WO2016023942A1

WO2016023942A1 - Kit for the treatment of glaucoma, drainage device and insertion arrangement and implantation method

Info

Publication number: WO2016023942A1
Application number: PCT/EP2015/068532
Authority: WO
Inventors: Hector Eduardo CHOLOMONIUK
Original assignee: MILLAN, Gabriela Veronica
Priority date: 2014-08-14
Filing date: 2015-08-12
Publication date: 2016-02-18
Also published as: AR097340A1

Abstract

A kit used for the treatment of Glaucoma which comprises an aqueous humor drainage device 50 and an insertion arrangement, which has a hollow needle 16 that contains said drainage device 50 inside, for its subsequent implantation into the eye, wherein said devices form a structural and functional unit that enables a novel transconjunctival implantation method without the need of a previous conjunctival opening or closure. Said drainage device 50 consists of a tube with lumen, that is implanted in the scleral hole of the eye created by said insertion arrangement needle 16, thus allowing the aqueous humor drainage from the anterior chamber 9 of the eye into the subconjunctival space for its subsequent reabsorption. The invention also includes an implantation method carried out by means of the kit.

Description

KIT FOR THE TREATMENT OF GLAUCOMA, DRAINAGE DEVICE AND INSERTION ARRANGEMENT AND IMPLANTATION METHOD

TECHNICAL FIELD OF THE INVENTION

The invention belongs to the field of medical devices, more specifically, a kit that comprises an aqueous humor drainage device, an insertion arrangement thereof and a method for the treatment of Glaucoma.

STATE OF THE ART BACKGROUND

The aqueous humor is an intraocular fluid produced by the ciliary body which migrates through the pupil into the anterior chamber, then through the trabecular meshwork into the Schlemm's canal and finally it is carried by veins which form aqueous fluid collection channels under the conjunctiva. When there is not enough aqueous humor outflow to offset the production rate at the ciliary body level, the intraocular pressure rises, thus resulting in the risk of glaucoma. Research has shown that sustained ocular hypertension may cause damage to the optic nerve, which transmits visual information to the brain.

The consequence of sustained ocular hypertension can be a progressive damage of the optic nerve, with the progressive impairment of the visual field, leading to blindness in advanced stages, Glaucoma being the second cause of blindness worldwide (Quigley HA et. al, 2006). There are medical treatments by means of eye drop instillation, Laser treatments (Trabeculoplasty with Argon laser) and surgical treatments. The first choice of treatments usually applied to patients with Glaucoma is the medical treatment with eye drops. In some cases, they are associated with complications due to the adverse effects of these drugs, allergic reactions or lack of effectiveness because of non-compliance on the part of the patient. In those patients for whom medical treatment fails to properly regulate intraocular pressure, glaucoma filtering surgery (GFS) is recommended in order to prevent progression of the optic nerve damage and visual impairment.

One of the classifications for the glaucoma filtering surgery may be:

1 ) Ab-interno procedures that consist of surgical techniques which may include tissue cuttings such as incisions in the trabeculate or drainage device implants from the inside of the eye (anterior chamber of the eye 9) towards outside, for which the anterior chamber of the eye must be previously entered with said drainage device; and

2) ab-externo procedures that consist of surgical techniques which comprise tissue cuttings (such as trabeculectomy) or drainage device implants from the outside to the inside of the eye (Anterior chamber of the eye ).

Trabeculectomy (ab-externo surgical procedure), consists of making an ocular tissue (trabeculate) resection to produce a fistula which connects the anterior chamber to the subconjunctival space, having been for many years, and today being, the traditional and most widely used surgery for the treatment of Glaucoma. However, flow control is still inaccurate, despite the introduction of several wound suture techniques. In addition, despite the good long-term results, it is associated with a high rate of early postoperative complications (Choroidal Detachment, Hypotalamia, anterior chamber bleeding and postoperative inflammation). Glaucoma filtering surgery has shown to be more effective in preventing the progression of the disease than other primary treatments. If it were possible to avoid the complications associated with poor flow control, these surgeries would be more widely used (Lim K.S.; 1998). In recent years, Glaucoma drainage devices (GDDs) have regained importance, through the development of implants with biocompatible materials and improved designs with the aim of reducing early postoperative complications in the traditional trabeculectomy. GDDs have the potential to regulate flow continuously, thus eliminating postoperative hypotonia. GDDs current situation is somehow similar to that of intraocular lens in the 1970s, with frequent complications attributable to the design and biocompatibility of the materials. Like the improved intraocular lenses which have revolutionized cataract surgery in the recent past, the new materials and designs can transform Glaucoma filtering surgery in a near future (Lim K.S. et al; 1998).

Some of the documents related to the state of the art of the aqueous humor drainage devices, the method for their implantation and, in some cases, their inserter are described below, taking into account the abovementioned classification.

Within group 1 , drainage devices which are implanted ab-interno, the following background can be included:

US 4,968,296 (1990) A, US 6,007,511 A (1999), US 6,638,239 B1 (2003), US 6,780,164 B2 (2004), US 7,291 ,125 B2 (2007), US 7,815,592 B2 (2010), US 20120323159 A1 (2012), US 8,337,509 B2 (2012), US 8,128,588 B2 (2012), US 8,372,026 B2 (2013), US 8,721 ,656 B2 (2014), refer to an aqueous humor drainage device which is implanted ab-interno by using any kind of inserter.

Document US 4,968,296 A describes an aqueous humor drainage device, an inserter thereof and a method for ab-interno implantation. The implant has a 0.25 mm lumen and connects the anterior chamber of the eye with the subconjunctival space. It has a kind of fastening disc on each side of the sclera, where one of them is implanted under the conjunctiva. The disadvantages of said drainage device lie in the fact that the disc outer diameter of the end which is implanted into the anterior chamber of the eye is 1 .25 mm and it could come into contact with the iris or endothelium in the anterior chamber of the eye in case of mild to moderate hypotalamia, thus causing tissue inflammation. Another disadvantage lies in the fact that its 0.25 mm lumen may produce an excessive aqueous humor flow, especially since the outer end is directly implanted into the subconjunctival space, without scleral protection, and where said subconjunctival ring without scleral protection could additionally erode the conjunctiva. In addition, the needle or cannula of the insertion device used for the implant must be large enough to allow the introduction of a drainage tube which is compacted up to a minimum of 0.75 mm. Likewise, the required implantation method has all the disadvantages of the ab-interno procedures stated below.

The abovementioned documents, US 7,291 ,125 B2, US 7,815,592 B2 and US 8,128,588 B2, refer to a drainage device composed of a tube and a disc which is implanted ab-interno into the suprachoroidal space by using an insertion device. The entire device is wound up to a diameter of 1 .5 mm, and the implant technique requires a corneal-scleral incision, injection of a viscoelastic substance in the anterior chamber, introduction of an instrument to the anterior chamber in order to perform a cyclodialysis (separation at the junction of the sclera and the choroid) assisted by the use of a gonioscopy lens; then, the drainage device is implanted into the created space, locating the disc in the intrascleral space and the tube in the anterior chamber. One of the disadvantages of this drainage device is its size, which can be up to 1 .5 mm when wound. Additionally, its implant technique has the disadvantages of the ab-interno procedures stated below, and it requires cyclodialysis before the implantation.

One of the disadvantages of the drainage device ab-interno implantation procedures is that a corneal incision is required to introduce the handling instruments to the anterior chamber of the eye, the corneal incisions (avascular area of the eye) being of higher risk as regards possible intraocular infections in relation to the scleral incisions, which are covered and protected by a conjunctiva with blood vessels and lymphatic system that provide protection. Turning the situation worse, said corneal incisions of the ab-interno procedures are generally made in the lower area of the cornea, leaving it in contact with the lacrimal lake, which contains usual germs of the ocular flora that may enter the eye since the implants are usually located in the upper part of the eye (180° from the corneal incision). Additionally, the ab-interno procedures often require the use of intraoperative gonioscopy lens to locate the incision site where said device is to be implanted, and this requires certain complexity and experience. Another important issue to consider is that any manipulation performed inside the anterior chamber of the eye may compromise its internal structures, such as the corneal endothelium and the crystalline lens, being potencially cataractogenic; therefore, it is advisable that these devices, designed to be inserted by ab-interno procedures, are implanted into patients who have already been operated on cataracts, or as specifically stated by the Company Glaukos in its webpage for its GDD called iStent® Trabecular Micro-Bypass, associated to a cataract surgery (joint procedure for which it was approved by the F.D.A.).

Within group 2 of the abovementioned classification (Ab-externo procedures), the following state of the art background can be included:

The following documents refer to drainage devices which consist of an aqueous humor drainage tube that connects the anterior chamber of the eye to one or two plates which serve as reservoir, and which are fixed to the sclera subconjunctivally: US 4,457,757 A (1984); US 4,750,901 A (1998); US 5,397,300 (1995); US 5,454,796 A (1995); US 5,882,327 A (1999) and US 6,050,970 (2000). The surgical technique is similar for most of said implants: wide conjunctival flap, scleral tunneling and closure in layers with sutures. The main complication of these devices is over-filtering, which is addressed by adding suture binding around the tube or inner valves which try to create flow resistance. Postoperative inflammation in these patients is often intense (Thomas R, 1998). Additionally, they may cause diplopia in some cases, especially when the plates are placed in the subTenon-conjunctival space of the nasal area (Prata et al 1993).

Other documents which refer to drainage devices which are implanted ab-externo are detailed below: US 4,634,418 A (1987), US 5,704,907 A (1998), US 6,450,984 B1 (2002), US 6,468,283 B1 (2002), US 6,589,203 B1 (2003), US 6,699,210 B2 (2004), WO 2004073564 A2 (2004), US 7,160,264 B2 (2007), US 20070293872 A1 (2007), US 20130184631 A1 (2013), US 2013/0184631 A1 (2013), US 8,628,492 B2 (2014).

A problem associated with traditional implants which include a tube and a plate or artificial reservoir, and are inserted ab-externo, is the size of the incision required for them to be implanted, where the resulting conjunctival wound must be large enough to expose the sclera and subsequently make a scleral tunnel to introduce the drainage tube in the anterior chamber and the plate or reservoir under the conjunctiva. Additionally, the scleral coat created must be sutured and, in some cases, implants must be fixed to the sclera with sutures, and the conjunctiva must also be closed with sutures. The larger the wound, the higher the risk of infection, inflammation and fibrosis, and therefore, a greater chance of surgery failure as well as a longer time to recovery. Additionally, procedures with large conjunctival incisions or large scleral tunnels may compromise another future ab-externo glaucoma surgery (Parul lchhpujani; 20 ).

Document US 6,468,283 B1 (2002) reveals an aqueous humor drainage device which is supported by its insertion device on the outside of its distal end and an application method thereof, where the drainage tube is inserted in a hole in the sclera, placing its distal end in the anterior chamber of the eye and its proximal end, which is disc- or plate- shaped, under the conjunctiva. The disadvantage of said implant lies in the fact that the plate or disc is designed to be implanted under the conjunctiva, in direct contact therewith, where lack of scleral protection may cause erosions in the conjunctiva with serious consequences, and additionally, if said device lumen, which directly drains into the subconjunctival space without scleral protection, is about 0.3 mm or even smaller, as stated in this document, it may cause a marked decompression of the eye due to hyperfiltering, with the consequences of postoperative hypotonia. In a study where the drainage devices related to this document were implanted by using the method which is also described herein, the authors concluded that the percentage of complications obtained seemed to be quite high (Wamsley et. al. 2004; Karmel 2004). Additionally, the implantation method requires a conjunctival opening to gain access to the sclera, which must be subsequently sutured to prevent aqueous humor leakage (Seidel's Phenomenon).

Document US 20130338564 A1 (2013) refers to a drainage device with an inner valve to prevent excessive aqueous humor drainage.

Document US 8,628,492 B2 (2014) also refers to a drainage device with at least one inner valve to prevent excessive aqueous humor drainage. This device has the disadvantage of requiring one or more inner valves to produce a suitable flow, and another disadvantage is that it requires fixing means which are not an integral part of, but are attached to, the drainage tube. This document mentions that it is implanted subconjunctivally by means of a needle 19G, but it does not specify how said implantation is performed, for example, it does not mention the place of the previous conjunctival opening or how the Tenon's membrane dissection is performed, or the specific method to access the sclera, or the specific place to incise it and enter the anterior chamber of the eye.

Document US 2013/0184631 A1 (2013) refers to a drainage device and an insertion device which has a needle to create a hole in the sclera. The drainage tube measures 8.5 mm and connects the anterior chamber with the subconjunctival space, placing its outer end under the conjunctiva. Said device has the disadvantage of requiring a previous conjunctival opening with the dissection of the Tenon's membrane exposing the sclera to incise it with the inserter needle, and then the conjunctiva must be sutured, thus causing an inflammatory reaction of the eye. Another disadvantage is that the small hole created by the insertion needle must be expanded with a stylet included in the needle proximal end or with another stylet in order to introduce the fixing means of the drainage device to the sclera.

Document WO 2004073564 A2 (2004) refers to a method and system to reduce flow resistance in an aqueous humor drainage device implanted into the eye. This system and the method thereof have the disadvantages of the ab- externo procedures which require a wide conjunctival incision and the scleral tunneling to insert the tube, the disadvantages of the ab-interno procedures which require the manipulation inside the anterior chamber of the eye, and the disadvantages of requiring an inner valve complex system to limit the aqueous humor drainage, plus an element passing through the valve to reduce flow resistance generated by said valve.

Some of the aqueous humor drainage devices have the advantage that they can be implanted by insertion systems, such as for example, the device in document US 2002/0133168 (2002), which describes an insertion system for implanting a drainage device for the Glaucoma disease ab-interno, from the anterior chamber of the eye by means of a corneal incision.

A more complex insertion system is proposed in document US 2004/0236343 A1 (2004).

Document WO 201 1 106781 A1 (201 1 ) refers to a device which contains a cable, wire or cutting element which is introduced in the Schlemm's canal to create a fistula with the suprachoroidal space after an opening of the conjunctiva, Tenon and sclera, and with the subsequent traditional closure in layers with sutures.

The abovementioned document US 6,589,203 B1 (2003) refers to a tube and a plate or reservoir which folds and is implanted by means of an insertion device in order to reduce the size of the conjunctival wound and for the closure thereof to be smaller than with the traditional implants, even though it still requires opening said conjunctiva and Tenon and creating a space under the conjunctiva by using any instrument to place said plate or reservoir under said membranes, which also causes a surgical trauma due to tissue manipulation with an inflammatory response.

Document US 2007/0293872 A1 consists of a drainage device composed of a tube, which works as a fistula, enclosed in a collapsible conduit which must be connected to a reservoir in one of its ends. The disadvantage of this device is that it requires a previous conjunctival opening, which must be then closed by sutures and the need of making a connection of the device during the surgical procedure, thus extending the surgical procedure and making it more complex.

There is a GDD called xen gel stent® from AqueSys, Inc. that is implanted into a scleral tunnel created by the inserter needle, placing its distal end on the sclera; such a device drains the aqueous humor from the anterior chamber of the eye into the subconjunctival space (Vera V., 2014), but its disadvantage is that it is implanted ab-interno (Preferred approach) with the abovementioned disadvantages for said approach. As this procedure is a potentially cataractogenic, it should be performed in association with a cataract surgery or in a patient who has previously had a cataract surgery. Additionally, requires a gonioscopy lens and the use of viscoelastic substance for its implantation. It is also described the possibility for an ab-externo approach for this GDD, but it requires previous dissection and pullback of the conjunctival and tenon tissue to allow access to the sclera for implant placement. After that, the conjunctiva must be sutured on a tight fashion. Furthermore, some GDDs have drainage tubes with a large inner lumen and they require inner valves which are attached to their inside in order to prevent excessive drainage and trying to avoid the complications caused as a result. However, the disadvantage of the drainage devices which have inner valves is that they make the manufacturing of said device more complex, thus increasing the costs, and additionally, they add another piece that may fail or stop working over time, and where elements such as inflammatory cells, blood cells or fibrin may be attached to, thus obstructing the drainage tube lumen.

If the device is not relatively affordable, if it does not have a simple manufacturing and implantation technique and does not provide reduced tissue damage for its implant, its medical application makes no sense in terms of the cost/benefit ratio in relation to traditional trabeculectomy, as published in a research work for one of the currently used GDDs (Tucker M E, 2014).

Advantages of the invention over the known art:

There is no document that specifically or literally refers to a GDD which can be implanted "transconjunctivally" due to its structural characteristics or its inserter. The drainage tube of as well as the inserter of the invention, are specifically designed to enable a transconjunctival implantation method without the need of a previous opening or subsequent closure of the conjunctival and tenon tissue. Some documents of the known art refer to a GDD that can be implanted subconjunctival^ by means of an inserter, but they do not clarify whether they are implanted transconjunctival^ or if they require a previous opening of the conjunctiva with scissors, and they do not clarify how the elastic and translucent membrane (Tenon's membrane) underlying the conjunctiva is treated in order to have access to the sclera and visualize the place to be incised in said sclera to enter the anterior chamber of the eye.

In the hypothetical case that it can be transconjunctival^ implanted, no document mentions how to solve the difficulties to visualize the inserter needle under the conjunctiva and the Tenon.

The invention comprises an insertion device with a needle having luminescent properties to improve needle visualization under the conjunctiva and the Tenon.

In some embodiments of the drainage device disclosed herein, the body 11 and the distal end 10b are implanted transconjunctival^ in the scleral thickness, with a small hypodermic needle that could be as small as a 28G needle, where no part of the GDD, once implanted, remains in direct contact with the conjunctiva to avoid erosions thereof. There are no documents that refer to GDD devices which are implanted ab-externo and are completely inserted by transconjunctival route in the intrascleral space without contacting the conjunctiva.

No document mentions that the fixing means to the eye consist of fragments belonging to the opposite walls or the same opposite walls of the drainage tube that open at angle (Figures 2A, 3A, 3C, 3D, 3E, 3F y 3G), thus allowing said fragments or walls to compress in order to enter the inserter needle and self expand, at least partially, when exiting it, remaining within the intrascleral space, without contacting the conjunctiva. This design of the fixing means implies an advantage as regards simple manufacturing and therefore, final costs. Another benefit of the invention is that not internal valve is required, diminishing costs and complexity.

In some embodiments of the drainage device disclosed herein, its proximal end 10b is implanted under the conjunctiva and the Tenon without injuring them as said Glaucoma drainage device is made out of a very soft biopolymer. There is no other GDD in the prior art documents or the market as this latest version (very soft biopolymer with the subconjunctival proximal end 10b and a transconjunctival route through a small hypodermic needle that could be as small as a 28G needle) that can be implanted into such a simple manner and so affordable to every ophthalmologist.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings included herein are only intended as being explanatory of the invention, but are not necessarily an exclusively exact embodiment thereof. Some of the embodiments of the present invention are illustrated below, without altering the true spirit thereof, since other advisable and preferred modifications are also included in the claims section.

Figure 1 A shows a schematic drawing of the eye at the iridocorneal angle level, including: the conjunctiva 1 , the sclero-corneal limbus 1 a, the Tenon's capsule 1b, the sclera 2, the choroid 2a, the cornea 3, the ciliary body 4, the iris 5, the crystalline lens 6, the Schlemm's canal 7, the trabeculate 8 and the anterior chamber 9, where the conjunctiva 1 and the Tenon 1 b, are shown separate from the sclera 2 only for explanatory purposes.

Figure 1 B shows a schematic drawing of the aqueous humor drainage device implanted into the eye that represents several preferred embodiments of the invention, said figure including: the conjunctiva 1 , the sclera 2, the choroid 2a, the cornea 3, the ciliary body 4, the iris 5, the crystalline lens 6, the anterior chamber 9, the front or distal end 10a and the rear or proximal end 10b of the drainage device 50.

Figure 1 C shows another preferred embodiment of the aqueous humor drainage device implanted into the eye, in an axial section that shows its inner lumen, said figure including: the conjunctiva 1 , the sclera 2, the choroid 2a, the cornea 3, the ciliary body 4, the iris 5, the crystalline lens 6, the anterior chamber 9, the front end 10a and the rear end 10b of the drainage device 50.

Figure 2A shows a perspective view of the aqueous humor drainage device according to a preferred embodiment of the present invention, including: the bevel 10 of the front or distal end 10a, the body 11 , the fragments of the fixing side walls 12, where the angle a between them and the hole 15 connecting the lumen to the outside are both open.

Figure 2B shows a side view of the aqueous humor drainage tube of Fig. 2A, including: the bevel 10 of the front or distal end 10a, the rear or proximal end 10b of the drainage tube, the body 11 of the drainage tube, the fragment of the side wall 12, used as fixing means.

Figure 3A shows a perspective view of another preferred embodiment of the aqueous humor drainage tube of the present invention, including: the front end 10a, the rear end 10b, the body 11 , the fragments of the side walls 12a y 12b, the opening angles a and β between them in both ends, the bottom 14 and the hole 15 which connects the lumen with the outside.

Figure 3B shows a side view of the aqueous humor drainage tube of figure 3A, including: the front end 10a, the rear end 10b, the body 11 of the drainage tube, the fragment of the front end side wall 12a and the fragment of the rear end side wall 12b.

Figure 3C shows a representation of the aqueous humor drainage tube in another preferred embodiment of the invention, including: the front end 10a with bevel, the rear end 10b with the side walls 13 open at angle a1 serving as a fixing system and the body 11.

Figure 3D shows a perspective view of the drainage device 50 proximal end 10b, including: the walls 13c which are open at an outward angle like flower petals, with wedge-shaped openings that serve as a fixing system, and only present in the proximal or rear end 10b.

Figure 3E shows a perspective view of another preferred embodiment of the drainage device 50, including: the distal end 10a and the proximal end 10b linked by the body 11 , and the opposite walls 13c of their ends 10a, 10b open at angle like flower petals, serving as a fixing system.

Figure 3F shows a representation of the aqueous humor drainage device in another preferred embodiment of the invention, including: a gap of its opposite walls 13 and 13a with opening at angle a1 and β1 respectively, at both ends 10a and 10b, and the body 11.

Figure 3G shows a representation of the aqueous humor drainage tube in another preferred embodiment of the invention, including: the front end 10a which is beveled and tilted below its lower wall 10c, the rear end 10b with the opposite walls open at angle a1 , and the body 11. Figure 3H shows an embodiment of the aqueous humor drainage device with a tube shape, exiting the insertion device needle, including: the hole 15 of the distal end 10a which connects the lumen with the exterior, the proximal end 10b, the insertion device needle 16, the distal portion 19 of the drainage device 50 pushing means. Figure 3I shows another embodiment of said drainage device, including: the distal end 10a, the proximal end 10b, the side fixing tabs 13b and the connection holes 15 of the lumen with the outside.

Figure 3J shows another embodiment of said drainage device, including: the distal end 10a, the proximal end 10b, the side fixing flaps 13b and the connection holes 15 of the lumen with the outside. Figure 3K shows another representation of the aqueous humor drainage device in another preferred embodiment of the invention, including: a gap of its opposite walls 13 and 13a with opening at angle a1 and β1 respectively, at both ends 10a and 10b, and the body 11 , wherein these lateral and opposing walls, bent backwards like hooks on both extremes. Figure 3L shows a representation of the aqueous humor drainage device in another preferred embodiment of the invention, consisting in a cylinder shaped body 11 with no inner conduit and two opposite ends 10a and 10b, made out of a porous biopolymer material.

Figure 3M illustrates another preferred embodiment of the aqueous humor drainage device 50 with a tube-like shape, including: the hole 15 of the distal end 10a which connects the lumen with the exterior, the proximal end 10b, and the lumen in discontinuous line.

Figure 4 shows an explanatory drawing of the insertion arrangement of the present invention in a longitudinal section that shows its inside: the needle 16, the body 17, the connection 26 of the needle 16 and the body 17, the connection 20 of the front part 19 of the plunger with the rear part 18 of the plunger and the front end 21 of the needle 16.

Figure 4A shows a side view of the insertion arrangement in one of the preferred embodiments of the present invention, including: the needle 16, the body 17, the connection 20 of the front part 19 of the plunger represented by the broken line with the rear part 18 of the plunger represented by the broken line and larger than the front part, the connection 26 of the needle 16 and the body 17, the connection 33 of the actuating arrangement 34 and the plunger 18 and 19, the groove 35 of the insertion device body 17.

Figure 5 shows the insertion arrangement of the drainage tube in one of the preferred embodiments of the present invention, including: the needle 16, the body 17, the rear part of the plunger 18, the front end 21 of the needle 16, the loading hole 22 of the drainage device 50, the side groove 23 which connects to the loading hole 22, the pressure actuated head 24a of the plunger, the male screw 25 built-in into the body 17 of the insertion arrangement and the 26 needle 16 - body 17 connection.

Figure 5A shows in detail the female inner screw of the insertion arrangement foldable head 24b in relation to Figure 5.

Figure 5B shows in detail the insertion arrangement needle where the drainage device is introduced, including: the loading hole 22 of the drainage device 50 in the needle 16 body and the groove 23 of the needle 16 body.

Figure 5C shows the opposite side of the insertion device needle of Figure 5B including: the groove 23 of the insertion arrangement needle 16 body.

Figure 5D shows in detail another preferred embodiment of the invention in relation to the insertion arrangement needle, including: the needle 16, the insertion arrangement body 17, the groove 23 in both side walls of the needle 16, the foldable needle 16 - body 17 connection 26 of the insertion arrangement and the drainage device 50 shown with broken lines in the inside of the needle 16, with its side walls 12 portions projected outwards.

Figure 5E shows a rear perspective view of another preferred variant of the invention in relation to the insertion arrangement needle, including: the needle 16 with an elliptical cross-section, and the end 21 thereof. Figure 5F shows another rear perspective view of another preferred variant of the invention in relation to the insertion arrangement needle, including: the needle 16 with a flat cross-section, and the distal end 21 thereof.

Figure 5G shows another rear perspective view of another preferred variant of the invention in relation to the insertion arrangement needle, including: the needle 16 with a round cross-section and without side grooves, and the distal end 21 thereof.

Figure 6 shows an enlarged image of the insertion arrangement needle tip 16, in one of the preferred embodiments of the invention, including: the front (also called the distal) end of the needle 21 , an edged 27 tip, an edged 21a bevel and a step 28 which acts as a scleral stop in the connection of the needle 16 front end 21 and its body.

Figure 7 shows one of the embodiments of the invention in relation to the insertion arrangement, in a longitudinal section thereof, including: the front (that is, the distal) end 21 of the needle 16, the front part 19 of the plunger and the rear part 18 of the plunger which is larger than the first portion 19 and the plunger head 24a.

Figure 8 shows in more detail the engagement of the foldable screwable head to the rear end male screw of said insertion device body in one of the preferred embodiments of the invention, including: the insertion device body 17, the rear part 18 of the plunger, the head 24a of the pressure actuated plunger, the rear end male screw 25 of the insertion device body 17 and the foldable head 24b with an inner female screw, represented in an axial section.

Figure 9A shows the introduction of the drainage tube folded on its bevel tip according to the embodiment example N°1 of the invention, within the needle inner conduit of the insertion arrangement according to the embodiment example N°2, using the method of the embodiment example N°3, the figure including: the front (or distal) end 10a and the beveled rear (or proximal) end 10b of the drainage tube 50, the body 11 of the drainage tube 50, the body 17 of the insertion arrangement, the plunger rear portion 18, composed of a long needle 21 G, the 0.25 mm diameter stainless steel inner wire 19 represented by a broken line, the end 21 of the insertion arrangement needle 16, the needle 16 - body 17 connection 26 of the insertion arrangement, the folding 32 in the bevel tip of the drainage tube 50.

Figure 9B shows the introduction of the drainage tube unfolded on its bevel tip according to the embodiment example N°1 of the invention, within the needle inner conduit of the insertion arrangement according to the embodiment example N°2, using the method of the embodiment example N°3 of the present invention, the figure including: the front end 10a and the beveled rear end 10b of the drainage tube 50, the body 11 of the drainage tube 50, the plunger rear portion 18, composed of a long needle 21 G, the 0.25 mm diameter stainless steel inner wire 19 represented by a broken line, the end 21 of the insertion arrangement needle

16, the needle 16 - body 17 connection 26 of the insertion device.

Figure 10 shows a schematic drawing of the insertion arrangement, according to the embodiment example N° 2 of the present invention, including: the needle 16, the insertion device body 17 (cut syringe), the 0.25 mm diameter stainless steel inner wire 19, the connection 26 of the needle 16 and the syringe

17, the connection 20 of the stainless steel cable 19 and the long 21 G hypodermic needle 18, the end 21 of the insertion arrangement needle 16, the head 24a of the long 21 G disposable hypodermic needle 18. DETAILED DESCRIPTION OF THE INVENTION

Due to the above mentioned problems of the known prior art, the invention disclosed herein is intended to provide, within the therapeutic arsenal of Glaucoma surgery, a drainage device that is implanted ab-externo to avoid the disadvantages of the ab-interno drainage devices, and that additionally has a small outer diameter to prevent protrusions or injuries of the sclera where it is inserted, that does not additionally require inner valve sophisticated systems for excessive drainage in which said valves may fail or stop working overtime and may be a place of potential adherence of elements such as fibrin and cells that may obstruct its lumen. The invention further provides a solution related to the wound size, since it can be implanted by means of an insertion device where it is preloaded, and where the insertion device allows a transconjunctival implantation method to be performed, that is to say, without the need of a previous conjunctival opening or closure thereof with sutures, cauterization or adhesives, as required by the prior art drainage devices implanted ab-externo. The invention is also intended to provide a simple system and method that can be used not only by those skilled in Glaucoma surgery but also by general ophthalmologists.

By way of introduction, and for a better understanding the present invention, figure 1A is shown, as a schematic drawing of the iridocorneal angle in an axial section of the eye.

It is important to mention that the conjunctiva 1 is an elastic and transparent mucous membrane, which covers the outer part of the eye, outside the cornea 3 (Figure 1 A), the latter 3 being a transparent and resistant membrane. The conjunctiva 1 is composed of an epithelium and a chorion containing histiocytes, mast cells, lymphocytes and blood vessels that serve as protection, nutrition and defense elements of the eye. Said conjunctiva 1 is loosely attached by its undersurface to a translucent and elastic membrane called the Tenon's capsule 1b (Figure 1 A) which is also adhered to the underlying sclera 2 (white, opaque, resistant membrane with some degree of slight elasticity).

This invention describes a kit for the treatment of Glaucoma disease, that comprises an aqueous humor drainage device 50 and an insertion arrangement which includes a needle 16 containing the first device 50 preloaded inside and wherein both pieces form a structural and functional unit designed to allow the performance of a novel transconjunctival implantation method, without previously opening the conjunctiva 1 , said method allowing to avoid the need to close the wounds with sutures, cauterization or adhesives once the implantation procedure has finished, since the conjunctival and scleral wounds produced are reduced to the size of a small hypodermic needle that could be as small as a 28G needle.

Figure 1 B shows one of the preferred embodiments of the invention where said aqueous humor drainage device 50 can be seen implanted into the eye, and where the distal (or front) end 10a is implanted into the anterior chamber 9 of the eye and the proximal (or rear) end 10b is implanted into the intrascleral space, thus allowing the aqueous humor drainage from the anterior chamber 9 of the eye into the subconjunctival space for later reabsorption.

Figure 1 C shows another preferred embodiment of the invention where said aqueous humor drainage device 50 can be seen implanted into the eye, where the distal end 10a is implanted into the anterior chamber 9 of the eye and the proximal end 10b is implanted into the subconjunctival space, thus allowing the aqueous humor drainage from the anterior chamber 9 of the eye into the subconjunctival space for later reabsorption.

In the two cases described above and represented in figures 1 B and 1 C, said drainage device 50 is inserted into the eye, by means of said insertion device, by using the transconjunctival implantation method in which, by means of said insertion device needle 16 containing said drainage device 50 preloaded, the conjunctiva 1 is incised away from the sclero-corneal limbus 1a, and then, the needle is moved forward underneath said conjunctiva 1 or conjunctiva 1 and Tenon 1b towards the cornea 3, to incise the sclera 2 at the intended distance from the sclero-corneal limbus 1a and subsequently enter the anterior chamber 9 of the eye with said needle 16, where the implantation of said drainage device 50 is then performed by placing at least one portion of said drainage device 50 into the hole in the sclera 2 created by said insertion device needle 16, and placing the distal end 10a in the anterior chamber 9 of the eye to drain the aqueous humor from said chamber into the subconjunctival space. Said distance between the incision of the conjunctiva 1 and the incision of the sclera 2, together with the small hole created in said conjunctiva 1 by the insertion device needle 16 and the scleral incision coating by said conjunctiva 1 , allow a safer surgery process, since they reduce postoperative infection risks. Said drainage device 50 of the invention comprises: a) In the majority of the embodiments of the invention (Figures: 2A₎2B,3A,3B,3C₎3D,3E,3F,3G,3H,3I,3J,3K,3M), a tube-like body 11 with two opposite ends 10a, 10b, and an inner conduit, which defines an outer diameter from 0.127mm to 0.5 mm, and an inner diameter from 0.05mm to 0.35mm, and where each opposite end 10a, 10b, have at least one hole 15 which connects said inner conduit to the outside.

In many preferred embodiments of the invention, said drainage device 50, has a body 11 outer diameter from 0.127 to 0.31 mm and inner diameter from 0.05 to 0.152 mm, depending on the draining needs according to the case to be treated.

In a preferred embodiment of the invention, at least one of the holes 15 that connect the inner conduit of the drainage device 50 to the outside has the same diameter as the inner conduit of said drainage device 50.

In other preferred embodiments of the invention, at least one of the holes 15 that connect the inner conduit of the drainage device 50 to the outside has a different diameter from the inner conduit of said drainage device 50. b) In one of the preferred embodiment of the invention (Fig. 3L), an aqueous humor drainage device 50 having a cylinder shaped body with two opposite ends 10a,10b, composed of a porous biopolymer material with no inner conduit, wherein said drainage device 50 is hydrated and swells in contact with liquid, and allows the passage of liquid from one end to the other.

c) A total length of the drainage device 50 from 2 mm to 8.5 mm.

In some preferred embodiments, the total length of said drainage device 50 is from 2.5 to 3.5 mm. d) A constituting material thereof, including, but not limited to, at least one of the materials selected from the following group: stainless steel, titanium, nickel- titanium alloys, synthetic biopolymers including ΡΜΜΑ,ΡΗΕΜΑ, Fluorocarbon, hydrogels, polyacetals, polyamide elastomers, polyester elastomers, poly(olefine) elastomers, poly(urethanes), Carbothane®, Pellethane®, Tecoflex®, Tecophilic®, Tecoplast®, Tecothane® and silicones, as well as copolymers, biocompatible ceramic materials, or a combination thereof.

In some preferred embodiments, the constituting material of said drainage device 50, comprises some of the materials selected from the following group: Carbothane®, Pellethane®, Tecoflex®, Tecophilic®, Tecoplast®, Tecothane®. e) In many of the embodiments of the invention, a fixing means applied to the eye, comprising, but not limited to, at least one item selected from the following group: a) at least a pair of side opposite flaps 13d (see Figure 3J), an open-angle gap of at least a portion of the opposite walls 12, 12a, 12b, 13, 13a, 13c, (see Figures 2A, 3A, 3C, 3D, 3E, 3F, 3G, 3K) belonging to said drainage device, c) burrs, d) folding 10c of the distal end 10a (See Figure 3G), e) spines; f) spurs; g) clamps; h) fragments of different shapes and materials; i) outer surface roughness ,j) tabs 13b (see Figure 3I); k) hooks (see Figure 3K) or I) a combination thereof, and where said fixing means, is or are placed in at least one of the portions of said drainage device 50, selected from the following group: the rear end (or proximal end) 10b of said drainage device 50 (Figures 2A, 2B, 3C, 3D ), both ends 10a, 10b of said drainage device 50 (Figures 3A, 3B, 3E, 3F, 3G, 3J,3K), the body 11 of the drainage device 50 (Figure 31), the body 11 and the rear end 10b of the drainage device 50 (Not shown in the figures), or on the bottom side of said drainage device 50 (Figure 3J).

Said fixing means may additionally have several shapes and inclination angles, and a length from 0.2 mm to 1 .5 mm from said drainage device 50 body 11.

In some embodiments of the invention, the fixing means includes pieces which are not an integral part of the drainage tube, said pieces being made of several materials and attached to the drainage device 50 by means of glue or by welding. In several preferred embodiments of the invention, the fixing means is an integral part of said drainage device, thus simplifying manufacturing and reducing production costs; in these cases, said fixing means is composed of at least a fragment of both opposite walls belonging to said drainage device 50, both walls or wall fragments being open at angle (Figures 2A, 3A, 3C, 3D, 3E, 3F, 3G3K), and said splay angle being greater than 5°, vertically or horizontally oriented, in any of their ends 10a, 10b. Said opposite walls or opposite wall fragments are so flexible that enable the insertion and sliding of said drainage device 50 inside the insertion device needle 16, by aligning with said drainage device 50 body 11 and at least partially returning to the original angle when exiting said insertion device needle 16.

In other embodiments, said drainage device 50 also has fixing means 13b, 13d (see Figures 3I, 3J), which can be folded to align themselves with the drainage device 50 body 11 in order to enter said insertion device needle 16, and at least partially returning to their original state when exiting said insertion device needle 16.

In some preferred embodiments of the invention (Figures 3H, 3L, 3M), the anchoring system to the eye, comprises the compression of the body 11 of the drainage device 50 carried out by the sclera 2, along the scleral hole (Figures 1 b, 1 c) created by the insertion needle 16 where it is preloaded. f) A finish of any of said drainage device 50 ends 10a, 10b, comprising, but not limited to, any of the several configurations selected from the group consisting of: right-angled to the tube axis, beveled, flattened, tilted down (See distal end 10a of Figure 3G), trumpet shaped, pointed, fish mouth-shaped (Figures 3C, 3F, 3G), an extension of said distal end 10a lower wall (See Figure 3A) capable of preventing possible aqueous flow blocking by the iris 5, flower-shaped (Figures 3D, 3E), or a combination thereof. In several preferred embodiments of the invention, said drainage device 50 distal end 10a has a beveled finish to prevent potential obstructions by the iris of the hole 15 in said end.

In another embodiment of said drainage device 50, both ends 10a, 10b, can have the same kind of finish (Figures 3A, 3B, 3E, 3F, 3H, 3K, 3L, 3M). In another embodiment of said drainage device (Figure 3G), the distal or front end 10a, has a beveled finish and is tilted down 10c. Some variations related to the drainage device 50 of the invention are listed below:

In some preferred embodiments of the invention, the front (or distal) end 10a of the drainage device 50, which is implanted into the anterior chamber of the eye, has a hole on the front and another hole behind it, on the upper part of said drainage tube, in order to enable the aqueous humor flow in the event that the iris 5 obstructs the first hole (this variant is not shown in the figures).

In some embodiments of the present invention, the outer surface of said drainage device does not have any kind of additional coating or treatment. In another embodiment of the invention, said drainage device has an outer surface treatment selected from the group consisting of: a passivation treatment, a polymer coating such as silicone, acrylics or parylene, a copolymer coating, or hydroxoapatite film coating.

In some embodiments of the invention, the cross-section of the drainage device 50 body 11 is round.

In other embodiments of the invention, the cross-section of the drainage device 50 body 11 is elliptical.

In another embodiment of the invention, the cross-section of the drainage device 50 body11 is flat. Below, there is a detailed description of some examples of the preferred embodiments of the invention, in relation to the aqueous humor drainage device, without affecting the spirit of the invention, since it may include some of the above mentioned modifications, which are not illustrated in the figures.

In one of the preferred embodiments illustrated in Figures 2A and 2B, the front end 10a of the drainage tube 50 has a beveled cut 10 and is implanted into the anterior chamber 9 of the eye, while its body 11 , is implanted into the intrascleral space formed by the insertion device needle 16, thus allowing the aqueous humor flow from the anterior chamber 9 of the eye into the subconjunctival space for further reabsorption. In addition, said drainage device has a fixing arrangement which is only present in the rear end (or proximal end) 10b and comprises two fragments of the side opposite walls 12 open at angle, and therefore, with no additional welds, thus simplifying the process and reducing production costs, and where said side wall 12 fragments are at an angle a greater than 5° and smaller than 180° between them, before entering said insertion device needle 16. Said fixing means have certain flexibility in order to compress and slide inside said insertion device needle 16 and they have certain memory to recover, at least partially, their opening angle a, after exiting said needle 16.

In another preferred embodiment of the present invention, in relation to the drainage device represented in figures 2A, 2B, 3C, 3I, the frontal end 10a has any of the above described fixing systems that prevent it from being expelled from the anterior chamber 9 of the eye (Not shown in the figures).

Figures 3A and 3B show another preferred embodiment of the present invention in relation to the drainage device 50. In this example, both ends 10a and 10b, have two fragments of the side opposite walls 12a, 12b open at angle a and β, preferably greater than 5° and smaller than 180°, before entering the needle 16, and they have certain flexibility such as that described for Figures 2A and 2B. In addition, the front end 10a has a bottom 14, which may have different lengths and shapes, that may act as a fixing means with a downward inclination angle to the axis of the tube body 11 , and it serves to prevent the iris 5 from obstructing the hole 15 through which the aqueous humor enters. The two fragments of the front end 10a side opposite walls 12a prevent the removal of the drainage tube 50, while the two fragments of the rear end 10b side opposite walls 12b act as fixing means outside the anterior chamber.

In another preferred embodiment of the present invention, in relation to the drainage device 50 represented in figures 3A and 3B, the angle β formed between the fragments of the front end 10a side opposite walls 12a is such that there is no need for a bottom 14 in said end, since the iris 5 will not obstruct the hole 15 through which the aqueous humor enters (Not shown in the figures).

Figure 3C shows another preferred embodiment of the invention in relation to said drainage device 50, which consists of a tube with an inner lumen that connects to the outside through its ends 10a y 10b. Its front (or distal) end 10a has a beveled finish, while the rear (or proximal) end 10b has an expansion of the diameter in relation to the body 11 , where two of its opposite walls 13 (by opposite walls meaning: side walls or bottom and top) open outwardly at open angle a1 , to serve as a fixing means to the eye. Said rear end 10b walls 13 additionally have such a flexibility that they can compress to enter or pass through the lumen of the insertion device needle 16 and self-expand, at least partially, when exiting it.

In another preferred embodiment of the invention, in relation to the drainage device 50 and represented in Figure 3D, the fixing means to the eye comprises the expansion of the proximal end 10b, where the walls 13c in said end are at least partially open like four flower petals, and where said walls have such a flexibility that they can compress to enter said insertion device hollow needle 16 and then expand when exiting said needle 16.

In another preferred embodiment of the invention, in relation to the drainage device 50 and represented in Figure 3E, the fixing means to the eye comprises the expansion of both ends 10b and 10b, where the walls in said ends are at least partially open like four flower petals, and where said walls have such a flexibility that they can compress to enter and slide in the lumen of said insertion device hollow needle 16 and then expand when exiting said needle 16.

Another preferred embodiment of the invention in relation to the drainage device 50 is represented in Figure 3F and consists of a tube with an inner lumen which connects to the outside through its ends 10a y 10b. Its front end 10a has an expansion of the diameter in relation to the body 11 in order to serve as a retaining system in the anterior chamber 9 of the eye, while the rear end 10b also has an expansion of the diameter which serves as a fixing system inside the scleral tunnel (Figure 1 B) created by the insertion device needle 16 or into the subconjunctival space (Figure 1C). This expansion consists of an outward opening at an open angle a1 and β1 of two of the opposite walls 13, 13a, belonging to ends 10b and 10a, by opposite walls meaning: side walls or bottom and top. Said ends have a wedged opening with an angle a1 and β1 between both opposite walls 13, 13a, which have such a flexibility that they can compress to enter or pass through the lumen of the insertion device needle 16 and self-expand, at least partially, when exiting the needle, to perform the implantation of the drainage tube 50 into the eye.

Another preferred embodiment in relation to the drainage tube 50 is represented in Figure 3G and consists of a tube with an inner lumen which connects to the outside through its ends 10a y 10b. Its front end 10a has an upper bevel and is tilted below its lower wall 10c in relation to the body 11 axis, which serves as a retaining means, while its rear end 10b has an expansion where two of its opposite walls 13, by opposite walls meaning: side walls or bottom and top, open outwardly at an open angle to serve as fixing means to the scleral tunnel created by the insertion device needle 16, having a wedged opening with an angle a1 between both walls 13, which have such a flexibility that they can compress to enter or pass through the lumen of the insertion device needle 16 and self-expand, at least partially, when exiting the needle in order to perform the implantation of the drainage tube 50. As previously mentioned in figures 3C, 3F and 3G, the expansion of the ends is achieved with an open-angle opening of its opposite walls, by opposite walls meaning the side walls or the bottom and the top; therefore, the wedged openings with angle crt and β1 may be vertically or horizontally oriented. Other preferred embodiment of the invention represented in Figure 3H comprises, a tube shaped body with an inner conduit, and two opposite ends 10a, 10b. Said drainage device 50, is constituted by a biopolymer material which is hydrated and swells in contact with liquid, thus allowing the anchoring to the eye when implanted. Its distal end 10a is implanted into the anterior chamber 9 of the eye and its proximal end 10b into the scleral thickness 2 (Figure 1 B) or into the subconjunctival space (Figure 1 C), depending on the length of said drainage device 50. The aqueous humor enters said drainage device 50 lumen through at least one hole 15 on the distal end 10a, and exits through at least a hole, located on at least its proximal end 10b, into the subconjunctival space. Another variant related to the Figure 3H, include several holes that connect the lumen with the exterior along the tube (Not shown in the figures).

The figure 3K represents another preferred embodiment of the drainage device 50 which consists of a tube with an inner lumen which connects to the outside through its ends 10a y 10b. Its front end 10a has an expansion of the diameter in relation to the body 11 , in order to serve as a retaining system in the anterior chamber 9 of the eye, while the rear end 10b also has an expansion of the diameter which serves as a fixing system outside the anterior chamber. This expansion consists of an outward opening at an open angle a1 and β1 of two of the opposite walls 13, 13a, belonging to ends 10b and 10a, which are backwards bent at the tip, meaning by opposite walls: side walls or bottom and top. Said ends have a wedged opening with an angle a1 and β1 between both opposite walls 13, 13a, which have such a flexibility that they can compress to enter or pass through the lumen of the insertion device needle 16 and self-expand, at least partially, when exiting the needle, to perform the implantation of the drainage tube 50 into the eye. Other preferred embodiment of the invention, represented in Figure 3L, comprises a cylinder shaped body, made out of a porous biopolymer material with no inner conduit, and wherein said drainage device 50 is hydrated and swells in contact with liquid, and allows the passage of liquid from one end to the other, and where the anchoring system to the eye comprises the compression of the body 11 of the drainage device 50 carried out by the sclera, along the scleral hole created by the insertion needle 16 where it is preloaded. Thus its distal end 10a is implanted into the anterior chamber 9 of the eye and its proximal end 10b into the scleral thickness 2 (Figure 1 B) or into the subconjunctival space (Figure 1 C), depending on the length of said drainage device 50. The aqueous humor enters said drainage device 50 through the distal end 10a, and exits through its proximal end 10b, into the subconjunctival space.

Other preferred embodiment of the invention, represented in Figure 3M, comprises a tube-like shape, an inner conduit and two ends 10a, 10b, with at least one hole on each end that connect the lumen with the exterior, allowing the passage of liquid from one end to the other, and where the anchoring system to the eye comprises the compression of the body 11 of the drainage device 50 carried out by the sclera, along the scleral hole created by the insertion needle 16 where it is preloaded. Thus its distal end 10a is implanted into the anterior chamber 9 of the eye and its proximal end 10b into the scleral thickness 2 (Figure 1 B) or into the subconjunctival space (Figure 1 C), depending on the length of said drainage device 50. The aqueous humor enters said drainage device 50 through the distal end 10a, and exits through its proximal end 10b, into the subconjunctival space.

Another variant related to the Figure 3M, include several holes that connect the lumen with the exterior along the tube (Not shown in the figures).

In all cases, the drainage devices of the present invention are preloaded in the insertion arrangement needles 16 of the invention and are delivered ready to use, packed and sterilized.

The kit for the treatment of Glaucoma allows for a procedure even without the use of a surgical microscope, since the implantation method is very simple and easy, and this could take place in places which are far from medical centers and have limited resources in terms of equipment.

Said insertion device of the drainage device 50 (Figures 4A, 5, 5A, 7 and 10) included in the treatment kit of the present invention, comprises: a body 17, a pushing means 18 and 19, an actuating means 24a, 24b, 34 of said pushing means 18 and 19, and as previously mentioned, a hollow needle 16 which serves to contain said drainage device 50 inside (Figure 5D) as well as to incise and penetrate the conjunctiva 1 without a previous incision thereof, moving forward into the cornea under said conjunctiva 1 , or conjunctiva 1 and Tenon 1 b up to the intended place for the incision in the sclera 2, in order to make a hole in this last membrane 2, entering the anterior chamber 9 of the eye, where said drainage device 50 is implanted, placing at least a part of said drainage device 50 in said hole in the sclera 2, and the front end 10a in the anterior chamber 9 of the eye.

Said needle 16 inner conduit of said insertion device connects to the outside by its front end 21 , while through its rear (or proximal) end, it connects to and meets the body 17 inner conduit, where the rear part of the needle 16 joins to 26 the front (or distal) part of said insertion device body 17, said connection 26 being fixed or removable. In said insertion device inner conduit, there is a pushing means 18 and 19, which when actuated, allows its distal portion 19 to slide inside the needle 16 inner conduit, pushing the aqueous humor drainage device 50 to be implanted into the eye.

As shown in Figure 4, the pushing means 18 and 19 may be composed of a front cable or wire 19 attached to a rod 18 of a larger diameter in its rear end in a point 20, or composed of a front cable or wire 19 attached 20 to a tube 18 of a larger diameter in its rear end, or it may be completely composed of only one cable or wire 19 with only one diameter (Not shown in the figures).

The front cable or wire 19 of said pushing means is preferably made of, but not limited to, stainless steel, and has such a diameter that allows it to slide inside the needle 16 lumen, generally from 0.2 mm to 0.5 mm, and such a length that allows it to reach at least the tip of said needle 16 end 21 , when actuating the actuating means to the maximum, while in the cases that have another cable, rod, or tube in said pushing means rear end 18, they can be composed of several materials, whether plastic or metal. The plunger, or pushing means 18 and 19, is pushed by an actuating arrangement, which can have different mechanisms such as sliding of a knob 34 (Figure 4A), button, trigger or lever, or it can have a pressure mechanism 24a (Figures 5, 7 and 8), or screw 24b mechanism (Figures 5, 5A and 8), which makes it slide forward, pushing the aqueous humor drainage device 50, which is inside said needle 16 inner conduit of said insertion device, into its front end 21 , for its implantation into the eye.

Said insertion device needle 16 can have different diameters along its length, and its inner conduit is the place where the aqueous humor drainage tube 50 is inserted, remaining there, prepared for its subsequent implantation into the eye, the loading being possible through the front (or distal) end, or through said needle 16 rear (or proximal) end (Figures 5D,5E,5F,5G) or through a hole 22 (Figures 5, 5B) in said needle 16 body, created for such purpose. Said insertion device needle 16 has a length from 1 .5 to 4 cm, and it can be straight, curved or angled, and it has an outer diameter from 0.35 mm to 1 .2 mm, an inner diameter from 0.22 mm to 0.8 mm, and its end 21 has a length from 1 .5 mm to 6 mm. Likewise, in some embodiments, said insertion device needle 16 is completely made of only one material, while in other embodiments of the invention, said insertion device needle 16 is made of a combination of materials; the materials used in both cases being selected from the following group: metal, ceramic, glass, diamond, sapphire, quartz or polymers derived from plastic, and in the event of using glass, sapphire or diamond, they are located in said needle distal end 21.

Furthermore, the lumen of said insertion device needle 16 has a cross- section selected from the following group: round (Figures 5D and 5G), elliptical (Figure 5E), or flat (Figure 5F).

According to all the preferred embodiments of the present invention in relation to said insertion device, said needle 16 has in its front end 21 an edged finish, which serves to incise the conjunctiva 1 , the Tenon 1b and the sclera 2 and penetrate the anterior chamber 9 of the eye, without requiring previous incisions in the conjunctiva, even though it will be understood by those skilled in the art that, if desired, a previous incision of the conjunctiva 1 and Tenon 1b could be made, thus exposing the sclera 2, to subsequently incise it and enter the anterior chamber 9 of the eye. Likewise, the front end 21 of the insertion device needle 16 may comprise an edged bevel all along its length with only one cutting angle as in the hypodermic needles, or as shown in Figure 6, it may have more than one cutting angle 21a, 27, and include the combination of one edged area 21a, 27 with another blunt area 28 and an area with bevel with an area without bevel, which do not necessarily have the same width and length.

In one preferred embodiment of the invention, said insertion device needle 16 has, at least in its distal end 21 which incises the sclera, luminescent properties, among which fluorescence and phosphorescence are included, therefore, when being stimulated by a suitable means such as for example a light with UV (Ultraviolet) filter, such as Wood's light or a cobalt blue filtered light, a fluorescence phenomenon is produced, allowing visualization under the conjunctiva 1 and the Tenon's capsule 1b to incise the sclera 2 at the intended distance from the sclero-corneal limbus 1a.

Furthermore, the body 17 of the different insertion devices may be made of metal, or preferably, plastic materials or by-products, and they may have different lengths.

In one of the preferred embodiments of the invention, shown in Figure 4A, the displacement of the plunger or pushing means 18 and 19, is performed by sliding a knob 34 along a groove 35 located in the insertion device body 17. Said knob 34 is connected 33 to said insertion device inner plunger 18. In another preferred embodiment in relation to the insertion device in Figure

4A, the actuating knob 34 is attached 33 to the distal cable or wire 19, and does not have the proximal segment 18 of the plunger. (Not shown in the drawings).

Figures 5 and 5A represent another preferred embodiment of the present invention, where the rear end of the plunger 18 axially exceeds the body 17 of the insertion device in its rear part, and connects to a head 24a (similar to a syringe with plunger) at such a distance from the body 17 that it can push the plunger 18 and 19, until its distal portion 19 frontally exceeds the tip 21 of the insertion device needle 16 when the head 24a of the plunger is actuated up to its stop. Furthermore, as also shown in Figure 8 in an enlarged image of the rear area of the insertion device in Figure 5, the rear end of said insertion device body 17 has an outer male screw 25 in which a second foldable head 24b with inner female screw is embedded and screwed, the second head being larger than the first pressure head 24a and enclosing it, so that when the screw is actuated, this second head 24b compresses the first head 24a and this one, in turn, actuates the plunger 18 and 19, pushing the drainage device 50 contained in the needle 16 lumen outwardly. The screwable removably head 24b provides the option to the operator of choosing the pressure 24a or screwable 24b system.

One preferred embodiment in relation to the insertion device needle 16 is shown in Figures 5B y 5C, where the needle 16 body has an opening 22, which serves to load the aqueous humor drainage tube 50 inside, and additionally has two opposite grooves 23, which are longitudinal and axial to said needle 16 body, where both have different lengths and are smaller than said needle 16 lumen, with the aim of containing the drainage tube 50 inside and additionally being the place where the fixing means of the drainage tube 50 proximal end 10b rest and slide (See fixing means 12, 12b, of Figures 2A,2B,3A,3B ), and project outwards from the needle 16 through said grooves 23. Said grooves 23 provide stability to the aqueous humor drainage tube 50, which has said fixing means 12, 12b inside said needle 16 inner conduit, where it is preloaded, and they prevent possible rotations during the implantation. In the event of using an insertion device with this kind of needle 16, the distal end 10a fixing means 12a of the drainage device in Figure 3A, 3B, slide into said grooves 23 when inserting said drainage tube 50 into said needle 16 but then they are pushed inwardly and remain inside the needle 16 lumen, without the needle projecting outwards until the implantation of said drainage device 50.

As shown in figure 5D, in another preferred embodiment of the invention, the loading of the drainage device 50 is performed on the rear end of the insertion device needle 16, making the drainage device 50 fixing means match, such as for example, the fragments of the side walls 12, 12a, 12b (Figures 2A, 3A), with the grooves 23 existing in the rear (or proximal) end of the needle 16. In the case of the drainage device 50 related to figure 3A, the fixing means of the end 10a must be pushed into the said needle 16 lumen when they reach the distal portion of said needle 16 side grooves 23. The needle 16 is fixed or removably attached 26 to the insertion device body 17, and by pushing the plunger 18, 19, the drainage device 50 is moved along the needle 16 lumen until said drainage device 50 is placed in the middle-rear part of the needle 16, and the fixing elements of the rear end 10b, such as the side wall 12, 12b fragments (Figures 2A, 3A), protrude from the side grooves 23 and said drainage device 50 remains in said position until its implantation.

In another preferred embodiment represented in figure 5E, the loading of the drainage device 50 is also performed by the rear end of the insertion device needle 16, but in this case, said needle 16 has a cross-section of its inner diameter with elliptical shape all along its length. In another preferred embodiment represented in figure 5F, the loading of the drainage device 50 is also performed by the rear end of the insertion device needle 16, but in this case, said needle 16 has a cross-section of its inner diameter with flat shape all along its length.

In another preferred embodiment represented in figure 5G, the loading of the drainage device 50 is also performed by the rear end of the insertion device needle 16, but in this case, said needle 16 has a cross-section of its inner diameter with round shape all along its length, without side grooves in its body.

Figure 6 shows one of the preferred embodiments of the present invention in relation to said insertion device needle 16, where its tip 21 has an edge 27, which serves to incise the conjunctiva 1 , the Tenon 1b and the sclera 2 penetrating into the anterior chamber 9 of the eye, thus allowing the transconjunctival implantation of said drainage device 50 without the need of a previous conjunctival opening or closure by sutures, cauterization or adhesives, or if desired, as it will be understood by those skilled in the art, after making a small previous opening of the conjunctiva 1 and Tenon 1b exposing the sclera 2, such as performed by the methods mentioned in the state of the art, but in this latter case, the conjunctival wound must be closed by sutures, cauterization or adhesives. Said tip 27 has an inclination angle different from the beveled area 21a immediately after it, and in the rear part of the end 21 attached to the needle 16 body there is a step 28 with a straight or almost straight angled cut, which serves as a stop to the needle 16 advancement in the sclera 2.

Below, there is a description of the examples performed by the inventor in relation to the aqueous humor drainage device 50, the insertion arrangement thereof, and the method used for its performance, without altering the true spirit of the present invention, since the drainage device 50 and insertion device thereof may have desirable modifications, such as those previously described, for the present invention to be feasible from the medical and industrial point of view.

Embodiment example N° 1 : For the creation of the drainage tube 50, 30 G and 32 G disposable hypodermic needles were used. In some of them, the bevel front (or distal) part was folded 32 to the opposite side of said disposable hypodermic needle inner conduit at an angle lower than 45° (see Fig. 9A), controlling said needles with a 10X zoom microscope, while in others, the bevel was left unfolded (see Figure 9B). Such 30G and 32G disposable hypodermic needles were cut and then examined under a microscope, by using only the 3 front millimeters of the needle containing the bevel and discarding the rest of the needle. The cut segments were measured with caliper and observed under a microscope, discarding those segments which presented significant cut deformations or measured more than 3.5 or less than 2.5 mm. Embodiment example N° 2: In order to manufacture the insertion arrangement (Shown in Figures 9A, 9B and 10), 25G disposable hypodermic needles 16 were used for containing the 32G drainage devices 50 of Example 1 , while 23G disposable hypodermic needles 16 were used for containing the 30G drainage devices 50 of Example 1 , 1 cm³ syringes were cut to a length of 2.5 to 5 cm, using only the part joining them to the needles 16 and discarding the rest. Said syringe sections were used to form the body 17 of the insertion arrangement. Likewise, 12 cm sections of 0.25 mm stainless steel wire for dental use were cut to be used as distal portion 19 of the pushing plunger. These last sections 19 were threaded separately, in the 23G and 25G disposable hypodermic needles16, each of them with their inner cable19 and then, the 1 ml cut syringe sections were threaded 17 with wire 19, adjusting the disposable hypodermic needles threaded with the stainless steel section 19 to the cut syringe sections 17 in a traditional manner. The wire 19 end protruding from the syringe section 17 was inserted in the inner conduit of another long 21 G disposable hypodermic needle whose bevel was removed, and was fixed by compressing said long 21 G needle with a clamp, thus said long 21 G needle forming the plunger rear (or proximal) section 18, so that said long 21 G needle head 24A is the area pushed to actuate the plunger 18, 19. The other cable or steel wire end 19 emerging from the distal end 21 of the 23G and 25G needles 16 was cut until it protruded 1 to 2 mm from the needle bevel 16 when the plunger 18, 19 head 24A was pushed to the maximum, thus forming the insertion arrangement.

Embodiment example N° 3: As shown in figures 9A and 9B, the drainage tubes 50 of Example 1 were inserted in the insertion arrangement needles 16 of Example 2, with the bevel facing upwards in all cases. To that purpose, the plunger 18, 19 was retracted from these insertion devices, and the 30G and 32G drainage tubes 50 were inserted inside said 23G and 25G disposable hypodermic needles 16, respectively. Segments with part of their bevel folded 32, which did not fit in the inner conduit of the injection needle 16 because of having a large burr, were discarded. In all cases, the beveled end, hereinafter the rear end 10b of the drainage tubes, was first introduced in the inner conduit of the injection needles 16 (Figs. 9A and 9B) with the bevel facing upwards, coinciding with the bevel 21 of the injection needle end 16, but in opposite direction, leaving the cross-section front (or distal) end 10a, pointing at the outlet of the injection needle 16 in order to be the first part of the tube to exit the needle 16 when actuating the plunger 18, 19, while the beveled end or rear end 10B of the drainage tube 50 was the last one to exit. Although in this example, the front end 10a of the drainage tube 50, which remains implanted in the anterior chamber 9, was perpendicular to the axis thereof, such end must preferably have modifications in order to avoid possible obstructions of its entrance hole with the iris 5 in the anterior chamber 9 of the eye. After inserting the drainage tubes 50 in the insertion device needle 16, the system behavior was observed under a microscope when the plunger 18 19 head 24a was actuated to expel the drainage tube 50, observing a greater stability inside the needle 16 in those drainage tubes 50 with a part 32 of their bevel folded (Figure 9A), while the drainage tubes 50 which did not have a folded bevel (Figure 9B) came out of the containing needle 16 when the needle was repeatedly shaken.

Embodiment example N° 4: Research was conducted on the performance of the drainage tubes 50 according to Example 1 , on pig eyes and rabbit eyes with the aim of assessing the efficacy of said drainage tubes 50. Materials and Method: 8 pig eyes and 6 rabbit eyes were used, all of which had been killed less than 24 hours earlier. Some of the pig eyes used were enucleated and others were exenterated, including in this latter case, the ocular annexes, while rabbit eyes were left in situ. 30G drainage tubes 50 of Example 1 , with part of the bevel folded 32 in opposite direction to the inner conduit, (Fig. 9A) and 30G drainage tubes 50 of Example 1 , with unfolded bevel (Fig. 9B), were used, all of them pre-loaded inside the 23G needles 16 of the insertion arrangements of Example 2, according to the method provided in Example 3. A Moller Wedel® Ophthalmic surgery microscope was used. The enucleated eyes were fixed with clamp systems, and since they presented some hypotonia, a 27G needle connected to a Ringer solution bottle through an IV line was introduced in the anterior chamber 9 through the sclero-corneal limbus 1 a in order to create tension in them so as to resemble the actual state. The exenterated pig eyes presented greater tension than the enucleated eyes, due to the presence of their annexes, as in the case of the rabbit eyes, which were not enucleated or exenterated. A traction suture was placed on the exenterated pig eyes and rabbit eyes to better expose the area to be incised. In some of the pig eyes, the conjunctiva 1was dissected to access the sclera 2, since the former was very thick and opaque, thus making it difficult to visualize the needle16 end 21 below the conjunctiva 1 and the Tenon 1 b to incise the sclera 2 in the intended place, while the needle 16 of the insertion device used in this example was inserted transconjunctivally in the rabbit eyes, by incising the conjunctiva 1 and the Tenon 1 b far from the limbus 1 a, moving towards the cornea 3 through the subconjunctival space. By using said needle 16 in both cases (pig and rabbit eyes), a scleral 2 incision was made at a distance from the sclero- corneal limbus 1 a between 3 to 3.5 mm; then, by lowering the insertion device body 17, and, consequently changing the inclination angle of said needle 16, the latter was moved through the scleral thickness 2 by 1 -2 mm, where again, the inclination angle of the needle 16 was changed to enter the anterior chamber 9 of the eye, in parallel to the iris plane 5, at the iridocorneal angle. When visualizing the bevel of said insertion device needle 16 in the anterior chamber 9 of the eye, the plunger 18 19 head 24a was pushed until the drainage tube 50 appeared in the needle 16 bevel. Then, as said insertion device was being removed, the plunger 18, 19 head 24a was pushed further, until the needle 16 was completely removed, leaving the unbeveled end 10a (distal end) of the drainage tube 50 in the anterior chamber 9 of the eye, and the beveled end (or proximal end) 10b in the scleral thickness 2, thus the drainage device 50 being implanted into the eye (Figure B). Subsequently, Ringer's solution was pressure injected in the anterior chamber 9 by using a 27G needle in those cases which were not connected to a Ringer's bag, and the cornea 3 and the sclera 2 were pressed around the incision to assess the implant 50 stability. Additionally, Fluoresceine was injected in the anterior chamber 9 to evaluate filtering through the drainage tube 50. This procedure was repeated with the other drainage tubes 50 pre-loaded in their insertion systems in the other eyes, to assess the system and method reproducibility, and to evaluate implant 50 performance. Liquid was injected under the conjunctiva in an attempt to separate it from the underlying tenon and move forward with the needle 16 between them, but this made visualization of the sclera 2 even more difficult. Additionally, the method of this example 4 was tested, without using the surgery microscope, to evaluate the technical degree of difficulty under these conditions. Results: Implants 50 with part of the bevel unfolded (Figure 9B) showed less stability through the previously mentioned manipulation and even two of them were expelled from their implantation area; however, none of the implants 50 with folded bevel 32 was expelled, despite the scleral incision made with a 23G needle, while the external diameter of the implant 50 fitted with a 30G needle. None of the drainage devices 50 fell in the anterior chamber 9 of the eye during the implantation or during said manipulation. One of the drainage devices 50 implanted into a rabbit eye had its distal end lOablocked by the iris 5, without liquid flow. This was caused because the distal end 10a was unbeveled, and because all rabbit eyes used in this study showed a narrow to moderately narrow iridocorneal angle, as opposed to what happened in pig eyes. It is worth remembering that all aqueous humor drainage devices must be implanted into eyes with an open iridocorneal angle. Furthermore, except in the blockage case and in the two cases of implant 50 expelling, in the rest of the cases, fluoresceine filtering was achieved through said drainage tube 50. In some cases, visualization of the needle 16 end 21 became difficult due to the conjunctival or tenon tissue dragging, in which cases, flattening and stretching of the conjunctiva 1 and the tenon 1 b must be performed to improve their visualization. In some cases, the Tenon's membrane 1 b made it difficult to visualize said needle 16 end 21 , due to its thickness or because of being more opaque. Furthermore, the implantation method without the use of the microscope proved to be equally easy, reproducible and effective. Conclusion: The implant 50 proved to be effective to drain liquid from the anterior chamber 9 of the eye into the outside. The implantation method by means of the insertion device used, proved to be simple, short and reproducible although the viscoelastic substance was not used in the anterior chamber 9, and despite the hardness of the tissues such as the conjunctiva 1 , the tenon 1 b and the sclera 2, which was greater in many of the eyes used, specially in pigs, than the usual hardness observed in adult human beings who are subject to a Glaucoma surgery. In the case of the present embodiment example N° 4, the unbeveled end was implanted in distal situation, into the anterior chamber 9, while the beveled end of the drainage tube 50 was implanted in proximal situation to evaluate the scleral fixing effect in those cases with part of the bevel folded 32 and to compare it to those cases with unfolded bevel; however, in several preferred embodiments of the invention, the distal end 10a implanted in the anterior chamber 9 of the eye have modifications to avoid drainage blocking. Embodiment example N° 5: Since an important aspect of the invention method consists of locating through the conjunctiva 1 and the tenon 1b (Figure 1A), the place intended to be incised in the sclera 2 with the insertion device needle, taking into account the existing distance to the sclero-corneal limbus 1a, a study was conducted to evaluate the visualization of the hypodermic needles under the conjunctiva 1 and the underlying Tenon's capsule 1b under different conditions. Purpose of the study: finding an affordable method which improves visualization of the needle or cutting element belonging to the aqueous humor insertion device, under the conjunctiva 1 and the Tenon's capsule 1b to enable the implantation of drainage devices into the eye by means of a transconjunctival implantation method.

As previously mentioned, the conjunctiva 1 is an elastic and transparent mucous membrane attached to other underlying elastic and translucent membrane called Tenon's capsule 1 b. Therefore, in some occasions, manipulations under the conjunctiva land the Tenon's capsule 1 b, do not provide good visualization. Additionally, if a subconjunctival anesthetic is injected to perform an ocular surgery, these tissues are soaked in said anesthetic, making visualization even more difficult. Furthermore, when the needle 16 is introduced under both membranes 1 and 1 b and it slides forward, it drags, by friction, and gathers tissue, thus adding another difficulty to said needle visualization. Likewise, when a gap is intended to be created between the conjunctiva 1 and the Tenon 1 b by means of liquid injection, the tissues are also soaked in this liquid, thus making visualization of the underlying sclera 2 even more difficult. Materials and method: Three 23 G needles (Needles A, B and C), fluorescent acrylic paint, fish eyes, and pig and rabbit eyes which had been killed less than 24 hours earlier, a standard white incandescent lamp and a UV (Ultraviolet) filtered light, commonly called black light, and a cobalt blue filtered light were used. Needle A was painted with a single coat of said fluorescent acrylic paint only on the bevel inner wall, needle B had the outside of its body and the bevel inner wall painted by using the same technique, and needle C was left unpainted. None of the needles A and B was previously painted with top coat, although this was advisable to achieve a better adherence of the fluorescent paint to the stainless steel of the needle, with the aim of evaluating the adherence of the fluorescent paint under these conditions. The paint was allowed to dry for 24 hs. Subsequently, the three needles were introduced below the conjunctiva and the Tenon's capsule in the fish eyes, pig eyes and rabbit eyes. Then, the visualization of such needles was assessed when lighting with standard white incandescent light, as that in surgery microscopes, and then with UV filtered light and blue cobalt filtered light lamps. Results: Both membranes, the conjunctiva 1 and the sclera, 1b were in most cases, thicker, more resistant and opaque than the usual for said membranes in adult human beings, and they were more similar in the case of rabbits, although, even so, in some of these last cases, the Tenon's capsule was thick. Flattening and stretching of the conjunctiva 1 and the Tenon 1 b favored visualization of the three needles (A, B and C). Needle A showed excellent paint adherence on the bevel inner wall although it had not been previously painted with top coat, while needle B body showed regular to poor paint adherence on the body and excellent adherence on the bevel inner wall. Lighting with UV filtered light resulted in a much higher visualization in all of the eyes in relation to the traditional white lightning, in the painted section of needles A, B under the conjunctiva 1 and the Tenon 1 b. Visualization of the needle end with luminescent paint was good enough under the UV filtered light so as not to require painting the needle body surface to serve as a guide. Conclusion: The needle having luminescent properties incorporated at least in its distal end enables localizing such end under the conjunctiva 1 and the Tenon's capsule 1b when being stimulated by a suitable means, as in this case, with a UV filtered light or a cobalt blue filtered light, in order to incise the sclera 2 at the intended distance from the sclero-corneal limbus 1a and to make the transconjunctival implantation of the drainage device 50, without the previous conjunctival opening, which in some cases becomes difficult when illuminating with conventional white light. The present invention also comprises a method for the treatment of

Glaucoma which comprises the following steps:

anesthetizing the patient's eye by using eye drops, optionally subconjunctival anesthesia, or subTenonian anesthesia, unpacking the insertion arrangement where the drainage device is contained in a pre-loaded manner;

implanting the drainage device 50, by using the transconjunctival insertion device, beginning with a conjunctival incision by means of the inserter needle 16 far from the incision to be made in the underlying sclera 2 to enter the anterior chamber 9, and advancing under the conjunctiva 1 , or the conjunctiva 1 and the Tenon 1b, until incising in the scleral 2 thickness at a distance of 1 to 3.5 mm from the sclero-corneal limbus 1a, to subsequently enter the anterior chamber 9 of the eye, in parallel to the iris, by using a method which does not require the previous opening of the conjunctiva 1 , thus, providing the possibility of not requiring the closure of the conjunctival wound with sutures, cauterization or adhesives; and

where at least a portion of the drainage device 50 is implanted in the scleral hole 2 of the eye created by the insertion device needle 16, thus allowing the aqueous humor drainage from the anterior chamber 9 of the eye into the subconjunctival space.

As previously mentioned, although embodiment examples of the present invention have been described and shown, desirable and preferred modifications may be made. Therefore, the purpose of the claims section is to cover all those changes and modifications which are within the true spirit and scope of the present invention.

REFERENCES:

- GLAUKOS; web: http://www.glaukos.com/istent.

- Karmel M (2004) quoted by Chaudhry et al, 2012. Filtering surgery takes a new direction: Will it revolutionize the field? Eye Net; 8:33-36.

- Lim K S, Allan B D S, Lloyd A W, Muir A, Khaw P T; Glaucoma drainage devices; past, present, and future; Br J Ophthalmol 1998;82:1083-1089 doi:10.1 136/bjo.82.9.1083.

-Parul lchhpujani and Marlene R. Moster (201 1 ). Novel Glaucoma Surgical Devices, Glaucoma - Basic and Clinical Concepts, Dr. Shimon Rumelt (Ed.), ISBN: 978-953-307-591 -4, InTech, DOI: 10.5772/23554. Available from: http://www.intechopen.com/books/glaucoma-basic-and-clinical-concepts/novel- glaucoma-surgical-devices.

-Prata JA Jr, Minckler DS, Green RL (1993). Pseudo-Brown's syndrome as a complication of glaucoma drainage implant surgery. Ophthalmic Surg; 24(9):608- 1 1 ).

-Quigley HA, Broman AT, The number of people with glaucoma worldwide in 2010 and 2020; Br J Ophthalmol. 2006 Mar; 90(3):262-7.

-Singh Parul, Kuldeep Krishna, Tyagi Manoj, Sharma Parmeshwari D, Kumar Yogesh. Glaucoma drainage devices. Journal of Clinical Ophthalmology and Research - May-Aug 2013 - Volume 1 - Issue 2.

-Thomas R, Braganza A, Chandrasekhar G, Honavar S, Mandal A K, Ramakrishnan R, Rao B S, Sihota R, Sood N N, Shantha B, Vijaya L. The role of artificial drainage devices in glaucoma surgery. Indian J Ophthalmol 1998;46: 41 - 6. - Tucker Miriam E., 10/03/2014 Ex-PRESS Shunt 3-Year Outcomes Don't Top Trabeculectomy American Glaucoma Society (AGS) 24th Annual Meeting: Abstract 5, presented February 27, 2014; abstract 29, presented March 1 , 2014.

- Wamsley S, Moster MR, Rai S, Alvim HS, Fontanarosa J. Results of the use of the Ex-PRESS miniature glaucoma implant in technically challenging, advanced glaucoma cases: a clinical pilot study. Am J Ophthalmol. 2004 Dec;138(6):1049-51 .

- Vera V, Horvath C, XEN Gel Stent: The Solution Designed by AqueSys®, Surgical Innovations in Glaucoma, Part V, pp 189-198, DOI: 10.1007/978-1 -4614- 8348-9J 7, print ISBN: 978-1 -4614-8347-2, online ISBN: 978-1 -4614-8348-9, 2014.

RELATED PATENTS

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-US 4.750.901 A; 14/06/1988; Molteno Anthony C B; Implant for drainage of aqueous humour

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Claims

WHAT WE CLAIM

1 . A kit used for the treatment of Glaucoma, comprising:

an aqueous humor drainage device (50);

an insertion arrangement that has a hollow needle (16) within which said drainage device (50) is inserted and is located in a preloaded manner for its subsequent implantation into the eye;

the kit allowing the transconjunctival implantation of said drainage device (50) by using said insertion device, without requiring the previous opening of said conjunctiva (1 ), and thus providing the possibility of not requiring the closure of the conjunctival wound by sutures, cauterization or adhesives; wherein said kit is able to carry out said implantation method without the use of a surgical microscope; and

wherein at least one portion of said drainage device (50) is implanted into the hole in the sclera (2) of the eye, created by said insertion device needle (16), its distal (or front) end (10a) is implanted into the anterior chamber (9) of the eye and, therefore, its proximal (or rear) end (10b) is implanted in the opposite direction, outwards from the anterior chamber (9), thus allowing the aqueous humor drainage from the anterior chamber (9) of the eye into the subconjunctival space.

2. An aqueous humor drainage device (50) comprised within the kit according to claim 1 , comprising: a tube-like body (1 1 ) with an inner lumen (or inner conduit), that defines an outer diameter and an inner diameter; two opposite ends (10a, 10b), each of them having at least one hole (15) that connects said drainage tube (50) lumen to the outside.

3. The aqueous humor drainage device (50) according to claim 2, wherein said drainage device (50) has a tube-like shape in its entirety.

4. The aqueous humor drainage device (50) according to claim 2, wherein said drainage device (50) has a fixing means selected from the group that consists of: at least a pair of side opposite flaps (13d), an open-angle gap of at least a portion of the opposite walls (12,12a,12b,13,13a,13c) belonging to said drainage device, folding (10c) of the distal end (10a), tabs (13b), burrs, roughness of the outer surface, tabs, hooks or a combination thereof, and

wherein said fixing means may additionally have several shapes and inclination angles, and a length from 0.2 mm to 1 .5 mm from said drainage device (50) body (1 1 ); and

wherein said fixing means, have such a flexibility that allows for the insertion and sliding of said drainage device (50) into said insertion arrangement needle (16), aligning themselves with said drainage device (50) body (1 1 ) and returning, at least partially, to said original angle when exiting said needle (16).

5. The aqueous humor drainage device (50) according to any of claims 2 - 4, further comprising a finish of any of its ends, selected from the group consisting of: straight angled to the tube axis, beveled, flattened, tilted down (10c) plus an upper bevel, trumpet shaped, pointed, fish mouth-shaped, with an extension of said distal end (10a) lower wall capable of preventing possible aqueous flow blocking by the iris, flower-shaped, lateral and opposing walls of the tips bent backwards like hooks on one or both extremes or a combination thereof .

6. The aqueous humor drainage device (50) according to any of claims 2 - 5, wherein the constituting material comprises any of the options selected from the group consisting of: stainless steel, titanium, nickel-titanium alloys, synthetic biopolymers, as well as copolymers, biocompatible ceramic materials, or a combination thereof.

7. The aqueous humor drainage device (50) according to any of claims 2 - 5, wherein the constituting material comprises any of the following options: Carbothane®, Pellethane®, Tecoflex®, Tecophilic®, Tecoplast®, Tecothane®.

8. The aqueous humor drainage device (50) according to claim 3, composed of a biopolymer material, which is hydrated and swells in contact with liquid, thus facilitating the anchoring to the eye when implanted, and allowing the passage of liquid from one end to the other.

9. The aqueous humor drainage device (50) according to claim 1 , comprising:

a cylinder shaped body, made out of a porous biopolymer material with no inner conduit, and wherein said drainage device (50) is hydrated and swells in contact with liquid, and allows the passage of liquid from one end to the other, and where the anchoring system to the eye comprises the compression of the body

(1 1 ) of the drainage device (50) carried out by the sclera, along the scleral hole created by the insertion needle (16) where it is preloaded.

10. The aqueous humor drainage device (50) according to any of claims 2 - 9, comprising:

a total length from 2 mm to 8.5 mm; an outer diameter of said drainage (50) device body (1 1 ) from 0.127 mm to 0.5 mm; and an inner diameter of said drainage (50) device body (1 1 ) from 0.05 mm to 0.35 mm.

1 1 . The aqueous humor drainage device (50) according to any of claims 2 - 9, comprising a total length from 2.5mm to 3.5 mm; an outer diameter of said drainage tube (50) body (1 1 ) from 0.127 mm to 0.31 mm; and an inner diameter of said drainage tube (50) body (1 1 ) from 0.05 mm to 0.152 mm.

12. An insertion arrangement comprised in the kit according to claim 1 , comprising:

a) said hollow needle (16), capable of containing said drainage device (50) inside and incise the conjunctiva (1 ) the Tenon (1 b) and the sclera (2) in order to insert said aqueous humor drainage device (50) into the eye;

b) a body (17) with an inner conduit, wherein the latter connects by its distal end to and meets the inner conduit of said hollow needle (16), wherein the latter connects to the outside by its distal end (21 );

c) a pushing means that has: a distal portion (19) capable of sliding into said hollow needle (16) inner conduit and another proximal portion (18) capable of sliding into said insertion arrangement body (17); and

d) an actuating arrangement (24a, 24b, 34) which actuates said pushing means (18, 19) to implant said drainage device (50) into the eye.

13. The insertion arrangement according to claim 12, wherein said insertion arrangement needle (16) includes luminescent properties at least in said distal end (21 ), which facilitates visualization under the conjunctiva and Tenon's capsule when stimulated by a source capable of producing said luminescence phenomenon, thus facilitating to locate the place wherein the sclera is to be incised to access the anterior chamber of the eye.

14. A method for treating Glaucoma carried by means of the kit according to claim , comprising the following steps:

anesthetizing the patient's eye by using eye drops, optionally subconjunctival anesthesia or subTenonian anesthesia, unpacking the insertion arrangement wherein the drainage device is contained in a pre-loaded manner; implanting the drainage device (50), by using the transconjunctival insertion device, beginning with a conjunctival incision by means of the inserter needle (16) belonging to the kit of the invention, far from the incision to be made in the underlying sclera (2) to enter the anterior chamber (9), and advancing under the conjunctiva (1 ), or the conjunctiva (1 ) and the Tenon (1 b), until incising in the scleral (2) thickness at a distance of 1 to 3.5 mm from the sclera-corneal limbus (1 a), to subsequently enter the anterior chamber (9) of the eye, in parallel to the iris (5), by using a method which does not require the previous opening of the conjunctiva (1 ), thus providing the possibility of not requiring the closure of the conjunctival wound with sutures, cauterization or adhesives; and

wherein at least a portion of the drainage device (50) is implanted into the scleral hole (2) of the eye created by the insertion device needle (16), thus allowing the aqueous humor drainage from the anterior chamber (9) of the eye into the subconjunctival space.