Glaucoma Devices

Abstract

Disclosed is a glaucoma device (10, 1010) comprising: an implant body (15, 1015) including an anterior portion (20, 1020), a distal portion (35, 1035), a plurality of arms (40, 1040) extending between the anterior portion (20, 1020) and the distal portion (35, 1035) to provide connection therebetween; and a fluid network extending from the anterior portion (20, 1020) along at least one of the arms (40, 1040) to the distal portion (35, 1035), the fluid network providing a plurality of outlet channels (90, 1090) for fluid exit therefrom; and a fluid inlet cannula (30, 1030) arranged on the anterior portion (20, 1020) of the implant body (15, 1015) and adapted for fluid connection with ocular tissue.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to Australian Provisional Patent Application No. 2022904037, filed December 28, 2022. The entire disclosure of Australian Provisional Patent Application No. 2022904037 is incorporated herein by reference in its entirety for all purposes.

[0002] The present invention relates to glaucoma devices and components thereof, particularly to devices and components thereof for reducing intraocular pressure in the eye. [Background technology]

[0003] Glaucoma is a progressive neurological disorder of the eye, the main risk factor for which is high intraocular pressure (IOP). Untreated glaucoma can lead to inevitable vision loss and is the most common cause of inevitable blindness worldwide.

[0004] Glaucoma is a chronic disease and requires ongoing treatment and management to slow its progression. Existing management strategies for glaucoma rely on reducing the eye's IOP, which may be achieved through topical ointments, lasers, or surgery. Current glaucoma surgical techniques have relatively high mutation and failure rates and are expensive to manage due to high postoperative demands.

[0005] The failure of glaucoma surgery is due to wound healing, and all efforts are focused on anti-scar strategies. Despite this, glaucoma surgery continues to experience complications and failures. Research conducted over many years has demonstrated that fluid flow alone can lead to surgical failure, which is a significant issue since fluid flow is central to the effectiveness of surgery. Summary of the Invention [Problem to be solved by the invention]

[0006] It is an object of the present invention to substantially overcome, or at least ameliorate, one or more disadvantages of existing arrangements, or at least provide a useful alternative to existing arrangements. [Means for solving the problem]

[0007] The front part and a distal portion; a plurality of arms extending between the front and distal portions to provide a connection therebetween; an implant body including a fluid network extending from the front portion along at least one arm to a distal portion, the fluid network providing a plurality of outlet channels for fluid therethrough; Disclosed herein is a glaucoma device including: a fluid inlet cannula disposed on a front portion of the implant body and adapted to be in fluid communication with ocular tissue.

[0008] The fluid network is a fluid inlet channel provided in the front surface; a fluid delivery channel provided in at least one arm for delivering fluid distally; and a distal fluid distribution channel provided in the distal portion and connected to the plurality of outlet channels.

[0009] The fluid network may further include a forward fluid distribution channel in at least one arm for conveying fluid forward of the plurality of outlet channels.

[0010] The fluid network is The device may further include a fluid distribution hub that provides a fluid connection between the fluid delivery channel and the distal fluid distribution channel, with the forward fluid distribution channel extending from the fluid distribution hub.

[0011] The fluid network may extend from a fluid inlet channel provided in the front portion, along each of the fluid delivery channels in the arms, towards a distal fluid distribution channel provided in the distal portion, and back along each of the forward fluid distribution channels in the arms.

[0012] Multiple outlet channels may be provided in each of the distal and forward fluid distribution channels to allow fluid to exit one or more of the arms preferentially to the distal portion.

[0013] The fluid network may provide between about 70 and 220 outlet channels. In one form, the fluid network may provide about 190 outlet channels.

[0014] The fluid network may alternatively provide about 150 to 180 outlet channels, and in one form the fluid network may provide about 163 outlet channels.

[0015] The fluid network may be adapted to provide a resistance to aqueous humor fluid flow of 2.00 to 4.80 mmHg.min / uL (Hagen-Poiseuille flow with a fluid dynamic viscosity of 0.72 mPa.s). In one embodiment, the fluid network may be adapted to provide a resistance to aqueous humor fluid flow of 3.00 to 3.80 mmHg.min / uL. In another embodiment, the fluid network may be adapted to provide a resistance to aqueous humor fluid flow of 2.80 to 3.80 mmHg.min / uL. Resistance may be measured with or without the use of flow modifiers such as luminal stents.

[0016] The entrance cannula is a first end having a first opening adapted to connect with ocular tissue; a second end having a second opening connected to a fluid port in the front portion of the implant body; The device may include a lumen extending between the first and second openings to provide a fluid connection between the first and second ends.

[0017] The inlet cannula may extend at an angle of about 145 degrees relative to the implant body. In another form, the inlet cannula may extend at an angle of about 150 degrees relative to the implant body.

[0018] The inlet cannula may be articulated separately from the implant body.

[0019] The plurality of arms include: The inner arm, a first side arm disposed on a first side of the inner arm and spaced apart to form a first window; and a second side arm arranged on a second side of the inner arm and spaced therefrom to form a second window.

[0020] The distal portion may extend between the first side portion and the second side portion to form a third window between the plurality of arms and the distal portion.

[0021] The implant body may have a length of about 16 to 23 millimeters and a width of about 5 to 8 millimeters.

[0022] The implant body may have a length of about 20 millimeters and a width of about 6.5 millimeters. In another form, the implant body may have a length of about 19.5 millimeters and a width of about 5.5 millimeters.

[0023] The implant body may have a thickness of less than about 0.6 millimeters.

[0024] The implant body may have a thickness of about 0.15 millimeters to 0.6 millimeters. In another form, the implant body may have a thickness of about 0.21 millimeters.

[0025] The implant body may have a thickness that gradually tapers from the anterior portion to the distal portion.

[0026] The implant body may have a thickness of about 0.2 millimeters at the anterior portion and about 0.4 millimeters at the distal portion.

[0027] The implant body may further include at least one suture hole for surgically securing the implant body to ocular tissue.

[0028] At least one suture hole may be provided adjacent the plurality of arms, and a plurality of outlet channels may be provided within the fluid distribution channel surrounding the suture hole to allow fluid to exit therefrom.

[0029] Each arm may have a width of about 1 millimeter and a thickness or depth that gradually tapers to 0.25 to 0.4 millimeters.

[0030] The implant body may be formed from a flexible or resilient polymeric material.

[0031] The implant body may be formed from medical grade polydimethylsiloxane (silicone).

[0032] a front portion adapted to be in fluid communication with ocular tissue; a distal portion; a plurality of arms extending between the front and distal portions to provide a connection therebetween; Further disclosed herein is a glaucoma device including an implant body including a fluid network that provides an internal fluid resistance whereby the fluid network extends from the anterior portion along at least one arm to the distal portion, the fluid network providing a plurality of outlet channels for fluid to exit therefrom.

[0033] The front part and a distal portion; an arm extending between the front and distal portions to provide a connection therebetween; an implant body including a fluid network extending from the anterior portion along the arms to a distal portion, the fluid network providing a plurality of outlet channels for fluid therefrom; Further disclosed herein is a glaucoma device including: an inlet cannula disposed on the anterior portion of the implant body, the inlet cannula adapted to be in fluid communication with ocular tissue.

[0034] Further disclosed herein is an inlet cannula for a glaucoma device, the inlet cannula comprising: a first end having a first opening adapted to connect with ocular tissue; a second end having a second opening adapted to connect with an implant body of a glaucoma device; The cannula has a body including a lumen extending between a first opening and a second opening to provide a fluid connection between the first end and the second end.

[0035] The second end of the cannula body may be wider than the first end of the cannula body.

[0036] The first end may have a bevel or relief to allow the lumen to open anteriorly from the iris tissue.

[0037] The first end may have a radius to facilitate insertion into ocular tissue.

[0038] The lumen may have a diameter of at least 0.08 millimeters.

[0039] The lumen may have a diameter of about 0.127 millimeters.

[0040] The cannula body may have an oval cross section.

[0041] The cannula body may have a length of about 1.60 millimeters. In another form, the cannula body may have a length of about 2.00 millimeters.

[0042] The cannula body may have a width of about 0.59 to 0.75 millimeters. In another form, the cannula body may have a width of about 0.64 to 0.82 millimeters.

[0043] The cannula body may have a thickness or depth of about 0.28 to 0.40 millimeters. In another form, the cannula body may have a thickness or depth of about 0.31 to 0.43 millimeters.

[0044] The cannula body may further include one or more flanges projecting outwardly from the cannula body to enhance the sealing characteristics of the cannula body.

[0045] Each flange may project outward from the cannula body in a direction parallel to the implant body of the glaucoma device and parallel to the corneal tissue.

[0046] Each flange may project outwardly from the cannula body at an angle of approximately 145-155 degrees. In one form, each flange may project outwardly from the cannula body at an angle of approximately 150 degrees.

[0047] Each flange may have a flared configuration.

[0048] Each flange may have a width of about 0.75 millimeters and a depth / thickness of about 0.4 millimeters. In another form, each flange may have a width of about 0.815 millimeters and a depth / thickness of about 0.422 millimeters.

[0049] The flange or flanges may be: a first flange disposed adjacent to and spaced from a surface of the second end of the cannula body; a second flange spaced from the first flange; and a third flange spaced apart from the second flange.

[0050] The first flange may be spaced from the surface of the second end by a distance of about 0.125 millimeters.

[0051] The second flange may be spaced apart from the first flange by a distance of about 0.125 millimeters, and the third flange may be spaced apart from the second flange by a distance of about 0.125 millimeters.

[0052] For a more complete understanding of the present invention, exemplary embodiments thereof will now be described in more detail below with reference to the accompanying drawings, in which like reference characters indicate like parts and in which: [Brief explanation of the drawings]

[0053] [Figure 1] FIG. 1 is a schematic isometric view of a glaucoma device with a fluid inlet cannula according to one embodiment. [Figure 2] FIG. 2 is a schematic side view of the glaucoma device shown in FIG. 1 without the inlet cannula. [Figure 3] 2 is a schematic plan view of the glaucoma device shown in FIG. 1 without the inlet cannula. [Figure 4] FIG. 2 is a schematic bottom view of the glaucoma device shown in FIG. 1 without the inlet cannula. [Figure 5] FIG. 1 is a schematic isometric view of an inlet cannula according to one embodiment. [Figure 6] FIG. 6 is a schematic front view of the inlet cannula shown in FIG. 5. [Figure 7] FIG. 6 is a schematic side view of the inlet cannula shown in FIG. 5. [Figure 8] FIG. 6 is a schematic plan view of the inlet cannula shown in FIG. 5. [Figure 9] FIG. 10 is a schematic isometric view of a glaucoma device with a fluid inlet cannula, according to another embodiment. [Figure 10] FIG. 10 is a schematic side view of the glaucoma device shown in FIG. 9. [Figure 11] FIG. 10 is a schematic plan view of the glaucoma device shown in FIG. 9. [Figure 12] FIG. 10 is a schematic bottom view of the glaucoma device shown in FIG. 9. DETAILED DESCRIPTION OF THE INVENTION

[0054] 1-8 of the accompanying drawings generally depict an embodiment of a glaucoma device 10 and its components adapted for the treatment and management of intraocular pressure (IOP) in the eye. The glaucoma device 10 is adapted to be surgically implanted in the subconjunctival space of the eye to drain and / or distribute aqueous humor.

[0055] The glaucoma device 10 includes an implant body 15 preferably formed from a flexible or resilient biocompatible material. Suitable biocompatible materials may include, but are not limited to, polymeric materials such as silicone or polyurethane. In one form, the material may be medical-grade polydimethylsiloxane (silicone), i.e., PDMS. It is contemplated that the overall dimensions of the implant body 15 may be approximately 10-25 millimeters (mm) in length, less than approximately 10 mm in width, and less than approximately 0.5 mm in thickness / depth. In one form, the implant body may have a length of approximately 16-23 mm, a width of approximately 5-8 mm, and a thickness / depth of less than approximately 0.6 mm. In one preferred form, the implant body 15 has a length of approximately 20 mm, a width of approximately 6.5 mm, and a thickness / depth that tapers to approximately 0.15 mm to 0.6 mm. In a more preferred form, the implant body 15 has a thickness / depth that tapers to approximately 0.2 mm to 0.4 mm. However, it will be appreciated that the dimensions of the implant body 15 are not necessarily limited to the preferred dimensions set forth above, but may be adjusted depending on the design requirements of the glaucoma device 10 .

[0056] The implant body 15 includes a stem or anterior (front) portion 20, which may include a fluid port 25 therein. The fluid port 25 may provide an opening through which the implant body 15 can be fluidly connected to ocular tissue. In one embodiment, as described in more detail below, the glaucoma device 10 may further include or be provided with a fluid inlet cannula 30 to facilitate fluid connection between the implant body 15 and ocular tissue, particularly the anterior chamber of the eye. It should be understood that the implant body 15 is intended to rest against the sclera and between the rectus muscles of the eye.

[0057] In the depicted embodiment, as best shown in FIG. 1 , the anterior surface 20 may be elongated and have a width of approximately 0.5 mm to 2 mm. In one form, the anterior surface 20 may have a length of approximately 2.5 mm, a width of approximately 1.3 mm, and a low-profile thickness / depth that gradually tapers to approximately 0.21 mm to 0.25 mm. As described above with respect to the dimensions of the entire implant body 15, it will be recognized that the dimensions of the anterior surface 20 are not necessarily limited to the preferred dimensions shown above and may be adjusted depending on the design requirements of the glaucoma device 10. The placement of the anterior surface 20 may at least enable surgical handling, whereby the flat or low-profile surface (which may include a smooth edge) may be able to compress ocular tissue and form a fluid seal (possibly with the aid of surgical sutures, as described in more detail below). The low-profile, smooth edge and gradually tapered thickness / depth of the anterior surface 20 may also at least reduce the risk of erosion through tissue.

[0058] The implant body 15 further includes a distal portion 35 and may further include a plurality of arms 40 extending between the anterior portion 20 and the distal portion 35. In the depicted embodiment, the implant body 15 includes three elongated arms: an inner (central) arm 40a, a first side (circumferential) arm 40b, and a second side (circumferential) arm 40c. The inner arm 40a extends along a central longitudinal axis of the implant body 15. The first side arm 40b is arranged on a first side of the inner arm 40a and is spaced therefrom by a first opening or window 42. A mirror image of the first side arm 40b is the second side arm 40c, which is arranged on a second side of the inner arm 40a and is spaced therefrom by a second opening or window 44. In one form, each of the arms 40 may have a width of 1 mm and a thickness / depth that gradually tapers from 0.25 mm to 0.4 mm. The number of arms 40 provided may be adjusted depending on the design requirements of the glaucoma device 10. In one particular embodiment (not shown), the implant body 15 may be provided with a single arm 40 extending between the anterior portion 20 and the distal portion 35. However, it should be understood that as the number of arms 40 increases, the number of outlet channels (described in detail below) may also increase to reduce the rate of fluid outflow, which in turn provides a gentler fluid perfusion to protect tissue.

[0059] As will be appreciated in the depicted embodiment, arms 40a, 40b, and 40c diverge symmetrically from anterior portion 20, thus increasing the effective surface area of ​​implant body 15 and potentially expanding fluid exit locations, as described in further detail below. As discussed above, implant body 15 may have a thickness / depth that gradually tapers from approximately 0.2 mm (anterior portion) to approximately 0.4 mm (distal portion). This arrangement may aid in at least ease of implantation (rigidity) and may also increase the surface area of ​​implant body 15. However, it will be appreciated that implant body 15 need not necessarily include a tapered thickness / depth, but may instead have a constant thickness / depth depending on the design requirements of device 10.

[0060] The distal portion 35 preferably has a smooth or radiused shape provided by an arcuate member 50, which may surround a third opening or window 52. In embodiments whereby the implant body 15 has three arms 40, as depicted in the figures, the arcuate member 50 extends between or loops around the first and second side arms 40b and 40c. Thus, a third window 52 may be provided between the arcuate member 50 and the arms 40. The arcuate member 50 of the distal portion 35 may have a width of approximately 5.5 mm. It is contemplated that the distal portion 35 is at least 20% narrower than the width of the entire implant body 15 (which, as indicated above, may be approximately 6.5 mm). This arrangement may at least aid in the ease of implantation of the implant body 15.

[0061] A bridge portion 55 may be arranged between the arcuate member 50 and the arms 40 of the distal portion 35 to surround the third window 52. In the depicted embodiment, the bridge portion 55 also connects the arms 40a, 40b, and 40c. It will be appreciated that this arrangement of the distal portion 35 may at least increase the surface area and effective surface area of ​​the implant body 15.

[0062] It will also be appreciated that the top edges of each portion of the implant body 15 (i.e., the anterior portion 20, the distal portion 35, and the arm portions 40) are preferably smooth or rounded to reduce the risk of eroding adjacent tissue. In one form, the top edges / corners may have a radius of at least 0.4 mm. It is also contemplated that the top surface area of ​​the implant body 15 may be less than the footprint (i.e., the area created by the footprint around the implant body 15). In one form, the top surface area of ​​the implant body is less than 60% of the footprint of the implant body 15. In this regard, the footprint of the implant body 15 should preferably be at least 100 mm 2 It is thought that this is the case.

[0063] The implant body 15 may further include one or more suture apertures or holes 60 for surgically securing the implant body 15 to ocular tissue. In the depicted embodiment, the implant body 15 includes two suture holes 60 arranged between the arms 40 and the anterior portion 20. The suture holes 60 may at least provide an area for securing the implant body with sutures, such as 10-0 nylon sutures. In the depicted embodiment, the suture holes 60 may have a triangular shape, although it will be appreciated that the shape and configuration of the suture holes 60 are not necessarily limited to the depicted shape and configuration and may be adjusted depending on the design requirements of the glaucoma device 10. In other embodiments (not shown), the implant body 15 may not include suture apertures or holes.

[0064] The implant body 15 further includes a fluid network extending from the anterior portion 20 along at least one arm 40 to the distal portion 35. In the depicted embodiment, as best shown in FIGS. 1 and 3 , the fluid network begins at a fluid port 25 in the anterior portion 20 where fluid from the ocular tissue may enter the implant body 15, branches off in a first direction along each arm 40 toward the bridge portion 55, forms a loop around the distal portion 35, and then returns in a second direction (opposite the first direction) along each arm 40. It will be appreciated that the fluid network may at least provide the implant body 15 with internal microfluidic resistance channels to manage tissue response.

[0065] The fluid network may include a fluid inlet channel 70 provided in the anterior portion 20, a fluid delivery channel 72 provided in at least one arm 40, and a distal fluid distribution channel 74 provided in the distal portion 35. The fluid delivery channel 72 may have a width of approximately 0.051 mm, and the fluid distribution channel 74 may have a width of approximately 0.035 mm. The fluid network may also include one or more forward fluid distribution channels 75 provided in one or more arms 40. Thus, in embodiments in which the implant body 15 has three arms 40 as depicted in the figures, each of the arms 40a, 40b, and 40c includes a fluid delivery channel 72 and at least one forward fluid distribution channel 75. It will be appreciated that the one or more fluid delivery channels 72, distal fluid distribution channel 74, and forward fluid distribution channel 75 may carry fluid to at least various portions of the implant body 15 and distribute the fluid to various perfusion outlet channels, as described in more detail below. Each channel 70, 72, 74, and 75 may have an internal dimension greater than 0.01 mm in width.

[0066] The fluid network may further include a fluid distribution hub 80 positioned on the bridge portion 55, which provides fluid connections between each fluid delivery channel 72 and the distal fluid distribution channel 74 of the arm 40. As best shown in FIGS. 1 and 3 , fluid from the ocular tissue may travel along the fluid inlet channel 70, along each fluid delivery channel 72, along the distal fluid distribution channel 74, and along the fluid distribution hub 80. The fluid may also loop back up the arm 40 via the forward fluid distribution channel 75. In the illustrated embodiment, four forward fluid distribution channels 75 are provided. A first forward fluid distribution channel 75 extends from the fluid distribution hub 80 along the length of the side arm 40b. Similarly, a second forward fluid distribution channel 75 extends from the fluid distribution hub 80 along the length of the side arm 40c. A third forward fluid distribution channel 75 is provided as a loop extending from the fluid distribution hub 80 between the side arm 40b and the inner arm 40a (surrounding the window 42). Similarly, a fourth additional fluid distribution channel 75 is provided as a loop extending from the fluid distribution hub 80 between the side arm 40c and the inner arm 40a (surrounding the window 44).

[0067] Thus, in the depicted embodiment, the fluid network extends from the fluid inlet channel 70 provided in the anterior portion 20, along each fluid delivery channel 72 in the arms 40, to the fluid distribution channel 74 provided in the distal portion 35, to the fluid distribution hub 80, and to the forward fluid distribution channel 75 provided in the arms 40. The fluid network may have an overall length of greater than about 50 mm and an overall height of 0.035 to 0.040 mm. In one form, the fluid network has an overall length of about 200 mm, and in a preferred form, the fluid network has an overall length of about 194 mm. However, it will be recognized that the length of the fluid network is not necessarily limited to the preferred lengths shown above and may be adjusted depending on the design requirements of the glaucoma device 10.

[0068] The fluid network may provide multiple outlet channels 90 for fluid to exit therefrom (i.e., to the subconjunctival space) via perfusion. For clarity, not all of the outlet channels 90 are labeled with reference numerals in the figures. In the depicted embodiment, the outlet channels 90 provide one or more fluid distribution hubs 80, distal fluid distribution channels 74 in the distal portion 35, and forward fluid distribution channels 75 in the arms 40. It will be appreciated that each outlet channel 90 may extend transversely to the extension of the respective hub 80 or channels 74, 75. In some embodiments (not shown), outlet channels may be provided in one or more fluid delivery channels 72 or any other portion of the implant body 15. Thus, the outlet channels 90 may be able to exit fluid from one or more arms 40, bridge portion 55, and / or distal portion 35 of the implant body 15.

[0069] It is contemplated that the fluid network may include more than 20 outlet channels 90. In one embodiment, the fluid network includes 70-220 outlet channels 90. In another embodiment, the fluid network includes 150-180 outlet channels 90, and in a preferred embodiment, the fluid network includes 160-170 outlet channels 90. In a more preferred embodiment, the fluid network includes 163 outlet channels 90. However, it will be appreciated that the number of outlet channels 90 provided is not necessarily limited to the preferred amount set forth above and may be adjusted depending on the design requirements of the glaucoma device 10. The outlet channels 90 may be spaced apart by up to 2 mm. In one embodiment, the outlet channels 90 are spaced apart by 0.30-0.80 mm. The outlet channels 90 may each have a width of approximately 0.035 mm.

[0070] The placement and relative sizes of the outlet channel 90 and fluid distribution channels 74, 75 are believed to at least reduce hydraulic stress on the local ocular tissue. It should be appreciated that a greater local supply (or "pressure presentation") of aqueous humor may reduce the absorptive capacity of the tissue / capsule that forms around the implant. Thus, it will be appreciated that the overall placement of the outlet channel 90 and fluid network may at least promote preferential fluid distribution distally, away from the point of entry to the ocular tissue, before expelling from the implant body 15. This is particularly because, in one embodiment, the fluid distribution hub 80 is positioned distally along the implant body 15 (the hub 80 is where the fluid delivery channel 72 directs flow), and additionally or alternatively due to the placement and relative sizes of the outlet channel 90 and fluid distribution channels 74, 75. Thus, more fluid may exit the implant body 15 distally than anteriorly, and this particular flow distribution configuration may at least match, in distance, the relative capacity of the ocular tissue to absorb fluid (aqueous humor). This particular flow distribution structure may also ensure that fluid is not distributed adjacent the anatomic limbus (i.e., near the entry point of the implant body 15, which is fluid port 25 on the anterior portion 20). It is understood that this region has good absorption capacity but a higher rate of complications. In preferred embodiments, it is believed that this particular flow distribution structure may ensure that fluid is not distributed within approximately 3 mm of the anatomic limbus, and that only a small portion of the fluid draining from the eye is directed to tissues anterior to the Tenon's insertion (anatomical). It will be appreciated that in embodiments, most of the fluid draining from the eye is directed to tissues approximately 6 mm to 21 mm from the anatomic limbus, preferably approximately 12 mm from the anatomic limbus.

[0071] The fluid network configuration may provide a microfluidic resistance to aqueous humor fluid flow of 2.00 to 4.80 mmHg.min / uL so that fluid flow from the implant body 15 can be optimized. In one embodiment, the microfluidic resistance is 3.80 to 4.00 mmHg.min / uL. In another embodiment, the microfluidic resistance is 2.80 to 3.80 mmHg.min / uL. In a preferred embodiment, the microfluidic resistance is approximately 3.40 mmHg.min / uL. It should be understood that too little fluid flow may not effectively treat glaucoma, while too much fluid flow may result in low intraocular pressure, characterized as an unhealthy IOP reduction. Microfluidic resistance may be calculated, for example, using the Hagen-Poiseuille equation (or a derivative thereof) for a fluid with a kinematic viscosity of 0.72 mPa.s. Resistance may also be measured with or without the use of fluid modifications, such as endoluminal stents.

[0072] Returning to the fluid inlet cannula 30 of the glaucoma device 10, as best shown in FIGS. 5-8 , the inlet cannula 30 may include a cannula body 100 having a first end 105, a second end 110, and an internal lumen 115. The cannula body 100 is preferably formed from a flexible or resilient biocompatible material. Suitable biocompatible materials may include, but are not limited to, polymeric materials such as silicone or polyurethane. In one form, the material may be medical-grade polydimethylsiloxane (silicone), or PDMS. In a preferred form, the inlet cannula 30 is articulated separately from the implant body 15. In embodiments (not shown), the inlet cannula 30 may be integrally formed with the implant body 15. In certain embodiments, the inlet cannula 30 may be provided as a separate device for various other uses, such as a diagnostic device or other device for drug delivery. As a result, it will be appreciated that the inlet cannula 30 may not necessarily be limited to applications involving glaucoma devices, but may include alternative or additional features customized for other applications.

[0073] In one example of a diagnostic device application, the inlet cannula 30 may be used during ophthalmic surgery to characterize the condition of the ocular tissues of a patient with elevated IOP and / or glaucoma as an aid in diagnosis. The inlet cannula 30 may also be used to stabilize the IOP at a safe level (and prevent hypotony) in a patient undergoing ophthalmic surgery.

[0074] In application of such a diagnostic device, it is believed that the inlet cannula 30 may assist ophthalmic surgeons in understanding the drainage capacity and permeability of the trabecular meshwork of the eye to predict the effective ocular porosity (EOP) outflow function of the tissue.

[0075] In another example of a drug delivery application, the inlet cannula 30 may be connected to a drug delivery reservoir device that can slowly release a drug, substance, or gene therapy vector, for example, into the intended tissue at the surgical site. The surgical site may include tissue within the eye or alternatively, tissue outside the eye. The ocular tissue may include the subretinal space, the vitreous cavity, or the anterior chamber.

[0076] In embodiments whereby the inlet cannula 30 is used with a glaucoma device, the first end 105 of the inlet cannula 30 may have a first opening 120 adapted for connection with or insertion into ocular tissue, particularly the anterior chamber of the eye. The second end 110 may have a second opening 125 that may be adapted for connection with the fluid port 25 in the anterior portion 20 of the implant body 15. In one form, the second portion 110 (the inlet cannula “base”) may be wider than the first end 105 to enable the second end 110 to be strongly connected or adhered to the anterior portion 20 of the implant body 15. Additionally, this arrangement may enable the cannula body 100 to have a tapered longitudinal profile (i.e., smaller at the first end 105 and larger at the second end 110) distal to the implant body 15 to facilitate implantation or insertion into ocular tissue.

[0077] Lumen 115 extends between first opening 120 and second opening 125 to provide a fluid connection between first end 105 and second end 110. As described in more detail below, it is contemplated that lumen 115 may be open anteriorly and angled away from the iris to reduce the likelihood of lumen 115 becoming blocked due to iris closure. In use, fluid from the ocular tissue may enter inlet cannula 30 via first opening 120, flow through lumen 115 to second opening 125, and then enter fluid port 25 in front portion 20 of implant body 15 to be dispersed therefrom.

[0078] In one form, the lumen 115 may have a diameter of at least 0.080 mm (80 microns), and in a preferred form, the lumen 115 has a diameter of about 0.127 mm (127 microns). It will be appreciated that the diameter of the lumen 115 may be large enough so that there is a low chance of it becoming blocked by debris (e.g., debris present after surgery, or particles or cells present in normal aqueous humor). However, it will be appreciated that the dimensions of the lumen 115 are not necessarily limited to the preferred dimensions set forth above, and may be adjusted depending on the design requirements of the glaucoma device 10.

[0079] In the depicted embodiment, as best shown in FIG. 5 , the first end 105 may include a beveled or angled (removed) portion 130 and a radiused portion 135 to facilitate insertion into ocular tissue. As discussed above, the beveled or angled (removed) portion 130 may at least reduce the likelihood of occlusion of the lumen 115 due to iris occlusion. In a preferred form, the first end 105 may have a diameter of less than 0.5 mm and may be positioned so as not to protrude more than 1 mm into the anterior chamber of the eye. In one form, the radiused portion 135 may have a diameter of approximately 0.295 mm. In another form, the radiused portion 135 may have a diameter of approximately 0.200 mm. In a preferred form, the radiused portion 135 may have a diameter of approximately 0.206 mm. It will also be appreciated that the dimensions of the first end 105 are not necessarily limited to the preferred dimensions shown above and may be adjusted depending on the design requirements of the glaucoma device 10.

[0080] It will be appreciated that the overall shape and scale / dimensions of cannula body 100 may conform to the trajectory of a single or multiple bevel needles, such as a 27-gauge needle, to optimize insertion into ocular tissue. Additionally, as best shown in FIGS. 6 and 8 , cannula body 100 may have an elliptical cross-section to promote a fluid seal with the entry hole in ocular tissue. The two widest points of the elliptical cross-section may also have a sharp or pointed configuration. It is believed that the elliptical cross-section of cannula body 100 generally conforms to the cross-section of the trajectory or passage created by a single or multiple bevel needles through ocular tissue. The cross-section of cannula body 100 may be more circular distally (i.e., toward first end 105) to help facilitate implantation.

[0081] In use, the entrance cannula 30 may enter the ocular tissue at an angle of approximately 145 degrees anteriorly (relative to the implant body 15) to conform to the ocular anatomy, reducing the risk of blockage and improving ease of implantation. The overall length of the cannula body 100 may be approximately 1.50 mm to 2.50 mm to penetrate the cornea. In one form, the cannula body 100 may have an overall length of approximately 1.60 mm. In another form, the cannula body 100 may have an overall length of approximately 2.00 mm. The cannula body 100 may also have a width of approximately 0.55 mm to 0.85 mm and a thickness / depth of approximately 0.25 mm to 0.45 mm. In one form, the cannula body 100 may have a width of approximately 0.59 mm to 0.75 mm and a thickness / depth of approximately 0.28 mm to 0.40 mm. In another form, the cannula body 100 may have a width of about 0.64 mm to 0.82 mm and a thickness / depth of about 0.31 mm to 0.43 mm. It will also be recognized that the dimensions of the cannula body 100 are not necessarily limited to the preferred dimensions set forth above, but may be adjusted depending on the design requirements of the glaucoma device 10.

[0082] The inlet cannula 30 may include one or more ridges or flanges projecting outward from the cannula body 100 to facilitate fixation / positioning of the inlet cannula 30 in the ocular tissue and to reduce or prevent leakage of aqueous humor. Each flange may be positioned parallel to the scleral tissue layer and, in use, parallel to the implant body 15. Each flange may also have a flared configuration or may have a constant cross-section along the length of the cannula body 100. Each flange may project outward from the cannula body 100 in a direction transverse to the central longitudinal axis 118 of the lumen 115, or alternatively, in a direction generally transverse to the direction of extension of the cannula body 100. Each flange may also have a sharp edge or may be raked back to seal fluid and secure the inlet cannula 30 within the surrounding ocular tissue layer. The placement of one or more flanges, as described above, may at least prevent or reduce extraneous lumen fluid flow between the outside of the inlet cannula 30 and the ocular tissue, and may reduce or prevent total aqueous humor leakage. Thus, in this placement, implantation of the glaucoma device 10 may be less likely to result in post-operative IOP reduction.

[0083] As best shown in particular in FIGS. 5-7, the cannula body 100 may include a first or base flange 140, a second or middle flange 145, and a third or end flange 150. Referring to FIG. 7, each flange may project at an angle A relative to the central longitudinal axis 118 of the lumen 115. The angle A may be approximately 145-155 degrees. In one configuration, the angle A may be approximately 145 degrees. In another configuration, the angle A may be approximately 150 degrees. It will be appreciated that in this arrangement, a slightly flatter angle of incidence may at least enable the tip of the implant body 15 to be positioned further away from the limbus. The first or base flange 140 may have a distance B from the surface 155 of the second end 110. The second or middle flange 145 may have a distance C to the first or base flange 140. The third or end flange 150 may have a distance D to the second or middle flange 145. In one form, each distance B, C, and D may be 0.125 mm. In one form, each flange may also have a width of about 0.75 mm and a depth / thickness of about 0.4 mm. In another form, each flange may have a width of about 0.815 mm and a depth / thickness of about 0.422 mm. It will also be recognized that the dimensions of the flanges are not necessarily limited to the preferred dimensions set forth above, but may be adjusted depending on the design requirements of the glaucoma device 10.

[0084] 9-12 of the accompanying drawings, a further embodiment of a glaucoma device 1010 and its components is schematically depicted. It will be appreciated that the glaucoma device 1010 functions in generally the same manner as the glaucoma device 10 described above, and like reference numerals will be used to indicate like features. For clarity, descriptions of like features of this embodiment will not be repeated, and it will be understood that one or more like features or functions of the glaucoma device 10 embodiment described above are applicable to the glaucoma device 1010 embodiment.

[0085] In this embodiment of the glaucoma device 1010, the implant body 1015 may have an overall length of about 19.5 mm, an overall width of about 5.5 mm, and an overall thickness / depth of about 0.21 mm. It should be appreciated that an implant body with a lower profile and width may at least reduce the risk of erosion of the tissue around the implant. In this embodiment, the thickness / depth may be constant.

[0086] In the depicted embodiment, the stem or anterior (front) portion 1020 may have a length of approximately 2.50 mm, a width of approximately 1.00 mm, and a low profile thickness / depth of approximately 0.21 mm. It should be understood that this area of ​​height of the implant body may be part of a mitigation strategy to reduce the risk of tissue erosion where the implant is most exposed to the overlying tissue. It should also be recognized that reducing the profile may increase patient comfort. As indicated above, the overall width of the implant body 1015 may be approximately 5.5 mm. The implant body 1015 may have a shoulder 1022 (see FIG. 11 ), which may be defined as the distance between the straight portions of the lateral arms 1040 b, 1040 c and the free end of the anterior portion 1020. This shoulder 1022 may have a length of approximately 8.00 mm. It should be understood that this arrangement may at least reduce the risk of interfering with the rectus muscles adjacent to the implant.

[0087] In the depicted embodiment, the implant body 1015 includes a single suture aperture or hole 1060. It should be understood that this arrangement may at least allow for a reduction in the overall width of the implant body 1015 (reducing the shoulder 1022), while maintaining an accessible suture hole. It should also be understood that this arrangement may at least allow for improved manufacturability. In the depicted embodiment, the suture hole 1060 has a circular shape, but it will be recognized that the shape and configuration of the suture hole 1060 is not necessarily limited to the shape and configuration shown, and may be adjusted depending on the design requirements of the glaucoma device 1010.

[0088] In the embodiment of the implant body 15 described above, the fluid network of the implant body 1015 may include a fluid network extending from the front portion 1020 along at least one arm 1040 to the distal portion 1035. In this embodiment, the fluid network includes a fluid inlet channel 1070 provided in the front portion 1020, a fluid delivery channel 1072 provided in each of the side arms 1040b, 1040c, and a distal fluid distribution channel 1074 provided in the distal portion 1035. As a result, in this embodiment, the inner arm 1040a of the implant body 1015 does not include a fluid delivery channel. Each of the fluid delivery channels 1072 provided in the side arms 1040b, 1040c may have a width of approximately 0.068 mm. The fluid inlet channel 1070 may have a width of approximately 0.120 mm, and the fluid distribution channel 1074 may have a width of approximately 0.050 mm. The fluid network may also include a forward fluid distribution channel 1075 provided in each of the side arms 1040b, 1040c. The fluid network may have a total channel height of approximately 0.039 mm. As best shown in FIG. 11 , fluid from the ocular tissue may travel along the fluid inlet channel 1070, along each of the fluid delivery channels 1072, along the distal fluid distribution channel 1074, and along the fluid distribution hub 1080. The fluid may loop back up the arms 1040 via the forward fluid distribution channel 1075.

[0089] In this embodiment of the implant body 1015, the fluid network includes 160-170 outlet channels 1090. In a preferred form, the fluid network includes 163 outlet channels 1090. The outlet channels 1090 may each have a width of approximately 0.030 mm. In this embodiment, the suture holes 1060 also provide multiple outlet channels 1090 connected to fluid distribution channels 1075 surrounding the suture holes 1060. The fluid network configuration is also believed to provide a microfluidic resistance to aqueous humor fluid flow of 2.80-3.80 mmHg.min / uL, preferably 3.20-3.40 mmHg.min / uL, to optimize post-operative intraocular pressure. It will also be appreciated that this fluid network configuration may provide an appropriate resistivity between the outlet channels 1090 and the distribution channels 1074 and 1075, thereby allowing for more uniform distribution of aqueous humor and increasing the effective surface area of ​​the implant for fluid outflow.

[0090] The various configurations of the glaucoma devices described above may have one or more of the following advantages: The implant body is designed to provide specifically optimal resistance to aqueous humor fluid flow through the placement of fluid channels in the fluid network; The size of the irrigation outlet channel and the preferred distribution of fluid flow, as a function of the size, may at least reduce stress on the local tissue; The inlet cannula design may provide a sealed entrance to the ocular tissue, which may also reduce the risk of hypotony, balanced against ease of implantation; The glaucoma device is also designed to be sterile, easy for the surgeon to use, and not easily migrate after implantation; The overall placement of the implant body and inlet cannula may therefore rapidly reduce IOP within a target range to treat glaucoma, and may also improve long-term treatment results by at least reducing the severity of, and maintaining, tissue response.

[0091] It will be further recognized that various design features of the entrance cannula may reduce the likelihood of intraocular inflammation or damage to the corneal endothelium of the eye. Such design features include, for example, a small entrance cannula size to remain in place within the anterior chamber, an incision insertion technique, angling away from the cornea and iris, multiple flanges to reduce entry cannula movement within the tissue, and cross-sectional shapes and flanges that act to reduce fluid leakage outside the entrance cannula. Such advantageous design features also include a tapered profile of the cannula body, an opening extending toward the center, and flanges around the outer opening.

[0092] While specific embodiments of the present invention have been illustrated and described herein, those skilled in the art will recognize that various alternative and / or equivalent implementations exist. It should be recognized that the exemplary embodiment or embodiments are merely examples and are not intended to be limiting in any way in scope, applicability, or configuration. Rather, the foregoing Summary of the Invention and Detailed Description will provide those skilled in the art with a convenient road map for implementing at least one exemplary embodiment, and it will be understood that various changes can be made in the function and arrangement of elements described in an exemplary embodiment without departing from the scope as set forth in the appended claims and their legal equivalents. In general, this application is intended to cover any adaptations or variations of the specific embodiments discussed herein.

[0093] It will also be recognized that, as used herein, the terms "comprise," "comprising," "include," "including," "contain," "containing," "have," "having," and any variations thereof, are intended to be understood in an inclusive (i.e., non-exclusive) sense, such that the processes, methods, devices, apparatuses, or systems described herein are not limited to the enumerated features or components or elements or steps, but may include other elements, features, components, or steps not expressly listed or inherent to such processes, methods, articles, or apparatuses. Furthermore, as used herein, the terms "a" and "an" are intended to be understood to mean one or more, unless expressly stated otherwise. Moreover, the terms "first," "second," etc. are used as designators only and are not intended to impose numerical requirements on their objects or to establish a particular order of importance. [Explanation of symbols]

[0094] 10 Glaucoma Devices 15 Implant body 20 Front part 25 fluid ports 30 Inlet Cannula 35 distal 40 Arm 40a Inner arm 40b First side arm 40c Second Side Arm 42 First Window 44 Second Window 50 Arcuate Member 52 The Third Window 55 Hashibe 60 suture holes 70 fluid inlet channels 72 fluid delivery channels 74 distal fluid distribution channel 75 forward fluid distribution channel 80 Fluid Distribution Hub 90 Exit Channel 100 Cannula body 105 first end 110 second end 115 Lumen 118 central longitudinal axis 120 First opening 125 Second Opening 130 Inclined or angled section 135 R Section 140 First or base flange 145 Second or intermediate flange 150 Third or End Flange 1010 Glaucoma Device 1015 Implant body 1020 Front part 1022 Shoulder 1035 Distal part 1040 Arm 1040a Inner arm 1040b First Side Arm 1040c Second Side Arm 1042 First Window 1044 Second Window 1050 Arc-shaped member 1052 Third Window 1055 Hashibe 1060 suture hole 1070 Fluid Inlet Channel 1072 Fluid Delivery Channel 1074 Distal Fluid Distribution Channel 1075 forward fluid distribution channel 1080 Fluid Distribution Hub 1090 Exit Channel

Claims

1. The front part and a distal portion; a plurality of arms extending between the front and distal portions to provide a connection therebetween; an implant body including a fluid network extending from the front portion along at least one of the arms to the distal portion, the fluid network providing a plurality of outlet channels for fluid therefrom; a fluid inlet cannula disposed on the anterior portion of the implant body and adapted to be in fluid communication with ocular tissue.

2. The fluid network comprises: a fluid inlet channel provided in the front surface; a fluid delivery channel provided in at least one of said arms for delivering fluid distally; The glaucoma device of claim 1 , further comprising a distal fluid distribution channel provided in the distal portion and connected to the plurality of outlet channels.

3. The glaucoma device of claim 2 , wherein the fluid network further comprises a forward fluid distribution channel in at least one of the arms for conveying fluid forward of the plurality of outlet channels.

4. The fluid network comprises: The glaucoma device of claim 3 , further comprising a fluid distribution hub providing a fluid connection between the fluid delivery channel and the distal fluid distribution channel, the anterior fluid distribution channel extending from the fluid distribution hub.

5. 5. The glaucoma device of claim 3, wherein the fluid network extends from the fluid inlet channel provided in the anterior portion, along each of the fluid transport channels in the arms, toward the distal fluid distribution channel provided in the distal portion, and back along each of the anterior fluid distribution channels in the arms.

6. 6. The glaucoma device of claim 5, wherein the plurality of outlet channels are provided in each of the distal and anterior fluid distribution channels to allow fluid to exit from one or more of the arms preferentially to the distal portion.

7. The glaucoma device of any one of claims 1 to 6, wherein the fluid network provides between about 70 and 220 of the outlet channels.

8. The glaucoma device of any one of claims 1 to 7, wherein the fluid network provides between about 150 and 180 of the outlet channels.

9. The glaucoma device of any one of claims 1 to 8, wherein the fluid network provides approximately 163 of the outlet channels.

10. 10. The glaucoma device of any one of claims 1 to 9, wherein the fluid network is adapted to provide a resistance to aqueous humor fluid flow of 2.00 to 4.80 mmHg.min / uL (Hagen-Poiseuille flow with a fluid dynamic viscosity of 0.72 mPa.s).

11. 11. The glaucoma device of claim 10, wherein the fluid network is adapted to provide a resistance to aqueous humor fluid flow of 2.80 to 3.80 mmHg.min / uL.

12. 12. The glaucoma device of claim 10 or 11, wherein the resistance is measured with or without the use of flow modification such as a luminal stent.

13. The inlet cannula comprises: a first end having a first opening adapted to connect with the ocular tissue; a second end having a second opening connected to a fluid port in the front portion of the implant body; 13. The glaucoma device of claim 1, comprising an internal cavity extending between the first opening and the second opening to provide a fluid connection between the first end and the second end.

14. The glaucoma device of any one of claims 1 to 13, wherein the inlet cannula extends at an angle of about 150 degrees relative to the implant body.

15. The glaucoma device of any one of claims 1 to 14, wherein the inlet cannula is articulated separately from the implant body.

16. The plurality of arms include: The inner arm, a first side arm disposed on a first side of the inner arm and spaced apart to form a first window; a second side arm arranged on a second side of the inner arm and spaced apart to form a second window.

17. 17. The glaucoma device of claim 16, wherein the distal portion extends between the first side portion and the second side portion to form a third window between the plurality of arms and the distal portion.

18. The glaucoma device of any one of claims 1 to 17, wherein the implant body has a length of about 16 to 23 millimeters and a width of about 5 to 8 millimeters.

19. 20. The glaucoma device of claim 18, wherein the implant body has a length of about 19.5 millimeters and a width of about 5.5 millimeters.

20. The glaucoma device of any one of claims 1 to 19, wherein the implant body has a thickness of less than about 0.6 millimeters.

21. 21. The glaucoma device of claim 20, wherein the implant body has a thickness of about 0.21 millimeters.

22. The glaucoma device of any one of claims 1 to 21, wherein the implant body further comprises at least one suture hole for surgically securing the implant body to the ocular tissue.

23. 23. The glaucoma device of claim 22, wherein the at least one suture hole is provided adjacent the plurality of arms, and the plurality of outlet channels are provided in a fluid distribution channel surrounding the suture hole to allow fluid to exit therefrom.

24. The glaucoma device of any one of claims 1 to 23, wherein each of the arms has a width of about 1 millimeter.

25. The glaucoma device of any one of claims 1 to 24, wherein the implant body is formed from a flexible or elastic polymeric material.

26. 26. The glaucoma device of claim 25, wherein the implant body is formed from medical grade polydimethylsiloxane (silicone).

27. a front portion adapted to be in fluid communication with ocular tissue; a distal portion; a plurality of arms extending between the front and distal portions to provide a connection therebetween; a fluid network that provides an internal fluid resistance whereby the fluid network extends from the anterior portion along at least one of the arms to the distal portion, the fluid network providing a plurality of outlet channels for fluid to exit therefrom.

28. 1. An inlet cannula for a glaucoma device, comprising: a first end having a first opening adapted to connect with ocular tissue; a second end having a second opening adapted to connect with an implant body of a glaucoma device; An inlet cannula having a cannula body including a lumen extending between the first opening and the second opening to provide a fluid connection between the first end and the second end.

29. 30. The inlet cannula of claim 28, wherein the second end of the cannula body is wider than the first end of the cannula body.

30. 30. The inlet cannula of claim 28 or 29, wherein the first end has a bevel or relief for opening the lumen anteriorly from the iris tissue.

31. 31. An inlet cannula according to any one of claims 28 to 30, wherein the first end has a radius for easier insertion into the ocular tissue.

32. An inlet cannula according to any one of claims 28 to 31, wherein the lumen has a diameter of at least 0.08 millimeters.

33. 33. The inlet cannula of claim 32, wherein the lumen has a diameter of about 0.127 millimeters.

34. An inlet cannula according to any one of claims 28 to 33, wherein the cannula body has an oval cross section.

35. The inlet cannula of any one of claims 28 to 34, wherein the cannula body has a length of about 2.00 millimeters.

36. The inlet cannula of any one of claims 28 to 35, wherein the cannula body has a width of about 0.64 to 0.82 millimeters.

37. 37. The inlet cannula of any one of claims 28 to 36, wherein the cannula body has a thickness or depth of about 0.31 to 0.43 millimeters.

38. An inlet cannula according to any one of claims 28 to 37, wherein the cannula body further comprises one or more flanges projecting outwardly from the cannula body to enhance the sealing characteristics of the cannula body.

39. 39. The inlet cannula of claim 38, wherein each flange projects outwardly from the cannula body in a direction parallel to the implant body of the glaucoma device and parallel to the corneal tissue.

40. 40. The inlet cannula of claim 39, wherein each flange projects outwardly from the cannula body at an angle of approximately 145-155 degrees.

41. 41. The inlet cannula of claim 40, wherein each flange projects outwardly from the cannula body at an angle of approximately 150 degrees.

42. An inlet cannula according to any one of claims 38 to 41, wherein each flange has a flared configuration.

43. An inlet cannula according to any one of claims 38 to 42, wherein each flange has a width of about 0.815 mm and a depth / thickness of about 0.422 mm.

44. The one or more flanges are: a first flange disposed adjacent to and spaced from a surface of the second end of the cannula body; a second flange spaced from the first flange; An inlet cannula according to any one of claims 38 to 43, comprising a third flange spaced from the second flange.

45. 45. The inlet cannula of claim 44, wherein said first flange is spaced from said surface of said second end by a distance of about 0.125 millimeters.

46. 46. ​​The inlet cannula of claim 45, wherein the second flange is spaced a distance of about 0.125 millimeters from the first end and the third flange is spaced a distance of about 0.125 millimeters from the second flange.

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