Modular tube shunt system for glaucoma treatment

Abstract

A system for treating glaucoma is disclosed, comprising a modular tube shunt implant with a flexible plate and a separable fluid drainage tube, which are inserted separately and connected post-insertion. The system includes a tube inserter featuring a delivery cannula with a needle-tipped distal end and a plunger with an ejection rod, configured to puncture the sclera and deliver the tube into the anterior chamber. A plate inserter, also comprising a cannula and plunger, is configured to deploy the flexible plate in a compact form through the same small conjunctival incision, where it expands to lie flat against the sclera. The connection mechanism enables the plate and tube to be easily connected through the incision. The system is designed for minimally invasive surgery, utilising small-diameter cannulas for efficient deployment of both components, reducing tissue damage and recovery time.

Description

Modular Tube Shunt System for Glaucoma TreatmentField of the Invention

[0001] The present invention relates to medical devices and methods for the treatment of glaucoma. Specifically, it concerns a modular tube shunt system designed to manage intraocular pressure by facilitating fluid drainage from the eye, utilising a minimally invasive procedure involving separate inserters for a flexible plate and fluid drainage tube, which are deployed and connected through a small incision in the conjunctiva.Background of the Invention

[0002] Glaucoma is a group of eye conditions that can lead to optic nerve damage and vision loss, often associated with elevated intraocular pressure. The natural drainage system in the eye becomes obstructed over time, leading to increased pressure that can damage the optic nerve, which is responsible for transmitting visual information from the eye to the brain.

[0003] One approach to treating glaucoma involves the surgical insertion of tube shunts to provide an alternative pathway for aqueous humour drainage.

[0004] US 2018 / 01 10650 A1 (DA SILVA CURIEL JEANNETTE M A et al.) 26 April 2018 [hereinafter referred to as D5] discloses using an applicator designed for delivering a microshunt into the cornea which comprises a fixture body and a distal portion equipped with a cutting means capable of creating an incision in the cornea for microshunt placement. The microshunt is held within a cannula lumen and is retained around using a plunger-type deployment mechanism. This mechanism allows the microshunt to be deployed once the distal section of the applicator passes through the cornea and into the anterior chamber.

[0005] The deployment process is facilitated by an actuator mounted on the handle, which controls the plunger to release the microshunt. The microshunt can be coupled with a fluid-restricting or delivery element during the procedure, using a screw- unscrew mechanism to attach it securely. This ensures the device is properly positioned within the eye to manage fluid flow and reduce intraocular pressure bybypassing the trabecular meshwork. The opening in the cornea for insertion may be created using various methods, such as a laser or knife, and can be oriented in different directions based on the procedure's requirements.

[0006] US 2005 / 0107734 A1 (CORONEO MINAS T.) 19 May 2005 [hereinafter referred to as D6] discloses a method for treating glaucoma involves the insertion of a flexible ocular device made of biocompatible elastomeric material. This device consists of a fluid drainage tube with a foldable plate at one end. The plate is designed to anchor the device on the inner surface of the sclera, while the other end of the drainage tube remains open to allow fluid communication.

[0007] The procedure begins by making a small self-sealing incision at the junction of the cornea and sclera, which leads into the anterior chamber of the eye. The anterior chamber is then filled with a viscoelastic substance to facilitate the process. Using a hollow cannula, the foldable ocular device is introduced into the suprachoroidal space, which is created by cyclodialysis. The plate is positioned to secure the device on the sclera’s inner surface, while the drainage tube is placed in the anterior chamber to regulate the pressure of the aqueous humor.

[0008] Once the device is correctly positioned, the cannula and viscoelastic material are removed, completing the procedure.

[0009] Although the prior art arrangements described in D5 and D6 provide methods for treating glaucoma through the insertion of drainage devices, they present several challenges and limitations that may complicate the surgical procedure. In the case of D5, the process involves the use of a plunger to insert a microshunt housed within a cannula. One issue with this design is the complexity introduced by having the microshunt located around the plunger, within a wider cannula. This arrangement can lead to difficulties in maintaining alignment during insertion, increasing the potential for misalignment or deformation of the microshunt as it is being deployed. Additionally, the need for a separate cutting mechanism to create the corneal incision adds an extra procedural step, potentially increasing the invasiveness of the procedure and extending the surgery time.

[0010] In D6, while the flexible ocular device allows for fluid drainage, the process requires creating a suprachoroidal space through cyclodialysis, which is a more invasive and technically demanding step. The need for this additional procedure can lead to increased risks of complications, such as tissue damage or improper placement of the device. Moreover, the foldable plate anchoring the drainage tube to the sclera may require a larger incision and more precise manipulation to ensure proper positioning, further complicating the procedure.

[0011] These prior art methods highlight potential drawbacks in the context of glaucoma treatment, such as the risk of misalignment, the need for multiple steps or invasive techniques, and the potential for procedural complications. The complex configurations and additional steps required in these approaches may increase the overall complexity of the procedure, leading to longer surgery times and heightened risks of tissue damage or improper device placement. Furthermore, the larger incisions and multiple components involved can contribute to extended recovery times and a higher likelihood of postoperative complications.Summary of the Disclosure

[0012] A system for the treatment of glaucoma is provided, comprising a modular tube shunt implant with two key components: a flexible plate and a separable fluid drainage tube. The system includes two distinct inserters for the plate and tube, enabling a minimally invasive, two-step operational procedure. This approach allows for the separate deployment of the implant components through a small incision in the conjunctiva, followed by their subsequent connection.

[0013] The tube inserter comprises a delivery cannula with a needle-tipped distal end and a plunger with a longitudinal ejection rod that operates within the cannula. The tube inserter is configured to securely retain the drainage tube within the cannula, allowing the distal needle to puncture the sclera and access the anterior chamber. The plunger is then operated to eject the tube longitudinally from the cannula into the anterior chamber while the cannula is simultaneously retracted. This single, rapid motion ensures that the distal end of the tube is correctly positioned in the anteriorchamber, while the proximal end of the tube remains accessible through the small conjunctival incision against the sclera.

[0014] The plate inserter is configured with a chamber and a delivery cannula. The flexible plate is loaded into the inserter in a compact form and then ejected through the same small conjunctival incision. The plunger forces the plate through the cannula, where it opens up and flattens against the sclera. Following this, the plate and tube are easily connected through the small incision via the connection mechanism.

[0015] The tube inserter is preferably designed such that the external diameter of the drainage tube matches the internal diameter of the delivery cannula, preventing deformation or bending during ejection.

[0016] Both the tube inserter and the plate inserter are designed to work with relatively small cannulas, such as preferably less than 3 mm in diameter. This allows for the deployment of both the tube and the plate through a single small conjunctival incision, minimising tissue damage and enabling a less invasive surgical approach. By simplifying the insertion and connection process, the present system enhances procedural efficiency and reduces the potential for complications.

[0017] According to one aspect, there is provided a system for the treatment of glaucoma is provided, comprising a modular tube shunt implant that includes a flexible plate and a separable fluid drainage tube. The system further includes a tube inserter and a plate inserter, each configured to deliver the tube and plate through a small conjunctival incision. The tube inserter comprises a delivery cannula with a needle-tipped distal end and a plunger with an ejection rod, which allows the tube to be ejected into the anterior chamber while the cannula is simultaneously withdrawn. The plate inserter delivers the flexible plate in a compact form, where it expands and lies flat against the sclera, and the plate is connected to the tube via a connection mechanism through the same small incision.

[0018] According to an embodiment, the plate inserter is configured with a chamber that funnels towards the delivery cannula, compressing the flexible plate into a compact form during insertion. This allows for easy insertion through the cannula,ensuring that the plate can be smoothly deployed through the small conjunctival incision. Preferably, the cannula of the plate inserter is less than 3 mm in diameter, minimising tissue damage and reducing the invasiveness of the procedure.

[0019] In a preferred arrangement, the delivery cannula of the tube inserter is designed to retain the tube such that the external diameter of the tube conforms closely to the internal diameter of the cannula. This alignment prevents deformation or bending during insertion, ensuring reliable and accurate positioning of the tube in the anterior chamber. This feature simplifies the insertion process, allowing for quick deployment of the tube with reduced risk of misalignment.

[0020] Optionally, the flexible plate may include a well that defines a reservoir for aqueous humour drainage. This well structure enhances the regulation of intraocular pressure by providing an effective fluid management system once the implant is in place.

[0021] In another embodiment, the plate may be provided with apertures for securement stitches, preferably located at the anterior edge of the plate. These apertures allow for secure attachment of the plate to the sclera during the procedure, providing stability and proper positioning of the implant.

[0022] According to a further embodiment, the connection mechanism may comprise a funnel insertion channel and a semicylindrical engagement channel for receiving the proximal end of the tube. This connection mechanism allows for quick and secure attachment of the tube to the plate once both components have been inserted.

[0023] Optionally, the connection mechanism may instead include a sleeve on the plate into which the distal end of the tube is inserted. This configuration provides a straightforward method for fluid connection between the plate and the tube after insertion.

[0024] In another embodiment, the connection mechanism may comprise an interlocking engagement designed to secure the tube in place with respect to the plate. This interlocking feature ensures that the tube remains securely attached to the plate, minimising the risk of disconnection during and after surgery.

[0025] Preferably, both the tube inserter and the plate inserter utilise cannulas that are less than 3 mm in diameter. This ensures that both components can be delivered through a small incision, reducing surgical trauma and improving recovery time.

[0026] In an optional embodiment, the plate may retain an active element, such as a pressure sensor operably coupled to a transmitter to monitor intraocular pressure. This feature allows for real-time feedback and improved control over the fluid management system within the eye.

[0027] According to another embodiment, the active element may include a flow control mechanism comprising pincers that pinch the proximal end of the tube to regulate fluid flow. This mechanism offers precise control over the rate of aqueous humour drainage, optimising intraocular pressure regulation post-implantation.

[0028] In a further embodiment, the plate may include a retention tab terminating in a barb, allowing for secure attachment to the sclera without the need for sutures. The barb provides a stable engagement with the sclera, reducing the complexity of the surgical procedure and minimising the risk of postoperative complications.

[0029] In accordance with another aspect there is provided a method of inserting the implant is provided, comprising inserting a distal end of the tube into the anterior chamber using the tube inserter. In this method, the cannula of the tube inserter punctures the sclera, and the plunger is operated to eject the tube while the cannula is simultaneously retracted, leaving the tube in place. This process ensures the distal end of the tube is correctly positioned in the anterior chamber while the proximal end remains accessible for connection through the conjunctival incision.

[0030] According to an embodiment of the method, the tube is ejected from the cannula in a longitudinal manner by the operation of the plunger, ensuring that the tube remains aligned throughout the process.

[0031] The method further includes inserting the flexible plate using the plate inserter, where the plate is ejected through the same conjunctival incision in a compact form. Once delivered, the plate opens up and lies flat against the sclera, ready for connection to the tube. The connection of the plate to the proximal end of the tube is then performed through the incision using the connection mechanism.

[0032] Optionally, the method may further comprise securing the plate to the sclera using the securement apertures provided on the plate. In another embodiment, the connection between the plate and the tube is achieved using a funnel insertion channel and a semicylindrical engagement channel as described in the system.

[0033] According to another embodiment of the method, the active element is inserted into the well of the plate. The active element may comprise a flow control mechanism, which is operated to control fluid flow through the proximal end of the tube.

[0034] The method may further comprise using a flow control mechanism with pincers that can be actuated to regulate the flow of aqueous humour through the drainage tube, providing precise control over intraocular pressure.

[0035] In a further embodiment, the method includes securing the plate to the sclera without the use of sutures, by utilising a retention tab on the plate that terminates in a barb. This method step simplifies the overall procedure and minimises the need for additional tools, reducing the potential for postoperative complications.

[0036] In yet another embodiment of the method, the barb of the retention tab is inserted through a scleral flap and engages with the edge of a proximal scleral incision to secure the plate in place, ensuring proper alignment and stability during the procedure.

[0037] Other aspects of the invention are also disclosed.Brief Description of the Drawings

[0038] Notwithstanding any other forms which may fall within the scope of the present invention, preferred embodiments of the disclosure will now be described, by way of example only, with reference to the accompanying drawings in which:

[0039] Figure 1 shows a tube inserter in accordance with an embodiment.

[0040] Figures 2-4 illustrate the use of the tube inserter to deploy a tube from its needle, wherein Figure 2 shows the tube fully retained within the needle before insertion, Figure 3 shows the plunger commencing to push the tube from the needle, and Figure 4 shows the tube nearly fully ejected from the needle.

[0041] Figures 5-7 demonstrate the insertion of the tube into the anterior chamber using the tube inserter, wherein Figure 5 shows the insertion of the needle throughthe sclera into the anterior chamber, Figure 6 shows the operation of the plunger pushing the tube into the anterior chamber while the needle is being withdrawn, and Figure 7 shows the tube fully inserted with the needle withdrawn.

[0042] Figure 8 shows a plate inserter in accordance with an embodiment.

[0043] Figures 9-12 depict the use of the plate inserter to deploy a plate in a compact form, wherein Figure 9 shows the plate retained within the inserter chamber, Figure10 shows the plunger beginning to force the plate through the funnelled outlet, Figure11 shows the plate in its compact configuration at the outlet, and Figure 12 shows the plate fully ejected and expanded to lie flat against the sclera.

[0044] Figure 13 shows the plate with a well designed to hold and dissipate fluid from the tube, along with the placement of apertures for securement stitches.

[0045] Figure 14 displays the wall of the well with a push-in profile, featuring a funnel insertion channel leading to a semicylindrical engagement channel.

[0046] Figure 15 demonstrates the alignment of the tube with the push-in profile, preparing for insertion.

[0047] Figure 16 depicts the tube’s proximal end being pushed sideways through the funnel insertion channel until it engages with the semicylindrical channel.

[0048] Figure 18 shows an alternative embodiment where the plate includes a sleeve into which the distal end of the tube is inserted.

[0049] Figures 21-24 illustrate a different connection mechanism involving a tube engagement and interlocking engagement, wherein Figure 21 shows the plate with the well and tube engagement, Figure 22 shows the insertion of the proximal end of the tube into the tube engagement, Figure 23 shows the gate being fitted over the tube, and Figure 24 shows the interlocking engagement securing the tube in place.

[0050] Figure 27 displays the active element with a flow control mechanism within the well of the plate.

[0051] Figures 28-30 depict the operation of the flow control mechanism, wherein Figure 28 shows the pincers fully open allowing unrestricted flow, Figure 29 shows the pincers partially closed to partially occlude flow, and Figure 30 shows the pincers fully closed to block fluid flow from the tube.

[0052] Figures 31 -40 illustrate the step-by-step process of implant insertion, including making an incision, retracting the conjunctival flap, inserting the tube through the sclera, ejecting the plate, securing the plate and tube, connecting the tube to the plate, inserting the active element, closing the conjunctival flap, and suturing the incision. Specifically, Figure 31 shows the initial conjunctival incision, Figure 32 shows the retraction of the conjunctival flap, Figure 33 shows the insertion of the tube through the sclera into the anterior chamber, with the tube remaining in place as shown in Figure 34. Figure 35 illustrates the plate being ejected in compact form, Figure 36 shows the plate expanding to lie flat against the sclera, Figure 37 depicts the connection of the tube to the plate, Figure 38 shows the insertion of the active element into the well, and Figure 39 shows the closure of the conjunctival flap and suturing. Finally, Figure 40 illustrates the complete concealment of the plate beneath the conjunctival flap, with the distal end of the tube positioned within the anterior chamber.

[0053] Figures 41 -43 show an embodiment of the plate designed to be affixed without sutures, featuring a retention tab with a barb, wherein Figure 41 shows the plate with the retention tab, Figure 42 shows the positioning of the retention tab for insertion, and Figure 43 shows the engagement of the barb to secure the plate.

[0054] Figures 44-47 illustrate the securement of the plate using the retention tab, including the creation of a scleral flap, the insertion of the retention tab, and the engagement of the barb to hold the plate in place, wherein Figure 44 shows the creation of the scleral flap, Figure 45 shows the insertion of the retention tab through the distal incision, Figure 46 shows the advancement of the retention tab through the tunnel, and Figure 47 shows the engagement of the barb with the proximal incision edge.

[0055] Figures 48-50 depict an alternative internal insertion method, where the tube is inserted through the cornea, across the anterior chamber, and through the opposite corneal wall, wherein Figure 48 shows the insertion of the needle through the cornea, Figure 49 shows the advancement of the needle across the anterior chamber, and Figure 50 shows the tube being ejected as the needle is withdrawn.Description of Embodiments

[0056] The system for the treatment of glaucoma comprises a modular tube shunt implant, which includes a flexible plate 101 and a fluid drainage tube 102. The plate 101 and tube 102 are designed to be inserted separately, with a connection mechanism allowing the tube 102 to be connected to the plate 101 after insertion. The modular design facilitates minimally invasive insertion of the implant components, allowing the surgeon to deploy each component separately and subsequently connect them through a small incision made in the conjunctiva.

[0057] With reference to Figure 13, the plate 101 may comprise a well 103 or similar structure that defines a reservoir for aqueous humour draining from the tube 102 to pool and dissipate. The plate 101 may optionally include securement apertures 104, designed for securing the plate 101 to the sclera with stitches before the tube 102 is connected. In the embodiment shown, a pair of apertures 104 is located at the anterior edge of the plate 101 .

[0058] As further illustrated in Figure 13, the connection mechanism may include a wall 105 of the well 103, configured to connect to the proximal end of the tube 102. The securement apertures 104 may be positioned close to the connection mechanism. In certain embodiments, the apertures 104 are located on either side of the connection mechanism.

[0059] Referring to Figure 14, the wall 105 of the well 103 may include a push -in profile 106, comprising a funnel insertion channel 107 leading to a semicylindrical engagement channel 108. As shown in Figure 15, the tube 102 is aligned with the push-in profile 106. In Figure 16, the proximal end of the tube 102 is pushed sideways through the funnel insertion channel 107 until it engages the semicylindrical engagement channel 108, as illustrated in Figure 17.

[0060] Figure 18 depicts an alternative embodiment in which the plate 101 includes a sleeve 109, into which the distal end of the tube 102 is inserted, as shown in Figures 19 and 20. The sleeve 109 may define a channel 1 10 that interfaces with an opening 1 1 1 , leading from the sleeve 109 to the well 103.

[0061] Figures 21 to 24 illustrate another embodiment where the connection mechanism includes the wall 105 of the well 103, comprising a tube engagement 112 and an interlocking engagement 1 13. In Figure 23, the proximal end of the tube 102 is inserted into the tube engagement 112, after which a gate 1 14 is fitted over it. The gate 1 14 may have interlocking formations 1 15 that engage with the corresponding interlocking engagements 113 to secure the gate 114 against the wall 105, thus securing the tube 102 in place.

[0062] The system includes a tube inserter 116, as shown in Figure 1 , which comprises a delivery cannula 1 17 defining a needle-tipped distal end 139 and a plunger 1 18 comprising a longitudinal ejection rod 118 operative within a lumen 141 defined by the cannula 117. The tube inserter 116 is configured for longitudinally loading the tube 102 within the lumen 141 as shown in Figure 2, puncturing a sclera 129 with the needle-tipped distal end 139 to access an anterior chamber 119 as is shown in Figure 3, and operation of the plunger 140 to cause the ejection rod 118 to eject the tube 102 from the cannula 117, leaving a distal end of the tube 102 within the anterior chamber 1 19 whilst the cannula 1 17 is simultaneously retracted, and wherein a proximal end of the tube is accessibly located against the sclera 129 through an incision 127 made within the conjunctiva.

[0063] Preferably, the tube inserter 1 16 is designed to tightly retain the tube 102 within the lumen of the cannula 1 17, with the external diameter of the tube 102 conforming to the internal diameter of the cannula 1 17. This tight fit ensures the tube is stably aligned during insertion, preventing deformation or bending as it is pushed from behind by the ejection rod 118.

[0064] Figure 2 shows the tube 102 fully retained within the cannula 117 before insertion. Figure 3 illustrates the operation of the plunger 140, commencing the expulsion of the distal end 139 of the tube 102 from the cannula 1 17 by the ejection rod 118 pushing the tube 102 from behind. Figure 4 shows the tube 102 almost entirely ejected from the cannula 1 17 by the ejection rod 118.

[0065] Figures 5 to 7 illustrate the technique for inserting the tube 102 using the tube inserter 1 16. Figure 5 shows the insertion of the needle-tipped distal end 139 of thecannula 1 17 through the sclera 129 into the anterior chamber 1 19. Figure 6 demonstrates the operation of the plunger 140 to push the ejection rod 1 18 through the lumen 141 of the cannula 1 17 to force the tube 102 from the distal end of the cannula 1 17 into the anterior chamber 1 19, while the cannula 1 17 is simultaneously withdrawn. This allows the distal end of the tube 102 to fluidly interface with the aqueous humour within the anterior chamber 1 19. The cannula 1 17 is withdrawn, leaving the tube 102 in place, as shown in Figure 7, with the proximal end of the tube 102 remaining accessible through the conjunctival incision 127.

[0066] Figures 48 to 50 depict an alternative internal insertion method, where the needle-tipped distal end of the cannula 1 17 of the tube inserter 1 16 is first inserted through a proximal wall 137A of the cornea or sclera 129, across the anterior chamber 1 19, and through a distal wall 137B of the cornea or sclera 129. The tube 102 is then ejected from the cannula 1 17 as it is drawn back through the distal wall 137B, leaving the tube 102 passing through the distal wall 137B and out of the proximal wall 137A, as shown in Figure 50.

[0067] The plate 101 is flexible to allow for delivery in compact form, and may be made from biocompatible elastomeric materials such as medical-grade silicone or polyurethane, which provide the necessary compliance for safe implantation within the eye.

[0068] Figure 8 shows the system including a plate inserter 120 comprising a chamber 121 , delivery cannula 142, and a plunger 122. The plate inserter 120 is configured for loading the plate 101 within the chamber 121 and operation of the plunger 122 to force the plate 101 through the delivery cannula 142 in a compact form through the incision 127 in the conjunctiva, whereafter the plate 101 opens up to a flat form adjacent to the proximal end of the tube 102, ready for connection.

[0069] The body of the plate 101 and the well 103 can be integrally formed from the same elastomeric material, enabling both components to flex together as a unit. This integral design allows the plate and well 103 to collapse into a compact form during insertion, ensuring smooth delivery through the cannula 142 and facilitatingdeployment within the ocular environment while maintaining structural integrity and ensuring proper functionality after expansion.

[0070] The chamber 121 funnels toward the outlet 123, compressing the flexible plate 101 into the compact form for easy insertion through the small conjunctival incision 127. This configuration allows the plate 101 to be loaded in the chamber 121 in noncompact form, as is shown in Figure 8, whereafter the funneling or constricting of the chamber 121 towards the cannula 142 forces the plate 101 into compact form, as is shown in Figure 1 1 . Specifically, Figure 9 shows the plate 101 within the chamber 121 before ejection. Figure 10 illustrates the operation of the plunger 122, forcing the plate 101 against the constricting edges of the funnelled portion of the chamber 121 , where the plate 101 begins to assume a more compact configuration. Figure 1 1 shows the plate 101 in its compact configuration within the outlet 123. Once the plate 101 is ejected from the outlet 123, as depicted in Figure 12, it opens up to lie flat against the sclera 129. Preferably, the cannula 142 has an external diameter of less than 3 mm.

[0071] Figures 25 and 26 depict an embodiment where the plate 101 retains an active element 124, which may be positioned within the well 103. The active element 124 may include a battery and a sensor operably coupled to a transmitter to transmit sensor readings. In one embodiment, the sensor is a pressure sensor, and the transmitter sends pressure readings.

[0072] Figure 27 illustrates an embodiment where the active element 124 comprises a flow control mechanism 125, which may be controlled according to pressure readings obtained by the pressure sensor. In the embodiment shown in Figures 28 to 30, the flow control mechanism 125 includes a pair of pincers 126 designed to pinch the proximal end of the tube 102. A pinching mechanism, which may be hydraulically or electronically operated (such as a piezoelectric pinching mechanism), controls the pincers 126. Figure 28 shows the pincers 126 fully open, allowing unrestricted flow from the proximal end of the tube 102. Figure 29 shows the pincers 126 partially closed to partially occlude the flow from the tube 102. Figure 30 depicts the pincers126 fully closed, thereby fully blocking the proximal end of the tube 102 to prevent fluid flow from the anterior chamber 1 19.

[0073] Figures 41 to 43 illustrate an embodiment of the plate 101 designed to be affixed without sutures. As shown in Figure 41 , instead of the securement apertures 104 for sutures described above, the plate 101 includes a retention tab 131 projecting from one side of the plate 101 , generally located adjacent to the well 103. The retention tab 131 terminates in a barb 132, which preferably has a flat underside and a hooked upper surface.

[0074] Figures 44 to 47 illustrate the securement of the plate 101 using the retention tab 131 . As shown in Figure 44, a crescent surgical blade 134 or a similar tool is used to create a flap 136 in the sclera 129 by making a proximal incision 135A

[0075] and a distal incision 135B, forming a tunnel under the flap 136 between the incisions 135.

[0076] Figures 45 and 46 show the insertion of the retention tab 131 , barb 132 first, through the distal incision 135B, through the tunnel under the flap 136 of the sclera 129 until the barb 132 emerges from the proximal incision 135A. Figure 42 shows the plate 101 having a curved profile to position the retention tab 131 for insertion. The upper surface hook profile of the barb 132 engages against the edge of the proximal incision 135A, thereby securing the plate 101 in place. The smooth undersurface of the retention tab 131 minimises irritation to the underlying tissue.

[0077] Once the plate 101 is secured in place using the retention tab 131 , the tube 102 is attached. The barb 132 may define a retention notch 133 to accommodate the tube 102 as it reaches the adjacent well 103.

[0078] Figures 31 to 39 illustrate the insertion of the implant using the present system. Figure 31 shows the initial small incision 127 made within the conjunctiva. Figure 32 shows the retraction of the conjunctival flap 128 formed by the incision 127 to expose the sclera 129.

[0079] Figure 33 depicts the insertion of the cannula 1 17 of the tube inserter 1 16 through the sclera 129 near the iris 130, with the distal end 139 of the cannula 1 17 protruding into the anterior chamber 1 19. The plunger 140 is then operated to causethe ejection rod 118 to push the tube 102 out of the distal end of the cannula 117 while the cannula 1 17 is simultaneously retracted, leaving the tube 102 in place with its distal end within the anterior chamber 119 as shown in Figure 34 with its proximal end accessibly located through the incision 127 and ready for connection to the plate 101.

[0080] Figure 35 illustrates the operation of the plunger 122 of the plate inserter 120 to force the plate 101 out of the outlet 123 in a compact form. Once ejected from the outlet 123, as shown in Figure 36, the plate 101 opens up to lie flat against the sclera 129. The plate 101 may then be secured in place using the retention tab 131 as depicted in Figures 41 to 47, as shown in Figure 37. At this stage, the tube 102 and the plate 101 remain disconnected.

[0081] Figure 38 illustrates the connection of the tube 102 to the plate 101 through the incision 127 using the connection mechanism. According to the embodiment shown in Figures 14 to 17, the proximal end of the tube 102 is pushed into the funnel insertion channel 107 to be retained within the semicylindrical engagement channel 108. The tube 102 can be placed within the retention notch 133 of the barb 132.

[0082] Figure 39 depicts the insertion of the active element 124 into the well 103. Finally, Figure 40 illustrates the closing of the conjunctival incision 127 with sutures, concealing the plate 101 beneath the conjunctival flap with the distal end of the tube 102 within the anterior chamber 119.

[0083] This system provides a minimally invasive, two-step operational procedure, with the two distinct inserters specifically configured for reliable and efficient insertion of the tube and plate. The tube inserter 1 16 allows for the direct placement of the tube 102 into the anterior chamber 119, maintaining alignment and preventing deformation through the action of the ejection rod 118 within the delivery cannula 117, as illustrated in Figures 5 to 7. The plate inserter 120 is configured to deliver the flexible plate 101 in a compact form through the delivery cannula 142, as shown in Figures 8 to 12, where it expands and lies flat against the sclera 129 after insertion. This arrangement, with the plate and tube inserted through a small conjunctival incision 127, allows for connection of the components through the incision using theconnection mechanism shown in Figures 14 to 17. The procedure facilitates deployment through small incisions, reducing the need for larger openings and offering more controlled and precise placement of the implant components.

[0084] The foregoing description, for purposes of explanation, used specific nomenclature to provide a thorough understanding of the invention. However, it will be apparent to one skilled in the art that specific details are not required in order to practise the invention. Thus, the foregoing descriptions of specific embodiments of the invention are presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed as obviously many modifications and variations are possible in view of the above teachings. The embodiments were chosen and described in order to best explain the principles of the invention and its practical applications, thereby enabling others skilled in the art to best utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated. It is intended that the following claims and their equivalents define the scope of the invention.

Claims

Claims1 . A system for the treatment of glaucoma comprising: a modular tube shunt implant comprising a flexible plate and a separable fluid drainage tube defining a connection mechanism therebetween; a tube inserter comprising a delivery cannula defining a needle-tipped distal end and a plunger comprising a longitudinal ejection rod operative within a lumen defined by the cannula, the tube inserter configured for longitudinally loading the tube within the lumen, puncturing a sclera with the needle-tipped distal end to access an anterior chamber, and operation of the plunger to cause the ejection rod to eject the tube from the cannula, leaving a distal end of the tube within the anterior chamber whilst the cannula is simultaneously retracted, and wherein a proximal end of the tube is accessibly located against the sclera through an incision made within the conjunctiva; a plate inserter comprising a chamber, delivery cannula, and a plunger, the plate inserter configured for loading the plate within the chamber and operation of the plunger to force the plate through the delivery cannula in a compact form through the incision in the conjunctiva to deploy in an open form adjacent the proximal end of the fluid drainage tube; and wherein the connection mechanism is configured for connecting the plate to the fluid drainage tube through the incision.

2. The system as claimed in claim 1 , wherein the chamber of the plate inserter funnels toward the delivery cannula, compressing the flexible plate into a compact form during insertion through the delivery cannula.

3. The system as claimed in claim 1 , wherein the delivery cannula of the tube inserter is configured to retain the fluid drainage tube such that the external diameter of the fluid drainage tube conforms to the internal diameter of the cannula.

4. The system as claimed in claim 1 , wherein the plate comprises a well defining a reservoir for aqueous humour.

5. The system as claimed in claim 1 , wherein the plate comprises securement apertures for securing the plate to the sclera.

6. The system as claimed in claim 5, wherein the securement apertures are located at an anterior edge of the plate.

7. The system as claimed in claim 1 , wherein the connection mechanism comprises a funnel insertion channel and a semicylindrical engagement channel for receiving the proximal end of the fluid drainage tube.

8. The system as claimed in claim 1 , wherein the connection mechanism comprises a sleeve on the plate into which a distal end of the fluid drainage tube is inserted.

9. The system as claimed in claim 1 , wherein the connection mechanism comprises an interlocking engagement configured to secure the fluid drainage tube in place with respect to the plate.

10. The system as claimed in claim 1 , wherein the delivery cannula of the fluid drainage tube inserter and the plate inserter is less than 3 mm in diameter.1 1 . The system as claimed in claim 1 , further comprising an active element retained within the well of the plate.

12. The system as claimed in claim 1 1 , wherein the active element comprises a pressure sensor operably coupled to a transmitter to transmit sensor readings.

13. The system as claimed in claim 1 1 , wherein the active element comprises a flow control mechanism.

14. The system as claimed in claim 13, wherein the flow control mechanism comprises pincers configured to pinch the proximal end of the fluid drainage tube to control fluid flow.

15. The system as claimed in claim 1 , wherein the plate comprises a retention tab terminating in a barb, the barb configured to secure the plate to the sclera without the use of sutures.

16. The system as claimed in claim 15, wherein the barb includes a flat underside and a hooked upper surface configured to engage with an edge of a scleral incision.

17. The system as claimed in claim 15, wherein the retention tab defines a retention notch to accommodate the fluid drainage tube as it reaches the adjacent well of the plate.

18. A method of inserting an implant for treating glaucoma, the method comprising: inserting a distal end of a fluid drainage tube into an anterior chamber using a tube inserter as claimed in claim 1 , wherein the cannula punctures a sclera and is retracted as the plunger simultaneously ejects the fluid drainage tube; inserting a flexible plate using a plate inserter as claimed in claim 1 , wherein the plate is ejected through an incision in a compact form and opens up flat against the sclera; and connecting the plate to the proximal end of the fluid drainage tube through the incision.

19. The method as claimed in claim 18, wherein the fluid drainage tube is ejected from the cannula longitudinally by operation of the plunger.

20. The method as claimed in claim 18, further comprising securing the plate to the sclera using securement apertures located on the plate.

21. The method as claimed in claim 18, wherein the plate and fluid drainage tube are connected using a connection mechanism comprising a funnel insertion channel and a semicylindrical engagement channel.

22. The method as claimed in claim 18, further comprising inserting an active element into the well of the plate, wherein the active element comprises a flow control mechanism.

23. The method as claimed in claim 22, wherein the flow control mechanism comprises pincers that are operated to control fluid flow through the proximal end of the fluid drainage tube.

24. The method as claimed in claim 18, wherein the fluid drainage tube inserter and plate inserter each comprise delivery cannulas that are less than 3 mm in diameter.

25. The method as claimed in claim 18, further comprising securing the plate to the sclera without sutures using a retention tab of the plate terminating in a barb.

26. The method as claimed in claim 25, wherein the barb is inserted through a scleral flap and engages with an edge of a proximal scleral incision to secure the plate in place.

27. The method as claimed in claim 25, wherein the barb defines a retention notch to accommodate the fluid drainage tube as it reaches the adjacent well of the plate.

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