RU2795098C2 - Multi-luminal syringes for intraocular injections - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: invention relates to syringes for intraocular injection. A multi-lumen syringe for intraocular injection includes a first lumen, a second lumen, one or more needles fluidly connected to the lumen, and a needle sheath located around the one or more needles. Moreover, the needle case includes n actuators based on proximity/contact/pressure on the far edge of the needle case.

EFFECT: moreover, the syringe is configured to switch between at least two configurations: the first configuration, in which at least one of the actuators is not activated, and each tip of one or more needles is located near and fixed relative to the far edge; and a second configuration in which n actuators are actuated and one or more needles can be extended beyond the far edge.

14 cl, 7 dwg

Description

FIELD OF TECHNOLOGY TO WHICH THE INVENTION RELATES

The present invention relates generally to syringes for intraocular injection.

BACKGROUND OF THE INVENTION

Vitreous drug delivery is a common procedure for the treatment of various retinal disorders, including age-related macular degeneration (AMD), diabetic retinopathy, and retinal vein occlusion. The use of intravitreal injections has increased significantly with the advent of anti-vascular endothelial growth factor (anti-VEGF) drugs. Currently, injections into the vitreous body are one of the most frequently performed medical procedures. In the US alone, more than 6 million were held in 2016.

However, there is a need in the art for improved, safer, and more reliable vitreous injection devices and methods.

DISCLOSURE OF THE INVENTION

Aspects of the invention, in some embodiments, relate to syringes for intraocular injection. In particular, but not exclusively, aspects of the invention, in some embodiments, relate to multi-lumen syringes for intraocular injection and/or extraction of intraocular substances.

According to an aspect of some embodiments, a multi-lumen syringe is provided for intraocular injection and/or withdrawal of intraocular substances, wherein the syringe includes a first lumen, a second lumen, one or more needles in fluid communication with the lumens, and a needle sheath disposed around one or more needles, and the syringe is configured to switch between at least two configurations:

- the first configuration, in which each tip of one or more needles is located near and fixed relative to the far edge; And

- a second configuration in which one or more needles can be extended beyond the far edge,

in which the first needle and/or the second needle can be fenestrated at the tip and/or on the tube, thereby creating one or more entry or exit openings in the first and/or second needle. The tip of the needle may only function as an eye-piercing blade, and the opening(s) allowing substance to enter/exit through the needle may/may be in the tube rather than at the tip. In particular, according to some such embodiments, this may allow the tip to be narrower and thus sharper compared to an open (and hollow) tip (which is configured to deliver fluid through it).

According to an aspect of some embodiments, a multi-lumen syringe is provided for intraocular injection and/or withdrawal of intraocular substances. The syringe includes a first lumen, a second lumen, one or more needles connected to the lumens in a fluid medium, and a needle sheath located around one or more needles. The needle sheath includes a plurality of n proximity/contact/pressure based actuators at the distal edge of the needle sheath. The syringe is configured to switch between at least two configurations:

- the first configuration, in which at least one of the actuators is not activated, and each tip of one or more needles is located near and fixed relative to the far edge;

- a second configuration in which n actuators are actuated and one or more needles can be extended beyond the far edge.

In 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 when all or substantially all of the distal edge contacts the surface of the eye so as to actuate n actuators, the possibility of introducing one or more needles perpendicular to the surface of the eye is provided.

In some embodiments, the syringe is configured to automatically switch back from the second configuration to the first configuration, thereby ensuring that fluids cannot be injected or withdrawn after the insertion of one or more needles if the syringe is tilted such that the far edge no longer contacts completely or across essentially completely with the surface of the eye.

In some embodiments, the actuators are push buttons, and in a second configuration, the push buttons are pressed beyond a threshold.

In some embodiments, in at least one pair of n actuators, they are located opposite or substantially opposite on the far edge, thus helping to ensure that even with n = 2, in the second configuration, the far edge remains stationary on the eye. , and the needles are perpendicular or substantially perpendicular to the surface of the eye.

In some embodiments, the actuators are contact/pressure based actuators. The position(s) of the far edge actuators are such that when the far edge is placed on a subject's eye, the multilumen syringe cannot be switched from the first configuration to the second configuration unless all or substantially all of the far edge is in contact with the eye (i.e. all or substantially all of the actuating devices are actuated).

In some embodiments, the actuators are contact/pressure based actuators. The positions of the far edge actuators are such that when the far edge is placed on a subject's eye, one or more pistons of the multilumen syringe are blocked and cannot move (i.e., be pushed and/or drawn out) unless all or substantially all of the far edge is is in contact with the eye (ie, all or substantially all of the actuators are activated).

In some embodiments, the actuators and/or other components are further configured to measure intraocular pressure.

In some embodiments, one or more needles are retractable. In some such embodiments, the needle sheath is stationary.

In some embodiments, the needle sheath is retractable and/or compressible. According to some such embodiments, one or more of the needles are stationary.

In some embodiments, the second lumen is located within the first lumen.

In some embodiments, the one or more needles include at least two needles: a first needle and a second needle. The first needle is in fluid communication with the first lumen, and the second needle is in fluid communication with the second lumen.

In some embodiments, the second needle is located in the first needle.

In some embodiments, the second lumen is adjacent to the first lumen and the second needle is adjacent to the first needle.

In some embodiments, the needle sheath is cylindrical.

In some embodiments, the first needle and/or the second needle are fenestrated at the tip and/or tube, thereby creating one or more entry or exit openings in the first and/or second needle. Fenestration can refer to the hole(s) in the needle. In some embodiments, the tip of the needle may only function as an eye-piercing blade, and the opening(s) allowing substance to enter/exit through the needle may/may be in the tube rather than at the tip. In particular, in some such embodiments, this may allow the tip to be narrower and thus sharper than an open (and hollow) tip (which is configured to deliver fluid through it).

In some embodiments, the first needle is fenestrated and/or the second needle is fenestrated in that it includes side openings on the respective needle tubes. The side openings allow fluid to enter or exit through them.

In some embodiments, the first needle contains one or more cutting elements and/or the second needle contains one or more cutting elements.

In some embodiments, at least some of the cutting elements are movable in or on a respective needle.

In some embodiments, the first needle is fenestrated and includes one or more first needle side openings on the first needle tube. The second needle includes one or more cutting elements of the second needle placed on it, which are located near the respective side openings of the first needle side openings.

In some embodiments, one or more of the cutting elements of the first needle are movable in respective side openings of the second needle so as to cut material adjacent to the side openings of the second needle when the needles are inserted into the subject's eye.

According to some embodiments, the first needle and the second needle are movable relative to each other.

According to some embodiments, the relative motion of the first needle and/or the second needle includes oscillatory motion, reciprocating motion, back and forth lateral motion, rotations, vibrations, or any combination thereof.

In some embodiments, the first needle and/or the second needle are movable. According to some embodiments, the first needle and/or the second needle, together with each of the respective lumens or sub-lumens, is movable. In some embodiments, such movement of the first needle and/or the second needle may include oscillatory motion, reciprocating motion, back and forth lateral motion, rotations, vibrations, or any combination thereof.

According to some embodiments, the cutting elements may be stationary in the first and/or second needle such that relative movement between the first and/or second needle generates a cutting effect.

In some embodiments, pushing and/or pulling the first piston and/or the second piston actuates the cutting elements included in the first needle and/or the second needle.

In some embodiments, at least some of the cutting elements are stationary on the respective needles, whereby pushing and/or pulling the first piston and/or the second piston can cause cutting motion of the stationary cutting elements.

According to such embodiments, at least some of the cutting elements that are attached to the second needle are located adjacent to the side openings on the first needle, whereby the pushing and/or pulling of the first piston and/or the second piston causes their cutting movement (cutting elements, attached to the second needle) into/through the side openings.

According to such embodiments, at least some of the cutting elements that are secured in the first needle are located adjacent to the side openings on the second needle, whereby the pushing and/or pulling of the first piston and/or the second piston causes the cutting elements to move in/through side openings.

In some embodiments, the far edge radius is from about 3 mm to about 4 mm. The syringe is configured such that when the user advances the distal edge to the subject's eye, the distal edge is visible to the user to facilitate insertion of the one or more needles at a distance of about 3 mm to about 4 mm from the edge of the cornea in the eye.

In some embodiments, the needle sheath, or one or more needles, may include an extension/marker (eg, a circular extension, eg, a flange or band (eg, a silicone band)). Elongation defines a distance from about 3 mm to about 4 mm from one or more needles. The syringe is configured such that when the user advances the distal edge to the subject's eye, the extension is visible to the user to facilitate insertion of the needles from about 3 mm to about 4 mm from the edge of the cornea in the eye. In some such embodiments, the extension/marker may be coated/coated with a protective material (e.g., silicone or any other material known in the art) that can come into contact with the cornea without causing damage to the cornea and/or conjunctiva by the material or rough force caused by contact, which reduces the risk of erosive damage (or any other type of damage to the cornea and/or conjunctiva due to interaction/contact with the extension/marker). The extension/marker may be designed to contact or be relatively close to the eye. The extension/marker can act as a stabilizer when it comes into contact with the eye, as it increases the support of the syringe in contact with the eye, thus minimizing possible tilt of the syringe.

In some embodiments, the needle sheath, when compressed, defines a distance of about 3 mm to about 4 mm from one or more needles. The syringe is configured such that when the user advances the distal edge of the subject's eye, the needle sheath is compressed to facilitate insertion of the one or more needles to a distance of about 3 mm to about 4 mm from the corneal edge in the eye. According to some such embodiments, the needle sheath may be coated with a protective material (e.g., silicone or any other material known in the art) that can come into contact with the cornea without causing damage to the cornea and/or conjunctiva by the material or brute force caused by contact, which reduces the risk of erosive damage (or any other type of damage due to interaction/contact with the needle sheath) of the cornea and/or conjunctiva.

In some embodiments, respective distances between adjacent actuators from a plurality of actuators are equal or substantially equal.

In some embodiments, the far edge is oval or elliptical.

In some embodiments, the proximal end of the needle sheath is connected to the distal end of the second lumen.

In some embodiments, the syringe further includes a first piston reciprocating in the first lumen and a second piston reciprocating in the second lumen.

According to some embodiments, the second lumen is located in the first lumen and the second piston is located in the first piston.

In some embodiments, the first piston and the second piston are operatively coupled such that pushing or pulling the first piston causes the second piston to move back and/or pushing or pulling the second piston causes the first piston to move.

In some embodiments, the syringe is configured to controllably switch between at least two modes of operation in a second configuration:

a free-motion mode in which the first piston and the second piston can move independently of each other; And

at least one counter-movement mode, in which the first piston and the second piston are operatively connected such that pushing or pulling the first piston causes the second piston to push and/or pushing or pulling the second piston causes the first piston to push back.

According to some embodiments, at least one counter-motion mode includes at least two counter-motion modes:

a first counter-movement mode in which a volume change in the first lumen due to motion of the first piston causes an opposite and equal volume change in the second lumen due to the induced motion of the second piston and vice versa; And

the second mode of countermovement, in which the change in volume in the first lumen due to the movement of the first piston causes an opposite in sign and different in magnitude change in volume in the second lumen due to the induced movement of the second piston and vice versa.

In some embodiments, the first piston is configured to prevent it from being pushed and/or pulled beyond the first piston push threshold and/or the first piston pull threshold.

In some embodiments, the second piston is configured such that it is prevented from being pushed and/or pulled in excess of the second piston push threshold and/or the second piston pull threshold.

In some embodiments, at least one of the pistons is configured to allow fluid to be injected only after the other of the pistons has been pulled to extract a (preset) amount of intraocular fluid.

In some embodiments, the syringe includes a locking mechanism configured to prevent the first piston from being pushed (for fluid delivery) when the volume set by the second piston in the second lumen is less than a threshold volume.

In some embodiments, the syringe includes a locking mechanism configured to prevent the second piston (for fluid injection) from being pushed through when the volume given by the first piston in the first lumen is less than a threshold volume.

In 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 indicated to be in an extended configuration (to ensure that fluid is withdrawn from the eye). before introduction).

In some embodiments, the syringe includes a locking mechanism configured to push the second plunger (to inject fluid) only when indicated that the first plunger is in an extended configuration (to ensure fluid is withdrawn from the eye prior to administration ).

In some embodiments, at least one of the pistons is configured to withdraw intraocular fluid only after the other of the pistons is pushed to introduce a (preset) amount of fluid.

In some embodiments, the syringe includes a locking mechanism configured to prevent the first piston from being drawn out (to extract fluid) when the volume given by the second piston in the second lumen is greater than a threshold volume.

In some embodiments, the syringe includes a locking mechanism configured to prevent the second piston from being drawn out (to extract fluid) when the volume given by the first piston in the first lumen is greater than a threshold volume.

In some embodiments, the syringe includes a locking mechanism configured to allow the first plunger to be withdrawn (to withdraw intraocular fluid) only when the second plunger is indicated to be in a pushed configuration (to ensure fluid is injected into the eye before extraction).

In some embodiments, the syringe includes a locking mechanism configured to allow the second plunger to be pulled out (to withdraw intraocular fluid) only when the first plunger is indicated to be in a pushed configuration (to ensure that fluid is injected into the eye). before extraction).

In some embodiments, the locking mechanism may or may not be engaged, thus allowing independent movement of each of the pistons.

In some embodiments, the syringe is configured to insert one or more needles into the eye of a subject at a predetermined rate and/or pressure, or within a predetermined range of rates and/or pressures.

In some embodiments, the syringe may be connected via pistons, lumen, sublumen, and/or any combination thereof to a system (eg, station) capable of controlling the operation and functions of the syringe. In some such embodiments, the system is configured to generate positive or negative pressures in the lumen or sublumen of the syringe and thereby actuate the pistons and allow fluid to be drawn from the lumen and/or sublumen and/or a substance to be injected into the subject's eye. According to some such embodiments, the system may be configured to control the rate of insertion of the needles, the force of insertion, and the pressure of the injected fluids.

In some embodiments, the second configuration limits the extension of the tips of one or more needles to more than about 1 cm from the distal edge of the needle sheath.

In some embodiments, the first lumen is divided, at least along its portion, into two or more sublumens of the first lumen.

In some embodiments, each of the sublumen of the first lumen is associated with a respective piston. The first needle is divided into subneedles. Each of the sub-needles is fluidly connected to one of the sub-lumen of the first lumen, respectively.

In some embodiments, the second lumen is divided, at least along its portion, into two or more second lumen sublumen.

In some embodiments, each of the sublumen of the second lumen is associated with a respective piston. The second needle is divided into subneedles. Each of the sub-needles is fluidly connected to one of the sub-lumen of the second lumen, respectively.

In some embodiments, in which the first lumen includes a plurality of first lumen sublumen and/or the second lumen comprises a plurality of second lumen sublumen, the two or more sublumen are fluidly coupled to a common lumen. According to some such embodiments, the syringe further includes a valve system (e.g., including check valves) configured to fluidly release or controlled fluid release of at least some of the sublumen that are configured to fluidly communicate. common lumen environment.

In some embodiments, each of the tips of one or more needles is bevelled and located in a second plane. The angle between the second plane and the plane defined by the far edge is acute.

According to some embodiments, in the first configuration, pushing and/or pulling out the pistons is not possible.

In some embodiments, the first needle is fenestrated and/or the second needle is fenestrated.

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

In some embodiments, at least some of the cutting elements are movable in or on a respective needle.

In some embodiments, the first needle is fenestrated and includes one or more first needle side openings on the first needle tube. The second needle includes one or more cutting elements of the first needle placed on it, which are located near the respective side openings of the side openings of the second needle.

In some embodiments, one or more of the cutting elements of the first needle are movable in respective side openings of the second needle so as to cut material adjacent to the side openings of the second needle when the needles are inserted into the subject's eye.

According to some embodiments, the first needle and the second needle are movable relative to each other.

According to some embodiments, the relative motion of the first needle and/or the second needle includes oscillatory motion, reciprocating motion, back and forth lateral motion, rotations, vibrations, or any combination thereof.

In some embodiments, the syringe is disposable and can be replaced after each use, or at least some of the removable components of the syringe are disposable and can be replaced after each use. Disposable items may include, for example, needle(s), lumen(s) or sublumen(s) of a syringe, or the entire syringe.

In some embodiments, the syringe, for example, in one or more of its lumen or sublumen, may include at least one agent that facilitates rapid analysis of the intraocular fluid through interaction with the intraocular fluid.

In some embodiments, an indicator substance and/or enzyme-labeled immunosorbent assay (ELISA) and/or chemical pads located in the lumen(s)/sublumen(s) of the syringe or on the wall of the lumen(s) can be used to facilitate rapid testing. / sublumen(s), to detect one or more intraocular substances, for example, but not limited to, vascular endothelial growth factor levels, interleukin-6 levels, and TNF levels. In addition, the assay may include testing for the presence of one or more substances including, but not limited to, proteins, glucose, ketones, hemoglobin, acetone, nitrites, leukocytes, pH, and specific gravity to test for infection by various pathogens.

In some embodiments, the syringe may include chemical(s) (located, for example, in the lumen(s)/sublumen(s) of the syringe) that are configured to react with compounds present in ophthalmic substances to create characteristic color. The color change may provide qualitative results, which only determine whether the sample is positive or negative, or semi-quantitative results, which, in addition to providing a positive or negative reaction, also provide an estimate of the quantitative result. Further, the colors produced in the reactions correlate (eg, substantially proportionally) with the concentration of the substance for which the sample is being tested.

Semi-quantitative values may be presented to the user as, for example: trace, 1+, 2+, 3+ and 4+, although test results may also be presented in milligrams per deciliter, etc. Automated readers (eg, but not limited to, mobile (eg, handheld) computing devices implemented as an application on a smartphone, cameras, desktop, or standalone devices) may also provide/present results.

In some embodiments, automated readers are operatively linked to computerized systems configured to store and analyze results and provide interpretation and results to a user.

In some embodiments, the rapid assay may include an indicator substance and/or an enzyme-labeled immunosorbent assay (ELISA) and/or chemical pads. In some embodiments, the rapid assay may include a paper-based ELISA indicator, as is known to those skilled in the art.

In some embodiments, a station is provided for injecting and/or withdrawing fluid from a subject's eye. The station includes:

- the case including the monitor,

- controller,

- a control circuit that can be shared between the body and the controller.

The housing includes one or more tube openings for one or more respective tubes and one or more wire openings for one or more respective wires. The station is configured to be connected via one or more tubes and one or more wire openings to a syringe for intraocular injection, for example, but not limited to, the multi-lumen syringe described above, as well as a single-lumen syringe. Thus, the station is configured to control one or more functions and/or operating parameters of the syringe.

According to some embodiments, the controller is enclosed in a housing.

According to some embodiments, the housing includes a docking station for the controller.

In some embodiments, the tubes and/or wires are disposable.

In some embodiments, tubes and/or wires form an integral part of the station.

In some embodiments, the control circuitry is configured to allow switching between syringe configurations and modes.

In some embodiments, operating parameters include volume of fluid injected/withdrawn, force applied to insert the needle, needle insertion rate, fluid injection/withdrawal rate, which lumens are working and which are not during use of the syringe, which lumen to be used for insertion, and which lumen to be used for extraction.

In some embodiments, functions and parameters can be controlled using controller accessories, tubing buttons, wires, and/or a syringe.

According to some embodiments, controller accessories include a foot pedal.

In some embodiments, the station is configured to control lumen/sublumen pressure and thus move the pistons at predetermined speeds over a predetermined range of speeds and inject and extract fluids into and out of a subject's eye at predetermined speeds.

According to some embodiments, the station is configured to control the relative motion of the needle(s) and/or the motion of the cutting elements.

In some embodiments, the housing and/or tubes include at least one agent that facilitates rapid analysis of the intraocular fluid by interacting the agent with the intraocular fluid.

In some embodiments, the monitor is configured to display analyzed data from intraocular fluid rapid analysis in a qualitative, semi-quantitative, and/or quantitative format.

In some embodiments, the control circuitry further includes at least one computer processor configured to analyze sensor readings from sensors located in the syringe and/or tubes, and optionally a memory configured to store the analysis results.

In some embodiments, the computer processor is further configured to provide a diagnosis based on sensor readings.

According to some embodiments, the monitor may be configured to display the results of the analysis and, if necessary, the diagnosis.

In some embodiments, the station further includes a support structure including an adjustable height stand configured to support the chassis and a base from which the adjustable height stand extends and which supports the adjustable height stand.

In some embodiments, the station is mobile. In some such embodiments, the base is mounted on wheels.

In some embodiments, a station may include a transmitter and/or receiver configured to transmit and/or receive readings to/from a remote station (eg, another station or server/cloud).

In some embodiments, a remote station may be configured to communicate with a local station to store data, analyze current reading data, and/or compare current readings with previously received readings from the remote station or multiple remote stations, and/or transmit data to the station. .

According to an aspect of some embodiments, a multi-lumen syringe disclosed herein is provided wherein a substance is pre-loaded into one or more of the lumen or sublumen. Such a substance may include a fluid such as, but not limited to, a fluid including a drug, a saline solution, etc. Such a substance may also include a material that can be used to analyze fluids extracted from the eye.

According to an aspect of some embodiments, a method for introducing into and/or withdrawing a fluid from the eye is provided. The method includes the use of a multi-lumen syringe disclosed herein in accordance with some embodiments. The method includes:

approach of the distal tip of the syringe to the eye/contact of the distal tip of the syringe with the subject's eye, wherein "distal syringe tip" may mean the distal tip of at least one of the needles (for example, but not limited to, standard needles, fenestrated needles, and/or needles including cutting elements) and/or the far edge of the sheath surrounding the needle(s);

if necessary, contacting the subject's eye with the far edge, switching from the first configuration (in which each tip of one or more needles is located near, and secured, relative to the far edge of the syringe) to the second configuration (in which one or more needles can extend out of the far edge) by bringing the far edge to the surface of the eye;

introducing at least one of the needles into the eye;

withdrawing the first plunger of the syringe to withdraw fluid from the eye;

pushing the second plunger of the syringe to inject fluid into the eye, and

moreover, the last two stages can be carried out simultaneously or sequentially and in any order.

According to some embodiments, the method may further include operably linking the syringe to one or more systems (e.g., local station and/or remote station described herein) wherein, as described above, the system is configured to partially or completely control operation and/or functions of the syringe or its components.

In some embodiments, the method may further include analyzing (eg, real-time analysis) fluids extracted from the eye.

Some embodiments of the present invention may include some, all, or none of the above advantages. Those skilled in the art can readily understand one or more other technical advantages from the figures, descriptions, and claims included herein. In addition, while specific benefits are listed above, various embodiments may include all, some, or none of the listed benefits.

Unless otherwise stated, all technical and scientific terms used herein are to be understood in the same sense as they are commonly understood by those skilled in the art to which this invention pertains. In case of conflict, the definitions given in the description of the invention should be followed. The singular forms used herein are to be understood in the sense of "at least one" or "one or more" unless the context clearly indicates otherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

Some embodiments of the invention are described here with reference to the accompanying drawings. From the description, in conjunction with the drawings, one skilled in the art can understand how certain embodiments may be practiced. The drawings are provided for the purpose of illustrating the description and no attempt is made to show the structural details of the embodiment in more detail than is necessary for a fundamental understanding of the invention. For clarity, some objects in the drawings are shown not to scale.

On the drawings:

fig. 1a is a schematic exploded view of a multi-lumen syringe according to some exemplary embodiments;

fig. 1b schematically shows the distal portion of the multi-lumen syringe shown in FIG. 1a, according to some embodiments;

fig. 2 schematically depicts the multi-lumen syringe shown in FIG. 1a, the needles of which are inserted into the subject's eye, according to some exemplary embodiments;

fig. 3 is a sectional view of the lumen of a multi-lumen syringe according to some embodiments;

fig. 4 is a schematic partial view of a fenestrated needle according to some embodiments;

fig. 5 is a schematic partial view of a needle including one or more cutting elements according to some embodiments;

fig. 6 is a schematic partial view of a two-needle syringe in which each of the needles is fenestrated and/or includes cutting elements, in accordance with some embodiments; And

fig. 7 schematically depicts a station for introducing fluid into and/or withdrawing fluid from a subject's eye, in accordance with some embodiments.

IMPLEMENTATION OF THE INVENTION

The principles, uses and implementations of the present invention can be better understood with reference to the accompanying description and figures. Having studied the description and figures presented here, a person skilled in the art will be able to implement the principles of the invention without much effort or experimentation. In the drawings, like reference numerals designate the same parts throughout.

In the specification and claims, the words “comprise” and “have” and their forms are not limited to the items in the list with which the words can be associated.

As used herein, the term "approximately" may be used to indicate the value of a quantity or parameter (eg, the length of an element) in a continuous range of values close to (and including) a given (specified) value. In some embodiments, "about" may indicate a parameter value between 80% and 120% of a given value. For example, the statement "the length of the element is approximately 1 m" is equivalent to the statement "the length of the element is from 0.8 m to 1.2 m". In some embodiments, "about" may indicate a parameter value between 90% and 110% of a given value. In some embodiments, "about" may indicate a parameter value between 95% and 105% of a given value.

As used herein in some embodiments, the terms “substantially” and “approximately” may be used interchangeably.

As used herein in some embodiments, the term “fluid” may mean a liquid, gel, or gas. For example, “fluid” can mean a gas, such as CO ₂ , a drug-carrying gas, a drug, a solution, such as a saline solution, a drug containing a solution, a suspension, such as a suspension containing drug particles/droplets, etc. d. In some embodiments, the term "fluid" may also refer to intraocular fluid. In some embodiments, the term “drug” may mean any pharmaceutically active ingredient, such as, but not limited to, a compound, combination of compounds, or composition, with or without carriers and/or excipients. The drug may be in the form of a liquid, gel, dissolved/suspended particles, or gas.

используется на чертежах для представления оси, указывающей “из страницы”.For ease of description, some of the figures use a 3D Cartesian coordinate system (with x , y , and z orthogonal axes). Note that the orientation of the coordinate system relative to the depicted object may vary from figure to figure. Additionally, symbol

used in drawings to represent an axis indicating "from page".

As used herein in some embodiments, the term "longitudinal" in relation to direction/axis means direction/axis along/parallel/opposite to the z- axis. In some embodiments, the term "far" in relation to direction means in the negative direction of the z- axis. In some embodiments, the term "near" in relation to direction means "in the positive direction of the z- axis". In some embodiments, the term “far” in relation to a position (e.g., element/component) may mean a position near or in the body of the subject, while the term “near” refers to a position more distant from the body of the subject (relative to the far position).

According to an aspect of some embodiments, a multilumen syringe is provided. In FIG. 1a shows a schematic exploded view of a multi-lumen syringe 100. In some embodiments, the syringe 100 includes a first lumen 102, a second lumen 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 in fluid communication with the first lumen 102. The second needle 114 is in fluid communication with the second lumen 104. The first piston 122 is configured to be controlled reciprocating within the first lumen 102. The second piston 124 is configured to be controlled reciprocating movements in the second lumen 104.

The first needle 112 includes the tip 126 of the first needle (at its distal end). The second needle 114 includes the tip 128 of the second needle (at its distal end). The first piston 122 includes a first piston seal 132 (eg, at its distal end). The second piston 124 includes a second piston seal 134 (at its distal end).

According to some embodiments and as indicated in the drawings, the second lumen 104 is longitudinally located within the first lumen 102 along its length. According to some such embodiments, the first lumen 102 and the second lumen 104 are concentric. According to some embodiments and as indicated in the drawings, the second needle 114 is longitudinally located within the first needle 112 along its length. According to some such embodiments, the first needle 112 and the second needle 114 are concentric.

The injected volume is typically 0.05 ml. It is assumed that the maximum safe volume for administration without prior withdrawal of the substance prior to administration is from 0.1 ml to 0.2 ml. Thus, in some embodiments, withdrawal and/or administration of the substance may be in the range of 0-0.4 ml, such that the total amount of substance added or removed from the eye is approximately 0.2 ml.

In some embodiments, needle size may vary according to the substance being administered, with 27 gauge needles often used for crystalline substances such as triamcinolone acetonide and 30 gauge needles being commonly used for the anti-VEGF agents ranibizumab, bevacizumab, and aflibercept. Studies have shown that thinner, sharper needles require less force to penetrate and result in less drug efflux. Some doctors have begun using 31-gauge needles (a size commonly used by diabetics for testing blood sugar and administering insulin) because a smaller needle size may reduce patient discomfort.

The needle gauges mentioned above refer to the outer, first needle 112. Thus, the second needle 114 has a smaller gauge.

The length of the needle may be about 0.5 to 0.62 inches (12.7 to 15.75 mm). Longer needles may increase the risk of retinal damage if the patient accidentally leans forward during the procedure.

In some embodiments not shown in the drawings, the second needle 114 is adjacent to the first needle 112.

The needle case 140 is longitudinally positioned about the first needle 112 (and the second needle 114) and terminates at the distal edge 142. According to some embodiments and as indicated in the drawings, the needle case 140 is cylindrical. In some embodiments, the distal edge 142 is oval or elliptical. In some embodiments, and as shown in the drawings, the far edge 142 is circular. According to some such embodiments, the radius of the far edge 142 (and needle sheath 140) is from about 3 mm to about 4 mm, which allows the operator of the syringe 100 to reliably inject at a (recommended) distance of about 3 mm to about 4 mm from the edge of the cornea of the eye. subject.

In some embodiments, the needle sheath 140 is connected to the outer walls (not indicated) of the first lumen 102. In some embodiments, the needle sheath 140 has a larger diameter than the first lumen 102 and the needle sheath 140, or at least a proximal portion thereof, is slidable in the first gap 102. The far edge 142 includes a plurality of n actuators 148 (shown in FIG. 1b). According to some embodiments, the distance between adjacent agents (of agents 148) is the same or substantially the same for all pairs of adjacent agents. In some embodiments, actuators 148 are actuated at a pressure greater than a threshold pressure. In some such embodiments, actuators 148 include pressure sensors. According to some embodiments, the actuators are actuated by a contact. According to some such embodiments, the actuators 148 include contact sensors. In some embodiments, actuators 148 include proximity sensors. According to some embodiments, and as indicated in FIG. 1b, the actuators 148 are push buttons and are actuated when pressed beyond a threshold distance/level. In some such embodiments, one or more actuators 148 or one or more dedicated sensors (located at the far edge 142) can measure intraocular pressure (e.g., but not limited to, measure near or relatively near various surfaces of the eye, i. cornea or sclera) by various methods known in the art for measuring intraocular pressure. In some embodiments, actuators 148 or one or more specific sensors (located on the far edge 142) may operate in a feedback system that controls (e.g., limits) the movement of piston 124 and/or 122 and/or the total amount of substance injected. and/or extracted from the eye, based on the measured intraocular pressure. In some embodiments of the system, feedback to the operator may be given by presenting intraocular pressure on the display unit or by means of sound (not shown).

The syringe 100 is controlled to switch between two configurations: a first configuration and a second configuration. In the first configuration, at least m (where 1 ≤ m ≤ n - 1) actuators 148 are not actuated (i.e., n - m or less actuators 148 are actuated) and needle tips 126 and 128 are adjacent and secured , relative to the far edge 142. Thus, the tip 126 of the first needle and the tip 128 of the second needle are not exposed. In a second configuration, at least n - m + 1 actuators 148 are actuated (whereby m - 1 or less actuators 148 are not actuated) and needle tips 126 and 128 can open (i.e., tips 126 and 128 the needles can extend beyond the far edge 142). Each pair of n and m values corresponds to a separate embodiment.

In some embodiments, in a second configuration, needles 112 and 114 and needle sheath 140 are capable of movement relative to each other (eg, allow needle tips 126 and 128 to be opened).

In particular, the syringe 100 is configured to switch from the first configuration to the second configuration when the number of actuated actuators (of the actuators 148) reaches n - m + 1, and switch from the second configuration to the first configuration when the number of actuated execution units falls below n - m + 1.

In some embodiments, in the first configuration, at least one of the actuators 148 is not activated (i.e., m = 1), and in the second configuration, all of the actuators 148 are activated.

In some embodiments, needle sheath 140 is fixed and needles 112 and 114 are longitudinally movable (ie, retract and advance) in a second configuration. In some embodiments, needles 112 and 114 are fixed and needle sheath 140 is longitudinally movable in a second configuration. In some embodiments, needles 112 and 114 and needle sheath 140 are longitudinally retractable in a second configuration (i.e., as needles 112 and 114 move away, needle sheath 140 approaches, and vice versa). In some embodiments, the proximal end 152 of the needle sheath 140 is fixed, and in a second configuration, the distal edge 142 is retractable. Thus, the needle sheath 140 is configured to be compressed in the second configuration.

According to additional or alternative embodiments, the syringe 100 can be controlled to switch between two configurations: a first configuration and a second configuration. In the first configuration, at least m (where 1 ≤ m ≤ n - 1) actuators 148 are not actuated and pistons 124 and/or 122 are blocked. In a second configuration, at least n - m +1 actuators 148 are actuated and pistons 124 and/or 122 are free to extend/push. This ensures that liquid cannot be injected into or withdrawn from the eye unless the syringe is positioned substantially perpendicular to the surface of the eye and is in proper contact with it.

In FIG. 1b is a schematic representation of the distal portion 158 of a syringe 100 according to some embodiments, where the actuators 148 are push buttons.

In FIG. 2 schematically depicts a syringe 100 and an eye 200 according to some embodiments. Syringe 100 is shown with needles 112 and 114 inserted into eye 200. In particular, distal edge 142 is shown in contact with surface 202 of eye 200 such that needles 112 and 114 are inserted into eye 200 at a right angle (perpendicular) to surface 202, which increases safety and reliability of intraocular injection, thus minimizing the possibility of damage to the lens, retina and other ocular structures.

In use, syringe 100 may be switched from a first configuration to a second configuration by bringing the far edge 142 to a surface (e.g., surface 202 of eye 200), for example, to actuate at least n - m +1 actuators 148. Syringe 100 may be configured such that when the distal edge 142 is applied to a flat or rounded surface (particularly the surface of the eye), when at least n - m +1 actuators 148 are actuated, the needles 112 and 114 are at right angles, or substantially at right angles to the surface.

In some embodiments, the distal edge 142 defines a plane perpendicular to the needles 112 and 114, which allows, if the entire distal edge 142 is brought into contact with a flat or rounded surface, the needles 112 and 114 are perpendicular to the surface. In some such embodiments, actuation of all actuators 148 ensures that all or substantially all of the distal edge 142 contacts the surface and that the needles 112 and 114 are perpendicular or substantially perpendicular to the surface. In some embodiments, at least two actuators 148, such as actuators 148a and 148b shown in FIG. 1b are opposite each other at the far edge 142 (e.g., when the far edge 142 is circular, the diameter of the far edge 142 extends between the two actuators), thus ensuring that when the two actuators are actuated by driving the far edge 142 into contact with the surface of the eye, needles 112 and 114 are perpendicular to the surface.

As used herein, the term "edge" (eg, far edge 142) can refer to both thin and wide edges. For example, in some embodiments, the surface area of the far edge 142 may be from about 10% to about 90% of the total plane area defined by the far edge 142.

In some embodiments, the far edge 142 allows, for example, to be positioned stably on the surface 202. For example, the dimensions of the far edge 142 can be chosen to do so, and/or the far edge 142 can be made of a material or can be covered with a material, for example, to facilitating stable contact between the needle sheath 140 and the eye 200, while bringing the far edge 142 to it. In some embodiments, needle sheath 140 (or at least the far edge 142) may be wider (eg, have a larger diameter) than the first lumen 102, or wider in at least one axis (eg, when the far edge 142 is oval or cylindrical), for example, to improve the contact stability between the far edge 142 and the surface 202.

In some embodiments, the first piston 122 and the second piston 124 operate independently of each other. In particular, the first piston 122 can be pushed or pulled regardless of the position of the second piston 124 and regardless of whether the second piston is pushed or, conversely, pulled.

According to some embodiments, pushing and/or pulling the first piston 122 may cause the second piston 124 to move back and/or vice versa. For example, when the second piston 124 is pushed (eg, when administering medication to a subject's eye), the first piston 122 automatically retracts (eg, drawing fluid from the eye).

In some embodiments, syringe 100 may have a plurality of counter-motion modes and may be controlled to switch between them. By way of a non-limiting example, in the first mode of countermotion, an increase or decrease in the first volume is accompanied by an opposite in sign and equal in magnitude change in the second volume (as described above), while in the second mode of countermotion, an increase or decrease in the first volume is accompanied by an opposite in sign and half as much in the value of the change in the second volume. Thus, in the second counter-move mode, when the first needle 112 is used to administer the first amount of medicament, half the first amount of fluid is withdrawn using the second needle 114. The second counter-move mode can be used for injection into an eye with low intraocular pressure.

In some embodiments, in cases where insertion and withdrawal are substantially simultaneous, the length of the first needle 112 may be different from the length of the second needle 114 (not shown), causing different needles to reach different positions in the eye.

In some embodiments, the syringe 100 may operate in a free-motion mode where the movements of the first piston 122 and the second piston 124 are independent of each other.

In some embodiments, syringe 100 may operate in a motion-restricted mode. In some embodiments, syringe 100 includes a locking mechanism to facilitate such operation. In some embodiments, the locking mechanism is configured such that the first piston 122 can only be pushed (to inject fluid) with an indication that the second piston 124 is placed in an extended configuration (to ensure that fluid is removed from the eye prior to infusion). ) and/or vice versa (the first and second pistons change roles).

Additionally or alternatively, the locking mechanism may be configured to allow the first piston 122 to be pulled out (to extract the intraocular fluid) only when indicating that the second piston 124 is placed in a pushed configuration (to ensure that the fluid is injected into the eye prior to extraction) and/or vice versa (the first and second pistons change roles).

In some embodiments, the syringe 100 is configured such that, in the second configuration, the needles 112 and 114 can only (remotely) protrude a predetermined distance relative to the far edge 142. In some embodiments, the predetermined distance is approximately 1 cm. The predetermined distance is selected, for example to ensure, on the one hand, (i) the safety of using the syringe 100, since too deep insertion of the needle into the eye can damage/damage the internal structures of the eye, such as the retina, and on the other hand, (ii) sufficiently deep insertion of the needles 112 and 114, thus guaranteeing penetration through all the layers that make up the outer surfaces of the eye.

In some embodiments, syringe 100 allows needles 112 and 114 to be inserted into a subject's eye at a predetermined rate and/or pressure, or within a predetermined range of rates and/or pressures. This reduces the discomfort experienced by the subject, especially when the needle(s) is(are) inserted into the eye too quickly or too slowly and/or with too much or too little force.

In some embodiments, syringe 100 includes at least one additional lumen (not shown) longitudinally adjacent to first lumen 102. In some such embodiments, syringe 100 further includes at least one additional needle (not shown) , longitudinally located adjacent to the first needle 112. Additionally or alternatively, according to some embodiments, the syringe 100 includes at least one additional lumen (not shown) longitudinally located within the second lumen 104. According to some such embodiments, the syringe 100 additionally includes at least one additional needle (not shown) longitudinally located within the second needle 114.

In FIG. 3 is a schematic sectional view of a multi-lumen syringe 300, in accordance with some embodiments. Syringe 300 is similar to, but differs from, syringe 100 in that at least one of its first lumen 302 and second lumen 304 includes a plurality of sublumen extending longitudinally thereto. In particular, in FIG. 3 shows a schematic sectional view of the first lumen 302 and the second lumen 304. In some embodiments and as indicated in FIG. 3, the first lumen 302 is divided into a plurality of first lumen sublumen 352 extending parallel to each other, and the second lumen 304 is divided into a plurality of second lumen sublumen 354 extending parallel to each other. In some embodiments, each of the sublumen 352 of the first lumen is in fluid communication with the first needle (not shown; similar to the first needle 112) and each of the sublumen 354 of the second lumen is in fluid communication with the second needle (not shown; similar to the second needle 114) .

By way of non-limiting and illustrative example, in FIG. 3, the first lumen 302 includes four sublumen (sublumen 352a, sublumen 352b, sublumen 352c, and sublumen 352d), and the second lumen 304 includes four sublumen (sublumen 354a, sublumen 354b, sublumen 354c, and sublumen 354d).

According to some embodiments, syringe 300 includes a first plurality of pistons and a second plurality of pistons (not shown). Each piston in the first set may be associated with a respective sublumen of the sublumen 352 of the first lumen. Each piston in the second set may be associated with a respective sublumen of sublumen 354 of the second lumen.

More generally, in some embodiments, some of the first lumen sublumen 352 and/or second lumen sublumen 354 may be associated with a common piston, while others of the first lumen sublumen 352 and/or second lumen sublumen 354 may not be associated with common piston, but, on the contrary, are associated with a separate corresponding piston.

In some embodiments, syringe 300 includes one or more additional needles (not shown) such that some of the first lumen sublumen 352 and/or some of the second lumen sublumen 354 are in fluid communication with one or more additional needles.

In FIG. 4 is a schematic partial view of a fenestrated needle 400, in accordance with some embodiments. The fenestrated needle 400 includes one or more side openings 406 along the tube 408 of the fenestrated needle 400. The side openings 406 may be, for example, circular, elliptical (as indicated in FIG. 4), or even rectangular. In some embodiments, the side openings 406 may differ in shape and/or size (eg, the length of the major axis in the case of elliptical side openings 406) from each other. Side openings 406 may also differ from each other in their location along tube 408. In particular, different side openings (from side openings 406) may differ from each other by their respective distances from the (distant) tip 410 of tube 408, and/or may be located opposite , or substantially opposite each other (ie, on opposite walls of tube 408).

In some embodiments, the side ports 406 may be located at the distal portion of the tube 408, for example, to ensure that the side ports 406 are located in the vitreous when the fenestrated needle 400 is properly inserted into the subject's eye, thereby increasing the safety of the procedure.

In some embodiments, the side openings 406 may additionally function as cutting elements, since the movement of the fenestrated needle 400 in the eye may result in cutting of substances in the eye that come into contact with the side openings 406. The movement may include longitudinal movement (e.g., reciprocating - translational movement), lateral movement (for example, back and forth movement in the yz plane, with the needle remaining parallel to the z- axis throughout), rotation (about the z- axis and/or around the negative z- axis), vibration, and/or a combination of these. In some embodiments, one or more of the listed movements may be oscillatory. In some embodiments, the movements may be generated by a mechanical (pressure based), electrical, electromagnetic, electromechanical, or piezoelectric motor (not shown), which may be enclosed, for example, in a lumen to which the fenestrated needle 400 is fluidly connected. According to some in such embodiments, the edges 418 of the side openings 406 may be sharp (e.g., similar to the edge of a razor blade) to increase the efficiency of cutting the side openings 406.

Because fluid (the vitreous) can be located in cavities of the liquefied vitreous, the inclusion of side openings 406 (in addition to the opening defined by tip 410) increases the likelihood of fluid being drawn out of the vitreous. In particular, since the vitreous fluid does not form a single fluid body in the vitreous, the addition of a plurality of side openings that are distributed along the length of the needle tube increases the likelihood of the needle (while being inserted into the vitreous) in fluid communication with more than one body. fluid. Additionally, as mentioned above, the side openings 406 can further act as cutting elements, thereby potentially releasing fluid from the cavities located around the fenestrated needle 400, which can then be withdrawn through the side openings 406.

In some embodiments, a fenestrated needle having no hole at its tip (not shown) may also be used. Such a fenestrated needle only includes side openings similar to the side openings 406 of the fenestrated needle 400. Because such a needle does not have an opening at its tip, the tip may have a smaller diameter and thus, advantageously, be very sharp.

Considering again the syringe 100, in some embodiments not shown in the drawings, the first needle 112 is fenestrated in substantially the same manner as the fenestrated needle 400 or the fenestrated needle described above. Additionally or alternatively, the second needle 114 may be fenestrated.

Considering again the syringe 300, according to some embodiments not shown in the drawings, the first needle of the syringe 300 (i.e., the outer needle of the syringe 300, which may be fluidly connected to the sublumen 352 of the first lumen) is fenestrated, essentially similar to the fenestrated needle 400 or a fenestrated needle as described above. Additionally or alternatively, the second needle of the syringe 300 (ie, the inner needle of the syringe 300, which may be fluidly connected to the sublumen 354 of the second lumen) may be fenestrated.

In some embodiments, a multi-lumen syringe is provided. The syringe may be similar to the embodiments of syringe 100 or syringe 300 including a fenestrated needle, such as a fenestrated needle 400 (or a fenestrated needle, as described above), but differs from it by the absence of at least one of the needle sheath (for example, needle sheath 140) and actuators such as actuators 148 or the like.

In FIG. 5 is a schematic partial view of a needle 500 including cutting elements, in accordance with 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 in the eye may cause cutting in it of substances that come into contact with the cutting elements 502. The movement may include longitudinal movement (eg, reciprocating movement), lateral movement, rotations, vibrations, and/or a combination thereof. In some embodiments, one or more of the listed movements may be oscillatory. In some embodiments, the movements may be generated by a mechanical (pressure based), electrical, electromagnetic, electromechanical, or piezoelectric motor (not shown), which may be enclosed, for example, in the needle 500 or in a lumen to which the needle 500 is fluidly connected. .

Considering again the syringe 100, according to some embodiments not shown in the drawings, the second needle 114 includes one or more external cutting elements, for example, external cutting elements 502 and/or one or more internal cutting elements, for example, internal cutting elements 504 Additionally or alternatively, according to some embodiments, the first needle 112 includes one or more internal cutting elements. If necessary, the first needle 112 may include one or more external cutting elements.

Considering again the syringe 300, according to some embodiments not shown in the drawings, the inner needle of the syringe 300 includes one or more external cutting elements, for example, external cutting elements 502 and/or one or more internal cutting elements, for example, internal cutting elements 504. Additionally or alternatively, according to some embodiments, the outer needle of the syringe 300 includes one or more internal cutting elements. Optionally, the outer needle of the syringe 300 may include one or more external cutting elements.

In some embodiments, a multi-lumen syringe is provided. The syringe may be similar to the embodiments of syringe 100 or syringe 300 including a needle with cutting elements, such as needle 500, but differs from it by the absence of at least one of the needle sheath (for example, needle sheath 140) and actuators. , for example, actuators 148 or the like.

In FIG. 6 is a schematic partial view of a two-needle assembly 600, according to some embodiments. The two-needle assembly 600 includes a first needle 612 and a second needle 614. In some embodiments and as indicated in FIG. 6, the second needle 614 is located in and along the first needle 612. In some embodiments, the first needle 612 is fenestrated substantially similarly to the fenestrated needle 400. Additionally and/or alternatively, in 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, for example, at least one of the internal cutting elements 658. Additionally or alternatively, according to some embodiments, the second needle 614 is fenestrated. Optionally, the first needle 612 may include one or more internal and/or external cutting elements.

By way of non-limiting example and as indicated in FIG. 6, the first needle 612 may include one or more apertures 606 (e.g., one or more of the apertures 406), and the second needle 614 may include at least one outer cutting element 656 (e.g., one or more of the outer cutting elements 502) and at least one internal cutting element 658 (for example, one or more of the internal cutting elements 504). In some embodiments, one or more of the at least one outer cutting element 656 may be located on or near one or more openings 606 to allow cutting of elements from the vitreous body for insertion through the openings 606 or through the second lumen needle tip. In addition, in some embodiments, internal cutting elements may be located in the first and/or second lumen and may cut elements from the vitreous entering through the tip of the needle.

In some embodiments, the two-needle assembly 600 may be configured to perform relative motion between the first needle 612 and the second needle 614, such as: (i) a longitudinal reciprocating relative motion (in which the first needle 612 reciprocates while while the second needle 614 is stationary, the second needle 614 reciprocates while the first needle 612 is stationary, or in which the first needle 612 and the second needle 614 move at different speeds, such as in opposite directions), (ii) transverse relative motion, (iii) relative rotational motion (in which the first needle 612 and the second needle 614 rotate around the z- axis at different angular velocities, eg in opposite senses).

Considering again the syringe 100, according to some embodiments not shown in the drawings, where the first needle 112 and/or the second needle 114 are fenestrated (as described above) and/or include cutting elements (as described above), the first needle 112 and the second the needle 114 is arranged in a two-needle configuration substantially similar to the first needle 612 and the second needle 614 of the two-needle assembly 600. In particular, the first needle 112 and/or the second needle 114 may be configured to perform relative motion between them as described above with respect to the first needle. 612 and a second needle 614. According to some such embodiments, the syringe 100 can be configured such that pushing and/or pulling one or both of the first piston 122 and the second piston 124 drives (e.g., vibrates) the cutting elements. According to additional and/or alternative embodiments, the syringe 100 may be configured such that pushing and/or pulling one or both of the first piston 122 of the second piston 124 generates relative motion between the first needle 112 and the second needle 114 (e.g., relative longitudinal motion between them), thus causing movement (or additional movement) of the cutting elements.

Considering again the syringe 300, according to some embodiments not shown in the drawings, where its outer needle (i.e. syringe 300) and/or its inner needle are fenestrated (as described above) and/or include cutting elements (as described above), the outer needle and the inner needle are arranged in a two-needle configuration substantially similar to the first needle 612 and the second needle 614 of the two-needle assembly 600. In particular, the outer needle and/or the inner needle (syringe 300) can be configured to perform relative movement between them. , as described above with respect to the first needle 612 and the second needle 614. In some such embodiments, the syringe 300 may be configured such that pushing and/or pulling on one or more plungers of the syringe 300 causes movement of the cutting elements. According to additional and/or alternative embodiments, the syringe 300 may be configured such that pushing and/or pulling one or more plungers of the syringe 300 generates relative motion between the outer needle and the inner needle, thereby causing movement (or additional movement) cutting elements.

In some embodiments, a multi-lumen syringe is provided. The syringe may be similar to the embodiments of syringe 100 or syringe 300 including a two-needle assembly, such as two-needle assembly 600, but differs from it by the absence of at least one of the needle sheath (for example, needle sheath 140) and actuators, for example, drive devices 148 or the like.

In some embodiments, a multi-lumen syringe is provided. The syringe may be similar to syringe 100 or syringe 300, but differ from it in that it includes a single needle, similar to either the first needle 112, the fenestrated needle 400, or the needle 500, or another needle configuration described herein above. The first lumen and the second lumen of the syringe (which are analogous to the first lumen 102 and the second lumen 104, respectively, or the first lumen 302 and the second lumen 304, respectively) are in fluid communication with the needle.

In FIG. 7 schematically depicts a station 700 for introducing fluids into and/or withdrawing fluids from a subject's eye, in accordance with some embodiments. Station 700 is configured for use with syringe 750 that is operatively associated with station 700. In particular, in some embodiments, station 700 may be configured to control at least some of the functions of syringe 750, such as, for example, the rate of administration. In some embodiments, syringe 750 may be a multi-lumen syringe, such as multi-lumen syringe 100, multi-lumen syringe 300, other multi-lumen syringes described above, and similar multi-lumen syringes. In some embodiments, syringe 750 may be a multi-lumen syringe similar to multi-lumen syringes 100 and 300 but does not include at least one of a needle sheath (e.g., needle sheath 140) and actuators, such as actuators 148 or similar. In some alternative embodiments, syringe 750 may include a single lumen, as discussed below.

According to some embodiments, station 700 includes a housing 701 that includes a monitor 703. Station 700 may further include a controller 705 operated by a user. In some embodiments, the controller 705 is included in the housing 701, for example, and as indicated in FIG. 7 in the form of a control panel 707 (for example, a touch panel). A control circuitry (not shown) may be shared between the controller 705 and other parts of the body 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 circuit is further configured to control the operation of the monitor 703, etc.

In some embodiments, the controller 705 may be detachably mounted on the housing 701 (eg, in a docking station that may be included as part of the housing 701) and may be used both when docked and as a portable device. According to some embodiments, the controller 705 may include a control panel 707 as well as one or more additional auxiliary control devices (not shown; which allow control of various functions from the control panel 707), such as a foot pedal, which may be configured in this manner. , for example, to allow the user to control the rate(s) of insertion.

In some embodiments, the station 700 may further include a support structure 711 on which the housing 701 may be mounted. In some embodiments, the support structure 711 includes an adjustable height stand 723 on which the housing 701 may be mounted, and a base 727 that supports pedestal 723. In some embodiments, station 700 is mobile. In some such embodiments, base 727 is mounted on a mechanism that assists movement of station 700, such as wheels 729. In some alternative embodiments, station 700 may be stationary.

As indicated in FIG. 7, housing 701 is fluidly connected to syringe 750 by one or more tubes 731 (piping) and/or one or more wires 733 (eg, electrical wires and/or optical fibers). In some embodiments, tubes 731 and wires 733 are detachably connectable to housing 701. In some such embodiments, tubes 731, and if necessary, wires 733, are disposable and can be replaced after each use. In some embodiments, the syringe 750 is disposable and can be replaced after each use. In some embodiments, components of syringe 750, such as plunger(s), lumen(s), and needle(s), are disposable and can be replaced after each use, thus minimizing patient/subject contamination of instruments/components. In some such embodiments, syringe 750 may come "out of the box" connected to tubing 731, and optionally wires 733. In some embodiments not shown in FIG. 7, tubes 731 and wires 733 are located in a single cable. In some embodiments, wires 733, and optionally tubing 731, form part of station 700 and are releasably connected to syringe 750.

It should be understood that syringe 750 may be a multilumen syringe, and in particular, an embodiment of multilumen syringe 100, multilumen syringe 300, each of the other multilumen syringes described above, or the like. Each possibility corresponds to a separate embodiment. The various embodiments of the tubes 731 may differ from each other according to the multi-lumen syringe with which they can be connected. For example, the number of tubes (in tubes 731) may vary according to the number of lumens or sublumen in the multilumen syringe. In particular, according to some embodiments, the number of tubes may be equal to the number of lumens or the number of sublumen in the multilumen syringe to which they are respectively to be attached. Likewise, different embodiments of wires 733 may differ from each other according to the multilumen syringe with which they are connected (for example, according to the number of pistons in the multilumen syringe).

In some embodiments, the operating parameters of the syringe 750 may be controlled via the controller 705, controller accessories (eg, a foot pedal), and/or buttons and/or the like. on tubing 731, wires 733, and/or syringe 750. By way of non-limiting example, operating parameters may include the volume of fluid injected/withdrawn, the force applied to insert the needle, the speed of needle insertion, the rate of fluid injection/withdrawal, which lumens are working and which are not (e.g., blocked) during use of the 750 syringe (i.e., the 705 controller can be used to “unblock” and “block” the lumen), which lumen is to be used for insertion, and which lumen is to be used to withdraw , etc.

In some embodiments, in which the syringe 750 includes a needle assembly, such as a two-needle assembly 600, or the like, the relative movement of the needles (including the type of movement, e.g., longitudinal or rotational, movement speed) can be initiated/selected/controlled via controller 705, controller accessories and/or buttons and/or the like. on tubes 731, wires 733, and/or syringe 750. In some embodiments, in which the syringe needle 750 includes cutting elements, such as cutting elements 502 and/or 504, the movement of the cutting elements may be initiated/selected/controlled through the controller 705 , controller accessories and/or buttons and/or the like. on tubing 731, wires 733 and/or syringe 750.

In some embodiments, tubing 731 and/or wires 733 may be operatively connected to one or more syringe plungers, one or more syringe lumen and/or sublumen, one or more lumen and/or sublumen components (e.g., motors to generate motion). needles, motors to generate movement of the plungers, to apply positive or negative pressure to pneumatically drive the plungers and/or to the substance in the lumen and/or to the needle(s)), one or more syringe needles and/or one or more components in and/or on needles (eg, cutting elements), thereby operatively associating station 700 (ie, control circuitry in station 700) with them.

In some embodiments, station 700 can be configured to control pressures in the lumen of syringe 750 (and in sublumen in embodiments where the lumens of syringe 750 include sublumen). In particular, station 700 can be configured to generate positive and negative luminal pressures to control rates of pressure change and thus control rates of fluid injection into and fluid out of the eye. In some embodiments, station 700 is configured to control the movement of the plungers and thus control the pressures and rates of change within the lumen of the syringe. In some embodiments, station 700 may include a pump mechanically connected to the lumens in the syringe via tubes 731. In some embodiments, the movement of the pistons is controlled by the pump.

In some embodiments, syringe 750 is a single lumen syringe. In some such embodiments, tubes 731 include two tubes that can effectively take on the role of lumens in syringe 100, the first of the two tubes being fluidly connected to the first lumen 102 and the second of the two tubes being fluidly connected to second lumen 104. Similarly, in some embodiments where syringe 750 is a single lumen syringe, tubes 731 include or consist of a single double lumen tube that can effectively take on the role of lumens in syringe 100.

In some embodiments where syringe 750 is a single lumen syringe, tubes 731 include a plurality of tubes that can effectively take on the role of sublumen in syringe 300. In some such embodiments, some of the tubes may be multilumen. Similarly, in some embodiments where syringe 750 is a single lumen syringe, tubing 731 includes or consists of a single multilumen tube that can effectively take on the role of the lumens in syringe 100.

In some embodiments, the control circuitry may include processing circuitry configured to analyze sensor readings from sensors located in the syringe 750 (e.g., one of the lumen used to withdraw intraocular fluid) in one or more tubes 731, and even in package 701. For example, according to some embodiments, wires 733 may include one or more optical fibers coupled to a CCD or CMOS sensor in package 701. In such embodiments, the processing circuitry may be configured to analyzing image data from the eye or fluids in the lumen/sublumen. Alternatively, optical sensors (eg, CMOS sensors) may be included in the syringe. The processing circuitry may include at least one computer processor and a memory capable of storing analysis results. In some embodiments, the computer processor may be configured to provide a diagnosis based on the results of the analysis. In some embodiments, the processing and/or storage and/or analysis of the results may be performed at a remote central location (eg, 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. In some embodiments, monitor 703 may be configured to display analysis results (and diagnosis in embodiments for diagnostics).

In some embodiments, the housing 701 may include a compartment for accommodating one or more removable fluid containers (not shown). The containers may be configured to be fluidly connected to tubing 731, which in turn may be fluidly connected to the lumens in the syringe 750, allowing the lumens to be fluidly connected to the containers. In such embodiments, fluid to be administered may be stored in an appropriate container at station 700. Other containers may be intended for withdrawal of fluid and may initially be empty (i.e., until station 700 is used) or may include a substance , prepared for interaction with the recovered fluid. In some embodiments, the containers including the recovered fluid may be removed for laboratory analysis. According to some embodiments, station 700 may include equipment configured to analyze recovered fluid, or at least provide initial analysis thereof. According to additional/alternative embodiments, station 700 may include equipment configured to transmit and/or receive readings to/from a remote central location (eg, a server or servers).

In some embodiments, the housing 701, one or more of the tubes 731, and/or the syringe 750 may include at least one agent that facilitates rapid analysis of the intraocular fluid by interacting said agent with the intraocular fluid.

In some embodiments, monitor 703 may be configured to display analyzed data from intraocular fluid rapid analysis in a qualitative, semi-quantitative, and/or quantitative format.

In some embodiments, syringe 750 may be an embodiment of a known syringe. In some embodiments, syringe 750 may be made from the parts described in FIG. 1-6, including, but not limited to, pistons, lumens, sublumen and needles in the form of a multi-lumen needle, a single needle, or any combination of needles 112, 114, 400 and 500, and a two-needle assembly 600.

Obviously, some features of the invention, which for clarity are described in the context of separate embodiments, can also be provided together in a single embodiment. On the contrary, various features of the invention, which for brevity are described in the context of a single embodiment, can also be provided separately or in any suitable subcombination or in accordance with any other described embodiment of the invention. No feature described in the context of an embodiment should be considered an essential feature of that embodiment unless explicitly stated.

Although the steps of the methods according to some embodiments may be described in a specific order, the methods of the invention may include some or all of the steps described in a different order. The method of the invention may include several of the steps described or all of the steps described. No particular step of the disclosed method should be considered as an essential step of this method, unless explicitly stated.

While the invention has been described in connection with specific embodiments, it is clear that there may be numerous alternatives, modifications, and variations that are obvious to those skilled in the art. Accordingly, the invention covers all such alternatives, modifications and variations that fall within the scope of the following claims. It should be understood that the invention is not required to be limited in its application to the design details and layout of the components and/or methods set forth herein. In practice, other embodiments may be implemented, and the embodiment may be implemented in different ways.

The phraseology and terminology used herein is for purposes of description and should not be considered limiting. The citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art of the invention. Section headings are used here for ease of understanding of the description of the invention, and should not be construed as a necessary limitation.

Claims (19)

1. A multi-lumen syringe for intraocular injection, containing a first lumen, a second lumen, one or more needles connected in fluid with the lumens, and a needle case located around one or more needles; wherein the needle sheath contains n actuators based on proximity/contact/pressure at the distal edge of the needle sheath; moreover, the syringe is configured to switch between at least two configurations: the first configuration, in which at least one of the actuators is not activated, and each tip of one or more needles is located near and fixed relative to the far edge; And the second configuration, in which n actuators are actuated, and the possibility of extending one or more needles away from the far edge is provided. 2. The multi-lumen syringe of claim 1, wherein the plane defined by the distal edge of the needle sheath is perpendicular or substantially perpendicular to one or more needles, thereby ensuring that when all or substantially all of the distal edge contacts the surface of the eye so as to result in actuating n actuators, it is possible to introduce one or more needles perpendicular to the surface of the eye. 3. The multi-lumen syringe of claim 2, wherein the syringe is configured to automatically switch back from the second configuration to the first configuration, thereby making it impossible to inject or withdraw fluids after insertion of one or more needles if the syringe is tilted such that the far edge no longer contacts completely or substantially completely with the surface of the eye. 4. Multilumen syringe according to any one of paragraphs. 1-3, in which the actuators are push buttons, and in the second configuration, push buttons are pressed beyond the threshold value. 5. Multilumen syringe according to any one of paragraphs. 1-4, in which at least one pair of actuators of n actuators are located oppositely or substantially oppositely on the far edge. 6. Multilumen syringe according to any one of paragraphs. 2-5, wherein the actuators are contact/pressure based actuators and the actuators are positioned at the far edge such that when the far edge is placed over the subject's eye, the syringe cannot be switched from the first configuration to the second configuration if all or substantially all of the far edge is not in contact with the eye. 7. Multilumen syringe according to any one of paragraphs. 1-6, in which one or more needles are retractable and in which the needle sheath is stationary. 8. Multilumen syringe according to any one of paragraphs. 1-6, in which the needle sheath is retractable and/or compressible, and in which one or more needles are fixed. 9. Multilumen syringe according to any one of paragraphs. 1-8, wherein the one or more needles comprise at least two needles: a first needle and a second needle, wherein the first needle is fluidly connected to the first lumen and the second needle is fluidly connected to the second lumen. 10. The multi-lumen syringe according to claim 9, wherein the second needle is located in the first needle and/or the second lumen is adjacent to the first lumen and the second needle is adjacent to the first needle. 11. Multilumen syringe according to any one of paragraphs. 1-10 further comprising a first piston reciprocating in the first lumen and a second piston reciprocating in the second lumen. 12. The multi-lumen syringe of claim 11, wherein the first piston and the second piston are operatively coupled such that pushing or pulling the first piston causes the second piston to counter-move and/or pushing or pulling the second piston causes the first piston to counter-move. 13. Multilumen syringe according to any one of paragraphs. 11 and 12, further comprising a locking mechanism configured to allow the first piston to be pushed only when the second piston is indicated to be in an extended configuration, thereby allowing extraction of intraocular fluid prior to injection, and/or the locking mechanism is configured to provide allowing the first plunger to be drawn out only when the second plunger is indicated to be pushed into a pushed configuration, thus allowing injection prior to withdrawal of the intraocular fluid. 14. Multilumen syringe according to any one of paragraphs. 11-13, in which the first piston is designed in such a way that it is prevented from being pushed and/or pulled out in excess of the threshold pushing speed of the first piston and/or the threshold pulling speed of the first piston, and/or in which the second piston is designed in such a way that it is prevented from pushing and/or pulling in excess of the threshold push speed of the second piston and/or the threshold pull speed of the second piston. 15. Multilumen syringe according to any one of paragraphs. 1-14, further comprising at least one substance that facilitates rapid analysis of the intraocular fluid by interacting the substance with the intraocular fluid, and wherein said at least one substance is located in the lumen(s) or sublumen(s) of the syringe.

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