JP6909356B2 - Manual adjustable intraocular flow regulation - Google Patents

Description

Glaucoma is an eye disease that affects millions of people.

Glaucoma is an increase in intraocular pressure as a result of either impaired eye drainage to properly remove aqueous humor from the anterior chamber of the eye or overproduction of aqueous humor by the ciliary body of the eye. Associated with. Aqueous humor and the resulting increase in intraocular pressure can result in irreversible damage to the optic nerve and retina, which can lead to irreversible retinal damage and blindness.

Glaucoma can be treated in many different ways. One mode of treatment is to use a drug such as a beta blocker or prostaglandin to either reduce the production of aqueous humor or increase the flow of aqueous humor from the anterior chamber of the eye. Including delivering to. Glaucoma filtration surgery is a surgical procedure typically used to treat glaucoma. The procedure involves reducing intraocular pressure by placing a shunt in the eye to create a pathway for draining aqueous humor from the anterior chamber of the eye. The shunt is typically positioned in the eye to create a drainage path between the anterior chamber of the eye and the area of lower pressure. Such a fluid flow path allows the aqueous humor to exit the anterior chamber.

U.S. Pat. No. 6,544,249 U.S. Patent Application Publication No. 2008/0108333 U.S. Pat. No. 6,007,511 U.S. Patent Application Publication No. 2014/0236066 U.S. Patent Application Publication No. 2016/0354244 U.S. Patent Application Publication No. 2016/03542245 U.S. Patent Application Publication No. 2012/01/23434 U.S. Patent Application Publication No. 2012/01/23439 U.S. Patent Application Publication No. 2013/0150770 U.S. Patent Application Publication No. 2012/0197175

Gere (Mechanics offices, 6th Edition, 2004, Thomason) Samani et al. (Phys. Med. Biol. 48: 2183, 2003) Erkamp other (Measuring The Elasticmodulus Of Small Tissue Samples, Biomedical Engineering Department and Electrical Engineering and Computer Science Department University ofmichigan Ann Arbor, mI 48109-2125, and, Institute ofmathematical 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 Atlantas Symposium Proc., Pp. 1193-1196, IEEE Cat. No. 96CH35993, IEEE, New York, 1996) Parker (Ultrasondmed. Biol. 16: 241-246, 1990)

The importance of reducing intraocular pressure (IOP) in slowing the progression of glaucoma is well supported by the literature. Surgical intervention is justified when drug treatment fails or is unacceptable. There are various surgical filtration methods for reducing intraocular pressure by creating a fluid flow path between the anterior chamber and the subconjunctival tissue. In one particular method, an intraocular shunt is implanted by guiding a needle holding the shunt through the cornea, across the anterior chamber, through the trabecular meshwork and sclera into the subconjunctival space. See, for example, U.S. Pat. No. 6,544,249, U.S. Patent Application Publication No. 2008/0108333, and U.S. Pat. No. 6,007,511, which are incorporated herein by reference in their entirety.

However, existing implantable shunts are not always able to effectively regulate fluid flow from the anterior chamber. The fluid flow through a conventional shunt is passive from the anterior chamber to the drainage structure of the eye. Moreover, in some situations, the embedded shunt may allow too much flow from the anterior chamber. If fluid flows from the anterior chamber at a flow rate higher than that can be produced in the anterior chamber, the intraocular pressure in the anterior chamber of the eye can be unnecessarily low as a result of surgery. This condition is known as hypotension. Hypotension occurs when the intraocular pressure is generally less than about 799.9 Pa (6 mmHg). Risks associated with low intraocular pressure and hypotension include blurred vision, collapse of the anterior chamber, and, in some cases, serious damage to the eye. Such risks require additional surgical intervention to repair. However, if the fluid flow from the eye is not large enough, the pressure in the anterior chamber will not be relieved and damage to the optic nerve and retina may still occur.

Therefore, the present disclosure includes the recognition that these issues may be considered and may be most effective if the intraocular shunt can be adjusted or modified once or multiple times after implantation. Therefore, some of the embodiments disclosed herein allow an intraocular implant or shunt to drain fluid from the anterior chamber of the eye, and allow the clinician to adequately relieve pressure. To allow permeation to avoid hypotonia while ensuring, or to selectively adjust flow rate, flow rate limitation, or other flow parameters of the intraocular shunt, such as an occlusion. Provides a usage that allows the removable part to be removed. In some methods, a clinician's finger-like tool or other device can be used to manually adjust or modify the shunt by applying force to the outer surface of the eye.

For example, an intraocular shunt, after being implanted in the eye, extends between the anterior chamber of the eye and the location of lower pressure in the eye. The clinician can determine the position of the shunt in the eye with or without, for example, an imaging device or tool such as an angle mirror. Once the position of the shunt is determined, a force can be applied to the outer surface of the eye to modify the structure of the shunt, remove the removable portion, or change the degree of flow restriction through the shunt.

The applied force can separate the removable portion from the outflow portion of the intraocular shunt. Prior to separation, the removable portion can block the fluid flow through the intraocular shunt or, optionally, allow a degree of fluid flow to pass through the shunt. After the removable portion is separated, the degree of flow limiting through the shunt is reduced, after which the flow through the shunt can be increased.

As noted above, manually manipulating or exerting force on the shunt using a tool such as a finger or other device to manually manipulate one or more removable areas or parts of the shunt. Can be adjusted or modified with. A removable area or portion of the shunt that can be modified by applying forces such as compression, shear, and / or tension.

In some embodiments, the force applied to the eye may be a massage exercise. In addition, in some embodiments, the clinician can use the fingers to manually apply force to the outer surface of the eye. Alternatively, in some embodiments, the clinician can use the tool to apply force to the outer surface of the eye.

The removable portion can include individual components of the shunt, such as a plug and / or a narrowed tubular compartment of the shunt. When present, these removable parts allow partial or complete flow limiting to limit the flow through the shunt. However, when a force is applied to the shunt, the removable portion can at least partially or completely displace or separate from the rest or body of the shunt, resulting in removal, reduction, or separation of flow restrictions. The reduction of the flow limit begins.

For example, in some embodiments, the removable portion can have a first medial cross-sectional dimension and the body of the intraocular shunt can have a second medial cross-sectional dimension. The cross-sectional dimension of the body of the intraocular shunt can be larger than the cross-sectional dimension of the removable portion. In some embodiments, when a force is applied, the cross-sectional dimension of the body of the intraocular shunt can be smaller than the cross-sectional dimension of the removable portion.

In some embodiments, the removable portion can be positioned at least partially within the intraocular shunt. However, in some embodiments, the removable portion may be attached to the outer surface or end or surface of the shunt body. In some embodiments, when the removable portion is removed, the flow rate through the intraocular shunt can be increased from zero to non-zero flow rate. Alternatively, when the removable portion is removed, the permissible flow rate may increase from a non-zero flow rate to a higher flow rate. Further, in some embodiments, after the removable portion has been separated from the shunt, the removable portion can be separated from the outflow portion of the shunt. Then, in some embodiments, the removable portion can be removed from the eye. However, in some embodiments, the removable portion can also be left in the eye to cover the outflow area with a "tent" around the outflow end of the shunt.

The accompanying drawings, which are included to provide a further understanding of the technology of the subject and which are incorporated and in part thereof herein, illustrate aspects of the present disclosure and, with a detailed description, the technology of the subject. It serves to explain the principle of.

FIG. 6 is a partial cross-sectional view of an eye showing cutout insertion of a deployed device according to some embodiments. It is a figure which shows the schematic arrangement of the intraocular shunt in the adhesive space in a tenon sac according to some examples. FIG. 6 is a cross-sectional view of an intraocular shunt having a removable portion according to some embodiments. FIG. 6 is a cross-sectional view of an intraocular shunt having a removable portion according to some embodiments. FIG. 6 is a cross-sectional view of another intraocular shunt having a removable portion, according to some embodiments. FIG. 6 is a cross-sectional view of another intraocular shunt having a removable portion, according to some embodiments. FIG. 6 is a cross-sectional view of another intraocular shunt having a removable portion, according to some embodiments. FIG. 6 is a cross-sectional view of another intraocular shunt having a removable portion, according to some embodiments. FIG. 6 is a cross-sectional view of another intraocular shunt having a removable portion, according to some embodiments. It is a figure which shows the removal of a part of the removable part of a shunt by some examples. It is a figure which shows the removal of a part of the removable part of a shunt by some examples. It is a figure which shows the removal of a part of the removable part of a shunt by some examples. It is a figure which shows the removal of a part of the removable part of a shunt by some examples. It is a figure which shows the removal of a part of the removable part of a shunt using a tool by some examples. It is a figure which shows the removal of a part of the removable part of a shunt using another tool by some examples. It is a figure which shows the removal of a part of the removable part of a shunt by another tool by some examples.

In the following detailed description, a number of specific details are provided to provide a full understanding of the technology of the subject. It should be understood that the techniques of this subject can be practiced without some of these specific details. In other cases, known structures and techniques are not shown in detail so as not to obscure the technique of the subject.

As noted above, glaucoma filtration surgery can often result in unnecessarily low intraocular pressure in the anterior chamber of the eye, often resulting in hypotonia. The disclosure allows clinicians to largely prevent hypotonia after glaucoma filtration surgery, while allowing clinicians to ensure adequate pressure relief by adjusting the flow through the intraocular shunt. Provided are various embodiments of methods and devices that can be performed. As used herein, a "shunt" is a hollow microfistula tube approximately similar to the type described in US Pat. No. 6,544,249, and one or more lumens or penetrations. Includes other structures, including other channels.

One aspect of some embodiments is the recognition that there are various unpredictable factors associated with the success of surgical intervention. Basically, successful surgical intervention reduces intraocular pressure without causing hypotension. To be successful, the flow through the shunt and the resulting intraocular pressure in the anterior chamber are various unpredictable, such as aqueous humor production, aqueous humor viscosity, and other biological outflow restrictions. Biological factors must be accounted for.

The biological spill limitation associated with the shunt depends on the overall spill resistance or limitation of the target space in which the shunt is located. For example, biological outflow restrictions in the subconjunctival space are: (1) the strength and amount and thickness of the Tenon sac adhesion, if present (eg, cut out), and (2) more or less fluid in the conjunctiva. Conjunctival thickness and consistency, which can allow diffusion into the inferior vessels and tear film, (3) existing fibrous adhesions, (4) presence of lymphatic outflow pathways (some pathways are Lymphatic pathways can often be created and augmented days and weeks after the onset of flow), although they may already be present at the time of shunt placement), (5) diffusion into superior conjunctival vessels. Amount of, (6) Amount of increased fibrosis after implant placement (which can be triggered by aqueous humor and can begin to form within the first 1 to 4 weeks after surgery, resulting in significant or complete outflow restriction. ) Depends on. Most of these factors vary widely from patient to patient, and most are currently unpredictable. The possible fibrotic response is the largest change factor in biological outflow resistance, and the flow is completely obstructed within 1 week postoperatively, with virtually no outflow restriction over the first 3 months postoperatively. It can vary, up to the point of doing so.

These patient fluctuations and the dynamic nature of the fluctuations make it very difficult to maintain optimal intraocular pressure with the shunt placed "statically" after surgery. A "static" shunt arrangement does not change any of its own flow resistance parameters or shunt outflow resistance, such as the length, lumen diameter or other features that affect the flow rate through the shunt. It can be referred to as an implantable and maintained procedure or surgery. Therefore, excluding changes in biological flow resistance within the target space, such as those mentioned just before, a "static" or "static" shunt arrangement will vary to the flow parameters or shunt outflow resistance of the shunt. Does not bring.

Static shunts usually result in significant outflow in the early postoperative phase (1 day to 2 weeks) due to the lack of fibrous tissue (or other biological outflow restrictions) early on. This often results in lower intraocular pressure in the anterior chamber than desired for this early stage, often hypotonic, and the risk of complications associated with such low intraocular pressure. May increase. Then, after the initial stage (eg, days to weeks), some patients are likely to have higher intraocular pressure than desired (eg, above 2666 Pa (20 mmHg)). Experience a strong fibrotic reaction that can produce restricted outflow.

Some of the examples disclosed herein provide methods for overcoming these problems and uncertainties of conventional surgery. For example, to provide a flow-adjustable shunt that can be manually modified or automatically adjusted after surgery without surgical intervention to maintain optimal outflow resistance that can compensate for the increased biological outflow resistance. Can be done. In fact, the applicant's own US patent application Publication No. 2014/0236066, filed February 19, 2013, the US patent filed June 2, 2016, each incorporated herein by reference in its entirety. Modify the flow resistance of the shunt after it has been implanted, as disclosed in Publication No. 2016/03542244 and US Patent Application Publication No. 2016/03542245 filed June 2, 2016. Although methods and devices that allow for additional intervention are disclosed, the disclosure provides methods and devices that allow clinicians to quickly evaluate and modify shunts without surgical intervention. do. The entire procedure may be performed with or without surface anesthesia and can be performed in an outpatient setting, thus simplifying the procedure for the patient, reducing costs, reducing latency, and reducing recovery time. It becomes possible to shorten it.

As used herein, a "non-surgical intervention" is considered to be one in which the patient's eye is not amputated or punctured. This non-surgical intervention allows clinicians to limit biological efflux in the target space, usually by increasing biological effluent resistance and increasing intraocular pressure, at changing tissue stages (eg, as mentioned above). It can be made possible to monitor and maintain optimal intraocular pressure throughout. Moreover, such procedures offer distinctly different advantages over traditional interventions that require significant invasive procedures and often require long-term healing by the patient.

Therefore, in some embodiments, the shunt device and method of use avoid prematurely low postoperative intraocular pressure and hypotension and control the subsequent reduction in outflow resistance to control biological outflow resistance (eg, e.g.). Can provide considerable initial outflow resistance to compensate for the increase in target space fibrosis). The shunt can be configured so that the flow resistance is adjusted manually or surgically by the clinician, or is automatically adjusted, especially over time (eg, by using a soluble compartment). It can be configured as follows.

Various structures and / or regions of low eye pressure targeted for aqueous humor drainage include Schlemm's canal, subconjunctival space, superior vena cava, suprachoroidal space, intrathecal adhesive space, and subarachnoid space. including. The shunt is implanted using an incision technique (eg, entering through the conjunctiva and inward through the sclera) or a cutting technique (eg, entering through the cornea, crossing the anterior chamber, through the trabecular meshwork and sclera). be able to. For example, cutting techniques for implanting an intraocular shunt in the subconjunctival space include, for example, Yu et al. (US Pat. No. 6,544,249 and US Patent Application Publication, whose entire contents are incorporated herein by reference. 2008/0108333) and Priwes (US Pat. No. 6,007,511).

Some methods can include inserting a hollow shaft into the eye that is configured to hold the intraocular shunt. In some embodiments, the hollow shaft may be a component of a deployment device capable of deploying an intraocular shunt. The hollow shaft may be coupled to the deployment device or may be part of the deployment device itself. Suitable deployment devices for deploying shunts according to the invention are, but are not limited to, US Pat. Nos. 6,007,511 and US Pat. No. 6,544, the entire contents of which are incorporated herein by reference. Includes deployment devices described in US Patent Application Publication No. 249 and US Patent Application Publication No. 2008/010933. The deployed devices are co-pending and co-owned US Patent Application Publication No. 2012/0123434, November 15, 2010, filed November 15, 2010, the entire contents of which are incorporated herein by reference. May include devices such as those described in U.S. Patent Application Publication No. 2012/0123439 filed in, and Co-pending U.S. Patent Application Publication No. 2013/015570 filed on December 8, 2011. can.

A shunt is a shunt from the anterior chamber to a lower pressure area, such as Schlemm's canal, subconjunctival space, superior vena cava, suprachoroidal space, intrathecal adhesive space, submucosal space, or other areas of the eye. It can be deployed into the eye from the shaft to form a passage. The hollow shaft is then pulled out of the eye. Methods for delivering and implanting bioabsorbable or persistent tubes or shunts, and implanting devices for performing such methods, are generally the applicant's co-pendence in which their entire contents are incorporated by reference. U.S. Patent Application Publication No. 2013/015770 filed on December 8, 2011, U.S. Patent Application Publication No. 2012/0197175 filed on December 8, 2011, and U.S. Patent No. 6 , 544,249 and US Pat. No. 6,007,511. Examples of shunts disclosed herein can be practiced using such methods and other methods as discussed herein.

Some methods can be performed by making an incision in the eye before inserting the deployment device. However, in some cases, the method may be performed without making an incision in the eye prior to inserting the deployment device. In some embodiments, the shaft connected to the deployment device has a sharp point or tip. In some embodiments, the hollow shaft is a needle. An exemplary needle that can be used is Terumo Medical Corp. Commercially available from (Elkinton, Maryland). In some embodiments, the needle can have a hollow interior and an oblique tip to hold the intraocular shunt inside the hollow interior of the needle. In some embodiments, the needle can have a hollow interior and a triple grinding point or tip.

Some methods can be performed without the need to remove anatomical or feature parts of the eye, including, but not limited to, trabecular meshwork, iris, cornea, or aqueous humor. Some methods can be performed without causing substantial eye inflammation, such as subconjunctival bleb formation or endophthalmitis. Some methods include inserting a hollow shaft, which is configured to hold an intraocular shunt, through the cornea, across the anterior chamber, through the trabecular meshwork, into the scleral or intrathecal adhesive space. It can be achieved using a shunting technique. However, some methods may be performed using the incision technique.

In some methods performed using the excision technique, the angle of entry through the cornea can be modified to give the optimal placement of the shunt within the intra-Tenon capsule adhesive space. The hollow shaft can be inserted into the eye at an angle above or below the corneal rim, as opposed to entering through the corneal rim. For example, the hollow shaft can be inserted about 0.25 mm to about 3.0 mm above the corneal margin. The shaft can be inserted about 0.5 mm to about 2.5 mm above the corneal margin. The shaft can also be inserted above the corneal margin by about 1.0 mm to about 2.0 mm, or any particular value within any of these ranges. For example, the hollow shaft is about 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. It can be inserted above the corneal margin at a distance of 0 mm.

In addition, in some embodiments, by placing the shunt away from the corneal rim at the exit site, as provided by the approach angle above the corneal rim, in addition to the conjunctival lymphatic system, the superior scleral lymphatic network Allows access to more lymphatic channels for drainage of aqueous humor, such as. Higher angles of entry also result in a flatter placement in the adhesion space within the Tenon's capsule, resulting in less bending of the shunt.

Some, as discussed in US Patent Application Publication No. 2013/015770, filed December 8, 2011, which is a co-pending application of the applicant, which is incorporated herein by reference in its entirety. In embodiments, the depth of penetration into the tenon-capsular adhesive space may be important when performing several methods to ensure that the intraocular shunt is properly positioned and functioning.

In some methods, the distal tip of the hollow shaft can puncture the scleral and intracapsular adhesive spaces without coring, removal, or distortion of the surrounding ocular tissue. The shunt is then deployed from the shaft. Preferably, the distal portion of the hollow shaft (as opposed to the distal tip) fully penetrates the intra-Tenon capsule adjunction space before the shunt is deployed from the hollow shaft.

According to some embodiments, the hollow shaft can include a flat bevel needle, such as a needle with a triple grinding point. The tip bevel can enter the adjunction space within the Tenon's capsule by first puncturing through the sclera and creating a horizontal slit. In some methods, the needle can be further advanced so that the entire flat bevel penetrates the adhesive space within the Tenon's capsule and expands and opens the tissue to the full diameter.

Moreover, according to one aspect of some methods, the material around the opening is sufficiently stretched to prevent the shunt from being squeezed within the zone, thus preventing shunt damage due to squeezing or stenosis. To prevent this, the flat bevel portion of the needle can push open the intrashunt flow path. The entry of the entire flat bevel into the adhesive space within the Tenon's capsule causes slight strain and trauma in the local area. However, when the shunt is deployed to the eye, this area eventually surrounds the shunt and fits into the shunt.

With reference to the drawings, FIG. 1 is a schematic showing how to access the eye and deliver an intraocular shunt for the treatment of glaucoma. As mentioned, some of the methods disclosed herein allow for clipping techniques. As also mentioned, the excision technique may not be required to carry out the procedure or method disclosed herein. For example, the shunt may be delivered using a notch technique, as discussed herein.

FIG. 1 shows the general anatomy of eye 2. As shown, the cornea 12 is on the anterior surface of the anterior chamber 10 of the eye 2, and the iris 14 is on the posterior surface of the anterior chamber 10 of the eye 2. Below the iris 14 is the crystalline lens 16. The conjunctiva 18 is a thin, transparent tissue that covers the outer surface of the eye 2. The anterior chamber 10 is filled with aqueous humor 20. The aqueous humor 20 flows out into the space 22 below the conjunctiva 18 through the trabecular meshwork (not shown in detail) of the sclera 24. The aqueous humor 20 is drained from the space 22 below the conjunctiva 18 through a venous drainage system (not shown).

FIG. 1 shows a surgical intervention in which an intraocular shunt is implanted in the eye using a delivery device 40 that holds the shunt and the shunt is deployed in the eye 2. FIG. 1 shows a cutting technique in which the delivery device 40 is inserted into the anterior chamber 10 through the cornea 12. However, as mentioned above, the implant may also be placed using an incision technique that allows the conjunctiva or Tenon's sac to be cut and retracted prior to placing the shunt.

Referring to FIG. 1, the delivery device 40 can be advanced across the anterior chamber 10 in a technique referred to as transpupil implant insertion. The delivery device is inserted through the anterior horn until it accesses the target space, such as Schlemm's canal, subconjunctival space, superior vena cava, suprachoroidal space, subarachnoid space, subarachnoid space, or other area. It can be advanced through the sclera 24 as desired. The shunt is then deployed from the deployment device and is conventional in the eye, such as intrascleral veins, collecting tubes, Schlemm's canals, trabecular aqueous humor outflow, uveoscleral outflow to the ciliary muscle, conjunctival lymphatic system, etc. Creates a conduit between the anterior chamber and the target space to allow the aqueous humor to flow out through the drainage channel.

In some embodiments, the delivery device 40 can include a hollow shaft 42 that is configured to hold an intraocular shunt. The shaft can hold the shaft inside the hollow interior of the shaft. Alternatively, the hollow shaft may hold the shaft on the outer surface of the shaft.

FIG. 2 gives a cross-sectional view of a portion of the eye 2 and gives further details regarding the particular anatomy of the eye and the placement of the intraocular shunt 50. In particular, FIG. 2 shows a shunt 50 embedded in the adhesion space within the Tenon's capsule between the conjunctiva 18 and the sclera 24. In some embodiments, the intracapsular arrangement of the tenon does not cut the conjunctiva, controls the scleral outlet position, and pretreats the intrascleral adhesive space prior to the procedure, or by manipulating the tenon during the procedure. Can be achieved. By placing the shunt 50 in the adhesive space within the Tenon's capsule, the aqueous humor 20 can diffuse into the subconjunctival space. According to some examples, the outflow restriction of the subconjunctival space is the strength, amount, and thickness of the tenon sac adhesive (if present, such as when placed in a cutting technique), the thickness of the conjunctiva, and Consistency (which can allow more or less fluid to diffuse into the subconjunctival vessels and lacrimal cavity), as well as existing fibrous adhesions, may be relied upon.

FIG. 2 shows one of the various possible arrangements of the shunt 50 in the eye. As discussed herein, the methods and devices provided herein can be implemented in which the shunt is placed in communication with other anatomical features of the eye. Therefore, some methods and devices disclosed herein include a shunt from the anterior chamber to Schlemm's canal, subconjunctival space, superior vena cava, suprachoroidal space, intrathecal adhesive space, subarachnoid space, or eye. It can be carried out when forming a passage to a lower pressure area, such as other areas.

The method of implementation may be fully automatic, partially automatic (and therefore partially manual), or fully manual. For example, in a fully automated procedure, the shunt can be delivered by a clinician remotely controlling the robot, by needles, plungers, optional guidewires, and, as a result, robot embedding that controls the advance of the shunt. can. In such a fully automatic remote control procedure, the clinician's hand typically does not touch the implant device during the surgical procedure. Alternatively, the shunt may be delivered to the desired area of the eye using a "handheld" implant device. Details regarding handheld implantable devices and the steps and procedures of the implant method are incorporated herein by reference in their entirety, co-pending US Patent Application Publication No. 2012, filed December 8, 2011. It is described in / 0197175 and US Patent Application Publication No. 2013/0150770 filed on December 8, 2011. Insertion of the needle into the eye and certain repositioning or adjustment steps can be performed manually by the clinician. For fully manual devices and methods, all positioning, repositioning, adjustment and implantation steps can be performed manually by the clinician.

Some examples disclosed herein include an intraocular shunt that is configured to form an excretory pathway from the anterior chamber of the eye to the target space. Thus, the shunt is such that the aqueous humor flows from the anterior chamber to the anterior chamber, such as the intrascleral vein, the collecting tube, Schlemm's canal, the trabecular meshwork outflow, the uveoscleral outflow to the ciliary muscle, the conjunctival lymph system, etc. , Can allow outflow through the conventional drainage channel of the eye.

Some embodiments disclosed herein have a cylindrical outer wall and, in some embodiments, a generally cylindrical shunt having a hollow interior that extends at least partially along the length of the shunt. including. The shunt can have a wall that defines the main compartment inner diameter, lumen size, diameter, or flow path cross-sectional size or diameter from about 10 μm to about 300 μm. The shunt can have walls that define luminal dimensions or diameters from about 20 μm to about 200 μm. In addition, the shunt can have walls that define luminal dimensions or diameters from about 30 μm to about 100 μm. In some embodiments, the shunt can have a wall that defines a lumen size or diameter of about 50 μm.

As mentioned above, the restricted compartment can allow complete occlusion of the lumen of the shunt. In some embodiments, the restricted compartment can also be provided with a lumen or passageway having a certain inner diameter. For example, the inner diameter of the restricted compartment may be from about 10 μm to about 70 μm. In some embodiments, the limiting compartment inner diameter may be from about 15 μm to about 35 μm. In some embodiments, the limiting compartment inner diameter may be about 20 μm. Moreover, in some embodiments, the inner diameter of the shunt may remain the same, increase or decrease when moistened.

The outer dimensions or diameter of the walls of some examples may be from about 100 μm to about 300 μm, from about 125 μm to about 250 μm, from about 140 μm to about 180 μm, or about 160 μm. Further, the wall thickness of some examples may be from about 30 μm to about 80 μm, from about 40 μm to about 50 μm, or about 45 μm. Moreover, in some embodiments, the outer diameter of the shunt may increase when moistened.

In some embodiments, the intraocular shunt can be long enough to form an excretory pathway from the anterior chamber of the eye to the target space. The length of the shunt is especially important for achieving placement within the target space. A shunt that is too long will stretch beyond the target space and can be irritating to the eye. For example, if the target space is the scleral lumen, a shunt that is too long can irritate the conjunctiva, which can lead to a failure of the filtration procedure. Moreover, in such examples, shunts that are too short do not allow adequate access to drainage pathways such as the suprascleral or conjunctival lymphatic system.

In some embodiments, the shunt can be of any length that allows the drainage of aqueous humor from the anterior chamber of the eye into the target space. In some embodiments, the shunt can have a total length in the range of about 1 mm to about 12 mm, whether dry or completely moistened. The length may be in the range of about 2 mm to about 10 mm, or in the range of about 4 mm to about 8 mm, or any particular value within the above range. In some embodiments, the length of the shunt ranges from about 5 mm to about 8 mm, or, for example, about 5.0 mm, 5.1 mm, 5.2 mm, 5.3 mm, 5.4 mm, 5.5 mm, 5. 5mm, 5.7mm, 5.8mm, 5.9mm, 6.0mm, 6.1mm, 6.2mm, 6.3mm, 6.4mm, 6.5mm, 6.6mm, 6.7mm, 6.8mm, 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. Any specific value within this range, such as 7.9 mm, or 8.0 mm. Moreover, in some embodiments, the length of the shunt may remain the same or increase when moistened. For example, the length of the shunt can be increased from about 5 mm when dry to about 6 mm when expanded and fully hydrated.

Of the total length of the shunt, the axial length of the restricted compartment may be from about 0.1 mm to about 6 mm. In some embodiments, the restricted compartment length may be from about 0.5 mm to about 4 mm. In some embodiments, the restricted compartment length may be about 2 mm.

In addition, some embodiments of the shunt may have different shapes and dimensions that can be adapted by the eye. According to the embodiments disclosed herein, the outer diameter (eg, main compartment or restricted compartment), the inner diameter (eg, main compartment or restricted compartment), the segment (eg, main compartment or restricted compartment). Intraocular shunts can be formed with dimensions within the various dimensional ranges disclosed for length and overall length.

For example, some embodiments can be configured such that the shunt has a total length of about 6 mm, a main compartment inner diameter of about 150 μm, and a restricted compartment inner diameter of about 40 μm to about 63 μm.

The drawings show examples of intraocular implants or shunts that can have a first flow that can be modified to a second flow by changing the implant configuration without the need for surgical intervention. There is.

Some implants can be configured to have a first flow that can be changed to a second flow by removing, separating, or removing the removable portion of the restricted compartment. In some embodiments, the first stream may be smaller than the second stream through the implant. Therefore, modification or removal of the compartment can reduce flow resistance through the implant and, as a result, allow increased flow through the implant.

For example, a drawing may be a flow regulated implant or a flow-regulated implant having one or more partially obstructive or flow limiting compartments and one or more non-obstructive or non-restrictive main compartments. Examples and configurations of the shunt are shown.

Some examples of shunts disclosed herein can provide the desired initial flow resistance or flow value to prevent excessive outflow from the anterior chamber of the eye, thus lowering intraocular pressure and. Avoid hypotension. However, when biological outflow resistance occurs, the clinician can adjust the flow resistance or flow value of the shunt to prevent high intraocular pressure. Therefore, some examples herein allow the clinician to adjust or regulate the flow rate of the shunt. The geometry and dimensions of the components of these shunts can be manipulated to provide the desired flow resistance, if desired. Accordingly, the examples illustrated and discussed do not limit the scope of features or teachings herein.

According to some embodiments, the shunt may be configured so that the clinician can adjust the flow resistance or flow value to provide a flow rate of from about 1 μL per minute to about 3 μL per minute. .. In addition, the shunt may be configured to allow the clinician to adjust the flow resistance or flow value to provide a flow rate of approximately 2 μL per minute.

3-5 show examples of intraocular shunts where the removable portion allows complete or total obstruction of fluid flow through the shunt. 3 and 4 show an embodiment in which the removable portion is positioned within the lumen of the shunt, while FIG. 5 shows an embodiment in which the removable portion is positioned around the outflow end of the shunt. .. According to some embodiments, the flow blockage is inserted into the lumen, attached to the outflow end, or otherwise shunt spill to block the flow through the lumen. It may be a separate component or material that is coated on the edges. Thus, in some embodiments, FIGS. 3-5 show the shunt where the flow through the shunt is blocked first, while FIGS. 6-9 show the flow through the shunt being reduced, but there. Indicates a shunt that is not blocked or completely closed so as not to allow flow through.

With reference to FIG. 3, the intraocular shunt 60 can include an elongated body having a wall 62 defining a shunt lumen 64 extending through it. The shunt 60 may include opposing ends (eg, inlet end 66 and outflow end 68). The inlet end 66 is vacant and can allow inflow, and the outflow end 68 can include one or more limiting portions. The shunt 60 may include a restricted compartment 70 that is obstructive or restricts flow, and a non-obstructive or non-restricted main compartment 72. The shunt lumen 64 can be extended through the main compartment 72. In the illustrated embodiment, the flow through the restricted compartment 70 is blocked or blocked.

FIG. 4 shows the restricted compartment 70 of the shunt 60 in more detail. The restriction compartment 70 may include flow limiting means, removable portions, or plugs 74 that are positioned within lumen 64 at the outflow end 68 of the shunt 60. The plug 74 can include a generally circular disc or cylinder that is inserted into the lumen 64. The stopper 74 can provide a breakable seal over the outflow end 68.

The plug 74 can be provided with an axial thickness (measured along the longitudinal axis) that allows the plug 74 to be easily removed from the outflow end 68. For example, in some embodiments, the plug 74 may have an axial thickness that is less than the width 79 of the wall 62 of the shunt 60. Further, in some embodiments, the stopper 74 can be provided with an axial thickness approximately equal to the width 79 of the wall 62 of the shunt 60. Thus, in some embodiments, the thickness of the plug 74 may be from about 30 μm to about 80 μm, from about 40 μm to about 50 μm, or from about 45 μm.

Further, the width 79 of the wall may be about twice, three times, or four times as large as the width 78 of the stopper 74. Thus, in some embodiments, the thickness of the plug 74 may be from about 7 μm to about 40 μm, from about 10 μm to about 25 μm, or from about 15 μm.

However, in some embodiments, the width 78 of the stopper 74 may be greater than the width 79 of the wall 62. For example, the width 78 of the stopper 74 may be about twice, three times, or four times as large as the width 79 of the wall 62. Moreover, with respect to the total length of the shunt itself, the width 78 of the stopper 74 ranges from about 0.1% to about 40% of the total length of the shunt, from about 30% to about 40%, from about 20%. Between about 30%, between about 15% and about 20%, between about 10% and about 15%, between about 5% and about 10%, between about 3% and about 5% , Between about 2% and about 3%, between about 1% and about 2%, between about 0.5% and about 1%, between about 0.1% and about 0.5% , May be between about 0.2% and about 0.5%, or between about 0.3% and about 0.4%. Thus, in some examples, the plug 74 is from about 8 μm to about 3200 μm, from about 16 μm to about 2400 μm, from about 24 μm to about 1600 μm, from about 32 μm to about 1200 μm, from about 40 μm to about 800 μm, about 80 μm. May have a width of 78 from about 400 μm or from about 160 μm to about 240 μm.

As shown in FIG. 4, in some embodiments, the plug 74 can extend over the outflow end 68. The plug 74 may be positioned entirely within the lumen 64. However, the plug 74 may also cover a portion of the end face of the outflow end 68.

In some embodiments, to form the shunt 60, the shunt 60 is immersed in a solution to allow capillary action or wicking force, pumping the solution into lumen 64 and forming a plug in it. be able to. Alternatively, the solution can be injected or drawn into the lumen 64. However, the plug 74 can also be inserted into the lumen 64 as a solid material that is held in place by friction fitting or gluing.

As further illustrated below and in FIGS. 10A-10D showing examples similar to those shown in FIGS. 3 and 4, the plug 74 has a lumen 64 to allow flow through the lumen 64. It can be removed and displaced from within. Therefore, in some embodiments, the outflow end 68 of the shunt 60 may be flexible and deformable in response to compressive loads. The compressive load applied to the outflow end 68 can shift or move the wall 62 of the shunt 60, thus overcoming the frictional or adhesive engagement between the outer surface 76 of the plug 74 and the inner surface of the lumen 64. Thereby, the stopper 74 is removed. When the outer surface 76 of the plug 74 slides against the inner surface of the lumen 64, the plug 74 can be removed from the lumen 64, resulting in an opening of the blockage created by the plug 74.

As mentioned above, in some embodiments, the inner diameter of the shunt 60 may remain the same, increase or decrease when moistened. Further, in some embodiments, a removable portion or plug 74 (which imparts flow restriction at the outflow end or restriction compartment 70) that is coupled to or present within the restriction compartment 70 of lumen 64. The inner diameter of the shunt 60 can increase while expanding at a rate lower than or less than the inner diameter of the shunt 60. Therefore, the stopper 74 may be in a "breakable" state after the shunt 60 has been implanted and moistened, and after a desired time period (which can be set based on the formulation of the shunt and removable portion). can. In addition, or alternative, the shunt 60 and / or plug 74 may disassemble at different rates to allow the plug 74 to be in a fractureable state. In the fractureable state, the stopper 74 may have reduced engagement with the outflow end 68, and thus the stopper 74 is more easily removed or broken in response to an external force such as a compressive force. Becomes possible.

Similarly, FIG. 5 shows an intraocular shunt 80 with an elongated body having a wall 82 defining a shunt lumen 84 extending through it. The shunt 80 may include opposing ends (eg, inlet end 86 and outflow end 88). The inlet end 86 is vacant and can allow inflow, and the outflow end 88 can include one or more limiting portions. The shunt 80 may include a restricted compartment 90 that is obstructive or restricts flow, and a non-obstructive or non-restricted main compartment 92. The shunt lumen 84 can be extended through the main compartment 92. In the illustrated embodiment, the flow through the restricted compartment 90 is blocked or blocked.

The restriction compartment 90 may include a flow limiting means or cap 94 that is positioned around the outflow end 88 of the shunt 80 (and can at least partially extend within the lumen 84). The cap 94 may contain a constant mass of material that is coated to the outflow end 88 and dried around it. For example, in some embodiments, the shunt 80 can be immersed in a solution that coats the outflow end 88 and forms a cap or stopper on the outflow end 88 of the shunt 80. However, the cap 94 can also be attached to the outflow end 88 as a solid material or layer that is held in place by friction fitting or gluing.

As mentioned above in connection with FIGS. 3, 4 and 10A-10D, the cap 94 is removed and removed from the outflow end 88 of the shunt 80 to allow flow through the lumen 84. It can be displaced. Therefore, in some embodiments, the outflow end 88 of the shunt 80 may be flexible and deformable in response to compressive loads. The compressive load applied to the outflow end 88 can shift or move the wall 82 of the shunt 80, resulting in a cap by overcoming frictional or adhesive engagement between the cap 94 and the outer surface of the shunt 80. 94 is removed. As the cap 94 slides against the outer surface of the shunt 80, the cap 94 can be separated from the outflow end 88 of the shunt 80, resulting in an opening of the blockage created by the cap 94.

In some embodiments, the cap 94 may comprise an outer cross-sectional profile that is larger than the outer diameter of the shunt 80. The cap 94 may include one or more proximal projecting surfaces 96 extending outward from the outer surface 98 of the shunt 80. The protruding surface 96 can allow the force applied by the clinician (eg, compressive force) to more easily cause an axial displacement of the cap 94 with respect to the shunt 80 when the clinician removes the cap 94. can.

Moreover, in some embodiments, the cap 94 advantageously tends to ensure that the cap 94 has greater compressive strength or resistance to compression than the shunt 80 (longitudinal axis). (Measured along) can be provided. Therefore, when a compressive force is applied to the shunt 80 and the cap 94, the shunt 80 tends to be deformed or compressed to a degree larger than that of the cap 94 in the radial direction. Therefore, such an action may tend to cause disengagement between the outflow end 88 of the shunt 80 and the cap 94.

Moreover, in some embodiments, the outer diameter of the shunt 80 may remain the same, increase or decrease when moistened. In some embodiments, a removable portion or cap 94 (which imparts flow restriction at the outflow end or restriction compartment 90) that is coupled to or covers the restriction compartment 90 of lumen 84. The outer diameter of the shunt 80 may remain the same or increase while expanding to a degree greater than or greater than the outer diameter of the shunt 80. Therefore, the cap 94 may be in a "breakable" state after embedding and watering the shunt 80 and after a desired time period (which can be set based on the formulation of the shunt and removable portion). can. In addition, or alternative, the shunt 80 and / or cap 94 may disassemble at different rates to allow the cap 94 to be in a fractureable state. In the fractureable state, the cap 94 may have reduced engagement with the outflow end 88, and thus the cap 94 is more easily removed or broken in response to an external force such as a compressive force. Becomes possible.

FIG. 6 shows a shunt 100 having an elongated body with a wall 102 defining a shunt lumen 104 extending through it. The shunt 100 may include opposing ends (eg, inlet end 106 and outflow end 108). The inlet end 106 is vacant and can allow inflow, and the outflow end 108 can include one or more limiting portions. The shunt 100 can include a restricted compartment 110 that is obstructive or restricts flow, and a non-obstructive or non-restricted main compartment 112. The flow can be provided through the restricted compartment 110, but the resistance is greater than when passing through the main compartment 112. The shunt lumen 104 can be extended through the main compartment 112. Restriction 110 may include a gelatin tube. The gelatin tube can be inserted into the shunt lumen 104.

FIG. 6 shows the restricted compartment 110 of the shunt 100 in more detail. The restriction compartment 110 or gelatin tube can include a wall 118 defining the auxiliary lumen 120. The wall 118 can specify an inner dimension different from that of the wall 102. For example, the wall 118 can define a cross section or profile that is smaller than the cross section or profile of the wall 102, thus making the lumen 104 larger than the lumen 120. In some embodiments, the auxiliary lumen 120 can generally extend coaxially with the shunt lumen 104, but the auxiliary lumen 120 is configured to be spaced away from the central axis of the shunt lumen 104. Can be done.

For example, the auxiliary lumen 120 can also traverse the restriction compartment 110 and / or be separated from the central axis of the restriction compartment 110 and at the same time extend longitudinally along the restriction compartment 110. The wall 118 can specify a constant or variable thickness. In addition, the auxiliary lumen 120 can be at least partially surrounded by a wall 118 forming the restriction compartment 110. However, the wall 118 can be discontinuous and the auxiliary lumen 120 can be bounded between the wall 118 and the wall 102 of the restricted compartment 110. Therefore, lumen 104 and lumen 120 may have a common interface in some embodiments.

In some embodiments, as shown in FIG. 6, the restriction compartment 110 can be molded as a plug configured such that the wall 110 defines an outer diameter approximately equal to the inner diameter of the shunt lumen 104. Therefore, the plug can be inserted into the lumen 104 to connect the plug to the main compartment 112.

In addition, the restricted compartment 110 is detachably coupled to the main compartment 112, such as to allow the clinician to manually remove, separate, or remove the restricted compartment 110 from the outflow end 108 of the shunt 100. can do. For example, the restricted compartment 110 can be detachably coupled to the main compartment 112, so that the restricted compartment 110 can be completely or at least partially removed from the main compartment 112. For example, the restriction compartment 110 can include a metal stylus or structure that is inserted into the shunt lumen 104, which can be removed later.

In addition, the restricted compartment 110 can contain the same or different gelatin material as the main compartment 112. For example, the restricted compartment 110 can contain a material having a different decomposition rate than that of the main compartment 112, which is larger or smaller, facilitating the removal or disassembly of the restricted compartment 110 from the main compartment 112. It can be achieved by cross-linking, having additional materials, or other structures.

Further, in some embodiments, the limiting compartment can be formed using a material or component that is formed separately from the limiting end and is later joined or coupled to the limiting end. For example, restricted compartments can be glued, scientifically coupled, or rubbed or tightly fitted, or fit engagement between complementary structures such as protrusions and detents. It can be mechanically combined by such means.

To facilitate removal, the limiting compartment 110 may include an enlarged portion 124 having a limiting end 122 abutting the inlet end 106. The enlarged portion 124 may remain at least partially outside the lumen 104 to allow removal, separation, or removal of the restricted compartment 110 as described herein. As shown in FIG. 6, the auxiliary lumen 120 of the restricted compartment 110 continues through the enlarged portion 124. In some embodiments, the enlarged portion 124 can have a cross section or outer profile similar to that of the wall 102. Further, in some embodiments, the restriction compartment 110 may be a solid plug lacking or having no lumen extending through it.

The shunt 100 can be configured such that the two or more compartments have different flow limits or values. Thus, in some cases, the clinician may manually manipulate or adjust the overall flow limit or value of the shunt 100 by manipulating one or more compartments of the shunt 100. In some embodiments, this operation can be performed without surgery. In addition, in some embodiments, the clinician may utilize a shunt or shunt system that automatically or passively adjusts the overall flow limit or flow value of the shunt over time. ..

The flow resistance or flow value of a given compartment of a shunt may be related to the geometric constraints or properties of that given compartment. A geometric constraint or property can be one or more of diameter or radius, length of a given compartment, cross-sectional area of a channel, surface roughness, or other such geometric properties. May be good. In some embodiments, for the purposes of the present disclosure, the flow resistance or flow value is a numerical representation, coefficient, or equation that predicts a mathematical calculation of the fluid flow rate through a given compartment of a given fluid. May be. For example, the flow value may represent the ratio of the inner diameter or radius of a given compartment to the axial length. As a result of higher flow values, higher flow rates can occur. Further, in some embodiments, the flow resistance can be the reciprocal of the flow value, for example, the ratio of the axial length of a given compartment to the inner diameter or radius. Generally, the higher the flow resistance, the lower the flow rate. In addition, flow resistance can largely depend on the shunt length, inner diameter and viscosity of the liquid (aqueous humor).

式中、Φは体積流量であり、Ｖは注がれる液体の体積（立方メートル）であり、ｔは時間（秒）であり、ｖはチューブの長さに沿った平均流速（メートル／秒）であり、Δｘは流れ方向における距離（メートル）であり、Ｒはチューブの内径（メートル）であり、ΔＰは２つの端部の間の圧力差（パスカル）であり、ηは動的流体粘度（パスカル秒（Ｐａ・ｓ））、Ｌはｘ方向におけるチューブの全長（メートル）である。 The flow rate through the shunt, and thus the pressure exerted on the shunt by the fluid, is calculated by Hagen-Poiseuille's equation.

In the equation, Φ is the volumetric flow rate, V is the volume of liquid to be poured (cubic meters), t is the time (seconds), and v is the average flow velocity (meters / second) along the length of the tube. Yes, Δx is the distance (meters) in the flow direction, R is the inner diameter (meters) of the tube, ΔP is the pressure difference (Pascal) between the two ends, and η is the dynamic fluid viscosity (Pascal). Seconds (Pa · s)), L is the total length (meters) of the tube in the x direction.

For example, the shunt 100 can be configured such that the flow through the restricted compartment 110 defines a flow resistance or flow value. The main compartment 112 can define a first flow cross-section range, and the restricted compartment 110 can define a second flow cross-section range that is smaller than the first flow cross-section range. The first flow resistance or flow value can be determined by the geometric constraints or characteristics of the restriction compartment 110. Such constraints may include other features such as the length of the restricted compartment 110, the inner diameter or radius of the wall 118, and the inner surface roughness of the wall 118.

In addition, the second flow cross-sectional range or profile of the restricted compartment 110 can be any of a variety of geometric profiles. For example, the second flow cross-section range or profile may be circular, rectangular, square, polygonal, or other shape. The second flow cross-section range or profile can be configured to provide a cross-sectional area smaller than the main compartment 112. The second flow cross-sectional range or profile may be constant or variable along the longitudinal extension range of the restricted compartment 110.

Similarly, the main compartment 112 can specify a flow resistance or flow value that is different from the first flow resistance or flow value of the restricted compartment 110. Similar to the flow resistance or flow value of the restricted compartment 110, the flow resistance or flow value of the main compartment 112 can be determined by the geometric constraints or characteristics of the main compartment 112 as described above. Therefore, the geometric constraints of the main compartment 112 may differ from the geometric constraints of the restricted compartment 110, resulting in different flow resistance or flow values.

その後、２つの数をともに加算することによって計算することができる：ΔＰ_{ｔｏｔａｌ}＝ΔＰ_ｍａｉｎ＋ΔＰ_{ｐａｒｔｉａｌｌｙ ｃｏｎｓｔｒａｉｎｅｄ}。３つ以上の区画がある場合、それらは適応的にともに加算される。 _{The overall pressure drop ΔP total} over the shunt, consisting of the _main compartment and the _{partially constrained} compartment, was calculated separately for each compartment as ΔP mine and ΔP partial contour according to the above equation.

It can then be calculated by adding the two numbers together: ΔP _total = ΔP _mine + ΔP _{pearly contoured} . If there are three or more compartments, they are adaptively added together.

_{The ΔP total} of any given shunt represents the minimum IOP of the eye for any given flow rate Ф. The flow rate Ф through the shunt is the location of the shunt and the amount of ambient tissue resistance from about 10% to about 90% of the bunch of water produced in the eye, typically typically from about 1 to about 3 μl / min. Depends on.

As shown in FIG. 6, the shunt 100 can include a single restricted compartment 110 and a single main compartment 112. However, the shunt 100 may include a plurality of restricted compartments and / or a plurality of main compartments (see, eg, FIGS. 7-9).

A given restricted compartment can also specify multiple cross-sectional flow ranges or inner diameters. For example, as shown in FIG. 7, the restricted compartment can have distinctly different step or subsections with distinctly different cross-sectional flow ranges or inner diameters.

FIG. 7 shows an embodiment of a shunt 140 in which the obstructive or flow limiting restricted compartment 142 comprises a first obstruction component 150 and a second obstruction component 152. The first occlusion component 150 and the second occlusion component 152 can be inserted into the lumen 144 formed by the shunt wall 146 of the shunt 140. The first occlusion component 150 and the second occlusion component 152 can also be pre-assembled prior to insertion into the shunt lumen 144. The first blockage component 150 and the second blockage component 152 can specify different inner cross-sectional dimensions (eg, diameter) that give distinctly different flow resistances or flow values. Therefore, in some embodiments, the clinician can manually remove, separate, or remove two or more restricted compartments to adjust the flow resistance or flow value of the shunt, thus the clinician , It is possible to achieve two or more different flow resistances or flow values through the shunt. For example, an initial manual operation, such as that described below with respect to FIGS. 10A-10D, can be applied to remove, separate, or remove the second blockage component 152 from the first blockage component 150. Therefore, only the first blockage component 150 remains bound to the shunt 140. The clinician can then optionally further apply manual manipulation to remove, separate, or remove the first occlusion component 150 from the shunt 140.

For example, as in the embodiment shown in FIG. 7, the restricted compartment can be formed using a tube that is configured to fit within the shunt lumen. In addition, restricted compartments can be formed using components, coatings, or other materials that are layered along the inner surface of the shunt wall. Components, coatings, or other materials can stretch at least partially around the inner surface of the shunt wall. In some embodiments, the component, coating, or other material can be stretched to completely surround the perimeter, and in some embodiments, the component, coating, or other material is a shunt wall. Can be stretched longitudinally along the inner surface of the shunt. In any configuration, the overall cross-sectional flow range of the restricted compartment can be smaller than the overall cross-sectional flow range of the main compartment.

In some embodiments, the restricted compartment can be formed by varying the dimensions of the shunt along the restricted compartment. In addition, the restricted compartment can be separated from the main compartment by perforations, thin shunt walls, or other such structures that allow preferential disassembly or fracture at the joints. Thus, the restricted compartment can be formed integrally with the main compartment of the shunt or from a single piece of material continuous with the main compartment of the shunt.

FIG. 8 shows yet another embodiment of a shunt 200 having a plurality of obstructive or flow limiting restricted compartments 202, 204 and a plurality of main compartments 206, 208. Restricted compartments 202, 204 can include the same or different flow resistances or flow values. As shown, the restricted compartment 202 can specify an axial length that is slightly longer than the restricted compartment 204. Therefore, the flow resistance of the restricted compartment 202 can be made larger than the flow resistance of the restricted compartment 204. In some embodiments, the inner diameters or radii of the restricted compartments 202, 204 may also vary. Further, the main compartment 206 can be arranged between the restricted compartments 202, 204.

As mentioned above in connection with the embodiment shown in FIG. 7, the restricted compartments 202, 204 are manually set by the clinician to separate one or both of the restricted compartments 202, 204 from the shunt 200. Can be operated. Therefore, non-surgical interventions can be performed to adjust the flow value of the shunt 200, as described below in connection with FIGS. 10A-10D.

Similar to any of the geometric parameters of the examples taught or disclosed herein, obstructive or flow limiting to achieve the desired overall flow resistance or flow value of the shunt. Other features and aspects of the shunt 200, such as the distance between the restricted compartments 202, 204, can vary.

In addition, FIG. 9 shows an embodiment similar to FIG. 6 described above. FIG. 9 shows a shunt 250 with a first restricted compartment 252 and a second restricted compartment 254, which are detachably coupled to each other and to the main compartment 260 of the shunt 250. Can be done. FIG. 9 shows that the first restricted compartment 252 and the second restricted compartment 254 include different inner diameters 272 and 274, which may also differ from the inner diameter 276 of the main compartment 260. However, the first restricted compartment 252, the second restricted compartment 254, and the main compartment 260 may have the same inner diameter as each other, or may have different inner diameters.

As mentioned above in connection with the examples shown in FIGS. 3-8, the clinician removes, separates, or removes one or both of the restricted compartments 252 and 254 from the body 260 of the shunt 250. Therefore, the shunt 250 can be operated manually.

In any of the examples disclosed herein, the clinician may perform a single or multiple incremental manual non-surgical intervention that can alter the flow resistance of the shunt. Can be made possible. Other configurations or combinations of shunts shown in FIGS. 3-9 can be implemented and are contemplated as part of the present disclosure.

Using a flow-adjustable shunt disclosed or taught herein, the clinician can modify the flow resistance or flow value of one or more parts of the shunt to modify the overall flow resistance or flow value of the shunt. Manual non-surgical interventions can be performed to adjust the flow value. This allows the clinician to ensure that the shunt maintains optimal overall flow resistance in response to any increase in biological spill restriction. Therefore, during a postoperative visit, the clinician should monitor for changes in the tissue surrounding the shunt or drainage channel, measure and track intraocular pressure, and maintain optimal intraocular pressure when necessary. The flow resistance or flow value can be adjusted or modified.

As mentioned above, after the shunt is placed in the eye and healed, the surrounding tissue produces a biological outflow restriction such as fibrosis that may limit or reduce the flow through the shunt. there's a possibility that. Tissue reactions that alter the overall outflow resistance of the shunt typically stabilize about 1-10 weeks after surgery.

The clinician can perform postoperative examinations to correct the shunt in subsequent procedures after the threshold time period has elapsed. This time period may be from about 8 weeks to about 3 months. In many cases, 10 weeks may be sufficient time to achieve stabilization and healing. If appropriate, of course, shunt modifications can be made.

As part of the postoperative examination, the clinician can verify that the intraocular pressure is at the desired level. In general, normal intraocular pressure ranges from about 1333 Pa (10 mmHg) to about 2666 Pa (20 mmHg). If the intraocular pressure is at an undesired level (eg, greater than 2666 Pa (20 mmHg)), the clinician can modify the shunt accordingly.

The clinician can modify the shunt to reduce the flow resistance or flow value of the shunt. For example, the clinician can remove a portion from the shunt and, in some cases, the portion from the eye. Removal, separation, or removal of a portion of the shunt can reduce the flow resistance of the shunt, resulting in increased flow through the shunt, reducing and reducing intraocular pressure.

Thus, in some embodiments, the shunt has (1) significant initial outflow resistance to avoid early low postoperative intraocular pressure and hypotonia, and (2) biological outflow resistance (eg, eg). Methods and devices are provided that can provide the ability to reduce subsequent outflow resistance to compensate for the increase in target space fibrosis).

In order to change the flow resistance or flow value of the shunt, some embodiments of the shunt will allow the clinician to use one or more embodiments, compartments, or all of the restricted compartments that are obstructive or limit the flow of the shunt. It can be configured so that the shunt can be manually manipulated through non-surgical intervention for removal. In some cases, the clinician can remove, separate, or remove the restricted portion of the shunt, resulting in increased flow for optimal long-term intraocular pressure performance.

In some methods, the shunt can be positioned so that the limiting end is located within the anterior chamber of the eye. In addition, in some methods, the shunt can be positioned so that the limiting end is located in the target space or in a location with lower pressure. In addition, in some embodiments, the shunt can be configured and positioned such that one or more obstructive or flow limiting compartments or ends are located within the anterior chamber and target space. ..

According to some embodiments, the shunt can be positioned such that its limiting end is positioned within the target space or lower pressure location, such as within the subconjunctival space of the eye. For example, FIGS. 10A-10D show a shunt 380 implanted in the eye 302. The shunt 380 may include an inflow end 386 and an outflow end 384. The inflow end 386 can be positioned within the anterior chamber 310 of the eye 302. In addition, the outflow end 384 can be placed within the subconjunctival space 320 of the eye 302. Therefore, the shunt 380 may be operational to allow the pressure of the fluid in the anterior chamber 310 to relieve to a lower pressure location, such as the subconjunctival cavity 320 of the eye 302. As mentioned above, the obstructive or flow limiting shunt 382 located within the outflow end 384 is subject to low intraocular pressure, such as hypotension, over time. Certain biological spill restrictions may be formed that may tend to ensure that they are avoided, but may reduce the overall shunt or flow rate of the shunt 380. The restricted compartment 382 can be coupled to the shunt 380, such as by being at least partially located within the lumen 383 of the shunt 380. Examples of the shunt 380 shown in FIGS. 10A to 10D are the same as those illustrated above and FIG. As further discussed below, FIGS. 10A-10D allow the clinician to manually manipulate the restricted compartment 382 within the shunt 380 to adjust the flow resistance or flow value of the shunt 380 without surgical intervention. Here are the steps you can take.

10A-10D show various aspects of the embodiment in which the shunt 380 can be mechanically modified. FIG. 10A shows the shunt 380 in the initial position or configuration where the flow resistance through the shunt is at its maximum. After the clinician determines that the reduction in flow resistance is justified, the clinician can then locate the shunt 380 with respect to the structure of the eye 302 and be prepared to manipulate or modify the configuration of the shunt 380.

For example, FIGS. 10B and 10C show a clinician's finger stroke in performing a non-surgical method for mechanically modifying a shunt 380 to adjust the flow resistance or flow value of the shunt 380. As shown, the limiting portion 382 squeezes the conjunctiva 321, exerts pressure on the eye, and moves the finger posteriorly along the conjunctiva 321 above the shunt 380 to shunt the shunt 380. It can be removed from the end 384.

As discussed above, in some embodiments, the restriction compartment 382 may include a fluid restriction portion that can be removed from the lumen 383 of the shunt 380. Further, the restriction compartment 382 can be detachably attached to the inside of the lumen 383 of the shunt 380. In some embodiments, the restricted compartment 382 can comprise a plug, a reduced cross-sectional area, or any other suitable blockage. The restricted compartment 382 can be placed entirely within the shunt 380, or at least partially outwardly around the shunt 380. The restricted compartment 382 can be removed from the shunt 380 by overcoming the adhesion or friction retention of the restricted compartment 382 within the shunt 380.

According to some embodiments, the restricted compartment 382 can be removed from within the shunt 380 by exerting a force on the outer surface 381 of the shunt 380 by deforming the shunt 380.

In some embodiments, the shunt 380 is formed from a material that is flexible and / or compressible in other ways. For example, pressure or force can be applied to the outer surface 381 of the shunt 380 to compress, bend, or otherwise deform the shunt 380. In some embodiments, when a force is applied to the outer surface 381 of the shunt 380, the internal cross-sectional area of the shunt 380 can be reduced from the initial cross-sectional area to a compressed or reduced cross-sectional area.

In some embodiments, the restricted compartment 382 located within the shunt 380 does not have to be as compressed as the shunt 380 when an external force is applied to the outer surface 381 of the shunt 380. For example, the restricted compartment 382 can contain structural strengths that differ from those of the shunt 380, such as thicker walls, different materials, or other such structural variants. Therefore, when the shunt 380 is deformed, the restricted compartment 382 can be urged outward, from a region with a reduced cross-sectional area to a region with a larger cross-sectional area, or outward from the shunt 380. In some embodiments, the restricted compartment 382 is slid through the shunt 380 by applying a force in front of the restricted compartment 382 and guided backwards to reduce the anterior cross-sectional area of the restricted compartment 382, limiting the compartment 382. The compartment 382 can be pushed or urged outward from the shunt lumen 383 or otherwise away from the shunt 380.

In some embodiments, an external force can be applied directly to the outer surface 381 of the shunt 380 to deform the shunt 380. In some embodiments, an external force can be applied to the tissue of the eye 302, thereby compressing the outer surface 381 of the shunt 380, or otherwise, to the outer surface 381, as shown in FIG. 10C. Can transmit power. In the illustrated example, the shunt 380 is located in the subconjunctival region 320. Therefore, a force can be applied to the conjunctiva 321 to compress the conjunctiva 321 and transfer the force to the outer surface 381 of the shunt 380.

As shown in FIGS. 10B and 10C, in the illustrated embodiment, the clinician applies force to the eye 302 with a finger 340 to massage eye tissue such as the conjunctiva 321 and compress the shunt 380. Can be done. As shown in FIG. 10D, the compression of the shunt 380 allows the restricted compartment 382 to be pushed out of the restricted end 384 and separated from the shunt 380 within the subconjunctival cavity 320.

As shown in FIG. 10C, in some embodiments, when the restricted compartment 382 is urged outward from the shunt 380, the restricted compartment 382 can be urged outward from the outflow end 384. In some embodiments, after the restricted compartment 382 has been urged outward from the shunt 380, the restricted compartment 382 can be separated from the outflow end 384, resulting in the restricted compartment 382, as shown in FIG. 10D. There is a small space between and the outflow end 384. In this way, the spill can be generally left free through the spill end 384. In some embodiments, the restricted compartment 382 can be removed from the eye or left in place to act as a spacer that prevents blockage and retains the outflow through the outflow end 384. This may be especially true for restricted compartment 382 materials that remain very gentle in the eye, such as gelatin materials. In some embodiments, the limiting portion 382 may be separated from the outflow end portion 384 by only about 0.2 mm to about 2 mm. Further, the limiting portion 382 may be separated from the outflow end portion 384 by only about 0.5 mm to about 1 mm.

In some embodiments, the limiting portion 382 can be removed from the eye 302 after the limiting portion 382 has been separated from the outflow end 384.

Referring to FIG. 11, in the illustrated embodiment, the roller tool 342 can be used instead of the finger to apply force or massage the eye 302. In some embodiments, the roller tool 342 can be used to apply force to the eye 302 while minimizing the shear forces applied to the eye 302. The roller tool 342 may be any suitable tool suitable for use with the eye 302.

With reference to FIG. 12, the wedge-shaped tool 344 can be used to apply force or massage the eye 302. In some embodiments, the wedge-shaped tool 344 can be used to apply pressure or force to the eye 302 while applying some shear force to urge the restricted compartment 382 outward from the shunt 380. can. In some embodiments, the wedge-shaped tool 344 can also be in the form of a flat paddle (not shown) that can be used to apply a wide range of forces to the eye 302.

In some embodiments, the restricted compartment 382 can be removed by applying force directly to the restricted compartment 382. In some embodiments, the restricted compartment 382 can be withdrawn from lumen 383 or otherwise urged outward from lumen 383.

Some embodiments may also provide methods or devices that use minimally invasive surgical techniques to remove and / or remove restricted compartments of the shunt. For example, referring to FIG. 13, in the illustrated embodiment, the restricted compartment 382 can be removed, separated, or removed from the shunt 380 without any manipulation of the outer surface 381 of the shunt 380.

In some embodiments, the recovery tool 346 can be used to puncture the conjunctiva and engage the restricted compartment 382. The tool 346 can then slide the restricted compartment 382 outward from the shunt 380. The recovery tool 346 can grip or otherwise engage the restricted compartment 382, allowing the clinician to withdraw the restricted compartment 382 after overcoming friction and / or adhesion within the lumen 383. can do.

In some embodiments, the recovery tool 346 may include a scalpel, a hypodermic needle, or other surgical tool.

Flow-regulated shunts allow early protection for hypotonia and subsequent gradual reduction of flow restrictions without any postoperative surgical intervention (as discussed herein). , Additional methods and devices can also be provided. The shunt is also non-obstructive or non-limiting, whether used independently in some embodiments or in conjunction with other aspects of the embodiments disclosed herein. Can be provided with a shunt and a soluble plug or compartment that is obstructive, restrictive, or restricts flow. The main compartment and / or the restricted compartment can also be removable or separable from the shunt, as discussed in the examples above. Such soluble plugs or compartments can be incorporated into, and can be used in addition to, any of the plugs, caps, or other removable parts of the embodiments described above.

The shunt can be configured so that the flow can move more easily through the main compartment than through the restricted compartment. The main compartment may include a wall defining a first flow cross-sectional range. Dissolvable limiting compartments can include openings, lumens, or walls that define the flow path through which fluids can pass, but with greater resistance than when passing through the main compartment. Thus, in some embodiments, the presence of a soluble compartment may slow the flow through the shunt, but does not completely limit it. Alternatively, the soluble compartment may be arranged to limit flow in the early stages after the surgical procedure, but dissolve over time, resulting in increased soluble compartment and thus flow through the shunt. can.

In some embodiments, the shunt may comprise one or more soluble restriction compartments. For example, a shunt can be provided with a soluble limiting compartment at its single end. The shunt can include two or more soluble limiting compartments, both closely spaced or separated from each other at opposite ends of the shunt. In some methods, the solubilizable compartment can be located either in the anterior chamber or in a lower pressure area such as the subconjunctival space. One aspect of some embodiments is anterior to the soluble compartment due to the possibility that particulate matter or debris may float in the shunt lumen and block the flow through the soluble compartment within the subconjunctival lumen. It is recognized that placement in the chamber can be advantageous (compared to having a soluble compartment only within the subconjunctival lumen).

In addition, the restricted compartment may include a wall defining an opening, lumen, or flow path. As similarly mentioned with respect to the other embodiments above, the walls of the restricted compartment can define a second flow section range. The second flow section range can be smaller than the first flow section range of the main compartment. In some embodiments, the wall can define a generally tubular opening, lumen, or flow path. In addition, the openings, lumens, or channels may be square, polygonal, triangular, or various other random shapes. The wall can be configured so that the opening, lumen, or flow path can extend along the central axis of the restricted compartment. However, the opening, lumen, or flow path can also traverse the restricted compartment and / or be separated from the central axis of the restricted compartment and at the same time extend longitudinally along the restricted compartment. In addition, openings, lumens, or channels can be surrounded by materials that form limiting compartments. However, openings, lumens, or channels can also be formed between the walls of the restricted compartment and the walls of the main compartment.

In addition, the material forming the shunt's soluble limiting compartment can be configured to dissolve according to the desired dissolution rate, dissolution sequence, and / or dissolution pattern. The solubilizable compartment can contain more than one type of material. The material can be axially layered, circumferentially offset, or otherwise positioned to give a differential or stepwise melting sequence or pattern. The material can have variable or different dissolution rates.

Only all or part of the shunt may be soluble. For example, the soluble compartment may contain a soluble biocompatible material. The material can be configured to dissolve over a set or desired time period, from days to months, based on the desired length of hypotension protection.

In some embodiments, the material selected for the shunt or restriction compartment can include gelatin or other similar material. In some examples, the gelatin used to make the shunt may include type B gelatin derived from bovine skin. Preferred gelatins are PB Leiner gelatin, Type B, 225 Bloom, USP from bovine skin. Another material that can be used to make the shunt is also Sigma Chemical. A type A gelatin derived from porcine skin available from. Such gelatin is available in Code G-9382 from the Sigma Chemical Company in St. Louis, Missouri. Other suitable gelatins include bovine bone gelatin, porcine bone gelatin and human-derived gelatin. In addition to gelatins, microfistula shunts may be made from hydroxypropyl methylcellulose (HPMC), collagen, polylactic acid, polyglycolic acid, hyaluronic acid and glycosaminoglycans.

The shunt material can be crosslinked. For example, when gelatin is used, cross-linking can increase the intermolecular and intramolecular bonds of the gelatin substrate. Any means for cross-linking gelatin can be used. In some examples, the gelatin shunt formed can be treated with a solution of a cross-linking agent such as, but not limited to, glutaraldehyde. Other compounds suitable for cross-linking include 1-ethyl-3- [3- (dimethylamino) propyl] carbodiimide (EDC). Cross-linking by radiation such as gamma rays or electron beams (e-rays) may be used as an alternative.

The soluble compartment may contain the same, similar or different material as the material of the shunt. In some examples, the soluble compartment material may be made from gelatin, which may resemble the gelatin used to make the shunt, and those gelatins are the amount of cross-linking they are undergoing. Is different.

In some examples, the shunt can be crosslinked by contacting the shunt with a solution of about 25% glutaraldehyde over a selected time period. One suitable form of glutaraldehyde is 1G5882 grade glutaraldehyde available from the Sigma-Aldrich Company in Germany, but other glutaraldehyde solutions may also be used. The pH of the glutaraldehyde solution is preferably in the range of 7 to 7.8, more preferably in the range of 7.35 to 7.44, and typically about 7.4 ± 0.01. do. If necessary, the pH can be adjusted by adding an appropriate amount of base, such as sodium hydroxide, as needed.

For example, a "persistent" implant can be crosslinked by holding it in a 25% Gluderaldehyde solution for 16 hours. This saturates the crosslinks, resulting in a persistent implant that does not dissolve over any dominant time frame (eg, 10 years). However, in such examples, gelatin with much less cross-linking (shorter cross-linking time used and / or lower gluderaldehyde concentration) may be used in the soluble compartment. By reducing the amount of cross-linking time and / or gluderaldehyde concentration, less than complete cross-linking can be achieved, resulting in dissolution of the material over an adjustable time frame. Dissolvable compartments may be provided using other soluble materials and other cross-linking techniques.

According to some methods, the dissolution time can be at least about 15 minutes to several years by adjusting the gluderaldehyde concentration, cross-linking time, cross-linking temperature and / or the geometry of the soluble compartment. The dissolution time may also be at least about 1 hour to several months. For example, a soluble compartment of gelatin that is not completely crosslinked can dissolve within about 20 minutes. Therefore, the gruderaldehyde concentration, cross-linking time, and / or geometry (longitudinal length, opening or flow path size, etc.) of the soluble compartment are adaptive to adjust the dissolution rate of the soluble compartment. It can be fixed.

With respect to the internal dimensions or diameter and length of the shunt, as well as the length of the meltable compartment, and the design considerations of the dimensions of the flow path, the longer the "pipe", the higher the fluid resistance, the "pipe" radius and As the cross-sectional area increases, the fluid resistance decreases. Specifically, the flow value and the resulting pressure value can be determined using formulas known in the art. The flow rate of the flow through tubes with different inner cross-sectional areas can be calculated using such an equation. The calculation of laminar flow through the tube can be performed using the Hagen-Poiseuille equation described above. Assuming that flow limiting of a large shunt shunt is not important, the pressure difference ΔP between the shunt inlet and outlet is the length L and inner diameter (radius R) of the plugged / constrained portion of the shunt. Given only by.

In addition, according to some methods, the shunt may be made by immersing a core or substrate, such as a wire of appropriate diameter, in a solution of a material, such as gelatin. In some methods, in order to form a shunt with one or more restricted compartments (eg, soluble portions), the core or substrate may be one or more corresponding to the desired inner profile of the shunt. It can be configured to include peaks, valleys, protrusions, and / or shunts. The core or substrate can be coated or soaked multiple times to be coated with the desired number of layers or materials. For example, the core material or substrate can have a first compartment with a small outer diameter and a second compartment with a large outer diameter. The smaller outer diameter compartments can be immersed in the coating or solution so that the outer diameter along the first compartment is approximately equal to the larger outer diameter of the second compartment. After that, the first section and the second section of the core material or the base material can be immersed in the solution and dried. Therefore, when removed, the shunt can have an inner diameter that narrows in its restricted compartment corresponding to the first compartment of the core or substrate. Other details and features of the method of preparing and making shunts are incorporated herein by reference in their entirety, US Patent Application Publication No. 2012/0197175, filed December 8, 2011, and It is disclosed in US Patent Application Publication No. 2013/015570 filed December 8, 2011.

For gelatin implants, the solution dissolves gelatin powder in deionized water or sterile water for injection and mixes the dissolved gelatin thoroughly to ensure complete dissolution of gelatin, at about 55. It can be prepared by placing it in a water tank at a temperature of ° C. In one example, the ratio of solid gelatin to water is from about 10% to about 50% by weight of gelatin to about 50% to about 90% by weight of water. In some examples, the gelatin solution contains about 40% by weight of gelatin dissolved in water. The resulting gelatin solution is preferably bubble-free and has a viscosity from about 200 cp (centipores) to about 500 cp. The solution may also have viscosities from about 260 cp to about 410 cp.

As further discussed herein, gelatin solutions are biologics, preparations, drugs, and / or other chemicals selected to regulate the body's response to shunt implantation and subsequent healing processes. May include. Examples of suitable drugs are antimitotic agents such as mitomycin C or 5-fluorouracil, anti-VEGF (such as Lucintes, McGen, Avastin, VEGF or steroids), anticoagulants, antimetabolites, angiogenesis. Includes inhibitors or steroids. The shunt formed by containing a biologic, preparation, drug, or other chemical in liquid gelatin is impregnated with the biologic, preparation, drug, or other chemical.

According to some examples, the shunt can include a drug or drug elution moiety for delivery of the drug to one or more target locations in the eye. The drug elution moiety can be provided in combination with any of the examples disclosed or taught herein. For example, the shunt can include a drug elution moiety. Therefore, some embodiments provide a shunt that also acts as a drug delivery device inside the eye.

One or more agents can be carried for delivery to the target location by shunt. The shunt itself can carry the drug and can be partially or completely soluble. For example, one or more agents can be carried within one or more soluble coatings along the surface of the shunt. The drug-eluting soluble coating can be stretched along the entire length of the shunt or only a portion of the length of the shunt. The agent can also be carried as a component of the soluble compartment, according to some examples. In some embodiments, time-controlled drug release can be achieved by configuring a soluble coating or moiety to provide the desired dissolution rate. Therefore, such a drug-eluting portion of the shunt can allow drug delivery, even in the absence of water flow.

Aspects relating to the embodiment of the drug delivery shunt are discussed in co-pending U.S. Patent Application Publication No. 2012/0197175, filed December 8, 2008, which is incorporated herein by reference in its entirety. There is.

Various types of agents may be used, including glaucoma, steroids, other anti-inflammatory agents, antibiotics, dry eye, allergies, conjunctivitis and the like.

At least one compartment of the shunt can contain one or more agents to provide a drug elution moiety. In some embodiments, one or more agents can be provided along the entire length of the shunt. However, in some embodiments, one or more agents may be provided along less than the entire shunt or only a portion of the shunt. For example, the drug can be incorporated into only one of the ends of the shunt to provide a single drug elution end that can be placed in the anterior chamber or lower pressure location. Further, in addition to being formed along the edges of the shunt, the drug elution portion may also be formed along the middle portion of the shunt. Thus, some examples allow targeted drug release within the anterior chamber, sclera, and / or within the subconjunctival cavity, depending on the location and composition of the drug elution site. be able to.

In some embodiments, the shunt can comprise multiple drug elution moieties that can give different dissolution times and / or form each to be embedded with different drugs. Therefore, in some embodiments, the two or more agents may be delivered simultaneously at independent release timings.

For example, the shunt can be provided with a plurality of solubilizable compartments, each of which can be given different dissolution times and / or formed to be embedded with different agents.

The shunt can also be implanted in the suprachoroidal cavity so that the drug can be delivered at either or along one or both ends (one end is the anterior chamber). Inside and the other end is in the suprachoroidal cavity, or the entire shunt is completely on the choroid). Some methods allow multiple shunts (having the same or different agents and having the same or different release timings) to be implanted in different locations (eg, subconjunctival space, suprachoroidal space, anterior chamber, etc.). Can be implemented.

Histocompatibility shunt In some embodiments, the shunt can include a material having a modulus that matches the modulus of tissue surrounding the shunt. For example, the intraocular shunt can be flexible and can have a modulus of elasticity that is substantially the same as the modulus of elasticity of the surrounding tissue within the implantation site. As such, some examples of intraocular shunts can be easily flexible, cannot elute, or cause tissue reactions, and cannot move when implanted.

Therefore, when implanted in the eye using a cutting procedure, such as some of the methods described herein, some examples of intraocular shunts are of subconjunctival bleb formation or endophthalmitis. Can not cause substantial eye irritation, such as. Additional exemplary features of the intraocular shunt embodiment are discussed in more detail below. Thus, some embodiments of the shunt can be configured to have the flexibility to adapt to the surrounding tissue, without the need for any type of anchor that interacts with the surrounding tissue. , Allows you to stay in place after embedding. As a result, it allows some embodiments of the shunt to keep fluid flow out of the anterior chamber of the eye after implantation without causing irritation or inflammation of the tissues surrounding the eye.

Modulus or modulus, as discussed in US Patent Application Publication No. 2013/015570, a co-pending application of the applicant, filed December 8, 2011, which is incorporated herein by reference in its entirety. The elastic modulus is a mathematical description of the tendency of an object or substance to be elastically deformed when a force is applied. See also Gere (Mechanics of Materials, 6th Edition, 2004, Thomason) (which is incorporated herein by reference in its entirety). The elastic modulus of body tissue can be determined by one of ordinary skill in the art. For example, Samani et al. (Phys. Med. Biology 48: 2183, 2003), Erkamp et al. (Institute of Electrical and Electronics Engineers Engineering Digital Academy, Electronics Engineers, Electronics Engineers), and others (Institute of Electrical and Electronics Engineers). and Computer Science Department 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 other (IEEE Trans. Ultrason. Ferroelec. Freq. Control 43 : 191-194, 1996), Hall (In 1996 Ultrasonics Symposium Proc., Pp. 1193-1196, IEEE Cat. No. 96CH35993, IEEE, New York, 1996), and Parker (Ul. 246, 1990).

The elastic moduli of tissues of various organs are 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 of which are incorporated herein by reference in their entirety, are the cornea of the eye. And the elastic modulus of the sclera. Chen, Hall, and Parker show elastic moduli of various muscles and livers. Erkamp indicates the elastic modulus of the kidney.

In some embodiments, the shunt can include a material having a modulus that matches the modulus of elasticity of the eye tissue, especially the scleral tissue. In some embodiments, the compatible material is a material that is softer than the scleral structure or slightly harder than the scleral structure, but still soft enough to impede the movement of the shunt. .. The elastic modulus of the anterior scleral tissue is approximately 2.9 ± 1.4 × 10 ⁶ N / m ² , and the elastic modulus of the posterior scleral tissue is 1.8 ± 1.1 × 10 ⁶ N / m ^2. Is. In some examples, the material may include gelatin. In some examples, gelatin may include cross-linked gelatin derived from bovine or porcine collagen. In addition, the shunt may contain one or more biocompatible polymers such as polycarbonate, polyethylene, polyethylene terephthalate, polyimide, polystyrene, polypropylene, poly (styrene-b-isobutylene-b-styrene), or silicone rubber. It may be included.

U.S. Patent Application Publication No. 2013/0150770, filed December 8, 2011, and December 8, 2011, which are the applicant's co-pending applications, the entire contents of which are incorporated herein by reference. Some embodiments of the shunt may include optional features, as discussed in US Patent Application Publication No. 2012/0197175 filed in Japan. For example, some embodiments may include a flexible material that responds to pressure, i.e., the dimensions or diameter of the flexible portion of the shunt will vary depending on the pressure applied to that portion of the shunt. In addition, the shunt may include one or more side ports. In addition, some embodiments of the shunt may also include overflow ports. Some embodiments of the shunt may also be provided with one or more protrusions at its ends to facilitate directing the fluid flow out of the organ. According to some embodiments, the shunt can also be configured such that the ends of the shunt include longitudinal slits. Other variants and features of the shunt can be incorporated into the examples disclosed herein.

In addition to providing a safe and efficient way to relieve intraocular pressure in the eye, the implantable shunts disclosed herein also flow (due to resistance to the lymphatic outflow tract). It has been observed that it can also contribute to the regulation and stimulate the growth of functional drainage structures between the eye and the lymphatic and / or vascular system. These drainage structures drain fluid from the conjunctiva, which also results in less diffusion of blebs, smaller bleb reservoirs, or no blebs to form.

The formation of drainage pathways formed by the lymphatic system and / or veins to them may have applications beyond the treatment of glaucoma. Therefore, the method of shunt implantation may be useful for the treatment of other tissues and organs where excretion may be desired or required.

In addition, it has been observed that absorption of a fully lysable shunt forms a "natural" microfistula shunt or pathway surrounded by cells. This "natural" shunt is stable. The implantable shunt remains in place long enough to allow the formation of a cell-fused cover (thus leaving the opposite sides of the formed shunt separate). Once these cells are formed, they are stable, thus eliminating the need for foreign matter to be placed within the formed space.

Deploying an intraocular shunt into the eye in accordance with the present disclosure can be achieved using a hollow shaft configured to hold the shunt, as described herein. The hollow shaft may be coupled to the deployment device or may be part of the deployment device itself. Suitable deployment devices for deploying shunts according to the invention are, but are not limited to, US Pat. Nos. 6,007,511 and US Pat. No. 6,544, the entire contents of which are incorporated herein by reference. Includes deployment devices described in US Patent Application Publication No. 249 and US Patent Application Publication No. 2008/010933. In another embodiment, the deployed device is a co-pending and co-owned US Patent Application Publication No. 2012/01/23434, filed November 15, 2010, the entire contents of which are incorporated herein by reference. As described in US Patent Application Publication No. 2012/0123439 filed November 15, 2010, and Simultaneously Pending US Patent Application Publication No. 2013/015570 filed December 8, 2011. Devices can be included.

Although the detailed description includes many details, these should not be construed as limiting the scope of the technology of the subject, but only as exemplifying various examples and embodiments of the technology of the subject. Should be interpreted. It should be understood that the scope of the art of this subject includes other embodiments not discussed in detail above. Without departing from the scope of the present disclosure, various other modifications, modifications and modifications can be made in the configuration, operation and details of the techniques and devices of the subject matter disclosed herein. Unless otherwise expressed, when an element is referenced in the singular, this is intended to mean "unique" unless explicitly stated. Not intended to mean "one or more". In addition, it is not necessary to address all the problems that can be solved by the various embodiments of the present disclosure in order for the device or method to be included within the scope of the present disclosure.

Examples of Technical Sections of the Subject Various examples of aspects of the present disclosure are set forth below as sections for convenience. These are given as examples and do not limit the technology of this subject.

Item 1. A method of adjusting the flow of an intraocular shunt implanted in the eye to determine the position of the intraocular shunt in the eye that extends between the anterior chamber of the eye and the location of lower pressure in the eye. And by applying force to the outer surface of the eye to separate or displace the removable portion with respect to the outflow portion of the intraocular shunt, as a result, it is possible to increase the flow rate through the intraocular shunt. A method that involves applying force.

Item 2. The removable portion includes a first medial cross-sectional dimension, the intraocular shunt contains a second medial cross-sectional dimension that is greater than the first medial cross-sectional dimension, and applying force is greater than the first medial cross-sectional dimension. The method of claim 1, comprising compressing the second inner cross-sectional dimension so that it is also smaller.

Item 3. The method of paragraph 1 or 2, wherein applying force comprises increasing the permissible flow rate from about zero to a non-zero flow rate.

Item 4. The method of any one of paragraphs 1 to 3, wherein applying force comprises increasing the permissible flow rate from a non-zero flow rate.

Item 5. Applying force includes any of paragraphs 1 to 4, including separating the removable portion from the intraocular shunt and then positioning the removable portion in a location distant from the outlet of the outflow portion. The method described in paragraph 1.

Item 6. The method of paragraph 5, further comprising removing the removable portion from the eye after separating the removable portion from the outflow portion.

Item 7. The method according to any one of paragraphs 1 to 6, wherein the outflow portion is placed in the subconjunctival space of the eye.

Item 8. The method of paragraph 7, wherein applying force comprises applying force to the conjunctiva of the eye in order to apply force to the outer surface of the eye.

Item 9. The method according to any one of paragraphs 1 to 8, wherein at least a portion of the removable portion is disposed internally within the intraocular shunt.

Item 10. The method of any one of paragraphs 1-9, wherein the removable portion is at least partially located outside the shunt prior to applying force.

Item 11. The method of any one of paragraphs 1 to 10, further comprising allowing the removable portion to disassemble in a lower pressure location after applying force to the outer surface of the eye. ..

Item 12. The method according to any one of paragraphs 1 to 11, wherein the removable portion comprises a decomposable material, a viscoelastic material, or any combination of the above.

Item 13. The method according to any one of paragraphs 1 to 12, wherein the removable portion includes a plurality of removable portions.

Clause 14. The method according to any one of paragraphs 1 to 13, wherein the removable portion comprises a drug.

Clause 15. The method according to any one of paragraphs 1 to 14, wherein applying force to the outer surface of the eye comprises applying force with a finger.

Item 16. The method according to any one of paragraphs 1 to 15, wherein applying force to the outer surface of the eye comprises applying force through a tool.

Clause 17. The method of paragraph 16, wherein the tool includes a roller tool.

Clause 18. The method of paragraph 16, wherein the tool comprises a wedge-shaped tool.

Clause 19. A method of adjusting the flow rate of the intraocular shunt so that the inflow portion of the intraocular shunt is located in the anterior chamber of the eye and the outflow portion of the intraocular shunt is located in a location where the pressure of the eye is lower. By inserting an intraocular shunt into the eye, the outflow portion of the intraocular shunt is limited by the removable portion when inserted in a lower pressure location, after insertion and insertion. A method comprising applying force to a lower pressure location to remove a removable portion from the outflow portion of the intraocular shunt in order to vary the flow rate through the intraocular shunt.

Item 20. The removable portion includes a first medial cross-sectional dimension, the intraocular shunt contains a second medial cross-sectional dimension that is greater than the first medial cross-sectional dimension, and applying force is greater than the first medial cross-sectional dimension. 19. The method of claim 19, comprising compressing the second inner cross-sectional dimension so that it is also smaller.

Clause 21. 19. The method of paragraph 19 or 20, wherein applying force comprises increasing the permissible flow rate from about zero to a non-zero flow rate.

Clause 22. The method of any one of paragraphs 19 to 21, wherein applying force comprises increasing the permissible flow rate from a non-zero flow rate.

Clause 23. Applying force comprises removing the removable portion from the intraocular shunt and then positioning the removable portion within a location distant from the outlet of the outflow portion, any of paragraphs 19-22. The method described in paragraph 1.

Clause 24. 23. The method of claim 23, further comprising removing the removable portion from the spilled portion and then removing the removable portion from the eye.

Item 25. The method of any one of paragraphs 19 to 24, wherein the outflow portion is located within the subconjunctival space of the eye.

Clause 26. 25. The method of paragraph 25, wherein applying force comprises applying force to the conjunctiva of the eye in order to apply force to a location where the pressure is lower.

Clause 27. The method of any one of paragraphs 19-26, wherein at least a portion of the removable portion is disposed internally within the intraocular shunt.

28. The method of any one of paragraphs 19-27, wherein the removable portion is at least partially located outside the shunt prior to applying force.

Clause 29. 19. the method of.

Item 30. The method of any one of paragraphs 19-29, wherein the removable portion comprises a decomposable material, a viscoelastic material, or any combination of the above.

Clause 31. The method according to any one of paragraphs 19 to 30, wherein the removable portion includes a plurality of removable portions.

Clause 32. The method according to any one of paragraphs 19 to 31, wherein the removable portion comprises a drug.

Item 33. The method according to any one of paragraphs 19 to 32, wherein inserting the intraocular shunt into the eye comprises inserting the intraocular shunt via an incision technique.

Clause 34. The method according to any one of paragraphs 19 to 33, wherein inserting the intraocular shunt into the eye comprises inserting the intraocular shunt via a cutting technique.

Item 35. The method of any one of paragraphs 19-34, wherein applying force to a location with lower pressure comprises applying force with a finger.

Clause 36. The method of any one of paragraphs 19-35, wherein applying force to a location with lower pressure comprises applying force through a tool.

Clause 37. 36. The method of paragraph 36, wherein the tool includes a roller tool.

38. 36. The method of paragraph 36, wherein the tool comprises a wedge-shaped tool.

Clause 39. A method of adjusting the flow rate of an intraocular shunt implanted in the eye, which is to determine the location of the outflow end of the intraocular shunt beneath the condyle of the eye. It is possible to operate to allow flow from, and to massage the outflow end of the shunt to remove the plug from the shunt's lumen, resulting in a modified flow through the shunt. Methods, including being massaged.

Item 40. The plug includes a first medial cross-sectional dimension, the intraocular shunt contains a second medial cross-sectional dimension that is greater than the first medial cross-sectional dimension, and massaging the outflow end is a first medial cross-sectional dimension. 39. The method of claim 39, comprising compressing the second inner cross-sectional dimension so that it is smaller than.

Clause 41. 39. The method of claim 39 or 40, wherein massaging the outflow end comprises increasing the permissible flow rate from about zero to a non-zero flow rate.

Clause 42. 39. The method of any one of paragraphs 39-41, wherein massaging the outflow end comprises increasing the permissible flow rate from a non-zero flow rate.

Clause 43. Massaging the outflow end comprises removing the plug from the lumen and then positioning the plug in a location distant from the outlet of the outflow end, any one of paragraphs 39-42. The method described in the section.

Clause 44. 43. The method of claim 43, further comprising removing the plug from the eye after removing the plug from the outflow end.

Clause 45. The method according to any one of paragraphs 39 to 44, wherein the outflow end is located within the subconjunctival space of the eye.

Clause 46. 39. The method of any one of paragraphs 39-45, wherein massaging the outflow end comprises massaging the conjunctiva of the eye to massage the outflow end of the intraocular shunt.

Clause 47. 39. The method of any one of paragraphs 39-46, wherein at least a portion of the plug is placed internally within the intraocular shunt.

Clause 48. 39. The method of any one of paragraphs 39-47, wherein the stopper is at least partially placed outside the shunt prior to massaging the outflow end.

Clause 49. The method of any one of paragraphs 39-48, further comprising allowing the plug to disassemble after massaging the outflow end.

Item 50. The method according to any one of paragraphs 39 to 49, wherein the stopper comprises a decomposable material, a viscoelastic material, or any combination of the above.

Item 51. The method according to any one of paragraphs 39 to 50, wherein the plug comprises a plurality of plugs.

Clause 52. The method according to any one of paragraphs 39 to 51, wherein the stopper comprises a drug.

Clause 53. 39. The method of any one of paragraphs 39-52, further comprising inserting an intraocular shunt into the eye such that the inflow portion of the intraocular shunt is located within the anterior chamber of the eye.

Clause 54. 58. The method of paragraph 53, wherein inserting the intraocular shunt into the eye comprises inserting the intraocular shunt via a notch technique.

Clause 55. The method of paragraph 53, wherein inserting the intraocular shunt into the eye comprises inserting the intraocular shunt via a cutting technique.

Clause 56. The method according to any one of paragraphs 39 to 55, wherein massaging the outflow end comprises applying mechanical force to the plug.

Clause 57. 56. The method of paragraph 56, wherein massaging the outflow end of the shunt comprises applying force to the conjunctiva of the eye to remove the plug from the lumen.

Clause 58. 58. The method of claim 57, wherein applying force to the conjunctiva comprises applying force with a finger.

Clause 59. 58. The method of claim 57, wherein applying force to the conjunctiva comprises applying force through a tool.

Item 60. The method of paragraph 59, wherein the tool includes a roller tool.

Item 61. 59. The method of paragraph 59, wherein the tool comprises a wedge-shaped tool.

Clause 62. 56. The method of claim 56, wherein applying mechanical force to the stopper comprises applying mechanical force through a tool.

Clause 63. 62. The method of paragraph 62, wherein the tool is a recovery tool.

Clause 64. A shunt for draining fluid from the anterior chamber of the eye that blocks the flow through the lumen, if any, with the main compartment having an inflow end, an outflow end, and a wall defining the lumen. It features a removable part that is coupled to the outflow end, which provides a breakable seal over the outflow end and is configured to collapse under compressive force on the shunt. The collapse of the removable part allows the fluid to flow from the anterior chamber through the lumen to the inflow end towards the outflow end, and as a result, when positioned in the eye, the fluid. A shunt that is released through the outflow end at a location where the pressure is lower than the anterior chamber.

Clause 65. 64. The shunt according to paragraph 64, wherein the removable portion comprises a disc-shaped membrane bonded to the outflow end.

Clause 66. 65. The shunt according to paragraph 65, wherein the wall of the main compartment comprises a first thickness, the membrane comprises a second thickness, and the first thickness is greater than the second thickness.

Clause 67. 65. The shunt according to paragraph 65, wherein the wall of the main compartment comprises a first thickness, the membrane comprises a second thickness, and the first thickness is equal to the second thickness.

Clause 68. 65. The shunt according to paragraph 65, wherein the wall of the main compartment comprises a first thickness, the membrane comprises a second thickness, and the first thickness is three times smaller than the second thickness.

Clause 69. The shunt according to any one of paragraphs 65 to 68, wherein the membrane is positioned in the lumen.

Item 70. The shunt according to any one of paragraphs 65 to 68, wherein the membrane comprises a plug.

Clause 71. The shunt according to paragraph 64, wherein the removable portion has a bulb shape and overlaps the outer surface of the shunt adjacent to the outflow end.

Clause 72. 31. The shunt according to paragraph 71, wherein the removable portion comprises an outer cross-sectional profile that is larger than the outer diameter of the shunt.

Clause 73. The shunt according to any one of paragraphs 64 to 72, wherein the removable portion comprises a first material and the main compartment comprises a second material different from the first material.

Clause 74. The shunt according to any one of paragraphs 64 to 73, wherein the removable portion is soluble.

Item 75. The shunt according to any one of paragraphs 64 to 74, wherein the shunt comprises crosslinked gelatin.

Clause 76. The shunt according to any one of paragraphs 64 to 75, wherein the removable portion comprises an axial thickness of about 0.1% to about 40% of the total length of the shunt.

Clause 77. The shunt according to any one of paragraphs 64 to 76, wherein the removable portion comprises an axial thickness of about 30% to about 40% of the total length of the shunt.

Clause 78. The shunt according to any one of paragraphs 64 to 77, wherein the removable portion comprises an axial thickness of about 20% to about 30% of the total length of the shunt.

Clause 79. The shunt according to any one of paragraphs 64 to 78, wherein the removable portion comprises an axial thickness of about 15% to about 20% of the total length of the shunt.

Item 80. The shunt according to any one of paragraphs 64 to 79, wherein the removable portion comprises an axial thickness of about 10% to about 15% of the total length of the shunt.

Item 81. The shunt according to any one of paragraphs 64 to 80, wherein the removable portion comprises an axial thickness of about 5% to about 10% of the total length of the shunt.

Clause 82. The shunt according to any one of paragraphs 64 to 81, wherein the removable portion comprises an axial thickness of about 3% to about 5% of the total length of the shunt.

Clause 83. The shunt according to any one of paragraphs 64 to 82, wherein the removable portion comprises an axial thickness of 2% to about 3% of the total length of the shunt.

Clause 84. The shunt according to any one of paragraphs 64 to 83, wherein the removable portion comprises an axial thickness of 1% to about 2% of the total length of the shunt.

Item 85. The shunt according to any one of paragraphs 64 to 75, wherein the removable portion comprises an axial thickness of from about 8 μm to about 3200 μm.

Clause 86. The shunt according to any one of paragraphs 64 to 75 or 85, wherein the removable portion comprises an axial thickness of from about 16 μm to about 2400 μm.

Clause 87. The shunt according to any one of paragraphs 64 to 75 or 85 or 86, wherein the removable portion comprises an axial thickness of from about 24 μm to about 1600 μm.

Item 88. The shunt according to any one of paragraphs 64 to 75 or 85 to 87, wherein the removable portion comprises an axial thickness between about 30 μm and about 80 μm.

Clause 89. The shunt according to any one of paragraphs 64 to 75 or 85 to 88, wherein the removable portion comprises an axial thickness between about 40 μm and about 50 μm.

Item 90. The shunt according to any one of paragraphs 64 to 75 or 85 to 89, wherein the removable portion has an axial thickness of about 45 μm.

Clause 91. The shunt according to any one of paragraphs 64 to 75 or 85 to 87, wherein the removable portion comprises an axial thickness of 32 μm to about 1200 μm.

Clause 92. The shunt according to any one of paragraphs 64 to 75, 85 to 87, or 91, wherein the removable portion comprises an axial thickness of about 40 μm to about 800 μm. ..

Clause 93. The removable portion comprises an axial thickness of about 80 μm to about 400 μm, any one of paragraphs 64 to 75, 85 to 87, or 91 or 92. The shunt described in.

Clause 94. The removable portion comprises an axial thickness of about 160 μm to about 240 μm, any one of paragraphs 64 to 75, 85 to 87, or 91 to 93. The shunt described in the section.

Item 95. 64. The method of making a shunt, wherein the outflow end of the shunt is immersed in a layer of liquid or viscous material, allowing the material to be bonded to the outflow end. A method that involves allowing and drying the material to form a removable portion.

Item 96. 64. A method of manufacturing a shunt, comprising inserting a material into the outflow end of the shunt to form a removable portion and to bond the removable portion to the outflow end. ..

Further Consideration In some embodiments, any of the terms herein may depend on any one of the independent terms or any one of the dependent terms. In one embodiment, any of the terms (eg, dependent or independent term) can be combined with any other one or more terms (eg, dependent or independent term). In one embodiment, the claim may include some or all of the words (eg, steps, actions, means or components) cited within a term, sentence, phrase, or paragraph. In one embodiment, the claims may include some or all of the words cited in one or more terms, sentences, phrases, or paragraphs. In one embodiment, some of the words in each of the terms, sentences, phrases, or paragraphs may be removed. In one embodiment, additional words or elements can be added to a term, sentence, phrase, or paragraph. In one embodiment, the techniques of the subject can be practiced without utilizing some of the components, elements, functions, or actions described herein. In one embodiment, additional components, elements, functions, or actions can be utilized to implement the techniques of the subject.

When an element is referenced in the singular, this is not intended to mean that it is unique, unless specifically stated so, and means one or more. do. For example, the "one (a)" module may refer to one or more modules. Elements preceded by "one (a, an)," "the," or "said" do not preclude the existence of additional same elements, unless further constrained.

Headings and subheadings, if present, are used for convenience only and do not limit the invention. The word exemplary is used to mean serve as an example or case. To the extent that terms such as include, have, etc. are used, such terms are to be prepared when the term to be prepared when used as a transitional term in the claims is interpreted. Similarly, it is intended to be inclusive. Related terms such as first and second can be used to distinguish one entity or action from another, and not necessarily any actual such relationship or between such entities or actions. It does not require order and does not imply.

One aspect, its aspect, another aspect, some aspects, one or more aspects, one embodiment, its embodiment, another embodiment, some embodiments, one or more embodiments, one. Examples, its Examples, Other Examples, Some Examples, One or More Examples, One Configuration, Its Configuration, Another Configuration, Several Configurations, One or Multiple Configurations, Subject The techniques, the present disclosure, the disclosure of the present invention, other variants, etc. are for convenience only, and disclosures relating to such phrases are essential to the art of the subject, or such. It does not imply that the disclosure applies to all configurations of the technology of this subject. Disclosures relating to such phrases may apply to all configurations, or to one or more configurations. Disclosures relating to such phrases can provide one or more examples. A phrase such as one or several aspects can refer to one or more aspects, and vice versa, which also applies to the other above-mentioned phrases.

The phrase "at least one of" that precedes a series of items with the term "and" or "or" that separates any of the items modifies the list as a whole, not each member of the list. do. The phrase "at least one of" does not require the selection of at least one item, rather the phrase is of any one of the items and / or any combination of items. It is permissible to include at least one of at least one and / or at least one of each of the items. As an example, the phrases "at least one of A, B and C" or "at least one of A, B or C" are A only, B only or C only; of A, B and C, respectively. Any combination; and / or refers to at least one of each of A, B, and C.

It is understood that the particular sequence or hierarchy of steps, actions, or processes disclosed is an example of an exemplary approach. It is understood that a particular order or hierarchy of steps, actions, or processes may be performed in a different order, unless explicitly stated otherwise. Part of a step, operation, or process may be performed at the same time. The attached method claims, if present, present some elements of steps, actions or processes in sample order and are not intended to be limited to the particular order or hierarchy presented. These may be performed continuously, linearly, in parallel, or in a different order. It is understood that the instructions, operations, and systems described may generally be integrated together in a single software / hardware product, or may be packaged in multiple software / hardware products. sea bream.

In one embodiment, terms such as being combined can be referred to as being directly combined. In another aspect, terms such as being combined can be referred to as being indirectly combined.

Terms such as top, bottom, anterior, posterior, lateral, horizontal, and vertical refer to any frame of reference rather than the usual gravitational frame of reference. Therefore, such terms may extend upward, downward, diagonally, or horizontally in a gravity reference system.

The present disclosure is provided to allow one of ordinary skill in the art to practice the various aspects described herein. In some cases, known structures and components are shown in block diagram format so as not to obscure the technical concept of the subject. The present disclosure provides various examples of the technology of the subject, and the technology of the subject is not limited to these examples. Various modifications to these embodiments will be readily apparent to those skilled in the art and the principles described herein can be applied to other embodiments.

All structural and functional equivalents to the elements of the various aspects described throughout this disclosure, which will be known to those of skill in the art or will be known later, are expressly incorporated herein by reference. It is intended to be covered by the claims. Moreover, all content disclosed herein is not intended to be dedicated exclusively to the public, whether or not the disclosure is exemplified within the claims. .. Any element of a patent claim is a "step" that the element "does" unless the element is explicitly described using the phrase "means for" or in the case of a method claim. Unless stated using the phrase, it should be construed under the provisions of Article 112, paragraph 6 of the US Patent Act.

The titles of the invention, background techniques, brief descriptions of drawings, abstracts, and drawings are incorporated herein by this disclosure and are provided as exemplary examples of this disclosure, not as a limiting description. It is submitted with the understanding that it will not be used to limit the scope or meaning of the claims. In addition, in embodiments for carrying out the invention, the description provides exemplary examples and confirms that various features are grouped together in various embodiments for the purpose of streamlining the present disclosure. Can be done. The disclosure method should not be construed as reflecting the intent that the claimed subject matter requires more features than explicitly stated in each claim. Rather, as reflected in the claims, the inventive subject lies in features that are less than all features of a single disclosed configuration or operation. The scope of claims is incorporated herein into a form for carrying out an invention, and each claim is itself independent as a separately claimed subject matter.

The claims are not intended to be limited to the aspects described herein, they are in line with the full scope of the written claims and include all legal equivalents. It is something to do. Nevertheless, none of the claims is intended to cover or be construed as such to cover subjects that do not meet the requirements of applicable patent law.

Claims (17)

A shunt for draining fluid from the anterior chamber of the eye that blocks the inflow end, the outflow end, and the main compartment with walls defining the lumen and, if present, the flow through the lumen. Provided with a removable portion coupled to the outflow end portion, the removable portion provides a breakable seal over the outflow end portion and receives a compressive force applied to the shunt. The removable portion is crushed and removed or taken out so that the fluid flows from the anterior chamber through the lumen to the inflow end toward the outflow end. As a result, when positioned in the eye, the fluid is released through the outflow end at a location where the pressure is lower than the anterior chamber, shunt. The shunt according to claim 1, wherein the removable portion includes a disk-shaped membrane bonded to the outflow end. The second aspect of the invention, wherein the wall of the main compartment comprises a first thickness, the film comprises a second thickness, and the first thickness is greater than the second thickness. Shunt. 2. The wall of the main compartment comprises a first thickness, the membrane comprises a second thickness, the first thickness being equal to the second thickness, claim 2. Shunt. The wall of the main compartment comprises a first thickness, the membrane comprises a second thickness, and the first thickness is three times as thick as the second thickness. The shunt according to claim 2. The shunt according to claim 2, wherein the membrane is positioned in the lumen. The shunt according to claim 2, wherein the membrane comprises a stopper. The shunt according to claim 1, wherein the removable portion has a bulb shape and overlaps the outer surface of the shunt adjacent to the outflow end portion. The shunt according to claim 8, wherein the removable portion has an outer cross-sectional profile that is larger than the outer diameter of the shunt. The shunt according to claim 1, wherein the removable portion comprises a first material, and the main compartment comprises a second material different from the first material. The shunt according to claim 1, wherein the removable portion is soluble. The shunt according to claim 1, wherein the removable portion has an axial thickness between about 30 μm and about 80 μm. The shunt according to claim 1, wherein the removable portion has an axial thickness of about 45 μm. The shunt according to claim 1, wherein the removable portion has an axial thickness of about 0.1% to about 40% of the total length of the shunt. The shunt according to claim 1, wherein the removable portion has an axial thickness from about 8 μm to about 3200 μm. The method for producing the shunt according to claim 1.
Immersing the outflow end of the shunt in a layer of liquid or viscous material, allowing the material to be bonded to the outflow end, and soaking.
A method comprising drying the material to form a removable portion. The method for producing the shunt according to claim 1.
A method comprising inserting a material into the outflow end of the shunt to form a removable portion and to attach the removable portion to the outflow end.

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