Modular tube diverter system for glaucoma treatment

Abstract

A system for treating glaucoma is disclosed that includes a modular tube diverter implant having a flexible plate and a separable fluid drainage tube that are separately inserted and connected after insertion. The system includes a tube inserter featuring a delivery cannula having a needle tip-like distal end and a plunger having a pop-up rod configured to pierce the sclera and deliver the tube into the anterior chamber. A plate inserter, also including a cannula and a plunger, is configured to deploy the flexible plate in a compact form through the same small conjunctival incision, where the flexible plate is deployed to fit over the sclera. The connecting mechanism can easily connect the plate and the pipe through the notch. The system is specially designed for minimally invasive surgery, and therefore efficient deployment of the two components is achieved through the small-diameter cannula, and tissue damage and recovery time are reduced.

Description

Invention Field

[0001] This invention relates to medical devices and methods for treating glaucoma. Specifically, it relates to a modular tubular shunt system designed to regulate intraocular pressure by promoting fluid drainage of the eye using minimally invasive surgery, comprising separate inserters for a flexible plate and a fluid drainage tube, both deployed and connected through a small incision within the conjunctiva. Background Technology

[0002] Glaucoma is a group of eye diseases that can cause damage to the optic nerve and visual field defects, and is usually associated with elevated intraocular pressure. Over time, the eye's natural drainage system becomes blocked, leading to increased pressure, which can damage the optic nerve responsible for transmitting visual information from the eye to the brain.

[0003] One method of treating glaucoma involves surgically inserting a shunt tube to provide an alternative route for aqueous humor drainage.

[0004] U.S. Patent US2018 / 0110650 A1 [hereinafter referred to as D5], filed April 26, 2018, by DA SILVA CURIEL JEANNETTE MA et al., discloses an applicator designed for delivering a microshunt to the cornea. The applicator includes a fixation body and a distal portion equipped with a cutting device capable of making an incision in the cornea for microshunt placement. The microshunt is placed within the cannula lumen and held around it using a plunger-type deployment mechanism. Once the distal portion of the applicator passes through the cornea and enters the anterior chamber, the mechanism enables microshunt deployment.

[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 securely attached to a flow-limiting or delivery element during surgery using a tightening-loosening mechanism. This ensures the device is correctly positioned within the eye, thereby regulating fluid flow and reducing intraocular pressure by bypassing the trabecular meshwork. The corneal opening for insertion can be formed using various methods, such as lasers or scalpels, and can be oriented in different directions depending on the requirements of the surgical procedure.

[0006] US Patent 2005 / 0107734 A1 (hereinafter referred to as D6), filed May 19, 2005 by Coroneo Minas T., discloses a method for treating glaucoma, comprising inserting a flexible ocular device made of a biocompatible elastomer material. The device consists of a fluid drainage tube with a foldable plate at one end. The plate is designed to anchor the device to the inner surface of the sclera, while the other end of the drainage tube remains open to allow for fluid communication.

[0007] The procedure begins with a small, self-sealing incision made at the junction of the cornea and sclera, leading to the anterior chamber of the eye. The anterior chamber is then filled with a viscoelastic material to facilitate the process. Using a hollow cannula, a foldable ocular device is introduced into the suprachoroidal space created by ciliary body dissection. A positioning plate is used to secure the device to the inner surface of the sclera, while a drainage tube is placed within 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, thus completing the surgical procedure.

[0009] While the prior art solutions described in D5 and D6 provide methods for treating glaucoma by inserting a drainage device, these solutions present several challenges and limitations that can complicate the procedure. In the case of D5, the procedure involves using a plunger to insert a microshunt housed within a cannula. One issue with this design is the complexity of positioning the microshunt around the plunger within a wide cannula. This approach can lead to difficulty maintaining alignment during insertion, increasing the likelihood of misalignment or deformation of the microshunt during deployment. Furthermore, the need for a separate cutting mechanism to create the corneal incision adds an extra surgical step, potentially increasing the invasiveness of the procedure and prolonging the operation time.

[0010] In D6, while flexible ocular devices can achieve fluid drainage, this process requires creating a suprachoroidal space through ciliary body dissection, a more invasive and technically demanding step. The need for this additional surgical procedure may increase the risk of complications such as tissue damage or improper device placement. Furthermore, anchoring the drainage tube to the sclera with a foldable plate may require larger incisions and more precise manipulation to ensure correct positioning, further complicating the procedure.

[0011] These existing techniques highlight potential drawbacks in the context of glaucoma treatment, including the risk of misalignment, the need for multiple steps or invasive techniques, and potential surgical complications. The complex construction and additional steps required in these methods increase the overall complexity of the procedure, leading to prolonged operation time, increased risk of tissue damage, or improper device placement. Furthermore, larger incisions and the involvement of multiple components may result in prolonged recovery time and an increased likelihood of postoperative complications. Summary of the Invention

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

[0013] The tube inserter includes a delivery cannula with a needle-like distal end and a plunger with a longitudinal ejection lever that operates within the cannula. The tube inserter is configured to securely hold the drainage tube within the cannula, allowing the distal needle to pierce the sclera and enter the anterior chamber. The plunger is then operated to longitudinally eject the tube from the cannula into the anterior chamber while simultaneously retracting the cannula. This single, rapid movement ensures that the distal end of the tube is correctly positioned in the anterior chamber, while the proximal end remains accessible against the sclera through a small conjunctival incision.

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

[0015] The tube inserter is preferably designed to match the outer diameter of the drainage tube with the inner diameter of the delivery tube, thereby preventing deformation or bending during ejection.

[0016] Both the tube inserter and plate inserter are designed to work with relatively small cannulas, preferably with a diameter of less than 3 mm. This allows both the tube and plate to be deployed through a single, smaller conjunctival incision, minimizing tissue damage and enabling a less invasive surgical approach. By simplifying the insertion and connection process, this system improves surgical efficiency and reduces the likelihood of complications.

[0017] According to one aspect, a system for treating glaucoma is provided, comprising: a modular tube shunt implant including a flexible plate and a detachable fluid drainage tube. The system also includes a tube inserter and a plate inserter, each configured to deliver the tube and plate through a smaller conjunctival incision. The tube inserter includes a delivery cannula having a needle-like distal end and a plunger with an ejection lever that ejects the tube into the anterior chamber upon simultaneous withdrawal of the cannula. The plate inserter delivers the flexible plate in a compact form, wherein the flexible plate unfolds and lies flat against the sclera, and the plate is connected to the tube via a connecting mechanism through the same smaller incision.

[0018] According to one embodiment, the plate inserter is configured with a chamber that contracts in a funnel shape toward the delivery cannula, thereby compressing the flexible plate into a compact form during insertion. This allows for easy insertion via the cannula, ensuring smooth deployment of the plate through a small conjunctival incision. Preferably, the cannula diameter of the plate inserter is less than 3 mm, thereby minimizing tissue damage and reducing the invasiveness of the procedure.

[0019] In the preferred arrangement, the delivery cannula of the tube inserter is designed as a retaining tube, ensuring that the outer diameter of the cannula closely matches the inner diameter of the insertion tube. This alignment prevents deformation or bending during insertion, thereby ensuring reliable and accurate tube positioning in the anterior chamber. This feature simplifies the insertion process, enabling rapid tube deployment and reducing the risk of misalignment.

[0020] Optionally, the flexible plate may include a reservoir defining a reservoir for aqueous humor drainage. Once the implant is in place, this reservoir enhances the regulation of intraocular pressure by providing an effective fluid management system.

[0021] In another embodiment, the plate may have holes for securing sutures, preferably located at the front edge of the plate. These holes allow the plate to be securely attached to the sclera during surgery, thereby achieving stability and proper positioning of the implant.

[0022] According to another embodiment, the connection mechanism may include a funnel-shaped insertion channel and a semi-cylindrical engagement channel for receiving the proximal end of the tube. Once both components are inserted, this connection mechanism allows the tube to be quickly and securely attached to the plate.

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

[0024] In another embodiment, the connection mechanism may include an interlocking joint designed to hold the tube in place relative to the plate. This interlocking feature ensures that the tube remains securely attached to the plate, thereby minimizing the risk of detachment during and after surgery.

[0025] Preferably, both the cannula inserter and the plate inserter use cannulas with a diameter of less than 3 mm. This ensures that both components can be delivered through smaller incisions, reducing surgical trauma and shortening recovery time.

[0026] In one alternative embodiment, the board may hold active components, such as pressure sensors, operatively coupled to the transmitter to monitor intraocular pressure. This feature enables real-time feedback and more precise control of the eye's fluid management system.

[0027] According to another embodiment, the active element may include a flow control mechanism comprising a clamp that clamps the proximal end of the tube to regulate fluid flow. This mechanism enables precise control of the aqueous humor drainage rate, thereby optimizing intraocular pressure regulation after implantation.

[0028] In another embodiment, the plate may include a retaining tab terminating at a barb, thereby enabling secure attachment to the sclera without the need for sutures. The barb achieves stable engagement with the sclera, reducing the complexity of the surgical procedure and minimizing the risk of postoperative complications.

[0029] According to another aspect, a method for inserting an implant is provided, comprising: inserting the distal end of a tube into the anterior chamber using a tube inserter. In this method, the cannula of the tube inserter pierces the sclera, and the cannula is retracted while an actuating plunger ejects the tube, thereby leaving the tube in place. This process ensures that the distal end of the tube is correctly positioned in the anterior chamber, while the proximal end remains accessible for connection through a conjunctival incision.

[0030] According to one embodiment of the method, the tube is ejected from the insertion cannula longitudinally by operating the plunger, ensuring that the tube remains aligned throughout the process.

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

[0032] Optionally, the method may further include securing the plate to the sclera using fixing holes disposed on the plate. In another embodiment, the connection between the plate and the tube is achieved using the funnel-shaped insertion channel and the semi-cylindrical engagement channel described in the system.

[0033] According to another embodiment of the method, an active element is inserted into a reservoir in the plate. The active element may include a flow control mechanism that is operated to control the fluid flow rate through the proximal end of a clamping tube.

[0034] The method may also include: using a flow control mechanism with clamps, which can actuate the clamps to regulate the flow of aqueous humor through the drainage tube, thereby achieving precise control of intraocular pressure.

[0035] In another embodiment, the method includes securing the plate to the sclera without the use of sutures by using a retaining tab on the plate that terminates in a barb. This method simplifies the entire surgical procedure and minimizes the need for additional tools, thereby reducing the likelihood of postoperative complications.

[0036] In another embodiment of the method, the barbs of the retainer are inserted through the scleral flap and engage with the edge of the proximal scleral incision to secure the plate in place, thereby ensuring proper alignment and stability during the procedure.

[0037] Other aspects of the invention are also disclosed. Attached Figure Description

[0038] Although any other form may fall within the scope of this invention, preferred embodiments of the invention will now be described by way of example only with reference to the accompanying drawings, in which: Figure 1 A tube inserter according to one embodiment is shown.

[0039] Figures 2 to 4 The diagram illustrates the deployment of a tube, starting from its needle, using a tube inserter. Figure 2 The tube was shown to remain completely inside the needle before insertion. Figure 3 It shows the plunger that begins to push the tube from the needle, and Figure 4 The tube is shown as having almost completely popped out of the needle.

[0040] Figures 5 to 7 The use of a tube inserter to insert a tube into the anterior chamber is shown, wherein, Figure 5 This shows the needle being inserted into the anterior chamber through the sclera. Figure 6 The procedure of pushing the tube into the anterior chamber as the needle is being withdrawn is illustrated. Figure 7 This shows the tube fully inserted and the needle removed.

[0041] Figure 8 A plate inserter according to one embodiment is shown.

[0042] Figures 9 to 12 The use of a board inserter to deploy boards in a compact form is shown, wherein, Figure 9 This shows the plate remaining inside the inserter chamber. Figure 10 This shows the state in which the plunger begins to force the plate through the funnel-shaped outlet. Figure 11 The plate is shown in a compact configuration at the outlet, and Figure 12 This shows the plate fully popped out and unfolded to lie flat against the sclera.

[0043] Figure 13 The diagram shows a plate with a reservoir designed to contain and dissipate fluid from the pipe, as well as the location of holes for securing the sutures.

[0044] Figure 14 The wall of a reservoir well with a push-in profile is shown, characterized by a funnel-shaped insertion channel leading to a semi-cylindrical joint channel.

[0045] Figure 15 The tube is shown aligned with the push-in profile, ready for insertion.

[0046] Figure 16 The diagram shows the proximal end of the tube being pushed laterally through a funnel-shaped insertion channel until it engages with a semi-cylindrical channel.

[0047] Figure 18 An alternative embodiment is shown in which the plate includes a sleeve into which the distal end of the tube is inserted.

[0048] Figures 21 to 24 Another different connection mechanism is shown, including a pipe joint and an interlocking joint, wherein, Figure 21 The plate and pipe joint with the reservoir well is shown. Figure 22 The diagram shows the proximal end of the tube being inserted into the tube joint. Figure 23 A gate installed above the pipe is shown, and Figure 24 The interlocking joint that secures the tube in place is shown.

[0049] Figure 27 The active element with a flow control mechanism is shown inside the liquid storage well of the plate.

[0050] Figures 28 to 30 The operating principle of the flow control mechanism is shown, in which, Figure 28 This illustrates the state where the clamps are fully open, thus achieving unrestricted flow. Figure 29 The diagram shows a state where the clamps are partially closed to partially block the flow, and Figure 30 The image shows the state where the clamps are fully closed to block the flow of fluid from the pipe.

[0051] Figures 31 to 40 The procedure for step-by-step implant insertion is illustrated, including making an incision, opening the conjunctival flap, inserting the tube through the sclera, ejecting the plate, fixing 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 The initial conjunctival incision state is shown. Figure 32 The conjunctival flap is shown to be in the open position. Figure 33 This illustrates inserting a tube through the sclera into the anterior chamber, with the tube remaining in place, according to... Figure 34 As shown. Figure 35 The board is shown popped out in a compact form. Figure 36 The image shows the plate unfolded and flat against the sclera. Figure 37 The connection status between the pipe and the plate is shown. Figure 38 The active element is shown being inserted into the reservoir well, and Figure 39 The closure and suturing of the conjunctival flap are shown. Finally, Figure 40 The image shows the plate completely hidden beneath the conjunctival flap, with the distal end of the tube located within the anterior chamber.

[0052] Figures 41 to 43 An embodiment of a plate designed for fixation without stitching is shown, characterized by retaining tabs with barbs, wherein, Figure 41 A plate with retaining tabs is shown. Figure 42 The position of the retaining tab for insertion is shown, and Figure 43The joint of the barb used to secure the plate is shown.

[0053] Figures 44 to 47 The process of securing a plate using retaining tabs is illustrated, including creating a scleral flap, inserting the retaining tabs, and engaging the barbs that hold the plate in place. Figure 44 The process of creating a scleral flap is shown. Figure 45 The insertion process of holding the tab through the distal cut is illustrated. Figure 46 The process of maintaining the tab by tunneling is shown, and Figure 47 The process of joining the barb to the proximal cut edge is shown.

[0054] Figures 48 to 50 An alternative internal insertion method is shown, wherein the tube is inserted through the cornea, across the anterior chamber, and through the opposing corneal wall, wherein... Figure 48 The needle is shown being inserted through the cornea. Figure 49 The process of advancing the needle across the anterior chamber is shown, and Figure 50 This shows the process of the tube being ejected as the needle is pulled out. Detailed Implementation

[0055] The system for treating glaucoma includes a modular tube shunt implant comprising a flexible plate 101 and a fluid drainage tube 102. The plate 101 and tube 102 are designed for individual insertion, wherein a connection mechanism allows the tube 102 to be attached to the plate 101 after insertion. The modular design facilitates minimally invasive insertion of the implant components, allowing the surgeon to deploy each component individually and subsequently connect them by creating a small incision in the membrane.

[0056] refer to Figure 13 The plate 101 may include a reservoir 103 or a similar structure that defines a reservoir for draining aqueous humor from the collection and dissipation pipe 102. The plate 101 may optionally include fixing holes 104 designed to secure the plate 101 to the sclera with sutures prior to connection to the pipe 102. In the illustrated embodiment, a pair of holes 104 are located at the front edge of the plate 101.

[0057] according to Figure 13 As further shown, the connection mechanism may include a wall 105 of the storage well 103, configured to connect to the proximal end of the pipe 102. A fixing hole 104 may be positioned close to the connection mechanism. In some embodiments, the hole 104 is located on either side of the connection mechanism.

[0058] refer to Figure 14 The wall 105 of the storage well 103 may include: a push-in profile 106, including a funnel-shaped insertion channel 107 leading to a semi-cylindrical engagement channel 108. According to Figure 15As shown, tube 102 is aligned with the push-in profile 106. In Figure 16 In the middle, the proximal end of tube 102 is pushed laterally through the funnel-shaped insertion channel 107 until it engages with the semi-cylindrical engagement channel 108, according to Figure 17 As shown.

[0059] Figure 18 An alternative embodiment is shown, wherein plate 101 includes sleeve 109, the distal end of tube 102 inserted therein, according to Figure 19 and Figure 20 As shown. The casing 109 can define a channel 110 that connects to the opening 111 interface, leading from the casing 109 to the storage well 103.

[0060] Figures 21 to 24 Another embodiment is shown, wherein the connection mechanism includes: a wall 105 of a storage well 103, including a pipe joint 112 and an interlocking joint 113. Figure 23 In this process, the proximal end of the pipe 102 is inserted into the pipe joint 112, and then a gate 114 is installed above it. The gate 114 may have an interlocking structure 115, which engages with a corresponding interlocking joint 113 to fix the gate 114 to the wall 105, thereby fixing the pipe 102 in place.

[0061] The system includes a tube inserter 116, according to Figure 1 As shown, it includes a delivery cannula 117 defining a distal tip 139, and a plunger 118 including a longitudinal ejection rod 118 operable within a lumen 141 defined by the cannula 117. The cannula inserter 116 is configured to longitudinally load the cannula 102 into the lumen 141, according to... Figure 2 As shown, the distal tip 139 of a needle is used to puncture the sclera 129 to enter the anterior chamber 119, according to... Figure 3 As shown, and the operating plunger 140, while the ejector rod 118 ejects the tube 102 from the cannula 117, the cannula 117 is retracted, thereby leaving the distal end of the tube 102 in the anterior chamber 119; and wherein the proximal end of the tube is accessiblely abutting the sclera 129 through an incision 127 made in the conjunctiva.

[0062] Preferably, the tube inserter 116 is designed to hold the tube 102 tightly within the lumen of the insertion tube 117, wherein the outer diameter of the tube 102 matches the inner diameter of the insertion tube 117. This tight fit ensures stable alignment of the tube during insertion, preventing it from deforming or bending when pushed from behind by the ejector rod 118.

[0063] Figure 2 This shows the tube 102 fully contained within the insertion cannula 117 prior to insertion. Figure 3The operation of plunger 140 is shown, wherein ejector rod 118 pushes tube 102 from the rear, initiating the expulsion of distal end 139 of tube 102 from insertion tube 117. Figure 4 The image shows the tube 102 almost completely ejected from the insertion tube 117 by the ejection lever 118.

[0064] Figures 5 to 7 The technique of inserting tube 102 using tube inserter 116 is shown. Figure 5 The image shows the distal tip 139 of the cannula 117 penetrating the sclera 129 and being inserted into the anterior chamber 119. Figure 6 The diagram illustrates the state in which the operating plunger 140 pushes the ejection rod 118 through the lumen 141 of the cannula 117 to force the tube 102 from the distal end of the cannula 117 into the anterior chamber 119 while the cannula 117 is simultaneously withdrawn. This allows the distal end of the tube 102 to be fluidly connected to the aqueous humor within the anterior chamber 119. Withdrawing the cannula 117 leaves the tube 102 in place, according to... Figure 7 As shown, the proximal end of tube 102 remains accessible through conjunctival incision 127.

[0065] Figures 48 to 50 An alternative internal insertion method is shown, wherein, firstly, the distal tip of the cannula 117 of the cannula inserter 116 is inserted through the proximal wall 137A of the cornea or sclera 129, across the anterior chamber 119, and through the distal wall 137B of the cornea or sclera 129. Then, when the cannula 102 is pulled back through the distal wall 137B, the cannula is ejected from the cannula 117, thereby allowing the cannula 102 to pass through the distal wall 137B and exit the proximal wall 137A, according to... Figure 50 As shown.

[0066] Plate 101 is flexible enough to be delivered in a compact form and can be made of biocompatible elastomer materials such as medical-grade silicone or polyurethane, which provide the necessary compliance for safe implantation in the eye.

[0067] Figure 8 A system including a plate inserter 120 is shown, the plate inserter comprising a chamber 121, a delivery cannula 142, and a plunger 122. The plate inserter 120 is configured to load a plate 101 into the chamber 121 and to operate the plunger 122 to force the plate 101 through a cut 127 in the conjunctiva in a compact form through the delivery cannula 142, thereafter the plate 101 unfolds into a flattened form near the proximal end of the cannula 102, ready for connection.

[0068] The body of plate 101 and reservoir 103 can be integrally formed from the same elastomeric material, allowing the two components to bend together as a single unit. This integral design allows the plate and reservoir 103 to collapse into a compact form during insertion, ensuring smooth delivery via cannula 142 and facilitating deployment in the eye environment, while maintaining structural integrity and ensuring proper functioning after deployment.

[0069] The chamber 121 contracts in a funnel shape toward the outlet 123, thereby compressing the flexible plate 101 into a compact form for easy insertion through the small conjunctival incision 127. This configuration allows the plate 101 to be loaded in a non-compact form within the chamber 121, according to... Figure 8 As shown; thereafter, chamber 121 contracts or shrinks in a funnel shape toward cannula 142, thereby forcing plate 101 into a compact form, according to Figure 11 As shown. Specifically, Figure 9 The state of the plate 101 before ejection is shown within the chamber 121. Figure 10 The diagram shows the state in which the operating plunger 122 forces the plate 101 against the contracting edge of the funnel-shaped portion of the chamber 121, wherein the plate 101 begins to exhibit a more compact configuration. Figure 11 The diagram shows plate 101 in a compact configuration within outlet 123. Once plate 101 is ejected from outlet 123, according to... Figure 12 As shown, it will unfold to lie flat against the sclera 129. Preferably, the outer diameter of the cannula 142 is less than 3 mm.

[0070] Figure 25 and Figure 26 One embodiment is shown in which a plate 101 holds an active element 124 that may be located within a reservoir well 103. The active element 124 may include a battery and a sensor operatively coupled to a transmitter for sending sensor readings. In one embodiment, the sensor is a pressure sensor, and the transmitter sends pressure readings.

[0071] Figure 27 One embodiment is shown in which the active element 124 includes a flow control mechanism 125, which can be controlled based on pressure readings obtained from a pressure sensor. Figures 28 to 30 In the illustrated embodiment, the flow control mechanism 125 includes a pair of clamps 126 designed to clamp the proximal end of the tube 102. The clamps 126 can be controlled by a hydraulically or electronically operated clamping mechanism (e.g., a piezoelectric clamping mechanism). Figure 28 The state shown is such that the clamp 126 is fully open, thereby enabling unrestricted flow from the proximal end of the tube 102. Figure 29 The image shows the clamp 126 partially closed to partially block the flow from the tube 102. Figure 30The diagram shows the state in which the clamp 126 is fully closed, thereby completely blocking the proximal end of the tube 102 to prevent fluid flow from the anterior chamber 119.

[0072] Figures 41 to 43 An embodiment of a plate 101 designed for fixation without stitching is shown. According to... Figure 41 As shown, instead of the aforementioned fixing hole 104 for suturing, plate 101 includes a retaining tab 131 projecting from one side of plate 101, typically located near reservoir well 103. The retaining tab 131 terminates at a barb 132, which preferably has a flat lower surface and a hook-shaped upper surface.

[0073] Figures 44 to 47 The process of fixing plate 101 using retaining tab 131 is shown. According to Figure 44 As shown, a crescent-shaped scalpel blade 134 or similar tool is used to form a flap 136 on the sclera 129 by making a proximal incision 135A and a distal incision 135B, thereby forming a tunnel beneath the flap 136 between the incisions 135.

[0074] Figure 45 and Figure 46 The process of inserting and retaining tab 131 is shown, in which barb 132 first passes through distal incision 135B, then through tunnel 136 below flap 136 of sclera 129, until barb 132 emerges from proximal incision 135A. Figure 42 Plate 101 is shown with a curved profile to position and retain tab 131 for insertion. The upper surface hook profile of barb 132 engages with the edge of the near end notch 135A, thereby securing plate 101 in place. The smooth lower surface of retaining tab 131 minimizes irritation to underlying tissues.

[0075] Once the plate 101 is secured in place using the retaining tab 131, the pipe 102 is attached. The barb 132 can define the retaining notch 133 to receive the pipe 102 when it reaches the adjacent reservoir well 103.

[0076] Figures 31 to 39 The procedure for inserting an implant using this system is shown. Figure 31 The initial small incision 127 made within the conjunctiva is shown. Figure 32 The state of retracting the conjunctival flap 128 formed by the incision 127 to expose the sclera 129 is shown.

[0077] Figure 33The illustration shows the insertion of the cannula 117 of the cannula inserter 116 through the sclera 129 near the iris 130, with the distal end 139 of the cannula 117 protruding into the anterior chamber 119. The plunger 140 is then operated to retract the cannula 117 while simultaneously pushing the distal end of the cannula 117 out with the ejection lever 118, thereby leaving the cannula 102 in place with its distal end within the anterior chamber 119, according to... Figure 34 As shown, its proximal end is accessiblely positioned via cutout 127 and ready to be connected to plate 101.

[0078] Figure 35 The process is illustrated where the plunger 122 of the control plate inserter 120 forces the plate 101 out of the outlet 123 in a compact form. Once ejected from the outlet 123, according to... Figure 36 As shown, plate 101 will unfold to lie flat on sclera 129. Then, plate 101 can be used according to... Figures 41 to 47 The fixing tab 131 shown is fixed in place, according to Figure 37 As shown. During this stage, pipe 102 and plate 101 remain disconnected.

[0079] Figure 38 The diagram shows the state where the tube 102 is connected to the plate 101 via the cutout 127 using a connecting mechanism. According to... Figures 14 to 17 In the illustrated embodiment, the proximal end of tube 102 is pushed into funnel-shaped insertion channel 107 to be held within semi-cylindrical engagement channel 108. Tube 102 can be placed within retaining notch 133 of barb 132.

[0080] Figure 39 The diagram shows the state in which the active element 124 is inserted into the reservoir well 103. Finally, Figure 40 The conjunctival incision 127 is shown closed with sutures, thereby concealing the plate 101 beneath the conjunctival flap, while the distal end of the tube 102 is located within the anterior chamber 119.

[0081] This system enables a minimally invasive, two-step surgical procedure in which two different inserters are specifically configured for reliable and efficient insertion of tubes and plates. The tube inserter 116 allows the tube 102 to be placed directly in the anterior chamber 119, thereby maintaining alignment and preventing deformation through the action of the ejector rod 118 within the delivery tube 117, according to... Figures 5 to 7 As shown. The plate inserter 120 is configured to deliver the flexible plate 101 in a compact form via the delivery cannula 142, according to... Figures 8 to 12 As shown, after insertion, the flexible plate 101 unfolds and lies flat against the sclera 129. This arrangement, in which the plate and tube are inserted through a small conjunctival incision 127, allows the component to be used. Figures 14 to 17The connecting mechanism shown is linked through an incision. The surgical procedure facilitates deployment through a smaller incision, thereby reducing the need for a larger opening and enabling more controlled and precise placement of implant components.

[0082] For purposes of explanation, specific terminology has been used in the foregoing description to provide a comprehensive understanding of the invention. However, it will be apparent to those skilled in the art that specific details are not required to practice the invention. Therefore, for purposes of illustration and description, the foregoing description of specific embodiments of the invention is presented. These are not intended to be exhaustive or to limit the invention to the precise forms disclosed, as many modifications and variations are apparent in light of the foregoing teachings. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, thereby enabling others skilled in the art to best utilize the invention and various embodiments with various modifications to suit a particular intended use. The following claims and their equivalents are intended to define the scope of the invention.

Claims

1. A system for treating glaucoma, comprising: A modular tubular shunt implant includes a flexible plate and a separable fluid drainage tube, wherein a connection mechanism is defined between the flexible plate and the fluid drainage tube; A tube inserter includes a delivery cannula defining a distal tip and a plunger, the plunger including a longitudinal ejection rod operable within a lumen defined by the cannula; the tube inserter is configured to longitudinally load the cannula within the lumen, pierce the sclera with the distal tip to enter the anterior chamber, and to operate the plunger such that the ejection rod ejects the cannula from the cannula while retracting the cannula, leaving the distal tip of the cannula in the anterior chamber; Furthermore, the proximal end of the tube is accessiblely abutted against the sclera through an incision made within the conjunctiva; A plate inserter includes a chamber, a delivery cannula, and a plunger. The plate inserter is configured to load the plate into the chamber, and to operate the plunger to force the plate through the incision in the conjunctiva in a compact form through the delivery cannula, so as to deploy it in an open form near the proximal end of the fluid drainage tube. The connecting mechanism is configured to connect the plate to the fluid drainage tube through the cut.

2. The system according to claim 1, wherein, The chamber of the plate inserter contracts in a funnel shape toward the delivery cannula, thereby compressing the flexible plate into a compact form during insertion through the delivery cannula.

3. The system according to claim 1, wherein, The delivery cannula of the tube inserter is configured to hold the fluid drainage tube such that the outer diameter of the fluid drainage tube matches the inner diameter of the insertion cannula.

4. The system according to claim 1, wherein, The plate includes a storage well that defines the water reservoir.

5. The system according to claim 1, wherein, The plate includes fixing holes for securing the plate to the sclera.

6. The system according to claim 5, wherein, The fixing hole is located at the front edge of the plate.

7. The system according to claim 1, wherein, The connection mechanism includes a funnel-shaped insertion channel and a semi-cylindrical engagement channel for receiving the proximal end of the fluid drainage tube.

8. The system according to claim 1, wherein, The connection mechanism includes a sleeve on the plate, into which the distal end of the fluid drainage tube is inserted.

9. The system according to claim 1, wherein, The connecting mechanism includes an interlocking joint configured to fix the fluid drainage tube in place relative to the plate.

10. The system according to claim 1, wherein, The diameters of the delivery cannulas of both the fluid drainage tube inserter and the plate inserter are less than 3 mm.

11. The system of claim 1, further comprising an active element held in the reservoir well of the plate.

12. The system according to claim 11, wherein, The active element includes a pressure sensor operatively coupled to a transmitter for sending sensor readings.

13. The system according to claim 11, wherein, The active element includes a flow control mechanism.

14. The system according to claim 13, wherein, The flow control mechanism includes clamps configured to clamp the proximal end of the fluid drain tube to control the fluid flow rate.

15. The system according to claim 1, wherein, The plate includes a retaining tab terminating at a barb, the barb being configured to secure the plate to the sclera without the use of sutures.

16. The system according to claim 15, wherein, The barb includes a flat lower surface and a hook-shaped upper surface configured to engage with the edge of the scleral incision.

17. The system according to claim 15, wherein, The retaining tab defines a retaining recess to receive the fluid drain tube when it reaches an adjacent reservoir well of the plate.

18. A method of inserting an implant for treating glaucoma, comprising: The distal end of the fluid drainage tube is inserted into the anterior chamber using the tube inserter according to claim 1, wherein, The cannula pierces the sclera and retracts as the plunger ejects the fluid drainage tube. A flexible plate is inserted using the plate inserter according to claim 1, wherein the plate pops out in a compact form through a cut and unfolds to lie flat against the sclera; and The plate is connected to the proximal end of the fluid drainage tube through the cut.

19. The method according to claim 18, wherein, The fluid drainage tube is ejected longitudinally from the insertion tube by operating the plunger.

20. The method of claim 18, further comprising: The plate is secured to the sclera using the mounting holes located on the plate.

21. The method according to claim 18, wherein, The plate and the fluid drainage tube are connected using a connecting mechanism that includes a funnel-shaped insertion channel and a semi-cylindrical engagement channel.

22. The method of claim 18, further comprising: An active element is inserted into the reservoir of the plate, wherein the active element includes a flow control mechanism.

23. The method according to claim 22, wherein, The flow control mechanism includes clamps that are operated to control the fluid flow rate by clamping the proximal end of the fluid drainage tube.

24. The method according to claim 18, wherein, The fluid drainage tube inserter and the plate inserter each include a delivery cannula with a diameter of less than 3 mm.

25. The method of claim 18, further comprising: The plate is secured to the sclera without the use of stitches by using a retaining tab that terminates at a barb.

26. The method of claim 25, wherein, The barb is inserted through the scleral flap and engages with the edge of the proximal scleral incision, thereby securing the plate in place.

27. The method of claim 25, wherein, The barb defines a retaining notch to accommodate the fluid drain pipe as it reaches an adjacent reservoir well of the plate.

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