IMPLANT TO TREAT RETINAL VEIN OCCLUSION

PRIORITY CLAIM AND CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to and benefit of U.S. Provisional Application No. 63/106,100, filed October 27, 2020, entitled “IMPLANT TO TREAT RETINAL VEIN OCCLUSION”, the entire contents of which are hereby incorporated by reference in their entirety including all tables, figures, and claims, and relied upon.

BACKGROUND

[0002] The field of the invention generally relates to implantable devices and related methods for the treatment of retinal vein occlusion.

[0003] Generally, retinal veins drain via a distinct circulatory system, which is located on the anterior surface of the retina. Retinal vein occlusion (RVO) is a diseased state in which one or more retinal veins become occluded. Occlusion can take several forms. Central RVO (CRVO) occurs when the central retinal vein is occluded, such as at the lamina cribrosa and the entire retina is affected. Branched RVO (BRVO) occurs when one of the larger veins that feeds the central retinal vein is occluded, and a portion of the retina is affected, while other areas of the retina are still able to drain.

[0004] Various attempts to clear such blockages or occlusions (whether surgically or medically) have not been successful. Injections of anti-vascular endothelial growth factor (anti- VEGF) agents, such as Ranibizumab or Bevacizumab, are a typical treatment modality for treating RVO; however, these anti-VEGF treatments address the sequelae of the condition only, such as macular edema, and re-treatment is typically required several times per year. Establishing a new venous flow path is, thus, a common curative procedure for remedying occlusions. Newly established venous flow paths bypass the blockage(s), in order to drain the retinal circulation. Specifically, in this procedure, a new flow path or new blood vessel, called an anastomosis, is formed between two circulatory systems. As mentioned above, the retinal circulatory system is located on the surface of the retina; there is also an independent circulatory system located on the opposite side of the retina, called the choroid. Normally, these circulatory systems are isolated. But, by linking these systems, a detour flow path can be created to circumvent the occlusion. [0004] One such procedure for forming a new venous flow path is a chorioretinal anastamosis (CRA) procedure. With the CRA procedure, a new flow path is created between the retinal veins and the veins in the choroid via a high-powered laser or, alternatively, by microsurgical cutting. Undesirably, these CRA procedures leave open wounds and require that the venous network anastomose, to form new veins connecting both sides (e.g., retinal vein side and choroid vein side). Furthermore, these CRA procedures successfully lead to the formation of a functional CRA in only a fraction of attempts. Therefore, the standard of practice is to attempt multiple CRA procedures (with multiple cuts or laser treatments) per eye in the hope that at least one will result in a functional CRA. As can be expected, this is undesirable as it results in multiple open wounds along the retinal surface.

SUMMARY

[0005] The present disclosure provides for new devices and related methods for the treatment of RVO. Specifically, the disclosure relates to permanent implants, which connect the retinal vein side and choroid vein side of the retina of the eye, in order to treat RVO. Instead of forming a wound tract, the devices herein establish a new rigid and permanent flow pathway for blood flow and eventual vein formation. Once inserted, the implant creates an anastomosis, or new flow path, between the retinal vein that it is inserted into and/or through, and the veins in the underlying choroid. This allows for targeted, and thus more efficient, anastomosis formation.

[0006] In light of the disclosure herein, and without limiting the scope of the invention in any way, in a first aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, an intraocular implant includes a proximal end, a distal end, and a lumen, disposed between the proximal end and the distal end. When implanted into an eye, the proximal end is in fluid communication with a retinal vein of the eye and the distal end is in fluid communication with a choroid of the eye.

[0007] In a second aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the distal end of the implant includes a plurality of retention features configured for retention in the choroid of the eye or in a sclera of the eye.

[0008] In a third aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the plurality of retention features includes a beveled end with a flange. [0009] In a fourth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the distal end includes a plurality of prongs, configured to capture the retinal vein of the eye prior to implantation.

[0010] In a fifth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the distal end includes a blade, configured to transect or puncture the retinal vein of the eye.

[0011] In a sixth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the distal end is configured to receive a trocar blade, the trocar blade configured to transect or puncture the retinal vein of the eye.

[0012] In a seventh aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the proximal end is configured for manipulation by a surgeon.

[0013] In an eighth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the proximal end includes a rectangular protrusion.

[0014] In a ninth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the lumen includes a fluid pathway. The implant includes a fluid inlet at the proximal end and a fluid outlet at the distal end, such that the fluid pathway is disposed between the fluid inlet and the fluid outlet and the fluid pathway is in fluid communication with each of the fluid inlet and the fluid outlet.

[0015] In a tenth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, an intraocular implant system includes an intraocular implant and a trocar. The intraocular implant includes a proximal end, a distal end, and a lumen, disposed between the proximal end and the distal end. A distal end of the trocar is configured to extend through the intraocular implant via the lumen. When implanted into an eye, the intraocular implant system is configured to transect or puncture a retinal vein of an eye and create a wound channel in the eye.

[0016] In an eleventh aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the distal end of the intraocular implant is configured to reside within a choroid of the eye or a sclera of the eye. [0017] In a twelfth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the distal end of the intraocular implant includes a plurality of retention features configured for retention in a choroid of the eye or a sclera of the eye.

[0018] In a thirteenth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the plurality of retention features of the intraocular implant includes a beveled end with a flange.

[0019] In a fourteenth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the distal end of the intraocular implant includes a plurality of prongs, configured to capture the retinal vein of the eye prior to implantation.

[0020] In a fifteenth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the distal end of the trocar includes a blade, configured to transect or puncture the retinal vein of the eye.

[0021] In a sixteenth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the proximal end of the intraocular implant is configured for manipulation by a surgeon.

[0022] In a seventeenth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the proximal end of the intraocular implant includes a rectangular protrusion.

[0023] In an eighteenth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the lumen includes a fluid pathway. The intraocular implant includes a fluid inlet at the proximal end and a fluid outlet at the distal end, such that the fluid pathway is disposed between the fluid inlet and the fluid outlet and the fluid pathway is in fluid communication with each of the fluid inlet and the fluid outlet.

[0024] In a nineteenth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the system further includes a cannula, such that the trocar and the intraocular implant are configured to reside within the cannula prior to implantation.

[0025] In a twentieth aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, the cannula includes a plurality of notches at a distal end, the plurality of notches configured to capture the retinal vein for alignment with the intraocular implant. [0026] Additional features and advantages of the disclosed devices, systems, and methods are described in, and will be apparent from, the following Detailed Description and the Figures. The features and advantages described herein are not all-inclusive and, in particular, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the figures and description. Also, any particular embodiment does not necessarily have to have all of the advantages listed herein. Moreover, it should be noted that the language used in the specification has been selected for readability and instructional purposes, and not to limit the scope of the inventive subject matter.

BRIEF DESCRIPTION OF THE FIGURES

[0027] Various embodiments and features of devices, systems, and methods disclosed herein will be described with reference to the following drawings. The drawings, associated descriptions, and specific implementations are provided to illustrate embodiments of the invention and not to limit the scope of the disclosure.

[0028] FIG. 1 A illustrates a schematic of a tissue model of a human eye.

[0029] FIG. IB illustrates a schematic of the tissue model of a human eye, with several example embodiments of implants in both un-inserted and inserted configurations.

[0030] FIG. 2 illustrates side and perspective views of an example embodiment of an implant with a circular barb.

[0031] FIG. 3 illustrates side and perspective views of an example embodiment of a flat implant with dual anchors.

[0032] FIG. 4 illustrates side and perspective views of an example embodiment of a three- dimensional implant with dual anchors.

[0033] FIG. 5 illustrates side and perspective views of example embodiments of closed tube implants.

[0034] FIG. 6 illustrates side and perspective views of an example embodiment of a hypodermic needle implant.

[0035] FIG. 7 illustrates side and perspective views of an example embodiment of a three- dimensional implant with a circular barb.

[0036] FIG. 8 illustrates side views of an example embodiment of an applicator cannula. [0037] FIG. 9 illustrates perspective views of example embodiments of soft tissue barbed implants.

[0038] FIG. 10 illustrates a side view of insertion of a soft tissue barbed implant.

[0039] FIG. 11 illustrates a perspective view of an example embodiment of a vein deflection implant.

[0040] FIG. 12 illustrates a perspective view of insertion of a vein deflection implant.

[0041] FIG. 13 illustrates perspective views of an example embodiment of a spearpoint seton implant.

[0042] FIG. 14 illustrates a perspective view of insertion of a spearpoint seton implant.

[0043] FIG. 15 illustrates perspective views of example embodiments of a tube seton implants.

[0044] FIG. 16 illustrates a perspective view of insertion of a tube seton implant.

[0045] FIGS. 17 to 20 illustrate additional embodiments of open tube implants with and without trocar inserters, similar to FIG. 2.

[0046] FIG. 21 illustrates additional embodiments of a flat implant, similar to FIG. 3.

[0047] FIGS. 22 to 23 illustrate additional embodiments of three-dimensional implants with dual anchors, similar to FIG. 4.

[0048] FIG. 24 illustrates an additional embodiment, with cutting surfaces on the inserter.

[0049] FIGS. 25 to 26 illustrate additional embodiments of closed tube implants, similar to FIG. 5.

[0050] FIGS. 27 to 29 illustrate additional embodiments of implants with surface features.

[0051] FIG. 30 illustrates an additional embodiment of a hybrid tube design with surface features.

[0052] FIG. 31 illustrates an additional embodiment, directed toward vessel redirection.

[0053] FIG. 32 illustrates an additional embodiment, directed toward a valved implant.

DETAILED DESCRIPTION

[0054] There is a need for new devices, and related methods, for treating RVO, which establish a new flow pathway for blood flow and encourage vein formation between the retinal vein side and choroid vein side of the retina of the eye. To achieve these desired results, an RVO implant must accurately puncture one or more retinal vein walls, allowing for the elution of venous blood. Then, the RVO implant must create a tract through retinal thickness, such as from the retinal vein side to the choroid vein side. Specifically, the RVO implant must create a perforation of Bruch’s membrane, which is a multi-layered collagenous structure with basement membranes. Then, the RVO implant must create entry into the chori ocapillaris, which is a sheet-like structure of capillaries located just below Bruch’s membrane at the inner-most surface of the choroid. In this way, the RVO implant advantageously creates a flow path from the one or more retinal veins to the choriocapillaris of the choroid, such that blood can readily flow from the punctured retinal vein to the choroid.

[0055] Turning now to the figures, FIGS. 1 A and IB illustrate schematics of a tissue model of a human eye, including depictions with implants in both un-inserted and inserted configurations. For example, FIG. 1A illustrates a perspective view including a cross-sectional depiction of multiple veins, in varying retinal environments. Namely, three veins are illustrated. A small vein 10, which would typically be further from the optic disk, is approximately 100 pm in diameter. A large vein 12, which would typically be near the optic disk, is approximately 200 pm in diameter. An extra-large vein 14, which would be expected in a patient experiencing RVO, is approximately 300 pm in diameter. Each of these three veins are depicted in three different retinal environments. When the veins are disposed in anterior locations of the eye, they are proximate to normal retinal walls 16, such as a 200 pm thick retinal wall. When the veins are disposed in posterior locations of the eye, they are proximate to thicker retinal walls 18, such as a 400 pm thick retinal wall. When the veins are disposed in posterior locations of the eye with a patient experiencing RVO, they are proximate to even thicker retinal walls 20, such as a 600 pm thick retinal wall. Below each retinal wall, there is choroid 22 (typically 300 pm thick) and sclera 24 (typically anywhere from 250 to 1000 pm thick). It should be appreciated that the above described thicknesses are exemplary, and other thicker or thinner anatomical dimensions should be expected.

[0056] Furthermore, it should be appreciated, with particular reference to FIG. IB and the rest of the figures herein, that a number of different implants are disclosed herein, having a number of different structural features and configurations. Generally, the implants disclosed herein provide efficacy in creating an anastomosis in various complimentary ways. In some embodiments, the implant provides a permanent closed-wall conduit or other tubing, to carry blood flow from the retinal vein to the choroid. In some particular embodiments, the conduit or tubing is perforated or mesh-like, so that the retinal tissue is stented open to create a flow path; the perforations or mesh ensure that the implant can more easily be endotheliazed by cellular though- growth, which will lower the risk of thrombosis. In some embodiments, the implant creates a wound tract through the retina and holds the tissue open the tissue to prevent the wound from collapsing closed, but does not actually create a closed conduit for blood flow. In some particular embodiments, the implant is intended to provide an immediate flow path for blood to flow from the retinal vessel to the choroid, but then further allow for anatomical blood vessel formation through this space. In these embodiments, after formation of the anastomotic vessel, the implant will no longer be in blood contact. Some embodiments may include both a closed flow channel and features to help a blood vessel to form, in parallel.

[0057] In some embodiments, the implant is configured to pierce through the center of the retinal vein. In other embodiments, the implant is configured to slice through a wall on one side of the vein. In yet other embodiments, the implant is configured to fully transect the vein.

[0058] Once implanted, as described in greater detail herein, it should be appreciated that in some embodiments the implant includes anchoring features, to anchor the implant into the sclera. In other embodiments, the implant is not configured to penetrate all the way to the sclera, and rather includes features for anchoring the implant into retinal tissue instead, such as the choroid or between the choroid and the sclera.

[0059] Similar to FIG. 1A, FIG. IB illustrates a perspective view including a cross- sectional depiction of multiple veins, along with several implants in both un-inserted and inserted configurations. Specifically, FIG. IB illustrates a model retina, including, from left to right, three sizes of retinal veins: 100 pm, 200 pm, and 300 pm diameters. Furthermore, FIG. IB illustrates two different thicknesses of retina: 400 pm and 600 pm thick. Lastly, FIG. IB illustrates a uniform choroid (300 pm thick) and sclera (1000 pm) thick. At the outset, it is worth noting that some implants illustrated are shown on thicker retina and/or on different vein diameters. None of these particular retina and/or vein diameters are specific to a particular implant’s design. In other words, all implants illustrated and disclosed herein are capable of being used on any retinal thickness and any vein diameter. Similarly, some of the implants illustrated are shown with an applicator cannula; however, all implants illustrated and disclosed herein may be configured for use with or without an applicator cannula, or any other applicator or inserter for that matter.

[0060] As noted, FIG. IB illustrates several different configurations of implants. First, FIG. IB illustrates a tube-like design implant 102, with two large slots on each side. In this particular embodiment, cutting is performed by a trocar blade on the inserting instrument itself. The implant 102 is mounted onto this inserting instrument. The implant 102 is inserted through the middle of a retinal vein, to a depth such that the proximal end of the implant 102 fully enters the targeted retinal vein. Once inserted, the distal end of the implant will have penetrated the sclera. The implant 102 includes a retention barb, which lodges into the sclera and retains the implant 102 in place as the inserter is withdrawn.

[0061] Second, FIG. IB illustrates a flat design implant 104, with an anchor on each side. In this particular embodiment, the implant 104 includes a cutting feature, such that the implant 104 itself is configured to puncture, partially transect, or fully transect the vein as it is inserted. The two anchors, or prongs, capture the vein prior to the beginning of vein transection by the cutting feature of implant 104; these anchors, or prongs, ensure that the vein is properly cut and that the vein does not inadvertently displace to the left or right. Further, these anchors, or prongs, anchor the implant 104 into the sclera, such as via barbed tips, upon complete insertion of the implant 104 into the tissue. The implant 104 may include a center channel, configured to hold open the retinal tissue and provide for blood flow, along with anastomotic vessel formation. The implant 104 may further include a capped distal end, to prevent bleeding into the vitreous cavity.

[0062] Third, FIG. IB illustrates three-dimensional design implant 106, with an anchor on each side. Namely, this implant 106 has a cylindrical design (as opposed to the flat design of implant 104). For example, implant 106 may be machined from rod stock. Similar to implant 104, implant 106 includes two anchors, or prongs, configured to capture the vein as the implant 106 begins transection. Likewise, similar to implant 104, implant 106 includes a center channel and a capped distal end. Implant 106 may further include a spherical feature at its distal end; this spherical feature is useful for gripping and manipulation of the implant 106 via an inserter device or other surgical tool. Similar features of different sizes and shapes may be employed in place of this spherical feature for the same purpose.

[0063] Fourth, FIG. IB illustrates closed tube implant 108, which includes one or more flow inlet holes and flow outlet holes. As illustrated in FIG. IB and described in more detail herein, implant 108, but also any of the implants shown in FIG. IB or described elsewhere herein, may be implanted via an inserter cannula or other applicator. More specifically, implant 108 is inserted through a vein, such that one or more of the fluid inlet holes are positioned within the vein after implantation; this ensures that implant 108 and its fluid inlet hole(s) are in fluid communication with the vein. Similarly, the one or more flow outlet holes are positioned at the choroid after implantation. Thus, blood drains from the vein, through the fluid inlet holes, along the implant 108, through flow outlet holes, and into the choroid. Implant 108 may further include a barb at its distal end, providing tissue retention into the choroid and/or retina. Implant 108 may include a capped distal end, to prevent bleeding into the vitreous cavity.

[0064] Fifth, FIG. IB illustrates a hypodermic needle implant 110, which includes a custom tip and a slotted side. As illustrated in FIG. IB and described in more detail herein, implant 110 may implanted via an inserter cannula or other applicator. More specifically, implant 110 is inserted through the center of a vein, such that a portion of the sharp tip enters the sclera for anchoring. After implantation, there is a gap between the proximal end of the implant 110 and the vein; nonetheless, the implant 110 holds the wound tract open, via the slotted side, so that blood more readily flows toward the choroid. Moreover, by holding open the wound tract, implant 110 provides improved chances of forming a functioning CRA.

[0065] Sixth, FIG. IB illustrates a scleral anchor implant 112, which includes an anchor on its distal end and an internal flow channel. This anchor serves to cut through the center of the vein, as the implant 112 is inserted. The implant 112 is inserted until its anchor is embedded into scleral tissue and the proximal end of the flow channel is located within the vein itself.

[0066] Generally, implants 102, 104, 106, 108, 110, and 112 may be constructed of metal, metal alloy, a rigid polymer, or glass, crystalline, or ceramic material, such as sapphire, ruby, or the like. In a particular embodiment, implants 102, 104, 106, 108, 110, and 112 are constructed of titanium and, more particularly, stearalkonium heparin-coated implant grade titanium (Ti 6A1 4V ELI). In other embodiments, implants 102, 104, 106, 108, 110, and 112 are constructed of other materials, such as stainless steel, nitinol, zirconia, sapphire, polymers, or bio-resorbable polymers. In an example embodiment, implants 102, 104, 106, 108, 110, and 112 are constructed of bio-resorbable polymers, such as poly(lactic-co-glycolic acid). In this embodiment, once implanted, the implant props open a wound (as described in greater detail herein); after an anastomosis has formed, the implant partially or fully dissolves. Additionally or alternatively, implants 102, 104, 106, 108, 110, and 112 may be coated with added materials, such as polyvinylidene fluoride-co-hexafluoropropylene, or other related antithrombotic coatings.

[0067] Implants, including implants 102, 104, 106, 108, 110, and 112 along with a number of additional implants, will now be described with more particularity. It should be appreciated, however, that none of the features described with an individual implant, such as implant 102, are limited to that particular implant. Rather, unless explicitly noted, any feature or functionality described herein is implant-agnostic. Any feature or functionality is combinable with any other feature or functionality, as should be appreciated by one having ordinary skill in the art.

[0068] FIG. 2 illustrates side and perspective views of an example embodiments of implant 102, having a circular barb 114. More particularly, implant 102 includes a proximal end 116 and a distal end 118. The circular barb 114 is disposed at the distal end 118. Implant 102 is delivered on a pre-loaded applicator 120 that includes a sharp trocar blade 122. During insertion, a surgeon pierces a vein with the sharp trocar blade 122, and inserts implant 102 through the pierced vein and into ocular tissue, including the retina, choroid, and sclera. For example, distal end 118 and circular barb 114 are lodged into the sclera, such that implant 102 is securely implanted. In a particular embodiment, circular barb 114 is a 360° retention ridge. In an embodiment, trocar blade 122 is the only sharp component of the combined implant 102 and pre-loaded applicator 120, configured for cutting the retina vein and dissecting the retina, choroid, and sclera. In a different embodiment, the distal end 118 of implant 102 may additionally or alternatively include a cutting surface, configured for cutting the retina vein and dissecting the retina, choroid, and sclera.

[0069] Implant 102 may further include a lumen 124, such as an open channel disposed within the interior of implant 102, from the proximal end 116 to the distal end 118. When an open channel, lumen 124 may also be generally referred to as a blood flow path. Additionally, implant 102 may include a flange 126, configured to seat with a portion of applicator 120 for controlled implantation. Flange 126 may further prevent bleeding into the vitreous cavity.

[0070] In a particular embodiment, implant 102 has a 180 pm outer diameter between the proximal end 116 and distal end 118; implant 102 has a 100 pm inner diameter at the lumen 124. Similarly, flange 126 has a diameter of approximately 240 pm. It should be appreciated, however, that these dimensions are exemplary only, and that larger and/or smaller dimensions of individual components and implants are contemplated herein.

[0071] During implantation, for example, implant 102 comes pre-loaded onto a single-use applicator 120. In a preferred embodiment the implant 102 and applicator 120 are sized to fit through a standard trocar cannula entry system used in vitreoretinal surgeries, such as 23 G, 25 G, 27G, and other related gauges, for example. In some embodiments, the implant 102 and applicator 120 include its own vitreoretinal entry system. In some embodiments, the implant 102 and applicator 120 do not require a vitreoretinal entry system, such that the applicator 120 is configured to penetrate the sclera of the eye during implantation. The implant 102 is generally configured to be implanted after standard vitrectomy is performed in the eye, including posterior hyaloid separation and removal of the posterior cortical vitreous in order to gain access to the retinal surface. In some embodiments, however, the implantation procedure occurs without first performing a vitrectomy to remove the vitreous humor; for example, implant 102 is pushed through the vitreous humor to reach the retina surface.

[0072] As previously noted, implant 102 includes lumen 124. Once implant 102 is fully inserted, lumen 124 provides for blood flow, from the retinal vein to the choroid. Namely, once implant 102 is fully inserted, a proximal end of lumen 124 is in fluid communication with the retinal vein and a distal end of lumen 124 is in fluid communication with the choroid. Lumen 124 further provides space for eventual anatomical blood vessel formation, from the retinal vein to the choroid. Each of these benefits, increased blood flow and blood vessel formation, improve drainage and thus reduce RVO.

[0073] Advantageously, implant 102 provides for targeted, and thus more efficient, anastomosis formation. In an embodiment, only one implant 102 is required per diseased eye. In a different embodiment, two implants 102 are required per diseased eye: one implant in the superior quadrant and one implant in the inferior quadrant. In this particular embodiment, applicator 120 may be pre-loaded with two implants 102, such that both can be implanted without having to withdraw applicator 120 from the eye prior to implantation of the second implant. In another embodiment applicator 120 may be pre-loaded with a plurality of implants 102, such as three or more.

[0074] Implant 102, along with applicator 120, provides for an accurate and repeatable surgical procedure. The surgeon can identify a targeted vein, and insert implant 102 into and through this targeted vein. The procedure efficiently punctures and/or severs the targeted vein, and maintains patency. Via the lumen 124, the implant 102 creates an immediate and defined blood flow path, from the retina to the choroid. This immediate and defined blood flow path encourages anastomosis formation. Via the flange 126, for example, the implant 102 prevents undesirable bleeding into the vitreous cavity.

[0075] Continuing on with additional features of the various implants herein, FIG. 3 illustrates side and perspective views of an example embodiment of flat implant 104, with dual anchors 128. More particularly, implant 104 includes a proximal end 130 and a distal end 132. The dual anchors 128 are disposed at the distal end 132. Dual anchors 128 are configured to trap a retinal vein, and prevent the vein from being displaced as the implant 104 contacts the vein during implantation. Implant 104 may further include a blade 134, configured to puncture, partially transect, or fully transect the vein as implant 104 is inserted through the vein. It should be appreciated that blade 134, trocar blade 122 as previously described, and other related blades described herein may include any of flat blades, curved blades, angled blades, sharp points, needles, or any other sharp component configured for piercing and/or transecting an anatomical feature.

[0076] Beyond mere vein transection, in some embodiments, blade 134 nudges both transected ends of the retinal vein into the choroid or, additionally or alternatively, into a lumen 136 (described below) for improved anastomosis formation. In an embodiment, implant 104 is inserted through the vein and into ocular tissue including the retina, choroid, and sclera, such that the dual anchors 128 are lodged into the sclera. In an embodiment, implant 104 is inserted until a lip 138 at the proximal end 130 contacts the surface of the retina.

[0077] Implant 104 may further include the lumen 136, such as an open channel within the interior of implant 104 from the proximal end 130 to the distal end 132. The proximal end 130 of implant 104, including the lip 138, are configured to prevent bleeding into the vitreous cavity.

[0078] In a particular embodiment, implant 104 has a thickness of 100 pm and a width of 175 pm at the lumen 136. Similarly, implant 104 has a width of 250 pm between the dual anchors 128. It should be appreciated, however, that these dimensions are exemplary only, and that larger and/or smaller dimensions of individual components and implants are contemplated herein.

[0079] FIG. 4 illustrates side and perspective views of an example embodiment of three- dimensional implant 106, with dual anchors 140. More particularly, implant 106 includes a proximal end 142 and a distal end 144. The dual anchors 140 are disposed at the distal end 144. Dual anchors 140 are configured to trap a retinal vein, and prevent the vein from being displaced as the implant 106 contacts the vein during implantation. Each anchor of dual anchors 140 may further include one or more anchor bars, which are generally orthogonal to the rest of implant 106.

[0080] Implant 106 may further include a blade 146, configured to puncture, partially transect, or fully transect the vein as implant 106 is inserted through the vein. Beyond mere vein transection, in some embodiments, blade 146 nudges both transected ends of the retinal vein into the choroid or, additionally or alternatively, into a lumen 148 (described below) for improved anastomosis formation. In an embodiment, implant 106 is inserted through the vein and into ocular tissue including the retina, choroid, and sclera, such that the dual anchors 140 are lodged into the sclera. In an embodiment, implant 106 is inserted until a lip 150 at the proximal end 142 contacts the surface of the retina.

[0081] Implant 106 may further include the lumen 148, such as an open channel within the interior of implant 106 from the proximal end 142 to the distal end 144. The proximal end 142 of implant 106, including the lip 150, are configured to prevent bleeding into the vitreous cavity. In an embodiment, implant 106 further includes a bulbous tip 152. Bulbous tip 152 provides for improved gripping and manipulation via surgical tools.

[0082] In a particular embodiment, implant 106 has a thickness of 150 pm at the lumen 148 and 100 pm at the blade 146 and dual anchors 140. Similarly, implant 106 has a width of 200 pm at the lumen 148 and a width of 300 pm between the anchors 140. In an embodiment, lip 150 has a diameter of 500 pm. In an embodiment, bulbous tip 152 has a diameter of 350 pm. It should be appreciated, however, that these dimensions are exemplary only, and that larger and/or smaller dimensions of individual components and implants are contemplated herein.

[0083] FIG. 5 illustrates side and perspective views of example embodiments of closed tube implants 108. More particularly, implant 108 includes a proximal end 154 and a distal end 156. Implant 108 includes a sharp tip or barb 158 at its distal end 156. Barb 158 is configured to pierce through a retinal vein as the implant 108 is inserted through the vein. In an embodiment, implant 108 is inserted through the vein and into ocular tissue, including the retina and choroid, such that the tip of the barb 158 reaches but does not penetrate the sclera. In this embodiment, the barb 158 may be specifically sharp enough to cut through the softer vein and retina tissue, but not sharp enough to penetrate the sclera without excessive force. In another embodiment, the distal end 156 of implant 108 includes a retention barb, configured for retaining the implant 108 in the choroid and/or retina.

[0084] Implant 108 further includes a flow inlet 160, a flow outlet 162, and a fluid pathway 164 disposed between the flow inlet 160 and flow outlet 162. Flow inlet 160 and flow outlet 162 may be singular openings or, alternatively, may be a plurality of openings such as two, three, or four discrete openings. When inserted, the flow inlet 160 is in fluid communication with the retinal vein; likewise, when inserted, the flow outlet 162 is in fluid communication with the choroid. In an embodiment, the barb 158 reaches but does not penetrate the sclera, to ensure that flow outlet 162 is appropriately positioned within the thickness of the choroid (which is approximately 300 pm thick) after implantation of implant 108. Once implant 108 is fully implanted, blood from the retinal vein readily flows into the flow inlet 160, through the fluid pathway 164, out of the flow outlet 162, and into the choroid. This directed flow, provided by fluid pathway 164, prevents bleeding into the vitreous cavity. The fluid pathway 164, being contained within the lumen of a unperforated tube, ensures that flow through the fluid pathway 164 will remain unobstructed by tissue that might otherwise be able to collapse into and occlude the fluid pathway 164. The fluid pathway 164 further provides a self-contained pathway for future anastomosis formation.

[0085] In a particular embodiment, implant 108 has a 200 pm outer diameter and a 125 pm inner diameter along the flow pathway 164. Similarly, the implant 108 has a width of 100 pm at the flow inlet 160 and a diameter of 150 pm at the flow outlet 162. In a particular embodiment, the dimensioning and spacing of the flow inlet 160 and flow outlet 162 are configured to match anatomical dimensioning and spacing of the retinal vein and choroid, respectively. It should be appreciated, however, that these dimensions are exemplary only, and that larger and/or smaller dimensions of individual components and implants are contemplated herein.

[0086] FIG. 6 illustrates side and perspective views of an example embodiment of hypodermic needle implant 110. More particularly, implant 110 includes a proximal end 166 and a distal end 168. Implant 110 includes a sharp tip and/or blade 170 at its distal end 168. Blade 170 is configured to pierce through a retinal vein as the implant 110 is inserted through the vein. In an embodiment, implant 110 is inserted through the vein and into ocular tissue, including the retina, choroid, and sclera such that the end of the blade 170 anchors into the sclera. In an embodiment, the distal end 168 of implant 110 includes a retention barb, configured for retaining the implant 110 into the sclera.

[0087] Implant 110 may further include a lumen 172, such as an open channel within the interior of implant 110 from the proximal end 166 to the distal end 168. In an embodiment, once fully implanted, implant 110 is positioned below the retinal surface, such that both the distal end 168 and the proximal end 166 have passed entirely through the retinal vein. For example, the proximal end 166 is retained within the retina. Once implanted, blood flows into the retinal wound created by implant 110 and/or pre-loaded inserter 174, and then into the choroid via lumen 172. In another embodiment implant 110 remains at least partially within the retinal vein, but does not extend all the way to the choroid. In this instance, the blood flows from the retinal vein via lumen 172 to the distal end 168 of the implant and then through the retinal wound created by pre-loaded inserter 174 and into the choroid. In another embodiment, the total length of implant 110 is larger than illustrated in FIG. 6, such that, once implanted, proximal end 166 remains within the retinal vein or extends above the retinal vein and distal end 168 is positioned with the choroid or sclera. In an embodiment, implant 110 is implanted via a pre-loaded inserter 174, such as a sharp hypodermic needle. In another embodiment, the pre-loaded inserter 174 is not sharp.

[0088] As described above, in certain embodiments, implant 110 does not span the complete distance from the retinal vein, or surface of the retina, to the choroidal vein or choroid, but nonetheless provides benefits by stenting the retinal tissue along a portion of this distance to enable blood flow between the two locations and/or provide a scaffold for future blood vessel formation along the wound tract. The implant, upon implantation, may reside below the retinal vein or, conversely, may not extend all the way to the depth of the choroid. In some embodiments both conditions may be realized. While implant 110 is an exemplary design of such an implant that does not span the complete distance (as noted above), it should be appreciated that any embodiment described herein may be dimensioned and adapted in a similar manner.

[0089] In a particular embodiment, implant 110 has a 200 pm outer diameter and a 125 pm inner diameter along the lumen 172. It should be appreciated, however, that these dimensions are exemplary only, and that larger and/or smaller dimensions of individual components and implants are contemplated herein.

[0090] FIG. 7 illustrates side and perspective views of an example embodiment of three- dimensional implant 112, with a circular barb 176. More particularly, implant 112 includes a proximal end 178 and a distal end 180. The circular barb 176 is disposed at the distal end 180. Circular barb 176 is configured to pierce through a retinal vein as the implant 112 is inserted through the vein. In an embodiment, implant 112 is inserted through the vein and into ocular tissue, including the retina, choroid, and sclera, such that the circular barb 176 anchors into the sclera.

[0091] Implant 112 may further include a lumen 182, such as an open channel within the interior of implant 112 from the proximal end 178 to the distal end 180. In an embodiment, implant 112 further includes a bulbous tip 184. Bulbous tip 184 provides for improved gripping and manipulation via surgical tools. [0092] In a particular embodiment, implant 112 has a 200 pm outer diameter along lumen 148 and a 100 pm width at lumen 148. In a particular embodiment, implant 112 has a shaft diameter of 80 pm at the location of circular barb 176, which itself reaches a diameter of 130 pm at its lip. It should be appreciated, however, that these dimensions are exemplary only, and that larger and/or smaller dimensions of individual components and implants are contemplated herein.

[0093] FIG. 8 illustrates side views of an example embodiment of an applicator cannula 186. More specifically, FIG. 8 illustrates applicator cannula 186 being used with implant 110 and pre-loaded inserter 174 (as described in detail above with respect to FIG. 6).

[0094] Generally, it should be appreciated that applicator cannula 186 may be configured to be used with any of the implants and/or inserter devices as disclosed herein. In an embodiment, a distal end of applicator cannula 186 includes a recessed pocket 188. For example, recessed pocket 188 may be configured for trapping or straddling a retinal vein and ensuring that the implant is aligned with the vein’s center, prior to piercing, cutting, and/or implantation. Recessed pocket 188 may have a cross-sectional shape that is oblong, stepped, lipped, or otherwise non-circular, such that it more effectively accommodates (e.g., centers and holds in-place) veins of different diameters, including veins as small as 50 pm or as large as 400 pm in diameter. Recessed pocket 188 may include notches to trap and align the vein, prior to implantation of an implant. In an embodiment, recessed pocket 188 includes two flat portions at the distal end of cannula 186; recessed pocket 188 further includes two v-shaped notches disposed at the distal end of cannula 186.

[0095] Generally, it should be appreciated that any of the implants 102, 104, 106, 108, 110, and 112 discussed above may be inserted via any of the inserter devices, cannulas, applicators, and the like. With that in mind, some particular exemplary implant designs and related insertion methods are disclosed herein, including soft tissue barbed implants, vein deflection implants, spearpoint seton implants, and tube seton implants.

[0096] FIGS. 9 and 10 illustrate two variants of soft tissue barbed implants 202, 204. Via soft tissue barbed implants, 202, 204, the implants 202, 204 are configured to be implanted into soft tissue layers only, while avoiding penetrating the sclera of the eye.

[0097] A first variant of soft tissue barbed implant 202 includes a blade 206 aligned with the flow pathway of vein 208. For example, blade 206 is a slim trocar blade positioned in the center of implant 202. Blade 206 advantageously provides the cutting edge during implantation, in order to cut vein 208 and create a wound tract or wound channel to the sclera. For example, blade 206 creates a wound channel through the choroid. Blade 206 further ensures that implant 202 does not require any sharp surfaces itself. In an example embodiment, soft tissue barbed implant 202 includes a 250 pm shaft diameter. Slim trocar blade 206 may further ensure that the trocar slit is as narrow as possible, thus reducing the likelihood of bleeding from vein 208 into the vitreous cavity after implantation. In an alternate embodiment, a wound tract is formed, such as with a blade, and an implant, such as soft tissue barbed implant 202 is inserted into this pre-formed wound tract.

[0098] A second variant of soft tissue barbed implant 204 includes a blade 210 aligned transverse to the flow pathway of vein 212. In an example embodiment, soft tissue barbed implant 204 includes a 300 pm shaft diameter. In each embodiment, the soft tissue barbed implant 202, 204 is configured to be aligned on the distal end of a trocar 214, 216. Trocar 214 includes blade 206 at its distal tip. Trocar 216 includes blade 210 at its distal tip.

[0099] Trocars 214, 216 are dimensioned to fit within a cannula system or other similar inserters (e.g., fit within a 23G, 25G, or 27G outer cannula). For example, trocar 214 is disposed within inserter 218. Similarly, for example, trocar 216 is disposed within inserter 220. In an embodiment, inserter 218, 220 includes a notch, to help capture the vein 208, 212 and position the implant for proper alignment with the vein 208, 212.

[0100] FIG. 10 illustrates insertion of soft tissue barbed implant 202. As illustrated, the blade 206 on trocar 214 is aligned with the flow pathway of vein 208. Blade 206 slices through vein 208 along its flow pathway as blade 206 is inserted through vein 208. Soft tissue barbed implant 202 is inserted until the blunt tip 222 of implant 202 contacts the sclera. In an embodiment, the blunt tip 222 of implant 202 is conical, configured to penetrate through the retina and choroid but provides a tactile stop upon reaching the sclera. At this point, the tip of blade 206 extends slightly into the sclera, whereas the barb 224 of implant 202 resides in choroid tissue. For example, barb 224 includes oversized barb lips that provide retention in soft tissue layers such as the retina and/or choroid. The head of implant 202 may compress the retina surface.

[0101] Soft tissue barbed implant 202, 204 is configured to compensate for retina thickness variability. For example, if the retina and choroid layers are too thin, the implant 202 head may protrude from the optimal/intended position. Similarly, for example, if the retina and choroid layers are too thick, the implant 202 head may act to locally compress the tissue (creating an indentation).

[0102] FIG. 11 illustrates vein deflection implant 226. Vein deflection implant 226 is generally configured to transect a vein and direct the two cut ends of the vein downward, towards the choroid. Vein deflection implant 226 includes a head 228, configured for use with forceps or a custom inserter. In an embodiment, head 228 is a rectangular protrusion extending from the proximal end of vein deflection implant 226, but may be other sizes and shapes in other embodiments. Implant 226 further includes a transecting blade 230 and two prongs 232, extending from either side of the transecting blade 230. In an embodiment, blade 230 is a sharp curved blade. The two prongs 232 are configured to trap a vein between the prongs for subsequent cutting via transecting blade 230. Prongs 232 are also configured to anchor vein deflection implant 226 within the sclera of the eye. For example, prongs 232 may include one or more retention barbs.

[0103] FIG. 12 illustrates insertion of vein deflection implant 226. Generally, vein deflection implant 226 is configured for self-arresting implantation, such that implantation ceases when blade 230 contacts the sclera of the eye. While blade 230 easily cuts soft retina and choroid tissues, it will “stop” when it contacts the scleral tissue. When inserted, the vein is transected by blade 230; both ends of the transected vein are directed downward toward the choroid. Advantageously, this directional urging may prevent undesirable bleeding into the vitreous cavity as well as position both ends of the transected vein close to or within the choroid. Further, vein deflection implant 226 is configured to be used with any retinal thickness. Namely, insertion is stopped by scleral contact with blade 230, regardless of the prior thicknesses of retinal and choroidal tissue.

[0104] FIG. 13 illustrates spearpoint seton implant 234. Spearpoint seton implant 234 is generally configured to breach a vein and subsequently act as a seton to maintain patency of a wound tract extending from the retina through the choroid. Spearpoint seton implant 234 includes a head 236, configured for use with forceps or a custom inserter. In an embodiment, head 236 is a rectangular protrusion extending from the proximal end of spearpoint seton implant 234. Implant 234 further includes a sharp spearpoint blade 238 located at the distal end of spearpoint seton implant 234. Spearpoint seton implant 234 may be inserted via a cannula inserter that includes notches 240 to help capture the vein and position the implant 234 correctly. Spearpoint seton implant 234 further includes dual lips 242 on either side of blade 238. Dual lips 242 are configured to retain implant 234 within the sclera of the eye upon insertion. Spearpoint seton implant 234 may additionally include a blood flow channel 244

[0105] FIG. 14 illustrates insertion of spearpoint seton implant 234. Generally, spearpoint seton implant 234 is configured to be inserted until the proximal end or head makes contact with the retina (as seen visually by the surgeon). Spearpoint seton implant 234 is configured for variability of retinal thickness; retinal thickness variability is compensated for by how far the spearpoint seton implant 234 extends into the sclera. The proximal end or head of spearpoint seton implant 234 acts as a cap, to prevent bleeding into the vitreous cavity of the eye.

[0106] FIG. 15 illustrates tube seton implants 246, 248. As illustrated, tube seton implant 246 is configured for insertion via trocar 250. Similarly, as illustrated, tube seton implant 248 is configured for insertion via trocar 252. While illustrated as such, it should be appreciated that tube seton implants 246, 248 are interchangeable. Each of tube seton implants 246, 248 are configured to be implanted a partial depth into the sclera for anchoring. Tube seton implant 246 includes straight sidewalls with a barbed end 254. Tube seton implant 248, by comparison, includes straight sidewalls, a barbed end 256, and a flared sidewall 258 disposed between the straight sidewalls and the barbed end 256. For example, flared sidewall 258 is configured to prevent over-penetration of tube seton implant 248 into sclera. Flared sidewall 258 is configured to easily translate through retinal tissue and choroid tissue, but stop at the scleral tissue. Barbed ends 254, 256 are configured to retain implants 246, 248 within the sclera of the eye.

[0107] Tube seton implants 246, 248 may be inserted via a cannula inserter that includes notches to help capture the vein and position the implant 246, 248 correctly. Each of trocars 250, 252 may include a blade configured to extend within an interior of implant 246, 248. The blade advantageously provides the cutting edge during implantation, in order to cut the vein and create a wound tract in the sclera. The blade further ensures that implant 246, 248 does not require any sharp surfaces itself. In an alternate embodiment, a wound tract is formed, such as with a blade, and an implant, such as tube seton implant 246, is inserted into this pre-formed wound tract.

[0108] FIG. 16 illustrates insertion of tube seton implant 246. For example, tube seton implant 246 is configured to be inserted into the tissue until the proximal end of tube seton implant 246 is flush with (or slightly below) the surface of the retina as visually observed by the surgeon. By comparison, for example, tube seton implant 248 is configured to be inserted into the tissue until the flared sidewall 258 provides a tactile defined stop. Tube seton implant 246 is configured for insertion variability of retinal thickness, as it can be inserted to a variable depth into the sclera. By comparison, tube seton implant 248 may stick out of retina or (alternatively) be disposed far below the retinal surface, depending on retinal thickness.

[0109] FIGS. 17 to 20 illustrate additional embodiments of open tube implants with and without trocar inserters, similar to implant 102 illustrated by FIG. 2. Namely, in various embodiments the lumen, such as lumen 124 of implant 102, may be any of a fully open channel, a partially open channel, or a closed channel with fluid inlets/outlets. The implant itself, such as implant 102, may include additional retention barbs along its length, such as along the length of the lumen, for added retention capabilities. The implant may further include retention barbs at distal end 118 that extend distally to penetrate deeper into the sclera, illustrated by FIG. 20. The implant may further include stop surfaces or other features, to indicate to the surgeon when the distal end of the implant has reached the sclera and/or when the proximal end of the implant has reached the retina.

[0110] FIG. 21 illustrates additional embodiments of a flat implant, similar to implant 104 illustrated by FIG. 3. Namely, in various embodiments the implant, such as implant 104, may include one anchor (as opposed to a dual anchor configuration). In an embodiment, the single anchor is disposed at the center of the implant or along a side of the implant.

[0111] FIGS. 22 to 23 illustrate additional embodiments of three-dimensional implants with dual anchors, similar to implant 106 illustrated by FIG. 4. Namely, in various embodiments the implant, such as implant 106, may include blades or other cutting features, configured to puncture, partially transect, or fully transect the vein as implant is inserted through the vein. Beyond mere vein transection, in some embodiments, these blades or other cutting features nudge both transected ends of the retinal vein into the choroid or, additionally or alternatively, into a lumen or other channel for improved anastomosis formation.

[0112] FIG. 24 illustrates an alternative embodiment, with venous capture and cutting surfaces on the inserter itself, wherein the implant itself is blunt and/or does not include any cutting surfaces.

[0113] FIGS. 25 to 26 illustrate additional embodiments of closed tube implants, similar to implant 108 illustrated by FIG. 5. Namely, in various embodiments the implant, such as implant 108, may include multiple flow inlets and/or flow outlets configured to provide for fluid communication between a retinal vein and the choroid. The flow inlets and/or flow outlets may be more numerous and/or positioned at various positions along the axial length of the implant to increase the likelihood that one or more are appropriately positioned within the retinal vein, with respect to the flow inlets, or within the choroid, with respect to the flow outlets, after implantation.

[0114] FIGS. 27 to 29 illustrate additional embodiments of implants with surface features. More particularly, in various embodiments, the implants may create flow paths adjacent to the body of the implant and/or through the body of the implant, as opposed to through a closed lumen. The implants may include features located at the distal end, such as a lip that disrupts the tissue along the insertion tract. Furthermore, the implants may include features such as ribs that hold open the wound tract so that the tissue does not fully close onto the main body of the implant, thereby maintaining flow paths alongside the main body. These additional flow paths may further provide for anastomotic vessel formation. The implants may further include additional retention features and/or features for preventing bleeding into the vitreous cavity.

[0115] FIG. 30 illustrates an alternative embodiment of a hybrid tube design with surface features. More particularly, in an embodiment, the implant includes a central lumen for primary flow, plus additional surface features along the exterior of the implant to provide additional flow and/or angiogenesis.

[0116] FIG. 31 illustrates an additional embodiment, directed toward vessel redirection. More particularly, in an embodiment, the implant includes a vessel cutting edge 260 configured to puncture, partially transect, or fully transect the retinal vein as implant is inserted through the vein. Beyond mere vein transection, in some embodiments, the implant includes a beveled edge 262 that nudges both transected ends of the retinal vein into the choroid for improved anastomosis formation and hemorrhage prevention. The implant may include a short-term retention feature 264, for retaining the implant into the choroid or other anatomical layer. The implant may further include a long term retention feature 266 such as a fenestration, for tissue through-growth.

[0117] FIG. 32 illustrates an additional embodiment, directed toward a valved implant. More particularly, in an embodiment, the implant includes an elastomeric valve that seals the implant on the proximal end, after the trocar is removed, which prevents bleeding into the vitreous cavity.

[0118] Embodiments have been described in connection with the accompanying drawings. However, it should be understood that the figures are not necessarily drawn to scale. Distances, angles, and other dimensions are merely illustrative and do not necessarily bear an exact relationship to actual dimensions and layout of the devices illustrated. In addition, the foregoing embodiments have been described at a level of detail to allow one of ordinary skill in the art to make and use the devices, systems, and methods described herein. A wide variety of variation is possible. Components, elements, and/or steps can be altered, added, removed, or rearranged. While certain embodiments have been explicitly described, other embodiments will become apparent to those of ordinary skill in the art based on this disclosure. The scope of certain inventions disclosed herein is indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.