these parts are similar to those 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 to define, for example, 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.

[0093] Each of the first handle 802 and the second handle 803 includes a respective first contact surface 804 and a second contact surface 805. The first contact surface 804 and the second contact surface 805 are shaped to be positioned on an outer surface of the eye 10. The first contact surface 804 and the second contact surface 805 may each include at least one retaining member 817. The retaining member 817 is configured to maintain 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 repelling members 817.

[0094] The second handle 803 defines a needle guide channel that extends through the second handle 803 to the opening defined by the second contact surface 805. The needle guide channel 824 is sized to receive the needle 20 therethrough and into the eye 10.

[0095] The eye needle guide 800 is convertible 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 that is sized to receive a portion of the sclera 14 therein.

[0096] When the eye needle guide 800 is in the open position, the eye needle guide 800 can be positioned on the eye 10 so 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 converted from the open position to the holding position, which can cause the holding member 817 to pull the sclera 14 into the cavity 808. The force applied by the holding member 817 can cause the surface of the eye 10 to assume 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 through the needle guide channel 824 and directly into the target space 839 below the sclera 14 in a manner substantially similar to that described above with respect to the eye needle guide 100.

[0097] Fig.23 A cross-sectional view illustrating an alternative aspect of an eye needle guide 900 in accordance with aspects of the present disclosure. Fig.23 The various portions of the alternative aspects of the eye needle guide 900 disclosed in Figures 1 to 21 10. The eye needle guide 900 may include aspects of the eye needle guides 100, 200, 300, 400, 500, 600, and 700 described in detail above, and the functions of these parts are similar to 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 to enter the eye 10. The eye needle guide 900 may include a handle 907 that may extend from the body 902. The handle 907 is manipulated by a user to adjust the body 102 and position the body on the eye 10.

[0098] The housing 902 has a contact surface 904 and a needle guide channel 924 that opens 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.

[0099] When the ocular needle guide 900 is positioned on the eye 10, the user can apply a force F in a direction toward the eye 10. The applied force F can force the sclera 12 into the cavity 908 and assume the shape of the contact surface 904. The shape of the sclera 14 in contact with the contact surface 904 is substantially parallel to the needle guide channel 924. The needle 20 can be inserted through the needle guide channel 924 and directly into the target space 939 below the sclera 14 in an orientation substantially parallel to the contact surface 904. The needle guide channel 924 can guide the needle 20 into the suprachoroidal space.

[0100] Eyed needle guide 900 may be referred to as a "press fit" eyed needle guide. FIG. 24A to FIG. 24F Alternative aspects of press fit eyed needle guides 900 ′, 900 ″, 900 ″′, 900 ″″, 900 ″″′, and 900 ″″″ are illustrated. FIG. 24A to FIG. 24F The various parts of the alternative aspects of the eye needle guide disclosed in Fig.23 1 and 10. The eye needle guide 900 of FIG. 1 may be configured to include aspects of the eye needle guide 900 described in detail above, and the functions of these parts are similar to those described above. It should be understood that other configurations of press-fit eye needle guides may include a needle guide channel and a contact surface that at least partially defines a landing zone of the type described above that is configured to receive a needle for injecting a therapeutic agent into the eye 10. For example, a speculum press may include a needle guide channel and may be shaped to define a landing zone having an elongated direction substantially parallel to the needle guide channel.

[0101] Fig.25 and Fig.26 Cross-sectional views illustrating alternative aspects of an eye needle guide 1000 in accordance with aspects of the present disclosure. Fig.25 and Fig.26 The various portions of the alternative aspects of the eye needle guide 1000 disclosed in Figures 1 to 20 , Fig.23 as well as FIG. 24A to FIG. 24F Aspects of the eye needle guides 100, 200, 300, 400, 500, 600, 700 and 900 described in , and the functions of these parts are similar to those described above. The eye needle guide 1000 includes a housing 1002 shaped to be positioned on the outer surface of the eye 10.

[0102] 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 elongated 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 opens into the cavity 1008. The needle guide channel 1024 is substantially parallel to the elongated direction of the landing zone 1005 partially defined by the contact surface 1004. The injection fluid channel 1028 extends through the housing 1002 and opens into the cavity 1008. The injection fluid channel 1028 has an opening defined by the contact surface 1004, the opening being radially located between the needle guide channel 1024 and a portion of the contact surface 1004 that pulls the sclera 14 away from the choroid 12. The injection fluid channel 1028 is sized to receive a medication injection device therein to inject medication into the eye 10 .

[0103] When the ocular needle guide 1000 is positioned on the eye 10, the first injection device 1050 can be inserted into the injection fluid channel 1028. The medicament 1048 can be injected into the eye 10 to create a bubble 1052 that deforms the choroid 12, thereby pushing the surface of the eye 10 into the cavity 1008 of the body 1002. The sclera 14 can assume the shape of the contact surface 1004 so that the sclera 14 is substantially parallel to the direction of the needle guide channel 1024. The needle 20 can be inserted through the needle guide channel 1024 and through the bubble 1052 of the medicament 1048 in the eye 10, and directly into the target space 1039 below the sclera 14 with an orientation substantially parallel to the elongation direction of the landing zone. The needle guide channel 1024 can guide the needle into the suprachoroidal space. The needle 20 can include a needle stop 24 to control the insertion depth so that the needle 20 does not extend beyond the landing zone and / or through the target space 1039 and back into the sclera 14.

[0104] It should be understood that the above description provides some examples of the disclosed systems and methods. However, it is contemplated that other embodiments of the present disclosure may differ in detail from the above examples. For example, any of the aspects disclosed herein may be combined with features disclosed with respect to any of the other aspects disclosed herein. All references to the present disclosure or its examples are intended to refer to the specific examples being discussed at the moment, and are not intended to more generally imply any limitation on the scope of the present disclosure. All distinctions and disparaging language regarding certain features are intended to indicate a lack of preference for these features, but unless otherwise indicated, they are not completely excluded from the scope of the present disclosure.

[0105] A person skilled in the art will readily appreciate that existing or later developed processes, machines, manufacture, compositions of matter, means, methods or steps that perform substantially the same function or achieve substantially the same results as the corresponding embodiments described herein may be utilized in accordance with the present disclosure.

Claims

1. An ocular needle guide configured to enter the subchoroidal space below the choroid of an eye, or to enter the suprachoroidal space between the sclera of the eye and the choroid of the eye, the ocular needle guide comprising: a housing having a contact surface and a needle guide surface, The contact surface defines a cavity within the housing, the contact surface extending at least partially along a contact plane, the needle guide surface extending about 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 such that the needle guide channel leads to the cavity via the opening, the needle axis being substantially parallel to the contact plane, Wherein the ocular needle guide is configured to be positioned on the eye and to draw a portion of the sclera away against a surface portion of the contact surface.

2. An 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 such that the pressure channel leads to the cavity via the second opening.

3. An 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, wherein the pressure channel leads to the cavity via the plurality of openings.

4. An 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 extends along the contact plane, and the first surface portion is angularly offset from the contact plane, so that the cavity is defined by the first surface portion and the second surface portion, wherein the first opening is defined by the first surface portion, and wherein the second opening is defined by the second surface portion.

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

6. The eye needle guide of 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. An eye needle guide according to claim 1, wherein the contact surface extends between a first radial outermost end and a second radial outermost end, wherein the cavity is positioned between the first radial outermost end and the second radial outermost end, wherein the shell includes a first retaining element positioned adjacent to the first radial outermost end and a second retaining element positioned adjacent to the second radial outermost end, wherein when the surface of the eye contacts the contact surface, the first retaining element and the second retaining element provide a retaining force to retain the sclera within the cavity.

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

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

10. An eye needle guide according to claim 1, wherein the housing comprises a first housing portion and a second housing portion, the first housing portion comprising the needle guide channel and the second housing portion comprising a portion of the contact surface extending along the contact plane, wherein the needle axis extends through the opening of the contact surface and is opposite to the contact plane, and The first shell part is capable of moving relative to the second shell part so that the shell can be converted between a first depth position and a second depth position, wherein 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 different from the first depth distance.

11. The eye needle guide of claim 1 , wherein the contact surface has an outer peripheral edge extending around the contact surface, wherein the eye needle guide further comprises: A gasket is coupled to the housing and extends radially outward from the outer peripheral edge of the contact surface, the gasket comprising a flexible material.

12. The eye needle guide of claim 1, wherein the housing extends at least partially circumferentially about a housing axis, and wherein the contact surface extends at least partially in a conical shape.

13. The ocular needle guide of claim 12, wherein the housing comprises a lasik ring.

14. The eyed needle guide of claim 12, wherein 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, and the contact plane is a first contact plane, wherein the contact surface extends at least partially along a second contact plane, and wherein the housing further comprises a second needle guide surface extending about a second needle guide axis to define a second needle guide channel, the second needle guide channel extending through the housing to a second needle opening defined by the contact surface such that the second needle guide channel leads to the cavity via the second needle opening, the needle axis being substantially parallel to the second contact plane.

15. The ocular needle guide of claim 1 configured to be positioned on the eye and to pull a portion of the sclera away from the choroid into the cavity and against the surface portion of the contact surface.

16. A drug kit, comprising: The eye needle guide according to claim 1; and A needle is configured to be inserted through the needle guide channel along the needle axis. The pharmaceutical kit according to claim 16 , wherein the distal tip of the needle is tapered.

18. The kit according to claim 16, further comprising: A stopper is coupled to the needle, wherein the needle is insertable into the cavity of the housing a predetermined distance, wherein the stopper is positioned to substantially prevent the needle from extending into the cavity a distance greater than the predetermined distance.

19. An ocular needle guide for accessing a space beneath the sclera of an eye, the ocular needle guide comprising: a first body portion having a first contact surface and a needle guide surface extending about a needle axis to define a needle guide channel extending through the housing to an opening defined by the first contact surface; and a second body portion having a second contact surface extending 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 convertible between an aligned position and an open position, wherein in the aligned position the first contact surface and the second contact surface define a cavity, the needle guide channel leads to the cavity via the opening, and the needle axis is substantially parallel to the contact plane, and wherein in the open position the needle axis is angularly offset from the contact plane.

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

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

22. An eye needle guide according to claim 19, wherein the first contact surface and the second contact surface are shaped so 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.

23. A method of delivering a therapeutic agent to an eye, the method comprising: positioning an eye needle guide on the eye, the eye needle guide comprising a housing having a contact surface and a needle guiding surface, the contact surface defining a cavity within the housing, the contact surface extending at least partially along a contact plane, the needle guiding surface extending about a needle axis to define a needle guiding channel, the needle guiding channel extending through the housing to an opening defined by the contact surface such that the needle guiding channel leads to the cavity via the opening, the needle axis being substantially parallel to the contact plane, wherein when the ocular needle guide is positioned on the eye, a portion of the sclera of the eye is positioned within the cavity and a surface of the eye contacts the contact surface; as well as After positioning the ocular needle guide on the eye, a needle is inserted through the needle guide channel through the sclera.

24. The method of claim 23, wherein the housing further comprises a pressure surface, the pressure surface defining a pressure channel, the pressure channel extending through the housing to a second opening defined by the contact surface, the method further comprising: Negative pressure is provided to the pressure channel such that the negative pressure provides a retaining force to retain the sclera within the cavity.

25. The method of claim 23, wherein the housing comprises a first housing portion and a second housing portion, the first housing portion comprising the needle guide channel and the second housing portion comprising 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 eye needle guide on the eye, the housing is transitioned from an open position to a holding position, wherein in the holding position the needle guide channel is spaced a first distance from the contact surface on the second housing portion, and wherein in the open position the needle guide channel is spaced a second distance from the contact surface of the second housing portion that is greater than the first distance.

26. An ocular needle guide for accessing a space beneath the sclera of an eye, the ocular needle guide comprising: a housing having a first contact surface defining a cavity within the housing and a post guide surface defining a post passage within the housing; and 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 through the post about a needle axis 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 from a position within the needle guide channel through the opening, the distal axis portion of the needle axis being substantially parallel to at least a portion of the first contact surface, wherein the column is capable of moving within the column channel to define a first depth position within the cavity and a second depth position within the cavity, wherein in the first depth position, the distal axis portion of the needle axis is spaced apart from a substantially parallel portion of the first contact surface by a first depth distance, and in the second depth position, the distal axis portion of the needle axis is spaced apart from a substantially parallel portion of the first contact surface by a second depth distance different from the first depth distance.

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