Intravitreal injection instrument

Abstract

The disclosed technology herein relates to an intravitreal injection instrument. The injection instrument includes a handle extending along a length of the instrument. The proximal end of the handle is coupled to a proximal end of an injection guide. The injection guide includes a rigid body having a first member and a second member that define a channel therein. The channel extends from a distal end of the injection guide to an interior portion of the body near the proximal end of the injection guide. A width of the channel is sized to receive a needle therein. The injection guide and handle are arranged at an obtuse angle from one another.

Description

Docket #: 206030-0314-OOWOINTRA VITREAL INJECTION INSTRUMENTCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to US Provisional Patent Application No. 63 / 698,722, filed on September 25, 2024, incorporated herein by reference in its entirety.BACKGROUND

[0002] An intravitreal injection is a procedure in which a health care provider (HCP) injects medicine into the eye to treat a variety of eye conditions. There are key steps during the procedure that pose challenges that if not overcome can potentially result in complications that can lead to blindness. The first key step is using an eyelid speculum to retract the eyelids to allow access to the site of injection site at the sclera, the white part of the eyeball. The second key step is ensuring the eye is stabilized and looking in the right direction, which is usually done by asking the patient to look in a certain direction. The third key step is to ensure the injection site is sterile, which is usually done with povidone iodine drops or povidone iodine soaked cotton bud application over the injection site. The fourth key step is to mark the precise injection site, which is either 3.5mm (for a pseudophakic) or 4mm (for a phakic) away from the sclera (the part where the cornea meets the sclera). The fifth key step is to ensure the correct angle and depth of needle insertion, which is HCP dependent and achieved through years of experience. The sixth key step is to ensure the patient does not move their eye during the injection, which is achieved by asking the patient to look at a single point and is patient dependent. Patient or HCP related errors in any of these key steps can lead to a blinding complication. As such, there is a need in the art for instruments to efficiently assist safe and effective intravitreal injections. The present invention satisfies these needs.SUMMARY

[0003] The present disclosure relates generally to ophthalmologic instruments, and more particularly, to intravitreal injection instruments.PAGE 1 OF 15Docket #: 206030-0314-OOWO

[0004] In one or more aspects, the disclosed technology relates to an intravitreal injection instrument. In one or more cases, the injection instrument includes a handle extending along a length of the instrument. In one or more cases, the proximal end of the handle is coupled to a proximal end of an injection guide. In one or more cases, the injection guide includes a rigid body having a first member and a second member that define a channel therein. In one or more cases, the channel extends from a distal end of the injection guide to an interior portion of the body near the proximal end of the injection guide. In one or more cases, a width of the channel is sized to receive a needle therein. In one or more cases, the injection guide and handle are arranged at an obtuse angle from one another.

[0005] A variety of additional aspects will be set forth in the description that follows. The aspects can relate to individual features and to combination of features. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the broad inventive concepts upon which the embodiments disclosed herein are based.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The following drawings are illustrative of particular embodiments of the present disclosure and therefore do not limit the scope of the present disclosure. The drawings are not to scale and are intended for use in conjunction with the explanations in the following detailed description.

[0007] FIG. 1A is a perspective view of an example intravitreal injection instrument.

[0008] FIG. IB is a side view of the example intravitreal injection instrument of FIG. 1A.

[0009] FIG. 1C is a top view of the example intravitreal injection instrument of FIG. 1A.

[0010] FIG. 2A is a perspective view of another example intravitreal injection instrument.

[0011] FIG. 2B is a bottom view of the example intravitreal injection instrument of FIG. 2A.

[0012] FIG. 3 illustrates an example process to perform an intravitreal injection.

[0013] FIG. 4A illustrates an example process to perform an intravitreal injection.

[0014] FIG. 4B is an enlarged view of the intravitreal injection process illustrated in FIG. 4A.

[0015] FIG. 5A is a perspective view of an example intravitreal injection instrument with an example marking end.PAGE 2 OF 15Docket #: 206030-0314-OOWO

[0016] FIGs. 5B and 5C illustrate enlarged views of the example marking end of FIG. 5 A.DETAILED DESCRIPTION

[0017] The following discussion omits or only briefly describes conventional features of ophthalmologic instruments that are apparent to those skilled in the art. It is noted that various embodiments are described in detail with reference to the drawings, in which like reference numerals represent like parts and assemblies throughout the several views. Reference to various embodiments does not limit the scope of the claims attached hereto. Additionally, any examples set forth in this specification are intended to be non-limiting and merely set forth some of the many possible embodiments for the appended claims. Further, particular features described herein can be used in combination with other described features in each of the various possible combinations and permutations.

[0018] Unless otherwise specifically defined herein, all terms are to be given their broadest reasonable interpretation including meanings implied from the specification as well as meanings understood by those skilled in the art and / or as defined in dictionaries, treatises, etc. It is noted that, as used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless otherwise specified, and that the terms “includes” and / or “including,” when used in this specification, specify the presence of stated features, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.

[0019] Relative terms such as “horizontal,” “vertical,” “up,” “down,” “top,” and “bottom” as well as derivatives thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then described or as shown in the drawing figure under discussion. These relative terms are for convenience of description and normally are not intended to require a particular orientation. Terms including “inwardly” versus “outwardly,” “longitudinal” versus “lateral” and the like are to be interpreted relative to one another or relative to an axis of elongation, or an axis or center of rotation, as appropriate. Terms concerning attachments, coupling and the like, such as “connected” and “interconnected,” refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments orPAGE 3 OF 15Docket #: 206030-0314-OOWO relationships, unless expressly described otherwise. The term “operatively or operably connected” is such an attachment, coupling or connection that allows the pertinent structures to operate as intended by virtue of that relationship.

[0020] Reference throughout the specification to “one embodiment”, “an embodiment” or “some embodiments” means that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment of the subject matter disclosed. Thus, the appearance of the phrases “in one embodiment”, “in an embodiment” or “in some embodiments” in various places throughout the specification is not necessarily referring to the same embodiment. Further, the particular features, structures or characteristics of “one embodiment”, “an embodiment” or “some embodiments” may be combined in any suitable manner with each other to form additional embodiments of such combinations. It is intended that embodiments of the disclosed subject matter cover modifications and variations thereof. Terms such as “first,” “second,” “third,” etc., merely identify one of a number of portions, components, steps, operations, functions, and / or points of reference as disclosed herein, and likewise do not necessarily limit embodiments of the present disclosure to any particular configuration or orientation.

[0021] Moreover, throughout this disclosure, various aspects of the invention can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual numbers within that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, 6, and any whole and partial increments there between. This applies regardless of the breadth of the range. As used herein, the term “about” in reference to a measurable value, such as an amount, a temporal duration, and the like, is meant to encompass the specified value and / or variations of plus or minus 20%, plus or minus 10%, plus or minus 5%, plus or minus 1%, and plus or minus 0.1% of the specified value, as such variations are appropriate.PAGE 4 OF 15Docket #: 206030-0314-OOWO

[0022] The terms “proximal,” “distal,” “anterior,” “posterior,” “medial,” “lateral,” “superior,” and “inferior” are defined by their standard usage indicating a directional term of reference. For example, “proximal” refers to a position that is situated nearer to the center of a body or point of attachment, while “distal” refers to a position that is situated away from the center of the body or point of attachment. In another example, “anterior” refers to the front of a body or structure, while “posterior” refers to the rear of a body or structure. In another example, “medial” refers to the direction towards the midline of a body or structure, and “lateral” refers to the direction away from the midline of a body or structure. In some examples, “lateral” or “laterally” may refer to any sideways direction. In another example, “superior” refers to the top of a body or structure, while “inferior” refers to the bottom of a body or structure. It should be understood, however, that the directional term of reference may be interpreted within the context of a specific body or structure, such that a directional term referring to a location in the context of the reference body or structure may remain consistent as the orientation of the body or structure changes.

[0023] The terms “patient,” “subject,” “individual,” and the like are used interchangeably herein, and refer to any animal amenable to the systems, devices, and methods described herein. The patient, subject or individual may be a mammal, for example, a human.

[0024] Providing an accurate and consistent means for needle guidance and entry is a challenge. Conventional intravitreal injection instruments may not guide a needle when manually inserted into an injection site. Moreover, these instruments may not prevent the needle from being pushed too far into the injection site. The embodiments described herein provide an intravitreal injection guide to safely and accurately inject a needle into an injection site.

[0025] FIGs. 1A, IB, and 1C illustrate various views of an example intravitreal injection instrument 100 (hereinafter “instrument 100”). The instrument 100 includes a handle 102 that extends along a length LI of the instrument 100. An injection guide 104 is disposed on a proximal end 110 of the handle 102. In one or more cases, the instrument 100 may be used in surgical applications, such as, but not limited to, a spectrum of ophthalmic surgery conditions. For instance, the instrument 100 may be used in intravitreal injection procedures.PAGE 5 OF 15Docket #: 206030-0314-OOWO

[0026] The handle 102 may be grasped to control the use of the guide 104. The handle 102 includes a body that is an elongated rigid member. In some cases, the body of the handle 102 may have a uniform cylindrical shape. In other cases, the body of the handle 102 may have a narrower cylindrical shape at the proximal end 110 of the handle 102 and a larger cylindrical shape at the distal end of the handle 102. In some cases, the narrower cylindrical shaped body may have a uniform cylindrical body. In other cases, the narrower cylindrical shaped body may taper towards the proximal end 110 of the handle 102. The narrower portion of the body of the handle 102 may increase visibility of the injection site.

[0027] The guide 104 is a rigid body 106 having members 112a, 112b spaced apart from one another forming a channel 114. The guide 104 is small and has compact size. For example, the size of the body 106 may be compact enough to fit on the eye when placed against the limbus and lower eyelid. The members 112a, 112b of the body 106 form a shape that defines the channel 114 therebetween. For example, the body 106 may be formed in a U-like shape, a horseshoe shape, a crescent shape, and the like. The channel 114 may be sized to allow a needle to pass therethrough to an injection site. The body 106 of the guide 104 may thin enough to not interfere with the needle entry for an injection, yet thick enough to ensure a safe stop to prevent the needle from being accidentally pushed too far into the injection site.

[0028] In one or more cases, one or more parts of the guide 104, such as the body 106 and / or handle 102, may be transparent or semi-transparent. As such, the transparent or semitransparent body provides increased visualization of the area underneath the body 106, such as a portion of the eye. Further, by being able to view the area underneath the body 106 minimizes risk complications. One or more parts of the guide 104 may be formed of surgical grade material, including, but not limited to, plastics and / or other FDA approved biocompatible materials. Further, the instrument 100 may be recyclable and cost effective to manufacture. In one or more other cases, one or more parts of the guide 104, such as the body 106 and / or handle 102, is formed of an opaque or solid material. For example, the body 106 may be formed of metal, such as surgical steel.

[0029] In one or more cases, the edges of the body 106, such as edges 118, 116a, 116b, may be rounded (e g. having a bullnose edge) or formed in another smooth / ergonomic shape to prevent damaging tissue around the injection site. In one or more cases, the edges 116a, 116bPAGE 6 OF 15Docket #: 206030-0314-OOWO of the body 106 are angled towards the channel 114. In such cases, the angled edges 116a, 116b provide an increased field of view. In one or more other cases, the edges may be arranged at the same angle as one another. For example, the edges 216a, 216b of body 206 may be linearly arranged with one another, as illustrated in FIG. 2A.

[0030] In one or more cases, a protrusion 108 extends upwards from a top surface 126 of the body 106. For example, the protrusion 108 extends upwards from the body 106 forming a right angle with respect to the top surface 126 of the body 106, as illustrated in FIG. IB. The proximal end 110 of the handle 102 may be coupled with the protrusion 108. In some cases, the inner surface 120 of the protrusion 108 is curved. The curved inner surface 120 of the protrusion 108 provides an increased field of view for a user holding the instrument 100. Further, the curved inner surface 120 of the protrusion 108 provides an increased area for manipulating / inserting a needle of a syringe through the channel 114 and into the injection site. In other cases, the inner surface 120 of the protrusion 108 is a flat surface. The protrusion 108 may be used to retain a portion of tissue away from an injection site during an injection. For example, the outer surface 121 of the protrusion 108 may provide a physical barrier that gently retracts an eyelid and keeps the eyelid from closing during an injection procedure (e.g., as illustrated in FIG. 4A). In one or more other cases, the body 106 is substantially planar, such that the body 106 does not include a protrusion 108 (e.g., the body 206 illustrated in FIG. 2A). As such, the proximal end 110 of the handle 102 may be coupled with the planar surface of the body 106. In such cases, the rear of the body 106 (e.g., the outer surface 121) and / or the rear of the handle 102 may be used to act as a physical barrier between tissue and a needle during the injection procedure.

[0031] In one or more cases, the members 112a, 112b extend outwards from the protrusion 108, as illustrated in FIG. 1C. The inner walls 117a, 117b of members 112a, 112b define the channel 114. In some cases, the end 122 of the channel 114 is curved. The curved end 122 of the channel 114 may be sized to interface with a curvature of a needle to guide the needle to the injection site. In one or more cases, the channel 114 is substantially parallel such that the inner walls 117a, 117b of members 112a, 112b that define the channel 114 are parallel to one another from the distal end at the edges 116a, 116b to the end 122 of the channel 114. In one or more other cases, the channel 114 is formed in a V-like shape such that the inner wallsPAGE 7 OF 15Docket #: 206030-0314-OOWO117a, 117b narrow from the distal end at the edges 116a, 116b to the end 122 of the channel 114. In one or more cases, the inner walls 117a, 117b of the members 112a, 112b may be parallel to one another when extending from the top surface 126 of the body 106 to the bottom surface 124 of the body 106. In one or more other cases, the inner walls 117a, 117b are formed at an angle when extending from the top surface 126 of the body 106 to the bottom surface 124 of the body 106. For example, the inner walls 117a, 117b may angle outwards when extending from the top surface 126 of the body 106 to the bottom surface 124 of the body 106.

[0032] In one or more cases, the edges 116a, 116b of the body 106 are curved. The edges 116a, 116b may be curved, for example, corresponding to the curvature of the limbus of an eye. By curving the edges 116a, 116b to correspond to the curvature of the limbus, the instrument 100 may have a better anatomical placement on the eye. The edges 116a, 116b of the body 106 may interface with (e.g., sit on) the limbus of the eye. For instance, as illustrated in FIGs. 4A and 4B, the body 106 of the instrument 100 may be positioned on the eye 302, such that the upper eyelid 308 rests on the outer surface 121 of the rear of the body 106 and the edges 116a, 116b rest on the limbus 306 of the eye 302. In another example, the body 106 may be positioned on the eye 302, such that the lower eyelid 304 rests on the outer surface 121 of the rear of the body 106 and the edges 116a, 116b rest on the limbus 306 of the eye 302.

[0033] As the curved edges 116a, 116b of members 112a, 112b provide a more accurate placement on the limbus, the instrument 100 provides a more accurate perpendicular distance measure of the injection site. For instance, the end 122 of the channel 114 may be positioned about 3.5 mm to 4.0 mm from the outer surface 121 of the edges 116a, 116b of the guide 104. These distances may reflect the standardized distance from the limbus to the injection site for an intravitreal injection. For instance, these distances may reflect the standardized distance from the limbus for a pseudophakic and phakic patient, respectively. In some cases, the surface 126 may include one or more markers to indicate a distance from the outer surface 121 of the edges 116a, 116b to a position along the channel 114. In other words, the marker may be used to indicate a distance along the channel 114 with respect to the limbus when the guide 104 is positioned on an eye. For example, as illustrated in FIG. 2A, markings 202a,PAGE 8 OF 15Docket #: 206030-0314-OOWO202b may indicate a distance of about 3.5mm from the outer surface 121 of the edges 116a, 116b. In such cases, an injection between markings 202a, 202b may occur about 3.5mm from the limbus. The markings 202a, 202b may, for example, be used to indicate an injection site for a patient who had their lens (e.g., cataract) removed and a thin artificial lens placed on the eye. In another example, markings 212a, 212b may indicate a distance of about 4mm from the outer surface 121 of the edges 116a, 116b. The markings 212a, 212b may, for example, be used to indicate an injection site for a patient who has a thicker lens (e.g., a natural lens). Similar to the markers 202a, 202b, 212a, 212b of body 204, the body 106 may also include markers 202a, 202b, 212a, 212b positioned along the channel 114 to indicate a distance with respect to the limbus (e.g., limbus 306), and the features of markers of body 106 include the same or similar features of the body 204, as described herein. The markers 202a, 202b, 212a, 212b aid in identifying injection sites in the eye that would avoid injecting into a lens of the eye whether the lens in natural or artificial. Embodiments are contemplated in which the markers 212a, 212b may be positioned along the channel 114 and used to indicate a distance of 4mm from the limbus for all patients, irrespective of whether they have a natural or artificial lens, as this is a safe distance in both scenarios.

[0034] As an alternative to the channel 114, the body 106 may include one or more apertures sized to receive a needle therein. The one or more apertures may be positioned at various distances along the body 106 that, for example, reflect the standardized distance from the limbus to the injection site for an intravitreal injection. In some cases, an aperture extends perpendicular from the top surface 126 to the bottom surface 124 of the body 106. In other cases, the aperture extends at an angle from the top surface 126 to the bottom surface 124 of the body 106. As such, by extending at an angle through the body 106, an opening of the aperture on the top surface 126 may be offset from an opening of the aperture on the bottom surface 124.

[0035] In one or more cases, the handle 102 and guide 104 are positioned at angle Al with respect to one another, as illustrated in FIG. IB. For example, the angle Al between the handle 102 and guide 104 is an obtuse angle that is steep enough to ensure the handle 102 does not compress the eyelid or surrounding facial features, but not too steep to prevent the handle 102 or a hand holding the handle 102 from impairing the view of the guide 104.PAGE 9 OF 15Docket #: 206030-0314-OOWOFurther, the angle Al between the handle 102 and the guide 104 is an obtuse angle that is large enough that the handle 102 does not impede positioning a needle of a syringe through the channel 114. In one or more cases, the handle 102 and guide 104 are fixed to one another, such that the angle Al between the handle 102 and guide 104 remains fixed. In one or more other cases, the handle 102 and guide 104 are hingedly connected to one another, such that the handle 102 and guide 104 may be moved with respect to one another and fixed at an angle. That is, a user may set the handle 102 and guide 104 at a variety of angles to perform an injection.

[0036] FIG. 2A is a perspective view of another example intravitreal injection instrument 200 (hereinafter “instrument 200”). FIG. 2B is a bottom view of the instrument 200. The instrument 200 includes one or more of the same or similar features as instrument 100, and a description of those features is not repeated. The guide 204 may be distinguishable from guide 104. For example, in some cases, the guide 204 may include squared edges 208. In another example, the edges 216a, 216b of body 206 may be linearly arranged with one another. Further, in yet another example, the bottom surface 124 of the body 204 may include a gripping surface 210 that is configured to interface with the eye. For instance, as illustrated in FIG. 3, during an intravitreal injection, the body 204 of the instrument 200 may be positioned on the eye 302, such that the outer surface 121 of the body 204 retains the lower eyelid 304 and the edges 216a, 216b rest on the limbus 306 of the eye 302. The gripping surface 210 may include a textured surface. The gripping surface 210 may be positioned on the smooth ocular surface of the eye 302, in which the textured surface prevents the instrument 200 from slipping on the eye. That is, the gripping surface 210 may prevent an inadvertent injection at an incorrect position that may cause injury to other delicate ocular structures, such as the lens or cornea. The gripping surface 210 may include one or more gripping features, such as gripping feature 210a. The gripping features may be raised bodies on the gripping surface 210. The gripping features may be arranged in a variety of patterns. A gripping feature may be formed in a variety of shapes, such as, but not limited to, a pyramidal-shape, a cube-like shape, a cylindrical shape, and the like. In one or more cases, the shape of the gripping feature may have smooth edges or edges that are not too sharp so as to avoid abrasions from forming when rubbing or compressing the gripping surface 210PAGE 10 OF 15Docket #: 206030-0314-OOWO against the eye. It is noted that the body 106 of instrument 100 may include one or more features of the gripping surface 210 on the bottom surface 124 of the body 106.

[0037] FIG. 5A is a perspective view of an example intravitreal injection instrument 500 (hereinafter “instrument 500”) with an example marking end 502. The instrument 500 may include one or more of the same or similar features as instruments 100 and 200, and as such a description of these features is not repeated. For example, the instrument 500 may include the injection guide 104 (i.e., the stabilizing end of the instrument 500) positioned at the proximal end 110. The instrument 500 is distinguishable from instruments 100 and 200 in that instrument 500 includes a marking end 502 on the distal end 501 of the handle 102. The marking end 502 may include marking prongs 504a and 504b spaced apart from one another by a width Wl. In an example, the prongs 504a and 504b may be spaced about 4mm apart from one another to mark the exact injection point from the limbus. The 4mm spacing between prongs 504a and 504b may correspond to a distance that can be universally used for artificial and natural lenses. In other examples, the prongs 504a and 504b may be spaced 3.5mm or 4mm apart to correspond to injections for patients with artificial or natural lenses, respectfully. The prongs 504a and 504b may be rigid bodies having dull and / or blunt ends.

[0038] To mark the injection site using the marking end 502, the prongs 504a and 504b may be dipped into a sterilizing iodine solution. This has the added benefit of marking the white sclera with, for example, the brown colored iodine solution to help visualization. An eyelid, such as eyelid 308 of eye 302, may be pulled away from the eye, and the iodine solution on the prongs 504a and 504b may be applied to the eye. For instance, one prong (e.g., prong 504b) may be used to locate the limbus, and the other prong (e.g., prong 504a) may be used to locate the injection site. When the prong is positioned either over or adjacent to the limbus, one or both prongs 504a and 504b may be pressed against the eye to mark the injection site with the iodine solution. Having marked the injection site, the handle 102 may be flipped to utilize the guide 104 to hold the eyelid away from the injection site, stabilize the eye, allow accurate injection needle position / angle / depth of placement. This therefore allows for safe and efficient intravitreal injection to be performed.

[0039] Instruments 100, 200, and 500 may be manufactured via, for example, but not limited to, additive manufacturing, machining, injection molding, casting, plastic processing, and thePAGE 11 OF 15Docket #: 206030-0314-OOWO like. In some cases, the instruments 100, 200, and 500 may be formed from a lightweight polymer via, for example, injection molding, an extrusion process, or other like processes. In other cases, the instruments 100, 200, and 500 may be formed with a plastic scintillator by curing and laminating single layers by irradiating ultraviolet light with certain wavelength and intensity to a liquid plastic scintillator resin.

[0040] The various embodiments described above are provided by way of illustration only and should not be construed to limit the claims attached hereto. Those skilled in the art will readily recognize various modifications and changes that may be made without following the example embodiments and applications illustrated and described herein, and without departing from the spirit and scope of the following claims.PAGE 12 OF 15

Claims

Docket #: 206030-0314-OOWOCLAIMSWhat is claimed is:

1. An intravitreal injection instrument, the instrument comprising: a handle extending along a length of the instrument, wherein the proximal end of the handle is coupled to a proximal end of an injection guide; and the injection guide comprising a rigid body having a first member and a second member that define a channel therein, wherein the channel extends from a distal end of the injection guide to an interior portion of the body near the proximal end of the injection guide, wherein a width of the channel is sized to receive a needle therein, and wherein the injection guide and handle are arranged at an obtuse angle from one another.

2. The instrument of claim 1, wherein the injection guide comprises a transparent or semi-transparent material.

3. The instrument of claim 1, wherein edges of the injection guide are rounded.

4. The instrument of claim 1, wherein the first member and the second member of the injection guide form a U-like shape.

5. The instrument of claim 1, wherein the injection guide further comprises a protrusion on the proximal end of the injection guide, the protrusion extending upwards from a top surface of the body.

6. The instrument of claim 5, wherein the protrusion is positioned at a right angle with respect to the top surface of the body.PAGE 13 OF 15Docket #: 206030-0314-OOWO7. The instrument of claim 5, wherein the proximal end of the handle is coupled with the protrusion.

8. The instrument of claim 1, wherein a rear surface at the proximal end of the body is curved.

9. The instrument of claim 1, wherein a bottom surface of the body comprises a textured surface.

10. The instrument of claim 1, wherein a top surface comprises one or more markings positioned along the channel to indicate a distance from the distal end of the injection guide.

11. The instrument of claim 1, wherein a distal end of the handle comprises a first prong and a second prong spaced apart from one another.

12. The instrument of claim 11, wherein the first prong and the second prong are spaced apart from one another by about 4 millimeters.

13. The instrument of claim 11, wherein the first prong and the second prong each comprise a rigid body having a blunt end.PAGE 14 OF 15

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