Transplant device

Abstract

The device has a first end, a second end, and a lower side. The device includes a hollow conical portion at the first end and a hollow cylindrical portion at the second end. The first end is configured to engage with an intraocular lens injector. The second end includes a sharp tip configured to penetrate eye tissue. An opening is formed on the lower side of the device, and the opening is configured to allow a medical implantable device, which extends from the second end toward the first end and is received at the first end for implantation into the eye, to pass therethrough. The opening is defined by a first inclined portion and a second inclined portion that extend from the sharp tip toward the first end, a first parallel portion and a second parallel portion that extend from the inclined portions, a first recess and a second recess that extend from the parallel portions, and a plane that extends from the recesses.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application is an international (PCT) patent application related to and claiming the benefit of co - owned and co - pending U.S. Provisional Patent Application No. 63 / 357307, filed on June 30, 2022, entitled "IMPLANTATION DEVICE", the content of which is incorporated herein by reference in its entirety.

[0002] The present invention relates to a device for use in implanting a medical device into tissue. In particular, the present invention relates to a device for use in implanting a medical device into the tissues of the human eye.

Background Art

[0003] In the field of ophthalmology, various diseases have a chronic nature. Many of these diseases are age - related, which results in increased complexity for the treating physicians. One common problem in the treatment of eye diseases is patient compliance, that is, the situation where, despite the existence of an effective treatment method, the patient does not appropriately follow the treatment, whether intentionally or not.

[0004] In response to this treatment problem, various solutions have been attempted and are still being developed to provide a sustained - release mechanism for active pharmaceutical ingredients (APIs). These solutions include those that contain inserts placed in various parts of the eye (such as within the tear canal, within the eye chamber, or subconjunctivally). The proper and efficient placement of the device is very important for the safety of the process and the success of the treatment. There is also a commercial significance in the nature of the placement process to avoid an unpleasant treatment for the patient.

[0005] When inserting an insert subconjunctivally, the process of "carving a pocket" is often involved within the eye tissue. In this process, a snip is formed in the conjunctiva, the conjunctiva is separated from the underlying tissue, and then the snip needs to be closed. Usually, this surgery is performed under local anesthesia, which is stressful and inconvenient for the patient. Furthermore, due to variations in this technique, the insert may not fit firmly in the predetermined position, and as a result, the insert may be dislocated to the extent that it is pushed out of the eyeball through the conjunctiva and the treatment is aborted.

[0006] Delivery systems in the form of intraocular lens ("IOL") injectors are commercially available in various shapes and designs. However, all of them are characterized by a blunt tip sized to fit the corneal incision, and it is necessary to form the incision in advance with a dedicated instrument. Such delivery devices are also designed to be used in a specific orientation with respect to the eye, taking into account ergonomics and safety.

[0007] In this specification, some embodiments of the present invention will be exemplarily described with reference to the accompanying drawings. Here, referring to the drawings in detail, it is emphasized that the particulars shown are for illustration and for the purpose of explaining embodiments of the present invention. In this regard, it will be apparent to those skilled in the art how embodiments of the present invention can be implemented when described together with the drawings.

Brief Description of the Drawings

[0008]

Figure 1

Figure 2

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Figure 8

[0009] In one embodiment, an implantation device has a first end and a second end opposite the first end. The first end is configured to engage an intraocular lens injector. The second end includes a pointed tip configured to penetrate eye tissue and an insertion portion configured to allow a device to be implanted through the intraocular lens injector for implantation in the eye.

[0010] In some embodiments, the device includes a body having a first end, a second end opposite the first end, an upper side extending from the first end to the second end, and a lower side opposite the upper side. The body includes a first portion that is hollow and has a substantially conical shape with respect to the longitudinal axis, the first portion extending from the first end of the body to a transition at an intermediate between the first end and the second end of the body, and a second portion that is hollow and has a substantially cylindrical shape with respect to the longitudinal axis, the second portion extending from the transition to the second end of the body. The first portion and the second portion define a passage having a first inner diameter at the first end and a second inner diameter at the second end. The first inner diameter is larger than the second inner diameter. The first end is configured to engage an intraocular lens injector. The second end includes a sharp tip configured to penetrate eye tissue. The insertion port is formed on the lower side of the body and extends from the second end of the body toward the first end. The insertion port is configured such that a transplantable device received at the first end of the body from an intraocular lens injector that engages the first end of the body for transplanting the transplantable device into the eye can pass therethrough. The insertion port is defined by a first inclined portion and a second inclined portion extending from the upper side of the body toward the longitudinal axis and from the sharp tip toward the first end of the body when viewed from the side of the body, a first parallel portion and a second parallel portion extending in a direction from a corresponding one of the first inclined portion and the second inclined portion toward the first end of the body, a first recess and a second recess extending in a direction from a corresponding one of the first parallel portion and the second parallel portion in a direction toward the first end of the body, in a direction toward the longitudinal axis of the body, and in a direction beyond the longitudinal axis of the body, and a plane extending in a direction from the first recess and the second recess toward the first end of the body and away from the longitudinal axis. Each of the first inclined portion and the second inclined portion is concave with respect to the longitudinal axis when viewed from the side of the body. The first inclined portion and the second inclined portion are disposed within the second portion of the body. Each of the first parallel portion and the second parallel portion is substantially parallel to the longitudinal axis when viewed from the side of the body. The first inclined portion and the second inclined portion extend across the transition between the first portion and the second portion of the body. The first recess and the second recess are concave with respect to the longitudinal axis when viewed from the side of the body.The first recess and the second recess are disposed within the first portion of the body. The plane is inclined at a bevel angle that is acute with respect to the longitudinal axis of the body when viewed from the side of the body. The plane is disposed within the first portion of the body.

[0011] In some embodiments, each transition between the first recess and the second recess and the plane is curved.

[0012] In some embodiments, the bevel angle ranges from 10 degrees to 14 degrees. In some embodiments, the pointed tip is inclined at a lancet angle ranging from 8 degrees to 12 degrees with respect to the plane.

[0013] In some embodiments, the first recess and the second recess have a radius of curvature in the range of 1 millimeter to 3 millimeters.

[0014] In some embodiments, the pointed tip defines a tip angle in the range of 60 degrees to 68 degrees.

[0015] In some embodiments, the device is configured to be used with an implantable device having an implantable device length. The insertion port has a length that is 0.5 mm to 2 mm greater than the implantable device length along the longitudinal axis.

[0016] In some embodiments, the second portion of the body and the first parallel portion and the second parallel portion define an arc angle in the range of 90 degrees to 150 degrees.

[0017] In some embodiments, the second portion of the body has an inner diameter in the range of 1.5 mm to 3 mm.

[0018] In some embodiments, the first end of the body has an inner diameter in the range of 2 mm to 5 mm.

[0019] In some embodiments, the length of the device along the vertical axis is in the range of 7 mm to 20 mm.

Best Mode for Carrying Out the Invention

[0020] Of these disclosed advantages and improvements, other objects and advantages of the present invention will become apparent from the following description in conjunction with the accompanying drawings. Detailed embodiments of the present invention are disclosed herein. However, it should be understood that the disclosed embodiments are merely exemplary of the present invention, which can be embodied in various forms. Furthermore, each of the examples described in connection with the various embodiments of the present invention is for illustrative purposes only and not limiting.

[0021] Throughout this specification and the claims, the following terms have the meanings explicitly associated herein unless the context clearly dictates otherwise. As used herein, the expressions "in one embodiment," "in an embodiment," and "in some embodiments" do not necessarily refer to the same embodiment, but may. Further, the expressions "in another embodiment" and "in some other embodiments" as used herein do not necessarily refer to different embodiments, but may. Thus, as described below, the various embodiments of the present invention can be readily combined without departing from the scope or spirit of the present invention.

[0022] As used herein, the term "based on" is not exclusive and allows for being based on additional elements not recited, unless the context clearly dictates otherwise. Further, throughout this specification, the meanings of "a," "an," and "the" include plural references. The meaning of "in" includes "in" and "on." All ranges used herein are inclusive; that is, they include the upper and lower limits as well as all values therebetween.

[0023] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Further, terms as defined in commonly used dictionaries are to be interpreted as having a meaning that coincides with the meaning in the context of the relevant art and this disclosure, and are not to be interpreted in an idealized or overly formal sense unless explicitly so defined.

[0024] The present disclosure describes exemplary embodiments of an add-on insertion device configured to couple to a standard commercially available intraocular lens delivery system. It will be apparent to those skilled in the art that the general principles embodied in the exemplary devices may be embodied in other devices as well.

[0025] Figures 1-8 show various views of an exemplary implantation device 100 (for simplicity, "device 100"). Certain ones of Figures 1-8 include dimensions of certain aspects of device 100, with lengths shown as measured in millimeters and angles shown as measured in degrees. However, the specific dimensions shown in Figures 1-8 are exemplary only, and it will be apparent to those skilled in the art that other dimensions are possible without departing from the general concepts embodied by exemplary embodiments including, but not limited to, those described herein. Figure 1 is a perspective view of device 100. Figure 2 is a side view of device 100. Figure 3 is a bottom view of device 100. Figure 4 is a front view of device 100. Figure 5 is a detailed bottom view of the tip of device 100. Figure 6 is a detailed front view of a portion of device 100 shown in Figure 4. Figure 7 is a cross-sectional view of device 100 taken at the location indicated as 7-7 in Figure 2. Figure 8 is a detailed view of a portion of the cross-sectional view shown in Figure 7.

[0026] Referring now to Figures 1-3, device 100 has a body that includes a connecting portion 110 (i.e., a first portion) and a protruding portion 120 (i.e., a second portion) that meet at an arcuate transition portion 130. Device 100 is oriented about a longitudinal axis A. Connecting portion 110 includes a first end 112 configured to couple to an intraocular lens ("IOL") cartridge and a second end 114 that is opposite the first end 112 and that coincides with transition portion 130. In some embodiments, connecting portion 110 is hollow and has a generally frustoconical shape with a portion removed therefrom, as described below, relative to longitudinal axis A. Protruding portion 120 includes a first end 122 that coincides with transition portion 130 and a second end 124 that is opposite the first end 122. In some embodiments, protruding portion 120 is hollow and has a substantially cylindrical shape with a portion removed therefrom, as described below, relative to longitudinal axis A. In some embodiments, the hollow interior of connecting portion 110 and the hollow interior of protruding portion 120 cooperate to define a passageway.

[0027] In some embodiments, device 100 is formed from a single material (e.g., is monolithic). In some embodiments, device 100 is formed from a biocompatible material having sufficient rigidity to hold a sharp edge. In some embodiments, the material is an alloy. In some embodiments, the material is alloy steel. In some embodiments, the material is a stainless alloy steel. In some embodiments, the material is 304L stainless steel. In some embodiments, the material is a polymer. In some embodiments, the polymer is polymethyl methacrylate resin (“PMMA”).

[0028] Referring now to FIG. 2, device 100 includes an upper portion 102 and a bottom portion 104. Referring now to FIG. 3, device 100 includes a left side 106 and a right side 108 (e.g., a first side and a second side). As used herein, the terms “top,” “bottom,” “left,” and “right” are used to provide a frame of reference for describing the various elements of device 100, and when used, device 100 can be oriented in any orientation with respect to a real-world coordinate system, and it will be apparent to those skilled in the art that the upper portion 102, bottom portion 104, left side 106, or right side 108 need not be oriented such that a particular orientation is disposed.

[0029] Next, referring to FIGS. 1-3, the bottom 104 of the device 100 includes an insertion portion 140 that includes a specific surface described below. In some embodiments, the insertion portion 140 defines an insertion opening. In some embodiments as shown in FIGS. 1-3, the insertion portion 140 is symmetric (i.e., the two sides of the insertion portion 140 are mirror images of each other with respect to opposite sides of the longitudinal axis A). However, in other embodiments, the insertion portion 140 is not symmetric (i.e., different on the "left" side and the "right" side of the device). In some embodiments, the insertion portion 140 includes a plane 142 formed in the connection portion 110. In some embodiments, the plane 142 is inclined with respect to the longitudinal axis A. In some embodiments, the plane 142 is inclined at an angle of 5 degrees to 45 degrees with respect to the longitudinal axis A. In some embodiments, the plane 142 allows the device 100 to smoothly progress along the eye tissue.

[0030] Continuing to refer to FIGS. 1-3, in some embodiments, the insertion portion 140 includes a first protrusion and a second protrusion 144 that extend from the plane 142 toward the longitudinal axis A and away from the first end 112 of the connection portion 110. In some embodiments, as viewed from the side as shown in FIG. 2, the protrusions 144 are convex with respect to the longitudinal axis A, with the first protrusion of the protrusions 144 located on the left side 106 and the second protrusion of the protrusions 144 located on the right side 108 of the device 100. In some embodiments, the size of the first protrusion and the second protrusion 144 (e.g., the radius of curvature of the first protrusion and the second protrusion) is determined as the size necessary to provide a smooth transition between the plane 142 and the first recess and the second recess 146. In some embodiments, the radius of curvature of the first protrusion and the second protrusion 144 is from 0 (e.g., the first protrusion and the second protrusion 144 are missing and the plane 142 transitions directly to the first recess and the second recess 146) to 3.5 millimeters.

[0031] Continuing to refer to FIGS. 1-3, in some embodiments, the insertion portion 140 includes first and second recesses 146 that extend from each of the first convex portion and the second convex portion 144 in a direction toward and beyond the longitudinal axis A and away from the first end portion 112 of the connection portion 110 as viewed from the side as shown in FIG. 2. In some embodiments, the first and second recesses 146 are concave with respect to the bottom 104 of the device 100. In some embodiments, the radius of curvature R1 of the first and second recesses 146 is from 1 millimeter to 3 millimeters. In some embodiments, the radius of curvature R1 of the first and second recesses 146 is from 1 millimeter to 2.5 millimeters. In some embodiments, the radius of curvature R1 of the first and second recesses 146 is from 1 millimeter to 2 millimeters. In some embodiments, the radius of curvature R1 of the first and second recesses 146 is from 1 millimeter to 1.5 millimeters. In some embodiments, the radius of curvature R1 of the first and second recesses 146 is from 1.5 millimeters to 3 millimeters. In some embodiments, the radius of curvature R1 of the first and second recesses 146 is from 1.5 millimeters to 2.5 millimeters. In some embodiments, the radius of curvature R1 of the first and second recesses 146 is from 1.5 millimeters to 2 millimeters. In some embodiments, the radius of curvature R1 of the first and second recesses 146 is from 2 millimeters to 3 millimeters. In some embodiments, the radius of curvature R1 of the first and second recesses 146 is from 2 millimeters to 2.5 millimeters. In some embodiments, the radius of curvature R1 of the first and second recesses 146 is from 2.5 millimeters to 3 millimeters.

[0032] Continuing to refer to FIGS. 1-3, in some embodiments, as viewed from the side as shown in FIG. 2, the insertion portion 140 includes a first parallel portion and a second parallel portion 148 that extend parallel to the longitudinal axis A in a direction away from the first end portion 112 of the connection portion 110 from each of the first recess and the second recess 146. In some embodiments, the first parallel portion and the second parallel portion 148 are generally parallel to the longitudinal axis A (e.g., an angle of 10 degrees or less with respect to the longitudinal axis A). In some embodiments, the first parallel portion and the second parallel portion extend across the transition portion 130 from the connection portion 110 to the protrusion portion 120.

[0033] Continuing to refer to FIGS. 1-3, in some embodiments, as viewed from the side as shown in FIG. 2, the insertion portion 140 includes a first inclined portion and a second inclined portion 150 that extend in a direction away from the first end portion 112 of the connection portion 110 and in a direction away from the longitudinal axis A from each of the first parallel portion and the second parallel portion 148. In some embodiments, the first inclined portion and the second inclined portion 150 are concave with respect to the longitudinal axis A.

[0034] Continuing to refer to FIGS. 1-3, in some embodiments, the first inclined portion and the second inclined portion 150 meet at a tip 152. In some embodiments as shown in FIG. 3, the tip 152 is aligned with the longitudinal axis A when the device 100 is viewed from the bottom, i.e., the tip 152 is centered with respect to the left side 106 and the right side 108. In some embodiments, the tip 152 is asymmetric (e.g., not centered with respect to the left side 106 and the right side 108). Referring now to FIG. 5, in some embodiments, the first inclined portion and the second inclined portion 150 meet at a tip angle β. In some embodiments, the tip angle β is 64.8 degrees. In some embodiments, the tip angle β is between 60 degrees and 70 degrees. In some embodiments, the tip angle β is between 60 degrees and 68 degrees. In some embodiments, the tip angle β is between 60 degrees and 66 degrees. In some embodiments, the tip angle β is between 60 degrees and 64 degrees. In some embodiments, the tip angle β is between 60 degrees and 62 degrees. In some embodiments, the tip angle β is between 62 degrees and 70 degrees. In some embodiments, the tip angle β is between 62 degrees and 68 degrees. In some embodiments, the tip angle β is between 62 degrees and 66 degrees. In some embodiments, the tip angle β is between 62 degrees and 64 degrees. In some embodiments, the tip angle β is between 64 degrees and 70 degrees. In some embodiments, the tip angle β is between 64 degrees and 68 degrees. In some embodiments, the tip angle β is between 64 degrees and 66 degrees. In some embodiments, the tip angle β is between 66 degrees and 70 degrees. In some embodiments, the tip angle β is between 66 degrees and 68 degrees. In some embodiments, the tip angle β is between 68 degrees and 70 degrees. In some embodiments, the tip angle β is between 64.5 degrees and 65.5 degrees.

[0035] Next, referring to FIG. 2, the connection portion 110 has an outer diameter OD1 at its first end portion 112. In some embodiments, the outer diameter OD1 varies based on the size (e.g., diameter) of the implantable device to be implanted by use of the device 100. In some embodiments, the outer diameter OD1 is between 2.0 mm and 5.0 mm. In some embodiments, the outer diameter OD1 is between 2.0 mm and 4.5 mm. In some embodiments, the outer diameter OD1 is between 2.0 mm and 4.0 mm. In some embodiments, the outer diameter OD1 is between 2.0 mm and 3.5 mm. In some embodiments, the outer diameter OD1 is between 2.0 mm and 3.0 mm. In some embodiments, the outer diameter OD1 is between 2.0 mm and 2.5 mm. In some embodiments, the outer diameter OD1 is between 2.5 mm and 5.0 mm. In some embodiments, the outer diameter OD1 is between 2.5 mm and 4.5 mm. In some embodiments, the outer diameter OD1 is between 2.5 mm and 4.0 mm. In some embodiments, the outer diameter OD1 is between 2.5 mm and 3.4 mm. In some embodiments, the outer diameter OD1 is between 2.5 mm and 3.0 mm. In some embodiments, the outer diameter OD1 is between 3.0 mm and 5.0 mm. In some embodiments, the outer diameter OD1 is between 3.0 mm and 4.5 mm. In some embodiments, the outer diameter OD1 is between 3.0 mm and 4.0 mm. In some embodiments, the outer diameter OD1 is between 3.0 mm and 3.5 mm. In some embodiments, the outer diameter OD1 is between 3.5 mm and 5.0 mm. In some embodiments, the outer diameter OD1 is between 3.5 mm and 4.5 mm. In some embodiments, the outer diameter OD1 is between 3.5 mm and 4.0 mm. In some embodiments, the outer diameter OD1 is between 4.0 mm and 5.0 mm. In some embodiments, the outer diameter OD1 is between 4.0 mm and 4.5 mm. In some embodiments, the outer diameter OD1 is between 4.5 mm and 5.0 mm. In some embodiments, the outer diameter OD1 is between 3.0 mm and 3.8 mm. In some embodiments, the outer diameter OD1 is between 3.1 mm and 3.7 mm. In some embodiments, the outer diameter OD1 is between 3.2 mm and 3.6 mm.In some embodiments, the outer diameter OD1 is between 3.3 mm and 3.5 mm. In some embodiments, the outer diameter OD1 is approximately 3.4 millimeters. In some embodiments, the outer diameter OD1 is 3.4 millimeters.

[0036] Next, referring to FIG. 3, the connection portion 110 has a hollow, substantially conical shape with an inner diameter ID at its first end portion 112. In some embodiments, the inner diameter ID is configured to provide a press fit with an IOL injector to which the device 100 is coupled, in combination with the conical shape of the connection portion 110. In some embodiments, the inner diameter ID may be received at the first end portion 112 and depend on the size of the implantable device implanted by use of the device 100. In some embodiments, the inner diameter ID is from 1.8 mm to 4.8 mm. In some embodiments, the inner diameter ID is from 1.8 mm to 4.3 mm. In some embodiments, the inner diameter ID is from 1.8 mm to 3.8 mm. In some embodiments, the inner diameter ID is from 1.8 mm to 3.3 mm. In some embodiments, the inner diameter ID is from 1.8 mm to 2.8 mm. In some embodiments, the inner diameter ID is from 1.8 mm to 2.3 mm. In some embodiments, the inner diameter ID is from 2.3 mm to 4.8 mm. In some embodiments, the inner diameter ID is from 2.3 mm to 4.3 mm. In some embodiments, the inner diameter ID is from 2.3 mm to 3.8 mm. In some embodiments, the inner diameter ID is from 2.3 mm to 3.3 mm. In some embodiments, the inner diameter ID is from 2.3 mm to 2.8 mm. In some embodiments, the inner diameter ID is from 2.8 mm to 4.8 mm. In some embodiments, the inner diameter ID is from 2.8 mm to 4.3 mm. In some embodiments, the inner diameter ID is from 2.8 mm to 3.8 mm. In some embodiments, the inner diameter ID is from 2.8 mm to 3.3 mm. In some embodiments, the inner diameter ID is from 3.3 mm to 4.8 mm. In some embodiments, the inner diameter ID is from 3.3 mm to 4.3 mm. In some embodiments, the inner diameter ID is from 3.3 mm to 3.8 mm. In some embodiments, the inner diameter ID is from 3.8 mm to 4.8 mm. In some embodiments, the inner diameter ID is from 3.8 mm to 4.3 mm. In some embodiments, the inner diameter ID is from 4.3 mm to 4.8 mm. In some embodiments, the inner diameter ID is from 2.8 mm to 3.4 mm. In some embodiments, the inner diameter ID is from 2.9 mm to 3.3 mm.In some embodiments, the inner diameter ID is from 3.0 mm to 3.2 mm. In some embodiments, the inner diameter ID is approximately 3.1 millimeters. In some embodiments, the inner diameter ID is 3.1 millimeters.

[0037] Continuing to refer to FIG. 3, the connection portion 110 has a wall thickness WT at its first end. In some embodiments, the wall thickness WT is constant throughout the device 100. In some embodiments, the wall thickness WT varies within the device 100. In some embodiments, the wall thickness WT is from 0.08 mm to 0.2 mm. In some embodiments, the wall thickness WT is from 0.08 mm to 0.17 mm. In some embodiments, the wall thickness WT is from 0.08 mm to 0.14 mm. In some embodiments, the wall thickness WT is from 0.08 mm to 0.11 mm. In some embodiments, the wall thickness WT is from 0.11 mm to 0.2 mm. In some embodiments, the wall thickness WT is from 0.11 mm to 0.17 mm. In some embodiments, the wall thickness WT is from 0.11 mm to 0.14 mm. In some embodiments, the wall thickness WT is from 0.14 mm to 0.2 mm. In some embodiments, the wall thickness WT is from 0.14 mm to 0.17 mm. In some embodiments, the wall thickness WT is from 0.17 mm to 0.2 mm. In some embodiments, the wall thickness WT is from 0.13 mm to 0.17 mm. In some embodiments, the wall thickness WT is from 0.14 mm to 0.16 mm. In some embodiments, the wall thickness WT is about 0.15 mm. In some embodiments, the wall thickness WT is 0.15 mm.

[0038] Continuing to refer to FIG. 3, the device 100 has an overall length LT measured from the first end 112 of the connecting portion 110 to the tip 152, parallel to the vertical axis A. In some embodiments, the overall length LT is from 7.0 mm to 20.0 mm. In some embodiments, the overall length LT is from 7.0 mm to 16.75 mm. In some embodiments, the overall length LT is from 7.0 mm to 13.5 mm. In some embodiments, the overall length LT is from 7.0 mm to 10.25 mm. In some embodiments, the overall length LT is from 10.25 mm to 20.0 mm. In some embodiments, the overall length LT is from 10.25 mm to 16.75 mm. In some embodiments, the overall length LT is from 10.25 mm to 13.5 mm. In some embodiments, the overall length LT is from 13.5 mm to 20.0 mm. In some embodiments, the overall length LT is from 13.5 mm to 16.75 mm. In some embodiments, the overall length LT is from 16.75 mm to 20.0 mm. In some embodiments, the overall length LT is from 14 mm to 20 mm. In some embodiments, the overall length LT is from 15 mm to 19 mm. In some embodiments, the overall length LT is from 16 mm to 18 mm. In some embodiments, the overall length LT is about 17 mm. In some embodiments, the overall length LT is between 17 mm and 17.3 mm. In some embodiments, the overall length LT is 17.16 mm.

[0039] Next, referring to FIG. 2, the device has a length L2 measured from the transition portion between the recess 146 and the parallel portion 148 to the tip 152 parallel to the vertical axis A. In some embodiments, the length L2 is determined by the length along the insertion axis of the insert according to the purpose of use of the device 100. In some embodiments, the length L2 is equal to the length along the insertion axis of the insert according to the purpose of use of the device 100. In some embodiments, the length L2 is approximately equal to the length along the insertion axis of the insert according to the purpose of use of the device 100. In some embodiments, the length L2 is in the range between (1) a length equal to the length along the insertion axis of the insert according to the purpose of use of the device 100 and (2) a length 0.1 millimeter greater than the length along the insertion axis of the insert according to the purpose of use of the device 100. In some embodiments, the length L2 is 2 mm to 6 mm. In some embodiments, the length L2 is 2 mm to 5 mm. In some embodiments, the length L2 is 2 mm to 4 mm. In some embodiments, the length L2 is 2 mm to 3 mm. In some embodiments, the length L2 is 3 mm to 6 mm. In some embodiments, the length L2 is 3 mm to 5 mm. In some embodiments, the length L2 is 3 mm to 4 mm. In some embodiments, the length L2 is 4 mm to 6 mm. In some embodiments, the length L2 is 4 mm to 5 mm. In some embodiments, the length L2 is 5 mm to 6 mm. In some embodiments, the length L2 is 5.1 mm to 5.5 mm. In some embodiments, the length L2 is 5.2 mm to 5.4 mm. In some embodiments, the length L2 is approximately 5.3 mm. In some embodiments, the length L2 is 5.3 millimeters.

[0040] Continuing to refer to FIG. 2, the device 100 has a length L1 measured parallel to the vertical axis A from the first end 112 of the connection portion 110 to the transition portion between the recess 146 and the parallel portion 148. In some embodiments, the length L1 is determined as a function of the overall length LT of the device 100 and the length L2. In some embodiments, the length L1 is the overall length LT minus the length L2. In some embodiments, the length L1 is 11.9 mm.

[0041] Continuing to refer to FIG. 2, the device has a length L3 measured parallel to the vertical axis A from the first end 112 of the conical portion to the transition between the plane 142 and the convex portion 144. In some embodiments, the length L3 is selected to ensure that the insert inserted using the device 100 is properly installed. In some embodiments, the length L3 is at least 0.1 millimeter greater than the length of the "beak" of the insert being inserted. In some embodiments, the length L3 ranges from 1 millimeter to 14 millimeters. In some embodiments, the length L3 ranges from 1 millimeter to 10.75 millimeters. In some embodiments, the length L3 ranges from 1 millimeter to 7.5 millimeters. In some embodiments, the length L3 ranges from 1 millimeter to 4.25 millimeters. In some embodiments, the length L3 ranges from 4.25 millimeters to 14 millimeters. In some embodiments, the length L3 ranges from 4.25 millimeters to 10.75 millimeters. In some embodiments, the length L3 ranges from 4.25 millimeters to 7.5 millimeters. In some embodiments, the length L3 ranges from 7.5 millimeters to 14 millimeters. In some embodiments, the length L3 ranges from 7.5 millimeters to 10.75 millimeters. In some embodiments, the length L3 ranges from 10.75 millimeters to 14 millimeters. In some embodiments, the length L3 ranges from 9 millimeters to 10 millimeters. In some embodiments, the length L3 ranges from 9.2 millimeters to 9.6 millimeters. In some embodiments, the length L3 is approximately 9.5 millimeters. In some embodiments, the length L3 is approximately 9.4 millimeters. In some embodiments, the length L3 is 9.4 millimeters.

[0042] Continuing to refer to FIG. 2, this device has a length L4 measured from the transition between the flat surface 142 and the convex portion 144 to the tip 152, parallel to the vertical axis A. In some embodiments, the length L4 is determined as a function of the overall length LT and the length L3 of the device 100. In some embodiments, the length L4 is the overall length LT minus the length L3. In some embodiments, the length L4 is 7.75 millimeters.

[0043] Continuing to refer to FIG. 2, the connection portion 110 defines an opening angle α. In some embodiments, the opening angle α depends on an external device (e.g., an intraocular lens inserter) to which the device 100 is configured to connect. In some embodiments, the opening angle α is from 3.2 degrees to 8.5 degrees. In some embodiments, the opening angle α is from 3.2 degrees to 7.2 degrees. In some embodiments, the opening angle α is from 3.2 degrees to 5.9 degrees. In some embodiments, the opening angle α is from 3.2 degrees to 4.5 degrees. In some embodiments, the opening angle α is from 4.5 degrees to 8.5 degrees. In some embodiments, the opening angle α is from 4.5 degrees to 7.2 degrees. In some embodiments, the opening angle α is from 4.5 degrees to 5.9 degrees. In some embodiments, the opening angle α is from 5.9 degrees to 8.5 degrees. In some embodiments, the opening angle α is from 5.9 degrees to 7.2 degrees. In some embodiments, the opening angle α is from 7.2 degrees to 8.5 degrees. In some embodiments, the opening angle α is from 5.75 degrees to 6.75 degrees. In some embodiments, the opening angle α is from 6 degrees to 6.5 degrees. In some embodiments, the opening angle α is approximately 6.25 degrees. In some embodiments, the opening angle α is 6.24 degrees.

[0044] Next, referring to FIG. 3, when viewed as shown in FIG. 3, the first parallel portion and the second parallel portion 148 define a width W1. In some embodiments, the width W1 can vary according to the size of the insert inserted using the device 100. In some embodiments, the width W1 is wide enough to protect the full width (e.g., diameter) of the insert inserted by use of the device 100 from contact with the conjunctiva when the insert is deployed. In some embodiments, the width W1 is between 1.5 and 2.5 millimeters. In some embodiments, the width W1 is between 1.5 and 2.25 millimeters. In some embodiments, the width W1 is between 1.5 and 2 millimeters. In some embodiments, the width W1 is between 1.5 and 1.75 millimeters. In some embodiments, the width W1 is between 1.75 and 2.5 millimeters. In some embodiments, the width W1 is between 1.75 and 2.25 millimeters. In some embodiments, the width W1 is between 1.75 and 2 millimeters. In some embodiments, the width W1 is between 2 and 2.5 millimeters. In some embodiments, the width W1 is between 2 and 2.25 millimeters. In some embodiments, the width W1 is between 2.25 and 2.5 millimeters. In some embodiments, the width W1 is between 1.7 and 2.1 millimeters. In some embodiments, the width W1 is between 1.8 and 2.0 millimeters. In some embodiments, the width W1 is about 1.9 millimeters. In some embodiments, the width W1 is 1.91 millimeters.

[0045] Next, referring to FIG. 4, the protrusion 120 defines an inner diameter ID1. In some embodiments, the inner diameter ID1 can vary depending on the size of the insert that is inserted by use of the device 100. In some embodiments, the inner diameter ID1 is from 1.5 to 3.0 millimeters. In some embodiments, the inner diameter ID1 is from 1.5 to 2.75 millimeters. In some embodiments, the inner diameter ID1 is from 1.5 to 2.5 millimeters. In some embodiments, the inner diameter ID1 is from 1.5 to 2.25 millimeters. In some embodiments, the inner diameter ID1 is from 1.5 to 2 millimeters. In some embodiments, the inner diameter ID1 is from 1.5 to 1.75 millimeters. In some embodiments, the inner diameter ID1 is from 1.75 to 3.0 millimeters. In some embodiments, the inner diameter ID1 is from 1.75 to 2.75 millimeters. In some embodiments, the inner diameter ID1 is from 1.75 to 2.5 millimeters. In some embodiments, the inner diameter ID1 is from 1.75 to 2.25 millimeters. In some embodiments, the inner diameter ID1 is from 1.75 to 2 millimeters. In some embodiments, the inner diameter ID1 is from 2 to 3 millimeters. In some embodiments, the inner diameter ID1 is from 2 to 2.75 millimeters. In some embodiments, the inner diameter ID1 is from 2 to 2.5 millimeters. In some embodiments, the inner diameter ID1 is from 2 to 2.25 millimeters. In some embodiments, the inner diameter ID1 is from 2.25 to 3 millimeters. In some embodiments, the inner diameter ID1 is from 2.25 to 2.75 millimeters. In some embodiments, the inner diameter ID1 is from 2.25 to 2.5 millimeters. In some embodiments, the inner diameter ID1 is from 2.5 to 3 millimeters. In some embodiments, the inner diameter ID1 is from 2.5 to 2.75 millimeters. In some embodiments, the inner diameter ID1 is from 2.75 to 3 millimeters. In some embodiments, the inner diameter ID1 is from 1.5 to 1.9 millimeters. In some embodiments, the inner diameter ID1 is from 1.6 to 1.8 millimeters. In some embodiments, the inner diameter ID1 is about 1.7 millimeters. In some embodiments, the inner diameter ID1 is 1.70 millimeters.

[0046] Next, referring to FIG. 8, the protrusion 120 defines an arc angle γ that represents a portion of a complete (i.e., circular) cylinder that the protrusion 120 spans. In some embodiments, the arc angle γ can vary depending on the size of the insert inserted by use of the device 100. In some embodiments, the arc angle γ is between 90 degrees and 150 degrees. In some embodiments, the arc angle γ is between 90 degrees and 135 degrees. In some embodiments, the arc angle γ is between 90 degrees and 120 degrees. In some embodiments, the arc angle γ is between 90 degrees and 105 degrees. In some embodiments, the arc angle γ is between 105 degrees and 150 degrees. In some embodiments, the arc angle γ is between 105 degrees and 135 degrees. In some embodiments, the arc angle γ is between 105 degrees and 120 degrees. In some embodiments, the arc angle γ is between 120 degrees and 150 degrees. In some embodiments, the arc angle γ is between 120 degrees and 135 degrees. In some embodiments, the arc angle γ is between 135 degrees and 150 degrees. In some embodiments, the arc angle γ is between 100 degrees and 120 degrees. In some embodiments, the arc angle γ is between 105 degrees and 115 degrees. In some embodiments, the arc angle γ is approximately 110 degrees. In some embodiments, the arc angle γ is 110 degrees.

[0047] Next, referring to FIG. 2, the protrusion 120 defines a height H measured vertically from the first and second parallel portions 148 to the upper portion 102 perpendicular to the vertical axis A. Based on the cylindrical shape of the protrusion 120, the height H is a function of the width W1 shown in FIG. 3 and the angle γ shown in FIG. 8. As described above, in some embodiments, the width W1 can vary according to the size of the insert inserted by the use of the device 100. Thus, by depending on the width W1, in some embodiments, the height H can also vary according to the size of the insert inserted by the use of the device 100. In some embodiments, the height H is from 0.1 millimeter to 1.5 millimeters.. In some embodiments, the height H is from 0.1 millimeter to 1.15 millimeters.. In some embodiments, the height H is from 0.1 millimeter to 0.8 millimeter.. In some embodiments, the height H is from 0.1 millimeter to 0.45 millimeter.. In some embodiments, the height H is from 0.45 millimeter to 1.5 millimeters. In some embodiments, the height H is from 0.45 millimeter to 1.15 millimeters. In some embodiments, the height H is from 0.45 millimeter to 0.8 millimeter. In some embodiments, the height H is from 0.8 millimeter to 1.5 millimeters. In some embodiments, the height H is from 0.8 millimeter to 1.15 millimeters. In some embodiments, the height H is from 1.15 millimeters to 1.5 millimeters. In some embodiments, the height H is from 0.5 millimeter to 0.9 millimeter. In some embodiments, the height H is from 0.6 millimeter to 0.8 millimeter. In some embodiments, the height H is about 0.7 millimeter. In some embodiments, the height H is 0.7 millimeter.

[0048] Continuing to refer to FIG. 2, as shown in FIG. 2, when viewed from the side, the first inclined portion and the second inclined portion 150 define a bevel angle δ with respect to the vertical axis A. In some embodiments, the bevel angle δ is the base grind angle of the needle tip of the device 100, that is, the reference angle at which the grinding of the first inclined portion and the second inclined portion 150 is formed. In some embodiments, among the materials of the device 100, the portions forming the first inclined portion and the second inclined portion 150 are first rough machined to the bevel angle δ, and then finish machined to form the edges of the first inclined portion and the second inclined portion 150. In some embodiments, the bevel angle δ is between 10 degrees and 14 degrees. In some embodiments, the bevel angle δ is between 11 degrees and 13 degrees. In some embodiments, the bevel angle δ is between 11.5 degrees and 12.5 degrees. In some embodiments, the bevel angle δ is about 12 degrees. In some embodiments, the bevel angle δ is 12 degrees. In some embodiments, the plane 142 is also aligned at an angle δ (that is, inclined at an angle δ with respect to the vertical axis A).

[0049] Continuing to refer to FIG. 2, as shown in FIG. 2, when viewed from the side, the first inclined portion and the second inclined portion 150 define a thickness T. In some embodiments, the thickness T varies along the insertion direction. In some embodiments, the thickness T is thin enough to provide smooth insertion into the eye. In some embodiments, the thickness T defines the amount of material removed measured perpendicular to the plane defined by the angle δ that defines the first inclined portion and the second inclined portion 150. In some embodiments, the thickness T is from 0.08 to 0.2 millimeters. In some embodiments, the thickness T is from 0.08 to 0.17 millimeters. In some embodiments, the thickness T is from 0.08 to 0.14 millimeters. In some embodiments, the thickness T is from 0.08 to 0.11 millimeters. In some embodiments, the thickness T is from 0.11 to 0.2 millimeters. In some embodiments, the thickness T is from 0.11 to 0.17 millimeters. In some embodiments, the thickness T is from 0.11 to 0.14 millimeters. In some embodiments, the thickness T is from 0.14 to 0.2 millimeters. In some embodiments, the thickness T is from 0.14 to 0.17 millimeters. In some embodiments, the thickness T is from 0.17 to 0.2 millimeters. In some embodiments, the thickness T is from 0.13 to 0.17 millimeters. In some embodiments, the thickness T is from 0.14 to 0.16 millimeters. In some embodiments, the thickness T is about 0.15 millimeters. In some embodiments, the thickness T is 0.15 millimeters.

[0050] Continuing to refer to FIG. 2, the tip 152 forms a lancet angle ε with respect to the bevel angle δ that defines the first and second inclined portions 150. In some embodiments, the lancet angle ε is configured to provide smooth insertion of the tip 152 into the eye tissue. In some embodiments, the lancet angle ε is between 8 degrees and 12 degrees. In some embodiments, the lancet angle ε is between 9 degrees and 11 degrees. In some embodiments, the lancet angle ε is between 9.5 degrees and 10.5 degrees. In some embodiments, the lancet angle ε is approximately 10 degrees. In some embodiments, the lancet angle ε is 10 degrees.

[0051] In some embodiments, the tip 152 and the first and second inclined portions 150 form a sharp tip suitable for penetrating the conjunctiva of the human eye. In some embodiments, the upper portion 102 of the device 100 is appropriately polished smoothly so that when the tip 152 penetrates the eye, it slides inside the eye and under the conjunctiva. In some embodiments, the bottom portion 104 of the device 100 is appropriately polished to avoid contact with the sclera of the eye after the tip 152 penetrates the eye. In some embodiments, at least a part of the outer surface of the device 100 (for example, the surface away from the longitudinal axis A) is smooth to a level of arithmetic surface roughness (Ra) of 3.2 μm or more. In some embodiments, at least a part of the inner surface of the device 100 (for example, the surface facing the longitudinal axis A) is smooth to a level of arithmetic surface roughness (Ra) of 3.2 μm or more.

[0052] In some embodiments, the insertion portion 140 can be said to have a "duck-bill" shape with a profile of sufficient size such that the insert passes through the device 100 (e.g., enters the device through the first end portion 112 of the connection portion 110 and exits the device through the insertion portion 140), and is inserted into the eye while minimizing contact with the conjunctiva. In some embodiments, the length of the insertion portion 140 (e.g., measured along the longitudinal axis A) can vary according to the length of the insert inserted by use of the device 100. In some embodiments, the length of the insertion portion 140 is at least 0.5 mm longer than the length of the insert. In some embodiments, the length of the insertion portion 140 is 2.0 mm or less longer than the length of the insert. In some embodiments, the length of the insertion portion 140 is between 0.5 mm and 2.0 mm longer than the length of the insert. In some embodiments, the width of the insertion portion 140 (e.g., measured perpendicular to the longitudinal axis A in a plan view as shown in FIG. 4) can vary according to the width of the insert inserted by use of the device 100. In some embodiments, the width of the insertion portion 140 can vary according to the unfolded width of the insert inserted into the eye in a folded state. In some embodiments, the width of the insertion portion 140 is at least 60% of the unfolded width of the insert.

[0053] In some embodiments, device 100 is used as follows. The user couples device 100 to an intraocular lens inserter (or other suitable device) by engaging connection portion 110 with the intraocular lens inserter. Device 100 is inserted into the eye by penetrating the patient's conjunctiva with tip 152 and sliding tip 152 to a desired insertion position. As described above, due to the smoothness of the outer surface of device 100, the device can be easily moved to the insertion position while minimizing friction. Once device 100 is properly positioned, the user deploys an insert (e.g., an insert that provides delayed release of an API) through device 100 and discharges it from device 100 via insertion portion 140 in a manner consistent with standard operation of the intraocular lens inserter. Following deployment of the insert, the user withdraws device 100 from the eye. In some embodiments, device 100 is single-use and is discarded after withdrawal from the eye. In some embodiments, device 100 is reusable and can be used in subsequent insertion processes after appropriate sterilization. The exemplary method described above presents an improvement over prior art for insertion of such inserts in that the insertion is accomplished in one step, as opposed to a two-step process required by conventional devices, where the practitioner first forms a pocket with a scalpel and then inserts the intraocular lens inserter into the pocket to deploy the insert. Thus, such a one-step insertion process presents a one-step process for implantation of an intraocular lens insert, as opposed to a two-step process required by conventional devices. As a result, the exemplary embodiments simplify and shorten the placement procedure, thereby increasing the patient's willingness to undergo the procedure and, in parallel, increasing its success rate.

[0054] Although many embodiments of the present invention have been described, these embodiments are for illustrative purposes only and are not limiting, and it is understood that many modifications may become apparent to those skilled in the art. For example, all dimensions discussed herein are provided by way of example only and are intended to be illustrative and not limiting.

Claims

Claim 1 A body having a first end portion, a second end portion opposite to the first end portion, an upper side extending from the first end portion to the second end portion, and a lower side opposite to the upper side, wherein the body is a first portion having a hollow and substantially conical shape with respect to the longitudinal axis, and extends from the first end portion of the body to a transition portion intermediate the first end portion and the second end portion of the body, is a second portion having a hollow and substantially cylindrical shape with respect to the longitudinal axis, and extends from the transition portion to the second end portion of the body, and includes the first portion and the second portion define a passage having a first inner diameter at the first end portion and a second inner diameter at the second end portion, and the first inner diameter is larger than the second inner diameter, the first end portion is configured to engage an intraocular lens injector, the second end portion includes a pointed tip configured to penetrate eye tissue, an insertion port is formed on the lower side of the body, and the insertion port extends from the second end portion of the body toward the first end portion of the body, the insertion port is configured to pass a transplantable device received at the first end portion of the body from an intraocular lens injector that engages the first end portion of the body for transplanting a transplantable device into the eye, when viewed from the side of the body, the insertion port is a first inclined portion and a second inclined portion extending from the upper side of the body toward the longitudinal axis and from the pointed tip toward the first end portion of the body, and each of the first inclined portion and the second inclined portion is recessed with respect to the longitudinal axis when viewed from the side of the body, and the first inclined portion and the second inclined portion are disposed within the second portion of the body, is a first parallel portion and a second parallel portion extending in a direction from a corresponding one of the first inclined portion and the second inclined portion toward the first end portion of the body, and each of the first parallel portion and the second parallel portion is substantially parallel to the longitudinal axis when viewed from the side of the body, and the first inclined portion and the second inclined portion extend across a transition portion between the first end portion and the second end portion of the body, A first recess and a second recess extending from a corresponding one of the first parallel portion and the second parallel portion toward the first end of the main body and extending beyond the longitudinal axis of the main body toward the longitudinal axis, wherein the first recess and the second recess are recessed with respect to the longitudinal axis when viewed from the side surface of the main body, and the first recess and the second recess are disposed in the first portion of the main body, the first recess and the second recess, A plane extending from the first recess and the second recess toward the first end of the main body and away from the longitudinal axis of the main body, wherein the plane is inclined at a bevel angle that is an acute angle with respect to the longitudinal axis of the main body when viewed from the side surface of the main body, and the plane is disposed in the first portion of the main body, the plane, Defined by, Device.

2. Each transition portion between the first recess and the second recess and the plane is curved. The device according to claim 1.

3. The bevel angle is in the range of 10 degrees or more and 14 degrees or less. The device according to claim 1.

4. The pointed tip is inclined with respect to the plane at a lancet angle in the range of 8 degrees or more and 12 degrees or less. The device according to claim 3.

5. The first recess and the second recess have a radius of curvature in the range of 1 mm or more and 3 mm or less. The device according to claim 1.

6. The pointed tip defines a tip angle in the range of 60 degrees or more and 68 degrees or less. The device according to claim 1.

7. The device is configured to be used with a transplantable device having a transplantable device length, The insertion port has a length along the longitudinal axis that is 0.5 mm or more and 2 mm or less larger than the transplantable device length. The device according to claim 1.

8. The second portion of the main body and the first parallel portion and the second parallel portion define an arc angle in the range of 90 degrees or more and 150 degrees or less. The device according to claim 1.

9. The second portion of the main body has an inner diameter in the range of 1.5 mm or more and 3 mm or less. The device according to claim 1.

10. The first end of the main body has an inner diameter in the range of 2 mm or more and 5 mm or less. The device according to claim 1.

11. The length of the device along the longitudinal axis is in the range of 7 mm or more and 20 mm or less. The device according to claim 1.

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