Medical devices and ocular implants for the treatment of eye disorders

Abstract

A medical device for office-based / operating room minimally invasive bleb-forming glaucoma surgery, the medical device including a proximal segment for grasping by a user, the distal segment including a puncturing member coupled to and extending from the distal segment, the puncturing member configured to receive and deliver an ocular implant into an ocular tissue layer to obtain a channel, the proximal and distal segments configured to couple to one another at a pivot point between an unlocked configuration and a locked configuration, and in the unlocked configuration, the proximal and distal segments are rotatable relative to one another about an axis of rotation at the pivot point.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 432,270, filed December 13, 2022, and U.S. Provisional Patent Application No. 63 / 466,798, filed May 16, 2023. The contents of each of the above-referenced documents are incorporated herein by reference in their entirety.

[0002] Technical Field The present disclosure relates to ophthalmic systems, and more particularly, to ophthalmic systems including medical devices and ocular implants for the treatment of ocular diseases. [Background technology]

[0003] background Glaucoma is a group of eye diseases characterized by optic neuropathy that may be associated with elevated intraocular pressure (IOP). Glaucoma is the number one cause of irreversible blindness in the world. The primary goal of treatment is to lower IOP through medication or surgical procedures. Typically, surgical procedures and medical devices for the treatment of eye disorders such as glaucoma are based on either an inside-the-eye (ab interno) or outside-the-eye (ab externo) approach.

[0004] A recent development in the practice of glaucoma treatment is the use of microincision glaucoma surgery (MIGS), which refers to a group of surgical procedures that typically involve the implantation of small ocular implants. MIGS surgery attempts to minimize intraoperative and postoperative management with the goal of minimizing dependency on topical medications, as well as providing a less invasive method of lowering IOP than standard glaucoma surgery. Several ophthalmic systems and procedures have been proposed.

[0005] U.S. Patent No. 9,993,368 (Glaukos et al.) describes an ab interno system for treating glaucoma. The system includes a delivery device having a handpiece and an elongated delivery member, and an ocular implant including a body having a proximal section and a distal section relative to the handpiece of the delivery device, where at least the distal section is curved to fit within and extend along a portion of Schlemm's canal of the eye following implantation using the delivery device. The elongated delivery member is configured for ab interno insertion of the ocular implant through a corneal incision and sized to extend across the anterior chamber. The elongated delivery member is also configured to retain the ocular implant therein prior to implantation and to deliver the ocular implant through the trabecular meshwork and into and along a portion of Schlemm's canal of the eye.

[0006] U.S. Patent No. 9,693,899 (Ivantis et al.) describes an ab interno system for treating glaucoma. The system includes a segment, a cannula connected to the segment, the cannula sized and configured for insertion into Schlemm's canal of a human eye, and a delivery mechanism disposed on the segment. The delivery mechanism is configured to advance and retract an ocular implant within the cannula. An orientation mechanism is disposed on the segment, wherein the orientation mechanism is configured to control rotation of the cannula, and the ocular implant maintains its orientation relative to the cannula as the cannula is rotated.

[0007] Because of the advantages of MIGS procedures over more conventional therapies, efforts are underway to improve such procedures and related ophthalmic systems. Summary of the Invention

[0008] overview This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key or essential aspects of the claimed subject matter.

[0009] In one broad aspect, the present disclosure relates to a medical device comprising a proximal segment for grasping by a user, an ocular implant, and a distal segment including a puncture member coupled to and extending from the distal segment, wherein the puncture member is configured to receive and deliver the ocular implant into an ocular tissue layer to obtain a channel, wherein the proximal and distal segments are configured to couple to each other at a pivot point between an unlocked configuration and a locked configuration, and wherein in the unlocked configuration the proximal and distal segments are rotatable relative to each other about an axis of rotation at the pivot point.

[0010] In some embodiments, the medical device may include one or more of the following features: Any feature described herein and / or illustrated in the accompanying drawings that is applicable to the medical device. A locking mechanism for reversibly securing the proximal and distal segments in a locked configuration. The puncture member includes an elongated hollow body for receiving the ocular implant. The medical device is configured to retract the penetrating member from the extended position to a retracted position. The piercing member includes a piercing tip at its distal end. Further including an actuator assembly configured to actuate the puncture member. The actuator assembly includes a manually operable actuator, and the actuator assembly is further configured to operably couple the actuator to the puncture member. The distal segment includes an interior surface defining an interior cavity, and the medical device further includes an interior casing disposed within the interior cavity and configured to couple to the piercing member. Engagement of the actuator couples the actuator with the inner casing. Release of the actuator causes axial displacement of the inner casing towards the proximal end of the distal segment, which retracts the piercing member towards said distal segment. The medical device further includes an ocular implant, wherein the ocular implant has an elongate body having an interior surface defining a substantially continuous lumen, and the ocular implant is contained within the puncture member. The medical device has a length of about 100 mm to about 300 mm, preferably about 145 mm. The piercing member has a size corresponding to a needle gauge of 23 to 30, preferably a size corresponding to a needle gauge of 27. The piercing member has a length of about 8.0 mm to about 20.0 mm, preferably about 13.0 mm.

[0011] In one broad aspect, the present disclosure relates to an ocular implant comprising an elongate body having an interior surface defining a lumen forming a corresponding channel, and first and second engaging elements located on the surface of the elongate body, wherein the first and second engaging elements extend away from the surface of the elongate body, the first and second engaging elements are in a spaced apart relationship along the surface of the elongate body, and the first and second engaging elements are compressible toward the elongate body.

[0012] In some embodiments, the ocular implant may include one or more of the following features: Any feature described herein and / or illustrated in the accompanying drawings that is applicable to the ocular implant. The first and second engagement elements are angled towards each other. The first and second engaging elements have a rod shape and extend at an acute angle from the elongate body. The ocular implant has a substantially circular cross-section over its entire length. The first and second engaging elements have a combined width with the elongate body of about 0.400 mm to about 0.800 mm, preferably 0.600 mm. The first and second engaging elements are spaced apart by a distance of about 1.8 mm to about 2.2 mm, preferably about 2.0 mm. The elongate body has an outer wall defining an outer diameter of about 0.100 mm to about 0.450 mm, preferably 0.254 mm. The implant has a lumen cross-sectional diameter of about 0.010 mm to about 0.250 mm, preferably about 0.051 mm. The ocular implant has a length of about 5.0 mm to about 6.5 mm, preferably about 6.35 mm.

[0013] In one broad aspect, the present disclosure relates to a method including obtaining a medical device as described herein, rotating a distal segment about a rotation axis at a pivot point to select an actuation angle between the distal segment and a proximal segment in an unlocked configuration, and performing insertion of an ocular implant in an ocular tissue layer to form a drainage channel in a locked configuration.

[0014] In some embodiments, the method may include one or more of the following features: Any feature described herein and / or illustrated in the accompanying drawings that is applicable to said method. Performing the insertion includes positioning the medical device at a first point relative to the eye and advancing the medical device along the longitudinal axis of the distal segment until the puncture member contacts the exterior surface of the ocular tissue layer. Performing the insertion further includes advancing the medical device to cause the puncture member to perform an incision in an axial cutting motion in the ocular tissue layer, and advancing the puncture member through the incision and into and through the tissue layer. Advancement of the piercing member through the incision and into and through the tissue layers is performed until the piercing member reaches a desired depth. The desired depth is determined based on the position of one or more markings on the puncture member relative to the ocular tissue layer. Performing the insertion further includes retracting the puncture member toward the distal end of the distal segment, which causes release and delivery of the ocular implant into the ocular tissue layer.

[0015] In one broad aspect, the present disclosure relates to a medical device comprising a proximal segment for grasping by a user, an ocular implant, a distal segment including a puncture member coupled to and extending from the distal segment, the puncture member configured to receive and deliver the ocular implant into an ocular tissue layer to obtain a channel, the puncture member including one or more markings on a surface thereof that indicate when the puncture member has reached a desired depth into the ocular tissue layer.

[0016] In some embodiments, the medical device may include one or more of the following features: Any feature described herein and / or illustrated in the accompanying drawings that is applicable to the medical device. The ocular implant includes an elongate body having an interior surface defining a lumen forming a channel, and first and second engaging elements located on a surface of the elongate body, wherein the first and second engaging elements are configured to engage or abut an ocular tissue structure to prevent movement of the ocular implant relative to the eye. The one or more markings include a first marking and a second marking disposed on the surface of the piercing member at locations that correspond to the respective positions of the first and second engaging elements. The first marking and the second marking ocular are arranged on the surface of the piercing member at a distance of about 1.8 mm to about 2.2 mm, preferably 2.0 mm, from each other. The piercing member has a size corresponding to a needle gauge of 23 to 30, preferably a size corresponding to a needle gauge of 27. The piercing member has a length of about 8.0 mm to about 20.0 mm, preferably about 13.0 mm.

[0017] All features of exemplary embodiments described in this disclosure and which are not mutually exclusive may be combined with one another. Elements of one embodiment may be utilized in other embodiments without further recitation. Other aspects and features of the present invention will become apparent to those skilled in the art upon review of the following description of specific embodiments in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0018] A detailed description of certain exemplary embodiments is provided herein below with reference to the accompanying drawings, in which: [Figure 1] FIG. 1 is a cross-sectional schematic diagram of the human eye; [Figure 2] FIG. 2 is a non-limiting perspective view of one embodiment of a medical device in a first position according to one embodiment of the present disclosure; [Figure 3] 3 is a non-limiting perspective view of the medical device of FIG. 2 in a second position according to one embodiment of the present disclosure; [Figure 4A] FIG. 4A is a front view of an ocular implant according to one embodiment of the present disclosure; [Figure 4B] FIG. 4B is a non-limiting longitudinal cross-sectional view of the ocular implant of FIG. 4A; [Figure 5A]FIG. 5A is a non-limiting illustration of a piercing member for use with the medical device of FIG. 2 according to one embodiment of the present disclosure; [Figure 5B] FIG. 5B is a perspective elevational view of a puncture member housing an ocular implant according to one embodiment of the present disclosure; [Figure 6] 6A-6D are non-limiting cross-sectional views of a medical device having a puncture member and an ocular implant according to an embodiment of the present disclosure; [Figure 7] 7A-7B are non-limiting cross-sectional views of a distal segment of a medical device according to an embodiment of the present disclosure; [Figure 8] FIG. 8 is a non-limiting cross-sectional view showing a puncture member of a medical device and a delivered ocular implant according to an embodiment of the present disclosure; [Figure 9A] FIG. 9A is a non-limiting elevational view of a medical device having a cap for covering a piercing member according to an embodiment of the present disclosure; [Figure 9B] 9B is a non-limiting side view of the medical device of FIG. 9A according to an embodiment of the present disclosure; [Figure 10] FIG. 10 is a non-limiting exploded view of a medical device according to an embodiment of the present disclosure; [Figure 11] FIG. 11 is a non-limiting elevational view of a distal end on a piercing member according to an embodiment of the present disclosure.

[0019] In the drawings, exemplary embodiments are illustrated by way of example. It is to be expressly understood that the description and drawings are for the purpose of illustrating particular embodiments only and are an aid to understanding. They are not intended as a definition of the limits of the disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0020] Detailed Description The present technology is described in more detail below. This description is not intended to be a detailed catalog of all the different ways in which the technology can be implemented or all the functions that can be added to the technology. For example, features illustrated with respect to one embodiment can be incorporated into other embodiments, and features illustrated with respect to a particular embodiment can be omitted from that embodiment. Furthermore, numerous modifications and additions to the various embodiments suggested herein will be apparent to those skilled in the art in light of this disclosure, without those modifications and additions departing from the present technology. Therefore, the following description is intended to illustrate some embodiments of the technology and is not intended to exhaustively specify all permutations, combinations, and variations thereof.

[0021] Described herein is a medical device configured to form a channel in a target tissue layer, such as an ocular tissue layer for the treatment of an ocular disorder or disease, such as a drainage channel for reducing intraocular pressure. For example, the eye may be a human eye.

[0022] In some embodiments, the medical device can deliver and position the ocular implant in an ocular tissue layer, for example, a tissue layer interfacing with the anterior chamber that allows drainage of excess fluid from inside the anterior chamber.

[0023] In some embodiments, the medical device may be useful for the treatment of glaucoma.

[0024] In some embodiments, the medical device is configured to form a channel in an ab externo ophthalmic manner in the target tissue layer.

[0025] The inventors have surprisingly observed that commercially available ophthalmic medical devices or systems suffer from one or more drawbacks that are more easily observed by physicians when performing ophthalmic procedures: a) PreserFlo TMThe MicroShunt (InnFocus Inc., Miami, FL) is implanted via an ab externo approach performed under local anesthesia, where aqueous humor draining from the anterior chamber is directed through the MicroShunt to a filtering bleb created beneath the conjunctiva and Tenon's capsule. Following confirmation of flow, the distal end of the MicroShunt is pushed under the Tenon's capsule and conjunctiva. After verifying that the device is straight and tissue-free, sutures are required to reattach the Tenon's capsule and conjunctiva over the device and to the limbus. This medical device requires an operating room (OR), a glaucoma surgeon, ocular dissection, and represents an invasive procedure; b) Xen TM Gel stents (Aquesys Inc, Aliso Viejo, CA) are implanted in the OR using a sub-Tenon (90%), retrobulbar, or ab interno approach under local anesthesia. The implant is placed using a goniolens to assess positioning in the angle, ideally just above the trabecular meshwork to avoid bleeding and to avoid the iris and endothelium. c) iStent TM (Glaukos, Aliso Viejo, CA) implanted under local anesthesia in the OR using an ab interno approach, which requires goniolens guidance for insertion angle, at least 1.5 mm of eye opening (i.e., increased risk of infection), and implantation in the trabecular meshwork (drainage spot); d) Hydrus TM Microstent (Ivantis TM The corneal graft (Alcon, Irvine, CA) is implanted into Schlemm's canal using a preloaded delivery cannula in the OR using an ab interno approach through a small clear corneal puncture with visualization of the angle performed via a goniolens. The delivery cannula is slightly curved to conform to the morphology of the angle and Schlemm's canal.

[0026] PreserFlo TMWith the exception of the MicroShunt, these commercially available ophthalmic devices and systems require ab interno procedures. While such ab interno subconjunctival filtration procedures are successful in reducing intraocular pressure, there is a risk that the intraocular shunt may be deployed too close to the conjunctiva, resulting in conjunctival irritation and subsequent inflammation and / or scarring, which may cause the glaucoma filtration procedure to fail (see Yu et al., Progress in Retinal and Eye Research, 28:303-328 (2009)). Furthermore, commercially available shunts currently utilized in such procedures are not ideal for ab interno subconjunctival placement due to their length (i.e., too long) and / or the materials used to fabricate them (e.g., gold, polymer, titanium, or stainless steel), and may cause significant irritation to the tissue surrounding the shunt as well as the conjunctiva if deployed too close.

[0027] Interocular procedures are also generally demanding, as the success of such procedures depends significantly on the surgeon's skill and ability to accurately visualize the path of surgical instruments within the anterior chamber and reach the filtration angle. Furthermore, there are inherent risks to important organs such as the iris and lens, as well as angle structures, which remain unobserved without additional gonioscopic lenses.

[0028] The medical devices and procedures described herein address at least one or more of the reported shortcomings of commercially available ophthalmic medical devices or systems and offer at least one or more of the following advantageous features:

[0029] For example, the medical devices described herein can be used for the treatment of eye disorders, such as glaucoma, without the need for an operating room.

[0030] For example, the medical devices described herein provide safe, minimally invasive externa ophthalmic procedures, such as for implantation of ocular implants under local anesthesia only, such as for implantation of ocular implants under the conjunctiva or under Tenon's capsule.

[0031] For example, the medical devices described herein can be considered generally safer because they generally open up smaller openings into the ocular tissue layers.

[0032] For example, the medical devices described herein allow for greater flexibility and ease of manipulation in terms of adjustable actuation angles, which may facilitate the approach angle of the eye.

[0033] For example, the medical devices described herein allow for greater flexibility and ease of operation in terms of being usable by either left-handed or right-handed users (ambidextrous use).

[0034] For example, the medical devices described herein can be held and operated using only one hand, leaving the other hand free for other purposes.

[0035] For example, the medical devices described herein allow for greater flexibility and ease of manipulation in terms of a marking on the puncture member indicating that the ocular tissue layer has been penetrated to the desired depth.

[0036] For example, the medical devices described herein may provide one or more of the following advantageous features: Reduced tissue trauma: The needle-delivered externa implants described herein minimize the need for tissue dissection, thereby eliminating the need for PreserFlo, which requires conjunctival dissection. TM Reduces trauma and potential scarring compared to procedures such as MicroShunt. Lower risk of infection: With the externa needle approach described herein, the integrity of the internal structures of the eye is less compromised, which may result in a reduced risk of infection compared to traditional methods that require more extensive manipulation of internal ocular tissues. Preservatives involve tissue dissection and surgical intervention, which increases the complexity of the procedure, tissue trauma, and the potential for scarring. Material and size compatibility: Considering the complexities in materials and sizes of existing shunts, the invention described herein may offer implants that are better suited in terms of material compatibility and size, thus reducing irritation to surrounding tissues. Patient comfort and recovery: The less invasive nature of the needle-based ab externo procedures described herein may enhance patient comfort during surgery and potentially lead to faster recovery times with less post-operative discomfort. Surgical efficiency: Less manipulation within the anterior chamber is required, which simplifies the surgical process and may also reduce the duration of the surgery. Predictable outflow direction: Like traditional ab externo approaches, the procedure described herein allows for a controlled and predictable direction of aqueous humor outflow, potentially resulting in more successful and diffuse subconjunctival filtering blebs. Reduced stress for the patient: Procedures that are perceived as less invasive, such as the needle-based approach described herein, may alleviate patient anxiety associated with more traditional surgical environments. Potential for improved long-term outcomes: The combination of reduced tissue dissection, less invasive techniques, and controlled outflow may contribute to improved long-term success and functionality of implants.

[0037] Such technical advantages of the medical devices described herein will become more apparent to those skilled in the art in light of this disclosure.

[0038] Eye structure The relevant structures of the eye will first be briefly described to provide background for the anatomical terminology used herein.

[0039] Figure 1 is a stylized depiction of a normal human eye. Certain anatomical details, familiar to those skilled in the art, have been omitted for clarity and convenience.

[0040] The anterior chamber 100 is shown bounded on its anterior surface by the cornea 102. The cornea 102 is connected on its periphery to the sclera 104, a tough fibrous tissue that forms the white shell of the eye. The trabecular meshwork 106 is located on the periphery of the anterior chamber 100. The trabecular meshwork 106 extends circumferentially 360 degrees around the anterior chamber 100. Located on the peripheral surface of the trabecular meshwork 106 is Schlemm's canal 108. Schlemm's canal 108 extends circumferentially 360 degrees around the meshwork 106. At the apex formed between the iris 110, the meshwork 106, and the sclera 104 is the angle 112.

[0041] eye implants In a broad embodiment, the present disclosure relates to an ocular implant.

[0042] In some embodiments, the ocular implant, when properly positioned in the eye, may allow fluid to flow from one ocular location to another. For example, aqueous humor may flow out of the anterior chamber 110 of the eye, thereby reducing internal pressure within the eye. For example, the ocular implant may have an interior surface defining one or more lumens that may form one or more corresponding channels for allowing such aqueous humor flow. In some embodiments, the ocular implant has an interior surface defining a substantially continuous single lumen that forms a corresponding substantially continuous single channel. That is, the ocular implant, when properly positioned in the eye, may be used to treat glaucoma. This is envisioned to include primary open-angle glaucoma and secondary open-angle glaucoma. However, it is contemplated that the ocular implant could be used to treat other types of glaucoma, as well as other ocular diseases that require relief of intraocular pressure through drainage of aqueous humor, such as pigment dispersion syndrome, neovascular glaucoma, uveitic glaucoma, chronic angle-closure glaucoma, and pseudoexfoliation syndrome.

[0043] Additionally or alternatively, the ocular implants of the present disclosure can be used to deliver substances, such as drugs or therapeutic agents, into the eye. For example, saline or a viscoelastic fluid. Saline fluid can be used for irrigation. For example, the viscoelastic fluid can include hyaluronic acid, chondroitin sulfate, cellulose, derivatives or mixtures thereof, or solutions thereof. In one variation, the viscoelastic fluid includes sodium hyaluronate. In another variation, the viscoelastic composition can further include a drug. For example, the viscoelastic composition can include a drug suitable for treating glaucoma, reducing or lowering intraocular pressure (IOP), reducing 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 also be used. For example, steroids such as prednisolone, prednisone, cortisone, cortisol, triamcinolone, or shorter-acting steroids may be used. Examples of antimetabolites include 5-fluorouracil or mitomycin C. In yet another variation, the implant delivers only the drug without the viscoelastic composition. Physiological saline may also be used as a fluid.

[0044] In some embodiments, the ocular implants of the present disclosure may also be coated on at least a portion of the interior surface, at least a portion of the exterior surface, or both, with a compound useful for treating ocular hypertension, glaucoma or pre-glaucoma, infection, or post-surgical scarring or inflammation, and / or with a compound useful for reducing friction and thus facilitating insertion into the eye.

[0045] In some embodiments, the ocular implants of the present disclosure may also be formed to be solid, semi-solid, or bioabsorbable.

[0046] Further exemplary embodiments of the disclosed ocular implants having various structural configurations are described in more detail below.

[0047] In some embodiments, ocular implant 10 includes an elongate body 20 that is configured so that, when properly installed in the eye, aqueous humor can flow out of the anterior chamber 110 of the eye, thereby reducing internal pressure within the eye. For example, elongate body 20 can have an interior surface 25 that defines a lumen that forms a corresponding channel for allowing such flow of aqueous humor.

[0048] In some embodiments, elongate body 20 can have a substantially circular cross-section along at least a portion thereof. For example, elongate body 20 can have a substantially circular cross-section along its entire length. In some embodiments, elongate body 20 can have a substantially rectangular, elliptical, or hexagonal cross-section along at least a portion thereof. In some embodiments, elongate body 20 can have more than one cross-sectional shape along its length, for example, a combination of a cylindrical cross-sectional shape and an elliptical cross-sectional shape along its length.

[0049] In some embodiments, elongate body 20 may have a cross-sectional size or shape such that the inner diameter of a lumen defined therein is substantially constant along at least a portion thereof. For example, elongate body 20 may have a cross-sectional size or shape such that the inner diameter of a lumen defined therein is substantially constant over its entire length.

[0050] In some embodiments, elongate body 20 can have a cross-sectional shape such that the inner diameter of the lumen is tapered along at least a portion thereof. For example, elongate body 20 can have a cross-sectional shape such that the inner diameter of the lumen is tapered along its entire length.

[0051] In some embodiments, elongate body 20 can be substantially straight along at least a portion thereof. For example, elongate body 20 can be substantially straight along its entire length, as shown in FIG. 4B. In some embodiments, elongate body 20 can be bent or curved in a temporary or permanent manner, depending on the particular application. In some embodiments, elongate body 20 can be rigid or flexible, depending on the particular application.

[0052] In some embodiments, the elongate body 20 can have a length suitable for proper placement within the eye. For example, the elongate body 20 can have a length such that the ocular implant 10 is positioned comfortably within the eye and traverses desired ocular structures, such as the sclera 104, when properly positioned within the eye. For example, the elongate body 20 can have a length Y between about 1.0 and about 12.0 mm, including any value or range therein. For example, a length Y of about 5.0 mm to about 6.5 mm. For example, a length Y of about 6.0 mm, 6.3 mm, about 6.35 mm, or about 6.4 mm, preferably about 6.35 mm.

[0053] In some embodiments, the elongate body 20 can have a lumen cross-sectional size appropriate for proper function. In some embodiments, the lumen cross-sectional diameter S can be such that it facilitates drainage of aqueous humor from the eye, for example, through passive drainage. For example, the lumen can have a cross-sectional diameter S of about 0.010 mm to about 0.250 mm, including any value or range therein. For example, the lumen can have a cross-sectional diameter S of 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 about 0.051 mm or about 0.053 mm.

[0054] In some embodiments, the elongate body 20 can have an outer wall defining an outer diameter OD suitable for proper function. In some embodiments, the elongate body 20 has an outer diameter OD such that the ocular implant 10 is positioned comfortably within the eye when properly positioned therein. For example, an outer diameter OD of about 0.100 mm to about 0.450 mm, including any value or range therein. 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 about 0.254 mm.

[0055] In some embodiments, the elongate body 20 further includes a first engaging element 30 and a second engaging element 40 located on a surface of the elongate body 20. For example, the first and second engaging elements 30, 40 both extend away from the surface of the elongate body 20. The first and second engaging elements 30, 40 are configured such that when the ocular implant 10 is properly positioned in the eye, the first and second engaging elements 30, 40 engage or abut ocular tissue structures to prevent movement of the ocular implant 10 relative to the eye, thus enabling its proper function. For example, the first and second engaging elements 30, 40 may be configured such that when the ocular implant 10 is correctly positioned in the eye, the engaging element 30 engages with or is adjacent to the inner surface of a tissue layer, such as the sclera 104 (i.e., the surface facing the anterior chamber 100 of the eye), while the engaging element 40 engages with or is adjacent to the outer surface of the tissue layer, such as the sclera 104 (i.e., the surface facing the outer surface of the eye, opposite the anterior chamber 100 of the eye).

[0056] As shown in FIG. 4A , the first and second engaging elements 30, 40 are advantageously positioned at the distal and proximal portions of the elongate body 20, respectively. In other words, the first and second engaging elements 30, 40 are spaced apart along the longitudinal axis of the elongate body 20. For example, the first and second engaging elements 30, 40 may be positioned at position D, which may be, for example, about 1.5 mm to about 3.0 mm from the respective proximal or distal ends of the elongate body 20, including any value or range therein. For example, position D may be about 1.80 mm, about 2.00 mm, about 2.20 mm, or about 2.30 mm from the respective proximal or distal ends of the elongate body 20. For example, position D may be about 2.18 mm.

[0057] In some embodiments, the first and second engaging elements 30, 40 can include protrusions extending from the elongate body 20 at an angle α relative to the surface of the elongate body 20. For example, the angle α relative to the exterior surface of the elongate body 20 can be an acute angle, such as from about 5 degrees to less than 90 degrees. For example, the engaging element 30 can bend toward the engaging element 40; or the engaging element 40 can bend toward the engaging element 30; or both the first and second engaging elements 30, 40 can bend toward each other. For example, the protrusions can have any suitable shape, such as a hook, rod, bar, disk, shelf, step, or any other suitable shape. Preferably, the first and second engaging elements 30, 40 have a rod shape extending at an acute angle from the elongate body. In some embodiments, the first and second engaging elements 30, 40 can include one or more protrusions projecting away from the elongate body 20.

[0058] In some embodiments, the first and second engaging elements 30, 40 may advantageously be deformable. For example, the first and second engaging elements 30, 40 may be compressed toward the elongate body 20, e.g., in response to a compressive force, and then returned to their initial position when needed, e.g., upon release of the compressive force. For example, the first and second engaging elements 30, 40 may be made of a resilient material.

[0059] Advantageously, the first and second engaging elements 30, 40 are positioned from one another at a distance X along the surface of the elongate body 20 that allows them to engage with or abut the desired ocular structures. For example, distance X may be such that the first and second engaging elements 30, 40 engage with or abut the inner and outer surfaces of the sclera, respectively, when the ocular implant 10 is properly positioned in the eye. For example, the first and second engaging elements 30, 40 may be spaced such that approximately one-third of the elongate body 20 is between the first and second engaging elements 30, 40. It is also contemplated that the first and second engaging elements 30, 40 may be variably spaced along the length of the elongate body 20, without limitation, to ensure proper function and safety of the ocular implant 10. For example, distance X may be from about 1.8 mm to about 2.2 mm, including any value or range therein. 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.

[0060] In some embodiments, the first and second engaging elements 30, 40 may advantageously have protrusions located opposite each other on the elongate body 20, as shown in FIG. 4B , to prevent movement of the ocular implant 10 relative to the eye when the ocular implant 10 is being properly positioned within the eye. For example, the ocular implant 10 may be delivered into the anterior chamber 100 through the cornea 102 or the iridocorneal angle 112. For example, the ocular implant 10 may be delivered into the iridocorneal angle through a scleral tunnel. In certain embodiments, the ocular implant 10 may be inserted under other ocular structures, such as the conjunctiva, Tenon's capsule, or the like, for example, through the sclera into the iridocorneal angle in the anterior chamber 100. For example, the first and second engaging elements 30, 40 may have protrusions that extend away from the elongate body 20, thereby forming a combined width Z with the elongate body 20 of about 0.400 mm to about 0.800 mm, including any value or range therein. For example, a combination width Z of about 0.500 mm, about 0.600 mm, or about 0.700 mm. For example, a combination width Z of about 0.600 mm.

[0061] In certain embodiments, the ocular implant 10 may have one or more of the following size 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 between the first and second engaging elements of about 2.0 mm.

[0062] In some embodiments, because engaging element 40 does not enter the ocular tissue layer, it may then be less flexible than engaging element 30, which does enter the ocular tissue layer. This may allow engaging element 30 to be deformed to fit within a small incision in the ocular tissue layer, thereby inserting ocular implant 10 into the ocular tissue layer, and may allow engaging element 30 to expand once it passes through the incision and the ocular implant 10 is in place in the ocular tissue layer.

[0063] The reader will recognize that such deformable and expandable capabilities of engaging element 30 provide a technical advantage in that the procedure for inserting an ocular implant into an ocular tissue layer requires a smaller incision in the ocular tissue layer than would otherwise be required if engaging element 30 did not have such capabilities.

[0064] In some embodiments, the ocular implant 10, including the elongate body 20 and the first and second engaging elements 30, 40, can all be made from the same medical-grade material. Alternatively, either or both of the first and second engaging elements 30, 40 can be made from a medical-grade material that is separate from the elongate body 20 itself. For example, such medical-grade materials include poly(methyl methacrylate) (PMMA), silicone, acrylic, hydrophobic acrylate, hydrophilic acrylate, COLLAMER, etc. TM , poly(styrene-block-isobutylene-block-styrene) (“SIBS”), or any combination thereof. Preferably, silicone.

[0065] In one non-limiting embodiment, the ocular implant 10 can be obtained by molding the ocular implant over a stretched wire 50, where the wire 50 can be stretched through a manufacturing mold for the ocular implant. For example, an ocular implant material in viscous, semi-viscous, or liquid form can be poured into the mold, while the wire 50 is stretched therethrough so that, upon hardening, the wire 50 is surrounded by the ocular implant. The presence of the wire 50 during the manufacturing of the ocular implant 10 can enable the formation of an interior surface 25 defining a substantially continuous single lumen that forms a corresponding substantially continuous single channel. Other approaches to manufacturing the ocular implant 10 that enable the formation of an interior surface 25 defining a substantially continuous single lumen that forms a corresponding substantially continuous single channel can be envisioned by those skilled in the art. Laser cutting, a known process, can be used to obtain the engaging elements 30, 40 described herein. In another embodiment, the first and second engaging elements 30, 40 can be obtained directly from a molding process without the need for laser cutting. Other suitable techniques, such as die cutting, laser cutting and simple molding, may also be used.

[0066] As such, a manufacturing method for ocular implant 10 may include shaping ocular implant 10 over a stretched wire 50, where the wire 50 extends through a manufacturing mold. Molding may further include injecting a material in a viscous, semi-viscous, or liquid form into the manufacturing mold containing the stretched wire 50. Molding may further include hardening the material to obtain ocular implant 10. The method may further include removing the stretched wire 50 from ocular implant 10 to obtain an interior surface 25 defining a substantially continuous single lumen that forms a corresponding substantially continuous single channel. Optionally, prior to removing the stretched wire 50 from ocular implant 10, the stretched wire 50 may be useful in guiding and positioning the ocular implant 10 within the lumen of the puncture member 510.

[0067] medical devices 2 illustrates a non-limiting implementation of a medical device arranged and configured in accordance with certain features, aspects, and advantages of the present disclosure. The illustrated medical device may be used to create channels in ocular tissue layers, such as in the delivery of an ocular implant, or any other type of medical device that would benefit from any or all of the features, aspects, and advantages of the present disclosure described below.

[0068] As used herein, the term "tissue layer" encompasses both a single tissue layer and a group of layers, such as adjacent stacked layers (multiple layers) or separate layers. However, the default interpretation typically refers to a single tissue layer. Furthermore, when referring to a "tissue layer (singular)," it often refers to a tissue wall characterized by a specific thickness and two sides (outer and inner, or proximal and distal). In this context, the created channel or hole extends between these two sides of the tissue wall. For example, the channel could be located at the scleral-corneal junction of an individual's eye. This application could be used to address glaucoma by reducing intraocular pressure, achieved by facilitating fluid communication between the anterior chamber of the eye and the interface connecting the episclera and conjunctival tissue, or, for example, under the subconjunctival or sub-Tenon region.

[0069] In some embodiments, the medical device 200 includes at least two segments: a proximal segment 65 for grasping by the user, and a distal segment 60 that contains the components for the desired ophthalmic procedure.

[0070] In some embodiments, the proximal segment 65 may have at least one segment of its surface that is raised, recessed, grooved, or textured to improve grip by a user or to improve comfort for the user. The user may be a medical practitioner, such as an ophthalmologist.

[0071] In some embodiments, the distal segment 60 can be separated from the medical device 200 for decommissioning, disposal, sterilization, etc. In one embodiment, the proximal segment 65 can be separated from the medical device 200 for decommissioning, disposal, sterilization, etc.

[0072] In some embodiments, the distal segment 60 can be formed of first and second housing portions 62, 64 (as shown in FIG. 10 ). For example, the first and second housing portions 62, 64 can be configured to assemble one over the other via suitable coupling means. In one practical, non-limiting implementation, the second housing portion 64 can include a plurality of circumferentially spaced projections 66. Accordingly, the first housing portion 62 can include a plurality of circumferentially spaced notches 68 that receive corresponding projections 66 to assemble the first and second housing portions 62, 64, thus forming the distal segment 60.

[0073] In some embodiments, the proximal segment 65 can be formed from first and second housing portions 72, 74 (as shown in FIG. 10 ). For example, the first and second housing portions 72, 74 can be configured to assemble one over the other via any suitable coupling means. For example, the second housing portion 74 can include a plurality of circumferentially spaced projections 66′. Accordingly, the first housing portion 72 can include a plurality of circumferentially spaced notches 68′ that receive corresponding projections 66′ to assemble the first and second housing portions 62, 64, thus forming the proximal segment 65.

[0074] In some embodiments, the proximal segment 65 is coupled to the distal segment 60 through any suitable coupling element. For example, the proximal segment 65 can be coupled to the distal segment 60 through any suitable coupling element that allows the proximal segment 65 to be rotatable relative to the distal segment 60. For example, the proximal segment 65 can be coupled to the distal segment 60 about an axis of rotation r such that the proximal segment 65 and the distal segment 60 are rotatable relative to each other about the axis of rotation r at a pivot point 85. For example, the axis of rotation r can be substantially perpendicular to the longitudinal axis Ω of the proximal segment 65.

[0075] In some embodiments, the proximal segment 65 and the distal segment 60 are configured to selectively couple to one another from an unlocked configuration and a locked configuration. In the unlocked configuration, the proximal segment 65 and the distal segment 60 are rotatable relative to one another about an axis of rotation r at a pivot point 85. In the locked configuration, the proximal segment 65 and the distal segment 60 remain coupled to one another at a user-selected angle β unless the unlocked configuration is achieved.

[0076] In some embodiments, the medical device 200 may include a locking mechanism 80 for reversibly securing the proximal segment 65 and the distal segment 60 in a locked configuration. Such a locking mechanism 80 may provide a technical advantage in that the medical device 200 may be locked in position at a desired angle β, allowing a user to select an appropriate actuation angle that may facilitate an ophthalmic procedure. For example, such an actuation angle may be useful for adapting the medical device 200 to anatomical variability between a user's left and right eyes, anatomical variability between eyes for different individuals, a user's (e.g., physician's) personal preference, a physician's left-handed or right-handed use, etc. A user (e.g., physician) may thus easily select a desired angle β to move the medical device 200 from a first position (e.g., shown in FIG. 2 ) to a second position (e.g., shown in FIG. 3 ). Advantageously, a user may lock the medical device 200 in the first or second position using the locking mechanism 80 described herein.

[0077] For example, the locking mechanism 80 may be, without limitation, a knob that can be screwed and unscrewed, a latch or clamp that can reversibly secure the proximal segment 65 and the distal segment 60 in a user-desired position, a ratchet-like rotating member that allows rotation between the proximal segment 65 and the distal segment 60, etc.

[0078] In some embodiments, medical device 200 may include an optional Belleville spring 135 (best shown in FIG. 10 ) configured to maintain pressure against locking mechanism 80 when it is loosened (e.g., via threads on a knob). Such a configuration may allow for a more pleasant user experience, for example, by allowing for a clicking sensation when distal segment 60 is rotated relative to proximal segment 65.

[0079] In some embodiments, either or both of the proximal segment 65 and the distal segment 60 can be autoclaved or sterilized by some other method. For example, either or both of the proximal segment 65 and the distal segment 60 can be made from any suitable material, such as, but not limited to, polyethylene (PE), including low density PE, high density PE, and ultra-high molecular weight PE; polypropylene (PP); polytetrafluoroethylene; thermoplastic polyurethane; polycarbonate; polyphthalic acid; acrylic; acrylonitrile butadiene styrene (ABS); silicone.

[0080] In some embodiments, the proximal segment 65 and the distal segment 60 may be configured to have a shape that facilitates handling during use of the medical device 200 .

[0081] In some embodiments, the medical device 200 can have a suitable length that is convenient for a user to hold and operate with a single hand. For example, the medical device 200 can have a length L from the proximal end of the proximal segment 65 to the distal end of the distal segment 60 of about 100 mm to about 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.

[0082] In some embodiments, the medical device 200 can have a suitable thickness that is convenient for a user to hold and operate with a single hand. For example, the medical device 200 can have a thickness d1 of the distal segment 65 of 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 about 7.4 mm. For example, the medical device 200 can have a thickness d2 of the proximal segment 65 together with the actuator 90 of 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, or about 17.0 mm, preferably about 15.4 mm.

[0083] In an actual non-limiting implementation of the present disclosure, the medical device 200 described herein includes an ocular implant 10, shown in Figures 4A and 4B.

[0084] puncture member In some embodiments, the medical device 200 described herein is particularly useful for attaching an ocular implant to form a drainage channel within the eye. As will be apparent from the description below, in some embodiments, the medical device described herein may include an ocular implant, i.e., the medical device is adapted to deliver and position the ocular implant within a patient's eye.

[0085] In a non-limiting practical implementation, medical device 200 includes a puncture member 510 coupled to and extending from the distal end of distal segment 60 shown in Figure 5A. For example, medical device 200 can be configured such that puncture member 510 includes an elongated hollow body for receiving an ocular implant therein.

[0086] In some embodiments, the medical device 200 is configured to retract the puncture member 510 from an extended position to a retracted position. For example, the medical device 200 can be configured to retract the puncture member 510 along the longitudinal axis of the distal segment 60, away from the eye. In other words, the medical device 200 can be configured to retract the puncture member 510 from a first position, in which the puncture member 510 extends from the distal segment 60 and is visible to the user, to a second position, in which the puncture member 510 is at least partially contained within a distal portion of the distal segment 60. In use, retracting the puncture member 510 toward the distal segment 60 causes delivery of the ocular implant within the eye, i.e., leaving the implant 10 within the eye. The puncture member 510 can be configured to retract into the internal cavity of the distal segment 60, for example, to retract sufficiently far into the internal cavity of the distal segment 60 to deliver the ocular implant into the eye.

[0087] In some embodiments, the puncture member 510 may have one or more markings 120 on its outer surface that are visible to the user to assist the user in placing the ocular implant within the eye. Such one or more markings 120 may aid in the insertion of the puncture member 510 within the eye, for example, to a desired ocular location and / or to a specified depth, and may facilitate implantation of the ocular implant 10 within the patient's eye. For example, such markings 120 may be obtained by laser tagging, which may serve as an intuitive guide for the user during an ophthalmic procedure, as described later in this document.

[0088] In some embodiments, the puncture member 510 may have at least a portion thereof that is transparent, thus allowing one or more markings 120 to be located on the inner surface of the transparent portion. Additionally, the presence of at least a portion of the puncture member 510 that is transparent may further allow a user to visualize the internal contents of the puncture member 510, such as an ocular implant.

[0089] In some embodiments, the puncture member 510 can be configured to perform an incision on a tissue layer, such as the outer surface of the sclera 104. For example, the incision can be performed by the puncture member 510 slicing through the tissue layer at an entry point. For example, the medical device 200 can be positioned at a first point relative to the eye and advanced along its longitudinal axis until the puncture member 510 contacts the outer surface of the ocular tissue layer. At this point, the puncture member 510 is referred to as being in a first position. As the medical device 200 advances further toward the tissue layer, the puncture member 510 then performs the incision from the first position. Advantageously, the puncture member 510 can perform the incision with an axial cutting action. In other words, the cutting action does not require any rotational movement of the puncture member 510.

[0090] For example, the puncture member 510 can be further configured to penetrate into and through a tissue layer upon axial displacement of the medical device 200 toward the tissue layer. Advantageously, the puncture member 510 is configured to penetrate smoothly and easily into and through a tissue layer with minimal force, and thus, it can have a smooth (e.g., polished) outer surface to minimize friction during penetration into and through the tissue layer.

[0091] In some embodiments, the puncturing member 510 includes an elongate body having a puncturing tip 70 at its distal end, as shown in FIG. 11 . For example, the puncturing tip 70 may have a needle bevel shape, e.g., a sharp, angular tip. For example, the puncturing tip 70 may have a cannula-style pointed / machined distal end. For example, the puncturing tip 70 may have a relatively shallow primary bevel angle that allows ocular tissue material to slide off more easily. For example, the puncturing tip 70 may have a primary bevel angle of about 10° to about 15°, preferably about 12°.

[0092] In some embodiments, the puncturing member 510 may be of any gauge suitable for puncturing the eye to create an incision of a corresponding size sufficient to fit the ocular implant 10 therethrough.

[0093] In some embodiments, the puncture member 510 may serve at least a dual purpose: puncturing an ocular tissue layer and retaining an ocular implant for placement and delivery to the eye. For example, the puncture member 510 may be configured to accommodate the ocular implant 10, such as within its lumen, as shown in FIG. 5B . In such embodiments, the first and second engaging elements 30, 40 may advantageously be able to deform (e.g., bend or compress) toward the elongate body 20, allowing the ocular implant 10 to fit within the lumen of the puncture member 510. In some cases, the first and second engaging elements 30, 40 may transition between the folded and deployed configurations by mechanical means, such as a lever or switch. In other cases, the first and second engaging elements 30, 40 may transition between the configurations by a passive mechanism, such as the resilience or free movement of the first and second engaging elements 30, 40. The first and second engaging elements 30, 40 may be stored in a folded configuration within the piercing member 510.

[0094] In some embodiments, the puncture member 510 includes one or more markings 120 (e.g., laser tags) on its surface. Such one or more markings 120 can serve as cues for the user. For example, during insertion of the puncture member 510 into and through a tissue layer, the one or more markings 120 (e.g., laser tags) can indicate when the puncture member 510 has reached a desired depth into the ocular tissue layer.

[0095] In some embodiments, one or more markings 120 are positioned in spaced relation on the surface of the puncture member 510 at locations that coincide with the respective positions of the first and second engaging elements 30, 40. As discussed elsewhere in this document, the first and second engaging elements are positioned along the surface of the elongate body 20 at a distance X from one another that allows them to engage or abut the desired ocular structure. Accordingly, one or more markings 120 can similarly be positioned on the surface of the puncture member 510 at a corresponding distance X' from one another that is equal to the distance X. For example, a distance X' of about 1.8 mm to about 2.2 mm, including any value or range therein; for example, a distance X' of about 1.9 mm, about 2.0 mm, or about 2.1 mm; or a distance X' of about 2.0 mm.

[0096] For example, when the ocular implant 10 is installed in the puncture member 510, the ocular implant 10 can be positioned within the lumen of the puncture member 510 such that the respective positions of the first and second engaging elements 30, 40 coincide with one of one or more markings 120. In some embodiments, the puncture member 510 can include a first marking 120 at a first position that coincides with the position of the engaging element 30, and a second marking 120 at a second position that coincides with the position of the engaging element 40. As such, during the procedure, the user can rely on the markings 120 as a cue; at the second marking 120, the user is guided to release a control point (e.g., actuator 90), which allows the ocular implant 10 to remain in place, as described elsewhere in this document. This technique ensures that the ocular implant 10 remains in its intended position through a controlled and intuitive process, rather than being forced to do so.

[0097] In some embodiments, the piercing member 510 may have a suitable size that may be selected from any one of the needle gauge sizes listed in Table 1.

[0098] [Table 1]

[0099] In some embodiments, the piercing member 510 has a size corresponding to a needle gauge of 23 to 30. Preferably, the piercing member 510 has a size corresponding to a needle gauge of 27.

[0100] In some embodiments, the puncture member 510 has a length L2 of about 8.0 mm to about 20.0 mm, including any value or range therein. For example, the puncture 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 about 13.0 mm.

[0101] 9A and 9B , the medical device 200 may include a cap 900 configured to attach and secure over the puncture tip 70 of the puncture member 510. Such a cap 900 may be advantageous, for example, to avoid potential needle sticks when handling, disposing of, or disassembling the medical device 200. The cap 900 includes a port 910 that may be configured adjacent the distal end of the distal segment 60, such as when the cap 900 covers the entire length of the puncture member 510.

[0102] Actuation Assembly In a broad embodiment, the medical device 200 includes an actuation assembly configured to actuate the puncture member 510 to deliver the ocular implant 10 into the eye. While the following text describes a particular implementation of the actuation assembly with reference to the drawings, the reader will nevertheless understand that variations may be used to achieve similar results.

[0103] 7A-7B illustrate non-limiting practical implementations of an actuation assembly, including suitable components or combinations of components, capable of providing the functionality described herein. For example, the actuation assembly includes a control point that can be engaged by a user to actuate the puncture member 510 to deliver the ocular implant 10 into an eye, such as a human eye. In some embodiments, the control point can take the form of an actuator 90. For example, the actuator 90 can be conveniently located on the outer housing of the distal segment 60. For example, the actuator 90 can be located on a proximal portion of the distal segment 60 for ease of access with a finger, preferably the index finger.

[0104] Advantageously, actuator 90 can be shaped to facilitate its ambidextrous actuation. For example, as shown in FIG. 6A, actuator 90 can be shaped to include extensions 92, 94, respectively, extending away from distal segment 60. In use, when distal segment 60 and proximal segment 65 are in the locked configuration, extensions 92, 94 can be advantageously located on either side of pivot point 85 to facilitate actuation with either the left or right hand holding proximal segment 65.

[0105] In some embodiments, the actuator 90 can be a slider, trigger, wheel, or any other form that can be easily engaged with only one finger, preferably the index finger.

[0106] 6A, actuator 90 may include teeth or some other form along its edge that can provide friction to improve a user's ability to confidently engage and release actuator 90, even when moisture is present or when the user is wearing gloves. Additionally, to improve the safety of using medical device 200, actuator 90 may include a locking mechanism or means to prevent unintentional engagement or release of the actuator.

[0107] In some embodiments, the actuator 90 may be made of the same material as the distal segment 60 or a different material.

[0108] In some embodiments, the actuator 90 may include a return mechanism designed to facilitate, assist, or direct the actuator 90 to return to the second position when a user releases the actuator 90, as shown by arrow 700′ in FIG. 6C . For example, the return mechanism may include a spring assembly or band. For example, the return mechanism may include a spring assembly 130 connecting the actuator 90 to the distal segment 60. In use, pushing the actuator 90 toward the proximal end of the distal segment 60 extends the spring assembly 130 along the longitudinal axis of the distal segment 60, and releasing the actuator 90 retracts the spring assembly 130, i.e., drives the actuator 90 away from the proximal end of the distal segment 60, as shown in FIG. 6C . Of course, many other forms of return mechanisms may be devised to return the actuator 90 to the first position when a user releases the actuator 90.

[0109] In some embodiments, the actuation assembly may further include a protrusion 125 extending toward the distal end of the distal segment 65. For example, the protrusion 125 may be configured to operably couple to the actuator 90 such that actuation of the actuator 90 from a first position to a second position causes axial displacement of the protrusion 125 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 shown in FIG. 3A, where the protrusion 125 and the actuator 90 may be made from a solidary body, e.g., the protrusion 125 may extend from the actuator 90.

[0110] Lock and Release Mechanism In some embodiments, the medical device 200 can be configured to implement a locking and release mechanism designed to hold the implant 10 securely in place until correct placement is achieved. For example, a user can activate the locking and release mechanism by engaging and releasing the control points discussed above. Specific actual implementations of the locking and release mechanisms will now be described.

[0111] In some embodiments, the medical device 200 includes an inner casing 150 (or “bridge”) located at the distal portion of the distal segment 60 .

[0112] In some embodiments, distal segment 60 includes an interior surface that defines an interior cavity 15 that is configured to receive an interior casing 150 .

[0113] In some embodiments, the inner casing 150 can be configured to operably couple the protrusions 125 to the puncture member 510. Such coupling can be permanent or temporary. Non-limiting implementations of temporary coupling are now discussed.

[0114] In some embodiments, inner casing 150 can be configured to engage protrusion 125 upon actuation of actuator 90 from a first position to a second position. In other words, axial displacement of protrusion 125 along the longitudinal axis of distal segment 60 in response to actuation of actuator 90 from a first position to a second position causes engagement between protrusion 125 and inner casing 150.

[0115] In some embodiments, inner casing 150 advantageously includes an engagement element 145 at its proximal portion configured to engage with protrusion 125. For example, actuation of actuator 90 from a first position to a second position causes protrusion 125 to engage with engagement element 145 of inner casing 150. For example, protrusion 125 may include an engagement element 140 located on its distal portion and configured to engage with a complementary engagement element 145. For example, protrusion 125 may include a prong or other type of extension element on which first and second engagement elements 140 are located. Engagement of first and second engagement elements 140, 145 functionally couples actuator 90 to inner casing 150, which allows for coordinated movement between actuator 90 and inner casing 150. Embodiments including such a feature may provide audible feedback to the operator (and others working with the operator) in the form of a clicking sound corresponding to engagement of engagement elements 140, 145.

[0116] In some embodiments, one of the first and second engaging elements 140, 145 can be a protrusion or pin, while the other of the first and second engaging elements 140, 145 can be a slot configured for engagement with the protrusion or pin. For example, one of the first and second engaging elements 140, 145 can be located on a distal portion of the protrusion 125 connected to the actuator 90, while the other of the first and second engaging elements 140, 145 can be a corresponding recess located on a proximal portion of the inner casing 150. Of course, many other forms of complementary engaging elements can be devised that operatively couple the actuator 90 to the inner casing element 150.

[0117] 6B, actuating actuator 90 from a first position to a second position (a pushing motion indicated by arrow 700) effectively moves first and second engagement elements 140 located on prongs 135 that extend from projection 125 toward inner casing 150. In some embodiments, projection 125 and prongs 135 are unitary components, while in other embodiments, projection 125 and prongs 135 are formed by multiple components joined together in any suitable manner.

[0118] For example, the prongs 135 may be made of a resilient material with some flexibility so that upon contacting the top surface 160 of the inner casing 150, the distal portions of the prongs 135 housing the engaging elements 140 are pushed out slightly radially to engage corresponding recesses in the first and second engaging elements 145 located on the proximal portion of the inner casing 150. Upon engaging the recesses in the first and second engaging elements 145, the prongs 135, being made of a resilient material (e.g., a resilient plastic), may snap back, compressing the first and second engaging elements 140 against the first and second engaging elements 145 and thus securing the prongs 135 to the inner casing 150. An embodiment including such a feature may provide audible feedback to the operator (and others working with the operator) of the rate of progress of the release operation of the intraocular device 10, generally in the form of a clicking sound corresponding to the prongs 135 snapping back.

[0119] In a non-limiting practical implementation, the actuator 90 begins in a first position where it is disconnected from the inner casing 150, as shown in FIG. 6A. In this position, the user inserts the puncture member 510 into the patient's eye to a specified depth. As previously discussed, when the puncture member 510 includes markings 120 (e.g., laser tags), these can be advantageously used to provide guidance regarding the specified depth. Once the puncture member 510 is positioned at the desired location and specified depth, the user actuates the actuator 90 toward a second position (shown as 700), which causes the first and second engagement elements 140, 145 to engage with each other so that the actuator 90 is operatively coupled to the inner casing 150 to create a single component, as shown in FIG. 6B.

[0120] Finally, the user releases the actuator 90, for example, by releasing the pressure (shown as 700′) applied to the actuator 90, so that the return mechanism retracts the actuator 90 from the second position to the first position. Because the first and second engagement elements 140, 145 are engaged with one another, the actuator 90 and inner casing 150 are operatively coupled such that retraction of the actuator 90 away from the proximal end of the distal segment 60 also retracts the inner casing 150 toward the proximal end of the distal segment 60. Movement of the inner casing 150 toward the proximal end of the distal segment 60 also retracts the puncture member 510 operatively coupled to the inner casing 150 at least partially within the cavity 15 and through the support 175 connected to the distal segment 60, which results in release of the ocular implant 10.

[0121] In some embodiments, the medical device may include a tube 170 defining a channel that is held in place by a support 175 connected to the distal segment 60. The tube 170 may house at least a portion of a puncture member 510 within the channel. During movement of the inner casing 150 in response to release 700′ of the actuator 90, as shown in FIG. 6C , the support 175 and associated tube 170 are held in place by virtue of the support 175 connecting to the distal segment 60, while the inner casing 150 and attached puncture member 510 move relative to the support 175.

[0122] In some embodiments, the medical device 200 is configured to prevent lateral movement of the inner casing 150, for example, when the medical device 200 is manipulated.

[0123] For example, in one embodiment, medical device 200 can include retention members 155 associated with the interior surfaces of segments 60 located on each side of inner casing 150. Retention members 155 extend along a majority (>50%) of the lateral dimension of inner casing 150 and engage and prevent lateral movement of inner casing 150 while allowing longitudinal movement thereof, as shown in FIG.

[0124] For example, in another embodiment, medical device 200 may include a retention member 155' associated with the interior surface of segments 60 located on each side of inner casing 150. Retention member 155' extends along a small portion (<50%) of the lateral dimension of inner casing 150 and engages and prevents lateral movement thereof, as shown in FIG. 7A. In this example, inner casing 150 may further include flexible arms 160 disposed on or integral with either side of inner casing 150. For example, flexible arms 160 may extend from a proximal portion toward a distal portion of inner casing 150 such that a distal end of flexible arm 160 engages or abuts a corresponding distal portion of one of retention members 155', as shown in FIG. 7A.

[0125] In the parked position, this arrangement prevents lateral movement of inner casing 150, and inner casing 150 is restrained from sliding along the longitudinal axis of distal segment 60. Such a configuration can prevent inadvertent movement of inner casing 150 when inserting puncture member 510 into the eye.

[0126] For example, the distal end of flexible arm 160 may include a bulge or other suitable structure at its distal portion that engages or abuts a corresponding distal portion of one of retaining members 155', as shown in Figure 7A. A suitable structure of the distal portion of flexible arm 160 is one that allows flexible arm 160 to bend around an obstacle, such as the distal end of retaining member 155'.

[0127] Indeed, as inner casing 150 retracts toward the proximal portion of distal segment 60, flexible arm 160 bends toward inner casing 150 (shown as an arrow in FIG. 7B ) and slides over retaining member 155′. Embodiments including such a feature may provide audible feedback to the operator (and others working with the operator) of the rate of progress of the release operation of intraocular device 10, perhaps in the form of a clicking sound corresponding to the movement of flexible arm 160.

[0128] As shown in FIGS. 5B and 8, the medical device 200 may include a stopper 400 disposed within the piercing member 510.

[0129] In some embodiments, stopper 400 may be a solid, tubular structure having a contact surface 410 adjacent the proximal end of implant 10 and configured to prevent axial displacement of ocular implant 10 toward the distal end of distal segment 60. In use, ocular implant 10 remains at a specified depth while puncture member 510 is at least partially retracted within internal cavity 15 inside distal segment 60. Stopper 400 and contact surface 410 may be made from any medical-grade material, such as a medical-grade metal, e.g., medical-grade tungsten, titanium, stainless steel, copper, cobalt chromium, aluminum, magnesium, or any alloy thereof, a medical-grade plastic, etc. Preferably, tungsten.

[0130] Ophthalmic procedures In a non-limiting practical implementation of the present disclosure, the medical devices described herein can be used to form drainage channels within the eye with the insertion of an ocular implant into the ocular tissue layers. Advantageously, the procedure can be performed in an outpatient clinic using only local anesthesia, without the need for an operating room. More advantageously, the procedure can be performed in an externa approach.

[0131] In general, the medical devices described herein are designed for use in methods for performing insertion of an ocular implant in an ocular tissue layer to form a drainage channel. After obtaining the medical device, a user can select an unlocked configuration and select an actuation angle between the distal and proximal segments by rotating the distal segment about an axis of rotation at a pivot point.

[0132] For example, performing the insertion can include placing the medical device at a first point relative to the eye and advancing the medical device along the longitudinal axis until the puncture member contacts the exterior surface of the ocular tissue layer, with the puncture member in the first position.

[0133] For example, performing the insertion may further include distally advancing the medical device to cause the puncture member to make an incision in an axial cutting motion in the ocular tissue layer and advancing the puncture member through the incision and into and through the tissue layer. Such advancement may occur, for example, until the puncture member reaches a desired depth. For example, the desired depth may be determined based on one or more markings on the puncture member.

[0134] For example, performing the insertion may further include retracting the puncture member toward the distal end of the distal segment to cause delivery of the ocular implant into the ocular tissue layer. Advantageously, the medical device is configured to securely hold the implant during insertion. Once the implant reaches a desired depth, indicated, for example, by one or more markings (e.g., laser tags), the user can activate the ocular implant release mechanism by simply engaging and releasing a designated control point on the device (e.g., an actuator). This action unlocks the ocular implant release mechanism, as described elsewhere in this document, which allows for controlled release of the implant at a precise location. This design ensures that the implant is not forcibly pushed or positioned, but rather is gently and precisely released at the intended location.

[0135] An actual non-limiting implementation will now be described with reference to the drawings.

[0136] 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 may be separate components that require assembly before use.

[0137] A user can select a desired actuation angle β between the distal segment 60 and the proximal segment 65. In the unlocked configuration, the user rotates the distal segment about an axis of rotation at a pivot point to select an actuation angle β between the distal segment 60 and the proximal segment 65. The user can then use the locking mechanism 80 to lock the distal segment 60 and the proximal segment 65 at the desired actuation angle β. For example, the desired actuation angle β may be selected based on whether the user is right-handed or left-handed, based on the anatomy of the patient's eye, etc.

[0138] The user then positions the medical device 200 at a first point relative to the eye and advances the puncture member 510 along the longitudinal axis of the distal segment 60 until it contacts a tissue layer, for example, the outer surface of the sclera 104. As the medical device 200 is further advanced toward the tissue layer, the puncture member 510 then performs an incision in the ocular tissue layer with an axial cutting action. For example, the incision may be performed using the distal cutting tip 70 of the puncture member 510.

[0139] Use then further involves advancing the medical device 200 toward the tissue layer such that the puncture member 510 penetrates the incision into and through the tissue layer. Notably, advancing the puncture member through the incision into and through the tissue layer is performed until the puncture member reaches a desired depth. For example, the desired depth can be determined based on the position of one or more markings 120 (e.g., laser tagging) on ​​the puncture member relative to the ocular tissue layer, which can serve as a cue for the user to indicate when the desired depth has been reached. For example, one or more markings 120 (e.g., laser tagging) disposed along the puncture member 510 can be present in locations that coincide with the respective positions of the first and second engaging elements 30, 40.

[0140] The user then retracts the puncture member toward the distal end of the distal segment 60, causing the release and delivery of the ocular implant into the ocular tissue layer. This can be accomplished by engaging a control point on the device to unlock the ocular implant release mechanism and cause delivery of the ocular implant 10. For example, the user can engage the actuator 90, which operably couples the actuator 90 to the inner casing 150. For example, engaging the actuator 90 can bring the distal end of the prongs 135 closer to the proximal end of the inner casing 150 such that the engaging elements 140, 145 engage with each other, operably coupling the actuator 90 to the inner casing 150. The user can then release the actuator 90, which retracts the inner casing 150 and the puncture member 510 in a direction toward the proximal portion of the distal segment 60—i.e., in use, away from the ocular tissue layer. For example, releasing the actuator 90 may be performed by releasing finger pressure on the actuator 90 such that a return mechanism causes the actuator 90 to retract toward the first position, and also causes the inner casing 150 and the puncture member 510 to retract toward the proximal portion of the distal segment 60. The presence of stoppers 400, 400′ disposed within the puncture member 510 may be useful to further prevent any back displacement of the ocular implant (i.e., the ocular implant remains in place) as the puncture member 510 retracts toward the distal end of the distal segment 60, which may facilitate gentle and controlled delivery of the ocular implant.

[0141] As will be apparent to the reader, the presence of one or more markings (e.g., laser tags) along the location element 510 can be useful to guide the user as to when he / she should activate the actuator 90. This technique ensures that the implant is not forcibly pushed, but rather remains in its intended position through a controlled and intuitive process.

[0142] In some embodiments, once used, the medical device 200 can be disposed of.

[0143] In some embodiments, when used, the distal segment 60 of the medical device 200 can be discarded and replaced with a distal segment loaded with a new inner casing 150 containing a new ocular implant 10.

[0144] In some embodiments, when in use, the distal segment 60 of the medical device 200 can be opened and loaded with a new inner casing 150 that houses a new ocular implant 10 .

[0145] Other examples of implementations will be apparent to the reader in view of the teachings of this description, and as such will not be further described herein.

[0146] It should be noted that titles or subtitles may be used throughout this disclosure for the convenience of the reader, but in no way should they limit the scope of the invention. Furthermore, certain theories may be proposed and disclosed herein; however, they in no way, right or wrong, should limit the scope of the invention insofar as the invention is made in accordance with this disclosure without regard to any particular theory or scheme of operation.

[0147] All references cited throughout the specification are hereby incorporated by reference in their entirety for all purposes.

[0148] References throughout the specification to "some embodiments," etc., mean that a particular element (e.g., a feature, structure, and / or characteristic) described in connection with the invention is included in at least one embodiment described herein and may or may not be present in other embodiments. Further, it should be understood that the described inventive features may be combined in any suitable manner in the various embodiments.

[0149] It will be understood by those skilled in the art that throughout this specification, the use of the term "a" before a term includes embodiments containing one or more of the term to which the term refers. It will also be understood by those skilled in the art that throughout this specification, the term "comprising," which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.

[0150] Unless defined otherwise, 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 pertains. In case of conflict, the present document, including definitions, will control.

[0151] As used in this disclosure, the terms "around," "about," or "approximately" are generally intended to mean within a margin of error generally accepted in the art. Thus, numerical quantities given herein generally include a margin of error such that the term "around," "about," or "approximately" can be inferred unless explicitly stated. For example, a variation of ±5% is encompassed by the term "around," "about," or "approximately."

[0152] While various embodiments of the disclosure have been described and illustrated, it will be apparent to those skilled in the art in light of this description that numerous modifications and variations are possible, the scope of which is more particularly defined in the appended claims.

Claims

1. 1. A medical device, comprising: a) a proximal segment for the user to grasp; b) ocular implants, and c) a distal segment including a puncture member coupled to and extending therefrom, wherein the puncture member is configured to receive and deliver the ocular implant into an ocular tissue layer to obtain a channel; Including, wherein the proximal segment and the distal segment are configured to couple to each other at a pivot point between an unlocked configuration and a locked configuration, and in the unlocked configuration, the proximal segment and the distal segment are rotatable relative to each other about a rotation axis at the pivot point, a medical device.

2. The medical device of claim 1 , further comprising a locking mechanism for reversibly securing the proximal and distal segments in a locked configuration.

3. 3. The medical device of claim 1 or 2, wherein the puncture member comprises an elongated hollow body for receiving an ocular implant.

4. The medical device of claim 1 , wherein the medical device is configured to retract the puncture member from the extended position to the retracted position.

5. The medical device of claim 1 , wherein the piercing member includes a piercing tip at its distal end.

6. The medical device of claim 1 , further comprising an actuator assembly configured to actuate the puncture member.

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

8. The medical device of claim 7 , wherein the distal segment includes an interior surface defining an interior cavity, and the medical device further includes an interior casing disposed within the interior cavity and configured to couple to the piercing member.

9. The medical device of claim 8 , wherein engagement of the actuator couples the actuator with the inner casing.

10. 10. The medical device of claim 9, wherein release of the actuator causes axial displacement of the inner casing toward the proximal end of the distal segment, which retracts the piercing member toward the distal segment.

11. 11. The medical device of any one of claims 1 to 10, wherein the medical device further comprises an ocular implant, wherein the ocular implant has an elongate body with an interior surface defining a substantially continuous lumen, and the ocular implant is contained within the puncture member.

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

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

14. 14. The medical device of 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 about 13.0 mm.

15. An ocular implant comprising: an elongate body having an interior surface defining a lumen forming a corresponding channel; and first and second engaging elements located on the surface of the elongate body, wherein the first and second engaging elements extend away from the surface of the elongate body, the first and second engaging elements are in a spaced apart relationship along the surface of the elongate body, and the first and second engaging elements are compressible toward the elongate body.

16. 16. The ocular implant of claim 15, wherein the first and second engaging elements are angled toward each other.

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

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

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

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

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

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

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

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

25. 25. The method of claim 24, wherein performing the insertion comprises positioning the medical device at a first point relative to the eye and advancing the medical device along the longitudinal axis of the distal segment until the puncture member contacts an exterior surface of the ocular tissue layer.

26. 26. The method of claim 25, wherein performing the insertion further comprises advancing the medical device to cause the puncture member to perform an incision in an axial cutting motion in the ocular tissue layer, and advancing the puncture member through the incision and into and through the tissue layer.

27. 27. The method of claim 26, wherein advancing the puncture member through the incision and into and through the tissue layers is performed until the puncture member reaches a desired depth.

28. 28. The method of claim 27, wherein the desired depth is determined based on the position of one or more markings on the puncture member relative to the ocular tissue layer.

29. 29. The method of any one of claims 26 to 28, wherein performing the insertion further comprises retracting the puncture member toward the distal end of the distal segment, which causes release and delivery of the ocular implant into the ocular tissue layer.

30. 1. A medical device, comprising: a) a proximal segment for the user to grasp; b) ocular implants; c) a distal segment including a puncture member coupled to and extending therefrom, wherein the puncture member is configured to receive and deliver the ocular implant into an ocular tissue layer to obtain a channel; Including, A medical device wherein the puncturing member includes one or more markings on a surface thereof that indicate when the puncturing member has reached a desired depth into the ocular tissue layer.

31. 31. The medical device of claim 30, wherein the ocular implant comprises an elongate body having an interior surface defining a lumen forming a channel, and first and second engaging elements located on the surface of the elongate body, wherein the first and second engaging elements are configured to engage with or abut an ocular tissue structure to prevent movement of the ocular implant relative to the eye.

32. 32. The medical device of claim 31 , wherein the one or more markings include a first marking and a second marking disposed on the surface of the puncture member at locations that correspond to the respective positions of the first and second engaging elements.

33. 33. The medical device of claim 32, wherein the first marking and the second marking are disposed on the surface of the puncture member at a distance of about 1.8 mm to about 2.2 mm, preferably 2.0 mm, from each other.

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

35. 35. The medical device of 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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