Method and apparatus for facilitating access to an eye

Abstract

An ocular access instrument (20) includes an attachment assembly (32) configured to engage the 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 inward against the eye displaces the choroid from the sclera, thereby creating an enlarged suprachoroidal space. The ocular access instrument can further include a needle guide (40) that is configured to receive a needle and guide the needle into the enlarged suprachoroidal space.

Description

METHOD AND APPARATUS FOR FACILITATING ACCESS TO AN EYETECHNICAL FIELD

[0001] This disclosure relates generally to pharmaceutical devices and related methods for delivering a therapeutic agent, and more particularly to ocular guides and related methods for facilitating needle access to an interior of an eye.BACKGROUND

[0002] The eye is a complex organ with a variety of specialized tissues that provide the optical and neurological processes for vision. Accessing the eye for medical treatment is hindered by the small size and delicate nature of the tissues. The posterior region of the eye, including the retina, macula, choroid, and optic nerve, is especially difficult to access due to the recessed position of the eye within the orbital cavity. In addition, topical eye drops penetrate poorly into the posterior region, further restricting treatment options.

[0003] The suprachoroidal space is a potential space in the eye for treatment options. The suprachoroidal space is located between the sclera, which is the outer layer of the eye, and the choroid, which is the inner vascular tunic disposed between the sclera and the retina. The suprachoroidal space extends from the anterior portion of the eye near the ciliary body to the posterior end of the eye near the optic nerve. Normally the suprachoroidal space is not evident due to the close apposition of the choroid to the sclera from the intraocular pressure of the eye. Since there is no substantial attachment of the choroid to the sclera, the tissues separate to form the suprachoroidal space when fluid accumulation or other conditions occur. The suprachoroidal space provides a potential route of access from the anterior region of the eye to treat the posterior region.

[0004] Accessing the suprachoroidal space of the eye is a delicate procedure that requires substantial skill and time. There are several methods for accessing this space in order to deliver a therapeutic agent, but the complexity and time required are a barrier to widespread use. Any attempt to puncture the sclera with a needle in an attempt to access a specific depth (and therefore a specific inter-layer space) faces the challenge of providing enough force to penetrate the relatively tough sclera tissue without over penetrating. This challenge is exaggerated by the compliant nature of the eye and no means to provide support to the opposite side of the tissue being penetrated.SUMMARY

[0005] In one example, an ocular access instrument can include an instrument body, an attachment assembly supported by the instrument body, and an actuator assembly supported by the instrument body. The attachment assembly can have an attachment member. The attachment assembly can be movable to an attachment position whereby the attachment member is attached to a sclera of the eye. The actuator assembly can include an abutment member. The actuator assembly can be movable to an actuated position whereby the abutment member bears against the sclera at a location spaced from the attachment member, thereby increasing a distance between the sclera and the choroid so as to create an enlarged suprachoroidal space.

[0006] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description section. 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 constrained to limitations that solve any or all disadvantages noted in any part of this disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The foregoing summary, as well as the following detailed description of illustrative embodiments of the present application, will be better understood when read in conjunction with the appended drawings. For the purposes of illustrating the locking structures of the present application, there is shown in the drawings illustrative embodiments. It should be understood, however, that the application is not limited to the precise arrangements and instrumentalities shown. In the drawings:

[0008] Fig. 1 A is a perspective view of an ocular access instrument having an attachment assembly and an actuator assembly, and a needle guide constructed in accordance with one example, the ocular access instrument configured to be placed against an eye;

[0009] Fig. IB is a perspective view of the ocular access instrument of Fig. 1A shown placed against the eye, having portions cut away to show the attachment assembly in an attachment position and the actuator assembly in an actuated position to create an enlarged suprachoroidal space of the eye;

[0010] Fig. 1C is a perspective view of the ocular access instrument of Fig. IB, shown with a needle guided through the needle guide and into the enlarged suprachoroidal space;

[0011] Fig. 2A is an exploded perspective view of the ocular access instrument of Fig. 1A;

[0012] Fig. 2B is a perspective view of an ocular access instrument constructed in another example;

[0013] Fig. 3 A is a sectional side elevation view of the ocular access instrument of Fig. 1 A, shown disposed against the eye in an initial configuration whereby each of the attachment assembly and the actuator assembly are disposed in a respective initial position;

[0014] Fig. 3B is a sectional end elevation view of the ocular access instrument of Fig. 3A;

[0015] Fig. 4A is a sectional side elevation view of the ocular access instrument of Fig. 3A, whereby the attachment assembly is shown in the attachment position, and the actuator assembly is shown in an intermediate position;

[0016] Fig. 4B is a sectional end elevation view of the ocular access instrument of Fig. 4A;

[0017] Fig. 5A is a sectional side elevation view of the ocular access instrument of Fig. 4A, whereby the actuator assembly is disposed in an abutment position;

[0018] Fig. 5B is a sectional end elevation view of the ocular access instrument of Fig. 5A;

[0019] Fig. 6A is a sectional side elevation view of the ocular access instrument of Fig. 5A, whereby the actuator assembly is disposed in an actuated position to create an enlarged suprachoroidal space;

[0020] Fig. 6B is a sectional end elevation view of the ocular access instrument of Fig. 6A;

[0021] Fig. 7A is a sectional side elevation view of the ocular access instrument of Fig. 6A, showing a needle extending through the needle guide and into the suprachoroidal space; and

[0022] Fig. 7B is an enlarged sectional side elevation view of an enlarged portion of Fig. 7A.DETAILED DESCRIPTION

[0023] Certain terminology used in this description is for convenience only and is not limiting. The words “axial”, “radial”, “circumferential”, “outward”, “inward”, “upper,”, “lower”, “top”, and “bottom” designate directions in the drawings to which reference is made.As used herein, the term “substantially,” “approximately,” derivatives thereof, and words of similar import, when used to describe a size, shape, orientation, distance, spatial relationship, or other parameter includes the stated size, shape, orientation, distance, spatial relationship, or other parameter, and can also include a range up to 10% more and up to 10% less than the stated parameter, including 5% more and 5% less, including 3% more and 3% less, including 1% more and 1% less. The term “substantially,” “approximately,” and the like are intended to mean considerable in extent or largely but not necessarily wholly (but can include wholly) that which is specified. All ranges disclosed herein are inclusive of the recited endpoint and independently combinable (for example, the range of “from 2 grams to 10 grams” is inclusive of the endpoints, 2 grams and 10 grams, and all the intermediate values). The terminology includes the abovelisted words, derivatives thereof and words of similar import.

[0024] Referring to Figs. 1A-1C, an 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 an eye 22 (see Fig. 3A). The eye 22 can be a human eye, or the eye of a nonhuman animal. The ocular access instrument 20 can include an instrument body 30, an attachment assembly 32 supported by the instrument body 30, and an actuator assembly 34 supported by the instrument body 30. The attachment assembly 32 and the actuator assembly 34 are independently movable with respect to the instrument body 30. In particular, the attachment assembly 32 is movable in an attachment direction from a respective initial or detachment position shown in Fig. 1A to an attachment position shown in Fig. IB, whereby the attachment assembly 32 removably attaches to the eye, and in particular to the sclera 26. The actuator assembly 34 is movable in an engagement direction from a respective initial or disengagement position to an actuated position whereby the actuator assembly 34 applies a force to the eye that increases a distance between the sclera 26 and the choroid 28, thereby creating the enlarged suprachoroidal space 24.

[0025] The attachment assembly 32 can include at least one attachment member 36 such as a pair of attachment members 36 that are spaced from the eye 22 when the attachment assembly 32 is in the respective initial or detachment position. Thus, in the respective initial position, the attachment members 36 do not engage the sclera 26 of the eye 22. In the attachment position, the attachment members 36 attach to the sclera 26 of the eye 22 at respective attachment locations. In particular, the attachment members 36 can extend into the sclera 26 when the attachment assembly is in the attachment position. The attachment assembly32 is further movable in a detachment direction from the attachment position toward the respective initial or detachment position, whereby the attachment members 36 are removed from the eye 22, and in particular from the sclera 26. It should be appreciated that the detachment position can be defined by the initial position of the attachment assembly 32, or any other position of the attachment assembly 32 whereby the attachment members 36 do not engage or attach to the eye 22.

[0026] The actuator assembly 34 can include at least one abutment member 38 such as a pair of abutment members 38 that are spaced from the eye 22 when the actuator assembly 34 is in the initial or disengagement position as shown at Fig. 1 A, and bears against the eye 22 when the attachment assembly 32 is in the actuated position as shown at Fig. IB. As the abutment member 38 moves in the engagement direction and applies a force against the eye 22, and in particular to the sclera 26, the force causes the sclera 26 to and choroid to become inwardly displaced. However, the attachment members 36 prevent the sclera 26 from becoming inwardly displaced at the attachment locations, thereby creating the enlarged suprachoroidal space 24 as shown at Fig. IB. The actuator assembly 34 is further movable in a disengagement direction from the actuated position to the respective initial or disengagement position. In the disengagement position, the abutment members 38 are removed from the eye 22, and in particular from the sclera 26. It should be appreciated that the detachment position can be defined by the initial position of the actuator assembly 34 or any other position of the actuator assembly 34 whereby the at least one abutment member 38 does not apply a force to the eye 22 that is sufficient to create the enlarged suprachoroidal space 24.

[0027] As shown at Fig. 1C, the ocular access instrument 20 can further include a needle guide 40 that is configured to receive a needle 42 and guide the needle 42 into the enlarged suprachoroidal space 24 to deliver a therapeutic agent into the enlarged suprachoroidal space 24.

[0028] Referring now to Fig. 2A, the ocular access instrument 20 will be described in more detail. In particular, the attachment assembly 32 can include a handle 44, a pivot shaft 45 that is pivotally attached to the instrument body 30, and the attachment members 36 can extend from the pivot shaft 45. The handle 44 and the pivot shaft 45 can, in combination, define an attachment body 35. The handle 44 and the pivot shaft 45 can be monolithic with each other or discretely attached to each other as desired. Similarly, the attachment members 36 can bemonolithic with the handle 44, or discretely attached to the handle 44 as desired. The attachment assembly 32 can further include a pivot member 46, such as a pivot pin, that pivotally couples the attachment assembly 32, and in particular the handle 44, to the instrument body 30. The pivot pin can extend through the handle 44 and apertures of the instrument body 30 to pivotally couple the attachment assembly 32 to the instrument body 30.

[0029] The instrument body 30 defines a proximal end 31 and a distal end 33 opposite the proximal end 31 in a distal direction. Conversely, the proximal end 31 is opposite the distal end 33 in a proximal direction. The distal end 33 can be defined by a pair of distal walls 41 that are opposite each other along a transverse direction T. The distal walls 41 can define respective distal ends that, in turn, define seats 58 that are configured to abut the eye 22 during operation. It is appreciated that any suitable sleeves or sheaths can be placed onto the walls 41, and it can still be said that the walls 41 define the abutment members seats 58.

[0030] The handle 44 can define an engagement surface 48, such that the pivot member 46 is disposed between the engagement surface 48 and the at least one attachment member 36. An attachment force applied to the engagement surface 48 causes attachment assembly 32 to move in the attachment direction from the detachment position to the attachment position. In particular, the attachment force applied to the engagement surface 48 of the handle 44 can drive handle 44 to pivot about a pivot axis defined by the pivot member 46 along a first pivot direction from the detachment position to the attachment position. The pivot axis can be a fixed pivot axis that does not move in either of the proximal and distal directions during operation. Thus, the attachment direction can be defined by the first pivot direction. The attachment assembly 32 can define at least one stop member 51 such as a pair of stop members 51 that are configured to abut the instrument body 30 so as to limit the amount that the attachment assembly 32 pivots in the first pivot direction. The stop members 51 can extend from the handle 44. The attachment assembly 32 is further movable in a detachment direction from the attachment position to the detachment position.

[0031] The pivot axis is oriented along a pivot axis direction. The pivot axis direction can be defined by the transverse direction T. The attachment members 36 can extend from the handle 44, and can be disposed adjacent each other along the direction that is defined by the pivot axis. The attachment members 36 can define hooks 37 having sharpened distal tips 39. The hooks 37 can be curved in respective planes that are oriented perpendicular to the directiondefined by the pivot axis. As will be described in more detail below, pivoting the handle 44 about the pivot axis in the first pivot direction causes the attachment members 36 to be driven into the sclera, and pivoting the handle about the pivot axis in a second direction opposite the first pivot direction causes the attachment members 36 to be removed from the sclera.

[0032] With continuing reference to Fig. 2A, the actuator assembly 34 includes an actuator member 52, and an actuator shaft 54 that extends 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 can define abutment members 38 that are configured to abut the eye 22 during operation. In particular, the actuator member 52 can extend proximally from a proximal end of the actuator shaft 54, and the abutment members 38 can extend distally from a distal end of the actuator shaft 54. The actuator member 52 and the actuator shaft 54 can, in combination, define an actuator body 53. The actuator member 52 and the actuator shaft 54 can be monolithic with each other or discretely attached to each other as desired. Similarly, the abutment members 38 can be monolithic with the actuator shaft 54 or can be discretely attached to the actuator shaft 54 as desired.

[0033] The abutment members 38 can be adjacent each other, and spaced from each other along the pivot axis direction. Thus, the abutment members 38 can be spaced from each other in the same direction along which the attachment members 36 are spaced. The abutment members 38 can be spaced from each other a sufficient distance such that the attachment members 36 are disposed between the abutment members 38. As will be described in more detail below, the actuator member 52 is configured to receive an engagement force that causes the actuator assembly 34 to move in the engagement direction. In particular, the actuator assembly 34 can be driven to translate along a direction of translation in the engagement direction. The direction of translation can be defined by a distal direction. Movement of the actuator assembly 34 in the engagement direction can cause the actuator assembly 34 to move from the initial position to the actuated position. The actuator assembly 34 is further movable in the disengagement direction, which can be defined by movement or translation of the actuator assembly 34 in a proximal direction opposite the distal direction. Movement of the actuator assembly 34 in the disengagement position causes the actuator assembly 34 to move in a direction from the actuated position toward the initial position. The proximal and distaldirections are both oriented along the longitudinal direction L. The longitudinal direction L is oriented substantially perpendicular to the transverse direction T.

[0034] The actuator assembly 34 can further define a slot 56 that extends through the actuator body 53 along the pivot axis direction, which as described above can be defined by the transverse direction T. The slot 56 can be sized and configured to receive the pivot member 46. The slot 56 can extend through the actuator shaft 54, but can extend through either or both of the actuator shaft 54 and the actuator shaft 54 and the actuator member 52. The slot 56 can be sized to receive the pivot member 46, and can elongate along the engagement and disengagement directions of the actuator assembly 34. Thus, the pivot member 46 can be configured to ride in the slot 56 selectively in the engagement and disengagement directions. In one example, the slot 56 can be a straight linear slot that is elongate along the longitudinal direction L. Thus, pivot member 46 can thus travel in the slot 56 along the longitudinal direction as the actuator assembly 34 moves between the respective initial position and the actuated position.

[0035] In one example, the actuator assembly 34 can include a traveler 57 that is supported by the actuator body 53, and in particular by the actuator shaft 54. In one example, the actuator shaft 54 can include at least one wall 55 that defines the at least one abutment member 38. The at least one wall 55 can include opposed walls 55 that are spaced from each other, and the traveler 57 can extend between the walls 55. The opposed walls 55 are configured to be disposed between the distal walls 41 of the instrument body 30. The walls 55 define respective distal ends that, in turn, define the abutment members 38. It is appreciated that any suitable sleeves or sheaths can be placed onto the walls 55, and it can still be said that the walls 55 define the abutment members 38. The slot 56 can extend through the actuator shaft 54, and in particular through each of the opposed walls 55 of the actuator assembly 34. The walls 55 can be spaced from each other along the transverse direction T a distance sufficient to receive the attachment body 35, and in particular the pivot shaft 45 therebetween. The traveler 57 can ride along a ramped cam surface 47 of the attachment body 35, and in particular of the pivot shaft 45, during operation. The ramped cam surface 47 can define a slope along a lateral direction A as the ramped cam surface 47 extends along the longitudinal direction L. The lateral direction A can be oriented substantially perpendicular to each of the longitudinal direction L and the transverse direction T. The ramped cam surface 47 can flare laterally outward as it extends in the proximal direction, and conversely flares laterally inward as it extends in the distal direction.

[0036] With continuing reference to Fig. 2A, the needle guide 40 can extend from the instrument body 30. In one example, the needle guide 40 can be discretely attached to the instrument body 30. In other examples, the needle guide 40 can be monolithic with the instrument body 30. Either way, it can be said that the needle guide 40 is supported by the instrument body 30.

[0037] The ocular access instrument 20 can further include an ocular locator 60 that is configured to position the ocular access instrument 20 at a desired location and orientation relative to the eye 22 during operation of the instrument 20 (i.e., during movement of the attachment assembly 32 and the actuator assembly 34). The ocular locator 60 can extend from the instrument body 30. For instance, the ocular locator 60 can be monolithic with the instrument body 30 or discretely attached to the instrument body 30 as desired. In one example, the ocular locator 60 is configured to abut the eye 22 at a predetermined location of the eye 22 such that the attachment members 36 engage respective the sclera 26 at respective desired locations and the abutment members 38 abut the sclera at respective desired locations (see Fig. IB). The respective desired locations can be posterior of the limbus, such that the needle 42 can be injected into the enlarged suprachoroidal space at a location posterior of the limbus. In one example, the ocular locator 60 can be positioned on the anterior hemisphere of the eye 22. For instance, the ocular locator 60 can be positioned about the cornea so that the ocular locator is disposed about the iris. In one example, the ocular locator 60 can be configured as an annular body such as an annular ring 62 that surrounds the iris. The ocular locator 60 can be rigidly coupled to the instrument body 30 in one example. In other examples, the instrument body 30 can be positionally manipulated with respect to the ocular locator 60.

[0038] Referring to Fig. 2B, the ocular locator 60 can alternatively be configured as a mounting bracket 64 that can be secured to any suitable structure external of the eye 22 as desired. In one example, the mounting bracket 64 can be configured to be secured to a speculum, an operating table, or any alternative structure that is fixed with respect to the eye 22. An arm 66 can extend between the mounting bracket 64 and the instrument body 30. The arm 66 can be adjustable so as to define a desired position of the instrument body 30 when the mounting bracket 64 is secured to the structure.

[0039] Operation of the ocular access instrument 20 will now be described with initial reference to Figs. 3A-3B. In particular, the ocular access instrument 20 is shown with theattachment assembly 32 in the respective initial or detachment position and the actuator assembly 34 in the respective initial position. The ocular access instrument 20 can be positioned such that respective distal ends of the distal walls 41 of the instrument body 30 are positioned against the eye 22, such that the seats 58 are disposed against the eye 22, and in particular the sclera 22. Thus, the ocular access instrument 20 defines a working region 23 of the eye 22 between the distal walls 41, and in particular between the seats 58. During operation of the ocular access instrument 20, the working region 23 of the eye 22 will define the enlarged suprachoroidal space.

[0040] When the attachment assembly 32 is in the detachment position, the attachment members 36 are disposed outward from the eye 22, and in particular from the sclera 26. Further, the engagement surface 48 of the handle 44 is disposed outward with respect to the instrument body 30 in the lateral direction A. Further, the ocular access instrument 20 is configured to maintain the attachment assembly 32 in the respective initial position absence the attachment force applied to the handle 44 that urges the attachment assembly 32 to move to the attachment position. In particular, the traveler 57 abuts the ramped cam surface 47 of the attachment body 35, and resists pivoting of the attachment assembly 32 about the pivot axis in the first pivot direction. In this regard, abutment between the traveler 57 and the ramped cam surface 47 can prevent inadvertent pivoting of the attachment assembly 32 in the attachment direction from the respective initial position toward the attachment position.

[0041] When the actuator assembly 34 is in the respective initial position, the proximal end of the actuator member 52 can extend proximal of the proximal end 31 of the instrument body 30. In one example, the proximal end of the actuator member 52 can define a plunger 68 that is configured receive the engagement force that causes the actuator assembly 34 to move in the engagement direction. The actuator member 52, and in particular the plunger, can be engaged by a user’s thumb that applies the engagement force. Thus, a user’s thumb can engage the actuator member 52 while the user’s fingers of the same hand can engage the handle 44. The fingers can apply the attachment force to the attachment assembly 32, and the user’s thumb can apply the engagement force to the actuator member 52 of the actuator assembly 34. The engagement force can be oriented in the distal direction.

[0042] The pivot member 46 extends through the instrument body 30 and further through the slot 56 of the actuator assembly 34, such that the pivot member 46 is configured to travel inthe proximal direction in the slot 56 as the actuator assembly moves in the engagement direction. Engagement between the pivot member 46 and the instrument body 30 can prevent translation of the attachment assembly 32 relative to the instrument body 30. In one example, the pivot member 46 can extend through the slot 56 at or proximate to a distal end of the slot 56. Therefore, abutment between the pivot member 46 and the actuator body 53 at the distal end of the slot 56 can prevent the actuator assembly 34 from being removed from the instrument body 30. The opposed walls 55 of the actuator assembly 34 can be positioned such that the abutment members 38, which can be defined by the distal ends of the opposed walls 55, are disposed outward from the eye 22, and in particular from the sclera 26, when the actuator assembly 34 is in the respective initial position. In one example, the abutment members 38 of the actuator assembly 34 are spaced from the eye in the proximal direction, or direction opposite the engagement direction. In one example, the abutment members 38 can be offset in the proximal direction from the seats 58 defined by the distal end of the instrument body 30. Thus, it can be said that the abutment members 38 are recessed in or disposed in the instrument body 30 when the actuator assembly 34 is in the respective initial position.

[0043] The ocular access instrument 20 is configured to maintain the actuator assembly 34 in the respective initial position absence an engagement force applied to the actuator member 52 that urges the actuator assembly 34 to move to the actuated position. In particular, the instrument body 30 can support a securement member 70 that is configured to be disposed in a first or distal detent 72a of the actuator body 53, and in particular the actuator member 52. The securement member 70 can be spherically shaped or can define any suitable alternative shape as desired. Mechanical interference between the securement member 70 and the actuator body 53 in the first detent 72a can resist movement of the actuator assembly 34 in the distal direction relative to instrument body 30. In this regard, abutment between the traveler securement member 70 and the actuator body 30 in the first detent 72a can prevent inadvertent movement of the actuator assembly 34 in the distal direction from the initial position toward the actuated position.

[0044] Referring now to Figs. 4A-4B, the attachment assembly 32 is shown in the attachment position. In particular, an attachment force is applied to the handle 44, and in particular to the engagement surface 48 of the handle 44, that is sufficient to cause the handle 44 to pivot about the pivot axis in the first pivot direction with respect to the instrument body 30.The user can apply the attachment force with his or her fingers against the engagement surface 48. In particular, the ocular access instrument can be gripped or otherwise engaged by the user with the thumb bearing against the proximal end of the actuator member 52, such as the plunger 68, and one or more the fingers bearing against the engagement surface 48 of the handle 44. The attachment force can thus be provided by the user’s fingers. The attachment force causes the attachment assembly 32 to move in the attachment direction. It should be appreciated that the attachment assembly 32 can be moved in the attachment direction in any suitable alternative manner as desired.

[0045] As the attachment assembly 32 moves in the attachment direction, which can be defined by a pivotal motion relative to the instrument body 30 from the respective initial position to the attachment position, the attachment members 36 travel along an arcuate path. Thus, the attachment members 36 can be driven into the sclera 26 along the arcuate path. Accordingly, it can be said that the attachment members 36 attach to the sclera at respective attachment locations 61 of the sclera. For instance, the attachment members 36 can be driven into the sclera 26. In one example, the attachment members 36 are driven into the sclera 26 along a direction that is substantially tangent to the sclera 26. In particular, the sharpened distal tips 39 of the hooks 37 are driven into the sclera 26. In one example, the attachment members 36 are driven into but not through the sclera 26. Thus, the attachment members 36 are driven into an outer surface of the sclera 26 but not through an inner surface of the sclera that faces the choroid 28 and is opposite the outer surface. In other examples, the attachment members 36 can be driven through the sclera 26 but not into the choroid 28. In still other examples, in particular when the attachment members 36 define hooks 37, the attachment members can enter the outer surface of the sclera 26, extend along a portion of the sclera 26 between the outer and inner surfaces of the sclera 26, and exit the sclera 26 at its outer surface. When the attachment assembly 32 is in the attachment position the attachment members 36 can be positioned no further distal than a plane that 1) is defined by the seats 58, and 2) is oriented perpendicular to the longitudinal direction L. For instance, the attachment members 36 can be spaced from the plane in the proximal direction.

[0046] When the attachment assembly 32 has pivoted to the attachment position, the stop members 51 abut the instrument body 30, thereby preventing further pivotal movement of the attachment assembly 32 in the first pivot direction with respect to the instrument body 30. Thus, abutment of the stop members 51 and the instrument body 30 prevents the attachment assembly32 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.

[0047] The attachment force can be oriented toward the instrument body 30, and causes the ramped cam surface 47 to urge the traveler 57 to ride along the ramped cam surface 47 in the distal direction relative to the instrument body 30. Movement of the traveler 57 in the distal direction relative to the instrument body 30 and the attachment assembly 32 provides clearance between the ramped camp surface 47 and the traveler 57 for further pivotal movement of the attachment assembly 32 in the first pivot direction. When the attachment assembly 32 has moved to the attachment position, the traveler 57 can be in abutment with the ramped cam surface 47.

[0048] Because the traveler 57 is translatably fixed to the actuator body 53, movement of the traveler 57 in the distal direction during movement of the attachment assembly 32 to the attachment position causes the actuator assembly 34 to move in the engagement direction relative to the instrument body 30 from the respective initial position to an intermediate position. As shown, the engagement direction of the actuator assembly 34 can be defined by a direction of translation. The direction of translation can, in turn, be defined by the distal direction. Thus, the actuator assembly 34 moves from its respective initial position to the intermediate position that is spaced from the initial position in the engagement direction, which can be defined by the distal direction. In the intermediate position, the abutment members 38 are spaced from the eye 22 in the proximal direction (or direction opposite the engagement direction). Because in the intermediate position, the abutment members 38 are spaced from the eye 22, and thus do not apply a force to the eye 22 sufficient to create an enlarged suprachoroidal space, the actuator assembly 34 can be said to be in the disengagement position when the actuator assembly 34 is in the intermediate position.

[0049] Movement of the actuator assembly 34 in the engagement direction to the intermediate position can cause the securement member 70 to ride out of the first detent 72a and travel along a surface 76 of the actuator body 53, and in particular of the actuator member 52, in the proximal direction. The surface 76 of the actuator body 53 defines the first detent 72a and a second or proximal detent 72b that is spaced from the first detent 72a in the proximal direction. The surface 76 can be defined by the actuator member 52. Thus, the securement member 70moves in the proximal direction along the surface 76 from the first detent 72a toward the second detent 72b.

[0050] Further, the pivot member 46 disposed in the slot 56 can travel in the slot 56 as the actuator assembly 34 moves in the engagement direction from the initial position. In particular, because the slot 56 moves in the engagement direction relative to the pivot member 46, the pivot member 46 can move in the slot 56 in a direction opposite the engagement direction. Thus, the pivot member 46 can move in the slot in the proximal direction as the actuator member 46 moves in the engagement direction. Because the actuator member 34 is further movable in engagement direction from the intermediate position, the slot 56 extends from the pivot member 46 in the proximal direction when the actuator assembly 34 is in the intermediate position.

[0051] Referring now to Figs. 5A-5B, the actuator assembly 34 can move from the intermediate position to an abutment position whereby the abutment members 38 abut the eye 22, and in particular the sclera 26, at respective abutment locations 63. The abutment locations 36 can defined at respective outermost extents of the working region 23 of the eye. In particular, the abutment members 38 can move distally toward and to the eye 22 as the actuator assembly 34 moves in the engagement direction to the abutment position. During operation of the ocular access instrument 20, the actuator assembly 34 can move continuously in the engagement direction from the intermediate position to the actuated position without stopping at the abutment position shown in Fig. 5A-5B. However, the actuator assembly 34 is shown in the abutment position for descriptive purposes. In some instances, the surgeon may wish to stop movement of the actuator assembly 34 in the abutment position when the actuator assembly 34 is in the abutment position to inspect the eye 22 prior to further movement of the actuator assembly 34 to the actuated position to define the enlarged suprachoroidal space 24 (see Figs. 6A-6B).

[0052] As described above, the actuator assembly 34 is configured to receive an engagement force that drives the actuator assembly 34 to move in the engagement direction. The engagement force can be applied to the actuator member 52, and in particular to the plunger 68 as described above. In particular, after the attachment assembly 32 has been moved or pivoted to the attachment position, the actuator assembly 34 can be moved in the engagement direction from the intermediate position shown at Figs. 4A-4B to the abutment position shown in Figs. 5A-5B. In particular, the actuator assembly 34 can be translated from the intermediate positionin the engagement direction to the abutment position. Thus, as shown in Figs. 3A-5B, the actuator assembly 34 is movable in the engagement direction from the respective initial position to the abutment position. It should be appreciated that the abutment position of the attachment assembly 32 is disposed between the respective initial position and the actuated position. In the abutment position, the abutment members 38 abut the eye 22 but do not apply a force to the eye 22 sufficient to create an enlarged suprachoroidal space. Therefore, the actuator assembly 34 can be said to be in the disengagement position when the actuator assembly 34 is in the abutment position.

[0053] Because the traveler 57 extends from the actuator body 53 and is positionally fixed to the actuator body 53, movement of the actuator assembly 34 in the engagement direction causes the traveler 57 to similarly move in the engagement direction with respect to the ramped cam surface 47. Thus, the traveler 57 moves to a position spaced from the ramped cam surface 47. Because the engagement direction of the actuator assembly 34 can be defined by the distal direction in one example, the traveler 57 moves away from the ramped cam surface 47 in the distal direction as the actuator assembly 34 is moved in the engagement direction after the attachment assembly 32 has been moved to the attachment position.

[0054] As shown, the instrument body 30 defines at least one actuator member that is configured to guide the movement of the actuator assembly 34 between the respective initial position and the actuated position. In one example, the actuator member can be configured as at least one guide channel 74. As shown, the instrument body 30 includes a pair of guide channels 74 each defined by a respective inner guide wall 78 of the instrument body 30 and an outer guide wall 78 of the instrument body 30. In one example, the outer guide wall 78 can be defined by the distal end 33 of the instrument body 30. In particular, first and second outer guide walls 78 can be defined by the distal walls 41 of the instrument body, respectively, that cooperate with first and second inner guide walls 78 so as to define first and second actuator guide channels 74. The actuator guide channels 74 can be sized to receive respective ones of the opposed walls 55 of the actuator shaft 54, and guide the opposed walls 55 of the actuator assembly 34 as the opposed walls move 55 during selective movement of the actuator assembly 34 in the engagement and disengagement directions.

[0055] Due to the curvature of the eye 22, and because the at least one wall 55 is disposed between the walls 41 of the instrument body 30, the one or more abutment members 38defined by the at least one wall 55 can be offset in the proximal direction with respect to the seats 58 defined by the distal end of the instrument body 30 when the actuator assembly 34 is in the abutment position. Nevertheless, both the abutment members 38 and the seats 58 can be in simultaneous contact with the eye 22, and in particular the sclera 26, when the actuator assembly 34 is in the abutment position.

[0056] As shown in Fig. 5A, the securement member 70 travels proximally along the surface 76 of the actuator body 53 as the actuator assembly 34 moves in the engagement direction from the intermediate position to the abutment position. Thus, when the actuator assembly 34 moves from the respective initial position to the abutment position, the securement member 70 travels out of the first or distal detent 72a along the surface 76 toward the second or proximal detent 72b. The securement member 70 is disposed between the first and second detents 72a and 72b when the actuator assembly 34 is in the abutment position.

[0057] Further, the pivot member 46 disposed in the slot 56 can travel in the slot 56 as the actuator assembly 34 moves in the engagement direction from the intermediate position to the abutment position. In particular, because the slot 56 moves in the engagement direction relative to the pivot member 46, the pivot member 46 can move in the slot 56 in a direction opposite the engagement direction. Thus, the pivot member 46 can move in the slot in the proximal direction as the actuator member 46 moves in the engagement direction to the abutment position. Because the actuator member 34 is further movable in engagement direction from the abutment position to the actuated position, the slot 56 extends from the pivot member 46 in the proximal direction when the actuator assembly 34 is in the abutment position.

[0058] Referring now to Figs. 6A-6B, the engagement force applied to the actuator assembly 34 can move the actuator assembly in the engagement direction relative to the instrument body 30 and the grip assembly 32 to the actuated position. In the actuated position, the abutment members 38 can apply an abutment force to the eye 22, and in particular the sclera 26, in the distal direction. The abutment force applied by the abutment members 38 to the eye 22 can be in an inward direction of (i.e. into) the eye 22. The abutment force applied by the abutment members 38 to the eye 22 is sufficient to displace the sclera 26 and the underlying choroid 28 inwardly or distally to an inwardly displaced position with respect to the attachment locations 61 of the sclera 26 and a region of the sclera 26 immediately adjacent the attachment locations 61. The immediately adjacent region of the sclera 26 can include locations of thesclera 26 between the abutment locations 63 in one example. The attachment locations 61 and immediately adjacent regions of the sclera 26 can be collectively referred to as a select suprachoroidal region. The select suprachoroidal region can be adjacent the abutment locations 63.

[0059] Because the attachment members 36 remain positionally fixed as the abutment members 38 move distally with respect to the instrument body 30, the attachment members 36 prevent the sclera 26 from becoming inwardly displaced at the select suprachoroidal region. However, because the attachment members 36 of the attachment assembly 32 are not secured to the choroid 28, the inward displacement of the abutment members 38 against the eye 22 causes a substantial entirety of the choroid 28 at the select suprachoroidal region to become inwardly displaced with respect to the sclera 26 at the select suprachoroidal region. Because the choroid 28 and the sclera 26 separate at the select suprachoroidal region, thereby increasing a distance between the choroid 28 and the sclera 26, the enlarged suprachoroidal region 24 is defined at the select suprachoroidal region.

[0060] It should be appreciated that the abutment members 38 move to a position that is distal of the seats 58 defined by the distal end of the instrument body 30. Accordingly, the abutment members 38 can move the eye 22 to a position spaced from the seats 58 in the distal direction. Thus, in some examples, the seats 58 of the instrument body 30 no longer abut the eye 22 when the actuator assembly 34 is in the actuated position.

[0061] It should therefore be appreciated that in one mode of operation, the movement of the abutment members 38 in the distal direction to the actuated position causes the choroid 28 and the sclera 26 to move inwardly at the abutment locations 63 with respect to the sclera 36 at the attachment locations 61. The result is that the choroid 28 moves distally with respect to the sclera 26 at the select suprachoroidal region, thereby separating the sclera 26 and the choroid in the manner described above.

[0062] However, in another mode of operation, the user can elect to pull the instrument body 30, and thus the grip assembly 32, in the proximal direction relative to the actuator assembly 34, which again causes the actuator assembly 34 to move in the distal direction with respect to the instrument body 30 and the grip assembly 32 to the actuated position. In this example, the attachment members 36 can pull the sclera 26 proximally away from the choroid 28 in the select suprachoroidal region while the abutment members 38 brace the eye 22 at theabutment locations 63 to precent proximal movement of the choroid at the select suprachoroidal region, thereby causing the sclera 26 and the choroid 28 to separate.

[0063] In still other modes of operation, the actuator assembly 34 can move distally relative to the eye 22 as described above, while the instrument body 30 is pulled in the proximal direction relative to the actuator assembly 34 as described above. This causes both the abutment members 38 to inwardly displace the eye at the abutment locations 63, and the attachment members 36 to pull the sclera 26 proximally away from the choroid 38. Thus, both the sclera 26 and the choroid 28 can move away from each other to create the separation of the sclera 26 and the choroid 28 at the select suprachoroidal region. It can therefore be said that the ocular access instrument 20 can be configured to move either or both of the sclera 26 and the choroid 28 away from the other of the sclera 26 and choroid 28, which increases a distance between the sclera 26 and the choroid 28 so as to create the enlarged suprachoroidal space 24. In particular, moving either or both of the attachment members 36 and the abutment members 48 can cause either or both of the to move away from the other of the sclera 26 and the choroid 28.

[0064] With continuing reference to Figs. 6A-6B, because the traveler 57 extends from the actuator body 53 and is positionally fixed to the actuator body 53, movement of the actuator assembly 34 in the engagement direction from the abutment position to the actuated position causes the traveler 57 to similarly move in the engagement direction with respect to the ramped cam surface 47. Thus, the traveler 57 moves to a position spaced further from the ramped cam surface 47. Because the engagement direction of the actuator assembly 34 can be defined by the distal direction in one example, the traveler 57 moves further away from the ramped cam surface 47 in the distal direction as the actuator assembly 34 is moved in the engagement direction from the abutment position to the actuated position. The opposed walls 55 of the actuator shaft 54 can be guided in the guide channels 74 in the manner described above as the actuator assembly 34 moves or translates to the actuated position.

[0065] As shown in Fig. 6A, the securement member 70 travels proximally along the surface 76 of the actuator body 53 as the actuator assembly 34 moves in the engagement direction from the intermediate position to the abutment position. When the actuator assembly 34 moves from the abutment position to the actuated position, the securement member 70 travels along the surface 76 and into the second or proximal detent 72b. Mechanical interference between the securement member 70 and the actuator body 53 in the second detent 72b can resistmovement of the actuator assembly 34 in the proximal direction relative to instrument body 30. In this regard, abutment between the traveler securement member 70 and the actuator body 30 in the second detent 72b can prevent inadvertent movement of the actuator assembly 34 in the disengagement direction an amount sufficient to reduce or eliminate the enlarged suprachoroidal space 24. In one example, the securement member 70 and the second detent 72b can have substantially matching curvatures, such that the securement member 70 can nest in the second detent 72b. The curvatures can be defined by diameters of respective spheres in some examples. In this regard, the device can provide either or both of tactile and audible feedback when the actuator assembly is in the actuated position. In other examples, the second detent 72b can be configured as an elongate channel that is longer along the longitudinal direction than the securement member 70. The second detent 72b can be shaped and configured to prevent the actuator assembly 34 from over-traveling in the direction from the abutment position to the actuated position.

[0066] Further, the pivot member 46 disposed in the slot 56 can travel in the slot 56 as the actuator assembly 34 moves in the engagement direction from the abutment position to the actuated position. In particular, because the slot 56 moves in the engagement direction relative to the pivot member 46, the pivot member 46 can move in the slot 56 in a direction opposite the engagement direction. Thus, the pivot member 46 can move in the slot in the proximal direction as the actuator member 46 moves in the engagement direction to the abutment position. The pivot member 46 can be disposed at a proximal end of the slot 56 when the actuator assembly 34 is in the actuated position. Thus, abutment between the pivot member 46 and the actuator body 53 in the slot 56 can prevent further movement of the pivot member 46 in the slot 56 in the proximal direction, which thus prevents further movement of the actuator assembly 34 in the engagement direction. Accordingly, the ocular access instrument 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 separation forces that are applied to the eye 22 that causes separation between the sclera 26 and the choroid 28.

[0067] Referring now to Figs. 7A-7B, and as described above, the ocular access instrument 20 can 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 that extends through the needle guide body 86 andis configured to receive the needle 42 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 elongate along a central axis that is aligned with a location that is distal of the sclera 26 in the enlarged suprachoroidal space 24. Thus, the location is also distal of the attachment members 36 and the attachment locations 61 of the sclera 26 when the attachment assembly 34 is in the actuated position. The location is also proximal of the choroid 28 in the enlarged suprachoroidal space 24. Accordingly, 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.

[0068] The central axis of the needle guide channel 88 can define any suitable angle 0 with respect to the longitudinal direction L, and thus with respect to each of the proximal and distal directions, as desired. The angle 0 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 0 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 one particular example, the angle 0 can be approximately 78 degrees.

[0069] In one example, the needle guide 40 can be positionally and angularly fixed to the instrument body 30, thus the angle 0 can be a fixed angle. The fixed angle can be fixed with respect to each of the instrument body 30 and the actuator assembly 34. In another example, the needle guide 40 can be positionally and / or angularly adjustable with respect to the instrument body. For instance, the needle guide 40 can be attached to the instrument body 30 by an arm that allows the needle guide 40 to be movable in any one or more up to all of the longitudinal direction L, the transverse direction T, and the lateral direction A with respect to each of the instrument body 30 and the actuator assembly 34. The arm can further allow the needle guide 40 to be angularly adjustable relative to the instrument body 30 and the actuator assembly 34 so as to adjust the angle 0 as desired.

[0070] The angle 0 is suitable such that, after the suprachoroidal space 24 has been created, the needle 42 can be driven through the needle guide channel 88, such that a 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 channel88 can guide the needle 42 to be driven into the enlarged suprachoroidal space 24 at the angle 0. Once the needle 42 has been driven into the enlarged suprachoroidal space 24, a therapeutic agent can then be delivered from the needle 42, for instance from the distal end of the needle 42, and into the enlarged suprachoroidal space 24.

[0071] In one example, a syringe 80 can include a syringe housing 82, and the needle 42 can extend from the syringe housing. The syringe housing 82 can contain a predetermined quantity of the therapeutic agent. The syringe 80 can include a plunger that is driven into the syringe housing 82 to force the predetermined quantity of therapeutic to travel from the syringe housing 82, through the needle 42, and out of the needle into the suprachoroidal space 24. In other examples, a quantity of therapeutic agent can be continuously delivered into the enlarged suprachoroidal space 24 through the needle 42 using any suitable continuous delivery system.

[0072] Referring now to Figs. 3A-7B in general, 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 from the needle channel 88. The ocular access instrument 20 can be removed from the eye. For instance, the attachment assembly 32 can be moved from the attachment position to the detachment position whereby the attachment members 38 are removed from the sclera 26. Further, the actuator assembly 34 can be moved from the engagement position to the disengagement position. In one example, movement of the actuator assembly 34 from the abutment position shown in Figs. 6A-6B toward the initial position shown in Figs. 3A-3B can cause the attachment assembly 32 to be moved from the attachment position shown in Figs. 4A-4B to the detachment position shown in Figs. 3A-3B.

[0073] In particular, a user can apply a disengagement force to the actuator member 52 that causes the actuator assembly 34 to move in the disengagement direction opposite the engagement direction. In one example, the disengagement force can be applied to the plunger 68. As described above, the disengagement direction can be defined by the proximal direction. Thus, the actuator assembly 34 can translated in the proximal direction as it moves in the disengagement direction. Movement of the actuator assembly 34 in the disengagement direction relative to the instrument housing 30 and the attachment assembly 32 causes the abutment members 38 to move from the actuated position shown in Figs. 6A-6B to the abutment position shown in Figs. 5A-5B, which removes the abutment force from the abutment members 38 to the eye 22. Consequently, the enlarged suprachoroidal space 24 can be removed as the ocular accessinstrument 20 no longer separates the sclera 26 and the choroid 28 from each other. As the actuator assembly 34 is moved in the disengagement position from the actuated position, the traveler 57 can move toward the ramped cam surface 47. When the actuator assembly 34 is moved to the abutment position, the traveler can be spaced from the ramped cam surface 47 in the engagement direction of the actuator assembly.

[0074] The actuator assembly 34 can continue to be driven in the disengagement direction from the abutment position shown in Figs 5A-5B to the intermediate position shown in Figs. 4A-4B. It should be appreciated that movement of the actuator assembly 34 in the disengagement direction from the actuated position to the intermediate position can be continuous. Further, because the traveler 47 is spaced from the ramped cam surface 47, movement of the actuator assembly 34 from the actuated position to the intermediate position does not cause the attachment assembly 32 to move in the detachment direction. As shown in Fig. 4A, the traveler 57 can abut the ramped cam surface 47 when the actuator assembly 34 is in the intermediate position.

[0075] Accordingly, further movement of the actuator assembly in the disengagement direction from the intermediate direction toward the respective initial position causes the traveler 57 to ride along the ramped cam surface 47, thereby causing the attachment assembly 32 to move in the detachment direction. Movement of the attachment assembly 32 in the detachment direction is opposite the attachment direction. Thus, movement of the attachment assembly 32 in the detachment direction can be defined by pivotal movement of the actuation assembly 32 in a second pivot direction about the pivot axis opposite the first pivot direction. In particular, the ramped cam surface 47 is sloped such that movement of the traveler 57 in the proximal direction while the traveler 57 rides along the ramped cam surface 47 drives the attachment assembly 32 to pivot about the pivot axis in the second pivot direction relative to the instrument body 30. Movement of the attachment assembly 32 in the detachment direction from the attached position causes the attachment members 36 to be removed from the sclera 36 as shown in Figs. 3A-3B. Once the attachment members 36 have been removed from the sclera 36, the ocular access instrument can be removed from the eye 22.

[0076] Referring to Figs. 1-7B generally, either or both of the attachment members 36 can be disposed in a respective catheter. Each catheter can be configured as a sleeve that surrounds the respective attachment member 36. Each attachment members 36 can extenddistally out from the catheter. The attachment members 36 can be driven through the sclera in the manner described above, which can cause the catheter to likewise be driven through the sclera. Alternatively, the catheter can be moved distally along the attachment member 36 until the catheter extends through the sclera. Each attachment member 36 can then be withdrawn from the sclera and the catheter, thereby leaving the catheter in place extending through the sclera. Each catheter can thus provide access to the inter-layer space for further blunt dissection and / or delivery of a therapeutic agent to the eye beneath the sclera.

[0077] With further reference to Figs. 1A-7B generally, while the attachment assembly 32 can include attachment members 36 that are configured to be removably attached to the sclera 26 in the manner described herein, it should be appreciated that the attachment members 36 can be alternatively configured as desired. For instance, the attachment members 36 can be replaced by a cutting member that includes a cutting blade configured to make an incision into or through the sclera 26 when the attachment assembly moves to the attachment position. Thus, a user can have access to the choroid 28 and the suprachoroidal space through the incision as desired.

[0078] It will be appreciated that the foregoing description provides examples of the disclosed apparatus and methods. However, it is contemplated that other implementations of the disclosure may differ in detail from the foregoing examples. For example, any of the aspects disclosed herein can incorporate features disclosed with respect to any of the other aspects disclosed herein. As an example, while movement of the attachment assembly 32 has been described as a pivotal movement, it should be appreciated that the attachment 32 assembly can define any suitable alternative movement as desired from the respective initial position and the attachment position, including but not limited to linear movement along a straight direction, linear movement along a curvilinear direction, or rotational movement. Similarly, while movement of the actuator assembly 34 has been described as a translational movement along a straight direction, it should be appreciated that the attachment 32 assembly can define any suitable alternative movement as desired from the respective initial position and the attachment position, including but not limited to translational movement along a curvilinear direction, pivotal movement, or rotational movement.

[0079] All references to the disclosure or examples thereof are intended to reference the particular example being discussed at that point and are not intended to imply any limitation as to the scope of the disclosure more generally. All language of distinction and disparagement withrespect to certain features is intended to indicate a lack of preference for those features, but not to exclude such from the scope of the disclosure entirely unless otherwise indicated. As one of ordinary skill in the art will readily appreciate from that processes, machines, manufacture, composition of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present disclosure.

Claims

What is claimed is:

1. An ocular access instrument comprising: an instrument body; an attachment assembly supported by the instrument body and having an attachment member, wherein the attachment assembly is movable relative to the instrument body to an attachment position whereby a sharpened tip of the attachment member is configured to be inserted into a sclera of the eye; and an actuator assembly supported by the instrument body and having an abutment member, the actuator assembly movable with respect to the instrument body to an actuated position whereby the abutment member is configured to bear against the sclera at a location spaced from the attachment member, thereby increasing a distance between the sclera and the choroid so as to create an enlarged suprachoroidal space.

2. The ocular access instrument of claim 1 , wherein the attachment assembly is movable in an attachment direction from a detachment position, whereby the attachment member is configured to be spaced from the eye, to the attachment position.

3. The ocular access instrument of claim 2, wherein the movement of the attachment member in the attachment direction is configured to cause the attachment member to extend into but not through the sclera when the attachment assembly is in the attachment position.

4. The ocular access instrument of any one of the preceding claims, wherein the actuator assembly is movable in an engagement direction from a respective initial position, whereby the abutment member is configured to be spaced from the eye, to the actuated position.

5. The ocular access instrument of any one of the preceding claims, further comprising a needle guide having a needle guide channel extending along a central axis that is aligned with a location distal of 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 ocular access instrument 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 ocular access instrument of any one of claims 5 to 6, wherein the actuator assembly is movable in a distal direction from the respective initial position to the actuated position.

8. The ocular access instrument 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 with respect to the distal direction.

9. The ocular access instrument of claim 8, wherein the angle is between approximately 70 and approximately 80 degrees with respect to the distal direction.

10. The ocular access instrument of claim 9, wherein the angle is approximately 78 degrees.

11. The ocular access instrument of any one of claims 5 to 10, wherein the needle guide is positionally and angularly adjustable relative to the instrument body.

12. The ocular access instrument of any one of the preceding claims, wherein the attachment member defines a hook.

13. The ocular access instrument of any one of the preceding claims, wherein the attachment member travels along an arcuate path as the attachment assembly moves from the respective initial position to the attachment position.

14. The ocular access instrument of claim 13, wherein the attachment assembly includes a handle that is pivotally attached to the instrument body, and the attachment member extends from the handle.

15. The ocular access instrument of claim 13, wherein a pivot member pivotally attaches the handle to the instrument body, and the pivot member is disposed between the attachment member and an engagement surface of the handle.

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

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

18. The ocular access instrument of any one of the preceding claims, wherein the body defines a distal end that is configured to abut the eye when the ocular access instrument is placed against the eye.

19. The ocular access instrument of claim 18, wherein the body defines a pair of walls that each define distal ends that are configured to abut the eye when the ocular access instrument is placed against the eye.

20. The ocular access instrument of claim 19, wherein the distal ends lie in a plane that is perpendicular to a direction of movement of the actuator assembly, and the attachment members pivot to a location that is no further distal than the distal ends of the walls.

21. The ocular access instrument of any one of the preceding claims, wherein the actuator assembly is translatable along a direction of translation between the respective initial position and the actuated position.

22. The ocular access instrument of any one of the preceding claims, wherein the actuator assembly further defines an abutment position disposed between the respective initial position and the actuated position, wherein in the abutment position the abutment member is configured to abut the sclera without applying a force to the eye sufficient to create the enlarged suprachoroidal space.

23. The ocular access instrument of any one of the preceding claims, wherein a pivot member pivotally couples the attachment assembly to the instrument body, the pivot member extendsthrough an elongate slot of the actuator assembly, wherein the pivot member travels in the slot as the actuator assembly moves between the respective initial position and the actuated position.

24. The ocular access instrument of one of the preceding claims, wherein the instrument body comprises a guide member that guides movement of the abutment member between the respective initial position and the actuated position.

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

26. The ocular access instrument of claim 25, wherein the ocular locator is configured to abut the eye.

27. The ocular access instrument of claim 25, wherein the ocular locator is configured to attach to a structure external of the eye.

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

29. The ocular access instrument of any one of the preceding claims, wherein movement of the actuator assembly in a disengagement direction causes the attachment assembly to move in a detachment direction thereby removing the attachment member from the sclera.

30. The ocular access instrument of claim 29, wherein the actuator assembly comprises a traveler, the attachment assembly defines a ramped surface, and the traveler rides along the ramped surface as the actuator assembly moves in the disengagement direction, thereby driving the attachment assembly to move in the disengagement direction.

31. A method of accessing a suprachoroidal space of an eye, the method comprising the steps of: applying an attachment force to an attachment assembly of an ocular access instrument, which causes an attachment member to attach to a sclera;after the step of applying the attachment force, applying an engagement force to an actuator assembly of the ocular access instrument, thereby causing an abutment member of the actuator assembly to abut the eye; and moving either or both of the attachment member and the abutment member, thereby causing either or both of the sclera and the choroid to move away from the other of the sclera and the choroid so as to define an enlarged suprachoroidal space.

32. The method of claim 31 , wherein the step of applying the attachment force causes the attachment member to move in an attachment direction from a detachment position, whereby the attachment member is spaced from the eye, to an attachment position whereby the attachment member attaches to the sclera.

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

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

35. The method of any one of claims 31 to 34, wherein the step of applying the engagement force causes the abutment member to move in an engagement direction from a disengagement position, whereby the abutment member is spaced from the eye, to an abutment position whereby the abutment member abuts the sclera.

36. The method of claim 35, further comprising applying the engagement force to the actuator assembly so as to move the abutment member in the engagement direction from the abutment position to an actuated position whereby the abutment member applies an abutment force that causes the choroid to move inwardly.

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

38. The method of any one of claims 31 to 37, wherein the step of applying the attachment force causes the attachment member to attach to the sclera at a select suprachoroidal region, the step of applying the engagement force causes the abutment member to abut the eye at anabutment location adjacent the select suprachoroidal region, and the moving step causes the select suprachoroidal region to define the enlarged suprachoroidal space.

39. The method of any one of claims 31 to 38, further comprising the step of guiding a needle through a needle guard of the ocular access instrument and into the enlarged suprachoroidal region, and delivering a therapeutic agent into the enlarged suprachoroidal space.

40. The method of claim 39, wherein any one of claims 31 to 39, further comprising, after delivery of the therapeutic agent, moving the engagement assembly in a disengagement direction, which removes the abutment member from the eye.

41. The method of claim 40, wherein the step of moving the engagement assembly in the disengagement direction causes the attachment member to move in a detachment direction that removes the attachment member from the sclera.

Images