Injection machine

Abstract

An injector for use in ophthalmic applications, having a gas supply tube and a liquid supply tube, wherein in a joint member in fluid communication with an outflow cannula, the two supply tubes are interconnected, and in the injector, a selective flow member is disposed near the joint member in the gas supply tube to allow gas to pass through while preventing the passage of liquid.

Description

【Technical Field】 【0001】 The present invention relates to an injector for delivery to the eye. The present invention further relates to a system comprising such an injector and a control device. 【Background Art】 【0002】 WO 2017 / 218610 A1 pamphlet describes an injector for delivering a therapeutic agent subretinally, having two fluid supply ducts for delivering bleb fluid and a therapeutic agent. The fluid ducts are connected to a valve assembly including an actuating arm operable to switch valves. 【0003】 Therefore, conventional injectors require active intervention by the user to block the flow of bleb fluid while injecting a therapeutic agent into the patient's eye, and vice versa, to close the valve assembly. The clear fluid also does not serve as an indicator to the user of the point at which the valve is actuated. Often, a delay in valve actuation affects the composition being delivered. 【0004】 Fluid that is not delivered to the eye remains in the injector downstream of the valve and is mixed with the active agent when the active agent is being delivered, and vice versa. 【0005】 Therefore, control of the content and amount of delivery by conventional injectors is relatively low. 【Summary of the Invention】 【Problems to be Solved by the Invention】 【0006】 An object of the present invention is to provide an injector for gases and fluids for ophthalmic use that enables rapid and safe perfusion of liquids and gases into the eye during surgery. A further object of the present invention is to provide a system comprising an injector and a control device that provides highly controlled delivery of gases and fluids to the eye during surgery. 【Means for Solving the Problems】 【0007】 According to a first aspect, the present invention provides an injector for use in ophthalmic applications having a gas supply tube and a liquid supply tube, wherein the supply tubes are interconnected at a junction member in fluid communication with an outflow cannula. In the gas supply tube, a selective flow member is disposed near the junction member, which allows gas to pass through while blocking the passage of liquid. The injector of the present invention enables simple and controlled delivery of liquid and gas to the eye of a person who is vulnerable to injury during surgery. Since the selective flow member blocks only the liquid, the gas may flow in two directions, particularly through the gas supply tube. This two-way gas flow provides the possibility of both delivering gas to the eye and aspirating excess gas in the tube in the opposite direction. The liquid is blocked by the selective flow member, forming a small volume of liquid buffer in the gas supply tube. This buffer is formed within the injector to prevent the delivery of any gas into the eye when only liquid is to be delivered. This buffer can be created passively within the injector of the present invention without the need for user intervention. Further, since the liquid cannot pass through the selective member, the volume of the buffer is controlled by the position of the selective member along the gas supply tube. As a result, the volume of the buffer remains small enough to be removed when switching back to gas delivery. Therefore, the volume of liquid between the selective flow member and the junction member, which is required as a buffer but needs to be removed before gas delivery, can be minimized, accelerating the switching between liquid delivery and gas delivery. Thus, the switching between liquid irrigation and gas irrigation to the eye is accelerated. Excess gas can also be reinjected / aspirated directly back to or in the direction of the gas supply since the gas can flow through the selective flow member, thereby improving the intraocular pressure during liquid delivery. 【0008】 In a further embodiment, the selective flow member consists of a membrane comprising polytetrafluoroethylene, PTFE, and the maximum pore size of the membrane is 0.2 to 1.0 μm. The PTFE selective flow member forms a highly hydrophobic membrane that is porous enough to allow gas passage while blocking liquid flow by using relatively small pores. The membrane also provides bacterial retention by blocking bacteria sized larger than the maximum pore size. As a result, only normal air flow is perfused into the eye. 【0009】 In a further embodiment, the thickness of the PFTE membrane is 0.01 to 1 mm. By using a relatively thin hydrophobic material, most of the gas can pass through it. Therefore, the membrane does not affect the gas flow rate during gas delivery. The gas delivery time is not affected. 【0010】 In a further embodiment, the selective flow member disposed near the junction member in the gas supply tube can be filled with up to 1.5 mL, preferably up to 0.5 mL, more preferably up to 0.1 mL of liquid. A buffer volume controlled to be less than 1.5 mL accelerates the removal of the liquid buffer when gas is delivered to the eye. In this way, the switching from liquid delivery mode to gas delivery mode is faster, while ensuring that there is sufficient gas in the ready-to-deliver tube without the need for immediate further supply from an external device. 【0011】 In a further embodiment, the selective flow member is disposed within the chamber in the gas supply tube, the chamber having a first segment and a second segment, the second segment being closest to the joining member, each of the first segment and the second segment having an opening in its surface, the selective flow member dividing the chamber into a first compartment close to the first segment and a second compartment close to the second segment, each of the first compartment and the second compartment being in fluid connection with the gas supply tube via the opening, and the liquid in the second compartment being prevented from entering the first compartment. The selective flow member maintained within the chamber may be in contact with both the liquid and gas volumes. The chamber results in an injector of compact design and allows for the formation of a liquid buffer within the chamber to prevent gas delivery during liquid injection. 【0012】 In a further embodiment, each of the first segment and the second segment has a connector extending radially on its surface to the opening for receiving the gas supply tube, the gas supply tube being in fluid connection with the first and second compartments of the chamber via the opening. The gas supply tube can be connected to the chamber via the connector while reducing the likelihood of tube bending and twisting radially onto the surface of the chamber. 【0013】 In a further embodiment, the first segment and the second segment are integral elements of the chamber. Providing a chamber of a single element provides maximum sealing of the chamber contents. 【0014】 In a further embodiment, the first segment and the second segment are releasably connected. The releasable connection of the chamber portion allows the chamber to be opened for cleaning and / or replacement of the membrane of the selective flow member. 【0015】 In a further embodiment, the opening in the surface of the first segment and the opening in the surface of the second segment are substantially aligned along the axis of the gas supply tube. Aligning the openings with the main direction of the gas supply tube results in a more compactly designed injector. 【0016】 In a further embodiment, the volume of the chamber is 1 mL, preferably 0.3 mL, more preferably 0.1 mL. The chamber has small dimensions, thereby enabling a user, such as a surgeon, to easily handle it by hand while still providing a sufficient volume of liquid to prevent gas delivery during liquid injection. 【0017】 In a further embodiment, the chamber has a round shape, such as a disc shape or a spherical shape. The round-shaped chamber provides a user-friendly smooth entity that can be held by hand. 【0018】 In a further embodiment, the fluid connection between the gas supply tube and the opening includes one or more luer connectors. The fluid tight connection between the tube and the interior of the chamber is brought about by the use of such additional connector elements. 【0019】 In a second aspect, the present invention provides a system comprising a control device, a gas supply unit, and a liquid supply unit, wherein each of the gas supply unit and the liquid supply unit is connected to a gas supply tube and a liquid supply tube of an injector as described in any of the preceding claims, and the control device is adapted to: operate the gas supply unit to push gas at a gas pressure X into the gas supply tube beyond a selective flow member and supply the gas to an outflow cannula, and switch to supply liquid to the outflow cannula by flowing liquid to the selective flow member at a liquid pressure higher than the gas pressure X. The system of the present invention provides a controlled outflow and improves the intraocular pressure caused by excess gas that can be aspirated back towards the gas supply unit during liquid delivery. The system allows for a rapid switch from liquid to gas flow and vice versa, thanks to the control of the sufficient gas pressure during injection and aspiration. 【0020】 In a further embodiment, the control device is further adapted to operate the liquid supply unit in the step of operating the gas supply unit, to push the liquid beyond the liquid supply tube, and to form liquid to gas junction forms in the liquid supply tube. Further control in gas delivery may be provided by the system, where a gas buffer is created in the liquid supply tube by the precise control of the control device of the pressures of both the gas and the liquid. 【0021】 In a further embodiment, the control device is adapted to control the pressure of the liquid and the gas within each supply tube within a range of 0 to 200 mmHg. By the precise control of the pressures of the liquid and the gas over a wide pressure range, either the liquid or the gas can be injected into the outflow cannula or aspirated towards the ophthalmic device by applying various pressures. 【0022】 The present invention will be described in more detail below with reference to the accompanying drawings. 【Brief Description of the Drawings】 【0023】 【Figure 1A】 Shows a schematic view of the injector according to the present invention. 【Figure 1B】 Shows a schematic view of the injector according to the present invention during liquid delivery to the eye. 【Figure 1C】 Shows a schematic view of the injector according to the present invention during gas injection. 【Figure 2】 Shows a perspective view of the injector according to an embodiment of the present invention. 【Figure 3】 Shows an exploded view of the disc-shaped chamber of the injector according to the embodiment of FIG. 2. 【Figure 4】 Shows a perspective view of the injector according to another embodiment of the present invention. 【Figure 5】 Shows an exploded view of the disc-shaped chamber of the injector according to the embodiment of FIG. 4. 【Figure 6】 Shows a flowchart of the system according to the present invention. 【Mode for Carrying Out the Invention】 【0024】 Figure 1A shows a schematic view of injectors 1, 20 for delivery to the eye according to the present invention. The injectors 1, 20 include a gas supply tube 2, a liquid supply tube 3, joining members 4, 24, a selective flow member 5, and an outflow cannula 12. Both the gas supply tube 2 and the liquid supply tube 3 function as introduction tubes of the device to allow a gas such as air and a liquid such as water, a cleaning solution, BSS, etc. to be delivered to the eye respectively. The injected gas and liquid assist in maintaining sufficient perfusion to the eye, for example, at the subretinal level during surgery, and / or guarantee postoperative protection and healing. As shown, the gas and liquid are input into the respective supply tubes 2, 3 of the injector from an ophthalmic device 50, and the tubes 2, 3 can be connected to the ophthalmic device via a connector 51. A connector 51 as shown connects both the gas and liquid supply tubes 2, 3 to the ophthalmic device 50. In other embodiments (not shown) within the scope of the present invention, there may be a first connector connecting the gas supply tube 2 to the ophthalmic device 50 and a second connector different from the first connector connecting the liquid supply tube 3 to the ophthalmic device 50. The ophthalmic device 50 corresponds to a work station and may further include any of electronics, a work arrangement configuration, and a supply unit. It should be noted that the connector 51 can be any connector known to those skilled in the art that provides a fluid-tight connection between the injectors 1, 40 and the ophthalmic device 50. The same applies to each of the separate first and second connectors. The joining members 4, 24 are connection elements of the injectors 1, 20 that connect the gas supply tube 2, the liquid supply tube 3, and the outflow cannula 12. The joining members shown are in a T shape and connect both the introduction supply tubes 2, 3 to the outflow cannula 12. It will be understood that other embodiments including joining parts of different shapes, for example, a Y-shaped joining part, are also within the scope of the present invention. The joining members 4, 24 open into the passage of the liquid from the liquid supply tube 3 or the gas from the gas supply tube 2. The outflow cannula 12 extends from the proximal end 11 of the joining members 4, 24 to allow either gas or liquid to flow out from the supply tube at its distal end 10. The outflow cannula 12 has an outlet at its distal end 10, which can be placed in or near the eye to deliver gas or liquid to the eye.The selective flow member 5 is connected to the gas supply tube 2 at a distance from the junction members 4, 24. This distance is equal to the volume V of the gas supply tube 2. B The selective flow member 5 corresponds to a volume V of the gas delivery tube 2 that is bounded by the position of the selective flow member 5. The selective flow member 5 serves to block the flow of liquid into the gas delivery tube 2 in the direction of the ophthalmic device 50. However, the selective flow member 5 allows a bidirectional flow of gas therethrough. The selective flow member 5 may be formed by a hydrophobic filter. The liquid is drawn into a volume V of the gas delivery tube 2 that is bounded by the position of the selective flow member 5. B This volume of buffer in the gas delivery tube 2 ensures that gas does not enter the eye during liquid delivery. The selective flow element 5 is illustrated in more detail in Figures 1B-1C during liquid and gas delivery, respectively. 【0025】 FIG. 1B shows a schematic diagram of the injector 1, 20 according to the invention when delivering a liquid 6. The outlet of the outflow cannula 12 at the distal end 10 is positioned in the eye 15. The liquid 6, for example a BSS solution, is first released from the ophthalmic device 50 into the liquid supply tube 3. During liquid delivery, the pressure in the gas supply tube 2 is lower than the pressure in the liquid supply tube 3. The release and reinjection / aspiration of liquid and gas from / to the ophthalmic device 50 may be at least partially controlled by an electronic control device (not shown) in the ophthalmic device 50. During the release of the liquid 6, the liquid 6 fills the liquid supply tube 3 through the junction member 4, 24 and partially enters the gas supply tube 2 over the distance between the junction member 4, 24 and the selective flow member 5. In this way, a volume V B As previously mentioned, the selective flow element 5 prevents the liquid 6 from filling the gas supply tube 2 beyond the selective flow element 5 in the direction of the ophthalmic device 50. In that way, the volume V B The buffer portion is passively formed. 【0026】 Figure 1C shows a schematic view of injectors 1, 20 according to the present invention during the delivery of gas 7. The outlet of the outflow cannula 12 at the distal end 10 is positioned within the eye 15. In this mode, gas 7 is released from the ophthalmic device 50 into the gas supply tube 2 at pressure X. The gas 7 can flow through the selective flow member 5. The gas may also, in a preferred embodiment, optionally be released into a portion of the gas supply tube 2 to fill the volume V G within the liquid - free liquid supply tube 3. Therefore, a gas buffer can optionally be formed within the liquid supply tube 3, and any liquid 6 is prevented from being delivered into the eye 15. Further, the gas can be delivered into the eye 15 via the outflow cannula 12. When switched back to the liquid supply as in Figure 1B, the gas 7 can be aspirated into the ophthalmic device 50 when first flowing through the selective flow member 5, thus releasing the buffer volume V B which can then be refilled with liquid 6 again. 【0027】 Figure 2 shows a perspective view of the injector 1 according to an embodiment of the present invention. The injector 1 includes, as shown in Figures 1A - 1C, a gas supply tube 2, a liquid supply tube 3, a joining member 4, an outflow cannula 12, and a selective flow member (not shown). The selective flow member 5 is located within a disc - shaped chamber 8 and is disposed within the liquid supply tube 2 at a distance from the joining member 4 to form the buffer volume V BEnable. The illustrated disk-shaped chamber 8 includes two interconnected circular parts or segments 13, 14. In an alternative embodiment, the chamber 8 may have a different shape, such as rectangular or square. Each segment 13, 14 is connected to the gas supply tube 2 on its outer surface through openings 18, 19 located at the center of the disk on each side of the chamber 8. The openings 18, 19 may be circular. Note that other embodiments with openings of any shape and not at the center are also within the scope of the present invention. A liquid-tight connection between the gas supply tube 2 and the selective flow member 5 at each opening 18, 19 can be facilitated by one or more Luer connectors 16, 17. The same applies to the close joint between the joint member 4 and the outflow cannula 12, which may include a Luer connector 9. Note that alternative embodiments within the scope of the present invention may include other connectors and / or be manufactured to provide a fluid-tight connection between two elements. 【0028】 Figure 3 shows an exploded view of the disk-shaped chamber 8 of the injector 1 according to the embodiment of Figure 2. The segments 13, 14 surround the selective flow member 5. The selective flow member 5 includes a membrane of the selective flow material. The membrane of the selective flow material divides the volume of the disk-shaped chamber 8 into a first compartment and a second compartment: a gas compartment in the direction of the ophthalmic device 50 and a liquid buffer compartment on the side of the joint member 4. The membrane of the selective flow material includes polytetrafluoroethylene PTFE, a material that is highly hydrophobic or water-repellent. The selective flow membrane containing PTFE further incorporates micropores with a maximum pore size in the range of 0.2 - 1.0 μm. The thickness of the membrane is preferably in the range of 0.01 - 1 mm. This selective flow sheet of PTFE enables a high gas flow through the sheet from the gas chamber to the liquid chamber. However, according to the description of Figures 1A - 1C, the same sheet blocks the flow of water and water-based solutions, such as BSS, through the sheet from the liquid chamber to the gas chamber. 【0029】 Figure 4 shows a perspective view of an injector 40 according to another embodiment of the present invention. The injector 40 includes a gas supply tube 2, a liquid supply tube 3, a joining member 24, an outflow cannula 12, and a selective flow member (not shown), as shown in FIGS. 1A - 1C. The selective flow member 5 is shown in the exploded view of FIG. 5. The selective flow member 5 is located within the disc - shaped chamber 25 and near the joining member 24, enabling a buffer volume V B in the liquid supply tube 2. The illustrated disc - shaped chamber 25 includes two interconnected circular parts or segments 26, 27. In other embodiments, the chamber may have a different shape, such as rectangular or square, with corresponding segments. Each segment 26, 27 includes radially extending connectors 28, 29 on its surface for receiving the gas and liquid supply tubes 2, 3 respectively. The connector 29 also includes the portion of the gas tube 2 that connects to the liquid supply tube 3 at the joining member 24 (not shown) within the connector 29. With the connectors 28, 29 holding it, the gas supply tube 2 is connected to the central openings 32, 33 in each segment of the chamber respectively. The selective flow member 5 may further be fluidly connected to the outflow cannula 12 by an additional joint member 30. The joint between the joining member 24 and the outflow cannula 12 may also include a luer connector 31. It should be noted that alternative embodiments within the scope of the present invention may include other connectors and / or be manufactured to provide a fluid - tight connection between two elements. 【0030】 Figure 5 shows an exploded view of the disk-shaped chamber 25 of the injector 40 according to the embodiment of FIG. 4. The device is shown at a new angle that allows a better view of the selective flow member 5. Segments 26, 27 surround the selective flow member 5. The selective flow member 5 is formed by a membrane of a selective flow material. The membrane of the selective flow material divides the volume portion of the disk-shaped chamber 25 into a gas compartment near segment 26 and a liquid buffer compartment in the direction of the outflow cannula 12 near segment 27. The openings 32, 33 of the chamber segments are circular as shown in FIG. 5, but may be of different shapes. The openings may also be in another position shifted from the center of the chamber 25 in each part of the chamber. The fluid-tight connection between the gas supply tube 2 and the disk-shaped chamber 25 at each opening 32, 33 can be facilitated by one or more luer connectors within a connector (not shown). It should be noted that alternative embodiments within the scope of the present invention may include other connectors and / or be manufactured to provide a fluid-tight connection between two elements. The sheet of the selective flow material includes PTFE, a highly hydrophobic or water-repellent material. The selective flow sheet includes PFTE with a maximum pore size in the range of 0.2 to 1.0 μm. The thickness of the membrane is preferably in the range of 0.01 to 1 mm. This selective flow sheet of PTFE allows a high gas flow through the sheet from the gas chamber to the liquid chamber. However, according to the description of FIGS. 1A-1C, the same sheet blocks the flow of water and water-based solutions, such as BSS, through the sheet from the liquid chamber to the gas chamber. 【0031】 Figure 6 shows a schematic diagram of the system 100 according to the present invention. The system includes a control device 110, a liquid supply unit 120, and a gas supply unit 130. The control device 110 can assist and / or fully control the respective discharging and refilling operations of the liquid supply unit 120 and the gas supply unit 130 for the liquid and gas supply tubes of the injection devices 1 and 40. At least one of the control device 110 and the liquid and gas supply units 120 and 130 may be part of the ophthalmic device 50, and preferably all are part of the ophthalmic device 50. In other embodiments, the ophthalmic device includes at least one of a liquid supply unit, a gas supply unit, or a control device, but other elements are separate. The control device 110 controls the liquid supply unit and the gas supply unit that are in fluid connection with the injection devices 1 and 40 via valves (not shown) near the liquid and gas supply units 120 and 130, and the injection device is one of FIGS. 1, 2, or 4. The valves, in combination with the pressure provided by the supply units, result in the control of the system. The control device can control the gas delivered to the injection device at pressure X. The control device can further be used to suck the liquid and / or gas in the respective supply tubes of the injector returning to their respective supply units when switching from one mode to the other (liquid-gas and vice versa) by applying the pressure of the liquid. The pressure in the supply tube is generally 200 mmHg or less, preferably 160 mmHg or less. The selective flow member 5 of the injectors 1 and 40 ensures that the liquid does not need to be sucked up to the gas tube and the gas supply unit of the ophthalmic device.

Claims

[Claim 1] An injector (1, 40) for use in ophthalmic applications, having a gas supply tube (2) and a liquid supply tube (3), wherein both supply tubes are interconnected at a connecting member (4, 24) that is in fluid communication with the outflow cannula (12), An injector (1, 40) is characterized in that a selective flow member (5) is placed near the connecting member (4, 24) inside the gas supply tube (2) to allow gas to pass through while preventing liquid from passing through. [Claim 2] The injector (1, 40) according to claim 1, wherein the selective flow member (5) is made of a membrane containing polytetrafluoroethylene, PTFE, and the maximum pore size of the membrane is 0.2 to 1.0 μm. [Claim 3] The injector (1, 40) according to claim 2, wherein the thickness of the membrane is 0.01 to 1 mm. [Claim 4] The injector (1, 40) according to any one of claims 1 to 3, wherein the selective flow member (5) is located within the gas supply tube (2) near the connecting member (4, 24) and can be filled with liquid to a maximum of 1.5 mL, preferably to a maximum of 0.5 mL, and more preferably to a maximum of 0.1 mL. [Claim 5] The selective flow member (5) is located in a chamber (8, 25) within the gas supply tube (2), the chamber (8, 25) having a first segment (13, 26) and a second segment (14, 27), the second segment (14, 27) being closest to the joining member (4, 27), and each of the first segment (13, 26) and the second segment (14, 27) having an opening (18, 19, 32, 33) on its surface, and the The injector (1, 40) according to any one of claims 1 to 3, wherein the selective flow member (5) divides the chamber (8, 25) into a first compartment near the first segment (13, 26) and a second compartment near the second segment (14, 27), and each of the first and second compartments is fluidly connected to the gas supply tube (2) via the openings (18, 19, 32, 33), and the liquid in the second compartment is prevented from entering the first compartment. [Claim 6] The injector (1, 40) according to claim 5, wherein each of the first segment and the second segment (26, 27) has connectors (28, 29) on its surface that extend radially to the openings (32, 33) for receiving the gas supply tube (2), and the gas supply tube (2) is fluidly connected to the first and second compartments of the chamber (25) via the openings (32, 33). [Claim 7] The injector (1, 40) according to claim 5, wherein the first segment (13, 26) and the second segment (14, 27) are integral elements of the chamber (8, 25). [Claim 8] The injector (1, 40) according to claim 5, wherein the first segment (13, 26) and the second segment (14, 27) are releasably connected. [Claim 9] The injector (1, 40) according to claim 5, wherein the openings (18, 32) on the surface of the first segment (13, 26) and the openings (19, 33) on the surface of the second segment (14, 27) are substantially aligned along the main axis of the gas supply tube (2). [Claim 10] The injector (1, 40) according to claim 5, wherein the volume of the chamber (8, 25) is 1 mL, preferably 0.3 mL, and more preferably 0.1 mL. [Claim 11] The injector (1, 40) according to claim 5, wherein the chambers (8, 25) are round in shape, for example, disc-shaped or spherical. [Claim 12] The fluid connection between the gas supply tube (2) and the openings (18, 19, 32, 33) includes one or more Luer connectors (16, 17), as described in claim 5, injector (1, 40). [Claim 13] A system (100) comprising a control device (110), a gas supply unit (120), and a liquid supply unit (130), wherein each of the gas supply unit (120) and the liquid supply unit (130) is connected to the gas supply tube (2) and the liquid supply tube (3) of the injector (1, 40) described in any one of claims 1 to 3, and the control device (110) is: - The gas supply unit (120) is operated to push the gas into the gas supply tube (2) with gas pressure X, over the selective flow member (5), and to supply the gas to the outlet cannula (12), and - By flowing the liquid to the selective flow member (5) at a liquid pressure higher than the gas pressure X, the supply of liquid (130) through the outlet cannula (12) is switched, and liquid is supplied to the outlet cannula (12). The system (100) is adapted to this. [Claim 14] The system (100) according to claim 13, wherein the control device is further adapted to operate the liquid supply unit (130) in the step of operating the gas supply unit (120) to push the liquid over the liquid supply tube (3) to form a gas-liquid joint configuration in the liquid supply tube (3). [Claim 15] The system (100) according to claim 13, wherein the control device is adapted to control the pressure of the liquid and the pressure of the gas in each supply tube (2, 3) within a range of 0 to 200 mmHg.

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