Ophthalmic cannula guides, applicators, and marking devices

Abstract

The device (200) includes a pair of rigid legs (210) extending parallel to each other along a plane. Each leg of the pair has a sharp tip (215). The device also includes a head (210) which includes a top surface (222), a bottom surface (224), a pair of end surfaces (226), a pair of side surfaces (227), and a guide notch (230) extending upward from the bottom surface. The guide notch is configured to work with the surface of the sclera of the patient's eye to define a guide opening oriented laterally with respect to the plane associated with the legs and dimensioned to receive a cannula having a substantially flat external shape. The head further includes a pair of receptacles (240) extending laterally inward from each of the side surfaces of the pair. Each receptacle of the pair is configured to engage with a deployment device.

Description

Background Art

[0001] Background The human eye includes several layers. The white outer layer is the sclera, which surrounds the choroid layer. The retina is located inside the choroid layer. The sclera contains collagen and elastic fibers and protects the choroid and retina. The choroid layer includes a vasculature that supplies oxygen and nutrients to the retina. The retina includes photosensitive tissue containing rods and cones. The macula is located at the center of the retina at the posterior part of the eye, and is generally centered on the axis passing through the centers of the lens and cornea of the eye (i.e., the optical axis). The macula provides central vision, particularly via cone cells.

[0002] Macular degeneration is a medical condition affecting the macula such that people suffering from macular degeneration may experience loss or reduction of central vision while retaining some degree of peripheral vision. Macular degeneration can be caused by various factors such as age-related macular degeneration (also known as "AMD") and genetics. Macular degeneration can occur in a "dry" (non-exudative) form, in which cell debris known as drusen accumulates between the retina and the choroid, resulting in areas of geographic atrophy. Macular degeneration can also occur in a "wet" (exudative) form, in which blood vessels grow from the choroid behind the retina. Even though people with macular degeneration may retain some degree of peripheral vision, the loss of central vision can have a significant adverse impact on quality of life. Furthermore, the quality of the remaining peripheral vision may deteriorate and in some cases may be lost. Accordingly, it may be desirable to administer treatment for macular degeneration to prevent or restore vision loss caused by macular degeneration. In some cases, it may be desirable to administer such treatment in a highly localized manner, such as by delivering a therapeutic substance to the subretinal layer (beneath the neurosensory layer of the retina and above the retinal pigment epithelium) directly adjacent to the area of geographic atrophy near the macula. However, since the macula is located at the back of the eye and beneath the delicate layers of the retina, accessing the macula in a practical manner can be difficult.

[0003] Although various surgical methods and instruments have been fabricated and used to treat the eye, it is believed that no one prior to the present inventors fabricated or used the present invention as described in the attached claims. [Brief explanation of the drawing]

[0004] This specification concludes with claims that specifically point to and explicitly claim this art, which is considered to be better understood from the description of the following specific examples in conjunction with the accompanying drawings, and similar reference numbers identify the same elements.

[0005] [Figure 1] A perspective view of an example of an instrument for subretinal administration of therapeutic agents via a suprachoroidal approach is shown.

[0006] [Figure 2] Figure 1 shows a perspective view of the device attached near the patient, along with a combination of medical devices.

[0007] [Figure 3] A perspective view of an example of a guide tack that may be used to guide the cannula of the instrument shown in Figure 1 during the procedure for subretinal administration of therapeutic agents is shown.

[0008] [Figure 4] Figure 3 shows a front view of the guide tack.

[0009] [Figure 5] Figure 3 shows a bottom view of the guide tack.

[0010] [Figure 6] Figure 3 shows a side view of the guide tack.

[0011] [Figure 7] Figure 6 shows a cross-sectional view of the guide tack in Figure 3, along line 7-7.

[0012] [Figure 8]Shows a perspective view of an example of a deployment instrument that may be used to deploy the guide tack of Figure 3 in a patient's eye.

[0013] [Figure 9A] Shows a top view of the deployment instrument of Figure 8, illustrating a pair of lever arms of the deployment instrument in a closed state for gripping the guide tack of Figure 3.

[0014] [Figure 9B] Shows a top view of the deployment instrument of Figure 8, illustrating the pair of lever arms in an open state for releasing the guide tack of Figure 3.

[0015] [Figure 10] Shows a perspective view of an example of a marking instrument that may be used to mark a patient's eye.

[0016] [Figure 11] Shows a side view of the distal end of the marking instrument of Figure 10.

[0017] [Figure 12] Shows a cross-sectional view of the distal end of the marking instrument of Figure 10, taken along line 12-12 of Figure 11.

[0018] [Figure 13] Shows a front view of the distal end of the marking instrument of Figure 10.

[0019] [Figure 14A] Shows a top view of a patient's eye, where the marking instrument of Figure 10 is used to mark the guide tack deployment site and the sclerotomy site on the eye.

[0020] [Figure 14B] Shows a top view of the eye of Figure 14A, where the deployment instrument of Figure 8 is being used to deploy the guide tack of Figure 3 into the eye.

[0021] [Figure 14C] Shows a top view of the eye of Figure 14A, with the guide tack of Figure 3 deployed in the eye.

[0022] [Figure 14D] Figure 14A shows a supra-view of the eye, with a scleral incision made at the site of the scleral incision.

[0023] [Figure 14E] Figure 14A shows a suprascal view of the eye, where the cannula of the instrument in Figure 1 is guided through the guide tuck in Figure 3 to the scleral incision in Figure 14D.

[0024] [Figure 15A] This shows a lateral cross-sectional view of the patient's eye.

[0025] [Figure 15B] Figure 3 shows the guide tuck deployed in the eye, and a scleral incision is being made; Figure 15A shows a lateral cross-sectional view of the eye.

[0026] [Figure 15C] Figure 15A shows a lateral cross-sectional view of the eye, in which the cannula of the instrument shown in Figure 1 is inserted between the sclera and choroid of the eye through the scleral incision opening.

[0027] [Figure 15D] Figure 15A shows a lateral cross-sectional view of the eye, where the distal end of the cannula is located adjacent to the target position.

[0028] [Figure 15E] Figure 15A shows a lateral cross-sectional view of the eye, where the needle of the instrument in Figure 1 advances through the choroid to access the subretinal space at the target location.

[0029] [Figure 15F] Figure 15E shows a needle dispensing a first volume of pre-bleb fluid, resulting in separation between the retinal region and the choroid at the target location, as shown in Figure 15A, a lateral cross-sectional view of the eye.

[0030] [Figure 15G]Figure 15E shows the needle dispensing the therapeutic agent between the retinal region and the choroid at the target location, as shown in Figure 15A, a lateral cross-sectional view of the eye.

[0031] The drawings are not intended to be limiting in any way, and various embodiments of the Art are intended to be carried out in various other ways, including those not necessarily shown in the drawings. The accompanying drawings incorporated herein and forming part of this specification illustrate some aspects of the Art and, together with the description, help to illustrate the principles of the Art. However, it should be understood that the Art is not limited to the exact arrangement shown. [Modes for carrying out the invention]

[0032] Detailed explanation The following description of specific examples of the Art should not be used to limit its scope. Other examples, features, aspects, embodiments, and advantages of the Art will be apparent to those skilled in the art from the following description, which is illustrative and represents one of the best modes intended for carrying out the Art. As should be understood, all other different apparent embodiments of the Art described herein are possible without departing from the Art. Therefore, the drawings and descriptions should be considered illustrative and not restrictive in nature.

[0033] It will be further understood that one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the teachings, expressions, embodiments, examples, etc. described below should not be viewed in isolation from one another. Various suitable ways in which the teachings herein may be combined will be readily apparent to those skilled in the art, given the teachings herein. Such modifications and variations are intended to be included within the claims.

[0034] To clarify the disclosure, the terms “proximal” and “distal” are defined herein in relation to the surgeon or other operator holding a surgical instrument having a distal surgical end effector. The term “proximal” refers to the location of an element closer to the surgeon or other operator, while the term “distal” refers to the location of an element closer to the surgical end effector of the surgical instrument and further away from the surgeon or other operator.

[0035] Furthermore, terms such as “about” and “approximately” used herein in relation to any numerical value or range of values ​​are intended to include an appropriate tolerance that enables the referenced exact value, as well as the referenced feature or combination of features, to function for the intended purposes described herein.

[0036] I. Examples of devices for subretinal administration of therapeutic agents

[0037] Figure 1 shows an example of an instrument (100) configured for use in a procedure for subretinal administration of a therapeutic agent into a patient's eye (101) via a suprachoroidal approach. The instrument (100) comprises a body (110) and a flexible cannula (130) extending distally from the body (110). The cannula (130) in this example has a cross-sectional profile configured to allow the cannula (130) to pass non-traumatically along the suprachoroidal space, as will be described in more detail below. The cannula (130) is generally configured to support a needle (150) that is slidable within the cannula (130), as will be described in more detail below.

[0038] In this example, the cannula (130) comprises a flexible material such as polyether block amide (PEBA), but any other suitable material or combination of materials may be used. The cannula (130) in this example is flexible enough to conform to the specific structure and contour of the patient's eye, but the cannula (130) has sufficient column strength to allow the cannula (130) to advance between the sclera (104) and choroid (106) of the patient's eye (101) without buckling. The cannula (130) includes a laterally oriented opening (not shown) near the distal end (132) of the cannula (130). The opening may be formed by a U-shaped lateral recess of the cannula (130) that leads to the open distal end (not shown) of a needle guide lumen within the cannula (130). The distal end (132) is non-traumatic and, as a result, is configured to result in separation between the sclera and choroidal layers (104, 106) via blunt dissection, as described in more detail below, thereby allowing the cannula (130) to advance between such layers (104, 106) without traumatizing the sclera or choroidal layers (104, 106).

[0039] As merely an example, a cannula (130) may be configured and operable in accordance with at least some of the teachings of U.S. Patent No. 10,226,379, issued March 12, 2019, entitled “Method and Apparatus for Subretinal Administration of Therapeutic Agent,” which is incorporated herein by reference in its entirety; U.S. Patent No. 10,646,374, issued May 12, 2020, entitled “Apparatus and Method to From Entry Bleb for Subretinal Delivery of Therapeutic Agent,” which is incorporated herein by reference in its entirety; and U.S. Provisional Patent No. 63 / 455,131, filed March 28, 2023, entitled “Apparatus for Subretinal Administration of Therapeutic Agent via Dual-Curved Needle,” which is incorporated herein by reference in its entirety and / or in any other appropriate manner.

[0040] The needle (150) can be advanced distally so as to protrude from the opening of the cannula (130). The needle (150) in this example has a sharp distal tip (not shown) that defines the lumen (not shown). The distal tip may have a lancet configuration. In some other versions, the distal tip has a tribevel configuration, such as described in U.S. Patent No. 10,226,379, or any other configuration, the disclosure of U.S. Patent No. 10,226,379, is incorporated herein by reference in its entirety. Further other suitable forms that the distal tip may take will be apparent to those skilled in the art in view of the teaching herein. In this example, when the cannula (130) is positioned in the suprachoroidal lumen, as will be described in more detail below, the substantially rectangular, substantially elliptical, or otherwise substantially flat cross-sectional shape of the cannula (130) prevents the cannula (130) from rotating around its longitudinal axis. This results in a consistent and predictable orientation of the opening of the cannula (130), as will be described in more detail below, and thereby a consistent and predictable exit path for the needle (150) as it advances distally to the cannula (130). As just a further example, the needle (150) may include one or more pre-formed curves in accordance with at least some of the teachings of U.S. Patent No. 10,478,553, issued November 19, 2019, entitled “Apparatus for Subretinal Administration of Therapeutic Agent via a Curved Needle,” and / or U.S. Provisional Patent Application No. 63 / 455,131, filed March 28, 2023, entitled “Apparatus for Subretinal Administration of Therapeutic Agent via Dual-Curved Needle,” the entire disclosure of which is incorporated herein by reference.

[0041] As shown in Figure 1, the instrument (100) in this example further comprises an operating knob (120) located on the top (114) of the body (110). The operating knob (120) is rotatable relative to the body (110), thereby selectively translating the needle (150) longitudinally relative to the cannula (130). In particular, the operating knob (120) is rotatable in a first angular direction to drive the needle (150) distally relative to the cannula (130) and is rotatable in a second angular direction to drive the needle (150) proximal relative to the cannula (130). As mere example, the instrument (100) may provide such function via the knob (120) in accordance with at least some of the teachings of U.S. Patent No. 10,646,374, the disclosure thereof is incorporated herein by reference in whole. Other suitable methods by which the rotational motion of the knob (120) can be converted into the linear motion of the needle (150) will be obvious to those skilled in the art in view of the teachings herein. Similarly, other suitable methods (150) by which the needle (150) can be actuated longitudinally with respect to the cannula (130) will be obvious to those skilled in the art in view of the teachings herein. As also shown in Figure 1, the conduit assembly (140) extends proximal to the body (110). The conduit assembly (140) is configured to house one or more fluid conduits (not shown) that are in fluid communication with the needle (150). In some versions, such fluid conduits are coupled to a source of pre-bleb fluid and therapeutic agent.

[0042] II. Examples of systems for subretinal administration of therapeutic agents

[0043] Figure 2 shows a scenario in which the instrument (100) is positioned relative to the patient. In this example, a drape (160) is placed over the patient, and an opening (161) is formed in the drape (160) near the patient's eye (101). An eyelid retractor (162) is used to keep the eye (101) open. A fixation device (164) is placed adjacent to the eye (101). The fixation device (164) may be used to fix an instrument, such as a viewing scope, to the patient. A magnetic pad (166) is attached to the drape (160) near the opening (161) adjacent to the eye (101). The instrument (100) is placed on the magnetic pad (166) and is detachably fixed to it via magnetic attraction. In this example, one or more permanent magnets (not shown) are located within the body (110) near the base (112), and these magnets are magnetically attracted to one or more ferrous elements (not shown) contained within a magnetic pad (166). As merely an example, these magnets and the magnetic pad (166) may be configured in accordance with at least part of the teachings of U.S. Patent No. 10,806,629, issued October 20, 2020, entitled “Injection Device for Subretinal Delivery of Therapeutic Agent,” the entire disclosure of which is incorporated herein by reference. The instrument (100) is oriented to allow insertion of the flexible cannula (130) of the instrument (100) into the eye (101). An example of the process for inserting and positioning the cannula (130) into the eye (101) is described below in more detail with reference to Figures 15A–15G.

[0044] In this example, the instrument (100) is connected to a fluid delivery system (180) via a conduit assembly (190). In this example, the fluid delivery system (180) includes a bleb fluid source (182) and a therapeutic fluid source (184). The bleb fluid source (182) is connected to a bleb fluid conduit (192) of the conduit assembly (190), and the therapeutic fluid source (184) is connected to a therapeutic conduit (194) of the conduit assembly (190). The conduits (192, 194) are in fluid communication with the needle (150). In some versions, the fluid sources (182, 184) include syringes. In some other versions, the fluid sources (182, 184) include a separate reservoir and one or more associated pumps and / or valves, etc.

[0045] III. Examples of cannula guides

[0046] In some cases, a suture loop assembly (not shown) may be placed in the patient's eye (101) to stabilize and guide the cannula (130) while it is being inserted into the incision (107) of the eye (101). Those skilled in the art will recognize that forming the suture loop assembly can be somewhat time-consuming. Furthermore, it can be difficult to maintain consistent spacing between the suture loops of the suture loop assembly and between the suture loops and the eye (101). Variations in such spacing can result in variations in the entry angle and / or force required to insert the cannula (130) through the suture loop assembly. Therefore, it may be desirable to have a device that provides stabilization and guidance functions for the suture loop assembly, while being faster to attach to the eye (101), easier to attach, and yielding more consistent results than the suture loop assembly. Exemplary examples of such devices are described in more detail below. The devices described below may require a lower level of expertise, resulting in faster placement times, minimizing variability due to surgeon skill, and requiring less surgical training. At the end of the procedure, the device can be removed from the eye (101) to ensure no foreign body remains in the eye (101).

[0047] Figures 3–7 show an example of a guide tuck (200) that may be used to guide a cannula (130) through an incision (107) in the eye (101) instead of using a suture loop assembly. The guide tuck (200) in this example includes a pair of legs (210) and a head (220), the legs (210) extending downward from the head (220). The free end of each leg (210) includes a sharp tip (212). In the illustrated example, each sharp tip (212) has a tribevel configuration. In particular, each sharp tip (212) includes three facets (214) that converge together at a distal point (215), but each pair of adjacent facets (214) also converges at a corresponding proximal point (219). This tribevel configuration facilitates relatively easy puncture of the eye (101) when the operator pushes the sharp tip (212) into the eye (101). Alternatively, the sharp tip (212) may have any other suitable configuration that allows the sharp tip (212) to puncture the tissue layers of the eye (101), including, but not limited to, various eye puncture tip configurations known in the art. In some versions, the sharp tip (212) and / or other parts of the leg (210) can be textured to improve the grip of tissue layers of the eye (101), such as the sclera (104).

[0048] The head (220) in this example has a top surface (222), a bottom surface (224), a pair of end surfaces (226), a pair of side surfaces (227), and a pair of chamfers (228) extending between the top surface (222) and each end surface (226). The head (220) further defines a guide notch (230) extending upward from the bottom surface (224) of the head (220). The guide notch (230) is oriented along an axis that traverses a plane defined between the legs (210). When the guide tack (200) is fixed to the eye (101), the guide notch (230) is configured to cooperate with the exposed surface (105) of the sclera (104) to define a guide opening. The guide opening, defined by the surface (105) of the sclera (104) and the guide notch (230), is sized and configured to slidably receive the cannula (130).

[0049] As best illustrated in Figures 4 and 5, the guide notch (230) in this example is defined by an upper notch surface (232) and a pair of outer notch surfaces (234). When viewed along the direction shown in Figure 4, the surfaces (232, 234) are configured such that, along a plane defined between the legs (210), the guide notch (230) is deflected outward from the centerline of the guide tack (200) in the central region of the guide notch (230) along the height of the guide notch (230). This configuration facilitates the cannula (130) to be captured within the guide opening defined by the surface (105) of the sclera (104) and the guide notch (230), ensuring that the cannula (130) remains at an appropriate distance from the surface (105) of the sclera (104).

[0050] When viewed along the direction shown in Figure 5, the surfaces (232, 234) are configured such that, along a plane perpendicular to the plane defined between the legs (210), the guide notch (230) is deflected inward toward the center line of the guide tack (200) in the central region of the guide notch (230) along the height of the guide notch (230). This configuration minimizes the amount of contact between the cannula (130) and the head (220), thereby minimizing the amount of friction between the cannula (130) and the head (220) as the cannula (130) slides through the surface (105) of the sclera (104) and the guide opening defined by the guide notch (230). By reducing friction, the risk of the cannula (130) accidentally pulling the guide tack (200) away from the eye (101) can be reduced as the cannula (130) slides through the guide opening defined by the surface (105) of the sclera (104) and the guide notch (230). Despite minimizing contact between the cannula (130) and the head (220) in this way, when the cannula (130) is positioned through the guide opening defined by the surface (105) of the sclera (104) and the guide notch (230), the surfaces (232, 234) may still provide sufficient contact to maintain the stability of the cannula (130).

[0051] In the illustrated example, in the central region of the guide notch (230), the upper notch surface (232) is separated from the bottom surface (224) of the head (220) by a vertical distance to define the minimum height (H) of the guide opening defined by the surface (105) of the sclera (104) and the guide notch (230). In some versions, the minimum height (H) of the guide opening defined by the surface (105) of the sclera (104) and the guide notch (230) may be substantially shorter. In this regard, the minimum height (H) of the guide opening defined by the surface (105) of the sclera (104) and the guide notch (230) may be about 0.27 mm to about 0.43 mm. For example, the minimum height (H) of the guide opening defined by the surface (105) of the sclera (104) and the guide notch (230) may be about 0.35 mm. Such a relatively short minimum height (H) of the guide opening, defined by the surface (105) of the sclera (104) and the guide notch (230), may allow the upper notch surface (232) to bias the cannula (130) toward the sclera (104), thereby improving the ability of the guide tack (200) to maintain the cannula (130) in a substantially tangential orientation to the scleral incision (107).

[0052] As is most commonly seen in Figures 5-7, the head (220) in this example further includes a pair of gripping features in the form of receptacles (240) extending laterally inward from each side (227) of the head (220), with each side (227) being substantially U-shaped. In the illustrated example, each receptacle (240) is defined by a corresponding lateral inner surface (242), a corresponding top surface (244), and a corresponding pair of end surfaces (246), and each receptacle (240) opens along its bottom. As shown in Figures 5-6, the pair of end surfaces (246) may taper toward each other in the lateral inward direction. As shown in Figures 6-7, each top surface (244) may taper downward in the lateral inward direction, and each lateral inner surface (242) may be substantially vertical (e.g., nearly vertical). Each receptacle (240) can be configured to facilitate the operator grasping the head (220) via a deployment device, such as a deployment device (300) described later. For example, each receptacle (240) may be configured to selectively accept a corresponding portion of such a deployment device, enabling the operator to grasp and manipulate the guide tack (200) using such a deployment device. In this way, the receptacle (240) can be used to assist in positioning the guide tack (200) in the eye (101).

[0053] As a further example, a guide tack (200) may be configured and operable in accordance with at least a portion of the teachings of U.S. Patent No. 11,000,410, issued May 11, 2021, entitled “Guide Apparatus for Tangential Entry into Suprachoroidal Space,” the entirety of which is incorporated herein by reference.

[0054] IV. Examples of unfolding devices

[0055] Figures 8–9B show an example of a deployment device (300) that may be used to place a guide tack (200) on an eye (101). The device (300) in this example includes a pair of lever arms (302) extending distally from a proximal end (304). In the illustrated example, the lever arms (302) are also rotatably connected to each other at separate positions along their respective lengths via a hinge in the form of a living hinge (306), and each lever arm (302) includes a proximal portion (308) located proximal to the living hinge (306) and a distal portion (309) located distal to the living hinge (306). In this way, the lever arms (302) may be rotatable relative to each other about the living hinge (306) between a closed state (Figure 9A) and at least one open state (Figure 9B) in which the proximal portions (308) are deflected toward each other and the distal portions (309) are deflected toward each other. In some versions, the living hinge (306) may be configured to elastically bias the lever arms (302) toward the closed state. In the illustrated example, the lever arms (302), proximal ends (304), and hinge (306) are formed integrally with each other as a single (e.g., monolithic) part, but it will be understood that the lever arms (302), proximal ends (304), and hinge (306) may be joined to each other in any other suitable way.

[0056] The proximal portion (308) of the lever arm (302) includes respective curved regions defining respective finger rests (310) that extend inward toward each other, in order to allow the operator's hand to easily grasp and manipulate the proximal portion (308) of the lever arm (302). For example, one finger rest (310) may accommodate the operator's thumb, and the other finger rest (310) may accommodate the operator's index finger, so that the operator can grasp both proximal portions (308) with one hand and / or bias the proximal portions (308) toward each other by performing a pinching motion with the thumb and index finger of the operator's hand. As will be described in more detail below, the rotatable coupling of the lever arms (302) to each other via the living hinge (306) allows such biasing of the proximal portions (308) toward each other to cause the distal portions (309) to pivot outward from each other around the living hinge (306).

[0057] The distal portion (309) of the lever arm (302) includes each distal finger (312) extending laterally inward toward each other. In this regard, each distal finger (312) may extend substantially perpendicular to the longitudinal axis of the deployment instrument (300). The distal fingers (312) are configured to cooperate with each other to selectively grasp the guide tuck (200). For example, each distal finger (312) may be configured to selectively receive at least partially into the corresponding receptacle (240) of the guide tuck (200) so that the distal fingers (312) can thereby collectively grasp the guide tuck (200), at least when the lever arm (302) is in a closed position. In some versions, each distal finger (312) may have a shape complementary to the shape of the corresponding receptacle (240), and each distal finger (312) may be configured to interlock with the corresponding receptacle (240) when received inside.

[0058] As shown in the figure, even when the lever arm (302) is in the closed position, the distal fingers (312) are separated from each other. In this regard, when the lever arm (302) is in the closed position, the distal fingers (312) may be separated from each other by a gap sufficient to accommodate the head portion (220) of the guide tack (200) between the receptacles (240). When the lever arm (302) is in the closed position, the finger rests (310) may be separated from each other by a gap sufficient to allow the proximal portions (308) to approach each other, thereby increasing the gap between the distal fingers (312) to a sufficient extent to pull the distal fingers (312) away from the corresponding receptacles (240) of the guide tack (200).

[0059] In an example of a method for placing a guide tack (200) on an eye (101) using an instrument (300), the lever arm (302) may initially be in a closed position. The operator can grasp the proximal portion (308) of each lever arm (302) by positioning the operator's thumb and index finger along the finger rest (310) of the proximal portion (308), and can perform a pinching motion with the operator's thumb and index finger to move the lever arm (302) to an open position, thereby increasing the gap between the distal fingers (312). Next, the operator can position each distal finger (312) laterally outside the corresponding receptacle (240) of the guide tack (200), and the operator can release their grip on the proximal portion (308) of the lever arm (302) so that the lever arm (302) can elastically move toward the closed position so that each distal finger (312) can be received inside the corresponding receptacle (240) of the guide tack (200), as shown in Figure 9A. The operator can then place the guide tack (200) on the eye (101) by manipulating the instrument (300). If the operator wants to release the guide tack (200) from the time the leg (210) of the guide tack (200) is fully inserted into the eye (101) and the head (220) of the guide tack (200) is in contact with the surface (105) of the sclera (104), the operator can again perform a pinching motion with the operator's thumb and index finger to move the lever arm (302) to the open position, thereby increasing the gap between the distal fingers (312) so that each distal finger (312) is retracted from the corresponding receptacle (240) of the guide tack (200), as shown in Figure 9B.

[0060] V. Examples of marking devices

[0061] Figures 10–13 show an example of a marking instrument (400) that may be used to mark the site where a guide tack (200) should be placed in the eye (101) and / or where a scleral incision (107) should be formed. The instrument (400) in this example includes a handle (402), a shaft (404), and a marking head (406). The handle (402) is sized and constructed to be easily grasped and manipulated by the operator's hand (e.g., using a pencil grip).

[0062] In the illustrated example, the marking head (406) includes a first prong (412), a pair of second prongs (413), an elongated elliptical marking feature (414), and a pair of third prongs (416). In this example, the prongs (412, 413, 416) are pointed, but are configured to be non-traumatic so as not to puncture the sclera (104) when the prongs (412, 413, 416) are pressed against the surface (105) of the sclera (104) to mark the surface (105) as described herein. The first prong (412) is configured to be positioned in the limbus of the eye (101), thereby serving as a reference for the position of the other prongs (413, 416) and marking feature (414) of the marking head (410). The second prong (413) is positioned and separated to correspond to the location and length of the scleral incision (107). The third prong (416) is positioned and separated to correspond to the location and spacing of the leg (210) of the guide tack (200). Thus, the third prong (416) is positioned to correspond to the location of the ciliary body flattening when the first prong (412) is positioned in the limbus. The elongated elliptical marking feature (414) is sized and constructed to correspond to the configuration of the head (220) of the guide tack (200). The elongated elliptical marking feature (414) surrounds the third prong (416).

[0063] During use, the operator can press the marking head (410) onto the ink pad, then position the first prong (412) on the limbus of the eye (101), and press the marking head (410) onto the surface (105) of the sclera (104) to leave a mark in the same manner as described below with reference to Figure 14C. The operator can then observe the position of the markings left by the third prong (416) and insert the legs (210) of the guide tack (200) into the positions of those markings. Once the guide tack (200) is fully seated on the surface (105) of the sclera (104), the operator can verify proper positioning by observing the correspondence between the markings left by the elongated marking feature (414) and the head (220) of the guide tack (200). Next, the surgeon can form a scleral incision (107) by using a scalpel to cut between the markings left by the second prong (413).

[0064] It will be understood that the marking head (410) may have any other suitable configuration for leaving a marking on the eye (101) in any other desired arrangement. For example, the marking head (410) may be configured and operable in accordance with at least a portion of the teachings of U.S. Patent No. 11,000,410, issued May 11, 2021, entitled “Guide Apparatus for Tangential Entry into Suprachoroidal Space,” the entirety of which is incorporated herein by reference.

[0065] VI. Examples of how to use guide tacks

[0066] Figures 14A–14E illustrate an example of a procedure in which a guide tack (200) is used to guide a cannula (130) into the patient's eye (101). As shown in Figure 14A, the sclera of the patient's eye (101) is accessed by incising a flap in the conjunctiva and incising the conjunctiva by pulling the flap posteriorly. After such an incision is completed, the exposed surface (105) of the sclera (104) may optionally be blanched using a cauterizing instrument to minimize bleeding. Once conjunctival dissection is complete, the exposed surface (105) of the sclera (104) may optionally be dried using a WECK-CEL or other suitable absorption device. The marking head (406) of the marking instrument (400) is pressed against the exposed surface (105) to impart a first and second pair of marks (510, 512) and an oval mark (513) to the exposed surface (105). As a mere example, the marking head (406) may initially be coated with pigment material such that the marking head (406) (for example, by pressing the marking head (406) against the ink pad) leaves some of the pigment on the exposed surface (105) to produce marks (510, 512, 513). In this example, the mark (510) is located in the ciliary body flattened region of the eye (101).

[0067] Next, as shown in Figure 14B, the operator can use the deployment instrument (300) to position the guide tack (200) in the eye (101). In particular, the operator can align the tip (212) with the mark (510) and then push the guide tack (200) toward the eye (101), thereby puncturing the eye (101) with the tip (212). The operator may further bias the guide tack (200) toward the eye (101) until the bottom surface (224) of the head (220) contacts the exposed surface (105). The contact between the bottom surface (430) and the exposed surface (105) ensures a consistent spacing between the upper notch surface (232) and the surface (105) so that the height of the guide opening defined by the guide notch (230) and the surface (105) does not vary from procedure to procedure.

[0068] As shown in Figure 14C, when the operator removes the deployment instrument (300), the guide tack (200) is fixed to the eye (101). In this example, the leg (210) is configured to have a length less than the thickness of the sclera (210) so that the leg (210) does not puncture the choroid (106) when the guide tack (200) is fully seated on the eye (101). This is shown in Figures 15C to 15G and will be described in more detail below. As mentioned above, in some versions, after the guide tack (200) is in place, as shown in Figure 14C, the sharp tip (212) and / or other parts of the leg (210) can be textured to improve the grip on the sclera (210).

[0069] As shown in Figure 14D, the surgeon then uses a conventional scalpel (520) to form a scleral incision (107). The scleral incision (107) is formed between the marks (512) so that the marks (512) are used to identify the end of the scleral incision (107). As just one example, the scleral incision (107) may be approximately 3 mm long and extend between the centers of the marks (512). The scleral incision (107) extends across the entire thickness of the sclera and removes all scleral fibers. The scleral incision (107) is performed with particular care to avoid penetrating the choroid (106). Thus, the scleral incision procedure provides access to the space between the sclera (104) and the choroid (106). Once the scleral incision (107) has been formed in the eye (101), blunt dissection may optionally be performed to locally separate the sclera (104) from the choroid (106). Such peeling can be performed using a small, blunt, elongated instrument, as will be apparent to those skilled in the art in consideration of the teachings herein.

[0070] After the scleral incision (107) is formed, as shown in Figure 14E, the cannula (130) passes through the guide opening defined by the exposed surface (105) and guide notch (230) of the guide tack (200), and then through the scleral incision (107). In particular, the cannula (130) is inserted into the space between the sclera (104) and the choroid (106). As described above, the guide tack (200) can stabilize the cannula (130). Furthermore, the guide tack (200) maintains the cannula (130) in an orientation approximately tangential to the scleral incision (107). Such a tangential orientation can reduce trauma when guiding the cannula (130) through the scleral incision (107), stabilize the cannula (130), and prevent damage to surrounding tissues. Once the cannula (130) is inserted through the guide tack (200) into the scleral incision (107), the surgeon may use forceps or other instruments to further guide the cannula (130) along a non-traumatic route. Of course, the use of forceps or other instruments is optional and may be omitted in some cases.

[0071] In some versions, the cannula (130) may further include at least one depth marker (not shown) on the outer surface of the cannula (130). The depth marker may be configured so that the operator can visually observe the position of the depth marker with respect to the guide tack (200) or the scleral incision (107) in order to determine when the cannula (130) has been inserted to a predetermined insertion depth. As just one example, the depth marker may be positioned to correspond to an initial cannula (130) insertion depth of about 5 mm relative to the scleral incision (107). The depth marker may be configured in accordance with at least a portion of the teachings of U.S. Patent No. 11,000,410, issued May 11, 2021, entitled “Guide Apparatus for Tangential Entry into Suprachoroidal Space,” the entire disclosure of which is incorporated herein by reference.

[0072] As yet another merely illustrative variation, the cannula (130) may include an outwardly projecting depth-stopping feature that abuts against the guide tack (200) to physically limit the depth to which the cannula (130) is inserted into the eye (101). In some such versions, the depth-stopping feature is configured to allow selective positioning of the depth-stopping feature along the length of the cannula (130) so that the operator can select a desired insertion depth before passing the cannula (130) through the guide opening. Here again, one or more depth markers can be used to assist the operator in selecting the position of the depth-stopping feature, which is adjustable along the length of the cannula (130). Various suitable forms that the depth-stopping feature can take will be apparent to those skilled in the art in view of the teachings herein.

[0073] After reaching the state shown in Figure 14E and after the cannula (130) has been inserted into the eye (101) to the appropriate depth, the procedure can be continued as described below with reference to Figures 15D to 15G. After injecting the therapeutic agent (341) into the subretinal space, the cannula (130) can be withdrawn from the eye (101), and the guide tac (200) can also be removed from the eye (101). The scleral incision (107) can then be closed using any appropriate conventional technique. As described below, the site where the needle (150) penetrated the choroid (106) self-seals, and as a result, no further steps are needed to seal the delivery site through the choroid (106). Also as mentioned above, the site where the leg (210) penetrated the eye (101) self-seals, so no further steps are needed to seal the puncture site into which the leg (210) was inserted.

[0074] VII. Examples of subretinal administration of therapeutic agents

[0075] Figures 15A–15G show examples of procedures that may be performed using the aforementioned instruments to deliver a therapeutic agent to the subretinal space of the eye (101) via a suprachoroidal approach. As mere examples, the procedures described herein may be used to treat macular degeneration and / or other ocular conditions. While the procedures described herein are discussed in relation to the treatment of age-related macular degeneration, no such limitation is intended or implied. For example, some alternative procedures may be used to treat retinitis pigmentosa, diabetic retinopathy, and / or other ocular conditions using the same techniques described herein. Furthermore, the procedures described herein may be used to treat either dry or wet age-related macular degeneration, among other conditions.

[0076] In this example, the procedure begins with the operator fixing the tissues surrounding the patient's eye (101) (e.g., the eyelids) using an instrument such as a retractor (162) and / or any other instrument suitable for fixation. During the fixation described herein with respect to the tissues surrounding the eye (101), the eye (101) itself may remain free to move. Once the tissues surrounding the eye (101) are fixed, an eye chandelier port (514) is inserted into the eye (101) as shown in Figure 15A to provide intraocular illumination when viewing the inside of the eye (101) through the pupil. In this example, the eye chandelier port (514) is positioned in the inferior medial quadrant so that a scleral incision in the superior temporal quadrant can be performed. The eye chandelier port (514) is positioned to direct light into the inside of the eye (101) to illuminate at least a portion of the retina (108) (e.g., including at least a portion of the macula). As can be understood, such illumination corresponds to an area of ​​the eye (101) that is targeted for delivery of the therapeutic agent.

[0077] In this example, at the stage shown in Figure 15A, the optical fiber (515) has not yet been inserted into the port (514), and only the chandelier port (514) has been inserted. In some other versions, the optical fiber (515) may be inserted into the chandelier port (514) at this stage. In any case, a microscope may be optionally used to visually inspect the eye and confirm the proper positioning of the eye chandelier port (514) relative to the target site. Although Figure 15A shows a specific positioning of the eye chandelier port (514), the eye chandelier port (514) may have any other suitable positioning, as will be apparent to those skilled in the art in view of the teachings herein.

[0078] Once the eye chandelier port (514) is in place, the sclera (104) can be accessed by incising the conjunctival flap and pulling the flap posteriorly to incise the conjunctiva. After such incision is complete, the exposed surface of the sclera (104) may optionally be blanched using a cauterizing instrument to minimize bleeding. Once conjunctival dissection is complete, the exposed surface of the sclera (104) may optionally be dried using a WECK-CEL or other suitable absorption device.

[0079] Subsequently, as described above, the eye (101) may be marked using the marking instrument (400). The surgeon may then use the marks (510, 512) created using the marking instrument (400) to unfold the guide tuck (200) and perform the scleral incision procedure using a conventional scalpel (520) or other suitable cutting instrument, as shown in Figure 15B.

[0080] The scleral incision procedure creates a small incision (107) through the sclera (104) of the eye (101). The scleral incision procedure is performed with particular care to avoid penetrating the choroid (106). Thus, the scleral incision procedure provides access to the space between the sclera (104) and the choroid (106). Once the incision (107) has been made in the eye (101), blunt dissection may optionally be performed to locally separate the sclera (104) from the choroid (106). Such dissection may be performed using a small, blunt, elongated instrument, as will be apparent to those skilled in the art considering the teachings herein.

[0081] Once the scleral incision is made, the surgeon may insert the cannula (130) of the instrument (100) into the space between the sclera (104) and the choroid (106) through the incision (107). As can be seen in Figure 15C, the cannula (130) is guided into the incision through a guide tuck (200). The guide tuck (200) can stabilize the cannula (130) during insertion. Furthermore, the guide tuck (200) maintains the cannula (130) in a direction approximately tangential to the curvature of the sclera (104) and choroid (106). Such a tangential orientation can reduce trauma as the cannula (130) is guided through the incision. Once the cannula (130) is inserted into the incision through the guide tuck (200), the surgeon may use forceps or other instruments to further guide the cannula (130) along a non-traumatic route. Of course, the use of forceps or other instruments is optional and may be omitted in some examples. The cannula (130) is advanced until its distal end (132) is positioned near the target area in the subretinal space opposite the choroid (106). In the example shown, this target area is located posterior to the eye (101). As the cannula (130) advances from the anterior to the posterior position, it conforms to the curvature of the eye (101). Various suitable methods for visualizing the distal end (132) and thereby observing the proper positioning of the distal end (132) will be apparent to those skilled in the art in light of the teachings herein.

[0082] Although not illustrated, in some examples, the cannula (130) may include one or more markers on its surface to indicate various insertion depths. While optional, such markers may be desirable to help the surgeon identify the appropriate insertion depth when the cannula (130) is guided along a non-traumatic pathway. For example, the surgeon may visually observe the position of such markers relative to the guide tack (200) and / or the scleral incision (104) as an indicator of the depth to which the cannula (130) is inserted into the eye (101). As just one example, one such marker may correspond to a depth of approximately 6 mm of insertion of the cannula (130).

[0083] As shown in Figure 15D, once the cannula (130) is at least partially inserted into the eye (101), if the optical fiber (515) has not yet been inserted at this stage, the surgeon may insert the optical fiber (515) into the eye chandelier port (514). With the eye chandelier port (514) in place and assembled with the optical fiber (515), the surgeon may activate the eye chandelier port (514) by directing light through the optical fiber (515) to illuminate the eye (101), thereby visualizing the inside of the eye (101). Further adjustments to the positioning of the cannula (130) may optionally be made at this point to ensure proper positioning relative to the area of ​​geographic atrophy of the retina (108). In some cases, the surgeon may wish to rotate the eye (101) to orient the pupil of the eye (101) towards the surgeon in order to optimize visualization of the inside of the eye (101) through the pupil.

[0084] Figures 15C–15D show a cannula (130) being guided between the sclera (104) and choroid (106) to position its distal end (132) at the site of therapeutic agent delivery. In this example, the delivery site corresponds to the nearly posterior region of the eye (101) adjacent to the area of ​​geographic atrophy of the retina (108). In particular, the delivery site in this example is located above the macula in the potential space between the neurosensory retina and the retinal pigment epithelium. As a mere example, the operator may rely on direct visualization via a microscope guided through the pupil of the eye (101) as the cannula (130) advances through the range of motion shown in Figures 15C–15D, with illumination provided via a fiber (515) and port (514). The cannula (130) may be at least partially visible through the retina (108) and choroid (106) of the eye (101). Visual tracking can be enhanced in a version that uses optical fiber to emit visible light through the distal end of the cannula (130).

[0085] As shown in Figure 15D, once the cannula (130) is advanced to the delivery site, the operator can advance the needle (150) of the instrument (100) as described above by operating the knob (120). As can be seen in Figure 15E, the needle (150) is advanced relative to the cannula (130) so that it penetrates the choroid (106) without penetrating the retina (108). Just before penetrating the choroid (106), the needle (150) may appear directly visualized as "tenting" the surface of the choroid (106). In other words, the needle (150) may deform the choroid (106) by pushing it upward, resulting in an appearance similar to a tent pole deforming the roof of a tent. Such a visual phenomenon can be used by the operator to identify whether the choroid (106) is about to be punctured and to identify the final puncture site. The specific amount of needle (150) advancement sufficient to "tenting" the choroid (106) and initiate the subsequent puncture can be any appropriate amount, but is not limited, and may be determined by many factors such as the general patient anatomy, the local patient anatomy, the operator's preference, and / or other factors. As mentioned above, examples of the range of needle (150) advancement may be between approximately 0.25 mm and approximately 10 mm, or more specifically, between approximately 2 mm and approximately 6 mm.

[0086] In this example, after confirming that the needle (150) has advanced properly by visualizing the aforementioned tenting effect, the operator injects an equilibrium salt solution (BSS) or other similar solution as the needle (150) advances toward the cannula (130). Such a BSS may form a leading bleb (540) in front of the needle (150) as the needle (150) advances through the choroid (106). The leading bleb (540) may be desirable for two reasons. Firstly, as shown in Figure 15F, the leading bleb (540) may provide the operator with an additional visual indicator to show when the needle (150) is properly positioned at the delivery site. Secondly, the leading bleb (540) may create a barrier between the needle (150) and the retina (108) once the needle (150) has penetrated the choroid (106). Such a barrier may push the retinal wall outward, thereby minimizing the risk of retinal perforation as the needle (150) is advanced to the delivery site. In some versions, a foot pedal is operated to push the leading bleb (540) out of the needle (150). Alternatively, other suitable features that may be used to push the leading bleb (540) out of the needle (150) will be apparent to those skilled in the art in light of the teachings herein.

[0087] Once the operator visualizes the preceding bleb (540), the operator may stop injecting the BSS, leaving a fluid pocket as can be seen in Figure 15F. The therapeutic agent (542) may then be injected by activating a fluid delivery system (180) or any other fluid delivery device, such as those described in the various references cited herein. The therapeutic agent (542) to be delivered may be any suitable therapeutic agent configured to treat an eye condition. Some merely illustrative examples of suitable therapeutic agents may include, but are not limited to, drugs having smaller or larger molecules, therapeutic cell solutions, specific gene therapy solutions, tissue plasminogen activators, and / or any other suitable therapeutic agents, as will become apparent to those skilled in the art in light of the teachings herein. As merely an example, therapeutic agents (542) may be provided in accordance with at least some of the teachings of U.S. Patent No. 7,413,734, issued August 19, 2008, entitled “Treatment of Retinitis Pigmentosa with Human Umbilical Cord Cells,” the entire disclosure of which is incorporated herein by reference. In addition to being used to deliver therapeutic agents (542), instruments (100) and their variations may be used to induce drainage and / or perform other procedures.

[0088] In this example, the amount of therapeutic agent (542) ultimately delivered to the delivery site is approximately 50 μL, but any other suitable amount may be delivered. In some versions, a foot pedal is activated to push the drug (542) out of the needle (150). Alternatively, other suitable features that may be used to push the drug (542) out of the needle (150) will be apparent to those skilled in the art in light of the teachings herein. The delivery of the therapeutic agent (542) can be visualized by the expansion of a fluid pocket, as can be seen in Figure 15G. As illustrated, the therapeutic agent (542) essentially mixes with the fluid in the preceding bleb (540) once the therapeutic agent (542) is injected into the subretinal space.

[0089] Once delivery is complete, the needle (150) may be retracted by rotating the knob (120) in the opposite direction to the direction used to advance the needle (150), and the cannula (130) may then be withdrawn from the eye (101). Due to the size of the needle (150), the site where the needle (150) penetrates the choroid (106) self-seals, and as a result, no further steps are needed to seal the delivery site through the choroid (106). The guide tack (200) and chandelier (514) may be removed, and the incision in the sclera (104) may be closed using any suitable conventional technique.

[0090] As described above, the preceding procedure may be performed to treat a patient with macular degeneration. In some such examples, the therapeutic agent (542) delivered by the needle (150) may include cells derived from the postpartum umbilical cord and placenta. As described above, as merely an example, the therapeutic agent (542) may be provided in accordance with at least some of the teachings of U.S. Patent No. 7,413,734, the entire disclosure of which is incorporated herein by reference. Alternatively, the needle (150) may be used to deliver any other suitable substance in addition to, or instead of, those described in U.S. Patent No. 7,413,734 and / or elsewhere herein. As merely an example, the therapeutic agent (542) may include a variety of drug types, including but not limited to small molecules, large molecules, cells, and / or gene therapies. It should also be understood that macular degeneration is merely an exemplary example of a condition that can be treated by the procedures described herein. Other biological conditions that can be addressed using the instruments and procedures described herein will be obvious to those skilled in the art.

[0091] The above procedures are incorporated herein by reference in their entirety by U.S. Patent No. 10,226,379, U.S. Patent No. 9,949,874, issued April 24, 2018, entitled “Therapeutic Agent Delivery Device with Convergent Lumen,” which is incorporated herein by reference in its entirety by U.S. Patent No. 9,925,088, issued March 27, 2018, entitled “Sub-Retinal Tangential Needle Catheter Guide and Introducer,” which is incorporated herein by reference in its entirety by U.S. Patent No. 10,322,028, issued June 18, 2019, entitled “Method and Apparatus for Sensing Position Between Layers of an Eye,” which is incorporated herein by reference in its entirety by U.S. Patent No. 10,322,028, issued June 18, 2019, entitled “Motorized Suprachoroidal Injection of Therapeutic,” which is incorporated herein by reference in its entirety by U.S. Patent No. 10,226,379, issued in its entirety by U.S. Patent No. 9,949,874, issued April 24, 2018, entitled “Therapeutic Agent Delivery Device with Convergent Lumen,” which is incorporated herein by reference in its entirety by U.S. Patent No. 9,925,088, issued March 27, 2018, entitled “Sub-Retinal Tangential Needle Catheter Guide and Introducer,” which is incorporated herein by reference in its entirety by U.S. Patent No. 10,226,379, issued September 4, 2018, entitled “Motorized Suprachoroidal Injection of Therapeutic This may be done in accordance with any of the teachings in U.S. Patent No. 10,064,752, entitled “Therapeutic Agent Delivery Device with Advanceable Cannula and Needle,” issued on 5 March 2019, entitled “Therapeutic Agent Delivery Device,” issued on 16 April 2019, entitled “Therapeutic Agent Delivery Device,” entitled “Therapeutic Agent Delivery Device,” and / or the entirety of the disclosure thereof, entitled International Publication No. 2022 / 136913, entitled “Ocular Cannula Guide,” published on 30 June 2022.

[0092] VIII. Examples of Combinations

[0093] The following examples illustrate various non-exclusive methods by which the teachings herein may be combined and applied. It should be understood that the following examples are not intended to limit the scope of claims that may be presented at any time in this application or any subsequent application thereof. No abandonment is intended. The following examples are provided for illustrative purposes only. It is conceivable that various teachings herein may be arranged and applied in many other ways. Furthermore, it is intended that some variations may omit certain features mentioned in the following examples. Accordingly, none of the embodiments or features mentioned below should be considered important unless so expressly indicated at a later date by the inventors or their successors. If any claims containing additional features other than those mentioned below are presented in this application or any subsequent application relating to this application, those additional features shall not be presumed to have been added for any reason relating to patentability.

[0094] Example 1

[0095] A device comprising: (a) a pair of rigid legs extending parallel to each other along a plane, each leg of the pair having a sharp tip; and (b) a head, the head having (i) a top surface, (ii) a bottom surface, (iii) a pair of end surfaces, (iv) a pair of side surfaces, and (v) a guide notch extending upward from the bottom surface, configured to work in cooperation with the surface of the sclera of the patient's eye to define a guide opening oriented laterally with respect to the plane associated with the legs and dimensioned to receive a cannula having a substantially flat outer shape; and (vi) a pair of receptacles extending laterally inward from each of the pair of side surfaces, each receptacle of the pair configured to engage with a deployment device.

[0096] Example 2

[0097] The apparatus as described in Example 1, wherein each leg of the pair of legs is textured to grasp the sclera of the patient's eye.

[0098] Example 3

[0099] The apparatus according to any one of Examples 1 to 2, wherein each receptacle of a pair of receptacles is at least partially defined by a corresponding lateral inner surface.

[0100] Example 4

[0101] The apparatus according to Example 3, wherein the lateral inner surfaces of each receptacle of the pair of receptacles are substantially vertical.

[0102] Example 5

[0103] The apparatus according to any one of Examples 1 to 4, wherein each receptacle of a pair of receptacles is at least partially defined by a corresponding upper surface.

[0104] Example 6

[0105] The apparatus as described in Example 5, wherein the upper surface of each receptacle of the pair tapers downward in a lateral-inward direction.

[0106] Example 7

[0107] The apparatus according to any one of Examples 1 to 6, wherein each receptacle of a pair of receptacles is at least partially defined by a corresponding pair of end faces.

[0108] Example 8

[0109] The apparatus according to Example 7, wherein the pair of end faces of each receptacle of the pair of receptacles taper toward each other in a lateral inward direction.

[0110] Example 9

[0111] The apparatus according to any one of Examples 1 to 8, wherein each receptacle of a pair of receptacles is open along its bottom.

[0112] Example 10

[0113] The apparatus according to any one of Examples 1 to 9, wherein each side of a pair of sides is U-shaped.

[0114] Example 11

[0115] The apparatus according to any one of Examples 1 to 10, wherein the guide notch is defined by an upper notch surface and a pair of outer notch surfaces.

[0116] Example 12

[0117] The apparatus as described in Example 11, wherein the central region of the upper notch surface is separated from the bottom surface of the head to define the height of the guide opening.

[0118] Example 13

[0119] The apparatus described in Example 12, having a height between approximately 0.27 mm and approximately 0.43 mm.

[0120] Example 14

[0121] The apparatus described in Example 13, having a height of approximately 0.35 mm.

[0122] Example 15

[0123] A system comprising (a) an apparatus as described in any of Examples 1 to 14, and (b) a dispensing device comprising a pair of distal fingers, wherein each distal finger of the pair of distal fingers is configured to be received inside the corresponding receptacles of a pair of receptacles.

[0124] Example 16

[0125] The deployment device further comprises a pair of lever arms rotatably connected to each other by a hinge, the pair of lever arms configured to pivot relative to each other about the hinge between a closed state and an open state, and each distal finger of a pair of distal fingers positioned distal to the hinge, the system according to Example 15.

[0126] Example 17

[0127] The system according to Example 16, wherein a pair of distal fingers are configured to move away from each other when a pair of lever arms pivot relative to each other around a hinge from a closed to an open position.

[0128] Example 18

[0129] The system according to any one of Examples 16 to 17, wherein each lever arm of a pair of lever arms includes a finger rest positioned near a hinge, and the finger rests are operable to move toward each other, causing the pair of lever arms to pivot relative to each other from a closed to an open position around the hinge.

[0130] Example 19

[0131] The system according to any one of Examples 16 to 18, further comprising a marking instrument, the marking instrument comprising (i) a handle, (ii) a shaft, and (iii) a marking head configured to mark the scleral incision site of the patient's eye.

[0132] Example 20

[0133] A system comprising (a) the apparatus described in any of Examples 1 to 14, and (b) a marking instrument comprising (i) a handle, (ii) a shaft, and (iii) a marking head configured to mark the scleral incision site of the patient's eye.

[0134] Example 21

[0135] The system according to Example 20, comprising a first prong configured such that the marking head is positioned over the orbicularis of the patient's eye.

[0136] Example 22

[0137] The system according to any one of Examples 20 to 21, comprising a marking head and a pair of separated second prongs positioned to mark the scleral incision site.

[0138] Example 23

[0139] The marking head includes an elongated elliptical marking feature sized and configured to correspond to the external shape of the head of the device, as described in any of Examples 20 to 22.

[0140] Example 24

[0141] The system according to any one of Examples 20 to 23, comprising a pair of spaced-apart third prongs positioned to mark insertion points for a pair of legs of the device.

[0142] Example 25

[0143] A device comprising: (a) a proximal end; (b) a pair of lever arms extending distally from the proximal end and each including a distal finger; and (c) a hinge that rotatably connects the pair of lever arms to each other such that each lever arm of the pair includes a proximal portion located near the hinge and a distal portion located near the hinge, wherein the pair of lever arms are rotatable relative to each other about a hinge by bringing their proximal portions closer together from a closed state in which the distal fingers are separated from each other by a gap sized to accommodate a portion of a guide tuck gripped by the distal fingers, and an open state in which the gap between the distal fingers is increased to release the guide tuck from the distal fingers.

[0144] Example 26

[0145] The apparatus according to Example 25, wherein each distal finger of a pair of distal fingers is positioned distal to the hinge.

[0146] Example 27

[0147] The apparatus according to any one of Examples 25 to 26, wherein the hinge includes a living hinge.

[0148] Example 28

[0149] The apparatus according to any one of Examples 25 to 27, wherein each lever arm of a pair of lever arms includes a finger rest positioned near a hinge, and the finger rests are operable to move toward each other, causing the pair of lever arms to pivot relative to each other from a closed to an open position around the hinge.

[0150] Example 29

[0151] A system comprising (a) an apparatus as described in any of Examples 25 to 28, and (b) a guide tack configured to guide a cannula toward the eye of a patient, and the guide tack being grasped by the distal fingers of the apparatus.

[0152] Example 30

[0153] A method for inserting a cannula into a patient's eye, the method comprising: (a) inserting a pair of distal fingers of a deployment instrument into the corresponding receptacles of a guide tack, thereby grasping the guide tack with the deployment instrument; (b) inserting the legs of the guide tack into the ciliary body flattened region of the eye, the guide tack further comprising a head fixed to the upper end of the legs, the head comprising a guide notch that, in cooperation with the surface of the eye, defines a guide opening oriented laterally to a plane defined between the legs; (c) forming a scleral incision near the guide tack; (d) inserting a cannula through the guide opening; and (e) inserting a cannula through the scleral incision, the guide tack being configured to guide the cannula substantially tangentially through the scleral incision.

[0154] IX. Others

[0155] It should be understood that other types of procedures may be used, insofar as some of the examples herein are described in relation to a cannula guide located near an already formed scleral incision. For example, in some variations of the procedures described herein, the cannula guide may be fixed to the eye (20) first, and then the scleral incision may be formed after the cannula guide has been fixed to the eye (20). Other suitable steps and sequences that may be performed in procedures involving a combination of scleral incision and a cannula guide will be apparent to those skilled in the art in light of the teachings herein.

[0156] It should be understood that any version of the device described herein may include a variety of other features in addition to or instead of those described above. For example, any of the devices described herein may also include one or more of the various features disclosed in any of the various references incorporated herein by reference.

[0157] It should be understood that one or more of the teachings, expressions, embodiments, examples, etc., described herein can be combined with one or more of the other teachings, expressions, embodiments, examples, etc., described herein. Therefore, the aforementioned teachings, expressions, embodiments, examples, etc., should not be viewed in isolation from one another. Various appropriate ways in which the teachings herein can be combined will be readily apparent to those skilled in the art, given the teachings herein. Such modifications and variations are intended to be included within the claims.

[0158] Any patent, publication, or other disclosure material that is said to be incorporated herein by reference shall be incorporated herein only to the extent that the incorporated material, in whole or in part, does not contradict any existing definitions, descriptions, or other disclosure material contained herein. Therefore, to the extent necessary, disclosures expressly contained herein supersede any conflicting material incorporated herein by reference. Any material, or any part thereof, that is said to be incorporated herein by reference but contradicts any existing definitions, descriptions, or other disclosure material contained herein shall be incorporated herein only to the extent that the incorporated material does not create a conflict between the incorporated material and the existing disclosure material.

[0159] The versions described above may be designed to be discarded after a single use or to be designed for multiple uses. In either or both cases, the versions may be refurbished for reuse after at least one use. Refurbishment may involve any combination of steps of disassembling the device, subsequently cleaning or replacing certain parts, and then reassembling it. In particular, several versions of the device may be disassembled, and any number of specific parts or components of the device may be selectively replaced or removed in any combination. During the cleaning and / or replacement of specific parts, several versions of the device may be reassembled for subsequent use at a refurbishment facility or by the operator immediately before the procedure. Those skilled in the art will understand that refurbishment of a device may utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. All use of such techniques and the resulting refurbished devices are within the scope of this application.

[0160] As merely an example, the versions described herein may be sterilized before and / or after the procedure. In one sterilization technique, the device is placed in a closed, airtight container such as a plastic or TYVEK bag. The container and the device may then be placed in a field of radiation that can penetrate the container, such as gamma rays, X-rays, or high-energy electrons. The radiation can kill bacteria on the device and inside the container. The sterilized device may then be stored in a sterile container for later use. The device may also be sterilized using any other techniques known in the art, including, but not limited to, beta or gamma rays, ethylene oxide, or vapor.

[0161] While various embodiments of the present invention have been shown and described, further adaptations of the methods and systems described herein can be achieved by appropriate modifications by those skilled in the art without departing from the scope of the invention. Some of such potential modifications have been mentioned, and others will be obvious to those skilled in the art. For example, the examples, embodiments, geometric shapes, materials, dimensions, proportions, steps, etc. described herein are illustrative and not essential. Accordingly, the scope of the invention should be considered with respect to the following claims and is understood not to be limited to the details of the structure and operation shown and described herein and in the drawings.

[0162] [Implementation Method] (1) A device, (a) A pair of rigid legs extending parallel to each other along a plane, wherein each leg of the pair has a sharp tip, and (b) A head, wherein the head is (i) The top surface and, (ii) The bottom surface and, (iii) A pair of end faces and (iv) A pair of sides, (v) A guide notch extending upward from the bottom surface, configured to cooperate with the surface of the sclera of the patient's eye to define a guide opening oriented laterally with respect to a plane associated with the leg portion and having a substantially flat outer shape, (vi) A head comprising a pair of receptacles extending laterally inward from each of the pair of sides, wherein each receptacle of the pair is configured to engage with a deployant, A device equipped with the following features. (2) The apparatus according to Embodiment 1, wherein each leg of the pair of legs is textured to grasp the sclera of the patient's eye. (3) The apparatus according to any one of embodiments 1 to 2, wherein each receptacle of the pair of receptacles is at least partially defined by a corresponding lateral inner surface. (4) The apparatus according to Embodiment 3, wherein the lateral inner surface of each receptacle of the pair of receptacles is substantially vertical. (5) The apparatus according to any one of embodiments 1 to 4, wherein each receptacle of the pair of receptacles is at least partially defined by a corresponding upper surface.

[0163] (6) The apparatus according to Embodiment 5, wherein the upper surface of each receptacle of the pair of receptacles tapers downward in a lateral inward direction. (7) The apparatus according to any one of embodiments 1 to 6, wherein each receptacle of the pair of receptacles is at least partially defined by a corresponding pair of end faces. (8) The apparatus according to Embodiment 7, wherein the pair of end faces of each of the pair of receptacles taper toward each other in a lateral inward direction. (9) The apparatus according to any one of embodiments 1 to 8, wherein each receptacle of the pair of receptacles is open along its bottom. (10) The apparatus according to any one of embodiments 1 to 9, wherein each of the pair of sides is U-shaped.

[0164] (11) The apparatus according to any one of embodiments 1 to 10, wherein the guide notch is defined by an upper notch surface and a pair of outer notch surfaces. (12) The apparatus according to embodiment 11, wherein the central region of the upper notch surface is separated from the bottom surface of the head so as to define the height of the guide opening. (13) The apparatus according to Embodiment 12, wherein the height is between approximately 0.27 mm and approximately 0.43 mm. (14) The apparatus according to embodiment 13, wherein the height is approximately 0.35 mm. (15) A system, (a) The apparatus described in any of Embodiments 1 to 14, and (b) A deploying device comprising a pair of distal fingers, wherein each distal finger of the pair of distal fingers is configured to be received inside the corresponding receptacle of the pair of receptacles. A system equipped with these features.

[0165] (16) The deployment device further comprises a pair of lever arms rotatably connected to each other by a hinge, the pair of lever arms being configured to pivot relative to each other about the hinge between a closed state and an open state, and each distal finger of the pair of distal fingers being positioned distal to the hinge, the system according to embodiment 15. (17) The system according to embodiment 16, wherein the pair of distal fingers are configured to move away from each other when the pair of lever arms pivot relative to each other around the hinge from the closed state to the open state. (18) The system according to any one of embodiments 16 to 17, wherein each lever arm of the pair of lever arms includes a finger rest positioned near the hinge, and the finger rests are movable toward each other to pivot the pair of lever arms toward each other from the closed state to the open state about the hinge. (19) Further comprising a marking device, the marking device is (i) Handle and (ii) The shaft and (iii) A marking head configured to mark the scleral incision site of the patient’s eye A system according to any one of embodiments 16 to 18, comprising: (20) A system, (a) The apparatus described in any of Embodiments 1 to 14, and (b) A marking device, (i) Handle and (ii) The shaft and (iii) A marking instrument comprising a marking head configured to mark the scleral incision site of the patient's eye, A system equipped with these features.

[0166] (21) The system according to embodiment 20, wherein the marking head includes a first prong configured to be positioned on the orbicularis of the patient. (22) The system according to any one of embodiments 20 to 21, wherein the marking head includes a pair of separated second prongs positioned to mark the scleral incision site. (23) The system according to any one of embodiments 20 to 22, wherein the marking head includes an elongated elliptical marking feature that is sized and configured to correspond to the external shape of the head of the device. (24) The system according to any one of embodiments 20 to 23, wherein the marking head includes a pair of spaced-apart third prongs arranged to mark insertion points for the pair of legs of the device. (25) A device, (a) Proximal end, (b) A pair of lever arms extending distally from the proximal end, each including a distal finger, (c) A hinge that rotatably connects the pair of lever arms such that each lever arm of the pair includes a proximal portion located near the hinge and a distal portion located near the hinge, A device wherein the pair of lever arms are rotatable relative to each other about a hinge by bringing their proximal portions closer together, from a closed state in which the distal fingers are separated from each other by a gap sized to accommodate a portion of the guide tuck gripped by the distal fingers, to an open state in which the gap between the distal fingers is increased to release the guide tuck from the distal fingers.

[0167] (26) The apparatus according to embodiment 25, wherein each distal finger of the pair of distal fingers is positioned distal to the hinge. (27) The apparatus according to any one of embodiments 25 to 26, wherein the hinge includes a living hinge. (28) The apparatus according to any one of embodiments 25 to 27, wherein each lever arm of the pair of lever arms includes a finger rest positioned near the hinge, and the finger rests are movable toward each other to pivot the pair of lever arms toward each other from the closed state to the open state about the hinge. (29) A system, (a) an apparatus according to any one of embodiments 25 to 28, and (b) The guide tuck, wherein the guide tuck is configured to guide a cannula to the patient's eye, and the guide tuck is grasped by the distal finger of the device. A system equipped with these features. (30) A method of inserting a cannula into a patient's eye, wherein the method is (a) Inserting a pair of distal fingers of the deployment instrument into the corresponding receptacles of the guide tack, thereby grasping the guide tack with the deployment instrument. (b) Inserting the legs of the guide tuck into the ciliary region of the eye, wherein the guide tuck further includes a head fixed to the upper end of the legs, the head including a guide notch that cooperates with the surface of the eye to define a guide opening oriented laterally to a plane defined between the legs. (c) Form a scleral incision near the guide tuck, (d) Inserting a cannula through the guide opening, and (e) Inserting the cannula through the scleral incision, wherein the guide tuck is configured to guide the cannula substantially tangentially through the scleral incision. Methods that include...

Claims

1. It is a device, (a) A pair of rigid legs extending parallel to each other along a plane, wherein each leg of the pair has a sharp tip, and (b) A head, wherein the head is (i) Top surface and, (ii) Bottom surface and, (iii) A pair of end faces, (iv) A pair of sides, (v) A guide notch extending upward from the bottom surface, configured to cooperate with the surface of the sclera of the patient's eye to define a guide opening oriented laterally with respect to a plane associated with the leg portion and having a substantially flat outer shape, (vi) A head comprising a pair of receptacles extending laterally inward from each of the pair of sides, wherein each receptacle of the pair is configured to engage with a deployant, A device equipped with the following features.

2. The apparatus according to claim 1, wherein each leg of the pair of legs is textured to grasp the sclera of the patient's eye.

3. The apparatus according to any one of claims 1 to 2, wherein each receptacle of the pair of receptacles is at least partially defined by a corresponding lateral inner surface.

4. The apparatus according to claim 3, wherein the lateral inner surface of each receptacle of the pair of receptacles is substantially vertical.

5. The apparatus according to any one of claims 1 to 2, wherein each receptacle of the pair of receptacles is at least partially defined by a corresponding upper surface.

6. The apparatus according to claim 5, wherein the upper surface of each receptacle of the pair of receptacles tapers downward in a lateral inward direction.

7. The apparatus according to any one of claims 1 to 2, wherein each receptacle of the pair of receptacles is at least partially defined by a corresponding pair of end faces.

8. The apparatus according to claim 7, wherein the pair of end faces of each of the pair of receptacles taper toward each other in a lateral inward direction.

9. The apparatus according to any one of claims 1 to 2, wherein each receptacle of the pair of receptacles is open along its bottom.

10. The apparatus according to any one of claims 1 to 2, wherein each of the pair of sides is U-shaped.

11. The apparatus according to any one of claims 1 to 2, wherein the guide notch is defined by an upper notch surface and a pair of outer notch surfaces.

12. The apparatus according to claim 11, wherein the central region of the upper notch surface is spaced apart from the bottom surface of the head to define the height of the guide opening.

13. The apparatus according to claim 12, wherein the height is between approximately 0.27 mm and approximately 0.43 mm.

14. The apparatus according to claim 13, wherein the height is approximately 0.35 mm.

15. It is a system, (a) The apparatus according to any one of claims 1 to 2, and (b) A deploying device comprising a pair of distal fingers, wherein each distal finger of the pair of distal fingers is configured to be received inside the corresponding receptacle of the pair of receptacles. A system equipped with these features.

16. The deployment device further comprises a pair of lever arms rotatably connected to each other by a hinge, the pair of lever arms configured to pivot relative to each other about the hinge between a closed state and an open state, and each distal finger of the pair of distal fingers is positioned distal to the hinge, the system according to claim 15.

17. The system according to claim 16, wherein the pair of distal fingers are configured to move away from each other when the pair of lever arms pivot relative to each other around the hinge from the closed state to the open state.

18. The system according to claim 16, wherein each of the pair of lever arms includes a finger rest positioned near the hinge, the finger rests are movable toward each other, and are operable to pivot the pair of lever arms toward each other around the hinge from the closed state to the open state.

19. The system further includes a marking device, and the marking device is (i) the handle and (ii) Shaft and, (iii) A marking head configured to mark the scleral incision site of the patient’s eye The system according to claim 16, comprising:

20. It is a system, (a) The apparatus according to any one of claims 1 to 2, and (b) A marking device, (i) the handle and (ii) Shaft and, (iii) A marking instrument comprising a marking head configured to mark the scleral incision site of the patient's eye, A system equipped with these features.

21. The system according to claim 20, wherein the marking head includes a first prong configured to be positioned on the orbicularis of the patient.

22. The system according to claim 20, wherein the marking head includes a pair of separated second prongs positioned to mark the scleral incision site.

23. The system according to claim 20, wherein the marking head includes an elongated elliptical marking feature configured to be dimensional to correspond to the outer shape of the head of the device.

24. The system according to any one of claims 20, wherein the marking head includes a pair of spaced-apart third prongs arranged to mark insertion points for the pair of legs of the device.

25. It is a device, (a) Proximal end, (b) A pair of lever arms extending distally from the proximal end, each including a distal finger, (c) A hinge that rotatably connects the pair of lever arms such that each lever arm of the pair of lever arms includes a proximal portion located near the hinge and a distal portion located near the hinge, A device wherein the pair of lever arms are rotatable relative to each other about a hinge by bringing their proximal portions closer together, from a closed state in which the distal fingers are separated from each other by a gap sized to accommodate a portion of the guide tuck gripped by the distal fingers, to an open state in which the gap between the distal fingers is increased to release the guide tuck from the distal fingers.

26. The apparatus according to claim 25, wherein each distal finger of the pair of distal fingers is positioned distal to the hinge.

27. The apparatus according to any one of claims 25 to 26, wherein the hinge includes a living hinge.

28. The apparatus according to any one of claims 25 to 26, wherein each lever arm of the pair of lever arms includes a finger rest positioned near the hinge, and the finger rests are movable toward each other to pivot the pair of lever arms toward each other around the hinge from the closed state to the open state.

29. It is a system, (a) The apparatus according to any one of claims 25 to 26, and (b) The guide tuck, wherein the guide tuck is configured to guide the cannula to the patient's eye, and the guide tuck is grasped by the distal finger of the device. A system equipped with these features.

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