Intraocular device for dual incision

Abstract

A microsurgical device and methods of use thereof can be used to treat various conditions, including eye conditions, such as glaucoma, using minimally invasive surgical techniques. A dual blade device can be used to cut the trabecular meshwork ("TM") in the eye. The device tip provides access to the Schlemm's canal by its size (i.e., e.g., 0.2-0.3 mm wide) and configuration in which a ramp lifts the TM away from the outer wall of the Schlemm's canal and directs the TM to first and second lateral elements to create first and second incisions through the TM. The size and configuration of the blades are such that the entire TM strip is removed without leaving TM leaflets and without causing collateral damage to adjacent tissue.

Description

[0001] This application is a divisional application of the application filed on October 22, 2018, with application number 201880069048.4 (international application number PCT / US2018 / 056935) and entitled "Intraocular Device for Double Incision".

[0002] Related applications

[0003] This application claims priority to U.S. Patent Application No. 15 / 791,204, filed October 23, 2017, which is incorporated herein by reference. Background Technology

[0004] In many medical and surgical procedures, it is desirable to cut and remove strips of tissue of controlled width from the body of a human or veterinary patient. For example, it may sometimes be desirable to create incisions of controlled width (e.g., wider than those made by a typical scalpel, cutting blade, or needle) in the eyes, skin, mucous membranes, tumors, organs, or other tissues in a person or animal. Additionally, it may sometimes be desirable to remove a strip or a quantity of tissue from the body of a person or animal for use as a biopsy sample, for chemical / biological analysis, for preservation or archiving of DNA for identification purposes, etc. Furthermore, some surgical procedures require the removal of tissue strips of known width from anatomical locations within the patient's body.

[0005] A surgical procedure used to treat glaucoma involves removing a strip of tissue of known width from an anatomical location within the patient's body. This ophthalmic procedure is sometimes called goniotomy. In goniotomy, a device is inserted into the anterior chamber of the eye to cut or remove a strip of tissue approximately 2–10 mm or longer and 50–230 μm wide, and is used to remove the entire thickness of the tissue strip from the trabecular meshwork. The trabecular meshwork is a loose, porous network of tissue that covers collecting canals called the scleral sinuses. A fluid called aqueous humor is constantly produced in the anterior chamber of the eye. In healthy individuals, aqueous humor flows through the trabecular meshwork, into the scleral sinuses, and out of the eye through a series of canals called collector channels. In patients with glaucoma, the increased flow resistance through the trabecular meshwork can impair the drainage of aqueous humor from the eye, leading to increased intraocular pressure. By removing the entire thickness of the trabecular meshwork, the goniotomy procedure can restore normal drainage of aqueous humor from the eye, allowing it to drain through the open area where the trabecular meshwork strip has been removed. Summary of the Invention

[0006] The embodiments of this disclosure can be used in surgical interventions. For example, some embodiments relate to a microsurgical device and its method of use, which utilizes minimally invasive surgical techniques to treat a variety of medical conditions, including but not limited to eye diseases such as glaucoma. Specifically, the device may be a double-blade device for cutting the trabecular meshwork (“TM”) in the eye. Specifically, the device may have a device tip that provides an entrance to the scleral venous sinus by means of its size (i.e., for example, between approximately 0.2 and 0.3 mm in width) and construction, in which the entering blade tip is angled upward to provide a wedge-shaped or ramp-like action for cutting the TM.

[0007] To facilitate understanding of this disclosure, several terms are defined below.

[0008] The terms defined herein have the meanings commonly understood by one of ordinary skill in the art relating to this disclosure. For example, terms such as “a,” “an,” and “the” are not intended to refer to a single entity, but rather to encompass a whole class of matters which may be illustrated by specific examples.

[0009] As used herein, the terms "patient" or "subject" refer to a living mammalian organism, such as a human, monkey, cow, sheep, goat, dog, cat, mouse, rat, guinea pig, or a transgenic species thereof. In some embodiments, the patient or subject is a primate. Non-limiting examples of human subjects are adults, adolescents, infants, and fetuses.

[0010] "Prevention" or "preventing" includes: (1) suppressing the onset of the disease in a subject or patient who may be at risk and / or susceptible to the disease but has not yet experienced or exhibited any or all of the pathology or symptoms of the disease, and / or (2) slowing the onset of the pathology or symptoms of the disease in a subject or patient who may be at risk and / or susceptible to the disease but has not yet experienced or exhibited any or all of the pathology or symptoms of the disease.

[0011] As used herein, the term "therapeuticly effective amount" or "pharmaceutically effective amount" means an amount that, when administered to a subject or patient for the treatment of a disease, is sufficient to achieve the treatment of the disease or to alleviate one or more symptoms of the disease or condition (e.g., pain relief).

[0012] As used herein, the terms "treat" and "treating" are not limited to situations where the subject (e.g., the patient) is cured and the disease is eradicated. Rather, embodiments of this disclosure also contemplate treatments that merely alleviate symptoms, improve (to some extent) and / or slow disease progression. Embodiments of this disclosure are not intended to be limited to situations where the disease or ailment is cured. Symptom relief is sufficient.

[0013] As used in this article, "goniotomy" refers to a surgical procedure primarily used to treat various types of glaucoma (e.g., primary open-angle glaucoma).

[0014] As used in this article, the "trabecular meshwork" refers to the area of ​​tissue in the eye located around the base of the cornea, near the ciliary body (between the scleral spur and Schwalbe's line), and responsible for draining aqueous humor from the eye through the anterior chamber (the chamber at the front of the eye covered by the cornea). This tissue is spongy and lined with trabecular cells; it allows fluid to drain into circular channels in the eye called the scleral venous sinuses, ultimately flowing into the bloodstream.

[0015] As used in this article, the "scleral venous sinus" refers to a circular channel in the eye that collects aqueous humor from the anterior chamber and delivers it to the bloodstream through the collector channel and the anterior ciliary vein.

[0016] As used in this article, “eye disease” refers to various eye conditions, including but not limited to glaucoma-optic neuropathy, suspected glaucoma-ocular hypertension, primary open-angle glaucoma, primary angle-closure glaucoma, primary open-angle glaucoma, normal or low intraocular pressure glaucoma, pseudoexfoliative glaucoma, dispersive pigment glaucoma, angle-closure glaucoma (acute, subacute, chronic), neovascular or inflammatory glaucoma, ocular hypertension, and other types of glaucoma associated with intraocular pressure imbalance.

[0017] As used in this article, "low intraocular pressure" refers to reduced intraocular pressure. The statistical definition of low intraocular pressure (IOP) is an intraocular pressure ("IOP") below 6.5 mmHg, which is more than 3 standard deviations below the mean IOP. The clinical definition of low IOP is an IOP low enough to cause disease (vision loss). Vision loss due to low IOP can be caused by corneal edema, astigmatism, macular cystoid edema, macular degeneration, or other conditions. Low-tension macular degeneration is characterized by low IOP associated with fundus abnormalities, including choroidal folds, acute optic disc edema, and vascular tortuosity.

[0018] As used in this article, "Schwarzschild's line" refers to an anatomical line found on the inner surface of the cornea that delineates the outer boundary of the corneal endothelial cell layer. Specifically, it represents the termination of the posterior elastic lamina of the cornea.

[0019] As used in this article, "posterior elastic lamina of the cornea" refers to the basement membrane located between the intrinsic material of the cornea (also known as the stroma) and the corneal endothelial cell layer.

[0020] As used in this article, the "scleral spur" refers to the ring-shaped structure composed of collagen in the human eye, which is the projection of the sclera into the anterior chamber. It is the origin of the longitudinal fibers of the ciliary muscle and attaches to the front of the trabecular meshwork. Open-angle glaucoma (OAG) and angle-closure glaucoma (CAG) can be treated with muscarinic receptor agonists (such as pilucarpine), which cause contraction of the ciliary muscle and rapid pupillary constriction, which pulls on the scleral spur and causes the trabecular meshwork to be stretched and separated. This opens the fluid pathway and promotes drainage of aqueous humor into the scleral venous sinuses, ultimately reducing intraocular pressure.

[0021] As used in this article This refers to minimally invasive electrosurgical or ablation tools used in the surgical management of glaucoma in adults, adolescents, and infants. Unlike trabeculectomy, it utilizes... The surgical procedure does not create external filtering blebs, nor does it leave a permanent hole in the eye. Instead, The electrosurgical instrument opens the pathway to the eye's natural drainage system.

[0022] For example, embodiments of this disclosure are described in accordance with the various aspects described below.

[0023] According to some embodiments, a method for cutting a trabecular meshwork is disclosed, the method comprising: providing an apparatus for cutting the trabecular meshwork, the apparatus comprising: a platform for elevating a portion of the trabecular meshwork away from the outer wall of the scleral venous sinus, the platform including an end located distally on the platform and a planar ramp extending from the distal side of the platform to the proximal side of the platform, opposite to the distal side of the platform, wherein the ramp increases from a distal thickness at the distal side to a proximal thickness greater than the distal thickness at the proximal side; and a first transverse element and a second transverse element for creating a first incision and a second incision through the trabecular meshwork, the first transverse element and the second transverse element (i) having a width The gap is separated, and (ii) it extends from the proximal side of the platform; the end is inserted into the patient's scleral venous sinus; a ramp is advanced between the trabecular mesh and the outer wall of the scleral venous sinus, such that (i) a portion of the trabecular mesh is raised away from the outer wall of the scleral venous sinus, (ii) this portion remains attached to an adjacent portion of the trabecular mesh on the opposite side of the ramp, and (iii) this portion is guided to the first transverse element and the second transverse element; and as the trabecular mesh is raised away from the outer wall of the scleral venous sinus, a first incision and a second incision are created through the trabecular mesh using each of the first transverse element and the second transverse element, such that the strip of the trabecular mesh has a width corresponding to the width of the gap between the first incision and the second incision.

[0024] Creating the first and second incisions may include creating only the first and second incisions. After creating the first and second incisions, the strip between the first and second incisions remains intact. The method may further include removing the strip from the trabecular meshwork after the strip reaches the desired length. This removal may be performed with forceps. Creating the first and second incisions may be performed without ablation or burning of the trabecular meshwork. The first and second incisions may be created when this portion of the trabecular meshwork is stretched to elevate away from the outer wall of the scleral venous sinus. The first and second incisions may be created when this portion of the trabecular meshwork is under tension greater than that of the trabecular meshwork in its natural state. The method may further include receiving a portion of the strip within a gap while creating the first and second incisions. A first transverse element may create the first incision along a first portion of the trabecular meshwork guided along a first side of the platform, and a second transverse element may create the second incision along a second portion of the trabecular meshwork guided along a second side of the platform.

[0025] According to some embodiments, a method for cutting a trabecular meshwork is disclosed, the method comprising: inserting the distal end of a platform into a patient's scleral venous sinus; advancing a ramp of the platform between the trabecular meshwork and the outer wall of the scleral venous sinus such that (i) a portion of the trabecular meshwork is raised away from the outer wall of the scleral venous sinus, (ii) the portion remains attached to an adjacent portion of the trabecular meshwork on the opposite side of the ramp, and (iii) the portion is guided to a first transverse element and a second transverse element, the first transverse element and the second transverse element being separated by a gap and extending from the proximal side of the platform opposite to the distal side of the platform; wherein the rampwork increases from a distal thickness at the distal side to a proximal thickness at the proximal side greater than the distal thickness; and, as the trabecular meshwork is raised away from the outer wall of the scleral venous sinus, creating a first incision and a second incision through the trabecular meshwork using each of the first transverse element and the second transverse element such that a strip of the trabecular meshwork has a width between the first incision and the second incision corresponding to the width of the gap.

[0026] Creating the first and second incisions involves creating only the first and second incisions. After creating the first and second incisions, the strip between the first and second incisions can remain intact. The method may further include removing the strip from the trabecular meshwork after the strip reaches the desired length. This removal can be performed with forceps. Creating the first and second incisions can be performed without ablation or burning of the trabecular meshwork. The first and second incisions can be created when the portion of the trabecular meshwork is stretched and lifted away from the outer wall of the scleral venous sinus. The first and second incisions can be created when the portion of the trabecular meshwork is under tension greater than that of the trabecular meshwork in its natural state. The method may further include receiving a portion of the strip within the gap while creating the first and second incisions. A first lateral element can create the first incision along a first portion of the trabecular meshwork guided along a first side of the platform, and a second lateral element can create the second incision along a second portion of the trabecular meshwork guided along a second side of the platform.

[0027] According to some embodiments, an apparatus for cutting a trabecular meshwork is disclosed, the apparatus comprising: a platform for elevating a portion of the trabecular meshwork away from the outer wall of the scleral venous sinus, the platform including an end located distal to the platform and a planar ramp extending from the distal side of the platform to a proximal side of the platform opposite to the distal side of the platform, wherein the ramp increases from a distal thickness at the distal side to a proximal thickness greater than the distal thickness at the proximal side; and a first transverse element and a second transverse element for creating a first incision and a second incision through the trabecular meshwork, the first transverse element and the second transverse element (i) being separated by a gap having a width, and (ii) extending from the proximal side of the platform.

[0028] The platform may further include a first side extending from a proximal side to a distal side and a second side extending from a proximal side to a distal side, the first side and the second side being configured to maintain a portion of the beam net attached across the slope to adjacent portions of the beam net on opposite sides of the slope. The first side and the second side may each form a ramp of the platform. The first side and the second side may each form a protruding portion of the platform. A first lateral element may extend from the first side, and a second lateral element may extend from the second side. The proximal segments of the first side and the second side may be parallel to each other, and the distal segments of the first side and the second side may intersect at their ends. The first lateral element and the second lateral element may be straight. The slope may increase from a distal width at the distal side to a proximal width greater than the distal width at the proximal side. The maximum width spanning the first lateral element and the second lateral element is, for example, not less than the maximum width spanning the slope. The angle between the slope and the first lateral element and the second lateral element may be between 90 degrees and 180 degrees.

[0029] According to some embodiments, an apparatus for cutting a trabecular meshwork is disclosed, the apparatus comprising: a platform for lifting a portion of the trabecular meshwork away from the outer wall of the scleral venous sinus, the platform including an end located distally on the platform and a ramp extending from the distal side of the platform to a proximal side opposite the distal side of the platform, wherein the ramp increases from a distal thickness at the distal side to a proximal thickness greater than the distal thickness at the proximal side; and a first lateral element and a second lateral element for creating a first incision and a second incision through the trabecular meshwork, the first lateral element and the second lateral element extending proximally from the platform.

[0030] The platform may further include a first side extending from a proximal side to a distal side and a second side extending from a proximal side to a distal side. The first and second sides may each form a ramp of the platform. The first and second sides may each form a protruding portion of the platform. A first lateral element may extend from the first side, and a second lateral element may extend from the second side. The proximal segments of the first and second sides may be parallel to each other, and the distal segments of the first and second sides intersect at their ends. The first and second lateral elements may be straight. The ramp may increase in width from a distal width at the distal side to a proximal width greater than the distal width at the proximal side. The maximum width spanning the first and second lateral elements is, for example, not less than the maximum width spanning the ramp. The angle between the ramp and the first and second lateral elements is between 90 degrees and 180 degrees.

[0031] Additional features and advantages of this technology will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the technology. The advantages of this technology will be realized and obtained through the written description and its claims, as well as the structures particularly pointed out in the accompanying drawings.

[0032] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory, and are intended to provide further explanation of the claimed technology. Attached Figure Description

[0033] The accompanying drawings are included to provide a further understanding of the technology and are incorporated in and form a part of this specification. The drawings illustrate various aspects of the technology and, together with the specification, serve to explain the principles of the technology.

[0034] Figure 1 This image shows a representative histological specimen of the anterior chamber angle structure of a human patient after incision using a microvitrectomy-retinal (“MVR”) blade. The incision extends through the full-thickness trabecular meshwork and scleral venous sinuses, and into the adjacent sclera (black arrows). Most of the trabecular meshwork remains on either side of the incision (black arrows). The scleral venous sinuses are marked with an asterisk. Light micrograph, hematoxylin-eosin, magnification X100.

[0035] Figure 2 It shows the use of Representative histological specimen of the anterior chamber angle structure after dissection. The incision extends through the full thickness of the trabecular meshwork without damaging the adjacent sclera. A portion of the trabecular meshwork has been removed centrally, with a suitable amount of residual tissue on both sides of the incision (black arrows). The charred edges of the incision are indicated. The scleral venous sinus is marked with an asterisk. SS = scleral process. Light micrograph, hematoxylin and eosin, magnification X100.

[0036] Figure 3 A representative histological specimen of the anterior chamber angle structure of a human patient is shown after incision using a dual-blade device. The incision extends through the full thickness of the trabecular meshwork without damaging the adjacent sclera. Near-complete removal of the trabecular meshwork tissue has been achieved (black arrow). The scleral venous sinus is marked with an asterisk. SS = scleral process. Light micrograph, hematoxylin-eosin, magnification X100.

[0037] Figure 4 An embodiment of a double-blade device for treating glaucoma is shown. The device is shown with two cutting blades (black arrows) exposed and a distal point (asterisk) designed to pierce the trabecular meshwork (“TM”) and enter the scleral venous sinus. Once inside the tube, the device is advanced, causing the TM to move up a ramp from the distal point toward the double cutting blades, which then cleanly cut the presented TM. The distance between the two blades is designed to closely match the width of the TM within the range of the human eye. The illustration is a photograph of a first prototype device made of medical-grade stainless steel.

[0038] Figure 5 Four different angles of the manufacturing embodiments of this disclosure are shown at 40X magnification.

[0039] Figure 6 Two different angles of the manufacturing embodiments of this disclosure are shown at 40X magnification. The dimensional scale indicates the scale.

[0040] Figure 7 The side angle of a manufacturing embodiment of this disclosure is shown at 40X magnification. The dimensional scale indicates the scale.

[0041] Figure 8 An angled side view of one embodiment of the device is shown, as well as an enlarged detailed view of the operating end of the device with a beveled platform.

[0042] Figure 9 An angled side view of one embodiment of the device is shown, along with a magnified detailed view of the operating end of the device with a beveled platform. Measurements of specific parts are indicated.

[0043] Figure 10A front view of one embodiment of the device and an enlarged detailed view of the operating end of the device with a beveled platform are shown.

[0044] Figure 11 A front view of one embodiment of the device and an enlarged detailed view of the operating end of the device with the beveled platform 5 are shown. Measurements of specific parts are indicated.

[0045] Figure 12 A front view of one embodiment of the device and an enlarged detailed view of the operating end of the device with the beveled platform 5 are shown. Examples of different angles at which the handle 1 is attached to the beveled platform 5 relative to the Z-axis are shown. The increasing platform thickness as the platform extends from the insertion end 6 toward the back of the platform 7 is also indicated.

[0046] Figure 13 A straight top view of one embodiment of the device is shown, as well as an enlarged detailed view of the operating end of the device with a beveled platform 5.

[0047] Figure 14 A straight top view of one embodiment of the device is shown, along with an enlarged detailed view of the operating end of the device with the beveled platform 5. Measurements of specific parts are indicated.

[0048] Figure 15 An angled side view of one embodiment of the device is shown, along with a magnified detailed view of the operating end of the device with the beveling platform 5. The darker areas provide a view of the dimensions of the beveling platform. The attachment angles of the tool shaft 4 and the first and second blades relative to the beveling platform 5 are indicated.

[0049] Figure 16 An angled side view of one embodiment of the device is shown, along with a magnified detailed view of the operating end of the device with the beveling platform 5. The darker areas provide a view of the dimensions of the beveling platform. Measurements of specific parts are indicated.

[0050] Figure 17 A front view of one embodiment of the device and an enlarged detailed view of the operating end of the device with the beveled platform 5 are shown. Examples of different attachment angles of the handle 1 to the beveled platform 5 relative to the Z-axis and X-axis at 0 degrees, 15 degrees, and 30 degrees clockwise are shown. The platform thickness, which increases as the platform extends from the insertion end 6 toward the back of the platform 7 and from the first side (on the right) to the second side (on the left), is also shown.

[0051] Figure 18AA front view of one embodiment of the device and an enlarged detailed view of the operating end of the device with the beveled platform 5 are shown. Examples of different attachment angles of the handle 1 to the beveled platform 5 with respect to the Z-axis and X-axis at 0 degrees, 15 degrees, and 30 degrees counterclockwise are shown. The platform thickness, which increases as the platform extends from the insertion end 6 toward the back of the platform 7 and from the second side (on the left) toward the first side (on the right), is also shown.

[0052] Figure 18B One possible form of the device is shown, in which it is integrated into an endoscope.

[0053] Figure 19A Devices for use with trabecular meshwork and scleral venous sinuses according to some embodiments of the present disclosure are shown.

[0054] Figure 19B An apparatus for elevating the trabecular mesh away from the scleral sinus is shown according to some embodiments of the present disclosure.

[0055] Figure 19C An apparatus for cutting small beam mesh according to some embodiments of the present disclosure is shown.

[0056] Figure 19D An apparatus for joining small beam mesh strips according to some embodiments of the present disclosure is shown.

[0057] Figure 20 An incision extending into the sclera is shown in the trabecular meshwork, where most of the trabecular meshwork remains intact. Figure 20 The image shows the damage to the sclera below the scleral venous sinus caused by the blade.

[0058] Figure 21 It shows The post-treatment condition showed remnants of the trabecular meshwork and charred tissue. Tissue fragments blocked the collector channels. Figure 21 Thermal damage to TM is shown. For The surgery (designed to replace goniotomy and improved by removing a portion of the trabecular meshwork) uses The device is used to join the trabecular meshwork and to apply ablation to it. The circle indicates the area where a small section of the trabecular meshwork has been removed; however, numerous lobes of the trabecular meshwork and charred tissue remain on either side of the treated area. In this prior method, the device “burns” the tissue, and this burning produces inflammation, leading to further scarring and ultimately, failure of the surgically induced opening into the scleral venous sinus. Additionally, the ablation creates numerous air bubbles during the procedure, making visualization difficult during the actual surgery. These problems do not occur in the embodiments of this disclosure. Figure 21 A picture was shown A representative photograph.

[0059] Figure 22 The tissue after treatment using the apparatus according to an embodiment of the present disclosure is shown. Figure 22 The structure at the normal location adjacent to TM is shown to be undamaged. Figure 22 The image shows complete excision of the TM tissue, with no remaining TM lobules.

[0060] Figure 23 Another description of the construction of a dual-blade device according to an embodiment of the present disclosure is shown.

[0061] Figure 24 A side view of an exemplary device according to an embodiment of the present disclosure is shown.

[0062] Figure 25 An embodiment according to this disclosure is shown. Figure 25 Front view of the device.

[0063] Figure 26 An embodiment according to this disclosure is shown. Figure 25 Front view of the device.

[0064] Figure 27 An embodiment according to this disclosure is shown. Figure 25 Front view of the device.

[0065] Figure 28 An embodiment according to this disclosure is shown. Figure 25 Front view of the device.

[0066] Figure 29 The anatomical structures at the eye section of interest are shown. Handle 1 is inside the eye, extending parallel to the scleral venous sinus on the opposite side, as outlined by circles. The angle between handle 1 and the ramp will allow the blade to enter the scleral venous sinus and cut the tissue. The first angle will cause the ramp to face the observer. However, a second angle is also necessary, following the black line, to allow the device to also fit within the angular space of the scleral venous sinus. Detailed Implementation

[0067] In the following detailed description, specific details are set forth to provide an understanding of the present technology. However, it will be apparent to those skilled in the art that the present technology can be implemented without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the present technology.

[0068] As anticipated in this paper, the dual-blade device for goniotomy offers several practical advantages. First, the dual-blade device can be reusable and can be added to a standard cataract surgery tray. Second, the absence of moving parts or the need for a connected irrigation or separate power supply allows for the inexpensive manufacture and rapid acquisition of the surgical technique. This will allow for easy and economical access to the new technology, especially in areas with limited medical resources worldwide. The simple design and material requirements of the dual-blade device embodiments will further reduce costs. Finally, compared to other techniques for TM removal, the dual-blade device design conforms to the anatomy of the scleral venous sinus, minimizes damage to adjacent tissues, and provides excellent control over the excised tissue. Therefore, the proposed dual-blade minimally invasive glaucoma surgery (“MIGS”) device presents a novel technique for performing goniotomy with or without cataract extraction. In some embodiments, the dual-blade device enables more complete removal of TM tissue from the anterior chamber angle in a simple and inexpensive manner compared to conventional devices. Irrigation eye studies support the potential of this technique to significantly reduce IOP.

[0069] Glaucoma is considered one of the leading causes of blindness worldwide. A modifiable risk factor for the disease is intraocular pressure (“IOP”). Conventional treatments primarily focus on lowering IOP using medications or surgically through laser or incision procedures. The main areas obstructing aqueous humor outflow (accompanied by subsequent IOP dysregulation) are believed to be located near the trabecular meshwork (“TM”) and distal outflow structures. Anterior chamber goniotomy or trabeculotomy in adults with glaucoma has not been associated with significant success in lowering IOP. Instead, these surgeries have been reported to be more successful in congenital glaucoma, in which the membrane covering the TM is considered the primary factor obstructing aqueous humor outflow. Recently, attempts have been made to remove the TM in adult patients using ab internodontic trabeculectomy, with mixed results.

[0070] One reason for the poor long-term efficacy of this approach in adults may be related to incomplete removal of the TM and the formation of a membrane on the remaining TM lobules (accompanied by subsequent increases in IOP). It is unclear how more complete TM tissue removal differs from simply cutting the TM (e.g., single-incision goniotomy) or ablating the TM by removing tissue (e.g.,...). The procedure was compared to surgery performed in Neomedix, Tustin, California, USA. The dual-blade device is specifically designed to conform to the drainage angle anatomy of the human eye. This device allows for double-incision goniotomy by engaging the TM and cutting the target tissue, while minimizing damage to the lobule left in situ and adjacent tissues. The device was designed and manufactured at the University of Colorado Eye Center. The tissue effect of this device was compared to single-incision goniotomy using a microvitretin (“MVR”) blade (BD, Franklin Lake, New Jersey, USA) and procedures using… The tissue effects of the device ablation™ were investigated. A human eye perfusion study was also completed to evaluate the efficacy of each protocol in reducing IOP.

[0071] Recently, the trend towards innovation in MIGS has become increasingly apparent. The risks and drawbacks of protective filtration and shunt procedures have driven this paradigm shift, despite the proven long-term efficacy of these incision procedures. Disadvantages of traditional incision procedures include unpredictable IOP reduction outcomes, prolonged visual recovery, risks of vision loss and long-term infection, frequent follow-up, and long-term failure rates. Examples include endoscopic transscleral cyclophotocoagulation, utilizing… Intraocular trabeculectomy and spinal canaloplasty using the iScience illumination catheter (iScience, Menlo Park, California) have been introduced to address the limitations of full-thickness surgery, most notably eliminating the presence of the filtering bleb. However, a major drawback of all these procedures is the need for additional equipment and, in some cases, a steep learning curve. The increased equipment costs are a significant barrier, particularly for providers, hospitals, and surgical centers, potentially requiring several procedures to recoup the initial investment. Providers and patients may also face objections from insurance companies regarding coverage of procedures lacking long-term efficacy data. The need for additional equipment also limits the use of these procedures for patients in underserved areas of the world.

[0072] Anterior chamber goniotomy is commonly referred to as a surgical procedure to treat glaucoma. Glaucoma can be caused by blockage in the trabecular meshwork and / or inhibition of the development of certain structures within the anterior (frontal) segment of the eye. These changes lead to an excess of fluid within the eye, which can cause pressure that can damage the internal structures of the eye, resulting in optic neuropathy and vision loss.

[0073] One type of glaucoma that can be treated with goniotomy is known as congenital glaucoma. Congenital glaucoma is caused by a condition that reduces or completely obstructs the outflow of fluid from the eye. Ocular syndromes and abnormalities that predispose children to congenital glaucoma include: Reiger abnormalities; Peter abnormalities; Axenfeld syndrome; and Axenfeld-Rieger syndrome. Systemic diseases that can affect the eye in ways that may lead to glaucoma include: Marian syndrome; rubella (German measles); and phacomatoses, including neurofibromatosis and Sturge-Weber syndrome. Because these conditions affect the whole body and the eye, a pediatrician or family physician will help diagnose and treat them.

[0074] One purpose of goniotomy is to remove the obstruction to the outflow of aqueous humor from the eye, which in turn reduces intraocular pressure (“IOP”). This is a treatment method used for any type of glaucoma, including primary open-angle glaucoma and chronic angle-closure glaucoma.

[0075] Before surgery begins, the patient may be given a miotic, a medication that causes the pupil to constrict. Partial closure improves the surgeon's view and access to the trabecular meshwork; it also protects the lens of the eye from trauma during surgery. Other medications may be administered to lower intraocular pressure. Anterior chamber goniotomy can be performed without the use of a miotic. In some embodiments, the device can be used to set a dilated (non-constricted) pupil, as described in the prior art.

[0076] Once the necessary medications have been administered and the patient is anesthetized, the surgeon can use forceps or sutures to stabilize the eye in the correct position. The patient's head can be rotated away from the surgeon to make it easier to see the internal structures of the eye. Next, the surgeon uses a small needle knife or goniotomy scalpel to puncture the cornea while simultaneously examining the inside of the eye through a microscope or small magnifying glass. While the surgeon performs the goniotomy, an assistant can use a syringe to introduce fluid into the anterior chamber of the eye through a viscoelastic tube.

[0077] The gonioscope can then be placed over the eye. While the eye is rotated by an assistant, the surgeon sweeps a blade or needle across the eye in a 90-120 degree arc, creating an incision in the anterior trabecular meshwork, avoiding the posterior portion of the meshwork to reduce the risk of iris and lens damage. Endoscopic visualization can also be used to guide the incision. In some embodiments, the device can be placed at the tip of the endoscope, eliminating the need for a gonioscope during treatment.

[0078] Once the scalpel and tube are removed, saline solution is introduced through the opening to maintain the integrity of the eye, and the opening is sealed with sutures. The surgeon then administers antibiotics and corticosteroids to the eye to prevent infection and reduce inflammation. The head can then be rotated away from the incision site to prevent blood from pooling. A second eye can be operated on simultaneously. If the surgery needs to be repeated, another area of ​​the eye can be treated.

[0079] Currently, there remains a need in this field for the development of instruments that are simple, inexpensive, and precise for performing surgeries that cut TM in the eye and effectively remove full-thickness TM strips without leaving TM lobules, as well as other surgeries where it is desirable to remove tissue strips from larger pieces of tissue.

[0080] Anterior chamber goniotomy simply cuts the tumescent tissue (TM) to separate it into two lobes; all other devices strive to improve upon this basic form of TM cutting. Because it is merely a cut, it leaves the entire tissue (albeit segmented), resulting in scarring and increased pressure on the eye. This is likely why "newer" devices attempt to cut and remove the true TM from the area above the scleral venous sinus. Complete removal of the TM without leaving lobes is a key feature that distinguishes the embodiments of this disclosure from conventional blade goniotomy (e.g., using an MVR blade). The anatomical design of the devices of this disclosure is better suited for the efficient removal of intact tissue strips, particularly the TM, with minimal or no invasiveness to surrounding tissues.

[0081] Compared to other conventional devices, some specific advantages of the embodiments described herein include, but are not limited to:

[0082] 1. Parts that do not move mechanically.

[0083] 2. No ablation or burns to the tissue.

[0084] 3. Two blades are positioned on the side of the device, which cuts the beam mesh (TM) precisely, leaving very little TM (current devices leave a lot of TM, which then scabs).

[0085] 4. Similar to what has been described in standard anterior chamber goniotomy for decades, access to the scleral venous sinus is accomplished using the tip of a blade. Other devices use a non-blade footplate to access the scleral venous sinus.

[0086] 5. The size of the device allows for complete cutting and precise fitting into the scleral venous sinus.

[0087] 6. The blade tip angles up to the two side blades to present the TM to the two sliding blades, which allows for more precise cutting.

[0088] 7. Before the advent of double blades, there were no blades or cutting features on the sides of the ramp.

[0089] 8. The cutting of TM using a double blade occurs at the point where it is lifted from the natural rest position of TM.

[0090] In some embodiments, an apparatus includes: a handle 1, a tool shaft and a handle joint 2, a tool shaft 3, a tool shaft and a beveling platform joint 4, a beveling platform 5, a first end / beveling platform end / insertion blade end 6, a second end / back side of the beveling platform 7, a first side 8, a second side 9, a first blade 10 and a second blade 11.

[0091] In some embodiments, the device 12 includes: a handle 1 that is necked to a tool shaft 3 via a first engagement 2, wherein the tool shaft widens to form a beveling platform 5 via a second engagement 4, wherein the beveling platform 5 includes an insert blade end 6 at a distal end of the beveling platform 5, which includes a ramp 13 returning from the insert blade end toward the rear end of the beveling platform 5; and a first lateral element (e.g., a blade) 10 and a second lateral element (e.g., a blade) 11 along the side of the beveling platform 5. In some embodiments, the side of the beveling platform 5 includes a first side 8 and a second side 9. In some embodiments, the platform 5 includes: a first side 8 extending from a proximal side of the platform 5 to a distal side of the platform 5; and a second side 9 extending from a proximal side of the platform 5 to a distal side of the platform 5. In some embodiments, the first side 8 and the second side 9 each form a slope of the platform 5. In some embodiments, the first side 8 and the second side 9 each form a protrusion of the platform 5. In some embodiments, the proximal segments of the first side 8 and the second side 9 are parallel to each other, and the distal segments of the first side 8 and the second side 9 intersect at end 6. In some embodiments, a first lateral element extends from a first side, and a second lateral element extends from a second side.

[0092] In some embodiments, the first transverse blade 10 and the second transverse blade 11 are vertically aligned with the bottom of the beveling platform. In some embodiments, the first transverse blade 10 and the second transverse blade 11 are straight. In some embodiments, the first transverse blade 10 and the second transverse blade 11 are parallel to each other.

[0093] In some embodiments, the ramp 13 increases in width from a distal side (e.g., at end 6) to a proximal side (e.g., adjacent to the transverse blades 10, 11), the proximal width being greater than the distal width. The ramp 13 can be planar, concave, and / or convex. When the ramp 13 is planar, it can provide a gradual stretching of the TM lifted by the platform 5 and traversing the ramp 13. In some embodiments, the maximum width across the first and second transverse elements is not less than the maximum width across the ramp. This allows a cutout to be formed at the outer periphery of the platform, where the first side 8 and the second side 9 lift and present the TM to the transverse blades 10, 11.

[0094] In some embodiments, the device 12 includes a bottom surface 15 configured to abut against the outer wall of the scleral venous sinus 22 during surgery. The bottom surface 15 may be planar, convex, concave, or a combination thereof. For example, the bottom surface 15 may include a recessed portion between at least two lateral edges. For example, the lateral edges may be located below a first side 8 and a second side 9 of the ramp 13, and a recessed portion may be formed between the lateral edges. During surgery, the lateral edges may come into contact with the outer wall of the scleral venous sinus 22.

[0095] In some embodiments, the device 12 includes a handle 1 and a beveling platform 5, wherein the platform 5 is configured at a specific angle and orientation relative to the handle 1. In some embodiments, the device 12 includes a handle 1 and a beveling platform 5, wherein the platform 5 is freely rotatable in at least two dimensions. In some embodiments, the handle 1 and the beveling platform 5 are operably attached in the YZ axis at an angle ranging from 90 degrees to 120 degrees (e.g., ...). Figure 15 (as shown in the diagram). In some embodiments, the handle 1 and the beveling platform 5 are operably attached in the XZ axis at an angle ranging from 90 degrees to 180 degrees (as shown in the diagram). Figure 10 (as shown in the diagram). In some embodiments, the platform 5 rotates freely relative to the handle 1 in the XY dimension. In some embodiments, the platform 5 is held at a fixed angle relative to the handle 1 in the XY, XZ, and YZ dimensions (e.g., as shown in the diagram). Figure 15 (as shown in the diagram). In some embodiments, the platform 5 can rotate freely in the positive Z dimension relative to the handle 1.

[0096] In some embodiments, the beveling platform 5 includes a first end / beveling platform end / insertion blade end 6 and a second end / back face of the beveling platform 7, wherein the thickness of the second end / back face 7 of the beveling platform is between 2 and 30 times greater than that of the first end / beveling platform end / insertion blade end 6. This thickness can be measured along the Z-axis, for example, through the surface of the ramp 13 and the base of the platform 5. In some embodiments, the dimensions of the beveling platform 5 depend on formula A.2 +B 2 =C 2 Wherein, A is the length of the bevel cutting platform 5 from the tip 6 of the insert blade to the back surface of the bevel cutting platform 7, B is the height of the bevel cutting platform 5, and C is the length of the slope formed by the tip of the insert blade to the height of the bevel cutting platform. In some embodiments, the height of the bevel cutting platform 5 does not exceed 0.5 mm. In some embodiments, the length of the bevel cutting platform 5 from the tip 6 of the insert blade to the back surface of the bevel cutting platform 7 does not exceed 1.0 mm. In some embodiments, the width of the bevel cutting platform 5 does not exceed 0.35 mm. In some embodiments, the first end / bevel cutting platform end / insert blade end 6 includes a microsurgical lancet. In some embodiments, the first end / bevel cutting platform end / insert blade end 6 includes an angle between 20 degrees and 90 degrees. In some embodiments, the bevel cutting platform 5 increases in thickness in the Y-axis direction from the tip of the microblade toward the second end / back surface of the bevel cutting platform 7.

[0097] In some embodiments, the first end / beveled platform end / insertion blade end 6 includes a sharp end with a fine edge having surgical sharpness. In some embodiments, the first end / beveled platform end / insertion blade end 6 includes a lancet. In some embodiments, the beveled platform 5 further includes a first blade 10 and a second blade 11. In some embodiments, the first blade 10 is attached to a first side 8 of the second end / back surface of the beveled platform 7. In some embodiments, the first blade 10 and the beveled platform 5 are operably attached in the YZ axis at an angle ranging between 90 degrees and 180 degrees (e.g., ...). Figure 15 (as shown in the figure). In some embodiments, the angle is preferably between 90 degrees and 120 degrees in the YZ axis (e.g. Figure 15 (as shown in the diagram). In some embodiments, the second blade 11 and the beveling platform 5 are operably attached in the YZ axis at an angle ranging from 90 degrees to 120 degrees (as shown in the diagram). Figure 15 (As shown in the figure). In some embodiments, the first blade 10 and the handle 1 are operably positioned in the YZ axis at an angle ranging from 90 degrees to 120 degrees (as shown in the figure). Figure 15 (As shown in the figure). In some embodiments, the second blade 11 and the handle 1 are operably positioned in the YZ axis at an angle ranging from 90 degrees to 120 degrees (as shown in the figure). Figure 15 (as shown in the diagram). In some embodiments, the second blade 11 is attached to the second side 9 of the second end / back face of the beveling platform 7. In some embodiments, the beveling platform 5 increases in thickness in the X-axis direction from the second side 9 toward the first side 8 (e.g., as shown in the diagram). Figure 17(As shown in the diagram). In some embodiments, the beveling platform 5 increases in thickness in the X-axis direction from the second side 9 toward the first side 8, and the beveling platform 5 increases in thickness in the Y-axis direction from the tip of the microblade at the first end 6 toward the second end / back side of the beveling platform 7 (as shown in the diagram). Figure 17 As shown in Figure 18). In some embodiments, the beveling platform 5 increases in thickness from the first side 8 toward the second side 9 in the X-axis direction (as shown in Figure 18). In some embodiments, the beveling platform 5 increases in thickness from the first side 8 toward the second side 9 in the X-axis direction, and the beveling platform 5 increases in thickness from the end of the microblade of the first end 6 toward the second end / back of the beveling platform 7 in the Y-axis direction (as shown in Figure 18). In some embodiments, the first blade 10 and the second blade 11 are parallel (e.g., as shown in Figure 18). Figure 15 (As shown in the illustration). In some embodiments, the first blade 10 and the second blade 11 extend above the top surface of the second end / back surface of the beveling platform 7. In some embodiments, the first blade 10 and the second blade 11 are positioned relative to the top surface of the second end / back surface of the beveling platform 7 at an angle between approximately 100 degrees and 140 degrees (e.g., as shown in the illustration). Figure 15 (As shown in the diagram). In some embodiments, the beveling platform 5 is approximately 0.3 mm wide. In some embodiments, the beveling platform 5 is approximately 0.2 mm wide. In a preferred embodiment, the beveling platform 5 is approximately 0.25 mm wide. In some embodiments, the beveling platform 5 is approximately 1.0 mm long. In some embodiments, the beveling platform 5 is approximately 0.4 mm high. In some embodiments, the highest point on the beveling platform 5 is the first blade and the second blade. Device 12 (in Figure 8 , Figure 10 , Figure 13 and Figure 15 (As shown in the image) can be provided as a pre-sterilized, single-purpose disposable probe or tip that attaches to a standard surgical instrument head.

[0098] The embodiments disclosed herein are not intended to be limited to any particular construction material; however, it is believed that preferred materials include titanium, stainless steel, polyetheretherketone (PEEK), shape memory alloys, and shape memory polymers. In some embodiments, the device of this disclosure is made of a metallic alloy material. In some embodiments, the device of this disclosure is rigid at room temperature but more flexible at body temperature. In some embodiments, portions of the device of this disclosure are rigid at room temperature but more flexible at body temperature. In some embodiments, portions of the device are made of different materials. In some embodiments, portions of the device are made of materials with different stiffnesses. In some embodiments, the tool shaft is flexible. In some embodiments, the tool shaft is made of a lower density material.

[0099] The embodiments disclosed herein are not intended to be limited to any particular construction material; however, it is believed that preferred materials include titanium, stainless steel, polyetheretherketone (PEEK), shape memory alloys, and shape memory polymers. In some embodiments, the device of this disclosure is rigid at room temperature but more flexible at body temperature. In some embodiments, portions of the device of this disclosure are rigid at room temperature but more flexible at body temperature. In some embodiments, portions of the device are made of different materials. In some embodiments, portions of the device are made of materials with different stiffnesses. In some embodiments, the tool shaft is flexible. In some embodiments, the tool shaft is made of a lower density material.

[0100] The tip can be formed from various metals or polymers with sufficient rigidity to support the lifting of tissue (such as TM). The blade can be made of the same material as the distal tip and handle 1, or it can be made of a separate material (stainless steel or titanium) that allows for greater tolerances at the razor edge. Shape memory polymers or alloys can be used to enhance the functionality of the device by allowing for alteration confirmation after the device is placed in the eye and exposed to body temperature. During the insertion and removal steps from the eye, a removable sheath can be used to cover the distal cutting tip so that the tip is not damaged due to movement through the clear corneal wound.

[0101] The device can be made in different colors (such as blue or black) so that it can be visualized through the semi-transparent TM tissue for better guidance.

[0102] According to some embodiments, the device disclosed herein can be used to cut tissue, such as the trabecular meshwork. The device can be introduced through a clear corneal incision (incision size between 0.5 mm and 2.8 mm in width) and advanced through the pupil or through the iris body into the anterior chamber to engage the trabecular meshwork (TM) on opposite sides of the anterior chamber. The anterior chamber can be filled with a viscoelastic agent to stabilize the chamber during surgery. For example, as... Figure 19A As shown, once the target tissue 20 (e.g., TM) is reached, the end of the device 6 can be used to access the scleral venous sinus (“SC”) 22.

[0103] According to some embodiments, such as Figure 19A As shown, ramp 13 can be used to elevate TM 20 away from the outer wall of the scleral venous sinus 22. According to some embodiments, such as... Figure 19BAs shown, the advancement of platform 5 can stretch TM 20 as it advances up ramp 13 without tearing the strip 20a of TM 20 on ramp 13. For example, the first side 8 and the second side 9 can allow TM 20 on ramp 13 (e.g., distal to the first and second transverse blades 10, 11) to remain connected to TM 20 not lifted by ramp 13. When TM 20 is lifted, it is under greater tension than when TM 20 is not lifted from SC 22. Advancement of ramp 13 facilitates the presentation of TM 20 to the first transverse blade 10 and the second transverse blade 11. According to some embodiments, such as... Figure 19C As shown, when TM 20 is lifted (e.g., stretched and / or under tension), TM 20 contacts the first transverse blade 10 and the second transverse blade 11. In this configuration, the first transverse blade 10 and the second transverse blade 11 cut a first slit and a second slit in TM 20 to form a strip 20a of TM 20. Due to the lifting of TM 20, the slits are formed more easily and precisely. During the advancement of platform 5, at least a portion of strip 20a can be received within the gap 14 between the first transverse blade 10 and the second transverse blade 11. Strip 20a may have a width W corresponding to a distance D across the gap 14. Width W may be measured along the X-axis (e.g., across the first and second slits and laterally (e.g., orthogonally) to the advancement direction of device 12) to form strip 20a. Distance D may be measured along the X-axis (e.g., across the first and second transverse blades 10 and laterally (e.g., orthogonally) to the advancement direction of device 12) to form strip 20a. According to some embodiments, such as Figure 19D As shown, the strip 20a that has been separated from the remainder of TM 20 can be removed by means of device 30 (e.g., tweezers) or by suction.

[0104] The advancement of platform 5 and ramp 13 can proceed as the device advances clockwise or counterclockwise. The distal cutting portion is angled so that the dual blades are positioned in an optimal cutting position. This angle allows the cutting tip to bend to conform to the area between Schwarzschild's line and the scleral spur (SS), i.e., the area surrounding the SC. The SC is narrower near the cornea and wider near the SS, so the angled tip optimally presents tissue 20 at both edges of the TM. The ramp 13 of the cutting tip can be angled so that tissue 20 is continuously lifted toward the blades as the tip advances in a circumferential pattern. Between the cutting tip and the first and second transverse blades 10, 11, ramp 13 is shaped to avoid cutting tissue, so that the TM 20, lifted away from the outer wall of the scleral venous sinus 22, remains intact as it advances along ramp 13. For example, ramp 13 may include a convex or beveled edge that is not sharp enough to cut the TM 20. Endoscopic visualization can also be used to guide the cutting. In some embodiments, the device of this disclosure can be placed at the tip of an endoscope, thereby eliminating the need for a diagonal scope during treatment. In some embodiments, the device of this disclosure can be placed at the tip of an endoscope and can be engaged with a TM under direct observation of an endoscopic camera.

[0105] In some embodiments, a method for cutting strips 20a of tissue 20 (e.g., TM) of width W from a tissue block includes the following steps: a) providing an apparatus comprising: i) a handle attached to a beveling platform; ii) a front insert blade end of the beveling platform extending rearward to a rear end of the beveling platform without cutting features; iii) a first side of the beveling platform to which a first transverse blade is fixed; iv) a second side of the beveling platform to which a second transverse blade is fixed; v) at least a first transverse cutting edge and a second transverse cutting edge formed by the blade at a position substantially perpendicular to and rearward of the opposing edges of the front insert blade end of the beveling platform, the first cutting edge and the second cutting edge being separated by a gap 14 of distance D, which is approximately equal to the width W of the strip 20a of tissue 20 to be cut (this is in Figure 10 , Figure 13 and Figure 15(as shown in the diagram); b) advancing the tip of the front insert blade of the oblique cutting platform through the tissue 20, such that the first and second cutting edges are positioned adjacent to the tissue 20 to be cut; c) advancing the distal end such that the cutting edges cut a strip 20a of approximately width W of the tissue 20, and the cut strip 20a of the tissue 20 remains substantially intact. In some embodiments, the majority of the tissue 20 is in vivo. In some embodiments, the majority of the tissue 20 is outside the body. In some embodiments, the device is integrated into an endoscope. In some embodiments, the cutting is directly visualized. In some embodiments, the majority of the tissue 20 is located in a human or animal subject. In some embodiments, the strip 20a of the tissue 20 is removed for diagnostic or therapeutic purposes. In some embodiments, the subject has glaucoma, and the method is performed to remove the strip 20a of the trabecular meshwork from the subject's eye to promote drainage of aqueous humor from the eye, thereby reducing intraocular pressure. In some embodiments, the eye has a dilated pupil. In some embodiments, step b includes: inserting the device into the anterior chamber of the eye; positioning the tip of the oblique cutting platform near or within the trabecular meshwork of the eye; and advancing the cutting tube such that the cutting edge cuts a strip 20a of approximately width W from the trabecular meshwork. In some embodiments, the device provided in step a of the method further includes the tip of the oblique cutting platform, wherein the tip of the oblique cutting platform is advanced through the trabecular meshwork and into the scleral venous sinus, and thereafter the tip of the oblique cutting platform is advanced through the scleral venous sinus as the cutting tube is advanced to cut the strip 20a of tissue 20. In some embodiments, the device provided in step a further includes means for cutting the strip 20a of tissue 20 after the strip 20a of tissue 20 reaches a desired length, wherein the method further includes the step of cutting the strip 20a of tissue 20 after the strip 20a of tissue 20 reaches the desired length. In some embodiments, the method is performed to form an incision in the skin, mucous membrane, organ, tumor, or other anatomical structure. In some embodiments, the method is performed to remove tissue 20 from the vascular system. In some embodiments, the method is performed to remove tissue 20 from the lymphatic system. In some embodiments, the method further includes the step of: c) removing strips 20a of tissue 20.

[0106] The embodiments disclosed herein are not intended to be limited to any particular endoscope; it is believed that the device can be optimized for use in ophthalmic endoscopic systems. One such system is commercially known as "Endo Optiks".

[0107] The device may have a distal port that allows for the injection of fluids to deliver locally balanced saline solutions, medications, viscoelastic agents, or therapeutic agents, or to flush away blood backflow that occurs during this type of surgery. The ultimate goal of this procedure may be to remove the entire segment of the TM without leaving visible tissue lobules (as occurs when other devices cut the TM in spaces that are not intended). This procedure can be combined with cataract extraction and can be performed before or after cataract extraction, as well as during pupillary dilation. It can also be combined with other intraocular surgeries, such as those based on the iris or vitreoretinal area.

[0108] Situations where the use of this device may benefit include:

[0109] 1. Primary open-angle glaucoma;

[0110] 2. Normal or low intraocular pressure glaucoma;

[0111] 3. Pseudoexfoliative glaucoma;

[0112] 4. Pigmentary dispersive glaucoma;

[0113] 5. Angle-closure glaucoma (acute, subacute, chronic);

[0114] 6. Neovascular or inflammatory glaucoma;

[0115] 7. Ocular hypertension;

[0116] 8. Other types of glaucoma associated with high intraocular pressure.

[0117] This device can be used for research purposes to obtain TM or other small portions of tissue for laboratory studies, or to obtain cells for in vitro culture. It can also be used to cut anterior synechiae or other cellular or fibrovascular membranes at the drainage angle, such as in patients with ICE syndrome or neovascular glaucoma.

[0118] This disclosure is not intended to limit the embodiments to any particular method, medical objective, or device; however, it is believed that the device can be optimally designed for removing the trabecular mesh of the eye, removing small blood vessels (such as veins, arteries, lymphatic vessels, or other vessels with lumens), and for creating a hole or opening in the tympanic membrane of the ear. This disclosure is not intended to limit the embodiments to any particular institution; however, it is believed that creating an opening in the tympanic membrane of the ear may be helpful in treating ear diseases.

[0119] Example

[0120] There are some drawbacks to using the traditional incision method for anterior chamber angle incision. Figure 20This image shows an incision extending into the sclera within the trabecular meshwork, with most of the meshwork still present. For this procedure (considered the gold standard for “cutting” the trabecular meshwork and traditionally called “goniotomy”), an MVR blade is used to create a single incision in the trabecular meshwork, opening into the scleral venous sinus. In this image, a histological sample from the surgery is present, showing an incision extending through the trabecular meshwork and into the sclera. Numerous lobes of the trabecular meshwork remain on either side of the incision. These lobes have scarred and closed the opening that was formed in the scleral venous sinus. This foreshadows the long-term benefit of reducing intraocular pressure, which is the goal of the surgery.

[0121] use The device also has some drawbacks in surgery. For this type of surgery (designed to replace anterior chamber goniotomy and improved by removing segments of the trabecular meshwork), using... The device is used to join the beam mesh, and an ablation technique is applied to the beam mesh, such as... Figure 21 As shown in the diagram. The circle indicates the area where a small section of the trabecular meshwork has been removed; however, there are still numerous lobes of the trabecular meshwork and charred tissue on both sides of the treated area. Figure 21 It shows The post-treatment results showed trabecular meshwork remnants and charred tissue. Tissue debris blocked the collector channels, the device "burned" the tissue, and the burns caused inflammation, leading to further scarring and ultimately, failure of the surgical opening into the scleral venous sinus. Additionally, numerous air bubbles formed during the procedure due to the ablation, making visualization during the actual surgery difficult. These problems do not occur in the embodiments of this disclosure, which is a major advantage.

[0122] Figure 22 The tissue after treatment using the apparatus according to an embodiment of this disclosure is shown. The data shows complete removal of the trabecular meshwork, with no residual leaflets and no signs of tissue burns. Figure 22 The illustration shows a close-up of the circular area. A representative image of the device is shown in... Figure 22 In the illustration on the left.

[0123] There is a second angle between handle 1 and ramp 13, which is in Figure 23 Not shown in the diagram. The ramp 13 not only forms an angle with the handle 1 (as shown in the diagram) Figure 23 (As shown on the right side of the image). It also forms an angle in the Z-axis. (The pivot is located at "#") away from the page being observed. In some embodiments, the angle between the handle 1 and the ramp 13 ranges between approximately 90 degrees and 120 degrees. It is believed that the ramp 13 pierces the tissue, which then slides along the ramp 13 from A to B. The blade (*) then cuts the tissue as the device advances.

[0124] One drawback of conventional blades is that the footplate is located in the scleral venous sinus. Because there is no ramp 13 and a second angle between the tip and the handle, the second angle would have a pivot at the "*", which would create the device's pivot below ramp 13.

[0125] Now for reference Figures 24-26 The device 12 may have features similar to those shown in other figures. For example... Figure 24 As shown, the platform 5 of the device 12 may include: an end 6 located on the distal side of the platform 5; and a top surface (e.g., a ramp) 13 extending from the distal side of the platform 5 to the proximal side of the platform 5, the proximal side being opposite to the distal side of the platform 5. For example, the top surface 13 may extend from the end 6 to one or more transverse elements 10, 11.

[0126] like Figure 24 As further shown, platform 5 may include a bottom surface 15 extending from an end 6 at the distal end of platform 5 to a rear portion 7 of platform 5 opposite to end 6. The bottom surface 15 of device 12 may be positioned opposite the top surface 13. The bottom surface 15 may be configured to abut against the outer wall of the scleral venous sinus during surgery (see [link to surgical procedure]). Figures 19A-19C At least a portion of the bottom surface 15 may be flat and / or planar. The rear portion 7 may define a curved or circular surface that transitions from the bottom surface 15 to a portion of the shaft 4.

[0127] like Figure 25 and Figure 26 As shown, the opposite sides 8 and 9 of platform 5 can extend downward from the top surface 13. The opposite sides 8 and 9 can be planar and / or parallel to each other. The top surface 13 can transition to the opposite sides 8 and 9 via transition features. Although in Figures 24-26 The diagram shows a circular bevel, but transition features can have one or more other shapes, including curves, circles, chamfers, rounded corners, etc.

[0128] Transition features can be provided between the bottom surface 15 and the opposite sides 8, 9. For example, the bottom surface 15 can transition to the opposite sides 8, 9 using transition segments 28, 29, respectively. Although in Figures 24-26 The diagram shows chamfers for the transition sections 28 and 29, but the transition features can have one or more other shapes, including bends, circles, bevels, fillets, etc. Along the transition features, the width of the device 12 can transition from a first width between opposite sides 8 and 9 to a second width across the bottom surface 15 that is smaller than the first width. The transition from the first width to the second width can be gradual, linear, stepped, or other types of transition.

[0129] Now for reference Figures 26-28The bottom surface 15 of device 12 may include surface features that enhance interaction with the outer wall of the scleral venous sinus during surgery. For example, the bottom surface 15 may be a plane, a convex surface, a concave surface, or a combination thereof. By further example, such as... Figure 27 and Figure 28 As shown, the bottom surface 15 may include a recessed portion 40 between at least two protrusions. The recessed portion 40 may be defined by a gap, space, or void. A first protrusion 38 may be positioned below a first side 8 and / or a first transition segment 28 of the platform 5. The first protrusion 38 may be formed at least partially by at least a portion of the first transition segment 28. A second protrusion 39 may be positioned below a second side 9 and / or a second transition segment 29 of the platform 5. The second protrusion 39 may be formed at least partially by at least a portion of the second transition segment 29. Each of the protrusions 38, 39 may extend from a rear portion 7 of the platform 5 toward an end portion 6. The protrusions 38, 39 may be spaced apart by the recessed portion 40 extending therebetween. Figure 26 and Figure 27 As shown, the transition between the protrusions 38, 39 and the recessed portion 40 can be stepped, thus forming one or more edges. Additionally or alternatively, the transition between the protrusions 38, 39 and the recessed portion 40 can be gradual, curved, rounded, beveled, chamfered, linear, or other types of transition. For example, the recessed portion 40 may include a recessed feature. The recessed portion 40 may extend to and intersect with the rear portion 7 of the platform 5.

[0130] Adjacent to end 6, the bottom surface 15 may provide a continuous (e.g., planar) portion 16 that is not interrupted by the recessed portion 40. End 6 may be separated from the recessed portion 40 by this continuous portion 16. Accordingly, the bottom surface 15 may include a planar distal portion and a non-planar proximal portion along its length. End 6 and the region immediately adjacent to end 6 (e.g., the continuous portion 16) may be continuous such that the recessed portion 40 does not intersect with end 6. The recessed portion 40 may extend distally from the rear portion 7, for example, not exceeding the opposite sides 8, 9 and / or transition segments 28, 29. Figure 28 As shown, the recessed portion 40 may terminate at its distal end with a transition feature, which may be, for example, gradual, curved, rounded, beveled, chamfered, linear, stepped, or other types of transition.

[0131] The distal planar portion provides a flat surface to facilitate access to tissue using the distal end 6. The proximal non-planar portion (e.g., protrusions 38, 39 and recess 40) interacts with the scleral venous sinus during surgery. As the platform 5 moves, at least some of the tissue can be received within the recess 40 between the protrusions 38, 39. The protrusions 38, 39 provide a smaller surface area for exposure to tissue (e.g., the scleral venous sinus). Accordingly, the proximal non-planar portion of the bottom surface 15 provides greater maneuverability of the platform 5 as it moves along the tissue.

[0132] Figure 29 A cross-section of the eye is shown, in which one embodiment of the handle 1 is inside the eye, extending parallel to and across the opposite side of the scleral venous sinus, outlined by a circle. The angle between the handle 1 and the ramp 13 will allow the blade to enter the scleral venous sinus and cut the tissue. In this figure, the first angle will align the ramp 13 towards the observer. However, a second angle is also required, following the black line, to allow the device to also fit within the angular space of the scleral venous sinus.

[0133] Prior to the start of the study, approval was obtained from the Colorado Multiple Institutional Review Board for the use of human materials in preclinical research, adhering to the principles of the Declaration of Helsinki. Informed consent was obtained from donors or relatives for use in the eye bank's research, and human eyeballs were obtained from the eye bank.

[0134] For histological analysis, six limbal specimens were obtained from the Rocky Mountain Lions Eye Bank (Aurora, Colorado, USA) and the San Diego Eye Bank (San Diego, California, USA). Tissue specimens were removed from storage media and mounted on a platform with the TM side facing up, secured in place with tissue pins. Two specimens were used for each of the three processing methods studied. A single incision was made along the length of the two limbuses on the central TM using an MVR blade under microscopic visualization. The device, with its footplate at the end, was inserted into the scleral venous sinus under microscopic visualization. Once in place, the footplate was used to apply continuous ablation while the endplate was slowly advanced across the extent of the TM sample. A standard power setting of 0.8W was used during treatment. A dual-blade device was used to cut the TM from two samples. The TM was cut using the blade tip in a manner similar to that used for anterior chamber goniotomy, and then the blade was advanced clockwise along the extent of the TM. At the distal end, the blade tip was tilted upward to cut the complete TM band, and this process was repeated counterclockwise to cut the remaining TM tissue.

[0135] All tissue samples were then immediately preserved overnight in 4% paraformaldehyde / phosphate buffer at 4°C, and then radially cut into quarter-circles. Marginal sections were histologically prepared and embedded in paraffin, with the cut edges of the tissue facing the front of the block. Tissue segments (6 mm thick) were cut and stained with Meyer's hematoxylin-eosin Y (Richard Allen Scientific, Kalamazoo, NY, USA). Bright-field imaging was performed using a Nikon Eclipse 80i microscope (Milmell, NY, Nikon), equipped with a Nikon D5-Fil color camera and Nikon CFI 103 / Plan Fluor objectives.

[0136] Human eye perfusion studies: A total of 12 pseudolens donors without a history of glaucoma were obtained from various eye banks across the country for perfusion studies on each device. The perfusion system used a standard programmable injector pump (Pump 11 Plus; Harvard University Equipment, Holliston, Massachusetts, USA). Pressure was monitored via an online real-time pressure sensor (research-grade pressure transducer; Harvard University Equipment) connected to a single-channel graphic recorder (Pharmacia REC-481; Pharmacia / Pfizer New York, NY, USA). 1.14 mm inner diameter polyethylene tubing (PE-160; Warner Instruments, Connecticut, USA) was used for all connections.

[0137] In each case, the human eyeball was first prepared as follows: Dulbecco's modified Eagle medium (DMEM; Invitrogen / Life Technology, Carlsbad, California, USA) was injected through the optic nerve using a 26-dosing needle until the eyeball returned to its spherical shape. An infusion line (terminating in another 26-dosing needle) was inserted obliquely through the anterior chamber of the eye, across the cornea and pupil, terminating below the iris. The eyeball was surrounded by moist gauze, and the infusion pump (filled with DMEM) was set to an initial inflow rate of 7 mL / min. IOP was allowed to increase until it reached 30 mmHg. The infusion rate was then reduced to 2–5 mL / min to maintain a stable IOP for at least 60 minutes prior to TM incision. In each case, the preoperative IOP was measured prior to incision. A 1.7mm stainless steel keratoscalpel (BD) is used to create a tri-oblique, clear corneal incision near the limbus, and the anterior chamber is filled with sufficient viscoelastic agent (Healon GV; Abbott Medical Optics, Illinois, USA) to maintain the anterior chamber and provide adequate visualization during surgery in each case. Each technique is performed under microscope-assisted conditions using a standard direct anterior gonioscope at the anterior gonioscope view. The surgical procedure for each device is as described above. In each case, approximately 100–180 degrees of TM is treated. For each device, treatment begins 180 degrees away from the corneal incision and extends clockwise along that angle. Then, the device extends counterclockwise from the same starting point. Every effort is made to treat the maximum possible power for each device. In dual-blade devices and In this case, the instrument is rotated 180 degrees after the initial pass to guide the device tip along the treatment direction. IOP is allowed to stabilize before measurement. Each of the three surgical techniques studied was performed on a total of four eyes.

[0138] The mean and standard deviation of preoperative and postoperative IOP, as well as the percentage change in IOP, were calculated for each device. A student-matched test was used to compare preoperative and postoperative IOP for each device. A p-value <0.05 was considered statistically significant.

[0139] Two limbal sections were analyzed for each device. Six-micrometer-thick tissue sections were selected at different clock times, processed with each device, and stained with Mayer's hematoxylin and eosin Y (Richard-Allan Sciences, Ltd.). Results for all sections from each device tested were consistent. Incisions using the MVR blade revealed complete cuts through the entire thickness of the TM tissue. However, minimal removal of the TM left numerous lobules of tissue on the scleral venous sinus. The incisions extended deeply through the scleral venous sinus, causing significant damage to the adjacent deep sclera in most sections. Figure 1 ). It also achieved an opening into the scleral venous sinus through the entire TM tissue. Although the device also removed most of the central TM, a significant amount of residual lobule tissue remained. The residual TM demonstrated extensive charring caused by thermal damage. It was also noted that tissue debris blocked the distal collector channel. Figure 2 Tissue cut using a dual-blade device demonstrated more complete TM removal without collateral damage. Figure 3 ).

[0140] Data from human eye perfusion studies are included in Table 1. The range of TM treatment varies from 100 to 180 degrees between different devices and eyes. All three treatment modalities achieved a significant reduction in IOP measured 30 minutes post-treatment. (Using a dual-blade device and...) After treatment, the average IOP decreased by 40%, while the MVR blade achieved a 31% reduction. Despite The percentage decrease in IOP was greater for dual-blade devices, but there was no statistically significant difference in IOP decrease between devices (dual-blade / MVR P = 0.13; dual-blade / P = 0.96; / MVR P = 0.12). For any device, there was no correlation between the degree of treatment of TM and the percentage change in IOP (r2 = 0.077-0.271).

[0141]

[0142]

[0143] Histological analysis of human cadaver eye tissue processed using a dual-blade device achieved more complete removal of TM tissue while avoiding any identifiable damage to surrounding tissues. Treatment using other TM removal methods, such as those employing… The MVR blade technique for goniotomy and intraocular trabeculectomy did not yield histological results comparable to the dual-blade device. While histological data were obtained from in vitro limbal treatment, similar findings were observed when the intraocular protocol was used on the perfused eye. The near absence of TM lobules in the dual-blade device may reduce the chance of future physical occlusion, and the absence of tissue damage may also reduce inflammation or subsequent fibrosis at the surgical site.

[0144] In addition to potentially favorable histological outcomes, the dual-blade device resulted in a significant reduction in IOP in a human eye perfusion model. Although all three devices produced similar immediate IOP reductions after use in the perfusion model, it remains unclear how the more complete removal of TM tissue and reduced collateral damage using the dual-blade device of this disclosure will translate into long-term shell surgery outcomes when used for glaucoma treatment. No correlation was found between the extent of TM treatment and IOP reduction. IOP reduction likely depends more on the number of downstream collector channels exposed than on the absolute amount of TM removal.

[0145] To provide a low-cost MIGS device that can be widely used by ophthalmologists, one embodiment of this disclosure proposes a medical-grade stainless steel dual-blade device capable of successfully removing TM tissue without causing identifiable collateral damage. In some embodiments, the device includes a unique dual-edge blade design that uses precise geometry to allow for more complete removal of TM tissue. Figure 4 It is believed that the procedure is performed intraocularly and is viscoelastic to maintain the anterior chamber. For example, the size and tip of the blade allow for smooth entry into the scleral venous sinus, similar to the technique used for conventional anterior chamber goniotomy. Once in place, the tip is advanced through the scleral venous sinus, and the TM is lifted along a designed ramp that guides tissue toward a set of blades positioned specifically for cutting and removing the TM. This is juxtaposed between the outer and inner walls of the scleral venous sinus to provide protection during ablation. Unlike traditional footplates, the dual-blade device transversely cuts and elevates the TM away from the outer wall of the scleral venous sinus. It is believed that by elevating the TM along the ramp of the device as it moves forward, maximum tissue removal will result when the dual-blade device is positioned above and strategically angled for cutting. Furthermore, it is believed that the angle between the distal cutting edge and the handle is designed to allow for maximum angle treatment through an incision while avoiding trauma to the superior cornea or inferior scleral spur. The excised TM can then be removed from the eye using forceps, or, if combined with cataract extraction, aspirated during the irrigation / aspiration phase. Additionally, the device according to embodiments of this disclosure can be easily passed through a small, clear corneal incision of as little as 1.2 mm, thus eliminating the need for additional incisions when combined with phacoemulsification cataract extraction.

[0146] As described by Jacobi and colleagues, another known device for intraocular trabeculectomy is called a "gonioscraper." This device consists of a handle and a curette tip and is used to remove TM tissue by scraping within the scleral venous sinus. The curette tip is aligned with the handle and does not conform to the geometry of the drainage angle and adjacent structures. Following promising preclinical trials, a non-randomized clinical trial was completed in 25 eyes. The preoperative IOP was 34.7 ± 7.1 mmHg (2.2 ± 0.56 dapoxetine), and the mean follow-up time was 32 months. Based on the success criterion of postoperative IOP ≤ 19 mmHg with one dose of antihypertensive drug, 15 eyes (60%) were successful. Nevertheless, some patients experienced complications, including localized posterior elastic lamina detachment and / or anterior chamber hemorrhage. Histological analysis of stock human eyes treated with curettage showed successful removal of TM tissue, but damage to the septum and endothelium of the lateral and posterior walls of the scleral venous sinus. In the data provided herein, similar damage to adjacent sclera was observed when using MVR blades, but such damage was not apparent when using an embodiment of the dual-blade device provided in this disclosure. Additionally, this disclosure provides a blade device geometry designed to minimize any impact on adjacent tissues (e.g., Descemet's membrane of the cornea) by utilizing specific angles between the handle and the distal blade, and specific angles between the cutting blade and the adjacent cutting tip.

[0147] In the past few years, there have been discussions about Reports of device successes and failures. In recent reports... A retrospective study comparing intraocular trabeculectomy with other procedures revealed that over the past two years, the use of... The success rate of eye treatment is low. (In 115 cases...) Of the treated eyes, only 22.4% were successful, with failure defined as IOP > 21 mmHg or IOP decrease < 20%. It is conceivable that residual lobules could obstruct the scleral venous sinus and / or more distal collector passage after the initial opening is removed with the TM, leading to interventional failure. The dual-blade device will overcome this. This failure mechanism after treatment is due to the more complete removal of TM tissue without any residual lobules.

[0148] The foregoing description is provided to enable those skilled in the art to implement the various constructions described herein. Although the technology has been specifically described with reference to various accompanying drawings and constructions, it should be understood that these are for illustrative purposes only and should not be considered as limiting the scope of the technology.

[0149] Many other methods may be used to implement this technology. The various functions and elements described herein may be divided in ways other than those shown without departing from the scope of this technology. Various modifications to these constructions will be apparent to those skilled in the art, and the general principles defined herein can be applied to other constructions. Therefore, those skilled in the art can make many changes and modifications to this technology without departing from its scope.

[0150] It should be understood that the specific order or hierarchy of steps in the disclosed method is an illustration of an exemplary scheme. Based on design preferences, it should be understood that the specific order or hierarchy of steps in the method can be rearranged. Some steps may be performed simultaneously. The appended method claims present the elements of the various steps in a sample order and are not intended to limit one to the specific order or hierarchy presented.

[0151] For example, phrases such as "aspect" do not imply that the aspect is essential to the present technology, nor do they imply that the aspect is applicable to all constructions of the present technology. Disclosure relating to an aspect may apply to all constructions, or one or more constructions. An aspect may provide one or more examples of the present disclosure. For example, phrases such as "aspect" may refer to one or more aspects, and vice versa. For example, phrases such as "embodiment" do not imply that the embodiment is essential to the present technology, nor do they imply that the embodiment is applicable to all constructions of the present technology. Disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples of the present disclosure. For example, phrases such as "embodiment" may refer to one or more embodiments, and vice versa. For example, phrases such as "construction" do not imply that the construction is essential to the present technology, nor do they imply that the construction is applicable to all constructions of the present technology. Disclosure relating to a construction may apply to all constructions, or one or more constructions. A construction may provide one or more examples of the present disclosure. For example, phrases such as "construction" may refer to one or more constructions, and vice versa.

[0152] As used herein, the phrase “at least one of…” preceding a series of items (using the terms “and” or “or” to separate any of these items) modifies the list as a whole, rather than each member of the list (i.e., each item). The phrase “at least one of…” does not require selection of at least one of each of the listed items; rather, the phrase implies including at least one of any of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. For example, the phrases “at least one of A, B, and C” or “at least one of A, B, or C” each refer to only A, only B, or only C; any combination of A, B, and C; and / or at least one of each of A, B, and C.

[0153] Terms such as “top,” “bottom,” “front,” and “rear” used in this disclosure should be understood as referring to any arbitrary frame of reference, rather than a common gravitational frame of reference. Therefore, the top surface, bottom surface, front surface, and rear surface can extend upward, downward, obliquely, or horizontally in a gravitational frame of reference.

[0154] Furthermore, where the terms “comprising,” “having,” or similar are used in the specification or claims, the terms are intended to be inclusive in a manner similar to how the term “comprise” is interpreted when used as a transitional word in a claim.

[0155] The word “exemplary” is used herein to mean “serving as an example, instance or illustration”, and any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or superior to other embodiments.

[0156] Unless otherwise specified, elements mentioned in the singular do not mean "one and only one," but rather "one or more." Male pronouns (e.g., his) include female and neutral pronouns (e.g., her and its), and vice versa. The term "some" refers to one or more. Underlined and / or italicized headings and subheadings are used for convenience only and are not intended to limit the technology, nor are they mentioned in connection with the explanation of the description of the technology. All structural and functional equivalents of elements throughout the various constructions described herein that are known or will be known hereafter by one of ordinary skill in the art are expressly incorporated herein by reference and are intended to be covered by the technology. Furthermore, nothing disclosed herein is intended to be made public, whether or not such disclosure is expressly stated in the foregoing description.

[0157] While certain aspects and embodiments of the present technology have been described, these aspects and embodiments are presented by way of example only and are not intended to limit the scope of the present technology. In fact, the novel methods and systems described herein may be embodied in various other forms without departing from their spirit. The appended claims and their equivalents are intended to cover any forms or modifications that fall within the scope and spirit of the present technology.

Claims

1. An apparatus for cutting a trabecular meshwork, the apparatus comprising: a platform for lifting a portion of the trabecular meshwork away from an outer wall of a Schlemm’s canal, the platform including a tip at a distal side of the platform and a top surface extending from the distal side of the platform to a proximal side of the platform, wherein the proximal side of the platform is opposite the distal side of the platform, the platform increasing in thickness from the distal side to the proximal side; a first side and a second side extending from the top surface, wherein the first side and the second side are parallel to each other; a first lateral element and a second lateral element for creating a first cut and a second cut through the trabecular meshwork, the first lateral element and the second lateral element extending from the proximal side of the platform; and a bottom surface opposite the top surface, wherein the bottom surface includes a first protrusion and a second protrusion separated by a gap and a planar portion adjacent to the tip, wherein the tip is separated from the gap by the planar portion.

2. The apparatus of claim 1, wherein, the first protrusion is parallel to the first side and the second protrusion is parallel to the second side.

3. The apparatus of claim 1, wherein, the bottom surface has a maximum width that is less than a maximum width of the platform.

4. The apparatus of claim 1, wherein, the platform forms a first bevel connecting the top surface to the first side and a second bevel connecting the top surface to the second side.

5. The apparatus of claim 1, wherein, the gap extends from the proximal side of the platform to the planar portion of the bottom surface.

6. The apparatus of claim 1, wherein, the gap includes a distal end that transitions into a rounded shape of the planar portion of the bottom surface.

7. The apparatus of claim 1, wherein, the bottom surface is connected to a back surface of the apparatus opposite the tip by a rounded surface.

8. The apparatus of claim 1, wherein, the first protrusion and the second protrusion are connected to the back surface of the apparatus opposite the tip by a rounded surface.

9. The apparatus of claim 8, wherein, the gap extends to the back surface.

10. The apparatus of claim 1, wherein, the transition between the first protrusion and the second protrusion and the gap is stepped and forms one or more edges.

11. The apparatus of claim 1, wherein, the transition between the first protrusion and the second protrusion and the gap is curved and forms a concave feature.

12. An apparatus for cutting a trabecular meshwork, the apparatus comprising: a platform for lifting a portion of the trabecular meshwork away from an outer wall of a Schlemm’s canal, the platform including a tip at a first end of the platform and a top surface extending from the first end of the platform to a second end of the platform, the platform increasing in thickness from the first end to the second end; a first lateral element and a second lateral element for creating a first cut and a second cut through the trabecular meshwork, the first lateral element and the second lateral element extending from the second end of the platform; and a bottom surface opposite the top surface, wherein the bottom surface includes a first protrusion and a second protrusion separated by a gap and a planar portion adjacent to the tip, wherein the tip is separated from the gap by the planar portion.

13. The device of claim 12, further comprising a first side and a second side extending from the top surface, wherein, the first protrusion is parallel to the first side and the second protrusion is parallel to the second side.

14. The apparatus of claim 12, wherein, the bottom surface has a maximum width that is less than a maximum width of the platform.

15. The apparatus of claim 12, wherein, the gap extends from the second end of the platform to the planar portion of the bottom surface.

16. The apparatus of claim 12, wherein, The gap includes a rounded end into a planar portion of the bottom surface.

17. The apparatus of claim 12, wherein, The first and second protrusions are connected to an outer surface of the second end by rounded surfaces, and wherein the gap extends to the outer surface.

18. The apparatus of claim 12, wherein, The transition between the first and second protrusions and the gap is stepped and forms one or more edges.

19. The apparatus of claim 12, wherein, The transition between the first and second protrusions and the gap is curved and forms a recessed feature.

Images