Ocular implant and method for manufacturing the same

Abstract

An ocular implant (10) for conveying intraocular fluid away from a site of excess intraocular fluid in a patient, the implant (10) comprising: a body (12) including one or more drainage channels (20) each having an outlet (24) in fluid communication with a drainage site located away from the site of excess intraocular fluid; and an elongated tubular member (30) in fluid communication with the body (12), the member (30) having a first end portion (32) providing an inlet (38), a second end portion (34) providing an end (40), and an elongated tubular member (30) having a first end portion (32) providing an inlet (38), a second end portion (34) providing an end (40), and an elongated tubular member (30) in fluid communication with the inlet (38) and the end (40). and a tubular member (30) having a lumen extending between the first end portion (34) and the second end portion (40), the inlet (38) being fluidly communicable with a site of excess intraocular fluid such that intraocular fluid can flow through the inlet (38) and through the lumen toward the end portion (40), the second end portion (34) including one or more openings (42) each fluidly communicable with a respective one of the one or more drainage channels (20) to allow intraocular fluid to flow from the second end portion (34) to each of the outlets (24).

Description

Technical Field

[0001] The present invention relates to an intraocular implant, and more particularly, but not limited thereto, to an eye shunt for the treatment of glaucoma.

Background Art

[0002] Glaucoma is an eye disease generally characterized by insufficient regulation of the intraocular pressure, commonly referred to as intraocular pressure (IOP). An increase in IOP above physiologically normal levels can lead to irreversible damage and blindness in the affected eye.

[0003] Known intraocular implants typically aim to improve the pathology of glaucoma by diverting or shunting the aqueous humor, a fluid within the eye, away from the site of excess fluid in an attempt to reduce the IOP to physiologically normal levels.

[0004] Many of these known intraocular implants do not provide adequate regulation of IOP or have other potential drawbacks such as relatively high cost and low accessibility.

[0005] Objectives An object of the present invention is to substantially overcome or at least improve one or more of the above-mentioned drawbacks.

Summary of the Invention

[0006] Herein described is an intraocular implant for transporting intraocular fluid away from a site of excess intraocular fluid within a patient, the implant comprising a body including one or more drainage channels each having an outlet in fluid communication with a drainage site positioned away from the site of excess intraocular fluid, an elongate tubular member in fluid communication with the body, the member having a first end portion providing an inlet, a second end portion providing an end, and a lumen extending between the inlet and the end, The inlet is fluid-connected to the area of ​​excess intraocular fluid so that intraocular fluid can pass through the inlet and flow through the lumen toward the end. An implant is disclosed, in which a second end portion includes one or more openings, each capable of fluid communication with one or more drainage channels, to allow intraocular fluid to flow from the second end portion to each of the outlets.

[0007] Preferably, the main body includes a plurality of drainage channels in the form of elongated tubular elements.

[0008] Preferably, each element is arranged parallel to one another to form an array.

[0009] Preferably, the second end portion is at least partially located within the main body and extends in a direction that spans the array.

[0010] Preferably, the second end portion extends across each of the channels.

[0011] Preferably, the elongated tubular member is in the form of a modified medical drainage catheter.

[0012] Preferably, the main body is in the form of a modified multi-tube medical drain.

[0013] This specification also describes a device for a guided assembly of an ophthalmic implant, wherein the implant comprises a body and an elongated tubular member, the body comprising a plurality of elongated open-end tubular elements arranged parallel to each other to form an array, the member comprising a first end portion and a second end portion, and the device comprises A base for positioning the main body, To restrict the movement of the body relative to the base, the first and second side walls extend from the base around the base, and the first and second side walls are arranged in a direction transverse to each other, The first side wall includes an opening to allow the perforating device to perforate each of the tubular elements of the body to form a passage extending across the array, thereby allowing the second end portion to pass through the passage. A device is disclosed in which the second side wall includes a plurality of openings, the plurality of openings being aligned with one of each of the open ends of a tubular element such that a drilling device can drill through the openings, through the open ends, and across the second end portion.

[0014] Preferably, the first side wall includes a first notch located at the outer end portion of the opening, and the second side wall includes a plurality of second notches, each located at the respective outer end portion of the opening, the first and second notches, at least, facilitate the passage of a drilling device.

[0015] Preferably, the device further includes at least a support portion formed integrally with the base to facilitate handling of the device.

[0016] Preferably, the support portion includes a contoured grip portion substantially aligned with the first side wall.

[0017] Preferably, the opening is a first channel extending through the first side wall, and each of the openings is a second channel extending through the second side wall.

[0018] This specification further describes a method for guiding the assembly of an ophthalmic implant configured to transport intraocular fluid away from areas of excess intraocular fluid within a patient, wherein the method is To provide a device for a guided assembly of an ophthalmic implant, the device is The base and, Including first and second side walls extending from the base around the base, the first and second side walls being arranged in a direction transverse to each other, The first side wall includes an opening, Providing a device in which a second side wall includes a plurality of openings Providing a multi-tubular medical drain, the drain having a plurality of elongated tubular elements arranged parallel to each other to form an array, each of the elements having an outlet formed at each end of the element Determining the size of the drain so that the drain can be positioned on the base of the device Positioning the drain on the base and arranging the drain such that each of the outlets is aligned with one of the respective openings Piercing the drain through the openings to form a passage through the drain extending across the array Providing a medical catheter having a first end portion providing an inlet, a second end portion providing an end, and a lumen extending between the inlet and the end Positioning the second end portion through the passage of the drain Piercing the second end portion through each of the openings to form a plurality of openings in the second end portion, each of the openings being in fluid communication with one of the respective outlets

[0019] Here, exemplary embodiments of the present disclosure are described only as examples with reference to the accompanying description and drawings

Brief Description of the Drawings

[0020] [Figure 1] Schematic front view of an ophthalmic implant according to an embodiment of the present disclosure [Figure 2] Schematic side view of the ophthalmic implant of FIG. 1 [Figure 3] Perspective view of a device according to an embodiment of the present disclosure for a guided assembly of the ophthalmic implant of FIG. 1 [Figure 4] Perspective view of a device according to another embodiment of the present disclosure for a guided assembly of the ophthalmic implant of FIG. 1 [Figure 5] FIG. 1 is a perspective view of a device according to yet another embodiment of the present disclosure of a guided assembly of an ocular implant of FIG. 1. [Figure 6] FIG. 4 is a flowchart generally showing steps associated with a method of a guided assembly of the ocular implant of FIG. 1 using the device of FIG. 3, FIG. 4, or FIG. 5. DETAILED DESCRIPTION OF THE INVENTION

[0021] Referring to FIGS. 1 and 2 of the accompanying drawings, an ocular implant or shunt 10 for transporting intraocular fluid away from a site of excess intraocular fluid within a patient is schematically illustrated. In the illustrated embodiment, the shunt 10 is configured to transport aqueous humor away from the anterior chamber of the eye. The shunt 10 can be used in the treatment of glaucoma by being configured to reduce intraocular pressure (IOP) towards a physiologically normal level.

[0022] The shunt 10 includes a body 12. In the illustrated embodiment, the body 12 has a generally rectangular configuration and has a pair of longitudinally opposed proximal portions 14 and distal portions 16 and a pair of opposing lateral portions 18 each extending in a direction transverse to between the proximal portion 14 and the distal portion 16. The body 12 has a longitudinal dimension of about 20 mm, a height dimension of about 15 mm, and a width dimension of about 2 mm. However, it should be understood that the shape and dimensions of the body 12 can be varied. For example, the body 12 can have a circular, square, hexagonal, or other polygonal configuration.

[0023] The main body 12 includes a plurality of drainage channels in the form of elongated tubular elements 20. Each tubular element 20 has a pair of opposing open end portions 22 that form the lateral portion 18 of the main body 12. Outlets 24 (Figure 2) are provided at each end portion 22 to fluidize into a drainage site for excess intraocular fluid, i.e., a Schlemm's channel located away from the anterior chamber. The length 26 of each element 20 extends between the respective end portions 22 and provides a lumen that extends between the outlets 24 through which intraocular fluid or aqueous humor can flow. In the illustrated embodiment, each of the length 26 and the outlets 24 has an outer diameter of about 2 mm. Each of the elements 20 is preferably formed of a material that provides relatively good flexibility, elasticity, and biocompatibility, such as medical-grade silicone.

[0024] Each tubular element 20 is joined to an adjacent tubular element 20 on its longitudinal side to form a parallel array of tubular elements 20. The array has an axis of symmetry 28 that extends in a direction traversing between the proximal portion 14 and the distal portion 16 of the element 20. The elements 20 arranged in the outer longitudinal portion of the array form the proximal portion 14 and the distal portion 16. In this way, the arrangement of the tubular elements 20 provides the body 12 with a substantially undulating or corrugated outline.

[0025] In one or more embodiments, the main body 12 can be conveniently formed by modifying a standard multi-tube medical tissue drain (such as an abdominal drainage tube) that is readily available in clinical settings (such as hospitals) around the world.

[0026] The shunt 10 further includes an elongated tubular member 30 that is in fluid communication with the main body 12. The member 30 has a first end portion 32 that provides an inlet 38, a second end portion 34 that provides a distal end 40, and a longitudinal portion 36 that extends between the inlet 38 and the end portion 40. The longitudinal portion 36 provides a lumen through which intraocular fluid or aqueous humor can flow. The first end portion 32, the longitudinal portion 36, and the second end portion 34 preferably have an outer diameter in the range of about 0.5 mm to 0.9 mm, more preferably 0.7 mm. The member 30 may preferably be formed of the same material as the main body 12, or of other suitable material.

[0027] The inlet 38 is fluid-communicated with the area of ​​excess intraocular fluid (i.e., the anterior chamber) so that intraocular fluid can pass through the inlet 38 and flow through the lumen of the longitudinal section 36 toward the end section 40.

[0028] In the illustrated embodiment, the second end portion 34 extends through a passage or tunnel formed along an axis 28 passing through each of the elements 20. The distal end 40 of the second end portion 34 terminates in the element 20 forming the distal portion 16. However, it may be assumed that the second end portion 34 is positioned directly above the element 20 or offset with respect to the axis 28.

[0029] The second end portion 34 is penetrated to provide a plurality of openings 42 (Figure 2) in the longitudinal lumen 36. Each opening 42 is fluid-communicable with one of each of the longitudinal lumens of the plurality of elements 20 in the longitudinal 26, allowing intraocular fluid to flow from the longitudinal lumen 36 of the second end portion 34 to each of the longitudinal lumens 26 toward the outlet 24. It should be understood that each of the openings 42 has a diameter smaller than the diameter of the second end portion 34.

[0030] In one or more embodiments, the component 30 can be conveniently formed by modifying a standard medical drainage catheter readily available in clinical settings (such as hospitals) worldwide. The size of the catheter (i.e., standard dimensions) can be selected according to suitability for the application. In a preferred embodiment, the catheter size is 24G to provide a shunt drainage rate of approximately 6 ml / min.

[0031] The main body 12 may include one or more eyelets (not shown) to facilitate suturing the shunt 10 to the patient's eye.

[0032] The waveform shape of the main body 12 facilitates the continuous filling of each of the elements 20 with intraocular fluid according to the IOP. Thus, the shunt 10 can provide a valve effect without moving any components so that when the IOP is relatively high, the fluid flow through the shunt 10 increases, thereby increasing the drainage velocity. Conversely, when the IOP is relatively low, the fluid flow through the shunt 10 decreases, thereby decreasing the drainage velocity.

[0033] Furthermore, the corrugated tubular element 20 has the ability to be filled with a sustained-release drug formulation (e.g., pellets or gel) as needed to reduce postoperative inflammation, minimize additional scar tissue formation, or have an additional IOP-reducing effect. The advantage of the configuration of the open end portion 22 of the tubular element 20 means that the element 20 can be refilled at a later date as needed.

[0034] Referring to Figure 3, a device or fixture 50 for the guided assembly of the shunt 10 is schematically illustrated.

[0035] The jig 50 has a generally rectangular configuration and includes a base 52 having a substantially flat receiving surface 54. A first axis 56 extends perpendicular to the surface 54. Side walls 58 extend upward from the base 52 in a direction parallel to the axis 56 around the base 52 in order to partially enclose the surface 54. Each of the side walls 58 preferably has a height measured from the surface 54 that is greater than the width of the body 12. The side walls 58 are arranged in a first pair of opposing side walls 58a and a second pair of opposing side walls 58b. The first pair of opposing side walls 58a is arranged perpendicular to the second pair of opposing side walls 58b.

[0036] The jig 50 has a second shaft 60 and a third shaft 62, the third shaft 62 being perpendicular to the second shaft 60. Each of the shafts 60 and 62 extends perpendicular to the first shaft 56 between each pair of opposing side walls 58. That is, the second shaft 60 extends between the first pair of opposing side walls 58a, and the third shaft 62 extends between the second pair of opposing side walls 58b.

[0037] The jig 50 includes a hole 64 extending through one of the side walls 58 of a first pair 58a in a direction parallel to the axis 60. In the illustrated embodiment, the hole 64 is aligned with the axis 60 and located in the center between a second opposing pair of side walls 58b. The hole 64 has a diameter greater than or equal to the diameter of the tubular member 30. A cylindrical projection 63 is formed on the side wall 58 concentrically with the hole 64 and extends in a direction transverse away from the side wall 58. As described below, the projection 63 and the hole 64 are configured to act as guides for a drilling device (such as a needle) to form a passage across each of the elements 20 of the body 12.

[0038] The fixture 50 further includes a plurality of openings 66 extending through each of the side walls 58 of the second pair 58b in a direction parallel to the axis 62. In the illustrated embodiment, each of the openings 66 is equally spaced along the side walls 58 of the second pair 58b. The number of openings 66 preferably corresponds to the number of elements 20. However, it should be understood that the fixture 50 may have more openings 66 than the number of elements 20. Each of the openings 66 has a diameter greater than or equal to the diameter of the opening 42. Each of the openings 66 extending through one of the side walls 58 of the second pair 58b is aligned with each of the openings 66 extending through the other side wall 58 of the second pair 58b. As described below, each of the openings 66 is configured to function as a lateral guide for the penetration of the second end portion 34 to form each of the openings 42.

[0039] The jig 50 further includes a number of straight grooves 68 that are cut through each of the side walls 58 to the surface 54 and are positioned obliquely to the axes 60, 62. It should be understood that the arrangement and shape of the grooves 68 may be changed. The grooves 68 are configured to function as guides for the scalpel cuts of the body 12, as described below.

[0040] A support base (not shown) may be formed integrally with the jig 50 to assist in handling the jig 50.

[0041] The fixture 50 can be manufactured from commonly available 3D-printable thermoplastics (such as polylactic acid (PLA) and acrylonitrile butadiene styrene (ABS)) and by a three-dimensional (3D) printing process using computer-aided design (CAD) software. It should be understood that the fixture 50 can be easily 3D printed and sterilized to facilitate the rapid, guided assembly of the shunt 10 during surgery, as described below. The CAD model of the fixture 50 can be easily shared with developing countries, and the costs associated with packaging, transporting, storing, and logistical aspects of the implant can be minimized compared to other implantable devices.

[0042] Referring to Figure 4, a device or fixture 150 for the guided assembly of the shunt 10 is schematically illustrated. Fixture 150 has a similar basic structure to fixture 50. Features of fixture 150 that are equivalent to features of fixture 50 are provided with the same reference numerals as the features of fixture 50, incremented by 100.

[0043] The jig 150 has a generally rectangular configuration and includes a base 152 having a substantially flat receiving surface 154. A first axis 156 extends perpendicular to the surface 154. Side walls 158 extend upward from the base 152 in a direction parallel to the axis 156 around the base 152 in order to partially enclose the surface 154. Each of the side walls 158 preferably has a height measured from the surface 154 that is greater than the width of the body 12. The side walls 158 are arranged in a first pair of opposing side walls 158a and a second pair of opposing side walls 158b. The first pair of opposing side walls 158a is arranged perpendicular to the second pair of opposing side walls 158b.

[0044] The jig 150 has a second shaft 160 and a third shaft 162, the third shaft 162 being perpendicular to the second shaft 160. Each of the shafts 160 and 162 extends perpendicular to the first shaft 156 between each pair of opposing side walls 158. That is, the second shaft 160 extends between the first pair of opposing side walls 158a, and the third shaft 162 extends between the second pair of opposing side walls 158b.

[0045] The jig 150 includes a pair of opposing holes 164 extending through one of each of the side walls 158 of a first pair 158a in a direction parallel to the axis 160. In the illustrated embodiment, the holes 164 are aligned with the axis 160 and located centered between a second pair of opposing side walls 158b. The holes 164 have a width dimension greater than or equal to the diameter of the tubular member 30. Preferably, the holes 164 are positioned at a depth measured from a surface 154 in the middle of the body 12. Wedge-shaped notches 165 are formed on each of the side walls 158a at each of the outer or outer ends of the holes 164 to facilitate guiding the tubular member 30 through each of the holes 164. As described below, the holes 164 are configured to serve as guides for a drilling device (such as a needle) to form a passage across each of the elements 20 of the body 12.

[0046] The jig 150 further includes a plurality of openings 166 extending through each of the side walls 158 of the second pair 158b in a direction parallel to the axis 162. In the illustrated embodiment, each of the openings 166 is equally spaced along the side walls 158 of the second pair 158b. The number of openings 166 preferably corresponds to the number of elements 20. However, it should be understood that the jig 150 may have more openings 166 than the number of elements 20. Each of the openings 166 has a width dimension equal to or greater than the diameter of the opening 42. The openings 166 are preferably located at a depth measured from the surface 154 in the middle of the body 12. Further wedge-shaped notches 167 are formed on each of the side walls 158b at the respective outer or outer ends of each of the openings 166 to facilitate the guidance of a drilling device through each of the openings 166. Each of the openings 166 extending through one of the side walls 158 of the second pair 158b is aligned with the respective opening 166 extending through the other side wall 158 of the second pair 158b. As described below, each of the openings 166 is configured to function as a lateral guide for the penetration of the second end portion 34 to form each of the openings 42.

[0047] The jig 150 further includes a number of straight grooves 168a that are cut through each of the side walls 158 to or past the surface 154 and are positioned obliquely to the axes 160, 162. Further straight grooves 168b, 168c are formed across each pair of side walls 158a, 158b and extend parallel to the axes 160, 162 to or past the surface 154. It should be understood that the arrangement and shape of the grooves 168a, 168b, 168c may be modified. As described below, the grooves 168a, 168b, 168c are configured to function as guides for the scalpel cuts of the body 12.

[0048] The jig 150 further includes support portions 170 formed integrally with the base 152, and more specifically, integrally with each of the side walls 158b. Each support portion 170 extends in a direction substantially parallel to the axis 162 in a direction away from the respective side wall 158b. Each support portion 170 includes a pair of contoured grip portions 172 that are substantially aligned with the side wall 158a to facilitate handling of the jig 150. Reinforcement portions 174 extend between the pair of grip portions 172 to provide rigidity to the support portions 170. Reinforcement portions 174 may also be used as clamping surfaces to further facilitate handling of the jig 150.

[0049] The fixture 150 can be manufactured by a three-dimensional (3D) printing process using commonly available 3D-printable thermoplastics (such as polylactic acid (PLA) and acrylonitrile butadiene styrene (ABS)) and computer-aided design (CAD) software. It should be understood that the fixture 150 can be easily 3D printed and sterilized to facilitate the rapid, guided assembly of the shunt 10 during surgery, as described below. The CAD model of the fixture 150 can be easily shared with developing countries, and the costs associated with packaging, transporting, storing, and logistical aspects of the implant can be minimized compared to other implantable devices.

[0050] Referring to Figure 5, a device or fixture 250 for the guided assembly of the shunt 10 is schematically illustrated. Fixture 250 is identical in configuration to fixture 150, except for the configuration of the hole 164 and the opening 166. In fixture 250, the hole 164 and the opening 166 are replaced by first and second channels 264, 266 that extend linearly through a pair of side walls 158a, 158b, respectively. Each of the channels 264 has a width dimension greater than or equal to the diameter of the tubular member 30. Each of the channels 266 has a width dimension greater than or equal to the diameter of the opening 42. The channels 264, 266 preferably extend to a depth measured from the surface 154 in the middle of the body 12.

[0051] Therefore, the remaining features of jig 250, which are identical to jig 150, are not further described and are provided with the same reference number in Figure 5.

[0052] It should be understood that the configuration of channels 264 and 266 can improve the convenience, 3D printing reproducibility, and ease of mass production of jig 250 when compared to jig 150.

[0053] Here, the guided assembly method of the shunt 10 using the jig 50 is described with reference to the flowchart in Figure 6.

[0054] The jig 50 is provided in step 101. Then, in step 103, a standard multi-tube medical tissue drainage tube (such as an abdominal tissue drain) is sized to allow the tube to fit onto the surface 54, while being laterally supported by the side walls 58. Then, in step 105, the tube is positioned on the surface 54 and arranged so that each of the tube's outlets aligns with one of the openings 66 of the side walls 58 of the second pair 58b.

[0055] In step 107, a needle or other suitable piercing device is inserted through the projection 63 and the hole 64, piercing the tube in a direction parallel to the axis 64 and forming a passage or tunnel through the array of tubes. In this way, the body 12 of the shunt 10 is formed.

[0056] In step 109, the needle is removed, and a cannula (or other suitable silicone tube) of a predetermined standard size is inserted through the projection 63 and hole 64 and partially positioned within the passage of the tube array, i.e., through the body 12. Alternatively, it should be understood that the cannula may be introduced into the passage in step 107 by being provided at the operating end of the needle when the needle punctures the tube, and subsequently the needle is withdrawn from the tube, leaving the cannula partially in the passage.

[0057] In step 111, additional needles or other suitable piercing devices are successively inserted to create each of the openings 42 by piercing through each of the openings 66 and through the tube exit in a direction across the cannula. In this way, member 30 is formed. It should be understood that the needles used to form the passages may be held within the body 12 while additional needles are used to form each of the openings 42.

[0058] Next, the body 12 of the shunt 10 may be trimmed in any step 113 by utilizing the groove 68 for guided scalpel excision of the body 12 to easily conform the body 12 to a spheroidal shape or to remove excess tubing material to reduce the effective rigidity of the shunt 10. This may at least help reduce the peripheral shape of the shunt 10 to the extent of erosion. The therapeutic agent may be inserted (and periodically replenished) into each of the elements 20 of the parallel tube array, either as a paste or as a liquid encapsulated with an inhibitor (e.g., medical-grade carbomethylcellulose or petrolatum) that allows for the gradual local release of the drug. The clinician may define the dosage according to the patient's specific needs.

[0059] Next, the assembled shunt 10 can be removed from the jig 50 and subsequently implanted in the patient using conventional methods.

[0060] It should be understood that the guided assembly method of the shunt 10 using fixture 50 described above can be performed in substantially the same manner using fixtures 150 and 250 instead of fixture 50. It should be understood that the wedge-shaped cutouts 165 and 167 of fixtures 150 and 250 can facilitate the guided entry of the needle or other suitable puncture device and cannula during steps 107, 109, and 111. The grip portion 172 and reinforced portion 174 of fixtures 150 and 250 can further facilitate the handling of fixtures 150 and 250 during steps 107, 109, 111, and 113.

[0061] In another aspect of this disclosure, fixtures 50, 150, 250 may be used to mold a rapidly curing biocompatible elastomer resin chassis (not shown) around member 30. This can replace or enhance the parallel tube array by shaping the tube array to the contour of a spheroid. This can mitigate shunt movement. Second fixtures may exist for shaping the parallel tube array to the contour of a spheroid that fits the patient's eye, and / or to assist in surgical implantation and secure fixation. The design of the fixtures may be adjusted in the clinic to fit the diameter and / or shape of the anatomical structure of the patient's eye for a given deployment position. The elastomer resin may consist of liquid silicone resin (platinum-catalyzed liquid silicone rubber), thermoplastic polyurethane resin, thermoplastic resin, polycaprolactone, or other rapidly curing biocompatible elastomers with low durometer hardness (Shore hardness 20A to 55D). The polymer material used may be biostable, partially bioabsorbable, or partially soluble.

[0062] In further embodiments of this disclosure, the chassis described above may include a number of reservoirs (typically 1 to 4) that can be used to help regulate IOP changes, for example, to store and gradually release bioactive therapeutic agents that help manage glaucoma, or antibiotics or antimicrobial agents, anti-occlusive agents, or biocompatible agents that can be used to estimate flow rates within the shunt. The reservoirs may be replenished periodically by an ophthalmologist. In further iterations, a dedicated applicator may be used by an optometrist to refill the eluting reservoirs with glaucoma drugs or the like.

[0063] In a further embodiment of this disclosure, both the chassis and the shunt tube are molded using a 3D printing process that utilizes a rapidly curing biocompatible elastomer resin (e.g., platinum-catalyzed liquid silicone rubber). The molded shunt may include a change in the luminal cross-section in a portion of the shunt to form a valve along the longitudinal of the tube. This valve may be cylindrical or ellipsoidal in shape. The valve shape factor allows the active pressure of the shunt fluid to influence the size of the valve, so that the IOP can be estimated in real time by monitoring the profile of the bulge caused by the valve under the sclera of the patient's eye.

[0064] It should be understood that the shunt 10 and fixtures 50, 150, and 250 described above, utilizing readily available clinical consumables, can provide a relatively low-cost, effective, robust, and safe intervention for the treatment of glaucoma.

[0065] Those skilled in the art will understand that various modifications to the described shunts and / or fixtures can be made without departing from the scope of the disclosure herein.

[0066] Reference list [Table 1]

Claims

1. An ophthalmic implant for transporting intraocular fluid away from areas of excess intraocular fluid within a patient, wherein the implant is An elongated tubular member having a first end portion providing an inlet, a second end portion providing an end, and a lumen extending between the inlet and the end, A body comprising a plurality of elongated tubular elements that are in fluid communication with the elongated tubular member, each of the plurality of elongated tubular elements having a longitudinal portion extending between a pair of outlets, each of the outlets being able to communicate with a drainage portion located away from the portion of the excess intraocular fluid, and the outlets of the pair of outlets being located on different sides of the elongated tubular member, The inlet is in fluid communication with the portion of the excess intraocular fluid so that the intraocular fluid can pass through the inlet and flow through the lumen toward the end. The second end portion includes a plurality of openings, each capable of fluid communication with one of the longitudinals of the plurality of elongated tubular elements, in order to allow the intraocular fluid to flow from the second end portion to each of the outlets. An implant in which adjacent elements of the aforementioned multiple elongated tubular elements are directly joined to each other along their respective longitudinal lengths.

2. The implant according to claim 1, wherein each of the plurality of elongated tubular elements is arranged parallel to one another to form an array.

3. The implant according to claim 2, wherein the second end portion is at least partially located within the main body and extends in a direction transverse to the array.

4. The implant according to claim 2 or 3, wherein the second end portion extends across each of the plurality of elongated tubular elements.

5. The implant according to any one of claims 1 to 4, wherein the elongated tubular member is formed from a medical drainage catheter.

6. The implant according to any one of claims 1 to 5, wherein the main body is formed from a multi-tube medical drain.

7. A device for a guided assembly of an ophthalmic implant, wherein the implant has a body and an elongated tubular member, the body includes a plurality of elongated open-end tubular elements arranged parallel to each other to form an array, the member includes a first end portion and a second end portion, and the device is A base for positioning the main body, To restrict the movement of the main body relative to the base, the first and second side walls extend from the base around the base, wherein the first and second side walls are arranged in a direction transverse to each other, The first side wall includes an opening that allows the perforating device to perforate each of the tubular elements of the body to form a passage extending across the array, thereby allowing the second end portion to pass through the passage. A device wherein the second side wall includes a plurality of openings, the plurality of openings being aligned with each of the open ends of each of the tubular elements such that the drilling device can drill through the openings, through the open ends, and across the second end portion.

8. The device according to claim 7, wherein the first side wall includes a first notch portion located at the outer end portion of the opening, and the second side wall includes a plurality of second notches, each located at the respective outer end portion of the opening, and the first and second notches facilitate passage of the drilling device.

9. The device according to claim 7 or claim 8, further comprising a support portion integrally formed with the base portion to facilitate handling of the device.

10. The device according to claim 9, wherein the support portion includes a contoured grip portion substantially aligned with the first side wall.

11. The device according to any one of claims 7 to 10, wherein the opening is a first channel extending through the first side wall, and each of the openings is a second channel extending through the second side wall.

12. A method for guiding the assembly of an ophthalmic implant configured to transport intraocular fluid away from areas of excess intraocular fluid within a patient, wherein the method is: To provide the device according to any one of claims 7 to 11, To provide a multi-tube medical drain, wherein the drain has a plurality of elongated tubular elements arranged parallel to each other to form an array, and each of the elements has an outlet formed at each end of the element. The size of the drain is determined so that the drain can be positioned on the base of the device, The drain is positioned on the base, and each of the outlets is the opening of the device. The drains are arranged so as to be aligned with one of each of them, To form a passage for the drain extending across the array, the drain is to be perforated through the opening of the device. To provide a medical catheter having a first end portion providing an entrance, a second end portion providing an end, and a lumen extending between the entrance and the end, Positioning the second end portion through the passage of the drain, A method comprising perforating the second end portion through each of the openings to form a plurality of openings in the lumen, wherein each of the openings is capable of fluid communication with one of the outlets.

Images