Multi-lumen syringe for intraocular injection

Abstract

Provided herein is a multi-lumen syringe for intraocular injection comprising a first lumen, a second lumen, one or more needles fluidically connected to the lumens, and a needle guard disposed around the one or more needles; wherein the needle guard comprises a plurality of n proximity / contact / pressure actuators located on a distal edge of the needle guard; wherein the syringe is switchable between at least two configurations: a first configuration in which at least one of the actuators is not actuated and each tip of the one or more needles is positioned and fixed proximally relative to the distal edge; and a second configuration in which the n actuators are actuated and the one or more needles are allowed to extend distally beyond the distal edge.

Description

[0001] This application is a divisional application of the application filed on August 5, 2019, with application number 201980065829.0 and invention title "Multi-chamber syringe for intraocular injection". Technical Field

[0002] This disclosure generally relates to syringes for intraocular injection. background

[0003] Intravitreal drug delivery is a common procedure for treating various retinal diseases, including age-related macular degeneration (AMD), diabetic retinopathy, and retinal vein occlusion. The use of intravitreal injections has increased significantly since the introduction of anti-vascular endothelial growth factor (anti-VEGF) drugs. Currently, intravitreal injections are one of the most frequently performed medical procedures. In the United States alone, more than 6 million were performed in 2016.

[0004] There remains a need in the field for improved, safer, and more reliable intravitreal injection devices and methods.

[0005] Overview

[0006] According to some embodiments of this disclosure, aspects of this disclosure relate to syringes for intraocular injection. More specifically, but not exclusively, according to some embodiments of this disclosure, aspects of this disclosure relate to multi-lumen syringes for intraocular injection and / or aspiration of intraocular materials.

[0007] According to some embodiments, a multi-chamber syringe is provided for intraocular injection and / or extraction of intraocular material, wherein the syringe includes a first chamber, a second chamber, one or more needles fluidly connected to the chambers, and a needle sheath disposed around the one or more needles, wherein the syringe is switchable between at least two configurations:

[0008] - A first configuration, in which each tip of the one or more needles is positioned and fixed proximally relative to the distal edge; and

[0009] -Second configuration, in which one or more needles can extend distally beyond the distal edge.

[0010] The first and / or second needle may have perforations in the tip and / or shaft, thus forming one or more entry or exit ports to the first and / or second needle. The tip of the needle may serve solely as a blade for piercing the eye, and one or more ports allowing material to pass through the needle may be in the shaft, rather than at the tip. Specifically, according to some such embodiments, this allows for a narrower and thus sharper tip compared to an open (and hollow) tip (which is configured to deliver fluid through it).

[0011] According to aspects of some embodiments, a multi-chamber syringe is provided for intraocular injection and / or aspiration of intraocular materials. The syringe includes a first chamber, a second chamber, one or more needles fluidly connected to these chambers, and a needle sheath disposed around the one or more needles. The needle sheath includes a plurality of n proximity / contact / pressure actuators on a distal edge of the needle sheath. The syringe is switchable between at least two configurations:

[0012] - First configuration, in which at least one of the actuators is not actuated, and each tip of one or more needles is positioned and fixed proximally relative to the distal edge.

[0013] - Second configuration, in which n actuators are actuated and one or more needles can extend distally beyond the distal edge.

[0014] According to some embodiments, the plane defined by the distal edge of the needle sheath is perpendicular or substantially perpendicular to one or more needles, thereby ensuring that one or more needles can be inserted perpendicular to the surface of the eye when all or substantially all of the distal edges contact the surface of the eye to actuate n actuators.

[0015] According to some embodiments, the syringe is configured to automatically switch from a second configuration back to a first configuration, thereby ensuring that after one or more needles have been inserted, if the syringe is tilted such that the distal edge no longer fully or substantially fully contacts the surface of the eye, it is no longer possible to inject or withdraw fluid.

[0016] According to some embodiments, the actuator is a push-button, and in a second configuration, the push-button is pushed in beyond a threshold level.

[0017] According to some embodiments, in at least one pair of actuators from n actuators, the actuators are positioned relative to or substantially relative to each other on the distal edge, thereby helping to ensure that even when n=2, in the second configuration, the distal edge rests stably on the eye, and the needle is positioned perpendicular to or substantially perpendicular to the surface of the eye.

[0018] According to some embodiments, the actuator is a contact / pressure actuator. The position (orientation) of the actuator on the distal edge is such that when the distal edge is placed on the subject's eye, the multi-chamber syringe cannot be switched from the first configuration to the second configuration unless all or substantially all of the distal edge is in contact with the eye (i.e., all or substantially all of the actuators are actuated).

[0019] According to some embodiments, the actuator is a contact / pressure actuator. The actuator is positioned on the distal edge such that when the distal edge is placed on the subject's eye, one or more plungers of the multi-chamber syringe are locked and cannot be moved (i.e., pushed and / or pulled) unless all or substantially all of the distal edge is in contact with the eye (i.e., all or substantially all of the actuators are actuated).

[0020] According to some embodiments, the actuator and / or other components are also configured to measure eye pressure.

[0021] In some embodiments, one or more needles are retractable. In some such embodiments, the needle sheath is fixed.

[0022] According to some embodiments, the needle sheath is retractable and / or compressible. According to some such embodiments, one or more needles are fixed.

[0023] According to some embodiments, the second cavity is disposed within the first cavity.

[0024] According to some embodiments, one or more needles include at least two needles: a first needle and a second needle. The first needle is fluidly connected to a first cavity, and the second needle is fluidly connected to a second cavity.

[0025] According to some embodiments, the second needle is placed inside the first needle.

[0026] According to some embodiments, the second cavity is adjacent to the first cavity, and the second needle is adjacent to the first needle.

[0027] According to some embodiments, the needle sheath is cylindrical.

[0028] According to some embodiments, the first and / or second needles have perforations in their tip and / or shaft, thereby forming one or more entry or exit ports to the first and / or second needles. The perforation may be an opening in the needle. According to some embodiments, the tip of the needle may serve solely as a blade for piercing the eye, and one or more ports allowing material to pass through the needle may be in the shaft, rather than at the tip. Specifically, according to some such embodiments, this allows for a narrower and thus sharper tip compared to an open (and hollow) tip (which is configured to deliver fluid through it).

[0029] According to some embodiments, the first needle has a perforation and / or the second needle has a perforation in the sense that a side port is included on the corresponding needle shaft. The side port allows fluid to enter or exit through it.

[0030] According to some embodiments, the first needle includes one or more cutting elements and / or the second needle includes one or more cutting elements.

[0031] According to some embodiments, at least some of the cutting elements are configured to move in or on a corresponding needle.

[0032] According to some embodiments, the first needle has a perforation and includes one or more first needle side ports on the first needle shaft. The second needle includes one or more second needle cutting elements positioned adjacent to corresponding side ports among the first needle side ports.

[0033] According to some embodiments, one or more of the first needle cutting elements are configured to move within a corresponding second needle side port when the needle is inserted into the subject's eye in order to cut material adjacent to the second needle side port.

[0034] According to some embodiments, the first needle and the second needle are configured for relative movement between the first needle and the second needle.

[0035] According to some embodiments, the relative motion includes oscillating motion, reciprocating motion, lateral motion, rotation, vibration, or any combination thereof of the first and / or second needles.

[0036] According to some embodiments, the first needle and / or the second needle are configured for movement. According to some embodiments, the first needle and / or the second needle, together with each of their respective cavities or sub-lumens, are configured for movement. According to some embodiments, such movement may include oscillating motion, reciprocating motion, lateral movement, rotation, vibration, or any combination thereof of the first needle and / or the second needle.

[0037] According to some embodiments, the cutting element can be fixed inside the first needle and / or the second needle, such that the relative movement between the first and / or the second needle produces a cutting effect.

[0038] According to some embodiments, pushing and / or pulling the first plunger and / or the second plunger actuates the cutting element included in / above the first needle and / or the second needle.

[0039] According to some embodiments, at least some of the cutting elements are fixed to corresponding needles, such that pushing and / or pulling the first plunger and / or the second plunger can cause a cutting motion of the fixed cutting elements.

[0040] According to such an embodiment, at least some of the cutting elements fixed on the second needle are positioned adjacent to the side port on the first needle, such that pushing and / or pulling the first plunger and / or the second plunger causes their (the cutting elements fixed on the second needle) to cut in / through the side port.

[0041] According to such an embodiment, at least some of the cutting elements fixed within the first needle are positioned adjacent to the side ports on the second needle, such that pushing and / or pulling the first plunger and / or the second plunger causes the cutting elements to make a cutting motion in / through the side ports.

[0042] According to some embodiments, the radius of the distal edge is between approximately 3 mm and approximately 4 mm. The syringe is configured such that the distal edge is visible to the user when the user brings it against the subject's eye, thereby facilitating the insertion of one or more needles at a location between approximately 3 mm and approximately 4 mm from the limbus in the eye.

[0043] According to some embodiments, the needle sheath or one or more needles may include an extension / marker (e.g., a circumferential extension, such as a flange or band (e.g., a silicone band)). This extension defines a distance between approximately 3 mm and approximately 4 mm from one or more needles. The syringe is configured such that the extension is visible to the user when the user brings the distal edge against the subject's eye, thereby facilitating needle insertion at a location between approximately 3 mm and approximately 4 mm from the limbus in the eye. According to some such embodiments, the extension / marker may be coated with a protective material (such as silicone or any other material known in the art) that allows contact with the cornea without causing damage to the cornea and / or conjunctiva due to exposure to the material or shear forces resulting from contact, thereby reducing the risk of erosive damage to the cornea and / or conjunctiva (or any other type of damage resulting from exposure to or contact with the extension / marker). The extension / marker may be designed to contact or be relatively close to the eye. When the extension / marker comes into contact with the eye, the extension / marker can act as a stabilizer because it extends the base of the syringe that comes into contact with the eye, thus minimizing the possible tilting of the syringe.

[0044] According to some embodiments, when compressed, the needle sheath defines a distance between approximately 3 mm and approximately 4 mm from one or more needles. The syringe is configured such that when the user brings the distal edge against the subject's eye, the needle sheath is compressed, thereby facilitating the insertion of one or more needles at a distance between approximately 3 mm and approximately 4 mm from the limbus of the eye. According to some such embodiments, the needle sheath may be coated with a protective material (such as silicone or any other material known in the art) that can contact the cornea without causing damage to the cornea and / or conjunctiva due to exposure to the material or shear forces resulting from contact, thereby reducing the risk of erosive damage to the cornea and / or conjunctiva (or any other type of damage resulting from exposure to / contact with the needle sheath).

[0045] According to some embodiments, the corresponding distances between adjacent actuators from a plurality of actuators are equal or substantially equal.

[0046] According to some embodiments, the distal edge is oval or elliptical.

[0047] According to some embodiments, the proximal end of the needle sheath is connected to the distal end of the second cavity.

[0048] According to some embodiments, the syringe also includes a first plunger configured for reciprocating motion in a first cavity and a second plunger configured for reciprocating motion in a second cavity.

[0049] According to some embodiments, the second cavity is disposed within the first cavity, and the second plunger is disposed within the first plunger.

[0050] According to some embodiments, the first plunger and the second plunger are functionally associated such that pushing or pulling the first plunger causes the second plunger to move in the opposite direction, and / or pushing or pulling the second plunger causes the first plunger to move in the opposite direction.

[0051] According to some embodiments, the syringe is configured to allow controllable switching between at least two operating modes in a second configuration:

[0052] Free movement mode, in which the first and second plungers can move independently of each other; and

[0053] At least one reverse motion mode, wherein the first plunger and the second plunger are functionally associated such that pushing or pulling the first plunger causes the second plunger to move in the opposite direction, and / or pushing or pulling the second plunger causes the first plunger to move in the opposite direction.

[0054] According to some embodiments, at least one reverse motion mode includes at least two reverse motion modes:

[0055] A first reverse motion mode, wherein the volume change in the first cavity caused by the movement of the first plunger results in an opposite-sign and equal-sign volume change in the second cavity caused by the induced movement of the second plunger, and vice versa; and

[0056] The second reverse motion mode, wherein the volume change in the first cavity caused by the movement of the first plunger results in a change in the volume of the second cavity with opposite signs and different sizes caused by the induced movement of the second plunger, and vice versa.

[0057] According to some embodiments, the first plunger is configured to prevent it from pushing and / or pulling beyond a threshold pushing speed and / or a threshold pulling speed of the first plunger.

[0058] According to some embodiments, the second plunger is configured to prevent it from pushing and / or pulling beyond a threshold pushing speed and / or a threshold pulling speed of the second plunger.

[0059] According to some embodiments, at least one of the plungers is configured to allow injection of fluid only after the other of the plungers has been pulled to extract a (predetermined) amount of eye fluid.

[0060] According to some embodiments, the syringe includes a locking mechanism configured to prevent the first plunger from being pushed (to inject fluid) when the volume defined by the second plunger within the second chamber is less than a threshold volume.

[0061] According to some embodiments, the syringe includes a locking mechanism configured to prevent a second plunger from being pushed (to inject fluid) when the volume defined by the first plunger within the first chamber is less than a threshold volume.

[0062] According to some embodiments, the syringe includes a locking mechanism configured to allow the first plunger to be pushed to inject fluid only when the second plunger is instructed to be moved into a pull configuration (to ensure that fluid is withdrawn from the eye before injection).

[0063] According to some embodiments, the syringe includes a locking mechanism configured to allow the second plunger to be pushed to inject fluid only when the first plunger is indicated to be displaced into a pull configuration (to ensure that fluid is withdrawn from the eye before injection).

[0064] According to some embodiments, at least one of the plungers is configured to allow the eye fluid to be withdrawn only after the other of the plungers has been pushed to inject a (predetermined) amount of fluid.

[0065] According to some embodiments, the syringe includes a locking mechanism configured to prevent the first plunger from being pulled (to extract fluid) when the volume defined by the second plunger within the second chamber is greater than a threshold volume.

[0066] According to some embodiments, the syringe includes a locking mechanism configured to prevent a second plunger from being pulled (to extract fluid) when the volume defined by the first plunger within the first chamber is greater than a threshold volume.

[0067] According to some embodiments, the syringe includes a locking mechanism configured to allow the first plunger to be pulled to withdraw eye fluid only when the second plunger is instructed to be moved into the push configuration (ensuring that the fluid is injected into the eye before withdrawal).

[0068] According to some embodiments, the syringe includes a locking mechanism configured to allow the second plunger to be pulled to withdraw eye fluid only when the first plunger is indicated to be displaced into a push configuration (ensuring that the fluid is injected into the eye before withdrawal).

[0069] According to some embodiments, the locking mechanism can be enabled or disabled, thereby allowing independent movement of each plunger.

[0070] According to some embodiments, the syringe is configured to allow one or more needles to be inserted into the eye of a subject at a predetermined speed and / or pressure or at a predetermined speed and / or pressure range.

[0071] According to some embodiments, the syringe can be coupled via a plunger, a lumen, a sub-lumen, and / or any combination thereof to a system (e.g., a station) configured to control the operation and function of the syringe. According to some such embodiments, the system is configured to generate positive or negative pressure in the lumen or sub-lumen of the syringe, thereby moving the plunger and causing the lumen and / or sub-lumen to aspirate fluid from the subject's eye and / or inject a substance into the subject's eye. According to some such embodiments, the system can be configured to control the insertion speed of the needle, the insertion force, and the pressure of the injected fluid.

[0072] According to some embodiments, in the second configuration, the tips of one or more needles are restricted to protrude more than about 1 cm distally relative to the distal edge of the needle sheath.

[0073] According to some embodiments, the first cavity is divided into two or more first cavity sub-cavities at least along a portion thereof.

[0074] According to some embodiments, each of the first sub-cavities is associated with a corresponding plunger. The first needle is divided into sub-needles. Each of these sub-needles is fluidly connected to one of the first sub-cavities, respectively.

[0075] According to some embodiments, the second cavity is divided into two or more second cavity sub-cavities at least along a portion thereof.

[0076] According to some embodiments, each of the second sub-cavities is associated with a corresponding plunger. The second needle is divided into sub-needles. Each of these sub-needles is fluidly connected to one of the second sub-cavities, respectively.

[0077] According to some embodiments, the first cavity includes a plurality of first cavity sub-cavities and / or the second cavity includes a plurality of second cavity sub-cavities, two or more sub-cavities being fluidly associated with a common cavity. According to some such embodiments, the syringe also includes a valve system (e.g., including a one-way valve) configured to fluidly separate or controllably fluidly separate at least some of the sub-cavities fluidly associated with the common cavity.

[0078] According to some embodiments, each tip of one or more needles is angled and lies on a second plane. The angle between the second plane and the plane defined by the distal edge is an acute angle.

[0079] According to some embodiments, in the first configuration, pushing and / or pulling the plunger is prohibited.

[0080] According to some embodiments, the first needle has a perforation and / or the second needle has a perforation.

[0081] According to some embodiments, the first needle includes one or more cutting elements and / or the second needle includes one or more cutting elements.

[0082] According to some embodiments, at least some of the cutting elements are configured to move in or on a corresponding needle.

[0083] According to some embodiments, the first needle has a perforation and includes one or more first needle side ports on the first needle shaft. The second needle includes one or more first needle cutting elements thereon, these first needle cutting elements being positioned adjacent to corresponding side ports in the second needle side ports.

[0084] According to some embodiments, one or more of the first needle cutting elements are configured to move within a corresponding second needle side port in order to cut material adjacent to the second needle side port when the needle is inserted into the subject's eye.

[0085] According to some embodiments, the first needle and the second needle are configured for relative movement between the first needle and the second needle.

[0086] According to some embodiments, the relative motion includes oscillating motion, reciprocating motion, lateral motion, rotation, vibration, or any combination thereof of the first and / or second needles.

[0087] According to some embodiments, the syringe is disposable and can be replaced after each use, or at least some removable parts of the syringe are disposable and can be replaced after each use. Disposable elements may include, for example, a needle, a syringe cavity or sub-cavity, or the entire syringe.

[0088] According to some embodiments, the syringe, for example, in one or more cavities or subcavities of the syringe, may include at least one substance that facilitates rapid analysis of the eye fluid through interaction with the eye fluid.

[0089] According to some embodiments, rapid analysis can be facilitated by indicator substances and / or enzyme-linked immunosorbent assays (ELISA) and / or chemical pads, located in the lumen / sub-lumen of a syringe or on the wall of the lumen / sub-lumen, for the detection of one or more intraocular substances, such as, but not limited to, vascular endothelial growth factor levels, interleukin-6 levels, and TNF levels. Furthermore, the analysis may include testing for the presence of one or more substances, including but not limited to proteins, glucose, ketones, hemoglobin, acetone, nitrite, leukocytes, pH, and specific gravity, to test for infection by various pathogens.

[0090] According to some embodiments, the syringe may include a chemical (e.g., located in the cavity / sub-cavity of the syringe) configured to react with compounds present in the ocular substance to produce a characteristic color. The change in color can provide a qualitative result that determines only whether the sample is positive or negative, or a semi-quantitative result that, in addition to providing a positive or negative reaction, provides an estimate of a quantitative result. In the latter, the color obtained by the reaction is related to (e.g., substantially proportionally) the concentration of the substance being tested in the sample.

[0091] Semi-quantitative values ​​can be presented to the user, such as trace, 1+, 2+, 3+, and 4+, although test results can also be presented in milligrams per deciliter. Automatic readers (e.g., but not limited to, in mobile (e.g., handheld) computing devices, implemented as applications in smartphones, cameras, desktop computers, or standalone devices) can also provide / present the results.

[0092] According to some embodiments, the automatic reader is functionally associated with a computerized system configured to store and analyze results and provide interpretations and outcomes to the user.

[0093] According to some embodiments, rapid analysis may include indicator substances and / or enzyme-linked immunosorbent assays (ELISA) and / or chemical pads. According to some embodiments, rapid analysis may include indicator substances based on paper-based ELISAs known to those skilled in the art.

[0094] According to some embodiments, a station is provided for injecting and / or withdrawing fluid from a subject's eye. The station includes:

[0095] - Housing, which includes the monitor.

[0096] - Controller.

[0097] - Control circuitry, which can be distributed between the housing and the controller.

[0098] The housing includes one or more tube ports for one or more corresponding tubes, and one or more wire ports for one or more corresponding wires. The station is configured to connect to a syringe via one or more tube ports and one or more wire ports for intraocular injection, such as, but not limited to, the multi-lumen syringe and single-lumen syringe described above. The station is thus configured to control one or more functions and / or operating parameters of the syringe.

[0099] According to some embodiments, the controller is included in the housing.

[0100] According to some embodiments, the housing includes a plug-in station for the controller.

[0101] According to some embodiments, the tubing and / or wires are disposable.

[0102] According to some embodiments, pipes and / or lines form an integral part of the station.

[0103] According to some embodiments, the control circuitry is configured to allow switching between syringe configurations and modes.

[0104] According to some embodiments, the operating parameters include the volume of fluid injected / extracted, the force applied to insert the needle, the speed of needle insertion, the rate of fluid injection / extraction, which cavities are operable and which are not operable during use of the syringe, which cavity is used for injection and which cavity is used for extraction.

[0105] According to some embodiments, functions and parameters can be controlled by controller accessories, buttons located on tubes, lines and / or syringes.

[0106] According to some embodiments, the controller accessory includes a foot pedal.

[0107] According to some embodiments, the station is configured to control the pressure within the cavity / subcavity, thereby moving the plunger at a predetermined speed within a predetermined speed range to inject the substance into the subject's eye and to extract fluid from the subject's eye at a predetermined rate.

[0108] According to some embodiments, the station is configured to control the relative movement of the needle and / or the movement of the cutting element.

[0109] According to some embodiments, the housing and / or tube include at least one material that facilitates rapid analysis of the eye fluid through its interaction with the eye fluid.

[0110] According to some embodiments, the monitor is configured to display analytical data from rapid analysis of ocular fluid in qualitative, semi-quantitative, and / or quantitative formats.

[0111] According to some embodiments, the control circuitry also includes at least one computer processor configured to analyze sensor readings from sensors located in the syringe and / or tube, and optionally includes a memory configured to store the analysis results.

[0112] According to some embodiments, the computer processor is also configured to provide diagnostics based on sensor readings.

[0113] According to some embodiments, the monitor can be configured to display analysis results and optional diagnostics.

[0114] According to some embodiments, the station also includes a support structure comprising a height-adjustable mounting member configured to support the housing, and a base from which the height-adjustable mounting member extends and supports the height-adjustable mounting member.

[0115] According to some embodiments, the station is mobile. According to some such embodiments, the base is mounted on wheels.

[0116] According to some embodiments, the station may include a transmitter and / or a receiver configured to transmit readings to a remote station (e.g., another station or server / cloud) and / or receive readings from a remote station (e.g., another station or server / cloud).

[0117] According to some embodiments, a remote station may be configured to communicate with a local station, store data, analyze data for a given reading and / or compare a given reading with previously obtained readings from the remote station or multiple remote stations, and / or transmit data to the station.

[0118] According to aspects of some embodiments, this document provides a multi-chamber syringe as disclosed herein, wherein one or more of the cavities or sub-cavities are pre-loaded with a substance. Such a substance may include fluids, such as, but not limited to, fluids containing drugs, saline solutions, etc. Such a substance may also include materials configured for analyzing fluids extracted from the eye.

[0119] According to aspects of some embodiments, this document provides a method for injecting fluid into and / or withdrawing fluid from the eye. According to some embodiments, the method includes utilizing a multi-chamber syringe disclosed herein. The method includes:

[0120] Approach / contact the subject's eye with the distal tip of the syringe, wherein the distal tip of the syringe may be the distal tip of at least one of a standard needle, a perforated needle, and / or a needle including a cutting element and / or the distal edge of the sheath surrounding the needle.

[0121] Optionally, the subject's eye is brought into contact with the distal edge, thereby switching from a first configuration (where each tip of one or more needles is positioned and fixed proximally relative to the distal edge of the syringe) to a second configuration (where one or more needles can extend distally beyond the distal edge) by bringing the distal edge against the surface of the eye.

[0122] Insert at least one of the needles into the eye;

[0123] Pull the first plunger of the syringe to draw fluid from the eye;

[0124] Push the second plunger of the syringe to inject fluid into the eye; and

[0125] The latter two steps can be performed simultaneously or sequentially in any order.

[0126] According to some embodiments, the method may also include functionally associating the syringe with one or more systems (e.g., local stations and / or remote stations (e.g., as described herein)), as described above, wherein the systems are configured to partially or completely control the operation and / or function of the syringe or its components.

[0127] According to some embodiments, the method may also include analyzing (e.g., real-time analysis) the fluid extracted from the eye.

[0128] Specific embodiments of this disclosure may include some, all, or none of the advantages described above. One or more other technical advantages may be readily apparent to those skilled in the art, based on the accompanying drawings, description, and claims included herein. Furthermore, although specific advantages have been listed above, various embodiments may include all, some, or none of the listed advantages.

[0129] Unless otherwise specified, 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 disclosure pertains. In case of conflict, the patent specification (including definitions) shall prevail. As used herein, unless the context clearly indicates otherwise, the indefinite articles “a” and “an” mean “at least one” or “one or more”. Brief description of the attached diagram

[0130] Some embodiments of this disclosure are described herein with reference to the accompanying drawings. The description, taken in conjunction with the drawings, makes it apparent to those skilled in the art how some embodiments can be practiced. The drawings are for illustrative purposes and are not intended to show structural details of the embodiments in more detail than necessary for a basic understanding of this disclosure. For clarity, some objects depicted in the drawings are not to scale.

[0131] In the diagram:

[0132] Figure 1a This is a schematic exploded view of a multi-chamber syringe according to some exemplary embodiments;

[0133] Figure 1b The illustration schematically depicts a representation according to some embodiments. Figure 1a The distal section of a multi-chamber syringe;

[0134] Figure 2 The illustration schematically depicts, according to some exemplary embodiments, Figure 1a A multi-chamber syringe, wherein the needle of the multi-chamber syringe is inserted into the subject's eye;

[0135] Figure 3 This is a cross-sectional view of the cavity of a multi-cavity syringe according to some embodiments.

[0136] Figure 4 This is a schematic partial view of a perforated needle according to some embodiments.

[0137] Figure 5 This is a schematic partial view of a needle including one or more cutting elements according to some embodiments;

[0138] Figure 6This is a schematic partial view of a dual-needle injector according to some embodiments, wherein each needle has a perforation and / or includes a cutting element; and

[0139] Figure 7 A station for injecting fluid into and / or withdrawing fluid from a subject's eye, according to some embodiments, is schematically depicted. Detailed description

[0140] The principles, uses, and implementations taught herein can be better understood by referring to the accompanying description and figures. By carefully reading the description and figures provided herein, those skilled in the art will be able to implement the teachings without much effort or experimentation. In the figures, the same reference numerals always refer to the same parts.

[0141] In the description and claims of this application, the words “comprising” and “having” and their forms are not limited to the components in the list that may be associated with these words.

[0142] As used herein, the term "about" can be used to specify the value of a quantity or parameter (e.g., the length of an element) as a range of values ​​near (and including) a given (stated) value. According to some embodiments, "about" can specify a parameter value between 80% and 120% of a given value. For example, the statement "the length of the element is about 1 m" is equivalent to the statement "the length of the element is between 0.8 m and 1.2 m." According to some embodiments, "about" can specify a parameter value between 90% and 110% of a given value. According to some embodiments, "about" can specify a parameter value between 95% and 105% of a given value.

[0143] As used herein, the terms “generally” and “about” may be used interchangeably according to some embodiments.

[0144] As used herein, according to some embodiments, the term "fluid" can refer to a liquid, gel, or gas. For example, "fluid" can refer to a gas (such as CO2, a drug-carrying gas), a drug, a solution (such as a saline solution, a drug-containing solution), a suspension (such as a suspension containing drug particles / droplets), etc. According to some embodiments, the term "fluid" can also refer to ocular fluids. According to some embodiments, the term "drug" can refer to any active pharmaceutical ingredient, such as, but not limited to, a compound, a combination of compounds, or a composition thereof, with or without a carrier and / or excipients. Drugs can be in the form of liquids, gels, dissolved / suspended particles, or gases.

[0145] For ease of description, a three-dimensional Cartesian coordinate system (with orthogonal axes x, y, and z) is introduced in some figures. Note that the orientation of the coordinate system relative to the depicted object can vary from one figure to another. Furthermore, the symbol ⊙ is used in the figures to indicate an axis pointing "outside the page".

[0146] As used herein, according to some embodiments, the term "longitudinal" regarding direction / axis refers to a direction / axis along / parallel to / opposite to the z-axis. According to some embodiments, the term "distal" regarding direction refers to a direction along the negative z-axis. According to some embodiments, the term "proximal" regarding direction refers to a direction along the positive z-axis. According to some embodiments, the term "distal" regarding location (e.g., the location of an element / component) may refer to a location near or within the subject's body, while the term "proximal" refers to a location further away from the subject's body (relative to the distal location).

[0147] According to some embodiments, a multi-chamber syringe is provided. Figure 1a This is a schematic exploded view of a multi-chamber syringe 100; according to some embodiments, the syringe 100 includes a first chamber 102, a second chamber 104, a first needle 112, a second needle 114, a first plunger 122, a second plunger 124, and a needle sheath 140. The first needle 112 is fluidly connected to the first chamber 102. The second needle 114 is fluidly connected to the second chamber 104. The first plunger 122 is configured for controllable reciprocating motion within the first chamber 102.

[0148] The second plunger 124 is configured for controlled reciprocating motion within the second cavity 104.

[0149] The first needle 112 includes a first needle tip 126 (at the distal end of the first needle). The second needle 114 includes a second needle tip 128 (at the distal end of the second needle). The first plunger 122 includes a first plunger seal 132 (e.g., at the distal end of the first plunger). The second plunger 124 includes a second plunger seal 134 (at the distal end of the second plunger).

[0150] According to some embodiments, and as depicted in the figures, a second cavity 104 is longitudinally disposed within a first cavity 102 along the length of the first cavity 102. According to some such embodiments, the first cavity 102 and the second cavity 104 are concentrically disposed. According to some embodiments, and as depicted in the figures, a second needle 114 is longitudinally disposed within a first needle 112 along the length of the first needle 112. According to some such embodiments, the first needle 112 and the second needle 114 are concentrically disposed.

[0151] The most commonly used injection volume is 0.05 ml. Without pre-injection aspiration of the substance, the maximum safe injection volume is believed to be 0.1 ml to 0.2 ml. Therefore, according to some embodiments, the aspiration and / or injection of the substance can be performed in the range of 0-0.4 ml, such that the net amount is approximately 0.2 ml of substance added to or removed from the eye.

[0152] According to some implementations, needle size can vary depending on the substance being injected. A 27-gauge needle is often used for crystalline substances such as triamcinolone, and a 30-gauge needle is commonly used for anti-VEGF agents such as ranibizumab, bevacizumab, and aflibercept. Studies have shown that smaller, sharper needles require less penetration and thus reduce drug backflow. Some physicians have begun using 31-gauge needles (the size typically used by diabetic patients for blood glucose monitoring and insulin injections) because the smaller needle size reduces patient discomfort.

[0153] The needle specifications described above are related to the outer first needle 112. Thus, the second needle 114 is characterized as a smaller specification.

[0154] The needle length can be between approximately 0.5 inches and 0.62 inches (12.7 mm to 15.75 mm). A longer needle may increase the risk of retinal damage if the patient moves forward unexpectedly during the procedure.

[0155] According to some embodiments not depicted in the figure, the second needle 114 is adjacent to the first needle 112.

[0156] The needle sheath 140 is longitudinally disposed around the first needle 112 (and the second needle 114) and terminates at a distal edge 142. According to some embodiments, and as depicted in the figures, the needle sheath 140 is cylindrical. According to some embodiments, the distal edge 142 is oval or elliptical. According to some embodiments, and as depicted in the figures, the distal edge 142 is circular. According to some such embodiments, the radius of the distal edge 142 (and the needle sheath 140) is between about 3 mm and about 4 mm, thereby allowing the operator of the syringe 100 to reliably inject at a (recommended) distance of about 3 mm to about 4 mm from the limbus of the subject's eye.

[0157] According to some embodiments, the needle sheath 140 is attached to the outer wall (not numbered) of the first cavity 102. According to some embodiments, the needle sheath 140 has a larger diameter than the first cavity 102, and the needle sheath 140, or at least its proximal portion, is configured to slide on the first cavity 102. The distal edge 142 includes a plurality of n actuators 148 (e.g., ...). Figure 1b(As shown). According to some embodiments, for all adjacent actuator pairs, the distance between adjacent actuators (from actuator 148) is the same or substantially the same. According to some embodiments, actuator 148 is actuated when pressure above a pressure threshold is applied to actuator 148. According to some such embodiments, actuator 148 includes a pressure sensor. According to some embodiments, the actuator is actuated by contact. According to some such embodiments, actuator 148 includes a contact sensor. According to some embodiments, actuator 148 includes a proximity sensor. According to some embodiments, and as shown... Figure 1b As depicted, actuator 148 is a push button, actuated when pushed beyond a threshold level. According to some such embodiments, one or more actuators 148 or one or more dedicated sensors (located on the distal edge 142) enable the measurement of intraocular pressure using various methods known in the art for reading intraocular pressure (e.g., but not limited to, measurement near or relatively near various ocular surfaces, i.e., the cornea or sclera). In some embodiments, actuator 148 or one or more dedicated sensors (located on the distal edge 142) can operate in a closed-loop system, controlling (e.g., limiting) the movement of plungers 124 and / or 122 and / or the total volume of material injected and / or withdrawn from the eye based on the measured intraocular pressure. In some embodiments of the system, feedback to the operator can be given by presenting the intraocular pressure on a display unit or by sound (not shown).

[0158] The syringe 100 can be controllably switched between two configurations: a first configuration and a second configuration. In the first configuration, at least m actuators 148 (where 1 ≤ m ≤ n-1) are not actuated (making nm or fewer actuators 148 actuated), and needle tips 126 and 128 are positioned and fixed proximally relative to the distal edge 142. That is, the first needle tip 126 and the second needle tip 128 are not exposed. In the second configuration, at least n-m+1 actuators 148 are actuated (making m-1 or fewer actuators 148 not actuated), and needle tips 126 and 128 can be exposed (i.e., needle tips 126 and 128 can extend distally beyond the distal edge 142). Each pair of values ​​for n and m corresponds to a separate embodiment.

[0159] According to some embodiments, in the second configuration, needles 112 and 114 and needle sheath 140 are capable of relative movement with respect to each other (so as to allow exposure of needle tips 126 and 128).

[0160] More specifically, the syringe 100 is configured to switch from a first configuration to a second configuration when the number of actuated actuators (from actuator 148) reaches n-m+1, and to switch from the second configuration to the first configuration when the number of actuated actuators drops below n-m+1.

[0161] According to some embodiments, in a first configuration, at least one of the actuators 148 is not actuated (i.e., m = 1), and in a second configuration, all of the actuators 148 are actuated.

[0162] According to some embodiments, the needle sheath 140 is fixed, and needles 112 and 114 are configured for longitudinal (i.e., distal and proximal) movement in a second configuration. According to some embodiments, needles 112 and 114 are fixed, and the needle sheath 140 is configured for longitudinal movement in a second configuration. According to some embodiments, needles 112 and 114 and the needle sheath 140 are configured for longitudinally opposite movements in the second configuration (i.e., when the movement of needles 112 and 114 is distal, the movement of the needle sheath 140 is proximal, and vice versa). According to some embodiments, the proximal end 152 of the needle sheath 140 is fixed, and in the second configuration, the distal edge 142 is retractable. That is, the needle sheath 140 is configured to allow compression in the second configuration.

[0163] According to another or alternative embodiment, the syringe 100 can be controllably switched between two configurations: a first configuration and a second configuration. In the first configuration, at least m actuators 148 (where 1 ≤ m ≤ n-1) are not actuated, and plungers 124 and / or 122 are locked. In the second configuration, at least n–m+1 actuators 148 are actuated, and plungers 124 and / or 122 are freely pulled / pushed. This ensures that liquid will not be injected into or withdrawn from the eye unless the syringe is substantially perpendicular to and in proper contact with the surface of the eye.

[0164] Also refer to Figure 1b , Figure 1b The distal segment 158 ​​of a syringe 100 according to some embodiments thereof is schematically depicted, wherein the actuator 148 is a push button.

[0165] Also refer to Figure 2 , Figure 2 A syringe 100 and an eye 200 according to some embodiments are schematically depicted. The syringe 100 is shown having needles 112 and 114 inserted into the eye 200. More specifically, the distal edge 142 is shown as contacting the surface 202 of the eye 200, such that needles 112 and 114 are inserted into the eye 200 at right angles to (perpendicular to) the surface 202, which increases the safety and reliability of intraocular injection, thereby minimizing potential damage to the lens, retina, and other ocular structures.

[0166] In use, the syringe 100 can switch from a first configuration to a second configuration by bringing its distal edge 142 against a surface (e.g., surface 202 of the eye 200), thereby actuating at least n-m+1 actuators 148. The syringe 100 can be configured such that when the distal edge 142 abuts against a flat or rounded surface (particularly the surface of the eye) and at least n-m+1 actuators 148 are actuated, needles 112 and 114 are positioned at right angles, or substantially right angles, to the surface.

[0167] According to some embodiments, the distal edge 142 defines a plane perpendicular to the needles 112 and 114, such that the perpendicular positioning of the needles 112 and 114 relative to a flat or arched surface is ensured by bringing all the distal edges 142 into contact with that surface. According to some such embodiments, actuation of all actuators 148 ensures that all or substantially all of the distal edges 142 are in contact with the surface, and ensures that the needles 112 and 114 are perpendicular to or substantially perpendicular to the surface. According to some embodiments, at least two of the actuators 148 (e.g., Figure 1b The actuators 148a and 148b are positioned relative to each other on the distal edge 142 (e.g., when the distal edge 142 is circular, the diameter of the distal edge 142 extends between the two actuators), thereby ensuring that when the two actuators are actuated by bringing the distal edge 142 into contact with the surface of the eye, the needles 112 and 114 are perpendicular to the surface.

[0168] As used herein, the term "edge" (e.g., distal edge 142) may refer to a thin and wide edge. For example, according to some embodiments, the surface area of ​​distal edge 142 may be measured to be between about 10% and about 90% of the total area of ​​the plane defined by distal edge 142.

[0169] According to some embodiments, the distal edge 142 is configured to allow it to be stably mounted on the surface 202. For example, the size of the distal edge 142 may be chosen for this purpose, and / or the distal edge 142 may be made of, or coated with, a material that facilitates stable contact between the needle sheath 140 and the eye 200 when the distal edge 142 abuts against the eye 200. According to some embodiments, the needle sheath 140 (or at least the distal edge 142) may be wider than the first cavity 102 (e.g., having a larger diameter), or at least wider along one axis (e.g., when the distal edge 142 is oval or cylindrical), in order to contribute to greater stability of the contact between the distal edge 142 and the surface 202.

[0170] According to some embodiments, the operation of the first plunger 122 and the second plunger 124 is independent of each other. In particular, the first plunger 122 can be pushed or pulled independently of the position of the second plunger 124, and independently of whether the second plunger is pushed or pulled, and vice versa.

[0171] According to some embodiments, pushing and / or pulling the first plunger 122 can cause the second plunger 124 to move in the opposite direction, and / or vice versa. For example, when the second plunger 124 is pushed (e.g., to inject a drug into the subject's eye), the first plunger 122 is automatically pulled back (e.g., to withdraw fluid from the eye).

[0172] According to some embodiments, the syringe 100 may have multiple reverse movement modes and can be controllably switched between these modes. As a non-limiting example, in a first reverse movement mode, an increase or decrease in the first volume is accompanied by a change in the second volume with the opposite sign and equal size (as described above), while in a second reverse movement mode, an increase or decrease in the first volume is accompanied by a change in the second volume with the opposite sign and half the size. That is, in the second reverse movement mode, when the first needle 112 is used to inject the first amount of medication, the second needle 114 is used to withdraw a fluid volume equal to half the first amount. The second reverse movement mode can be used for injection into eyes with low intraocular pressure.

[0173] According to some embodiments, when the injection and withdrawal are performed substantially simultaneously, the length of the first needle 112 may be different from the length of the second needle 114 (not shown), such that each needle will reach a different location inside the eye.

[0174] According to some embodiments, the syringe 100 can operate in a free-movement mode, wherein the movements of the first plunger 122 and the second plunger 124 are independent of each other.

[0175] According to some embodiments, the syringe 100 can operate in a restricted movement mode. According to some embodiments, the syringe 100 includes a locking mechanism that facilitates such operation. According to some embodiments, the locking mechanism is configured to allow the first plunger 122 to be pushed to inject fluid (to ensure fluid is withdrawn from the eye before injection) and / or vice versa (to switch the roles of the first and second plungers) only when the second plunger 124 is indicated to be displaced into a pull configuration.

[0176] Alternatively or concurrently, the locking mechanism may be configured to allow the first plunger 122 to be pulled to withdraw eye fluid only when the second plunger 124 is indicated to be moved to the push configuration (to ensure that the fluid is injected into the eye before withdrawal) and / or vice versa (to switch the roles of the first and second plungers).

[0177] According to some embodiments, the syringe 100 is configured such that, in a second configuration, needles 112 and 114 (distal) can only protrude to a predetermined extent relative to the distal edge 142. According to some embodiments, the predetermined extent is approximately 1 cm. The predetermined extent is chosen to ensure, on the one hand, (i) the safety of using the syringe 100, since inserting the needles too deeply into the eye may damage / injure the internal structures of the eye (such as the retina), and on the other hand, (ii) that the needles 112 and 114 are inserted deep enough to ensure penetration of all layers constituting the outer surface of the eye.

[0178] According to some embodiments, syringe 100 is configured to allow needles 112 and 114 to be inserted into the subject's eye at a predetermined speed and / or pressure, or at a predetermined speed and / or pressure range. This can help reduce discomfort experienced by the subject, particularly when the needle is introduced into the eye too quickly or too slowly and / or with too much or too little force.

[0179] According to some embodiments, the syringe 100 includes at least one additional cavity (not shown) longitudinally disposed around the first cavity 102. According to some such embodiments, the syringe 100 also includes at least one additional needle (not shown) longitudinally disposed around the first needle 112. Additionally or alternatively, according to some embodiments, the syringe 100 includes at least one additional cavity (not shown) longitudinally disposed within a second cavity 104. According to some such embodiments, the syringe 100 also includes at least one additional needle (not shown) longitudinally disposed within the second needle 114.

[0180] Figure 3 This is a schematic cross-sectional view of a multi-chamber syringe 300 according to some embodiments. The syringe 300 is similar to the syringe 100, but differs in that at least one of the first chamber 302 and the second chamber 304 of the syringe 300 includes a plurality of sub-chambers extending longitudinally therein. More specifically, Figure 3 This is a schematic cross-sectional view of the first cavity 302 and the second cavity 304. According to some embodiments, and as... Figure 3 As depicted, the first cavity 302 is divided into a plurality of first cavity sub-cavities 352 extending parallel to each other, and the second cavity 304 is divided into a plurality of second cavity sub-cavities 354 extending parallel to each other. According to some embodiments, each of the first cavity sub-cavities 352 is fluidly connected to a first needle (not shown; similar to first needle 112), and each of the second cavity sub-cavities 354 is fluidly connected to a second needle (not shown; similar to second needle 114).

[0181] As a non-restrictive and illustrative example, in Figure 3In the first cavity 302, there are four sub-cavities (sub-cavities 352a, 352b, 352c and 352d), and the second cavity 304 includes four sub-cavities (sub-cavities 354a, 354b, 354c and 354d).

[0182] According to some embodiments, the syringe 300 includes a first plurality of plungers and a second plurality of plungers (not shown). Each of the first plurality of plungers may be associated with a corresponding sub-cavity from a first sub-cavity 352. Each of the second plurality of plungers may be associated with a corresponding sub-cavity from a second sub-cavity 354.

[0183] More generally, according to some embodiments, some of the first cavity sub-cavities 352 and / or the second cavity sub-cavities 354 may be associated with a common plunger, while other sub-cavities in the first cavity sub-cavities 352 and / or the second cavity sub-cavities 354 may not be associated with a common plunger, but rather with a unique, individual plunger.

[0184] According to some embodiments, the syringe 300 includes one or more additional needles (not shown) such that some of the first cavity 352 and / or some of the second cavity 354 are fluidly associated with one or more additional needles.

[0185] Figure 4 This is a schematic partial view of a perforated needle 400 according to some embodiments. The perforated needle 400 includes one or more side ports 406 along an axis 408 of the perforated needle 400. The side ports 406 may be, for example, circular, elliptical (e.g.,...). Figure 4 (As depicted), or even rectangular. According to some embodiments, the side ports 406 may differ from each other in shape and / or size (e.g., when the side ports 406 are elliptical, they may differ from each other in length along the main axis). The side ports 406 may also differ from each other in their positioning along the axis 408. Specifically, the different side ports (from side port 406) may differ from each other in their respective distances from the (far) tip 410 of the axis 408, and / or may be positioned opposite or substantially opposite each other (i.e., on opposite walls of the axis 408).

[0186] According to some embodiments, the side port 406 may be located on the distal portion of the shaft 408 to help ensure that the side port 406 is located within the vitreous body when the perforated needle 400 is properly inserted into the subject's eye, thereby increasing the safety of the procedure.

[0187] According to some embodiments, the side port 406 can also be used as a cutting element, since the movement of the perforated needle 400 within the eye can result in cutting material in the eye that comes into contact with the side port 406. This movement can include longitudinal movement (e.g., reciprocating motion), lateral movement (e.g., back-and-forth movement in the yz plane, wherein the needle always remains parallel to the z-axis), rotation (about the z-axis and / or about the negative z-axis), vibration, and / or combinations thereof. According to some embodiments, one or more of the listed movements can be oscillatory. According to some embodiments, the movement can be generated by a mechanical (pressure-based), electric, electromagnetic, electromechanical, or piezoelectric motor (not shown), which can, for example, be housed in a cavity to which the perforated needle 400 is fluidly connected. According to some such embodiments, the edge 418 of the side port 406 can be sharp (e.g., similar to the edge of a razor blade) to increase the cutting effectiveness of the side port 406.

[0188] Since the (vitreous) fluid can be contained within the liquefied vitreous cavity, the inclusion of side ports 406 (in addition to the port defined by tip 410) increases the possibility of fluid extraction from the vitreous. More specifically, since the vitreous fluid does not form a single body of fluid within the vitreous, the addition of multiple side ports distributed along the length of the needle axis increases the possibility of the needle (when inserted into the vitreous) establishing fluid communication with more than one single body of fluid. Furthermore, as mentioned above, side ports 406 can also function as cutting elements, potentially releasing fluid from a cavity positioned around the perforated needle 400, which can then be extracted via side ports 406.

[0189] According to some embodiments, this can also be applied to perforated needles (not shown) that do not have an opening at their tip. Such perforated needles only include a side port 406 similar to that of a perforated needle 400. Since such needles do not have an opening at their tip, the tip can have a small diameter and therefore can be advantageously very sharp.

[0190] Referring again to syringe 100, according to some embodiments not depicted in the figure, the first needle 112 is perforated in a manner substantially similar to that of the perforated needle 400 or the perforated needle described above. Alternatively or alternatively, the second needle 114 may be perforated.

[0191] Referring again to syringe 300, according to some embodiments not depicted in the figures, the first needle of syringe 300 (i.e., the outer needle of syringe 300, which may be fluidly connected to the first cavity 352) is perforated in a manner substantially similar to that of the perforated needle 400 or the perforated needle described above. Additionally or alternatively, the second needle of syringe 300 (i.e., the inner needle of syringe 300, which may be fluidly connected to the second cavity 354) may be perforated.

[0192] According to some embodiments, a multi-chamber syringe is provided. The syringe may be similar to embodiments of syringe 100 or syringe 300, which includes a perforated needle, such as a perforated needle 400 (or the perforated needle described above), but differs in that the syringe does not include at least one of a needle sheath (e.g., such as needle sheath 140) and an actuator (such as actuator 148 or similar).

[0193] Figure 5 This is a schematic partial view of a needle 500 including cutting elements according to some embodiments. The needle 500 includes one or more external cutting elements 502 and / or one or more internal cutting elements 504. Movement of the needle 500 within the eye can result in cutting material in the eye that comes into contact with the cutting elements 502. This movement can include longitudinal movement (e.g., reciprocating motion), lateral movement, rotation, vibration, and / or combinations thereof. According to some embodiments, one or more of the listed movements can be oscillatory. According to some embodiments, the movement can be generated by a mechanical (pressure-based), electric, electromagnetic, electromechanical, or piezoelectric motor (not shown), which may, for example, be housed within the needle 500 or within a cavity to which the needle 500 is fluidly connected.

[0194] Referring again to syringe 100, according to some embodiments not depicted in the figures, the second needle 114 includes one or more external cutting elements (such as external cutting element 502) and / or one or more internal cutting elements (such as internal cutting element 504). Additionally or alternatively, according to some embodiments, the first needle 112 includes one or more internal cutting elements. Optionally, the first needle 112 may include one or more external cutting elements.

[0195] Referring again to syringe 300, according to some embodiments not depicted in the figures, the inner needle of syringe 300 includes one or more external cutting elements (such as external cutting element 502) and / or one or more internal cutting elements (such as internal cutting element 504). Alternatively or additionally, according to some embodiments, the outer needle of syringe 300 includes one or more internal cutting elements. Optionally, the outer needle of syringe 300 may include one or more external cutting elements.

[0196] According to some embodiments, a multi-chamber syringe is provided. The syringe may be similar to embodiments of syringe 100 or syringe 300, which include a needle (such as needle 500) with a cutting element needle, but differs in that the syringe does not include at least one of a needle sheath (e.g., such as needle sheath 140) and an actuator (such as actuator 148 or similar).

[0197] Figure 6 This is a schematic partial view of a dual-needle assembly 600 according to some embodiments. The dual-needle assembly 600 includes a first needle 612 and a second needle 614. According to some embodiments, and as... Figure 6 As depicted, a second needle 614 is disposed within and along the first needle 612. According to some embodiments, the first needle 612 has a perforation in a manner substantially similar to that of a perforated needle 400. Additionally and / or alternatively, according to some embodiments, the second needle 614 includes one or more external cutting elements (such as at least one external cutting element 656) and / or one or more internal cutting elements (such as at least one internal cutting element 658). Additionally and / or alternatively, according to some embodiments, the second needle 614 has a perforation. Optionally, the first needle 612 may include one or more internal and / or external cutting elements.

[0198] As a non-restrictive example, and as Figure 6 As depicted, the first needle 612 may include one or more ports 606 (such as one or more of ports 406), and the second needle 614 may include at least one external cutting element 656 (such as one or more of external cutting elements 502) and at least one internal cutting element 658 (such as one or more of internal cutting elements 504). In some embodiments, one or more of the at least one external cutting element 656 may be located at or near one or more ports 606, enabling the element to be cut from the glass body at a point of entry through the port 606 or through the needle tip of the second cavity. Furthermore, in some embodiments, the internal cutting element may be located on the first cavity and / or the second cavity, and can cut the element from the glass body at a point of entry through the needle tip.

[0199] According to some embodiments, the dual-needle assembly 600 may be configured to allow relative movement between the first needle 612 and the second needle 614, such as: (i) longitudinal reciprocating relative movement (where the first needle 612 moves in a reciprocating manner while the second needle 614 is stationary, the second needle 614 moves in a reciprocating manner while the first needle 612 is stationary, or where the first needle 612 and the second needle 614 move, for example, in opposite directions at different velocities), (ii) lateral relative movement, and (iii) relative rotational movement (where the first needle 612 and the second needle 614 rotate, for example, in opposite directions at different angular velocities about the z-axis).

[0200] Referring again to syringe 100, according to some embodiments not depicted in the figures, where the first needle 112 and / or the second needle 114 have perforations (as described above) and / or include cutting elements (as described above), the first needle 112 and the second needle 114 are arranged in a dual-needle configuration, substantially similar to the first needle 612 and the second needle 614 of the dual-needle assembly 600. Specifically, the first needle 112 and / or the second needle 114 can be configured to achieve relative movement between the first needle 112 and the second needle 114, as described above with respect to the first needle 612 and the second needle 614. According to some such embodiments, syringe 100 can be configured such that pushing and / or pulling one or both of the first plunger 122 and the second plunger 124 actuates the movement of the cutting elements (e.g., actuates their vibration). Additionally and / or alternatively, the syringe 100 may be configured such that pushing and / or pulling one or both of the first plunger 122 and the second plunger 124 produces relative movement between the first needle 112 and the second needle 114 (e.g., relative longitudinal movement between the first needle 112 and the second needle 114), thereby causing movement (or additional movement) of the cutting element.

[0201] Referring again to syringe 300, according to some embodiments not depicted in the figures, its outer needle (i.e., the outer needle of syringe 300) and / or inner needle of syringe 300 have perforations (as described above) and / or include a cutting element (as described above), the outer and inner needles being arranged in a dual-needle configuration, substantially similar to the first needle 612 and the second needle 614 of the dual-needle assembly 600. Specifically, the outer and / or inner needles (of syringe 300) can be configured to achieve relative movement between the outer and inner needles, as described above with respect to the first needle 612 and the second needle 614. According to some such embodiments, syringe 300 can be configured such that pushing and / or pulling one or more plungers of syringe 300 actuates the movement of the cutting element. Additionally and / or alternatively, syringe 300 can be configured such that pushing and / or pulling one or more plungers of syringe 300 creates relative movement between the outer and inner needles, thereby causing movement (or additional movement) of the cutting element.

[0202] According to some embodiments, a multi-chamber syringe is provided. The syringe may be similar to embodiments of syringe 100 or syringe 300, which include a dual-needle assembly, such as dual-needle assembly 600, but differs in that the syringe does not include at least one of a needle sheath (e.g., such as needle sheath 140) and an actuator (such as actuator 148 or similar).

[0203] According to some embodiments, a multi-chamber syringe is provided. This syringe may be similar to syringe 100 or syringe 300, but differs in that it comprises only a single needle, similar to a first needle 112, a perforated needle 400 or needle 500, or another needle configuration described herein. The first and second chambers of the syringe (which are similar to first chamber 102 and second chamber 104, or to first chamber 302 and second chamber 304, respectively) are both fluid-associated with the needle.

[0204] Figure 7 A station 700 for injecting and / or withdrawing fluid from the eye of a subject, according to some embodiments, is schematically depicted. Station 700 is configured for use with syringe 750, which is functionally associated with station 700. More specifically, according to some embodiments, station 700 may be configured to control the operation of at least some functions of syringe 750, such as, for example, injection rate. According to some embodiments, syringe 750 may be a multi-chamber syringe, such as multi-chamber syringe 100, multi-chamber syringe 300, other multi-chamber syringes described herein, and similar multi-chamber syringes. According to some embodiments, syringe 750 may be a multi-chamber syringe similar to multi-chamber syringes 100 and 300, but differing in that syringe 750 does not include at least one of a needle sheath (e.g., such as needle sheath 140) and an actuator (e.g., actuator 148 or similar). According to some alternative embodiments, syringe 750 may include only a single chamber, as detailed below.

[0205] According to some embodiments, station 700 includes a housing 701, and housing 701 includes a monitor 703. Station 700 may also include a user-operated controller 705. According to some embodiments, controller 705 is, for example, and as shown in... Figure 7 The depicted control panel 707 (e.g., a touch panel) is included in the housing 701. Control circuitry (not shown) may be distributed between the controller 705 and other parts of the housing 701. The control circuitry (e.g., electronic circuitry, one or more computer processors and memory components) is configured to allow a user to operate / control the functions of the syringe 750 using the controller 705. The control circuitry is also configured to control the operation of the monitor 703, etc.

[0206] According to some embodiments, controller 705 may be detachably mounted on housing 701 (e.g., on a plug-in station that may be included as part of housing 701) and may be used when plugged in and as a handheld device. According to some embodiments, controller 705 may include control panel 707 and one or more additional control accessories (not shown; which may control different functions from control panel 707), such as a foot pedal, which may be configured to, for example, allow the user to control the injection rate.

[0207] According to some embodiments, station 700 may further include a support structure 711 on which housing 701 may be mounted. According to some embodiments, support structure 711 includes a height-adjustable mounting member 723 and a base 727 supporting the mounting member 723, on which housing 701 may be mounted. According to some embodiments, station 700 is mobile. According to some such embodiments, base 727 is mounted on a mechanism (such as wheels 729) that facilitates movement of station 700. According to some alternative embodiments, station 700 may be stationary.

[0208] like Figure 7 As depicted, housing 701 is configured to be fluidly coupled to syringe 750 via one or more tubes 731 (conduits) and / or one or more wires 733 (e.g., electrical wires and / or optical fibers). According to some embodiments, tubes 731 and wires 733 are detachably connected to housing 701. According to some such embodiments, tubes 731 and optional wires 733 are disposable and can be replaced after each use. According to some embodiments, syringe 750 is disposable and can be replaced after each use. According to some embodiments, components of syringe 750, such as plunger, lumen, and needle, are disposable and can be replaced after each use, thereby minimizing contamination of the instrument / components due to the patient (subject). According to some such embodiments, syringe 750 can be "out of the box," connected to tube 731 and optionally to wire 733. According to some... Figure 7 In embodiments not depicted, tube 731 and wire 733 are disposed within a single cable. According to some embodiments, wire 733 and optional tube 731 form part of station 700 and are detachably connected to syringe 750.

[0209] It should be understood that syringe 750 can be a multi-lumen syringe, and in particular, embodiments of each of multi-lumen syringe 100, multi-lumen syringe 300, the other multi-lumen syringes described above, or similar multi-lumen syringes. Each possibility corresponds to a different embodiment. Different embodiments of tube 731 can differ from each other depending on how these tubes are configured to connect to the multi-lumen syringes. For example, the number of tubes (in tube 731) can vary depending on the number of lumens or sub-lumens in the multi-lumen syringe. In particular, according to some embodiments, the number of tubes can be equal to the number of lumens or sub-lumens in the multi-lumen syringes to which these tubes are intended to connect, respectively. Similarly, different embodiments of lines 733 can differ from each other depending on how these lines are configured to connect to the multi-lumen syringes (e.g., depending on the number of plungers in the multi-lumen syringe).

[0210] According to some embodiments, the operating parameters of the syringe 750 can be controlled via a controller 705, controller accessories (such as a foot pedal) and / or tube 731, line 733 and / or buttons and / or the like on the syringe 750. As a non-limiting example, operating parameters may include the volume of fluid injected / extracted, the force applied for needle insertion, the needle insertion speed, the rate of fluid injection / extraction, which cavities are operable and which are inoperable (e.g., blocked) during use of the syringe 750 (i.e., the controller 705 can be used to "enable" and "disable" cavities), which cavity is used for injection and which is used for extraction, etc.

[0211] According to some embodiments, the syringe 750 includes a needle assembly, such as a dual-needle assembly 600 or a similar assembly, wherein the relative movement of the needles (including the type of movement (e.g., longitudinal or rotational movement), and the speed of movement) can be initiated / selected / controlled via a controller 705, a controller accessory and / or a tube 731, a line 733 and / or buttons and / or the like on the syringe 750. According to some embodiments, the needle of the syringe 750 includes a cutting element, such as cutting elements 502 and / or 504, wherein the movement of the cutting element can be initiated / selected / controlled via a controller 705, a controller accessory and / or a tube 731, a line 733 and / or buttons and / or the like on the syringe 750.

[0212] According to some embodiments, tube 731 and / or line 733 may be functionally associated with one or more plungers of the syringe, one or more cavities and / or sub-cavities of the syringe, one or more components within the cavities and / or sub-cavities (such as a motor that generates the movement of the needle, a motor that generates the movement of the plunger to apply positive or negative pressure to pneumatically move the material and / or needle in the plunger and / or cavity), one or more needles of the syringe and / or one or more components within and / or on the needle (such as a cutting element), thereby functionally associating station 700 (i.e., the control circuitry in station 700) therewith.

[0213] According to some embodiments, station 700 may be configured to control the pressure in the cavity of syringe 750 (and the pressure in the sub-cavity in embodiments where the cavity of syringe 750 includes a sub-cavity). Specifically, station 700 may be configured to generate positive and negative pressure within the cavity to control the rate of pressure change, and thereby control the rate at which fluid is injected into and withdrawn from the eye. According to some embodiments, station 700 is configured to control the movement of a plunger, and thereby control the pressure in the cavity of syringe and its rate of change. According to some embodiments, station 700 may include a pump mechanically coupled to the cavity in syringe via tubing 731. According to some embodiments, the movement of the plunger is controlled by the pump.

[0214] According to some embodiments, syringe 750 is a single-lumen syringe. According to some such embodiments, tube 731 includes two tubes that effectively function as lumens in syringe 100, wherein a first tube is fluidly connected to a first lumen 102, and a second tube is fluidly connected to a second lumen 104. Similarly, according to some embodiments where syringe 750 is a single-lumen syringe, tube 731 includes or is composed of a single double-lumen tube that effectively functions as a lumen in syringe 100.

[0215] According to some embodiments where syringe 750 is a single-lumen syringe, tube 731 includes multiple tubes that can effectively function as sub-lumens in syringe 300. According to some such embodiments, some of the tubes may be multi-lumen. Similarly, according to some embodiments where syringe 750 is a single-lumen syringe, tube 731 includes a single multi-lumen tube or is composed of a single multi-lumen tube that can effectively function as a lumen in syringe 100.

[0216] According to some embodiments, the control circuitry may include processing circuitry configured to analyze sensor readings from sensors located in syringe 750 (e.g., in a cavity for aspirating fluid from the eye), in one or more tubes 731, and / or even in housing 701. For example, according to some embodiments, line 733 may include one or more optical fibers connected to a CCD or CMOS sensor in housing 701. In such embodiments, the processing circuitry may be configured to analyze image data from fluid within the eye or within a cavity / sub-cavity. Alternatively, an optical sensor (e.g., a CMOS sensor) may be included in the syringe. The processing circuitry may include at least one computer processor and a memory configured to store the analysis results. According to some embodiments, the computer processor may be configured to provide a diagnosis based on the analysis results. According to some embodiments, the processing and / or memory storage and / or analysis of the results may be performed at a remote central location (e.g., a server). Such a remote central location (e.g., a server) is configured to receive and analyze results obtained from one or more stations (such as station 700). According to some embodiments, monitor 703 may be configured to display the analysis results (and, in embodiments providing a diagnosis, display a diagnosis).

[0217] According to some embodiments, housing 701 may include compartments configured to accommodate one or more removable fluid containers (not shown). Containers may be fluidly connected to tubing 731, which in turn may be fluidly connected to a lumen in syringe 750, thereby allowing fluid coupling between the lumen and the container. In such embodiments, fluid intended for injection may be stored in a corresponding container in station 700. Other containers may be intended for fluid extraction and may initially be empty (i.e., prior to use of station 700) or may include a substance configured to interact with the extracted fluid. According to some embodiments, containers containing the extracted fluid may be removed for laboratory analysis. According to some embodiments, station 700 may include equipment configured to analyze the extracted fluid or at least provide its initial analysis. According to other / alternative embodiments, station 700 may include equipment configured to transmit readings to and / or receive readings from a remote central location (e.g., one or more servers).

[0218] According to some embodiments, one or more of the housing 701, tube 731, and / or syringe 750 may include at least one substance that facilitates rapid analysis of the eye fluid through its interaction with the eye fluid.

[0219] According to some embodiments, the monitor 703 may be configured to display analytical data from rapid analysis of ocular fluid in qualitative, semi-quantitative, and / or quantitative formats.

[0220] According to some embodiments, syringe 750 may be an embodiment of a syringe known in the art. According to some embodiments, syringe 750 may be as shown in Figure 1- Figure 6 The components described herein are made, including but not limited to, plungers, cavities, sub-cavities, and needles in any combination of multi-cavity needle structures, single-needle structures, or needles 112, 114, 400, and 500, as well as dual-needle assemblies 600.

[0221] It should be understood that, for clarity, certain features of this disclosure described in the context of individual embodiments may also be provided in combination in a single embodiment. Conversely, for brevity, various features of this disclosure described in the context of a single embodiment may also be provided individually or in any suitable sub-combination, or deemed suitable for any other described embodiment of this disclosure. Unless expressly stated otherwise, features described in the context of an embodiment are not considered essential features of that embodiment.

[0222] Although the steps of a method according to some embodiments may be described in a specific order, the method of this disclosure may include some or all of the described steps performed in a different order. The method of this disclosure may include some or all of the described steps. Unless expressly specified therein, a particular step in the disclosed method is not considered a necessary step of the method.

[0223] While this disclosure has been described in conjunction with specific embodiments thereof, it will be apparent to those skilled in the art that many alternatives, modifications, and variations may exist. Therefore, this disclosure covers all such alternatives, modifications, and variations falling within the scope of the appended claims. It should be understood that this disclosure is not necessarily intended to limit its application to the details and / or methods of the construction and arrangement of the components set forth herein. Other embodiments may be practiced, and embodiments may be performed in various ways.

[0224] The wording and terminology used herein are for descriptive purposes and should not be construed as restrictive. Any reference or identification in this application should not be construed as an admission that such references can be used as prior art in this disclosure. Section headings used herein are for ease of understanding and should not be construed as necessary limitations.

Claims

1. A multi-chamber syringe for intraocular injection, comprising a first chamber, a second chamber, a needle fluidly connectable to the first chamber and the second chamber, a first plunger, a second plunger, and a needle sheath disposed around the needle, the first chamber being configured to receive fluid drawn from the eye of a subject, the second chamber being configured to contain a substance to be injected into the eye of the subject, the first plunger being configured to reciprocate within the first chamber, and the second plunger being configured to reciprocate within the second chamber. The needle includes one or more cutting elements and is configured to cut material in the eye before being withdrawn from the subject's eye; and The multi-chamber syringe is configured to allow the first plunger to be pushed only when the second plunger is instructed to be moved to the pull configuration and / or to allow the second plunger to be pushed only when the first plunger is instructed to be moved to the pull configuration, thereby ensuring that eye fluid is withdrawn before injection.

2. The multi-chambered syringe of claim 1, wherein, The needle sheath includes a plurality of proximity / contact / pressure actuators located on the distal edge of the needle sheath, and the syringe is switchable between at least two configurations: a first configuration in which at least one of the actuators is not actuated and the tip of the needle is positioned and fixed proximally relative to the distal edge; and a second configuration in which all of the plurality of actuators are actuated and the needle is able to extend distally beyond the distal edge.

3. The multi-chambered syringe of claim 2, wherein, The plane defined by the distal edge of the needle sheath is perpendicular to the needle, thereby ensuring that the needle can be inserted perpendicularly to the surface of the eye when all the distal edges contact the surface of the eye to actuate the plurality of actuators.

4. The multi-chamber syringe according to claim 2 or claim 3, wherein, The actuator is a push button, and in the second configuration, the push button is pushed in beyond a threshold level.

5. The multi-chamber syringe according to claim 2, wherein, In at least one pair of actuators from the plurality of actuators, the actuators are positioned relative to each other on the distal edge.

6. The multi-chamber syringe according to claim 2, wherein, The actuator is a contact / pressure actuator, and wherein the actuator is positioned on the distal edge such that when the distal edge is placed on the subject's eye, the syringe cannot switch from the first configuration to the second configuration unless all of the distal edge is in contact with the eye.

7. The multi-chamber syringe according to claim 1, wherein, The needle is retractable.

8. The multi-chamber syringe according to claim 1, wherein, The needle sheath is retractable and / or compressible.

9. The multi-chamber syringe according to claim 1, wherein, The needle sheath is fixed.

10. The multi-chamber syringe according to claim 1, wherein, The needle is fixed.

11. The multi-chamber syringe according to claim 1, wherein, The second cavity is disposed within the first cavity.

12. The multi-chamber syringe according to claim 1, wherein, The second cavity is adjacent to the first cavity.

13. The multi-chamber syringe according to claim 1, wherein, The needle sheath is cylindrical.

14. The multi-chamber syringe according to claim 2, wherein, The radius of the distal edge is between 3 mm and 4 mm, and the syringe is configured such that the distal edge is visible to the user when the user brings the distal edge against the subject's eye, thereby facilitating the insertion of the needle at a position between 3 mm and 4 mm from the limbus of the eye.

15. The multi-chamber syringe according to claim 2, wherein, The needle sheath includes an extension that defines a distance between 3 mm and 4 mm from the needle, and wherein the syringe is configured such that the extension is visible to the user when the user brings the distal edge against the subject's eye, thereby facilitating the insertion of the needle into a position between 3 mm and 4 mm from the limbus of the eye.

16. The multi-chamber syringe according to claim 2, wherein, The needle sheath, when compressed, defines a distance between 3 mm and 4 mm from the needle, and the syringe is configured such that when the user brings the distal edge against the subject's eye, the needle sheath is compressed, thereby facilitating the insertion of the needle into a position between 3 mm and 4 mm from the limbus of the eye.

17. The multi-chamber syringe according to claim 2, wherein, The corresponding distances between adjacent actuators from the plurality of actuators are equal.

18. The multi-chamber syringe according to claim 2, wherein, The distal edge is oval or elliptical.

19. The multi-chamber syringe according to claim 1, wherein, The proximal end of the needle sheath is connected to the distal end of the second cavity.

20. The multi-chamber syringe according to claim 1, wherein, The second cavity is disposed within the first cavity, and the second plunger is disposed within the first plunger.

21. The multi-chamber syringe according to claim 1, wherein, The first plunger and the second plunger are functionally associated such that pushing or pulling the first plunger causes the second plunger to move in the opposite direction, and / or pushing or pulling the second plunger causes the first plunger to move in the opposite direction.

22. The multi-chamber syringe of claim 1, further comprising a locking mechanism configured to allow the first plunger to be pushed only when the second plunger is instructed to be moved into a pull configuration and / or to allow the second plunger to be pushed only when the first plunger is instructed to be moved into a pull configuration, thereby ensuring that eye fluid is withdrawn before injection.

23. The multi-chamber syringe according to claim 1, wherein, The first plunger is configured to prevent the pushing and / or pulling of the first plunger from exceeding a threshold pushing speed and / or a threshold pulling speed of the first plunger.

24. The multi-chamber syringe according to claim 1, wherein, The second plunger is configured to prevent the pushing and / or pulling of the second plunger from exceeding a threshold pushing speed and / or a threshold pulling speed of the second plunger.

25. The multi-chamber syringe according to claim 1, wherein, The syringe is configured to allow the needle to be inserted into the subject's eye at a predetermined speed and / or pressure, or at a predetermined speed and / or pressure range.

26. The multi-chamber syringe according to claim 2, wherein, In the second configuration, the tip of the needle is restricted to protrude more than 1 cm distally relative to the distal edge of the needle sheath.

27. The multi-chamber syringe according to claim 1, wherein, The first cavity is divided into two or more first cavity sub-cavities at least along a portion thereof.

28. The multi-chamber syringe according to claim 27, wherein, The second cavity is divided into two or more second cavity sub-cavities at least along a portion thereof.

29. The multi-chamber syringe according to claim 28, wherein, Each of the first and second sub-cavities is associated with a corresponding plunger, and wherein the needle is divided into sub-needles, each of which is fluidly connected to one of the first and second sub-cavities, respectively.

30. The multi-chamber syringe according to claim 2, wherein, The tip of the needle is angled and lies on a second plane, wherein the angle between the second plane and the plane defined by the distal edge is an acute angle.

31. The multi-chamber syringe according to claim 2, wherein, In the first configuration, pushing and / or pulling the first plunger and / or the second plunger is prohibited.

32. The multi-chamber syringe according to claim 1, wherein, The needle has a perforation.

33. The multi-chamber syringe according to claim 1, wherein, At least some of the cutting elements are configured to move in or on the needle.

34. The multi-chamber syringe according to claim 1, wherein, The needle has a perforation, and the needle includes one or more needle-side ports on the needle shaft.

35. The multi-chamber syringe according to claim 34, wherein, One or more of the cutting elements are configured to move within the needle-side port when the needle is inserted into the subject's eye in order to cut material adjacent to the needle-side port.

36. The multi-chamber syringe according to claim 1, wherein, The movement of the needle includes oscillating motion, reciprocating motion, lateral motion, rotation, vibration, or any combination thereof.

37. The multi-chamber syringe according to claim 1, wherein, The first cavity includes a plurality of first cavity sub-cavities and / or the second cavity includes a plurality of second cavity sub-cavities.

38. The multi-chamber syringe of claim 37, further comprising a valve system configured to fluidly separate at least some of the first and second chamber sub-chambers.

39. The multi-chamber syringe according to claim 1, wherein, The syringe is disposable.

40. The multi-chamber syringe of claim 37 further comprises at least one substance that facilitates rapid analysis of the ocular fluid through interaction with the ocular fluid, the at least one substance being located in the first or second chamber / first chamber sub-chamber or second chamber sub-chamber of the syringe.

41. The multi-chamber syringe according to claim 40, wherein, The rapid analysis includes enzyme-linked immunosorbent assay (ELISA).

42. The multi-chamber syringe according to claim 40, wherein, The rapid analysis involves a color-producing chemical reaction between a chemical indicator and intraocular substances.

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