Implants, deployment tools for insertion of implants, and systems for facilitating fluid conduction

Abstract

The present invention provides an implant configured to be deployed in an eye by a deployment tool to facilitate conduction of fluid from a posterior chamber of the eye to a suprachoroidal space, the implant comprising an elongate member, and an elongate member having a proximal section configured to be disposed in the posterior chamber of the eye and a distal section configured to be disposed in the suprachoroidal space of the eye, the elongate member is configured to maintain a curved configuration that substantially conforms to an anatomical curvature of the posterior chamber and the suprachoroidal space. The invention also provides a deployment tool for inserting the implant described herein into an eye to facilitate conduction of fluid from the posterior chamber of the eye to the suprachoroidal space, and provides a system for facilitating conduction of fluid from the posterior chamber of the eye to the suprachoroidal space.

Description

Technical Field

[0001] The present invention broadly relates to an implant, a deployment tool for inserting an implant, and a system for facilitating fluid conduction. Prior art

[0002] Glaucoma is a group of diseases in which the optic nerve is damaged due to abnormally high pressure within the eye. Clinical features in humans The two most common types of glaucoma include primary open-angle glaucoma (POAG) and primary angle-closure glaucoma (PACG). Both types of glaucoma are characterized by progressive and irreversible damage to the optic nerve axons and degeneration of retinal ganglion cells, often associated with elevated intraocular pressure (IOP).

[0003] Although the prevalence of POAG is higher than that of PACG worldwide, PACG tends to be a very large problem in East Asia. PACG is the main form of glaucoma and accounts for approximately 90% of all cases of glaucoma-related blindness in China.

[0004] In general, the normal range of IOP is between about 10 mmHg and about 21 mmHg. It is regulated by balancing the secretion of aqueous humor (AH) from the ciliary body in the posterior chamber and the drainage of AH from the anterior chamber angle, either through the trabecular meshwork / Schlemm's canals (TM / SC) or through the uveoscleral outflow pathway through the root of the iris. These are also referred to as conventional and unconventional pathways, respectively.

[0005] In ACG, the peripheral iris contacts the TM and the peripheral cornea to block the AH from escaping through the outflow pathway. Iris-corneal contact is due to the anterior bulging of the peripheral iris due to the pressure difference between the posterior and anterior chambers. This can be caused by increased flow resistance when the AH passes through the gap between the iris and the lens, which is associated with anatomical abnormalities, abnormal iris thickness and position, or high-pleated iris configuration.

[0006] In chronic ACG, the above angle gradually closes. Peripheral anterior synechiae (PAS; adhesion of the peripheral iris to structures in the anterior chamber angle) form due to long-term appositional contact between the iris and the trabecular meshwork. This long-term blockage eventually leads to irreversible changes in the meshwork to permanently block the normal outflow pathway at the site of the PAS.

[0007] The main goal of treating chronic ACG is to eliminate the underlying pathophysiologic mechanisms causing the angle closure, primarily pupillary block and peripheral angle crowding / high-fold iris. In addition to eye drops, laser peripheral iridotomy (LPI) is often the first line of treatment, however, its role as a long-term treatment is unsatisfactory as up to 53% of patients ultimately require surgery due to poor IOP control and failure of medical therapy. If the angle remains occluded after laser peripheral iridotomy, laser iridoplasty is further indicated, but this procedure is not effective when there is an established, massive PAS.

[0008] In ACG, lens extraction is increasingly considered an appropriate primary treatment compared with laser peripheral iridotomy due to its superior efficacy based on the EAGLE (Efficacy of Lens Extraction in Angle-Closure Glaucoma) trial and better cost-effectiveness. Unfortunately, lens extraction alone cannot eliminate residual PAS, especially in patients with chronic ACG.

[0009] The final treatment option for patients with such chronic ACG who are refractory to medical or the above treatments is trabeculectomy or insertion of a glaucoma drainage device (GDD), such as the tubular Molteno, Baerveldt, or Ahmed implants. Trabeculectomy is a technically complex procedure that can result in failure due to scarring, decreased quality of life due to herpes-related foreign body sensation, induction of astigmatism, and secondary cataracts. The reoperation rate is also relatively high.

[0010] Therefore, there is a treatment gap for safer and more effective methods to better improve the treatment outcomes of patients with chronic ACG, especially those with moderately severe disease. As an alternative to traditional glaucoma treatment, minimally invasive glaucoma surgery (MIGS) has shown good prospects in the future management of glaucoma. MIGS is characterized by: (i) an internal microincisional approach; (ii) minimal trauma / disruption of normal anatomy and physiology; (iii) significant / reliable IOP reduction; (iv) extremely high safety; and (v) rapid postoperative recovery with only regular follow-up.

[0011] Currently available MIGS approaches have been designed to treat mild to moderate POAG. Attempts to adapt such existing devices to chronic ACG have been unsuccessful, with failure rates of approximately 30% to 40% (compared to less than 5% when used in POAG patients). It is recognized that developing a MIGS-like approach to chronic ACG will require the design, development, and testing of new devices to focus more on, and ultimately be implemented in, Asian patient populations.

[0012] Existing MIGS devices are not suitable for the treatment of chronic angle-closure glaucoma for the following reasons: (i) the inability to achieve adequate visualization of the anterior chamber angle and surgical access for deployment of the MIGS device; (ii) dysfunction of conventional outflow pathways (e.g., trabecular meshwork / Schlemm's canal (TM / SC)) in patients with chronic angle-closure (particularly with established PAS lasting for more than 6 months); (iii) the risk of iris occlusion or reformation of peripheral anterior synechiae encapsulating the proximal inflow of the MIGS device, leading to drainage failure; (iv) the risk of long-term and sustained endothelial cell loss due to the anterior chamber location of the MIGS device, which can be exacerbated in patients with chronic angle-closure (this risk is particularly relevant to future regulatory approval of this device due to the withdrawal of the Alcon Cypass system in August 2018); and (v) the increased risk of scarring / fibrosis with the subconjunctival outflow MIGS approach, leading to repeat rescue surgeries, i.e., needling or subsequent device failure.

[0013] Therefore, there is a need for an implant, a deployment tool for inserting an implant, and a system for facilitating fluid conduction that can solve or at least ameliorate one of the above-mentioned problems. Summary of the invention

[0014] In one aspect, an implant is provided that is configured to be deployed in an eye by a deployment tool to facilitate conduction of fluid from the posterior chamber of the eye to the suprachoroidal space, the implant comprising an elongated member having a proximal segment configured to be disposed in the posterior chamber of the eye and a distal segment configured to be disposed in the suprachoroidal space of the eye, wherein when deployed in the eye, the elongated member is configured to maintain a curved configuration that substantially conforms to the anatomical curvature of the posterior chamber and the suprachoroidal space.

[0015] In one embodiment, the elongated member is configured to straighten to facilitate loading of the implant into the deployment tool for deployment, and to return to the curved configuration when deployed in the eye.

[0016] In one embodiment, the elongate member is preformed in the curved configuration at an angle that substantially matches an anatomical angle located between the posterior chamber and the suprachoroidal space of the eye.

[0017] In one embodiment, the elongated member has a maximum value of no more than 0.5 N.mm 2 The slender member has a bending stiffness such that the slender member can be moved from a portion of the sulcus or ciliary body to the suprachoroidal space of the eye along a delivery path formed by the puncture needle of the deployment tool without substantially deforming the puncture needle.

[0018] In one embodiment, the distal segment of the elongate member is curved with a radius of curvature substantially equal to a radius of curvature of the inner sclera of the eye.

[0019] In one embodiment, the elongate member is beveled at its proximal tip such that the bevel is configured to face away from the posterior surface of the iris when the implant is deployed in the eye.

[0020] In one aspect, a deployment tool for inserting an implant into an eye to promote conduction of fluid from the posterior chamber of the eye to the suprachoroidal space is provided, the deployment tool comprising: a catheter for entering the posterior chamber of the eye through an insertion site, the catheter comprising a distal tip configured to abut a ciliary sulcus or a portion of the ciliary body of the eye; and a puncture needle configured to be arranged in the catheter and to create a delivery path from the sulcus or a portion of the ciliary body to the suprachoroidal space of the eye; wherein the deployment tool allows the implant to move relative to the puncture needle along the delivery path, so that the distal segment of the implant is arranged in the suprachoroidal space of the eye and the proximal segment of the implant is arranged in the posterior chamber of the eye.

[0021] In one embodiment, the deployment tool further includes an implant actuator configured to be removably coupled to the implant and configured to move the implant distally along the delivery pathway relative to the introducer needle.

[0022] In one embodiment, the puncture needle includes a distal tip configured to dissect tissue to produce the delivery path; wherein the delivery path includes a first segment extending from the groove or a portion of the ciliary body to the inner surface of the sclera and a second segment extending from the inner surface of the sclera to the suprachoroidal space; and wherein the first segment and the second segment form a bend along the delivery path.

[0023] In one embodiment, the introducer needle is preformed in a curved configuration and is configured to straighten when deployed within the catheter and to return to the curved configuration when extended from the distal tip of the catheter to create the delivery pathway.

[0024] In one embodiment, the puncture needle has a stiffness of no more than 2.5 N / mm, thereby facilitating bending of the puncture needle along the corner of the delivery path.

[0025] In one embodiment, the conduit has a Young's modulus of at least 7.5 GPa such that the conduit does not substantially deflect when abutting the ciliary sulcus or a portion of the ciliary body of the eye.

[0026] In one embodiment, the deployment tool further includes a puncture needle holder, an implant actuator holder, and a catheter holder disposed thereon, wherein the puncture needle holder is configured to engage the proximal end of the puncture needle, the implant actuator holder is configured to engage the implant actuator, the catheter holder is configured to engage the catheter, and, optionally, wherein the puncture needle holder, the implant actuator holder and / or the catheter holder are each further coupled to respective controllers configured to optionally actuate the puncture needle, the implant actuator, and the catheter.

[0027] In one aspect, a system for facilitating conduction of fluid from a posterior chamber of an eye to a suprachoroidal space is provided, the system comprising: an implant comprising an elongated member having a proximal segment and a distal segment, wherein when deployed in the eye, the elongated member is configured to maintain a curved configuration that substantially conforms to the anatomical curvature of the posterior chamber and the suprachoroidal space; and a deployment tool comprising: a catheter for accessing the posterior chamber of the eye through an insertion site, the catheter comprising a distal tip configured to abut a portion of a ciliary sulcus or a ciliary body of the eye; and a puncture needle configured to be disposed within the catheter and to create a delivery path from the sulcus or a portion of the ciliary body to the suprachoroidal space of the eye; wherein the deployment tool allows the implant to move relative to the puncture needle in a distal direction along the delivery path, such that the distal segment of the implant is disposed in the suprachoroidal space of the eye and the proximal segment of the implant is disposed in the posterior chamber of the eye.

[0028] In one embodiment, the elongate member is configured to straighten to facilitate loading of the implant onto the distal end of the introducer needle.

[0029] In one embodiment, the implant and introducer needle are configured to be in a retracted position and disposed within the catheter prior to deployment.

[0030] In one embodiment, the insertion site is located on the cornea of ​​the eye; wherein the distal tip of the catheter is configured to be inserted through the corneal insertion site into the anterior chamber of the eye, and inserted across the pupil of the eye, and moved along the posterior surface of the iris to abut the ciliary sulcus or a portion of the ciliary body of the eye.

[0031] In one embodiment, the deployment tool further includes a puncture needle holder configured to engage the proximal end of the puncture needle and configured to extend the puncture needle distally from the distal tip of the catheter to allow the distal tip of the puncture needle to dissect tissue and create the delivery path; wherein the delivery path includes a first segment extending from the groove or a portion of the ciliary body to the inner surface of the sclera and a second segment extending from the inner surface of the sclera to the suprachoroidal space; and wherein the first segment and the second segment form a bend along the delivery path.

[0032] In one embodiment, the deployment tool further includes: an implant actuator configured to removably engage the implant; and an implant actuator holder configured to engage the implant actuator and configured to move the implant actuator so that the implant actuator engages the implant and the implant moves remotely along the delivery path relative to the puncture needle.

[0033] In one embodiment, the introducer needle holder is further configured to proximally retract the introducer needle such that the distal tip of the introducer needle is closer relative to the distal tip of the implant actuator.

[0034] definition

[0035] As disclosed herein, the various components of deployment tools and implants will be described using the terms "proximal end" and "remote end". As defined herein, the term "proximal end" should be broadly interpreted as meaning in the direction of an operator (e.g., a medical professional). As defined herein, the term "remote end" should be broadly interpreted as meaning in the direction of a subject (e.g., a patient). When referring to a specific feature of an implant, the terms "proximal end" and "remote end" refer to the relative position of a feature, e.g., when the implant is inserted into a subject, close to the operator or close to the subject.

[0036] As used herein, the terms "anterior" and "posterior" should be interpreted according to their commonly understood anatomical interpretation. Thus, "anterior" refers to the front of a subject (eg, a human), and "posterior" refers to the back of a subject.

[0037] As used herein, the terms "medial" and "lateral" should be interpreted according to their commonly understood anatomical interpretation. Thus, "medial" refers to a direction toward the midline of a subject (e.g., a human), and "lateral" refers to a direction away from the midline of a subject.

[0038] As used herein, the term "biocompatible" should be broadly interpreted to refer to the ability of an implant to perform its intended function without substantially producing any undesirable local or systemic effects in a subject receiving the implant.

[0039] As used herein, the term "biologically inert" should be broadly interpreted to refer to materials that do not substantially elicit an immune response in humans or animals when placed in an in vivo biological environment.

[0040] As used herein, the term "implant" should be broadly interpreted to refer to any object, other than living tissue, intended to be placed within the body of a mammal, such as a human.

[0041] As used interchangeably herein, the terms "eye" and "eyeball" refer to a human eye or a mammalian eye.

[0042] As used herein, the term "anterior chamber" refers to the area / space of the eye located behind the cornea and in front of the iris.

[0043] As used herein, the term "posterior chamber" refers to the area / space of the eye located behind the iris and in front of the lens.

[0044] As used herein, the term "suprachoroidal space" refers to the space of the eye between the choroid and the sclera that traverses the circumference of the posterior segment of the eye.

[0045] As used herein, the term "treat" should be broadly interpreted to mean attempting to temporarily inhibit / reduce the progression of a disease (eg, glaucoma) or attempting to permanently stop the progression of a disease. The disease ultimately does not require effective treatment.

[0046] As used herein, the term "substrate" should be broadly interpreted to refer to any supporting structure.

[0047] The term "layer" when used to describe a first material should be broadly interpreted as referring to a first depth of the first material, which can be distinguished from a second depth of the second material. The first material of the layer can exist as a continuous film, a discontinuous structure, or a mixture of either. The layer can also have a substantially uniform depth throughout or a varying depth. Thus, when a layer is formed from individual structures, each dimension of the individual structures can be different. The first material and the second material can be the same or different, and the first depth and the second depth can be the same or different.

[0048] When used herein to describe an object, the term "substantially light transmissive" should be broadly interpreted to mean that 50% or more of light incident normal to the surface of the object can be transmitted through the object. In some examples, a substantially light transmissive object allows 60% or more, 65% or more, 70% or more, 80% or more, 85% or more, 90% or more, or 95% or more of light incident normal to the surface of the object to be transmitted. In one example, a substantially light transmissive object allows more than 70% of light incident normal to the surface of the object to be transmitted.

[0049] As used herein, the term "micro" should be broadly interpreted to encompass sizes from about 1 micron to about 1000 microns.

[0050] As used herein, the term "nano" should be broadly interpreted to encompass dimensions less than about 1000 nm.

[0051] Unless otherwise stated, the terms “coupled” or “connected” used in this specification are intended to encompass a direct connection to the two or a connection through one or more intermediate components.

[0052] As used herein, the term "associated with" when referring to two components refers to a broad relationship between the two components. Relationships include, but are not limited to, physical, chemical, or biological relationships. For example, when component A is associated with component B, components A and B may be directly or indirectly attached to each other or component A may contain component B, and vice versa.

[0053] The term "adjacent" used herein when referring to two components means that one component is in close proximity to another component, and may be, but is not limited to, the components contacting each other, or may further include that the components are separated by one or more additional components disposed between these components.

[0054] The term "and / or" (eg, "X and / or Y") should be understood to mean "X and Y" or "X or Y," and should be considered to provide explicit support for both meanings or either meaning.

[0055] In addition, in the description herein, whenever used, the term "substantially" should be understood to include but not limited to "completely" or "thoroughly" and the like. In addition, whenever used, terms such as "including" and the like are intended to be non-restrictive descriptive language, because generally include the elements / components listed after these terms and other components that are not explicitly listed. For example, when "including" is used, mentioning "one" feature is also intended to be referring to "at least one" of the feature. In the appropriate context, terms such as "consisting of..." and the like can be regarded as subsets such as "including" and the like. Therefore, in the embodiments disclosed herein using terms such as "including" and the like, it should be understood that these embodiments use terms such as "consisting of..." and the like to provide teachings of corresponding embodiments. In addition, whenever used, terms such as "about", "approximately" and the like generally mean reasonable changes, such as changes of + / - 5% of the disclosed value, or changes of 4% of the disclosed value, or changes of 3% of the disclosed value, or changes of 2% of the disclosed value, or changes of 1% of the disclosed value.

[0056] In addition, in the description herein, certain values ​​may be disclosed within a range. The values ​​indicating the endpoints of a range are intended to illustrate preferred ranges. Whenever a range is described, the range is intended to cover and teach all possible subranges and single values ​​within the range. That is, the endpoints of a range should not be interpreted as rigid restrictions. For example, the description of a range of 1% to 5% is intended to clearly disclose subranges 1% to 2%, 1% to 3%, 1% to 4%, 2% to 3%, etc. and single values ​​within the range, such as 1%, 2%, 3%, 4% and 5%. It should be understood that individual values ​​within the range also include integers, fractions and decimals. In addition, whenever a range is described, the range is also intended to cover and teach values ​​up to 2 additional decimal points or significant numbers (as the case may be) from the displayed digital endpoints. For example, the description of a range of 1% to 5% is intended to have explicitly disclosed the ranges 1.00% to 5.00% and 1.0% to 5.0%, and to encompass all intermediate values ​​of the range (e.g., 1.01%, 1.02% ... 4.98%, 4.99%, 5.00% and 1.1%, 1.2% ... 4.8%, 4.9%, 5.0%, etc.). The above specific disclosure is intended to apply to any depth / breadth of a range.

[0057] In addition, when describing some embodiments, the present invention may have disclosed methods and / or procedures as a specific sequence of steps. However, unless otherwise required, it should be understood that the method or procedure should not be limited to the specific sequence of steps disclosed. Other step sequences may be feasible. The specific order of steps disclosed herein should not be interpreted as an undue limitation. Unless otherwise required, the method and / or procedure disclosed herein should not be limited to the steps performed in the written order. The sequence of steps can be changed and still remain within the scope of the present invention.

[0058] Furthermore, it should be understood that although the present invention provides embodiments having one or more features / characteristics discussed herein, one or more of such features / characteristics may also be abandoned in other alternative embodiments, and the present invention supports such abandonment and such associated alternative embodiments.

[0059] Description of Embodiments

[0060] Non-limiting embodiments disclosed below include: an implant configured to be deployed in an eye / eyeball by a deployment tool to facilitate conduction of fluid from the posterior chamber of the eye to the suprachoroidal space; a deployment tool for inserting an implant into an eye to facilitate conduction of fluid from the posterior chamber of the eye to the suprachoroidal space; a system, such as a delivery system, for facilitating conduction of fluid from the posterior chamber of the eye to the suprachoroidal space; and a method of inserting an implant into an eye to facilitate conduction of fluid from the posterior chamber of the eye to the suprachoroidal space.

[0061] Various embodiments of the implants, deployment tools, systems, and methods disclosed herein can be used to treat ocular diseases, such as chronic angle-closure glaucoma. Various embodiments of the implants, deployment tools, systems, and methods disclosed herein are used for surgical treatment of patients with chronic angle-closure glaucoma in combination with current standard treatments (e.g., lens extraction or ultrasonic phacoemulsification).

[0062] In particular, various implementations of the implants, deployment tools, systems, and methods disclosed herein can provide a delivery system using minimally invasive surgery that circumvents problems associated with existing MIGS devices and problems associated with chronic angle-closure glaucoma by providing one or more of the following advantages: (i) circumventing visualization and deployment issues in narrow iridocorneal angles; (ii) enlarging the unconventional (uveoscleral) outflow pathway, which is less prone to dysfunction than conventional outflow pathways; (iii) bypassing any reorganized peripheral anterior synechiae that would make anterior chamber devices susceptible to occlusion and subsequent failure; (iv) reducing the risk of chronic endothelial cell loss compared to other methods where the implant remains in the anterior chamber; and (v) causing less scarring or fibrosis than external or subconjunctival outflow methods.

[0063] Implants

[0064] In various embodiments, an implant is provided that is configured to be deployed in an eye by a deployment tool to facilitate conduction of fluid from the posterior chamber of the eye to the suprachoroidal space, the implant comprising an elongated member having a proximal segment configured to be disposed in the posterior chamber of the eye and a distal segment configured to be disposed in the suprachoroidal space of the eye, wherein when deployed in the eye, the elongated member is configured to maintain a curved configuration that substantially conforms to the anatomical curvature of the posterior chamber and the suprachoroidal space.

[0065] In various embodiments, the implant is used to create and maintain an outflow drainage shunt / tract / passageway / channel from the posterior chamber of the eye to the suprachoroidal space for fluid (e.g., aqueous humor) drainage, thereby enlarging the physiological uveoscleral outflow pathway. In one embodiment, the implant is an ocular implant. In one embodiment, the implant is a drainage shunt implant for draining aqueous humor.

[0066] In various embodiments, the elongated member includes an inlet port arranged at the proximal end / proximal tip of the elongated member, the inlet port is in fluid communication with the posterior chamber of the eye and is configured to receive fluid from the posterior chamber of the eye. In various embodiments, the elongated member further includes an outlet arranged at the remote / distal tip of the elongated member, the outlet is in fluid communication with the suprachoroidal space and is configured to discharge fluid into the suprachoroidal space. In various embodiments, the elongated member further includes a channel, the channel is configured to transmit fluid from the inlet port to the outlet port. The channel may include, but is not limited to, a single lumen arranged in a hollow tube, a plurality of interconnected or non-interconnected lumens (e.g., a plurality of parallel lumens) arranged in a hollow tube, an open channel with various cross-sectional profiles such as a semicircular cross-sectional profile, and a plurality of interconnected chambers arranged between the inlet port and the outlet port. In one embodiment, the implant is in the form of a hollow elongated member.

[0067] In various embodiments, when deployed / implanted in the eye, the implant is configured to maintain a curved configuration that substantially conforms to the anatomical curvature of the posterior chamber and the suprachoroidal space. In various embodiments, when deployed in the eye, the implant can be curved such that the proximal segment of the elongated member is spaced from the posterior surface of the iris of the eye. That is, the implant can be curved such that the proximal segment of the elongated member does not abut the posterior surface of the iris. This can advantageously minimize or prevent the implant from rubbing or scratching the iris, which can cause irritation or inflammation of the iris tissue and wear of the iris tissue and / or the implant.

[0068] In various embodiments, the implant is configured to be straightened to facilitate loading of the implant into the deployment tool for deployment, and to return to a curved configuration when deployed in the eye. In various embodiments, the implant may be configured to be biased in a curved configuration so that the implant can return to a curved configuration after deformation (e.g., straightening). During deployment, the implant may be straightened because it crosses a delivery path including a straight and curved path before implantation. The implant may be sufficiently flexible so that it maintains its curved form despite the straightening (bending stress is less than yield strength). The implant may possess creep resistance so that despite straightening over a period of time (e.g., over a deployment duration), the implant can maintain a curved configuration. The implant may be configured to return to a curved configuration after maintaining a substantially straightened state for a period of time of up to about 5 minutes, up to about 10 minutes, up to about 15 minutes, up to about 20 minutes, up to about 25 minutes, or up to about 30 minutes. For example, the implant can be made of polytetrafluoroethylene (PTFE) having an inner diameter from about 0.1 mm to about 0.8 mm.

[0069] In various embodiments, the implant is preformed / pre-bent in a curved configuration at an angle that substantially matches, mimics, or approximates the anatomical angle between the posterior chamber of the eye and the suprachoroidal space. In various embodiments, the implant may be bent at an angle or profile that is substantially the same or similar to the angle or profile seen at the interface / interface region between the posterior chamber and the suprachoroidal space. The anatomical angle between the posterior chamber of the eye and the suprachoroidal space may be defined by a first segment extending from a portion of the ciliary sulcus or ciliary body in the posterior chamber to the inner surface of the sclera of the eye in a substantially medial or lateral direction, and a second segment extending from the inner surface of the sclera into the suprachoroidal space in a substantially posterior direction. The angle formed by the first segment and the second segment may be defined as the anatomical angle between the posterior chamber of the eye and the suprachoroidal space.

[0070] In various embodiments, the curved configuration may include a bend angle in the range of from about 30° to about 60°. The bend angle is defined as the angle between a first imaginary line drawn from the proximal segment and perpendicular to the proximal segment and a second imaginary line drawn from the distal segment of the elongated member and perpendicular to the distal segment. The bend angle may be in a range having a starting point and an end point selected from the following data: 30°, 31°, 32°, 33°, 34°, 35°, 36°, 37°, 38°, 39°, 40°, 41°, 42°, 43°, 44°, 45°, 46°, 47°, 48°, 49°, 50°, 51°, 52°, 53°, 54°, 55°, 56°, 57°, 58°, 59° and 60°. The curved configuration may include a bend radius in the range of from about 0.5 mm to about 1 mm. The bend radius may be within a range having a starting point and an end point selected from the following data: 0.5 mm, 0.55 mm, 0.6 mm, 0.65 mm, 0.7 mm, 0.75 mm, 0.8 mm, 0.85 mm, 0.9 mm, 0.95 mm, and 1 mm. For example, the elongated member may be bent at one or more locations on the proximal segment and / or one or more locations on the distal segment. The elongated member may include one or more bendable segments, such as joints, between the proximal segment and the distal segment that allow bending / flexing.

[0071] In various embodiments, the implant may be made of a material that promotes a bent configuration / state. The implant may be made of a material having one or more mechanical properties that promote a bent configuration / state. The implant may be made of a material having one or more mechanical properties that simulate a portion of an eye (e.g., an iris). The one or more mechanical properties may include, but are not limited to, creep, ductility, elasticity, flexibility, plasticity, and stiffness. The implant or a portion thereof may be made of a substantially flexible / bendable / pliable material. The implant may be sufficiently flexible so that the implant substantially complies or yields in response to one or more forces applied to the implant by the surrounding tissue. For example, the implant may be configured to bend when pressed in a backward direction by the iris. The implant may have a Young's modulus that simulates that of a human iris. The Young's modulus of the implant may be lower, similar, or higher than that of a human iris. For example, an implant having a Young's modulus that simulates that of a human iris can be achieved by one or more combinations of: (1) a material having a Young's modulus less than 50 MPa, such as a polymer (e.g., poly(styrene-b-isobutylene-b-styrene) (SIBS)); and (2) a joint that allows flexure. In various embodiments, the implant can be made of one or more materials that are substantially light-transmissive so that the implant does not obstruct the subject's vision when deployed in the eye.

[0072] In various embodiments, the implant is configured to be substantially flexible. The implant or its distal segment may have a bending stiffness low enough to allow the implant or its distal segment to be sufficiently flexible to pass through a tortuous path (e.g., the angle between the posterior chamber and the choroid) during deployment. In various embodiments, the implant or its distal segment may have a bending stiffness of less than about 0.5 N.mm 2 , less than about 0.4N.mm 2 , less than about 0.3N.mm 2 , less than about 0.2N.mm 2 or less than about 0.1N.mm 2 In various embodiments, the implant can have a Young's modulus of greater than about 20 GPa, greater than about 25 GPa, greater than about 30 GPa, greater than about 35 GPa, greater than about 40 GPa, greater than about 45 GPa, or greater than about 50 GPa.

[0073] For example, the implant or its distal segment may have a strength of less than about 0.5 N.mm 2The implant may also be configured to be substantially more flexible than the puncture needle used to guide the implant, so that the implant does not deform (e.g., straighten) the guide puncture needle when passing over it. In various embodiments, the implant may have a bending stiffness that is lower than the bending stiffness of the puncture needle. In various embodiments, the lower bending stiffness of the implant allows the implant to follow the curvature or curved shape of the puncture needle. In one embodiment, the elongated member has a bending stiffness of no more than about 0.5 N.mm 2 The implant may have a bending stiffness of about 100 mm / s so that the elongated member can be moved from a portion of the ciliary body to the suprachoroidal space of the eye along a delivery path formed by a puncture needle of a deployment tool, and, for example, substantially does not deform the puncture needle when passing through the puncture needle. The implant may have a Young's modulus of more than about 20 GPa so that it has sufficient fracture strength to withstand buckling during deployment. The implant may possess sufficient creep resistance so that after being straightened for a duration of about 10 minutes, its bend angle changes by less than about 20%.

[0074] In various embodiments, the implant can be specifically shaped to facilitate a curved configuration / state.

[0075] In various embodiments, implant can comprise the incision (that is, material removal) at the proximal segment and / or remote segment of slender member, so that the cross-sectional area of ​​proximal segment and / or remote segment of slender member is reduced, by reducing the second moment of area and therefore reducing the bending strength of the implant at proximal segment and / or remote segment. For example, incision can comprise the removal of the semi-cylindrical part of the proximal segment of slender member material, so that the proximal segment of slender member comprises a semi-cylindrical shape / profile.

[0076] In various embodiments, the implant may also include an incision at a portion of the elongated member between the proximal segment and the remote segment to facilitate bending of the elongated member. The incision may have different shapes and patterns, and may include, but is not limited to, triangles, squares, rectangles, polygons, pentagons, hexagons, octagons, circles, ellipses, semicircles, spirals, sawtooths, sinusoids, spaced lines, and similar shapes. For example, the incision may involve removing material in a spiral manner to produce a "spring" configuration at the portion of the elongated member between the proximal segment and the remote segment. The incision may be achieved by laser cutting, for example, laser cutting a spiral in a polyimide or nitinol (nickel and titanium alloy) material.

[0077] In various embodiments, the portion of the elongated member between the proximal segment and the distal segment can be configured in a flexible shape that facilitates bending. For example, the portion of the elongated member between the proximal segment and the distal segment can be pleated to facilitate bending. For example, the implant can include a plurality of struts, such as thin struts that impart a tubular shape while maintaining flexibility. The struts can, for example, take the shape of coils or molded rings connected by longitudinal segments. As an example, the curved portion of the implant can have a flexible bellows-like or accordion-like structure with alternating rings of a first diameter and a second diameter formed from a rigid material such as Nitinol, wherein the first diameter and the second diameter are different.

[0078] In various embodiments, the implant has dimensions (e.g., length, thickness, diameter, and circumference) that are appropriately sized relative to the ocular dimensions of an adult eye in normal and diseased states to create a drainage shunt between the posterior chamber of the eye and the suprachoroidal space of the eye.

[0079] For example, as described in a study (Janakiranman Palani, "Change of ocular dimensions indifferent types of glaucoma", Visual Science Academy, available online on February 1, 2021), the eye size parameters considered in glaucoma may include axial length, corneal curvature, anterior chamber depth, anterior chamber volume, lens thickness, corneal thickness, relative lens position, and lens axial length factor. Eye size varies with different subtypes of glaucoma, starting with axial length, it can be found that the axial length of occlusible angle and primary angle-closure glaucoma is shorter than other types of glaucoma, ranging from 21.62mm to 22.83mm. The corneal curvature measured with a keratometer showed that the "K" value in angle-closure glaucoma cases was steeper than other types of glaucoma, ranging from 43.75D to 44.87D. It can be found that the anterior chamber depth of all types of ACG is shallow, ranging from 1.84mm to 2.69mm. The anterior chamber volume was a unique factor that was found to be less than 100 μl in ACG cases except for the high pleated iris configuration (i.e., 91 μl at very narrow angles and 113 μl in the high pleated iris configuration case). It was found that the central corneal thickness was thicker in cases of ocular hypertension than in other types of glaucoma, with values ​​ranging from 513 microns to 570 microns. The lens thickness was significantly thicker in ACG, ranging from 4.23 mm to 4.83 mm. In ACG cases, the lens was relatively anteriorly positioned, calculated using the formula given by Lowe (RLP=ACD+1 / 2LT / AL*10), which ranged from 2.13 to 2.20. The lens axial length factor was higher in ACG, with values ​​ranging from 2.0 to 2.10. Therefore, it should be recognized that the eye size in ACG cases is changed from normal eyes compared to other types of glaucoma.

[0080] Thus, in some embodiments, the implant is sized to fit one or more of the following eye size parameters / eye parameters of a human eye in a diseased state (e.g., glaucoma, PACG): axial length, corneal curvature, anterior chamber depth, anterior chamber volume, lens thickness, corneal thickness, relative lens position, and lens axial length factor. In some embodiments, the implant is sized to fit a human eye having an axial length in the range of from about 21 mm to about 23 mm (e.g., from about 21.62 mm to about 22.83 mm). In some embodiments, the implant is sized to fit a human eye having a corneal curvature in the range of from about 43 D to about 45 D (e.g., from about 43.75 D to about 44.87 D), as measured with a keratometer. In some embodiments, the implant is sized to fit a human eye having an anterior chamber depth in the range of from about 1.8 mm to about 2.8 mm (e.g., from about 1.84 mm to about 2.69 mm). In some embodiments, the implant is sized to fit a human eye having an anterior chamber volume in the range of from about 80 μl to about 120 μl. In some embodiments, the implant is sized to fit a human eye having a central corneal thickness in the range of from about 500 μm to about 600 μm (e.g., from about 513 μm to about 570 μm). In some embodiments, the implant is sized to fit a human eye having a lens thickness in the range of from about 4 mm to about 5 mm (e.g., from about 4.23 mm to about 4.83 mm). In some embodiments, the implant is sized to fit a human eye having a relative lens position in the range of from about 2 to 2.3 (e.g., from about 2.13 to about 2.20), as calculated using the formula given by Lowe (RLP=ACD+1 / 2LT / AL*10). In some embodiments, the implant is sized to fit a human eye having a lens axial length factor in the range of from about 1.9 to about 2.2, such as from about 2.0 to about 2.1.

[0081] As described in another study (Xinghuai Sun, Yi Dai, Yuhong Chen, Dao-Yi Yu, Stephen J. Cringle, Junyi Chen, Xiangmei Kong, Xiaolei Wang, Chunhui Jiang, "Primary angle closure glaucoma: What we know and what we don't know," Progress in Retinal and Eye Research, Vol. 57, 2017, pp. 26-45), a crowded anterior segment and narrow anterior chamber angle can be considered the basic anatomical features of PACG. The progression of the anterior chamber angle from narrow to closed involves different factors. The results suggest that iris thickness may play a role in the development of angle closure and ultimately PACG. Smaller ACA (anterior chamber area) and ACV (anterior chamber volume) are independently associated with narrow angles, even after controlling for other known ocular biometric parameters such as anterior chamber depth (ACD) and AL (axial length). Anterior chamber width (ACW), defined as the horizontal interscleral distance, may be a new risk marker for angle closure. The ACV of PACG patients was calculated to be 25% lower than that of normal subjects.

[0082] Thus, in some embodiments, the implant is sized to fit one or more of the following eye size parameters of a PACG patient: iris thickness, ACA, ACV, ACD, AL, and ACW.

[0083] As described in another study (Nongpiur ME, Sakata LM, Friedman DS, He M, Chan YH, Lavanya R, Wong Ty, Aung T. "Novel association of smaller anterior chamber width with angle closure in Singaporeans", Ophthalmology, 2010 Oct;117(10):1967-73), the changes in anterior chamber width (ACW) and its association with the presence of narrow angles were investigated. It was found that ACW was associated with narrow angles in two different studies in the Singaporean population, independent of age, sex, and AL, suggesting that smaller ACW may be a risk indicator for angle closure. The mean anterior chamber width measured in the studies was approximately 11.80 mm in normal patients versus 11.57 mm in patients with narrow angles.

[0084] Thus, in some embodiments, the implant is sized to fit PACG patients having an anterior chamber width ranging from about 11 mm to about 12 mm (e.g., an average anterior chamber width of about 11.57 mm). In various embodiments, the implant can have a size for an Asian population configuration, such as an anatomical size for an eye of an Asian population.

[0085] For example, in one study (Qin B, Tang M, Li Y, Zhang X, Chu R, Huang D., "Anteriorsegment dimensions in Asian and Caucasian eyes measured by optical coherencetomography", Ophthalmic Surg Lasers Imaging, 2012;43(2):135-142), the anterior segment dimensions of Asians and Caucasians measured using optical coherence tomography (OCT) were compared. It was found that the anterior segment of the eye of Asian Americans was smaller than that of Caucasians. Older subjects tend to have smaller anterior segment dimensions. This difference should be considered when developing ophthalmic devices and implants. Table 1 below is extracted from the study and provides univariate analysis of eye size and corneal refraction with respect to race and gender.

[0086] Table 1. Univariate analysis of eye size and corneal refraction relative to race and sex.

[0087]

[0088] SD = standard deviation; AC = anterior chamber; D = diopter.

[0089] Thus, in some embodiments, the implant is sized to fit one or more of the following ocular parameters of a human eye of a human subject, wherein the subject is an Asian or Caucasian subject, or wherein the subject is a male or female subject: corneal diameter, AC width, corneal vault, AC depth, corneal vault / diameter, axial length, limbal ellipticity, and corneal refraction. In some embodiments, the implant is sized to fit one or more ocular parameters selected from Table 1, each ocular parameter having a range of values, wherein the starting point and endpoint are defined by 1 standard deviation, 1.5 standard deviations, or 2 standard deviations of the mean value listed in Table 1.

[0090] The proximal section of the elongated member can have a length in the range of from about 0.5 mm to about 4 mm. The length of the proximal section can be in the range of having a starting point and an end point selected from the following data: 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm and 4 mm. In one embodiment, the length of the proximal segment is from about 0.5 mm to about 1 mm, so that the inlet port at the proximal end of the elongated member is not occluded by surrounding tissue. In another embodiment, the length of the proximal segment is from about 2 mm to 4 mm, so that the proximal segment is long enough to be visible / observable when the iris is dilated.

[0091] The remote section of the elongated member may have a length in the range of from about 1 mm to about 3 mm. The length of the remote section may be in the range of having a starting point and an end point selected from the following data: 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm and 3 mm.

[0092] In various embodiments, the proximal segment and / or the proximal tip of the implant includes a well-defined shape for enhancing the effectiveness of the implant.

[0093] In various embodiments, the elongated member may be inclined at its proximal tip such that the bevel is configured to face away from the rear surface / rear side of the iris when the implant is deployed in the eye. For example, the elongated member may be inclined at its proximal tip such that the bevel is configured to face away from the rear surface / rear side of the iris when the implant is deployed in the eye. In other words, the proximal tip of the implant may include a bevel configured to face away from the rear side of the iris when deployed in the eye. The beveled proximal tip of the implant may advantageously minimize / reduce the possibility of obstruction by the rear surface of the iris or prevent obstruction by the rear surface of the iris. For example, when the iris is pressed against the proximal segment of the implant, the implant may still conduct fluid as long as the beveled proximal tip faces away from the rear surface of the iris. Advantageously, the bevel may also increase the cross-sectional lumen area at the proximal tip through which fluid can pass (with reference to a non-beveled circular cross-sectional lumen), thereby promoting fluid drainage. The proximal tip of implant can comprise at least about 20 °, at least about 25 °, at least about 30 °, at least about 35 °, at least about 40 ° or at least about 45 ° oblique angle.The oblique angle is defined by the intersection between the inclined plane of the longitudinal axis of elongated member and the proximal tip of elongated member.The oblique angle can also be in the scope of having the starting point and terminal point selected from following data: 20 °, 21 °, 22 °, 23 °, 24 °, 25 °, 26 °, 27 °, 28 °, 29 °, 30 °, 31 °, 32 °, 33 °, 34 °, 35 °, 36 °, 37 °, 38 °, 39 °, 40 °, 41 °, 42 °, 43 °, 44 ° and 45 °.

[0094] The proximal tip of the implant may include an edge that is blunted to avoid bruising the iris. The blunted edge at the proximal tip of the implant may have a blunting radius of at least 0.05 mm, at least 0.06 mm, at least 0.07 mm, at least 0.08 mm, at least 0.09 mm, or at least 0.10 mm.

[0095] In various embodiments, the distal segment and / or distal tip of the implant includes a well-defined shape for enhancing the effectiveness of the implant.

[0096] In various embodiments, the distal tip of the implant may be tapered to facilitate entry of the implant at the implantation site. In various embodiments, the distal tip of the implant may be blunted (e.g., with a substantially flattened / flat tip) to ensure that the distal tip does not cause additional contusion of surrounding tissue, such as through choroidal tissue. The distal tip of the implant may have a blunting radius of no more than 0.1 mm, no more than 0.09 mm, no more than 0.08 mm, no more than 0.07 mm, no more than 0.06 mm, or no more than 0.05 mm.

[0097] In various embodiments, the remote segment of the elongated member may be substantially straight. In various embodiments, the remote segment of the elongated member may be curved with a radius of curvature that substantially matches, imitates or approaches the radius of curvature of the inner sclera of the eye. In various embodiments, the remote segment of the elongated member may be curved with a radius of curvature that is substantially similar to or equal to the radius of curvature of the inner sclera of the eye. In one example. The remote segment of the implant has a curvature equal to the curvature of the sclera, and the distal tip is blunted so that it does not pierce the choroidal tissue. In various embodiments, the remote segment of the implant may be curved with a radius of curvature greater than the radius of curvature of the inner sclera of the eye. In other words, the remote segment of the implant may have a radius of curvature (in the longitudinal or circumferential direction) greater than its intended path in the suprachoroidal space. This allows the remote segment of the implant to slide along its intended path along the inner surface of the sclera in the suprachoroidal space and prevents the distal tip of the elongated member from penetrating the choroidal layer and reentering the vitreous cavity of the eye.

[0098] In various embodiments, the implant includes a lumen (i.e., an inner lumen) that is arranged in the elongated member and extends longitudinally along the substantially entire length of the elongated member. In various embodiments, the lumen is used to transmit fluid from the inlet port at the proximal tip to the outlet port at the distal tip of the elongated member. The inner lumen may have a diameter from about 0.1mm to about 0.8mm. The diameter of the lumen may be within the range of the starting point and end point selected from the following data: 0.1mm, 0.15mm, 0.2mm, 0.25mm, 0.3mm, 0.35mm, 0.4mm, 0.45mm, 0.5mm, 0.55mm, 0.6mm, 0.65mm, 0.7mm, 0.75mm and 0.8mm. The implant may have a wall thickness that is sized to maintain a sufficiently small entry profile so that the implant can still pass through the puncture needle, through the ciliary tissue, through the opening formed in the choroidal tissue by the puncture needle, and enter the suprachoroidal space. The wall thickness of the lumen may be in the range of from about 0.05 mm to about 0.15 mm or have a starting point and an end point selected from the following data: 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, 0.1 mm, 0.11 mm, 0.12 mm, 0.13 mm, 0.14 mm, and 0.15 mm. In one embodiment, the implant is capable of achieving a drainage flow rate from about 2 μL / min to about 20 μL / min, which falls within the same order of magnitude as the physiological flow rate of aqueous humor in the eye. For example, the implant may include an inner lumen having a diameter from about 0.1 mm to about 0.2 mm, an elongated member having a total length from about 6 mm to about 8 mm and having a curved shape, and achieve a flow rate from about 2 μL / min to about 20 μL / min. The flow rate may be within a range having a start point and an end point selected from the following data: 2 μL / min, 2.5 μL / min, 3 μL / min, 3.5 μL / min, 4 μL / min, 4.5 μL / min, 5 μL / min, 5.5 μL / min, 6 μL / min, 6.5 μL / min, 7 μL / min, 7.5 μL / min, 8 μL / min, 8.5 μL / min, 9 μL / min, 9.5 μL / min, 10 μL / min, 10.5 μL / min, 11.5 μL / min, 12.5 μL / min, 13.5 μL / min, 14.5 μL / min, 15.5 μL / min, 16.5 μL / min, 17.5 μL / min, 18.5 μL / min, 19.5 μL / min, 20.5 μL / min, 21.5 μL / min, 22.5 μL / min, 23.5 μL / min, 24.5 μL / min, 25.5 μL / min, 26.5 μL / min, 27.5 μL / min, 28.5 μL / min, 29.5 μL / min, 30.5 μL / min, 31.5 μL / min, 32.5 μL / min, 33.5 μL / min 1μL / min, 11.5μL / min, 12μL / min, 12.5μL / min, 13μL / min, 13.5μL / min, 14μL / min, 14.5μL / min, 15μL / min, 15.5μL / min, 16μL / min, 16.5μL / min, 17μL / min, 17.5μL / min, 18μL / min, 18.5μL / min, 19μL / min, 19.5μL / min and 20μL / min.A range of fluid flow rates through the implant can be achieved by adjusting the dimensions of the implant (eg, diameter of the inner lumen, length of the implant, angle of the curved shape, etc.).

[0099] In various embodiments, the implant includes a cross-sectional profile configured to maximize the surface area of ​​the dissected suprachoroidal space. The implant may include one or more structural components extending from the outer surface of the elongated member, and the structural component is configured to maximize the surface area of ​​the implant in contact with the tissue in the suprachoroidal space. The structural component may include a plurality of projections extending from the outer surface of the elongated member. Each projection may include a lumen that is fluidly connected to the lumen of the elongated member, so that the lumen of the plurality of projections forms an interconnected network of lumens for enhancing fluid conduction. The structural component may include a plate-like or flange component extending from the outer surface of the elongated member so that the implant may have a shape like a plate. The structural component may include a forked finger-shaped element extending from the outer surface of the elongated member so that the implant may have a shape like a forked finger. The elongated member may be configured to be in a curved configuration so that the implant has an S shape.

[0100] The implant may have a width in the circumferential direction of more than about 0.1 mm, more than about 0.2 mm, more than about 0.3 mm, more than about 0.4 mm, more than about 0.5 mm, more than about 0.6 mm, more than about 0.7 mm, more than about 0.8 mm, more than about 0.9 mm, or more than about 1 mm. In one embodiment, the width of the implant in the circumferential direction exceeds 0.5 mm.

[0101] The implant can be expanded after deployment to achieve a larger cross-sectional profile. In one embodiment, the implant can be made of a wire structure / frame (e.g., coil, mesh, slotted tube) configured to expand radially in the deployed state. During insertion, the implant can maintain an undeployed state, allowing the implant to engage axially around a puncture needle with a relatively small outer diameter. The smaller diameter difference between the puncture needle and the implant promotes easier implant extrusion because the tip of the implant must push away less tissue. Once the implant is in position, it can be radially expanded to its optimal size in its deployed state.

[0102] In another embodiment, radial expansion can be achieved by having a balloon on the puncture needle that can be inflated to deform the implant. Radial expansion can also be achieved by making the implant from a shape memory material such as Nitinol and locking it in its undeployed state (e.g., by placing a sheath over it). The implant can be released after deployment.

[0103] In various embodiments, the implant is configured to be secured in a substantially fixed position such that the implant does not substantially migrate after implantation.

[0104] The implant (e.g., the proximal segment or portion thereof) may include one or more anchoring features that allow or facilitate retention of the implant within the ciliary tissue / muscle or suprachoroidal space of the eye. Anchoring features may include, but are not limited to, raised ridges, protruding legs, tabs, or combinations thereof. It should be appreciated that in various embodiments, structural components configured to maximize the surface area of ​​the implant in contact with tissue in the suprachoroidal space may also serve as anchoring features.

[0105] Implant can comprise one or more than one configuration pattern formed on the outer surface of implant, thereby forms patterned outer surface.One or more than one configuration pattern can be formed on the whole outer surface of implant or on a part thereof.Patterned surface can assist to provide and increase gripping force, makes implant fixed in basically fixed position and basically do not migrate or be difficult to migrate after implantation.

[0106] The implant (e.g., the distal segment or portion thereof) may include one or more depressions or holes formed on the outer surface of the implant to encourage tissue ingrowth so that the implant is secured in a substantially fixed position and does not migrate substantially or is not susceptible to migration after implantation.

[0107] Implant (for example remote section or part thereof) can comprise one or more than one texture portion on the outer surface of implant, thereby form rough outer surface.The texture portion on outer surface can assist to encourage tissue to grow inward, makes implant fixed in basically fixed position and basically do not migrate or be difficult to migrate after implantation.

[0108] The implant may be configured to adopt a particular configuration after implantation so that the implant is fixed in a substantially fixed position.The implant may also have an eccentric curvature, meaning that the implant is curved in more than one plane (eg, in both a longitudinal and a transverse plane).

[0109] In various embodiments, the implant is made of one or more biocompatible materials. Biocompatible materials may include, but are not limited to, PTFE, ePTFE, SIBS, silicone, polyimide, nitinol, stainless steel, titanium, polyurethane, siloxane, etc., or a combination thereof. The implant may include one or more types of coatings on its inner and outer surfaces. The coating may advantageously change the surface properties of the implant and impart useful properties such as antibacterial, antifouling, antifibrotic, anti-inflammatory, biocompatibility, immunomodulatory, etc. For example, the coating may have antifouling properties so that the inner lumen, inlet port, and outlet port are not blocked over time. For example, the coating may also have antifibrotic properties to inhibit fibrosis.

[0110] The implant (e.g., the proximal segment or portion thereof) may have an outer surface that is substantially smooth so that it does not scratch the rear surface of the iris (e.g., an outer surface for contacting surrounding tissue when implanted). The surface of the implant may be substantially smooth, with an average surface roughness of no more than about 0.1 micron, no more than about 0.2 micron, no more than about 0.3 micron, no more than about 0.4 micron, no more than about 0.5 micron, no more than about 0.6 micron, no more than about 0.7 micron, no more than about 0.8 micron, no more than about 0.9 micron, or no more than about 1 micron. In one embodiment, the surface of the implant may be substantially smooth, with an average surface roughness of no more than about 0.5 micron.

[0111] The implant may have an inner surface (e.g., within the inner lumen) that is substantially smooth so that it will not become blocked (e.g., by biological matter, such as particles suspended in the aqueous humor passing through the inner lumen). The surface of the implant may be substantially smooth, with an average surface roughness of no more than about 0.1 micron, no more than about 0.2 micron, no more than about 0.3 micron, no more than about 0.4 micron, no more than about 0.5 micron, no more than about 0.6 micron, no more than about 0.7 micron, no more than about 0.8 micron, no more than about 0.9 micron, or no more than about 1 micron. In one embodiment, the surface of the implant may be substantially smooth, with an average surface roughness of no more than about 0.5 micron.

[0112] In various embodiments, the implant includes one or more pointers / markers for facilitating the positioning of the implant in the eye. The implant may include visual markers for facilitating the positioning of the implant. The visual markers may assist the user in determining whether the implant is inserted to the correct depth. In one embodiment, the proximal tip of the implant is colored so that it is easily visible / observable when the pupil is dilated.

[0113] In various embodiments, the implant is described in the form of a hollow elongated member. However, it should be understood that the form of the implant is not limited thereto. In alternative embodiments, the implant may not have a hollow tube structure. In one example, the implant is not all side-locked, but has a cross-sectional profile of a U-shaped channel. In another example, the implant has a wire support structure, and the pillar forms a channel for fluid to pass through. In yet another example, the implant has more than one lumen, which may or may not be interconnected. In yet another example, the implant is porous and includes a plurality of interconnected chambers. In yet another example, the implant has an inlet or outlet to adopt the form of a U-shaped or Y-shaped structure.

[0114] Deployment Tools

[0115] In various embodiments, a deployer / deployment tool for inserting an implant into an eye to facilitate conduction of fluid from the posterior chamber of the eye to the suprachoroidal space is provided, the deployment tool comprising: a catheter for entering the posterior chamber of the eye through an insertion site, the catheter comprising a distal tip configured to abut the ciliary sulcus or a portion of the ciliary body of the eye; and a puncture needle disposed within the catheter and configured to create a delivery / guidance path from the sulcus or a portion of the ciliary body to the suprachoroidal space of the eye; wherein the deployment tool allows the implant to move through the catheter relative to the puncture needle, for example along the delivery path, so that the distal segment of the implant is disposed in the suprachoroidal space of the eye and the proximal segment of the implant is disposed in the posterior chamber of the eye.

[0116] The deployment tool may be configured to deploy the implant between the posterior chamber of the eye and the suprachoroidal space of the eye. The implant may be a drainage shunt implant for draining aqueous humor in the form of an elongated hollow member for maintaining a conduit between the posterior chamber of the eye and the suprachoroidal space, having a proximal end located at the posterior chamber and a distal end located in the suprachoroidal space.

[0117] In various embodiments, the deployment tool can further include an implant actuator configured to removably couple to or engage the implant and configured to move the implant distally along the delivery pathway relative to the introducer needle.

[0118] In various embodiments, the deployment tool further includes a housing / shell. The housing may include an outer surface for allowing an operator (e.g., a surgeon) to hold / grip the deployment tool and a chamber defined within the housing to accommodate various components of the deployment tool (e.g., a catheter, a puncture needle, and an implant actuator). The housing may further include one or more outlets / openings for allowing various components of the deployment tool (e.g., a catheter, a puncture needle, and an implant actuator) to extend out of the housing. The various components of the deployment tool may be configured to move independently of each other and / or move in a coordinated manner within the housing. For example, the catheter, the puncture needle, and the implant actuator may be concentrically configured within the housing along a common longitudinal axis so that one component can be controlled individually and moved independently of the other components. The concentric configuration within the housing along a common longitudinal axis may also facilitate coordinated (e.g., simultaneous) control and movement of two or more components along the longitudinal axis. This configuration may advantageously allow the puncture needle and the implant to move independently and / or in a coordinated manner within the confined space and operating space of the deployment tool.

[0119] The deployment tool may be a handheld tool. The housing may have a specific ergonomic shape and / or form to allow an operator (e.g., a surgeon) to easily manipulate. The deployment tool may include one or more controllers, such as electronic controllers, physical controllers (e.g., buttons, knobs, sliders, switches, levers, joysticks, etc.) arranged on the outer surface of the housing. Each of the one or more controllers may be associated with a component (e.g., a catheter, a puncture needle, and an implant actuator) that actuates the deployment tool. The actuation of the component may include the movement, positioning, and / or orientation of the control component. The actuated controller may be physical, electronic, manual, and / or automatic. For example, the deployment tool may have two sliding buttons arranged on the outer surface, one of which is connected to the implant actuator holder and one of which is connected to the puncture needle holder. The housing of the deployer may be ergonomically configured to enhance the user experience (e.g., easy precision control, manipulation, and disposal) and improve the comfort of the deployment tool during use. The housing of the deployer may be symmetrical, thereby allowing for both right-handed and left-handed users. One or more controls may be arranged on the outer surface of the housing in a manner that is easy to reach and / or easy to push smoothly so that there is little or no need for the operator to reposition the holding / gripping position of the deployment tool.

[0120] Alternatively, the deployment tool may be coupled to or integrated into a system for performing robotic or robot-assisted surgery. For example, the deployment tool may be integrated into a robotic arm. Robotic surgery may be used to perform complex procedures with greater precision, dexterity, and control than conventional techniques. Robotic surgery is often associated with minimally invasive surgery, in which the procedure is typically performed through a small incision.

[0121] catheter

[0122] In various embodiments, the catheter acts as an outer sheath for the implant, the puncture needle, and the implant actuator. The catheter may be in the form of an elongated member, such as a hollow elongated member having a distal end and a proximal end. The catheter may include an opening (i.e., a distal opening) disposed at the distal end of the elongated member to allow the puncture needle and / or the implant to extend and retract therefrom.

[0123] In various embodiments, the remote / distal tip of the catheter can be configured to abut a portion of a groove or a ciliary body. The abutment of the remote / distal tip of the catheter can provide feedback to the operator (e.g., a surgeon) that the remote end of the catheter has reached the appropriate position by visually observing the protrusion of the sclera or tactile detection. In one example, the abutment of the remote / distal tip of the catheter can cause the scleral area of ​​the eye to bulge outward, thereby providing a visual signal / prompt that the remote end of the catheter has reached the appropriate position. In another example, the catheter and / or the catheter holder can be coupled to a tactile sensor, such as a force sensor, which is configured to generate a tactile feedback signal when the catheter contacts a position in the eye (e.g., at a portion of a groove or a ciliary body). The tactile feedback signal can be further converted into other forms of signals, such as audio signals (e.g., beeps) and visual signals (e.g., light indicators).

[0124] In various embodiments, the catheter is configured to have a Young's modulus that is high enough so that it does not deflect when adjacent to the groove. For example, the catheter may have a Young's modulus of at least about 7.5 GPa so that the catheter does not substantially deflect when adjacent to the ciliary groove or a portion of the ciliary body of the eye. In various embodiments, the catheter has a bending stiffness that is higher than the puncture needle and the implant. The puncture needle may be preformed in a curved configuration and configured to be straightened when retracted to be arranged in the catheter. The catheter may have a bending stiffness that is higher than the puncture needle so that the portion of the puncture needle within the catheter must substantially conform to its longitudinal shape (e.g., a straight, elongated member). In addition, in various embodiments, the catheter does not bend or deflect when the puncture needle is retracted / pushed into the catheter and the catheter substantially maintains its shape.

[0125] In various embodiments, the distal end of the catheter can be configured to have a size that substantially follows the shape of the ciliary sulcus, thereby allowing an approximate and reproducible fit when the device is placed in the correct position. The distal tip of the catheter can be curved to substantially follow or mimic the shape of the ciliary sulcus. The distal tip of the catheter can have a distal tip geometry with a chamfer angle from about 10° to about 40° and a circumferential radius from about 5mm to about 7mm as appropriate. The catheter / ciliary sulcus guide has an allowable width of less than 2mm so that it fits through the corneal incision. The chamfer angle may be within a range having a starting point and an end point selected from the following data: 10°, 11°, 12°, 13°, 14°, 15°, 16°, 17°, 18°, 19°, 20°, 21°, 22°, 23°, 24°, 25°, 26°, 27°, 28°, 29°, 30°, 31°, 32°, 33°, 34°, 35°, 36°, 37°, 38°, 39° and 40°. The circumferential radius may be within a range having a starting point and an end point selected from the following data: 5mm, 5.1mm, 5.2mm, 5.3mm, 5.4mm, 5.5mm, 5.6mm, 5.7mm, 5.8mm, 5.9mm, 6.0mm, 6.1mm, 6.2mm, 6.3mm, 6.4mm, 6.5mm, 6.6mm, 6.7mm, 6.8mm, 6.9mm and 7.0mm.

[0126] In various embodiments, the distal tip of the catheter can be blunted so that it does not substantially cause contusion of the rear surface of the iris or the ciliary body. For example, the distal tip of the catheter can be blunted with an angle radius of at least about 0.1 mm, at least about 0.2 mm, at least about 0.3 mm, at least about 0.4 mm, or at least about 0.5 mm. The distal tip of the catheter can include an inner edge that is chamfered or rounded so that when the implant is released, no burrs will hook or attach to the implant.

[0127] In various embodiments, conduit can have a substantially smooth inner surface so that it does not scrape implant or hinder the sliding motion of implant.For example, the inner surface of conduit can have a surface finish (or average surface roughness) of no more than about 0.1 micron, no more than about 0.2 micron, no more than about 0.3 micron, no more than about 0.4 micron, no more than about 0.5 micron, no more than about 0.6 micron, no more than about 0.7 micron, no more than about 0.8 micron, no more than about 0.9 micron, no more than about 1 micron, no more than about 2 microns, no more than about 3 microns, no more than about 4 microns, no more than about 5 microns, no more than about 6 microns, no more than about 7 microns, no more than about 8 microns, no more than about 9 microns or no more than about 10 microns, so that it does not scrape implant or hinder the sliding motion of implant.This can be realized by various types of processing (such as chemical polishing, electropolishing etc.).

[0128] Catheter Holder

[0129] In various embodiments, the deployment tool further includes a catheter holder disposed thereon. The catheter holder is configured to couple to or engage the proximal end of the catheter. The catheter holder may be configured to remain within the housing of the deployment tool. The catheter holder may be configured to be fixed or slidable within the housing of the deployment tool. The catheter holder may be coupled to a controller (e.g., an electronic controller, a physical controller configured to actuate the catheter) to allow an operator to adjust the position of the catheter holder and, in turn, adjust the position of the catheter relative to the housing. The actuated controller may be physical, electronic, manual, and / or automatic.

[0130] Puncture needle

[0131] In various embodiments, the puncture needle is used to create a delivery path followed by the implant from the deployment tool to the implantation site (e.g., from a portion of the sulcus or ciliary body to the suprachoroidal space of the eye). In various embodiments, the puncture needle includes a distal / distal tip and a proximal / proximal tip, a distal segment / portion and a proximal segment / portion. The puncture needle can be positioned / retained within the implant. The puncture needle can be configured to move linearly within the implant actuator. The puncture needle can be configured to move linearly within the catheter.

[0132] In various embodiments, the puncture needle is configured to enter the suprachoroidal space of the eye by cutting / removing tissue. In various embodiments, the distal tip of the puncture needle is configured to dissect / cut / remove tissue (e.g., tissue of the ciliary body) to create a delivery path, wherein the delivery path includes a first segment extending from a portion of the sulcus or ciliary body to the inner surface of the sclera and a second segment extending from the inner surface of the sclera to the suprachoroidal space; and wherein the first segment and the second segment form an angle along the delivery path. The distal end of the puncture needle may be further configured to dissect the suprachoroidal space of the eyeball. The distal end of the puncture needle may be configured to pass through the ciliary body instead of the sclera, and then dissect backwards between the choroidal layer and the sclera by following the curvature of the sclera. The distal end of the puncture needle may be configured to have a tip shape and sharpness sufficient to pass through the ciliary tissue instead of the sclera.

[0133] In various embodiments, the puncture needle may be configured to form a curvature from the ciliary sulcus into the suprachoroidal space to create a delivery / guidance path that the implant can follow. The inventors have recognized that to create a delivery path, the puncture needle must be configured to apply an appropriate local cutting force, and the puncture needle must be flexible enough to deflect in a posterior direction at the sclera, for example, by following the curvature of the sclera. The angle at which the puncture needle is required to bend when deflecting in a posterior direction at the sclera may be sharper than the angle at which the puncture needle is required to bend when inserted from the anterior chamber of the eye. The creation of a delivery path by the puncture needle may depend on parameters such as the tip shape of the puncture needle, the profile at the remote segment of the puncture needle, the path taken by the puncture needle due to catheter constraints, the stiffness of the puncture needle, and the surface roughness of the puncture needle.

[0134] In various embodiments, the puncture needle has an outer diameter that is smaller than the inner diameter of the implant. The choice of using a small puncture needle with a larger hole implant (rather than a large puncture needle with a smaller implant) can advantageously create a tract through the ciliary muscle that is as small and atraumatic as possible to minimize the risk of damage to surrounding tissue (e.g., tissue of the ciliary body). The puncture needle can have an outer diameter in the range of from about 100 μm to about 150 μm. The outer diameter of the puncture needle may be within a range having a starting point and an end point selected from the following data: 100μm, 102μm, 104μm, 106μm, 108μm, 110μm, 112μm, 114μm, 116μm, 118μm, 120μm, 122μm, 124μm, 126μm, 128μm, 130μm, 132μm, 134μm, 136μm, 138μm, 140μm, 142μm, 144μm, 146μm, 148μm and 150μm.

[0135] In various embodiments, the distal tip of the puncture needle is shaped to facilitate tissue cutting and dissection in the eye. The distal tip of the puncture needle may be tapered or beveled. The distal tip of the puncture needle may taper from a cone angle of about 30° to about 60°. The cone angle may be within a range having a starting point and an end point selected from the following data: 30°, 31°, 32°, 33°, 34°, 35°, 36°, 37°, 38°, 39°, 40°, 41°, 42°, 43°, 44°, 45°, 46°, 47°, 48°, 49°, 50°, 51°, 52°, 53°, 54°, 55°, 56°, 57°, 58°, 59°, and 60°. The distal tip of the puncture needle may be tilted from an oblique angle of about 30° to about 45°. The bevel angle may be within a range having a starting point and an end point selected from the following data: 30°, 31°, 32°, 33°, 34°, 35°, 36°, 37°, 38°, 39°, 40°, 41°, 42°, 43°, 44°, and 45°. When the distal tip of the puncture needle contacts the sclera, the bevel or cone angle may promote a reaction force pointing in a posterior direction of the eye. This may help guide the puncture needle posteriorly.

[0136] In various embodiments, the puncture needle is configured to be bendable to facilitate the creation of a curved delivery path followed by the implant from the deployment tool to the implantation site. The flexible puncture needle can be pre-bent at an angle or contour that substantially mimics or conforms to the contour of the surrounding anatomical structures along the delivery path from the posterior chamber to the suprachoroidal space. The puncture needle can be configured so that: both the proximal and distal portions are substantially straight; one of the proximal or distal portions is substantially straight and one of the proximal or distal portions is curved; or both the proximal and distal portions are curved.

[0137] In one embodiment, both the proximal and distal portions are substantially straight. The puncture needle can be configured to adopt a curved configuration so that the distal portion is bent from about 30° to about 50° relative to the proximal portion toward the lower surface of the deployer (i.e., in a rearward direction facing the eye). The radius of curvature can be from about 0.2 mm to about 1 mm. The length of the distal portion of the puncture needle can be in the range of from about 1.5 mm to about 2.5 mm. The bend angle of the distal portion relative to the proximal portion can be in a range having a starting point and an end point selected from the following data: 30°, 31°, 32°, 33°, 34°, 35°, 36°, 37°, 38°, 39°, 40°, 41°, 42°, 43°, 44°, 45°, 46°, 47°, 48°, 49° and 50°. The bend radius may be within a range having a starting point and an endpoint selected from the following data: 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm and 1.0mm. The length of the remote portion of the puncture needle may be within a range having a starting point and an endpoint selected from the following data: 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2.0mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm and 2.5mm. The remote portion of the puncture needle is configured to be pushed into the suprachoroidal space and may be long enough to serve as a guide path for the implant to bend into the suprachoroidal space. At the same time, the remote portion cannot be too long so as not to increase the risk of penetrating the choroidal layer. When the implant moves on the puncture needle, the implant shields the tip of the puncture needle to further reduce the risk of the puncture needle causing unwanted contusion of the tissue.

[0138] In another embodiment, the distal tip of the puncture needle follows a curved path with a radius of curvature from about 4 mm to about 6 mm. The radius of curvature of the curved path can be within a range having a starting point and an end point selected from the following data: 4 mm, 4.1 mm, 4.2 mm, 4.3 mm, 4.4 mm, 4.5 mm, 4.6 mm, 4.7 mm, 4.8 mm, 4.9 mm, 5 mm, 5.1 mm, 5.2 mm, 5.3 mm, 5.4 mm, 5.5 mm, 5.6 mm, 5.7 mm, 5.8 mm, 5.9 mm and 6 mm. The tangent line of the distal tip can be at an angle of about 30° to about 50° relative to the horizontal line of the needle. The angle relative to the horizontal line of the needle can be within a range having a starting point and an end point selected from the following data: 30°, 31°, 32°, 33°, 34°, 35°, 36°, 37°, 38°, 39°, 40°, 41°, 42°, 43°, 44°, 45°, 46°, 47°, 48°, 49° and 50°.

[0139] In various embodiments, the path taken by the puncture needle is controlled by the catheter. The catheter can be shaped and / or sized to constrain the puncture needle to a more precise delivery path. The puncture needle (e.g., a flexible puncture needle) can be constrained when it leaves the catheter so that it forms a path that can pass through the ciliary body and choroid layer and deflect back at the sclera.

[0140] In one embodiment, the outer diameter of the puncture needle can be configured to be within a predefined tolerance range relative to the inner diameter of the catheter so that the puncture needle is substantially straight within the catheter. When the puncture needle extends from the distal opening of the catheter, the catheter is used to constrain the degree to which the puncture needle can bend. Therefore, the distal tip of the puncture needle forms a curved path as it extends so that it traverses the ciliary body and dissects the suprachoroidal space. The inner diameter of the catheter can be approximately 0.1 mm to about 1 mm larger than the outer diameter of the puncture needle. The tolerance range can be within a range having a start point and an end point selected from the following data: 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, and 1.0 mm.

[0141] In another embodiment, the distal tip of the catheter is curved or has an inner lumen with a curved configuration to guide the puncture needle along a curved path into the suprachoroidal space.

[0142] In various embodiments, the puncture needle is configured to be substantially flexible. In various embodiments, the puncture needle may be preformed in a curved configuration and configured to be straightened when arranged in a catheter and to return to a curved configuration when extended from the distal tip of the catheter to create a delivery path. In various embodiments, the puncture needle has a bending stiffness lower than the bending stiffness of the catheter, so that when the puncture needle is extended or retracted from the catheter, the puncture needle does not deform the catheter (e.g., bend or deflect). The puncture needle may be made of a flexible material with shape memory properties (such as nitinol, nitinol alloy, copper aluminum alloy, etc.). Thus, it maintains its curvature despite passing through a straight portion of the catheter (e.g., a ciliary groove guide).

[0143] In various embodiments, the stiffness of the puncture needle can be such that it can be bent at an angle of at least 20 degrees relative to its axis for a projected length of at least 0.53 mm (the length of the ciliary body). In various embodiments, the stiffness of the puncture needle can be such that it can be bent across a corner located at the inner sclera along a delivery path between the posterior chamber and the suprachoroidal space. In various embodiments, the puncture needle has a stiffness of no more than about 2.5 N / mm to facilitate bending of the puncture needle at an angle along the delivery path. If the puncture needle is too stiff, it will pierce the sclera instead of bending back into the suprachoroidal space. In one embodiment, the puncture needle is made of superelastic nitinol having a diameter from about 0.13 mm to about 0.17 mm to achieve the desired stiffness. In various embodiments, to prevent the puncture needle from buckling, the free length of the puncture needle (e.g., it is not supported by any external clamp or tube) is kept less than 8 mm.

[0144] The puncture needle can also be made flexible by providing a flexible joint in the needle. This can be achieved by making the puncture needle have multiple rigid sections connected by a flexible inner core.

[0145] In various embodiments, the puncture needle or a portion thereof is configured to have a substantially smooth surface finish to facilitate movement of the puncture needle through tissue in the eye. In various embodiments, the tapered or beveled tip (i.e., sharp face) of the puncture needle may have a surface finish that allows the tip to be sharp enough to pass through the ciliary body and smooth enough to slide along the inner surface of the choroid. For example, the surface finish may be a surface finish wherein the average surface roughness (Ra) is no more than 0.5 microns, no more than 1 micron, no more than 2 microns, no more than 3 microns, no more than 4 microns, no more than 5 microns, no more than 6 microns, no more than 7 microns, no more than 8 microns, no more than 9 microns, or no more than 10 microns. In one embodiment, the surface finish of the sharp face is no more than 4 microns. The tapered or beveled tip shape may also facilitate atraumatic entry into the ciliary body to minimize bleeding. The surface finish of the tapered or beveled tip may also be no more than 0.5 microns (Ra) to minimize tissue contusion. This may be achieved by various surface treatments (e.g., electropolishing, black oxide surface treatment, or the like). Black oxide surface treatment may also help prevent surface corrosion of the puncture needle.

[0146] In various embodiments, the puncture needle includes a feedback mechanism for enabling an operator (e.g., a surgeon) to confirm whether the puncture needle has indeed entered the correct space (e.g., the suprachoroidal space). The feedback mechanism can be configured to detect a loss of resistance as the tip of the puncture needle (e.g., a flexible puncture needle) travels through the ciliary muscle into the suprachoroidal space. For example, the puncture needle can be a hollow needle that allows fluid to be injected through the puncture needle. This can serve as a means of confirming whether the puncture needle has indeed entered the potential space between the two layers. If the puncture needle is in the proper space, a loss of fluid resistance will be felt. This can be detected by the surgeon tactilely or by a pressure sensor.

[0147] In various embodiments, the implant is configured to remain within the catheter as the introducer needle is pushed forward to create a delivery path from the deployment tool to the implantation site. In various embodiments, the deployment tool is configured to push the implant out after the introducer needle creates the delivery path so that the distal segment of the implant is disposed in the suprachoroidal space and the proximal segment of the implant remains in the posterior chamber of the eye. The deployment tool may be configured so that when the introducer needle is retracted from the implantation site, the implant is retained (i.e., does not substantially move or migrate from its deployed position) and does not follow the introducer needle as it is retracted.

[0148] It should be understood that in various embodiments, the puncture needle acts as an introducer to assist in the delivery and placement of the implant at the implantation site. In other embodiments, the deployment tool may include a separate introducer configured to assist in the delivery and placement of the implant at the implantation site. In one embodiment, the introducer adopts the form of a hollow tube with a lumen, a proximal / proximal tip, and a remote / distal tip. The introducer may have an inner diameter (i.e., the diameter of the lumen) greater than the outer diameter of the implant and the puncture needle, so that the implant and the puncture needle can be arranged in the lumen of the introducer. The implant may be configured to slide in the lumen of the introducer. The distal tip of the introducer may be tapered or beveled to facilitate its easy entry. The distal tip of the introducer may maintain an undeployed state with a relatively small cross-sectional profile to facilitate its insertion. The distal tip of the introducer may maintain a deployed state with a relatively large cross-sectional profile at the entry position (e.g., through the choroidal entry hole) to facilitate implant deployment and prevent / minimize implant wrinkling / curling at the entry position. For example, the introducer may include one or more retractable protrusions on the outer surface of the introducer radially disposed at the distal tip. One or more retractable protrusions may be configured to open or expand outward (eg, open like a flower) to create a larger cross-sectional profile.

[0149] Needle holder

[0150] In various embodiments, the deployment tool further includes a puncture needle holder disposed thereon. The puncture needle holder acts as a needle driver configured to move a puncture needle (e.g., a flexible puncture needle) out of the catheter and into the suprachoroidal space through the ciliary muscle of the eye. The puncture needle holder may be configured to couple to or engage the proximal end of the puncture needle. The puncture needle holder may be configured to remain within the housing of the deployment tool. The puncture needle holder may be configured to slide within the housing of the deployment tool. The puncture needle holder may be coupled to a controller (e.g., an electronic controller, a physical controller, such as a button, a knob, or a slider) configured to actuate the puncture needle, thereby allowing an operator (e.g., a surgeon) to adjust the position of the puncture needle holder and, in turn, adjust the position of the puncture needle relative to the housing. The controller may be disposed on the outer surface of the housing of the deployment tool. The actuated controller may be physical, electronic, manual, and / or automatic.

[0151] Implant Actuator

[0152] In various embodiments, the deployment tool further includes an implant actuator. In various embodiments, the implant actuator is configured to deploy (e.g., by pushing / propelling) an implant (e.g., a drainage shunt implant) so that the remote segment of the implant is located at the suprachoroidal space of the eye. The implant actuator may be configured to move substantially parallel to the catheter and substantially linearly within the catheter. The implant actuator may include a remote and a proximal end. The remote / remote face of the implant actuator may be configured to be detachably coupled to or engage the implant. In other words, the remote / remote face of the implant may be configured to engage (i.e., contact) and disengage (i.e., evacuate) a portion (e.g., proximal end) of the implant. The remote / remote face of the implant actuator may be configured to push the implant out of the deployer along the delivery / guidance path generated by the puncture needle.

[0153] In various embodiments, the implant actuator is configured to be slidably coupled to the puncture needle so that the implant actuator is configured to slide along the puncture needle (e.g., along the delivery path created by the puncture needle). The implant actuator may be in the form of a hollow tube. The implant actuator may have an inner diameter that is greater than the diameter of the puncture needle and less than the outer diameter of the implant. The inner diameter of the implant actuator may be from about 0.18 mm to about 0.25 mm. The inner diameter of the implant actuator may be within a range having a starting point and an end point selected from the following data: 0.18, 0.19, 0.20, 0.21, 0.22, 0.23, 0.24 and 0.25.

[0154] In various embodiments, the remote face of the implant actuator is configured to abut the proximal end / proximal face of the implant. The distal tip of the implant actuator may have a full-circle cross-sectional profile containing a stirrup strength higher than the stirrup strength of the implant and will not be forcibly opened by the implant. The distal tip of the implant actuator may have a shape complementary to the tip shape on the proximal tip of the implant. For example, the distal tip of the implant actuator may tilt upward, with an oblique angle from about 40 ° to about 50 °, so that it is complementary to the bevel tip shape on the proximal tip of the implant. This can advantageously promote the rotational directional control of the implant. Other suitable complementary matching configurations or engagements between the implant actuator and the implant may also be used.

[0155] In various embodiments, the implant actuator is configured to maintain the implant at the implantation site to facilitate the retraction of the puncture needle and / or catheter. Once implanted, there should be little or no contact (i.e., direct physical contact) between the implant and the deployer on its inner and outer surfaces so that the implant is not dragged out with the deployer during retraction. The implant actuator can be configured to maintain the implant at the implantation site throughout the retraction procedure (e.g., by maintaining the implant actuator in a fixed position relative to the housing).

[0156] In various embodiments, the puncture needle can be retracted relative to the implant actuator in the proximal direction so that the distal tip of the puncture needle is at a minimum spacing distance from the proximal end of the implant actuator. The puncture needle can be retracted relative to the implant actuator in the proximal direction so that the distal tip of the puncture needle is closer to (i.e., at a closer position) than the distal tip of the implant actuator. The catheter can also be retracted relative to the implant actuator in the proximal direction so that the proximal tip of the catheter is at a minimum spacing distance from the proximal end of the implant actuator. The catheter can be retracted relative to the implant actuator in the proximal direction so that the distal tip of the catheter is closer to (i.e., at a closer position) than the distal tip of the implant actuator.

[0157] In various embodiments, the minimum spacing distance from the proximal end of the implant actuator can be at least about 0.2 mm, at least about 0.3 mm, at least about 0.4 mm, or at least about 0.5 mm. The puncture needle and / or catheter can also be completely retracted into the implant actuator to not contact the implant. The catheter and puncture needle can be withdrawn one by one sequentially or simultaneously for ease of use. The deployment tool can include one or more spring systems coupled to the puncture needle and catheter to facilitate retraction into the housing.

[0158] In various embodiments, implant actuator is configured to decouple (that is, evacuate) with implant after implant is pushed into proper position. In various embodiments, implant actuator or its part is configured to have substantially smooth surface finish to promote after deployment, implant and implant actuator disengagement / decoupling, so that implant can not be unexpectedly / unintentionally stuck implant actuator. The surface finish of the remote face of implant actuator can have no more than 0.1 micron, no more than 0.2 micron, no more than 0.3 micron, no more than 0.4 micron, no more than 0.5 micron, no more than 0.6 micron, no more than 0.7 micron, no more than 0.8 micron, no more than 0.9 micron, no more than 1 micron, no more than 2 microns, no more than 3 microns, no more than 4 microns, no more than 5 microns, no more than 6 microns, no more than 7 microns, no more than 8 microns, no more than 9 microns or no more than 10 microns of average surface roughness (Ra).

[0159] Implant actuator holder

[0160] In various embodiments, the deployment tool further includes an implant actuator holder arranged thereon. The implant actuator holder may be configured to be coupled to or engaged to the proximal end of the implant actuator. The implant actuator holder may be configured to remain in the housing of the deployment tool. The implant actuator holder may be configured to slide in the housing of the deployment tool. The implant actuator holder may be attached to a controller (e.g., an electronic controller, a physical controller, such as a button, a knob, or a slider) configured to actuate the implant actuator to allow an operator (e.g., a surgeon) to adjust the position of the implant actuator holder, and then adjust the position of the implant actuator relative to the housing. The controller may be arranged on the outer surface of the housing of the deployment tool. The actuated controller may be physical, electronic, manual, and / or automatic.

[0161] Haptic feedback

[0162] In various embodiments, the deployment tool is configured to provide tactile feedback. The inventors have recognized that one difficulty associated with implanting an implant from the ciliary sulcus is that there is no direct visual feedback. The implanted area is hidden because it is behind the iris. Thus, the deployment tool may include features that allow tactile feedback to be provided to the operator (e.g., surgeon) after each implantation step to eliminate the need for visualization. In addition, it should be understood that excessive force should not be applied when pushing the puncture needle.

[0163] In one embodiment, the chamber of the housing may include an inner channel for allowing the puncture needle holder and the implant actuator holder to slide freely within the inner channel. The inner channel of the housing may be configured so that the friction between the puncture needle holder / implant actuator and the inner channel of the housing is less than 0.2N, which is negligible compared to the force encountered at the distal tip of the puncture needle / implant actuator. This facilitates providing tactile feedback to the operator (e.g., surgeon) as the puncture needle passes through the ciliary body, slides into the suprachoroidal space, and pushes the implant into the suprachoroidal space.

[0164] The inner passage of the housing may be substantially cylindrical. The puncture needle holder / implant actuator holder may have a substantially cylindrical outer surface, thereby allowing the puncture needle holder / implant actuator holder to slidably fit within the inner passage. The fit between the sliding assembly and the housing may be within a tolerance of less than 0.1 mm. The material of the housing and the puncture needle holder / implant actuator holder may have low friction, such as nylon, PC (polycarbonate), PEEK (polyetheretherketone) or the like. The surfaces of the inner passage and the puncture needle holder / implant actuator holder may be polished to a surface finish of less than about 1 micron (Ra) to allow free sliding.

[0165] The puncture needle, implant actuator and conduit can be configured concentrically along a common longitudinal axis to ensure that they can slide freely relative to each other. The implant actuator and conduit can have enough bending stiffness so that they remain straight and minimally contact with each other, rather than applying radial forces that cause friction. For example, the implant actuator and conduit can have enough bending stiffness of at least about 2000MPa.

[0166] In another embodiment, the puncture needle holder, implant actuator holder can be coupled to a drive mechanism of a nut and bolt assembly following a screw micrometer, wherein rotational movement of the proximal end results in controlled forward translation. For example, one full rotation can translate to a linear distance equal to the pitch of the screw, i.e., the distance between two consecutive threads of the screw.

[0167] In yet another embodiment, the introducer needle holder, implant actuator holder may be coupled to a drive mechanism in the form of a plunger mechanism. The plunger mechanism may have features or a spring or gas spring mechanism to assist in controlling the applied force, such as frictional resistance.

[0168] The following examples may provide alternative embodiments for feedback or confirmation to ensure successful deployment. In one example, a portion of the deployment mechanism may be shaped as an elongated member having a flexural strength lower than that required to puncture the sclera. If the force pushing the needle is too great, a portion of the deployment mechanism will bend to prevent further advancement. In another example, the puncture needle may be configured to contact a puncture needle holder, such as a needle driver with a sliding contact. If the force pushing the needle is too great, the puncture needle will move out of the puncture needle holder. If the force is too high and the proximal end of the puncture needle is bent, it will slide off the distal surface of the puncture needle holder. In yet another example, the actuation mechanism may be coupled to a force sensor. If the applied force is too high, some form of warning is activated, such as a visual indication (LED light turns on). Alternatively, the actuation mechanism may be driven by a motor that cuts off when the force detected by the force sensor exceeds a specified limit. The above method may be feasible due to the different toughness of the choroid layer relative to the sclera.

[0169] Systems for facilitating fluid conduction

[0170] In various embodiments, a system for facilitating conduction of fluid from the posterior chamber of an eye to the suprachoroidal space is provided, such as a delivery system, the system comprising: an implant comprising a slender member having a proximal segment and a distal segment, wherein when deployed in the eye, the slender member is configured to maintain a curved configuration that substantially conforms to the anatomical curvature of the posterior chamber and the suprachoroidal space; and a deployment tool comprising: a catheter for entering the posterior chamber of the eye through an insertion site, the catheter comprising a distal tip configured to abut a portion of the ciliary sulcus or ciliary body of the eye; and a puncture needle configured to be arranged in the catheter and to create a delivery path from the sulcus or a portion of the ciliary body to the suprachoroidal space of the eye; wherein the deployment tool allows the implant to move relative to the puncture needle in a distal direction along the delivery path, such as through the catheter, so that the distal segment of the implant is arranged in the suprachoroidal space of the eye and the proximal segment of the implant is arranged in the posterior chamber of the eye.

[0171] In various embodiments, the elongated member is configured to straighten to facilitate loading of the implant onto the distal end of the puncture needle. The puncture needle can be configured to extend so that its distal end is disposed outside the housing of the deployment tool to facilitate loading. The implant can be preformed in a curved configuration and configured to maintain the curved configuration when deployed in the eye. The implant can be configured to temporarily straighten to facilitate loading onto the puncture needle.

[0172] In various embodiments, the implant and the puncture needle are configured to be in a retracted position and arranged within a catheter prior to deployment. In various embodiments, the distal end of the puncture needle and the distal end of the implant are configured to be positioned within the catheter when in the retracted position. The puncture needle can be preformed in a curved configuration and configured to maintain the curved configuration when deployed in the eye to maintain the delivery path. The puncture needle and the implant can be configured to be temporarily straightened to facilitate retraction and arrangement within the catheter.

[0173] In various embodiments, the insertion site is located on the cornea of ​​the eye. In various embodiments, an incision is made on the cornea, such as a clear keratotomy (CCI), for example, using a separate tool, prior to inserting the catheter. In various embodiments, the distal tip of the catheter is configured to be inserted through the corneal insertion site into the anterior chamber of the eye, and inserted across the pupil of the eye, and moved along the posterior surface of the iris to abut the ciliary sulcus or a portion of the ciliary body of the eye. In various embodiments, the deployment tool may include one or more tactile feedback mechanisms configured to confirm that the distal tip of the catheter abuts the sulcus or a portion of the ciliary body.

[0174] In various embodiments, the deployment tool further includes a puncture needle holder configured to engage the proximal end of the puncture needle and configured to extend the puncture needle distally from the distal tip of the catheter to allow the distal tip of the puncture needle to dissect tissue and create a delivery path. In various embodiments, the delivery path includes a first segment extending from a portion of the sulcus or ciliary body to the inner surface of the sclera and a second segment extending from the inner surface of the sclera to the suprachoroidal space; wherein the first segment and the second segment form an angle along the delivery path.

[0175] In various embodiments, the deployment tool further includes: an implant actuator configured to detachably engage the implant; and an implant actuator holder configured to couple / engage the implant actuator and configured to move the implant actuator so that the implant actuator engages the implant and the implant moves distally relative to the puncture needle along the delivery path. The implant and the implant actuator can be configured to slide on the puncture needle along the delivery path until the implant reaches its intended position, and its distal segment is located in the suprachoroidal space and its proximal segment is located in the posterior chamber.

[0176] In various embodiments, the introducer needle holder is further configured to retract the introducer needle proximally such that the distal tip of the introducer needle is closer (ie, in a more proximal position) relative to the distal tip of the implant actuator.

[0177] In various embodiments, the deployment tool may further include a catheter holder configured to couple / engage the catheter and configured to move the catheter relative to the housing. The catheter holder may be configured to retract the catheter proximally so that the distal tip of the catheter is closer (i.e., in a closer position) relative to the distal tip of the implant actuator. The catheter holder may be configured to retract the catheter simultaneously or sequentially with the retraction of the puncture needle.

[0178] In various embodiments, the catheter holder, the puncture needle holder, and the implant actuator holder can be configured to be actuated in a substantially linear direction using one or more controllers arranged on the housing of the deployment tool. The catheter holder, the puncture needle holder, and the implant actuator holder can be configured to be positioned in a fully retracted state in which the catheter, the puncture needle holder, and the implant actuator holder are positioned at their closest positions within the housing. The catheter holder, the puncture needle holder, and the implant actuator holder can be configured to be positioned in a fully extended state in which the catheter, the puncture needle holder, and the implant actuator holder are positioned at their farthest positions within the housing. The catheter holder, the puncture needle holder, and the implant actuator holder can be further configured to move between their farthest and closest positions within the housing.

[0179] In various embodiments, one or more components of the implant, deployment tool, and system are biocompatible, bioinert, and sterile. In various embodiments, the portion of the implant, deployment tool, and system that contacts the eye (directly or indirectly) is biocompatible, bioinert, and sterile. In various embodiments, the entire implant and / or the entire deployment tool is completely biocompatible, bioinert, and sterile. Sterilization can be performed using suitable materials and techniques known in the art, such as ethylene oxide, gamma or electron beam radiation, plasma, or autoclave sterilization. Therefore, one or more components of the implant, deployment tool, and system are made of materials that can withstand the desired sterilization method without substantial or significant loss of its desired properties or function.

[0180] Method of inserting the implant into the eye

[0181] In various embodiments, a method of inserting an implant into an eye to facilitate conduction of fluid from a posterior chamber of the eye to the suprachoroidal space is provided, the method comprising: inserting a catheter through an insertion site such that a distal tip of the catheter is disposed in the posterior chamber of the eye; abutting the distal tip of the catheter against a portion of the sulcus or ciliary body of the eye; advancing a puncture needle to create a delivery path from the sulcus or a portion of the ciliary body to the suprachoroidal space of the eye; and moving the implant relative to the puncture needle along the delivery path such that a distal segment of the implant is disposed in the suprachoroidal space of the eye and a proximal segment of the implant is disposed in the posterior chamber of the eye.

[0182] In various embodiments, the method is performed using a specially designed deployment tool. The deployment tool is substantially similar in structure and function to the deployment tool in various embodiments disclosed herein. The implant is substantially similar in structure and function to the implant in various embodiments disclosed herein. The deployment tool may include a housing having an outer surface for allowing an operator to hold / grasp the deployment tool and a chamber defined in the housing to accommodate a catheter, a puncture needle, an implant actuator, and other components of the deployment tool. The deployment tool may further include a catheter holder, a puncture needle holder, and an implant actuator holder, each of which is coupled to the proximal end of the catheter, the puncture needle, and the implant actuator, respectively. The catheter holder, the puncture needle holder, and the implant actuator holder may be further coupled to one or more controllers (e.g., electronic controllers, physical controllers (e.g., buttons, knobs, sliders, switches, control rods, joysticks, etc.)) to allow the operator to actuate or control the movement and positioning of the catheter, the puncture needle, and the implant actuator. One or more controls may be arranged on an outer surface of the housing in an easily accessible or ergonomic manner so that the operator rarely or never needs to reposition or adjust the grip / grip position of the deployment tool.

[0183] In various embodiments, the method further includes loading the implant onto the puncture needle prior to insertion into the insertion site. Loading of the implant may include actuating the puncture needle holder to extend the puncture needle out of the housing of the deployment tool to facilitate loading. The implant may be configured to maintain a curved configuration when deployed / implanted in the eye. Loading of the implant may involve temporarily straightening the implant to conform to the shape or contour of the puncture needle.

[0184] In various embodiments, the method further includes retracting the introducer needle and the implant actuator after loading the implant such that a distal end of the introducer needle and a distal end of the implant are positioned within the catheter.

[0185] In various embodiments, the method includes inserting a catheter through an insertion site such that a distal tip of the catheter is disposed in a posterior chamber of an eye. The insertion site may be a location on the cornea of ​​the eye. Inserting the catheter through the insertion site may include making an incision in the cornea to allow passage of the catheter. Inserting the catheter through the insertion site may further include inserting the catheter through the cornea into the anterior chamber of the eye and moving the catheter across the pupil of the eye to enter the posterior chamber. Inserting the catheter through the insertion site may include moving the entire housing of the deployment tool while being held and manipulated by an operator such that the distal tip of the catheter is inserted through the cornea into the anterior chamber and through the pupil to the posterior chamber.

[0186] In various embodiments, the method includes bringing the distal tip of the catheter into abutment with a portion of the sulcus or ciliary body of the eye. This may include navigating / moving the catheter under the iris of the eye until the distal tip of the catheter is positioned and abuts the sulcus or ciliary body of the eye. The abutment of the distal tip of the catheter against the sulcus or ciliary body may be confirmed using one or more tactile feedback mechanisms provided by the deployment tool.

[0187] In various embodiments, the method includes advancing a puncture needle to create a delivery path from a portion of the sulcus or ciliary body to the suprachoroidal space of the eye. This may include extending the distal tip of the puncture needle from the distal tip of the catheter and dissecting tissue at a portion of the ciliary sulcus or ciliary body where the distal tip of the catheter is adjacent. The puncture needle holder may be advanced so that the puncture needle moves distally to pass through the ciliary body. The step of advancing the puncture needle to create a delivery path may further include: advancing the puncture needle to contact the inner side of the scleral wall of the eye; sliding the puncture needle along the inner side of the scleral wall of the eye; and dissecting the suprachoroidal space of the eye. In various embodiments, the puncture needle does not cut the scleral wall of the eye, that is, the scleral wall is spared from being cut.

[0188] In various embodiments, the method includes advancing an implant actuator to move the implant distally relative to the puncture needle, such that the distal segment of the implant is disposed in the suprachoroidal space of the eye and the proximal segment of the implant is disposed in the posterior chamber of the eye. Advancing the implant actuator to move the implant may include advancing the implant actuator retainer such that the implant actuator is also advanced distally and pushes the implant. Advancing the implant actuator to move the implant may further include sliding the implant on the puncture needle along the delivery path until the implant reaches its intended position with its distal segment in the suprachoroidal space and its proximal segment in the posterior chamber.

[0189] In various embodiments, the method further includes withdrawing the deployment tool from the insertion site (e.g., corneal incision) to leave the implant in place. This may include retracting the puncture needle holder so that the puncture needle is retracted until its distal tip is closer to the distal tip of the implant actuator. The puncture needle can be retracted in the proximal direction along the delivery path until the distal tip of the puncture needle is decoupled from the proximal tip of the implant. Withdrawing the deployment tool from the insertion site may further include retracting the catheter holder so that the catheter is retracted until its distal tip is closer to the distal tip of the implant actuator. The retraction of the catheter can be performed simultaneously with the retraction of the puncture needle.

[0190] In various embodiments, the method of inserting an implant can provide an intra-orbital approach for inserting a shunt directed from the ciliary sulcus behind the iris, through the ciliary muscle while avoiding the vascularized ciliary processes and ultimately into the underlying suprachoroidal space.

[0191] In various embodiments, the method of inserting the implant can advantageously provide an improved way to create and maintain an outflow drainage tract from the posterior chamber of the eye to the suprachoroidal space for drainage of aqueous humor, thereby enlarging the physiological uveoscleral outflow pathway. Embodiments of the methods disclosed herein can be classified as a form of minimally invasive glaucoma surgery (MIGS), which aims to improve the efficacy while maintaining a safety profile no greater than lens extraction / phacoemulsification alone.

[0192] In various embodiments, methods of inserting implants can advantageously address problems associated with existing MIGS devices and problems associated with chronic angle-closure glaucoma. Specifically, the methods disclosed herein can avoid approaches above the iris via a narrow iridocorneal angle, instead opting for the larger post-iris space created after lens removal. Embodiments of the methods disclosed herein can enlarge the uveoscleral outflow pathway, which is less prone to dysfunction than the TM / SC pathway. The methods disclosed herein can bypass any PAS or iris occlusion prior to recombination, thus providing an outflow drainage route regardless of any anterior iris-trabecular contact. Embodiments of the methods disclosed herein can result in a lower risk of chronic endothelial cell loss than leaving the implant in the anterior chamber, because the iris acts as a barrier between the implant and the corneal endothelium. Embodiments of the methods disclosed herein can result in less scarring and fibrosis than subconjunctival outflow and / or external routes.

[0193] Furthermore, in various embodiments of the methods disclosed herein, better therapeutic efficacy (ie, IOP reduction or medication reduction) may also be achieved compared to the TM / SC approach because the degree of blood pressure reduction is not limited by the superficial scleral venous pressure.

[0194] The inventors have recognized that embodiments of the methods disclosed herein may include some unique considerations. First, conventional visualization of the ciliary sulcus region is not feasible due to the overlying iris, and entry from the ciliary sulcus will involve careful and precise positioning to avoid damage to the adjacent ciliary processes and iris roots, which will result in bleeding or hyphema. Second, to maintain an endoscopic approach without scleral dissection, entry from the ciliary sulcus into the suprachoroidal space can be achieved by selectively cutting or resecting the superficial or proximal layers of tissue (i.e., choroid and / or ciliary muscle / tissue) without cutting the deep / remote layers (i.e., the medial side of the sclera). Third, due to the relative positioning of the ciliary sulcus, ciliary body, and suprachoroidal space, the implant has a bend in its deployed configuration, and an extended delivery mechanism can be used to achieve this purpose.

[0195] The inventors have also recognized that embodiments of the method disclosed herein cannot be safely and reproducibly implemented within a reasonable operating time using currently available devices and surgical tools. Thus, various embodiments of the implant and deployment tool disclosed herein can advantageously address the challenges inherent in this method by providing the ciliary sulcus to the suprachoroidal drainage shunt (implant) and surgical tool (deployment tool), thereby enabling successful intra-articular placement thereof.

[0196] Various embodiments of the implants, deployment tools, systems, and methods disclosed herein can provide a MIGS approach for chronic angle-closure glaucoma patients that addresses both drainage and the potential for rePAS (reorganization of peripheral anterior synechiae). Various embodiments of the implants, deployment tools, systems, and methods disclosed herein can facilitate access to the suprachoroidal space via the ciliary sulcus in a medial approach. Various embodiments of the implants, deployment tools, systems, and methods disclosed herein can achieve successful deployment of the implant by having one or more of the following characteristics: (i) providing a delivery pathway, such as a tortuous entry pathway from the ciliary sulcus to the suprachoroidal space; (ii) selectively cutting / resecting ciliary tissue while not cutting / resecting the sclera; (iii) providing a curved implant in its deployed configuration; (iv) customizing the shape, size, and sharpness of the puncture needle to allow passage through the choroidal tissue but not the sclera; (v) customizing the implant material and size so that it is flexible enough to follow the tortuous path of the puncture needle into the suprachoroidal space; and (vi) customizing the size of the distal portion of the implant and the puncture needle to minimize the chance of passing through the choroidal tissue into the vitreous body. BRIEF DESCRIPTION OF THE DRAWINGS

[0197] Figure 1 is a schematic diagram of an eye and an implant (eg, a drainage shunt implant) inserted therein, in accordance with an example embodiment.

[0198] Figure 2A is a schematic cross-sectional view of a deployer / deployment tool for inserting an implantable shunt to create and maintain an outflow drainage tract from the posterior chamber of the eye to the suprachoroidal space in an example embodiment.

[0199] Figure 2B is a perspective view of a deployer / deployment tool in an example implementation.

[0200] Figure 3 is a schematic cross-sectional side view of a deployment tool in another example embodiment.

[0201] Figure 4A is a schematic cross-sectional side view of a catheter of a deployment tool in an example embodiment.

[0202] Figure 4Bis a schematic cross-sectional side view of a catheter positioned at the sulcus of the ciliary body of an eye in an example embodiment.

[0203] Figure 5 is a schematic perspective view of a portion of a puncture needle in a first exemplary embodiment.

[0204] Figure 6 is a schematic perspective view of a portion of a puncture needle in a second exemplary embodiment.

[0205] Figure 7 is a schematic diagram of a puncture needle in a third exemplary embodiment.

[0206] Figure 8 is a schematic diagram of a puncture needle in a fourth exemplary embodiment.

[0207] Fig.9A is a first schematic cross-sectional view of a portion of a deployment tool in an example embodiment.

[0208] Fig. 9B is a second schematic cross-sectional view of a portion of a deployment tool in an example embodiment.

[0209] Fig. 9C is a third schematic cross-sectional view of a portion of a deployment tool in an example embodiment.

[0210] Fig.9D is a fourth schematic cross-sectional view of a portion of a deployment tool in an example embodiment.

[0211] Fig.10 is a schematic cross-sectional view of an implant (eg, a drainage shunt implant) in a first exemplary embodiment.

[0212] Fig.11 is a perspective view of an implant (eg, a drainage shunt implant) in a second exemplary embodiment.

[0213] Fig.12 is a perspective view of an implant (eg, a drainage shunt implant) in a third exemplary embodiment.

[0214] Fig.13 is a perspective view of a fourth exemplary embodiment of an implant, such as a drainage shunt implant.

[0215] Fig.14 is a schematic side view of an implant (eg, a drainage shunt implant) inserted into an eye in accordance with an example embodiment.

[0216] Fig.15 is a schematic side view of another example embodiment of an implant (eg, a drainage shunt implant) inserted into an eye.

[0217] Fig.16 is a side view of an implant (eg, a drainage shunt implant) in a fifth exemplary embodiment.

[0218] Fig.17 is a perspective view of an implant (eg, a drainage shunt implant) in a sixth exemplary embodiment.

[0219] Fig.18 is a perspective view of an implant (eg, a drainage shunt implant) in a seventh exemplary embodiment.

[0220] Fig.19 is a perspective view of an implant (eg, a drainage shunt implant) in an eighth exemplary embodiment.

[0221] Detailed description of the drawings

[0222] Those of ordinary skill will better understand and easily understand the exemplary embodiments of the present invention from the following discussion and, as appropriate, in conjunction with the drawings. It should be understood that other modifications related to structural, material, and optical changes may be made without departing from the scope of the present invention. The exemplary embodiments are not necessarily mutually exclusive, as some embodiments may be combined with one or more than one embodiment to form new exemplary embodiments. The exemplary embodiments should not be construed as limiting the scope of the present invention.

[0223] Figure 1 1 is a schematic diagram of an eye 100 and an implant inserted therein, such as in the form of a drainage shunt implant 102, in an exemplary embodiment. A drainage shunt is used to maintain an outflow drainage channel from a posterior chamber 104 of the eye to a suprachoroidal space 106. The drainage shunt implant 102 is in the form of an elongated hollow member having a proximal segment 108 disposed in the posterior chamber 104 of the eye 100 and a distal segment 110 disposed in the suprachoroidal space 106 of the eye 100. The suprachoroidal space is the space between the choroid 112 and the sclera 114 that traverses the circumference of the posterior segment of the eye 100. When deployed in the eye, the drainage shunt implant 102 maintains a curved configuration that substantially conforms to the anatomical curvature of the suprachoroidal space 106.

[0224] In an exemplary embodiment, the drainage shunt implant 102 is inserted into the appropriate position using an intraocular approach, wherein the drainage shunt implant 102 is delivered along a delivery / guide path created by a deployment tool. The drainage shunt implant 102 is advanced along the delivery path, moves through an insertion site on the cornea 116 to the anterior chamber 118, moves across the pupil 120 to enter the posterior chamber 104, moves between the posterior side of the iris 122 and the intraocular lens 124 to the groove of the ciliary body 126, moves through tissue (e.g., muscle of the ciliary body 126) toward the medial side of the sclera 114 while avoiding the vascularized ciliary processes, and moves in the suprachoroidal space 106 along the curvature of the sclera 114 toward the posterior side of the eye 100.

[0225] Figure 2A is a schematic cross-sectional view of a deployer / deployment tool 200 for inserting an implantable shunt to create and maintain an outflow drainage tract from the posterior chamber of the eye to the suprachoroidal space in an example embodiment. Figure 2B is a perspective view of a deployer / deployment tool 200 in an example embodiment. The implantable shunt may have the form of an elongated hollow member having a proximal end positioned at the posterior chamber and a distal end positioned in the suprachoroidal space of the eye.

[0226] like Figure 2A As shown in the figure, the deployment tool 200 includes a housing 202 in the form of a slender member having an outer surface for allowing an operator (e.g., a surgeon) to hold the deployment tool 200, an inner chamber for accommodating various components (e.g., a sliding component of the deployment tool 200), and openings for allowing various components (e.g., a sliding component) to extend out of the housing 202.

[0227] The deployment tool 200 further includes a catheter 204 in the form of a hollow elongated member having a distal end 206 with an opening and a proximal end 208 coupled / attached to a catheter holder 210. The catheter holder 210 is retained in the housing 202 and may be fixed to the housing 202 or slidable within the housing 202.

[0228] Deployment tool 200 further includes an introducer needle 212 in the form of an elongated member having a distal end and a proximal end. The distal end is configured to pass through the ciliary body and optionally dissect the suprachoroidal space of the eye. The proximal end of introducer needle 212 is coupled / fixed to an introducer needle holder 214, which is retained within housing 202 and is configured to be slidable within housing 202. The introducer needle holder 214 is attached to a first control (e.g., a first slidable knob 216) that can be actuated by an operator to control the position of the introducer needle holder 214 and the introducer needle 212.

[0229] The deployment tool 200 further includes an implant actuator 218 having a distal end and a proximal end. The distal end is used to push the drainage shunt implant out of the deployer 200. The proximal end of the implant actuator 218 is coupled / fixed / secured to an implant actuator holder 220, which is retained within the housing 202 and is configured to slide within the housing 202. The implant actuator holder 220 is attached to a second controller (e.g., a second slidable knob 222) that can be actuated by an operator to control the position of the implant actuator 218 and the implant actuator holder 220.

[0230] The catheter 204 acts as an outer sheath for the implantable shunt, the introducer needle 212, and the implant actuator 218. The implant actuator 218 is substantially parallel to the catheter 204 and moves linearly within the catheter 204. The introducer needle 212 is substantially parallel to the implant actuator 218 and is configured to move linearly within the implant actuator 218. The introducer needle 212 and the implantable shunt are configured to exit from an opening at the distal end 206 of the catheter 204.

[0231] like Figure 2B , the housing 202 is configured so that it is ergonomic and the buttons (e.g., 216, 222) are easy to push smoothly without having to change the grip. This allows the deployment tool 200 to be stably held during the procedure of inserting the implantable shunt. The deployment tool 200 has two slide controls 216, 222 arranged in a row on the top surface of the housing 202, one of which is connected to the puncture needle holder 214 and one of which is connected to the implant actuator holder 220. The housing 202 is symmetrical, thus allowing for use by both right-handed and left-handed users.

[0232] The deployer / deployment tool 200 can be used in an implantation procedure to create and maintain an outflow drainage tract from the posterior chamber of the eye to the suprachoroidal space using an intraocular approach. The implantation procedure can include the following steps:

[0233] (1) Load the implant onto the puncture needle.

[0234] (2) The introducer needle and implant actuator are at the most proximal position. The introducer needle and implant are completely within the catheter holder (in the linear direction).

[0235] (3) The deployer is inserted into the anterior chamber by moving the entire housing through the cornea. The catheter is passed through the pupil and moved under the iris until the distal tip abuts a portion of the sulcus or ciliary body.

[0236] (4) The puncture needle holder is advanced so that the puncture needle moves distally to pass through the ciliary body.

[0237] (5) The puncture needle holder is further advanced so that the puncture needle contacts the inner surface of the scleral wall and slides backward along it to dissect the suprachoroidal space.

[0238] (6) Advancing the implant actuator holder so that the implant actuator also advances distally and pushes the implant.

[0239] (7) The implant is slid into position over the puncture needle with its distal segment in the suprachoroidal space and its proximal segment in the posterior chamber.

[0240] (8) Retract the puncture needle holder so that the puncture needle is retracted until its distal tip is close to the distal tip of the implant actuator.

[0241] (9) Optionally retract the catheter holder so that the catheter is retracted until its distal tip is close to the distal tip of the implant actuator. This can be done simultaneously with the previous step (8).

[0242] (10) The deployer is withdrawn through the corneal incision, leaving the implant in place.

[0243] Figure 3 FIG. 2 is a schematic cross-sectional side view of a deployment tool 300 in another exemplary embodiment. The deployment tool 300 functions substantially similarly to the deployment tool 200. The deployment tool 300 includes a nut and bolt assembly 302 coupled to a puncture needle 304. Figure 2A and Figure 2B Deployment tool 300 utilizes an alternative needle driver mechanism to the slide control used in deployer 200 of the present invention, a nut and bolt assembly following a micrometer screw, wherein rotational movement of the proximal end results in controlled forward translation. One full rotation translates to a linear distance equal to the pitch of the screw, i.e., the distance between two consecutive threads of the screw.

[0244] Figure 4A is a schematic cross-sectional side view of a catheter 400 of a deployment tool in an example embodiment. Figure 4B is a schematic cross-sectional side view of a catheter 400 positioned at a sulcus 402 of a ciliary body 404 of an eye 406 in an example embodiment.

[0245] The configuration of the catheter 400 plays a role in properly placing the deployment tool at the groove 402 of the ciliary body 404. The catheter 400 includes a distal tip 408 configured to abut the groove 402 or a portion of the ciliary body 404 and an opening 410 for allowing a puncture needle 412 to be extended from or withdrawn into the catheter 400. This allows feedback to be provided to the operator (e.g., a surgeon) that the distal tip 408 of the catheter 400 has reached the appropriate location / position by visual observation of the bulge of the sclera or tactile detection.

[0246] The size of the distal tip 408 of the catheter 400 follows the shape of the ciliary sulcus 402 to allow for an approximate and reproducible fit when the deployment tool / device is placed in the correct position. Specifically, this is embodied by a distal tip geometry having a chamfer angle from about 10° to about 40° and optionally having a circumferential radius from about 5 mm to about 7 mm. The allowable width of the ciliary sulcus guide is less than 2 mm so that it fits through the corneal incision.

[0247] In an exemplary embodiment, the distal tip 408 of the catheter 400 is shown as being substantially continuous with the curved inner lumen 414 to guide the puncture needle 412 along a curved path into the suprachoroidal space. In other embodiments, the distal tip 408 of the catheter 400 may be curved and / or have an inner lumen having a curved configuration.

[0248] The distal tip of catheter 400 may be blunted with an angle radius exceeding 0.1 mm so that it does not cause contusion of the posterior surface of the iris or the ciliary body. Catheter 400 may have a Young's modulus exceeding 7.5 GPa so that it does not deflect when abutting the sulcus of eye 406 (not shown).

[0249] Figure 5 is a schematic perspective view of a portion of introducer needle 500 in the first exemplary embodiment. Figure 6 is a schematic perspective view of a portion of a puncture needle 600 in a second exemplary embodiment.

[0250] The configuration of the puncture needle plays a role in the anatomical dynamics of the tissue used to insert the implant (e.g., drainage shunt implant). The puncture needle 500, 600 is configured to pass through the ciliary body of the eye rather than the sclera and then dissect back between the choroid layer and sclera of the eye. In the end state, the puncture needle 500, 600 is configured to form a bend from the ciliary sulcus into the suprachoroidal space to create a delivery / guidance path that the implant (e.g., drainage shunt implant) can then follow.

[0251] The creation of a delivery path depends on several parameters such as the shape of the tip of the introducer needle, the profile at the distal section of the introducer needle, the path taken by the introducer needle due to the constraints of the catheter, the stiffness, and the surface roughness of the introducer needle.

[0252] Each of the puncture needles 500, 600 has an outer diameter ranging from about 100 μm to about 150 μm. The outer diameter of the puncture needles 500, 600 is smaller than the inner diameter of the implant.

[0253] As shown in the figure, the first puncture needle 500 has a distal tip 502 with a cone angle α of 30 to 60 degrees (see the side view of the distal tip 502). The second puncture needle 600 has a bevel tip 602 with a bevel angle β of 45 degrees (see the side view of the bevel tip 602). When the distal tip of the puncture needle contacts the sclera, the bevel or cone angle can promote a reaction force directed to the back of the eye. This helps to guide the puncture needle backwards.

[0254] Figure 7 700 in the third exemplary embodiment. The puncture needle 700 includes a proximal portion 702 and a distal portion 704, both of which are substantially straight. The puncture needle 700 further includes a tapered tip 706. The distal portion 704 can be bent toward the lower surface of the deployer (i.e., in a direction facing the rearward direction of the eye) at a bend angle γ of about 30 degrees to about 50 degrees relative to the proximal portion 702. The bending radius R can be 0.2mm to 1mm. The length of the distal portion 704 of the puncture needle 700 can be in the range of from about 1.5mm to about 2.5mm. The distal portion 704 is pushed into the suprachoroidal space of the eye and is long enough to serve as a guide path for the implant to bend into the suprachoroidal space. At the same time, the distal portion 704 is not too long to avoid increasing the risk of penetrating the choroidal layer of the eye. As the implant is moved over introducer needle 700, the implant shields tip 706 of introducer needle 700 to further reduce the risk of introducer needle 700 causing unwanted contusion of tissue.

[0255] In an alternative embodiment, the distal tip of the puncture needle follows a curved path with a radius of curvature of from about 4 mm to about 6 mm. A tangent line to the distal tip is at an angle of from about 30 degrees to about 50 degrees relative to the horizontal line of the needle.

[0256] When the puncture needle 700 is arranged concentrically in the catheter (compare Figure 4A When the diameter of the catheter is within 0.6 mm of the diameter of the puncture needle 700, the puncture needle 700 is substantially straightened in the catheter. Figure 4A When the catheter 700 is extended, the catheter is used to restrict the degree to which the catheter 700 can be bent. Therefore, the distal tip 706 of the puncture needle 700 forms a curved path when it is extended, so that it traverses the ciliary body and dissects the suprachoroidal space of the eye.

[0257] The puncture needle 700 can be made of a flexible material with shape memory properties, such as nitinol. Thus, the puncture needle 700 maintains its curvature despite being guided by a straight ciliary groove. The stiffness of the puncture needle does not exceed 2.5 N / mm, so that it can bend at an angle of more than 20 degrees relative to its axis for a protruding length of 0.53 mm (the length of the ciliary body). If the puncture needle is too stiff, it will pierce the sclera instead of bending back into the suprachoroidal space. In one embodiment, the puncture needle made of superelastic nitinol has a diameter of from about 0.13 mm to about 0.17 mm to achieve this stiffness. To prevent the puncture needle from buckling, the free length of the puncture needle (e.g., it is not supported by any external clamp or tube) is kept less than 8 mm.

[0258] The surface finish of the sharp face does not exceed 4 microns (RA) so that the tip can be sharp enough to pass through the ciliary body and smooth enough to slide along the inner surface of the choroid. The tapered or beveled tip shape can also promote atraumatic entry through the ciliary body to minimize bleeding. The surface finish of the tapered or beveled tip should also not exceed 0.5 microns (RA) to minimize tissue contusion. This can be achieved through various surface treatments (e.g., electropolishing, black oxide surface treatment). Black oxide surface treatment can also help prevent surface corrosion of the puncture needle.

[0259] Figure 8 800 in the fourth embodiment. The flexibility of the puncture needle 800 is achieved by providing a flexible joint in the needle. This can be achieved by having multiple rigid sections (such as 802 of the puncture needle 800) connected by a flexible inner core 804.

[0260] In a separate embodiment, the puncture needle is hollow. This allows fluid to be injected through the puncture needle. This can serve as a means of confirming whether the needle has actually entered the potential space between the two layers. If it is in the proper space, a loss of fluid resistance will be felt. This can be detected by an operator (e.g., a surgeon) tactilely or using a pressure sensor.

[0261] Fig.9A 900 is a first schematic cross-sectional view of a portion of a deployment tool 900 in an exemplary embodiment. The deployment tool 900 includes a catheter 902, a puncture needle 904 disposed within the lumen of the catheter 902, and an implant actuator 906. The catheter 902, the puncture needle 904, and the implant actuator 906 are concentrically arranged along a common longitudinal axis 908 such that the puncture needle 904 and the implant actuator 906 can slide freely along the longitudinal axis 908.

[0262] An implant 910 in the form of an elongated hollow member is loaded onto the puncture needle 904 so that the proximal end of the implant engages the distal end of the implant actuator 906. The implant 910 has an inner diameter that is greater than the diameter of the puncture needle 904. The implant 910 is configured so that it can slide freely along the puncture needle 904. The implant 910 is preformed in a curved configuration, straightened during deployment, and maintains its curved configuration after deployment. The deployment tool 900 is used to deploy the implant 910 using an intra-articular approach from the sulcus or a portion of the ciliary body to the suprachoroidal space of the eye so that when properly implanted, the proximal segment 912 is disposed in the posterior chamber of the eye and the distal segment 914 is disposed in the suprachoroidal space of the eye.

[0263] Fig.9A The relative positions of the puncture needle 904, implant actuator 906, and implant 910 within the catheter 902 are shown when the catheter 902 abuts the ciliary sulcus during operation. The puncture needle 904, implant actuator 906, and implant 910 are in their retracted positions such that they are completely within the lumen of the catheter 902.

[0264] Fig. 9B is a second schematic cross-sectional view of a portion of a deployment tool 900 in an example embodiment. Fig. 9B The relative positions of introducer needle 904, implant actuator 906, and implant 910 are shown as introducer needle 904 creates a delivery path during operation.

[0265] During the creation of the delivery path, the puncture needle 904 is advanced in the remote direction so that it extends from the remote opening of the catheter 902. The puncture needle 904 is advanced to pass through the ciliary body, contact the inner side of the scleral wall, bend and slide backward along the curvature of the scleral wall, and dissect the suprachoroidal space. When the puncture needle 904 is pushed forward, the implant 910 is maintained in the catheter 902. The catheter 902 remains adjacent to the ciliary sulcus. The implant 910 and the implant actuator 906 are maintained in their retracted positions within the lumen of the catheter 902.

[0266] Fig. 9C is a third schematic cross-sectional view of a portion of a deployment tool 900 in an example embodiment. Fig. 9C The relative positions of introducer needle 904, implant actuator 906, and implant 910 are shown as implant actuator 906 advances implant 910 along a delivery path created by introducer needle 904 during operation.

[0267] During insertion of the implant 910, the implant actuator 906 is advanced and pushes the implant 910 in the distal direction so that the implant 910 extends from the distal opening of the catheter 902. The implant 910 slides along the delivery path over the puncture needle 904 to its intended position. The deployer 900 then extends the implant 910 so that its distal segment 914 is located in the suprachoroidal space and the proximal segment 912 remains in the posterior chamber.

[0268] Fig.9D is a fourth schematic cross-sectional view of a portion of a deployment tool 900 in an example embodiment. Fig.9D The relative positions of introducer needle 904, implant actuator 906, and implant 910 are shown after introducer needle 904 is retracted into catheter 902 during operation.

[0269] During retraction, the puncture needle 904 is retracted so that the distal tip of the puncture needle 904 is close relative to the distal tip of the implant actuator. Once the puncture needle 904 is no longer in physical contact with the implant 910, the remote end of the implant actuator 906 is disengaged (i.e., withdrawn) from the proximal end of the implant 910. When the deployer 900 is retracted, it does not drag the implant 910 out with it.

[0270] In an exemplary embodiment, the implant actuator 906 is a hollow tube. Its inner diameter can be from about 0.18mm to about 0.25mm, so that it is larger than the diameter of the puncture needle and smaller than the outer diameter of the implant 910. In an exemplary embodiment, the remote / remote face of the implant actuator 906 abuts the proximal face of the implant 910. The cross-sectional profile of the distal tip of the implant actuator 906 can be a full circle, so that it has a stirrup strength higher than the stirrup strength of the implant and will not be forcibly opened by the implant 910. The distal tip of the implant actuator 906 can be tilted upward, with an angle of about 40° to about 50°, so that it complements the beveled tip shape on the proximal tip of the implant 910. This promotes the rotational orientation control of the implant.

[0271] In an exemplary embodiment, the surface finish of the distal face of the implant actuator 906 may not exceed 0.5 microns (Ra) to ensure that the implant 910 does not get stuck thereon. The inner edge of the distal tip of the catheter 902 may also be chamfered or rounded to ensure that no burrs will hook the implant 910 when the implant 910 is released. The inner surface of the catheter 902 may be smooth with a surface finish of no more than 0.5 microns (Ra) so that it does not scratch the implant 910 or hinder the sliding movement of the implant 910. This can be achieved by various types of treatments (such as chemical polishing, electropolishing, etc.).

[0272] In an exemplary embodiment, after the implant 910 is pushed into position, it is preferably free of contact with the deployer 900 on its inner and outer surfaces so that it is not dragged out with the deployer 900. The puncture needle 904 can be fully retracted into the implant actuator 906 so that the proximity of its distal tip to the closest edge of the opening on the implant actuator 906 is a minimum of 0.2 mm. In other words, the distal tip of the puncture needle 904 is at least 0.2 mm to the left of the proximal edge of the implant actuator 906, as shown in FIG. Fig.9D . The catheter 902 may also be retracted relative to the implant actuator 906 so that the proximity of its distal tip to the closest edge of the opening on the implant actuator 906 is a minimum of 0.2 mm. Throughout this procedure, the implant actuator 906 remains in position, i.e., it is in the same position relative to the housing of the deployer 900.

[0273] The catheter 902 and the puncture needle 904 can be withdrawn simultaneously for ease of use.

[0274] Fig.10 1 is a schematic cross-sectional view of an implant (e.g., drainage shunt implant 1000) in a first exemplary embodiment. Implant 1000 is used to conduct fluid (e.g., aqueous humor) from the posterior chamber of the eye / eyeball to the suprachoroidal space. Implant 1000 is in the form of a hollow elongated member / tubular member having a proximal segment 1002 configured to be disposed in the posterior chamber of the eye and a distal segment 1004 configured to be disposed in the suprachoroidal space of the eye. Implant 1000 further includes a proximal tip 1006 in fluid communication with the posterior chamber of the eye and configured to receive fluid from the posterior chamber of the eye. Implant 1000 further includes a distal tip 1008 in fluid communication with the suprachoroidal space of the eye and configured to discharge fluid into the suprachoroidal space of the eye.

[0275] The distal tip 1008 may be tapered to facilitate entry of the implant 1000, or blunted (radius < 0.1 mm) to ensure that it does not cause additional trauma, such as through choroidal tissue. Fig.10 , the distal tip 1008 is flat / blunted. The proximal tip 1006 of the implant 1000 is angled so that when implanted in the eye, the bevel is configured to face away from the posterior side of the iris.

[0276] The implant 1000 has an inner lumen with a diameter from about 0.1 mm to about 0.2 mm. Combined with an overall length from about 6 mm to about 8 mm and a curved shape, a flow rate from about 2 μL / min to about 20 μL / min can be achieved, which is on the same order of magnitude as the physiological flow rate of aqueous humor in the eye. The implant 1000 can have a wall thickness from about 0.05 mm to about 0.15 mm, so that the entry profile is small enough and the implant 1000 can still pass through the puncture needle, through the ciliary tissue and into the suprachoroidal space.

[0277] When deployed in the eye, the implant 1000 is configured to maintain a curved configuration that substantially conforms to the anatomical curvature of the suprachoroidal space so that the proximal segment 1002 does not rub against the iris of the eye. This can be achieved by:

[0278] Implant 1000 can be preformed according to the bending configuration, with a bend angle from about 40 degrees to about 60 degrees and a bending radius from about 0.5mm to about 1mm. During deployment, implant 1000 can be straightened when it crosses a curved path before implantation. Implant 1004 can be flexible enough so that it keeps its curved form, although there is the straightening (that is, bending stress is less than yield strength). Implant 1000 can have enough creep resistance so that it also keeps its form in the deployment duration (up to 10 minutes), although being straightened. Implant 1000 can be made of PTFE, with an internal diameter of 0.1mm to 0.8mm.

[0279] The implant 1000 or a portion thereof may be sufficiently soft so that it conforms to the anatomy of the eye (pressed down by the iris). The implant may be softer than the iris of the eye or nearly as soft as the iris of the eye. This low Young's modulus may be achieved by a combination of one or more of the following: (1) very soft materials (Young's modulus <50 mPa), such as SIBS; (2) joints that allow flexure.

[0280] Fig.11 1 is a perspective view of an implant (e.g., drainage shunt implant 1100) in a second exemplary embodiment. Implant 1100 is in the form of a hollow elongated member having a proximal segment / proximal section 1102 configured to be disposed in the posterior chamber of the eye and a distal segment / distal section 1104 configured to be disposed in the suprachoroidal space of the eye. Implant 1100 includes a cutout at proximal segment 1102 in which a semi-cylindrical portion of material is removed, such that proximal segment 1102 of implant 1100 includes a semi-cylindrical shape / profile. The cutout reduces the cross-sectional area of ​​the proximal segment, thereby reducing the second moment of area and thus reducing its bending strength.

[0281] Fig.12 1 is a perspective view of an implant, such as a drainage shunt implant 1200, in a third exemplary embodiment. The implant 1200 is in the form of a hollow elongated member having a proximal segment / proximal section 1202 configured to be disposed in the posterior chamber of the eye and a distal segment / distal section 1204 configured to be disposed in the suprachoroidal space of the eye. The implant 1200 includes a cutout at a curved portion 1206 such that a portion of the implant 1200 has a "spring" configuration in the form of a spiral 1206. This can be accomplished, for example, by laser cutting a spiral in a polyimide or nitinol material.

[0282] Fig.13 1 is a perspective view of an implant (e.g., drainage shunt implant 1300) in a fourth embodiment. Implant 1300 is in the form of a hollow elongated member having a proximal segment / proximal section 1302 configured to be disposed in the posterior chamber of the eye and a distal segment / distal section 1304 configured to be disposed in the suprachoroidal space of the eye. Implant 1300 further includes thin struts at curved portion 1306 that impart a tubular shape while maintaining flexibility. Such struts may, for example, take the shape of a coil or a molded ring connected by longitudinal segments. For example, as Fig.13 As shown in FIG. 1 , the curved portion 1306 has a "bellows" type configuration, with alternating rings of smaller and larger diameters formed from a rigid material such as Nitinol.

[0283] Fig.14 1 is a schematic side view of an implant, such as a drainage shunt implant 1400, inserted into an eye 1406 in an example embodiment. The implant 1400 is in the form of a hollow elongated member having a proximal segment / proximal section 1402 configured to be disposed in a posterior chamber 1408 of the eye 1406 and a distal segment / distal section 1404 configured to be disposed in a suprachoroidal space 1410 of the eye 1406.

[0284] The lengths of the proximal segment 1402 and the distal segment 1404 may be sized to ensure a good fit.

[0285] For example, the proximal segment 1402 may have a length of from about 0.5 mm to about 1 mm so that the proximal entrance is not blocked by surrounding tissue. For example, the length of the proximal segment may be from about 2 mm to about 4 mm so that it is long enough to be seen when the iris 1412 is dilated. Fig.14 , the implant 1400 further includes a proximal tip 1414 that is angled downward at an angle (e.g., from about 30 degrees to about 45 degrees) to reduce the possibility of being blocked by the posterior iris 1412. The edge of the proximal tip 1414 can be blunted (e.g., having a blunting radius of 0.05 mm or greater) to avoid iris 1412 contusion.

[0286] For example, the distal segment 1404 may have a length from about 1 mm to about 3 mm. The distal segment 1404 of the implant 1400 may be straight or have a radius of curvature greater than its intended path (in the longitudinal or circumferential direction) within the suprachoroidal space. This allows it to slide within the suprachoroidal space and prevents the distal tip from penetrating the choroidal layer and reentering the vitreous cavity. Fig.15 1 is a schematic side view of an implant (e.g., drainage shunt implant 1500) inserted into an eye 1506 in another exemplary embodiment. Fig.15 As shown in FIG. 1 , implant 1500 has a distal segment 1504 having a curved profile having a radius of curvature that substantially mimics the radius of curvature of the sclera.

[0287] Fig.16 1 is a side view of an implant (e.g., drainage shunt implant 1600) in the fifth exemplary embodiment. Implant 1600 is made of a wire structure (e.g., coil, mesh, slotted tube) that can be radially expanded in a deployed state. During insertion, implant 1600 maintains its undeployed state to allow it to engage axially around a puncture needle 1602 having a relatively small outer diameter. The smaller diameter difference between puncture needle 1602 and implant 1600 promotes implants to extend more easily because the tip of implant 1600 must push away less tissue. Once implant 1600 is in position, it can be radially expanded to its optimal size in its deployed state. This radial expansion can be achieved by, for example, arranging an inflatable balloon on puncture needle 1602 to deform implant 1600 or making implant 1600 from a shape memory material (e.g., nitinol) and locking it in its undeployed state (e.g., by arranging a sheath thereon). Implant is released after deployment.

[0288] Fig.17 1 is a perspective view of an implant in a sixth exemplary embodiment, such as a drainage shunt implant 1700. The implant 1700 is in the form of a hollow elongated member 1702 having a proximal end 1704, a distal end 1706, and a lumen 1708 extending between the proximal end 1704 and the distal end 1706. The proximal end 1704 is configured to be disposed in the posterior chamber of the eye and the distal end 1706 is configured to be disposed in the suprachoroidal space of the eye.

[0289] Implant 1700 further includes a plurality of structural components, such as protrusions, such as 1710, extending from the outer surface of hollow elongated member 1702. A plurality of protrusions (such as 1710) are spaced apart along hollow elongated member 1702 and are substantially perpendicular to the longitudinal axis of hollow elongated member 1702. A plurality of protrusions (such as 1710) are used to provide a cross-sectional profile of the surface area of ​​implant 1700 that maximizes contact with tissue in the suprachoroidal space. A plurality of protrusions (such as 1710) also act as anchors, so that implant 1700 is fixed in a substantially fixed position and does not migrate or is not easily migrated after implantation.

[0290] Fig.18 1 is a perspective view of an implant in a seventh exemplary embodiment, such as a drainage shunt implant 1800. The implant 1800 is in the form of a hollow elongated member 1802 having a proximal end 1804, a distal end 1806, and a lumen 1808 extending between the proximal end 1804 and the distal end 1806. The proximal end 1804 is configured to be disposed in the posterior chamber of the eye and the distal end 1806 is configured to be disposed in the suprachoroidal space of the eye.

[0291] Implant 1800 further includes a plurality of structural components, such as protrusions, such as 1810, extending from the outer surface of hollow elongated member 1802. Each protrusion 1810 includes a lumen 1812 in fluid communication with the lumen 1808 of hollow elongated member 1802. In an exemplary embodiment, a plurality of protrusions (e.g., 1810) include a plurality of lumens (e.g., 1812) in fluid communication with the lumen 1808 of hollow elongated member 1802 to form an interconnected lumen network. The interconnected lumen network can advantageously promote the conduction of fluid from the posterior chamber of the eye to the suprachoroidal space of the eye. A plurality of protrusions (e.g., 1810) are also used to provide a cross-sectional profile of the surface area of ​​implant 1800 that maximizes contact with tissue in the suprachoroidal space. A plurality of protrusions (e.g., 1810) also act as anchors, so that implant 1800 is fixed in a substantially fixed position and does not migrate or is not easily migrated after implantation.

[0292] It should be understood that the plurality of protrusions (eg, 1710, 1810) are not limited to Fig.17 and Fig.18 The plurality of protrusions (e.g., 1710, 1810) may be in the form of other shapes, including but not limited to conical, pyramidal, hemispherical, and the like. It should also be understood that the plurality of protrusions (e.g., 1710, 1810) are not limited to being arranged perpendicular to the longitudinal axis of the hollow elongated member 1702, 1802, such as Fig.17 and Fig.18 . A plurality of protrusions (e.g., 1710, 1810) may be formed at an inclined angle (e.g., between 30 and 60 degrees) relative to the longitudinal axis of the hollow elongated member 1702, 1802. A plurality of protrusions (e.g., 1710, 1810) may be inclined in the same direction (e.g., all protrusions may be inclined toward the proximal end 1704, 1804 or all protrusions may be inclined toward the distal end 1706, 1806) or in mixed directions (e.g., one group of protrusions may be inclined toward the proximal end 1704, 1804 and another group of protrusions may be inclined toward the distal end 1706, 1806).

[0293] Fig.19 1 is a perspective view of an implant (e.g., drainage shunt implant 1900) in an eighth exemplary embodiment. Implant 1900 is in the form of a hollow elongated member configured in a curved configuration (e.g., an S-shaped configuration). The S-shaped configuration provides a cross-sectional profile that maximizes the surface area of ​​implant 1800 that contacts tissue in the suprachoroidal space. The S-shaped configuration also facilitates fixation of implant 1900 in a substantially fixed position, such that implant 1900 does not migrate or is not prone to migration substantially after implantation.

[0294] application

[0295] Embodiments of the invention provided herein provide an implant, deployment tool, system, and method for producing and maintaining outflow drainage of aqueous humor from the posterior chamber of the eye to the suprachoroidal space in chronic ACG patients.

[0296] Advantageously, embodiments of the disclosed implants, deployment tools, systems, and methods may provide improved methods to treat chronic angle-closure glaucoma patients with established peripheral anterior synechiae to achieve sustained reductions in IOP while reducing antihypertensive medication requirements. Placement of drainage shunts in this manner in chronic ACG patients allows for the expansion of unconventional outflow pathways without the drainage being compromised by future iris obstruction or PAS reorganization. Further, due to the location of the implant in the posterior chamber, there is less risk of chronic and persistent endothelial cell loss than placement in the anterior chamber of the eye.

[0297] More advantageously, embodiments of the disclosed implants, deployment tools, systems, and methods may be applied to a variety of treatments for ocular diseases, including, for example: (i) treatment of chronic angle-closure glaucoma in conjunction with ultrasonic phacoemulsification or clear lens extraction (i.e., simultaneous placement of the device and removal of the lens); (ii) treatment of chronic angle-closure glaucoma in pseudophakic patients (i.e., as a rescue treatment for patients with progressive disease despite prior lens extraction); and (iii) treatment of patients with glaucoma and concurrent corneal pathology (e.g., corneal dystrophy or post-keratoplasty) resulting in relative contraindications to conventional anterior chamber placement of a MIGS device.

[0298] Those skilled in the art will appreciate that other changes and / or modifications may be made to the embodiments disclosed herein without departing from the spirit or scope of the invention as broadly described. For example, in the description herein, features of different exemplary embodiments may be mixed, combined, interchanged, incorporated, adopted, modified, included, etc., or the like between different exemplary embodiments. Therefore, the embodiments of the present invention are considered in all respects to be exemplary and not restrictive.

Claims

1. An implant configured to be deployed in an eye by a deployment tool to facilitate conduction of fluid from a posterior chamber of the eye to the suprachoroidal space, the implant comprising: an elongated member having a proximal segment configured to be disposed in the posterior chamber of the eye and a distal segment configured to be disposed in the suprachoroidal space of the eye, Wherein when deployed in the eye, the elongate member is configured to maintain a curved configuration that substantially conforms to the anatomical curvature of the posterior chamber and the suprachoroidal space.

2. The implant of claim 1, wherein the elongated member is configured to straighten to facilitate loading of the implant into the deployment tool for deployment, and to return to the bent configuration when deployed in the eye.

3. The implant of claim 1, wherein the elongated member is preformed in the curved configuration at an angle that substantially matches an anatomical angle located between the posterior chamber and the suprachoroidal space of the eye.

4. The implant of claim 1, wherein the elongated member has a strength of no more than 0.5 N.mm 2 The slender member has a bending stiffness such that the slender member can be moved from a portion of the sulcus or ciliary body to the suprachoroidal space of the eye along a delivery path formed by the puncture needle of the deployment tool without substantially deforming the puncture needle.

5. An implant according to claim 1, wherein the distal segment of the slender member is curved with a radius of curvature substantially equal to the radius of curvature of the inner sclera of the eye.

6. The implant of claim 1, wherein the elongated member is beveled at its proximal tip such that when the implant is deployed in the eye, the bevel is configured to face away from the posterior surface of the iris.

7. A deployment tool for inserting an implant into an eye to facilitate conduction of fluid from the posterior chamber of the eye to the suprachoroidal space, the deployment tool comprising: a catheter that enters the posterior chamber of the eye through an insertion site, the catheter comprising a distal tip configured to abut a portion of a ciliary sulcus or a ciliary body of the eye; and a puncture needle configured to be disposed within the catheter and to create a delivery path from the sulcus or a portion of the ciliary body to the suprachoroidal space of the eye; wherein the deployment tool allows the implant to be moved relative to the introducer needle along the delivery pathway such that a distal segment of the implant is disposed in the suprachoroidal space of the eye and a proximal segment of the implant is disposed in the posterior chamber of the eye.

8. The deployment tool of claim 7, further comprising an implant actuator configured to be removably coupled to the implant and configured to move the implant distally relative to the introducer needle along the delivery pathway.

9. The deployment tool according to claim 7, wherein the introducer needle comprises a distal tip configured to dissect tissue to create the delivery path; wherein the delivery path includes a first segment extending from the groove or a portion of the ciliary body to the inner surface of the sclera and a second segment extending from the inner surface of the sclera to the suprachoroidal space; and The first section and the second section form a bend along the conveying path.

10. The deployment tool of claim 9, wherein the introducer needle is preformed in a curved configuration and is configured to straighten when deployed within the catheter and to return to the curved configuration when extended from the distal tip of the catheter to create the delivery pathway.

11. The deployment tool of claim 9, wherein the introducer needle has a stiffness of no more than 2.5 N / mm, thereby facilitating bending of the introducer needle at the angle along the delivery path.

12. The deployment tool of claim 7, wherein the conduit has a Young's modulus of at least 7.5 GPa such that the conduit does not substantially deflect when abutting the ciliary sulcus or a portion of the ciliary body of the eye.

13. The deployment tool of claim 8, further comprising an introducer needle holder, an implant actuator holder, and a catheter holder disposed thereon, wherein the introducer needle holder is configured to engage a proximal end of the introducer needle, the implant actuator holder is configured to engage the implant actuator, the catheter holder is configured to engage the catheter, and wherein the introducer needle holder, the implant actuator holder, and / or the catheter holder are each further coupled to a respective controller configured to optionally actuate the introducer needle, the implant actuator, and the catheter, Optionally, wherein the introducer needle holder, the implant actuator holder and / or the catheter holder are each further coupled to a respective controller configured to optionally actuate the introducer needle, implant actuator and the catheter.

14. A system for promoting conduction of fluid from the posterior chamber of an eye to the suprachoroidal space, the system comprising: An implant comprising: an elongated member having a proximal segment and a distal segment, wherein when deployed in the eye, the elongate member is configured to maintain a curved configuration that substantially conforms to the anatomical curvature of the posterior chamber and the suprachoroidal space; and Deployment tools, which include: a catheter for entering the posterior chamber of the eye through an insertion site, the catheter comprising a distal tip configured to abut a portion of the ciliary sulcus or ciliary body of the eye; and a puncture needle configured to be disposed within the catheter and to create a delivery path from the sulcus or a portion of the ciliary body to the suprachoroidal space of the eye; wherein the deployment tool allows the implant to be moved relative to the introducer needle in a distal direction along the delivery path such that a distal segment of the implant is disposed in the suprachoroidal space of the eye and a proximal segment of the implant is disposed in the posterior chamber of the eye.

15. The system of claim 14, wherein the elongated member is configured to straighten to facilitate loading of the implant onto a distal end of the introducer needle.

16. The system of claim 15, wherein the implant and introducer needle are configured to be in a retracted position and disposed within the catheter prior to deployment.

17. The system according to claim 16, wherein the insertion site is located on the cornea of ​​the eye; The distal tip of the catheter is configured to be inserted through the corneal insertion site into the anterior chamber of the eye, inserted across the pupil of the eye, and moved along the posterior surface of the iris to abut the ciliary sulcus or a portion of the ciliary body of the eye.

18. The system of claim 17, wherein the deployment tool further comprises: an introducer needle holder configured to engage a proximal end of the introducer needle and configured to extend the introducer needle distally from the distal tip of the catheter to allow the distal tip of the introducer needle to dissect tissue and create the delivery path; wherein the delivery path includes a first segment extending from the groove or a portion of the ciliary body to the inner surface of the sclera and a second segment extending from the inner surface of the sclera to the suprachoroidal space; and The first section and the second section form an angle along the conveying path.

19. The system of claim 18, wherein the deployment tool further comprises: an implant actuator configured to removably engage the implant; and An implant actuator holder is configured to engage the implant actuator and is configured to move the implant actuator so that the implant actuator engages the implant and the implant moves distally relative to the introducer needle along the delivery pathway.

20. The system of claim 18, wherein the introducer needle holder is further configured to retract the introducer needle proximally such that the distal tip of the introducer needle is closer relative to the distal tip of the implant actuator.

Images