Intravitreous administration device and needleless syringe

Abstract

An intravitreal drug delivery tool (50) for positioning a needleless syringe for injecting a substance to be injected into the vitreous body of an eyeball without passing through an injection needle, the intravitreal drug delivery tool (50) being provided with: a guide (54) at least a part of which is formed in a shape corresponding to the outer edge of the cornea in the eyeball; and a positioning part (51) that is connected to the guide (54) and the needleless syringe, and that positions the needleless syringe when the guide (54) is disposed so as to be aligned with the outer edge of the cornea. The positioning unit (51) positions an injection port (77) from which the injection target substance is injected in the needleless injector at a position separated from the outer edge of the cornea toward the rear of the eyeball by a predetermined distance.

Description

Technical Field

[0001] This invention relates to intravitreal drug delivery devices and needle-free injectors. Background Technology

[0002] Intravitreal injections are used to treat age-related macular degeneration, retinal vein occlusion, and diabetic macular edema. During intravitreal injections, if the injection site is too close to the cornea, it may damage the cornea and lens; if the injection site is too far from the cornea and too far back in the eye, it may damage the retina. Therefore, guidelines exist that the injection needle should be inserted 3.5–4.0 mm posterior to the limbus.

[0003] Patent document 1 discloses a fixation device for intravitreal injection, which includes: an injection needle fixing plate having an injection needle insertion hole; and an eyeball fixator having a ring with a rough eyeball contact surface and for fixing the position of the injection needle insertion hole on the eyeball.

[0004] Existing technical documents

[0005] Patent documents

[0006] Patent Document 1: International Publication No. 2007 / 052730 Summary of the Invention

[0007] The problem that the invention aims to solve

[0008] The fixation device for intravitreal injection in Patent Document 1 is configured to determine the injection position by inserting an injection needle into an injection needle insertion hole, and therefore cannot be applied to needle-free injectors. Furthermore, with the fixation device for intravitreal injection in Patent Document 1, the operator performs the following procedure: holding the fixation device with one hand, aligning the ring with the limbus, holding the syringe with the other hand, inserting the injection needle through the injection needle insertion hole into the eyeball, and pressing the plunger to inject the medication. Therefore, the operator uses both hands for each operation, requiring careful attention to the movement of each hand, thus making accurate intravitreal injection difficult even when using the fixation device.

[0009] The technology disclosed herein was made in view of the above-mentioned actual situation, and its purpose is to provide a technique that facilitates intravitreal injection.

[0010] Solution for solving the problem

[0011] To address the aforementioned problems, the intravitreal drug delivery device of this disclosure is used for positioning a needleless injector, which injects the target substance into the vitreous body of the eyeball without using an injection needle. The intravitreal drug delivery device comprises:

[0012] The guide, at least a portion of which is formed in a shape corresponding to the outer edge of the cornea in the eyeball; and

[0013] A positioning unit, connected to the guide and the needleless injector, positions the outlet of the needleless injector from which the injected target substance is ejected at a predetermined distance from the outer edge of the cornea toward the posterior end of the eyeball when the guide is aligned with the outer edge of the cornea.

[0014] In the aforementioned intravitreal drug delivery device, it may also be,

[0015] The needle-free injector includes a receiving portion having a receiving space for accommodating the injected target substance, and an injection port for ejecting the injected target substance into the target area.

[0016] The positioning part is fitted into the receiving part of the needleless injector.

[0017] In the aforementioned intravitreal drug delivery device, it may also be,

[0018] The needle-free injector comprises: a receiving portion having a receiving space for receiving the injected target substance and an ejection port for ejecting the injected target substance into the target area; and a holding portion for holding the receiving portion.

[0019] The positioning part is fitted to the holding part of the needleless injector.

[0020] In the aforementioned intravitreal drug delivery device, it may also be,

[0021] The guide is formed in a curved shape along the outer edge of the cornea.

[0022] Alternatively, when the guide is positioned along the outer edge of the cornea, the positioning part may position the outlet of the needleless injector at a position 3.5 mm to 4.0 mm away from the outer edge of the cornea.

[0023] In the aforementioned intravitreal drug delivery device, it may also be,

[0024] The guide is formed as a straight line tangent to a portion of the outer edge of the cornea.

[0025] Alternatively, if the straight portion of the guide is configured to be tangent to the outer edge of the cornea, the positioning portion may position the outlet of the needleless injector at a position 3.5 mm to 4.0 mm away from the outer edge of the cornea.

[0026] In the aforementioned intravitreal drug delivery device, it may also be,

[0027] The positioning part has a concave-convex portion on the surface opposite the eyeball when the guide is positioned along the outer edge of the cornea.

[0028] In the aforementioned intravitreal drug delivery device, it may also be,

[0029] When the guide is disposed along the outer edge of the cornea, the surface opposite the eyeball has a concave-convex portion that inhibits misalignment.

[0030] To address the aforementioned problems, the needleless injector of this disclosure injects the target substance into the vitreous humor of the eyeball without the use of an injection needle. The needleless injector comprises:

[0031] The receiving part has a receiving space for receiving the injected target substance and an ejection port for ejecting the injected target substance into the eyeball;

[0032] The driving unit provides ejection energy for ejecting the injected target substance; and

[0033] The intravitreal drug delivery device determines the injection position of the needle-free injector relative to the eyeball.

[0034] The intravitreal drug delivery device comprises:

[0035] The guide, at least a portion of which is formed in a shape corresponding to the outer edge of the cornea in the eyeball; and

[0036] The positioning unit, connected to the guide and the needleless injector, positions the injection outlet at a predetermined distance from the outer edge of the cornea toward the posterior end of the eyeball when the guide is aligned with the outer edge of the cornea.

[0037] In the needle-free injector, it could also be,

[0038] The positioning part of the intravitreal drug delivery device is assembled into the receiving part.

[0039] In the needle-free injector, it could also be,

[0040] The needle-free injector also includes a retaining part for holding the receiving portion.

[0041] The positioning part of the intravitreal drug delivery device is assembled to the holding part.

[0042] In the needle-free injector, it could also be,

[0043] The guide is formed in a curved shape along the outer edge of the cornea.

[0044] Alternatively, when the guide is positioned along the outer edge of the cornea, the positioning part may position the outlet of the needleless injector at a position 3.5 mm to 4.0 mm away from the outer edge of the cornea.

[0045] In the needle-free injector, it could also be,

[0046] The guide is formed in a straight line tangent to a portion of the outer edge of the cornea. Alternatively, if the straight portion of the guide is configured to run along a tangent to the outer edge of the cornea, the positioning portion may position the outlet of the needleless injector at a position 3.5 mm to 4.0 mm away from the outer edge of the cornea.

[0047] In the needle-free injector, it could also be,

[0048] The positioning part has a concave-convex portion on the surface opposite the eyeball when the guide is arranged along the outer edge of the cornea.

[0049] In the needle-free injector, it could also be,

[0050] When the guide is disposed along the outer edge of the cornea, the surface opposite the eyeball has a concave-convex portion that inhibits misalignment.

[0051] Invention Effects

[0052] According to this disclosure, a technique that facilitates intravitreal injection can be provided. Attached Figure Description

[0053] Figure 1 This is a schematic diagram showing the appearance of a syringe.

[0054] Figure 2 This is a first sectional view of the syringe; its section will be described later. Figure 4 AA section in the middle.

[0055] Figure 3 This is a second sectional view of the syringe, the section of which will be described later. Figure 4 The BB section is orthogonal to the AA section.

[0056] Figure 4 This is a diagram showing the structure of the housing that makes up syringe 1.

[0057] Figure 5 This is a diagram showing the general structure of the syringe components.

[0058] Figure 6 It is a cross-sectional view showing the approximate structure of the container.

[0059] Figure 7 It is a diagram showing the approximate structure of the container.

[0060] Figure 8 This is a diagram showing the general structure of an intravitreal drug delivery device, viewed from a direction orthogonal to the direction of syringe ejection (side view).

[0061] Figure 9 yes Figure 8 A sectional view.

[0062] Figure 10 This is a diagram showing the intravitreal drug delivery device viewed from the top side.

[0063] Figure 11 This is a diagram showing an intravitreal drug delivery device viewed from the basal side.

[0064] Figure 12 It is a three-dimensional diagram showing the general structure of an intravitreal drug delivery device.

[0065] Figure 13A This diagram shows the configuration of the guide in a way that makes the distance between the guide site and the outer edge of the cornea equal.

[0066] Figure 13B This diagram shows the configuration of the guide in a way that aligns the portion of the guide closest to the positioning part with the outer edge of the cornea.

[0067] Figure 14 This is a schematic diagram illustrating the injection position when the guide is positioned aligned with the outer edge of the cornea.

[0068] Figure 15 This is a diagram showing the schematic configuration of the intravitreal drug delivery device and container according to the second embodiment.

[0069] Figure 16 This is a diagram showing the schematic configuration of the intravitreal drug delivery device and container according to the third embodiment.

[0070] Figure 17 This is a diagram used to illustrate the positional relationship between the container and the container holder in the third embodiment.

[0071] Figure 18 This is a cross-sectional view showing the schematic configuration of the intravitreal drug delivery device and container according to the fourth embodiment.

[0072] Figure 19 This is a diagram showing the intravitreal drug delivery device of the fourth embodiment as viewed from the top side.

[0073] Figure 20 This is a diagram showing the general configuration of the intravitreal drug delivery device according to the fifth embodiment.

[0074] Figure 21 This is a schematic diagram illustrating the injection position when an intravitreal drug delivery device is positioned aligned with the outer edge of the cornea.

[0075] Figure 22 This indicates that the circumferential length of the guide is formed to be greater than... Figure 20 The example is a shorter variation of the diagram.

[0076] Figure 23 This is a diagram showing an example of a guide with a straight guide section.

[0077] Figure 24 It means Figure 23 A diagram illustrating an example where the guiding part is aligned with the outer edge of the cornea.

[0078] Figure 25 This is a diagram showing an example of a circular guide portion aligned with the outer edge of the cornea.

[0079] Figure 26 This is a diagram showing an example of a guide 54F with a length measuring starting point set outside the tangent point between the guiding site and the outer edge of the cornea.

[0080] Figure 27 This is a diagram illustrating an example of a curved guide portion that protrudes towards the cornea.

[0081] Figure 28 This diagram shows an example of a circular guide portion configured to surround the injection site.

[0082] Figure 29 This is a diagram showing an example of a guide section that combines straight lines and curves. Detailed Implementation

[0083] <First Implementation>

[0084] Hereinafter, with reference to the accompanying drawings, the needleless injector (hereinafter referred to as "injector") 1 of the embodiment disclosed in this application will be described. The injector 1 is a needleless injector that uses the combustion energy of gunpowder to eject an ejaculate liquid equivalent to the injection target substance of this application into the eyeball (target area). That is, it is a device that injects by ejecting an ejaculate liquid into the target area without using an injection needle.

[0085] It should be noted that the various components and combinations thereof in each embodiment are merely examples, and appropriate additions, omissions, substitutions, and other modifications to the components can be made without departing from the spirit of this application. This application is not limited to the embodiments, but only to the claims. In this embodiment, "top side" and "base side" are used as terms in the syringe 1 to indicate their relative positional relationship in the longitudinal direction. The "top side" refers to the position near the top of the syringe 1 (described later), i.e., near the injection port 77, and the "base side" refers to the direction of the syringe 1 in the longitudinal direction opposite to the "top side," i.e., the syringe assembly 10 (refer to the following description). Figure 5 The direction of the igniter 22 side in the ).

[0086] <Composition of Syringe 1>

[0087] Here, Figure 1 This is a schematic diagram showing the appearance of syringe 1. Figure 2 This is a first sectional view of syringe 1, the section of which will be described later. Figure 4 Section AA in the image. Furthermore... Figure 3 This is a second sectional view of syringe 1, the section of which will be described later. Figure 4 The BB section is orthogonal to the AA section. Figure 4 This is a diagram showing the structure of the housing 2 that makes up the syringe 1. Figure 5 This is a diagram showing the schematic configuration of the syringe assembly 10. The syringe 1 is formed by assembling the syringe assembly 10 into the housing 2. Furthermore, a power cable 3 for supplying driving current to the igniter 22 within the syringe assembly 10 is connected to the housing 2. Figure 1 ).

[0088] It should be noted that, in the subsequent description of this application, the extruded liquid injected into the target area using syringe 1 is formed by containing a specified substance in a liquid medium that performs the desired effect or function of the target area. In this extruded liquid, the specified substance may be dissolved in the liquid medium, or it may be mixed but not dissolved.

[0089] Examples of substances included in the ejaculate include biologically derived substances that can be ejected onto the target area of ​​a living organism, and substances that exhibit the desired physiological activity. Examples of biologically derived substances include DNA, RNA, nucleic acids, antibodies, and cells. Examples of substances exhibiting physiological activity include drugs composed of low molecular weight molecules, proteins, peptides, etc., vaccines, inorganic substances such as metal particles used in thermotherapy and radiotherapy, and substances containing carriers with various pharmacological / therapeutic effects. Furthermore, the liquid serving as the medium for the ejaculate can be any substance suitable for delivering these specified substances into the target area, regardless of its aqueous or oily nature. Moreover, the viscosity of the liquid serving as the medium is not particularly limited, as long as the specified substances can be ejected through syringe 1.

[0090] In syringe 1, syringe assembly 10 is configured to be removable from and detachable from housing 2. During the preparation phase before syringe 1 is operational, fluid is introduced into the receiving space 75 (see reference 2) formed between the container (receiving portion) 70 and the plunger 80 included in syringe assembly 10. Figure 5 The syringe assembly 10 is a unit that is replaced each time an ejaculate is dispensed. Details about the syringe assembly 10 will be described later.

[0091] On the other hand, the housing 2 has a handle 2a for the user to grip and use the syringe 1, and is provided with multiple switches for operating the syringe 1 to eject the ejaculate fluid. It should be noted that the syringe 1 is configured so that the user can grip and operate it with one hand. Here, based on... Figure 4 The casing 2 will be described. Figure 4 middle, Figure 4 (a) indicates the appearance of housing 2 as viewed from the front. Figure 4 (b) shows the appearance of housing 2 as viewed from the side. Figure 4 (c) indicates the appearance of housing 2 as viewed from the rear. Figure 4 (d) indicates the appearance of housing 2 as viewed from above. Here, "front" refers to the part located at the farthest point from the user when the user grips housing 2. Figure 4 In (b), the part located on the left side, and "behind" refers to the part located closer to the user, in contrast. Figure 4 In (b), it is located on the right side. Therefore, when the user holds the housing 2 with one hand, their fingertips are hooked in front of the housing 2, which is the distal side, and their wrist is close to the rear of the housing 2, which is the proximal side. In addition, "above" refers to the part on the base side of the syringe 1.

[0092] Considering the user's grip, a handle portion 2a is provided at the front of the housing 2 to facilitate hooking by the user's fingertips. Multiple indentations are formed in the handle portion 2a to improve the hooking experience for the user's fingertips. Furthermore, to further stabilize the user's grip on the housing, the front side of the handle portion 2a has a gently sloping contour with raised and recessed areas (see reference). Figure 4 (b) makes it easy for the user's index and middle fingers to hook.

[0093] Furthermore, the housing 2 is equipped with two operating switches for operating the syringe 1: a first switch 5 and a second switch 6. The first switch 5 and the second switch 6 are connected to a control unit (not shown) such as a microcomputer. This control unit controls the supply of ignition current to the igniter 22 based on signals from each switch, thereby controlling the operation of the syringe 1. Here, the first switch 5 is a sliding switch located at the rear of the housing 2, and its sliding direction is the vertical direction of the housing 2 (the direction connecting the top and bottom ends). The first switch 5 is always subjected to upward force. By continuously sliding the first switch 5 downward (towards the top end) against its applied force for a certain period of time, the user can bring the syringe 1 to a standby state. This standby state refers to the state in which preparation for ejecting the ejaculate liquid is completed in the syringe 1, and it is also the state in which ejection will be performed if the user performs additional operations.

[0094] Next, the second switch 6 is a push-button switch located on the inclined surface 2b above the housing 2, which the user can press inwards towards the housing 2. When the syringe 1 is in a standby state due to the operation of the first switch 5, pressing the second switch 6 configures the control unit to supply ignition current to the igniter 22. Furthermore, a connector 4 for connecting the power cable 3 is provided in front of the inclined surface 2b above the housing 2. In this embodiment, the connector 4 is a USB (Universal Serial Bus) connector, and the power cable 3 is designed to be detachable from the housing 2.

[0095] It should be noted that, as described above, in this embodiment, power for operating the igniter 22 is supplied from the outside via the power cable 3. However, alternatively, a battery for supplying this power can be installed inside the housing 2. In this case, as long as there is remaining power in the battery, the housing 2 can be reused repeatedly while replacing the syringe assembly 10. Furthermore, when the battery runs out of power, it can simply be replaced.

[0096] Here, Figure 5 The schematic configuration of syringe assembly 10 is shown in the figure. (As shown) Figure 2 and Figure 3As shown, the syringe assembly 10 forms the syringe 1 by being assembled into the housing 2. Specifically, the syringe assembly 10 is an assembly including an actuator (drive unit) 20, an accessory 30, an intravitreal drug delivery device 50, a container 70, and a plunger 80. The assembly of the syringe assembly 10 will be described later.

[0097] Regarding the actuator 20, its main body 21 is formed in a cylindrical shape. The main body 21 has a central portion 21a at its center, a top portion 21b at its top end, and a base portion 21c at its base end. The internal spaces of the top portion 21b, the central portion 21a, and the base portion 21c are interconnected in the main body 21, and an opening 27 is provided at the top end of the top portion 21b. Here, an igniter 22 is mounted at the base portion 21c of the main body 21. This igniter 22 is an electric igniter that causes the initiating explosive to burn and generate ejection energy. The igniter 22 has an ignition lead 22b that is supplied with ignition current from the outside. This ignition lead 22b is connected to a socket 7 on the housing 2 side when the syringe assembly 10 is assembled with the housing 2. Furthermore, the assembly state of the igniter 22 relative to the main body 21 is determined such that the combustion products generated by the operation of the igniter 22 are released toward the central portion 21a of the main body 21. That is, the igniter 22 is mounted on the base end 21c of the main body 21 in such a way that the combustion product release surface 22c faces the central part 21a.

[0098] Here, the combustion energy of the initiating explosive used in the igniter 22 becomes the energy required to propel the injector 1 to the target area. It should be noted that the following explosives, or combinations thereof, are preferably used as the initiating explosive: zirconium and potassium perchlorate explosives (ZPP), titanium hydride and potassium perchlorate explosives (THPP), titanium and potassium perchlorate explosives (TiPP), aluminum and potassium perchlorate explosives (APP), aluminum and bismuth oxide explosives (ABO), aluminum and molybdenum oxide explosives (AMO), aluminum and copper oxide explosives (ACO), and aluminum and iron oxide explosives (AFO). These explosives generate high-temperature, high-pressure plasma upon immediate combustion after ignition, but if the combustion products condense at room temperature, they contain no gaseous components, thus exhibiting a characteristic of a rapid pressure drop. It should be noted that explosives other than these can also be used as the initiating explosive, provided that a suitable injectable liquid can be ejected.

[0099] The main body 21 is a cylindrical component, and the internal space of the central portion 21a is configured as a combustion chamber 20a. Furthermore, an external thread 26 is formed on a portion of the outer surface of the central portion 21a. The external thread 26 is configured to engage with the internal thread 32 of the accessory 30 (described later), and the effective lengths of the external thread 26 and the internal thread 32 are determined to ensure the required engagement force between them. Additionally, the internal space of the top portion 21b adjacent to the central portion 21a is formed in a cylindrical shape and is configured to allow the piston 40 to slide within this internal space.

[0100] Furthermore, when the igniter 22 is activated, combustion products are released into the combustion chamber 20a, and as the pressure in the combustion chamber 20a rises, the piston 40 slides towards its tip under this pressure. That is, the actuator 20 has a mechanism that uses the igniter 22 as the working source and the piston 40 as the output.

[0101] like Figure 5 As shown, Annex 30 is a component used for assembling the actuator 20, plunger 80, and container 70. The body 31 of Annex 30 can be made of resins such as known nylon 6-12, polyarylate, polybutylene terephthalate, polyphenylene sulfide, or liquid crystal polymers. Furthermore, these resins may contain fillers such as glass fibers or glass fillers; polybutylene terephthalate may contain 20% to 80% by mass of glass fibers; polyphenylene sulfide may contain 20% to 80% by mass of glass fibers; and liquid crystal polymers may contain 20% to 80% by mass of minerals. It should be noted that the material of Annex 30 is not limited to resin; it can also be metal or ceramic.

[0102] like Figure 5 As shown, the actuator 20 is disposed in the internal space of the main body 31 from the base end side to the center. Furthermore, the base end portion 21c of the actuator 20 is approximately located in the base end side region of the internal space where the actuator 20 is disposed, and the central portion 21a and the top portion 21b of the actuator 20 are approximately located in the top end side region with a diameter smaller than that of the base end side. In addition, an internal thread portion 32 is disposed on the inner wall surface of the main body 31, and the internal thread portion 32 is formed to engage with the external thread portion 26 provided in the central portion 21a of the actuator 20.

[0103] Moreover, such as Figure 5 As shown, the plunger 80 is disposed approximately in the internal space of the main body 31 in a region closer to the top than the region where the actuator 20 is disposed. The diameter of the region where the plunger 80 is disposed is smaller than the diameter of the region where the top portion 21b of the actuator 20 is disposed, and is a diameter that allows the plunger 80 to slide.

[0104] Furthermore, a portion of the container 70 is disposed approximately in the top-side region of the interior space of the main body 31. This region where the container 70 is disposed communicates with the region where the plunger 80 is disposed on its base end side, and its top side opens at the top surface of the attachment 30. An internal thread 36 for assembling the container 70 is formed on the inner wall of the region where the container 70 is disposed. The internal thread 36 is related to the following... Figure 6 , Figure 7 The external thread 74 of the container 70 shown is screwed in, thereby connecting the accessory 30 to the container 70.

[0105] Next, the plunger 80 will be described. The plunger 80 is a component that pressurizes the ejected fluid using energy received from the piston 40, and has a plunger rod 81 and a stop portion 82. The plunger rod 81 is formed, for example, of a resin material suitable for its pressurization, but is not limited thereto; for example, it may also be formed of the same material as that used in the attachment 30.

[0106] A stop portion 82, formed of an elastic component such as rubber, is fitted to the top end of the plunger rod 81. It should be noted that the specific material of the stop portion 82 can be, for example, butyl rubber or silicone rubber. Further examples include styrene-based elastomers, hydrogenated styrene-based elastomers, polyolefins mixed with polyethylene, polypropylene, polybutene, α-olefin copolymers, liquid paraffin, process oils, talc, casting powder, mica, and other powdered inorganic materials. Furthermore, various rubber materials (especially vulcanized rubber materials) such as polyvinyl chloride elastomers, olefin elastomers, polyester elastomers, polyamide elastomers, polyurethane elastomers, natural rubber, isoprene rubber, chloroprene rubber, nitrile rubber, and styrene-butadiene rubber, as well as mixtures thereof, can also be used as the material of the stop portion 82. Furthermore, the stop portion 82 slides within the container 70 while pressurizing the ejected liquid. Therefore, to ensure and adjust the sliding properties between the stop portion 82 and the inner wall surface 75a of the container 70's containing space 75, various substances can be used to coat or surface-process the surface of the stop portion 82 and the inner wall surface 75a of the container 70. As such coating agents, PTFE (polytetrafluoroethylene), silicone oil, diamond-like carbon, nanodiamonds, etc., can be used.

[0107] Figure 6 This is a cross-sectional view showing the approximate structure of container 70. Figure 7 This is an external view showing the general configuration of container 70. Container 70 is a component that contains the ejaculate liquid and defines the flow path for ejecting the ejaculate liquid, pressurized by plunger 80, to the target area. Container 70 is formed of a material that takes into account the pressurization of the plunger and the definition of the flow path. In this embodiment, container 70 is formed of resin material. It should be noted that container 70 is not limited to resin material, and may also be formed of, for example, the same material as that in Annex 30.

[0108] The container 70 has a space for containing the ejaculate liquid and is formed into a receiving space 75 for advancing the stop portion 82 of the plunger 80. It also has a flow path 76 connecting the receiving space 75 to an outlet 77 facing the outside of the container 70. Specifically, the container 70 has a body 70a that defines the receiving space 75 and has a cylindrical shape; and a nozzle portion 70c connected to the top end of the body 70a, defining the flow path 76. Furthermore, the nozzle portion 70c is configured to have a top end 70c2 and a tapered portion 70c1. The top end 70c2 internally includes a portion of the flow path 76 on the outlet 77 side. The tapered portion 70c1 connects the top end 70c2 to the body 70a and includes a top end outer surface 70c3 inclined relative to the central axis in the longitudinal direction of the attachment 30. A vitreous intradermal drug delivery device 50, described later, is embedded around the outer periphery of the top end 70c2.

[0109] In syringe assembly 10, such as Figure 5 As shown, the tip of the plunger 80 is embedded into the receiving space 75 of the container 70 in such a way that the stop 82 of the plunger 80 can slide in the receiving space 75 toward the nozzle 70c (tip side direction). With the plunger 80 embedded in the container 70 in this state, the space between the stop 82 of the plunger 80 and the container 70 becomes a storage space for the eluent, i.e., a space for sealing the eluent. In other words, when the plunger 80 is initially embedded in the receiving space 75 of the container 70, the tip surface of the stop 82 and the inner wall surface of the container 70, located closer to the tip surface of the stop 82, define the storage space. The flow path of the container 70 opens at the tip surface 73 of the nozzle 70c, forming an injection port 77. Therefore, when the plunger 80 slides within the receiving space 75, thereby pressurizing the eluent contained in the receiving space 75, the eluent is ejected from the injection port 77 through the flow path 76.

[0110] Furthermore, the inner diameter of the flow path 76 in the container 70 is made smaller than the inner diameter of the receiving space 75. With this configuration, the pressurized liquid is ejected from the ejection port 77 to the outside. Additionally, an external thread 74 for assembling the container 70 to the accessory 30 is formed on the outer periphery of the base end side. The external thread 74 engages with the internal thread 36 of the accessory 30.

[0111] The top end shape of the stop portion 82 in the plunger 80 is formed to approximately match the top end shape of the receiving space 75, which is defined by the inner wall surface 75a near the portion where the receiving space 75 connects to the flow path 76 (the innermost part of the receiving space 75). In this embodiment, both the top end shape of the stop portion 82 and the top end shape of the receiving space 75 are tapered shapes that narrow towards the top. Therefore, when the ejaculate is ejected, the gap between the stop portion 82 and the inner wall surface 75a of the container 70 is minimized as much as possible when the plunger 80 slides and reaches the innermost part of the receiving space 75, thus preventing ejaculate from remaining in the receiving space 75 and causing waste. However, the shape of the stop portion 82 is not limited to any particular shape, as long as the desired effect is achieved in the syringe 1 of this embodiment. Furthermore, the stop portion 82 is formed with an outer diameter slightly larger than the receiving space 75 of the container 70, so that when it is embedded in the receiving space 75 in a radially compressed state, it makes proper contact with the inner wall surface 75a in a manner that maintains an airtight seal with the container 70. It should be noted that, as long as a suitable ejaculate liquid can be ejected, the outer diameter of the stop portion 82 can also be approximately the same as the diameter of the receiving space 75, and is not formed to be larger than the diameter of the receiving space 75.

[0112] <Assembly of Syringe 1>

[0113] In assembling the syringe 1, the assembly of the syringe assembly 10 will be described first. With the stop 82 of the plunger 80 inserted into the innermost part of the receiving space 75 of the container 70, the outlet 77 of the container 70 is connected to the ejaculate fluid, and the plunger 80 is pulled back. The stop 82 is in close contact with the inner wall surface 75a of the receiving space 75, so a negative pressure is generated in the receiving space by its pull-back action, thereby filling the receiving space 75 with ejaculate fluid from the outlet 77. The pull-back amount of the plunger 80 at this time is set to such a level that when the container 70 is assembled with the accessory 30 in this state, the plunger 80 (plunger rod 81) exposed from the container 70 reaches the area for the piston 40 to be positioned in the internal space of the accessory 30.

[0114] When the container 70, with the receiving space 75 filled with the ejaculate liquid, is assembled to the attachment 30, the actuator 20 is further inserted into the attachment 30 from the base end side. The actuator 20 is inserted until the top surface of the piston 40, located at its top end 21b, reaches the base end surface of the plunger 80 within the attachment 30. At this point, the actuator 20 and attachment 30 are properly engaged by screwing the external thread 26 of the actuator 20's central portion 21a with the internal thread 32 of the attachment 30. The piston 40 assembled to the actuator 20 is then connected to the plunger 80. It should be noted that the connection between the piston 40 and the plunger 80 is not limited to simple contact; a fitting portion can also be provided at the top end of the piston 40 and the base end of the plunger 80 for engagement.

[0115] When the actuator 20 is assembled to the accessory 30, which is equipped with the container 70 and the plunger 80, as described above, the plunger 80 is pressed in such a way that it advances from the piston 40 toward the tip side, and within the container 70, the plunger 80 is positioned in a predetermined position (pre-operation position). At this time, in response to the pressing in of the plunger 80, excess ejaculate fluid in the container 70 is discharged from the ejection port 77, leaving a predetermined amount of ejaculate fluid in the container 70. It should be noted that the volume of the space for containing ejaculate fluid formed between the plunger 80, which is positioned in the pre-operation position, and the container 70 is determined to be the volume that ensures an appropriate amount of ejaculate fluid when the syringe 1 is operating. Therefore, when the syringe assembly 10 is assembled as described above, the amount of ejaculate fluid contained in the receiving space 75 of the container 70, i.e., the amount of ejaculate fluid to be ejected, is determined to be a predetermined amount.

[0116] The ignition lead 22b of the igniter 22 of the syringe assembly 10, configured in this way, is inserted into the socket 7 on the side of the housing 2, thereby loading it into the housing 2. Thus, a usable syringe 1 is prepared (see...). Figures 1-3 The user holds the syringe 1 by its housing 2 with one hand, and slides the first switch 5 located at the rear of the housing 2 for a predetermined time to put the syringe 1 into a standby state. Based on this, the user uses the intravitreal drug delivery device 50, as described later, to determine the position of the syringe 1 relative to the eyeball, so that the injection port 77 is in contact with the target area. In this state, the user presses the second switch 6, thereby activating the igniter 22, which pressurizes the injection fluid via the piston 40 and plunger 80, injecting the injection fluid into the target area.

[0117] <Composition of Intravitreal Drug Delivery Devices>

[0118] Next, the intravitreal drug delivery device 50 located at the tip of the syringe 1 will be described. Figure 8 This is a diagram showing the general structure of the intravitreal drug delivery device 50, and is a side view of the intravitreal drug delivery device 50 viewed from a direction orthogonal to the ejection direction of the syringe 1. Figure 9 yes Figure 8 sectional view, Figure 10 This is a diagram of the intravitreal drug delivery device 50 as viewed from the top side. Figure 11 This is a diagram of the intravitreal drug delivery device 50 viewed from the basal side. Figure 12 This is a three-dimensional diagram showing the approximate structure of the intravitreal drug delivery device 50.

[0119] The intravitreal drug delivery device 50 includes: a guide 54, at least a portion of which is formed in a curved shape along the outer edge of the cornea in the eyeball; a positioning part 51 connected to the guide 54 and the syringe 1; and a concave-convex part 52 provided on the eyeball side of the positioning part 51. It should be noted that in this embodiment, the guide 54 is configured along the outer edge of the cornea, but when the eyeball is viewed from the front, the outer edge of the cornea is approximately aligned with the outer edge of the iris. Therefore, in the following description, the outer edge of the cornea can also be referred to as the outer edge of the iris (black part of the eye). That is, the guide 54 can also be configured so that at least a portion of it runs along the outer edge of the iris.

[0120] The positioning part 51 is an annular member that allows the tip 70c2 of the nozzle 70c to pass through its inner space 511, and the positioning part 51 is externally fitted into the tip 70c2. That is, the intravitreal drug delivery device 50 of this embodiment is assembled into the container 70 of the syringe 1. The inner diameter of the positioning part 51, i.e., the outer diameter of the inner space 511, is formed to be approximately the same as or slightly smaller than the outer diameter of the tip 70c2, so that when the positioning part 51 is externally fitted into the tip 70c2, there is no clearance between it and the tip 70c2, resulting in an interference fit. The positioning part 51 can be detachably assembled to the tip 70c2, or it can be fixedly assembled to the tip 70c2 by bonding, welding, or the like. In this embodiment, the positioning part 51 is circular, surrounding the tip 70c2. The positioning part 51 is configured such that the position of the central axis of this circle, i.e., the central axis 59 of the positioning part 51 along the injection direction, coincides with the position of the injection port 77. Furthermore, in this embodiment, the injection port 77 is located on the central axis of the tip portion 70c2, and the positioning portion 51 is coaxially assembled with the tip portion 70c2. It should be noted that the positioning portion 51 is not limited to a circle; it can also be a shape such as a C-shape where a portion of a circle is missing. It should also be noted that in this embodiment, the intravitreal drug delivery device 50 and the container 70 are formed separately, but they can also be formed integrally with the container 70. In this case, the positioning portion 51 is not limited to a ring shape; it can be any shape that connects the container 70 and the guide member 54.

[0121] The base end face (base end face) 513 of the positioning part 51 is formed in a conical shape along the outer surface (conical surface) 70c3 of the top end face of the conical part 70c1 of the nozzle part 70c. Therefore, when the positioning part 51 is pressed against the target area during use of the syringe 1, the base end face 513 abuts against the outer surface 70c3 and is received, maintaining a highly accurate positional relationship between the intravitreal drug delivery device 50 and the syringe 1 in the injection direction. Furthermore, the top end face of the positioning part 51, i.e., the face opposite the eyeball during use (base surface) 512, has a concave-convex portion (anti-slip member) 52 to suppress misalignment relative to the eyeball.

[0122] The protrusion 52 has a plurality of protrusions 521, each of which is erected on the base surface 512 of the positioning part 51. The plurality of protrusions 521 are spaced apart from each other in the circumferential direction of the base surface 512. Thus, a recess 522 is formed between each protrusion 521. It should be noted that, in this embodiment, the protrusions 521 are evenly spaced and are arranged symmetrically about the axis 59.

[0123] The guide 54 determines the position of the syringe 1 based on the cornea of ​​the eyeball, which is the target area, and is therefore positioned in contact with or close to the eyeball when using the syringe 1. The side of the guide 54 that contacts or is close to the eyeball during use is called the tip side, and the side of the guide 54 that is away from the eyeball in the normal direction is called the base side. The guide 54 has an annular peripheral wall 541, and an internal space 542 extending from its tip to its base is provided inside the peripheral wall 541. The tip of the inner peripheral surface 543 of the peripheral wall 541 defining the internal space 542 is formed as a guide portion 544 along the outer edge of the cornea in the eyeball. In this embodiment, the guide portion 544 is circular. That is, the peripheral wall 541 of the guide 54 in this embodiment is formed in an annular shape so that the guide portion 544 is circular. Reference numeral 58 indicates the central axis of the circle formed by the peripheral wall 541. In this embodiment, the inner edge of the tip side of the peripheral wall 541 is designated as the guide portion 544, but the outer edge of the tip side of the peripheral wall 541 can also be designated as the guide portion 544. That is, the guide 54 can also be configured such that the outer edge of the tip side of the peripheral wall 541 (guide portion 544) runs along the outer edge of the cornea when the syringe 1 is used. In this case, the guide 54 is not limited to a ring shape, but can also be a circular plate or dome shape covering the cornea.

[0124] The material of the guide 54 is not particularly limited; for example, it can be formed from resin, metal, ceramic, etc. Furthermore, the guide 54 can also be formed from a transparent material. In this case, the guide 54 can also be formed from a translucent or colored transparent material to make the guiding portion 544 conspicuous. Furthermore, if at least a portion of the guide 54 is a transparent component, the guiding portion 544 may not be the edge of the guide 54; for example, it can be a line marked on a transparent component, configured to align with the outer edge of the cornea.

[0125] exist Figure 8 , Figure 9In the attached drawing, reference numeral 90 indicates the area of ​​the eyeball to be injected when using syringe 1. Reference numeral 92 indicates the position of the cornea within the eyeball. The guide 54 and positioning part 51 of the intravitreal drug delivery device 50 are connected in a predetermined positional relationship. The axis 59 of the positioning part 51 is located at a predetermined distance (interval) LA from the guide portion 544 of the guide 54. Here, the predetermined distance LA is, for example, 3.5 mm to 4.0 mm. It should be noted that the predetermined distance LA is, for example, the distance (shortest distance) between the closest part of the guide portion 544 to the axis 59 and the axis 59 connected by a straight line. Alternatively, the predetermined distance LA can also be the shortest distance between the guide portion 544 and the axis 59 when measuring distances along the spherical surface corresponding to the eyeball.

[0126] Furthermore, the intravitreal drug delivery device 50 is configured such that the central axis 59 of the positioning portion 51 forms a predetermined angle with respect to the guide 54. For example, when the guide 54 is positioned along the outer edge of the cornea, the positioning portion 51 is configured such that the central axis 59 faces the direction of the ejection of the fluid. Specifically, in this case, the positioning portion 51 is configured such that the central axis 59 passes through the center of the eyeball or is located posterior to the center of the eyeball (retinal side).

[0127] The top surface of the guide 54, i.e., the surface (base surface) opposite the eyeball when positioned along the outer edge of the cornea, has a protrusion / concave portion (anti-slip member) 53 to suppress misalignment relative to the eyeball. The protrusion / concave portion 53 of the guide 54, like the protrusion / concave portion of the aforementioned positioning portion 51, has multiple protrusions 531, each protrusion 531 erected on the base surface 545 of the guide 54. The multiple protrusions 531 are spaced apart from each other in the circumferential direction of the base surface 545. Thus, a recess 532 is formed between each protrusion 531. It should be noted that in this embodiment, the protrusions 521 are equally spaced, and each protrusion 531 is rotationally symmetrical about axis 58. It should be noted that the protrusions / concave portions 52 and 53 are not essential components and can be omitted appropriately. For example, the protrusion 52 may be provided only in the positioning part 51 and the protrusion 53 of the guide 54 may be omitted, or the protrusion 53 may be provided only in the guide 54 and the protrusion 52 of the positioning part 51 may be omitted.

[0128] The guide 54 of the intravitreal drug delivery device 50 is configured such that when using the syringe 1, the guide portion 544 follows the outer edge of the cornea in the eyeball of the recipient. Figure 13A This diagram illustrates the configuration of the guide 54 such that the distance between the guide portion 544 and the outer edge 61 of the cornea is equal. The intravitreal drug delivery device 50 is connected in such a manner that the guide 54 and the positioning portion 51 are in a predetermined positional relationship; therefore, when... Figure 13AWhen the guide portion 544 is aligned with the cornea, the position of the syringe tip equipped with the positioning portion 51 is also determined. In this embodiment, as shown... Figure 13A Thus, when the guide 54 is aligned with the cornea, the outlet 77 of the syringe 1 is positioned 3.5 mm to 4.0 mm away from the outer edge of the cornea. Furthermore, when the tip side of the guide portion 544 is in contact with the eyeball all around its circumference, the central axis 59 of the positioning portion 51 forms a predetermined angle relative to the eyeball, and the ejection direction of the ejaculate from the syringe 1 mounted on the positioning portion 51 is also determined. It should be noted that... Figure 13A In this case, the guide 54 is arranged such that the distance between the guide portion 544 and the outer edge 61 of the cornea is equal, but it is not limited to this. The guide 54 may also be arranged such that a part of the guide portion 544 is aligned with the outer edge 61 of the cornea. Figure 13B This diagram illustrates the configuration of the guide 54 such that the portion of the guide portion 544 closest to the positioning portion 51 aligns with the outer edge 61 of the cornea. The guide 54 and the positioning portion 51 can also be configured such that, as... Figure 13B The guide 54 is configured as shown, and the injection outlet 77 of the syringe 1 is positioned 3.5 mm to 4.0 mm away from the outer edge of the cornea.

[0129] Figure 14 This is a schematic diagram illustrating the injection position when the guide 54 is positioned aligned with the outer edge of the cornea. Figure 14 A indicates the positional relationship between the guide portion 544 of the guide 54 and the injection position P1. The guide portion 544 is circular, and the starting point for measuring the distance LA from the guide portion 544 to the injection position P1 is shown as the length measurement starting point 546.

[0130] like Figure 14 As shown in Figure B, when the guide portion 544 of the intravitreal drug delivery device 50 is positioned along the outer edge of the cornea 92, the length measuring starting point 546 is located on the outer edge of the cornea 92, and the injection position P1 is positioned in the normal direction of the outer edge of the cornea from the length measuring starting point 546. In this case, the shortest distance between the outer edge of the cornea and the injection position P1 is the length of the interval LA.

[0131] In contrast, such as Figure 14As shown in Figure C, when the guide portion 544 of the intravitreal drug delivery device 50 is not positioned along the outer edge of the cornea 92, even if the measuring starting point 546 is located on the outer edge of the cornea 92, the injection position P1 will not be positioned in the normal direction of the outer edge of the cornea from the measuring starting point 546. In this case, the shortest distance LB between the outer edge of the cornea and the injection position P1 is not the length of the interval LA, and the distance from the injection position P1 to the outer edge of the cornea may be less than 3.5 mm. Therefore, in this embodiment, the intravitreal drug delivery device 50 is configured such that the circular guide portion 544 is positioned along the outer edge of the cornea. It should be noted that when the guide portion 544 of the guide member 54 is aligned with the outer edge of the cornea, it is not limited to the guide portion 544 contacting the outer edge of the cornea. For example, as... Figure 14 As shown in D, it is also possible that, with the guide 54 configured to be separated from the surface of the eyeball in the radial direction, when viewed in the axial direction through the central axis 90X passing through the measuring starting point 546 and the center of the eyeball 99, the guide portion 544 and the outer edge of the cornea are configured to overlap.

[0132] Furthermore, when the intravitreal drug delivery device 50 is pressed against the eyeball, the contact surfaces 521 and 533 at the tips of the protrusions 52 and 531 of the protrusions 53 come into contact with the eyeball. Therefore, the contact surfaces 523 and 533 of each protrusion 521 and 531 are formed along a predetermined curved surface corresponding to the eyeball. Here, the predetermined curved surface is, for example, a sphere. By forming the contact surfaces 523 and 533 along a spherical surface with an average diameter of the eyeball, the intravitreal drug delivery device 50 can be used universally. Alternatively, the contact surfaces 523 and 533 can be configured such that they are formed along a spherical surface slightly larger than the average diameter of the eyeball. When the intravitreal drug delivery device 50 is pressed against the eyeball, in the case of an eyeball with a diameter less than the average diameter, the inner sides of the contact surfaces 523 and 533 mainly abut against the eyeball, and in the case of an eyeball with a diameter greater than the average diameter, the outer sides of the contact surfaces 523 and 533 mainly abut against the eyeball. It should be noted that the prescribed curved surface along which the contact surfaces 523 and 533 are formed is not limited to a spherical surface. As long as the contact surfaces 523 and 533 of each protrusion 521 and 531 abut against the eyeball, they can also be curved surfaces deviating from the spherical surface. For example, the contact surfaces 523 and 533 may be formed on the radial side of the intravitreal drug delivery device 50, along the inner side of the axis 58 and axis 59 and the outer side of the axis 58 and axis 59, respectively.

[0133] In this embodiment, with the guide 54 positioned along the outer edge of the cornea, the outlet 77 of the syringe 1 for ejecting the target substance is positioned at a predetermined distance from the outer edge of the cornea toward the posterior end of the eyeball. Thus, the intravitreal drug delivery device 50 of this embodiment avoids damage to the cornea and lens due to the injection site being too close to the cornea, and damage to the retina due to the injection site being too far away from the cornea, providing a technique that facilitates intravitreal injection.

[0134] Furthermore, with the guide 54 positioned along the outer edge of the cornea, the intravitreal drug delivery device 50 positions the outlet 77 of the syringe 1 at a position 3.5 mm to 4.0 mm away from the outer edge of the cornea, thus facilitating accurate intravitreal injections in accordance with guidelines.

[0135] Furthermore, when the intravitreal drug delivery device 50 is pressed against the eyeball, the concave and convex portions 52 and 53 are tangential to the surface of the eyeball, increasing the frictional force compared to the case where only the tip of the syringe 1 is pressed against the surface of the eyeball, thus suppressing the displacement of the syringe 1 relative to the target area of ​​the eyeball.

[0136] <Second Implementation>

[0137] This embodiment differs from the first embodiment described above in that the intravitreal drug delivery device 50A and the container 70 are integrally formed. It should be noted that other components are the same as in the first embodiment described above; therefore, identical reference numerals are used for the same elements, and further description is omitted.

[0138] Figure 15 This diagram shows a schematic configuration of the intravitreal drug delivery device 50A and container 70 according to the second embodiment. The intravitreal drug delivery device 50A includes a guide 54 and a positioning part 51A, and is integrally formed with the container 70. The positioning part 51A is a columnar member that connects the side of the guide 54 to the side of the container 70. The positioning part 51A connects the guide 54 and the container 70 in a manner that ensures a predetermined positional relationship between the guide 54 and the container 70. For example, the positioning part 51A is located at a predetermined distance LA from the guide portion 544 of the guide 54 along the central axis 70X of the top portion 70c2 of the container 70.

[0139] Furthermore, the positioning part 51A is configured such that the central axis 70X of the container 70 is at a predetermined angle relative to the guide 54. For example, the positioning part 51A connects the guide 54 to the container 70 such that, when the guide 54 is positioned along the outer edge of the cornea, the central axis 70X of the container 70 passes through the center of the eyeball or is located posterior to the center of the eyeball (retinal side).

[0140] In this way, with the guide 54 positioned along the outer edge of the cornea, the intravitreal drug delivery device 50A of this embodiment positions the injection port 77 at a predetermined distance from the outer edge of the cornea toward the posterior end of the eyeball. Therefore, the syringe 1 equipped with the intravitreal drug delivery device 50A of this embodiment can avoid damage to the cornea and lens due to the injection site being too close to the cornea, and damage to the retina due to the injection site being too far away from the cornea, thus providing a technique that facilitates intravitreal injection.

[0141] <Third Implementation Method>

[0142] This embodiment differs from the first embodiment described above in that it includes a container holder 71 for holding the container 70, and an in vivo drug delivery device 50B is mounted on the container holder (holding part) 71. It should be noted that the other components are the same as in the first embodiment described above; therefore, identical reference numerals are used for the same elements, and further description is omitted.

[0143] Figure 16 This is a diagram showing the schematic configuration of the intravitreal drug delivery device 50B and container 700 according to the third embodiment. Figure 17 This is a diagram used to illustrate the positional relationship between the container 700 and the container holder 71 in the third embodiment.

[0144] The container 70B of this embodiment does not have an external thread that engages with the internal thread 36 formed on the inner wall of the top side of the attachment 30. Therefore, the assembly of the container 70B with respect to the attachment 30 is achieved by the container holder 71. The container holder 71 has: a body 71a that defines the space for the inner container 70B; a threaded portion 71b that is connected to the base end of the body 71a and has an external thread that engages with the internal thread 36; and a contact portion 71c that is connected to the top side of the body 71a and has an inner surface 71c1 that contacts the outer surface 70c3 of the top side of the container 70B (see reference). Figure 17 In addition, such as Figure 17 As shown, the contact portion 71c is provided with an opening 71c2 that allows the top portion 70c2 of the container 700 to pass through.

[0145] A positioning portion 51B of an intravitreal drug delivery device 50B is fitted onto the top surface 71c3 of the container holder 71. The intravitreal drug delivery device 50B includes: a positioning portion 51B, arranged around an axis 59 along the ejection direction of the ejected liquid, surrounding the top portion 70c2; a guide 54 connected to the positioning portion 51B; and protrusions 52 and 53 provided on the top sides of the positioning portion 51B and the guide 54. The base end face (base end face) 514 of the positioning portion 51B is fitted to the top surface 71c3 of the container holder 71 by bonding, welding, or the like. It should be noted that in this embodiment, the intravitreal drug delivery device 50 is formed separately from the container holder 71, but it can also be integrally formed with the container holder 71.

[0146] The container 700 is accommodated in the container holder 71 with such a configuration so that the top end 70c2 passes through the opening 71c2. At this time, the target substance is injected into the container 700 to fill the accommodating space 75, and the plunger 80 is also installed. Furthermore, in this accommodated state, the outer surface 70c3 of the top end of the container 700 contacts the inner surface 71c1 of the container holder 71 on the top side, and the base end 70b of the container 700 contacts the threaded portion 71b of the container holder 71 on the base end side. Then, while keeping the container holder 71 accommodating the container 700, the external thread of the container holder 71 formed in the threaded portion 71b engages with the internal thread 36 of the attachment 30 until the end face of the base end 70b of the container 700 contacts the end face 35a of the third region 35 of the attachment 30. As a result, using the fastening force achieved through this screw engagement, the container 700 is assembled to the attachment 30 in the following state: the outer surface 70c3 of the top side of the container 700 is pressed from the top side toward the base side by the container holder 71, that is, pressed in the opposite direction to the movement direction of the plunger 80. Furthermore, at this time, the plunger 80 is positioned across the receiving space 75 within the container 700 and the area within the attachment 30 that generally accommodates the plunger 80.

[0147] The process of assembling the syringe assembly 10 by attaching the actuator 20 to the accessory 30 in this state and the process of assembling the syringe 1 are the same as those described in the first embodiment.

[0148] In this embodiment, the syringe 1 has an intravitreal drug delivery device 50B at the top of the container holder 71. With the guide 54 positioned along the outer edge of the cornea, the outlet 77 of the syringe 1 for injecting the target substance is positioned at a predetermined distance from the outer edge of the cornea towards the posterior end of the eyeball. Therefore, the intravitreal drug delivery device 50 of this embodiment avoids damage to the cornea and lens due to the injection site being too close to the cornea, and damage to the retina due to the injection site being too far away from the cornea, providing a technique that facilitates intravitreal injections.

[0149] <Fourth Implementation>

[0150] The difference between this embodiment and the first embodiment described above lies in the configuration of the concave and convex portions 52C and 53C. It should be noted that other configurations are the same as in the first embodiment described above; therefore, identical reference numerals are used for the same elements, and further description is omitted. Figure 18 This is a cross-sectional view showing the schematic configuration of the intravitreal drug delivery device 50C and container 70 according to the fourth embodiment. Figure 19 This is a diagram of the intravitreal drug delivery device 50C viewed from the top side.

[0151] like Figure 18 , Figure 19 As shown, the intravitreal drug delivery device 50C of this embodiment includes: a positioning part 51C surrounding the injection port 77; a guide 54 connected to the positioning part 51C; and a concave-convex part 52C and a concave-convex part 53C provided on the target area side of the positioning part 51C and the guide 54.

[0152] Multiple protrusions 521C are concentrically arranged on the base surface 512 of the positioning portion 51C opposite to the target area. Each protrusion 521C is spaced apart from the others radially from the base surface 512. Thus, a recess 522C is formed between each protrusion 521C. It should be noted that in this embodiment, the protrusions 521C are evenly spaced, and each protrusion 521C is rotationally symmetrical about axis 59. Each protrusion 521C appears circular when viewed from the top side, but it can also be divided into multiple parts, with a portion of the circle missing.

[0153] Furthermore, the protrusions 53C are provided concentrically on the surface (base surface) 545 of the guide 54 opposite to the target area, with a plurality of protrusions 531C. Each protrusion 531C is spaced apart from the other in the radial direction of the base surface 545. Thus, a recess 532C is formed between each protrusion 531C. It should be noted that in this embodiment, the protrusions 531C are evenly spaced, and each protrusion 531C is rotationally symmetrical about axis 58. Each protrusion 531C appears circular when viewed from the top side, but it may also be provided as a plurality of protrusions, with a portion of the circle missing.

[0154] In this embodiment, when the injection port 77 is pressed against the eyeball while using the syringe 1, the concave and convex portions 52C and 53C of the intravitreal drug delivery device 50C are tangent to the surface of the eyeball. Compared with the case where only the injection port 77 is pressed against the surface of the eyeball, the frictional force increases, which can suppress the deviation of the syringe 1 relative to the eyeball and provide a technique that is more convenient for intravitreal injection.

[0155] <Fifth Implementation>

[0156] The difference between this embodiment and the first embodiment described above lies in the configuration of the guide 54D. It should be noted that the other configurations are the same as in the first embodiment described above; therefore, identical elements are labeled with the same reference numerals and are not described again.

[0157] Figure 20 This is a diagram showing the schematic configuration of the intravitreal drug delivery device 50D according to the fifth embodiment. (See diagram below.) Figure 20 As shown, the peripheral wall 541D of the guide 54D of the intravitreal drug delivery device 50D in this embodiment is formed as a semi-circle when viewed from the base side. That is, compared with the guide 54 of the first embodiment, the guide 54D of this embodiment has a shape in which half of the side away from the positioning part 51 is cut off, while half of the side connected to the positioning part 51 is retained.

[0158] Figure 21 This is a schematic diagram illustrating the injection position when an intravitreal drug delivery device is positioned aligned with the outer edge of the cornea. Figure 21 Figure A shows the positional relationship between the guide portion 544 and the injection position P1 of the intravitreal drug delivery device 50D in this embodiment. The guide portion 544 in this embodiment is semi-circular, and similarly to the first embodiment described above, it is positioned along the outer edge of the cornea. In this embodiment, the intravitreal drug delivery device 50D connects the guide 54D and the positioning portion 51 in such a way that the injection position P1 is located in the normal direction of the outer edge of the cornea from the measuring starting point 546. Therefore, when using the syringe 1, if the guide portion 544 of the guide 54D is positioned along the outer edge of the cornea, the positioning portion 51 positions the outlet 77 of the syringe 1 at a predetermined distance from the outer edge of the cornea towards the posterior end of the eyeball. Thus, the syringe 1 equipped with the intravitreal drug delivery device 50D avoids damage to the cornea and lens due to the injection position being too close to the cornea, and damage to the retina due to the injection position being too far away from the cornea, providing a technique that facilitates intravitreal injections.

[0159] Furthermore, compared to the guide 54 of the first embodiment, the guide 54D of this embodiment has a smaller contact area with the eyeball. Therefore, even if the eyeball moves accidentally when the guide 54D is pressed against the eyeball, the possibility of eye injury is reduced. In addition, the miniaturization of the intravitreal drug delivery device 50D makes it easier to handle during the procedure, thus facilitating intravitreal injections. Furthermore, miniaturizing the guide 54D reduces manufacturing, handling, and management costs.

[0160] It should be noted that in this embodiment, a semi-circular guide 54D is provided on the side near the positioning part 51, but it is not limited to this. The guide 54D may also be formed on other parts of the circumference surrounding the cornea. Furthermore, the guide 54D is not limited to a semi-circle, as long as it is configured such that at least a portion of it runs along the outer edge of the cornea. Figure 22 This indicates that the circumferential length of the guide 54D is formed as a ratio Figure 20 The example is a shorter variant. The guide 54D is formed short like this, with... Figure 20 Compared to other examples, this approach can further reduce the possibility of eye damage, facilitate treatment during the procedure, and reduce costs.

[0161] <Variation Example>

[0162] In the foregoing embodiments, examples of guides 54 and 54D having curved guide portions 544 are shown, but the invention is not limited thereto; guides for intravitreal drug delivery devices may also have straight guide portions. Figure 23 This is a diagram showing an example of a guide 54E with a straight guide portion. Figure 23 A shows an example of a quadrilateral guide 54E formed by connecting four straight guide portions 544 in a manner that forms the sides of a quadrilateral. Figure 23 B shows an example where one side of the quadrilateral in A is omitted. Furthermore, Figure 23 C shows an example of guide 54E being formed as a straight line.

[0163] Figure 24 It means Figure 23 A diagram illustrating an example where the guiding site is aligned with the outer edge of the cornea. (See diagram for example.) Figure 24 As shown in A, Figure 23 The guide portion 544 shown in Figure A is configured to surround the cornea 92. For example, at least one of the four guide portions 544, the guide portion 544A having a measuring start point 546, is configured aligned with the outer edge of the cornea. Specifically, the guide portion 544A is tangent to the outer edge of the cornea at the measuring start point 546, and is configured along the tangent of the outer edge of the cornea at the measuring start point 546. In this way, the straight portion (guide portion 544A) of the guide 54E is configured along the tangent of the outer edge of the cornea, thereby ensuring a predetermined interval LA between the outer edge of the cornea and the injection position P1 in the normal direction of the outer edge of the cornea from the measuring start point 546.

[0164] exist Figure 23 In the guide 54E, the linear guide portion 544A is not configured along the outer edge of the cornea, but rather along the tangent of the outer edge of the cornea, thus offering the advantage of easy positioning for various corneal shapes. For example, in... Figure 25 When using the circular guide portion 544 as shown, if the cornea is of standard diameter, the diameter of the guide portion 544 matches the diameter of the cornea, thus facilitating alignment. However, if... Figure 25 As shown, when the diameter of the cornea 92 is larger than the diameter of the guiding portion 544, the outer edge of the cornea deviates further outward than the guiding portion 544 and is hidden beneath the peripheral wall of the guide 54, sometimes making it difficult to determine whether the measuring starting point 546 is located at the outer edge of the cornea. In contrast, in Figure 23 In the guide element 54E, the linear guide portion 544A does not follow the outer edge of the cornea, therefore... Figure 24 As shown in B, even when the diameter of the cornea is larger than usual, the outer edge of the cornea will not deviate to the outside of the guiding site 544 when the measuring starting point 546 is aligned with the outer edge of the cornea, making alignment easy. Furthermore, as... Figure 24 As shown in C, even when the diameter of the cornea is smaller than the usual diameter, compared to Figure 24 A, Figure 24 Similarly, by configuring the guiding portion 544A along a tangent to the outer edge of the cornea, the guide 54E can also be easily aligned. It should be noted that... Figure 23 B, Figure 23 The guide portion 544 shown in C can also be configured similarly. For example, Figure 24 D shows Figure 23 The example shown in C is where the guide portion 544 is tangent to the outer edge of the cornea at the position of the length measuring starting point 546 and is configured to run along the tangent of the outer edge of the cornea.

[0165] It should be noted that when the guiding portion 544A of the guide member 54E is aligned with the outer edge of the cornea, it is not limited to the guiding portion 544A contacting the outer edge of the cornea. For example, as described above... Figure 14 Similarly, when the guide 54E is configured to be separated from the surface of the eyeball in the radial direction, it can also be configured such that when viewed in the axial direction through the central axis 90X passing through the measuring starting point 546 and the center of the eyeball 99, the guide portion 544A overlaps with the outer edge of the cornea.

[0166] Figure 23 The guide 54E has a length measuring start point 546 on the guide portion 544A, but is not limited to this, and the length measuring start point can also be set outside the tangent point between the guide portion 544 and the outer edge of the cornea. Figure 26 This is a diagram showing an example of a guide 54F with a length measurement starting point set outside the tangent point between the guide site 544 and the outer edge of the cornea. Figure 26The guide 54F is configured as two straight guide portions 544 connected at a predetermined angle, each guide portion 544 being tangent to the outer edge of the cornea at a single point. The point where the line bisecting the inner angle 547 formed by the two guide portions 544 intersects the outer edge of the cornea is designated as the length measurement starting point 546. The guide 54F is configured such that the injection position P1 is located on the line extending outward from the inner angle 547 from the bisecting line. That is, the guide portions 544 and the injection position P1 are positioned as... Figure 26 The guide 54F and the positioning part 51 are connected in a positional relationship. Thus, the guide 54F is configured such that two guide portions 544 are each tangent to the outer edge of the cornea at a single point, thereby ensuring a predetermined interval LA between the outer edge of the cornea and the injection site P1.

[0167] Figure 27 This is a diagram illustrating an example of a curved guide portion 544 that protrudes towards the cornea. Figure 27 Even if the guiding part 544 is curved, it does not follow the shape of the outer edge of the cornea, therefore it is different from... Figure 23 Similarly, the guide 54E has the advantage of being easy to position for various corneal shapes.

[0168] Figure 28 This is a diagram showing an example of a circular guide portion 544 configured to surround the injection position P1. Figure 28 A schematic diagram shows the positional relationship between the guide site 544 and the injection site P1. Figure 28 The guide portion 544 can be, for example, the outer peripheral surface of the positioning portion 51. Figure 28 Figure B shows the cross-sectional shape when the outer peripheral surface of the positioning part 51 is set as the guide part 544. Figure 28 As shown, the positioning part 51 is configured such that the distance from the outer peripheral surface of the positioning part 51 (intravitreal drug delivery device) to the injection port 77 is a predetermined interval LA. Therefore, when the outer peripheral surface of the positioning part 51, which serves as the guide part 544, is positioned tangent to the outer edge of the cornea, the predetermined interval LA is ensured between the outer edge of the cornea and the injection position P1. Thus, an intravitreal drug delivery device that facilitates intravitreal injection can be realized with a simple configuration.

[0169] Figure 29 This is a diagram showing an example of a guide section 544 that combines straight lines and curves. Figure 29 The guide portion 544 has a shape that includes a straight portion 544B and a curved portion 544C. Figure 29 The guiding portion 544 is configured such that the guiding portion 544 is tangent to the outer edge of the cornea at the position of the length measuring starting point 546, thereby ensuring a prescribed interval LA between the outer edge of the cornea and the injection position P1. Figure 29 The guiding site 544 is not along the shape of the outer edge of the cornea, therefore it is different from... Figure 23 Similarly, the guide 54E has the advantage of being easy to position for various corneal shapes.

[0170] The embodiments of the intravitreal drug delivery device 50 disclosed herein have been described above, but the various solutions disclosed herein may also be combined with any other features disclosed herein.

[0171] Explanation of reference numerals in the attached figures

[0172] 1: Syringe;

[0173] 2: Shell;

[0174] 3: Power cable;

[0175] 4: Connector;

[0176] 5: First switch;

[0177] 6: Second switch;

[0178] 7: Socket;

[0179] 10: Syringe assembly;

[0180] 20: Actuator;

[0181] 21: Main body;

[0182] 22: Igniter;

[0183] 30: Attachments;

[0184] 40: Piston;

[0185] 50, 50A, 50B, 50C, 50D: Intravitreal drug delivery devices;

[0186] 51, 51A, 51B: Positioning unit;

[0187] 52, 52C: Concave and convex parts;

[0188] 53, 53C: Concave and convex parts;

[0189] 54, 54D: Guide components;

[0190] 70, 70B: Container;

[0191] 71: Container holder;

[0192] 77: Ejection port;

[0193] 80: Plunger.

Claims

1. An intravitreal drug delivery device for positioning a needleless injector, the needleless injector injecting a target substance into the vitreous body of the eyeball without an injection needle, the intravitreal drug delivery device comprising: The guide, at least a portion of which is formed in a shape corresponding to the outer edge of the cornea in the eyeball; and A positioning unit, connected to the guide and the needleless injector, positions the outlet of the needleless injector from which the injected target substance is ejected at a predetermined distance from the outer edge of the cornea toward the posterior end of the eyeball when the guide is aligned with the outer edge of the cornea.

2. The intravitreal drug delivery device according to claim 1, wherein, The needle-free injector includes a receiving portion having a receiving space for accommodating the injected target substance, and an ejection port for ejecting the injected target substance into the eyeball. The positioning part is fitted into the receiving part of the needleless injector.

3. The intravitreal drug delivery device according to claim 1, wherein, The needle-free injector comprises: a receiving portion having a receiving space for receiving the injected target substance and an ejection port for ejecting the injected target substance into the eyeball; and a retaining portion for retaining the receiving portion. The positioning part is fitted to the holding part of the needleless injector.

4. The intravitreal drug delivery device according to claim 1, wherein, The guide is formed in a curved shape along the outer edge of the cornea.

5. The intravitreal drug delivery device according to claim 4, wherein, When the guide is positioned along the outer edge of the cornea, the positioning part positions the outlet of the needleless injector at a position 3.5 mm to 4.0 mm away from the outer edge of the cornea.

6. The intravitreal drug delivery device according to claim 1, wherein, The guide is formed as a straight line tangent to a portion of the outer edge of the cornea.

7. The intravitreal drug delivery device according to claim 4, wherein, When the straight portion of the guide is configured to be tangent to the outer edge of the cornea, the positioning portion positions the outlet of the needleless injector at a position 3.5 mm to 4.0 mm away from the outer edge of the cornea.

8. The intravitreal drug delivery device according to any one of claims 1 to 7, wherein, The positioning part has a concave-convex portion on the surface opposite the eyeball when the guide is arranged along the outer edge of the cornea.

9. The intravitreal drug delivery device according to any one of claims 1 to 7, wherein, When the guide is disposed along the outer edge of the cornea, the surface opposite the eyeball has a concave-convex portion that inhibits misalignment.

10. A needleless injector for injecting a target substance into the vitreous body of the eye without using an injection needle, said needleless injector comprising: The receiving part has a receiving space for receiving the injected target substance and an ejection port for ejecting the injected target substance into the eyeball; The driving unit provides ejection energy for ejecting the injected target substance; and The intravitreal drug delivery device determines the injection position of the needle-free injector relative to the eyeball. The intravitreal drug delivery device comprises: The guide, at least a portion of which is formed in a shape corresponding to the outer edge of the cornea in the eyeball; and The positioning unit, connected to the guide and the needleless injector, positions the injection outlet at a predetermined distance from the outer edge of the cornea toward the posterior end of the eyeball when the guide is aligned with the outer edge of the cornea.

11. The needleless injector according to claim 10, wherein, The positioning part of the intravitreal drug delivery device is assembled into the receiving part.

12. The needleless injector according to claim 10, wherein, The needle-free injector also includes a retaining part for holding the receiving portion. The positioning part of the intravitreal drug delivery device is assembled to the holding part.

13. The needleless injector according to claim 10, wherein, The guide is formed in a curved shape along the outer edge of the cornea.

14. The needleless injector according to claim 13, wherein, When the guide is positioned along the outer edge of the cornea, the positioning part positions the outlet of the needleless injector at a position 3.5 mm to 4.0 mm away from the outer edge of the cornea.

15. The needleless injector according to claim 10, wherein, The guide is formed as a straight line tangent to a portion of the outer edge of the cornea.

16. The needleless injector according to claim 15, wherein, When the straight portion of the guide is configured to be tangent to the outer edge of the cornea, the positioning portion positions the outlet of the needleless injector at a position 3.5 mm to 4.0 mm away from the outer edge of the cornea.

17. The needleless injector according to any one of claims 10 to 16, wherein, The positioning part has a concave-convex portion on the surface opposite the eyeball when the guide is arranged along the outer edge of the cornea.

18. The needleless injector according to any one of claims 10 to 16, wherein, When the guide is disposed along the outer edge of the cornea, the surface opposite the eyeball has a concave-convex portion that inhibits misalignment.

Images