Method and apparatus for facilitating eye access

Abstract

An ocular access instrument (20) includes an attachment assembly (32) configured to engage a sclera of an eye, and an actuator assembly (34) configured to bear against the sclera. When the attachment assembly engages the sclera, movement of the actuator assembly inwardly against the eye displaces the choroid from the sclera, thereby creating an enlarged suprachoroidal space. The ocular access instrument may also include a needle guide (40) configured to receive the needle and guide the needle into the enlarged suprachoroidal space.

Description

Technical Field

[0001] This disclosure relates generally to drug delivery devices and methods for delivering therapeutic agents, and more specifically to ocular guides and methods for facilitating needle entry into the eye. Background Technology

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

[0003] The suprachoroidal space is a potential space in the eye for treatment options. It lies between the sclera (outer layer of the eye) and the choroid (a vascular membrane situated between the sclera and retina). The suprachoroidal space extends from the anterior portion of the eye near the ciliary body to the posterior portion near the optic nerve. Normally, the suprachoroidal space is not readily apparent because the choroid and sclera are closely juxtaposed due to intraocular pressure. Since the choroid is not substantially attached to the sclera, tissue separation occurs to form the suprachoroidal space when fluid buildup or other conditions arise. The suprachoroidal space provides a potential pathway from the anterior region of the eye to treat the posterior region.

[0004] Accessing the suprachoroidal space of the eye is a delicate procedure requiring considerable skill and time. Several methods exist for reaching this space to deliver therapeutic agents, but their complexity and time requirements limit their widespread use. Any attempt to penetrate the sclera with a needle to reach a specific depth (and thus a specific interlaminar space) faces the challenge of providing sufficient force to penetrate the relatively tough scleral tissue without over-penetration. This challenge is amplified by the compliant nature of the eye, and there is no means to provide support to the opposite side of the tissue being penetrated. Summary of the Invention

[0005] In one example, an ocular access device may include a device body, an attachment assembly supported by the device body, and an actuator assembly supported by the device body. The attachment assembly may have an attachment member. The attachment assembly is movable to an attachment position where the attachment member is attached to the sclera of the eye. The actuator assembly may include an adjacent member. The actuator assembly is movable to an actuation position where the adjacent member abuts against the sclera at a location spaced apart from the attachment member, thereby increasing the distance between the sclera and the choroid to create an enlarged suprachoroidal space.

[0006] This summary is provided in a simplified form to introduce some concepts that will be further described in the detailed description section below. This summary is not intended to identify key or essential features of the subject matter protected by the claims, nor is it intended to limit the scope of the subject matter protected by the claims. Furthermore, the subject matter protected by the claims is not limited to addressing any or all of the disadvantages described in any part of this disclosure. Attached Figure Description

[0007] The foregoing description 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. Exemplary embodiments are shown in the drawings to illustrate the locking structure of the present application. However, it should be understood that the present application is not limited to the precise arrangements and means shown. In the drawings: Figure 1A This is a perspective view of an eye access device constructed according to an example, having attachment components, actuator components, and a needle guide, the eye access device being configured to be placed against the eye. Figure 1B yes Figure 1A A perspective view of an ocular entry device shown placed against the eye, having a cut-off portion to show an attachment assembly in an attachment position and an actuator assembly in an actuated position to form an enlarged suprachoroidal space of the eye. Figure 1C yes Figure 1B A perspective view of the eye entering the instrument, showing the needle being guided through a needle guide and into the enlarged suprachoroidal space; Figure 2A yes Figure 1A An exploded perspective view of the eye entering the instrument; Figure 2B This is a perspective view of the eye entering the instrument, constructed in another example; Figure 3A yes Figure 1A A cross-sectional side front view of an eye access device shown in an initial configuration against an eye, in which each of the attachment assembly and the actuator assembly is positioned in a respective initial position. Figure 3B yes Figure 3A A cross-sectional end view of the eye entering the instrument; Figure 4A yes Figure 3A A cross-sectional side front view of the eye access device, wherein the attachment assembly is shown in the attachment position and the actuator assembly is shown in the intermediate position; Figure 4B yes Figure 4A A cross-sectional end view of the eye entering the instrument; Figure 5A yes Figure 4A A cross-sectional side front view of the eye entering the instrument, wherein the actuator assembly is located in an adjacent position; Figure 5B yes Figure 5A A cross-sectional end view of the eye entering the instrument; Figure 6A yes Figure 5A A cross-sectional side front view of the eye entering the instrument, wherein the actuator assembly is positioned in the actuated position to form an enlarged suprachoroidal space; Figure 6B yes Figure 6A A cross-sectional end view of the eye entering the instrument; Figure 7A yes Figure 6A A cross-sectional side front view of the eye-entry instrument, showing a needle extending through the needle guide and into the space above the choroid; and Figure 7B yes Figure 7A Enlarged cross-sectional side front view of the magnified portion. Detailed Implementation

[0008] Certain terms used in this specification are for convenience only and are not restrictive. The terms “axial,” “radial,” “circumferential,” “outward,” “inward,” “upper,” “lower,” “top,” and “bottom” indicate directions in the referenced figures. As used herein, when describing dimensions, shapes, orientations, distances, spatial relationships, or other parameters, the terms “substantially,” “approximately,” and their derivatives, as well as words with similar meanings, include the stated dimensions, shapes, orientations, distances, spatial relationships, or other parameters, and may also include ranges up to 10% more and down to 10%, including up to 5% more and down to 5%, including up to 3% more and down to 3%, including up to 1% more and down to 1%. The terms “substantially,” “approximately,” etc., are intended to indicate a considerable or substantial degree, but not necessarily entirely (but may fully include) what is specified. All ranges disclosed herein include the stated endpoints and can be combined independently (e.g., the range “2 grams to 10 grams” includes the endpoints 2 grams and 10 grams, and all intermediate values). Terms include the words listed above, their derivatives, and words with similar meanings.

[0009] refer to Figures 1A to 1C The ocular access instrument 20 is configured to guide a needle into an enlarged suprachoroidal space 24 defined between the sclera 26 and the choroid 28 of the eye 22 (see [link]). Figure 3AThe eye 22 can be a human eye or the eye of a non-human animal. The eye access device 20 may include a device body 30, an attachment assembly 32 supported by the device body 30, and an actuator assembly 34 supported by the device body 30. The attachment assembly 32 and the actuator assembly 34 are movable independently of the device body 30. Specifically, the attachment assembly 32 is movable in the attachment direction from... Figure 1A The corresponding initial or detachment position shown is moved to Figure 1B The attachment position shown is in which the attachment assembly 32 is removably attached to the eye, particularly the sclera 26. The actuator assembly 34 can be moved in the engagement direction from a corresponding initial or disengaged position to an actuated position, in which the actuator assembly 34 applies a force to the eye that increases the distance between the sclera 26 and the choroid 28, thereby creating an enlarged suprachoroidal space 24.

[0010] The attachment assembly 32 may include at least one attachment member 36, such as a pair of attachment members 36, which are spaced apart from the eye 22 when the attachment assembly 32 is in a respective initial or disengaged position. Thus, in the respective initial position, the attachment member 36 does not engage the sclera 26 of the eye 22. In the attachment position, the attachment member 36 is attached to the sclera 26 of the eye 22 at the respective attachment position. Specifically, when the attachment assembly is in the attachment position, the attachment member 36 may extend into the sclera 26. The attachment assembly 32 may also move in a disengagement direction from the attachment position toward the respective initial or disengaged position, in which the attachment member 36 is removed from the eye 22, and in particular from the sclera 26. It should be understood that the disengaged position may be defined by the initial position of the attachment assembly 32 or any other position of the attachment assembly 32 in which the attachment member 36 is not engaged or attached to the eye 22.

[0011] Actuator assembly 34 may include at least one abutment member 38, such as a pair of abutment members 38, when actuator assembly 34 is in a position such as Figure 1A In the initial or separated position shown, the pair of adjacent members are spaced apart from the eye 22, and when the attachment assembly 32 is in the position shown... Figure 1B In the actuated position shown, the pair of adjacent members rest against the eye 22. When the adjacent member 38 moves in the engagement direction and applies force to the eye 22, particularly the sclera 26, this force causes the sclera 26 and choroid to shift inward. However, the attachment member 36 prevents the sclera 26 from shifting inward at the attachment position, thereby forming as shown... Figure 1BThe enlarged suprachoroidal space 24 is shown. The actuator assembly 34 can also be moved from the actuated position to a corresponding initial or disengaged position in the disengagement direction. In the disengaged position, the adjacent member 38 is removed from the eye 22, and in particular from the sclera 26. It should be understood that the disengaged position can be defined by the initial position of the actuator assembly 34 or any other position where at least one of the adjacent members 38 of the actuator assembly 34 does not exert a force on the eye 22 sufficient to form the enlarged suprachoroidal space 24.

[0012] like Figure 1C As shown, the ocular access device 20 may also include a needle guide 40 configured to receive and guide a needle 42 into the enlarged suprachoroidal space 24 to deliver a therapeutic agent into the enlarged suprachoroidal space 24.

[0013] Now for reference Figure 2A The ocular access device 20 will be described in more detail below. Specifically, the attachment assembly 32 may include a handle 44, a pivot axis 45 pivotally attached to the device body 30, and an attachment member 36 extending from the pivot axis 45. The handle 44 and the pivot axis 45 may be combined to define the attachment body 35. The handle 44 and the pivot axis 45 may be integral with each other or discretely attached to each other as needed. Similarly, the attachment member 36 may be integral with the handle 44 or discretely attached to the handle 44 as needed. The attachment assembly 32 may also include a pivot member 46, such as a pivot pin, which pivotally engages the attachment assembly 32, particularly the handle 44, to the device body 30. The pivot pin may extend through orifices in the handle 44 and the device body 30 to pivotally engage the attachment assembly 32 to the device body 30.

[0014] The instrument body 30 defines a proximal end 31 and a distal end 33 opposite to the proximal end 31 in the distal direction. Conversely, the proximal end 31 is opposite to the distal end 33 in the proximal direction. The distal end 33 may be defined by a pair of distal walls 41 opposite each other in the transverse direction T. The distal walls 41 may define a corresponding distal end, which in turn defines a support 58 configured to abut the eye 22 during operation. It should be understood that any suitable sleeve or sheath may be placed on the wall 41, and it can still be said that the wall 41 defines the abutment support 58.

[0015] The handle 44 may define an engagement surface 48 such that a pivoting member 46 is disposed between the engagement surface 48 and at least one attachment member 36. An attachment force applied to the engagement surface 48 causes the attachment assembly 32 to move from a disengaged position to an attached position in the attachment direction. Specifically, the attachment force applied to the engagement surface 48 of the handle 44 may drive the handle 44 to pivot from a disengaged position to an attached position along a first pivot direction about a pivot axis defined by the pivoting member 46. The pivot axis may be a fixed pivot axis that does not move in either the proximal or distal direction during operation. Thus, the attachment direction may be defined by the first pivot direction. The attachment assembly 32 may define at least one stop member 51, such as a pair of stop members 51, configured to abut against the device body 30 to limit the amount of pivoting of the attachment assembly 32 in the first pivot direction. The stop member 51 may extend from the handle 44. The attachment assembly 32 may also move from the attached position to the disengaged position in the disengaged direction.

[0016] The pivot axis is oriented along the direction of the pivot axis. The direction of the pivot axis may be defined by the lateral direction T. Attachment members 36 may extend from the handle 44 and may be arranged adjacent to each other along the direction defined by the pivot axis. Attachment members 36 may define a hook 37 having a sharp distal tip 39. The hook 37 may be bent in a corresponding plane perpendicular to the direction defined by the pivot axis. As will be described in more detail below, pivoting the handle 44 about the pivot axis in a first pivot direction drives the attachment member 36 into the sclera, and pivoting the handle about the pivot axis in a second direction opposite to the first pivot direction removes the attachment member 36 from the sclera.

[0017] Continue to refer to Figure 2A The actuator assembly 34 includes an actuator member 52 and an actuator shaft 54 ​​extending from the actuator member 52. In one example, the actuator shaft extends from the actuator member 52 generally in a distal direction. The actuator shaft 54 ​​may define an abutment member 38 configured to abut the eye 22 during operation. Specifically, the actuator member 52 may extend proximally from a proximal end of the actuator shaft 54, and the abutment member 38 may extend distally from a distal end of the actuator shaft 54. The actuator member 52 and the actuator shaft 54 ​​may be combined to define an actuator body 53. The actuator member 52 and the actuator shaft 54 ​​may be integral with each other or discretely attached to each other as needed. Similarly, the abutment member 38 may be integral with the actuator shaft 54 ​​or discretely attached to the actuator shaft 54 ​​as needed.

[0018] Adjacent members 38 may be adjacent to each other and spaced apart from each other along the pivot axis direction. Therefore, adjacent members 38 may be spaced apart from each other in the same direction as the attachment member 36. The adjacent members 38 may be spaced apart sufficiently such that the attachment member 36 is positioned between the adjacent members 38. As will be described in more detail below, actuator member 52 is configured to receive an engagement force that causes actuator assembly 34 to move in the engagement direction. Specifically, actuator assembly 34 may be driven to translate in a translational direction along the engagement direction. The translational direction may be defined by a distal direction. Movement of actuator assembly 34 in the engagement direction causes actuator assembly 34 to move from an initial position to an actuated position. Actuator assembly 34 may also move in a separation direction, which may be defined by movement or translation of actuator assembly 34 in a proximal direction opposite to the distal direction. Movement of actuator assembly 34 in the separation position causes actuator assembly 34 to move in a direction from the actuated position toward the initial position. Both the proximal and distal directions are oriented along the longitudinal direction L. The longitudinal direction L is oriented substantially perpendicular to the transverse direction T.

[0019] Actuator assembly 34 may also define a slot 56 extending through actuator body 53 along a pivot axis direction, which, as described above, may be defined by a transverse direction T. The slot 56 may be sized and configured to receive pivot member 46. The slot 56 may extend through actuator shaft 54, but may extend through either or both of actuator shaft 54 ​​and actuator member 52. The slot 56 may be sized to receive pivot member 46 and may extend along both engagement and disengagement directions of actuator assembly 34. Thus, pivot member 46 may be configured to selectively travel in the slot 56 in both engagement and disengagement directions. In one example, slot 56 may be a straight slot extending along a longitudinal direction L. Therefore, as actuator assembly 34 moves between a corresponding initial position and an actuated position, pivot member 46 may thus travel in the longitudinal direction within slot 56.

[0020] In one example, actuator assembly 34 may include a slider 57 supported by actuator body 53, particularly by actuator shaft 54. In one example, actuator shaft 54 ​​may include at least one wall 55 defining at least one abutting member 38. The at least one wall 55 may include opposing walls 55 spaced apart from each other, and slider 57 may extend between walls 55. Opposing walls 55 are configured to be disposed between distal walls 41 of device body 30. Wall 55 defines a corresponding distal end, which in turn defines the abutting member 38. It should be understood that any suitable sleeve or sheath may be placed on wall 55, and it can still be said that wall 55 defines abutting member 38. Slot 56 may extend through actuator shaft 54, particularly through each of the opposing walls 55 of actuator assembly 34. Walls 55 may be spaced apart from each other in the lateral direction T sufficiently to receive attachment body 35, particularly receiving pivot shaft 45 therebetween. During operation, the slider 57 can travel along the ramped raised surface 47 of the attachment body 35, particularly the ramped raised surface 47 of the pivot shaft 45. As the ramped raised surface 47 extends along the longitudinal direction L, the ramped raised surface 47 can define a slope along the lateral direction A. The lateral direction A can be oriented substantially perpendicular to each of the longitudinal direction L and the transverse direction T. The ramped raised surface 47 can expand laterally outward as it extends in the proximal direction, and conversely, expand laterally inward as it extends in the distal direction.

[0021] Continue to refer to Figure 2A The needle guide 40 may extend from the instrument body 30. In one example, the needle guide 40 may be discretely attached to the instrument body 30. In other examples, the needle guide 40 may be integral with the instrument body 30. In either case, the needle guide 40 may be said to be supported by the instrument body 30.

[0022] The eye access device 20 may also include an eye locator 60 configured to position the eye access device 20 at a desired location and orientation relative to the eye 22 during operation of the device 20 (i.e., during movement of the attachment assembly 32 and the actuator assembly 34). The eye locator 60 may extend from the device body 30. For example, the eye locator 60 may be integral with the device body 30 or discretely attached to the device body 30 as needed. In one example, the eye locator 60 is configured to abut the eye 22 at a predetermined location, such that the attachment member 36 engages the corresponding sclera 26 at the corresponding desired location, and the abutment member 38 abuts the sclera at the corresponding desired location (see [link to relevant documentation]). Figure 1BThe desired location could be the posterior portion of the limbus, allowing the needle 42 to be introduced into the enlarged suprachoroidal space at the posterior portion of the limbus. In one example, the eye locator 60 can be positioned on the anterior hemisphere of the eye 22. For example, the eye locator 60 can be positioned around the cornea, such that the eye locator is positioned around the iris. In one example, the eye locator 60 can be configured as a ring-shaped body, such as a ring 62 surrounding the iris. In one example, the eye locator 60 can be rigidly coupled to the instrument body 30. In other examples, the instrument body 30 can be positionally manipulated relative to the eye locator 60.

[0023] refer to Figure 2B The eye locator 60 may alternatively be configured as a mounting bracket 64, which can be secured to any suitable structure outside the eye 22 as needed. In one example, the mounting bracket 64 may be configured to be secured to a speculum, operating table, or any alternative structure fixed relative to the eye 22. An arm 66 may extend between the mounting bracket 64 and the instrument body 30. The arm 66 may be adjustable to define the desired position of the instrument body 30 when the mounting bracket 64 is secured to the structure.

[0024] Now we will first refer to Figures 3A to 3B The operation of the ocular access device 20 is described. Specifically, the ocular access device 20 is shown with the attachment assembly 32 in a corresponding initial or disengaged position, and the actuator assembly 34 in a corresponding initial position. The ocular access device 20 can be positioned such that the corresponding distal ends of the distal walls 41 of the device body 30 are positioned against the eye 22, and the support 58 is positioned against the eye 22, particularly the sclera 22. Thus, the ocular access device 20 defines a working area 23 of the eye 22 between the distal walls 41, particularly between the supports 58. During operation of the ocular access device 20, the working area 23 of the eye 22 will define an expanded suprachoroidal space.

[0025] When the attachment assembly 32 is in the disengaged position, the attachment member 36 is positioned outward from the eye 22, particularly from the sclera 26. Furthermore, the engagement surface 48 of the handle 44 is positioned outward relative to the device body 30 in the lateral direction A. Additionally, the eye access device 20 is configured to hold the attachment assembly 32 in its respective initial position without the application of an attachment force to the handle 44 that would cause the attachment assembly 32 to move to the attachment position. Specifically, the slider 57 abuts against the ramped raised surface 47 of the attachment body 35 and resists pivoting of the attachment assembly 32 about the pivot axis in the first pivoting direction. In this respect, the abutment between the slider 57 and the ramped raised surface 47 prevents accidental pivoting of the attachment assembly 32 in the attachment direction from its respective initial position toward the attachment position.

[0026] When the actuator assembly 34 is in its respective initial position, the proximal end of the actuator member 52 may extend proximally to the proximal end 31 of the device body 30. In one example, the proximal end of the actuator member 52 may define a plunger 68 configured to receive an engagement force that moves the actuator assembly 34 in the engagement direction. The actuator member 52, particularly the plunger, may be engaged by the thumb of a user applying the engagement force. Thus, the user's thumb may engage the actuator member 52, while the fingers of the same hand may engage the handle 44. The fingers may apply an attachment force to the attachment assembly 32, and the user's thumb may apply an engagement force to the actuator member 52 of the actuator assembly 34. The engagement force may be oriented in a distal direction.

[0027] The pivot member 46 extends through the device body 30 and further through the slot 56 of the actuator assembly 34, such that the pivot member 46 is configured to travel in the proximal direction within the slot 56 when the actuator assembly moves in the engagement direction. Engagement between the pivot member 46 and the device body 30 prevents translation of the attachment assembly 32 relative to the device body 30. In one example, the pivot member 46 may extend through the slot 56 at or near its distal end. Therefore, the abutment between the pivot member 46 and the actuator body 53 at the distal end of the slot 56 prevents removal of the actuator assembly 34 from the device body 30. The opposing wall 55 of the actuator assembly 34 may be positioned such that, when the actuator assembly 34 is in its respective initial position, the abutment member 38, defined by the distal end of the opposing wall 55, is disposed outward from the eye 22, particularly from the sclera 26. In one example, the abutment member 38 of the actuator assembly 34 is spaced apart from the eye in a proximal direction or in a direction opposite to the engagement direction. In one example, the abutment member 38 may be offset in the proximal direction from the support 58 defined by the distal end of the device body 30. Thus, it can be said that when the actuator assembly 34 is in its respective initial position, the abutment member 38 is recessed or disposed in the device body 30.

[0028] The eye access device 20 is configured to hold the actuator assembly 34 in its respective initial position without the application of an engaging force to the actuator member 52 that would cause the actuator assembly 34 to move to the actuated position. Specifically, the device body 30 may support a retaining member 70 configured to be disposed in a first or distal engagement 72a of the actuator body 53, particularly the actuator member 52. The retaining member 70 may be spherical or may be defined by any suitable alternative shape as needed. Mechanical interference between the retaining member 70 and the actuator body 53 in the first engagement 72a resists movement of the actuator assembly 34 relative to the device body 30 in the distal direction. In this respect, the abutment of the retaining member 70 and the actuator body 30 in the first engagement 72a prevents accidental movement of the actuator assembly 34 in the distal direction from the initial position toward the actuated position.

[0029] Now for reference Figures 4A to 4B The attachment assembly 32 is shown in the attachment position. Specifically, an attachment force is applied to the handle 44, particularly to the engagement surface 48 of the handle 44, sufficient to pivot the handle 44 about a pivot axis relative to the instrument body 30 in a first pivot direction. The user can apply the attachment force by abutting the engagement surface 48 with his or her fingers. Specifically, the user can grasp or otherwise engage the eye-access instrument by abutting the proximal end of the actuator member 52 (such as the plunger 68) with his or her thumb and by abutting the engagement surface 48 of the handle 44 with one or more fingers. Thus, the attachment force can be provided by the user's fingers. The attachment force causes the attachment assembly 32 to move in the attachment direction. It should be understood that the attachment assembly 32 can be moved in the attachment direction in any suitable alternative manner as needed.

[0030] As the attachment assembly 32 moves in the attachment direction, the attachment member 36 travels along an arcuate path, which can be defined by a pivoting motion relative to the instrument body 30 from a corresponding initial position to an attachment position. Thus, the attachment member 36 can be driven into the sclera 26 along the arcuate path. Therefore, it can be said that the attachment member 36 is attached to the sclera at a corresponding attachment position 61. For example, the attachment member 36 can be driven into the sclera 26. In one example, the attachment member 36 is driven into the sclera 26 in a direction substantially tangential to it. Specifically, the sharp distal tip 39 of the hook 37 is driven into the sclera 26. In one example, the attachment member 36 is driven into the sclera 26 but does not penetrate it. Thus, the attachment member 36 is driven into the outer surface of the sclera 26 but does not penetrate the inner surface of the sclera facing the choroid 28 and opposite the outer surface. In other examples, the attachment member 36 may be driven through the sclera 26 but not into the choroid 28. In other examples, particularly when the attachment member 36 defines a hook 37, the attachment member may enter the outer surface of the sclera 26, extend along a portion of the sclera 26 between the outer and inner surfaces, and exit the sclera 26 at its outer surface. When the attachment member 32 is in the attached position, the attachment member 36 may be positioned less than a plane 1) defined by the support 58 and 2) oriented perpendicular to the longitudinal direction L. For example, the attachment member 36 may be spaced apart from this plane in the proximal direction.

[0031] When the attachment assembly 32 has pivoted to the attachment position, the stop member 51 abuts against the instrument body 30, thereby preventing further pivoting movement of the attachment assembly 32 relative to the instrument body 30 in the first pivoting direction. Therefore, the abutment of the stop member 51 and the instrument body 30 prevents the attachment assembly 32 from pivoting beyond the attachment position. When the attachment assembly 32 is in the attachment position, the engagement surface 48 of the handle 44 can be substantially flush with the instrument body 30.

[0032] The attachment force can be oriented towards the instrument body 30 and cause the ramped raised surface 47 to push the slider 57 relative to the instrument body 30 in a distal direction along the ramped raised surface 47. The distal direction movement of the slider 57 relative to the instrument body 30 and the attachment assembly 32 provides a gap between the ramped raised surface 47 and the slider 57 to allow for further pivoting movement of the attachment assembly 32 in the first pivoting direction. When the attachment assembly 32 has been moved to the attachment position, the slider 57 can abut against the ramped raised surface 47.

[0033] Because the slider 57 is translatably fixed to the actuator body 53, the distal movement of the slider 57 during the movement of the attachment assembly 32 to the attachment position causes the actuator assembly 34 to move from its respective initial position to an intermediate position relative to the device body 30 in the engagement direction. As shown, the engagement direction of the actuator assembly 34 can be defined by the translational direction. The translational direction can then be defined by the distal direction. Thus, the actuator assembly 34 moves from its respective initial position to an intermediate position spaced apart from the initial position in the engagement direction, which can be defined by the distal direction. In the intermediate position, the adjacent member 38 is spaced apart from the eye 22 in the proximal direction (or in the direction opposite to the engagement direction). Because the adjacent member 38 is spaced apart from the eye 22 in the intermediate position, and therefore no force is applied to the eye 22 sufficient to form an enlarged suprachoroidal space, the actuator assembly 34 can be said to be in a disengaged position when it is in the intermediate position.

[0034] The actuator assembly 34 moves to an intermediate position in the engagement direction, allowing the retaining member 70 to be removed from the first engaging portion 72a and to travel in the proximal direction along the surface 76 of the actuator body 53, particularly the actuator member 52. The surface 76 of the actuator body 53 defines the first engaging portion 72a and a second or proximal engaging portion 72b spaced apart from the first engaging portion 72a in the proximal direction. The surface 76 may be defined by the actuator member 52. Therefore, the retaining member 70 moves in the proximal direction along the surface 76 from the first engaging portion 72a toward the second engaging portion 72b.

[0035] Furthermore, when the actuator assembly 34 moves from its initial position in the engagement direction, the pivot member 46 disposed in the slot 56 can travel within the slot 56. Specifically, because the slot 56 moves relative to the pivot member 46 in the engagement direction, the pivot member 46 can move within the slot 56 in a direction opposite to the engagement direction. Therefore, when the actuator assembly 46 moves in the engagement direction, the pivot member 46 can move within the slot in a proximal direction. Because the actuator assembly 34 can move further from its intermediate position in the engagement direction, when the actuator assembly 34 is in its intermediate position, the slot 56 extends from the pivot member 46 in a proximal direction.

[0036] Now for reference Figures 5A to 5BThe actuator assembly 34 can move from an intermediate position to an adjacent position, in which the abutting member 38 abuts the eye 22, particularly the sclera 26, at a corresponding abutting position 63. The adjacent position 36 can be defined at the corresponding outermost extent of the working area 23 of the eye. Specifically, as the actuator assembly 34 moves to the adjacent position in the engagement direction, the abutting member 38 can move distally toward and into the eye 22. During operation of the eye access device 20, the actuator assembly 34 can continuously move from the intermediate position to the actuated position in the engagement direction without stopping at the intermediate position. Figures 5A to 5B The actuator assembly 34 is shown at the adjacent position. However, for illustrative purposes, the actuator assembly 34 is shown in the adjacent position. In some cases, the surgeon may wish to move the actuator assembly 34 further to the actuated position to define the enlarged suprachoroidal space 24 (see [reference]). Figures 6A to 6B Before that, when the actuator assembly 34 is in the adjacent position, stop the movement of the actuator assembly 34 in the adjacent position to check the eye 22.

[0037] As described above, actuator assembly 34 is configured to receive an engagement force that drives actuator assembly 34 to move in the engagement direction. As described above, the engagement force can be applied to actuator member 52, particularly plunger 68. Specifically, after attachment assembly 32 has moved or pivoted to the attachment position, actuator assembly 34 can move in the engagement direction from... Figures 4A to 4B The middle position shown is moved to Figures 5A to 5B The adjacent position is shown. Specifically, the actuator assembly 34 can be translated from the intermediate position to the adjacent position in the engagement direction. Therefore, as shown... Figures 3A to 5B As shown, actuator assembly 34 can move from a corresponding initial position to an adjacent position in the engagement direction. It should be understood that the adjacent position of attachment assembly 32 is located between the corresponding initial position and the actuated position. In the adjacent position, the abutment member 38 abuts the eye 22 but does not exert a force on the eye 22 sufficient to form an enlarged space on the choroid. Therefore, when actuator assembly 34 is in the adjacent position, it can be said that actuator assembly 34 is in the disengaged position.

[0038] Because the slider 57 extends from and is positioned to the actuator body 53, movement of the actuator assembly 34 in the engagement direction causes the slider 57 to move similarly relative to the ramp protrusion surface 47 in the engagement direction. Therefore, the slider 57 moves to a position spaced apart from the ramp protrusion surface 47. Since the engagement direction of the actuator assembly 34 in one example can be defined by a distal direction, after the attachment assembly 32 has moved to the attachment position, the slider 57 moves distally away from the ramp protrusion surface 47 as the actuator assembly 34 moves in the engagement direction.

[0039] As shown, the device body 30 defines at least one actuator member configured to cause movement of the actuator assembly 34 between a respective initial position and an actuated position. In one example, the actuator member may be configured as at least one guide channel 74. As shown, the device body 30 includes a pair of guide channels 74, each defined by a respective inner guide wall 78 and an outer guide wall 78 of the device body 30. In one example, the outer guide wall 78 may be defined by a distal end 33 of the device body 30. Specifically, the first outer guide wall 78 and the second outer guide wall 78 may be defined by a distal wall 41 of the device body, which cooperates with the first inner guide wall 78 and the second inner guide wall 78 to define the first actuator guide channel 74 and the second actuator guide channel 74. The actuator guide channel 74 can be sized to receive a corresponding wall in the opposing wall 55 of the actuator shaft 54, and during selective movement of the actuator assembly 34 in the engagement and disengagement directions, when the opposing wall 55 moves, it causes the opposing wall 55 of the actuator assembly 34 to move.

[0040] Due to the curvature of the eye 22, and because at least one wall 55 is disposed between the walls 41 of the device body 30, when the actuator assembly 34 is in the abutment position, one or more abutment members 38 defined by at least one wall 55 can be offset in the proximal direction relative to the support 58 defined by the distal end of the device body 30. However, when the actuator assembly 34 is in the abutment position, both the abutment members 38 and the support 58 can simultaneously contact the eye 22, particularly the sclera 26.

[0041] like Figure 5A As shown, when the actuator assembly 34 moves from the intermediate position to the adjacent position in the engagement direction, the retaining member 70 travels proximally along the surface 76 of the actuator body 53. Therefore, when the actuator assembly 34 moves from the corresponding initial position to the adjacent position, the retaining member 70 travels along the surface 76 toward the second or proximal engaging portion 72b, moving away from the first or distal engaging portion 72a. When the actuator assembly 34 is in the adjacent position, the retaining member 70 is disposed between the first engaging portion 72a and the second engaging portion 72b.

[0042] Furthermore, when the actuator assembly 34 moves from the intermediate position to the adjacent position in the engagement direction, the pivot member 46 disposed in the slot 56 can travel within the slot 56. Specifically, because the slot 56 moves relative to the pivot member 46 in the engagement direction, the pivot member 46 can move within the slot 56 in a direction opposite to the engagement direction. Therefore, when the actuator member 46 moves to the adjacent position in the engagement direction, the pivot member 46 can move within the slot in the proximal direction. Because the actuator member 34 can further move from the adjacent position to the actuated position in the engagement direction, when the actuator assembly 34 is in the adjacent position, the slot 56 extends from the pivot member 46 in the proximal direction.

[0043] Now for reference Figures 6A to 6B The engagement force applied to actuator assembly 34 can move the actuator assembly relative to device body 30 and gripping assembly 32 in the engagement direction to an actuated position. In the actuated position, abutment member 38 can apply an abutment force to eye 22, particularly sclera 26, in a distal direction. The abutment force applied to eye 22 by abutment member 38 can be in the inward direction of eye 22 (i.e., into eye 22). The abutment force applied to eye 22 by abutment member 38 is sufficient to displace sclera 26 and the underlying choroid 28 inward or distally to a position relative to attachment site 61 of sclera 26 and the region immediately adjacent to attachment site 61 of sclera 26. In one example, the region immediately adjacent to sclera 26 may include the position of sclera 26 between abutment sites 63. Attachment site 61 and the region immediately adjacent to sclera 26 may be collectively referred to as a selected suprachoroidal region. The selected suprachoroidal region may be adjacent to abutment site 63.

[0044] Because the attachment member 36 remains fixed in position as the adjacent member 38 moves distally relative to the instrument body 30, the attachment member 36 prevents the sclera 26 from shifting inward at the selected suprachoroidal region. However, because the attachment member 36 of the attachment assembly 32 is not fixed to the choroid 28, the inward displacement of the adjacent member 38 against the eye 22 causes substantially the entire choroid 28 at the selected suprachoroidal region to shift inward relative to the sclera 26 at the selected suprachoroidal region. Because the choroid 28 and sclera 26 separate at the selected suprachoroidal region, thereby increasing the distance between the choroid 28 and sclera 26, the enlarged suprachoroidal region 24 is confined to the selected suprachoroidal region.

[0045] It should be understood that the abutment member 38 moves to a position distal to the support 58 defined by the distal end of the device body 30. Therefore, the abutment member 38 can move the eye 22 to a position spaced apart from the support 58 in the distal direction. Thus, in some examples, when the actuator assembly 34 is in the actuated position, the support 58 of the device body 30 is no longer adjacent to the eye 22.

[0046] Therefore, it should be understood that in one mode of operation, the adjacent member 38 moves in the distal direction to the actuation position, causing the choroid 28 and sclera 26 to move inward at the adjacent position 63 relative to the sclera 36 at the attachment position 61. As a result, the choroid 28 moves distally relative to the sclera 26 at a selected region on the choroid, thereby separating the sclera 26 and the choroid in the manner described above.

[0047] However, in another mode of operation, the user may choose to pull the device body 30 proximally relative to the actuator assembly 34, and thus pull the gripping assembly 32, thereby again moving the actuator assembly 34 distally relative to the device body 30 and the gripping assembly 32 to the actuated position. In this example, the attachment member 36 may pull the sclera 26 proximally away from the choroid 28 in the selected suprachoroidal region, while the adjoint member 38 supports the eye 22 at the adjoint position 63 to move the percentage of the choroid in the selected suprachoroidal region proximally, thereby separating the sclera 26 and the choroid 28.

[0048] In other modes of operation, actuator assembly 34 can be moved distally relative to eye 22 as described above, while device body 30 is pulled proximally relative to actuator assembly 34 as described above. This causes adjoining member 38 to displace the eye inward at adjoining position 63, and attachment member 36 to pull sclera 26 proximally away from choroid 38. Thus, both sclera 26 and choroid 28 can move away from each other to create separation of sclera 26 and choroid 28 in a selected suprachoroidal region. Therefore, it can be said that ocular access device 20 can be configured to move either or both of sclera 26 and choroid 28 away from the other, thereby increasing the distance between sclera 26 and choroid 28 to form an enlarged suprachoroidal space 24. Specifically, moving either or both of attachment member 36 and adjoining member 48 can move either or both of them away from the other of sclera 26 and choroid 28.

[0049] Continue to refer to Figures 6A to 6B Because the slider 57 extends from and is fixed to the actuator body 53 in position, the movement of the actuator assembly 34 from the adjacent position to the actuated position in the engagement direction causes the slider 57 to move similarly relative to the ramp protrusion surface 47 in the engagement direction. Therefore, the slider 57 moves to a position spaced further away from the ramp protrusion surface 47. Since the engagement direction of the actuator assembly 34 can be defined by a distal direction in one example, the slider 57 moves further away from the ramp protrusion surface 47 in the distal direction as the actuator assembly 34 moves from the adjacent position to the actuated position in the engagement direction. When the actuator assembly 34 moves or translates to the actuated position, the opposing wall 55 of the actuator shaft 54 ​​can be guided in the guide channel 74 in the manner described above.

[0050] like Figure 6A As shown, when the actuator assembly 34 moves from the intermediate position to the adjacent position in the engagement direction, the retaining member 70 travels proximally along the surface 76 of the actuator body 53. When the actuator assembly 34 moves from the adjacent position to the actuated position, the retaining member 70 travels along the surface 76 and enters the second or proximal engagement portion 72b. The mechanical interference between the retaining member 70 and the actuator body 53 in the second engagement portion 72b resists movement of the actuator assembly 34 relative to the instrument body 30 in the proximal direction. In this respect, the abutment between the sliding retaining member 70 and the actuator body 30 in the second engagement portion 72b prevents accidental movement of the actuator assembly 34 in the disengagement direction, the amount of movement being sufficient to reduce or eliminate the enlarged space 24 on the choroid. In one example, the retaining member 70 and the second engagement portion 72b may have substantially matching curvatures, such that the retaining member 70 can be nested in the second engagement portion 72b. In some examples, the curvature may be defined by the diameter of the respective sphere. In this respect, the device can provide either or both tactile and auditory feedback when the actuator assembly is in the actuated position. In other examples, the second engagement 72b may be configured as an elongated channel longer than the retaining member 70 in the longitudinal direction. The second engagement 72b may be shaped and configured to prevent the actuator assembly 34 from overtraveling in the direction from the adjacent position to the actuated position.

[0051] Furthermore, when the actuator assembly 34 moves from the adjacent position to the actuated position in the engagement direction, the pivot member 46 disposed in the slot 56 can travel within the slot 56. Specifically, because the slot 56 moves relative to the pivot member 46 in the engagement direction, the pivot member 46 can move within the slot 56 in a direction opposite to the engagement direction. Therefore, when the actuator assembly 46 moves to the adjacent position in the engagement direction, the pivot member 46 can move within the slot in a proximal direction. When the actuator assembly 34 is in the actuated position, the pivot member 46 can be disposed at the proximal end of the slot 56. Therefore, the abutment of the pivot member 46 and the actuator body 53 within the slot 56 prevents further movement of the pivot member 46 within the slot 56 in the proximal direction, thus preventing further movement of the actuator assembly 34 in the engagement direction. Therefore, the eye access device 20 is configured to prevent further movement of the actuator assembly 34 in the engagement direction after the actuator assembly 34 has been moved to the actuated position, thereby limiting the separation force applied to the eye 22 that causes separation between the sclera 26 and the choroid 28.

[0052] Now for reference Figures 7A to 7BAs described above, the ocular access device 20 may include a needle guide 40 configured to guide a needle 42 to deliver a therapeutic agent into the enlarged suprachoroidal space 24. The needle guide 40 has a needle guide body 86 and a needle guide channel 88 extending through the needle guide body 86 and configured to receive and guide the needle 42 into the enlarged suprachoroidal space 24 when the actuator assembly 34 is in the actuated position. The needle guide channel 88 is elongated along a central axis aligned with a position distal to the sclera 26 in the enlarged suprachoroidal space 24. Therefore, this position is also distal to the attachment position 61 of the attachment member 36 and the sclera 26 when the attachment assembly 34 is in the actuated position. This position is also proximal to the choroid 28 in the enlarged suprachoroidal space 24. Therefore, the central axis of the needle guide channel 88 is configured to extend through the sclera 26 and into the enlarged suprachoroidal space 24 when the actuator assembly 34 is in the actuated position.

[0053] The central axis of the needle guide channel 88 can be defined at any suitable angle θ relative to the longitudinal direction L and therefore relative to each of the proximal and distal directions, as needed. The angle θ can be measured in a plane that includes both the central axis of the needle guide channel 88 and the longitudinal direction L. The angle θ can be between approximately 50 degrees and approximately 90 degrees, such as between approximately 60 degrees and approximately 80 degrees, such as between approximately 70 degrees and approximately 80 degrees. In a particular example, the angle θ could be approximately 78 degrees.

[0054] In one example, the needle guide 40 may be fixed to the instrument body 30 in position and angle, so that angle θ may be a fixed angle. The fixed angle may be fixed relative to each of the instrument body 30 and the actuator assembly 34. In another example, the needle guide 40 may be positionally and / or angularly adjustable relative to the instrument body. For example, the needle guide 40 may be attached to the instrument body 30 via an arm that allows the needle guide 40 to move relative to each of the instrument body 30 and the actuator assembly 34 in any or more of the longitudinal direction L, the transverse direction T, and the lateral direction A at most all of them. The arm may also allow the needle guide 40 to be angularly adjustable relative to the instrument body 30 and the actuator assembly 34 to adjust angle θ as needed.

[0055] Angle θ is appropriate such that, after the suprachoroidal space 24 has been formed, the needle 42 can be driven through the needle guide channel 88, such that the distal end of the needle 42 pierces the sclera 26 at the enlarged suprachoroidal space 24 and can be driven through the sclera 26 and into the enlarged suprachoroidal space 24. The needle guide channel 88 guides the needle 42 to be driven into the enlarged suprachoroidal space 24 at angle θ. Once the needle 42 has been driven into the enlarged suprachoroidal space 24, a therapeutic agent can be delivered from the needle 42 (e.g., from the distal end of the needle 42) into the enlarged suprachoroidal space 24.

[0056] In one example, syringe 80 may include syringe housing 82, and needle 42 may extend from syringe housing. Syringe housing 82 may contain a predetermined amount of therapeutic agent. Syringe 80 may include a plunger that is driven into syringe housing 82 to force the predetermined amount of therapeutic agent to travel from syringe housing 82 through needle 42 and out of needle into the suprachoroidal space 24. In other examples, any suitable continuous delivery system may be used to continuously deliver a quantity of therapeutic agent through needle 42 into the enlarged suprachoroidal space 24.

[0057] Now, the overall reference Figures 3A to 7B Once the therapeutic agent has been delivered to the enlarged suprachoroidal space 24, the needle 42 can be removed from the enlarged suprachoroidal space 24 and the needle channel 88. The ocular access device 20 can be removed from the eye. For example, the attachment assembly 32 can be moved from an attachment position to a disengagement position, in which the attachment member 38 is removed from the sclera 26. Furthermore, the actuator assembly 34 can be moved from an engagement position to a disengagement position. In one example, the actuator assembly 34 is removed from... Figures 6A to 6B The adjacent positions shown are oriented towards Figures 3A to 3B The movement of the initial position shown allows the attachment component 32 to move from... Figures 4A to 4B The attachment position shown is moved to Figures 3A to 3B The disengagement position is shown.

[0058] Specifically, the user can apply a separation force to the actuator assembly 52, which causes the actuator assembly 34 to move in a separation direction opposite to the engagement direction. In one example, the separation force can be applied to the plunger 68. As mentioned above, the separation direction can be defined by a proximal direction. Therefore, when the actuator assembly 34 moves in the separation direction, the actuator assembly 34 can translate in the proximal direction. The movement of the actuator assembly 34 relative to the device housing 30 and the attachment assembly 32 in the separation direction causes the abutment member 38 to... Figures 6A to 6B The actuation position shown is moved to Figures 5A to 5BThe abutment position shown eliminates the abutment force from the abutment member 38 to the eye 22. Therefore, the enlarged suprachoroidal space 24 is eliminated when the eye access device 20 no longer separates the sclera 26 and choroid 28 from each other. When the actuator assembly 34 moves from the abutment position to the dismount position, the slider 57 can move toward the ramp protrusion surface 47. When the actuator assembly 34 moves to the abutment position, the slider can be spaced apart from the ramp protrusion surface 47 in the engagement direction of the actuator assembly.

[0059] Actuator assembly 34 can continue to move in the separation direction from Figures 5A to 5B The adjacent positions shown are driven to Figures 4A to 4B The intermediate position is shown. It should be understood that the movement of the actuator assembly 34 from the actuated position to the intermediate position in the separation direction can be continuous. Furthermore, because the slider 47 is spaced apart from the ramp protrusion surface 47, the movement of the actuator assembly 34 from the actuated position to the intermediate position will not cause the attachment assembly 32 to move in the disengagement direction. Figure 4A As shown, when the actuator assembly 34 is in the middle position, the slider 57 can be adjacent to the ramp protrusion surface 47.

[0060] Therefore, further movement of the actuator assembly in the separation direction from the intermediate direction toward the corresponding initial position causes the slider 57 to travel along the ramp protrusion surface 47, thereby causing the attachment assembly 32 to move in the disengagement direction. The movement of the attachment assembly 32 in the disengagement direction is opposite to the attachment direction. Therefore, the movement of the attachment assembly 32 in the disengagement direction can be defined by the pivoting movement of the actuator assembly 32 about a pivot axis in a second pivot direction opposite to the first pivot direction. Specifically, the ramp protrusion surface 47 is inclined such that the movement of the slider 57 in the proximal direction as it travels along the ramp protrusion surface 47 drives the attachment assembly 32 to pivot about a pivot axis relative to the device body 30 in the second pivot direction. The movement of the attachment assembly 32 in the disengagement direction from the attachment position causes the attachment member 36 to be removed from the sclera 36, ​​as... Figures 3A to 3B As shown. Once the attachment member 36 has been removed from the sclera 36, ​​the ocular access device can be removed from the eye 22.

[0061] Generally refer to Figures 1 to 12 Figure 7BOne or both of the attachment members 36 may be disposed in the respective conduit. Each conduit may be configured as a sleeve surrounding the respective attachment member 36. Each attachment member 36 may extend distally from the conduit. The attachment member 36 may be driven through the sclera in the manner described above, which allows the conduit to be driven through the sclera in the same way. Alternatively, the conduit may be moved distally along the attachment member 36 until the conduit extends through the sclera. Then, each attachment member 36 may be retracted from the sclera and the conduit, thereby leaving the conduit in the appropriate position after extending through the sclera. Thus, each conduit provides access to the interlaminar space for further blunt dissection and / or delivery of therapeutic agents to the eye beneath the sclera.

[0062] Further overall reference Figures 1A to 7B While the attachment assembly 32 may include an attachment member 36 configured to be removably attached to the sclera 26 in the manner described herein, it should be understood that the attachment member 36 may alternatively be configured as needed. For example, the attachment member 36 may be replaced by a cutting member comprising a cutting blade configured to form an incision in or through the sclera 26 when the attachment assembly is moved to the attachment position. Thus, the user may access the choroid 28 and the suprachoroidal space through the incision as needed.

[0063] It should be understood that the foregoing description provides examples of the disclosed apparatus and methods. However, other embodiments of this disclosure are contemplated that may differ in detail from the foregoing examples. For example, any aspect of the aspects disclosed herein may be combined with features disclosed relative to any other aspect of the other aspects disclosed herein. For example, while the movement of attachment assembly 32 has been described as pivotal movement, it should be understood that attachment assembly 32 may define any suitable alternative movement as needed from the respective initial and attachment positions, including but not limited to linear movement along a straight direction, linear movement along a curved direction, or rotational movement. Similarly, while the movement of actuator assembly 34 has been described as translational movement along a straight direction, it should be understood that attachment assembly 32 may define any suitable alternative movement as needed from the respective initial and attachment positions, including but not limited to translational movement along a curved direction, pivotal movement, or rotational movement.

[0064] All references to this disclosure or its examples are intended to refer to the specific examples being discussed at this time, and not to imply any limitation on the scope of this disclosure in a more general sense. All distinguishing and derogatory language regarding certain features is intended to indicate a lack of preference for those features, but does not exclude them entirely from the scope of this disclosure unless otherwise specified. Those skilled in the art will readily appreciate that existing or future processes, machines, manufactures, material compositions, apparatuses, methods, or steps can be utilized according to this disclosure to perform substantially the same functions or achieve substantially the same results as the corresponding embodiments described herein.

Claims

1. An eye-accessing device, comprising: The main body of the instrument; An attachment assembly supported by the device body and having an attachment member, wherein the attachment assembly is movable relative to the device body to an attachment position, in which a sharp tip of the attachment member is configured to insert into the sclera of the eye. and An actuator assembly supported by the device body and having an abutment member, the actuator assembly being movable relative to the device body to an actuation position, in which the abutment member is configured to abut the sclera at a location spaced apart from the attachment member, thereby increasing the distance between the sclera and the choroid to form an enlarged suprachoroidal space.

2. The eye access device of claim 1, wherein the attachment component is movable in the attachment direction from a disengaged position to the attachment position, wherein in the disengaged position, the attachment component is configured to be spaced apart from the eye.

3. The eye access device of claim 2, wherein the movement of the attachment member in the attachment direction is configured such that when the attachment member is in the attachment position, the attachment member extends into the sclera but does not penetrate the sclera.

4. The eye access device according to any one of the preceding claims, wherein the actuator assembly is movable in the engagement direction from a corresponding initial position to the actuating position, wherein the adjacent member is configured to be spaced apart from the eye in the corresponding initial position.

5. The ocular access device according to any one of the preceding claims further includes a needle guide having a needle guide channel extending along a central axis, wherein the central axis is aligned with a position distal to the attachment member when the attachment assembly is in the actuated position, wherein the needle guide channel is configured to receive a needle and guide the needle into the enlarged suprachoroidal space when the actuator assembly is in the actuated position.

6. The eye access device of claim 5, wherein the central axis of the needle guide channel is configured to extend through the sclera when the actuator assembly is in the actuated position.

7. The eye access device according to any one of claims 5 to 6, wherein the actuator assembly is movable in a distal direction from the respective initial position to the actuation position.

8. The eye access device of claim 7, wherein the needle guide channel of the needle guide is oriented at an angle between approximately 60 degrees and approximately 90 degrees relative to the distal direction.

9. The eye access device of claim 8, wherein the angle relative to the distal direction is between approximately 70 degrees and approximately 80 degrees.

10. The eye access device according to claim 9, wherein the angle is approximately 78 degrees.

11. The eye access device according to any one of claims 5 to 10, wherein the needle guide is adjustable in position and angle relative to the device body.

12. The eye access device according to any one of the preceding claims, wherein the attachment member defines a hook.

13. The eye access device according to any of the preceding claims, wherein the attachment member travels along an arcuate path as it moves from the respective initial position to the attachment position.

14. The eye access device of claim 13, wherein the attachment component includes a handle pivotally attached to the body of the device, and the attachment member extends from the handle.

15. The eye access device of claim 13, wherein a pivoting member pivotally attaches the handle to the device body, and the pivoting member is disposed between the attachment member and the engagement surface of the handle.

16. The eye access device of claim 15, wherein the handle is configured to pivot relative to the device body about a pivot axis defined by the pivot member, the attachment member comprising a pair of attachment members adjacent to each other along a direction, and the pivot axis being oriented along the direction.

17. The eye access device of claim 16, wherein the abutment member comprises a pair of abutment members adjacent to each other in a direction substantially parallel to the pivot axis, such that the attachment member is disposed between the abutment members.

18. The eye access device according to any of the preceding claims, wherein the body defines a distal end, the distal end being configured to be adjacent to the eye when the eye access device is placed against the eye.

19. The eye access device of claim 18, wherein the body defines a pair of walls, each of the pair of walls defining a distal end, the distal end being configured to be adjacent to the eye when the eye access device is placed against the eye.

20. The eye access device of claim 19, wherein the distal end is located in a plane perpendicular to the direction of movement of the actuator assembly, and the attachment member is pivoted to a position less than the distal end of the wall.

21. The eye access device according to any of the preceding claims, wherein the actuator assembly is capable of translating along a translational direction between the respective initial position and the actuated position.

22. The eye access device according to any of the preceding claims, wherein the actuator assembly further defines an adjacent position disposed between the respective initial position and the actuation position, wherein in the adjacent position, the adjacent member is configured to abut the sclera without applying a force to the eye sufficient to form the enlarged choroidal space.

23. The eye access device according to any one of the preceding claims, wherein a pivoting member pivotally connects the attachment assembly to the device body, the pivoting member extending through an elongated slot of the actuator assembly, wherein the pivoting member travels in the slot as the actuator assembly moves between the respective initial position and the actuated position.

24. An eye access device according to any one of the preceding claims, wherein the device body includes a guide member that guides movement of the adjacent member between the respective initial position and the actuated position.

25. The eye access device according to any one of the preceding claims, wherein the device body includes an eye locator configured to position the eye access device in a position and orientation relative to the eye when the attachment assembly and the actuator assembly are in their respective initial positions, such that the eye access device remains in the position during movement of the attachment assembly and the actuator assembly.

26. The eye access device of claim 25, wherein the eye locator is configured to be adjacent to the eye.

27. The eye access device of claim 25, wherein the eye locator is configured to be attached to the exterior of the eye.

28. The eye access device of claim 27, wherein the structure comprises one of a speculum and an operating table.

29. The eye access device according to any of the preceding claims, wherein movement of the actuator assembly in the separation direction causes the attachment assembly to move in the disengagement direction, thereby removing the attachment member from the sclera.

30. The eye access device of claim 29, wherein the actuator assembly includes a slider, the attachment assembly defines a ramp surface, and the slider travels along the ramp surface as the actuator assembly moves in the separation direction, thereby driving the attachment assembly to move in the separation direction.

31. A method for entering the suprachoroidal space of the eye, the method comprising the steps of: An attachment force is applied to the attachment component of the eye-entry device, thereby attaching the attachment component to the sclera; After the step of applying the attachment force, the engagement force is applied to the actuator assembly of the eye access device, thereby causing the abutment member of the actuator assembly to abut the eye; as well as Move either or both of the attachment member and the adjacent member to move either or both of the sclera and the choroid away from the other of the sclera and the choroid, so as to define an enlarged space on the choroid.

32. The method of claim 31, wherein the step of applying the attachment force moves the attachment member from a disengaged position to an attached position in the attachment direction, in the disengaged position the attachment member is spaced apart from the eye, and in the attached position the attachment member is attached to the sclera.

33. The method of claim 32, wherein the attachment direction is defined by the pivoting movement of the attachment component.

34. The method according to any one of claims 32 to 33, wherein the attachment member travels along an arcuate path and enters the sclera.

35. The method according to any one of claims 31 to 34, wherein the step of applying the engagement force moves the abutment member from a separated position to an abutment position in the engagement direction, in the separated position the abutment member is spaced apart from the eye, and in the abutment position the abutment member is adjacent to the sclera.

36. The method of claim 35, further comprising applying the engagement force to the actuator assembly to move the abutment member from the abutment position to an actuated position in the engagement direction, wherein the abutment member applies an abutment force that moves the choroid inward.

37. The method according to any one of claims 35 to 36, wherein the engagement direction is defined by a distal translation direction toward the eye.

38. The method according to any one of claims 31 to 37, wherein the step of applying the attachment force causes the attachment member to be attached to the sclera at a selected choroidal region, the step of applying the engagement force causes the adjoining member to be abutted at an adjoining position adjacent to the selected choroidal region, and the moving step causes the selected choroidal region to define the enlarged choroidal space.

39. The method according to any one of claims 31 to 38, further comprising the following step: The guide needle passes through the eye into the needle guard of the instrument and into the enlarged suprachoroidal region, and delivers the therapeutic agent into the enlarged suprachoroidal space.

40. The method of claim 39, wherein the method further comprises: After the therapeutic agent is delivered, the adjoining assembly is moved in the separation direction to remove the adjacent member from the eye.

41. The method of claim 40, wherein the step of moving the joining assembly in the separation direction moves the attachment member in the disengagement direction, thereby removing the attachment member from the sclera.

Images