Ophthalmic device for treating glaucoma and related minimally invasive glaucoma surgery method

Abstract

The bypass device is implanted into body tissue using minimally invasive surgery to provide a flow path through the tissue. The bypass device includes a base having opposite first and second ends, and a bend tine attached to the base and configured in a bent position relative to the base. The base includes a flow space that exists where the bend tine is bent relative to the base, allowing fluid to flow through the bypass device. The bypass device further includes an anchor tine located adjacent the second end of the base to help secure the bypass device in place after implantation. The bypass device may be implanted in an eye using a MIGS procedure to treat glaucoma, allowing aqueous humor to flow through the flow space of the bypass device and exit through aligned elongated holes formed during implantation through the trabecular meshwork.

Description

[Technical Field]

[0001] The present invention relates generally to intraocular implantable bypass devices for treating glaucoma and to surgical procedures for implanting intraocular implantable bypass devices for use in treating glaucoma. [Background technology]

[0002] It is estimated that approximately 3 million people in the United States suffer from glaucoma, and more than 100,000 people are blind due to the condition. Glaucoma is the second leading cause of blindness among Americans ages 18 to 65 and the leading cause of blindness among African Americans. Glaucoma is an optic neuropathy, or damage to the optic nerve, characterized by elevated intraocular pressure. Increased intraocular pressure can result in changes in the appearance ("cup") and function ("blind spot") of the visual field of the optic nerve. If this intraocular pressure remains high for an extended period of time, it can lead to complete loss of vision.

[0003] The eyeball is a hollow structure that contains a clear fluid called aqueous humor. Aqueous humor is then continuously produced in the posterior chamber of the eye by the ciliary body. The aqueous humor passes around the lens and through the pupillary opening in the iris into the anterior chamber of the eye. Aqueous humor that enters the anterior chamber is drained through a tubular pathway that primarily includes the trabecular meshwork and Schlemm's canal. The trabecular meshwork and Schlemm's canal are located at the junction of the iris and cornea, called the drainage angle. The trabecular meshwork is composed of trabecular collagen beams that form a three-dimensional sieve-like structure and are lined with a single layer of trabecular cells. Furthermore, the outer wall of this trabecular meshwork coincides with the inner wall of Schlemm's canal, a tubular structure that exists around the cornea.

[0004] The aqueous humor is filtered through the trabecular meshwork and enters Schlemm's canal, from where it passes through a series of collecting ducts to the scleral venous system where it is absorbed. In healthy individuals, the amount of aqueous humor produced is approximately equal to the amount of aqueous humor outflow, so intraocular pressure remains approximately constant within the range of 10 mmHg to 21 mmHg. High pressure in the eye is caused by an imbalance of fluids inside the eye. In glaucoma, higher than normal resistance through the canalicular outflow system reduces outflow, causing an internal fluid imbalance and consequent elevated intraocular pressure. Specifically, the drainage angle formed by the cornea and iris remains open, but the tiny drainage canals within the trabecular meshwork are at least partially blocked. In other forms of glaucoma, outflow through the canalicular pathways may be reduced due to mechanical obstruction, inflammatory debris, or cellular blockage.

[0005] When the drainage system does not function properly, aqueous humor does not filter out of the eye at the normal rate. As aqueous humor accumulates, pressure within the eye increases. Increased intraocular pressure can compress the axons of the optic nerve, which carry visual signals from the eye to the brain, and can also impair the vascular supply to the optic nerve. Damage to the optic nerve is painless and progresses slowly, so vision loss can occur before a person realizes there is a problem.

[0006] Conventional treatments for glaucoma vary. For example, eye and systemic medications are used to treat glaucoma by reducing the production of aqueous humor or increasing its drainage from the eye.

[0007] Surgery may be performed as the first-line treatment or when medical therapy fails to lower intraocular pressure. For example, a surgical procedure may be performed to open an anatomically closed drainage pathway for aqueous humor to the outside of the eye. Trabeculectomy is a surgical procedure that creates a pathway for aqueous humor to travel to the surface of the eye. The anterior chamber is entered from below the scleral flap and the deep part of the sclera and part of the trabecular meshwork are excised. After surgery, aqueous humor passes through the hole and collects in a raised space below the conjunctiva (the subconjunctival reservoir). This fluid is then absorbed from the blood vessels of the conjunctiva or passes across the conjunctiva into the tear film. The drawback of this procedure is that the resulting bleb is very thin and often fails or ruptures, providing a pathway for bacteria that normally live on the surface of the eyeball and on the eyelids to enter the eye.

[0008] Another surgical procedure involves the use of an aqueous humor tube shunt. Typically, a needle is used to create a full-thickness hole in the limbus of the eye. A tube shunt is inserted into the eye through this hole, allowing aqueous humor to drain onto the surface of the eye. The tube is attached to a plate, which is placed under the extraocular muscles. This plate helps to create a reservoir under the conjunctiva through which aqueous humor drains. Aqueous humor shunts are associated with many complications. Thickened scar tissue walls can block the outflow of aqueous humor and limit the reduction of intraocular pressure. A filtering bleb may not form quickly or at all, resulting in unrestricted flow from the shunt to the outer surface, causing intraocular pressure to become too low and a variety of events that can damage the eye and lead to loss of function and vision. These shunts can erode the overlying tissue and create openings on the surface of the eye, providing a pathway for bacteria to enter the eye and potentially causing intraocular inflammation.

[0009] Laser surgery is a surgical procedure to reduce intraocular pressure, and includes cyclophotocoagulation (using a laser to burn the areas that produce aqueous humor, reducing aqueous humor production), iridotomy (using a laser to create a hole in the iris to improve fluid flow within the eye), and trabeculoplasty (using a laser to create a hole in the drainage area of the eye to improve fluid drainage within the eye). However, laser surgery is complicated and has various drawbacks, such as reduced effectiveness over time, inflammation, and associated complications.

[0010] Therefore, standard glaucoma surgery is a major operation with significant drawbacks. Although such surgery is highly effective in lowering intraocular pressure and preventing the progression of glaucoma, there are many potential complications. To overcome these drawbacks, more advanced techniques have been developed, commonly referred to as "minimally invasive glaucoma surgery," or MIGS. MIGS treatment is a small incision procedure using small instruments. While complication rates have decreased, some efficacy has been sacrificed in exchange for improved safety.

[0011] MIGS procedures generally fall into several categories, including mini-trabeculectomy, trabecular bypass surgery, totally internal or suprachoroidal shunts, mild or gentle laser photocoagulation, and intracanalicular grafting (ABiC). MIGS procedures are typically performed by bypassing the blocked trabecular meshwork (such as with trabecular bypass surgery or the use of a suprachoroidal shunt) to allow aqueous humor to drain into another potential space, or by opening Schlemm's canal and collecting duct (ABiC) and reducing aqueous humor production (laser photocoagulation). Because MIGS procedures offer advantages over conventional treatments, efforts are currently underway to improve MIGS procedures. Summary of the Invention [Problem to be solved by the invention]

[0012] The present invention relates to an implantable intraocular bypass device and related minimally invasive glaucoma surgery (MIGS) procedures that use the implantable intraocular bypass device to treat glaucoma. The MIGS technique described involves perforating the trabecular meshwork to create openings in the meshwork to facilitate the flow of aqueous humor into Schlemm's canal. [Means for solving the problem]

[0013] The implantable intraocular bypass device includes a plurality of curved tines. The curved teeth at the tip of the intraocular implant bypass device then first engage the trabecular meshwork, and the intraocular implant bypass device is then pushed forward to create an opening or window in the trabecular meshwork. Here, the tip of the distal bending tooth remains within Schlemm's canal. The distal curved teeth are pushed all the way to the posterior wall of Schlemm's canal. At that time, the introducer device is used to further push the proximal portion of the intraocular implant bypass device toward the trabecular meshwork, thereby engaging the second curved prong of the intraocular implant bypass device. The entire intraocular implant bypass device is then pushed out of the delivery device, causing both of the bending tines to advance, and this pushing action also widens the opening in the trabecular meshwork that is created by advancing the bending tines. The large opening formed in the trabecular meshwork naturally matches the flow space at the base of the implanted intraocular bypass device, allowing aqueous humor to flow freely into the space of Schlemm's canal and exit through the collecting canal. The anchoring teeth on the end of the intraocular implant bypass device act like a kickstand that rests on the trabecular meshwork when released from the delivery device. When the anchor teeth, which act as kickstands, are released from the tip of the introducer, the pushing action stops, creating an opening in the trabecular meshwork large enough to match the flow space through the intraocular implant bypass device. In this way, the flow space of the intraocular implant bypass device is naturally formed over the openings in the trabecular meshwork. The anchor tines prevent spontaneous posterior migration of the implanted intraocular bypass device. The intraocular implant bypass device can also be easily removed by lifting the anchor teeth away from the trabecular meshwork to relieve the kickstand function and sliding the bending teeth back towards the corresponding openings in the trabecular meshwork.

[0014] Thus, the intraocular implant bypass device may include one or more curved tines extending from the base of the intraocular implant bypass device. Various parameters of the curved teeth may be modified and optimized for a particular application or body type, including length, shape, width, tooth angle, size of the window formed where aqueous humor drains from the anterior chamber, and many other dimensions may be varied depending on the intended application or patient situation. The curvature of the base of the implanted intraocular bypass device is designed to match the normal curve of the trabecular meshwork / Schlemm's canal complex. The curvature of the implanted intraocular bypass device may vary depending on the corneal diameter of a particular patient. The posterior ends, i.e., anchor teeth, of the intraocular implant bypass device are curved so that the posterior ends can be directed toward the trabecular meshwork, and the angle, length, width, and many other dimensions of the anchor teeth may also vary depending on the intended use or patient condition.

[0015] The intraocular implantable bypass device is implanted through a very small incision, causing minimal tissue disruption, functions without destroying surrounding tissue, and is easily reversible, making it a minimally invasive glaucoma surgery (MIGS) device. Implantation of the intraocular implant bypass device is performed using a specially designed introducer. The distal end of the introducer device includes a cannula at its distal end into which the intraocular implant bypass device is placed and maintained in an initial retracted position. And, the introducer device further includes an advancement plunger disposed through the cannula and positioned posteriorly relative to the intraocular implant bypass device. The advancement plunger is operated by depressing one or more levers on the introducer device to advance the intraocular implant bypass device through the appropriate location as described above.

[0016] Thus, the present invention is an intraocular implantable bypass device that can be implanted in body tissue to provide a flow path through the body tissue, for example, through the trabecular meshwork as part of a glaucoma treatment. In an embodiment of the invention, the intraocular implant bypass device includes a base portion having a first end and a second end opposite the first end; first and second bend tines attached to the base portion and configured in a bent position relative to the base portion, the first bend tine being located closest to the first end of the base portion and the second bend tine being located between the first bend tine and the second end of the base portion, the base portion including a first flow space emanating from where the first bend tine is bent relative to the base portion and a second flow space emanating from where the second bend tine is bent relative to the base portion, the first flow space and the second flow space allowing fluid to flow through the intraocular implant bypass device; and an anchor tine located adjacent the second end of the base portion to help secure the intraocular implant bypass device in place during use.

[0017] Another aspect of the present invention is a minimally invasive glaucoma surgery (MIGS) for treating glaucoma using a method of implanting an intraocular implantable bypass device in the trabecular meshwork to define a flow path that allows the drainage of aqueous humor. In this embodiment, the MIGS method includes the steps of providing an intraocular implant bypass device according to any of the embodiments that bypasses the drainage system of the eye, including Schlemm's canal, the trabecular meshwork, and the collecting canal; placing the intraocular implant bypass device in an initial retracted position within the cannula so that the advancement plunger is positioned posteriorly relative to the intraocular implant bypass device within the cannula; forming a guide hole in the trabecular meshwork of the eye to access Schlemm's canal; and inserting the cannula having the intraocular implant bypass device and the advancement plunger into the guide hole. and positioning a cannula adjacent to the trabecular meshwork; manipulating the introducer to operate the advancement plunger and advance the intraocular implant bypass device through the cannula from an initial retracted position to an intermediate position, thereby exposing the first and second bend tines from the cannula; manipulating the introducer to operate the advancement plunger and advance the intraocular implant bypass device through the cannula from the initial retracted position to an intermediate position; puncturing the trabecular meshwork with ends of the first and second bend tines; and pushing the first and second bend tines into the trabecular meshwork. and operating the introducer to operate the advancement plunger to advance the intraocular implant bypass device through the cannula from the intermediate position to the extended position, wherein as the intraocular implant bypass device advances from the initial retracted position to the extended position, the first bending tines and the second bending tines open elongated flow holes in the trabecular meshwork, so that when the intraocular implant bypass device reaches the extended position, the elongated flow holes are aligned with the flow spaces in the base of the intraocular implant bypass device, and aqueous humor flows through the first flow space and the second flow space of the intraocular implant bypass device, advancing the trabecular meshwork. and operating the introducer to operate the advancement plunger to advance the intraocular implant bypass device through the cannula from the intermediate position to the extended position, the wire flowing through the cannula allowing it to flow into and exit Schlemm's canal through aligned elongated flow holes through the cannula; and withdrawing the cannula together with the wire, leaving the intraocular implant bypass device in place, wherein when the intraocular implant bypass device reaches the extended position and the cannula is removed, the anchor tines are positioned against the inner surface of the trabecular meshwork, and the anchor tines positioned against the inner surface of the trabecular meshwork are curved.and withdrawing the cannula, which generates a retention force to help maintain the bypass device in place.

[0018] The features of the present invention will become apparent upon reference to the following description and accompanying drawings. In the following description and drawings, embodiments of the present invention are disclosed in detail to illustrate certain aspects in which the principles of the present invention may be employed, but the present invention is not limited in scope accordingly. Rather, the invention includes all changes, modifications, and equivalents falling within the spirit and scope of the claims appended hereto. Features described and / or illustrated with respect to one embodiment may be used in other embodiments in the same or similar manner and / or in combination with or instead of features of other embodiments. [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 1 is a diagram showing a cross section of an eyeball. [Figure 2] FIG. 2 is a diagram showing an enlarged cross-sectional view of the anterior chamber angle of the eyeball of FIG. 1. [Figure 3] [Figure 4] [Figure 5] 1A-1C illustrate various views of an intraocular implant bypass device according to an embodiment of the present invention. [Figure 6] FIG. 6 illustrates an introducer device that can be used to surgically implant the intraocular implant bypass device of FIGS. 3-5. [Figure 7] 7 shows a cross-sectional view of a portion of the introduction device of FIG. 6. [Figure 8] 8A-8D show various views of the first stage of a MIGS procedure with the intraocular implant bypass device in an initial retracted position. [Figure 9] 9A-9D show various views of the second stage of the MIGS procedure with the intraocular implant bypass device in an intermediate position. [Figure 10]10A-10D show various views of the third stage of the MIGS procedure with the intraocular implant bypass device in its final extended position. [Figure 11] FIG. 10 illustrates a fourth stage of a MIGS procedure with the intraocular implant bypass device in its final extended position and the cannula and stent removed while the intraocular implant bypass device remains in its in-use position. DETAILED DESCRIPTION OF THE INVENTION

[0020] Embodiments will now be described with reference to the drawings, wherein like reference numerals are used to refer to like elements. The figures are not necessarily to scale.

[0021] FIG. 1 is a diagram showing a cross-section of an eye 10, and FIG. 2 is a diagram showing an enlarged cross-section of the anterior chamber angle of the eye 10 of FIG. 1, including the relative anatomical positions of the trabecular meshwork, the anterior chamber, and Schlemm's canal. A collagenous tissue known as the sclera 11 covers the eyeball 10 except for the portion covered by the cornea 12 . The cornea 12 is the transparent tissue that focuses and transmits light into the eye 10, and the pupil 14 is a circular hole in the center of the iris 13 (the colored part of the eye 10). The cornea 12 is connected to the sclera 11 at a junction called the limbus 15 . The ciliary body 16 begins inside the eyeball 10 and extends along the inside of the sclera 11 , where it becomes the choroid 17 . The choroid 17 is the vascular layer of the eye 10 that lies beneath the retina 18 . The optic nerve 19 transmits visual information to the brain and, as mentioned above, is gradually destroyed by glaucoma.

[0022] The anterior chamber 20 of the eyeball 10 is surrounded in front by the cornea 12 and in back by the iris 13 and the lens 26, and is filled with aqueous humor. As mentioned above, aqueous humor is a fluid produced primarily by the ciliary body 16 and passes through the pupil 14 into the anterior chamber angle 25 formed between the iris 13 and the cornea 12 . In a normal eye 10 , aqueous humor drains through the trabecular meshwork 21 . This aqueous humor passes through the trabecular meshwork 21 into Schlemm's canal 22 and enters the venous circulation through aqueous veins 23 where they join with blood-carrying veins. As described above, the intraocular pressure of the eyeball 10 is maintained by a complex balance between the secretion and outflow of aqueous humor. Glaucoma is characterized by the excessive accumulation of aqueous humor in the anterior chamber 20, which increases intraocular pressure and ultimately damages and destroys the optic nerve 19.

[0023] The present invention relates to an implantable intraocular bypass device and related minimally invasive glaucoma surgery (MIGS) procedures that use the implantable intraocular bypass device to treat glaucoma. In this embodiment, the intraocular implant bypass device 30 has a base portion 32 and a plurality of protrusions configured as curved teeth extending from the base portion 32 and forming openings that penetrate the trabecular meshwork 21. The intraocular implant bypass device 30 includes at least two such curved tines. Additionally, the bypass device 30 includes anchor tines 42 extending from the base portion 32 that help maintain the intraocular implant bypass device 30 in place after implantation. The base portion 32 may have a curvature that approximates the curvature of the iridocorneal angle structure. The curved teeth are inserted through the trabecular meshwork 21 into the desired position. In particular, the curved teeth may be inserted at locations where the trabecular meshwork 21 is obstructed as determined by visualization techniques. When the intraocular implant bypass device 30 is implanted, the anchor teeth 42 move along the inner surface of the trabecular meshwork 21, creating a retention force that helps keep the intraocular implant bypass device 30 in place. The base portion 32 of the intraocular implant bypass device 30 includes a flow space that exists from where the bending teeth are bent relative to the base portion 32, and this flow space allows fluid to flow through the intraocular implant bypass device 30.

[0024] 3-5 illustrate a bypass device 30 according to an embodiment of the present invention. The implantable intraocular bypass device 30 includes a base portion 32 formed with a curvature that approximates the curvature of the iridocorneal angle structure. The base portion 32 then defines a flow space through which fluid (eg, aqueous humor) flows through the intraocular implant bypass device 30 . As will be described in more detail below, the intraocular implant bypass device 30 is formed to include a plurality of protrusions configured as curved tines attached to a base portion 32 . The intraocular implant bypass device 30 also includes additional anchoring teeth that act to generate a retention force that helps maintain the intraocular implant bypass device 30 in place after implantation.

[0025] Furthermore, the implantable intraocular bypass device 30 may be formed using any suitable manufacturing process. Examples of manufacturing processes include, but are not limited to, laser cutting, photochemical etching, electrical discharge machining (EDM) or micromachining and micromolding from plastic substrates. Materials used to form the implantable bypass member include, for example, nitinol, platinum, titanium, stainless steel, gold, silicon, PMMA, polyimide, and the like. In this embodiment, the material of the implantable bypass member is Nitinol, and the shape undergoes a three-stage heat treatment to form the teeth and curves. A common base fixture may be used for all three heat treatment stages, but with different configurations and orientations, and the heat treatment is performed at 525°C for 7 minutes per stage.

[0026] In the embodiment of FIGS. 3 to 5, the bent teeth are configured to be bent relative to the base portion 32. The base portion 32 has a first end 31 and a second end 33 opposite the first end 31 . In the embodiment of FIGS. 3-5, the intraocular implant bypass device 30 includes a first bending tine 34 and a second bending tine 36 spaced apart along the base portion 32 . The first bent tooth 34 is positioned closest to the first end 31 of the base portion 32, and the second bent tooth 36 is positioned between the first bent tooth 34 and the second end 33 of the base portion 32. Each of the first or second curved teeth 34 or 36 includes an attachment portion 34a / 36a at which the first or second curved teeth 34 or 36 are attached to the base portion 32, a curved portion 34b / 36b extending from the attachment portion 34a / 36a and curved relative to the attachment portion 34a / 36a, a tooth body 34c / 36c extending from the curved portion 34b / 36b, and a pointed or arrow-shaped end 34d / 36d used to puncture the trabecular meshwork 21 during implantation, as described in more detail below. Furthermore, because the curved portions 34b / 36b are curved relative to the mounting portions 34a / 36a, the first curved tooth 34 or the second curved tooth 36 extends from the base portion 32 at an acute angle 34e / 36e relative to the base portion 32, respectively. Acute angles 34e and 36e may be the same or different. Additionally, although Figures 3-5 show two possible first and second flexion teeth 34, 36, any appropriate number of flexion teeth may be used depending on the particular situation, based on the extent and location of the obstructed portion of the trabecular meshwork 21.

[0027] A flow space exists within the base portion 32 from where the first bent tooth 34 and the second bent tooth 36 are bent relative to the base portion 32 . In the embodiment of FIG. 3, which includes two first and second bent teeth 34 and 36, a first flow space 38 exists from where the first bent tooth 34 bends relative to the base portion 32, and a second flow space 40 exists from where the second bent tooth 36 bends relative to the base portion 32. More generally, whatever number of curved teeth are formed on the intraocular implant bypass device 30, there will be a corresponding number of flow spaces from where the curved teeth curve relative to the base portion 32. As will be explained in more detail below, aqueous humor flows through first and second flow spaces 38, 40 of bypass device 30 and exits through trabecular meshwork 21.

[0028] The intraocular implant bypass device 30 also includes an anchor tine 42 formed on the second end 33 of the base portion 32 . The anchor tooth 42 includes a mounting portion 42a where the anchor tooth 42 is attached to the base portion 32, a curved portion 42b extending from the mounting portion 42a and curved relative to the mounting portion 42a, and a pointed or arrow-shaped end 42d. In contrast to the first and second bent teeth 34, 36, the angle 42e of the curved portion 42b of the anchor tooth 42 relative to the base portion 32 is an obtuse angle less than 180°, preferably between 150° and 170°. As will be explained in more detail below, the obtuse angle of the anchor tines 42 creates a retention force that helps keep the intraocular implant bypass device 30 in place after implantation.

[0029] A MIGS procedure to implant the intraocular implant bypass device 30 is generally performed as follows. The curved tooth at the tip of the intraocular implant bypass device 30 (i.e., the first curved tooth 34) first engages with the trabecular meshwork 21, and then the intraocular implant device is pushed forward using the introduction device 50 to form an opening or window in the trabecular meshwork 21. Here, the tip of the distal bending tooth remains within Schlemm's canal 22. The curved teeth at the tip are pushed all the way into the posterior wall of Schlemm's canal 22 . At this time, the introduction device 50 is used to further push the proximal portion of the intraocular implant bypass device 30 toward the trabecular meshwork 21, thereby engaging the second bending tooth (i.e., bending tooth 36) of the intraocular implant bypass device 30. Next, the entire intraocular implant bypass device 30 is pushed out of the introducer 50, causing both the first bending tine 34 and the second bending tine 36 to advance, and this pushing action also enlarges the opening in the trabecular meshwork 21. The large opening formed in this trabecular meshwork 21 naturally corresponds to the first flow space 38 and the second flow space 40 of the base portion 32 of the intraocular implantable bypass device 30, allowing aqueous humor to flow freely into the space of Schlemm's canal 22 and be discharged through the collecting canal. The anchor tines 42 on the second end 33 of the intraocular implant bypass device 30 act like a kickstand to rest on the trabecular meshwork 21 when released from the introducer 50 . When the anchor teeth 42, which act as kickstands, are released from the tip of the introducer device 50, the pushing action stops, and an opening of sufficient size is formed in the trabecular meshwork 21 to correspond to the first and second flow spaces 38, 40 through the intraocular implant bypass device 30. The anchor teeth 42 then prevent the intraocular implant device from spontaneously migrating backward. The intraocular implant bypass device 30 can also be easily removed by lifting the anchor teeth 42 from the trabecular meshwork 21 to reduce the kickstand function and sliding the first bending teeth 34 and second bending teeth 36 backward toward the corresponding openings in the trabecular meshwork 21.

[0030] The intraocular implant bypass device may be implanted using minimally invasive glaucoma surgery (MIGS), where the intraocular implant bypass device 30 is used to treat glaucoma. The MIGS procedure for implanting this intraocular implant bypass device 30 includes placing the intraocular implant bypass device 30 in an initial, retracted position within a specially designed introducer device 50, specifically within the cannula 72 of the introducer device 50. An advancement plunger 76 of the introducer device 50 is also positioned through the cannula 72 and is positioned posteriorly relative to the intraocular implant bypass device 30 . The advancement plunger 76 is operated by depressing one or more levers on the introduction device 50, causing the advancement plunger 76 to advance through the cannula 72, thereby advancing the intraocular implant bypass device 30 through the appropriate location described above.

[0031] FIG. 6 shows a perspective view of an introducer device 50 that can be used to surgically implant the intraocular implant bypass device 30, and FIG. 7 shows a cross-sectional view of a portion of the introducer device 50 of FIG. The introducer 50 includes a body 52 that terminates in a forward nose 54 . The main body 52 defines a recess 56 in which a first slider 58 and a second slider 60 are disposed. In particular, as can be seen in the enlarged view of FIG. 7, the first slider 58 has a front portion 62, a rear portion 64, and a bridge portion 66 that connects the front portion 62 and the rear portion 64 across the second slider 60 (the entire bridge portion 66 is shown in FIG. 6). First slider 58 and second slider 60 may be configured with ribbed top end 68 and ribbed top end 70, respectively. The ribbed top end 68 and the ribbed top end 70 have surfaces that interact strongly with the surgeon's hands, allowing, for example, the surgeon to press their thumbs along the ribbed top end 68 and the ribbed top end 70 against the first slider 58 and the second slider 60 to easily move the first slider 58 and the second slider 60. The introducer 50 further includes a cannula 72 extending through at least a portion of the first slider 58 and the second slider 60, with a front end 74 of the cannula 72 further extending through the forward nose 54 of the introducer 50. The introducer 50 further includes an advancement plunger 76 inserted into the cannula 72 and secured within the first slider 58 and the second slider 60 .

[0032] The forward end 74 of the cannula 72 may have a stent 78 attached thereto. An advancement plunger 76 is inserted through the cannula 72 and into the stent 78 . The intraocular implant bypass device 30 is positioned so that the advancement plunger 76 is positioned posteriorly relative to the intraocular implant bypass device 30 within the stent 78 . As previously mentioned, the base portion 32 of the intraocular implant bypass device 30 has a curvature that approximates the curvature of a typical iridocorneal angle, and therefore the stent 78 may have a corresponding curvature that approximates the curvature of a typical iridocorneal angle for use in implanting the intraocular implant bypass device 30.

[0033] The MIGS procedure begins with an incision made on the side of the eye's cornea, and access to Schlemm's canal through a small guide hole drilled in the trabecular meshwork. A viscoelastic (gel-like) material may then be introduced into the anterior chamber to maintain a suitable gap within the anterior chamber for implantation. This allows Schlemm's canal and collecting ducts to reopen, and also lubricates and dilates Schlemm's canal. The viscoelastic material may include a visualization agent, which may be a dye such as fluorescein, trypan blue, or other suitable dye, or a physically visible substance such as microbubbles. The visualization agent may be visualized using a suitable imaging technique, such as optical coherence tomography or ultrasound biomicroscopy. Imaging the visualization agent flowing through the aqueous humor drainage pathway allows for detailed observation of Schlemm's canal, trabecular meshwork, and collecting ducts, enabling the surgeon to further identify blocked and unblocked areas of the trabecular meshwork / Schlemm's canal / collecting ducts and to identify the optimal location for inserting the intraocular implantable bypass device 30 to bypass the blocked areas.

[0034] The surgeon manipulates the introducer device 50 to move the cannula 72 through the guide hole to the location where the intraocular implant bypass device 30 will be implanted into the trabecular meshwork 21 . The cannula 72 containing the stent 78 and the intraocular implantable bypass device 30 is guided along the curvature of the anterior chamber 20 of the eye 10 so as to be positioned appropriately to bypass the obstructed portion of the trabecular meshwork 21 . Additionally, cannula 72 may be used to introduce substances such as glaucoma medications, anti-inflammatory agents, antibiotic-releasing pellets, etc. into trabecular meshwork 21 and / or Schlemm's canal 22 to further reduce intraocular pressure and prevent inflammation and associated complications and infections. For example, a separate guidewire having a syringe-type tip may be inserted through cannula 72 below or adjacent to intraocular implant bypass device 30 . A guidewire with a syringe-type tip may be used to introduce the above-mentioned liquids and other substances into the trabecular meshwork 21 and / or Schlemm's canal 22.

[0035] 8-11 illustrate a MIGS procedure in which an intraocular implant bypass device 30 is surgically implanted within the eye 10 using an introducer device 50. FIG. In particular, Figures 8A-8D are various views of the first stage of a MIGS procedure with the intraocular implant bypass device 30 in an initial retracted position. In this first stage, when the intraocular implant bypass device 30 is in an initial retracted position, the intraocular implant bypass device 30 is completely or nearly completely encased within the stent 78 . The advancement plunger 76 of the introducer device 50 is passed through the cannula 72 toward the stent 78 , thereby positioning the advancement plunger 76 rearward relative to the intraocular implant bypass device 30 . A first curved tooth 34 at the tip of the bypass device 30 initially engages the trabecular meshwork 21 of the eye 10 opposite Schlemm's canal 22 (see particularly FIG. 8D).

[0036] 9A-9D are diagrams illustrating the second stage of a MIGS procedure with the intraocular implant bypass device 30 in an intermediate position. With further reference to Figures 6 and 7, in this second stage, the surgeon manipulates the introducer device 50 by advancing the first slider 58 from a first rearward position to a first forward position. By advancing the first slider 58, the first slider 58 advances the advancement plunger 76 forward, thereby further advancing the intraocular implant bypass device 30 through the stent 78 from the initial retracted position to the intermediate position. In this way, the second curved tooth 36 engages with the trabecular meshwork 21 . Next, the surgeon punctures the trabecular meshwork 21 with the arrow-shaped ends 34 d / 36 d of the first bending tooth 34 and the second bending tooth 36 , and presses the first bending tooth 34 and the second bending tooth 36 into the trabecular meshwork 21 . More specifically, as described above in connection with FIG. 3, in the bent configuration of the first bent tooth 34 and the second bent tooth 36, the curved portion 34b / 36b forms an acute angle with respect to the base portion 32. This curvature essentially creates multiple leaf springs, each with an associated spring force. When the surgeon applies pressure to the tissue of the trabecular meshwork 21 with the first bending tooth 34 and the second bending tooth 36, the first bending tooth 34 and the second bending tooth 36 are compressed toward the base portion 32, and this compressive force resists the spring force generated by the curved portions 34b / 36b of the first bending tooth 34 and the second bending tooth 36. This spring force against the compressive force assists the surgeon in pushing the arrow-shaped ends 34 d / 36 d of the first bending tine 34 and the second bending tine 36 through the trabecular meshwork 21 . Thus, in this second stage, the proximal portion of the intraocular implant bypass device 30 is pushed further toward the trabecular meshwork 21 using the introducer 50, thereby engaging the second curved tooth 36 of the intraocular implant bypass device 30. The entire intraocular implant bypass device 30 is then pushed out of the introducer 50, causing both the first bending tine 34 and the second bending tine 36 to advance, and this pushing action enlarges the opening in the trabecular meshwork 21.

[0037] 10A-10D are various views of the third stage of the MIGS procedure, with the intraocular implant bypass device 30 in its final, extended position. In a third stage, the surgeon further manipulates the introducer device 50 by advancing the second slider 60 from the second rearward position to the second forward position. Advancing the second slider 60 causes the second slider 60 to further advance the advancement plunger 76, thereby further advancing the intraocular implant bypass device 30 through the stent 78 from the intermediate position to the extended position. As described above, as the intraocular implant bypass device 30 advances from the intermediate position to the extended position, the first bending tine 34 and the second bending tine 36 create elongated flow holes in the trabecular meshwork 21 . As a result, when the intraocular implant bypass device 30 reaches its final extended position, the elongated flow holes in the trabecular meshwork 21 are aligned with corresponding first and second flow spaces 38, 40 through the base portion 32 of the intraocular implant bypass device 30. This configuration allows aqueous humor to flow through the base portion 32 via the first flow space 38 and the second flow space 40 of the intraocular implant bypass device 30, through aligned elongated flow holes through the trabecular meshwork 21, and into Schlemm's canal 22 where it can be discharged. In this third stage, the pushing action of the introduction device 50 continues, so that the opening of the trabecular meshwork 21 further expands. When the anchor tines 42 are released from the introducer 50, the pushing action stops. The large opening formed in the trabecular meshwork 21 naturally corresponds to the first flow space 38 and the second flow space 40 in the base portion 32 of the intraocular implantable bypass device 30, allowing aqueous humor to flow freely into the space of Schlemm's canal 22 and be discharged through the collecting canal. Anchor teeth 42 on second end 33 of bypass device 30 act like a kickstand to rest on trabecular meshwork 21 when released from introducer device 50 . This allows the anchor teeth 42 to prevent spontaneous posterior migration of the intraocular implant device.

[0038] FIG. 11 illustrates a fourth stage of the MIGS procedure with the intraocular implant bypass device 30 in its final extended position and the cannula 72 and stent 78 removed while the intraocular implant bypass device 30 remains in its use position. Once the intraocular implant bypass device 30 is properly positioned, the introducer 50 is withdrawn from the eye 10, thereby withdrawing the advancement plunger 76 and cannula 72 while leaving the intraocular implant bypass device 30 in place. When the intraocular implant bypass device 30 reaches its final extended position and the cannula 72 is removed along with the advancement plunger 76 , the anchor tines 42 rest against the inner surface of the trabecular meshwork 21 . In particular, the curved portion 42b of the anchor tooth 42 is curved, so that the anchor tooth 42 extends along the inner surface of the trabecular meshwork 21 in the direction opposite to the curvature of the inner surface of the trabecular meshwork 21. As a result, the force interaction between the anchor teeth 42 and the trabecular meshwork 21 acts like a kickstand, causing the base portion 32 of the intraocular implant bypass device 30 to rotate around the mounting portion 42a of the anchor teeth 42, thereby firmly pressing the base portion 32 against the inner surface of the trabecular meshwork 21. In this manner, the curved anchor teeth 42 positioned against the inner surface of the trabecular meshwork 21 create a kickstand function, providing a retaining force to help maintain the implanted intraocular implant bypass device 30 in place. The intraocular implant bypass device 30 can be easily removed by lifting the anchor teeth 42 from the trabecular meshwork 21 to reduce the kickstand action and sliding the first bending teeth 34 and second bending teeth 36 backward toward the corresponding openings in the trabecular meshwork 21. Thus, the intraocular implant bypass device 30 functions as a minimally invasive glaucoma surgery (MIGS) device because it is implanted through a very small incision, minimizes tissue disruption, functions without disrupting surrounding tissue, and is easily reversible.

[0039] In this embodiment, the advancement plunger is provided with a retention device that retains the intraocular implant bypass device 30 by holding, grasping, or otherwise securing the intraocular implant bypass device 30 with anchor tines 42. The holding device then provides additional control for the surgeon to manipulate the intraocular implant bypass device 30, such as by rotation or other manipulation, in addition to linear pushing with the advancement plunger, when advancing the intraocular implant bypass device 30 through the cannula 72 for implantation. The retention device may also be configured as a depression, tongs, hooks, or similar type of grasping device that can hold the intraocular implant bypass device 30 in place of the anchor tines 42 . In the case of a hook configuration, the anchor teeth 42 may be configured with holes, ridges, slots, or similar cooperating features capable of receiving the hooks. If the holding device is configured as a gripping device, the holding device may have an automatic release mechanism, such as a spring-loaded mechanism, that operates to release the intraocular implant bypass device 30 when the intraocular implant bypass device 30 is in its final implant position.

[0040] While the present invention has been shown and described with respect to specific embodiments, equivalent alterations and modifications will occur to those skilled in the art upon reading and understanding this specification and the accompanying drawings. In particular, with regard to the various functions performed by the above-described elements (components, assemblies, devices, compositions, etc.), the terms used to describe such elements (including references to "means") are intended, unless otherwise indicated, to correspond to any element that performs the specified function of the described element (i.e., is functionally equivalent), even if it is not structurally equivalent to the disclosed structure that performs that function in an embodiment of the present invention. Furthermore, while a particular feature of the present invention is described above in only one of several embodiments, such feature may be combined with one or more other features of other embodiments as may be desirable and advantageous for any particular application.

Claims

1. 1. A bypass device for providing a flow path through body tissue, comprising: a base portion having a first end and a second end opposite the first end; a first bend tooth and a second bend tooth attached to the base and configured in a bent position relative to the base, the first bend tooth being disposed proximate the first end of the base and the second bend tooth being disposed between the first bend tooth and the second end of the base; a first bent tooth and a second bent tooth, the base including a first flow space existing from where the first bent tooth bends relative to the base and a second flow space existing from where the second bent tooth bends relative to the base, the first flow space and the second flow space allowing fluid to flow through the bypass device; an anchor tooth disposed adjacent the second end of the base portion, the second bent tooth being disposed between the first bent tooth and the anchor tooth; A bypass device comprising:

2. the first bent tooth and the second bent tooth each extend from the base at an acute angle relative to the base; The bypass device of claim 1 , wherein said anchor tines extend at an obtuse angle relative to said base portion.

3. 2. The bypass device of claim 1, wherein each of the first bending tine, the second bending tine, and the anchor tine includes a mounting portion where the respective tine is attached to the base portion.

4. 4. The bypass device of claim 3, wherein each of the first bend tine, the second bend tine, and the anchor tine includes a curved portion extending from the respective attachment portion and a body extending from the curved portion.

5. the curved portion of the first bent tooth and the curved portion of the second bent tooth each extend from the base at an acute angle relative to the base; 5. The bypass device of claim 4, wherein the curved portion of the anchor tooth extends at an obtuse angle relative to the base portion.

6. 6. The bypass device of claim 5, wherein the obtuse angle of the curved portion of the anchor tine acts to create a retention force that helps maintain the bypass device in place after implantation.

7. 7. The bypass device of claim 5 or claim 6, wherein the obtuse angle of the curved portion of the anchor tooth is between 150° and 170°.

8. 8. The bypass device of claim 1, wherein the bent positions of the first and second bent teeth form a leaf spring having an associated spring force.

9. 9. The bypass device of claim 1, wherein each of the first bending tooth, the second bending tooth, and the anchor tooth includes an arrow-shaped end.

10. 10. The bypass device of claim 1, wherein the base portion has a curvature that approximates the curvature of the iridocorneal angle structure.

11. 1. A method of performing minimally invasive glaucoma surgery (MIGS) to treat glaucoma, comprising: providing a bypass device for bypassing the drainage system of the eye, including Schlemm's canal, the trabecular meshwork, and the collecting canal, said bypass device comprising: a base portion having a first end and a second end opposite the first end; a first bend tooth and a second bend tooth attached to the base and configured in a bent position relative to the base, the first bend tooth being disposed proximate the first end of the base and the second bend tooth being disposed between the first bend tooth and the second end of the base; a first bent tooth and a second bent tooth, the base including a first flow space existing from where the first bent tooth bends relative to the base and a second flow space existing from where the second bent tooth bends relative to the base, the first flow space and the second flow space allowing fluid to flow through the bypass device; an anchor tooth disposed adjacent the second end of the base portion, the second bent tooth being disposed between the first bent tooth and the anchor tooth; providing a bypass device comprising: providing an introducer device including a cannula and an advancement plunger inserted into the cannula; placing the bypass device in an initial retracted position within the cannula such that the advancement plunger is positioned rearward relative to the bypass device within the cannula; forming a guide hole in the trabecular meshwork of the eye to access the Schlemm's canal; inserting the cannula having the bypass device and the advancement plunger into the guide hole; and positioning the cannula adjacent to the trabecular meshwork; manipulating the introducer device to manipulate the advancement plunger and advance the bypass device through the cannula from the initial retracted position to an intermediate position, thereby exposing the first and second bend tines from the cannula; and manipulating the introducer device to manipulate the advancement plunger and advance the bypass device through the cannula from the initial retracted position to an intermediate position. puncturing the trabecular meshwork with ends of the first and second curved teeth; and pushing the first and second curved teeth into the trabecular meshwork; manipulating the introducer device to operate the advancement plunger to further advance the bypass device through the cannula from the intermediate position to an extended position; and operating the introducer to operate the advancement plunger to further advance the bypass device through the cannula from the intermediate position to the extended position, wherein the first and second bending tines open elongated flow holes in the trabecular meshwork as the bypass device advances from the initial retracted position to the extended position, such that the elongated flow holes are aligned with the first and second flow spaces in the base of the bypass device when the bypass device reaches the extended position, allowing aqueous humor to flow through the first and second flow spaces of the bypass device and through the aligned elongated flow holes through the trabecular meshwork into the Schlemm's canal and exit; withdrawing the cannula with the advancement plunger while leaving the bypass device in place, wherein when the bypass device reaches the extended position and the cannula is removed, the anchor tines rest against the inner surface of the trabecular meshwork and are curved to create a retention force that helps maintain the bypass device in place; 1. A method of performing minimally invasive glaucoma surgery (MIGS), comprising:

12. 12. A method for performing MIGS according to claim 11, wherein the bypass device is configured according to any one of claims 2 to 10.

13. 13. The method of performing MIGS of claim 11 or claim 12, wherein the introduction device further comprises a first slider and a second slider, and the method of performing MIGS further comprises: operating the first slider to operate the advancing plunger to advance the bypass device from the initial retracted position to the intermediate position; and operating the second slider to operate the advancing plunger to advance the bypass device from the intermediate position to the extended position.

14. 14. The method of performing MIGS of claim 11, wherein the bent positions of each of the first and second bent teeth form a leaf spring having an associated spring force, and wherein the step of puncturing the trabecular meshwork includes applying pressure to the trabecular meshwork with the ends of the first and second bent teeth to compress the first and second bent teeth against the spring force, the spring force helping to push the ends of the first and second bent teeth through the trabecular meshwork.

15. 15. The method of performing MIGS of any one of claims 11 to 14, wherein when the bypass device is in the extended position, the anchor tines extend along the inner surface of the trabecular meshwork with the curvature opposite the curvature of the inner surface of the trabecular meshwork, and force interaction between the anchor tines and the inner surface of the trabecular meshwork rotates the base portion of the bypass device and presses the base portion against the inner surface of the trabecular meshwork, helping to maintain the bypass device in place.

16. 16. The method of performing MIGS of any one of claims 11 to 15, wherein the introducer device further comprises a curved stent attached to a front end of the cannula, and wherein the bypass device passes through the curved stent when the introducer device is manipulated.

17. 17. The method of performing MIGS of any one of claims 11 to 16, further comprising the step of using visualization techniques to identify a location of an obstructed portion of the drainage system using visualization techniques, and wherein the bypass device is aligned with respect to the trabecular meshwork such that the first and second curved prongs are located at or near the respective obstructed portions of the trabecular meshwork determined by the visualization techniques.

18. 18. The method of performing MIGS of any one of claims 11 to 17, further comprising the step of injecting a viscoelastic substance into Schlemm's canal through the cannula, thereby dilating the Schlemm's canal and assisting in positioning the bypass device.

19. 19. The method of performing MIGS of any one of claims 11 to 18, further comprising the step of introducing one or more substances into the Schlemm's canal through the cannula, wherein the one or more substances include one or more of a glaucoma medication, an anti-inflammatory agent, and an antibiotic-releasing pellet.

20. 20. The method of performing MIGS of any one of claims 11 to 19, wherein the advancing plunger includes a retaining device, and further comprising the step of retaining the bypass device in place at the anchor teeth with the retaining device while advancing the bypass device with the advancing plunger.

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