Ocular implant and method of manufacturing the same

Abstract

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

Description

Technical Field

[0001] This invention relates to ocular implants, specifically, but not limited to, ocular shunts for the treatment of glaucoma. Background Technology

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

[0003] Known ocular implants are designed to improve the pathology of glaucoma by diverting or diverting fluid within the eye, known as aqueous humor, away from areas of excess fluid, in an attempt to reduce IOP to physiologically normal levels.

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

[0005] Purpose of the invention

[0006] The objective of this invention is to substantially overcome or at least improve one or more of the aforementioned disadvantages. Summary of the Invention

[0007] This article discloses an ocular implant for delivering intraocular fluid from areas of excess intraocular fluid within a patient's body, the implant comprising:

[0008] A body comprising one or more drainage channels, each having an outlet, the outlets being in fluid communication with a drainage site located away from the site of excessive intraocular fluid; and

[0009] An elongated tubular component capable of fluid communication with the main body, the component 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.

[0010] The inlet is in fluid communication with the area of ​​excess intraocular fluid, allowing the intraocular fluid to flow through the inlet and through the lumen to the end.

[0011] The second end portion includes one or more openings, each opening being in fluid communication with a corresponding drainage channel in the one or more drainage channels to allow the intraocular fluid to flow from the second end portion to each of the outlets.

[0012] Preferably, the body comprises a plurality of drainage channels in the form of elongated tubular elements.

[0013] Preferably, each element is arranged in parallel to each other to form an array.

[0014] Preferably, the second end portion is at least partially located within the body and extends laterally to the array.

[0015] Preferably, the second end portion extends laterally through each channel.

[0016] Preferably, the elongated tubular component is in the form of a modified medical drainage catheter.

[0017] Preferably, the main body is in the form of a modified multi-tube medical drainage tube.

[0018] This document also discloses a device for guiding the assembly of an ocular implant, the implant having a body and an elongated tubular component, the body comprising a plurality of elongated open tubular elements arranged parallel to each other to form an array, the component having a first end portion and a second end portion, the device comprising:

[0019] A base for positioning the main body; and

[0020] A first sidewall and a second sidewall, extending from the base at its outer periphery to restrict movement of the body relative to the base, wherein the first sidewall and the second sidewall are arranged laterally relative to each other.

[0021] The first sidewall includes an opening to allow a piercing device to pass through it to pierce each of the tubular elements of the body to form a laterally extending passage through the array, such that the second end portion can pass through the passage, and

[0022] The second sidewall includes a plurality of orifices aligned with a corresponding open end of each of the tubular elements, such that the piercing device can pass through the orifices and through the open end to pierce the second end portion laterally.

[0023] Preferably, the first sidewall includes a first cut portion disposed at the outer end portion of the opening, and the second sidewall includes a plurality of second cut portions, each of the plurality of second cut portions being disposed at the outer end portion of each opening, wherein the first cut portion and the second cut portion at least facilitate the passage of the piercing device.

[0024] Preferably, the device further includes a support portion integrally formed with the base to at least aid in gripping the device.

[0025] Preferably, the support portion includes a contoured gripping portion that is substantially aligned with the first sidewall.

[0026] Preferably, the opening is a first channel extending through the first sidewall, and each orifice is a second channel extending through the second sidewall.

[0027] This article also discloses a method for guiding the assembly of an ocular implant, the implant being configured to deliver intraocular fluid from a site of excess intraocular fluid within the patient, the method comprising:

[0028] A device is provided for guiding the assembly of the ocular implant, the device comprising:

[0029] Base; and

[0030] A first sidewall and a second sidewall, extending from the base at the outer periphery of the base, wherein the first sidewall and the second sidewall are arranged laterally relative to each other.

[0031] The first sidewall includes an opening, and

[0032] The second sidewall includes multiple openings;

[0033] A multi-tube medical drainage tube is provided, the drainage tube having a plurality of elongated tubular elements arranged parallel to each other to form an array, wherein each element has an outlet formed at each end of the element;

[0034] The drainage tube is sized to allow it to be positioned on the base of the device;

[0035] Position the drainage tube on the base and arrange the drainage tube such that each outlet is aligned with a corresponding orifice;

[0036] The drainage tube is pierced through the opening to form a passage that extends laterally through the array;

[0037] A medical catheter is provided 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;

[0038] Positioning the second end portion as a passage through the drainage tube; and

[0039] The second end portion is pierced through each orifice to form a plurality of openings in the second end portion, wherein each opening is in fluid communication with a corresponding outlet. Attached Figure Description

[0040] Preferred embodiments of the present disclosure will now be described by way of example only, with reference to the accompanying drawings and description, in which:

[0041] Figure 1 This is a schematic front view of an ocular implant according to an embodiment of the present disclosure;

[0042] Figure 2 yes Figure 1 A schematic side view of an eye implant;

[0043] Figure 3 This is for guided assembly according to embodiments of the present disclosure. Figure 1 A perspective view of the device used for eye implants;

[0044] Figure 4 It is a guide assembly according to another embodiment of the present disclosure. Figure 1 A perspective view of the device used for eye implants;

[0045] Figure 5 This is a guide assembly according to yet another embodiment of the present disclosure. Figure 1 A perspective view of the device for an eye implant; and

[0046] Figure 6 It is an illustrative representation of the use. Figure 3 , Figure 4 or Figure 5 Device-guided assembly Figure 1 A flowchart of the steps associated with the method of implanting an eye implant. Detailed Implementation

[0047] Refer to the attached diagram. Figure 1 and 2 The illustration schematically depicts an ocular implant or shunt 10 for draining intraocular fluid from areas of excess intraocular fluid within a patient. In the depicted embodiment, the shunt 10 is configured to drain aqueous humor out of the anterior chamber of the eye. The shunt 10 can be used to treat glaucoma by being configured to reduce intraocular pressure (IOP) to a physiologically normal level.

[0048] The shunt 10 includes a body 12. In the depicted embodiment, the body 12 is generally rectangular in configuration and has a pair of longitudinally opposed proximal portions 14 and distal portions 16, and a pair of opposing lateral sides 18 each extending laterally between the proximal portions 14 and the distal portions 16. The body 12 has a length dimension of approximately 20 mm, a height dimension of approximately 15 mm, and a width dimension of approximately 2 mm. However, it should be understood that the shape and size of the body 12 can vary. For example, the body 12 can be a circular, square, hexagonal, or other polygonal configuration.

[0049] The 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 forming a lateral side 18 of the body 12. Outlet 24 ( Figure 2Each end portion 22 is provided in fluid communication with a drainage site, such as Schlemm's channel, located away from areas with excessive intraocular fluid—i.e., the anterior chamber. The length 26 of each element 20 extends between the respective end portions 22 and provides a lumen extending between outlets 24 through which intraocular fluid or aqueous humor can flow. In the depicted embodiment, each of the length 26 and the outlet 24 has an outer diameter of approximately 2 mm. Each element 20 is preferably formed of a material that provides relatively good flexibility, elasticity, and biocompatibility, such as medical-grade silicone.

[0050] Each tubular element 20 is connected 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 extending laterally with respect to the elements 20 between the proximal portion 14 and the distal portion 16. Those elements 20 arranged on 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 a generally undulating or corrugated profile to the body 12.

[0051] In one or more embodiments, the body 12 can be conveniently formed by modifying a standard multi-tube medical tissue drainage tube (e.g., an abdominal drainage tube) that is readily available in clinical settings (e.g., hospitals) worldwide.

[0052] The diverter 10 further includes an elongated tubular component 30 in fluid communication with the body 12. Component 30 has a first end portion 32 providing an inlet 38, a second end portion 34 providing a distal end 40, and a length 36 extending between the inlet 38 and the end portion 40. The length 36 provides a lumen through which intraocular fluid or aqueous humor can flow. The first end portion 32, the length 36, and the second end portion 34 preferably have an outer diameter in the range of approximately 0.5 mm to 0.9 mm, more preferably 0.7 mm. Component 30 is preferably formed of the same material as the body 12, or may be formed of other suitable materials.

[0053] Inlet 38 is in fluid communication with a region of excess intraocular fluid (i.e., the anterior chamber), allowing intraocular fluid to flow through inlet 38 and through a lumen of length 36 to end 40.

[0054] In the depicted embodiment, the second end portion 34 extends through a passage or channel formed along axis 28 through each element 20. The distal end 40 of the second end portion 34 terminates within the element 20 forming the distal portion 16. However, it is conceivable that the second end portion 34 may be arranged entirely above the element 20 or offset relative to axis 28.

[0055] The second end portion 34 is perforated to provide multiple openings 42 leading to a lumen of length 36. Figure 2Each opening 42 is in fluid communication with a corresponding lumen of the length 26 of the plurality of elements 20 to allow intraocular fluid to flow from the lumen of the length 36 of the second end portion 34 to each lumen of the length 26 and toward the outlet 24. It should be understood that the diameter of each opening 42 is smaller than the diameter of the second end portion 34.

[0056] In one or more embodiments, component 30 can be conveniently formed by modifying a standard medical drainage catheter that is readily available in clinical settings worldwide, such as hospitals. The size (i.e., specification) of the catheter can be selected according to the suitability of the application. In a preferred embodiment, the catheter size is 24G to provide a shunt drainage rate of approximately 6 ml / min.

[0057] The body 12 may include one or more eyelets (not shown) to facilitate suturing the shunt 10 to the patient's eye.

[0058] The corrugated profile of the body 12 facilitates the sequential filling of each element 20 with intraocular fluid according to the IOP. Therefore, the shunt 10 provides a valve effect without any moving parts, such that if the IOP is relatively high, the fluid flow through the shunt 10 will increase, thereby increasing the drainage rate. Conversely, if the IOP is relatively low, the fluid flow through the shunt 10 will decrease, thereby reducing the drainage rate.

[0059] Furthermore, the corrugated tubular element 20 can be filled with sustained-release drug formulations (e.g., pills or gels) to reduce postoperative inflammation and minimize additional scar tissue formation, or to provide additional IOP reduction when needed. The configuration of the open end portion 22 of the tubular element 20 means that the element 20 can be refilled later as needed.

[0060] refer to Figure 3 The diagram schematically depicts a device or fixture 50 for guiding the assembly of the splitter 10.

[0061] The clamp 50 includes a base 52, which is rectangularly configured and has a generally flat receiving surface 54. A first axis 56 extends perpendicular to the surface 54. Sidewalls 58 extend upward from the base 52 along a direction parallel to the axis 56 around the outer periphery of the base 52 to partially surround the surface 54. Each sidewall 58 preferably has a height measured from the surface 54 that is greater than the width of the body 12. The sidewalls 58 are arranged as a first pair of opposing sidewalls 58a and a second pair of opposing sidewalls 58b. The first pair of opposing sidewalls 58a is arranged perpendicular to the second pair of opposing sidewalls 58b.

[0062] The clamp 50 has a second axis 60 and a third axis 62, wherein the third axis 62 is perpendicular to the second axis 60. Each of the axes 60 and 62 extends perpendicular to the first axis 56 between a respective pair of opposing sidewalls 58. That is, the second axis 60 extends between the first pair of opposing sidewalls 58a, and the third axis 62 extends between the second pair of opposing sidewalls 58b.

[0063] The clamp 50 includes a hole 64 extending through one of the sidewalls 58 of the first pair 58a in a direction parallel to the axis 60. In the depicted embodiment, the hole 64 is aligned with the axis 60 and centered between the second pair of opposing sidewalls 58b. The diameter of the hole 64 is equal to or greater than the diameter of the tubular member 30. A cylindrical protrusion 63 is formed concentrically with the hole 64 on the sidewall 58 and extends laterally away from the sidewall 58. As will be described below, the protrusion 63 and the hole 64 are configured to serve as guides for a piercing device (e.g., a needle) to form a passage laterally through each element 20 of the body 12.

[0064] The clamp 50 further includes a plurality of orifices 66 extending through each sidewall 58 of the second pair 58b in a direction parallel to axis 62. In the depicted embodiment, each orifice 66 is equidistant from the sidewalls 58 of the second pair 58b. The number of orifices 66 preferably corresponds to the number of elements 20. However, it should be understood that the clamp 50 may have a greater number of orifices 66 than the number of elements 20. The diameter of each orifice 66 is equal to or greater than the diameter of the opening 42. Each orifice 66 extending through one sidewall 58 of the second pair 58b is aligned with a corresponding orifice 66 extending through the other sidewall 58 of the second pair 58b. As will be described below, each orifice 66 is configured to function as a lateral guide for perforating the second end portion 34 to form each opening 42.

[0065] The clamp 50 further includes a plurality of straight grooves 68 that partially penetrate each sidewall 58 and cut downwards to the surface 54 and are arranged obliquely relative to axes 60, 62. It should be understood that the arrangement and shape of the grooves 68 may vary. As will be described below, the grooves 68 are configured to serve as guides for surgical cutting of the body 12.

[0066] A support base (not shown) may be integrally formed with the clamp 50 to help hold the clamp 50.

[0067] The clamp 50 can be manufactured using a three-dimensional (3D) printing process employing commonly used 3D printing thermoplastics (such as polylactic acid (PLA) and acrylonitrile butadiene styrene (ABS)) and computer-aided design (CAD) software. It should be understood that the clamp 50 can be easily 3D printed and sterilized to facilitate rapid intraoperative guided assembly of the shunt 10, as described below. Compared to other implantable devices, the CAD model of the clamp 50 can be easily shared with developing countries, minimizing costs associated with implant packaging, transportation, storage, and logistics.

[0068] refer to Figure 4 The diagram schematically depicts a device or fixture 150 for guiding the assembly of the splitter 10. The fixture 150 has a basic construction similar to that of the fixture 50. Features of the fixture 150 that are equivalent to those of the fixture 50 are represented by the same reference numerals as those of the fixture 50, with an additional reference numeral of 100.

[0069] The clamp 150 includes a base 152, which is rectangularly configured and has a generally flat receiving surface 154. A first axis 156 extends perpendicular to the surface 154. Sidewalls 158 extend upward from the base 152 along a direction parallel to the axis 156 around the outer periphery of the base 152 to partially surround the surface 154. Each sidewall 158 preferably has a height measured from the surface 154 that is greater than the width of the body 12. The sidewalls 158 are arranged as a first pair of opposing sidewalls 158a and a second pair of opposing sidewalls 158b. The first pair of opposing sidewalls 158a is arranged perpendicular to the second pair of opposing sidewalls 158b.

[0070] The clamp 150 has a second axis 160 and a third axis 162, wherein the third axis 162 is perpendicular to the second axis 160. Each of axes 160 and 162 extends perpendicular to the first axis 156 between a respective pair of opposing sidewalls 158. That is, the second axis 160 extends between the first pair of opposing sidewalls 158a, and the third axis 162 extends between the second pair of opposing sidewalls 158b.

[0071] The clamp 150 includes a pair of opposing holes 164 extending through a corresponding sidewall 158 of the first pair 158a in a direction parallel to axis 160. In the depicted embodiment, the holes 164 are aligned with axis 160 and centered between the second pair of opposing sidewalls 158b. The width dimension of the holes 164 is equal to or greater than the diameter of the tubular member 30. The holes 164 are preferably located at a depth measured from surface 154, which is at the midpoint of the body 12. Wedge-shaped cuts 165 are formed at the exterior or outer end of each hole 164 in each sidewall 158a to guide the tubular member 30 through each hole 164. As will be described below, the holes 164 are configured to serve as guides for piercing devices (e.g., needles) to form a passage laterally through each element 20 of the body 12.

[0072] The clamp 150 further includes a plurality of orifices 166 extending through each sidewall 158 of the second pair 158b in a direction parallel to axis 162. In the depicted embodiment, each orifice 166 is equidistant from the sidewalls 158 of the second pair 158b. The number of orifices 166 preferably corresponds to the number of elements 20. However, it should be understood that the clamp 150 may have a greater number of orifices 166 than the number of elements 20. The width dimension of each orifice 166 is equal to or greater than the diameter of opening 42. The orifices 166 are preferably located at a depth measured from surface 154, which is at the midpoint of body 12. Additional wedge-shaped notches 167 are formed at the corresponding outer or outer end of each orifice 166 in each sidewall 158b to facilitate guiding the piercing device through each orifice 166. Each aperture 166 extending through one sidewall 158 of the second pair 158b is aligned with a corresponding aperture 166 extending through the other sidewall 158 of the second pair 158b. As will be described below, each aperture 166 is configured to function as a lateral guide for perforating the second end portion 34 to form each opening 42.

[0073] The clamp 150 further includes a plurality of straight grooves 168a, which partially penetrate each sidewall 158 and cut downwards to or through the surface 154 and are arranged obliquely relative to axes 160, 162. Additional straight grooves 168b, 168c are formed across a corresponding pair of sidewalls 158a, 158b and extend downwards parallel to or through the surface 154 relative to axes 160, 162, respectively. It should be understood that the arrangement and shape of the grooves 168a, 168b, 168c can vary. As will be described below, the grooves 168a, 168b, 168c are configured to serve as guides for the surgical knife cutting of the body 12.

[0074] The clamp 150 further includes a support portion 170 integrally formed with the base 152, and more specifically, integrally formed with each sidewall 158b. Each support portion 170 extends away from the corresponding sidewall 158b in a direction generally parallel to axis 162. Each support portion 170 includes a pair of contoured gripping portions 172 generally aligned with the sidewall 158a to facilitate gripping of the clamp 150. A reinforcement 174 extends between these pairs of gripping portions 172 to provide rigidity to the support portion 170. The reinforcement 174 may also serve as a clamping surface to further facilitate gripping of the clamp 150.

[0075] The clamp 150 can be manufactured using a three-dimensional (3D) printing process employing commonly used 3D printing thermoplastics (such as polylactic acid (PLA) and acrylonitrile butadiene styrene (ABS)) and computer-aided design (CAD) software. It should be understood that the clamp 150 can be easily 3D printed and sterilized to facilitate rapid intraoperative guided assembly of the shunt 10, as described below. Compared to other implantable devices, the CAD model of the clamp 150 can be easily shared with developing countries, minimizing costs associated with implant packaging, transportation, storage, and logistics.

[0076] refer to Figure 5 The diagram schematically depicts a device or fixture 250 for guiding the assembly of the diverter 10. Fixture 250 has the same configuration as fixture 150, except for the arrangement of the holes 164 and orifices 166. In fixture 250, holes 164 and orifices 166 are replaced by a first channel 264 and a second channel 266 extending linearly through a corresponding pair of sidewalls 158a, 158b, respectively. The width of each channel 264 is equal to or greater than the diameter of the tubular component 30. The width of each channel 266 is equal to or greater than the diameter of the opening 42. Channels 264, 266 preferably extend to a depth measured from surface 154, said depth being located at the midpoint of the body 12.

[0077] The remaining features of the fixture 250, which is identical to fixture 150, will therefore not be described further, and... Figure 5 It is provided with the same attached icon number.

[0078] It should be understood that, compared with fixture 150, the configuration of channels 264 and 266 can improve the convenience of fixture 250, the repeatability of 3D printing, and the ease of mass production.

[0079] Reference Figure 6 The flowchart in the document describes a method for assembling the splitter 10 using a fixture 50.

[0080] In step 101, a clamp 50 is provided. Then, in step 103, a standard multi-tube medical tissue drainage system (e.g., an abdominal tissue drainage system) is sized so that the system can be fitted onto surface 54 while being laterally supported by sidewalls 58. Then, in step 105, the system is positioned on surface 54 and arranged such that each outlet of the system is aligned with a corresponding orifice 66 of the sidewall 58 in the second pair 58b.

[0081] In step 107, a needle or other suitable piercing device is inserted through the protrusion 63 and the hole 64 to pierce the tubing in a direction parallel to the axis 64, thereby forming a passage or channel through the tubing array. In this way, the body 12 of the diverter 10 is formed.

[0082] In step 109, the needle is removed, and a cannula of a predetermined specification (or other suitable silicone tubing) is inserted through the protrusion 63 and the hole 64 and partially positioned within the passage of the tubing 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 providing it to the operating end of the needle when the needle pierces the tubing and leaving a portion of the cannula within the passage when the needle is subsequently withdrawn from the tubing.

[0083] At step 111, another needle or other suitable piercing device is subsequently inserted through each orifice 66 and through the outlet of the tube to pierce the sleeve laterally, thereby creating each opening 42. In this way, component 30 is formed. It should be understood that the needle used to form the passage may remain within the body 12, while another needle is used to form each opening 42.

[0084] Then, in optional step 113, the body 12 of the shunt 10 can be cut off by using a scalpel to guide the removal of the body 12 through the use of grooves 68 to allow the body 12 to easily conform to the spherical geometry or by removing unnecessary tubing material to reduce the effective stiffness of the shunt 10. This may at least help to reduce the edge profile of the shunt 10 to prevent corrosion. The therapeutic agent may be inserted (and periodically replenished) into each element 20 of the parallel tubing array as a paste or as a liquid embedded with a sealing agent (such as medical-grade carboxymethyl cellulose or petroleum jelly) to allow for gradual local release of the agent. Clinicians may determine the dosage according to the specific needs of the patient.

[0085] The assembled shunt 10 can then be removed from the clamp 50 and implanted into the patient using conventional methods.

[0086] It should be understood that clamps 150 and 250 can also be used instead of clamp 50 in a substantially similar manner to guide the assembly of the diverter 10 using clamp 50 as described above. It should be understood that the wedge-shaped cuts 165 and 167 of clamps 150 and 250 can facilitate the entry of needles or other suitable piercing devices and cannulas during steps 107, 109, and 111. The gripping portions 172 and reinforcements 174 of clamps 150 and 250 can further facilitate holding clamps 150 and 250 during steps 107, 109, 111, and 113.

[0087] In another aspect of this disclosure, clamps 50, 150, and 250 may be used to mold a fast-curing biocompatible elastomer resin chassis (not shown) around component 30. This can either replace the parallel tubing array or reinforce the array by helping it solidify into a spherical profile. This can alleviate shunt migration. A second clamp may be present to conform the parallel tubing array to a spherical profile that matches the patient's eye and / or to aid surgical implantation and anchoring. The clamp design can be adjusted clinically to match the diameter and / or shape of the patient's eye anatomy at a given deployment location. The elastomer resin may consist of liquid silicone resin (platinum-catalyzed liquid silicone resin), thermoplastic polyurethane resin, thermoplastic plastic, polycaprolactone, or other low-hardness (Shore hardness 20A-55D) fast-curing biocompatible elastomer. The polymer material used may be biostable or partially bioabsorbable or partially soluble.

[0088] In another aspect of this disclosure, the chassis described above may contain multiple (typically 1-4) reservoirs that can be used to help regulate IOP changes and, for example, to store and gradually release bioactive therapeutic agents that help manage glaucoma or antibiotics or antibacterial agents, anti-obstructive agents, or biocompatible agents that can be used to infer flow rates within the shunt. The reservoirs may be periodically refilled by an ophthalmologist. In another alternative, an optometrist may use a specialized applicator to refill the elution reservoirs with glaucoma medications, etc.

[0089] In another aspect of this disclosure, both the chassis and the shunt tube are templated using a 3D printing process with a fast-curing biocompatible elastomer resin (e.g., platinum-catalyzed liquid silicone rubber). The templated shunt may incorporate variations in the lumen cross-section within a portion of the shunt to form a sphere along the length of the tube. This sphere may be cylindrical or spherical. A sphere shape factor will allow the active pressure of the shunt fluid to influence the size of the sphere, enabling real-time inference of IOP by monitoring the contour of the bulge caused by the sphere beneath the sclera of the patient's eye.

[0090] It should be understood that the shunt 10 and clamps 50, 150, 250 described above can provide a relatively low-cost, effective, robust and safe intervention for the treatment of glaucoma using readily available clinical consumables.

[0091] Those skilled in the art will understand that various modifications can be made to the described shunt and / or fixture without departing from the scope of this specification.

[0092] List of reference numerals

[0093] 10 shunt 16 distal section

[0094] 12 Main body 18 Lateral side

[0095] 14 Proximal portion 20 Tubular elements

[0096] 22. End portion of tubular element with 64 holes.

[0097] 24 outlets, 66 orifices

[0098] 26. Length of tubular element: 68. Groove.

[0099] 28 Symmetry axis 150 Fixture

[0100] 30 Tubular components 152 Base

[0101] 32 First end portion 154 of the tubular component Receiving surface

[0102] 34 The second end portion of the tubular component 156 The first axis

[0103] 36. Length of tubular component: 158. Sidewall

[0104] 38. Entrance 158a. First pair of opposing sidewalls.

[0105] 40 End of tubular component 158b Second pair of opposing sidewalls

[0106] 42 Opening 160 Second Axis

[0107] 50 Fixture 162 Third Axis

[0108] 52 base with 164 holes

[0109] 54 Receiving surface 166 orifices

[0110] 56 First axis 168a-b groove

[0111] 58 Sidewall 170 Supporting Part

[0112] 58a First pair of opposing sidewalls 172 Grip portion

[0113] 58b Second pair of opposing sidewalls 174 Reinforcing members

[0114] 60 Second Axis 264 First Channel

[0115] 62 Third Axis 266 Second Channel

[0116] 63 Cylindrical protrusion

Claims

1. An ocular implant for delivering intraocular fluid from a site of excess intraocular fluid within a patient, the implant comprising: The body comprises a plurality of elongated tubular elements, each of which has a length extending between outlet pairs, wherein, Each outlet is in fluid communication with a drainage site located away from the site of excessive intraocular fluid; as well as An elongated tubular component capable of fluid communication with the main body, the elongated tubular component 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 in fluid communication with the area of ​​excessive intraocular fluid, allowing the intraocular fluid to flow through the inlet and through the lumen to the end. The second end portion includes a plurality of openings, each in fluid communication with a corresponding length of the plurality of elongated tubular elements, to allow intraocular fluid to flow from the second end portion to each of the outlets. Wherein, the outlets of the outlet pair are located on different sides of the second end portion of the elongated tubular component, and In this configuration, adjacent elements among the plurality of elongated tubular elements are directly connected to each other along their respective lengths.

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

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

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

5. The implant according to claim 1, wherein, The elongated tubular component is formed from a medical drainage catheter.

6. The implant according to claim 1, wherein, The main body is formed by multiple medical drainage tubes.

7. A device for guiding the assembly of an ocular implant according to claim 1, the device comprising: A base for positioning the main body; and First and second sidewalls, extending from the base at its outer periphery to restrict movement of the body relative to the base, wherein, The first and second sidewalls are arranged laterally relative to each other. The first sidewall includes an opening to allow a piercing device to pass through it to pierce each of the elongated tubular elements of the body to form a laterally extending passage through the array, such that the second end portion can pass through the passage, and The second sidewall includes a plurality of orifices aligned with a corresponding open end of each of the elongated tubular elements, such that the piercing device can pass through the orifices and through the outlet to pierce the second end portion laterally.

8. The apparatus according to claim 7, wherein, The first sidewall includes a first cut portion disposed at the outer end portion of the opening, and wherein the second sidewall includes a plurality of second cut portions, each second cut portion being disposed at the outer end portion of each of the plurality of orifices, wherein the first cut portion and the second cut portions at least facilitate the passage of the piercing device.

9. The device of claim 8, further comprising a support portion integrally formed with the base to at least aid in gripping the device.

10. The apparatus according to claim 9, wherein, The support portion includes a contoured gripping portion that is substantially aligned with the first sidewall.

11. The apparatus according to claim 7, wherein, The opening is a first channel extending through the first sidewall, and each of the openings is a second channel extending through the second sidewall.

12. A method for guiding the assembly of the ocular implant according to claim 1, the method comprising: Provide the apparatus according to claim 7; A multi-tube medical drainage system is provided, the drainage tube having a plurality of elongated tubular elements arranged parallel to each other to form an array, wherein, Each of the elongated tubular elements has an outlet formed at each end of the elongated tubular element; The drainage tube is sized to allow it to be positioned on the base of the device; Position the drainage tube on the base and arrange the drainage tube such that each of the outlets is aligned with the corresponding orifice in the orifice of the device; The drainage tube is pierced through the opening of the device to form a passage that extends laterally through the array; A medical catheter is provided 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; Position the second end portion as a passage through the drainage tube; as well as The second end portion is pierced through each of the orifices to form a plurality of openings leading to the lumen, wherein each of the openings is in fluid communication with a corresponding outlet in the outlet.

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