Syringe device

Abstract

A syringe for ophthalmic applications, having a gas supply tube and a liquid supply tube, the two supply tubes being interconnected at a joint in fluid communication with an outflow cannula, characterized in that a selective flow member is placed in the gas supply tube at a location close to the joint, allowing passage of gas and blocking passage of liquid.

Description

Technical Field

[0001] The present invention relates to a syringe for ophthalmic delivery. The present invention also relates to a system comprising such a syringe and a control unit. Background Art

[0002] Patent publication number WO2017 / 218610A1 describes a syringe for delivering a therapeutic agent subretinally, having two fluid supply tubes for delivering a vesicular fluid and a therapeutic agent. The fluid tube is connected to a valve assembly that includes an actuating arm that can be operated to switch a valve.

[0003] Therefore, prior art syringes require active user intervention to close the valve assembly to block the flow of the vesicular fluid when injecting the therapeutic agent into the patient's eye, and vice versa. The transparent fluid also does not provide the user with an indication of when to actuate the valve. Typically, a delay in actuating the valve affects the composition delivered.

[0004] Fluid not delivered to the eye remains in the syringe downstream of the valve and can mix with the medication when it is delivered, and vice versa.

[0005] Therefore, control over the content and amount delivered using prior art syringes is relatively low.

[0006] An object of the present invention is to provide an injector of gases and fluids for ophthalmic applications which provides rapid and safe liquid and gas irrigation of the eye during surgery. Another object of the present invention is to provide a system comprising an injector and a control unit which provides highly controlled gas and fluid delivery to the eye during surgery. Summary of the invention

[0007] According to a first aspect, the present invention provides a syringe for ophthalmic applications, having a gas supply tube and a liquid supply tube, the two supply tubes being interconnected at a joint in fluid communication with an outflow cannula, characterized in that a selective flow member is placed in the gas supply tube at a position close to the joint member, allowing gas to pass and preventing liquid from passing. The syringe of the present invention allows a simplified and controlled delivery of liquid and gas to a sensitive human eye during surgery. In particular, since the selective flow member only blocks the liquid, the gas can flow through the gas supply tube in both directions. This two-way gas flow provides the possibility of 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. The buffer is formed in the syringe to prevent any gas from being delivered to the eye when only liquid is to be delivered. The buffer can be generated in the syringe of the present invention in a passive manner without user intervention. In addition, 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. Therefore, the volume of the buffer is kept small enough to be removed when switching back to gas delivery. The switch between liquid and gas delivery is thus accelerated, since the volume of liquid between the selective flow member and the coupling member, which needs to act as a buffer but needs to be removed before gas delivery, can be minimized. Thus, the switch between liquid and gas flushing of the eye is accelerated. Since the gas can flow through the selective flow member, excess gas during liquid delivery can also be directly re-injected / aspirated back into the gas supply or in the direction of the gas supply, which leads to improved intraocular pressure.

[0008] In another embodiment, the selective flow member is composed of a membrane comprising polytetrafluoroethylene, PTFE, having a maximum pore size of 0.2 μm to 1.0 μm. The selective flow member made of PTFE forms a highly hydrophobic membrane that is porous enough to allow gas to pass through while preventing liquid flow by using relatively small pores. The membrane also provides bacterial retention by blocking bacteria with a size larger than the maximum pore size. Therefore, only a clean air flow will be flushed into the eye.

[0009] In another embodiment, the thickness of the PFTE membrane is 0.01 mm to 1 mm. Using a relatively thin hydrophobic material allows most of the gas to pass through. Therefore, the membrane does not affect the flow rate during gas delivery. The time of gas delivery is not affected.

[0010] In another embodiment, the selective flow member is placed in the gas supply tube near the position of the joint so that it can be filled with a maximum of 1.5 mL of liquid, preferably a maximum of 0.5 mL of liquid, and more preferably a maximum of 0.1 mL of liquid. Controlling the buffer volume to be less than 1.5 mL speeds up the removal of the liquid buffer when the gas is delivered to the eye. In this way, switching from liquid delivery mode to gas delivery mode is faster while ensuring that there is enough gas in the tube ready for delivery without the need for further supply from the external unit immediately.

[0011] In another embodiment, the selective flow member is placed in a chamber in the gas supply tube, the chamber has a first section and a second section, the second section is closest to the joint, each of the first section and the second section has an opening on its surface, the selective flow member divides the chamber into a first compartment near the first section and a second compartment near the second section, each of the first compartment and the second compartment is connected to the gas supply tube fluid through the opening, and the liquid in the second compartment is prevented from entering the first compartment. The selective flow member maintained in the chamber can contact a certain volume of liquid and gas. The chamber provides a compact design for the syringe, allowing a liquid buffer to be formed in the chamber to prevent gas delivery during liquid injection.

[0012] In another embodiment, each of the first section and the second section has a connector on its surface extending radially to an opening to accommodate a gas supply tube, and the gas supply tube is fluidly connected to the first compartment and the second compartment of the chamber through the opening. The gas supply tube can be connected to the chamber through the connector while reducing possible bending and twisting of the tube in a radial direction relative to the surface of the chamber.

[0013] In another embodiment, the first section and the second section are integral elements of the chamber.By providing a single element chamber, maximum containment may be provided for the contents of the chamber.

[0014] In another embodiment, the first section and the second section are releasably connected.The releasable connection of the chamber components allows the chamber to be opened for cleaning and / or replacement of the membrane of the selective flow member.

[0015] In another embodiment, the openings in the surface of the first section and the openings in the surface of the second section are substantially aligned along the main axis of the gas supply tube. By aligning the openings with the main direction of the gas supply tube, a more compact design of the injector is provided.

[0016] In another embodiment, the volume of the chamber is 1 mL, preferably 0.3 mL, more preferably 0.1 mL. The chamber has a small size, which provides convenient handling for a user such as a surgeon, while still providing sufficient liquid volume to prevent gas delivery during liquid injection.

[0017] In another embodiment, the chamber has a rounded shape such as a disc or a sphere. The rounded shape of the chamber provides a user-friendly smooth entity that can be held in the hand.

[0018] In another embodiment, the fluid connection between the gas supply tube and the opening comprises one or more Luer connectors.By using these additional connection elements, a fluid tight connection is provided between the tube and the interior of the chamber.

[0019] In a second aspect, the invention provides a system comprising a control unit, a gas supply and a liquid supply, each of which is connected to a gas supply tube and a liquid supply tube of a syringe according to any of the preceding claims, respectively, the control unit being adapted to: activate the gas supply to push gas upwards into the gas supply tube, through the selective flow member at a gas pressure X, and supply the gas to the outflow cannula, and switch to the liquid supply via the outflow cannula by causing liquid to flow upwards to the selective flow member at a liquid pressure higher than the gas pressure X and by supplying liquid to the outflow cannula. The system of the invention provides a controlled outflow, and intraocular pressure is improved as excess gas can be sucked back in the direction of the gas supply when the liquid is delivered. The system allows rapid switching from liquid flow to gas flow and vice versa, thanks to adequate gas pressure control during injection and aspiration.

[0020] In another embodiment, the control unit is further adapted to activate the liquid supply during the step of activating the gas supply and push the liquid upward through the liquid supply tube, thereby forming a liquid-gas joint in the liquid supply tube. Further control of the gas delivery can be provided by the system, wherein a gas buffer zone is created in the liquid supply tube by precise control of the pressure of the gas and the liquid by the control unit.

[0021] In another embodiment, the control unit is adapted to control the liquid pressure and the gas pressure in each supply tube within the range of 0 mmHg to 200 mmHg. By accurately controlling the liquid and gas pressures within a wide pressure range, any of the liquid or gas can be injected into the outflow cannula or aspirated in the direction of the ophthalmic unit by applying different pressures. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The present invention will now be discussed in more detail with reference to the accompanying drawings, in which:

[0023] Figure 1A A schematic diagram of a syringe according to the invention is shown.

[0024] Figure 1B A schematic diagram of a syringe according to the present invention is shown when delivering a liquid to an eye.

[0025] Figure 1CA schematic diagram of an injector according to the invention is shown during gas injection.

[0026] Figure 2 A perspective view of a syringe according to an embodiment of the present invention is shown.

[0027] Figure 3 Shown according to Figure 2 Exploded view of the disc-shaped chamber of a syringe of an embodiment.

[0028] Figure 4 A perspective view of a syringe according to another embodiment of the present invention is shown.

[0029] Figure 5 Shown according to Figure 4 Exploded view of the disc-shaped chamber of a syringe of an embodiment.

[0030] Figure 6 A flow chart of a system according to the present invention is shown. Specific embodiments

[0031] Figure 1AThe schematic diagram of the syringe 1,20 for ophthalmic delivery according to the present invention is shown. The syringe 1,20 includes a gas supply tube 2, a liquid supply tube 3, a joint 4, a joint 24, a selective flow member 5 and an outflow sleeve 12. The gas supply tube 2 and the liquid supply tube 3 are both used as the inlet tube of the device, respectively for delivering gases such as air and liquids such as water or cleaning solution BSS into the eye. The injected gas and liquid help to maintain adequate flushing of the eye at the level of the retina during surgery, and / or ensure postoperative protection and healing. As shown, gas and liquid are input to each of the supply tubes 2,3 of the syringe from the ophthalmic unit 50, and the tubes 2,3 are connected to the ophthalmic unit 50 by connectors 51. The connector 51 shown connects the gas and liquid supply tubes 2,3 to the ophthalmic unit 50. In other embodiments (not shown) falling within the scope of the present invention, there may be a first connector connecting the gas supply tube 2 to the ophthalmic unit 50, and a second connector connecting the liquid supply tube 3 to the ophthalmic unit 50 different from the first connector. The ophthalmic unit 50 corresponds to a workstation and may also include any one of an electronic device, a work arrangement, and supplies. It should be noted that the connector 51 may be any connector known to those skilled in the art that provides a fluid-tight connection between the syringe 1, 40 and the ophthalmic unit 50. This also applies to each of the first and second connectors alone. The coupling 4, 24 is a connecting element of the syringe 1, 20, connecting the gas supply tube 2, the liquid supply tube 3, and the outflow sleeve 12. The coupling shown in the figure is T-shaped, connecting the two inlet supply tubes 2, 3 to the outflow sleeve 12. It should be understood that other embodiments including different shapes such as Y-shaped couplings also fall within the scope of the present invention. The coupling 4, 24 is open to the passage of liquid from the liquid supply tube 3 or gas from the gas supply tube 2. The outflow sleeve 12 extends from the proximal end 11 of the coupling 4, 24, and allows the gas or liquid from the supply tube to flow out at its distal end 10. The outflow sleeve 12 has an outlet at its distal end 10, and the outlet can be placed at or near the eye to deliver gas or liquid to the eye. The selective flow member 5 is connected to the gas supply pipe 2 at a distance from the joint 4, 24. This distance corresponds to the volume V of the gas supply pipe 2. B The selective flow piece 5 can either be an integral part of the gas supply tube 2 or can be attached to the gas supply tube 2 by the user. The selective flow piece 5 serves to prevent liquid from flowing into the gas supply tube 2 in the direction of the ophthalmic unit 50. However, the selective flow piece 5 allows gas to flow through it in both directions. The selective flow piece 5 can be formed by a hydrophobic filter. The liquid can occupy a volume V of the gas supply tube 2 defined by the position of the selective flow piece 5. B This volume of buffer liquid within the gas supply tube 2 ensures that no gas enters the eye during liquid delivery. Figure 1B to Figure 1CThe selective flow member 5 during liquid delivery and gas delivery will be described in detail respectively.

[0032] Figure 1B A schematic diagram of a syringe 1, 20 according to the present invention when delivering a liquid 6 is shown. The outlet of the outflow cannula 12 at the distal end 10 has been positioned into the eye 15. The liquid 6, such as a BSS solution, is first discharged from the ophthalmic unit 50 into the liquid supply tube 3. During the liquid delivery, the pressure in the gas supply tube 2 is lower than the pressure in the liquid supply tube 3. The discharge of liquid and gas from / to the ophthalmic unit 50 and the re-injection / aspiration can be at least partially controlled by an electronic control unit (not shown) in the ophthalmic unit 50. When the liquid 6 is discharged, the liquid 6 fills the liquid supply tube 3 through the joints 4, 24 and partially enters the gas supply tube 2 through the distance between the joints 4, 24 and the selective flow member 5. In this way, a volume V is formed in the gas supply tube 2. B As described above, the selective flow element 5 prevents the liquid 6 from filling the gas supply tube 2 outside the selective flow element 5 in the direction of the ophthalmic unit 50. In this way, the volume V B The buffer zone is formed passively.

[0033] Figure 1C A schematic diagram of an injector 1, 20 according to the invention during delivery of a gas 7 is shown. The outlet of the outflow cannula 12 at the distal end 10 has been positioned into the eye 15. In this mode, the gas 7 is discharged from the ophthalmic unit 50 into the gas supply tube 2 at a pressure X. The gas 7 can flow through the selective flow member 5. In a preferred embodiment, the gas can also be optionally discharged into a portion of the gas supply tube 2, filling a volume V in the liquid supply tube 3 that is free of liquid. G Thus, a gas buffer is optionally formed in the liquid supply tube 3, preventing any liquid 6 from being delivered into the eye 15. In addition, gas can be delivered into the eye 15 through the outflow cannula 12. When switching back to Figure 1B When the supply liquid is in the ophthalmic unit 50, the gas 7 can first be sucked into the ophthalmic unit 50 when flowing through the selective flow member 5, thereby freeing up the buffer volume V B , this volume can be filled again with liquid 6.

[0034] Figure 2 A perspective view of a syringe 1 according to an embodiment of the present invention is shown. Figures 1A to 1C As shown, the syringe 1 includes a gas supply tube 2, a liquid supply tube 3, a joint 4, an outflow sleeve 12 and a selective flow member (not shown). Figure 3 The selective flow member 5 is located in the disc-shaped chamber 8 and is placed in the liquid supply pipe 2 at a certain distance from the joint 4, allowing a buffer volume V B. The disc-shaped chamber 8 shown comprises two circular parts or segments 13, 14 connected to each other. In alternative embodiments, the chamber 8 may also have a different shape, such as a rectangle or a square. Each segment 13, 14 is connected to the gas supply tube 2 on its outer surface through an opening 18, 19 on each side of the chamber 8 in the center of the disc. The openings 18, 19 may be circular. It should be noted that other embodiments with openings of any shape and not centered also fall within the scope of the present invention. The liquid-tight connection between the gas supply tube 2 and the selective flow member 5 at each opening 18, 19 may be facilitated by one or more Luer connectors 16, 17. The same applies to the tight connection between the coupling 4 and the outflow sleeve 12, which may include a Luer connector 9. It should be noted that alternative embodiments falling within the scope of the present invention may include other connectors and / or be manufactured in a manner that provides a fluid-tight connection between the two elements.

[0035] Figure 3 Shown according to Figure 2 Exploded view of the disc-shaped chamber 8 of the syringe 1 of the embodiment. Segments 13, 14 surround the selective flow member 5. The selective flow member 5 includes a membrane of selective flow material. The membrane of selective flow material divides the volume of the disc-shaped chamber 8 into a first compartment and a second compartment: a gas compartment in the direction of the ophthalmic unit 50 and a liquid buffer compartment on the side of the coupling 4. The membrane of selective flow material includes polytetrafluoroethylene PTFE, which is a highly hydrophobic or water-repellent material. The selective flow membrane including PTFE also incorporates micropores with a maximum pore size of 0.2μm to 1.0μm. The thickness of the membrane is preferably 0.01mm to 1mm. This selective flow sheet of PTFE allows a large amount of gas to flow through the sheet from the gas chamber to the liquid chamber. However, according to Figures 1A to 1C As described in , the same sheet prevents water and water-based solutions such as BSS from flowing through the sheet from the liquid chamber to the gas chamber.

[0036] Figure 4 A perspective view of a syringe 40 according to another embodiment of the present invention is shown. Figures 1A to 1C As shown, the syringe 40 includes a gas supply tube 2, a liquid supply tube 3, a joint 24, an outflow sleeve 12 and a selective flow member (not shown). Figure 5 The selective flow member 5 is located in the disc-shaped chamber 25 in the liquid supply pipe 2 and close to the joint 24, allowing the buffer volume V B. The disc-shaped chamber 25 shown includes two circular parts or segments 26, 27 connected to each other. In other embodiments, the chamber may also have different shapes, such as a rectangle or square with corresponding segments. Each segment 26, 27 includes a connector 28, 29 extending radially on its surface to accommodate the gas and liquid supply tubes 2, 3 respectively. The connector 29 also includes a portion of the gas tube 2 connected to the liquid supply tube 3 at a joint 24 (not shown) inside the connector 29. In the connectors 28, 29 that hold it, the gas supply tube 2 is connected to the central openings 32, 33 on each segment of the chamber respectively. The selective flow member 5 can also be connected to the fluid of the outflow sleeve 12 through an additional joint 30. The joint between the joint 24 and the outflow sleeve 12 can also include a Luer connector 31. It should be noted that alternative embodiments falling within the scope of the present invention may include other connectors and / or be manufactured in a manner that provides a fluid-tight connection between the two elements.

[0037] Figure 5 Shown according to Figure 4 Exploded view of the disc-shaped chamber 25 of the syringe 40 of the embodiment. The device is shown from a new angle that allows a better view of the selective flow member 5. The segments 26, 27 surround the selective flow member 5. The selective flow member 5 is formed by a membrane of selective flow material. The membrane of selective flow material divides the volume of the disc-shaped chamber 25 into a gas compartment near the segment 26 and a liquid buffer compartment near the segment 27 in the direction of the flow out of the cannula 12. Figure 5 As shown, the openings 32, 33 on the chamber segments are circular, but may also have different shapes. The openings may also be located at other locations in the chamber sections, offset from the center of the chamber 25. The fluid-tight connection between the gas supply tube 2 and the disc-shaped chamber 25 at each opening 32, 33 may be facilitated by one or more Luer connectors within the connector (not shown). It should be noted that alternative embodiments falling within the scope of the present invention may include other connectors and / or be manufactured in a manner that provides a fluid-tight connection between the two elements. The sheet of selective flow material includes PTFE, which is a highly hydrophobic or waterproof material. The maximum pore size of the selective flow sheet including PFTE is 0.2μm to 1.0μm. The thickness of the membrane is preferably 0.01mm to 1mm. This selective flow sheet of PTFE allows a large amount of gas to flow through the sheet from the gas chamber to the liquid chamber. However, according to Figures 1A to 1C As described in , the same sheet prevents water and water-based solutions such as BSS from flowing through the sheet from the liquid chamber to the gas chamber.

[0038] Figure 6A schematic illustration of a system 100 according to the present invention is shown. The system comprises a control unit 110, a liquid supply 120 and a gas supply 130. The control unit 110 may assist and / or fully control the discharge of each of the liquid supply 120 and the gas supply 130 to the liquid and gas supply tubes of the syringe devices 1, 40, respectively, and the refilling of the liquid and gas supply tubes from the syringe devices 1, 40 in operation. The control unit 110 and at least one of the liquid and gas supplies 120, 130 may be part of the ophthalmic unit 50, preferably all of them are part of the ophthalmic unit 50. In other embodiments, the ophthalmic unit comprises at least one of the liquid supply, the gas supply or the control unit, while the other elements are separate entities. The control unit 110 controls the liquid supply and the gas supply which are fluidically connected to the syringe devices 1, 40 through valves (not shown) near the liquid and gas supplies 120, 130, which are shown in FIG. 1, Figure 2 or Figure 4 One of. These valves provide control of the system in conjunction with the pressure provided by the supply. The control unit can control the delivery of gas to the syringe device at a pressure X. The control unit can also be used to aspirate the liquid and / or gas in the corresponding supply tubes of the syringes back into their respective supplies by applying liquid pressure when switching from one mode to another (liquid-gas and vice versa). The pressure in the supply tubes is generally no more than 200 mmHg, preferably no more than 160 mmHg. The selective flow member 5 of the syringe 1, 40 ensures that no liquid can be aspirated upwards into the gas tube and gas supply of the ophthalmic unit.

Claims

1. A syringe (1, 40) for ophthalmic applications, comprising a gas supply tube (2) and a liquid supply tube (3), the gas supply tube (2) and the liquid supply tube (3) being connected to each other at a joint (4, 24) in fluid communication with an outflow cannula (12), It is characterized in that A selective flow member (5) is placed in the gas supply pipe (2) at a position close to the joint (4, 24) to allow gas to pass through and prevent liquid from passing through.

2. The syringe (1, 40) according to claim 1, wherein the selective flow element (5) consists of a membrane comprising polytetrafluoroethylene (PTFE), and the maximum pore size of the membrane is 0.2 μm to 1.0 μm.

3. The syringe (1, 40) according to claim 2, wherein the thickness of the film is 0.01 mm to 1 mm.

4. According to the syringe (1, 40) described in any one of the preceding claims, the selective flow member (5) is placed in the gas supply tube (2) at a position close to the coupling member (4, 24), so that a maximum of 1.5 mL of liquid can be filled, preferably a maximum of 0.5 mL of liquid can be filled, and more preferably a maximum of 0.1 mL of liquid can be filled.

5. The syringe (1, 40) according to any one of the preceding claims, wherein the selective flow member (5) is placed in a chamber (8, 25) in a gas supply tube (2), the chamber (8, 25) having a first section (13, 26) and a second section (14, 27), the second section (14, 27) being closest to the coupling member (4, 27), each of the first section (13, 26) and the second section (14, 27) having an opening (18, 19, 32, 33) on its surface, the selective flow member (5) dividing the chamber (8, 25) into a first compartment close to the first section (13, 26) and a second compartment close to the second section (14, 27), each of the first compartment and the second compartment being fluidically connected to the gas supply tube (2) via the opening (18, 19, 32, 33), and the liquid in the second compartment being prevented from entering the first compartment.

6. The syringe (1, 40) according to claim 5, each of the first section (26) and the second section (27) has a connector (28, 29) on its surface that radially extends to the opening (32, 33) to accommodate the gas supply tube (2), and the gas supply tube (2) is fluidically connected to the first compartment and the second compartment of the chamber (25) through the opening (32, 33).

7. The syringe (1, 40) according to any one of claims 5 or 6, the first section (13, 26) and the second section (14, 27) being an integral element of the chamber (8, 25).

8. The syringe (1, 40) according to any one of claims 5 or 6, wherein the first section (13, 26) and the second section (14, 27) are detachably connected.

9. The syringe (1, 40) according to any one of claims 5 to 7, wherein the openings (18, 32) in the surface of the first section (13, 26) and the openings (19, 33) in the surface of the second section (14, 27) are substantially aligned along the main axis of the gas supply tube (2).

10. The syringe (1, 40) according to any one of claims 5 to 9, wherein the volume of the chamber (8, 25) is 1 mL, preferably 0.3 mL, more preferably 0.1 mL.

11. The syringe (1, 40) according to any one of claims 5 to 10, the chamber (8, 25) having a circular shape, such as a disc or a sphere.

12. The syringe (1, 40) according to any one of claims 5 to 11, the fluid connection between the gas supply tube (2) and the opening (18, 19, 32, 33) comprising one or more Luer connectors (16, 17).

13. A system (100) comprising a control unit (110), a gas supply (120) and a liquid supply (130), each of the gas supply (120) and the liquid supply (130) being connected to a gas supply tube (2) and a liquid supply tube (3), respectively, of a syringe (1, 40) according to any of the preceding claims, the control unit (110) being adapted to: - activating the gas supply (120) to push gas upwards into the gas supply tube (2), through the selective flow member (5) at a gas pressure X, and supplying gas to the outflow sleeve (12), and - Switching to liquid supply (130) via the outflow cannula (12) by causing liquid to flow upwards towards the selective flow member (5) at a liquid pressure higher than the gas pressure X and by supplying liquid to the outflow cannula (12).

14. According to the system (100) according to claim 9, the control unit is also suitable for: in the step of activating the gas supply (120), activating the liquid supply (130) and pushing the liquid upward through the liquid supply pipe (3), thereby forming a liquid-gas joint in the liquid supply pipe (3).

15. The system (100) according to any one of the preceding claims, the control unit being adapted to control the liquid pressure and the gas pressure in each supply pipe (2, 3) within the range of 0 mmHg to 200 mmHg.

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