Vacuum feeding tool for facilitating the placement of thin-film intraocular implants in open or minimally invasive surgical sites.

Abstract

The present invention describes a device configured to enable efficient grasping and feeding of thin-film implants into open or minimally invasive surgical sites. An exemplary device comprises a tip portion configured to hold and protect the thin-film implant device during handling and placement at the surgical site, a handle portion configured to control a vacuum source, and a shaft portion configured to control and supply vacuum from the vacuum source to the tip portion.

Description

Technical Field

[0001] Cross - Reference to Related Applications: This application claims priority based on U.S. Provisional Patent Application No. 63 / 507,278, filed on June 9, 2023, entitled "VACUUM - BASED DELIVERY TOOL TO FACILITATE PLACEMENT OF THIN - FILM OCULAR IMPLANT IN OPEN OR MINIMALLY INVASIVE SURGICAL SITES", the content of which is hereby incorporated by reference in its entirety.

Background Art

[0002] Thin - film implants can pose unique challenges in maintaining proper grip with conventional surgical instruments, which may damage the thin - film implant, prevent the user from gripping the implant in the appropriate orientation, or prevent the implant from being maintained in a planar shape. Conventional surgical instruments may not be able to support the implant without causing damage when supplying the implant, especially when the supply of the implant is minimally invasive and needs to be pushed through a small incision or tunnel in the patient's tissue. Further, with conventional instruments, the user may not be able to finally place the implant properly without performing significant additional operations using multiple other instruments, for example, there may be a possibility that wrinkles or folds cannot be eliminated and the implant cannot be flattened at the surgical site.

[0003] Therefore, there is a need to provide an apparatus, system, and method configured to efficiently grip and supply at least one thin - film implant to an open or minimally invasive surgical site (e.g., an ophthalmic surgical site).

Summary of the Invention

Means for Solving the Problems

[0004] This specification describes apparatus, systems, and methods configured for manipulating and delivering at least one thin-film implant to an open or minimally invasive surgical site (e.g., an ophthalmic surgical site). In a preferred embodiment, the delivery tool or apparatus is configured to hold, for example, a fragile thin-film implant in an optimized delivery tool structure using vacuum, thereby holding and protecting the implant during handling and placement in a surgical site such as the patient's eye. The implant can be delivered to the surgical site by controlling the vacuum (e.g., depressurization and / or controlled release).

[0005] Among other features, this disclosure provides a convenient, reliable, and safe system that includes tools or feeding devices uniquely adapted for thin-film or miniature implants, ensuring secure placement in open or minimally invasive surgical sites. The system and method of this disclosure reduce variability associated with user-applied force using conventional tools such as forceps, and enable thin-film or minimally invasive feeding options for implants that can be folded into smaller or expanded forms.

[0006] In more specific aspects, the present disclosure relates to a device comprising: a tip portion configured to hold and protect a thin-film implant device during handling and placement at a surgical site; a handle portion configured to control a vacuum source; and a shaft portion configured to connect the handle portion and the tip portion and to control and supply vacuum from the vacuum source to the tip portion.

[0007] In some embodiments, the vacuum source may be housed in the handle portion of the device. In other embodiments, the vacuum source may be located outside the device. The tip portion, shaft portion, and handle portion may be substantially coplanar and linear. In another embodiment, the tip portion, shaft portion, and handle portion are arranged in different planes, and the shaft portion includes a number of bends along its longitudinal direction to offset the first plane of the tip portion from the longitudinal axis of the second plane of the handle portion. Furthermore, the vacuum source may include a power supply, which may include at least one of a syringe pump, a battery, or an AC power supply. In yet another embodiment, the tip portion of the device may be configured to include a blade tip mounted at its distal end to prepare for the surgical placement of a thin-film implantable device. In one implementation example, the blade tip may be deployable and connected to the handle portion via an actuator held by an actuator lever in the handle portion.

[0008] In certain embodiments, the apparatus may further include at least one pressure transducer positioned in a vacuum channel to detect the vacuum level of a vacuum source, and a display configured to display the vacuum level detected by the at least one pressure transducer. In one embodiment, the display may be mounted and installed on either the tip portion, the shaft portion, or the handle portion. In another embodiment, the display may be configured to display the vacuum level via one or more analog or digital signals. The display may include a light-emitting diode (LED) display. Furthermore, the one or more analog or digital signals may include visual or auditory signals configured to indicate the vacuum level detected by the at least one pressure transducer.

[0009] In further embodiments, the tip portion of the device may comprise a plurality of vacuum slots. The tip portion may have dimensions and shapes configured to accommodate different sizes of thin-film implant devices. For example, the distal and proximal edges of the tip portion may be rounded, beveled, or chamfered to facilitate smooth and easy entry into and exit from the surgical site. Furthermore, the tip portion may be made of biocompatible material. In one embodiment, the tip portion of the device may include an array of perforations configured to adjust the vacuum supply while maintaining support for the thin-film implant device. In further embodiments, the tip portion may include a non-planar tip-to-implant face. The tip-to-implant face may include a woven mesh or fabric of polymer fibers. For example, the tip-to-implant face may include a shallow nest in which the thin-film implant device is housed, and at least a portion of the periphery of the tip portion is higher than the uppermost surface of the thin-film implant device.

[0010] In a further embodiment, the tip of the device is changeable between a folded and an unfolded state, and the tip may be rolled up with a thin-film implant device bonded to the upper surface of the tip in the folded state, and unfolded to position the thin-film implant device at the surgical site. In one implementation example, the tip may include one or more wires extending into the shaft portion and connected to at least one component in the handle portion, each wire having a first end held at a selected position on the upper surface of the tip portion and a second end attached to the at least one component, and these ends may be configured to control the tension of one or more wires. In one embodiment, at least one component may include a lever or button mounted on the handle portion. Furthermore, the tip of the device may be made of an elastic material or articulated component to enable the folded and unfolded states of the tip. In a further embodiment, the tip may include one or more elastic struts to enable the unfolded state.

[0011] Additional features and advantages are described and will become apparent from the following detailed description and drawings. The features and advantages described herein are not exhaustive, and many additional features and advantages will become apparent to those skilled in the art, particularly in light of the drawings and description. Furthermore, no particular embodiment is required to possess all of the advantages described herein, and it is expressly intended that individual advantageous embodiments be claimed separately. It should also be noted that the language used herein has been selected primarily for readability and explanatory purposes and does not limit the subject matter of the invention. [Brief explanation of the drawing]

[0012] This application will be better understood from the detailed description and accompanying drawings.

[0013] [Figure 1] Figure 1 is a perspective view of a therapeutic device according to one embodiment. [Figure 2] Figure 2 is a magnified view of part A of the treatment device shown in Figure 1. [Figure 3] Figure 3 is a cross-sectional view of the treatment device along line III-III in Figure 2. [Figure 4] Figure 4 is a perspective view of a therapeutic device according to another embodiment. [Figure 5A] Figure 5A is a partial cross-sectional view of part A of the device shown in Figure 4, according to one embodiment. [Figure 5B] Figure 5B is a partial cross-sectional view of part A of the device shown in Figure 4, according to one embodiment. [Figure 5C] Figure 5C is a partial cross-sectional view of part A of the device shown in Figure 4, according to one embodiment. [Figure 6] Figure 6 shows a therapeutic device, according to one embodiment of the present disclosure, implanted in the anterior chamber of a patient's eye and between the conjunctival and scleral tissues. [Figure 7]Figure 7 shows a conventional forceps used to grasp a thin-film implant for placement inside a patient's eye. [Figure 8] Figure 8 shows a supply tool or apparatus for therapeutic use according to an exemplary embodiment of the present disclosure. [Figure 9(A)] Figure 9(A) shows the tip portion of a supply device according to one embodiment of the present disclosure, with or without a thin film implant. [Figure 9(B)] Figure 9(B) shows the tip portion of a supply device according to one embodiment of the present disclosure, with or without a thin film implant. [Figure 10(A)] Figure 10(A) shows a deployable surgical blade, or scalpel, incorporated into a supply device for therapeutic use, according to an exemplary embodiment of the present disclosure. [Figure 10(B)] Figure 10(B) is an implementation diagram of the prototype of Figure 10(A) according to one implementation example of this disclosure. [Figure 11] Figure 11 shows the tip portion of a feeding device including a slot supported by an internal reinforcing or support material, according to an exemplary embodiment of the present disclosure. [Figure 12] Figure 12 shows the folded and unfolded tip portion of the supply device according to an exemplary embodiment of the present disclosure. [Figure 13] Figure 13 is an internal view of the tip portion of a feeder including a pull wire, according to an exemplary embodiment of the present disclosure. [Figure 14] Figure 14 shows an alternative configuration for the tip portion of a supply device according to an exemplary embodiment of the present disclosure. [Figure 15(A)] Figure 15(A) is a screenshot showing an exemplary embodiment of the present disclosure, illustrating a method for handling at least one thin-film implant using a supply device and supplying it to an open or minimally invasive surgical site (e.g., an ophthalmic surgical site). [Figure 15(B)]FIG. 15(B) is a screenshot showing a method of handling at least one thin film implant using a supply device and supplying it to an open or minimally invasive surgical site (e.g., an ophthalmic surgical site) according to an exemplary embodiment of the present disclosure. [Figure 15(C)] FIG. 15(C) is a screenshot showing a method of handling at least one thin film implant using a supply device and supplying it to an open or minimally invasive surgical site (e.g., an ophthalmic surgical site) according to an exemplary embodiment of the present disclosure. [Figure 15(D)] FIG. 15(D) is a screenshot showing a method of handling at least one thin film implant using a supply device and supplying it to an open or minimally invasive surgical site (e.g., an ophthalmic surgical site) according to an exemplary embodiment of the present disclosure. [Figure 15(E)] FIG. 15(E) is a screenshot showing a method of handling at least one thin film implant using a supply device and supplying it to an open or minimally invasive surgical site (e.g., an ophthalmic surgical site) according to an exemplary embodiment of the present disclosure. <000…095><000…096>FIG. 15(F) is a screenshot showing a method of handling at least one thin film implant using a supply device and supplying it to an open or minimally invasive surgical site (e.g., an ophthalmic surgical site) according to an exemplary embodiment of the present disclosure. <000…097><000…098>FIG. 15(G) is a screenshot showing a method of handling at least one thin film implant using a supply device and supplying it to an open or minimally invasive surgical site (e.g., an ophthalmic surgical site) according to an exemplary embodiment of the present disclosure. <000…099><000…100>FIG. 15(H) is a screenshot showing a method of handling at least one thin film implant using a supply device and supplying it to an open or minimally invasive surgical site (e.g., an ophthalmic surgical site) according to an exemplary embodiment of the present disclosure. <000…101><000…102>FIG. 15(I) is a screenshot showing a method of handling at least one thin film implant using a supply device and supplying it to an open or minimally invasive surgical site (e.g., an ophthalmic surgical site) according to an exemplary embodiment of the present disclosure. <000…103> [Figure 15(J)] Figure 15(J) is a screenshot showing an exemplary embodiment of the present disclosure, illustrating a method for handling at least one thin-film implant using a supply device and supplying it to an open or minimally invasive surgical site (e.g., an ophthalmic surgical site). [Figure 15(K)] Figure 15(K) is a screenshot showing a method for handling at least one thin-film implant using a supply device and supplying it to an open or minimally invasive surgical site (e.g., an ophthalmic surgical site) according to an exemplary embodiment of the present disclosure. [Figure 15(L)] Figure 15(L) is a screenshot showing a method for handling at least one thin-film implant using a supply device and supplying it to an open or minimally invasive surgical site (e.g., an ophthalmic surgical site) according to an exemplary embodiment of the present disclosure. [Figure 15(M)] Figure 15(M) is a screenshot showing a method, according to an exemplary embodiment of the present disclosure, for handling at least one thin-film implant using a supply device and supplying it to an open or minimally invasive surgical site (e.g., an ophthalmic surgical site). [Modes for carrying out the invention]

[0014] Various aspects of this disclosure will be described with reference to the drawings. Throughout the drawings, similar elements are given the same reference numerals. For the sake of clarity, numerous specific details are provided in the following description to facilitate a full understanding of one or more aspects of this disclosure. However, it will be apparent that any of the aspects described below can be implemented, in some or all cases, without adopting the specific design details described below.

[0015] The apparatus, systems, and methods of this disclosure are for any one or more medical or surgical procedures involving fragile thin-film implants, such as cardiac surgery, anastomosis, non-surgical procedures, endoscopic procedures, non-invasive procedures, invasive procedures, port access procedures, fluoroscopy procedures, off-pump surgery, vascular surgery, neurosurgery, electrophysiological procedures, diagnostic and therapeutic procedures, ablation procedures, arrhythmia ablation procedures, endovascular procedures, treatment of one or more organs and / or blood vessels, electrocardiography, drug therapy, drug delivery procedures, delivery of biological factors, gene therapy, cell therapy, cancer treatment, radiotherapy, It should be understood that it can be used in procedures such as the manipulation or transplantation of genes, cells, tissues and / or organs, coronary angioplasty, placement or delivery of coated or uncoated stents, placement of cardiac reinforcement devices, placement of cardiac assist devices, atherectomy, manipulation and / or removal of atherosclerotic plaques, emergency procedures, cosmetic procedures, reconstructive surgery, biopsy procedures, autopsy procedures, surgical training procedures, childbirth procedures, congenital disease repair procedures, and medical procedures requiring the manipulation and delivery of one or more fragile, thin-film implants to the surgical site.

[0016] In one embodiment, this disclosure relates to the retention, placement, and delivery of a thin-film intraocular implant for the treatment or procedure of glaucoma, as detailed below. A glaucoma drainage implant is a small device (i.e., a thin-film device) placed inside a patient's eye for the treatment of glaucoma. Most glaucoma patients have abnormally high intraocular pressure (IOP) because they are unable to drain excess aqueous humor from the anterior chamber of the eye through the trabecular meshwork. If IOP is not reduced with appropriate treatment, high IOP continues to damage the optic nerve as the disease progresses, leading to visual impairment and even complete blindness. During glaucoma implant surgery, a small drainage opening may be made in the sclera (white part of the eye) of the patient's eye. This opening allows fluid from the eye to drain from beneath the delicate membrane covering the eyeball known as the conjunctiva. In some cases, medications or injections are administered locally to keep the pores open, and a thin-film glaucoma drainage device is placed under the conjunctiva on the outside of the eyeball to drain excess fluid from the eye, which is then drained to a location where the patient's capillaries and lymphatic system reabsorb it into the body, thereby lowering intraocular pressure.

[0017] To minimize scarring and postoperative discomfort for the patient, the conjunctival incision should be as small as possible, ideally less than 3 millimeters (mm). However, in many embodiments, the treatment device has a width of 3 to 10 millimeters (mm), preferably about 5 mm, to adequately drain aqueous humor from the anterior chamber of the patient's eye. This means the treatment device is wider than the desired incision width.

[0018] To enable minimally invasive insertion, the treatment device is folded or folded around the insertion device. The insertion device is configured so that, after the insertion device passes through the conjunctival incision, the treatment device is unfolded without being folded, and the treatment device is positioned flat or nearly flat within the subconjunctival pocket.

[0019] Throughout this specification, numerical ranges are used to concisely describe any value within a range. Any value within a range can be selected as the endpoint of the range. Furthermore, all references cited herein are incorporated herein by reference in their entirety. In the event of any conflict between the definitions in this disclosure and those of the references, this disclosure shall prevail.

[0020] The description of exemplary embodiments in accordance with the principles of this application is intended to be read in conjunction with the accompanying drawings, which shall be considered an integral part of the entire specification. In the description of embodiments of this application disclosed herein, references to directions or orientations are for illustrative purposes only and are not intended to limit the scope of this application. Relative terms such as “bottom,” “top,” “horizontal,” “vertical,” “upwards,” “downward,” “up,” “down,” “top,” “bottom,” and their derivatives (e.g., “horizontal,” “downward,” “upward,” etc.) should be interpreted as referring to directions shown in the drawings described or considered at that time. These relative terms are for illustrative purposes only and do not require that structures be constructed or operated in a particular direction unless expressly indicated.

[0021] Terms such as “attached,” “fixed,” “connected,” “joined,” and “interconnected” refer, unless otherwise specified, to relationships in which structures are held or attached to one another, directly or indirectly through intervening structures, and to both movable and fixed attachments or relationships. Furthermore, the features and advantages of this application are described by reference to the exemplary embodiments. Thus, this application should not be obviously limited to describing several possible non-limiting combinations of features that may exist in such exemplary embodiments, either individually or in combination with other features. The scope of this application is defined by the claims appended herein.

[0022] Unless otherwise specified, all percentages and quantities expressed herein and elsewhere should be understood to refer to weight percentages. Quantities stated are based on the weight of the material. In this application, the term “about” means ±5% of the reference value. In this application, the term “substantially not” means less than about 0.1% by weight based on the sum of the reference values.

[0023] In this specification, "subject" or "test subject" may be human or non-human animal, and may include, but is not limited to, rodents such as mice, rats, hamsters, and guinea pigs, rabbits, dogs, cats, sheep, pigs, goats, cattle, horses, and non-human primates such as apes and monkeys.

[0024] (Embodiment of a treatment device) Referring to Figures 1-3, the treatment device 1 includes a plate structure 200 having a first main exposed surface 201 and a second main exposed surface 202 on the opposite side, with a side surface 203 extending between them, or simply a plate. The plate structure 200 may comprise an extension portion 250 and a main body portion 240.

[0025] The plate structure 200 can be formed from any material having properties suitable for implantation and treatment. In some embodiments, the plate structure 200 can be formed from metals, polymers, ceramics (e.g., aluminum oxide), other composite materials, or combinations thereof. Examples of metals include, but are not limited to, aluminum, titanium, zinc, platinum, tantalum, copper, nickel, rhodium, gold, silver, palladium, chromium, iron, indium, ruthenium, osmium, tin, iridium, or combinations thereof, as well as alloys thereof. In some embodiments, alloys may include steel and nickel-titanium such as nitinol.

[0026] The polymer or polymer material used to form the plate structure 200 may include any of the polymers described herein.

[0027] Composite materials such as silicon composite materials can also be used. In one embodiment, the composite material may include silicon nitride (Si3N4). Silicon nitride may have known crystal structures such as trigonal α-Si3N4, hexagonal β-Si3N4, or cubic γ-Si3N4, but is not limited to these.

[0028] The plate structure 200, or the plate, may have a thickness in the range of approximately 1 nm to approximately 1000 nm, approximately 1 nm to approximately 500 nm, approximately 1 nm to approximately 400 nm, approximately 100 nm to approximately 1000 nm, approximately 200 nm to approximately 1000 nm, approximately 300 nm to approximately 1000 nm, approximately 400 nm to approximately 1000 nm, approximately 1 nm to approximately 900 nm, approximately 1 nm to approximately 800 nm, approximately 1 nm to approximately 700 nm, approximately 1 nm to approximately 600 nm, approximately 300 nm to approximately 500 nm, approximately 300 nm to approximately 600 nm, approximately 400 nm to approximately 600 nm, approximately 200 nm to approximately 600 nm, approximately 200 nm to approximately 500 nm, or approximately 50 nm to approximately 800 nm.

[0029] The plate structure 200 may include a multi-directional plate 210 having a first main surface 211 and a second main surface 212 on the opposite side. The multi-directional plate 210 may have multiple topographic features (e.g., repeating honeycomb patterns) formed on each of the first main surface 211 and the second main surface 212. Each of the first and second topographs may independently include multiple channels 232 and / or multiple open cells 222.

[0030] Multiple channels 232 may be interconnected to form a network of channels. The channels may be open or closed, allowing fluid to easily enter and flow through each of the multiple channels 232. The network may consist of intersecting channels in any suitable configuration to best facilitate fluid flow across the plate structure 200 through the multiple channels 232. In one embodiment, the channels 232 may be configured to form a hexagonal pattern. When the therapeutic device 1 shown in Figure 1 is implanted, fluid (e.g., aqueous humor) is driven by a pressure gradient to flow through the channels and across the surface of the plate structure 200.

[0031] In some embodiments, channel 232 may include a rib pattern. The rib pattern and / or channel shape within the plate can be varied depending on the severity of the disease (e.g., mild, moderate, or severe glaucoma). In one embodiment, larger or smaller channels can be used to lower intraocular pressure by different amounts. By making the change in intraocular pressure smaller, the risk of hypotension (a condition that can occur if intraocular pressure drops too low) can be reduced, and the effect of lowering intraocular pressure to the target value can be enhanced. In some embodiments, devices using smaller channels as described herein can reduce flow and reduce the risk of hypotension. Similarly, larger channels increase flow, allowing the device to lower intraocular pressure to even lower values.

[0032] The plate structure 200 may further include a first coating 280 applied to the first main surface 211 of the multi-directional plate 210. The first coating 280 may have a shape that conforms to a first topography of the first main surface 211 of the multi-directional plate 210. In other embodiments, the first coating 280 may form a topography that does not conform to the first topography of the first main surface 211 of the multi-directional plate 210.

[0033] The thickness of the first coating 280 may be in the range of about 0.1 μm to about 10 μm, or about 0.1 μm to about 2 μm (including all thicknesses and partial ranges between these). In one embodiment, the thickness is about 0.4 μm (400 nm) to about 0.6 μm (600 nm). In another embodiment, the thickness is about 0.4 μm (400 nm). In yet another embodiment, the thickness is about 1 μm to about 5 μm, about 1 μm to about 3 μm, about 2 μm to about 5 μm, or about 2 μm to about 4 μm. In one embodiment, the thickness is about 2 μm.

[0034] The plate structure 200 may further include a second coating 290 applied to the second main surface 212 of the multi-directional plate 210. The second coating 290 may have a shape that conforms to multiple surface features on the second main surface 212 of the multi-directional plate 210. In other embodiments, the second coating 290 may form a topography that does not conform to the second topography of the second main surface 212 of the multi-directional plate 210.

[0035] The thickness of the second coating 290 may be in the range of approximately 0.1 μm to approximately 10 μm, or approximately 0.1 μm to approximately 1 μm (including all thicknesses and partial ranges between these). In one embodiment, the thickness is approximately 0.4 μm (400 nm) to approximately 0.6 μm (600 nm). In another embodiment, the thickness is approximately 0.4 μm (400 nm). In yet another embodiment, the thickness is approximately 1 μm to approximately 5 μm, approximately 1 μm to approximately 3 μm, approximately 2 μm to approximately 5 μm, or approximately 2 μm to approximately 4 μm. In one embodiment, the thickness is approximately 2 μm.

[0036] In some embodiments, the plate structure 200 comprises only the first coating 280, i.e., without the second coating. In other embodiments, the plate structure 200 comprises only the second coating 290, i.e., without the first coating. In other embodiments, the plate structure 200 comprises both the first coating 280 and the second coating 290, so that the first and second coatings overlap and completely enclose the multi-directional plate 210. In such embodiments, the side surface 203 of the plate structure 200 may comprise at least one of the first coating 280 and the second coating 290.

[0037] In some embodiments, the first coating, the second coating, and any edge coatings can be thicker than the plate itself. In some embodiments, the thickness of the coatings can be one, two, or three orders of magnitude thicker than the plate structure. However, in other embodiments, the plate can be thicker than each coating, or thicker than the combined thickness of the two coatings.

[0038] The coatings described herein can be applied by any suitable deposition method, including but not limited to physical vapor deposition, chemical vapor deposition, atomic layer deposition, spray coating, spin coating, self-assembly, dip coating, or brushing.

[0039] The first coating 280 can be applied to the first main surface 211 by any suitable deposition method. In an unspecified example, the first coating 280 can be applied to the first main surface 211 by chemical vapor deposition, physical vapor deposition, or plasma-enhanced chemical vapor deposition. In another unspecified example, the first coating 280 can be applied to the first main surface 211 by atomic layer deposition. In yet another unspecified example, the first coating 280 can be applied to the first main surface 211 by spray coating. In yet another unspecified example, the first coating 280 can be applied to the first main surface 211 by dip coating. In yet another unspecified example, the first coating 280 may be applied to the first main surface 211 by brushing.

[0040] The second coating 290 can be applied to the second main surface 212 by any suitable deposition method. In an unspecified example, the second coating 290 can be applied to the second main surface 212 by chemical vapor deposition, physical vapor deposition, or plasma-enhanced chemical vapor deposition. In another unspecified example, the second coating 290 can be applied to the second main surface 212 by atomic layer deposition. In yet another unspecified example, the second coating 290 can be applied to the second main surface 212 by spray coating. In yet another unspecified example, the second coating 290 can be applied to the second main surface 212 by dip coating. In yet another unspecified example, the second coating 290 may be applied to the second main surface 212 by brushing.

[0041] The first coating 280 may be the same as the second coating 290. The first coating 280 and the second coating 290 may be different. The first coating 280 may be hydrophilic. The first coating 280 may be hydrophobic. The first coating 280 may be lipophilic. The first coating 280 may be oleophobic. The second coating 290 may be hydrophilic. The second coating 290 may be hydrophobic. The second coating 290 may be lipophilic. The second coating 290 may be oleophobic. The first coating 280 and the second coating 290 may be independently continuous. The first coating 280 and the second coating 290 may be independently discontinuous. In some embodiments, both the first coating 280 and the second coating 290 may be hydrophobic. In some embodiments, both the first coating 280 and the second coating 290 may be hydrophilic. In some embodiments, both the first coating 280 and the second coating 290 may be lipophilic or oleophobic.

[0042] The first coating 280 may be an organic material. The first coating 280 may be an inorganic material. The second coating 290 may be an organic material. The second coating 290 may be an inorganic material.

[0043] In some embodiments, the first coating 280 is hydrophilic and the second coating 290 is hydrophobic. Having at least one of the first coating 280 and / or the second coating 290 be hydrophobic may help prevent the therapeutic device 1 from accidentally adhering to tissue during implantation.

[0044] In some embodiments, the purpose of the first and / or second coating is to enhance the toughness of the device. The first and / or second coating can also enhance the biocompatibility of the device and / or reduce scar formation by reducing tissue and / or fibroblast adhesion. In some embodiments, the coatings described herein are hydrophobic and reduce tissue adhesion. In some embodiments, tissue adhesion can be reduced by more than 10%, more than 60%, more than 70%, more than 80%, more than 90%, more than 95%, more than 96%, more than 97%, more than 98%, or more than 99% compared to an uncoated plate.

[0045] In non-limiting embodiments, the first and / or second coating may contain a polymer such as parylene polymer (poly(para-xylylene)) or a derivative thereof. In other embodiments, the first and / or second coating may include aluminum oxide, a biocompatible film, a porous coating, or a lubricating coating. In one embodiment, the parylene polymer is chlorine-modified poly(para-xylylene) or fluorine-modified poly(para-xylylene). In one embodiment, the parylene polymer may be parylene C, parylene D, parylene N, derivatives thereof, or a combination thereof. In other embodiments, the first and / or second coating may contain aluminum oxide.

[0046] In other embodiments, other polymers can be used in addition to, or in combination with, or in place of, parylene polymers and / or aluminum oxide. In some embodiments, other polymer materials include rubber, synthetic rubber, silicone polymers, thermoplastic resins, thermosetting resins, polyolefins, polyisobutylene, acrylic polymers, ethylene-co-vinyl acetate, polybutyl methacrylate, vinyl halogenated polymers (e.g., polyvinyl chloride), polyvinyl ethers (e.g., polyvinyl methyl ether), polyvinylidene halogens, polyacrylonitrile, polyvinyl ketones, polyvinyl aromatics, polyvinyl esters, acrylonitrile-styrene copolymers, ABS resins, ethylene-vinyl acetate copolymers, and polyamides. Examples include, but are not limited to, polylactides such as poly(I) (e.g., nylon 66 and polycaprolactam), alkyd resins, polycarbonates, polyoxymethylene, polyimides, polyethers, epoxy resins, polyurethanes, rayons, cellulose, cellulose acetate, cellulose butyrate, cellulose acetate-butyrate, cellophane, cellulose nitrate, cellulose propionate, cellulose ethers, carboxymethyl cellulose, polytetrafluoroethylene (e.g., Teflon), poly(ether-ether-ketone), polylactiides such as PLA, PLGA, PLLA, derivatives thereof, or combinations thereof.

[0047] The resulting treatment device 1 may include a first plurality of channels 222 located on the first main exposed surface 201 of the plate structure 200, and the first plurality of channels 222 are hydrophilic due to the presence of the first coating 280. The resulting treatment device 1 may also include a second plurality of channels 232 located on the second main exposed surface 202 of the plate structure 200, and the second plurality of channels 232 are hydrophilic due to the presence of the second coating 290. As described above, the hydrophilic channels facilitate the flow of fluid through the channels after the treatment device 1 is implanted in the target eye.

[0048] Referring to Figures 4, 5A, 5B, and 5C, a therapeutic device 1001 according to another embodiment is schematically illustrated. The therapeutic device 1001 is similar to therapeutic device 1, except for the points described below. The description of therapeutic device 1 above generally applies to the therapeutic device 1001 described below, except for the differences specifically described below. The therapeutic device 1001 uses the same numbering system as therapeutic device 1, but the numbers are in the "1000" range.

[0049] The treatment device 1001 may include a plate structure 1200 having a first exposed main surface 1201 and a second exposed main surface 1202 on the opposite side. The plate structure 1200 may include a multi-directional plate 1210 having a first main surface 1211 on the opposite side of the second exposed main surface 1212. The multi-directional plate 1210 may have multiple topographic features (e.g., repeating honeycomb patterns) formed on each of the first main surface 1211 and the second main surface 1212. Each of the first and second topographies may independently include multiple channels 1232 and / or multiple open cells 1222.

[0050] Referring to Figure 5B, the plate structure 1200 may include a first drug therapy supply component 1070 located in an open space formed by a first topography formed by the first exposed surface 1211 of the multi-directional plate 1210. Specifically, the first supply component 1070 may be located in an open space formed by an open cell 1222 of the first topography formed by the first main surface 1211 of the multi-directional plate 1210.

[0051] The first drug therapeutic supply component 1070 may, but is not limited to, contain one or more active agents, such as therapeutic and / or pharmacological components. The first drug therapeutic supply component 1070 may occupy part, all, or substantially all of the free volume present in the open cell 1222 formed by the first topography.

[0052] In other embodiments, the active agent may be any compound or drug that has a therapeutic effect on the target. Non-limited active agents include, but are not limited to, macrolide antibiotics including FKBP-12 conjugates, estrogens, chaperone inhibitors, protease inhibitors, protein-tyrosine kinase inhibitors, leptomycin B, peroxisome proliferator-activated receptor gamma ligand (PPARγ), hypothemycin, nitric oxide, bisphosphonates, epidermal growth factor inhibitors, antibodies, steroids, proteasome inhibitors, antibiotics, anti-inflammatory agents, antisense nucleotides, transformed nucleic acids, messenger ribonucleic acids, TOP inhibitors, prostaglandins, cell proliferation inhibitory compounds, toxic compounds, anti-inflammatory compounds, chemotherapeutic agents, analgesics, antibiotics, protease inhibitors, statins, nucleic acids, polypeptides, growth factors and delivery vectors including recombinant microorganisms, cells, stem cells, liposomes, antimetabolites such as mitomycin C, combinations thereof, their prodrugs, their medicinal salts, their derivatives, and other similar substances.

[0053] The therapeutic device 1001 may further comprise a first coating 1050 applied to the first main surface 1211 of the multi-directional plate 1210. The first coating 1050 may cover both the first main surface 1211 of the multi-directional plate 1210 and the first drug therapeutic supply component 1070 present in open cells 1222 formed on the first main surface 1211 of the multi-directional plate 1210. The first coating 1050 may be in the form of a continuous film. The first coating 1050 may be flat. In other embodiments, the first coating 1050 may be shaped to conform to the substrate pattern formed by the multi-directional plate 1210 and the first supply component 1070.

[0054] Referring to Figure 5A, the plate structure 1200 may include a second drug therapy supply component 1080 located within an open void formed by a second topography formed by the second exposed surface 1212 of the multi-directional plate 1210. Specifically, the second supply component 1080 may be located within an open void formed by an open channel 1232 of the second topography formed by the second main surface 1212 of the multi-directional plate 1210. The second supply component 1080 may be the same as or different from the first supply component 1070.

[0055] The second drug therapeutic supply component 1080 may contain, but is not limited to, one or more therapeutic and / or pharmacological components, including anti-inflammatory agents, steroids, antibiotics, and analgesics. The second supply component 1080 may occupy part, all, or substantially all of the free volume present in the channel 1232 formed by the first topography.

[0056] The treatment device 1001 may further include a second coating 1060 applied to the second main surface 1212 of the multi-directional plate 1210. The second coating 1060 may cover both the second main surface 1212 of the multi-directional plate 1210 and the second supply component 1080 present in an opening channel 1232 formed in the second main surface 1212 of the multi-directional plate 1210. The second coating 1060 may be in the form of a continuous film. The second coating 1060 may be flat. In other embodiments, the second coating 1060 may be shaped to conform to the substrate pattern formed by the multi-directional plate 1210 and the second supply component 1080.

[0057] The second coating 1060 may be the same as or different from the first coating 1050. For each of the first and second coatings 1050, 1060, the resulting film is formed from a sustained-release material that slowly dissolves after exposure to aqueous humor or other bodily fluids, thereby releasing the first supply component 1070 from the channel 1232 of the therapeutic device 1001 after it has been implanted in the target.

[0058] Referring to Figure 5C, in another embodiment, the therapeutic device 1001 may comprise both first and second therapeutic supply components 1070, 1080, and together comprise first and second coatings 1050, 1060 for encapsulating the first and second supply components 1070, 1080.

[0059] In other embodiments, the plate structure 1200 may comprise at least one of the first coating 1050 and / or the second coating 1060 without the presence of the first and / or second supply components 1070,1080. In such embodiments, the first coating 1050 and / or the second coating 1060 form a film covering the open cells 1222 and / or open channels 1232 formed by the multi-directional plates.

[0060] The presence of films obtained from the first and / or second coatings 1050, 1060 may increase the overall strength of the resulting therapeutic device. Specifically, the layered structure of films formed by the first and second coatings 1050, 1060 bonded to the first and second main surfaces 1211, 1212 of the multi-directional plate 1210 enhances the mechanical integrity or completeness of the resulting therapeutic device.

[0061] In addition to achieving basic flexibility to conform to the curvature of the eye, the addition of the first and / or second coatings 1050, 1060 may provide a mechanism that allows the entire therapeutic device to conform to the elastic modulus of the surrounding tissue (e.g., conjunctival and scleral tissue), maximizing biocompatibility or integration with biological tissue. Findings from brain implant research have confirmed that the flexibility of implants in soft tissue allows the implant to adapt to the minute movements of the surrounding tissue, reducing tissue displacement and damage, and facilitating the implantation of therapeutic devices.

[0062] (Implementation of treatment device insertion) Figure 6 shows a treatment device 1 implanted between the conjunctival tissue 602 and scleral tissue 604 of a patient's eye 600 according to an exemplary embodiment of the present disclosure. The treatment device 1 is a biocompatible intraocular implant comprising a thin, flexible plate to facilitate safe, comfortable, and effective treatment. The treatment device 1 includes a plate structure 200 having a plurality of channels 232. The channels 232 in the embodiment are configured to facilitate the drainage of aqueous humor accumulated in the anterior chamber 606 of the eye 600 into a pocket (bleb) 608 located between the conjunctival tissue 602 and scleral tissue 604. This can reduce intraocular pressure caused by the accumulation of aqueous humor in the anterior chamber 606. The removed aqueous humor in the pocket 608 is gradually reabsorbed by the surrounding tissue, allowing for further removal of aqueous humor accumulated in the anterior chamber 606. This sustained drainage of aqueous humor (e.g., glaucoma drainage) reduces pressure within the eye 600 and protects the optic nerve. The redundant channels 232 of the plate structure 200 prevent unilateral occlusion by scar tissue. Furthermore, the thin profile of the plate structure 200 suppresses tissue erosion.

[0063] Figure 6 also shows the plate structure 200 including a notch 610 along its periphery. While the notch 610 is shown in the lower left portion of the plate structure 200, it should be understood that the notch 610 can be positioned anywhere around its periphery. Furthermore, although only one notch 610 is shown, the plate structure 200 may also contain two or more notches. The notch 610 is configured to facilitate proper placement and positioning of the plate structure 200 within the patient's eye. The notch 610 can indicate whether the channel 232 of the plate structure 200 is aligned upward or downward. Thus, the notch 610 provides a means for clinicians to confirm that the plate structure 200 is properly oriented.

[0064] Conventional ophthalmic surgical instruments include various forceps, tweezers, and spatulas. While surgical instruments come in a variety of shapes and sizes, none are suitable for supplying thin-film implants for glaucoma treatment (e.g., treatment device 1 in Figure 6). Most of these instruments have thin tips and shafts, requiring the user to constantly hold the implant in an ideal position to prevent dropping or damaging it during surgery. Furthermore, the contact area of ​​conventional instruments creates a risk of stress concentration and / or damage due to impact or perforation, while simultaneously leaving other important areas of the implant unsupported. Due to the lack of uniform and broad support across the entire surface of the thin-film implant, there is a risk of implant damage or displacement if the surgical access site or final supply site is a tight fit, or if the target site is even smaller than the implant itself in the case of minimally invasive supply. For example, Figure 7 shows conventional forceps (arrow 702) grasping a thin-film implant (arrow 704) for placement in the patient's eye during glaucoma implant surgery.

[0065] Furthermore, initial, intermediate, and final grasping of the device, movement within the surgical field, and initial and final placement at the implantation site may require various tools. Since surgical rooms are not always equipped with the same surgical instruments, and surgical users naturally tend not to want to use multiple tools for final placement, it is sometimes necessary to perform most or all of these functions with a single tool.

[0066] In accordance with aspects of this disclosure, Figure 8 shows a feeding device or tool 800 including a handle portion 802 for enabling control of a vacuum source and a shaft portion 804 for transmitting vacuum from the vacuum source to the tip portion 806 of the feeding tool 800. The handle portion 802 may also include a blade control unit 810 for controlling a deployable surgical blade as shown in Figures 10(A) and 10(B). The tip portion 806 may be customized to fit most or all of the shapes of thin-film implants. Figures 9(A) and 9(B) show close-up views of the tip portion 806 without a thin-film implant and the tip portion 806 with a thin-film implant, respectively. In one embodiment, the tip portion 806 may include a plurality of vacuum slots 902 as shown in Figure 9(A).

[0067] In some embodiments, returning to Figure 8, the handle portion 802 of the supply tool 800 may be configured to include a vacuum source and a control unit 808 for the vacuum source. The vacuum is the difference between the pressure in the surgical field and the pressure in the tool tip, which allows the thin-film implant (e.g., therapeutic device 1 in Figure 6) to be held on the tip portion 806 of the supply device 800 throughout the entire placement process. In some implementations, the vacuum does not need to be an absolute vacuum; even a small differential pressure may be sufficient to grip the implant throughout the process. This vacuum may be operated by a switch that can be manually drawn in by the user of the supply device 800 or by activating an internal pump.

[0068] Vacuum can be transmitted from the handle portion 802 through the shaft portion 804 to the tip portion 806 of the tool 800 via a medium such as air, water, saline solution, basic salt solution, or a suitable fluid such as a viscoelastic substance. Note that the medium must be suitable for contact with the tissues of the surgical site, such as the patient's eyes.

[0069] In one aspect, the vacuum of the supply device 800 can be generated on-board via a mechanism such as a syringe and plunger integrated into the handle portion 802. Alternatively, a battery- or AC-driven vacuum pump can be housed within the handle portion 802 to generate and maintain the vacuum. In yet another embodiment, a vacuum supply source from a hospital facility or treatment room can be connected to the handle portion 802, and the vacuum can be controlled by adjusting it in a binary, digital, or analog manner using a control mechanism within the handle portion 802.

[0070] The hollow tool tip portion 806 may be configured to provide a platform for mounting a thin-film implant during manufacturing or in the operating room. Vacuum can be applied before or after implant mounting. The pressure difference is transmitted through the hollow tip portion 806 via an open slot on the contact surface to which the thin-film implant is mounted (e.g., the vacuum slot 902 shown in Figure 9(A)). In a preferred embodiment, when vacuum is applied and the slot is completely covered, leakage can be prevented. Minor leakage will not be a problem if the vacuum source (pump or house vacuum) can overcome leakage and provide sufficient grip. If leakage is present, air and / or fluid from the surgical site will be drawn into the supply device. If fluid aspiration could fill the internal reservoir and compromise the vacuum, the supply device of this disclosure may be configured to incorporate or separately provide a fluid collection container via appropriate vacuum connectors and tubing (F-shaped, T-shaped, Y-shaped, or X-shaped vacuum connectors) to enable continuous vacuum.

[0071] To release the thin-film implant, the user can reduce or completely release the vacuum by controlling it with the handle. Furthermore, positive pressure can be applied through the handle portion 802 to push or detach the thin-film implant from the tool tip portion 806. After the tool is removed from the surgical site, the thin-film implant remains in its final form.

[0072] As shown in Figures 9(A) and 9(B), the implant surface of the tip portion 806 of the feeder may be configured to conform to the shape or condition of the thin-film implant and to support at least a portion of all critical areas of the implant as needed. In some implementations, if a particular area of ​​the implant is not critical and / or does not require support, the thin-film implant may protrude from the tip. Alternatively, if the entire implant fits within the tip without significantly exposing the vacuum slot, a single tool tip design can support implants of various sizes. The edges of the tip portion 806 may be rounded, beveled, or chamfered on the distal and / or proximal surfaces to facilitate smooth and easy entry and exit from the surgical site. It should be understood that the dimensions and shape of the tip portion 806 may be determined according to the shape of the thin-film implant. On one side, the tip portion 806 of the tool needs to be thin. For example, the tip portion 806 has a hollow core with a thickness in the range of about 0.1 to 5 mm, preferably about 0.5 mm, and a height of about 0.25 mm, and may be made of a suitable polymer such as polycarbonate or polyethylene, or a biocompatible material such as stainless steel or aluminum.

[0073] The size and placement of perforations in the tool may be determined to ensure sufficient grip on the thin-film implant during surgery and to prevent the implant from becoming dislodged, wrinkled, or damaged by user handling or tissue at the surgical site. The perforations may have an array of one or more holes with an inner diameter of 0.01 to 2 mm, a straight slot with sides of 0.1 to 5 mm, or other suitable shapes to ensure optimal vacuum transmission while maintaining support for the thin-film implant. In preferred embodiments, one or more rectangular slots of 0.25 mm × 2 mm may be included. In alternative embodiments, the connection surface between the tip and the implant may include a woven mesh or fabric of polymer fibers that effectively transmits vacuum. Several opening designs may be included on the connection surface between the tip and the implant, thereby drawing a portion of the thin-film implant under the surface of the tool tip and preventing the end of the implant from becoming dislodged during the handling or insertion process.

[0074] The tip surface of the tool may be flat or non-flat. In one embodiment, a non-flat tip surface, as shown in Figures 15(B), 15(C), and 15(D), can facilitate the grasping and feeding of at least one thin-film implant into the surgical site. In glaucoma implant surgery, the surgical site may be curved, like the eyeball, and the thin-film implant may have surface features, to which the tip surface must adapt. Consequently, the tip surface and vacuum perforation array may be non-flat to adapt to these surface features and characteristics of the surgical site and the implant.

[0075] Another non-planar configuration may include a shallow nesting area where a thin film implant is housed, with part or all of the area around the tool tip being at the same level as, or slightly higher than, the top surface of the thin film implant. Consequently, the edges of the thin film implant may be concealed from any tissue structures that could pull the implant away from the tool tip during deployment.

[0076] Referring to Figure 8, the shaft portion 804 of the tool 800 may be configured such that the handle portion 802 is separated from the tip portion 806 by a certain distance to accommodate the need to place a larger handle further away from the surgical site. In one embodiment, the shaft portion 804 may be a hollow structure with a length of 1 to 10 cm or more, an inner diameter of approximately 0.1 to 5 mm, and a slightly larger outer diameter. In a preferred embodiment, the shaft portion 804 is a 19 gauge shaft size with a length of 5 cm, an outer diameter of approximately 1 mm, and an inner diameter of 0.7 mm. The shaft portion 804 may be a hollow circular tube, or it may have other non-circular cross-sections. Subcutaneous tubing made of stainless steel is a common material used in medical devices for these purposes, but other tubing materials such as suitable polymers or metals may also be suitable. As shown in Figure 8, the shaft portion 804 may have multiple bends along its length (e.g., two bends 812, 814), and the plane of the tool tip 806 may be offset from the longitudinal axis of the handle portion 802, thereby ensuring clearance to prevent the handle 802 and / or the user's fingers from contacting anatomical structures around the surgical site, such as the eyebrows or nose in ophthalmic surgery. The shaft portion 804 may be made of an articulated structure or elastic material so that the user can adjust the degree of offset from the handle shaft to the tip. This can be achieved by an internal pull wire within the shaft portion 804. This pull wire is fixed at one position near the tool tip 806 or at a selected distal position on the shaft 804 of a desired deflection point, and at a second position in the handle portion 802, such as a lever or slider, that allows for deflection adjustment.

[0077] In another embodiment shown in Figure 10(A), a deployable surgical blade 1002 may be incorporated into the tool of Figure 9(A) according to one aspect of the present disclosure. Figure 10(B) shows an exemplary implementation of the prototype of Figure 10(A). Specifically, the tool tip 806 of the present disclosure may incorporate a surgical blade 1002 of a shape selected to facilitate the positioning of an implant within the surgical site. Such a blade 1002 may be configured to facilitate the positioning of a narrow tab-shaped portion of a thin-film implant within a scleral tunnel. According to one embodiment, the surgical blade 1002 may be attached to the handle portion 802 via an actuating member fixed to an actuating lever within the handle portion. The actuating member may be located within the tool shaft or alongside the tool shaft. The user can deploy the blade 1002 from the bottom of the sheath 1004 or the tool tip 806, expose the blade 1002 to make a suitable surgical incision, and then retract the blade 1002 for positioning the thin-film implant. In a preferred embodiment, the blade 1002 may be thin (e.g., 0.1 to 1.0 mm thick) and less than or equal to the width of the tool tip 806. The blade extension may be determined based on the required cutting depth and may range from 1 to 10 mm in length.

[0078] According to other aspects of this disclosure, incorporating reinforcing or supporting materials within the tool tip 806 makes it possible to resist mechanical forces associated with surgical handling and vacuum deployment. As shown in the split or exploded view of section 1102 of Figure 11, one or more internal reinforcing materials can be extended from the top to the bottom between the slots so that the surfaces are spaced apart and flatness is maintained. Otherwise, deflection or crushing of the vacuum surface may hinder vacuum transmission or cause mechanical damage to the tool tip 806. The internal reinforcing materials may include ribs, posts, or similar structures embedded in a plate, wall, or fiber mesh that transmit vacuum and support the vacuum surface of the tip 806.

[0079] Referring to Figure 12, the minimally invasive tool tip 806 is composed of an elastic or articulated component, or a material according to the aspects of the present disclosure, and the tool tip 806 may have two main forms. One form generally refers to a folded or collapsed form 1202 in which the vacuum tool tip 806 is rolled up with a flexible thin film implant bonded to its surface. With respect to the second form 1204, the tip 806 may be unfolded into a shape best suited to the final implant placement. For example, the tool may be minimally invasively supplied by form 1202 to pass through a surgical site that is significantly smaller than the final form 1204, thereby providing the advantages of minimizing tissue damage, bleeding, time required to prepare a larger surgical site, and patient pain or discomfort.

[0080] To pose the minimally invasive tool tip 806 into a folded (1202) or unfolded (1204) form, a mechanism to induce curling of the tool surface will be necessary. For example, referring to Figure 13, one or more pull wires 1301 may be fixed at an appropriate position on the tool surface and extended along or through the tool shaft to a lever or button in the handle. As shown in Figure 13, by arranging a pair of pull wires 1301 and applying tension to them via the handle mechanism, the tool surface can be selectively deformed to achieve a smaller shape for minimally invasive placement of thin-film implants. The linear portions 1302, 1304 represent one or more elastic ribs configured to enable the unfolded form 1204 shown in Figure 12, while also enabling a folded form 1202 when tension is applied to the pull wires. The lever in the handle allows the user to selectively curl or uncurl the tool tip 806 as appropriate. In other words, when the tool tip 806 is in the unfolded form 1204, it may be difficult to press the pull wire 1301 into a flat shape. Therefore, the unfolded form 1204 can be easily achieved by incorporating elastic struts 1302, 1304 as shown in Figure 13. In one embodiment, selective wire struts made of Nitinol are incorporated into the tool tip. When tension is applied to the pull wire 1301, these Nitinol struts readily bend elastically into a very tight shape, causing the wings of the tool tip 806 to curl. When the tension on the pull wire 1301 is released, the Nitinol struts straighten, and the tool tip 806 returns to a flat, unfolded shape or state.

[0081] Figure 14 shows, in one aspect of the present disclosure, a sheath configuration for the tool tip 806 that includes an additional support plate, or sheath component 1402, configured to protect the thin-film implant during the feeding process. The additional support plate 1402 secures the thin-film implant and assists in withdrawing the insertion tool from the scleral tunnel, completely enclosing the flat system. The thin-film implant is protected during insertion into the scleral tunnel, and the upper and lower components can be withdrawn independently, so that the thin-film implant remains fixed in the tunnel even after the insertion instrument is removed. In one embodiment, both the upper and lower components may utilize vacuum independently. The thin-film implant is further protected during the feeding process by being positioned between the sheath and the platform of the tool tip. In some implementations, when the vacuum is released, either the sheath 1402 or the tool tip 806 may be withdrawn independently. This would allow the thin-film implant to remain more stably in place at the surgical site when the feeding tool is withdrawn.

[0082] The tool tip 806 of this disclosure can be manufactured by micro-injection molding, micro-3D printing, fine-wire electrical discharge machining (EDM), or microcomputer numerical control (CNC) machining, etc. In one embodiment, the tool tip of this disclosure can be manufactured by micro-3D printing. The tool tip 806 may include multiple components to achieve a final assembled form that has the strength necessary to withstand handling and vacuum forces, while also properly transmitting vacuum. The thin-film implant may be pre-attached to the tool tip 806 during manufacturing and provided to the user in a sterile condition, or the user may separately attach the thin-film implant to the tool.

[0083] Figures 15(A), 15(B), 15(C), 15(D), 15(E), 15(F), 15(G), 15(H), 15(I), 15(J), 15(K), 15(L), and 15(M) are screenshots illustrating how the supply tool of this disclosure is used to handle and supply at least one thin-film implant to an open or minimally invasive surgical site (e.g., an ophthalmic surgical site). Figure 15(A) shows an embodiment of the thin-film implant 1502 of this disclosure (e.g., therapeutic device 1 in Figure 6). Figures 15(B), 15(C), and 15(D) show how the thin-film implant 1502 is progressively placed on the supply tip 1504 of the supply tool of this disclosure. Figure 15(E) shows a side view of the shaft portion 1506 of the supply tool. Figure 15(F) is a perspective view of the supply tool, which comprises a handle portion 1508 and several actual levers 1510, 1512 for deploying the vacuum and insertion blades. Figure 15(G) shows the system (supply tool and thin-film implant 1502) being deployed at a surgical site, such as the patient's eye. A scleral pocket has been pre-formed at this surgical site. Figure 15(H) shows the tip of the surgical blade 1514 being deployed into the scleral tissue to form a scleral tunnel for positioning the narrow portion of the thin-film implant 1502. Figure 15(I) shows the tip of the blade 1514 completing the tunnel to the anterior chamber through which the tip of the thin-film implant 1502 communicates. Figure 15(J) shows the supply tool with the thin-film implant attached being inserted into the anterior chamber of the eye, and Figure 15(K) shows the surgical blade 1514 being withdrawn. At this point, the vacuum may be released, reduced, or replaced with positive pressure to facilitate the removal of the thin-film implant 1502 from the tool tip 1504. Figure 15(L) shows the supply tool partially withdrawn, but the thin-film implant 1502 remains in place at the target surgical site, with its tip extending from the anterior chamber through the scleral tunnel to the subconjunctival pocket.Figure 15(M) shows the final position of the thin-film implant 1502 after the supply tool has been removed from the surgical site, and the inset shows aqueous humor flowing along the surface of the thin-film implant 1502 from the anterior chamber to the scleral bleb to lower intraocular pressure.

[0084] In additional embodiments, the supply tool of this disclosure may have several features, such as monitoring and communication of the vacuum state. For example, if a leak occurs or the thin-film implant is destroyed, the vacuum of the supply tool will be partially or completely released without the user noticing by the appearance of the tool tip. In some embodiments, the handle portion of the supply tool may be configured to detect the vacuum level by providing a monitor, such as a pressure transducer, in the vacuum path. Another feature, such as an electrical circuit or analog gauge, may evaluate the electrical value of the transducer and indicate the vacuum state via a light, light-emitting diode (LED), or LED display, showing an analog or digital value via numbers, colors, or other visual or auditory signals, indicating whether the vacuum is adequate for holding the thin-film implant. For example, when an adequate vacuum level is detected, the display may be configured to show a green light or a negative pressure value. If the vacuum level is not adequate or insufficient, the display may show, for example, a red light, "0", or a positive value. The dimensions, shape, and position of the display on the supply tool are determined according to the specific characteristics selected. For example, a sufficiently small display can be mounted on the handle, shaft, and / or tool tip, providing information to the user, especially when the user is focusing their gaze on the tool tip through a surgical microscope rather than the device's handle. The user can re-establish the vacuum as needed before beginning the installation procedure.

[0085] This technology is described in detail for illustrative purposes only, based on the most practical and preferred implementations currently available. However, such details are solely for the purpose of this description, and the technology is not limited to the disclosed implementations. Rather, it is intended to encompass variations and equivalent configurations within the spirit and scope of the attached claims. For example, it is assumed that, where possible, one or more features of any implementation can be combined with one or more features of any other implementation.

[0086] Unless otherwise specified, all numerical values ​​used in this specification and the claims to represent properties such as component amounts and molecular weights, reaction conditions, etc., should be understood in all cases to be modified by the term "approximately." Therefore, unless otherwise stated, the numerical parameters described herein and in the appended claims are approximations and may vary depending on the desired properties to be achieved by this application. At the very least, this is not intended to limit the application of the doctrine of equivalents to the claims, and each numerical parameter should be interpreted using the usual rounding method in light of the reported number of significant figures. While the numerical ranges and parameters defining the broad scope of this application are approximations, the numerical values ​​described in the specific examples are reported as accurately as possible. However, any numerical value inherently contains a certain degree of error that inevitably arises from the standard deviation in each test measurement.

[0087] In the context describing this application (particularly in the following claims), “a,” “an,” “the,” and similar demonstrative pronouns are to be interpreted as encompassing both singular and plural unless otherwise stated herein or explicitly denied in the context. Numerical ranges described herein are merely abbreviated expressions for individually referring to each individual number within that range. Unless otherwise specified, each individual number is incorporated herein as if it were individually stated. All methods described herein may be performed in any appropriate order unless otherwise specified or explicitly denied in the context. All examples or illustrative expressions provided herein (e.g., “like,” “etc.”) are for the sole purpose of clarifying this application and do not limit the claimed scope of this application. No word herein should be interpreted as indicating an element essential to the practice of this application but not claimed.

[0088] The group of alternative elements or embodiments disclosed herein should not be construed as limiting. Each group's components may be referenced and claimed individually or in any combination with other components within the same group or other elements described herein. For convenience and / or patentability reasons, one or more components of one group may be included in another group or removed from another. In the event of such additions or deletions, this specification shall be deemed to include the modified groups to satisfy the description of all Markush groups used in the appended claims.

[0089] Specific embodiments of this application are described herein, including the best mode known to the inventors for carrying out this application. Of course, a reading of the above description will reveal to those skilled in the art various variations of these embodiments. The inventors anticipate that those skilled in the art will appropriately adopt such variations, and intend that this application will not be limited to the forms specifically described herein. Accordingly, this application encompasses all modifications and equivalents of the subject matter described in the appended claims, to the extent permitted by applicable law. Furthermore, unless otherwise specified or explicitly denied in the context, any combination of all possible variations of the elements described above is also included in this application.

[0090] The specific embodiments disclosed herein may be further limited by the use of the expressions “consisting of” or “essentially consisting of” in the claims. The transitional term “consisting of” used in the claims, whether at the time of filing or added by amendment, excludes any elements, processes, or components not described in the claims. “Essentially consisting of” limits the scope of the claims to the described elements or processes and any additions that do not substantially affect the basic and novel characteristics. Exemplary embodiments of the application as claimed herein are implicitly or expressly described and implementable herein.

[0091] Finally, it should be understood that the embodiments disclosed herein are illustrative of the principles of the present invention. Other modifications that may be adopted are within the scope of the invention. Therefore, alternative configurations of the invention can be utilized according to the teachings herein, but are not limiting to the invention. Accordingly, the invention is not strictly limited to the configurations shown and described herein.

[0092] (Note) (Note 1) When handling a thin-film implant device and placing it at the surgical site, the tip portion is configured to hold and protect the thin-film implant device, A handle section configured to control the vacuum source, A shaft portion is configured to connect the handle portion and the tip portion, and to control and supply vacuum from the vacuum source to the tip portion. A device equipped with the following features.

[0093] (Note 2) The vacuum source is the apparatus described in Appendix 1, which is housed in the handle portion of the apparatus.

[0094] (Note 3) The vacuum source is the device described in Appendix 1, located outside the apparatus.

[0095] (Note 4) The device as described in Appendix 1, wherein the tip portion, the shaft portion, and the handle portion are arranged substantially in the same plane and form a straight line.

[0096] (Note 5) The apparatus according to Appendix 1, wherein the tip portion, the shaft portion, and the handle portion are arranged in different planes, and the shaft portion has a plurality of bends along its length, and the first plane of the tip portion is offset from the longitudinal axis of the second plane of the handle portion.

[0097] (Note 6) The apparatus as described in Appendix 1, wherein the vacuum source includes a power supply, and the power supply includes at least one of a syringe pump, a battery, or an AC power supply.

[0098] (Note 7) The apparatus according to Appendix 1, wherein the tip portion is configured to include a blade tip mounted at the distal end for preparation for surgical placement of the thin-film implant device.

[0099] (Note 8) The apparatus according to Appendix 7, wherein the blade tip is deployable and connected to the handle portion via an operating member held by an operating lever within the handle portion.

[0100] (Note 9) The apparatus according to Appendix 1, further comprising at least one pressure transducer positioned in a vacuum channel for detecting the vacuum level of the vacuum source.

[0101] (Note 10) The apparatus according to Appendix 9, further comprising a display configured to show the vacuum level detected by the at least one pressure transducer.

[0102] (Note 11) The device as described in Appendix 10, wherein the display is mounted and installed on either the tip portion, the shaft portion, or the handle portion.

[0103] (Note 12) The apparatus according to Appendix 10, wherein the display is configured to show the level of the vacuum via one or more analog or digital signals.

[0104] (Note 13) The aforementioned display is the apparatus described in Appendix 12, including a light-emitting diode (LED) display.

[0105] (Note 14) The apparatus according to Appendix 12, wherein the one or more analog or digital signals include a visual or auditory signal configured to indicate the level of vacuum detected by the at least one pressure transducer.

[0106] (Note 15) The aforementioned tip portion includes a plurality of vacuum slots, as described in Appendix 1.

[0107] (Note 16) The apparatus as described in Appendix 1, wherein the tip portion has dimensions and shape configured to accommodate different sizes of the thin-film implantable device.

[0108] (Note 17) The apparatus as described in Appendix 1, wherein the distal and proximal edges of the tip portion are rounded, beveled, or chamfered to facilitate smooth and easy entry into and exit from the surgical site.

[0109] (Note 18) The aforementioned tip portion is made of a biocompatible material, as described in Appendix 1.

[0110] (Note 19) The apparatus according to Appendix 1, wherein the tip portion includes an array of perforations configured to regulate the supply of vacuum while maintaining support for a thin-film implant device.

[0111] (Note 20) The device as described in Appendix 1, wherein the tip portion includes a connection surface between the tip and the implant, which is configured to be non-planar.

[0112] (Note 21) The device as described in Appendix 20, wherein the connection surface between the tip and the implant includes a woven mesh or fabric of polymer fibers.

[0113] (Note 22) The apparatus according to Appendix 20, wherein the connection surface between the tip and the implant includes a shallow nest in which the thin-film implant device is housed, and at least a portion of the area around the tip portion is higher than the uppermost surface of the thin-film implant device.

[0114] (Note 23) The apparatus as described in Appendix 1, wherein the tip portion can be configured between a folded state and an unfolded state, and in the folded state, the tip portion is in a rolled state with the thin film implant device attached to the upper surface of the tip portion, and in the unfolded state, the tip portion is in a state for positioning the thin film implant device at the surgical site.

[0115] (Note 24) The apparatus according to Appendix 23, wherein the tip portion includes one or more wires extending within the shaft portion and connected to at least one component within the handle portion, each wire having a first end held at a selected position on the upper surface of the tip portion and a second end attached to the at least one component.

[0116] (Note 25) The apparatus according to Appendix 24, wherein at least one component is configured to control the tension of one or more wires.

[0117] (Note 26) The apparatus according to Appendix 24, wherein the at least one component is a lever or button mounted on the handle portion.

[0118] (Note 27) The apparatus as described in Appendix 23, wherein the tip portion is made of an elastic material or an articulated component to allow the tip portion to be folded and unfolded.

[0119] (Note 28) The apparatus according to Appendix 23, wherein the tip portion includes one or more elastic struts to enable an extended state.

Claims

1. When handling a thin-film implant device and placing it at the surgical site, the tip portion is configured to hold and protect the thin-film implant device, A handle section configured to control the vacuum source, A shaft portion is configured to connect the handle portion and the tip portion, and to control and supply vacuum from the vacuum source to the tip portion. A device equipped with the following features.

2. The apparatus according to claim 1, wherein the vacuum source is housed in the handle portion of the apparatus.

3. The apparatus according to claim 1, wherein the vacuum source is located outside the apparatus.

4. The apparatus according to claim 1, wherein the tip portion, the shaft portion, and the handle portion are arranged substantially in the same plane and are in a straight line.

5. The apparatus according to claim 1, wherein the tip portion, the shaft portion, and the handle portion are arranged in different planes, and the shaft portion has a plurality of bends along its length, and the first plane of the tip portion is offset from the longitudinal axis of the second plane of the handle portion.

6. The apparatus according to claim 1, wherein the vacuum source includes a power supply, and the power supply includes at least one of a syringe pump, a battery, or an AC power supply.

7. The apparatus according to claim 1, wherein the tip portion is configured to include a blade tip mounted at the distal end for preparation for surgical placement of the thin-film implant device.

8. The apparatus according to claim 7, wherein the blade tip is deployable and connected to the handle portion via an operating member held by an operating lever in the handle portion.

9. The apparatus according to claim 1, further comprising at least one pressure transducer positioned in a vacuum channel for detecting the vacuum level of the vacuum source.

10. The apparatus according to claim 9, further comprising a display configured to display the vacuum level detected by the at least one pressure transducer.

11. The apparatus according to claim 10, wherein the display is mounted and installed on either the tip portion, the shaft portion, or the handle portion.

12. The apparatus according to claim 10, wherein the display is configured to display the vacuum level via one or more analog or digital signals.

13. The apparatus according to claim 12, wherein the display includes a light-emitting diode (LED) display.

14. The apparatus according to claim 12, wherein the one or more analog or digital signals include a visual or auditory signal configured to indicate the level of vacuum detected by the at least one pressure transducer.

15. The apparatus according to claim 1, wherein the tip portion includes a plurality of vacuum slots.

16. The apparatus according to claim 1, wherein the tip portion has dimensions and shape configured to accommodate different sizes of the thin-film implantable device.

17. The apparatus according to claim 1, wherein the edges of the distal and proximal surfaces of the tip portion are rounded, beveled, or chamfered to facilitate smooth and easy entry into and exit from the surgical site.

18. The apparatus according to claim 1, wherein the tip portion is made of a biocompatible material.

19. The apparatus according to claim 1, wherein the tip portion includes an array of perforations configured to regulate the supply of vacuum while maintaining support for a thin-film implant device.

20. The apparatus according to claim 1, wherein the tip portion includes a connection surface between the tip and the implant, which is configured to be non-planar.

21. The apparatus according to claim 20, wherein the connection surface between the tip and the implant includes a woven mesh or fabric of polymer fibers.

22. The apparatus according to claim 20, wherein the connection surface between the tip and the implant includes a shallow nest in which the thin-film implant device is housed, and at least a portion of the area around the tip portion is higher than the uppermost surface of the thin-film implant device.

23. The apparatus according to claim 1, wherein the tip portion can be configured between a folded state and an unfolded state, and in the folded state, the tip portion is in a rolled state with the thin film implant device attached to the upper surface of the tip portion, and in the unfolded state, the tip portion is in a state for positioning the thin film implant device at the surgical site.

24. The apparatus according to claim 23, wherein the tip portion includes one or more wires extending within the shaft portion and connected to at least one component within the handle portion, each wire having a first end held at a selected position on the upper surface of the tip portion and a second end attached to the at least one component.

25. The apparatus according to claim 24, wherein the at least one component is configured to control the tension of the one or more wires.

26. The apparatus according to claim 24, wherein the at least one component is a lever or button mounted on the handle portion.

27. The apparatus according to claim 23, wherein the tip portion is made of an elastic material or an articulated component to allow the tip portion to be folded and unfolded.

28. The apparatus according to claim 23, wherein the tip portion includes one or more elastic struts to enable an extended state.

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