BR112020008969A2 - manually adjustable intraocular flow regulation - Google Patents

Abstract

The present invention relates to an implanted intraocular shunt that can be manually manipulated, without surgical intervention, to modify the resistance of the shunt flow, thus providing relief of high intraocular pressure while avoiding hypotonia. For example, by applying pressure across a surface of the eye, a portion of the shunt can be displaced or separated from the shunt, thereby reducing resistance to the flow of the shunt.

Description

Invention Patent Descriptive Report for "MANUALLY ADJUSTABLE INTRAOCULAR FLOW REGULATION". Background

[0001] Glaucoma is an eye disease that affects millions of people. Glaucoma is associated with an increase in intraocular pressure resulting from the failure of the eye's drainage system to properly remove the aqueous humor from the anterior chamber of the eye or the overproduction of aqueous humor by a ciliary body in the eye. The accumulation of aqueous humor and the resulting intraocular pressure can result in irreversible damage to the optic nerve and retina, which can lead to irreversible damage to the retina and blindness.

[0002] Glaucoma can be treated in several different ways. One way of treatment involves delivering drugs such as beta blockers or prostaglandins to the eye, to reduce the production of aqueous humor or to increase the flow of aqueous humor from an anterior chamber of the eye. Glaucoma filtration surgery is a surgical procedure commonly used to treat glaucoma. The procedure involves placing a shunt in the eye to relieve intraocular pressure, creating a way to drain the aqueous humor from the anterior chamber of the eye. The shunt is typically positioned in the eye, in order to create a drainage path between the anterior chamber of the eye and a region of lower pressure. Such fluid flow pathways allow the aqueous humor to exit the anterior chamber. summary

[0003] The importance of reducing intraocular pressure (IOP) in delaying glaucomatous progression is well documented. When drug therapy fails, or is not tolerated, surgical intervention is justified. There are several methods of surgical filtration to decrease intraocular pressure, creating a fluid flow path between the anterior chamber and the subconjunctival tissue. In a specific method, an intraocular shunt is implanted by directing a needle that holds the shunt through the cornea, through the anterior chamber and through the trabecular and scleral mesh, and into the subconjunctival space. See, for example, United States Patent 6,544,249, United States Patent Publication 2008/0108933 and United States Patent 6,007,511, whose integrations are hereby incorporated by reference.

[0004] However, existing implantable shunts may not always effectively regulate the flow of fluid from the anterior chamber. The flow of fluid through a traditional shunt is passive, from the anterior chamber to an eye drainage structure. In addition, in some circumstances, an implanted shunt can allow a lot of flow from the anterior chamber. If fluid flows from the anterior chamber at a rate greater than that produced in the anterior chamber, surgery may result in an undesirably low intraocular pressure in the anterior chamber of the eye. This condition is known as hypotonia. Hypotonia occurs when the intraocular pressure is generally less than approximately 6 mmHg. Risks associated with low intraocular pressure and hypotonia include blurred vision, collapse of the anterior chamber and potentially significant damage to the eye. Such risks may require additional surgical intervention for repair. However, if fluid flow from the eye is not large enough, pressure in the anterior chamber will not be relieved and damage to the optic nerve and retina may still occur.

[0005] Therefore, the present disclosure addresses these problems and includes the perception that an intraocular shunt can be more effective if it can be adjusted or modified one or more times after implantation. Thus, some modalities disclosed in this document provide intraocular implants or leads to drain fluid from the anterior chamber of an eye and methods of use that allow the physician to remove a removable portion, such as an occlusion, to allow flow through it or to adjust the flow selectively. rate, flow restriction or other flow parameters of an intraocular shunt, in order to avoid hypotonia and ensure adequate pressure relief. In some methods, a tool or other device, such as the doctor's finger, can be used to apply force to an external surface of the eye to manually adjust or modify the shunt.

[0006] For example, after an intraocular shunt is implanted in the eye, it will extend between an anterior chamber of the eye and a location of lower pressure in the eye. A doctor can determine a shunt position in the eye, for example, with or without the use of an imaging device or imaging tool, such as a gonioscope. Once the position of the shunt is determined, a force can be applied to an external surface of the eye to modify the structure of the shunt to remove a removable portion or to change a degree of flow restriction through the shunt.

[0007] The applied force can separate the removable portion from the discharge portion of the intraocular shunt. Prior to separation, the removable portion may obstruct fluid flow through the intraocular shunt or alternatively, allow a degree of fluid flow through the shunt. After the removable portion is separated, the degree of flow restriction through the shunt will be reduced and a high flow through the shunt will then be possible.

[0008] As noted above, a tool or other device, such as a finger, can be used to manually manipulate or apply force to the shunt to manually adjust or modify one or more removable areas or parts of the shunt. Removable areas or parts of the shunt that can be modified by applying force, such as compression, shear and / or tension.

[0009] In some modalities, the force applied to the eye can be a massage movement. In addition, in some modalities, a doctor may use a finger to manually apply force to the outer surface of the eye. Alternatively, in some modalities, the doctor may use a tool to apply force to the outer surface of the eye.

[0010] The removable portions may comprise the discrete components of the shunt, such as a tubular plug and / or compressed section of the shunt. When present, these removable portions provide partial or complete flow restriction that limits flow through the shunt. However, when force is applied to the shunt, the removable portion can be at least partially or completely displaced or separated from the rest or body of the shunt, removing, reducing or initiating the decrease in flow restriction.

[0011] For example, in some embodiments, the removable portion may have a first internal transverse dimension and the body of the intraocular shunt may have a second internal transverse dimension. The transverse dimension of the intraocular shunt body may be greater than the transverse dimension of the removable portion. In some embodiments, when force is applied, the transverse dimension of the intraocular shunt body may become smaller than the transverse dimension of the removable portion.

[0012] In some embodiments, the removable portion can be, at least partially, positioned within the intraocular shunt. However, in some embodiments, the removable portion may be attached to an outer surface or end portion or surface of the shunt body. In some embodiments, when the removable portion is removed, a flow through the intraocular shunt can increase from zero to a non-zero flow. Alternatively, when the removable portion is removed, the allowable flow may increase from a non-zero flow to a higher flow. Still, in some modalities,

after the removable portion is separated from the shunt, the removable portion can be spaced away from the discharge portion of the shunt. After that, in some embodiments, the removable portion can be extracted from the eye. However, in some embodiments, the removable portion may still be left in the eye to "protect" the discharge area around the discharge end portion of the shunt. Brief description of the drawings

[0013] The attached drawings, which are included to further provide an understanding of the technology in question, are incorporated and form part of this specification, the illustrated aspects of the disclosure and together with the description serve to explain the principles of the technology in question.

[0014] Figure 1 is a partial cross-sectional diagram of an eye, illustrating the internal insertion ab of an implantation device, according to some modalities.

[0015] Figure 2 illustrates a schematic placement of an intraocular shunt within the intra-Tenon adhesion space, according to some modalities.

[0016] Figures 3 and 4 illustrate cross-sectional views of an intraocular shunt having a removable portion, according to some modalities.

[0017] Figures 5 to 9 illustrate cross-sectional views of other intraocular shunts having a removable portion, according to some modalities.

[0018] Figures 10A to 10D illustrate the release of a portion of a removable portion of a shunt, according to some modalities.

[0019] Figure 11 illustrates the release of a portion of the removable portion of a shunt, using a tool, according to some modalities.

[0020] Figure 12 illustrates the release of a portion of the removable portion of a shunt, using another tool, according to some modalities.

[0021] Figure 13 illustrates the removal of a portion of the removable portion of a shunt, using yet another tool, according to some modalities. Detailed Description

[0022] In the detailed description below, several specific details are set out to provide a complete understanding of the technology in question. It must be understood that the technology in question can be practiced without some of these specific details. In other cases, known structures and techniques were not shown in detail so as not to obscure the technology in question.

[0023] As noted above, glaucoma filtration surgery can usually result in an undesirably low intraocular pressure in the anterior chamber of the eye and can lead to hypotonia. The present disclosure provides several modalities of methods and devices that can allow a doctor to generally prevent hypotonia after glaucoma filtration surgery, while allowing the doctor to ensure adequate pressure relief by adjusting the flow through an intraocular shunt. As used herein, the term "shunt" includes hollow microfistula tubes similar to the type generally described in the U.S. Patent

6,544,249, as well as other structures that include one or more lumens or other flow paths through them.

[0024] One aspect of some modalities is the perception that there are several unpredictable factors related to the success of a surgical intervention. Fundamentally, a successful surgical intervention relieves intraocular pressure without causing hypotonia. To be successful, flow through a shunt and the resulting intraocular pressure in the anterior chamber must be responsible for several factors

Unpredictable biological 7IT3, such as amount of aqueous production, aqueous humor viscosity and other biological flow restrictions.

[0025] The biological flow restrictions associated with a shunt depend on the general resistance to flow or the restrictions of the target space in which the shunt is placed. The biological flow restrictions of the subconjunctival space, for example, depend on: (1) the strength, the quantity and the thickness of the adhesions of chins, if present (for example, placed in the inner b); (2) the thickness and consistency of the conjunctiva, which can allow more or less fluid to diffuse into the subconjunctival vessels and the tear film; (3) existing fibrotic adhesions; (4) the presence of lymphatic outlet pathways (some pathways may already exist at the time of shunt placement, but often lymphatic pathways can be created and increase days and weeks after the flow begins); (5) the amount of diffusion in episcleral vessels; (6) the amount of fibrosis accumulation after implant placement (which can be triggered by aqueous humor, begins to form in the first one to four weeks after surgery and can lead to significant or total restriction of output). Many of these factors vary widely from patient to patient and are, for the most part, unpredictable. The potential fibrotic response is the biggest factor in changing biological resistance to outflow and can range from no significant restriction on outflow in the first three postoperative months, to a total flow block within one week after surgery.

[0026] These variations of patients and their dynamic nature in the postoperative period make it difficult to maintain an ideal intraocular pressure with a "static" positioning. A "static" shunt placement can be referred to as a procedure or surgery in which a shunt is implanted and maintained without any change in its own flow resistance parameters or resistance to shunt output, such as length, lumen diameter or other features that would affect the flow through the shunt. Thus, excluding changes in biological resistance to flow in the target space, as mentioned immediately above, a "static" shunt or "static" shunt placement will not result in variations in flow parameters or shunt discharge resistance to the shunt.

[0027] A static shunt usually provides substantial output in the post-operative phase (one day to two weeks) due to the absence of fibrotic tissue (or other biological restrictions on output) early on. This can often lead to less than desirable intraocular pressure in the anterior chamber for this initial phase, usually hypotonia, and an increased risk of complications associated with these low intraocular pressures. Then, after the initial phase (for example, after a few days to a few weeks), some patients experience a strong fibrotic response that can create high biological flow restrictions that can result in greater than desired intraocular pressure (for example, above 20 mmHg).

[0028] Some - modalities “disclosed in this document provide a way to overcome these complications and uncertainties of traditional surgery. For example, an adjustable flow shunt can be provided that can be modified manually or self-adjusted after surgery without surgical intervention, in order to maintain an ideal resistance to water outflow that can compensate for an increase in biological resistance to water outflow. In fact, although methods and devices have been disclosed that allow additional intervention to modify the resistance to the flow of a shunt after implantation of the shunt, such as that disclosed in the applicant's own US 2014 publication 2014/0236066, filed on February 19, 2013 , US publication 2016/0354244, deposited on June 2, 2016, and US publication no 2016/0354245, deposited on June 2, 2016, the entirety of which is incorporated herein by reference, this disclosure provides methods and devices that allow a physician to quickly assess and modify a shunt without surgical intervention. The entire procedure can be performed with or without topical anesthesia and can be done on an outpatient basis, providing a simple procedure, reduced costs, low latency and short recovery time for the patient.

[0029] As used in this document, a "non-surgical intervention" is considered to be one in which the patient's eye is not cut or punctured. This non-surgical intervention can allow a physician to monitor and maintain optimal intraocular pressure during changes in tissue stages (for example, changes in the restriction of biological output from the target space, such as those mentioned above) that generally increase resistance to biological output and lead to greater intraocular pressure. In addition, these procedures provide distinct advantages over conventional interventions that generally require substantial invasive procedures and prolonged patient healing.

[0030] Therefore, in some modalities, shunt devices and methods of use can provide substantial initial resistance to flow, in order to avoid low intraocular pressures at the beginning of the operation and hypotonia and control over the subsequent decrease in flow resistance to compensate for increased biological resistance to flow (eg fibrosis of the target space). The shunt can be configured so that the flow resistance is adjusted manually or surgically by the physician or configured specifically to self-adjust (for example, through the use of dissolvable sections) over time.

[0031] Several structures and / or regions of the eye with lower pressure that have been directed towards the drainage of aqueous humor include the Schlemm canal, the subconjunctival space, the episcleral vein,

the supracoroidal space, the intra-Tenon adhesion space and the subarachnoid space. Shunts can be implanted using an external ab approach (for example, entering the conjunctiva and inwards through the sclera) or an internal ab approach (for example, entering the cornea, through the anterior chamber, through the trabecular and sclera mesh). For example, internal ab approaches to implant an intraocular shunt in the subconjunctival space are shown, for example, in Yu et al. (United States Patent 6,544,249 and United States Patent Publication 2008/0108933) and Prywes (United States Patent 6,007,511), the content of which is incorporated by reference here in its entirety.

[0032] Some methods may involve the insertion into the eye of a hollow shaft configured to support an intraocular shunt. In some embodiments, the hollow shaft can be a component of an implantation device that can implant the intraocular shunt. The hollow shaft can be attached to an implantation device or be part of the implantation device itself. Implantation devices that are suitable for implanting shunts according to the invention include, but are not limited to, implantation devices described in United States Patent 6,007,511, United States Patent

6,544,249 and North American Publication 2008/0108933, the contents of each of which are incorporated herein by reference in their entirety. Implantation devices may include devices such as those described in the co-ownership and co-ownership of North American Publication 2012/0123434, filed on November 15, 2010, North American Publication 2012/0123439, filed on November 15, 2010, and North Publication - Copending American 2013/0150770, deposited on December 8, 2011, contents that are incorporated by reference here in their entirety.

[0033] The shunt can be implanted from the axis to the eye so that the shunt forms a passage of the anterior chamber in an area of lower pressure, such as Schlemm's canal, the subconjunctival space, the episcleral vein, supracoroidal space, intra adhesion space -Tenon, subarachnoid space, or other areas of the eye. The concave axis is then removed from the eye. Methods for administering and implanting permanent or bioabsorbable tubes or shunts, as well as implantation devices for carrying out such methods, are generally disclosed in the applicant's copending applications, North American Publication 2013/0150770, filed on December 8, 2011, and Northern Publication -Americana 2012/0197175, filed on December 8, 2011, as well as in US Patent 6,544,249 and 6,007,511, each incorporated herein by reference in its entirety. Modalities of the shunts disclosed here can be implemented using such methods and others as discussed here.

[0034] Some methods can be conducted by making an incision in the eye before insertion of the implantation device. However, in some cases, the method can be conducted without making an incision in the eye before insertion of the implantation device. In some embodiments, the shaft that is connected to the implantation device has a sharp point or point. In some embodiments, the hollow shaft is a needle. Exemplary needles that can be used are commercially available from Terumo Medical Corp. (Elkington, Maryland). In some embodiments, the needle may have a hollow interior and a beveled tip, and the intraocular shunt may be maintained within the hollow interior of the needle. In some embodiments, the needle may have a hollow interior and a triple grounding point or tip.

[0035] Some methods can be conducted without the need to remove a portion or anatomical feature of the eye, including, but not limited to, the trabecular meshwork, the iris, the cornea or the aqueous humor. Some methods can be conducted without inducing substantial eye inflammation, such as subconjunctival bleeding or endophthalmitis. Some methods can be achieved using an internal approach ab by inserting the hollow axis configured to maintain the intraocular shunt through the cornea, through the anterior chamber, through the trabecular meshwork and in the intra-scleral or intra-Tenon adhesion space. However, some methods can be conducted using an external approach ab.

[0036] In some methods conducted using an internal ab approach, the angle of entry through the cornea can be changed to affect the optimal placement of the shunt in the intra-Tenon adhesion space. The concave axis can be inserted into the eye at an angle above or below the corneal limbus, in contrast to entry through the corneal limbus. For example, the concave axis can be inserted approximately 0.25 mm to approximately 3.0 mm above the corneal limbus. The axis can be inserted approximately 0.5 mm to approximately 2.5 mm above the corneal limbus. The axis can also be inserted from approximately 1.0 mm to approximately 2.0 mm above the corneal limbus, or any specific value within any of these ranges. For example, the concave axis can be inserted above the corneal limb at distances of approximately: 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1 , 6 mm, 1.7 mm, 1.8 mm, 1.9 mm, or 2.0 mm.

[0037] In addition, in some modalities, placing the shunt further away from the limbus at the exit site, as provided by an entry angle above the limbus, may provide access to more lymphatic channels for draining aqueous humor, such as the network episcleral lymphatic system, in addition to the conjunctival lymphatic system. A higher entry angle also results in a flatter placement in the intra-Tenon grip space, so there is less flexion of the shunt.

[0038] As discussed in the Applicant's copending request,

North American Publication 2013/0150770, deposited on December 8, 2011, the totality that is incorporated here by reference, in some modalities, to ensure the proper positioning and functioning of the intraocular shunt, the depth of penetration in the intra-adhesion space Tenon can be important when performing some methods.

[0039] In some methods, the distal tip of the hollow axis can pierce the sclera and the intra-Tenon adhesion space without removing the nucleus, removing or causing great distortion of the surrounding ocular tissue. The shunt is then implanted from the axis. Preferably, a distal portion of the hollow shaft (as opposed to the distal tip) completely enters the intra-Tenon's adhesion space before the shunt is implanted from the hollow shaft.

[0040] According to some modalities, the hollow shaft can comprise a flat beveled needle, like a needle that has a triple grounding point. The chamfer of the tip can first pierce the sclera and enter the intra-Tenon's adhesion space by making a horizontal slot. In some methods, the needle can be advanced further, so that the entire flat bevel penetrates the adhesion space of the intra-Tenon, to spread and open the fabric to a complete circular diameter.

[0041] Furthermore, according to one aspect of some methods, the intra-Tenon channel can be opened by the flat beveled part of the needle, so that the material around the opening is sufficiently stretched and prevents compression of the shunt in that area , thus preventing the shunt from failing due to tightness or constriction. The complete entry of the flat bevel in the adhesion space of the intra-Tenon causes minor distortions and trauma in the local area. However, this area finally surrounds and conforms to the shunt when the shunt is implanted in the eye.

[0042] With reference to the figures, Figure 1 is a schematic diagram that illustrates a way to access the eye and administer an intraocular shunt to treat glaucoma. As noted, some methods disclosed here provide an internal approach to ab. As noted, the internal approach ab may not be necessary to perform the procedures or methods disclosed here. For example, shunt can be administered using an external approach ab, as discussed here.

[0043] Figure 1 illustrates the general anatomy of an eye 2. As illustrated, an anterior aspect of the anterior chamber 10 of eye 2 is the cornea 12, and a posterior aspect of the anterior chamber 10 of eye 2 is the iris 14. Below iris 14 is lens 16. Conjunctiva 18 is a thin transparent tissue that covers an external surface of the eye 2. The anterior chamber 10 is filled with aqueous humor 20. The aqueous humor 20 drains into a space 22 below the conjunctiva 18 through from the trabecular mesh (not shown in detail) of the sclera 24. The aqueous humor is drained from the space (s) 22 below the conjunctiva 18 through a venous drainage system (not shown).

[0044] Figure 1 illustrates a surgical intervention to implant an intraocular shunt to the eye using a delivery device 40 that holds the shunt, and implanting the shunt into eye 2. Figure 1 illustrates an internal approach ab in which the device administration 40 was inserted through cornea 12 into the anterior chamber 10. As noted above, however, the implant can still be placed using an external ab approach, in which the conjunctiva or Tenon's capsule can be dissected and pulled back, before placing a shunt.

[0045] With reference to Figure 1, the delivery device 40 can be inserted through the anterior chamber 10 in what is referred to as a transpupillary implant insertion. The administration device can be inserted through the anterior angle and inserted through the sclera 24 until it accesses a target space, such as Schlemm's canal, the subconjunctival space, the episcleral vein, the supracoroidal space, the intra-Tenon adhesion space, the space subarachnoid, or other areas, as desired. The shunt is then implanted from the implantation device, producing a conduit between the anterior chamber and the target space to allow the aqueous humor to drain through the traditional drainage channels of the eye, such as the intrascleral vein, the collecting channel, the Schlemm canal, the trabecular flow, the uveoscleral flow to the ciliary muscle, the conjunctival lymphatic system or others.

[0046] In some embodiments, the delivery device 40 may comprise a concave axis 42 that is configured to maintain an intraocular shunt. The shaft may contain the shunt within the hollow interior of the shaft. Alternatively, the hollow shaft can hold the shunt on an external surface of the shaft.

[0047] Figure 2 provides a cross-sectional view of a portion of eye 2, and provides more details regarding certain anatomical structures of the eye and placement of an intraocular shunt 50. In particular, Figure 2 shows the shunt 50 implanted in the intra-Tenon adhesion between conjunctiva 18 and sclera 24. In some modalities, intra-tenon placement can be achieved by not dissecting the conjunctiva, controlling the location of the scleral outlet, and by pre-treatment of the intra-tenon adhesion space before or by tenon manipulation during the procedure. The placement of shunt 50 within the intra-Tenon adhesion space allows aqueous humor 20 to diffuse to the subconjunctival space. According to some modalities, the restrictions of discharge from the subconjunctival space may depend on the strength, quantity and thickness of the tenon adhesions (if present, for example, when placed inside the b), the thickness and consistency of the conjunctiva (which may allow more or less). less fluid to diffuse into subconjunctival vessels and lacrimal space) and existing fibrotic adhesions.

[0048] Figure 2 illustrates one of the variety of potential shunt 50 placements in the eye. As discussed here, methods and devices provided here can be implemented in which a shunt is placed in communication with other anatomical features of the eye. Thus, some methods and devices disclosed here can be implemented when a shunt forms a passage of the anterior chamber in an area of lower pressure, such as Schlemm's canal, the subconjunctival space, the episcleral vein, the supracoroidal space, the intra-adhesion space Tenon, the subarachnoid space, or other areas of the eye.

[0049] The implantation methods can be fully automated, partially automated (and, therefore, partially manual) or completely manual. For example, in a fully automated procedure, a shunt can be performed by a robotic implant, whereby a doctor controls the advance of the needle, plunger, optional guidewire and, as a result, shunt by remotely controlling a robot. In such fully automated procedures and remotely controlled, the doctor's hands do not normally come into contact with the implantation device during the surgical procedure. Alternatively, the shunt can be delivered to the desired area of the eye with a "portable" implantation device. Portable implantation devices, as well as details regarding the implementation method steps and procedures, are described in copending North American Order Publication 2012/0197175, filed on December 8, 2011, and 2013/0150770, filed on December 8 2011, the totals that are incorporated here by reference. The insertion of the needle into the eye as well as certain steps of repositioning or adjustment can be performed manually by the doctor. In the case of completely manual devices and methods, all steps of positioning, repositioning, adjustment and implantation can be performed manually by the doctor.

[0050] Some modalities disclosed here comprise intraocular shunts that are configured to form a drainage path from the anterior chamber of the eye to a target space. In this way, the shunt can allow the aqueous humor to drain from the anterior chamber and exit through the traditional drainage channels of the eye, such as the intrascleral vein, the collecting canal, the Schlemm canal, the trabecular discharge, the uveoscleral discharge for the ciliary muscle, the conjunctival lymphatic system or others.

[0051] Some - modalities “disclosed in this document comprise a shunt that generally has a cylindrical shape with an external cylindrical wall and, in some modalities, a concave interior that extends at least partially along the length of the shunt. The shunt may have a wall that defines an internal diameter of the main section, lumen dimension, diameter or a cross-sectional dimension or diameter of the flow path from approximately 10 µm to approximately 300 µm. The shunt may have a wall defining a dimension or diameter of the lumen of approximately 20 µm to approximately 200 µm. In addition, the shunt may have a wall that defines a lumen size or diameter from approximately 30 µm to approximately 100 µm. In some embodiments, the shunt may have a wall that defines a lumen size or diameter of approximately 50 µm.

[0052] As noted above, the restrictive section can provide complete occlusion of the internal lumen of the shunt. In some embodiments, the restrictive section may further comprise a lumen or passageway having an internal diameter. For example, the inside diameter of the restrictive section can be from approximately 10 µm to approximately 70 µm. In some embodiments, the inside diameter of the restrictive section can be approximately 15 µm to approximately 35 µm. In some embodiments, the inside diameter of the restrictive section can be approximately 20 µm. Also, in some modalities, the internal diameter of the shunt can remain the same, increase or decrease when hydrated.

[0053] The external dimension or wall diameter of some embodiments can be from approximately 100 µm to approximately 300 µm, from approximately 125 µm to approximately 250 µm, from approximately 140 µm to approximately 180 µm, or approximately 160 µm. In addition, the wall thickness of some embodiments may be approximately 30 µm to approximately 80 µm, from approximately 40 µm to approximately 50 µm, or approximately 45 µm. Also, in some modalities, the outer diameter of the shunt may increase when hydrated.

[0054] In some modalities, the intraocular shunt may be of a length that is sufficient to form a drainage path from the anterior chamber of the eye to the target space. The length of the shunt is important to achieve placement specifically in the target space. A shunt that is too long will extend beyond the target space and can irritate the eye. For example, if the target space is the intra-scleral space, a shunt that is too long can irritate the conjunctiva that can cause the filtration procedure to fail. Yet, in such modalities, a shunt that is too short will not provide sufficient access to drainage pathways such as the episcleral lymphatic system or the conjunctival lymphatic system.

[0055] In some modalities, the shunt can be any length that allows the aqueous humor to drain from an anterior chamber of an eye to the target space. In some embodiments, the shunt can have a total length in the range of approximately 1 mm to approximately 12 mm, whether in a dry or fully hydrated state. The length can be in the range of approximately 2 mm to approximately 10 mm or from approximately 4 mm to approximately 8 mm, or any specific value within said ranges. In some embodiments, the length of the shunt is approximately 5 mm to approximately 8 mm, or any specific value within that range, for example, as approximately:

5.0 mm, 5.1 mm, 5.2 mm, 5.3 mm, 5.4 mm, 5.5 mm, 5.5 mm, 5.7 mM,

5.8 mm, 5.9 mm, 6.0 mm, 6.1 mm, 6.2 mm, 6.3 mm, 6.4 mm, 6.5 mm,

6.6 mm, 6.7 mm, 6.8 mm, 6.9 mm, 7 mm, 7.1 mm, 7.2 mm, 7.3 mm, 7.4 mm, 7.5 mm, 7.6 mm, 7.7 mm, 7.8 mm. 7.9 mm, or 8.0 mm. Also, in some modalities, the length of the shunt can remain the same or increase when hydrated. For example, the length of the shunt can increase by approximately 5 mm when dry, swelling to a length of approximately 6 mm when fully hydrated.

[0056] Of the total length of the shunt, the axial length of the restrictive section can be from approximately 0.1 mm to approximately 6 mm. In some embodiments, the length of the Frestritika section can be approximately 0.5 mm to approximately 4 mm. In some embodiments, the length of the restrictive section can be approximately 2 mm.

[0057] Additionally, some shunt modalities can have different shapes and dimensions that can be accommodated by the eye. According to the modalities disclosed here, the intraocular shunt can be formed having dimensions within the various size ranges disclosed for external diameter (for example, the main section or restrictive section), internal diameter (for example, the main section or restrictive section ), segment lengths (for example, restrictive section or main section), and total length.

[0058] For example, some modalities can be configured so that the shunt has a total length of approximately 6 mm, a main section internal diameter of approximately 150 µm, and a restrictive section internal diameter of approximately 40 µm to approximately 63 µm .

[0059] The Figures illustrate modalities of an intraocular implant or shunt that can have a first flow that can be modified to a second flow, changing the implant configuration without requiring surgical intervention.

[0060] Some implants can be configured to have a first flow that can be changed to a second flow by dislodging, separating or removing a removable portion of the restrictive section thereof. In some embodiments, the first flow may be less than the second flow through the implant. Thus, the modification or removal of a section of it can decrease the resistance to flow through the implant and, thus, allow greater flow through the implant.

[0061] For example, the Figures illustrate modalities and configurations of flow-adjustable implants or shunts having one or more restrictive sections partially obstructive or flow limiting and one or more main sections non-obstructive or unrestricted.

[0062] Some modalities of the shunts disclosed here may provide a resistance to the desired initial flow or a flow value that prevents excessive flow from the anterior chamber of the eye, thus avoiding low intraocular pressures or hypotonia. However, after the development of biological resistance to discharge, a doctor can adjust the flow resistance or the flow value of the shunt to avoid high intraocular pressure. Therefore, some modalities in this document allow a doctor to adjust or regulate the flow of the shunt. The geometric configuration and component dimensions of these shunts can be manipulated as desired to provide the desired flow resistance. Therefore, the modalities illustrated and discussed do not limit the scope of the resources or teachings in this document.

[0063] According to some modalities, the shunt can be configured so that the doctor can adjust the flow resistance or flow value to provide a flow rate of approximately 1 ul per minute to approximately 3 ul per minute. In addition, the shunt can be configured so that the physician can adjust the flow resistance or the flow value to provide a flow rate of approximately 2 ul per minute.

[0064] Figures 3—5 illustrate modalities of intraocular shunts in which a removable portion provides a complete or total occlusion of fluid flow through the shunt. Figures 3 and 4 illustrate an embodiment in which the removable portion is positioned within a lumen of the shunt, while Figure 5 illustrates an embodiment in which the removable portion is positioned around a discharge end portion of the shunt. According to some embodiments, the flow occlusion can be a separate component or material that is inserted into the lumen, attached to the discharge end portion, or otherwise coated on the discharge end portion of the shunt to block flow through the lumen. Thus, in some embodiments, Figures 3—5 illustrate shunts in which the flow through the shunt is initially blocked while Figures 6-9 illustrate shunts in which the flow through the shunt is reduced, but not blocked or completely closed to prevent the flow through it.

[0065] With reference to Figure 3, an intraocular shunt 60 may comprise an elongated body having a wall 62 that defines a lumen of the shunt 64 extending through it. The shunt 60 may comprise opposite end portions (for example, an inlet end portion 66 and a discharge end portion 68). The inlet end portion 66 can be cleaned and allowed to flow into it, and the outlet end portion 68 can comprise one or more restrictions. Shunt 60 may comprise an obstructive or flow limiting restrictive section 70 and a non-restrictive or non-obstructive main section 72. The lumen of shunt 64 may extend through main section 72. In the illustrated embodiment, flow through the restrictive section 70 is occluded or blocked.

[0066] Figure 4 illustrates restrictive section 70 of shunt 60 in more detail. The restrictive section 70 may comprise a flow restrictor, removable portion, or plug 74 that is positioned within the lumen 64 in the discharge end portion 68 of the shunt 60. The plug 74 may comprise a generally circular disc or cylinder that is inserted into the lumen 64. Plug 74 can provide a burst seal by the discharge end portion 68.

The plug 74 can comprise an axial thickness (measured along the longitudinal axis) which allows the plug 74 to be easily dislodged from the discharge end portion 68. For example, in some embodiments, the plug 74 can comprise a thickness axial which is less than a width 79 of wall 62 of shunt 60. Still, in some embodiments, plug 74 may comprise an axial thickness that is approximately equal to width 79 of wall 62 of shunt 60. Thus, in some embodiments, the thickness of plug 74 may be approximately 30 µm to approximately 80 µm, from approximately 40 µm to approximately 50 µm, or approximately 45 µm.

[0068] In addition, the width 79 of the wall can be as much as two, three, or four times as good as the width 78 of plug 74.

Certainly, in some embodiments, the thickness of plug 74 may be approximately 7 µm to approximately 40 µm, from approximately 10 µm to approximately 25 µm, or approximately 15 µm.

[0069] However, in some embodiments, the width 78 of plug 74 may be greater than the width 79 of wall 62. For example, the width 78 of plug 74 may be as much as two, three, or four times as good as width 79 of wall 62. In addition, with respect to an overall length of the shunt itself, the width 78 of plug 74 can be between approximately 0.1% to approximately 40%, between approximately - 30% to approximately 40%, between approximately - 20% to approximately 30%, between approximately - 15% to approximately 20%, between approximately 10% to approximately 15%, between approximately 5% to approximately 10%, between approximately 3% to approximately 5%, between approximately 2% to approximately 3%, between approximately 1% to approximately 2%, between approximately 0.5% to approximately 1%, between - approximately - 0.1% to approximately - 0.5%, between approximately 0.2% to approximately 0.5 %, or between approximately 0.3% to approximately 0.4% of the comp general shunt performance. Certainly, in some embodiments, plug 74 may have a width 78 of approximately 8 µm to approximately 3200 µm, from approximately 16 µm to approximately 2400 µm, from approximately 24 µm to approximately 1600 µm, from approximately 32 µm to approximately 1200 µm, from approximately 40 µm to approximately 800 µm, from approximately 80 µm to approximately 400 µm, or from approximately 160 µm to approximately 240 µm.

[0070] As shown in Figure 4, in some embodiments, plug 74 can extend over discharge end portion 68. Plug 74 can be positioned completely within lumen 64. However, plug 74 can still cover a portion of end surfaces of the discharge end portion 68.

[0071] In some embodiments, to form shunt 60, shunt 60 can be dipped in a solution to allow capillary action or uptake forces to attract the solution to lumen 64 to form a plug in it. Alternatively, the solution can be injected or pulled into lumen 64. However, plug 74 can also be inserted into lumen 64 as a solid material that is held in place by a friction fit or adhesion.

[0072] As further illustrated below and in Figures 10A — 10D, which illustrate a modality similar to that shown in Figures 3 and 4, Plug 74 can be dislodged and moved from within lumen 64 to allow flow through lumen 64. Certainly, in some embodiments, the discharge end portion 68 of shunt 60 may be flexible and deformable in response to a compressive load. The compressive load applied to the discharge end portion 68 can alternate or move the wall 62 of the shunt 60, thereby releasing the plug 74 by overcoming the friction or adhesive engagement between an outer surface 76 of the plug 74 and an inner surface of the lumen 64. As the outer surface 76 of the plug 74 slides relative to the inner surface of the lumen 64, the plug 74 can be ejected from the lumen 64, thus clearing the obstruction created by the plug 74.

[0073] As noted above, in some embodiments, the internal diameter of shunt 60 may remain the same, increase, or decrease when hydrated. Also, in some embodiments, the inner diameter of shunt 60 may increase as a removable portion or plug 74 (providing flow restriction at the discharge end portion or restrictive section 70) coupled to or residing within restrictive section 70 of lumen 64 expands at a rate less than or less than the inner diameter of shunt 60. Thus, after implantation and hydration of shunt 60, and after a desired period has passed (which can be configured based on the formulation of the shunt and the portion removable), plug 74 may be in an “explosion” state. In addition, or alternatively, shunt 60 and / or plug 74 may degrade at different rates to allow plug 74 to be in an explosion state. In the blast state, plug 74 may have a reduced engagement with discharge end portion 68, thus allowing plug 74 to be more easily dislodged or broken under the application of an external force, such as a compressive force.

[0074] Similarly, Figure 5 illustrates an intraocular shunt 80 comprising an elongated body having a wall 82 that defines a lumen of shunt 84 extending through it. The shunt 80 may comprise opposite end portions (for example, an inlet end portion 86 and a discharge end portion 88). The inlet end portion 86 can be cleaned and allowed to flow into it, and the outlet end portion 88 can comprise one or more restrictions. Shunt 80 may comprise an obstructive or flow limiting restrictive section 90 and a non-restrictive or non-obstructive main section 92. The lumen of shunt 84 may extend through main section 92. In the illustrated embodiment, flow through the restrictive section 90 is occluded or blocked.

[0075] The restrictive section 90 may comprise a flow restrictor or cap 94 which is positioned around the discharge end portion 88 (and may extend, at least partially, within lumen 84) of the shunt 80. The cap 94 may comprise a mass of material that is coated in and dried around the discharge end portion 88. For example, in some embodiments, shunt 80 may be dipped in a solution that lines the discharge end portion 88 to form a cap or stop on the discharge end portion 88 of the shunt 80. However, the cap 94 can still be coupled to the discharge end portion 88 as a solid material or layer that is held in place by a friction or adhesion fit.

[0076] As noted above with reference to Figures 3, 4, and Figures 10A — 10D, the cover 94 can be dislodged and moved from the discharge end portion 88 of the shunt 80 to allow flow through lumen 84. Thus, in some embodiments, the discharge end portion 88 of shunt 80 may be flexible and deformable in response to a compressive load. The compressive load applied to the discharge end portion 88 may alternate or move the wall 82 of the shunt 80, thus releasing the cover 94 by overcoming the friction or adhesive engagement between the cover 94 and an external surface of the shunt 80. According to the cover 94 slides with respect to the outer surface of the shunt 80, the cover 94 can be separated from the discharge end portion 88 of the shunt 80, thus clearing the obstruction created by the cover 94.

[0077] In some embodiments, the cap 94 may comprise an outer cross-section profile that is greater than an outer diameter of the shunt 80. The cap 94 may comprise one or more proximal projection surfaces 96 that extends outwardly from an outer surface 98 of the shunt 80. The projection surfaces 96 may allow a force (for example, a compressive force) applied by a physician to more easily cause the axial displacement of the lid 94 with respect to the shunt 80 when the physician is releasing the lid 94.

[0078] In addition, in some embodiments, the cap 94 can advantageously comprise an axial thickness (measured along the longitudinal axis) which tends to ensure that the cap 94 has a greater compressive strength or compressive strength than the shunt 80. Certainly, as the compressive force is applied against the shunt 80 and the cap 94, the shunt 80 will radially deform or compress to a greater degree than the cap 94. Such an action may then tend to cause disengagement between the portion of discharge end 88 of shunt 80 and cover 94.

[0079] Also, in some modalities, the outer diameter of the shunt 80 can remain the same, increase, or decrease when hydrated. In some embodiments, the outer diameter of shunt 80 may remain the same or increase as long as a removable portion or cap 94 (providing flow restriction at the discharge end portion or restrictive section 90) coupled to or covering restrictive section 90 of the lumen 84 expands at a higher rate or to a greater degree than the outer diameter of the shunt 80. Thus, after implantation and hydration of the shunt 80, and after a desired period has passed (which can be configured based on the formulation of the shunt and the removable portion), cover 94 may be in an “explosion” state. In addition, or alternatively, shunt 80 and / or cap 94 may degrade at different rates to allow cap 94 to be in an explosion state. In the explosion state, the lid 94 may have a reduced engagement with the discharge end portion 88, thus allowing the lid 94 to be more easily dislodged or broken under the application of an external force, such as a compressive force.

[0080] Figure 6 illustrates a shunt 100 having an elongated body having a wall 102 that defines a lumen of shunt 104 extending through it. The shunt 100 may comprise opposite end portions (for example, an inlet end portion 106 and a discharge end portion 108). The inlet end portion 106 can be cleaned and allowed to flow into it, and the outlet end portion 108 can comprise one or more restrictions. Shunt 100 may comprise an obstructive or flow limiting restrictive section 110 and a non-restrictive or non-obstructive main section 112. Flow may be provided through restrictive section 110, but with greater resistance than through main section 112. The lumen of shunt 104 may extend through main section 112. Restrictive section 110 may comprise a gelatin tube. The gelatin tube can be inserted into the lumen of the shunt 104.

[0081] Figure 6 illustrates restrictive section 110 of shunt 100 in more detail. The restrictive section 110 or gelatin tube may comprise a wall 118 which defines a secondary lumen 120. Wall 118 may define a different internal dimension than wall 102. For example, wall 118 may define a cross section or profile which is smaller than the cross-section or profile of the wall 102, thus rendering the lumen 104 larger than the lumen 120. In some embodiments, the secondary lumen 120 can generally extend coaxially with the lumen of the shunt 104; however, secondary lumen 120 can be configured to be spaced away from a central axis of the lumen of shunt 104.

[0082] For example, secondary lumen 120 may further extend longitudinally along restrictive section 110 while traversing and / or is spaced away from the central axis of restrictive section 110. Wall 118 may define a constant or variable thickness. In addition, the secondary lumen 120 can be at least partially surrounded by the wall 118 forming the restrictive section 110. However, the wall 118 can be discontinuous, and the secondary lumen 120 can be connected intermediate to the wall 118 of the restrictive section 110 and the wall 102. Thus, lumen 104 and lumen 120 may have a boundary surface in common, in some embodiments.

[0083] In some embodiments, as shown in Figure 6, the restrictive section 110 can be formed as a plug that is configured so that the wall 110 defines an outer diameter that is approximately equal to the inner diameter of the lumen of the shunt 104. As such, the plug can be inserted into lumen 104 to couple the plug to main section 112.

[0084] Furthermore, restrictive section 110 can be removably coupled to main section 112, as to allow the physician to manually unblock, separate or remove restrictive section 110 from discharge end portion 108 of shunt 100. For example, the restrictive section 110 can be removably coupled to the main section 112, thus allowing the restrictive section 110 to be complete or, at least partially, removed from the main section

112. For example, restrictive section 110 may comprise a metal pen or frame that is inserted into the lumen of shunt 104, which can later be removed.

[0085] Additionally, restrictive section 110 may comprise a gelatin material that is the same or different from the main section

112. For example, restrictive section 110 may comprise a material that has a different rate of degradation than that of main section 112, which can be realized by having more or less additional cross-linking materials, or other structures that facilitate removal or degradation restrictive section 110 of main section 112.

[0086] In addition, in some embodiments, the restrictive section can be formed using a material or component that is formed separately from the restrictive end portion and subsequently joined or coupled to it. For example, the restrictive section can be adhered, chemically bonded, or mechanically coupled, as by a friction or by interference fit, or by coupling between complementary structures, such as protrusions and retainers.

[0087] To facilitate displacement, restrictive section 110 may include an enlarged portion 124 with a restrictive end portion 122 that abuts against the inlet end portion

106. The enlarged portion 124 may remain, at least partially, outside the lumen 104 to allow displacement, separation, or removal of the restriction section 110, as described herein. As shown in Figure 6, the secondary lumen 120 of the restrictive section 110 continues through the enlarged portion 124. In some embodiments, the enlarged portion 124 may have a cross-section or external profile that is similar to that of wall 102. Still, in some embodiments , the restrictive section 110 may be a solid plug without or without a lumen extending through it.

[0088] Shunt 100 can be configured so that two or more respective sections comprise different flow restrictions or flow values. Thus, in some cases, a physician can manually manipulate or adjust the total flow restriction or flow value of the shunt 100 by manipulating one or more sections of the shunt 100. In some embodiments, this manipulation can be performed without surgery. Also, in some modalities, a doctor may use a shunt or shunt system that self-adjusts or passively adjusts to change the total flow restriction or shunt flow value over time.

[0089] The resistance to flow or the flow value of a given section of the shunt may be related to the restrictions or geometric properties of the specified section. Geometric constraints or properties can be one or more of the diameter or radius, the length of the specified section, a cross-sectional area of the flow passage, surface roughness or other geometric characteristics. In some embodiments, for the purposes of this disclosure, flow resistance or flow value may be a numerical representation, coefficient or formula in which the mathematical calculation for a fluid flow rate through the section provided for a given fluid is predicated . For example, the flow value can represent a proportion of an internal diameter or radius and an axial length of the specified section. A higher flow rate may result in a higher flow rate. In addition, in some embodiments, resistance to flow may be the inverse of the flow value, for example, a ratio of an axial length and an internal diameter or radius of the specified section. Generally, greater resistance to flow would result in a lower flow rate. In addition, resistance to flow may depend mainly on the length of the shunt, internal diameter and liquid viscosity (aqueous humor).

[0090] The flow through the shunt, and thus the pressure exerted by the fluid in the shunt, is calculated by the Hagen-Poiseuille equation: Pp = E onR AR 4) RÉ MAP 7 x 7 where & is the volumetric flow; V is a volume of the spilled liquid (cubic meters); t is the time (seconds); v is the average fluid velocity over the length of the tube (meters / second); Ax is a distance in the flow direction (meters); R is the inner radius of the tube (meters); AP is the pressure difference between the two ends (pascal); n is the viscosity of dynamic fluid (pascal according to (Pa-s)); and L is the total length of the tube in the x direction (meters).

[0091] For example, shunt 100 can be configured so that flow through restrictive section 110 defines a flow resistance or flow value. The main section 112 can define a first flow cross area, and the restrictive section 110 can define a second flow cross area which is smaller than the first flow cross area. The first flow resistance or flow value can be determined by constraints or geometric properties of the restrictive section 110. Such restrictions may include the length of the restrictive section 110, the inside diameter or radius of the wall 118, and other features, such as a roughness of the internal surface of the wall 118.

[0092] In addition, the second flow cross section or profile of restrictive section 110 can be any one of a variety of geometric profiles. For example, the second transverse flow or profile area can be circular, rectangular, square, polygonal, or otherwise formed. The second flow cross section or profile can be configured to provide less cross area than the main section 112. The second flow cross section or profile can be constant or variable along the longitudinal extent of the restrictive section 110.

[0093] Similarly, main section 112 can define a flow resistance or flow value that is different than the first flow resistance or flow value of restrictive section 110. As with the flow resistance or flow value of the section restrictive 110, the flow resistance or flow value of main section 112 can be determined by the constraints or geometric properties of main section 112, as discussed above. Certainly, the geometric constraints of main section 112 may differ from the geometric constraints of restrictive section 110, resulting in different flow resistances or flow values.

[0094] The total pressure drop by the AP totai shunt consisting of a main section and a partially restricted section can be calculated for each section separately as APnmain and APpartially constrainea, according to the formula above: 4P = SPL

TRE and then adding the two numbers together: AP total = APmain + APpartially constrained. IF there are more than 2 sections, then they are certainly added together.

[0095] AP totai for any shunt represents the minimum IOP in the eye for a given flow O. The rate of flow & through the shunt depends on the location of the shunt and the amount of resistance of the surrounding tissue usually from approximately 10% to approximately 90% of the amount of aqueous production in the eye that is typically approximately 1 to approximately 3 µl / min.

[0096] As shown in Figure 6, shunt 100 can comprise a single restrictive section 110 and a single main section 112. However, shunt 100 can comprise multiple restrictive sections and / or multiple main sections (see, for example, Figures 7-9).

[0097] A given restrictive section can also define a plurality of cross flow areas or internal diameters. For example, as shown in Figure 7, the restrictive section can have distinct steps or subsections that have different cross-flow areas or internal diameters.

[0098] Figure 7 illustrates an embodiment of a shunt 140 in which an obstructive restrictive or flow limiting section 142 comprises first and second occlusion components 150, 152. The first occlusion component 150 and the second occlusion component 152 can be inserted into a lumen 144, formed by a shunt wall 146 of shunt 140. The first and second occlusion components 150, 152 can still be pre-assembled prior to insertion into the lumen of shunt 144. The first and second components of occlusion 150, 152 can define different internal transverse dimensions (e.g., diameters) that provide different flow resistances or flow values. Certainly, in some embodiments, a physician may manually dislodge, separate, or remove more than one restrictive section in order to adjust the flow resistance or shunt flow value, thus allowing the physician to reach two or more different flow resistances or values of flow through the shunt. For example, an initial manual manipulation, as discussed below with respect to Figures 10A — 10D, can be applied to release, separate, or remove the second occlusion component 152 from the first occlusion component 150, thus leaving only the first component of occlusion 150 coupled to shunt 140. Afterwards, the doctor can optionally dislodge, separate, or remove the first occlusion component 150 of shunt 140 by another application of manual manipulation.

[0099] For example, similar to the modality illustrated in Figure 7, the restrictive section can be formed using a tube configured to fit inside the lumen of the shunt. In addition, the restrictive section can be formed using a component, coating, or other material that is layered along the inner surface of the shunt wall. The component, coating, or other material may extend, at least partially, over the circumference of the inner surface of the shunt wall. In some embodiments, the component, liner, or other material may extend completely over the circumference, and in some embodiments, the component, liner, or other material may extend longitudinally along the inner surface of the shunt wall. In any configuration, the total cross-flow area of the restrictive section can be less than the total cross-flow area of the main section.

[0100] In some modalities, a restrictive section can be formed by varying a dimension of the shunt along the restrictive section. In addition, the restrictive section can be demarcated from the main section in a joint by perforations, a thin shunt wall, or other such structures to allow preferential degradation or breakage in the joint. Thus, the restrictive section can be formed integrally or of a single, continuous piece of material with the main section of the shunt.

[0101] Figure 8 illustrates yet another embodiment of a shunt 200 having a plurality of obstructive or flow limiting restrictive sections 202, 204 and a plurality of main sections 206, 208. The restrictive sections 202, 204 may comprise different resistances or flow values or flow values. As shown, restrictive section 202 can define a slightly longer axial length than restrictive section 204. Certainly, the flow resistance for restrictive section 202 may be greater than the flow resistance for restrictive section 204. In some embodiments , the inner diameter or radius of the restrictive sections 202, 204 may still vary. In addition, main section 206 can be arranged between restrictive sections 202, 204.

[0102] As noted above with respect to the modality shown in Figure 7, restrictive sections 202, 204 can be manually manipulated by a physician to separate one or both restrictive sections 202, 204 from shunt 200. Certainly, a non-surgical intervention can be performed to adjust the flow value of shunt 200, similar to that discussed below with respect to Figures 10A-10D.

[0103] As with any of the geometric parameters of the modalities taught or disclosed in this document, other characteristics and aspects of the shunt 200 can be very, such as the distance between the obstructive restrictive or flow limiting sections 202, 204, in order to reach an overall desired flow resistance result or flow value for the shunt.

[0104] Additionally, Figure 9 illustrates a modality similar to Figure 6, discussed above. In Figure 9, a shunt 250 is illustrated comprising the first and second restrictive sections 252, 254 that can be removably coupled together and to a main section 260 of the shunt 250. Figure 9 illustrates that the first and second sections restrictive 252, 254 comprise different internal diameters, 272, 274, which may still be different from the inner diameter 276 of main section 260. However, the first and second restrictive section 252, 254 and main section 260 may have the same or different internal diameters as each other.

[0105] As noted above with respect to the modalities shown in Figures 3-8, a physician can manually manipulate shunt 250 in order to release, separate, or remove one or both restrictive sections 252, 254 from main body 260 of shunt 250 .

[0106] In any of the modalities disclosed in this document, a doctor can be qualified to perform a single or multiple incremental manual, non-surgical interventions that can change the resistance to the flow of the shunt. Other configurations or combinations of the shunts illustrated in Figures 3-9 can be made and are contemplated as part of the present disclosure.

[0107] Using a flow-adjustable shunt disclosed or taught here, a physician may perform a manual non-surgical intervention to modify the flow resistance or the flow value of one or more portions of the shunt to adjust the general flow resistance or the shunt flow value. This allows the physician to ensure that the shunt maintains optimal overall resistance to flow in response to any increase in biological resistance to flow. Thus, during post-operative visits, the doctor can monitor any changes in the tissue around the shunt or drainage channels, measure and track intraocular pressure and, when necessary, adjust or modify the resistance or flow value, the in order to maintain an ideal intraocular pressure.

[0108] As noted above, after a shunt is placed in the eye, the surrounding tissue can create resistance to biological output, such as fibrosis, which can limit or reduce the flow through the shunt. The tissue reaction that alters the general shunt discharge resistance stabilizes after approximately 1 to 10 weeks after surgery.

[0109] A doctor can perform a postoperative examination to modify the shunt in a subsequent procedure after a cut-off period. This period can vary from eight weeks to three months.

Often, ten weeks can be a sufficient amount of time to achieve stabilization and healing. If appropriate, modification of the shunt can be carried out normally.

[0110] As part of the postoperative examination, the doctor can check whether the intraocular pressure is at the desired level. Normally, normal intraocular pressure is approximately 10 mmHg and approximately 20 mmHg. If the intraocular pressure is at an undesirable level (for example, greater than 20 mmHg), the doctor may modify the shunt accordingly.

[0111] The physician can modify the shunt to reduce the flow resistance or shunt flow value. For example, the doctor may remove a portion of the shunt, and in some cases, remove a respective portion of the eye. The displacement, separation, or removal of a portion of the shunt can reduce the resistance of the shunt flow and thus allow high flow through the shunt, relieving and reducing intraocular pressure.

[0112] Certainly, in some modalities, methods and devices are provided for a shunt to be able to provide: (1) substantial resistance to initial discharge in order to avoid low early intraocular pressures and hypotonia, and (2) the ability to subsequently reduce resistance discharge to compensate for increased resistance to biological output (eg fibrosis from the target space).

[0113] In order to change the flow resistance or flow value of the Shunt, some shunt modalities can be configured so that the doctor can manually manipulate the shunt, through a non-surgical intervention, in order to remove one or more aspects, sections, or all restrictive obstructive or flow limiting sections of the shunt. In some cases, the doctor may dislodge, detach, or remove a restrictive portion of the shunt and thus open the flow for optimal long-term intraocular pressure performance.

[0114] In some methods, the shunt can be positioned so that a restrictive end portion is arranged in the anterior chamber of the eye. Also, in some methods, the shunt can be positioned so that a restrictive end portion is disposed in the target space or a lower pressure location. In addition, in some embodiments, the shunt can be configured and positioned so that one or more obstructive or flow limiting restrictive sections or end portions are located in the anterior chamber and the target space.

[0115] According to some modalities, the shunt can be positioned so that the respective restrictive end portion is positioned in the target space or lower pressure location, as in the subconjunctival space of the eye. For example, Figures 10A-10D illustrate a shunt 380 that is implanted in an eye 302. Shunt 380 can comprise an inflow end portion 386 and a discharge end portion 384. The inflow end portion 386 can be positioned in the anterior chamber 310 of the eye

302. Furthermore, the discharge end portion 384 can be placed in the subconjunctival space 320 of the eye 302. Thus, the shunt 380 can be operative to provide pressure relief of the fluid in the anterior chamber 310 at a lower pressure location, such as the subconjunctival space 320 of the eye 302. As noted above, while an obstructive or flow limiting restrictive section 382 disposed at the discharge end portion 384 may tend to ensure that the condition of low intraocular pressure is avoided, such as hypotonia, over the time, certain biological discharge restrictions can be formed, which can reduce the general discharge or flow of shunt 380. Restrictive section 382 can be coupled to shunt 380, as being, at least partially, arranged within a lumen 383 of the shunt

380. The modality of shunt 380 shown in Figures 104-10D is similar to that illustrated above and in Figure 6. As discussed further below, Figures 10A4—10D illustrate the steps by which a physician can manually manipulate restrictive section 382 within the shunt 380 to adjust the flow resistance or flow value of the shunt 380 without surgical intervention.

[0116] Figures 10A-10D illustrate different aspects of modalities in which shunt 380 can be mechanically modified. Figure 10A illustrates shunt 380 in an initial position or configuration in which the resistance of flow through the shunt is at its maximum. After a doctor determines that a reduction in flow resistance is guaranteed, the doctor can then check the position of shunt 380 with respect to eye structures 302 and prepare to manipulate or modify the configuration of shunt 380.

[0117] For example, Figures 10B and 10C illustrate the stroke of a doctor's finger when performing a non-surgical method to mechanically modify shunt 380 to adjust the flow resistance or flow value of shunt 380. As illustrated, the restrictive portion 382 can be removed from the discharge end portion 384 the shunt 380 by pressing against the conjunctiva 321, applying pressure against the eye, and moving the finger and a posterior direction along the conjunctiva 321 above the shunt 380.

[0118] As discussed above, in some embodiments, restrictive section 382 may comprise a fluid restriction that can be removed from lumen 383 of shunt 380. In addition, restrictive section 382 can be removably attached to the inside of lumen 383 of shunt 380. In some embodiments, restrictive section 382 may comprise a plug, reduced cross-section, or any other suitable occlusion. Restrictive section 382 can be completely disposed within shunt 380, or, at least partially, externally disposed around shunt 380. Restrictive section 382 can be removed from shunt 380 by overcoming the adhesive or friction retention of restrictive section 382 within the shunt 380.

[0119] According to some modalities, restrictive section 382 can be removed from inside shunt 380 by applying force to the outer surface 381 of shunt 380 by deforming shunt 380.

[0120] In some modalities, the shunt 380 is formed by a material that is flexible and / or, otherwise, compressible. For example, pressure or force can be applied to the outer surface 381 of shunt 380 to compress, flex, or otherwise deform the shunt 380. In some embodiments, as force is applied to the outer surface 381 of shunt 380, cutting inner shunt 380 can be reduced from an initial cross-section to a compressed or reduced cross-section.

[0121] In some embodiments, restrictive section 382 disposed within shunt 380 may not compress as much as shunt 380 when external force is applied to the outer surface 381 of the shunt

380. For example, restrictive section 382 may comprise a structural strength different from that of shunt 380, such as a thicker wall, different material, or another structural variant. Therefore, as shunt 380 is deformed, restrictive section 382 can be installed away from the area with the cross section reduced to an area with a larger cross section or outside of shunt 380. In some embodiments, restrictive section 382 can be slid through of shunt 380 by applying a force anterior to restrictive section 382 and directed in a posterior direction to reduce the cross-section prior to restrictive section 382 and to tighten or urge restrictive section 382 outside the lumen of shunt 383 or, otherwise, away from shunt 380 .

[0122] In some embodiments, the external force can be applied directly to the outer surface 381 of shunt 380 to deform the shunt 380. In some embodiments, an external force can be applied to the tissues of the eye 302, which it can compress or, otherwise , transmit the force to the outer surface 381 of shunt 380, as shown in Figure 10C. In the example shown, shunt 380 is located in subconjunctival area 320. Therefore, the force can be applied to conjunctiva 321 to compress conjunctiva 321 and transmit a force to the outer surface 381 of shunt 380.

[0123] As shown in Figures 10B and 10C, in the example shown, a doctor can apply force to eye 302 with a finger 340 to massage the eye tissue, such as conjunctiva 321, to compress shunt 380. This compression of shunt 380 it can force the restrictive section 382 outside the restrictive end portion 384 to be spaced away from shunt 380 in the subconjunctival space 320, as shown in Figure 10D.

[0124] As shown in Figure 10C, in some embodiments, as restrictive section 382 is stimulated outside shunt 380, restrictive section 382 can be stimulated outside discharge end portion 384. In some embodiments, after restrictive section 382 be stimulated outside shunt 380, restrictive section 382 can be spaced away from discharge end portion 384 so that a small space is present between restrictive section 382 and discharge end portion 384, as shown in Figure 10D. In this way, the discharge through the discharge end portion 384 can generally remain clean. In some embodiments, the restrictive section 382 can be removed from the eye or left in place to act as a spacer that will tend to prevent blockage and preserve discharge through the discharge end portion 384. This can be particularly true for a restrictive section 382 that remains very quiet in the eye, like a gelatin material. In some embodiments, the restrictive portion 382 may be spaced away from the discharge end portion 384 by approximately 0.2 mm to approximately 2 mm. In addition, the restrictive portion 382 can be spaced away from the discharge end portion 384 by approximately 0.5 mm to approximately 1 mm.

[0125] In some embodiments, after restrictive portion 382 is spaced away from discharge end portion 384, restrictive portion 382 can be extracted from eye 302.

[0126] Referring to Figure 11, in the example shown, instead of a finger, a rolling tool 342 can be used to apply force or massage the eye 302. In some embodiments, using a rolling tool 342, a force can be applied to eye 302 while minimizing the shear force transmitted to eye 302. The rolling tool 342 can be any tool suitable for use in a 302 eye.

[0127] Referring to Figure 12, an intravenous tool 344 can be used to apply a force or massage the eye 302. In some embodiments, using the intravenous tool 344, pressure or force can be applied to the eye 302 while providing some force of shear to stimulate restrictive section 382 out of shunt 380. In some embodiments, intravenous tool 344 may still be in the form of a flat pad (not shown) that can be used to apply a wide area of force against eye 302.

[0128] In some embodiments, restrictive section 382 may be removed by applying force directly to restrictive section 382. In some embodiments, restrictive section 382 may be pulled or otherwise stimulated out of lumen 383.

[0129] Some modalities may even provide a method or device that uses a minimally invasive surgical procedure to release and / or remove a restrictive section of the shunt. For example, with reference to Figure 13, in the example shown, the restrictive section

382 can be dislodged, detached, or removed from shunt 380 without any manipulation of the outer surface 381 of shunt 380.

[0130] In some embodiments, a recovery tool 346 can be used to drill the conjunctiva and engage restrictive section 382. Tool 346 can then slide restrictive section 382 out of shunt 380. Recovery tool 346 can grasp or otherwise engage restrictive section 382 and allow a physician to pull out restrictive section 382 after overcoming a frictional force and / or adhesion force within lumen 383.

[0131] In some embodiments, the recovery tool 346 may comprise a scalpel, hypodermic needle or other surgical tool.

[0132] Additional methods and devices can also be provided in which a flow-adjustable shunt provides protection from early hypotonia and a gradual subsequent decrease in flow restriction without any postoperative surgical intervention (such as those discussed — here. In some modalities, if used independently of or in conjunction with other aspects of the modalities disclosed herein, the internal shunt lumen comprises a non-restrictive or non-obstructive main section and a dissolving, restrictive, restrictive flow limiting plug or section. the restrictive section can also be detachable or detachable from the shunt, as discussed in the modalities above, such dissolvable plugs are sections that can be incorporated into and used in addition to any of the plugs, caps, or other removable portions of the modalities discussed above.

[0133] The shunt can be configured so that the flow can move more easily through the main section than through the restricted section. The main section may comprise a wall that defines a first cross flow area. The restrictive dissolvable section may comprise a wall that defines an opening, lumen, or channel through which the fluid can pass, but with greater resistance than through the main section. Thus, in some embodiments, the presence of a dissolvable section may slow down, but not completely restrict the flow through the shunt. Instead, a dissolvable section may be located to restrict flow at an early stage after the surgical procedure, but to dissolve over time, thereby increasing flow through the dissolvable section and thus through the shunt.

[0134] In some embodiments, the shunt may comprise one or more restrictive dissolvable sections. For example, the shunt may comprise a restrictive dissolvable section at a single respective end portion. The shunt may comprise two or more restrictive dissolvable sections, spaced together or spaced apart from each other at the opposite end portions of the shunt. In some methods, a restrictive dissolvable section can be placed in the anterior chamber or in an area of lower pressure, such as the subconjunctival space. One aspect of some modalities is the realization that there may be an advantage of positioning a dissolvable section in the anterior chamber (compared to having the dissolvable section only in the subconjunctival space) due to the possibility that particles or debris float in the lumen of the shunt and block the flow through a dissolvable section in the subconjunctival space.

[0135] In addition, the restrictive section may comprise a wall that defines an opening, lumen, or channel. As observed similarly with respect to other modalities above, the wall of the restrictive section can define a second flow cross-section. The second cross-flow area may be less than the first cross-flow area of the main section. In some embodiments, the wall can define aperture (s), lumen (s), or channel (s) that are,

generally tubular. In addition, the opening (s), lumen (s), or channel (s) can be square, polygonal, triangular, or other varieties of random shapes. The wall (s) can be configured so that the opening (s), lumen (s), or channel (s) can (s) extend along an axis center of the restrictive section (s). However, the aperture (s), lumen (s), or channel (s) may still extend longitudinally along the restrictive section while traversing and / or spaced away from the central axis of the restrictive section. In addition, the opening (s), lumen (s), or channel (s) can be surrounded by the material forming the restrictive section. However, the opening (s), lumen (s), or channel (s) may still be formed intermediate to the wall of the restrictive section and the wall of the main section.

[0136] Additionally, the material forming the restrictive dissolvable section (s) of the shunt can be configured to dissolve according to a desired dissolution rate, dissolution order, and / or dissolution pattern . A restrictive dissolvable section can comprise more than one type of material. The material (s) can be layered axially, circumferentially displaced (s), or otherwise positioned (s) to provide an organized or standard differential or dissolution order. The material (s) may have variables or different dissolution rates.

[0137] All or just a portion of a shunt can be dissolvable. For example, the dissolvable section may comprise a biocompatible dissolvable material. The material can be configured to dissolve over a defined or desired period, from days to months, based on how long hypotonia protection is desired.

[0138] In some embodiments, the material selected for the shunt or restrictive section may comprise gelatin or other similar material. In some embodiments, the gelatine used to make the shunt may comprise Type B gelatine from bovine skin. A preferred gelatin is PB Leiner bovine skin gelatin, Type B, 225 Bloom, USP. Another material that can be used in making the shunts is a type A swine skin gelatin, also available from Sigma Chemical. This gelatin is available from Sigma Chemical Company of St. Louis, Mo., under the code G-9382. Still other suitable gelatines include bovine bone gelatine, pig bone gelatine and gelatines derived from humans. In addition to gelatins, the microfistula shunt can be made of hydroxypropylmethylcellulose (HPMC), collagen, polylactic acid, polylglycolic acid, hyaluronic acid and glycosaminoglycans.

[0139] The shunt material can be cross-linked. For example, when a gelatin is used, crosslinking can increase the inter and intramolecular bonding of the gelatin substrate. Any means for crosslinking gelatin can be used. In some embodiments, the formed gelatin shunts can be treated with a solution of a crosslinking agent, such as, but not limited to, glutaraldehyde. Other compounds suitable for cross-linking include 1-ethyl-3- [3- (dimethiamino) propyl] carbodiimide (EDC). Radiation crosslinking, as a gamma or electron beam (electronic beam), can be used as an alternative.

[0140] The dissolvable section may comprise an identical, similar or different material to the shunt material In some embodiments, the dissolvable section material may be made of gelatin, which may be similar to a gelatin used to make the shunt, with the different gelatines in the amount of crosslinking suffered.

[0141] In some modalities, the shunt can be cross-linked by contacting the shunt with a solution of approximately 25% glutaraldehyde for a selected period. A suitable form of glutaraldehyde is a glutaraldehyde grade 1G5882 available from the Sigma Aldridge Company in Germany, although other glutaraldehyde solutions can also be used. The pH of the glutaraldehyde solution should preferably be in the range of 7 to 78 and more preferably, 7.35- / 44 and typically approximately 7.4 + 0.01. If necessary, the pH can be adjusted by adding an appropriate amount of a base, such as sodium hydroxide, as needed.

[0142] For example, a "permanent" implant can be cross-linked, keeping it in a 25% gluderaldehyde solution for 16 hours. This saturates the crosslink and results in a permanent implant that does not dissolve for a significant period of time (for example, 10 years). However, in such embodiments, a gelatin that has undergone much less crosslinking (using a shorter crosslinking time and / or a lower concentration of gluderaldehyde) can be used for the dissolvable section. By decreasing the crosslinking time and / or the amount of gluderaldehyde concentration, it is possible to obtain less than the complete crosslinking, which results in a dissolving material over an adjustable period of time. Other dissolvable materials and other crosslinking techniques can be used to provide the dissolvable section.

[0143] According to some methods, by adjusting the gluderaldehyde concentration, the crosslinking time, the crosslinking temperature and / or the dissolvable section geometry, the dissolution time can be at least approximately 15 minutes to several years. The dissolution time can also be from at least 1 hour to several months. For example, a completely uncrosslinked gelatin-dissolving section can dissolve in approximately 20 minutes. Therefore, the concentration of gluderaldehyde, the crosslinking time and / or the geometry (longitudinal length, opening or size of the channel, etc.) of the dissolvable section can be modified accordingly to adjust the dissolution rate of the dissolvable section.

[0144] Regarding design considerations for internal dimension of the shunt or diameter and length and length of the dissolvable section and channel dimensions, the longer "tubes" have greater resistance to the fluid and the resistance to the fluid decreases as the radius of the "tube" and the cross-sectional area increases. Specifically, the resulting flow and pressure values can be determined using formulas known in the art. The flow rate for flow through a tube with different internal cross sections can be calculated using these formulas. The calculation of laminar flow through a tube can be performed using the Hagen-Poiseuille equation discussed above. Assuming that the flow restriction of a large lumen shunt is negligible, the pressure difference AP between the inlet and outlet of the shunt is given by the length L and the internal diameter (radius R) of the obstructed / restricted part of the shunt only.

[0145] In addition, according to some methods, the shunt can be done by immersing a core or substrate, such as a wire of suitable diameter, in a solution of material, such as gelatin. In some methods, to form derivations with one or more restrictive sections (for example, dissolvable parts), a core or substrate can be configured to include one or more peaks, valleys, ridges and / or indentations corresponding to the desired internal profile of the shunt. The core or substrate can be coated or dipped several times to become coated with a desired number of layers or materials. For example, a core or substrate may have a first section with a small outside diameter and a second section with a large outside diameter. The section with a smaller outside diameter can be coated or dipped in a solution so that the outside diameter along the first section is generally equal to the large outside diameter of the second section. After that, the first and second sections of the core or substrate can be immersed in a solution and dried. When removed, the shunt can therefore have an internal diameter that narrows in a restricted section of it, which corresponds to the first section of the core or substrate. Further details and characteristics of the methods of preparing and manufacturing a shunt are disclosed in North American Order Publications 2012/0197175, filed on December 8, 2011, and 2013/0150770, filed on December 8, 2011, the total of which is hereby incorporated by reference.

[0146] In the case of a gelatin implant, the solution can be prepared by dissolving a gelatin powder in deionized water or sterile water for injection and placing the dissolved gelatin in a water bath at a temperature of approximately 55 ºC. with a complete mixture to ensure complete dissolution of the gelatin. In one embodiment, the ratio of solid gelatin to water is approximately 10% to 50% gelatin by weight to 50% to 90% by weight of water. In some embodiments, the gelatin solution includes approximately 40% by weight, gelatin dissolved in water. The resulting gelatin solution is preferably devoid of any air bubbles and has a viscosity that is approximately 200 cp (centipoise) to approximately 500 cp. The solution can also have a viscosity of approximately 260 to approximately 410 cp.

[0147] As discussed here, the gelatin solution may include biological, pharmaceutical, drugs and / or other chemicals selected to regulate the body's response to the implantation of the shunt and the subsequent healing process. Examples of suitable agents include anti-mitolic pharmaceutical products, such as Mitomycin-C or 5-Fluorouracil, anticvVEGF (such as Lucintes, Macugen, Avastinn VEGF or steroids), anticoagulants, anti-metabolites, angiogenesis inhibitors or steroids. By including biological, pharmaceutical, pharmaceutical or other chemical products in the liquid gelatin, the formed shunt will be impregnated with biological, pharmaceutical, pharmaceutical or other chemical products.

[0148] According to some embodiments, the shunt may comprise a drug or drug-eluting portion for administration of the drug to one or more target sites within the eye. A drug eluting portion can be provided in combination with any of the modalities disclosed or taught in this document. For example, the shunt may comprise a drug-eluting portion. Thus, some modalities provide a shunt that also operates as a drug delivery device within the eye.

[0149] One or more drugs can be transported by the shunt for delivery to the target location (s). The shunt itself can carry a drug and can be partially or completely dissolvable. For example, one or more drugs can be transported in one or more dissolvable coatings along a surface of the shunt. The dissolvable drug-eluting coating (s) may extend over the entire length or just a portion of the length of the shunt. The drug (s) can also be transported as a component of a dissolvable section, according to some modalities. In some embodiments, a time-controlled drug release can be achieved by configuring the dissolvable coating or portion to provide a desired dissolution rate. Such drug eluting portions of the shunt can therefore provide drug delivery, even without aqueous flow.

[0150] Aspects related to the modalities of drug administration shunts are discussed in copending North American Publication 2012/0197175, deposited on December 8, 2008, the totality of which is incorporated herein by reference.

[0151] Various types of drugs can be used, including glaucoma, steroids, other anti-inflammatories, antibiotics, dry eye, allergy, conjunctivitis, etc.

[0152] At least one section of the shunt may comprise one or more drugs to provide a drug eluting portion. In some embodiments, one or more drugs can be delivered over the entire length of the shunt. However, in some embodiments, one or more drugs may be delivered over less than the entire shunt or over only a portion of the shunt. For example, a drug can be integrated at only one end of the shunt to provide a single drug eluting end that can be placed inside the anterior chamber or lower pressure location. In addition, unlike being formed along an end portion of the shunt, the drug eluting portion may still be formed along an intermediate portion of the shunt. Certainly, some modalities can provide a release of target drug into the anterior chamber, into the sclera, or into the subconjunctival space, depending on the location and configuration of the drug eluting portion.

[0153] In some embodiments, the shunt may comprise multiple drug eluting portions, which can be formed to provide different periods of dissolution and / or have different drugs incorporated into it. Certainly, in some modalities, two or more drugs can be administered simultaneously in the periods of independent release.

[0154] For example, the shunt can comprise multiple dissolvable sections, which can be formed to provide different dissolution periods and / or have different drugs incorporated into it.

[0155] The shunt can also be implanted in the supracoroidal space

(that one end portion in the anterior chamber and the other end portion in the supracoroidal space or with the entire shunt being completely supracoroidal) with the ability to deliver drugs to one or both end portions or along a respective intermediate portion. Some methods can be implemented so that multiple shunts (with the same or different drugs and with the same or different release periods) can be implanted in different locations (for example, the subconjunctival space, the supracoroidal space, the anterior chamber, etc. .). Fabric compatible shunts

[0156] In some embodiments, the shunt may comprise a material that has an elasticity module that is compatible with an elasticity module of the fabric around the shunt. For example, the intraocular shunt may be flexible and have a modulus of elasticity that is substantially identical to the modulus of elasticity of the surrounding tissue at the implant site. As such, some modalities of intraocular shunt can be easily folded, cannot corrode or cause a tissue reaction and cannot migrate once implanted.

[0157] Certainly, when implanted in the eye using an internal ab procedure, like some methods described here, some intraocular di shunt modalities may not induce substantial eye inflammation, such as subconjunctival bleeding or endophthalmitis. Additional exemplary characteristics of intraocular shunt modalities are discussed in more detail below. In this way, some shunt modalities can be configured to have a flexibility compatible with the surrounding tissue, allowing the shunt to remain in place after implantation without the need for any type of anchor that interacts with the surrounding tissue. Consequently, some shunt modalities can thus keep the fluid flow away from the anterior chamber of the eye after implantation without causing irritation or inflammation in the tissue around the eye.

[0158] As discussed in the applicant's copending application, North American Publication 2013/0150770, deposited on December 8, 2011, the entirety that is incorporated here by reference, modulus of elasticity or modulus of elasticity, is a mathematical description of the trend of an object or substance to be elastically deformed when a force is applied to it. See also Gere (Mechanics of Materials, 6th Edition, 2004, Thomson) (whose content is incorporated by reference here in its entirety). The modulus of elasticity of a body tissue can be determined by a person skilled in the art. See, for example, Samani et al. (Phys. Med. Biol. 48: 2183, 2003); Erkamp et al. (Measurement of the elastic modulus of small tissue samples, Department of Biomedical Engineering and Department of Electrical Engineering and Computer Science University of Michigan Ann Arbor, MI 48109-2125; and Institute of Mathematical Problems in Biology Russian Academy of Sciences, Pushchino, Moscow Region 142292 Russia); Chen et al. (IEEE Trans. Ultrason. Ferroelec. Freq. Control 43: 191-194, 1996); Hall, (in 1996, Ultrasonics Symposium Proc., Pp. 193-1196, IEEE Cat. No. 96CH35993, IEEE, New York, 1996); and Parker (Ultrasound Med. Biol. 16: 241-246, 1990), the content of which is incorporated by reference here in its entirety.

[0159] The modulus of elasticity of tissues of different organs is known in the art. For example, Pierscionek et al. (Br J Ophthalmol, 91: 801—803, 2007) and Friberg (Experimental Eye Research, 473: 429— 436, 1988), both incorporated by reference here in full, show the elasticity module of the cornea and sclera of the eye. Chen, Hall and Parker show the modulus of elasticity of different muscles and the liver. Erkamp shows the elasticity module of the kidney.

[0160] In some embodiments, the shunt may comprise a material that has an elasticity modulus that is compatible with the elasticity modulus of the tissue in the eye, particularly the scleral tissue. In some embodiments, compatible materials are those that are softer than scleral tissue or marginally harder than scleral tissue, but soft enough to prohibit shunt migration. The modulus of elasticity for the anterior scleral tissue is about 2.9 + 1.4 x 106 N / m2 and 1.8 + 1.1 x 106 N / m2 for the posterior scleral tissue. In some embodiments, the material may comprise gelatin. In some embodiments, gelatin may comprise a cross-linked gelatin derived from bovine or porcine collagen. In addition, the shunt may comprise one or more biocompatible polymers, such as polycarbonate, polyethylene, polyethylene terephthalate, polyimide, polystyrene, polypropylene, poly (styrene-b-isobutylene-b-styrene) or silicone rubber.

[0161] As discussed in the Applicant's copending application, North American Publication No. 2013/0150770, deposited on December 8, 2011, and North American Publication 2012/0197175, deposited December 8, 2011, the totals each one is incorporated here by reference, some shunt modalities may include optical features. For example, some embodiments may comprise a flexible material that is pressure reactive, that is, the size or diameter of the flexible portion of the shunt fluctuates depending on the pressures exerted on this portion of the shunt. In addition, the shunt may comprise one or more side doors. Additionally, some lumen modalities of the internal shunt comprise overflow ports. Some modalities of shunt may also comprise one or more tips at its end, in order to facilitate the conduction of fluid flow away from an organ. According to some modalities, the shunt can also be configured so that one end of the shunt includes a longitudinal slot. Other variations and characteristics of the shunt can be incorporated in the modalities disclosed in this document.

[0162] In addition to providing a safe and efficient way to relieve intraocular pressure in the eye, it has been observed that the implanted shunts disclosed here can also contribute to regulate the flow rate (due to the resistance of the lymphatic outflow tract) and stimulate the growth of functional drainage structures between the eye and the lymphatic and / or venous systems. These drainage structures evacuate fluid from the subconjunctiva, which also results in a low diffuse bubble, a small bubble reservoir, or no bubbles.

[0163] The formation of drainage paths formed by and for the lymphatic system and / or veins can have applications in addition to the treatment of glaucoma. Thus, shunt implantation methods can be useful in the treatment of other tissues and organs where drainage may be desired or necessary.

[0164] In addition, it has been observed that, as a fully dissolvable shunt is absorbed, a "natural" cell-aligned shunt or microfistula path is formed. This "natural" shunt is stable. The implanted shunt remains in place (thus keeping the opposite sides of the formed shunt apart) long enough to allow the formation of a confluent covering of the cells. Once these cells are formed, they are stable, thus eliminating the need for a foreign body to be placed in the formed space.

[00100] Implantation to the eye of an intraocular shunt according to this disclosure can be achieved using a concave axis configured to hold the shunt, as described here. The concave shaft can be attached to an implantation device or part of the implantation device. Implantation devices that are suitable for implanting shunts according to the invention include,

but are not limited to implantation devices described in United States Patent 6,007,511, United States Patent

6,544,249, and North American Publication 2008/0108933, contents that are incorporated here by reference in their entirety. In other embodiments, the implantation devices may include devices such as those as described in the copending North American Publication and co-ownership 2012/0123434, filed on November 2010, North American Publication 2012/0123439, filed on November 15, 2010, and Copending North American Publication 2013/0150770, deposited on December 8, 2011, contents that are incorporated by reference here in their entirety.

[0100] Although the detailed description contains many specifics, they should not be interpreted as limiting the scope of the technology in question, but only as illustrating different examples and aspects of the technology in question. It should be appreciated that the scope of the technology in question includes other modalities not discussed in detail above. Various other modifications, alterations and variations can be made in the arrangement, operation and details of the method and apparatus of the technology in question disclosed in this document without departing from the scope of this disclosure. Unless otherwise stated, the reference to an element in the singular does not mean "one and only one", unless it is explicitly stated, but it must mean "one or more". In addition, it is not necessary for a device or method to solve all problems that can be solved by different types of disclosure, in order to be included in the scope of disclosure. Technology Illustration of the Subject as Clauses

[0101] Several examples of aspects of the disclosure are described below as convenience clauses. These are provided as examples and do not limit the technology of the subject.

[0102] Clause 1. A method for adjusting an outflow of an intraocular shunt implanted in an eye, the method comprising: determining a position of the intraocular shunt in the eye extending between an anterior chamber of the eye and a location of lower pressure in the eye; and applying force to an external surface of the eye to separate or displace a removable portion with respect to an discharge portion of the intraocular shunt, thereby allowing high flow through the intraocular shunt.

[0103] Clause 2. Method according to claim 1, in which the removable portion comprises a first internal transverse dimension and the intraocular shunt comprises a second internal transverse dimension greater than the first internal transverse dimension, and in which the application of a force comprises compressing the second internal transverse dimension to be less than the first internal transverse dimension.

[0104] Clause 3. The method, according to any previous clause, in which the application of a force comprises increasing an allowable flow from approximately zero to a non-zero flow.

[0105] Clause 4. The method, according to any previous clause, in which the application of a force comprises increasing the permitted flow of a non-zero flow.

[0106] Clause 5. The method, according to any previous clause, in which the application of a force comprises positioning the removable portion at a location spaced far from an outlet of the discharge portion after separating the removable portion from the intraocular shunt.

[0107] Clause 6. The method, according to Clause 5, further comprising extracting the removable portion of the eye after separating the removable portion from the discharge portion.

[0108] Clause 7. The method, according to any previous clause, in which the discharge portion is located in a subconjunctival space of the eye.

[0109] Clause 8. The method, according to Clause 7, in which the application of a force comprises applying a force to a conjunctiva of the eye to apply a force to the external surface of the eye.

[0110] Clause 9. The method, according to any previous clause, in which at least a portion of the removable portion is disposed internally within the intraocular shunt.

[0111] Clause 10. The method, according to any previous clause, in which, before applying force, the removable portion is arranged, at least partially, outside the shunt.

[0112] Clause 11. The method, according to any previous clause, still comprising allowing the removable portion to degrade at the location of lower pressure after applying force to the outer surface of the eye.

[0113] Clause 12. The method, according to any previous clause, in which the removable portion comprises a degradable material, a viscoelastic material, or any combination thereof.

[0114] Clause 13. The method, according to any preceding clause, wherein the removable portion comprises a plurality of removable portions.

[0115] Clause 14. The method, according to any previous clause, in which the removable portion comprises a drug.

[0116] Clause 15. The method, according to any previous clause, in which the application of a force to the external surface of the eye comprises applying a force by a finger.

[0117] Clause 16. The method, according to any previous clause, in which the application of a force to the external surface of the eye comprises applying a force by a tool.

[0118] Clause 17. The method, according to Clause 16, in which a tool comprises a rolling tool.

[0119] Clause 18. The method, according to Clause 16, in which a tool comprises an intravenous tool.

[0120] Clause 19. A method for adjusting an intraocular Sshunt flow rate, the method comprising: inserting the intraocular shunt into an eye, so that an inflow portion of the intraocular shunt is located in an anterior chamber of the eye and a portion discharge of the intraocular shunt is located in a lower pressure location of the eye, the discharge portion of the intraocular shunt being restricted with a removable portion when inserted to the lower pressure location; and after insertion, apply force to the lower pressure location to release the removable portion of the discharge portion of the intraocular shunt to change a flow through the intraocular shunt.

[0121] Clause 20. The method, according to Clause 19, in which the removable portion comprises a first internal transverse dimension and the intraocular shunt comprises a second internal transverse dimension greater than the first internal transverse dimension, and in which the application of a force comprises compressing the second internal transverse dimension to be smaller than the first internal transverse dimension.

[0122] Clause 21. The method, according to any of Clauses 19-20, in which the application of a force comprises increasing an allowable flow from approximately zero to a non-zero flow.

[0123] Clause 22. The method, according to any one of Clauses 19-21, in which the application of a force comprises increasing an allowed flow of a non-zero flow.

[0124] Clause 23. The method, according to any of Clauses 19-22, in which the application of a force comprises positioning the removable portion at a location spaced far from an outlet of the discharge portion after releasing the removable portion from the intraocular shunt.

[0125] Clause 24. The method, according to Clause 23, further comprising extracting the removable portion of the eye after releasing the removable portion from the discharge portion.

[0126] Clause 25. The method, according to any of Clauses 19—24, in which the discharge portion is located in a subconjunctival space of the eye.

[0127] Clause 26. The method, according to Clause 25, in which the application of a force comprises applying a force to a conjunctiva of the eye to apply a force to the location of the lower pressure.

[0128] Clause 27. The method, according to any of Clauses 19-26, in which at least a portion of the removable portion is disposed internally within the intraocular shunt.

[0129] Clause 28. The method, according to any of Clauses 19-27, in which, before applying force, the removable portion is disposed, at least partially, external to the shunt.

[0130] Clause 29. The method, according to any of Clauses 19-28, further comprising allowing the removable portion to degrade at the lower pressure location after applying force to the lower pressure location.

[0131] Clause 30. The method, according to any of Clauses 19-29, wherein the removable portion comprises a degradable material, a viscoelastic material, or any combination thereof.

[0132] Clause 31. The method, according to any of the

Clauses 19-30, wherein the removable portion comprises a plurality of removable portions.

[00101] Clause 32. The method, according to any of Clauses 19-31, wherein the removable portion comprises a drug.

[0100] Clause 33. The method, according to any of Clauses 19-32, in which insertion of the intraocular shunt into the eye comprises inserting the intraocular shunt by an external approach ab.

[0101] Clause 34. The method, according to any of Clauses 19-33, in which the insertion of the intraocular shunt into the eye comprises inserting the intraocular shunt by an internal approach ab.

[0102] Clause 35. The method, according to any of Clauses 19-34, in which the application of a force to the location of the lower pressure comprises applying a force by a finger.

[0103] Clause 36. The method, according to any of Clauses 19-35, in which the application of a force to the location of the lower pressure comprises applying a force by a tool.

[0104] Clause 37. The method, according to Clause 36, in which a tool comprises a rolling tool.

[0105] Clause 38. The method, according to Clause 36, in which a tool comprises an intravenous tool.

[0106] Clause 39. A method for adjusting an outflow from an intraocular shunt implanted in an eye, the method comprising: determining a position of a discharge end of the intraocular shunt underlying an conjunctiva of the eye, the shunt being operative to allow flow of aqueous humor from an anterior chamber of the eye; and massage the discharge end of the shunt to release a plug from a lumen of the shunt thereby modifying a flow through the shunt.

[0107] Clause 40. The method, according to Clause 39, in which the plug comprises a first internal transverse dimension and the intraocular shunt comprises a second internal transverse dimension greater than the first internal transverse dimension, and in which the massage the discharge end comprises compressing the second internal transverse dimension to be smaller than the first internal transverse dimension.

[0108] Clause 41. The method, according to any one of Clauses 3940, in which the massage at the discharge end comprises increasing an allowed flow from approximately zero to a non-zero flow.

[0109] Clause 42. The method, according to any one of Clauses 3941, in which the massage at the discharge end comprises increasing an allowed flow of a non-zero flow.

[0110] Clause 43. The method, according to any of Clauses 3942, in which the massage of the discharge end comprises positioning the plug at a location spaced far from an outlet end of the discharge after releasing the plug from the lumen.

[0111] Clause 44. The method, according to Clause 43, further comprising extracting the plug from the eye after releasing the plug from the discharge end.

[0112] Clause 45. The method, according to any of Clauses 3944, in which the discharge end is located in a subconjunctival space of the eye.

[0113] Clause 46. The method, according to any of Clauses 3945, in which the discharge tip massage comprises massaging the conjunctiva of the eye to massage the discharge tip of the intraocular shunt.

[0114] Clause 47. The method, according to any of Clauses 39—46, in which at least a portion of the plug is disposed internally within the intraocular shunt.

[0115] Clause 48. The method, according to any of the

Clauses 3947, where before the massage at the discharge end, the plug is arranged, at least partially, external to the shunt.

[0116] Clause 49. The method, according to any of Clauses 3948, further comprising allowing the plug to degrade after massaging the discharge end.

[0117] Clause 50. The method, according to any of Clauses 39-49, in which the plug comprises a degradable material, a viscoelastic material, or any combination thereof.

[0118] Clause 51. The method, according to any of Clauses 39-50, in which the plug comprises a plurality of plugs.

[0119] Clause 52. The method, according to any of Clauses 39-51, in which the plug comprises a drug.

[0120] Clause 53. The method, according to any of Clauses 39-52, still comprising inserting the intraocular shunt into the eye, so that an inflow portion of the intraocular shunt is located in the anterior chamber of the eye.

[0121] Clause 54. The method, according to Clause 53, in which inserting the intraocular shunt into the eye comprises inserting the intraocular shunt by an external approach ab.

[0122] Clause 55. The method, according to Clause 53, in which inserting the intraocular shunt into the eye comprises inserting the intraocular shunt by an internal approach ab.

[0123] Clause 56. The method, according to any of Clauses 39-55, in which massaging the discharge end comprises applying a mechanical force to the plug.

[0124] Clause 57. The method, according to Clause 56, in which massaging the discharge end of the shunt comprises applying force to a conjunctiva of the eye to release the lumen plug.

[0125] Clause 58. The method, according to Clause 57, in which the application of a force to the conjunctiva comprises applying a force by a finger.

[0126] Clause 59. The method, according to Clause 57, in which the application of a force to the conjunctiva comprises applying a force by a tool.

[0127] Clause 60. The method, according to Clause 59, in which a tool comprises a rolling tool.

[0128] Clause 61. The method, according to Clause 59, in which a tool comprises an intravenous tool.

[0129] Clause 62. The method, according to Clause 56, in which the application of mechanical force to the plug comprises applying mechanical force by a tool.

[0130] Clause 63. The method, according to Clause 62, in which a tool is a recovery tool.

[0131] Clause 64. A shunt to drain fluid from an anterior chamber of an eye, the shunt comprising: a main section having an inflow end portion, a discharge end portion, and a wall defining a lumen, a removable portion coupled to the discharge end portion to block flow through the lumen when present, the removable portion providing a burst seal by the discharge end portion and being configured to break under application of compressive force against the shunt, in which the rupture of the removable portion allows fluid to flow through the lumen of the anterior chamber into the inflow end portion towards the discharge end portion so that, when positioned in the eye, fluid is released through the discharge end portion at a location having lower pressure than the previous chamber.

[0132] Clause 65. The shunt, according to Clause 64, in which the removable portion comprises a disk-shaped membrane coupled to the discharge end portion.

[0133] Clause 66. The shunt, according to Clause 65, in which the main section wall comprises a first thickness and the membrane comprises a second thickness, the first thickness being greater than the second thickness.

[0134] Clause 67. The shunt, according to Clause 65, in which the main section wall comprises a first thickness and the membrane comprises a second thickness, the first thickness being equal to the second thickness.

[0135] Clause 68. The shunt, according to Clause 65, in which the main section wall comprises a first thickness and the membrane comprises a second thickness, the first thickness being less than three times the second thickness.

[0136] Clause 69. The shunt, in accordance with any of Clauses 65—68, in which the membrane is positioned within the lumen.

[0137] Clause 70. The shunt, according to any of Clauses 65-68, in which the membrane comprises a plug.

[0138] Clause 71. The shunt, according to Clause 64, in which the removable portion has a bulbous shape and overlaps an external surface of the shunt adjacent to the discharge end portion.

[0139] Clause 72. The shunt, according to Clause 71, in which the removable portion comprises an external transverse profile greater than an external diameter of the shunt.

[0140] Clause 73. The shunt, in accordance with any of Clauses 64—72, in which the removable portion comprises a first material and the main section comprises a second material different from the first material.

[0141] Clause 74. The shunt, according to any of the

Clauses 64—73, where the removable portion is dissolvable.

[0142] Clause 75. The shunt, in accordance with any of Clauses 64—74, wherein the shunt comprises a cross-linked gelatin.

[0143] Clause 76. The shunt, according to any of Clauses 64-75, wherein the removable portion comprises an axial thickness of approximately 0.1% to approximately 40% of an overall length of the shunt.

[0144] Clause 77. The shunt, according to any of Clauses 64-76, wherein the removable portion comprises an axial thickness of approximately 30% to approximately 40% of an overall length of the shunt.

[0145] Clause 78. The shunt, according to any of Clauses 64-77, wherein the removable portion comprises an axial thickness of approximately 20% to approximately 30% of an overall length of the shunt.

[0146] Clause 79. The shunt, according to any of Clauses 64-78, wherein the removable portion comprises an axial thickness of approximately 15% to approximately 20% of an overall length of the shunt.

[0147] Clause 80. The shunt, according to any of Clauses 64-79, wherein the removable portion comprises an axial thickness of approximately 10% to approximately 15% of an overall length of the shunt.

[0148] Clause 81. The shunt, according to any of Clauses 64-80, wherein the removable portion comprises an axial thickness of approximately 5% to approximately 10% of an overall length of the shunt.

[0149] Clause 82. The shunt, according to any of Clauses 64-81, wherein the removable portion comprises an axial thickness of approximately 3% to approximately 5% of an overall length of the shunt.

[0150] Clause 83. The shunt, according to any of Clauses 64-82, wherein the removable portion comprises an axial thickness of 2% to approximately 3% of an overall length of the shunt.

[0151] Clause 84. The shunt, according to any of Clauses 64-83, wherein the removable portion comprises an axial thickness of 1% to approximately 2% of an overall length of the shunt.

[0152] Clause 85. The shunt, according to any of Clauses 64-75, wherein the removable portion comprises an axial thickness of approximately 8 µm to approximately 3200 µm.

[0153] Clause 86. The shunt, according to any of Clauses 64—75 or 85, wherein the removable portion comprises an axial thickness of approximately 16 µm to approximately 2400 µm.

[0154] Clause 87. The shunt, according to any of Clauses 64-75 or 85-86, wherein the removable portion comprises an axial thickness of approximately 24 µm to approximately 1600 µm.

[0155] Clause 88. The shunt, according to any of Clauses 64-75 or 85-87, wherein the removable portion comprises an axial thickness between approximately 30 pum to approximately 80 µm.

[0156] Clause 89. The shunt, according to any of Clauses 64-75 or 85-88, wherein the removable portion comprises an axial thickness between approximately 40 µm to approximately 50 µm.

[0157] Clause 90. The shunt, according to any of the

Clauses 64-75 or 85-89, wherein the removable portion comprises an axial thickness of approximately 45 µm.

[0158] Clause 91. The shunt, according to any of Clauses 64-75 or 85-87, wherein the removable portion comprises an axial thickness of 32 µm to approximately 1200 µm.

[0159] Clause 92. The shunt, according to any of Clauses 64-75, 85-87, or 91, wherein the removable portion comprises an axial thickness of approximately 40 µm to approximately 800 µm.

[0160] Clause 93. The shunt, according to any of Clauses 64-75, 85-87, or 91-92, wherein the removable portion comprises an axial thickness of approximately 80 µm to approximately 400 µm.

[0161] Clause 94. The shunt, according to any of Clauses 64-75, 85-87, or 91-93, wherein the removable portion comprises an axial thickness of approximately 160 µm to approximately 240 µm.

[0162] Clause 95. A method for fabricating the shunt, according to Clause 64, comprising: immersing the discharge end portion of the shunt in a layer of liquid or viscous material to allow the material to be coupled to the end portion discharge; and drying the material to form the removable portion.

[0163] Clause 96. A method for fabricating the shunt, according to Clause 64, comprising: inserting material into the discharge end portion of the shunt to form the removable portion and attaching the removable portion to the end portion of discharge.

Additional Considerations

[0164] In some embodiments, any of the clauses contained herein may depend on any of the independent clauses or on any of the dependent clauses. In one aspect, any of the clauses (for example, dependent or independent clauses) can be combined with any other or one or more “clauses (for example, dependent or independent clauses). In one aspect, a claim may include some or all of the words (for example, steps, operations, means or components) recited in a clause, a sentence, a sentence or a paragraph. In one aspect, a claim may include some or all of the words recited in one or more clauses, phrases, sentences or paragraphs. In one respect, some of the words in each of the clauses, phrases, sentences or paragraphs can be removed. In one aspect, additional words or elements can be added to a clause, sentence, sentence or paragraph. In one aspect, the technology in question can be implemented without using some of the components, elements, functions or operations described here. In one aspect, the technology in question can be implemented using additional components, elements, functions or operations.

[0165] A reference to an element in the singular is not intended to mean one and only one, unless specifically indicated, but one or more. For example, module "a" can refer to one or more modules. An element followed by "one", "one", "the" or "said / said" does not exclude, without additional restrictions, the existence of other additional elements.

[0166] Titles and subtitles, if any, are used for convenience only and do not limit the invention. The word exemplary is used to mean serving as an example or illustration. Insofar as the term include, possess or the like is used, that term must be inclusive in a similar way to the term understood, as understood is interpreted when used as a transitional word in a claim. Relational terms such as first and second and similar can be used to distinguish one entity or action from another without necessarily requiring or implying any real relationship or order between those entities or actions.

[0167] Phrases as one aspect, the aspect, another aspect, some aspects, one or more aspects, an implementation, the implementation, another implementation, some implementations, one or more implementations, one modality, the modality, another modality, some modalities , one or more modalities, a configuration, the configuration, another configuration, some configurations, one or more configurations, the technology in question, the disclosure, the present disclosure, other variations thereof and the like are for convenience and do not imply that a disclosure related to such phrase (s) is essential for the technology in question or that such disclosure applies to all configurations of the technology in question. Disclosure related to these phrases can apply to all configurations, or one or more configurations. A disclosure related to such phrase (s) may provide one or more examples. A sentence such as one aspect or some aspects can refer to one or more aspects and vice versa, and this applies in a similar way to other previous phrases.

[0168] A phrase "at least one of" that precedes a series of items, with the terms "and" or "or" to separate any of the items, modifies the list as a whole, rather than each member of the list. The phrase "at least one of" does not require selection of at least one item; instead, the phrase allows for a meaning that includes at least one of any of the items and / or at least one of any combination of the items and / or at least one of each of the items. For example, each of the phrases “at least one from A, B and C” or “at least

TUT3 one of A, B or C ”refers only to A, only B or only C; any combination of A, B and C; and / or at least one of each of A, BecC.

[0169] It is understood that the specific order or hierarchy of steps, operations or processes disclosed is an illustration of exemplary approaches. Unless explicitly stated to the contrary, it is understood that the specific order or hierarchy of steps, operations or processes may be carried out in a different order. Some of the steps, operations or processes can be performed simultaneously. The accompanying method states, if any, it presents elements of the various steps, operations or processes in a sample order and is not limited to the specific order or hierarchy presented. These can be executed in series, linearly, in parallel or in a different order. It should be understood that the instructions, operations and systems described can generally be integrated into a single software / hardware product or packaged into multiple software / hardware products.

[0170] In one aspect, a coupled term or the like can refer to being coupled directly. In another aspect, a coupled term or the like may refer to being indirectly coupled.

[0171] Terms such as top, bottom, front, rear, side, horizontal, vertical and the like refer to an arbitrary frame of reference, not the common gravitational frame of reference. Thus, this term can extend upwards, downwards, diagonally or horizontally in a gravitational frame of reference.

[0172] Disclosure is provided to allow anyone skilled in the art to practice the various aspects described here. In some cases, known structures and components are shown in the form of a block diagram to avoid obscuring the concepts of the technology in question. Disclosure provides several examples of the technology in question, and the technology in question is not limited to those examples. Various changes in these aspects will be readily apparent to those skilled in the art, and the principles described herein can be applied to other aspects.

[0173] All structural and functional equivalents to the elements of the various aspects described throughout the disclosure that are known or later known to those skilled in the art are expressly incorporated herein by reference and should be covered by the claims. Furthermore, nothing disclosed in this document is intended to be dedicated to the public, regardless of whether such disclosure is explicitly stated in the claims. No claim element shall be interpreted in accordance with the provisions of 35 USC 8121, sixth paragraph, unless the element is expressly recited using the phrase “means for” or, in the case of a method claim, the element is recited using the phrase “step to”.

[0174] The title, background, brief description of the drawings, summary and drawings are hereby incorporated into the disclosure and are provided as illustrative examples of the disclosure, not as restrictive descriptions. It is presented with the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the detailed description, it can be seen that the description provides illustrative examples and the various resources are grouped into various implementations in order to optimize the dissemination. The disclosure method should not be interpreted as reflecting an intention that the claimed object will require more resources than those expressly recited in each claim. On the contrary, as the claims reflect, the inventive object resides in less than all the resources of a single disclosed configuration or operation. The claims are hereby incorporated into the detailed description, with each claim alone as a separately claimed matter.

[0175] The claims are not intended to be limited to the aspects described here, but they must be given the full scope consistent with the language claims and cover all legal equivalents. However, none of the claims is intended to cover matters that do not satisfy the requirements of the applicable patent law, nor should they be interpreted in this way.

Claims (17)

1. —Shunt to drain fluid from an anterior chamber of an eye, characterized by the fact that it comprises: a main section having an inflow end portion, a discharge end portion, and a wall defining a lumen, a removable portion attached to the discharge end portion to block flow through the lumen when present, the removable portion providing a burstable seal through the discharge end portion and being configured to break under application of compressive force against the shunt, wherein the rupture of the removable portion allows fluid to flow through the lumen of the anterior chamber into the inflow end portion towards the discharge end portion so that, when positioned in the eye, fluid is released through the discharge end portion at one location having pressure lower than the anterior chamber. 2. "Shunt according to claim 1, characterized in that the removable portion comprises a disk-shaped membrane coupled to the discharge end portion. 3. —Shunt according to claim 2, characterized in that the wall of the main section comprises a first thickness and the membrane comprises a second thickness, the first thickness being greater than the second thickness. 4. "Shunt, according to claim 2, characterized by the fact that the wall of the main section comprises a first thickness and the membrane comprises a second thickness, the first thickness being equal to the second thickness. 5. —Shunt according to claim 2, characterized in that the wall of the main section comprises a first thickness and the membrane comprises a second thickness, the first thickness being less than three times the second thickness. 6. Shunt according to any one of claims 2 to 5, characterized by the fact that the membrane is positioned within the lumen. 7. —Shunt according to any one of claims 2 to 6, characterized in that the membrane comprises a plug. 8. —Shunt according to any one of the preceding claims, characterized in that the removable portion is bulbous in shape and overlaps an external surface of the shunt adjacent to the discharge end portion. 9. - “Shunt, according to claim 8, characterized by the fact that the removable portion comprises an external transverse profile greater than an external diameter of the shunt. 10. Shunt according to any one of the preceding claims, characterized in that the removable portion comprises a first material and the main section comprises a second material different from the first material. 11. Shunt according to any one of the preceding claims, characterized in that the removable portion is dissolvable. 12. Shunt according to any one of the preceding claims, characterized in that the removable portion comprises an axial thickness between approximately 30 µm to approximately 80 µm. 13. Shunt according to any one of the preceding claims, characterized in that the removable portion comprises an axial thickness of approximately 45 µm. 14. Shunt according to any one of the preceding claims, characterized in that the removable portion comprises an axial thickness of approximately 0.1% to approximately 40% of an overall length of the shunt. 15. Shunt according to any one of the preceding claims, characterized in that the removable portion comprises an axial thickness of approximately 8 µm to approximately 3200 µm. 16. Method for fabricating the shunt, as defined in any of the preceding claims, characterized by the fact that it comprises: dipping the discharge end portion of the shunt in a layer of liquid or viscous material to allow the material to be coupled to the portion discharge end; and drying the material to form the removable portion. 17. Method for fabricating the shunt, as defined in any of the preceding claims, characterized by the fact that it comprises: inserting a material into the discharge end portion of the shunt to form the removable portion and coupling the removable portion to the end portion discharge. YEAR RS Ã 24 | À À 2 2 A Fio. 1 FA> 2 12 10>> 50 <OZ Dr Z Gr AAA> l6 x 2 IN Wire. 2