Ocular cannula guide, applicator and marking instrument

Abstract

An apparatus (200) includes a pair of rigid legs (210) extending parallel to each other along a plane. Each leg of the pair of legs has a sharp tip (215). The apparatus also includes a head (210) including 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 upwardly from the bottom surface. The guide recess is configured to mate with a surface of a sclera of a patient's eye to define a guide opening oriented transversely with respect to the plane associated with the leg and sized to receive a cannula having a generally flat profile. The head further includes a pair of receptacles (240) extending laterally inward from respective ones of the pair of side surfaces. Each receptacle of the pair of receptacles is configured to engage a placement instrument.

Description

Background Technology

[0001] The human eye consists of several layers. The white outer layer is the sclera, which surrounds the choroid. The retina lies inside the choroid. The sclera contains collagen and elastic fibers, providing protection for the choroid and retina. The choroid contains the vascular system, which supplies oxygen and nutrients to the retina. The retina contains light-sensitive tissues, including rods and cones. The macula is located at the center of the retina at the back of the eye, usually centered on the optical axis (the axis that runs through the center of the lens and cornea). The macula provides central vision, especially through the cone cells.

[0002] Age-related macular degeneration (AMD) is a medical condition that affects the macula, causing people with AMD to experience loss or deterioration of central vision while retaining some degree of peripheral vision. AMD can be caused by a variety of factors, such as age (also known as "AMD") and genetics. AMD can occur in a "dry" (non-exudative) form, where cellular debris called drusen accumulates between the retina and choroid, resulting in map-like areas of atrophy. AMD can also occur in a "wet" (exudative) form, where blood vessels grow from the choroid behind the retina. Although people with AMD may retain some degree of peripheral vision, the loss of central vision can have a significant negative impact on their quality of life. Furthermore, the quality of the remaining peripheral vision may decline, and in some cases, it may even disappear. Therefore, treatment for AMD may be desired to prevent or reverse the vision loss caused by AMD. In some cases, it may be desirable to provide such treatment near the macula in a highly localized manner, such as by delivering therapeutic material directly adjacent to the subretinal layer (below the neurosensory layer of the retina and above the retinal pigment epithelium) of the map-like atrophy area. However, because the macula is located at the back of the eye and below the fragile layer of the retina, it may be difficult to access it in a practical way.

[0003] Although various surgical methods and instruments have been manufactured and used to treat the eyes, it is believed that no one had manufactured or used the invention described in the appended claims before the inventors. Attached Figure Description

[0004] Although this specification concludes with the claims that specifically point out and clearly claim protection for the present technology, it is believed that the present technology will be better understood from the following description of specific examples taken in conjunction with the accompanying drawings, in which the same reference numerals denote the same elements and wherein:

[0005] Figure 1 is a perspective view depicting an example of a device for subretinal administration of therapeutic agents via the suprachoroidal route.

[0006] Figure 2 depicts a perspective view of the device in Figure 1, which is installed near the patient and incorporates a combination of medical facilities.

[0007] Figure 3 is a perspective view depicting an example of a guide pin for the cannulation of the instrument of Figure 1 that can be used to guide the subretinal administration of a therapeutic agent during surgery.

[0008] Figure 4 depicts a front view of the guide pin in Figure 3;

[0009] Figure 5 depicts a bottom view of the guide pin in Figure 3;

[0010] Figure 6 depicts a side view of the guide pin of Figure 3;

[0011] Figure 7 depicts a cross-sectional view of the guide pin of Figure 3 taken along line 7-7 of Figure 6;

[0012] Figure 8 is a perspective view depicting an example of a placement device that can be used to place the guide pin of Figure 3 into a patient's eye.

[0013] Figure 9A depicts a top plan view of the placement device of Figure 8, showing a pair of lever arms of the placement device in a closed state to grasp the guide pin of Figure 3.

[0014] Figure 9B depicts a top plan view of the placement device of Figure 8, showing the pair of lever arms in the open position to release the guide pin of Figure 3.

[0015] Figure 10 is a perspective view depicting an example of a marking device that can be used to mark a patient's eye;

[0016] Figure 11 depicts a side view of the distal end of the marking device of Figure 10;

[0017] Figure 12 depicts a cross-sectional view of the distal end of the marking device of Figure 10 taken along line 12-12 of Figure 11;

[0018] Figure 13 depicts a front view of the distal end of the marking device of Figure 10;

[0019] Figure 14A depicts a top view of the patient's eye, with the marking instrument from Figure 10 used to mark the placement of the guide pins and the scleral incision site on the eye.

[0020] Figure 14B depicts a top view of the eye in Figure 14A, in which the guide pin of Figure 3 is placed in the eye using the placement device of Figure 8.

[0021] Figure 14C depicts a top view of the eye in Figure 14A, with the guide pin from Figure 3 placed in the eye;

[0022] Figure 14D depicts a top view of the eye in Figure 14A, with a sclerotomy performed at the site of the sclerotomy in Figure 14A.

[0023] Figure 14E depicts a top view of the eye in Figure 14A, where the cannula of the instrument in Figure 1 is inserted via... Figure 3 The guide pin is used to guide the sclerotomy in Figure 14D;

[0024] Figure 15A depicts a cross-sectional side view of the patient's eye;

[0025] Figure 15B depicts a cross-sectional side view of the eye in Figure 15A, with the guide pin of Figure 3 placed in the eye and a sclerotomy being performed.

[0026] Figure 15C depicts a cross-sectional side view of the eye of Figure 15A, in which the cannula of the instrument of Figure 1 is being inserted between the sclera and choroid of the eye through a sclerotomy opening.

[0027] Figure 15D depicts a cross-sectional side view of the eye in Figure 15A, with the distal end of the cannula positioned adjacent to the target location.

[0028] Figure 15E depicts a cross-sectional side view of the eye of Figure 15A, in which the needle of the instrument of Figure 1 is traveling through the choroid to enter the subretinal space at the target location.

[0029] Figure 15F depicts a cross-sectional side view of the eye of Figure 15A, wherein the needle of Figure 15E dispenses a first volume of guide vesicle fluid to provide separation between the retinal region and the choroid at the target location; and

[0030] Figure 15G depicts a cross-sectional side view of the eye of Figure 15A, in which the needle of Figure 15E dispenses therapeutic agent between the retinal region and the choroid at the target location.

[0031] The accompanying drawings are not intended to be limiting in any way, and various embodiments of the present technology are contemplated to be implemented in a variety of other ways, including those not necessarily depicted in the drawings. The drawings, which are incorporated in and form part of this specification, depict several aspects of the present technology and, together with the description, serve to explain the principles of the present technology; however, it should be understood that the present technology is not limited to the exact arrangement shown. Detailed Implementation

[0032] The following description of specific examples of the present technology should not be used to limit its scope. Other examples, features, aspects, embodiments, and advantages of the present technology will become apparent to those skilled in the art from the following description, which is one of the best modes contemplated for implementing the present technology for illustrative purposes. As will be appreciated, the technology described herein can have other different and apparent aspects, all of which do not depart from the present technology. Therefore, the drawings and descriptions should be considered illustrative in nature rather than limiting.

[0033] It should also be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any 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 each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art in light of the teachings herein. These modifications and variations are intended to be included within the scope of the claims.

[0034] For clarity, the terms “proximal” and “distal” are defined herein as relative to a surgeon or other operator holding a surgical instrument with a distal surgical end effector. The term “proximal” refers to the position where the element is closer to the surgeon or other operator, and the term “distal” refers to the position where the element is closer to the surgical end effector of the surgical instrument and further away from the surgeon or other operator.

[0035] Furthermore, the terms “about,” “approximately,” etc., used in conjunction with any numerical value or range of values ​​herein are intended to encompass one or more precise values ​​referenced, as well as appropriate tolerances that enable the referenced feature or combination of features to be used for the intended purpose described herein.

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

[0037] Figure 1 illustrates an example of an instrument (100) configured for use in a surgical procedure to administer a therapeutic agent to the subretinal space of a patient's eye (101) via a suprachoroidal route. The instrument (100) comprises a body (110) and a flexible cannula (130) extending distally from the body (110). In this example, the cannula (130) has a cross-sectional profile configured to allow for non-invasive passage along the suprachoroidal space, as will be described in more detail below. The cannula (130) is typically configured to support a needle (150) that can slide 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 also be used. The cannula (130) of this example is flexible enough to conform to the specific structure and contours of the patient's eye, but the cannula (130) has sufficient column strength to allow the cannula (130) to travel between the sclera (104) and choroid (106) of the patient's eye (101) without bending. The cannula (130) includes a laterally oriented opening (not shown) near the distal end (132) of the cannula (130). This opening may be formed by a U-shaped lateral recess in the cannula (130) leading to the open distal end (not shown) of the needle guide lumen within the cannula (130). The distal end (132) is non-invasive, such that the distal end (132) is configured to provide separation between the sclera and choroid (104, 106) via blunt dissection (as will be described in more detail below), thereby enabling the cannula (130) to travel between such layers (104, 106) without causing trauma to the sclera or choroid (104, 106).

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

[0040] The needle (150) may travel distally to protrude from the opening of the cannula (130). The needle (150) of this example has a sharp distal tip (not shown) and defines a lumen (not shown). This distal tip may have a lancet configuration. In some other versions, the distal tip has a tri-bevel configuration or any other configuration as described in U.S. Patent No. 10,226,379, the disclosure of which is incorporated herein by reference in its entirety. Other suitable forms that the distal tip may still take will be apparent to those skilled in the art in light of the teachings herein. In this example, when the cannula (130) is positioned in the suprachoroidal lumen, the generally rectangular, generally elliptical, or other generally flat cross-sectional profile of the cannula (130) prevents the cannula (130) from rotating about its longitudinal axis, as will be described in more detail below. This provides a consistent and predictable orientation of the opening of the cannula (130), thereby providing a consistent and predictable exit path for the needle (150) as it travels distally relative to the cannula (130), as will be described in more detail below. By way of further example only, the needle (150) may include one or more pre-formed bends according to at least some of the teachings of: U.S. Patent No. 10,478,553, entitled “Apparatus for Subretinal Administration of Therapeutic Agent via a Curved Needle,” published November 19, 2019, the disclosure of which is incorporated herein by reference in its entirety; and / or U.S. Provisional Patent Application No. 63 / 455,131, entitled “Apparatus for Subretinal Administration of Therapeutic Agent via Dual-Curved Needle,” filed March 28, 2023, the disclosure of which is incorporated herein by reference in its entirety.

[0041] As shown in Figure 1, the device (100) of this example further includes an actuation knob (120) located at the top portion (114) of the body (110). The actuation knob (120) is rotatable relative to the body (110) to selectively translate the needle (150) longitudinally relative to the cannula (130). Specifically, the actuation knob (120) is rotatable in a first angular direction to drive the needle (150) distally relative to the cannula (130); and in a second angular direction to drive the needle (150) proximally relative to the cannula (130). By way of example only, the device (100) may provide such functionality via the knob (120) in accordance with at least some of the teachings of U.S. Patent No. 10,646,374, the disclosure of which is incorporated herein by reference in its entirety. In light of the teachings herein, other suitable ways in which the rotational movement of the knob (120) can be converted into linear translation of the needle (150) will be apparent to those skilled in the art. Similarly, in light of the teachings herein, other suitable ways in which the needle (150) can be actuated longitudinally relative to the cannula (130) will be apparent to those skilled in the art. Also as shown in Figure 1, the catheter assembly (140) extends proximally from the body (110). The catheter assembly (140) is configured to include one or more fluid conduits (not shown) in fluid communication with the needle (150). In some versions, such fluid conduits are coupled to a source of guide bubble fluid and therapeutic agent.

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

[0043] Figure 2 illustrates the positioning of the instrument (100) relative to the patient. In this example, a surgical drape (160) is placed on the patient, with an opening (161) formed in the drape (160) near the patient's eye (101). A speculum (162) is used to keep the eye (101) open. A fixation device (164) is positioned adjacent to the eye (101). The fixation device (164) can be used to fix an instrument, such as a viewing mirror, relative to the patient. A magnetic pad (166) is adhered to the surgical 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 the magnetic pad via magnetic attraction. In this example, one or more permanent magnets (not shown) are positioned within the body (110) near the bottom portion (112); and these magnets are magnetically attracted to one or more ferrous elements (not shown) contained within the magnetic pad (166). By way of example only, these magnets and magnetic pads (166) can be constructed according to at least some of the teachings of U.S. Patent No. 10,806,629, entitled “Injection Device for Subretinal Delivery of Therapeutic Agent,” published on October 20, 2020, the disclosure of which is incorporated herein by reference in its entirety. The device (100) is oriented such that a flexible cannula (130) of the device (100) can be inserted into the eye (101). Examples of the process for inserting and positioning the cannula (130) in the eye (101) will be described in more detail below with reference to Figures 15A through 15G.

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

[0045] III. Examples of Intubation Guide Devices

[0046] In some cases, a suture loop assembly (not shown) may be installed in the patient's eye (101) to stabilize and guide the cannula (130) during insertion into the incision (107) in the eye (101). Those skilled in the art will recognize that the formation of the suture loop assembly can be time-consuming. Furthermore, it may be difficult to provide a consistent spacing between the suture loops of the suture loop assembly and between the suture loops and the eye (101). Such spacing variations can result in variations in the entry angle and / or the force required to insert the cannula (130) through the suture loop assembly. Therefore, it may be necessary to provide a device capable of providing stabilization and guidance of the suture loop assembly; however, such a device is faster and easier to install in the eye (101) than the suture loop assembly, resulting in more consistent outcomes. Illustrative examples of such a device are described in more detail below. The device described below can provide faster installation time, minimize variations due to surgical technique, and requires a lower level of expertise, thus requiring less surgical training. At the end of the procedure, the device can be removed from the eye (101) so that no foreign object remains in the eye (101).

[0047] Figures 3 through 7 illustrate an example of a guide pin (200) used to guide a cannula (130) through an incision (107) in the eye (101) instead of using a suture loop assembly. The guide pin (200) of this example includes a pair of legs (210) and a head (220), with the legs (210) extending downwards from the head (220). The free end of each leg (210) includes a sharp tip (212). In the example shown, each sharp tip (212) has a tri-beveled construction. Specifically, each sharp tip (212) includes three facets (214) converging at a distal point (215), while each pair of adjacent facets (214) also converges at a corresponding proximal point (219). The tri-beveled construction facilitates relatively easy piercing 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 construction that enables the sharp tip (212) to pierce the tissue layers of the eye (101), including but not limited to various eye-piercing tip constructions known in the art. In some versions, other portions of the sharp tip (212) and / or the legs (210) may be textured to provide improved gripping of the tissue layers of the eye (101), such as the sclera (104).

[0048] The head (220) of this example includes 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 the corresponding end surfaces (226). The head (220) further defines a guide recess (230) extending upward from the bottom surface (224) of the head (220). The guide recess (230) is oriented along an axis transverse to the plane defined between the legs (210). When the guide pin (200) is secured to the eye (101), the guide recess (230) is configured to mate 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 seen in Figures 4 and 5, the guide notch (230) of 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 the guide notch (230) deflects outward from the centerline of the guide pin (200) along the plane defined between the legs (210) at the height of the guide notch (230) in the central region of the guide notch (230). This configuration facilitates the capture of the cannula (130) within the guide opening defined by the surface (105) of the sclera (104) and the guide notch (230), thereby ensuring that the cannula (130) maintains 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 the guide notch (230) deflects inward toward the centerline of the guide pin (200) along the height of the guide notch (230) and along a plane perpendicular to the plane defined between the legs (210) in the central region 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) when the cannula (130) slides through the guide opening defined by the surface (105) of the sclera (104) and the guide notch (230). Reducing friction can decrease the risk of the cannula (130) inadvertently pulling the guide pin (200) from the eye (101) when the cannula (130) slides through the guide opening defined by the surface (105) of the sclera (104) and the guide notch (230). Despite the minimization of contact between the cannula (130) and the head (220), the surfaces (232, 234) can still provide sufficient contact to maintain the stability of the cannula (130) when it is positioned within the guide opening defined by the surface (105) of the sclera (104) and the guide notch (230).

[0051] In the example shown, in the central region of the guide notch (230), the upper notch surface (232) and the bottom surface (224) of the head (220) are vertically spaced apart 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) can be substantially short. 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) can be between about 0.27 mm and 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) can be about 0.35 mm. This relatively short minimum height (H) of the guide opening defined by the surface (105) of the sclera (104) and the guide notch (230) allows the upper notch surface (232) to push the cannula (130) toward the sclera (104) and thus improves the ability of the guide pin (200) to maintain the cannula (130) in an orientation that is approximately tangential to the scleral incision (107).

[0052] As best seen in Figures 5 through 7, the head (220) of this example further includes a pair of gripping features in the form of accommodating portions (240) extending laterally inward from corresponding side surfaces (227) of the head (220), such that each side surface (227) is generally U-shaped. In the illustrated example, each accommodating portion (240) is defined by a corresponding laterally inward surface (242), a corresponding upper surface (244), and a corresponding pair of end surfaces (246), wherein each accommodating portion (240) opens along its bottom. As shown in Figures 5 and 6, each pair of end surfaces (246) may taper toward each other in the laterally inward direction; and as shown in Figures 6 and 7, each upper surface (244) may taper downward in the laterally inward direction, while each laterally inward surface (242) may be substantially vertical (e.g., nearly vertical). Each receiving portion (240) may be configured to facilitate the holding of the head (220) by an operator via a placement device (such as the placement device (300) described below). For example, each receiving portion (240) may be configured to selectively receive a corresponding portion of such a placement device so that the operator can grasp and manipulate the guide pin (200) using the placement device. In this way, the receiving portion (240) may be used to assist in the installation of the guide pin (200) onto the eye (101).

[0053] As a further example, the guide pin (200) may be constructed and operated in accordance with at least some of the teachings of U.S. Patent No. 11,000,410 entitled “Guide Apparatus for Tangential Entry into Suprachoroidal Space”, published on May 11, 2021, the disclosure of which is incorporated herein by reference in its entirety.

[0054] IV. Examples of Instrument Placement

[0055] Figures 8 through 9B illustrate an example of a placement device (300) for mounting a guide pin (200) in an eye (101). The device (300) of 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 pivotally connected to each other at discrete locations along their respective lengths via a hinge in the form of a movable hinge (306), such that each lever arm (302) includes a corresponding proximal portion (308) on the proximal side of the movable hinge (306) and a corresponding distal portion (309) on the distal side of the movable hinge (306). In this manner, the lever arms (302) can pivot relative to each other about the movable hinge (306) between a closed state (Fig. 9A) and at least one open state (Fig. 9B), in which the proximal portions (308) are brought closer together and the distal portions (309) are deflected further away from each other. In some versions, the movable hinge (306) may be configured to elastically bias the lever arms (302) toward the closed state. Although in the illustrated example the lever arms (302), proximal ends (304) and hinges (306) are integrally formed as a single (e.g., monolithic) piece, it should be understood that the lever arms (302), proximal ends (304) and hinges (306) may be connected to each other in any other suitable manner.

[0056] The proximal portion (308) of the lever arm (302) includes a corresponding arcuate region defining a corresponding finger rest (310) extending inward toward each other to allow easy gripping and manipulation of the proximal portion (308) of the lever arm (302) by the operator's hand. For example, one finger rest (310) may receive the operator's thumb, while the other finger rest (310) may receive the operator's index finger, allowing the operator to grip both proximal portions (308) with a single hand and / or push the proximal portions (308) toward each other by pinching with the operator's thumb and index finger. As discussed in more detail below, since the lever arms (302) are pivotally connected to each other via a movable hinge (306), this pushing of the proximal portions (308) toward each other can cause the distal portions (309) to pivot away from each other about the movable hinge (306).

[0057] The distal portion (309) of the lever arm (302) includes corresponding distal fingers (312) extending laterally inward toward each other. In this respect, each distal finger (312) may extend substantially perpendicular to the longitudinal axis of the placement device (300). The distal fingers (312) are configured to cooperate with each other to selectively grasp the guide pin (200). For example, each distal finger (312) may be configured to be selectively at least partially received within a corresponding receiving portion (240) of the guide pin (200), such that at least when the lever arm (302) is in the closed state, the distal fingers (312) may thus collectively grasp the guide pin (200). In some versions, each distal finger (312) may have a shape complementary to the shape of the corresponding receiving portion (240), such that each distal finger (312) may be configured to cooperate with the corresponding receiving portion when received in the corresponding receiving portion (240).

[0058] As shown, even when the lever arm (302) is in the closed state, the distal fingers (312) are spaced apart from each other. In this respect, when the lever arm (302) is in the closed state, the distal fingers (312) can be spaced apart from each other by a gap sufficient to accommodate the portion of the head (220) of the guide pin (200) between the receiving portions (240). When the lever arm (302) is in the closed state, the finger supports (310) can be spaced apart from each other by a gap sufficient to allow the proximal portions (308) to approach each other and thus increase the gap between the distal fingers (312) to a level sufficient to retract the distal fingers (312) from the corresponding receiving portions (240) of the guide pin (200).

[0059] In an example of a method of installing the guide pin (200) on the eye (101) using the instrument (300), the lever arm (302) may initially be in a closed state. The operator may grasp the proximal portion (308) of the corresponding lever arm (302) by positioning the operator's thumb and forefinger along the finger rest (310) of the proximal portion (308), and may use the operator's thumb and forefinger to perform a pinching action to switch the lever arm (302) to an open state, thereby increasing the gap between the distal fingers (312). The operator can then laterally position each distal finger (312) on the outside of the corresponding receiving portion (240) of the guide pin (200) and loosen the operator's grip on the proximal portion (308) of the lever arm (302) to allow the lever arm (302) to elastically shift toward a closed state, so that each distal finger (312) can be received within the corresponding receiving portion (240) of the guide pin (200), as shown in FIG9A. The operator can then install the guide pin (200) on the eye (101) using the manipulator (300). When the operator wishes to release the guide pin (200) from the instrument (300) (e.g., when the prongs (210) of the guide pin (200) are fully inserted into the eye (101) and the head (220) of the guide pin (200) is adjacent to the surface (105) of the sclera (104), the operator may again perform a pinching action with the operator's thumb and forefinger to switch the lever arm (302) to the open state, thereby increasing the gap between the distal fingers (312) so that each distal finger (312) retracts from the corresponding receiving portion (240) of the guide pin (200), as shown in Figure 9B.

[0060] V. Examples of Marking Instruments

[0061] Figures 10 to 13 illustrate an example of a marking instrument (400) for marking the site where a guide pin (200) will be inserted into the eye (101) and / or where a sclerotomy (107) will be performed. The instrument (400) of this example includes a handle (402), a rod (404), and a marking head (406). The handle (402) is sized and configured to be easily gripped and manipulated by the operator's hand (e.g., using a pencil grip).

[0062] In the example shown, the marking head (406) includes a first serrated member (412), a pair of second serrated members (413), an elliptical marking feature (414), and a pair of third serrated members (416). Although the serrated members (412, 413, 416) are sharp in this embodiment, they are constructed to be non-invasive such that when the serrated members (412, 413, 416) are pushed against the surface (105) of the sclera (104) to mark the surface (105), the serrated members (412, 413, 416) will not pierce the sclera (104), as described herein. The first toothed member (412) is configured to be positioned at the limbus of the eye (101) and thus serve as a positional reference for the other toothed members (413, 416) and the marking feature (414) for the marking head (410). The second toothed member (413) is positioned and spaced to correspond to the position and length of the sclerotomy (107). The third toothed member (416) is positioned and spaced to correspond to the spacing of the legs (210) of the guide pin (200). Thus, when the first toothed member (412) is positioned at the limbus, the third toothed member (416) is positioned to correspond to the position of the ciliary body plana. The elliptical marking feature (414) is sized and configured to conform to the construction of the head (220) of the guide pin (200). An elliptical marking feature (414) surrounds a third pointed tooth (416).

[0063] In use, the operator presses the marker head (410) against the impression pad, then positions the first toothed member (412) at the limbus of the eye (101) and presses the marker head (410) against the surface (105) of the sclera (104) to leave a mark in a manner similar to that described below with reference to FIG14C. The operator can then observe the positioning of the marks left by the third toothed member (416) and insert the legs (210) of the guide pin (200) into the positions of these marks. When the guide pin (200) is fully seated against the surface (105) of the sclera (104), the operator can verify correct positioning by observing the correspondence between the marks left by the elliptical marker feature (414) and the head (220) of the guide pin (200). The operator can then perform a sclerotomy (107) by using a scalpel to make a cut between the marks left by the second serrated piece (413).

[0064] It should be understood that the marker head (410) may have any other suitable construction for leaving a mark on the eye (101) in any other desired arrangement. For example, the marker head (410) may be constructed and operated in accordance with at least some of the teachings of U.S. Patent No. 11,000,410, entitled “Guide Apparatus for Tangential Entry into Suprachoroidal Space”, published May 11, 2021, the disclosure of which is incorporated herein by reference in its entirety.

[0065] VI. Examples of using guide pins

[0066] Figures 14A to 14E illustrate examples of a procedure in which a cannula (130) is guided into a patient's eye (101) using a guide pin (200). As shown in Figure 14A, the conjunctiva is dissected by making an incision in the conjunctiva and pulling the flap back to access the sclera of the patient's eye (101). After this dissection is completed, the exposed surface (105) of the sclera (104) can optionally be cauterized with a cauterizing tool to whiten it and minimize bleeding. Once the conjunctival dissection is complete, the exposed surface (105) of the sclera (104) can optionally be dried using a WECK-CEL or other suitable absorbent device. The marking head (406) of a marking instrument (400) is pressed against the exposed surface (105) to apply a first pair of markings (510) and a second pair of markings (512), as well as an oval marking (513), to the exposed surface (105). By way of example only, pigment material may first be applied to the marking head (406) (e.g., by pressing the marking head (406) against the printing pad) so that the marking head (406) leaves some pigment on the exposed surface (105) to provide a mark (510, 512, 513). In this example, the mark (510) is located on the pars plana region of the ciliary body of the eye (101).

[0067] As shown in Figure 14B, the operator can then use the placement instrument (300) to install the guide pin (200) in the eye (101). Specifically, the operator can align the tip (212) with the mark (510) and then press the guide pin (200) toward the eye (101), thereby piercing the eye (101) with the tip (212). The operator can further push the guide pin (200) toward the eye (101) until the bottom surface (224) of the head (220) abuts the exposed surface (105). The abutment of the underside (430) with the exposed surface (105) will ensure 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) should not vary from surgery.

[0068] As shown in Figure 14C, when the operator removes the placement device (300), the guide pin (200) is anchored to the eye (101). In this example, the leg (210) is configured to have a length less than the thickness of the sclera (210) such that when the guide pin (200) is fully seated against the eye (101), the leg (210) will not puncture the choroid (106). This is in Figure 15C As shown in Figure 15G, these figures are described in more detail below. As mentioned above, in some versions, the sharp tip (212) and / or other portions of the legs (210) may be textured to provide improved clamping of the sclera (210) after the guide pin (200) has been installed, as shown in Figure 14C.

[0069] As shown in Figure 14D, the operator then uses a conventional scalpel (520) to create a scleral incision (107). The scleral incision (107) is created between markers (512) such that the markers (512) are used to identify the end of the scleral incision (107). By way of example only, the scleral incision (107) can be approximately 3 mm long, extending from center to center between the markers (512). The scleral incision (107) extends through the entire thickness of the sclera, removing all scleral fibers. Special care is taken when performing the scleral incision (107) 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 a scleral incision (107) has been performed 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 small, blunt, slender instruments, as will be apparent to those skilled in the art in light of the teachings herein.

[0070] After the sclerotomy (107) is established, and as shown in FIG14E, the cannula (130) is passed through a guide opening defined by the exposed surface (105) and the guide notch (230) of the guide pin (200), and then through the sclerotomy (107). Specifically, the cannula (130) is inserted into the space between the sclera (104) and the choroid (106). As described above, the guide pin (200) can stabilize the cannula (130). Furthermore, the guide pin (200) maintains the cannula (130) in an orientation that is approximately tangential to the sclerotomy (107). This tangential orientation can reduce trauma because the cannula (130) is guided through the sclerotomy (107) to stabilize the cannula (130) and prevent damage to surrounding tissues. When the cannula (130) is inserted into the sclerotomy (107) through the guide pin (200), the operator may use forceps or other instruments to further guide the cannula (130) along an atraumatic path. Of course, the use of forceps or other instruments is optional and may be omitted in some instances.

[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). This depth marker may be configured such that an operator can visually observe its position relative to the guide pin (200) or relative to the sclerotomy (107) to determine when the cannula (130) has been inserted to a predetermined insertion depth. By way of example only, the depth marker may be positioned to correspond to an initial cannula (130) insertion depth of approximately 5 mm relative to the sclerotomy (107). The depth marker may be constructed based on at least some of the teachings of U.S. Patent No. 11,000,410, entitled “Guide Apparatus for Tangential Entry into Suprachoroidal Space,” published May 11, 2021, the disclosure of which is incorporated herein by reference in its entirety.

[0072] As yet another illustrative variation, the cannula (130) may include an outwardly projecting depth limiting feature adjacent to the guide pin (200) to physically limit the depth of insertion of the cannula (130) into the eye (101). In some such versions, the depth limiting feature is configured to be selectively positioned along the length of the cannula (130), allowing the operator to select the desired insertion depth before passing the cannula (130) through the guide opening. Again, one or more depth markers may be used to assist the operator in selecting the position of the adjustable depth limiting feature along the length of the cannula (130). Various suitable forms that the depth limiting feature can take will be apparent to those skilled in the art in light of the teachings herein.

[0073] After achieving the state shown in Figure 14E, and after the cannula (130) has been inserted into the eye (101) to the appropriate depth, the procedure may continue as described below with reference to Figures 15D to 15G. After the therapeutic agent (341) is injected into the subretinal space, the cannula (130) can be withdrawn from the eye (101), and the guide pin (200) can also be removed from the eye (101). The sclerotomy (107) can then be closed using any suitable conventional technique. As described below, the site where the needle (150) penetrates the choroid (106) is self-sealing, so that no further steps are required to seal the delivery site penetrating the choroid (106). Also as described above, the site where the leg (210) penetrates the eye (101) is self-sealing, so that no further steps are required to seal the puncture site of the inserted leg (210).

[0074] VII. Examples of surgical procedures for subretinal application of therapeutic agents

[0075] Figures 15A through 15G illustrate examples of surgeries performed using the aforementioned facilities to deliver therapeutic agents to the subretinal space of the eye (101) via a suprachoroidal route. By way of example only, the methods described herein can be used to treat macular degeneration and / or other ocular conditions. Although the surgeries described herein are discussed in the context of treating age-related macular degeneration, they are not intended to, or imply, such limitations. For example, the same techniques described herein can be used in some alternative surgeries to treat retinitis pigmentosa, diabetic retinopathy, and / or other ocular conditions. Furthermore, the surgeries described herein can be used to treat other conditions such as dry or wet age-related macular degeneration.

[0076] In this example, the procedure begins with the operator stabilizing the tissues (e.g., eyelids) surrounding the patient's eye (101) using instruments such as a speculum (162) and / or any other suitable for stabilization. While this description of stabilization refers to the tissues surrounding the eye (101), the eye (101) itself remains free to move. As shown in Figure 15A, once the tissues surrounding the eye (101) have been stabilized, an eye chandelier port (514) is inserted into the eye (101) to provide intraocular illumination when viewing the interior of the eye (101) through the pupil. In this example, the eye chandelier port (514) is positioned in the inferior medial quadrant to allow for superior temporal quadrant sclerotomy. The eye chandelier port (514) is positioned to direct light into the interior 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 will be understood, such illumination corresponds to the area of ​​the eye (101) that is targeted for delivery of therapeutic agents.

[0077] In this example, at the stage shown in Figure 15A, only the chandelier port (514) is inserted; the optical fiber (515) has not yet been inserted into the port (514). In some other versions, the optical fiber (515) may be inserted into the chandelier port (514) at this stage. In either case, the eye may optionally be visually examined using a microscope to confirm the proper positioning of the eye chandelier port (514) relative to the target area. 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 light of the teachings herein.

[0078] Once the eye chandelier port (514) is positioned, the conjunctiva can be separated by making a flap in the conjunctiva and pulling the flap back to access the sclera (104). After such separation, the exposed surface of the sclera (104) can optionally be cauterized with a cauterizing tool to whiten it and minimize bleeding. Once the conjunctival separation is complete, the exposed surface of the sclera (104) can optionally be dried using a WECK-CEL or other suitable absorption device.

[0079] The eye (101) can then be marked using a marking instrument (400), as described above. The operator can then use the marks (510, 512) formed by the marking instrument (400) to place the guide pin (200) and perform a sclerotomy using a conventional scalpel (520) or other suitable cutting instrument, as shown in Figure 15B.

[0080] A sclerotomy creates a small incision (107) through the sclera (104) of the eye (101). Care must be taken during the sclerotomy to avoid penetrating the choroid (106). Thus, the sclerotomy provides access to the space between the sclera (104) and the choroid (106). Once the incision (107) is made in the eye (101), blunt dissection can optionally be performed to locally separate the sclera (104) from the choroid (106). Such dissection can be performed using small, blunt, slender instruments, as will be apparent to those skilled in the art given the teachings herein.

[0081] As the sclerotomy proceeds, the operator inserts the cannula (130) of the instrument (100) through the incision (107) into the space between the sclera (104) and the choroid (106). As can be seen in Figure 15C, the cannula (130) is guided through the guide pin (200) and into the incision. The guide pin (200) stabilizes the cannula (130) during insertion. Furthermore, the guide pin (200) maintains the cannula (130) in an orientation approximately tangential to the curvature of the sclera (104) and the choroid (106). This tangential orientation reduces trauma as the cannula (130) is guided through the incision. As the cannula (130) is inserted into the incision through the guide pin (200), the operator can use forceps or other instruments to further guide the cannula (130) along an atraumatic path. Of course, the use of forceps or other instruments is optional and may be omitted in some instances. The cannula (130) is advanced until the distal end (132) is positioned near a target area in the subretinal space on the opposite side of the choroid (106). In the example shown, this target area is located in the posterior portion of the eye (101); and the cannula (130) conforms to the curvature of the eye (101) as it advances from anterior to posterior positioning. In light of the teachings herein, various suitable methods for visualizing the distal end (132) to observe its proper positioning will be apparent to those skilled in the art.

[0082] Although not shown, in some instances, the cannula (130) may include one or more markings on its surface to indicate various insertion depths. While optional, such markings may be expected to assist the operator in identifying the appropriate insertion depth as the cannula (130) is guided along an atraumatic path. For example, the operator may visually observe the position of such markings relative to the guide pin (200) and / or relative to an incision in the sclera (104) as an indication of the depth at which the cannula (130) is inserted into the eye (101). By way of example only, one such marking may correspond to an insertion depth of approximately 6 mm for the cannula (130).

[0083] As shown in Figure 15D, once the cannula (130) is at least partially inserted into the eye (101), if the fiber (515) has not yet been inserted at this stage, the operator can insert the optical fiber (515) into the eye lamp port (514). With the eye lamp port (514) in place and assembled with the optical fiber (515), the operator can activate the eye lamp port (514) by guiding light through the optical fiber (515) to provide illumination to the eye (101) and thus visualize the interior of the eye (101). The positioning of the cannula (130) can optionally be further adjusted at this time to ensure proper positioning relative to the map-like atrophic area of ​​the retina (108). In some cases, the operator may wish to rotate the eye (101) to guide the pupil of the eye (101) toward the operator in order to optimize visualization of the interior of the eye (101) through the pupil.

[0084] Figures 15C through 15D illustrate a cannula (130) guided between the sclera (104) and choroid (106) to position the distal end (132) of the cannula (130) at the therapeutic delivery site. In this example, the delivery site corresponds to the approximate posterior region of a map-like atrophic area in the eye (101) adjacent to the retina (108). Specifically, in this example, the delivery site is above the macula, in the potential space between the neurosensory retina and the retinal pigment epithelium. By way of example only, as the cannula (130) travels through the range of motion shown in Figures 15C through 15D, the operator can rely on direct visualization through a microscope guided through the pupil of the eye (101) using illumination provided by the fiber optic cable (515) and port (514). The cannula (130) is 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 fibers to emit visible light through the distal end of the cannula (130).

[0085] Once the cannula (130) has traveled to the delivery site as shown in Figure 15D, the operator can advance the needle (150) of the instrument (100) via the actuation knob (120) as described above. As can be seen in Figure 15E, the needle (150) travels relative to the cannula (130) such that the needle (150) pierces the choroid (106) without penetrating the retina (108). Just before penetrating the choroid (106), the needle (150) can be directly visualized as “bulging” the surface of the choroid (106). In other words, the needle (150) can deform the choroid (106) by pushing it upwards, thus providing an appearance similar to the deformation of a tent pole at the top of a tent. The operator can use this visual phenomenon to identify whether the choroid (106) is about to be pierced and the location of any eventual piercing. The specific amount of travel of the needle (150) sufficient to initiate the “bulge” of the choroid (106) and subsequent puncture can be any suitable amount, as can be determined by a variety of factors, such as, but not limited to, general patient anatomy, local patient anatomy, operator preference, and / or other factors. Examples of the range of needle (150) travel, as described above, can 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 the operator has confirmed that the needle (150) has traveled properly by visualizing the bulge effect described above, the operator infuses a balanced salt solution (BSS) or other similar solution as the needle (150) travels relative to the cannula (130). This BSS can form a guide bubble (540) in front of the needle (150) as the needle (150) travels through the choroid (106). The guide bubble (540) may be desired for two reasons. First, as shown in Figure 15F, the guide bubble (540) can provide the operator with further visual indication of when the needle (150) is properly positioned at the delivery site. Second, once the needle (150) has penetrated the choroid (106), the guide bubble (540) can provide a barrier between the needle (150) and the retina (108). Such a barrier can push the retinal wall outward, thereby minimizing the risk of retinal perforation when the needle (150) travels to the delivery site. In some versions, a foot pedal is actuated to drive the guide bubble (540) out of the needle (150). Alternatively, other suitable features that can be used to drive the guide bubble (540) out of the needle (150) will be apparent to those skilled in the art, given the teachings herein.

[0087] Once the operator visualizes the guide bubble (540), the operator can terminate the BSS infusion, leaving a bag of fluid as can be seen in Figure 15F. The therapeutic agent (542) can then be infused via an actuated fluid delivery system (180) or some other fluid delivery device as described in the various references cited herein. The delivered therapeutic agent (542) can be any suitable therapeutic agent configured to treat an ocular condition. Some illustrative examples of suitable therapeutic agents may include, but are not limited to, drugs having small or large molecules, therapeutic cell solutions, specific gene therapy solutions, tissue plasminogen activators, and / or any other suitable therapeutic agent that will be apparent to those skilled in the art in light of the teachings herein. By way of example only, the therapeutic agent (542) may be provided in accordance with at least some of the teachings of U.S. Patent No. 7,413,734, entitled “Treatment of Retinitis Pigmentosa with Human Umbilical Cord Cells,” published August 19, 2008, the disclosure of which is incorporated herein by reference in its entirety. In addition to being used for delivery of the therapeutic agent (542) or as an alternative thereto, the device (100) and variations thereof may be used to provide drainage and / or perform other procedures.

[0088] In this example, the final amount of therapeutic agent (542) delivered to the delivery site is approximately 50 μL, but any other suitable amount may be delivered. In some versions, a foot pedal is actuated to drive the agent (542) out of the needle (150). Alternatively, other suitable features that may be used to drive the agent (542) out of the needle (150) will be apparent to those skilled in the art, given the teachings herein. The delivery of the therapeutic agent (542) can be visualized by the expansion of the fluid bag, as can be seen in Figure 15G. As shown, when the therapeutic agent (542) is injected into the subretinal space, the therapeutic agent (542) is substantially mixed with the fluid of the guide bubble (540).

[0089] Once delivery is complete, the needle (150) can be retracted by rotating the knob (120) in the opposite direction to the direction used to propel the needle (150); and then the cannula (130) can be withdrawn from the eye (101). Due to the size of the needle (150), the site where the needle (150) penetrates the choroid (106) is self-sealing, eliminating the need for further steps to seal the delivery site through the choroid (106). The guide pin (200) and the chandelier (514) can be removed, and the incision in the sclera (104) can be closed using any suitable conventional technique.

[0090] As described above, the aforementioned surgical procedure can be performed to treat patients with macular degeneration. In some such cases, the therapeutic agent (542) delivered by the needle (150) may contain cells derived from the postpartum umbilical cord and placenta. As described above, and by way of example only, 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 disclosure of which is incorporated herein by reference in its entirety. Alternatively, the needle (150) may be used to deliver one or more other suitable substances in addition to or in place of the substances described in U.S. Patent No. 7,413,734 and / or elsewhere herein. By way of example only, the therapeutic agent (542) may include a variety of pharmaceuticals, including but not limited to small molecules, macromolecules, cell and / or gene therapies. It should also be understood that macular degeneration is merely one illustrative example of a condition that can be treated by the surgical procedure described herein. Other biological conditions that can be addressed using the instruments and surgical procedures described herein will be apparent to those skilled in the art.

[0091] The surgical procedure described above can be performed according to any of the following teachings: U.S. Patent No. 10,226,379, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 9,949,874, entitled “Therapeutic Agent Delivery Device with Convergent Lumen,” published April 24, 2018, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 9,925,088, entitled “Sub-Retinal Tangential Needle Catheter Guide and Introducer,” published March 27, 2018, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 10,322,028, entitled “Method and Apparatus for Sensing Position Between Layers of an Eye,” published June 18, 2019, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Patent No. 10,322,028, entitled “Motorized Suprachoroidal Injection,” published September 4, 2018. U.S. Patent No. 10,064,752, entitled “Therapeutic Agent,” the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 10,219,936, entitled “Therapeutic Agent Delivery Device with Advanceable Cannula and Needle,” published March 5, 2019, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 10,258,502, entitled “Therapeutic Agent Delivery Device,” published April 16, 2019, the disclosure of which is incorporated herein by reference in its entirety; and / or International Publication No. WO 2022 / 136913, entitled “Ocular Cannula Guide,” published June 30, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0092] VIII. Combined Examples

[0093] The following examples illustrate various non-exhaustive ways in which the teachings herein can be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claim that may be set forth in this application or at any time in a subsequent filing of this application. No disclaimer is intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that certain features mentioned in the following examples may be omitted in some variations. Therefore, no aspect or feature mentioned below should be considered critical unless the inventor or successor to the inventor expressly indicates otherwise at a later date. If any claim set forth in this application or a subsequent application related to this application includes additional features beyond those mentioned below, it should not be presumed that such additional features were added for any reason related to patentability.

[0094] Example 1

[0095] A device comprising: (a) a pair of rigid legs extending parallel to each other along a plane, wherein each of the pair of legs has a sharp tip; and (b) a head comprising: (i) a top surface, (ii) a bottom surface, (iii) a pair of end surfaces, (iv) a pair of side surfaces, (v) a guide recess extending upward from the bottom surface, wherein the guide recess is configured to engage with a surface of the sclera of a patient's eye to define a guide opening oriented laterally relative to a plane associated with the legs and sized to receive a cannula having a generally flat profile; and (vi) a pair of receiving portions extending laterally inward from respective side surfaces of the pair of side surfaces, wherein each of the pair of receiving portions is configured to engage placement of an instrument.

[0096] Example 2

[0097] According to the device described in Example 1, each of a pair of legs is textured to hold the sclera of the patient's eye.

[0098] Example 3

[0099] According to any one of Examples 1 to 2, each of the pair of accommodating portions is defined at least partially by a corresponding lateral inner surface.

[0100] Example 4

[0101] According to the device described in Example 3, the lateral inner surface of each of the pair of accommodating portions is substantially vertical.

[0102] Example 5

[0103] The device according to any one of Examples 1 to 4, wherein each of the pair of accommodating portions is at least partially defined by a corresponding upper surface.

[0104] Example 6

[0105] According to the device described in Example 5, the upper surface of each of the pair of accommodating portions tapers downward in a laterally inward direction.

[0106] Example 7

[0107] The device according to any one of Examples 1 to 6, wherein each of the pair of receiving portions is at least partially defined by a corresponding pair of end surfaces.

[0108] Example 8

[0109] According to the device of Example 7, the pair of end surfaces of each of the pair of accommodating portions taper toward each other in a laterally inward direction.

[0110] Example 9

[0111] The device according to any one of Examples 1 to 8, wherein each of the pair of accommodating portions is open along its bottom.

[0112] Example 10

[0113] The device according to any one of Examples 1 to 9, wherein each of the pair of side surfaces is U-shaped.

[0114] Example 11

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

[0116] Example 12

[0117] According to the device of Example 11, 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.

[0118] Example 13

[0119] The device according to Example 12 has a height between approximately 0.27 mm and approximately 0.43 mm.

[0120] Example 14

[0121] The device according to Example 13 has a height of approximately 0.35 mm.

[0122] Example 15

[0123] A system comprising: (a) the device according to any one of Examples 1 to 14; and (b) a placement device, wherein the placement device includes a pair of distal fingers, wherein each of the pair of distal fingers is configured to be received within a corresponding receiving portion of a pair of receiving portions.

[0124] Example 16

[0125] According to the system described in Example 15, the placement device further includes a pair of lever arms pivotally connected to each other by a hinge, such that the pair of lever arms are configured to pivot relative to each other about the hinge between a closed state and an open state, wherein each of the pair of distal fingers is positioned distal to the hinge.

[0126] Example 17

[0127] According to the system described in Example 16, 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 state to an open state.

[0128] Example 18

[0129] According to any one of Examples 16 to 17, each of the pair of lever arms includes a finger support positioned proximal to the hinge, wherein the finger support is operable to move toward each other to pivot the pair of lever arms relative to each other about the hinge from a closed state to an open state.

[0130] Example 19

[0131] The system according to any one of Examples 16 to 18 further includes a marking device, wherein the marking device includes: (i) a handle, (ii) a rod, and (iii) a marking head configured to mark the sclerotomy site on the patient's eye.

[0132] Example 20

[0133] A system comprising: (a) the device according to any one of Examples 1 to 14; and (b) a marking instrument, wherein the marking instrument comprises: (i) a handle, (ii) a rod, and (iii) a marking head configured to mark a sclerotomy site on a patient's eye.

[0134] Example 21

[0135] According to the system described in Example 20, the marking head includes a first tooth-like element configured to be positioned at the limbus of the patient's eye.

[0136] Example 22

[0137] According to any one of Examples 20 to 21, the system wherein the marking head includes a pair of second pointed teeth positioned and spaced apart to mark the scleral incision site.

[0138] Example 23

[0139] According to any one of Examples 20 to 22, the system wherein the marking head includes an elliptical marking feature whose dimensions are set and configured to conform to the contour of the head of the device.

[0140] Example 24

[0141] According to any one of Examples 20 to 23, the marking head includes a pair of third pointed teeth positioned and spaced apart to mark insertion sites 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 including respective distal fingers; and (c) a hinge pivotally connecting the pair of lever arms to each other such that each of the pair of lever arms includes a proximal portion located on the proximal side of the hinge and a distal portion located on the distal side of the hinge, wherein the pair of lever arms are pivotable relative to each other about the hinge from a closed state and an open state via the proximal portions toward each other, wherein in the closed state the distal fingers are spaced apart from each other by a gap sized to accommodate a portion of a guide pin grasped by the distal fingers, and in the open state the gap between the distal fingers is increased to release the guide pin from the distal fingers.

[0144] Example 26

[0145] According to the device described in Example 25, each of a pair of distal fingers is positioned distal to the hinge.

[0146] Example 27

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

[0148] Example 28

[0149] According to any one of Examples 25 to 27, each of the pair of lever arms includes a finger support positioned proximal to the hinge, wherein the finger support is operable to move toward each other so that the pair of lever arms pivot relative to each other about the hinge from a closed state to an open state.

[0150] Example 29

[0151] A system comprising: (a) the device according to any one of Examples 25 to 28; and (b) a guide pin configured to guide a cannula relative to a patient's eye, wherein the guide pin is grasped by a distal finger of the device.

[0152] Example 30

[0153] A method of inserting a cannula into a patient's eye, the method comprising: (a) inserting a pair of distal fingers of a placement instrument into corresponding receiving portions of a guide pin, thereby grasping the guide pin with the placement instrument; (b) inserting a leg of the guide pin into a ciliary plana region of the eye, wherein the guide pin further includes a head fixed to an upper end of the leg, wherein the head includes a guide notch that engages with a surface of the eye to define a guide opening oriented laterally relative to a plane defined between the legs; (c) forming a sclerotomy near the guide pin; (d) inserting the cannula through the guide opening; and (e) inserting the cannula through the sclerotomy, wherein the guide pin is configured to guide the cannula through the sclerotomy in a substantially tangential orientation.

[0154] IX. Other

[0155] Given that the examples described herein are set in the context of an intubation guide positioned near an already formed scleral incision, it should be understood that other types of procedures may be employed. For example, in some variations of the procedures described herein, the intubation guide may first be secured to the eye (20); and then a scleral incision may be formed after the intubation guide has been secured to the eye (20). In light of the teachings herein, other suitable steps and sequences that may be performed in procedures involving a combination of a scleral incision and an intubation guide will be apparent to those skilled in the art.

[0156] It should be understood that any version of the apparatus described herein may include various other features besides or in lieu of the foregoing features. By way of example only, any device 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 any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the above teachings, expressions, embodiments, examples, etc., should not be viewed in isolation from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art in light of the teachings herein. These modifications and variations are intended to be included within the scope of the claims.

[0158] It should be understood that any patent publications or other disclosures deemed to be incorporated herein by reference are incorporated wholly or in part only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosures set forth in this disclosure. Therefore, and to the extent necessary, the disclosures expressly set forth herein supersede any conflicting material incorporated herein by reference. Any material or portion thereof deemed to be incorporated herein by reference but conflicting with existing definitions, statements, or other disclosures set forth herein will be incorporated only to the extent that the incorporated material does not conflict with existing disclosures.

[0159] The aforementioned version may be designed to be discarded after a single use, or it may be configured for multiple uses. In either case, the version may be adjusted for reuse after at least one use. Adjustment may include any combination of steps such as disassembling the device, subsequently cleaning or replacing specific components, and subsequently reassembling. Specifically, some versions of the device may be disassembled, and any number of specific components or parts of the device may be selectively replaced or removed in any combination. After cleaning and / or replacing specific components, some versions of the device may be reassembled at the adjustment facility for subsequent use, or reassembled by an operator immediately before surgery. Those skilled in the art will understand that the adjustment of the device can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques and the resulting adjusted device are within the scope of this application.

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

[0161] Various embodiments of the invention have been shown and described. Further modifications to the methods and systems described herein can be made by those skilled in the art through appropriate modifications without departing from the scope of the invention. Several such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc., discussed above are illustrative and not essential. Therefore, the scope of the invention should be considered in accordance with the appended claims and should be understood as not being limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. An apparatus comprising: (a) A pair of rigid legs extending parallel to each other along a plane, wherein each of the pair of legs has a sharp tip; and (b) a head, wherein the head comprises: (i) Top surface, (ii) Bottom surface (iii) A pair of end surfaces, (iv) A pair of side surfaces, (v) A guide notch extending upward from the bottom surface, wherein the guide notch is configured to mate with the surface of the sclera of the patient's eye to define a guide opening, the guide opening being laterally oriented relative to the plane associated with the leg and the guide opening being sized to receive a cannula having a generally flat profile. (vi) A pair of receiving portions, the pair of receiving portions extending laterally inward from respective side surfaces of the pair of side surfaces, wherein each of the pair of receiving portions is configured to engage a placement device.

2. The device of claim 1, wherein each of the pair of legs is textured to hold the sclera of the patient's eye.

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

4. The device of claim 3, wherein the lateral inner surface of each of the pair of receiving portions is substantially vertical.

5. The device according to any one of claims 1 to 4, wherein each of the pair of receiving portions is at least partially defined by a corresponding upper surface.

6. The device of claim 5, wherein the upper surface of each of the pair of accommodating portions tapers downward in a laterally inward direction.

7. The device according to any one of claims 1 to 6, wherein each of the pair of receiving portions is at least partially defined by a corresponding pair of end surfaces.

8. The device of claim 7, wherein the pair of end surfaces of each of the pair of receiving portions taper toward each other in a laterally inward direction.

9. The device according to any one of claims 1 to 8, wherein each of the pair of accommodating portions is open along its bottom.

10. The device according to any one of claims 1 to 9, wherein each of the pair of side surfaces is U-shaped.

11. The device according to any one of claims 1 to 10, wherein the guide recess is defined by an upper recess surface and an outer recess surface.

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

13. The device of claim 12, wherein the height is between about 0.27 mm and about 0.43 mm.

14. The device according to claim 13, wherein the height is about 0.35 mm.

15. A system comprising: (a) The device according to any one of claims 1 to 14; and (b) A placement device, wherein the placement device includes a pair of distal fingers, wherein each of the pair of distal fingers is configured to be received within a corresponding receiving portion of the pair of receiving portions.

16. The system of claim 15, wherein the placement device further comprises a pair of lever arms pivotally connected to each other by a hinge, such that the pair of lever arms are configured to pivot relative to each other about the hinge between a closed state and an open state, wherein each of the pair of distal fingers is positioned distal to the hinge.

17. The system of 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 about the hinge from the closed state to the open state.

18. The system of any one of claims 16 to 17, wherein each of the pair of lever arms includes a finger rest positioned proximal to the hinge, wherein the finger rest is operable to move toward each other to pivot the pair of lever arms relative to each other about the hinge from the closed state to the open state.

19. The system according to any one of claims 16 to 18, further comprising a marking device, wherein the marking device comprises: (i) Handle, (ii) the rod section, and (iii) A marking head configured to mark the scleral incision site on the patient's eye.

20. A system comprising: (a) The device according to any one of claims 1 to 14; and (b) a marking device, wherein the marking device comprises: (i) Handle, (ii) the rod section, and (iii) A marking head configured to mark the scleral incision site on the patient's eye.

21. The system of claim 20, wherein the marking head includes a first tooth-like member configured to be positioned at the limbus of the patient's eye.

22. The system according to any one of claims 20 to 21, wherein the marking head includes a pair of second pointed teeth positioned and spaced apart to mark the scleral incision site.

23. The system according to any one of claims 20 to 22, wherein the marking head includes an elliptical marking feature, the elliptical marking feature being sized and configured to conform to the contour of the head of the device.

24. The system according to any one of claims 20 to 23, wherein the marking head includes a pair of third pointed teeth positioned and spaced apart to mark the insertion sites of the pair of legs for the device.

25. An apparatus comprising: (a) Proximal end; (b) A pair of lever arms, the pair of lever arms extending distally from the proximal end and including corresponding distal fingers; (c) A hinge that pivotally connects the pair of lever arms to each other, such that each of the pair of lever arms includes a proximal portion located on the proximal side of the hinge and a distal portion located on the distal side of the hinge. The pair of lever arms are pivotable relative to each other about the hinge from a closed state and an open state via the proximal portion toward each other. In the closed state, the distal fingers are spaced apart by a gap sized to accommodate a portion of a guide pin gripped by the distal fingers. In the open state, the gap between the distal fingers is increased to release the guide pin from the distal fingers.

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

27. The device according to any one of claims 25 to 26, wherein the hinge comprises a movable hinge.

28. The device according to any one of claims 25 to 27, wherein each of the pair of lever arms includes a finger support positioned proximal to the hinge, wherein the finger support is operable to move toward each other to pivot the pair of lever arms relative to each other about the hinge from the closed state to the open state.

29. A system comprising: (a) The device according to any one of claims 25 to 28; and (b) the guide pin, wherein the guide pin is configured to guide the cannula relative to the patient's eye, wherein the guide pin is grasped by the distal finger of the device.

30. A method of inserting a cannula into a patient's eye, the method comprising: (a) Insert a pair of distal fingers of the placement device into the corresponding receiving portion of the guide pin, thereby gripping the guide pin with the placement device; (b) Inserting the legs of the guide pin into the ciliary body plana region of the eye, wherein the guide pin further includes a head fixed to the upper end of the legs, wherein the head includes a guide recess that engages with the surface of the eye to define a guide opening that is laterally oriented relative to the plane defined between the legs. (c) A sclerotomy is performed near the guide pin; (d) Insert the cannula through the guide opening; and (e) Inserting the cannula through the sclerotomy, wherein the guide pin is configured to guide the cannula through the sclerotomy in a substantially tangential orientation.

Images