Medical device and ocular implant for treating ocular disorders

Abstract

A medical device for minimally invasive glaucoma surgery for consulting / operating room filtration bubble formation. The medical device comprises: a proximal section for a user to grasp; a distal section including a piercing member coupled to and extending from the distal section, where the piercing member is configured to receive and deliver an ocular implant into a layer of ocular tissue to obtain a channel, where the proximal section and the distal section are configured to couple to each other at a pivot point between an unlocked configuration and a locked configuration, and where the piercing member is configured to receive and deliver the ocular implant into the layer of ocular tissue to obtain the channel. In the unlocked configuration, the proximal section and the distal section are rotatable relative to each other about an axis of rotation at the pivot point.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 432,270, filed on December 13, 2022, and U.S. Provisional Patent Application Serial No. 63 / 466,798, filed on May 16, 2023. The content of each of the above-referenced documents is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates to ophthalmic systems. More specifically, the present disclosure relates to ophthalmic systems including medical devices and ocular implants for treating eye diseases. Background Art

[0004] Glaucoma is a group of eye diseases characterized by optic nerve damage, which may be associated with elevated intraocular pressure (IOP). Glaucoma is the leading cause of irreversible blindness in the world. The main goal of treatment is to reduce IOP by means of drugs or surgery. Generally, surgical procedures and medical devices for treating eye disorders such as glaucoma are based on ab interno (intraocular) or ab externo (extraocular) methods.

[0005] The latest advancement in glaucoma treatment practice is the use of microincisional glaucoma surgery (MIGS), which refers to a group of surgical procedures that typically involve implanting small ocular implants. MIGS procedures attempt to minimize intraoperative and postoperative management and provide a less invasive method of reducing IOP than standard glaucoma surgery, with the goal of minimizing dependence on topical medications. Several ophthalmic systems and surgeries have been proposed.

[0006] U.S. Patent No. 9,993,368 (Glaukos Corporation et al.) describes an intraocular system for treating glaucoma. The system includes: a delivery device having a handle and an elongate delivery member; and an ophthalmic implant including a body having a proximal section and a distal section relative to the handle of the delivery device, wherein at least the distal section is curved so as to fit within and extend along a portion of Schlemm's canal of the eye after implantation using the delivery device. The elongate delivery member is configured for intraocular insertion of the ophthalmic implant through a corneal incision and is sized to span the anterior chamber. The elongate delivery member is also configured to hold the ophthalmic implant therein prior to implantation and to deliver the ophthalmic implant through the trabecular meshwork of the eye and into and along a portion of Schlemm's canal.

[0007] U.S. Patent No. 9,693,899 (Ivantis, Inc. et al.) describes an intraocular system for treating glaucoma. The system includes: a segment body; a cannula coupled to the segment body, the cannula sized and configured for insertion into Schlemm's canal of a human eye; and a delivery mechanism disposed on the segment body. The delivery mechanism is configured to advance and retract an ocular implant within the cannula. An orientation mechanism is disposed on the segment body, wherein the orientation mechanism is configured to control rotation of the cannula, and wherein the ocular implant maintains its orientation relative to the cannula when the cannula rotates.

[0008] Because MIGS surgery has advantages over more conventional treatment methods, efforts are being made to improve such surgeries and associated ophthalmic systems. SUMMARY OF THE INVENTION

[0009] This Summary of the Invention is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary of the Invention is not intended to identify key aspects or essential aspects of the claimed subject matter.

[0010] In one broad aspect, the present disclosure relates to a medical device that includes: a proximal segment for a user to grasp; an ocular implant; and a distal segment that includes a piercing member coupled to and extending from the distal segment, wherein the piercing member is configured to receive the ocular implant and deliver the ocular implant into an eye tissue layer to create a passageway, wherein the proximal segment and the distal segment are configured to be coupled to each other at a pivot point between an unlocked configuration and a locked configuration, and wherein, in the unlocked configuration, the proximal segment and the distal segment are rotatable relative to each other about a rotational axis at the pivot point.

[0011] In some embodiments, the medical device may include one or more of the following features:

[0012] · Any feature described herein and / or shown in the drawings that is applicable to the medical device.

[0013] · A locking mechanism for reversibly fixing the proximal segment and the distal segment in the locked configuration.

[0014] · The piercing member includes an elongate hollow body for receiving the ocular implant.

[0015] · The medical device is configured to retract the piercing member from an extended position to a retracted position.

[0016] · The piercing member includes a piercing tip at its distal end.

[0017] · Further includes an actuator assembly configured to actuate the piercing member.

[0018] · The actuator assembly includes a manually operable actuator, and wherein the actuator assembly is further configured to operably couple the actuator to the piercing member.

[0019] · The distal section includes an inner surface defining a lumen, and wherein the medical device further includes an inner shell disposed within the lumen and configured to couple to the piercing member.

[0020] · Engagement of the actuator couples the actuator to the inner shell.

[0021] · Release of the actuator axially displaces the inner shell toward the proximal end of the distal section, thereby retracting the piercing member toward the distal section.

[0022] · The medical device further includes an ocular implant, and wherein the ocular implant has an elongated body having an inner surface defining a substantially continuous inner lumen, and wherein the ocular implant is received within the piercing member.

[0023] · The medical device has a length of from about 100 mm to about 300 mm, preferably a length of about 145 mm.

[0024] · The piercing member has a size corresponding to a 23 to 30 gauge needle, preferably a size corresponding to a 27 gauge needle.

[0025] · The piercing member has a length of from about 8.0 mm to about 20.0 mm, preferably a length of about 13.0 mm.

[0026] In a broad aspect, the present disclosure relates to an ocular implant, comprising: an elongated body having an inner surface defining an inner lumen that forms a corresponding passageway; and a first engagement element and a second engagement element located at a surface of the elongated body, wherein the first engagement element and the second engagement element extend away from the surface of the elongated body, wherein the first engagement element and the second engagement element are in a spaced-apart relationship along the surface of the elongated body, and wherein the first engagement element and the second engagement element are compressible toward the elongated body.

[0027] In some embodiments, the ocular implant may include one or more of the following features:

[0028] · Any feature described herein and / or shown in the drawings that is applicable to the ocular implant.

[0029] · The first engagement element and the second engagement element are angled toward each other.

[0030] · The first engagement element and the second engagement element have a rod-like shape and extend from the elongated body at an acute angle.

[0031] · The ocular implant has a substantially circular cross-section along its entire length.

[0032] · The first engagement element and the second engagement element have a combined width with the elongate body of from about 0.400 mm to about 0.800 mm, preferably 0.600 mm.

[0033] · The first engagement element and the second engagement element are spaced apart by a distance of from about 1.8 mm to about 2.2 mm, preferably a distance of about 2.0 mm.

[0034] · The elongate body has an outer wall defining an outer diameter that is from about 0.100 mm to about 0.450 mm, preferably 0.254 mm.

[0035] · The implant has a lumen cross-sectional diameter of from about 0.010 mm to about 0.250 mm, preferably about 0.051 mm.

[0036] · The ocular implant has a length of from about 5.0 mm to about 6.5 mm, preferably a length of about 6.35 mm.

[0037] In a broad aspect, the present disclosure relates to a method comprising: obtaining a medical device as described herein; in an unlocked configuration, rotating the distal segment about a rotational axis at a pivot point to select an operative angle between the distal segment and the proximal segment; and in a locked configuration, performing an insertion of the ocular implant into an eye tissue layer to form a drainage channel.

[0038] In some embodiments, the method may include one or more of the following features:

[0039] · Any feature described and / or shown in the figures herein that is applicable to the method.

[0040] · Performing the insertion includes positioning the medical device relative to the eye at a first point and advancing the medical device along the longitudinal axis of the distal segment until the piercing member contacts the outer surface of the eye tissue layer.

[0041] · Performing the insertion further includes advancing the medical device to perform an incision in the eye tissue layer by an axial cutting motion with the piercing member, and advancing the piercing member through the incision and into and through the tissue layer.

[0042] · Performing the advancing of the piercing member through the incision and into and through the tissue layer until the piercing member has reached a desired depth.

[0043] · The desired depth is determined based on the position of one or more markers on the piercing member relative to the eye tissue layer.

[0044] · Performing the insertion further includes retracting the piercing member toward the distal end of the distal segment, thereby releasing and delivering the ocular implant into the eye tissue layer.

[0045] In a broad aspect, the present disclosure relates to a medical device that includes: a proximal section for a user to grasp; an ocular implant; and a distal section that includes a piercing member coupled to and extending from the distal section, wherein the piercing member is configured to receive the ocular implant and deliver the ocular implant into an eye tissue layer to create a passage, and wherein the piercing member includes one or more markings on its surface that indicate when the piercing member has reached a desired depth within the eye tissue layer.

[0046] In some embodiments, the medical device may include one or more of the following features:

[0047] · Any feature applicable to the medical device described herein and / or shown in the drawings.

[0048] · The ocular implant includes: an elongate body having an inner surface that defines an inner lumen that forms a passage; and a first engagement element and a second engagement element located at the surface of the elongate body, wherein the first engagement element and the second engagement element are configured to engage or abut against eye tissue structures to prevent the ocular implant from moving relative to the eye.

[0049] · The one or more markings include a first marking and a second marking disposed on the surface of the piercing member at positions that coincide with the respective positions of the first engagement element and the second engagement element.

[0050] · The first marking and the second marking are disposed on the surface of the piercing member and are spaced apart from each other by a distance of about 1.8 mm to about 2.2 mm, preferably 2.0 mm.

[0051] · The piercing member has a size corresponding to a 23 to 30 gauge needle, preferably corresponding to a 27 gauge needle.

[0052] · The piercing member has a length of about 8.0 mm to about 20.0 mm, preferably about 13.0 mm.

[0053] All features of the exemplary embodiments described in this disclosure and that are not mutually exclusive may be combined with each other. Elements of one embodiment may be used in other embodiments without further mention. After reading the following description of the specific embodiments in conjunction with the drawings, other aspects and features of the invention will become apparent to those of ordinary skill in the art. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] In this document, a detailed description of specific exemplary embodiments is provided below with reference to the drawings, in which:

[0055] Figure 1 It is a schematic cross-sectional view of the human eye;

[0056] Figure 2 It is a non-limiting perspective view of an embodiment of a medical device according to an embodiment of the present disclosure in a first position;

[0057] Figure 3 It is according to an embodiment of the present disclosure Figure 2 A non-limiting perspective view of an embodiment of the medical device in a second position;

[0058] Figure 4A It is a front view of an ocular implant according to an embodiment of the present disclosure;

[0059] Figure 4B It is Figure 4A A non-limiting longitudinal cross-sectional view of the ocular implant;

[0060] Figure 5A It is according to an embodiment of the present disclosure and Figure 2 A non-limiting view of a puncture member used with the medical device;

[0061] Figure 5B It is a top transparent view of a puncture member accommodating an ocular implant according to an embodiment of the present disclosure;

[0062] Figures 6A to 6D It is a non-limiting cross-sectional view of a medical device having a puncture member and an ocular implant according to an embodiment of the present disclosure;

[0063] Figures 7A to 7B It is a non-limiting cross-sectional view of the distal section of a medical device according to an embodiment of the present disclosure;

[0064] Figure 8 It is a non-limiting cross-sectional view showing that an ocular implant has been delivered using the puncture member of a medical device according to an embodiment of the present disclosure;

[0065] Figure 9A It is a non-limiting top view of a medical device with a cover covering the puncture member according to an embodiment of the present disclosure;

[0066] Figure 9B It is according to an embodiment of the present disclosure Figure 9A A non-limiting side view of the medical device;

[0067] Figure 10 It is a non-limiting exploded view of a medical device according to an embodiment of the present disclosure;

[0068] Figure 11 It is a non-limiting top view of the distal tip on the puncture member according to an embodiment of the present disclosure.

[0069] In the accompanying drawings, exemplary embodiments are shown by way of example. It should be clearly understood that the description and drawings are for the purpose of illustrating certain embodiments only and for assisting understanding. They are not intended to limit the disclosure. Detailed embodiments

[0070] The present technology will be described in more detail below. This description is not intended to exhaustively list all different ways in which the technology can be implemented, or all features that can be added to the technology. For example, features shown with respect to one embodiment can be incorporated into other embodiments, and features shown with respect to a particular embodiment can be deleted from that embodiment. Additionally, in view of the present disclosure, numerous variations and additions to the various embodiments presented herein will be apparent to those skilled in the art, and these variations and additions do not depart from the present technology. Accordingly, the following description is intended to illustrate some embodiments of the present technology, rather than exhaustively and explicitly define all of its permutations, combinations, and variations.

[0071] A medical device is described herein that is configured to form a channel in a target tissue layer. For example, a tissue layer of an eye for treating an eye disorder or disease. For example, a drainage channel for reducing intraocular pressure. For example, the eye can be a human eye.

[0072] In some embodiments, the medical device can deliver and position an ocular implant in the eye tissue layer. For example, a tissue layer that interfaces with the anterior chamber of the eye for enabling drainage of excess fluid from the interior of the anterior chamber of the eye.

[0073] In some embodiments, the medical device can facilitate the treatment of glaucoma.

[0074] In some embodiments, the medical device is configured to form a channel in the target tissue layer using an eye surgical method.

[0075] The inventors have unexpectedly found that there are one or more deficiencies in commercial ophthalmic medical devices or systems, which are more likely to be observed when medical practitioners perform ophthalmic surgeries:

[0076] a)PreserFlo TMThe MicroShunt (InnFocus, Miami, FL) is implanted via an extraocular approach performed under local anesthesia, where aqueous humor drained from the anterior chamber is directed via the microshunt to a filtration bleb created under the conjunctiva and Tenon's capsule. After flow confirmation, the distal end of the microshunt is tucked under the Tenon's capsule and conjunctiva. After ensuring the device is straight and tissue-free, the Tenon's capsule and conjunctiva need to be reattached to the device and to the limbus with sutures. This medical device requires an operating room (OR), a glaucoma surgeon, eye dissection, and represents an invasive procedure;

[0077] b) Xen TM The Gel Stent (Aquesys, Aliso Viejo, CA) is implanted in the OR using an intraocular approach under Tenon's capsule (90%), retrobulbar, or local anesthesia. Implantation uses a gonioscope to assess angular positioning, ideally just above the trabecular meshwork to avoid bleeding and avoid the iris and endothelium;

[0078] c) iStent TM (Glaukos, Aliso Viejo, CA) is implanted in the OR using an intraocular approach under local anesthesia, which requires visualization of the insertion angle using a gonioscope, an opening of at least 1.5 mm in the eye (i.e., increased risk of infection), and implantation in the trabecular meshwork (drainage site);

[0079] d) Hydrus TM The MicroStent (Alcon Ivantis, Irvine, CA TM ) is implanted into Schlemm's canal in the OR using an intraocular approach with a preloaded delivery cannula through a small clear corneal puncture while visualizing the angle via a gonioscope. The delivery cannula is slightly curved to conform to the angle and the morphology of Schlemm's canal.

[0080] Except for PreserFlo TMOutside of the microshunt, these commercially available ophthalmic medical devices and systems require intraocular surgery. While such intraocular subconjunctival filtration surgery has been successful in relieving intraocular pressure, there is a significant risk that the intraocular shunt may be deployed too close to the conjunctiva, resulting in irritation and subsequent inflammation and / or conjunctival scarring, which may lead to failure of glaucoma filtration surgery (see Yu et al., Progress in Retinal and Eye Research, 28:303-328 (2009)). Additionally, commercially available shunts currently used in such surgeries are not ideal for intraocular subconjunctival placement due to the length of the shunt (i.e., too long) and / or the materials used to fabricate the shunt (such as gold, polymers, titanium, or stainless steel), and may cause significant irritation to the tissues surrounding the shunt as well as the conjunctiva if deployed too close.

[0081] Intraocular surgery is also demanding because the success of such surgery typically depends significantly on the skills of the surgeon and the ability to precisely observe the path of surgical instruments within the anterior chamber and reach the filtration angle. Additionally, there are inherent risks to critical organs such as the iris and lens as well as the angle structures that cannot be observed without the use of an additional gonioscope.

[0082] The medical devices and procedures described herein address at least one or more of the drawbacks reported for commercially available ophthalmic medical devices or systems and provide at least one or more of the following advantageous features:

[0083] For example, the medical devices described herein can be used to treat eye disorders such as glaucoma without the need for an operating room.

[0084] For example, the medical devices described herein provide a safe, minimally invasive eye surgery. For example, only local anesthesia is used to implant the ocular implant. For example, the ocular implant is implanted under the conjunctiva or under the Tenon's capsule.

[0085] For example, the medical devices described herein may generally be considered safer due to the typically small openings in the eye tissue layers.

[0086] For example, the medical devices described herein allow for greater flexibility and ease of operation in terms of adjustable working angles, which can facilitate access to the eye angle.

[0087] For example, the medical devices described herein allow for greater flexibility and ease of operation in terms of being usable by both left-handed and right-handed users (ambidextrous).

[0088] For example, the medical devices described herein can be held and manipulated with only one hand, leaving the other hand free for other purposes.

[0089] For example, the medical devices described herein allow for greater flexibility and ease of operation with respect to one or more markings on a piercing member that indicate penetration of an eye tissue layer to a desired depth.

[0090] For example, the medical devices described herein may provide one or more of the following advantageous features:

[0091] · Reduced tissue trauma: Minimizing the need for tissue dissection through an extraocular implant delivered by a needle as described herein, thus reducing trauma and potential scarring compared to surgeries that require conjunctival dissection such as PreserFlo TM Microshunt.

[0092] · Reduced infection risk: Using an extraocular needle approach as described herein results in less impairment of the integrity of the internal structures of the eye, which may pose a lower risk of infection compared to traditional methods that require more extensive manipulation of the internal eye tissue. Preserflo involves tissue dissection and the operating room, which increases the complexity of the surgery, tissue trauma, and the likelihood of scarring.

[0093] · Material and size suitability: Given the complexity of existing shunt materials and sizes, the inventions described herein can provide an implant that is more suitable in terms of material compatibility and size, thus reducing irritation to surrounding tissues.

[0094] · Patient comfort and recovery: The minimally invasive nature of the needle-based extraocular surgery as described herein can enhance patient comfort during the surgery and may lead to a faster recovery time while reducing postoperative discomfort.

[0095] · Surgical efficiency: Fewer manipulations are required within the anterior chamber, simplifying the surgical procedure and potentially shortening the duration of the operation.

[0096] · Predictable outflow direction: Similar to traditional extraocular methods, the surgeries described herein allow for controlled and predictable aqueous humor outflow direction, potentially forming a more successful and diffuse subconjunctival filtration bleb.

[0097] · Reduced patient stress: Surgeries perceived as minimally invasive, such as the needle-based method described herein, can reduce patient anxiety associated with a more traditional surgical setting.

[0098] · Potential for improved long-term outcomes: The combination of reduced tissue dissection, minimally invasive techniques, and controlled outflow can contribute to increased long-term success and functionality of the implant.

[0099] According to the present disclosure, such technical advantages of the medical devices described herein will be more apparent to those skilled in the art.

[0100] Eye structure

[0101] The relevant structures of the eye will first be briefly described to provide a background for the anatomical terms used herein.

[0102] Figure 1 is a stylized depiction of a normal human eye. Certain anatomical details well known to those skilled in the art have been omitted for clarity and convenience.

[0103] The anterior chamber 100 is shown as being bounded on its anterior surface by the cornea 102. The cornea 102 is connected peripherally to the sclera 104, which is the tough fibrous tissue that forms the white outer shell of the eye. The trabecular meshwork 106 is located at the outer periphery of the anterior chamber 100. The trabecular meshwork 106 extends circumferentially 360 degrees around the anterior chamber 100. Located on the outer peripheral surface of the trabecular meshwork 106 is Schlemm's canal 108. Schlemm's canal 108 extends circumferentially 360 degrees around the trabecular meshwork 106. At the apex formed between the iris 110, the trabecular meshwork 106, and the sclera 104 is the angle of the anterior chamber 112.

[0104] Ocular implant

[0105] In broad embodiments, the present disclosure relates to an ocular implant.

[0106] In some embodiments, when the ocular implant is properly positioned in the eye, it may allow fluid to flow from one eye location to another. For example, aqueous humor may flow out of the anterior chamber 110 of the eye, thereby reducing the intraocular pressure of the eye. For example, the ocular implant may have an inner surface that defines one or more inner lumens, and the one or more inner lumens may form corresponding one or more channels to allow such flow of aqueous humor. In some embodiments, the ocular implant has an inner surface that defines a substantially continuous single inner lumen, and the single inner lumen forms a corresponding substantially continuous single channel. When the ocular implant is properly positioned in the eye, it may thus be used to treat glaucoma. This is contemplated to include primary open-angle glaucoma and secondary open-angle glaucoma. However, it is conceivable that the ocular implant may be used to treat other types of glaucoma, as well as other eye conditions that require relief of intraocular pressure by draining aqueous humor, such as pigment dispersion syndrome, neovascular glaucoma, uveitic glaucoma, chronic angle-closure glaucoma, and pseudoexfoliation syndrome.

[0107] Additionally or alternatively, the ocular implant of the present disclosure can be used to deliver substances to the eye, such as drugs or therapeutic agents. For example, saline or viscoelastic fluids. Saline fluid can be used for irrigation. For example, viscoelastic fluids can include hyaluronic acid, chondroitin sulfate, cellulose, its derivatives or mixtures or solutions thereof. In one variant, the viscoelastic fluid includes sodium hyaluronate. In another variant, the viscoelastic composition can also include a drug. For example, the viscoelastic composition can include drugs suitable for treating glaucoma, reducing or lowering intraocular pressure (IOP), alleviating inflammation and / or preventing infection. Drugs such as antimetabolites, steroids, heparin, other anticoagulants and fibrinolytic compounds can also be delivered in combination with the viscoelastic composition. Examples of glaucoma drugs include prostaglandins, beta blockers, miotics, alpha adrenergic agonists or carbonic anhydrase inhibitors. Anti-inflammatory drugs such as corticosteroids or other steroids can be used. For example, steroids such as prednisolone, prednisone, cortisone, hydrocortisone, triamcinolone or short-acting steroids can be employed. Examples of antimetabolites include 5-fluorouracil or mitomycin C. In yet another variant, the implant delivers only the drug and not the viscoelastic composition. A saline solution can also be the fluid employed.

[0108] In some embodiments, the ocular implant of the present disclosure can also be coated on at least a portion of the inner surface, at least a portion of the outer surface, or both, with a compound that is beneficial for treating ocular hypertension, glaucoma or pre-glaucoma, infection, postoperative scarring or inflammation, and / or coated with a compound that is beneficial for reducing friction and thus facilitating insertion into the eye.

[0109] In some embodiments, the ocular implant of the present disclosure can also be formed as solid, semi-solid or bioabsorbable.

[0110] Exemplary embodiments of the ocular implant of the present disclosure having various structural configurations will be described in further detail below.

[0111] In some embodiments, the ocular implant 10 includes an elongate body 20 that is configured such that when properly installed in the eye, aqueous humor can flow out of the anterior chamber 110 of the eye, thereby reducing the intraocular pressure in the eye. For example, the elongate body 20 can have an inner surface 25 that defines an inner lumen that forms a corresponding passage to permit such flow of aqueous humor.

[0112] In some embodiments, the elongate body 20 may have a substantially circular cross-section over at least a portion thereof. For example, the elongate body 20 may have a substantially circular cross-section over its entire length. In some embodiments, the elongate body 20 may have a substantially rectangular, oval, or hexagonal cross-section over at least a portion thereof. In some embodiments, the elongate body 20 may have more than one cross-sectional shape along its length, such as a combination of cylindrical and oval cross-sectional shapes along its length.

[0113] In some embodiments, the elongate body 20 may have a cross-sectional size or shape such that the inner diameter of the lumen defined therein is substantially constant along at least a portion thereof. For example, the elongate body 20 may have a cross-sectional size or shape such that the inner diameter of the lumen defined therein is substantially constant over its entire length.

[0114] In some embodiments, the elongate body 20 may have a cross-sectional shape such that the inner diameter of the lumen tapers along at least a portion thereof. For example, the elongate body 20 may have a cross-sectional shape such that the inner diameter of the lumen tapers over its entire length.

[0115] In some embodiments, the elongate body 20 may be substantially straight along at least a portion thereof. For example, the elongate body 20 may be substantially straight along its entire length as Figure 4B shown. In some embodiments, the elongate body 20 may be bent or curved in a temporary or permanent manner depending on the particular application. In some embodiments, the elongate body 20 may be rigid or flexible depending on the particular application.

[0116] In some embodiments, the elongate body 20 may have a length suitable for proper placement in the eye. For example, the elongate body 20 may have a length such that when the ocular implant 10 is properly positioned in the eye, the ocular implant can be comfortably placed in the eye and span a desired eye structure, such as the sclera 104. For example, the elongate body 20 may have a length Y between about 1.0 mm and about 12.0 mm, including any value or range therebetween. For example, a length Y of about 5.0 mm to about 6.5 mm. For example, a length of about 6.0 mm, 6.3 mm, about 6.35 mm, or about 6.4 mm, preferably a length Y of about 6.35 mm.

[0117] In some embodiments, the elongate body 20 may have a lumen cross-sectional size suitable for proper function. In some embodiments, the lumen cross-sectional diameter S may be set to facilitate the drainage of aqueous humor from the eye, for example, by passive drainage. For example, the lumen may have a cross-sectional diameter S of from about 0.010 mm to about 0.250 mm, including any value or range therebetween. For example, the lumen may have a cross-sectional diameter S of from about 0.035 mm to about 0.075 mm. For example, a lumen cross-sectional diameter S of about 0.050 mm, about 0.055 mm, or about 0.060 mm. For example, a lumen cross-sectional diameter S of about 0.050 mm, preferably a lumen cross-sectional diameter S of about 0.051 mm or about 0.053 mm.

[0118] In some embodiments, the elongate body 20 may have an outer wall defining an outer diameter OD that is suitable for proper function. In some embodiments, the elongate body 20 has an outer diameter OD such that when the ocular implant 10 is properly positioned in the eye, the ocular implant is comfortably positioned in the eye. For example, an outer diameter OD of from about 0.100 mm to about 0.450 mm, including any value or range therebetween. For example, an outer diameter OD of about 0.150 mm, about 0.200 mm, about 0.300 mm, or about 0.400 mm. For example, an outer diameter OD of about 0.255 mm, preferably an outer diameter OD of about 0.254 mm.

[0119] In some embodiments, the elongate body 20 further includes a first engagement element 30 and a second engagement element 40 located at the surface of the elongate body 20. For example, both the first engagement element 30 and the second engagement element 40 extend away from the surface of the elongate body 20. The first engagement element 30 and the second engagement element 40 are configured such that when the ocular implant 10 is properly positioned in the eye, the first engagement element 30 and the second engagement element 40 engage or abut against the eye tissue structure to prevent the ocular implant 10 from moving relative to the eye, thereby allowing the normal operation of the ocular implant. For example, the first engagement element 30 and the second engagement element 40 may be configured such that when the ocular implant 10 is properly positioned in the eye, the engagement element 30 engages or abuts against the inner surface (i.e., the surface facing the anterior chamber 100 of the eye) of the tissue layer (such as the sclera 104), while the engagement element 40 engages or abuts against the outer surface (i.e., the surface facing the outer surface of the eye, opposite to the anterior chamber 100 of the eye) of the tissue layer (such as the sclera 104).

[0120] As Figure 4AAs shown, the first engaging element 30 and the second engaging element 40 are advantageously positioned at the distal and proximal portions of the elongated body 20, respectively. In other words, the first engaging element 30 and the second engaging element 40 are in a spaced-apart relationship along the longitudinal axis of the elongated body 20. For example, the first engaging element 30 and the second engaging element 40 may be positioned at a position D from the respective proximal or distal end of the elongated body 20, which may be, for example, from about 1.5 mm to about 3.0 mm, including any value or range therebetween. For example, the position D from the respective proximal or distal end of the elongated body 20 is about 1.80 mm, about 2.00 mm, about 2.20 mm, or about 2.30 mm. For example, the position D of about 2.18 mm.

[0121] In some embodiments, the first engaging element 30 and the second engaging element 40 may include protrusions that extend from the elongated body 20 at an angle α relative to the surface of the elongated body 20. For example, the angle α relative to the outer surface of the elongated body 20 may be an acute angle, such as from about 5 degrees to less than 90 degrees. For example, the engaging element 30 may be angled towards the engaging element 40; or the engaging element 40 may be angled towards the engaging element 30; or both the first engaging element 30 and the second engaging element 40 may be angled towards each other. For example, the protrusion may have any suitable shape, such as hook-shaped, rod-shaped, strip-shaped, disk-shaped, flange-shaped, stepped, or any other suitable shape. Preferably, the first engaging element 30 and the second engaging element 40 have a rod-shaped shape that extends from the elongated body at an acute angle. In some embodiments, the first engaging element 30 and the second engaging element 40 may include one or more protrusions that project away from the elongated body 20.

[0122] In some embodiments, the first engaging element 30 and the second engaging element 40 may advantageously be deformable. For example, the first engaging element 30 and the second engaging element 40 are capable of compressing towards the elongated body 20, for example, in response to a compressive force, and then returning to their initial positions when needed (e.g., after releasing the compressive force). For example, the first engaging element 30 and the second engaging element 40 may be made of an elastic material.

[0123] Advantageously, the first engagement element 30 and the second engagement element 40 are positioned along the surface of the elongate body 20 at a distance X from each other such that they can engage or abut against a desired eye structure. For example, the distance X can be the distance at which the first engagement element 30 and the second engagement element 40 respectively engage or abut against the inner and outer surfaces of the sclera when the ocular implant 10 is correctly positioned in the eye. For example, the first engagement element 30 and the second engagement element 40 can be spaced such that approximately one-third of the elongate body 20 is located between the first engagement element 30 and the second engagement element 40. It is also contemplated that the first engagement element 30 and the second engagement element 40 can be, but are not limited to, variably spaced along the length of the elongate body 20 to ensure the proper functioning and safety of the ocular implant 10. For example, the distance X can be from about 1.8 mm to about 2.2 mm, including any value or range therebetween. For example, the distance X can be about 1.9 mm, about 2.0 mm, or about 2.1 mm. For example, a distance X of about 2.0 mm.

[0124] In some embodiments, as Figure 4B shown, the first engagement element 30 and the second engagement element 40 can advantageously have protrusions positioned relative to each other on the elongate body 20 to prevent migration of the ocular implant 10 relative to the eye when the ocular implant 10 is correctly positioned in the eye. For example, the ocular implant 10 can be delivered to the anterior chamber 100 through the cornea 102 or the iridocorneal angle 112. For example, the ocular implant 10 can be delivered to the iridocorneal angle through a scleral tunnel. In certain embodiments, for example, the ocular implant 10 can be inserted under other eye structures, such as the conjunctiva, the Tenon's capsule, and into the iridocorneal angle in the anterior chamber 100 through the sclera. For example, the first engagement element 30 and the second engagement element 40 can have protrusions extending away from the elongate body 20, thereby forming a combined width Z with the elongate body 20 that is from about 0.400 mm to about 0.800 mm, including any value or range therebetween. For example, a combined width Z of about 0.500 mm, about 0.600 mm, about 0.700 mm. For example, a combined width Z of about 0.600 mm.

[0125] In a specific embodiment, the ocular implant 10 can have one or more of the following dimensional characteristics: an outer diameter OD of about 0.254 mm, a cross-sectional diameter S of about 0.051 mm, a length Y of about 6.35 mm, a combined width Z of about 0.6 mm, and a distance X of about 2.0 mm between the first engagement element and the second engagement element.

[0126] In some embodiments, since the engagement element 40 does not enter the eye tissue layer, the engagement element may be less flexible than the engagement element 30 that enters the eye tissue layer. This may allow the ocular implant 10 to be inserted into the eye tissue layer by deforming the engagement element 30 to fit within a small incision in the eye tissue layer and, once the engagement element 30 has passed through the incision and the ocular implant 10 is in place within the eye tissue layer, allowing the engagement element to unfold.

[0127] The reader will recognize that this ability of the engagement element 30 to deform and unfold provides a technical advantage in that the surgery to insert the ocular implant into the eye tissue layer requires a smaller incision to be formed in the eye tissue layer compared to the incision required when the engagement element 30 does not have this ability.

[0128] In some embodiments, the ocular implant 10 including the elongate body 20 and the first engagement element 30 and the second engagement element 40 may all be made of the same medical grade material. Alternatively, either or both of the first engagement element 30 and the second engagement element 40 may be made of a medical grade material separate from the medical grade material of the elongate body 20. For example, such medical grade materials include, but are not limited to, polymethyl methacrylate (PMMA), silicone, acrylic, hydrophobic acrylate, hydrophilic acrylate, COLLAMER TM , poly(styrene-b-isobutylene-b-styrene) (“SIBS”) or any combination thereof. Silicone is preferred.

[0129] In a non-limiting embodiment, the ocular implant 10 may be obtained by molding the ocular implant over an elongate wire 50, where the wire 50 may extend through a manufacturing mold for the ocular implant. For example, an ocular implant material in a viscous, semi-viscous or liquid form may be injected into the mold while the wire 50 extends through the mold such that, after the material cures, the wire 50 is surrounded by the ocular implant. The presence of the wire 50 during the manufacture of the ocular implant 10 may allow for the formation of an inner surface 25 that defines a substantially continuous single inner lumen that forms a corresponding substantially continuous single channel. Those skilled in the art can envision other methods of manufacturing the ocular implant 10 that allow for the formation of the inner surface 25 for defining a substantially continuous single inner lumen that forms a corresponding substantially continuous single channel. Laser cutting of known surgeries may be used in order to obtain the engagement elements 30, 40 described herein. In another embodiment, the first engagement element 30 and the second engagement element 40 may be obtained directly from the molding step without laser cutting. Other suitable techniques may also be used, such as die cutting, laser cutting, and simple molds.

[0130] Accordingly, a method of manufacturing an ocular implant 10 can include molding the ocular implant 10 on an elongate wire 50 that extends through a manufacturing die. The molding can also include injecting a material in a viscous, semi-viscous, or liquid form into the manufacturing die that houses the elongate wire 50. The molding can also include curing the material to obtain the ocular implant 10. The method can further include removing the elongate wire 50 from the ocular implant 10 to obtain an inner surface 25 that defines a substantially continuous single inner lumen that forms a corresponding substantially continuous single channel. Optionally, prior to removing the elongate wire 50 from the ocular implant 10, the elongate wire 50 can facilitate guiding and positioning the ocular implant 10 inside the inner lumen of a piercing member 510.

[0131] Medical device

[0132] Figure 2 Illustrated is a non-limiting implementation of a medical device arranged and constructed in accordance with certain features, aspects, and advantages of the present disclosure. The illustrated medical device can be used to create a channel in an eye tissue layer, such as by delivering an ocular implant, or can be any other type of medical device that would benefit from any or all of the features, aspects, and advantages described hereinbelow.

[0133] As used herein, the term "tissue layer" encompasses a single tissue layer and collections of layers, such as adjacent stacked layers (multilayers) or different layers. However, the default interpretation is generally a single tissue layer. Additionally, when referring to a "tissue layer", it is typically with respect to a tissue wall characterized by a particular thickness and two sides (outer and inner, or proximal and distal). In this context, the created channel or pore extends between these two sides of the tissue wall. By way of example, the channel can be located at the scleral-corneal junction of an individual's eye. This application can be used to treat glaucoma by reducing intraocular pressure, for example by facilitating fluid communication between the anterior chamber of the eye and an interface connecting the outer scleral tissue to the conjunctival tissue or in the subconjunctival or sub-Tenon's space regions.

[0134] In some embodiments, the medical device 200 includes at least two segments: a proximal segment 65 for a user to grasp; and a distal segment 60 that includes components for a desired ophthalmic procedure.

[0135] In some embodiments, the proximal segment 65 can have at least one segment of surface that is convex, concave, grooved, or textured to improve the user's grip or increase the user's comfort. The user can be a medical practitioner, such as an ophthalmologist.

[0136] In some embodiments, the distal segment 60 can be separated from the medical device 200 for deactivation, disposal, sterilization, etc. In one embodiment, the proximal segment 65 can be separated from the medical device 200 for deactivation, disposal, sterilization, etc.

[0137] In some embodiments, the distal segment 60 can be formed with a first housing portion 62 and a second housing portion 64 (as Figure 10 shown). For example, the first housing portion 62 and the second housing portion 64 can be configured to be assembled to each other by suitable coupling means. In a practical non-limiting implementation, the second housing portion 64 can include a plurality of circumferentially spaced protrusions 66. Correspondingly, the first housing portion 62 can correspondingly include a plurality of circumferentially spaced notches 68 for receiving the corresponding protrusions 66, so as to assemble the first housing portion 62 and the second housing portion 64, thereby forming the distal segment 60.

[0138] In some embodiments, the proximal segment 65 can be formed with a first housing portion 72 and a second housing portion 74 (as Figure 10 shown). For example, the first housing portion 72 and the second housing portion 74 can be configured to be assembled to each other by any suitable coupling means. For example, the second housing portion 74 can include a plurality of circumferentially spaced protrusions 66'. Correspondingly, the first housing portion 72 can correspondingly include a plurality of circumferentially spaced notches 68' for receiving the corresponding protrusions 66', so as to assemble the first housing portion 62 and the second housing portion 64, thereby forming the proximal segment 65.

[0139] In some embodiments, the proximal segment 65 is coupled to the distal segment 60 by any suitable coupling element. For example, the proximal segment 65 can be coupled to the distal segment 60 by any suitable coupling element, allowing the proximal segment 65 to rotate relative to the distal segment 60. For example, the proximal segment 65 can be coupled to the distal segment 60 at a pivot point 85 such that the proximal segment 65 and the distal segment 60 can rotate relative to each other about a rotation axis r at the pivot point 85. For example, the rotation axis r can be substantially perpendicular to the longitudinal axis Ω of the proximal segment 65.

[0140] In some embodiments, the proximal segment 65 and the distal segment 60 are configured to selectively couple to each other from an unlocked configuration and a locked configuration. In the unlocked configuration, the proximal segment 65 and the distal segment 60 can rotate relative to each other about the rotation axis r at the pivot point 85. In the locked configuration, the proximal segment 65 and the distal segment 60 remain coupled to each other at an angle β selected by the user, unless the unlocked configuration is achieved.

[0141] In some embodiments, the medical device 200 can include a locking mechanism 80 for reversibly fixing the proximal segment 65 and the distal segment 60 in a locked configuration. Such a locking mechanism 80 can provide a technical effect that the medical device 200 can be locked in a position with a desired angle β, which allows the user to select a suitable working angle that can facilitate ophthalmic surgery. For example, such a working angle can be beneficial for adapting the medical device 200 to the anatomical differences between the user's left and right eyes, the anatomical differences between the eyes of different individuals, the personal preferences of the user (such as a medical practitioner), the use of the left or right hand by the medical practitioner, etc. Thus, the user (such as a medical practitioner) can easily select the desired angle β and move the medical device 200 from a first position (such as as Figure 2 shown) to a second position (such as as Figure 3 shown). Advantageously, the user can lock the medical device 200 in the first position or the second position using the locking mechanism 80 described herein.

[0142] For example, the locking mechanism 80 can be, but is not limited to, a knob that can be tightened and loosened, a latch or clamp that can reversibly fix the proximal segment 65 and the distal segment 60 in a position desired by the user, a ratchet-type rotating member that allows rotation between the proximal segment 65 and the distal segment 60, etc.

[0143] In some embodiments, the medical device 200 can include an optional disc spring 135 (best shown in Figure 10 ) for the Belleville spring, which is configured to maintain pressure on the locking mechanism when the locking mechanism 80 is released (such as via a knob thread). Such a configuration can bring a more pleasant user experience, such as by generating a clicking sound when the distal segment 60 rotates relative to the proximal segment 65.

[0144] In some embodiments, either or both of the proximal segment 65 and the distal segment 60 can be autoclaved or sterilized in some other way. For example, either or both of the proximal segment 65 and the distal segment 60 can be made of any suitable material, such as but not limited to: polyethylene (PE), including low-density PE, high-density PE, ultra-high molecular weight PE; polypropylene (PP); polytetrafluoroethylene; thermoplastic polyurethane; polycarbonate; polyphthalic acid; acrylic; acrylonitrile butadiene styrene (ABS); silicone, etc.

[0145] In some embodiments, the proximal segment 65 and the distal segment 60 can be configured to have a shape that facilitates manipulation during use of the medical device 200.

[0146] In some embodiments, the medical device 200 may have a suitable length that facilitates single-handed grasping and operation by the user. For example, the medical device 200 may have a length L between the proximal end of the proximal segment 65 and the distal end of the distal segment 60, and the length is about 100 mm to 300 mm, including any value or range therein. For example, a length L of about 120 mm, about 130 mm, about 140 mm, about 150 mm, about 160 mm, about 170 mm, about 180 mm, about 190 mm, about 200 mm, about 210 mm, or about 220 mm. For example, a length L of about 140 mm, about 145 mm, or about 150 mm. For example, a length L of about 145 mm.

[0147] In some embodiments, the medical device 200 may have a suitable thickness that facilitates single-handed grasping and operation by the user. For example, the medical device 200 may have a thickness d1 of the distal segment 65, and the thickness is about 6.0 mm to about 9.0 mm, including any value or range therein. For example, a thickness d1 of about 6.5 mm, about 7.0 mm, about 7.5 mm, or about 8.0 mm, preferably a thickness d1 of about 7.4 mm. For example, the medical device 200 may have a thickness d2 of the proximal segment together with the actuator 90, and the thickness is 10.0 mm to about 20.0 mm, including any value or range therein. For example, a thickness d2 of about 12.0 mm, about 14.0 mm, about 14.5 mm, about 15.0 mm, about 15.5 mm, about 16.0 mm, about 17.0 mm, preferably a thickness d2 of about 15.4 mm.

[0148] In a practical non-limiting implementation of the present disclosure, the medical device 200 described herein includes an ocular implant 10, as Figure 4A and Figure 4B shown.

[0149] Puncture member

[0150] In some embodiments, the medical device 200 described herein is particularly advantageous for installing an ocular implant in an eye to form a drainage channel. As will be apparent from the following description, in some embodiments, the medical device described herein may thus include an ocular implant, wherein the medical device is adapted to deliver and position the ocular implant in a patient's eye.

[0151] In a non-limiting practical implementation, the medical device 200 includes a puncture member 510 that is coupled to and extends from the distal end of the distal segment 60, as Figure 5A shown. For example, the medical device 200 may be configured such that the puncture member 510 includes an elongated hollow body for accommodating the ocular implant therein.

[0152] In some embodiments, the medical device 200 is configured to retract the piercing member 510 from the extended position to the retracted position. For example, the medical device 200 can be configured to retract the piercing member 510 along the longitudinal axis of the distal section 60 in a direction away from the eye. In other words, the medical device 200 can be configured to retract the piercing member 510 from a first position in which the piercing member 510 extends from the distal section 60 and is visible to the user, to a second position in which the piercing member 510 is at least partially received within the distal portion of the distal section 60. In use, retracting the piercing member 510 toward the distal section 60 delivers the ocular implant into the eye, i.e., leaves the implant 10 in the eye. The piercing member 510 can be configured to retract into the lumen of the distal section 60. For example, retract far enough into the lumen of the distal section 60 to deliver the ocular implant into the eye.

[0153] In some embodiments, the piercing member 510 can have one or more markings 120 visible to the user on its outer surface to assist the user in positioning the ocular implant in the eye. Such one or more markings 120 can assist in inserting the piercing member 510 into the eye, e.g., to a desired eye location and / or specified depth, to facilitate implanting the ocular implant 10 into the patient's eye. For example, such markings 120 can be obtained by laser marking. Such laser marking can serve as an intuitive guide for the user during ophthalmic surgery, as will be described later in this text.

[0154] In some embodiments, the piercing member 510 can have at least a portion that is transparent, allowing one or more markings 120 to be located on the inner surface of the transparent portion. Additionally, at least a portion of the piercing member 510 being transparent can also allow the user to visualize the internal contents of the piercing member 510, such as the ocular implant.

[0155] In some embodiments, the piercing member 510 can be configured to perform an incision on the outer surface of a tissue layer (e.g., the sclera 104). For example, an incision can be performed by slicing the tissue layer at the entry point using the piercing member 510. For example, the medical device 200 can be positioned relative to the eye at a first point and advanced along the longitudinal axis until the piercing member 510 contacts the outer surface of the eye tissue layer. At this point, the piercing member 510 is said to be in the first position. When the medical device 200 is advanced further toward the tissue layer, the piercing member 510 makes an incision from the first position. Advantageously, the piercing member 510 is capable of making an incision using an axial cutting motion. In other words, the cutting motion does not require any rotational movement of the piercing member 510.

[0156] For example, the piercing member 510 can also be configured to penetrate and pass through the tissue layer as the medical device 200 axially displaces towards the tissue layer. Advantageously, the piercing member 510 is configured to smoothly and easily penetrate and pass through the tissue layer with minimal force, and thus the piercing member can have a smooth (e.g., polished) outer surface to minimize friction during penetration and passage through the tissue layer.

[0157] In some embodiments, the piercing member 510 includes an elongate body having a piercing tip 70 at its distal end, as Figure 11 shown. For example, the piercing tip 70 can have a needle bevel shape, such as a sharp angled tip. For example, the piercing tip 70 can have a cannula-style sharp / machined distal end. For example, the piercing tip 70 can have a relatively shallow primary bevel angle that allows eye tissue material to more easily slide over it. For example, the piercing tip 70 can have a primary bevel angle of about 10° to about 15°, preferably about 12°.

[0158] In some embodiments, the piercing member 510 can be any gauge suitable for piercing the eye to form an incision having a corresponding size sufficient for an ocular implant 10 to pass through the incision.

[0159] In some embodiments, the piercing member 510 can have at least a dual purpose, namely piercing the eye tissue layer and holding the ocular implant in position and delivering it to the eye. For example, the piercing member 510 can be configured to receive the ocular implant 10, such as within its lumen, as Figure 5B shown. In such an embodiment, the first engagement element 30 and the second engagement element 40 can advantageously be deformable (e.g., bent or compressed) towards the elongate body 20 to allow the ocular implant 10 to fit within the lumen of the piercing member 510. In some cases, the first engagement element 30 and the second engagement element 40 can be switched between a folded configuration and a deployed configuration by a mechanical means (such as a lever or a switch). In other cases, the first engagement element 30 and the second engagement element 40 can be switched between configurations by a passive mechanism (such as the elasticity or free movement of the first engagement element 30 and the second engagement element 40). The first engagement element 30 and the second engagement element 40 can be stored in the piercing member 510 in a folded configuration.

[0160] In some embodiments, the piercing member 510 includes one or more markings 120 (e.g., laser markings) on its surface. Such one or more markings 120 can serve as a cue to the user. For example, during insertion and passage of the piercing member 510 through the tissue layer, the one or more markings 120 (e.g., laser markings) can indicate when the piercing member 510 has reached a desired depth within the eye tissue layer.

[0161] In some embodiments, one or more markers 120 are disposed on the surface of the piercing member 510 at positions that coincide with the respective positions of the first engagement element 30 and the second engagement element 40 in a spaced-apart relationship. As discussed elsewhere herein, the first engagement element and the second engagement element are positioned along the surface of the elongate body 20 at a distance X from each other, such that the first engagement element and the second engagement element can engage or abut a desired eye structure. Accordingly, one or more markers 120 may be similarly disposed on the surface of the piercing member 510 at a corresponding distance X' from each other, which is equal to the distance X. For example, the distance X' is from about 1.8 mm to about 2.2 mm, including any value or range therebetween. For example, a distance X' of about 1.9 mm, about 2.0 mm, or about 2.1 mm. For example, a distance X' of about 2.0 mm.

[0162] For example, when the eye implant 10 is installed into the piercing member 510, the eye implant 10 may be placed inside the lumen of the piercing member 510 such that the respective positions of the first engagement element 30 and the second engagement element 40 coincide with the respective positions of one or more markers 120. In some embodiments, the piercing member 510 may thus include a first marker 120 at a first position that coincides with the position of the engagement element 30, and a second marker 120 at a second position that coincides with the position of the engagement element 40. Accordingly, during the surgery, the user may rely on the markers 120 as a cue; at the second marker 120, the user is guided to release a control point (e.g., the actuator 90) such that the eye implant 10 can be held in place, as described elsewhere in this text. This technique ensures that the eye implant 10 is not pushed forcefully, but remains in its intended position through a controlled and intuitive process.

[0163] In some embodiments, the piercing member 510 may have a suitable size, which may be selected from any of the needle gauge sizes listed in Table 1:

[0164] Table 1

[0165]

[0166]

[0167] In some embodiments, the piercing member 510 has a size corresponding to a 23 to 30 gauge needle. Preferably, the piercing member 510 has a size corresponding to a 27 gauge needle.

[0168] In some embodiments, the piercing member 510 has a length L2 of from about 8.0 mm to about 20.0 mm, including any value or range therebetween. For example, the piercing member 510 has a length L2 of about 10.0 mm, about 11.0 mm, about 12.0 mm, about 13.0 mm, about 14.0 mm, about 15.0 mm, preferably a length L2 of about 13.0 mm.

[0169] In some embodiments, the medical device 200 may include a cap 900 configured to be mounted and secured over the piercing tip 70 of the piercing member 510, as Figure 9A and Figure 9B shown. Such a cap 900 may be beneficial in avoiding potential needle stick injuries, such as when manipulating, discarding, or deactivating the medical device 200. The cap 900 includes an opening 910 that may be configured to abut the distal end of the distal segment 60, such as when the cap 900 covers the entire length of the piercing member 510.

[0170] Actuation assembly

[0171] In broad embodiments, the medical device 200 includes an actuation assembly configured to actuate the piercing member 510 to deliver the ocular implant 10 into the eye. While specific implementations of the actuation assembly are described below with reference to the drawings, the reader will understand that variations may be employed to achieve a similar effect.

[0172] Figures 7A to 7B A non-limiting practical implementation of the actuation assembly is shown, which includes suitable components or combinations of components capable of providing the functions described herein. For example, the actuation assembly includes a control point that may be engaged by a user to actuate the piercing member 510 to deliver the ocular implant 10 into an eye, such as a human eye. In some embodiments, the control point may take the form of an actuator 90. For example, the actuator 90 may be conveniently located on the outer housing of the distal segment 60. For example, the actuator 90 may be located at the proximal portion of the distal segment 60 to facilitate access by a finger, preferably the index finger.

[0173] Conveniently, the actuator 90 may be shaped to facilitate two-handed actuation. For example, as Figure 6A shown, the actuator 90 may have a shape including extensions 92, 94 that both extend away from the distal segment 60. In use, when the distal segment 60 is in a locked configuration with the proximal segment 65, the extensions 92, 94 may be conveniently located on each side of the pivot point 85 to facilitate actuation by gripping the proximal segment 65 with the left or right hand.

[0174] In some embodiments, the actuator 90 may be a slider, trigger, wheel, or any other form that can preferably be easily engaged with only one finger, such as the index finger.

[0175] In some embodiments, and referring to Figure 6A , the actuator 90 may include teeth or some other form that can provide friction along its edge to improve the user's ability to reliably engage and release the actuator 90, even in the presence of moisture or when the user is wearing gloves. Additionally, to enhance the safety of using the medical device 200, the actuator 90 may include a locking mechanism or a device to prevent accidental engagement or release of the actuator.

[0176] In some embodiments, the actuator 90 may be made of the same or a different material as the distal segment 60.

[0177] In some embodiments, the actuator 90 may be equipped with a return mechanism that is designed to facilitate, assist, or cause the actuator 90 to return to the second position when the user releases the actuator 90, as Figure 6C shown by arrow 700' in. For example, the return mechanism may include a spring assembly or a band. For example, the return mechanism may include a spring assembly 130 that connects the actuator 90 to the distal segment 60. In use, pressing the actuator 90 towards the proximal end of the distal segment 60 causes the spring assembly 130 to extend along the longitudinal axis of the distal segment 60, and releasing the actuator 90 causes the spring assembly 130 to retract, thereby driving the actuator 90 away from the proximal end of the distal segment 60, as Figure 6C shown. Of course, many other forms of return mechanisms can be designed to cause the actuator 90 to return to the first position when the user releases the actuator 90.

[0178] In some embodiments, the actuator assembly may further include a protrusion 125 that extends towards the distal end of the distal segment 65. For example, the protrusion 125 may be configured to be operatively coupled to the actuator 90 such that actuation of the actuator 90 from the first position to the second position causes the protrusion 125 to axially displace along the longitudinal axis of the distal segment 60. Such coupling may be permanent or temporary. A non-limiting implementation of a permanent coupling is as Figure 3 shown in A, where the protrusion 125 and the actuator 90 may be made of an integrally formed body, for example, the protrusion 125 may extend from the actuator 90.

[0179] Locking and Release Mechanism

[0180] In some embodiments, the medical device 200 may be configured to implement a locking and release mechanism that is designed to firmly hold the implant 10 in place until precise placement is achieved. For example, the user may activate the locking and release mechanism by engaging and releasing the control points discussed above. Specific practical implementations of the locking and release mechanism will now be described.

[0181] In some embodiments, the medical device 200 includes an inner housing 150 (or “bridge”) located at the distal portion of the distal segment 60.

[0182] In some embodiments, the distal segment 60 includes an inner surface defining a lumen 15 configured to receive the inner housing 150.

[0183] In some embodiments, the inner housing 150 may be configured to operably couple the protrusion 125 to the piercing member 510. Such coupling may be permanent or temporary. Non-limiting implementations of temporary coupling will now be discussed.

[0184] In some embodiments, the inner housing 150 may be configured to engage the protrusion 125 upon actuation of the actuator 90 from a first position to a second position. In other words, axial displacement of the protrusion 125 along the longitudinal axis of the distal segment 60 in response to actuation of the actuator 90 from a first position to a second position results in engagement between the protrusion 125 and the inner housing 150.

[0185] In some embodiments, the inner housing 150 conveniently includes engagement elements 145 at its proximal portion, which are configured to engage the protrusion 125. For example, upon actuating the actuator 90 from a first position to a second position, the protrusion 125 is engaged with the engagement elements 145 of the inner housing 150. For example, the protrusion 125 may include engagement elements 140 located on its distal portion, which are configured to engage complementary engagement elements 145. For example, the protrusion 125 may include a fork or other type of extension element on which the first engagement element and the second engagement element 140 are located. The engagement of the first engagement element and the second engagement element 140, 145 functionally couples the actuator 90 to the inner housing 150, thus allowing integral movement between the actuator 90 and the inner housing 150. Embodiments incorporating these features may provide auditory feedback to the operator (and others working with the operator) in the form of a click corresponding to the engagement of the engagement elements 140, 145.

[0186] In some embodiments, one of the first engagement element and the second engagement element 140, 145 may be a protrusion or a pin, while the other of the first engagement element and the second engagement element 140, 145 may be a groove configured to engage the protrusion or the pin. For example, one of the first engagement element and the second engagement element 140, 145 may be located on the distal portion of the protrusion 125 connected to the actuator 90, while the other of the first engagement element and the second engagement element 140, 145 may be a corresponding recess located on the proximal portion of the inner housing 150. Of course, many other forms of complementary engagement elements that functionally couple the actuator 90 to the inner housing element 150 can be designed.

[0187] In a non-limiting practical implementation, such as Figure 6B shown, actuating the actuator 90 from a first position to a second position (a pressing motion indicated by arrow 700) effectively moves a first engagement element and a second engagement element 140 located on the tine 135 extending from the protrusion 125 towards the inner housing 150. In some embodiments, the protrusion 125 and the tine 135 are a single-piece component, while in other embodiments, the protrusion 125 and the tine 135 are formed by a plurality of components connected together in any suitable manner.

[0188] For example, the tine 135 can be made of an elastic material having a certain flexibility such that when contacting the upper surface 160 of the inner housing 150, the distal portion of the tine 135 containing the engagement element 140 is slightly pushed radially outward to engage corresponding depressions of the first engagement element and the second engagement element 145 located on the proximal portion of the inner housing 150. After engaging the depressions of the first engagement element and the second engagement element 145, the tine 135 made of an elastic material (such as an elastic plastic) can thus quickly recover, pressing the first engagement element and the second engagement element 140 onto the first engagement element and the second engagement element 145, thereby fixing the tine 135 to the inner housing 150. Embodiments including such features can provide auditory feedback to the operator (and others working with the operator) regarding the progress of the release operation of the eye device 10 in the form of a clicking sound corresponding to the quick recovery of the tine 135.

[0189] In a non-limiting practical implementation, the actuator 90 starts from a first position disconnected from the inner housing 150, such as Figure 6A shown. In this position, the user inserts the puncturing member 510 into the patient's eye to a specified depth. As discussed previously, when the puncturing member 510 includes markings 120 (such as laser markings), these markings can advantageously be used to provide guidance regarding the specified depth. Once the puncturing member 510 is positioned at the desired position and the specified depth, the user actuates the actuator 90 towards the second position (shown as 700), causing the first engagement element and the second engagement element 140, 145 to engage with each other such that the actuator 90 is functionally coupled to the inner housing 150 to form an integral component, as Figure 6B shown.

[0190] Finally, the user releases the actuator 90, e.g., by releasing the pressure applied to the actuator 90 (shown as 700’), such that the return mechanism retracts the actuator 90 from the second position to the first position. Since the first engagement element and the second engagement elements 140, 145 engage with each other, the actuator 90 and the inner housing 150 are functionally coupled such that retraction of the actuator 90 away from the proximal end of the distal segment 60 will also retract the inner housing 150 toward the proximal end of the distal segment 60. Movement of the inner housing 150 toward the proximal end of the distal segment 60 causes the piercing member 510 operatively coupled to the inner housing 150 to also at least partially retract into the lumen 15 and move via the support member 175 connected to the distal segment 60, thereby releasing the ocular implant 10.

[0191] In some embodiments, the medical device may include a tube 170 defining a passageway, which is held in place by a support member 175 connected to the distal segment 60. The tube 170 may house at least a portion of the piercing member 510 within its passageway. As Figure 6C shown, during movement of the inner housing 150 in response to release 700’ of the actuator 90, the support member 175 and the associated tube 170 remain in place since the support member 175 is connected to the distal segment 60, while the inner housing 150 and the attached piercing member 510 move relative to the support member 175.

[0192] In some embodiments, the medical device 200 is configured to prevent lateral movement of the inner housing 150, e.g., when manipulating the medical device 200.

[0193] For example, in one embodiment, the medical device 200 may include retaining members 155 associated with the inner surface of the segment body 60, which are located on each side of the inner housing 150. The retaining members 155 extend along a major portion (>50%) of the lateral dimension of the inner housing 150, engage and prevent its lateral movement, while allowing longitudinal movement of the inner housing 150, as Figure 6A shown.

[0194] For example, in another embodiment, the medical device 200 may include retaining members 155’ associated with the inner surface of the segment body 60, which are located on each side of the inner housing 150. The retaining members 155’ extend along a smaller portion (<50%) of the lateral dimension of the inner housing 150, engage and prevent its lateral movement, as Figure 7A shown. In this example, the inner housing 150 may further include flexible arms 160 located on or integrated with either side of the inner housing 150. For example, the flexible arms 160 may extend from the proximal portion of the inner housing 150 toward its distal portion such that the distal ends of the flexible arms 160 engage or abut corresponding distal portions of one of the retaining members 155’ as Figure 7A shown.

[0195] In the rest position, this arrangement prevents lateral movement of the inner shell 150, and the inner shell 150 is restricted to slide along the longitudinal axis of the distal section 60. This configuration can prevent accidental movement of the inner shell 150 when inserting the puncturing member 510 into the eye.

[0196] For example, the distal end of the flexible arm 160 may include a protrusion or other suitable structure at its distal portion, which engages or abuts against the corresponding distal portion of one of the retaining members 155' as shown. The suitable structure at the distal portion of the flexible arm 160 allows the flexible arm 160 to bend around an obstacle (such as the distal end of the retaining member 155'). Figure 7A As shown, the suitable structure at the distal portion of the flexible arm 160 allows the flexible arm 160 to bend around an obstacle (such as the distal end of the retaining member 155').

[0197] In fact, when the inner shell 150 retracts towards the proximal portion of the distal section 60, the flexible arm 160 bends towards the inner shell 150 (as shown by the arrow in Figure 7B and slides over the retaining member 155'. Embodiments incorporating this feature can provide auditory feedback to the operator (and others working with the operator) regarding the progress of the release operation of the eye device 10 in the form of a clicking sound corresponding to the movement of the flexible arm 160.

[0198] As shown in Figure 5B and Figure 8 the medical device 200 may include a stop 400 positioned within the puncturing member 510.

[0199] In some embodiments, the stop 400 may be a solid tubular structure having a contact surface 410 configured to abut against the proximal end of the implant 10, preventing axial displacement of the eye implant 10 towards the distal end of the distal section 60. In use, the eye implant 10 is held at a specified depth while the puncturing member 510 is at least partially retracted into the lumen 15 of the distal section 60. The stop 400 and the contact surface 410 may be made of any medical-grade material, such as medical-grade metal, such as medical-grade tungsten, titanium, stainless steel, copper, cobalt-chromium alloy, aluminum, magnesium, or any alloy thereof; medical-grade plastics, etc. Preferably tungsten.

[0200] Ophthalmic surgery

[0201] In a non-limiting practical implementation of the present disclosure, the medical device described herein can be used to form a drainage channel in the eye by inserting an eye implant into an eye tissue layer. Advantageously, the surgery can be performed in an outpatient setting using only local anesthesia, without the need for an operating room. More advantageously, the surgery can be performed using an extraocular method.

[0202] Generally, the medical device described herein is designed for a method of performing an ocular implant insertion into an eye tissue layer to form a drainage channel. After obtaining the medical device, the user can select the working angle between the distal segment and the proximal segment by selecting an unlocking configuration and rotating the distal segment about a rotational axis at a pivot point.

[0203] For example, performing the insertion can include positioning the medical device relative to the eye at a first point and advancing the medical device along the longitudinal axis until the piercing member contacts the outer surface of the eye tissue layer. In this step, the piercing member is in a first position.

[0204] For example, performing the insertion can further include advancing the medical device distally to cause the piercing member to perform an incision in the eye tissue layer by an axial cutting motion and advancing the piercing member through the incision and into and through the tissue layer. For example, such advancement can occur until the piercing member has reached a desired depth. For example, the desired depth can be determined based on the position of one or more markers on the piercing member.

[0205] For example, performing the insertion can further include retracting the piercing member toward the distal end of the distal segment, thereby delivering the ocular implant into the eye tissue layer. Advantageously, the medical device is configured to securely hold the implant during insertion. Once the implant has reached the desired depth indicated, for example, by one or more markers (such as laser marking), the user can activate the ocular implant release mechanism by simply engaging and releasing a designated control point (such as an actuator) on the device. This operation unlocks the ocular implant release mechanism, as described in other parts of this text, thereby allowing for a controlled release of the implant at the precise location. This design ensures that the implant is not pushed or placed forcefully, but is gently and accurately released into the intended position.

[0206] Actual non-limiting implementations will now be described with reference to the accompanying drawings.

[0207] First, the user obtains the medical device 200. In one example, the medical device 200 may already include the ocular implant 10. In another example, the medical device 200 and the ocular implant 10 can be separate components that need to be assembled prior to use.

[0208] The user can select the desired working angle β between the distal segment 60 and the proximal segment 65. Under the unlocking configuration, the user rotates the distal segment about a rotational axis at a pivot point to select the working angle β between the distal segment 60 and the proximal segment 65. Then, the user can use the locking mechanism 80 to fix the distal segment 60 and the proximal segment 65 at the desired working angle β. For example, the desired working angle β can be selected based on whether the user is right-handed or left-handed, based on the patient's eye anatomy, etc.

[0209] The user then positions the medical device 200 relative to the eye at a first point and advances it along the longitudinal axis of the distal section 60 until the piercing member 510 contacts the outer surface of the tissue layer (e.g., the sclera 104). When the medical device 200 is advanced further toward the tissue layer, the piercing member 510 performs an incision in the eye tissue layer using an axial cutting motion. For example, the incision can be performed using the distal cutting tip 70 of the piercing member 510.

[0210] The user then advances the medical device 200 further toward the tissue layer such that the piercing member 510 penetrates the incision and enters and passes through the tissue layer. It is noted that the piercing member is advanced through the incision and into and through the tissue layer until the piercing member has reached the desired depth. For example, the desired depth can be determined based on the position of one or more markers 120 (e.g., laser markings) on the piercing member relative to the eye tissue layer, and the one or more markers can serve as a cue to the user to indicate when the desired depth has been reached. For example, one or more markers 120 (e.g., laser markings) disposed along the piercing member 510 can be present at positions that coincide with the respective positions of the first engagement element 30 and the second engagement element 40.

[0211] The user then retracts the piercing member distally toward the distal end of the distal section, thereby releasing and delivering the ocular implant into the eye tissue layer. This can be performed by engaging a control point on the device to unlock the ocular implant release mechanism for delivery of the ocular implant 10. For example, the user can engage the actuator 90, which causes the actuator 90 to be functionally coupled to the inner housing 150. For example, engaging the actuator 90 can cause the distal end of the fork teeth 135 to approach the proximal end of the inner housing 150 such that the engagement elements 140, 145 engage each other, thereby functionally coupling the actuator 90 to the inner housing 150. The user can then release the actuator 90, which causes the inner housing 150 and the piercing member 510 to retract in the direction of the proximal portion of the distal section 60, i.e., in use, the direction away from the eye tissue layer. For example, releasing the actuator 90 can be performed by releasing the finger pressure on the actuator 90 such that the return mechanism retracts the actuator 90 toward the first position and causes the inner housing 150 and the piercing member 510 to also retract toward the proximal portion of the distal section 60. The presence of the stoppers 400, 400' positioned within the piercing member 510 can further prevent any retraction displacement of the ocular implant (i.e., the ocular implant remains in place) when the piercing member 510 is retracted distally toward the distal end of the distal section, thereby facilitating a gentle and controlled delivery of the ocular implant.

[0212] As the reader will appreciate, the presence of one or more markers (e.g., laser markings) along the position element 510 can facilitate guiding the user as to when the actuator 90 should be actuated. This technique ensures that the implant is not forcefully pushed but remains in its intended position through a controlled and intuitive process.

[0213] In some embodiments, after use, the medical device 200 can be discarded.

[0214] In some embodiments, after use, the distal segment 60 of the medical device 200 can be discarded and replaced with a distal segment loaded with a new inner shell 150 containing a new ocular implant 10.

[0215] In some embodiments, after use, the distal segment 60 of the medical device 200 can be opened and loaded with a new inner shell 150 containing a new ocular implant 10.

[0216] Given the teachings of this specification, other examples of implementations will become apparent to the reader and are therefore not further described herein.

[0217] Note that for the convenience of the reader, headings or subheadings may be used in this disclosure, but these should in no way limit the scope of the invention. Additionally, certain theories may be presented and disclosed herein; however, as long as the invention of this disclosure is practiced without regard to any specific theory or mechanism of action, whether these theories are correct or not, they should not limit the scope of the invention.

[0218] For all purposes, all references cited in this specification are hereby incorporated by reference in their entirety.

[0219] The mention of "some embodiments" etc. in this specification means that the specific elements (such as features, structures, and / or characteristics) described in connection with the present invention are included in at least one of the embodiments described herein and may or may not be present in other embodiments. Additionally, it should be understood that the described features of the invention can be combined in any suitable manner in the various embodiments.

[0220] Those skilled in the art will understand that in this specification, the term "a" before a term encompasses embodiments containing one or more of what the term refers to. Those skilled in the art will also understand that in this specification, the terms "comprising", "including", "containing", or "characterized by" are synonymous and are inclusive or open-ended and do not exclude additional, unrecited elements or method steps.

[0221] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In case of conflict, the present document (including the definitions) shall prevail.

[0222] As used in this disclosure, the terms "around", "about", or "approximately" generally denote within the error margins commonly accepted in the art. Thus, numerical quantities given herein typically include such error margins, such that the terms "around", "about", or "approximately" may be inferred if not explicitly stated. For example, the terms "around", "about", or "approximately" encompass variations of ±5%.

[0223] Although various embodiments of the present disclosure have been described and illustrated, it will be apparent to those skilled in the art upon consideration of this specification that numerous modifications and variations can be made. The scope of the invention is more particularly defined in the appended claims.

Claims

1. A medical device, the device comprising: a) a proximal segment for user grasping; b) an ocular implant; and c) a distal segment including a piercing member coupled to and extending from the distal segment, wherein the piercing member is configured to receive the ocular implant and deliver the ocular implant into an eye tissue layer to create a passageway; wherein the proximal segment and the distal segment are configured to be coupled to each other at a pivot point between an unlocked configuration and a locked configuration, and wherein, in the unlocked configuration, the proximal segment and the distal segment are rotatable relative to each other about a rotational axis at the pivot point.

2. The medical device according to claim 1, further comprising a locking mechanism for reversibly fixing the proximal segment and the distal segment in the locked configuration.

3. The medical device according to claim 1 or 2, wherein, The piercing member includes an elongate hollow body for receiving the ocular implant.

4. The medical device according to any one of claims 1 to 3, wherein, The medical device is configured to retract the piercing member from a protruded position to a retracted position.

5. The medical device according to any one of claims 1 to 4, wherein, The piercing member includes a piercing tip at its distal end.

6. The medical device according to any one of claims 1 to 5, further comprising an actuator assembly configured to actuate the piercing member.

7. The medical device according to claim 6, wherein, The actuator assembly includes a manually operable actuator, and wherein the actuator assembly is further configured to operably couple the actuator to the piercing member.

8. The medical device according to claim 7, wherein, The distal segment includes an inner surface defining an inner cavity, and wherein the medical device further includes an inner housing disposed within the inner cavity and configured to be coupled to the piercing member.

9. The medical device according to claim 8, wherein, Engagement of the actuator couples the actuator to the inner housing.

10. The medical device according to claim 9, wherein, Release of the actuator causes the inner housing to axially displace towards the proximal end of the distal segment, thereby causing the piercing member to retract towards the distal segment.

11. The medical device according to any one of claims 1 to 10, wherein, The medical device further includes the ocular implant, wherein the ocular implant has an elongate body having an inner surface defining a substantially continuous inner lumen, and wherein the ocular implant is received within the piercing member.

12. The medical device according to any one of claims 1 to 11, wherein, The medical device has a length of about 100 mm to about 300 mm, preferably a length of about 145 mm.

13. The medical device according to any one of claims 1 to 12, wherein, The piercing member has a size corresponding to a 23 to 30 gauge needle, preferably a size corresponding to a 27 gauge needle.

14. The medical device according to any one of claims 1 to 13, wherein, The piercing member has a length of about 8.0 mm to about 20.0 mm, preferably a length of about 13.0 mm.

15. An ocular implant, comprising: An elongate body having an inner surface defining an inner lumen that forms a corresponding passageway; and a first engagement element and a second engagement element located at the surface of the elongate body, wherein the first engagement element and the second engagement element extend away from the surface of the elongate body, wherein the first engagement element and the second engagement element are in a spaced-apart relationship along the surface of the elongate body, and wherein the first engagement element and the second engagement element are compressible towards the elongate body.

16. The ocular implant according to claim 15, wherein, The first engagement element and the second engagement element are angled towards each other.

17. The ocular implant according to claim 15 or 16, wherein, The first and second engagement elements have a rod - like shape and extend from the elongate body at an acute angle.

18. The ocular implant according to any one of claims 15 to 17, wherein, The ocular implant has a substantially circular cross - section over its entire length.

19. The ocular implant according to any one of claims 15 to 18, wherein, The first and second engagement elements and the elongate body have a combined width of from about 0.400 mm to about 0.800 mm, preferably 0.600 mm.

20. The ocular implant according to any one of claims 15 to 19, wherein, The first and second engagement elements are spaced apart by a distance of from about 1.8 mm to about 2.2 mm, preferably a distance of about 2.0 mm.

21. The ocular implant according to any one of claims 15 to 20, wherein, The elongate body has an outer wall defining an outer diameter that is from about 0.100 mm to about 0.450 mm, preferably 0.254 mm.

22. The ocular implant according to any one of claims 15 to 21, wherein, The ocular implant has a lumen cross - sectional diameter of from about 0.010 mm to about 0.250 mm, preferably about 0.051 mm.

23. The ocular implant according to any one of claims 15 to 22, wherein, The ocular implant has a length of from about 5.0 mm to about 6.5 mm, preferably a length of about 6.35 mm.

24. A method, comprising: a) obtaining a medical device as defined in any one of claims 1 to 14; b) in an unlocked configuration, rotating a distal segment about a rotational axis at a pivot point to select a working angle between the distal segment and a proximal segment; and c) in a locked configuration, performing an insertion of the ocular implant into an eye tissue layer to form a drainage channel.

25. The method according to claim 24, wherein, Performing the insertion includes: positioning the medical device relative to the eye at a first point; and advancing the medical device along the longitudinal axis of the distal segment until the piercing member contacts the outer surface of the eye tissue layer.

26. The method according to claim 25, wherein, Performing the insertion further includes: advancing the medical device such that the piercing member performs an incision in the eye tissue layer by an axial cutting motion, and advancing the piercing member through the incision and into and through the tissue layer.

27. The method according to claim 26, wherein, Performing the advancement of the piercing member through the incision and into and through the tissue layer until the piercing member has reached a desired depth.

28. The method according to claim 27, wherein, The desired depth is determined based on the position of one or more markers on the piercing member relative to the eye tissue layer.

29. The method according to any one of claims 26 to 28, wherein Performing the insertion further includes: retracting the piercing member towards the distal end of the distal segment, thereby releasing and delivering the ocular implant into the eye tissue layer.

30. A medical device, the device comprising: a) a proximal segment for a user to grasp; b) an ocular implant; c) a distal segment including a piercing member coupled to and extending from the distal segment, wherein the piercing member is configured to receive the ocular implant and deliver the ocular implant into an eye tissue layer to obtain a channel; wherein the piercing member includes one or more markers on its surface, the one or more markers indicating when the piercing member has reached a desired depth in the eye tissue layer.

31. The medical device according to claim 30, wherein, The ocular implant includes: an elongate body having an inner surface defining an inner lumen that forms the passageway; and a first engagement element and a second engagement element located at a surface of the elongate body, wherein the first engagement element and the second engagement element are configured to engage or abut against an eye tissue structure to prevent movement of the ocular implant relative to the eye.

32. The medical device according to claim 31, wherein, The one or more markers include a first marker and a second marker disposed at positions on a surface of the piercing member that coincide with respective positions of the first engagement element and the second engagement element.

33. The medical device according to claim 32, wherein, The first marker and the second marker are disposed on the surface of the piercing member and are spaced apart from each other by a distance of about 1.8 mm to about 2.2 mm, preferably 2.0 mm.

34. The medical device according to any one of claims 30 to 33, wherein, The piercing member has a size corresponding to a 23 to 30 gauge needle, preferably corresponding to a 27 gauge needle.

35. The medical device according to any one of claims 30 to 34, wherein, The piercing member has a length of about 8.0 mm to about 20.0 mm, preferably about 13.0 mm.

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