Incision guide tools for ophthalmic device implantation and methods of use - Patents.com

Abstract

A device configured to guide the creation of an incision in an eye, the device including an elongated handle and a foot plate having a plurality of struts defining a central opening extending between an upper surface and a lower surface of the foot plate. A first strut of the plurality of struts has a proximal blade guide surface that is straight and extends between two lateral struts of the plurality of struts. A second strut of the plurality of struts has a proximal limbal guide surface that is curved. The blade guide surface is spaced a distance from the limbal guide surface and identifies a target location for creating the incision relative to the limbus of the eye. The blade guide surface has a length between the two lateral struts that limits the length of an incision that can be made using a cutting blade inserted through the central opening.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to co-pending U.S. Provisional Patent Application No. 63 / 329,277, filed April 8, 2022, the disclosure of which is incorporated herein by reference in its entirety for all purposes. [Background technology]

[0002] An implantable device can be used to deliver a therapeutic agent to one or more locations in a patient. The implantable device can have a reservoir of therapeutic agent and a structure to hold the implantable device in a desired location in a patient. The implantable device can have a chamber for storing the therapeutic agent and can release the agent to the patient to provide a therapeutic benefit. After a period of time, the amount of fluid released may not be ideal and the fluid in the implantable device may be replaced, refilled, or exchanged to deliver an additional amount of therapeutic agent to extend the treatment.

[0003] Implantable devices for treating the posterior segment of the eye may be implanted through the sclera. As an example, an implantable therapeutic device may be positioned to extend from the pars plana region of the eye into the vitreous humor to release a drug directly into the eye. The pars plana region is generally about 3.0 mm to 4.0 mm away from the limbus, which is the boundary between the cornea and the sclera. To implant a therapeutic device, the conjunctiva may be elevated, incised, or punctured to access the sclera and a long, thin incision may be made within the sclera. The length of the incision may be important in terms of whether the device will seal with the eye when inserted through the incision. If the incision is too long, the fit between the device and the incision may become dislodged, and complications may occur.

[0004] Other surgical interventions involve making an incision in the sclera, including filtration procedures such as trabeculectomy and non-penetrating deep sclerectomy, or implanting a drainage device in the eye to drain aqueous humor from the anterior chamber, thereby reducing intraocular pressure. In many of these procedures, a scleral flap is surgically created.

[0005] Each of these surgical interventions involves manually making the scleral cuts using surgical instruments such as hand-held blades or knives, which can be technically demanding and time-consuming to achieve a uniform cut with appropriate dimensions. There are many risks and complications associated with these procedures that can adversely affect the outcome. Summary of the Invention

[0006] In an aspect, a device configured to guide the creation of an incision in the sclera of an eye using a cutting blade is described. The device includes an elongated handle extending along a longitudinal axis for at least a portion of its length and having a proximal end region and a distal end region, and a foot plate coupled to the distal end region of the elongated handle. The foot plate includes a plurality of struts defining a central opening extending between an upper surface and a lower surface of the foot plate. A first strut of the plurality of struts has a proximal blade guide surface that is straight and extends between two lateral struts of the plurality of struts. A second strut of the plurality of struts has a proximal limbal guide surface that is curved. The blade guide surface is spaced a distance from the limbal guide surface to identify a target location for creating the incision relative to the limbus of the eye. The blade guide surface has a length between the two lateral struts that limits the length of an incision that can be created between the two lateral struts using a cutting blade inserted through the central opening.

[0007] The blade guide surface between the upper and lower surfaces of the foot plate may extend vertically to prevent tunneling of the cutting blade against the sclera. The blade guide surface may have a rounded portion near the upper surface of the foot plate. The blade guide surface below the rounded portion may be about 0.005 inches to about 0.020 inches thick. The blade guide surface may have a chamfered edge near the upper surface of the foot plate. The chamfered edge may be about 10 degrees to about 30 degrees. The distance between the blade guide surface and the limbus guide surface may be about 3.9 mm to about 4.1 mm. The length between the two lateral struts may be about 3.45 mm to about 3.55 mm.

[0008] The angle between each of the two lateral struts and the blade guide surface may be approximately 90 degrees. The two lateral struts may be parallel to each other. The foot plate may be coupled to the distal end region of the elongated handle at a proximal end region of the foot plate near the location of the limbal guide surface. The thickness of the foot plate between the upper and lower surfaces may be less at the distal end region of the foot plate near the location of the blade guide surface than the thickness of the foot plate between the upper and lower surfaces near the proximal end region of the foot plate. The limbal guide surface may have a chamfered edge near the upper surface of the foot plate. Each of the two lateral struts may have a chamfered edge that leads to a central opening.

[0009] The foot plate can be coupled to the distal end region at an angle relative to the longitudinal axis of the elongated handle. The angle can be between 130 degrees and 140 degrees. The elongated handle can further include a shaft between the foot plate and the distal end region of the elongated handle. The shaft can extend at an angle of 20 degrees to 30 degrees relative to the longitudinal axis of the elongated handle. The first strut can have a curved distal surface. The multiple struts of the foot plate can create the shape of a square prism ring, a rectangular prism ring, or a trapezoid prism ring.

[0010] The underside of the foot plate may further include a plurality of cleats. The plurality of cleats may include at least a first set of cleats and a second set of cleats, the first set of cleats having an orientation relative to the underside different from the orientation of the second set of cleats. The first set of cleats may include at least two limbal cleats spaced apart from one another, each having a triangular prism shape, the triangular prism shape having a rectangular base and two rectangular sides that meet to form an elongated lateral edge. Each limbal cleat may be flush with the limbal guide surface, the lateral edges oriented to extend from a proximal direction to a distal direction relative to the underside of the foot plate. The second set of cleats may include at least two traction cleats spaced apart from one another, each having a triangular prism shape, the triangular prism shape having a rectangular base and two rectangular sides that meet to form an elongated lateral edge. The at least two traction cleats may be disposed away from the limbal guide surface. The at least two traction cleats may include two groups of two traction cleats, a first group of two traction cleats disposed on the underside of the first lateral strut and a second group of two traction cleats disposed on the underside of the second lateral strut. A lateral edge of each traction cleat may be oriented to extend perpendicular to a lateral edge of each limbal cleat. A lateral edge of each traction cleat may be oriented to extend parallel to a lateral edge of each limbal cleat and perpendicular to the blade guide surface. The cleats may have a minimum radius of about 0.0015 inches to prevent penetration and damage to the sclera when a force is applied by the foot plate to the eye. The cleats may be configured to create an indentation in the sclera when a force is applied by the device to the eye by the foot plate. The cleats may be configured to resist movement of the foot plate during application of a force by the cutting blade along the blade guide surface.

[0011] In some variations, one or more of the following may be optionally included in any workable combination in the above methods, apparatus, devices, and systems. Further details of the devices, systems, and methods are described in the accompanying drawings and the following description. Other features and advantages will be apparent from the description and drawings. [Brief description of the drawings]

[0012] These and other aspects are described in detail with reference to the following drawings, which are generally not to scale or comparative in absolute terms, but are intended to be illustrative, and the relative placement of features and elements may be altered for clarity of illustration.

[0013] [Figure 1A] 1A-1C are perspective views of an embodiment of an incision guide tool.

[0014] [Figure 1B] FIG. 1B is a side view of the incision guide tool of FIG. 1A. [Figure 1C] FIG. 1B is a top view of the incision guide tool of FIG. 1A.

[0015] [Figure 1D] FIG. 1B is a detailed view of the distal end region of the tool of FIG. 1A.

[0016] [Figure 2A] FIG. 13 is a detailed view of an embodiment of a foot plate.

[0017] [Figure 2B] FIG. 2B is a cross-sectional view of the footplate taken along line BB of FIG. 2A.

[0018] [Figure 2C] FIG. 2B is a top view of the footplate of FIG. 2A.

[0019] [Figure 2D] 1 illustrates the positioning of the footplate relative to the limbus of the eye.

[0020] [Figure 3A] FIG. 2B is a bottom view of the foot plate of FIG. 2A.

[0021] [Figure 3B] FIG. 2B is a cross-sectional view of the footplate of FIG. 2A taken along line AA. [Figure 3C] FIG. 2B is a cross-sectional view of the footplate of FIG. 2A taken along line AA.

[0022] [Figure 4A] FIG. 13 is a bottom view of another embodiment of an incision guide tool. [Figure 4B] 13 is a perspective view of another embodiment of an incision guide tool. FIG.

[0023] [Figure 5A] FIG. 13 is a top view of another embodiment of the foot plate.

[0024] [Figure 5B] FIG. 5B is a bottom view of the foot plate of FIG. 5A. [Figure 5C] FIG. 5B is a bottom view of the foot plate of FIG. 5A.

[0025] [Figure 5D] FIG. 5B is a side view from the proximal end of the footplate of FIG. 5A.

[0026] [Figure 6A] 1A-1C are perspective views of an embodiment of an incision guide tool.

[0027] [Figure 6B] FIG. 6B is a detailed view of the foot plate of the incision guide tool of FIG. 6A.

[0028] It should be understood that the drawings herein are for illustrative purposes only and are not intended to be drawn to scale. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] Described herein is a guide tool for making an incision through the surface of the eye with a cutting blade or knife to ensure that the ideal dimensions of the incision are achieved for implantation of a therapeutic device or the like. The incision guide tool described herein is particularly useful for guiding the creation of a scleral incision made using an ophthalmic microvitreoretinal (MVR) blade. Ophthalmic MVR blades are designed to create precise watertight ports in MVR surgery, side ports in small incision cataract surgery, as well as incisions for inserting transscleral drug delivery devices. In some embodiments, the blade is used to make a shallow angled "V" shaped incision. In other embodiments, the blade is used to make a generally straight incision. For example, U.S. Patent No. 8,808,727 describes the insertion of a drug delivery device, which is preferably inserted through a straight incision. Slit-shaped incisions are desired because they provide better wound closure with minimal leakage of intraocular fluid into the wound.

[0030] FIG. 1A is a perspective view, and FIG. 1B and FIG. 1C are side and top views, respectively, of an embodiment of an incision guide tool 100 configured to guide the creation of an incision in an eye using a hand-held cutting blade. In general, the guide tool 100 includes an elongated handle 105 and a foot plate 110 coupled to a distal end region of the elongated handle 105. The handle 105 can extend along a longitudinal axis A over at least a portion of its length. The elongated handle 105 can be coupled to a shaft 112 at a distal end region such that the shaft 112 connects the handle 105 to the foot plate 110. Each component of the tool 100 is described in more detail below.

[0031] The handle 105, shaft 112, and foot plate 110 can all be generally aligned with a longitudinal axis extending between the proximal and distal ends of the tool 100 (see FIG. 1C). The shaft 112 can be angled relative to the handle 105 and / or can follow an arc-like shape between the handle 105 and the foot plate 110 (see FIGS. 1B and 1D). An angle α between the longitudinal axis A of the handle 105 and the first region of the shaft 112 can be about 20 degrees to about 30 degrees, preferably about 25 degrees. The foot plate 110 can be disposed at an angle relative to the handle 105 and at an angle relative to the distal end region of the shaft 112. The foot plate 110 can be coupled to the distal end of the shaft 112 to form an angle β between the top surface of the distal end region of the shaft 112 and the top surface of the foot plate 110. The angle β can be about 130 degrees to about 140 degrees, preferably about 135 degrees. The angle between the shaft 112 and the handle 105, as well as the angle between the shaft 112 and the foot plate 110, provide for proper viewing of the target cutting area of ​​the eye. For example, the arcuate geometry of the shaft 112 ensures that the handle 105 can be placed on the patient's cornea 5 during use without substantial contact or interference (see FIG. 2D).

[0032] The embodiment of tool 100 shown in Figures 1A-1D illustrates that shaft 112 has a generally rounded profile. Shaft 112 is also shown in Figures 1A-1D to taper from a wider dimension near the proximal end where shaft 112 is coupled to handle 105 to a narrower dimension near the distal end where shaft 112 is coupled to foot plate 110. The distal end of shaft 112 need not be relatively narrow where it couples to foot plate 110. Shaft 112 can incorporate a distal end 113 that is at least as wide as or wider than proximal end 114 of shaft 112 (see Figures 6A-6B). The wider dimension of the distal end of shaft 112 provides good stability against contact with the eye during use.

[0033] FIG. 2A is a detailed view of an embodiment of a foot plate 110. FIG. 2B is a cross-sectional view of the foot plate 110 taken along line BB of FIG. 2A. FIG. 2C is a top view of the foot plate of FIG. 2A. The foot plate 110 can include a number of walls or struts 115 arranged to define a central opening 120 extending between the upper and lower surfaces of the foot plate 110. A distal strut 115a of the number of struts 115 has a proximal blade guide surface 122 and a distal forward surface 123. The blade guide surface 122 is proximal in that it faces toward the location of the junction between the foot plate 110 and the shaft 112, and in the context of a user, it is in the proximal direction or closer to the user's hand holding the handle 105 of the device 100. The forward surface 123 is distal in that it faces away from the location of the junction between the foot plate 110 and the shaft 112, or away from the user's hand holding the handle 105 of the device 100. A proximal strut 115b of the plurality of struts 115 is located opposite the distal strut 115a across the central opening 120 and has a proximal limbal guide surface 124 and a distal anterior surface 125. Again, the limbal guide surface 124 is proximal in that it faces or is closer to the user's hand holding the handle 105 of the device 100, and the anterior surface 125 is distal in that it faces away from the user's hand and toward the central opening 120. Both the blade guide surface 122 and the limbal guide surface 124 face in a proximal direction, and the surfaces 123, 125 of each strut 115a, 115b face in a distal direction.

[0034] 2A-2C, the blade guide surface 122 of the distal strut 115a may be substantially straight from end to end, while the limbal guide surface 124 may be curved from end to end. The straight geometry of the blade guide surface 122 is dimensioned to create a linear scleral incision with the blade 10 (as shown in FIG. 2D and described in more detail below). Points along the blade guide surface 122 align to define a straight line, whereas points along the limbal guide surface 124 do not align but instead follow an arc. It should be noted that terms such as straight should not be considered exact or perfect, but may include allowable manufacturing tolerances or imperfections. The curved geometry of the limbal guide surface 124 is dimensioned to provide visibility and alignment of the tool 100 with the limbal edge 15 of the eye during use. The arc length of the limbal guide surface 124 can vary, but is preferably about 5.5 mm or sufficient to provide guidance for placing a tool relative to the limbus or limbal edge 15. The proximal struts 115b can also incorporate limbal wings 126 (FIGS. 5A-5D) for additional length and guidance, if desired.

[0035] FIG. 2D shows the device 100 positioned on the surface of the eye such that the limbal guide surface 124 is aligned with the limbal edge 15. In use, when the limbal guide surface 124 is aligned with the limbal edge 15 and the blade guide surface 122 of the foot plate 110 extends a distance onto the sclera 20, the shaft 112 projects proximally onto the cornea 5. The conjunctiva 22 is moved so that the foot plate 110 is in direct contact with the sclera underlying the conjunctiva 22. FIG. 3A shows that the foot plate 110 can be coupled to a distal end region of the handle 105 (or shaft 112) at a proximal end region of the foot plate 110 near the location of the limbal guide surface 124. FIG. 3C shows that the blade guide surface 122 is a distance D away from the limbal guide surface 124 to target the location of the incision relative to the limbus of the eye. The distance D can be about 3.9 mm to about 4.1 mm, preferably about 4.0 mm, so that an incision can be formed at the location of the blade guide surface 122 about 4.0 mm away from the edge 15 of the limbus. The blade guide surface 122 also has a length L between the two lateral struts 115c, which limits the length of the incision that can be made using a cutting blade inserted into the central opening 120 and sliding between the two lateral struts 115c (see FIG. 2C). The length L can be about 3.45 mm to about 3.55 mm, preferably about 3.5 mm, so that the incision formed is preferably about 3.5 mm long. The distance D and length L can be greater than the preferred distance and length, respectively, to account for variability in use.

[0036] The distal end of the tool 100 (i.e., the distal anterior surface 123 of the distal strut 115a) may be curved to clearly distinguish it from the straight blade guide surface 122. The curvature of the limbal guide surface 124 and the curvature of the distal anterior surface 123 may be substantially the same. One or more marks, notches, or other visual indicators may be placed on the upper surface of the foot plate 110 near the blade guide surface 122 to indicate edges that are intended to guide a cut and edges that are not intended to guide a cut.

[0037] The geometry of the foot plate 110 may be substantially rectangular or square in that there may be four struts 115, with distal struts 115a and proximal struts 115b opposing each other and joined by a pair of opposing lateral struts 115c. The two lateral struts 115c may be generally parallel to each other such that the angle between each of the lateral struts 115c and the distal strut 115a near the blade guide surface 122 is approximately 90 degrees.

[0038] The struts 115 of the foot plate 110 preferably form a closed shape with a central opening 120. The two lateral struts 115c limit the length of the incision that can be made along the blade guide surface 122. The blade 10 is prevented from abutting the corner and making an incision outside the desired length. The shape of the multiple struts 115 with the central opening 120 can be a square prism ring or a rectangular prism ring. The closed ring shape improves visualization of the location of the incision even when the incision is made from inside the central opening 120 due to the blade guide surface 122 being at the proximal edge of the anterior strut 115a. This avoids the struts 115a blocking the user's view of the cut surface. Additionally, a square or rectangular prism ring with a generally right angle between each of the struts 115 can improve the blade's access and visualization to the incision site located within the dimensions of the central opening 120. The blade 10 can be inserted at a first corner (i.e., between the forward strut 115a and one of the lateral struts 115c) ensuring a full and complete incision is made across the blade guide surface 122 to the opposite corner (i.e., between the forward structure 115a and the opposing lateral strut 115c).

[0039] The foot plate 110 can have a geometry that does not necessarily include right angles between the struts 115. For example, the foot plate 110 can have multiple struts 115 arranged in a trapezoid or staircase shape or another shape such that the lateral struts 115c are not parallel to one another such that the angle between each of the lateral struts 115c and the distal strut 115a near the blade guide surface 112 is less than 90 degrees (see FIGS. 5A-5D). In comparison, prism ring shapes that have corners near the blade guide surface 122 that are less than 90 degrees, such as trapezoidal prism rings, can impair blade access to the incision site at these locations. An angle between the distal strut 115a and the lateral struts 115c that is less than 90 degrees can impede blade alignment with respect to the blade guide surface 122 and impair visualization by the user.

[0040] In yet another embodiment, the foot plate 110 incorporates multiple struts creating a branched shape with an open geometry such that the blade guide surface 122 is located on the distal side of the strut 115 (see Figures 4A-4B).

[0041] Figure 3A is a bottom view of the foot plate of Figure 2A. Figures 3B-3C are cross-sectional views of the foot plate of Figure 2A along line AA. The blade guide surface 122 between the upper and lower surfaces of the foot plate 110 can be flat and can extend substantially perpendicular to the plane of the central opening 120 or substantially parallel to a central axis C of the central opening 120 that extends between the upper and lower surfaces of the foot plate 110 (see Figure 3B). A flat blade guide surface 122 substantially parallel to the central axis C promotes perpendicular positioning of the blade relative to the sclera and prevents tunneling or shelving of the blade while making an incision in the sclera.

[0042] Generally, the blade 10 approaches the blade guide surface 122 of the foot plate 110 from the direction of the distal surface 123 (see FIG. 2D ). The blade 10 is inserted through a central opening 120 in the foot plate 110 such that a flat portion of the blade 10 abuts the blade guide surface 122 and a sharp blade tip contacts the sclera at the corner between the blade guide surface 122 and the lateral strut 115 c. The geometry of the blade guide surface 122 ensures that the blade 10 can be positioned perpendicular to the surface of the sclera as it is inserted through the opening 10 and into the surface 122, and also as it is inserted along the sclera as it moves laterally along the surface 122.

[0043] FIG. 3C shows that the blade guide surface 122 can have a rounded portion 128 near the top surface of the foot plate 110. The rounded portion 128 at the top edge of the guide surface 122 can be about 0.005 inches to about 0.010 inches, preferably about 0.008 inches. The blade guide surface 122 below the rounded portion 128 is substantially flat and configured to abut a flat portion of the blade when the blade is inserted vertically through the central opening 120. The flat portion of the blade guide surface 122 can have a thickness T of about 0.005 inches to about 0.020 inches, preferably about 0.010 inches. The height of the flat portion and the near vertical angle significantly reduces the risk of tunneling or shelving of the blade during use. In other embodiments, the blade guide surface 122 has a chamfered edge near the top surface of the foot plate 110 of about 10 degrees to about 30 degrees.

[0044] The height of the flat portion can be designed not only to promote the orientation of the blade relative to the sclera but also to ensure proper visualization of the incision site and the blade. The footplate 110 can have a proximal end region near where it is coupled to the handle 105 and a distal end region closer to the location of the distal strut 115a, for example having a blade guide surface 122. The thickness Td of the footplate 110 in the distal end region near the position of the blade guide surface 122 can be minimized to be less than the thickness Tp of the footplate 110 near the proximal end region (see FIG. 3C). For example, the thickness Td of the footplate 110 at the distal end can be about 0.015 inches to 0.020 inches, while the thickness Tp of the footplate 110 at the proximal end can be about 0.030 inches to 0.035 inches. This variation in the thickness of the footplate 110 along its length, having the thinnest portion near the distal end region of the footplate 110, improves visualization of the incision position and the blade. By minimizing the thickness of this distal strut 115a, the visibility of the incision position is improved. Further, the tapered thickness of the footplate 110 (i.e., Td < Tp) enables enhancing the visibility at the corner of the blade guide surface 122. In use, the footplate 110 is positioned relative to the eye. Depending on the procedure being performed and which eye is being treated, the footplate 110 can be positioned in the temporal upper quadrant such that the handle 105 extends across the cornea of the eye being treated towards the patient's nose. The limbus guide surface 124 is aligned with the limbus and the distal strut 115a is directed towards the patient's temple or hairline. The blade approaches the eye from above the footplate 110 and is inserted through the central opening 120 of the footplate 110 to incise the eye along the blade guide surface 122 in a direction substantially perpendicular to the surface of the sclera. The minimal thickness of the distal strut 115a minimizes the depth of the window 120, which otherwise could obstruct the surgeon's view at the incision site inside the window 120.The thickness Td is designed to provide good surface area for apposing the flat portion of the blade 10 against the blade guide surface 122 while preventing the foot plate from blocking the view of the blade 10 and the incision being made. The thinner distal struts 115a and shallower central opening 120 at the location of the blade guide surface 122 give the blade additional freedom, especially as it approaches the corner of the blade guide surface 122. The surgeon can more easily see the incision site and can also rotate, turn and angle the blade in a desired manner inside the opening 120 to achieve a perfect cut from corner to corner. The central opening 120 defined at the distal end by the narrower distal struts 115a acts as a thin stencil rather than as an obstruction.

[0045] Visualization of the limbus 15 can be improved by incorporating a chamfered edge 130 near the top surface of the foot plate 110 that leads to the limbus guide surface 124 (see FIGS. 3B-3C). Each of the lateral struts 115c can also have a chamfered edge 132 that leads to the central opening 120 (see FIGS. 2B-2C). The chamfered edge 132 of the lateral struts 115c can correspond to the angulation of the blade relative to the central opening 120 and enhance visualization of the incision being made. The chamfered edge 132 of the lateral struts 115c can form an angle of approximately 45 degrees. The angle between the edge 132 and the strut 115 can complement the shape of the blade used to create the scleral incision. For example, a 45 degree angle complements the diamond shaped tip of an MVR blade.

[0046] 3A and 6B, the underside of the foot plate 110 may include a plurality of cleats 135 grouped into different cleat sets 135a, 135b, 135c. The cleat sets 135a, 135c may be traction cleats and the cleat set 135b may be limbal cleats. The traction cleats and limbal cleats may be positioned relative to the foot plate 110 and relative to each other to provide different functions to the device 100, as described in more detail below.

[0047] At least two traction cleats 135a may be positioned near the distal end of the foot plate 110 at a distance from each other. Preferably, at least a first traction cleat 135a is positioned at a first location, such as near a corner of the blade guide surface 122 where the distal strut 115a meets the lateral strut 115c, and at least a second traction cleat 135a is positioned at a second location, such as near an opposing corner of the blade guide surface 122 where the distal strut 115a meets the opposing lateral strut 115c. Thus, the span between the first and second traction cleats 135a is greater than the width of the central opening 120 and thus the length L of the blade guide surface 122. The first set of cleats preferably includes two traction cleats 135a grouped at a first location and two traction cleats 135a grouped at a second location. The first and second locations of the traction cleat 135a are preferably further apart than the length of the blade guide surface 122 from lateral strut 115c to lateral strut 115c. The first and second locations of the traction cleat 135a can be located further distal to the central opening 120, as shown in Figures 3A and 6B, and / or can be located along at least a portion of the lateral strut 115c, as described below.

[0048] Each traction cleat 135a may have the shape of a triangular prism with a rectangular base and two rectangular sides that meet to form an elongated tip or lateral edge 137a. The lateral edge 137a creates a non-penetrating spike that provides traction without tissue damage or sclera penetration. The lateral edge 137a of each traction cleat 135a is oriented to extend from a proximal to a distal direction relative to the lower surface of the foot plate 110. The blade guide surface 122 extends laterally in a left-right direction. Thus, the lateral edge 137a of each traction cleat 135a is disposed perpendicular to the plane of the blade guide surface 122. This orientation provides a grip between the device 100 and the eye even during lateral movement of the blade 10 along the blade guide surface 122.

[0049] 3A and 6B, the underside of the foot plate may include a pair of limbal cleats 135b spaced a distance from one another and disposed near a proximal end of the foot plate 110. Preferably, at least a first limbal cleat 135b is disposed at a first location, such as near a corner of the limbal guide surface 124 where a proximal strut 115b meets a lateral strut 115c, and at least a second limbal cleat 135b is disposed at a second location, such as near an opposing corner where a proximal strut 115b meets an opposing lateral strut 115c. The span between the first and second limbal cleats 135b is generally greater than the width of the central opening 120. The first set of limbal cleats 135b preferably includes only one limbal cleat 135b at a first location and a second limbal cleat 135b at a second location, although more than one limbal cleat per location is contemplated herein. The first and second locations of the limbal cleat 135b are preferably further apart than the length of the blade guide surface 122 from lateral strut 115c to lateral strut 115c. The first and second locations of the limbal cleat 135b are preferably positioned such that at least one edge of its rectangular base lies flush with the limbal guide surface 124, although they may be positioned further distally.

[0050] Each limbal cleat 135b may have the shape of a triangular prism with a rectangular base and two rectangular sides that meet to form an elongated lateral edge 137b. The lateral edges 137b create spikes that provide traction without penetrating tissue imperfections. The lateral edges 137b of each limbal cleat 135b are oriented to extend from a proximal to a distal direction relative to the lower surface of the foot plate 110. Thus, the lateral edges 137b of each limbal cleat 135b are disposed perpendicular or orthogonal to the plane of the blade guide surface 122. This orientation provides additional traction of the tool against the ocular surface even during lateral movement of the blade along the blade guide surface 122. Thus, the tool 100 is fixed against the ocular surface even during lateral movement of the blade from side to side relative to the blade guide surface 122 to create an incision.

[0051] The foot plate 110 may incorporate an intermediate group 135c of traction cleats disposed on the underside of each of the lateral struts 115c. This group 135c of traction cleats may have a lateral edge 137c disposed perpendicular to the lateral edges 137a of the other groups 135a of traction cleats and perpendicular to the lateral edges 137b of the limbal cleats 135b. Figures 3A and 6B show a first group 135a of traction cleats near each corner of the blade guide surface 122 and a second group 135c of traction cleats on each lateral strut 115c. The lateral edges 137a of the first group 135a of traction cleats are all parallel to each other but perpendicular to the plane of the blade guide surface 122. The lateral edges 137c of the second group of traction cleats 135c all lie parallel to each other and to the plane of the blade guide surface 122, but are oriented perpendicular to the lateral edges 137a of the first group of traction cleats 135a.

[0052] The geometry of the cleats 135 is configured to provide a temporary boundary for the positioning of the tool 100 on the surface of the eye, even after removal of the tool 100. The limbal cleats 135b, among other things, define the limbal edge 15 and provide guidance for repositioning the tool 100 as needed. The limbal cleats 135b are positioned on the underside such that one edge of the rectangular base is flush with the limbal guide surface 124. Thus, the lateral edge 137b of each limbal cleat 135b terminates at the limbal edge 15. The distal traction cleats 135a can similarly define the location of the incision site. As described above, a traction cleat 135a can be positioned at each corner where the distal strut 115a meets the lateral strut 115c, such that the lateral edge 137b of each corner identifies the location of the incision therebetween.

[0053] Pressing the cleats 135 against the sclera and / or limbus of the eye can indent the eye surface so that upon removal of the foot plate 110, the indentations left behind can remain visible for a period of time during the procedure. The indentations provide guidance to the user if they wish to replace the foot plate 110 in the same position following the same alignment. The indentations act as temporary markers to align the device to the same position on the eye. The geometry of the cleats is such that applying force to the foot plate 110 will depress the sclera but will not penetrate it. The lateral edges 137 of the cleats 135 are at least somewhat rounded to avoid piercing or cutting tissue that may occur with a sharp needle or blade tip. The unique orientation of the set of cleats relative to each other and to the blade guide surface provides guidance regarding the location of the limbus and the location of the incision site. The indentations left by the cleats mirror this pattern and help to place the foot plate on the eye surface in the correct orientation.

[0054] The minimum radius at the lateral edges 137 of all foot plate cleats 135 is about 0.0015 inches. This minimum radius ensures that the cleats 135 are not sharp and do not penetrate the scleral surface of the eye. Each cleat 135 extends from the underside of the foot plate 110 to a height of about 0.015 inches to about 0.025 inches. The width along the base of each cleat may be about 0.035 inches to about 0.050 inches. The lateral edges 137 of each cleat 135 have corresponding dimensions to contact the sclera along the width of each cleat base along the corresponding length. The limbal cleat 135b may form an interior angle of about 90 degrees, whereas the traction cleats 135a, 135c may form an interior angle of about 60 degrees. The number, shape, arrangement, spacing, and grouping of the cleats may vary. Where a group of two cleats is described, the groups may be three or more cleats or only one cleat each.

[0055] Materials or combinations of materials suitable for the fabrication of the various components of the devices disclosed herein are provided throughout. It is understood that other suitable materials are contemplated. The device can be constructed from any medical grade material capable of providing the necessary functionality for the components. Materials that may be used in the device include materials compatible with standard sterilization processes by autoclaving or pressurized steam treatment, such as titanium alloys, stainless steel, or other medical grade materials. The device can be made from combinations of materials that fit together geometrically, are chemically bonded or welded together, are overmolded, encapsulated, or are other means for joining multiple materials. A given device element may be made of multiple materials. The different components (i.e., handle 105, shaft 112, and foot plate 110) can be formed from the same material or materials, or can be formed from different materials. In some implementations, the handle 105 is formed from a metallic material, and the shaft 112 and foot plate 110 are formed from a polymeric material. The shaft 112 and foot plate 110 may be injection molded polymer integrated into a single component configured to be coupled to the distal end of the handle 105 .

[0056] How to use

[0057] An example of the device 100 used during the implantation procedure is shown below. The conjunctiva and Tenon's capsule may be incised into a fornix-based flap at the limbus, and if necessary, a superficial and minimal wet cautery may be applied to the perforating vessels. Hemostasis of the scleral surface is confirmed and any excess blood from the surface of the sclera is removed. Wet field cautery may be performed, especially in the area of ​​the scleral-pars plana incision. After cauterization, the eye surface is dried with a cotton-tipped applicator or sponge. The curved limbal guide surface 124 of the foot plate 110 is aligned with the limbus 15 in the superior temporal quadrant. The foot plate 110 is positioned flat against the eye such that the cleat 135 provides stable positioning against the sclera 20. While maintaining the plate 110 flat against the sclera 20, the device 100 may be used to rotate the eye as needed to visualize the internal blade guide surface 122 through the central opening 120. A blade 10, such as a microvitreoretinal (MVR) blade, can be inserted through the central opening 120 such that the sharp point of the blade 10 is located at the first corner of the blade guide surface 122 and the flat surface of the blade abuts the blade guide surface 122. The sclera 20 can be gently incised by tracing the blade 10 flat along the blade guide surface 122 to the opposing corner using multiple passes of light in the same direction while ensuring that the blade 10 is substantially perpendicular to the surface of the eye. After an initial cut is made using the device 100 as a guide, a full thickness incision is made in the sclera 20 using the blade 10 until the pars plana is fully visible. The full thickness incision can be made with the device 100 in place or after the device 100 has been removed. When the device 100 is removed, a full thickness incision should be made without extending the incision beyond the length of this initial guided cut. The final scleral incision length is preferably about 3.5 mm and is vertical throughout the entire thickness through the sclera 20. If desired, the depression left by the cleat 135 can be used to reposition the device 100 over the eye, orienting the device 100 in the same position relative to the eye.

[0058] In various embodiments, the description is given with reference to the drawings. However, a particular embodiment may be implemented without one or more of these specific details or in combination with other known methods and configurations. In the description, numerous specific details, such as specific configurations, dimensions, and processes, are described to achieve a thorough understanding of the embodiment. In other instances, well-known processes and manufacturing techniques are not specifically described so as not to unnecessarily obscure the description. References throughout this specification to "one embodiment," "embodiment," "one implementation," "implementation," and the like mean that the described particular feature, structure, configuration, or characteristic is included in at least one embodiment or implementation. Thus, the appearance of the phrases "one embodiment," "embodiment," "one implementation," or "implementation" in various places throughout this specification do not necessarily refer to the same embodiment or implementation. Furthermore, particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0059] The devices and systems described herein may incorporate any of a variety of features. An element or feature of one embodiment of the devices and systems described herein may be incorporated alternatively or in combination with an element or feature of another embodiment of the devices and systems described herein. For the sake of brevity, various combinations are contemplated herein, but an explicit description of each of those combinations may be omitted. Furthermore, the devices and systems described herein may be placed in the eye and need not be specifically implanted as shown in the figures or as described herein. The various devices may be implanted, positioned, adjusted, etc. according to a variety of different methods and using a variety of different devices and systems. The various devices may be adjusted at any time before, during, and after implantation. Several representative descriptions of how the various devices may be implanted and positioned are provided, but for the sake of brevity, an explicit description of each method for each implant or system may be omitted.

[0060] Use of relative terms throughout the description may indicate relative positions or directions or orientations and is not intended to be limiting. For example, "distal" may indicate a first direction away from a reference point. Similarly, "proximal" may indicate a position in a second direction opposite to the first direction. Use of terms such as "upper," "lower," "top," "bottom," "front," "side," and "back," as well as "anterior," "posterior," "caudal," "cephalad," or used to establish a relative frame of reference, is not intended to limit the use or orientation of any of the devices described herein in various embodiments.

[0061] As used herein, the term "about" refers to a range of values ​​inclusive of the specified value that one of ordinary skill in the art would reasonably consider similar to the specified value. In an embodiment, the term "about" refers to within a standard deviation using measurements generally acceptable to one of ordinary skill in the art. In an embodiment, the term "about" refers to a range extending to + / - 10% of the specified value. In an embodiment, the term "about" includes the specified value.

[0062] While the specification contains many details, these should not be construed as limitations on the scope of what is claimed or what may be claimed, but rather as descriptions of features specific to particular embodiments. Certain features described herein in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, although features may be described above as acting in a particular combination and initially claimed as such, one or more features from the claimed combination may, in some cases, be cut out of the combination, and the claimed combination may be directed to a subcombination or a variation of the subcombination. Similarly, although operations are shown in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown, or in the sequential order, or that all of the operations shown be performed, to achieve desirable results. Only some examples and embodiments have been disclosed. Variations, modifications, and enhancements to the described examples and embodiments, as well as other embodiments, may be made based on what is disclosed.

[0063] In the above specification and claims, phrases such as "at least one of" or "one or more of" may appear before a list of consecutive elements or features. The term "and / or" may also be used in a list of two or more elements or features. Unless implicitly or explicitly contradicted by the context in which it is used, such phrases are intended to mean any of the listed elements or features individually or in combination with any of the other listed elements or features. For example, the phrases "at least one of A and B," "one or more of A and B," and "A and / or B" are each intended to mean "A only, B only, or A and B together." A similar interpretation is intended for lists containing more than two items. For example, the phrases "at least one of A, B, C," "one or more of A, B, C," and "A, B, and / or C" are intended to mean "A only, B only, C only, A and B together, A and C together, B and C together, or A, B and C together."

[0064] Use of the term "based on" above and in the claims means "based at least in part on" and means that unrecited features or elements are permitted.

Claims

1. 1. A device configured to guide the creation of an incision in a sclera of an eye using a cutting blade, comprising: an elongate handle extending along a longitudinal axis for at least a portion of its length and having a proximal end region and a distal end region; a footplate coupled to the distal end region of the elongated handle, the footplate comprising a plurality of struts defining a central opening extending between upper and lower surfaces of the footplate, a first strut of the plurality of struts having a proximal blade guide surface that is straight and extends between two lateral struts of the plurality of struts, and a second strut of the plurality of struts having a curved proximal limbal guide surface; the blade guide surface is spaced a distance from the limbal guide surface to identify a target location for making an incision relative to the limbus of the eye; The device, wherein the blade guide surface has a length between the two lateral struts that limits the length of the incision that can be made between the two lateral struts using a cutting blade inserted through the central opening.

2. 10. The device of claim 1, wherein the blade guide surface between the upper and lower surfaces of the foot plate extends vertically to prevent tunneling of the cutting blade against the sclera.

3. The device of claim 2 , wherein the blade guide surface has a rounded portion adjacent the top surface of the foot plate.

4. 4. The device of claim 3, wherein the blade guide surface below the radiused portion is between 0.005 inches and 0.020 inches thick.

5. The device of claim 2 , wherein the blade guide surface has a chamfered edge near the top surface of the foot plate.

6. The device of claim 5 , wherein the chamfered edge is greater than or equal to 10 degrees and less than or equal to 30 degrees.

7. The device of claim 1 , wherein the distance between the blade guide surface and the limbus guide surface is equal to or greater than 3.9 mm and equal to or less than 4.1 mm.

8. The device of claim 1 , wherein the length between the two lateral struts is equal to or greater than 3.45 mm and equal to or less than 3.55 mm.

9. The device of claim 1 , wherein the angle between each of the two lateral struts and the blade guide surface is 90 degrees.

10. The device of claim 9 , wherein the two lateral struts are parallel to one another.

11. The device of claim 1 , wherein the foot plate is coupled to the distal end region of the elongate handle at a proximal end region of the foot plate near the location of the limbal guide surface.

12. 12. The device of claim 11, wherein a thickness of the foot plate between the upper and lower surfaces is less at a distal end region of the foot plate near the location of the blade guide surface than a thickness of the foot plate between the upper and lower surfaces near the proximal end region of the foot plate.

13. The device of claim 1 , wherein the limbal guide surface has a chamfered edge near the upper surface of the foot plate.

14. The device of claim 1 , wherein each of the two lateral struts has a chamfered edge leading to the central opening.

15. The device of claim 1 , wherein the footplate is coupled to the distal end region at an angle relative to the longitudinal axis of the elongated handle.

16. 16. The device of claim 15, wherein the angle is greater than or equal to 130 degrees and less than or equal to 140 degrees.

17. The device of claim 1 , wherein the elongated handle further comprises a shaft between the foot plate and the distal end region of the elongated handle.

18. 20. The device of claim 17, wherein the shaft extends at an angle of greater than or equal to 20 degrees and less than or equal to 30 degrees relative to the longitudinal axis of the elongate handle.

19. The device of claim 1 , wherein the first strut has a curved distal surface.

20. The device of claim 1 , wherein the plurality of struts of the foot plate create a square prism ring, a rectangular prism ring, or a trapezoid prism ring shape.

21. The device of claim 1 , wherein the lower surface of the foot plate further comprises a plurality of cleats.

22. 22. The device of claim 21, wherein the plurality of cleats includes at least a first set of cleats and a second set of cleats, the first set of cleats having an orientation relative to the lower surface that is different than an orientation of the second set of cleats.

23. 23. The device of claim 22, wherein the first set of cleats comprises at least two limbal cleats spaced a distance from one another, each limbal cleat having a triangular prism shape having a rectangular base and two rectangular sides that meet to form an elongated lateral edge.

24. 24. The device of claim 23, wherein each limbal cleat is flush with the limbal guide surface and the lateral edges are oriented to extend in a proximal to distal direction relative to the lower surface of the foot plate.

25. 25. The device of claim 24, wherein the second set of cleats comprises at least two traction cleats spaced a distance from one another, each of the at least two traction cleats having a triangular prism shape having a rectangular base and two rectangular sides that meet to form elongated lateral edges.

26. 26. The device of claim 25, wherein the at least two traction cleats are positioned away from the limbal guide surface.

27. 27. The device of claim 26, wherein the at least two traction cleats include two groups of two traction cleats, a first group of two traction cleats being disposed on the lower surface of a first lateral strut and a second group of two traction cleats being disposed on the lower surface of a second lateral strut.

28. 27. The device of claim 26, wherein the lateral edge of each traction cleat is oriented to extend perpendicular to the lateral edge of each limbal cleat.

29. 27. The device of claim 26, wherein the lateral edge of each traction cleat is oriented to extend parallel to the lateral edge of each limbal cleat and perpendicular to the blade guide surface.

30. 22. The device of claim 21, wherein the plurality of cleats have a minimum radius of 0.0015 inches to prevent penetration and damage to the sclera when a force is applied by the foot plate against the eye.

31. 31. The device of claim 30, wherein the plurality of cleats are configured to create an indentation in the sclera when the device applies a force against the eye by the foot plate.

32. 22. The device of claim 21, wherein the plurality of cleats are configured to resist movement of the foot plate during application of a force by a cutting blade along the blade guide surface.

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