Apparatus and methods for creating channels in ocular tissue layers to treat ocular conditions

Abstract

Glaucoma surgical treatment involves creating a scleral-corneal drainage channel to ensure a long-lasting controlled fluid flow and reduce intraocular pressure. Limitations involve collateral damage to adjacent structures and the result is heavily dependent on the surgeon's expertise. The device described in this document solves such drawbacks. The device comprises a body for grasping, a puncturing member comprising a proximal segment and a distal segment, the distal segment comprising a puncturing tip at its distal end, and a distal stabilizer element extending from the distal end of the body, the distal stabilizer element comprising a lumen, wherein the puncturing member is configured to reciprocate between a storage position, in which the proximal segment is retracted inside the stabilizer lumen and the puncturing tip extends outwardly from the stabilizer, and an extended position, in which at least a portion of the proximal segment and the distal segment extend outwardly from the stabilizer.

Description

Cross-reference to related applications

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 623,894, filed January 23, 2024; U.S. Provisional Patent Application Serial No. 63 / 567,580, filed March 20, 2024; and UK Patent Application Serial No. 2417304.9, filed November 26, 2024. The contents of each of the foregoing references are incorporated herein by reference in their entirety. Technical Field

[0002] This disclosure relates to an apparatus and method for creating channels in ocular tissue layers for the specific purpose of treating ocular diseases or conditions. Background Technology

[0003] Glaucoma is a group of eye diseases characterized by optic nerve damage, possibly related to elevated intraocular pressure (IOP). Glaucoma is a leading cause of irreversible blindness worldwide. The primary goal of treatment is to lower IOP through medication or surgical procedures. Typically, surgical procedures and medical devices used to treat eye conditions such as glaucoma are based on intraocular (endoscopic) approaches. ab interno )) or external (external approach) ab externo )) method.

[0004] Surgical procedures involving the creation of scleral-corneal drainage channels have been proposed, with the goal of ensuring sustained, controlled fluid flow and reducing intraocular pressure.

[0005] For example, the use of the Kelly punch in ophthalmic surgery, while effective in creating precise channels or openings in ocular tissue, has several limitations that affect its broader applicability. Typically, this technique requires creating a conjunctival incision or dissecting a scleral flap to access the target tissue. Using the Kelly punch, a small segment of sclera or trabecular tissue is removed to create a direct drainage pathway. This opening facilitates the outflow of aqueous humor from the anterior chamber to the subconjunctival filtering bleb or other drainage area. The scleral flap and conjunctival layer are carefully repositioned and sutured to ensure proper wound healing while maintaining the drainage pathway. Despite its clinical applicability, Kelly punch surgery has certain limitations. For example, due to the manual nature of the procedure, the size and location of the created drainage channel may vary, potentially affecting the outcome. For instance, mechanical tissue removal using the Kelly punch may result in collateral damage to adjacent structures, leading to inflammation or prolonged recovery—the outcome is heavily dependent on the surgeon's expertise and requires a steep learning curve to achieve consistent results. Finally, the fixation design of the Kelly bite cutter may not be ideal for all anatomical variations, reducing its applicability in complex or atypical cases.

[0006] To address these challenges, alternative methods such as minimally invasive microsclerosing surgery (MIMS) have been proposed in U.S. Patent Application Publication No. 2020 / 0129331 (Sanoculis). MIMS technology eliminates the need for conjunctival or scleral flaps, creating a scleral channel using a minimally invasive device. While this method reduces tissue trauma and shortens surgical recovery time, it is not without its limitations. The size and positioning of the channel are predetermined by the device, a relatively large surgical system consisting of a multi-purpose control touchscreen, foot pedal, and disposable handpiece unit. Furthermore, achieving consistent results can be challenging in patients with variations in scleral thickness or anatomy. The high initial cost of the MIMS device and the need for specialized training further limit its accessibility and adoption in certain clinical settings. Importantly, MIMS… TM The system requires an operating room to prevent the conjunctiva or other eye tissues from getting stuck by the rotating cutting element.

[0007] These shortcomings highlight the need for continuous innovation to develop solutions that combine the precision of traditional approaches with the minimally invasiveness and simplicity of new ones, without compromising flexibility or accessibility. Summary of the Invention

[0008] This summary is provided to introduce, in a simplified form, some concepts 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 a broad aspect, this disclosure relates to an apparatus comprising: a body configured for gripping; a puncture member including a proximal segment and a distal segment, the distal segment including a puncture tip at its distal end; and a distal stabilizer element extending from the distal end of the body, the distal stabilizer element including a lumen, wherein the puncture member is configured to reciprocate between (i) a storage position and an extension position (ii) in the storage position, wherein the proximal segment is retracted within the stabilizer lumen and the puncture tip extends outward from the stabilizer, and in the extension position, at least a portion of the proximal segment and the distal segment extend outward from the stabilizer.

[0010] This device is particularly suitable for creating drainage channels in the tissue layers of the eye, such as the human eye.

[0011] In some embodiments, the device includes one or more of the following features: • The proximal segment is connected to the distal segment via a connecting wall, wherein the connecting wall is configured to define an open cavity nested between the distal edge of the proximal segment and the proximal edge of the distal segment.

[0012] • The distal segment also includes a medial protrusion at its proximal end, which includes a puncture edge.

[0013] • The puncture tip and the inner protrusion are aligned along the corresponding first longitudinal axis and second longitudinal axis, which are parallel to each other.

[0014] • In the storage position, the puncture member is configured to perform a first cutting motion on a first surface of the tissue layer using the puncture tip.

[0015] • The movement of the puncture member from the storage position to the extension position is configured to puncture the tissue layer such that the puncture tip passes through the tissue layer and extends beyond the second surface of the tissue layer, with the first and second surfaces opposite each other.

[0016] • The movement of the puncture member from the protruding position to the storage position is configured to perform a second cutting motion on the second surface of the tissue layer using the inner protrusion, the first cutting motion and the second cutting motion together forming a channel through the tissue layer.

[0017] • The first cutting motion and the second cutting motion are coaxial.

[0018] • The open cavity has a length sufficient to receive a soft tissue segment corresponding to the channel, preferably from about 1.50 mm to about 2.50 mm.

[0019] • The distal stabilizer element includes a distal end configured to abut against a first surface of the tissue layer after the first cutting motion.

[0020] • It also includes an actuator assembly configured to reciprocate the puncture member between a storage position and an extension position.

[0021] • The actuator assembly includes a manually operable actuator, and wherein the actuator assembly is further configured to operatively couple the actuator to the puncture member.

[0022] • The device body includes an inner surface defining an internal cavity, wherein the actuator assembly includes a rod extending through the internal cavity, and wherein the rod is configured to operatively couple the actuator to the puncture member.

[0023] • The puncture member has one or more of the following: a length of about 20 mm to about 50 mm; an outer diameter of about 0.050 mm to about 3.000 mm; an inner cross-section that is substantially circular with an inner diameter of about 0.040 mm to about 0.075 mm; and a body with a wall thickness of about 0.050 mm to about 0.400 mm.

[0024] • The puncture member consists of a larger radius on the proximal portion and a smaller radius near its distal portion.

[0025] In a broad aspect, this disclosure relates to a method comprising: obtaining a device as described herein, and forming a drainage channel in the ocular tissue layer by reciprocating motion of a puncture member entering and exiting the ocular tissue layer.

[0026] All features of the exemplary embodiments described in this disclosure, which are not mutually exclusive, can be combined with each other. Elements of one embodiment may be used in other embodiments without further mention. Other aspects and features of the invention will become apparent to those skilled in the art upon reading the following description of specific embodiments in conjunction with the accompanying drawings. Attached Figure Description

[0027] In this document, a detailed description of specific exemplary embodiments is provided below with reference to the accompanying drawings, in which: Figure 1 This is a cross-sectional diagram of the human eye.

[0028] Figure 2 This is a non-limiting perspective view of an embodiment of an apparatus for generating channels in ocular tissue layers according to an embodiment of the present disclosure.

[0029] Figure 3A It is based on the embodiments of this disclosure. Figure 2 A non-limiting cross-sectional perspective view of an embodiment of the device, wherein the actuator is in a first position.

[0030] Figure 3B It is based on the embodiments of this disclosure. Figure 3A A non-restrictive cross-sectional side view of the device, wherein the actuator is in the second position.

[0031] Figure 3C It is based on the embodiments of this disclosure. Figure 2 A non-limiting cross-sectional perspective view of another embodiment of the device, wherein the actuator is in a first position.

[0032] Figure 3D It is based on the embodiments of this disclosure. Figure 3A A non-restrictive cross-sectional side view of the device, wherein the actuator is in the second position.

[0033] Figures 4A to 4E It is an embodiment of the present disclosure for use with Figure 2 A non-restrictive view of a puncture component used together with a device to create a drainage channel in a patient's eye.

[0034] Figures 5A to 5D The use of silicone eye models according to embodiments of this disclosure and Figure 2 Non-restricted images of a device used to simulate ophthalmic surgery.

[0035] Figures 6A to 6C This is a non-limiting flowchart illustrating the steps of an ophthalmic surgical procedure for creating a drainage channel in a patient's eye according to an embodiment of the present disclosure.

[0036] Figure 7 This is a non-limiting side view illustration of a perforated tissue layer performed in an ophthalmic procedure to create a drainage channel in a patient's eye using the apparatus described herein, according to embodiments of this disclosure.

[0037] Figures 8A to 8C It is an embodiment of the present disclosure for use with Figure 2 Non-limiting perspective views of different embodiments of a puncture component used together with a medical device to create a drainage channel in a patient's eye.

[0038] Figures 8A1 to 8C1 Based on the embodiments of this disclosure and Figures 8A to 8C1 Non-limiting perspective views of each embodiment of the puncture component, shown together with the stabilizer.

[0039] Figure 9A and Figure 9B It is an embodiment of the present disclosure for use with Figure 2 Non-limiting perspective views of different embodiments of a puncture component used together with a medical device to create a drainage channel in a patient's eye.

[0040] Figure 10 Use according to embodiments of this disclosure outer road Method Figure 2 The device 200 for creating channels in the ocular tissue layer and the use of Inner road Method Figure 2 A non-restrictive top view of variant 200' used to generate channels in the ocular tissue layer.

[0041] Exemplary embodiments are illustrated by way of example in the accompanying drawings. It should be clearly understood that the specification and drawings are for illustrative purposes only and to aid understanding. They are not intended to limit the scope of this disclosure. Detailed Implementation

[0042] The present invention will be explained in more detail below. This specification is not intended to exhaustively list all different ways of implementing the technology, or all features that can be added to the technology. For example, features shown with respect to one embodiment may be incorporated into other embodiments, and features shown with respect to a particular embodiment may be removed from that embodiment. Furthermore, upon consideration of this disclosure, numerous variations and additions to the various embodiments presented herein will become apparent to those skilled in the art, without departing from the present invention. Therefore, the following description is intended to illustrate some embodiments of the technology, rather than to exhaustively describe all its permutations, combinations, and variations.

[0043] This article describes a device configured to form channels in a tissue layer. For example, a tissue layer of the eye used for treating eye conditions or diseases. For example, a drainage channel used to reduce intraocular pressure. For example, the eye can be a human eye.

[0044] In some embodiments, the device is configured to form a drainage channel in the ocular tissue layer through the reciprocating motion of the puncture member entering and exiting the ocular tissue layer.

[0045] For example, precisely forming a drainage channel can involve axial cutting motion using a puncture member. Advantageously, forming a drainage channel does not involve rotational cutting motion.

[0046] For example, forming a drainage channel may include a first axial cutting motion on a first surface of the tissue layer to form a first incision, and a second axial cutting motion on a second surface of the tissue layer to form a second incision, and removal of soft tissue segments, thereby forming a channel. For example, the first and second surfaces are located on opposite sides of the tissue layer.

[0047] Readers will easily understand that in this specification, "axial cutting motion" refers to cutting motion along an axis, as opposed to cutting motion using rotational motion.

[0048] In some implementations, the medical device is configured to remove a soft tissue segment from the ocular tissue layer bordering the anterior chamber, thereby enabling the drainage of excess fluid from within the anterior chamber.

[0049] In some embodiments, the medical device is configured to perform [operation] in the ocular tissue layer. outer road perforation.

[0050] In some embodiments, the medical device is configured to perform [operation] in the ocular tissue layer. Inner road perforation.

[0051] In some implementations, the medical device can be beneficial for treating glaucoma.

[0052] In some implementations, the drainage channel is a supportless functional channel, i.e., a tubeless channel.

[0053] Advantageously, the medical device and method of use described herein can be used to obtain a channel in the ocular tissue layer bordering the anterior chamber without creating a conjunctival incision or scleral flap. In other words, a drainage channel is formed in the ocular tissue layer by contacting the medical device with the intact ocular tissue layer.

[0054] In some embodiments, the surgical and medical devices described herein can be used to form a drainage channel in the tissue layer of the eye, wherein the drainage channel has a length of about 1.0 mm to about 2.5 mm (inclusive of any value or range therein). For example, a length of about 1.0 mm, about 1.5 mm, about 2.0 mm, or about 2.5 mm.

[0055] The inventors of this invention have surprisingly observed that commercial ophthalmic medical devices or systems have one or more drawbacks that are more readily observed by medical practitioners when performing ophthalmic surgery, and have provided at least one or more of the following advantageous features.

[0056] For example, the medical device described herein can be used in a clinical office environment without the need for an operating room.

[0057] For example, the medical device described herein can be used to create drainage channels in the ocular tissue layer through axial cutting motion, i.e., without the need for a rotating cutting tool, thereby minimizing the risk of damage to the ocular tissue caused by a rotating cutting tool.

[0058] For example, the medical device described herein allows for greater flexibility and ease of operation when configured for holding and manipulating with one hand, compared to existing bulky surgical MIMSs that require both foot pedal operation and hand gripping. TM The system forms a comparison.

[0059] For example, the medical device described herein allows for greater flexibility and ease of use in being usable by both left- and right-handed users (it can be used with both hands). Users can be medical practitioners, such as ophthalmologists.

[0060] For example, the medical device described herein may be a single-use device, thereby reducing the sterilization requirements of reusable systems.

[0061] For example, the medical device described herein and its related methods of use discussed herein demonstrate significant efficacy and practicality in the precise extraction of soft tissue. This is achieved by creating a well-defined, controlled pathway within the tissue layer. It should be noted that, as used herein, a “channel” refers to a pathway formed within the tissue after the corresponding soft tissue segment has been removed from the body. It is important to note that no components (such as implants) remain in the body to establish or maintain the integrity of the created channel.

[0062] For example, channels created using the medical device described herein offer significant advantages compared to other methods involving the placement of implants within tissue to ensure fluid drainage. This is because, using the medical device described herein and the relevant methods of use discussed herein, no residue remains within the tissue other than a gap, opening, or channel (where applicable) created between the two sidewalls of a specific tissue layer. To clarify, the resulting channel is essentially a hole through the tissue layer, with no artificial tubes or shunts within the target tissue. Therefore, the created channel can exhibit dynamic characteristics, acting as a pressure regulator. The channel can adjust its drainage efficiency by changing its size in response to pressure at both ends. As the pressure gradient increases, the channel opens or expands, and conversely, as the pressure gradient decreases, the channel closes or shrinks accordingly.

[0063] Based on this disclosure, such technical advantages of the medical devices and procedures described herein will become more apparent to those skilled in the art.

[0064] Eye structure First, a brief description of the relevant structures of the eye will be provided to give context to the anatomical terminology used in this article.

[0065] Figure 1 This is a stylized depiction of a normal human eye 50. For clarity and convenience, certain anatomical details well known to those skilled in the art have been omitted. The anterior chamber 100 is shown defined on its anterior surface by the cornea 102. The cornea 102 connects peripherally to the sclera 104, which is the tough fibrous tissue forming the white outer shell of the eye. The trabecular meshwork 106 lies on the outer periphery of the anterior chamber 100. The trabecular meshwork 106 extends 360 degrees circumferentially around the anterior chamber 100. Located on the outer peripheral surface of the trabecular meshwork 106 are the Schlem's canals 108. The Schlem's canals 108 extend 360 degrees circumferentially around the trabecular meshwork 106. At the apex formed between the iris 110, the trabecular meshwork 106, and the sclera 104 is the anterior chamber angle 112.

[0066] Medical devices Figure 2 and Figure 10 Non-limiting implementations of a medical device arranged and configured in accordance with certain features, aspects, and advantages of this disclosure are shown. The illustrated medical device can be used to create channels in tissue layers, particularly drainage channels in ocular tissue layers, or can be any other type of medical device that will benefit from any or all of the features, aspects, and advantages described below in this disclosure.

[0067] As used herein, the term "tissue layer" encompasses both a single tissue layer and a collection of multiple layers (such as adjacent stacked layers (multiple layers) or distinct layers). However, the default interpretation usually refers to a single tissue layer. Additionally, when "tissue layer" is mentioned, it generally refers to a tissue wall characterized by a specific thickness and two sides (lateral and medial, or proximal and distal). In this context, the formed channel or opening extends between these two sides of the tissue wall. For example, this channel could be located at the sclerocorneal junction of an individual eye. This application can be used to treat glaucoma by reducing intraocular pressure, for example, by promoting fluid communication between the anterior chamber of the eye and the interface connecting the outer scleral tissue and the conjunctival tissue, or in the subconjunctival or subglottic region.

[0068] In some embodiments, the medical device 200 includes a body 210 for grasping. For example, the body extends along a longitudinal axis Ω, such as... Figure 2 As shown.

[0069] In some embodiments, the body 210 may be formed of a first housing segment 240 and a second housing segment 260. For example, the first housing segment 240 and the second housing segment 260 may be configured for assembly onto each other by any suitable coupling means.

[0070] like Figures 2 to 3D As shown in the figures, for example, the coupling device may include a plurality of screws 10 for screwing the first housing segment 240 and the second housing segment 260 together to form the body 210. In other embodiments, the first housing segment 240 may include a plurality of circumferentially spaced protrusions 66. Correspondingly, the second segment 260 may include a plurality of circumferentially spaced recesses that receive corresponding protrusions 66 for assembling the first housing segment 240 and the second housing segment 260 to form the body 210.

[0071] In some embodiments, the body 210 may have at least one segment of its surface that is raised, recessed, grooved, or textured to improve the user's grip or enhance user comfort. The user may be a medical practitioner, such as an ophthalmologist.

[0072] In some embodiments, the body 210 can be autoclaved or otherwise sterilized. For example, the body 210 can be made of any suitable material, such as, but not limited to: polyethylene (PE), including low-density PE, high-density PE, or ultra-high molecular weight PE; polypropylene (PP); polytetrafluoroethylene; thermoplastic polyurethane; polycarbonate; polyphthalic acid; acrylic acid; acrylonitrile-butadiene-styrene copolymer (ABS); silicone, etc.

[0073] In some embodiments, the body 210 may be configured to have a shape that facilitates operation of the medical device 200. For example, during use, a user may bend and grasp the medical device 200 on a first side of the body 210 with one or more fingers (e.g., the middle finger) and bend and grasp it oppositely on a second side of the body 210 with the thumb, the first side being opposite to the second side.

[0074] In some embodiments, the body 210 may have suitable dimensions to facilitate operation of the medical device 200. For example, the body 210 may have a length LD of about 50 mm to about 150 mm (inclusive of any value or range). For example, the length LD is about 55 mm, about 60 mm, about 65 mm, about 70 mm, about 75 mm, about 80 mm, about 85 mm, about 90 mm, about 95 mm, about 100 mm, about 110 mm, about 120 mm, about 130 mm, about 140 mm, or about 150 mm. For example, a length LD of about 74 mm. For example, the body 210 may have a height H of about 10 mm to about 30 mm (inclusive of any value or range). For example, a height H of about 10 mm, about 15 mm, about 20 mm, about 25 mm, or about 30 mm. For example, a height H of about 15 mm. For example, the body 210 may have a depth D of about 8 mm to about 20 mm (inclusive of any value or range). For example, a depth D of about 8 mm, about 10 mm, about 12 mm, about 14 mm, about 16 mm, about 18 mm, or about 20 mm. For example, a depth D of about 12.5 mm.

[0075] The medical device 200 described herein includes components that can be adapted for specific ophthalmic surgeries. It will be apparent to the reader that the components described below are configured to operate in the eye (such as the human eye) to form a drainage channel. In some implementations, the medical device 200 may include other components that can benefit from the features and advantages described herein and can be adapted for similar ophthalmic surgeries.

[0076] puncture component In some embodiments, the medical device 200 described herein is equipped with a puncture member to form a channel in the tissue layer. This puncture member is particularly suitable for forming a drainage channel in the ocular tissue layer.

[0077] In a non-limiting practical implementation, the medical device 200 includes a puncture member 400. For example... Figure 2 As shown, the puncture member 400 may have a proximal portion that is partially housed within the distal end of the medical device 200. Figures 4A to 4E Details of the puncture member 400 shown in the figure.

[0078] In some embodiments, the puncture member 400 extends along the longitudinal axis Ω.

[0079] In some embodiments, the medical device 200 is configured to perform a perforation in the ocular tissue layer using a puncture member 400. As will be discussed further later herein, the medical device 200 is configured to perform such a perforation using the puncture member 400 via an axial cutting motion, i.e., without rotational motion.

[0080] For example, a perforation includes at least two cuts that complement each other to form a channel.

[0081] For example, the medical device 200 can be configured to make a first incision 1100 on a first surface of a tissue layer, such as the sclera 104, using a puncture member 400. For example, the first incision 1100 can be made by cutting the tissue layer at a first point of entry using the puncture member 400, such as... Figure 7 As shown.

[0082] For example, the medical device 200 may be positioned at a first point relative to the eye and advanced along a longitudinal axis until the puncture member 400 contacts a first surface of the ocular tissue layer. Advantageously, the ocular tissue layer is intact, i.e., without scleral folds. At this point, the puncture member 400 is referred to as being in the first position (relative to the medical device 200 or its components). As the medical device 200 advances further toward the tissue layer, the puncture member 400 then performs a first incision 1100 from the first position. Advantageously, the puncture member 400 is capable of performing the first incision 1100 by a first axial cutting motion. In other words, the cutting motion does not require any rotational motion of the puncture member 400 or the medical device 200. Given the teachings described herein, it will be apparent to the reader that such axial cutting motions are generally safer than the rotational cutting motions of existing systems or medical devices, which can cause damage to surrounding ocular tissues.

[0083] For example, the puncture member 400 can also be configured to penetrate and pass through the tissue layer as the medical device 200 is axially displaced toward the tissue layer. Advantageously, the puncture member 400 is configured to penetrate and pass through the tissue layer smoothly and easily with minimal force, so that the puncture member can have a smooth (e.g., polished) outer surface to minimize friction during penetration and passage through the tissue layer.

[0084] For example, once the puncture member 400 has reached the desired depth of penetration into and through the tissue layer, the medical device 200 can also be configured to axially move the puncture member 400 away from the body 210 (or its components) to a second position. In use, the medical device 200 moves (extends) the puncture member 400 away from the body 210 (or its components) to the second position while maintaining the same position relative to the eye. This extension allows the puncture member 400 to position at least its distal segment 412 outside the second surface of the tissue layer. The first and second surfaces of the tissue layer are spaced apart from and opposite each other, for example, the two sides of a tissue wall, such as the two sides of the sclera 104.

[0085] For example, the medical device 200 may be configured to make a second incision 1150 in a second surface of the tissue layer using a puncture member 400. For example, the second incision 1150 may be made by cutting the tissue layer at a second entry point using the puncture member 400. For example, each of the first and second entry points may be spaced apart from each other.

[0086] For example, the medical device 200 can be configured to retract the puncture member 400 toward the body 210 (or its components) from a second position back to a first position.

[0087] The reader will recognize that, advantageously, the first and second positions are along the same axis.

[0088] In use, the medical device 200 can be configured to retract the puncture member 400 from a second position to penetrate the second surface of the tissue layer, performing a second incision 1150 on the second surface of the tissue layer, while the medical device 200 remains in the same position relative to the eye. The movement of the puncture member 400 back to the first position further causes the puncture member 400 to enter and penetrate the tissue layer in the opposite direction to the direction performed when extending the puncture member 400 away from the body 210 (or its components). The direction of displacement of the puncture member 400 into and through the tissue layer is opposite to the direction performed when extending the puncture member 400 away from the body 210 (or its components), thereby completing the perforation 1200 and creating a drainage channel 500.

[0089] For example, the first incision 1100 and the second incision 1150 may each have complementary shapes to form the cross-section of the perforation 1200. Typically, the perforation 1200 represents the cross-section of the drainage channel 500. For example, when the cross-section of the drainage channel 500 is substantially circular, the first and second incisions may each form a portion of the complete perforation cross-section, such that they together form a substantially circular perforation. Therefore, the medical device 200 described herein allows the removal of a predefined soft tissue segment from the ocular tissue layer, thereby creating a corresponding drainage channel 500 with a predetermined geometry and orientation between two sidewalls of the tissue layer. For example, when each of the first incision 1100 and the second incision 1150 has a semi-circular shape that together forms the circular cross-section of the perforation 1200, the first entry point and the second entry point may each include corresponding vertices 1125, 1175 of the respective semicircles, these vertices being spaced apart from each other, such as... Figure 7 As shown.

[0090] Now refer to Figures 4A to 4E as well as Figures 9A to 9B Further details regarding the puncture component 400 will be discussed.

[0091] In some embodiments, the puncture member 400 includes a distal segment 412 configured to perform the first incision 1100. For example, the distal segment 412 may include a puncture tip 470 at its distal end, configured to cut tissue layers to perform the first incision 1100. For example, the puncture tip 470 may have a suitable cutting edge geometry, such as a beveled tip needle core, a beveled tip needle cannula, a lancet point needle core, a posterior beveled needle core, a posterior beveled needle cannula, etc. For example, the puncture tip 470 may have a primary bevel angle φ2 of about 15° to about 30° (preferably about 20°).

[0092] In some embodiments, the puncture member 400 has an elongated body with any needle gauge suitable for puncturing tissue layers and forming a perforation of a corresponding size, sufficient to form a drainage channel of the desired size in an eye (such as a human eye). For example, any needle gauge sizes listed in Table 1.

[0093] In some embodiments, the elongated body of the puncture member 400 may have a combination of needle gauge dimensions, for example, a larger radius on the proximal portion to increase strength, and a smaller radius near its distal portion (e.g., close to or at the tip) to allow for puncturing small incisions in the eye. For example, the elongated body of the puncture member 400 may have a proximal portion dimension corresponding to a 23GA needle gauge size, which tapers toward or at the tip to approximately a 27GA needle gauge size. The reader will understand that any other suitable combination of needle gauge dimensions may also be implemented in a particular embodiment.

[0094] Typically, when creating a drainage channel in a patient's eye, the medical device 200 is configured to remove a soft tissue segment from the eye.

[0095] In some embodiments, the distal segment 412 may also include a medial protrusion 412P at its proximal end. The medial protrusion 412P is configured to contact a second surface of the tissue layer when the medical device 200 retracts the puncture member 400 toward the body 210. The medial protrusion 412P includes a puncture edge such that the retraction movement of the puncture member 400 toward the body 210 initially causes the medial protrusion 412P to perform a second incision 1150 in the tissue layer. The retraction movement of the puncture member 400 toward the body further drives the medial protrusion 412P into and through the tissue layer, thereby completing the perforation. When the perforation is completed, the puncture member 400 cuts and removes a soft tissue segment from the tissue layer to form a drainage channel 500.

[0096] In some embodiments, the inner protrusion 412P may have sharp edges, each sharp edge forming an angle φ1 relative to the axis x passing through the tip of the inner protrusion 412P and extending through the puncture tip 470, the angle being about 25° to about 45°, including any value therein. For example, the angle φ1 is about 25°, about 30°, or about 35°.

[0097] In some embodiments, the puncture tip 470 and the inner protrusion 412P are aligned along a corresponding first longitudinal axis α and a second longitudinal axis β, which are parallel to each other.

[0098] In some embodiments, the elongated body of the puncture member 400 may have a proximal segment 414 connected to the distal segment 412 via a connecting wall 416. For example, the connecting wall 416 may have a sloping edge formed over at least a portion between the distal segment 412 and the proximal segment 414. The presence of such a sloping edge can reduce stress points caused by bending when the puncture member 400 is introduced into the tissue layer.

[0099] In some embodiments, the connecting wall 416 may be configured to define an open cavity 420 nested between the distal edge 414D of the proximal segment 414 and the proximal edge 412E of the distal segment 412. This open cavity 420 may be configured to receive at least a portion of a soft tissue segment removed from the tissue layer, preferably the entire removed soft tissue segment.

[0100] For example, the proximal edge 412E may be located at the base of the inner protrusion 412P.

[0101] In some embodiments, the elongated body of the puncture member 400 or a portion thereof (e.g., the distal segment 412) may have a cylindrical shape with a circular or substantially circular lateral outer cross-section, such as Figure 4DAs shown. For example, the elongated body of the puncture member 400 can have a shape corresponding to the cross-section of the desired drainage channel. For example, when the puncture member 400 has an elongated body with a circular or substantially circular lateral outer cross-section, the resulting drainage channel 500 has a circular or substantially circular cross-section 1200, as shown. Figure 7 As shown.

[0102] In some embodiments, the elongated body or a portion thereof (e.g., distal segment 412) of the puncture member 400 may be hollow at least in one section. In other embodiments, the elongated body or a portion thereof (e.g., distal segment 412) of the puncture member 400 may be hollow along its entire length. In other embodiments, the elongated body or a portion thereof (e.g., distal segment 412) of the puncture member 400 is solid (i.e., not hollow).

[0103] In some embodiments, the elongated body of the puncture member 400 is configured to penetrate a tissue layer over at least a portion of its length. For example, the elongated body of the puncture member 400 can have any suitable length for creating a drainage channel in an eye (such as a human eye). For example, the elongated body of the puncture member 400 can have a length of about 20 mm to about 60 mm (inclusive of any value or range therein). For example, lengths of about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, about 50 mm, about 55 mm, or about 60 mm. For example, in order to perform... outer road In surgery, the slender body of the puncture component 400 can have a length of about 30 mm, about 35 mm, or about 40 mm.

[0104] In some embodiments, the puncture member 400 includes an elongated body or a portion thereof (e.g., distal segment 412) configured to perform a perforation in the tissue layer to obtain a channel of desired size. The elongated body of the puncture member 400 may have dimensions corresponding to the needle gauges listed in Table 1: Table 1

[0105]

[0106] For example, the puncture element 400 can have a 27G needle gauge size.

[0107] In some embodiments, the puncture member 400 includes a proximal segment 414 and a distal segment 412, wherein the distal segment 412 includes a puncture tip 470 at its distal end. The puncture member 400 is configured to reciprocate from a storage position to an extended position. In the storage position, the proximal segment 414 is retracted within the lumen of the distal stabilizer element 220 (described elsewhere herein), and the puncture tip 470 extends outward from the stabilizer. In the extended position, at least a portion of the distal segment 412 and the proximal segment 414 extend outward from the stabilizer.

[0108] Figures 8A to 8C Variations 400', 400”, and 400”' of the puncture member 400 are shown. Figures 8A to 8C 400', 400”, 400”', and the corresponding stabilizing element 200 (described later herein) are shown. Such variants retain a combination of features suitable for performing the perforations described herein to access the tissue layer to obtain a channel of desired size. Notably, the cavity 420 may be defined between two cutting edges 412P and 414D.

[0109] For example, the elongated body or portion thereof of the puncture member 400 (e.g., the distal segment 412) may have an outer diameter dimension Z1 of about 0.050 mm to about 3.000 mm (inclusive of any value or range therein). Examples of outer diameter dimensions Z1 include about 0.050 mm, about 0.100 mm, about 0.150 mm, about 0.200 mm, about 0.250 mm, about 0.300 mm, about 0.350 mm, about 0.400 mm, about 0.425 mm, about 0.450 mm, about 0.475 mm, about 0.500 mm, about 0.600 mm, about 0.700 mm, about 0.750 mm, about 0.800 mm, or about 1.000 mm. Examples of outer diameter dimensions Z1 include about 0.630 mm, about 0.640 mm, or about 0.650 mm.

[0110] For example, the elongated body or portion thereof of the puncture member 400 (e.g., the distal segment 412) may have an inner diameter dimension W of about 0.040 mm to about 0.075 mm (inclusive of any value or range therein). For example, an inner diameter dimension W of about 0.040 mm, about 0.045 mm, about 0.050 mm, about 0.055 mm, about 0.060 mm, about 0.065 mm, about 0.070 mm, or about 0.075 mm. For example, an inner diameter dimension W of about 0.060 mm, about 0.065 mm, or about 0.070 mm.

[0111] In some embodiments, the elongated body or a portion thereof of the puncture member 400 (e.g., the distal segment 412) may have a wall thickness L of any suitable size. For example, a wall thickness L of about 0.050 mm to about 0.400 mm (inclusive). For example, a wall thickness L of about 0.050 mm, about 0.100 mm, about 0.150 mm, about 0.200 mm, about 0.250 mm, about 0.280 mm, about 0.300 mm, about 0.320 mm, about 0.340 mm, or about 0.360 mm. For example, a wall thickness L of about 0.300 mm, about 0.320 mm, or about 0.340 mm.

[0112] In some embodiments, the open cavity 420 may have a length measured between the distal edge 414D of the proximal segment 414 and the proximal edge of the distal segment 412, the length having any suitable size to receive and accommodate the soft tissue segment. For example, a length of about 1.50 mm to about 2.50 mm (inclusive). For example, a length of about 2.00 mm, about 2.10 mm, or about 2.20 mm.

[0113] In some embodiments, the open cavity 420 may have any suitable lateral height to receive and accommodate soft tissue segments. For example, a lateral height of about 0.200 mm to about 0.350 mm (inclusive). For example, a lateral height of about 0.220 mm, about 0.240 mm, about 0.260 mm, about 0.280 mm, about 0.300 mm, or about 0.320 mm. For example, a lateral height of about 0.260 mm, about 0.280 mm, or about 0.300 mm.

[0114] In some embodiments, components of the puncture member 400 may be made of a sufficiently hard and tough material that is rigid and will not bend when pushed / inserted / propelled through the tissue layer. For example, components of the puncture member 400 may be made of any medical-grade material, such as: medical-grade metals, such as medical-grade tungsten, titanium, stainless steel, copper, cobalt-chromium alloys, aluminum, magnesium, or any alloy thereof; medical-grade plastics, etc. Preferably, nitinol (nickel-titanium alloy), 17-7 PH stainless steel (chromium-nickel-aluminum, austenitic stainless steel), or 400 series stainless steel.

[0115] In some embodiments, the puncture member 400 can be manufactured by laser ablation. Advantageously, the puncture member 400 can be coated with an anti-stick coating to minimize or avoid adhesion to ocular tissue during use. For example, the puncture member 400 can be coated with a polytetrafluoroethylene (PTFE) coating to improve the cutting and penetration properties of the puncture member 400.

[0116] Distal stabilizer element In a non-limiting practical implementation, the medical device 200 also includes a distal stabilizer element 220 coupled to the distal end of the body 210 and extending from the distal end along the longitudinal axis Ω.

[0117] In some embodiments, when assembled, the medical device 200 is configured such that the distal stabilizer element 220 receives a section of the puncture member 400, such that the distal stabilizer element 220, the puncture member 400, and the body 210 are aligned or coaxial with the longitudinal axis Ω, as shown below. Figure 1 As shown.

[0118] In some embodiments, when the puncture member is in the first position, the distal stabilizer element 220 may accommodate a section of the puncture member 400, such as Figure 3A and Figure 3C As shown. In this embodiment, the distal segment 412 is advantageously exposed and extends distally in the longitudinal direction away from the distal stabilizer element 220. Exposure allows the distal segment 412 to perform the first incision 1100 as the medical device 200 advances axially (i.e., axially displaced) toward the tissue layer.

[0119] In some embodiments, the distal stabilizer element 220 includes a distal end 225, such as Figures 8A1 to 8C1 As shown. The distal end 225 is configured to abut against a first surface of the tissue layer as the puncture member 400 advances distally into and through the tissue layer to a desired depth. For example, such a configuration can allow stabilization or guidance of the medical device 200 during ophthalmic surgery.

[0120] When execution outer road During the procedure, the distal end 225 is configured to abut against the outer surface of the tissue layer, such as the outer surface of the sclera 104, as the puncture member 400 advances distally into and through the tissue layer to the desired depth.

[0121] When execution Inner road During the procedure, the distal end 225 is configured to abut against the inner surface of a tissue layer, such as the inner surface of the sclera 104, as the puncture member 400 advances distally and penetrates the tissue layer to the desired depth. The sclera's " Inner road "The surgery refers to the surgeon entering the sclera through a small incision at the edge of the cornea from inside the eye (50), rather than through an external incision in the conjunctiva and sclera (" outer road The surgical technique of '…'; essentially, it involves operating from the 'inside' of the eye to reach the sclera.

[0122] like Figure 3B and Figure 3DAs shown, the medical device 200 is also configured to extend the puncture member 400 outward from the distal stabilizer element 220, i.e., distally from the body 210. For example, distally from the distal end 225 of the distal stabilizer element 220. This distal extension can, for example, be performed along the longitudinal axis Ω. In use, when the puncture member 400 has reached the desired depth within the tissue layer through axial displacement of the medical device 200, the puncture member 400 can be extended distally in this way by actuating control points. This will be discussed in more detail elsewhere in this document.

[0123] For example, in outer road During surgery, the desired depth can be determined as the point at which the distal end 225 of the distal stabilizer element 220 abuts against the outer surface of the ocular tissue layer (such as the outer surface of the sclera 104). Conversely, in Inner road During the procedure, the desired depth can be determined as the point at which the distal end 225 of the distal stabilizer element 220 abuts against the inner surface of the ocular tissue layer.

[0124] In some embodiments, components of the distal stabilizer element 220 may be made of any medical-grade material, such as, for example: medical-grade metals, such as medical-grade tungsten, titanium, stainless steel, copper, cobalt-chromium alloys, aluminum, magnesium or any alloy thereof; medical-grade plastics, etc.

[0125] In some embodiments, the distal stabilizer element 220 has any suitable size for performing the functions described herein. For example, the distal stabilizer element 220 may have any size suitable for surrounding the puncture element 400 having its own needle gauge size.

[0126] For example, in some embodiments, the distal stabilizer element 220 may have an outer diameter of about 0.40 mm to about 1.00 mm (inclusive of any value or range therein). For example, an outer diameter of about 0.50 mm, about 0.55 mm, about 0.60 mm, about 0.65 mm, about 0.70 mm, about 0.75 mm, about 0.80 mm, about 0.85 mm, about 0.90 mm, about 0.95 mm, or about 1.00 mm. Preferably, the outer diameter is about 0.74 mm.

[0127] For example, in some embodiments, the distal stabilizer element 220 may have an inner diameter of about 0.30 mm to about 0.70 mm (inclusive of any value or range therein). Examples include inner diameters of about 0.30 mm, about 0.35 mm, about 0.40 mm, about 0.45 mm, about 0.50 mm, about 0.55 mm, about 0.60 mm, about 0.65 mm, and about 0.70 mm. Preferably, the inner diameter is about 0.57 mm.

[0128] For example, in some embodiments, the distal stabilizer element 220 may have a length of about 10 mm to about 30 mm (inclusive of any value or range therein). For example, a length of about 10 mm, about 15 mm, about 20 mm, about 25 mm, or about 30 mm.

[0129] For example, for execution outer road During surgery, the distal stabilizer element 220 can have a length L of approximately 10 mm to approximately 14 mm. ae .

[0130] For example, for execution Inner road During surgery, the distal stabilizer element 220 can have a length L of approximately 24 mm to approximately 28 mm. ai +L ae .

[0131] Readers will easily understand, for Inner road During surgery, the distal stabilizer element 220 can have a length L ae extra length L ai The extra length is approximately 10 mm to approximately 15 mm, such as approximately 12 mm, approximately 13 mm, approximately 14 mm or approximately 15 mm.

[0132] As described above, the puncture element 400 may have a needle gauge size that is small enough to perform reciprocating motion within the lumen of the distal stabilizer element 220.

[0133] Actuator assembly In a non-limiting practical implementation, the medical device 200 also includes an actuator assembly configured to induce axial displacement of the puncture member 400 to perform reciprocating motion within the lumen of the distal stabilizer element 220. For example, the actuator assembly may include any suitable component or combination of components capable of providing the functionality described herein. While the following text describes a specific implementation of the actuator assembly with reference to the accompanying drawings, the reader will understand that variations can be employed to achieve similar effects.

[0134] In some embodiments, the actuator assembly of the medical device 200 includes members that rotate and / or translate relative to each other in a manner proportional to the axial displacement movement of the puncture member 400.

[0135] Figures 3A to 3D A non-limiting practical implementation of an actuation assembly is shown, which includes suitable components or combinations of components capable of providing the functions described herein. For example, the actuation assembly includes a control point that a user can actuate to cause axial displacement of the puncture member 400.

[0136] For example, axial displacement of the puncture member 400 can allow the puncture member 400 to move from a retracted first position relative to the distal end of the body 210 or the distal end 225 of the distal stabilizer element 220. Figure 3A and Figure 3C Move to the extended second position ( Figure 3B and Figure 3D For example, the extended position could be a location where a segment of the puncture member 400 extends distally away from the body 210 (or to the distal end 225 of the distal stabilizer element 220), making the distal segment 412, the inner protrusion 412P, and the open cavity 420 visible to the user. For example, the retracted position could be where the puncture member 400 is at least partially housed within the internal cavity of the distal stabilizer element 220, making the open cavity 420 and optionally the inner protrusion 412P invisible to the user.

[0137] In one embodiment, the control point may take the form of an actuator 90. For example, the actuator 90 may be located on the proximal portion of the body 210 so that it is easily accessible to a finger (preferably the index finger).

[0138] In some implementations, the actuator 90 may be a slider, a trigger, a wheel, or any other form that can be easily actuated (preferably with just one finger, such as the index finger).

[0139] In some embodiments, the actuator 90 may include teeth or some other form that provides friction along its edges to improve the user's ability to reliably access, actuate (e.g., push), and release the actuator 90, even in the presence of moisture or when the user is wearing gloves. Furthermore, to enhance the safety of using the medical device 200, the actuator 90 may include a locking mechanism or means to prevent accidental activation or release of the actuator.

[0140] In some embodiments, the body 210 includes an inner surface 310 defining an internal cavity 300. The internal cavity 300 surrounds internal components of an actuator assembly that allows axial displacement of the puncture member 400.

[0141] In some embodiments, the actuator assembly is configured to operatively couple the actuator 90 to the puncture member 400. For example, the actuator assembly may include a rod 320 extending through the internal cavity 300, wherein the rod 320 is configured to operatively couple the actuator 90 to the puncture member 400. For example, the rod 320 and the actuator 90 may be separate components that cooperate to cause axial movement of the puncture member 400 along the longitudinal axis Ω. In another example, and as... Figures 3A to 3DAs shown, lever 320 and actuator 90 are connected to transmit finger movements applied to actuator 90 to puncture member 400. For example, lever 320 can be coupled to puncture member 400 via distal surface element 325 of lever 320.

[0142] In a non-limiting practical implementation, the actuator 90 (e.g., the pressing motion indicated by arrow 350) is moved relative to the body 210 from... Figure 3A and Figure 3C The first position shown is actuated to Figure 3B and Figure 3D The second position shown causes the puncture member 400 to extend along the longitudinal axis Ω in a direction away from the body 210 to the second position, as shown. Figure 3B As shown. For example, actuating the actuator 90 from a first position (e.g., a pressing motion as indicated by arrow 350) can effectively move the rod 320 connected to the actuator 90 toward the distal end of the body 210, which in turn causes the puncture member 400 to extend along the longitudinal axis Ω in a direction away from the body 210 to a second position. The first and second positions of the actuator 90 can be reversed, such that actuating the actuator 90 from one position to another can effectively move the rod 320 connected to the actuator 90 toward the distal end of the body 210.

[0143] In some embodiments, the actuator 90 may be equipped with a locking mechanism that holds the actuator 90 in a locked configuration in the actuated position even when the user releases the actuator 90. In such embodiments, a second actuation of the actuator 90 releases the locking mechanism, and then the actuator 90 returns to the first position.

[0144] In some embodiments, the actuator 90 may be without the aforementioned locking mechanism, such that when the user releases the actuator 90, the actuator 90 returns to the first position.

[0145] In some embodiments, the actuator 90 may be equipped with a return mechanism designed to facilitate, assist, or induce the actuator 90 to return to a first position. For example, the return mechanism may include a spring assembly 330 configured to return the actuator 90 to... Figure 3A and Figure 3C The first position is shown. For example, spring assembly 330 may include a helical spring 130 positioned above and around the distal segment of rod 320. Upon actuation of actuator 90, flange structure 140 extending away from the surface of rod 320 abuts against and compresses helical spring 130 toward the distal end of body 210. Helical spring 130 is selected to provide sufficient stored energy upon compression to facilitate, assist, or induce actuator 90 to return to its original position. Figure 3A and Figure 3C The first position shown.

[0146] In some embodiments, the actuator 90 may be associated with a non-powered device (e.g., those shown in the figures) to cause the puncture member 400 to extend and retract along the longitudinal axis Ω.

[0147] In some embodiments, the actuator 90 may be associated with a power device (e.g., an electric device), which is well known in the art, to cause the puncture member 400 to extend and retract along the longitudinal axis Ω.

[0148] In some embodiments, the actuator assembly of the medical device 200 may include a depth setting mode and a depth puncture mode for precise and controlled operation. For example, in the depth setting mode, a user selects a desired cutting depth outside the eye using an adjustable depth setting mechanism. This mechanism may include universal assembly components, such as a rotatable dial, a threaded adjustment member, or a slider mechanism, which allow the user to precisely control the position of the puncture member 400. Specifically, the universal assembly components may be non-electric. For example, the depth setting member (not shown) may be manipulated—such as by dial rotation, rotation, or linear translation relative to the body 210—to set a desired distance of movement of the puncture member 400 along the longitudinal axis Ω in a direction away from the body 210. In one example, a threaded interface may allow incremental adjustment, where rotating the depth setting member in one direction increases the distance of movement (depth), while rotating in the opposite direction decreases the set distance of movement. Alternatively, a spring-loaded pawl mechanism or a click-stop system may facilitate discrete adjustment. These components ensure that the depth setting mechanism provides reliable and repeatable accuracy for medical procedures.

[0149] Once the depth is selected, the medical device 200 is positioned relative to the eye, and the user initiates the depth puncture mode. This mode can be activated via an actuation control point (such as actuator 90), which can be a button, lever, switch, slider, or similar activation mechanism. Upon activation, internal components of the actuator assembly (such as a cam system, gear train, or linear drive mechanism) actuate to automatically move the puncture member 400 to a preset depth along the longitudinal axis Ω, extending outward (in a distancing direction) from the body 210. This ensures precise and controlled core retrieval or incision. The use of common assembly components (such as non-electric actuators, spring-loaded drives, tension springs, torsion bars, elastic bands, or pneumatic pistons) ensures smooth and controlled movement, preventing over-extension or deviation from the preset depth. Additionally, mechanical stops or guides can be incorporated to provide further control and limit movement within the desired range. This design ensures precise and controlled core retrieval or incision. The dual-mode functionality combining a depth setting mechanism and automatic puncture activation allows for enhanced user control and accuracy. These features support applications requiring highly specific depth adjustment during medical procedures, where the assembled components ensure compatibility with a variety of configurations and designs.

[0150] ophthalmic surgery In a non-limiting practical implementation of this disclosure, the medical device described herein can be used to create a drainage channel in the eye. Advantageously, the procedure can be performed on an outpatient basis using only local anesthesia, without the need for an operating room.

[0151] Typically, the medical device described herein is designed for use in methods of performing perforations in ocular tissue layers to form a channel. For example, the method includes: performing a first axial cutting motion on a first surface of the tissue layer to form a first incision, and performing a second axial cutting motion on a second surface of the tissue layer to form a second incision to complete the perforation and remove a soft tissue segment, the first and second surfaces being located on opposite sides of the tissue layer, and the first and second incisions together forming a channel.

[0152] Unrestricted practical implementation methods in Figures 6A to 6C An exemplary flowchart is shown. Method 600 includes a first step 610 of positioning a medical device at a first point relative to the eye. At step 700, method 600 includes forming a drainage channel in the ocular tissue layer by reciprocating motion of a puncture member entering and exiting the ocular tissue layer.

[0153] For example, step 700 of forming a drainage channel may include one or more of the following steps.

[0154] For example, at step 660, method 600 includes: performing a perforation in the ocular tissue layer using a medical device and removing a soft tissue segment to form a channel, wherein the perforation consists of an axial cutting motion.

[0155] For example, the perforation step 660 may include one or more of the following steps.

[0156] At step 620, method 600 may include advancing the medical device along its longitudinal axis until the puncture member contacts a first surface of the ocular tissue layer. At this step, the puncture member 400 is in a first position. For example, the puncture member 400 in the first position may be at least partially housed within the distal stabilizer element 220.

[0157] At step 630, method 600 may further include: advancing the medical device distally to cause the puncture member 400 to perform a first incision 1100 in the ocular tissue layer by a first axial cutting motion (e.g., along an axis substantially perpendicular to the surface of the tissue layer), and advancing the puncture member 400 through the first incision 1100 into and through the tissue layer. For example, such advancement may occur until the puncture member 400 has reached a desired depth. For example, the desired depth may be determined as the moment when the distal end 225 of the distal stabilizer 220 abuts against a first surface of the tissue layer.

[0158] At step 640, method 600 may further include: extending the puncture member 400 distally to a second position, beyond the second surface. For example, the puncture member 400 extends to the second position such that the distal segment 412 of the puncture member 400 is distally displaced through the tissue layer. For example, in the second position, when the procedure is... outer road During the procedure, the distal segment 412 of the puncture component 400 can reach the anterior chamber of the eye.

[0159] At step 650, method 600 may further include: retracting the puncture member 400 from the second position to the first position to perform a second incision 1150 on the second surface of the tissue layer and remove a soft tissue segment from the eye to form a drainage channel. For example, this retraction movement may cause the proximal edge 412P of the distal segment 412 of the puncture member 400 to pierce the second surface and perform the second incision 1150 with a second axial cutting movement. Retracting the puncture member 400 to the first position further causes the proximal edge 412P of the distal segment 412 of the puncture member 400 to complete the perforation 1200 and remove a soft tissue segment from the tissue layer, wherein the soft tissue segment substantially has the shape of a drainage channel. The drainage channel thus formed is substantially a scleral drainage channel. For example, the soft tissue segment may be contained within the cavity 420 of the puncture member 400.

[0160] In a practical, unrestricted implementation, when execution outer road During the procedure, the medical device 200 is positioned at an external point relative to the eye and advanced along its longitudinal axis until the puncture member 400 contacts the outer surface of the scleral tissue layer 104, i.e., the first surface. As the medical device 200 advances further toward the tissue layer, the puncture member 400 performs a first incision 1100 on the outer surface of the ocular tissue layer with an axial cutting motion. The medical device 200 then advances further toward the tissue layer such that the puncture member 400 pierces and penetrates the tissue layer. The medical device 200 then extends the puncture member 400 distally (e.g., protrudes) away from the body 210 to a second position such that the distal segment 412 of the puncture member 400 is positioned outside the second surface of the tissue layer. The medical device 200 then retracts the puncture member 400 back to the first position such that the puncture member 400 retracts toward the second surface of the tissue layer, performing a second incision 1150 on the second surface of the tissue layer. The retraction of the puncture member 400 to the first position further displaces it into and through the tissue layer to complete the perforation 1200 and remove the soft tissue segment. This step helps remove any obstructive tissue, thereby establishing an efficient pathway for aqueous humor drainage from the anterior chamber to external areas such as the subconjunctival or subfascial spaces or into specially created reservoirs.

[0161] When execution outer roadDuring the surgery, a scleral tunnel can be created by penetrating approximately 1.0 to 2.0 mm from the limbus into the ocular tissue layer to complete the procedure.

[0162] When execution Inner road During the procedure, the surgery can be performed by entering the anterior chamber 100 and advancing the medical device 200 to contact the inner surface of the ocular tissue layers. For example, the puncture member 400 is positioned above the trabecular meshwork, close to the iridocorneal angle. The puncture member 400 is then guided outward to reach a predetermined point in the subconjunctival or subfascial space to create a scleral tunnel.

[0163] In a practical, unrestricted implementation, when execution Inner road During the procedure, the surgery begins with a small incision in the cornea, just large enough to accommodate the puncture member 400, for example, large enough to accommodate a 23 to 27 gauge needle. This incision provides access to the anterior chamber 100. Prior to the procedure, the eye can be filled with a viscoelastic material, which stabilizes the internal structure and creates space for surgical manipulation. Next, the puncture member 400 is carefully inserted into the anterior chamber 100 through this opening. The medical device 200 is then further advanced along the longitudinal axis until the puncture member 400 contacts the tissue layer on the opposite side of the eye relative to the incision. As the medical device 200 further advances toward the tissue layer, the puncture member 400 performs a first incision 1100 on the inner surface of the ocular tissue layer with an axial cutting motion (i.e., without rotational motion). The medical device 200 is then further advanced toward the tissue layer such that the puncture member 400 penetrates and pierces the tissue layer to reach a predetermined point in the subconjunctival or subfascial space. The medical device 200 then extends the puncture member 400 distally (e.g., protrudes) away from the body 210 to a second position, such that the distal segment 412 of the puncture member 400 is positioned outside the second surface of the tissue layer. The medical device 200 then retracts the puncture member 400 back to a first position, such that the puncture member 400 retracts toward the second surface of the tissue layer, performing a second incision 1150 on the second surface of the tissue layer. The movement of the puncture member 400 back to the first position further displaces the puncture member 400 into and through the tissue layer to complete the perforation 1200 and remove the soft tissue segment. This step helps remove any obstructive tissue, thereby establishing an efficient pathway for aqueous humor drainage from the anterior chamber to external areas (such as the subconjunctival or subfascial spaces) or into a specially created reservoir. After positioning the device, the viscoelastic material initially introduced to facilitate the procedure is carefully removed by irrigation and aspiration.

[0164] The final step may involve injecting agents such as mitomycin C (MMC) or 5-fluorouracil (5-FU) into the subconjunctival or subfascial space. These agents enhance the effectiveness of the surgery and help reduce potential complications.

[0165] refer to Figure 5A Figure 5F illustrates a non-limiting technique for forming channels in tissue layers using the medical device of this disclosure. This example illustrates channel formation in a silicone simulated eye. outer road The procedure involves the device approaching the scleral tissue layer from outside the eye. A segment simulating the desired formation of a channel in the eye is shown.

[0166] like Figure 5A As shown, outer road The piercing procedure 600 includes a first step 610: piercing the outer surface of the ocular tissue layer (shown as sclera 104) with a piercing member 400 to obtain a first incision 1100. As previously described, the first incision 1100 is performed with a first axial cutting motion. Care should be taken not to actuate the actuator 90 at this point, as doing so would cause the piercing member 400 to extend prematurely away from the distal stabilizer element 220. Therefore, piercing the ocular tissue layer (shown as sclera 104) is performed by positioning the medical device 200 at a first point relative to the eye and advancing the medical device 200 along the longitudinal axis until the piercing member 400 contacts the outer surface of the ocular tissue layer.

[0167] Optionally, when performing ophthalmic surgery, before puncturing the sclera 104 with the puncture member 400, the user may wish to create a subconjunctival space to separate the conjunctiva from the sclera 104, for example by injecting a suitable solution into the conjunctiva, subconjunctival space, or subfascial space (depending on the ophthalmologist's preference), as shown in optional step 605 in Figure 6. For example, by injecting mitomycin C (MMC) or 5-fluorouracil (5-FU).

[0168] like Figure 5B As shown, the user then advances the medical device distally so that the puncture member 400 performs a first incision 1100 in the ocular tissue layer with a first axial cutting motion. Then, at step 620, the user advances the puncture member 400 distally through the first incision, into and through the ocular tissue layer. For example, distal advancement of the puncture member 400 into and through the ocular tissue layer can be performed by axially advancing the medical device 200 to advance the puncture member 400 distally into and through the tissue layer. This axial advancement of the medical device 200 can be performed until the distal end 225 of the distal stabilizer element 220 abuts the outer surface of the tissue layer, for example, on the outer surface of the sclera 104.

[0169] like Figure 5CAs shown, the medical device 200 then extends the distal end of the puncture member 400 away from the body 210 to a second position at step 630. This can be done, for example, by actuating the actuator 90 with appropriate finger pressure (such as with the index finger). More specifically, the puncture member 400 is extended through the tissue layer to the second position such that the distal segment 412 of the puncture member 400 is displaced distally through the tissue layer. For example, the distal segment 412 of the puncture member 400 is displaced distally through the tissue layer until the proximal protrusion 412P has completely penetrated the tissue layer beyond the second surface, for example, through the sclera 104. The reader will understand that in doing so, the puncture tip 470 may also penetrate the anterior chamber 100. Advantageously, the distal end 225 of the distal stabilizer element 220 remains on the outer surface of the tissue layer throughout this step, which provides safety and stability to the medical device 200.

[0170] like Figure 5D As shown, the medical device 200 then retracts the puncture member 400 to the first position at step 640. For example, the user can do this by releasing the actuator 90. This retraction of the puncture member 400 causes the proximal protrusion 412P to retract to the first position. This step causes the proximal protrusion 412P to make a second incision 1150 on the inner surface of the tissue layer and penetrate through the tissue layer to complete the perforation 1200 and remove the soft tissue segment from the eye. This step creates a drainage channel 500. Preferably, the removed soft tissue segment is received in the open cavity 420.

[0171] Specifically, when the distal end 225 is adjacent to the outer surface of the sclera 104, the proximal protrusion 412P can be retracted to the first position. Then, the user withdraws the medical device 200 from the eye.

[0172] In some implementations, the medical device 200 is a single-use device that can be discarded after use.

[0173] Given the teachings of this specification, other examples of implementations will become obvious to the reader and will therefore not be described further here.

[0174] It should be noted that, for the reader's convenience, headings or subheadings may be used in this disclosure, but these should in no way limit the scope of the invention. Furthermore, certain theories may be proposed and disclosed herein; however, as long as the invention according to this disclosure is practiced without regard to any specific theory or mode of operation, whether such theories are correct or not, they should not limit the scope of the invention.

[0175] For all purposes, all references cited in this specification are incorporated herein by reference in their entirety.

[0176] The references to "some embodiments" in this specification indicate that specific elements (e.g., features, structures, and / or characteristics) described in connection with the invention are included in at least one of the embodiments described herein, and may or may not be present in other embodiments. Furthermore, it should be understood that the described inventive features can be combined in any suitable manner in the various embodiments.

[0177] Those skilled in the art will understand that, in this specification, the term "a" preceding a term covers an implementation that includes one or more of the contents referred to by that term. Those skilled in the art will also understand that, in this specification, the term "comprising" is synonymous with "including," "containing," or "characterized by," and is inclusive or open-ended, and does not exclude additional, unlisted elements or method steps.

[0178] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. In case of conflict, this document (including the definitions) shall prevail.

[0179] As used in this disclosure, the terms “around,” “about,” or “approximately” generally refer to a range of error generally accepted in the art. Therefore, the numerical quantities given herein typically include such a range of error that the terms “around,” “about,” or “approximately” can be inferred unless explicitly stated otherwise. For example, the terms “around,” “about,” or “approximately” cover variations of ±5%.

[0180] Although various embodiments of the present disclosure have been described and illustrated, it will be apparent to those skilled in the art upon consideration of this specification that numerous modifications and variations can be made. The scope of the invention is more specifically defined in the appended claims.

Claims

1. An apparatus comprising: a) The main body, configured for gripping, b) A puncture member comprising a proximal segment and a distal segment, the distal segment including a puncture tip at its distal end, and c) A distal stabilizer element extending from the distal end of the body, the distal stabilizer element including a lumen. The puncture member is configured to reciprocate between (i) a storage position and (ii) an extension position, wherein in the storage position the proximal segment is retracted into the lumen of the stabilizer and the puncture tip extends outward from the stabilizer, and in the extension position at least a portion of the proximal segment and the distal segment extend outward from the stabilizer.

2. The apparatus according to claim 1, wherein, The proximal segment is connected to the distal segment via a connecting wall, wherein the connecting wall is configured to define an open cavity nested between the distal edge of the proximal segment and the proximal edge of the distal segment.

3. The apparatus according to claim 1 or 2, wherein, The distal segment also includes a medial protrusion at its proximal end, the medial protrusion including a puncture edge.

4. The apparatus according to claim 3, wherein, The puncture tip and the inner protrusion are aligned along the corresponding first longitudinal axis and second longitudinal axis, which are parallel to each other.

5. The apparatus according to claim 4, wherein, In the storage location, the puncture member is configured to perform a first cutting motion on a first surface of the tissue layer using the puncture tip.

6. The apparatus according to claim 5, wherein, The movement of the puncture member from the storage position to the extension position is configured to puncture the tissue layer such that the puncture tip passes through the tissue layer and extends beyond a second surface of the tissue layer, the first surface and the second surface being opposite to each other.

7. The apparatus according to claim 6, wherein, The movement of the puncture member from the protrusion position to the storage position is configured to perform a second cutting motion on the second surface of the tissue layer using the inner protrusion, the first cutting motion and the second cutting motion together forming a channel through the tissue layer.

8. The apparatus according to claim 7, wherein, The first cutting motion and the second cutting motion are coaxial.

9. The apparatus according to claim 7 or 8, wherein, The open cavity has a length sufficient to receive a soft tissue segment corresponding to the channel, preferably, the length is about 1.50 mm to about 2.50 mm.

10. The apparatus according to any one of claims 5 to 9, wherein, The distal stabilizer element includes a distal end configured to abut against the first surface of the tissue layer after the first cutting motion.

11. The apparatus of any one of claims 1 to 10, further comprising an actuator assembly configured to reciprocate the puncture member between the storage position and the extension position.

12. The apparatus according to claim 11, wherein, The actuator assembly includes a manually operable actuator, and wherein the actuator assembly is further configured to operatively couple the actuator to the puncture member.

13. The apparatus according to claim 12, wherein, The body of the device includes an inner surface defining an internal cavity, wherein the actuator assembly includes a rod extending through the internal cavity, and wherein the rod is configured to operatively couple the actuator to the puncture member.

14. The apparatus according to any one of claims 1 to 13, wherein, The puncture member has one or more of the following: a length of about 20 mm to about 50 mm; an outer diameter of about 0.050 mm to about 3.000 mm; an inner cross-section that is substantially circular with an inner diameter of about 0.040 mm to about 0.075 mm; and a body with a wall thickness of about 0.050 mm to about 0.400 mm.

15. The apparatus according to any one of claims 1 to 14, wherein, The puncture member includes a larger radius on the proximal portion and a smaller radius near its distal portion.

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