Implantable ocular drainage device for controlling intraocular pressure - Patent Application 20070122999

Abstract

The implantable ocular drainage device is configured to control intraocular pressure in an eye, the implantable ocular drainage device comprising a wall endlessly enclosing a reservoir, the wall defining a reservoir volume, the device further comprising at least one fluid inlet, at least one fluid outlet for filling the reservoir with fluid, and at least one fluid flow path providing fluid communication between the at least one fluid inlet and the at least one fluid outlet.

Description

[Technical Field]

[0001] The present invention relates to an implantable ocular drainage device for controlling intraocular pressure. [Background technology]

[0002] Glaucoma is an eye disease and a leading cause of unpreventable / irreversible blindness worldwide. Elevated intraocular pressure (IOP) is a major risk factor for glaucoma and is thought to be related to an imbalance between aqueous humor production and drainage due to an abnormally increased resistance to aqueous humor outflow. Next to drug therapy, which is often ineffective and causes severe side effects, surgical implants are available to lower IOP by providing an alternative route for the effective drainage of fluid, i.e., aqueous humor. Current glaucoma implants, such as long-tube glaucoma drainage devices, have a relatively high failure rate. Furthermore, implanting long-tube glaucoma drainage devices is difficult, time-consuming, and can only be performed by highly specialized surgeons. Over time, the implant often fails, primarily due to scarring or bleb fibrosis, resulting in elevated intraocular pressure.

[0003] Another example of an implantable ocular drainage device is disclosed in WO2022 / 111892. This known device comprises a magnetic microvalve mechanism that controls the flow of fluid so as to maintain a healthy intraocular pressure within the eye. Summary of the Invention

[0004] SUMMARY OF THE INVENTION It is an object of the present invention to provide an improved implantable ocular drainage device.

[0005] This object is achieved by an implantable ocular drainage device as defined in claim 1.

[0006] An implantable ocular drainage device is configured to control intraocular pressure within an eye, the implantable ocular drainage device comprising a wall endlessly enclosing a reservoir having a reservoir volume defined by the wall, the device further comprising at least one fluid inlet, at least one fluid outlet for filling the reservoir with fluid, and at least one fluid flow path providing fluid communication between the at least one fluid inlet and the at least one fluid outlet, the wall comprising at least one overflow member configured to control a maximum volume of fluid in the reservoir, the maximum volume of fluid in the reservoir being less than the reservoir volume.

[0007] An implantable ocular drainage device having a reservoir defined by a wall of the device is designed to collect fluid (hereinafter, aqueous humor) in the reservoir, and after collecting a predetermined maximum volume of aqueous humor in the reservoir, the aqueous humor is dispersed and exits the device by an overflow member in the wall.

[0008] The overflow element can be configured to direct the flow of aqueous humor away from the device for optimal drainage results. Furthermore, by allowing aqueous humor to pool in the reservoir and the overflow element to disperse it out of the device, optimal bleb formation around the implanted ocular drainage device is achieved. The bleb is the final barrier for aqueous humor before absorption into the venous system or through the conjunctiva and lymphatics into the tear film. Bleb size and cellular composition have a significant impact on IOP. Poor bleb formation can lead to glaucoma drainage device failure as a result of fibrosis and scarring of the filtering bleb. The design of the implanted ocular drainage device favors improved bleb size and cellular composition in that it facilitates bleb formation, including appropriately sized blebs that minimize resistance to aqueous humor outflow. Following implantation, the improved ocular drainage device has a relatively low failure rate.

[0009] Furthermore, the design of the device, which is primarily provided by an endless wall, makes it relatively easy to implant the device, i.e., to provide effective drainage of aqueous humor through the device, and in particular, to position the device (stable) in the desired, most optimal position.

[0010] In one aspect, when viewed from above, the endless wall defines a center that provides an imaginary origin used to define imaginary x- and y-axes, when viewed from above, the location of the fluid inlet coincides with the y-axis, and at least a portion of the at least one overflow member is provided in a wall portion of the wall opposite the fluid inlet with respect to the x-axis.

[0011] This configuration of the device with at least one posteriorly located overflow member has the effect of dispersing aqueous humor flow posteriorly, thereby directing bleb formation further onto the bulbus and facilitating optimal bleb formation for drainage by minimizing bleb fibrosis. This location of the overflow member or members relative to the fluid inlet and at least the upwardly opening reservoir provides an environment around the device that, when the device is implanted, results in superior drainage results.

[0012] In another embodiment, when viewed from above, the endless wall defines a center that provides an imaginary origin used to define imaginary x- and y-axes, when viewed from above, the location of the fluid inlet coincides with the y-axis, and at least a portion of the at least one fluid outlet is provided in a wall portion of the wall opposite the fluid inlet relative to the x-axis.

[0013] A posteriorly located fluid outlet for filling the reservoir of the implanted device maximizes tissue healing after implantation and drains fluids to a location posterior to the surgical site.

[0014] The implantable ocular drainage device may be made of a biocompatible, non-consumable (non-erodible) polymer. Exemplary polymers include silicone rubber, polypropylene, polytetrafluoroethylene, and preferably poly(styrene-block-isobutylene-block-styrene). Devices made of biocompatible, non-consumable polymers can be implanted through a relatively simple surgical procedure because they do not need to be patched with sclera (from a human donor) or other materials to prevent conjunctival erosion.

[0015] Furthermore, the wall may be ring-shaped or elliptical. Ring-shaped devices are suitable for secure placement on a spherical surface such as the eyeball. Therefore, the ring-shaped shape provides stable positioning on the eyeball, which contributes to a relatively high success rate of the implanted device. The device may also have a curved design that conforms to the curvature of the eye. Such a curved design not only facilitates positioning of the device within the eye, but also reduces distortion and / or deformation after the device is implanted.

[0016] Additionally or alternatively, a magnetic microvalve mechanism such as that disclosed in WO2022 / 111892 may be included in the ocular drainage device of the present disclosure, with the device having the magnetic microvalve mechanism being positioned within the reservoir volume, for example centrally, such that the device of the present disclosure is primarily provided around the periphery of the known device.

[0017] In one embodiment, the at least one overflow member is a notch in the wall, particularly in the top portion of the wall, such that the wall provides a reservoir volume defined by the height of the wall, the wall having a smaller height at the at least one notch, such that the maximum volume of fluid collected in the reservoir is smaller than the reservoir volume defined by the height of the wall portion(s) without the notch.

[0018] Alternatively, or in addition, the overflow member may be provided by at least one opening through the wall below the upper side of the wall, allowing fluid in excess of the maximum volume of fluid in the reservoir to exit the reservoir by the at least one opening. [Brief explanation of the drawings]

[0019] The invention will now be described in more detail with reference to the accompanying drawings, which show exemplary embodiments. [Figure 1] FIG. 1 shows a perspective view of a first embodiment of an implantable ocular drainage device after implantation. [Figure 2] 2A-2C show perspective and cross-sectional views of the implantable ocular drainage device shown in FIG. 1. [Figure 3] 2A-2C show perspective and cross-sectional views of the implantable ocular drainage device shown in FIG. 1. [Figure 4] 1 shows a perspective view of a second embodiment of an implantable ocular drainage device. [Figure 5] 5 shows a perspective top view of the implantable ocular drainage device shown in FIG. 4. [Figure 6] 1 shows a perspective view of a third embodiment of an implantable ocular drainage device. DETAILED DESCRIPTION OF THE INVENTION

[0020] In the following description, identical or corresponding parts have identical or corresponding reference numerals. Each feature disclosed with reference to a particular figure may also be combined with other features disclosed in the present disclosure, unless it is clear to one skilled in the art that these features are incompatible.

[0021] 1-6 show various embodiments of implantable ocular drainage devices 1;101;201 for controlling intraocular pressure. The ocular drainage devices 1;101;201 comprise a wall 3;103;203 endlessly surrounding a reservoir 5;105;205, the reservoir volume of which is defined by the wall 3;103;203. The device 1;101;201 further comprises at least one fluid inlet 7;107;207, at least one fluid outlet 9;109,109',109";209 for filling the reservoir with fluid, and at least one fluid flow path 11;111;211 providing fluid communication between the at least one fluid inlet and the at least one fluid outlet, and the wall 3;103;203 comprises at least one overflow member 13,13',13'',13''';113,113',113'';213,213' configured to control a maximum volume of fluid in the reservoir, wherein the maximum volume of fluid in the reservoir is smaller than the reservoir volume.

[0022] The device 1; 101; 201 further includes a tube 21; 121; 221, which is connected or connectable to the fluid inlet 7; 107; 207. The device 1; 101 includes a tube connector 12; 112 connected to the wall 3; 103, or the tube connector 12; 112 is integral with the wall. The tube connector has dimensions in the x-y plane defined by v (1-2 mm) and w (0.5-1 mm) and a height corresponding to the height of the wall 3; 103. FIG. 1 illustrates an implantable ocular drainage device 1, and the embodiments of the device 101; 201 illustrated in FIGS. 4-6 can be similarly implanted in the eye. FIG. 1 illustrates that the ring-shaped wall 3 is designed to be positioned subconjunctivally / sub-Tenon's space, and the end 21a of the tube 21 is designed to be positioned in the anterior chamber between the cornea and the lens. Arrow P1 in FIG. 1 illustrates how tube 21 of implanted device 1 drains intraocular fluid (aqueous humor) from the anterior chamber (between the cornea and the lens). Tube 21 and fluid flow path 11, which provides fluid communication between fluid inlet 7 and fluid outlet 9, allow open reservoir 5 to fill with aqueous humor. Overflow members 13, 13', 13'', 13''' distribute aqueous humor from the reservoir in a predetermined direction, i.e., backward, onto the eyeball, as shown by arrow P2 in FIG. 1, to direct bleb formation further onto the bulbus, which promotes optimal bleb formation for drainage by minimizing bleb fibrosis. To provide improved drainage of aqueous humor with the device 1;111;211 of the present disclosure, aqueous humor is collected in the reservoir 5 and dispersed out of the device 1 by the overflow member 13, 13', 13'', 13''', thereby providing optimal bleb formation around the implanted ocular drainage device 1 with minimal or no fibrosis.

[0023] As shown in the figures, the implantable ocular drainage device 1; 101; 201 has an open design provided by at least an upwardly open reservoir and an endless wall 3; 103; 203 with an overflow member 13, 13', 13'', 13''', 113, 113', 113'', 213, 213'. Without being bound by theory, it is believed that this open design of the implanted ocular drainage device contributes to providing a bleb of improved size and cellular composition around the implanted device. Optimal bleb formation with minimal or no fibrosis around the implanted ocular drainage device 1; 101; 201 improves aqueous humor drainage from the eye in a natural manner. The device 1; 101; 201 is made of a biocompatible, non-consumable polymer, preferably poly(styrene-block-isobutylene-block-styrene) (SIBS). SIBS minimizes inflammation, scarring, and capsule formation. The size and cellular composition of blebs that form around the device 1;101;201 are directly and positively influenced by SIBS. Fabricating glaucoma drainage devices 1;101;201 entirely from SIBS improves bleb control.

[0024] In the illustrated embodiment, the walls 3;103;203 are ring-shaped walls 3;103;203. The walls may also have a ring-like shape, such as oval-shaped walls 3;103;203. Ring-shaped or oval-shaped walls have the advantage that these shapes are adapted to provide stable and / or correct positioning on the eye, which contributes to a relatively high success rate of the implanted device 1;101;201. Alternatively, other shapes, such as rectangular or triangular walls, are also possible.

[0025] The maximum dimension of the walls 3, 103, 203 defining the reservoir 5, 105, 205 is defined between the outer portions of the opposing body walls, as indicated by D in FIG. 5, and D is 15 mm or less, preferably 12 mm or less. The distance d between the inner portions of the opposing body walls is 8 mm or less, preferably 5 mm or less. The distance d defines the volume of the reservoir 5, 105, 205. The device 1, 101, 201 has relatively compact dimensions, i.e., the device 1, 101, 201 can be manufactured relatively small, which makes the device 1, 101, 201 easy to implant yet relatively effective at draining aqueous humor from the eye. Furthermore, the height of the device 1, 101, 201 is relatively small compared to the maximum dimension of the walls 3, 103, 203, and the height of the device is substantially defined by the height H1 of the walls 3, 103, 203. The height H1 of the wall 3; 103; 203 is greater than 0.5 mm and less than 3 mm.

[0026] In the illustrated device 1;101;201, the wall 3;103;203 comprises at least one fluid inlet 7;107;207, at least one fluid outlet 9;109;209 debouching into the reservoir 5;105;205, and at least one fluid flow path 11;111;211 providing fluid communication between the at least one fluid inlet 7;107;207 and the at least one fluid outlet 9;109;209. As shown, the at least one fluid flow path 11;111;211 is located within the wall 3;103;203, and in a device 1;201 having a single fluid outlet 9, the minimum length of the flow path is 50% of the length of the endless wall 3;103. The minimum length of the flow path to obtain a posteriorly located fluid outlet for filling the reservoir of the implanted device is at least 25% of the length of the endless wall. In the embodiment shown, the flow channel 11;111 has the same shape as the wall 3;103, and the ring-shaped flow channel 11;111 extends in a ring shape inside the wall so that the length of the flow channel 11;111 substantially corresponds to the length of the endless wall 3;103.

[0027] As shown by the dotted circle R in FIG. 5, the ocular drainage device 1; 101; 201 of the present disclosure may also include a magnetic microvalve mechanism such as that disclosed in WO 2022 / 111892. For example, the magnetic microvalve mechanism shown in FIGS. 5A-D of WO 2022 / 111892 may be combined with the ocular drainage device 1; 101; 201 of the present disclosure, with the magnetic microvalve mechanism centrally located within the reservoir volume, as shown by the dotted circle in FIG. 5. The reservoir is then primarily disposed around the magnetic microvalve mechanism (circle R), which is also surrounded by an endless wall having an outflow member as disclosed herein. In such a configuration, at least one fluid outlet is provided at its center by the magnetic microvalve mechanism. In such a configuration, the fluid flow path extends with the magnetic microvalve mechanism, for example by a tubular flow path, and provides fluid communication between at least one fluid inlet 7; 107; 207 and at least one fluid outlet provided in the known device, for example by a tubular flow path (not shown) extending between the wall at the location of the fluid outlets 109, 109', 109'' shown in Figure 5 and the housing flow path of the magnetic microvalve mechanism.

[0028] 2 and 3 show details of the device 1 shown in FIG. 1. Referring to FIG. 3, the height indicated by H1 between the top 3a of the wall 3 and the bottom 3b of the wall 3 provides a reservoir volume defined by the height H1 of the wall 3, while the height H2 between the overflow member 13'' and the bottom 3b of the wall provides a maximum volume of fluid in the reservoir 5 before the fluid flows through the overflow member 13'' to the outside of the device 1, such that the overflow members 13, 13', 13'', and 13''' control the maximum volume of fluid in the reservoir 5. As is evident from the difference in height between H1 and H2 shown in FIG. 3, the maximum amount of fluid that can be collected in the reservoir 5 is less than the reservoir volume. The same principle applies to the embodiments shown in FIGS. 4-6. That is, the overflow members 13, 13', 13'', 13'''; 113, 113', 113''; 213, 213' are notches in the upper part of the wall 3; 103; 203, which notches define the maximum volume of fluid that can be collected in the reservoir 5; 105; 205. In principle, it would be possible to use only one notch in the wall of the device 1; 101; 201 to define the maximum volume, but in order to obtain a more optimal distribution of aqueous humor over / through the wall 3; 103; 203, at least two notches in the wall, preferably at least three notches in the wall, are provided.

[0029] As shown in the figures, the endless wall 3; 103; 203 of the device 1; 101; 201 has a centre M (a point on the centre line C of the wall as shown in Figures 2 and 5, or Figure 4) which provides an imaginary origin used to define an imaginary x-axis (see e.g. the cross-section line in Figure 2 designated XX) and a y-axis (dotted line y in Figure 2), and when viewed from above, the position of the fluid inlet 7 coincides with the y-axis and at least part of at least one overflow member 13, 13', 13'', 13'''; 113, 113', 113''; 213, 213', and / or at least part of at least one fluid outlet 9; 109, 109', 109''; 209 is provided in a wall portion of the wall 3; 103; 203 opposite the fluid inlet 7; 107; 207 in relation to the x-axis. That is, the x-axis (see dotted line XX in FIG. 2 ) divides the wall 3; 103; 203 into two portions, and at least a portion of at least one overflow member and / or at least a portion of at least one fluid outlet is provided in the portion of the two portions farthest from the fluid inlet 7; 107; 207. Therefore, the portion of the two portions closest to the fluid inlet 7; 107; 207 may not be completely equipped with an overflow member and / or a fluid outlet. In FIG. 2 , each overflow member 13, 13′″ is shown to be composed of two overflow member portions 13A, 13B, and 13A′″, 13B′″, with only portions 13A and 13A′″ being provided in the wall portion of the wall 3 opposite the fluid inlet 7 with respect to the x-axis. This configuration of the device 1;101;201 with at least one posteriorly located overflow member 13,13',13'',13''';113,113',113'';213,213' has the result that aqueous humor flow is dispersed posteriorly, thereby directing bleb formation further onto the bulbus, which facilitates optimal bleb formation for drainage by minimizing bleb fibrosis. Additionally or alternatively, posteriorly located fluid outlet(s) 9;109,109',109'';209 for filling reservoirs within the implanted device maximizes tissue healing after implantation.

[0030] The implantable ocular device 101; 201 shown in Figures 4-6 differs from the implantable ocular device 1 in that the implantable ocular device 101; 201 includes a membrane 125; 225 that is connected to the wall 103; 203 and provides the bottom of the reservoir 105; 205. The dimensions of the membrane 125; 225 in the x and y directions are greater than the dimensions of the wall 103; 203. The membrane 125; 225 has an elliptical shape when viewed from above (Figures 4 and 5). The maximum dimension of the membrane 125; 225 extending in the x direction (Figure 5) is 20 mm. The height of the membrane 125; 225 is less than the height of the body wall 103; 203. The height of the membrane 125; 225 is 0.5 mm or less, preferably about 0.1 mm. The membrane 125;225 allows for the incorporation of surface topography and / or openings 126 that allow for control of the nearby cellular environment, for example to facilitate wound healing or tissue fixation.

[0031] The device 101 further shows that the at least one outlet may comprise at least two spaced apart outlet openings in the wall 103, in particular three spaced apart outlet openings 109, 109', 109'' in the wall 103. At least a portion of the or each outlet opening 109, 109', 109'' is provided in a wall portion of the wall 103 opposite the fluid inlet 107 with respect to the x-axis, as explained above.

[0032] The devices 1; 101; 201 may have a curved design that conforms to the curvature of the eye. A device 201 with this curved design is shown in Figure 6. Such a curved design not only facilitates positioning of the device within the eye at the time of implantation and maintaining its position after implantation, but also reduces distortion and / or deformation after the device is implanted, which contributes to a more patient-friendly device after implantation.

[0033] Although not shown, an implantable ocular drainage device for controlling intraocular pressure may also be provided, comprising a wall endlessly surrounding a reservoir, the wall defining a reservoir volume, the wall further comprising at least one fluid inlet, at least one fluid outlet for filling the reservoir with fluid, and at least one internal fluid flow path providing fluid communication between the at least one fluid inlet and the at least one fluid outlet, the device having an open design provided by the reservoir that is open at least upward. The implantable ocular drainage device having a reservoir defined by the wall of the device is designed to collect fluid (hereinafter, aqueous humor) within the reservoir, and after collecting a maximum amount of aqueous humor within the reservoir, the aqueous humor exits the device by overflowing over the top of the wall. The accumulation of aqueous humor in the reservoir achieves optimal bleb formation around the implanted ocular drainage device. The wall of such a device may be ring-shaped or elliptical. The maximum dimension of the wall is defined between the outer portions of the opposing body walls, and the maximum dimension is, for example, 15 mm, preferably 12 mm. The fluid outlet(s) and / or (internal) fluid flow path of such a device may be arranged as described above and illustrated. Furthermore, such a device may have a curved design that conforms to the curvature of the eye, as disclosed in the present disclosure. The device may also be combined with a tube and / or membrane connected to the wall and providing the bottom of the reservoir, as shown in the figures and disclosed above.

Claims

1. 1. An implantable ocular drainage device for controlling intraocular pressure, the ocular drainage device comprising a wall endlessly enclosing a reservoir having a reservoir volume defined by the wall, the device further comprising at least one fluid inlet, at least one fluid outlet for filling the reservoir with fluid, and at least one fluid flow path providing fluid communication between the at least one fluid inlet and the at least one fluid outlet, the wall comprising at least one overflow member configured to control a maximum volume of fluid in the reservoir, the maximum volume of fluid in the reservoir being less than the reservoir volume.

2. 2. The apparatus of claim 1, wherein, when viewed from above, the endless wall defines a center that provides an imaginary origin used to define imaginary x- and y-axes, and when viewed from above, the location of the fluid inlet coincides with the y-axis, and at least a portion of the at least one overflow member is provided in a wall portion of the wall opposite the fluid inlet with respect to the x-axis.

3. 3. The apparatus of claim 1, wherein, when viewed from above, the endless wall defines a centre that provides an imaginary origin used to define imaginary x- and y-axes, and when viewed from above, the position of the fluid inlet coincides with the y-axis, and at least a portion of the at least one fluid outlet is provided in a wall portion of the wall opposite the fluid inlet relative to the x-axis.

4. 4. The device according to claim 1, wherein the wall is ring-shaped or elliptical-shaped.

5. 5. The device according to claim 1, wherein the device has an open design provided by at least an upwardly open reservoir and the endless wall carrying the overflow member.

6. 6. The device of claim 1, wherein the at least one overflow member is a cutout in the wall, preferably the at least one overflow member comprises at least two cutouts in the wall, more preferably at least three cutouts in the wall.

7. 7. Apparatus according to any preceding claim, wherein the at least one outlet comprises at least two spaced apart outlet openings in the wall, preferably at least three spaced apart outlet openings in the wall.

8. 8. The device of claim 1, further comprising a membrane connected to the wall and providing a bottom for the reservoir.

9. 10. The device of claim 8, wherein the membrane incorporates surface features and / or openings that allow for control of the nearby cellular environment.

10. 10. The device of claim 1, wherein the wall comprises the at least one fluid inlet, the at least one fluid outlet leading into the reservoir, and at least one fluid flow path providing fluid communication between the at least one fluid inlet and the at least one fluid outlet.

11. 11. The device of claim 1, further comprising a tube, the tube being connected or connectable to the fluid inlet.

12. 12. The device of claim 1, wherein the device has a curved design that conforms to the curvature of the eye.

13. 13. A device according to any preceding claim, wherein the maximum dimension of the wall is defined between the outer portions of the opposing body walls, said maximum dimension being 15mm, preferably 12mm.

14. 14. The device of claim 1, wherein the at least one fluid flow path is at least partially disposed within the wall for at least 25% of the length of the endless wall.

15. 15. The device of any of claims 1 to 14, wherein the device is made of a biocompatible, non-consumable polymer, preferably poly(styrene-block-isobutylene-block-styrene), and / or the device includes a magnetic microvalve mechanism for controlling intraocular pressure in the eye.

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