WO2024202781A1 - Administration device - Google Patents

Abstract

[Problem] To provide an administration device in which, in a state of being placed in vivo, a body part can be refilled with a substance to be administered, and which can adjust the volume of a swelling agent to generate an appropriate pressing force to release the substance to be administered. [Solution] An administration device 100 comprises: a first port part 50 which is disposed in a body part 10 and allows a swelling agent 30 to flow between a first region S1 provided in the body part and the outside of the body part; and a second port part 60 which is disposed in the body part 10 and allows substance A to be administered to flow between a second region S2 provided in the body part and the outside of the body part.

Description

Dosing device

The present invention relates to an administration device that administers a substance, such as a medicinal solution, while being placed in a living body.

Patent Document 1 discloses an osmotic delivery device, which is a sustained administration device that is placed in the body and continuously releases the administered drug over a long period of time.

The device in Patent Document 1 has a hollow container (main body), a piston (stopper) slidably held within the container, an osmotic agent that serves as a driving source for pressing the piston, a semipermeable membrane (liquid-permeable portion) that is disposed on the base end side of the container and allows liquid components in the body fluid (extracellular fluid) to permeate and come into contact with the osmotic agent, and a delivery orifice (release portion) that is disposed on the tip end side of the container and releases the drug pressed by the piston.

The inside of the container is divided into two regions (spaces) by the piston. One region is a drug-containing space (second region) located at the tip end of the container, separated by the piston. The other region is an osmotic agent-containing space (first region) located at the base end of the container, opposite the second region, separated by the piston.

The device of Patent Document 1 utilizes the principle of osmotic pressure to bring the liquid components in the body fluid that have permeated the semipermeable membrane into contact with an osmotic agent when releasing a drug. The osmotic agent swells in the first region upon contact with the liquid components, increasing the internal pressure of the first region. As the internal pressure of the first region increases, the piston slides toward the tip, and the drug contained in the second space partitioned off further toward the tip than the first region is released into the living body via the release section.

JP 2017-57212 A

The device of Patent Document 1, after being placed in a living body, is able to release the drug filled in the second space into the living body over a long period of time by allowing liquid components contained in bodily fluids to flow into the interior of the container. However, the above device is not structured to enable refilling with drug while it is placed in the living body. Therefore, if it is desired to administer more drug after a certain amount of drug filled in the container has been released, the device must be removed from the living body once, filled with drug, and then placed in the living body again. This procedure is invasive and places a large burden on the person to whom the drug is to be administered (hereinafter referred to as the "patient").

In addition, the osmotic agent (osmotic engine) used as the driving source for pressing the piston increases the internal pressure of the first region through a reaction that involves an increase in volume due to expansion. Therefore, the increase in internal pressure in the first region is irreversible. Therefore, if it is desired to administer more drug after releasing the drug filled in the second region, it is not enough to simply fill the second region with drug; it is also necessary to adjust the volume of the osmotic agent (replace the substance that makes up the osmotic agent) so that it can apply an appropriate pressing force to the piston.

At least one embodiment of the present invention has been made in consideration of the above circumstances, and specifically aims to provide an administration device that can refill the main body with the administered substance while it is placed in the living body, and can adjust the volume of the swelling agent so that an appropriate pressing force can be applied to the plug.

The present invention can be achieved by any one of the following means (1) to (14).

(1) An administration device having a body having an inner cavity capable of accommodating an administration substance that is to be released while the body is placed in the living body and having a release port formed at the tip, a plug capable of sliding liquid-tightly within the inner cavity, a swelling agent that is filled in a first region defined on the proximal side of the plug in the inner cavity and swells upon contact with a liquid component contained in the body fluid in the living body and moves the plug toward the tip, the administration substance that is filled in a second region defined on the distal side of the plug in the inner cavity and is released from the release port as the plug advances, a liquid-permeable portion that is disposed on the proximal side of the first region and is capable of allowing liquid components contained in the body fluid in the living body to pass through to the first region in response to osmotic pressure, a first port portion that is disposed on the body and enables the swelling agent to pass between the first region and the outside of the body, and a second port portion that is disposed on the body and enables the administration substance to pass between the second region and the outside of the body.

(2) The administration device according to (1) above, wherein the first port portion has a first septum configured to be puncturable by a first puncture member having an internal cavity, the second port portion has a second septum configured to be puncturable by a second puncture member having an internal cavity, and the administration device is configured such that, in a state in which the first region is communicated with the outside of the main body portion via the first puncture member punctured into the first septum and the second region is communicated with the outside of the main body portion via the second puncture member punctured into the second septum, the swelling agent filled in the first region is sucked through the first puncture member, thereby moving the stopper toward the base end side of the main body portion and allowing the substance to be administered to flow into the second region through the second puncture member.

(3) The administration device according to (1) or (2) above, wherein the first port portion has a swelling agent discharge port for discharging the swelling agent from the inner cavity of the main body portion and a swelling agent introduction port for filling the inner cavity of the main body portion with the swelling agent, and the second port portion has a substance discharge port for discharging the substance from the inner cavity of the main body portion and a substance introduction port for filling the substance into the inner cavity of the main body portion.

(4) An administration device according to any one of (1) to (3) above, having an opening/closing control unit disposed at the release port, which opens the release port to allow the substance to be administered to be released when the internal pressure of the cavity reaches a predetermined release pressure.

(5) An administration device according to any one of (1) to (4) above, in which the liquid permeable portion is configured to selectively allow permeation of liquid components contained in bodily fluids in a living body by osmotic pressure, and the administered substance is a liquid or gel-like drug.

(6) An administration device according to any one of (1) to (5) above, wherein the main body has a cylindrical outer shape with a predetermined length along the longitudinal direction.

(7) An administration device having a main body having an outlet through which an administered substance can be released into a living body; a first reservoir arranged in the main body and holding a swelling agent that swells upon contact with a liquid component contained in a body fluid in the living body; a second reservoir arranged in the main body and holding the administered substance and discharging the administered substance as the swelling agent swells; a liquid permeable portion arranged to communicate with the first reservoir and allowing liquid components contained in the body fluid in the living body to pass through to the first reservoir; a first port portion enabling the flow of the swelling agent between the first reservoir and the outside of the main body; a second port portion enabling the flow of the administered substance between the second reservoir and the outside of the main body; a first flow path extending between the first port portion and the first reservoir; a second flow path extending from the second port portion toward the second reservoir; and a third flow path moving the administered substance discharged from the second reservoir to the release port.

(8) The administration device according to (7) above, wherein the first port portion has a first septum configured to be puncturable by a first puncture member having an internal cavity, the second port portion has a second septum configured to be puncturable by a second puncture member having an internal cavity, and the administration device is configured such that, in a state in which the first reservoir is communicated with the outside of the main body portion via the first puncture member punctured into the first septum and the second reservoir is communicated with the outside of the main body portion via the second puncture member punctured into the second septum, the swelling agent filled in the first reservoir is sucked in through the first puncture member to contract the first reservoir and allow the substance to be administered to flow into the second reservoir through the second puncture member.

(9) The administration device according to (7) or (8) above, wherein the first port portion has a swelling agent discharge port for discharging the swelling agent from within the main body portion and a swelling agent introduction port for filling the swelling agent into the main body portion, and the second port portion has a substance discharge port for discharging the substance to be administered from within the main body portion and a substance introduction port for filling the substance to be administered into the main body portion.

(10) The administration device according to any one of (7) to (9) above, which has an opening/closing control unit disposed at the release port and which opens the release port to allow the substance to be administered to be released when the internal pressure of the main body reaches a predetermined release pressure.

(11) The administration device according to any one of (7) to (10) above, wherein the liquid permeable portion is configured to selectively allow permeation of liquid components contained in bodily fluids in a living body by osmotic pressure, and the administered substance is a liquid or gel-like drug.

(12) The administration device according to any one of (7) to (11) above, wherein the main body has a box-shaped structure with flat top and bottom surfaces, or a box-shaped structure with curved top and bottom surfaces.

(13) The administration device described in any one of (7) to (12) above, in which the first reservoir is configured as a space partitioned by the main body portion, and the second reservoir is disposed within the space that constitutes the first reservoir.

(14) The administration device according to any one of (7) to (13) above, wherein the first reservoir is disposed in the main body and is composed of a member containing the swelling agent therein, and the second reservoir is disposed inside the first reservoir so as to be surrounded by the swelling agent.

According to at least one embodiment of the present invention, the device can be refilled with the substance to be administered while it is indwelled in the living body, and the volume of the swelling agent can be adjusted so as to generate an appropriate pressing force for releasing the substance to be administered. Therefore, when administering further substance after administration of a predetermined amount of the substance filled in the device has been completed, it is possible to omit the procedure of removing the device from the living body and re-inserting the device in the living body after having been removed from the living body. Therefore, the burden on the patient using the administration device can be significantly reduced.

1 is a schematic cross-sectional view of an administration device according to a first embodiment. FIG. 1 is a partially enlarged cross-sectional view of the vicinity of a first port portion of the administration device according to the first embodiment. FIG. A partially enlarged cross-sectional view of the vicinity of the second port portion of the administration device according to the first embodiment. FIG. 2 is a partially enlarged cross-sectional view of the vicinity of the outlet of the administration device according to the first embodiment, showing the state in which the outlet is closed by the opening/closing control unit. FIG. 2 is a partially enlarged cross-sectional view of the vicinity of the release port of the administration device according to the first embodiment, showing the state when the substance to be administered is being released from the release port. FIG. 2 is a schematic cross-sectional view for explaining an example of use of the administration device according to the first embodiment. FIG. 2 is a schematic cross-sectional view for explaining an example of use of the administration device according to the first embodiment. FIG. 2 is a schematic cross-sectional view for explaining an example of use of the administration device according to the first embodiment. FIG. 2 is a schematic cross-sectional view for explaining an example of use of the administration device according to the first embodiment. FIG. 6 is an exploded perspective view of an administration device according to a second embodiment. FIG. 11 is a plan view showing a simplified configuration of an administration device according to a second embodiment. FIG. 11 is a schematic perspective view showing a second reservoir of the administration device according to the second embodiment. 13A is a partial cross-sectional view of the second reservoir taken along arrows 13A-13A shown in FIG. 12. A cross-sectional view for explaining the operation of the second reservoir of the administration device according to the second embodiment. A cross-sectional view for explaining the operation of the second reservoir of the administration device according to the second embodiment. A cross-sectional view for explaining the operation of the second reservoir of the administration device according to the second embodiment. FIG. 11 is an exploded perspective view of an administration device according to a modified example of the second embodiment.

Below, the form for carrying out the present invention will be described in detail with reference to the drawings. The embodiment shown here is an example to embody the technical idea of the present invention, and does not limit the present invention. Furthermore, all other possible forms, examples, and operating techniques that can be thought of by those skilled in the art without departing from the gist of the present invention are included in the scope and gist of the present invention, and are included in the scope of the invention described in the claims and their equivalents.

Furthermore, for the convenience of illustration and ease of understanding, the drawings attached to this specification may be depicted diagrammatically with appropriate changes in scale, aspect ratio, shape, etc. from the actual product, but these are merely examples and do not limit the interpretation of the present invention.

In addition, in the following explanation, when ordinal numbers such as "first" and "second" are used, unless otherwise specified, they are used for convenience and do not dictate any particular order.

In the administration device 100 of the first embodiment described below, the "tip side (downstream side)" is the side where the opening/closing control unit 70 is located in the axial direction of the main body unit (the side where the administered substance A is administered), and is indicated by the arrow X1 in the figure. The "base side (upstream side)" is the side opposite the tip side where the liquid permeable unit 40 is located (the side where the liquid components of the body fluids in the living body enter the main body unit 10), and is indicated by the arrow X2.

First Embodiment
The administration device 100 according to the first embodiment will be described.

The administration device 100 is a device that is placed in a living body and allows for intermittent administration of the substance A to be administered based on predetermined administration conditions while being continuously driven non-electrically. As described below, the administration device 100 has a first port portion 50 and a second port portion 60 that allow for the flow (filling and/or discharging) of the substance A to be administered and the swelling agent 30 inside and outside the main body portion 10 while placed in the living body.

The administration device 100 intermittently administers the substance A to the living body, and can release (administer) the substance A to the living body under predetermined administration conditions (administration conditions such as administration period, administration timing, and dosage). The administration device 100 can be configured to intermittently administer the substance A over a long period of time (at least several weeks to several months, or even several years).

The substance A to be administered can be, for example, a fluid composition that produces a predetermined effect when administered into a predetermined biological organ and that can be intermittently released from the device.

The administered substance A is, for example, a pharmaceutical agent (liquid) intended to treat a certain disease. Pharmaceutical agents include drugs. Drugs can be any physiologically or pharmacologically active substance, particularly those known to be delivered to the human or animal body. Drugs include, but are not limited to, drugs acting on peripheral nerves, adrenergic receptors, cholinergic receptors, skeletal muscles, cardiovascular system, smooth muscles, vascular system, synaptic sites, neurotransmitter junctions, endocrine and hormonal systems, immune system, reproductive system, skeletal system, local hormonal system, digestive and excretory system, histamine system, or central nervous system. Drugs also include, but are not limited to, drugs used to treat infectious diseases, chronic pain, diabetes, autoimmune diseases, endocrine diseases, metabolic disorders, and rheumatic diseases. Additionally, drugs include, but are not limited to, peptides, proteins, polypeptides (e.g., enzymes, hormones, cytokines), nucleic acids, oligonucleotides, viruses, viral vectors, plasmids, nucleoproteins, polysaccharides, glycoproteins, lipoproteins, cells, steroids, analgesics, local anesthetics, antibiotic preparations, anti-inflammatory corticosteroids, ophthalmic drugs, other small molecules of pharmaceutical use, or synthetic analogs of these species, and mixtures thereof.

In this embodiment, the object A is preferably composed of a liquid or gel-like drug to enable filling and discharging using syringes 210 and 220 (see Figures 3, 7, and 8) as described below.

Administration Device 100
1, 4, 5, and 6, administration device 100 includes a main body 10 having a lumen 11 capable of accommodating an administration object A to be released while the administration device is placed in a living body and having a release port 12 formed at a tip thereof, a plug 20 capable of sliding liquid-tightly within lumen 11, a swelling agent 30 filled in a first region S1 defined on the proximal side of lumen 11 relative to plug 20, which swells upon contact with a liquid component contained in bodily fluids in the living body and advances plug 20 toward the tip side, and a second region S2 defined on the distal side of lumen 11 relative to plug 20. the first region S2 and released from the release port 12 as the stopper body 20 advances; a liquid permeable portion 40 arranged on the base end side of the first region S1 and capable of allowing liquid components contained in bodily fluids in the living body to pass through to the first region S1 side in accordance with osmotic pressure; a first port portion 50 arranged on the main body portion 10 and enabling the passage of a swelling agent 30 between the first region S1 and the outside of the main body portion 10; and a second port portion 60 arranged on the main body portion 10 and enabling the passage of the object A to be administered between the second region S2 and the outside of the main body portion 10.

(Main body portion 10)
1, the main body 10 can be formed of a hollow tubular member that constitutes the housing of the administration device 100. An inner cavity 11 extending along the axial direction (longitudinal direction) of the main body 10 is formed inside the main body 10.

The main body 10 has a cylindrical outer shape with a predetermined length along the axial direction, and can be placed in a biological organ with a length in the longitudinal direction, such as a blood vessel or a tubular body cavity, and the substance A to be administered can be administered suitably in such a biological organ. The outer shape of the main body 10 is, for example, cylindrical, but is not limited to this. The main body 10 may have, for example, each end face located at both ends in the axial direction formed in a rectangular shape, or may have a prismatic shape with a cross section perpendicular to the axial direction formed in a polygonal shape.

The tip of the main body 10 is formed with an outlet 12 for releasing the administered substance A to the outside of the main body 10 (outside the lumen 11).

The administration device 100 is arranged in the following order from the base end of the main body 10 to the tip: the liquid permeable section 40, the swelling agent 30, the plug 20, and the opening/closing control section 70.

As shown in FIG. 1, the main body 10, in a state before administration (release) of the substance A to be administered into the living body and filled with a predetermined amount of the substance A, has a first region S1 defined on the tip side and a second region S2 defined on the base side, separated by the stopper body 20. In the following explanation, the state before administration of the substance A to be administered into the living body is referred to as the "initial filling state."

The first region S1 is a space defined between the liquid-permeable portion 40 and the plug 20 (the space between the mounting end of the liquid-permeable portion 40 in the main body 10 and the base end of the plug 20). The first region S1 can accommodate a swelling agent 30.

The second region S2 is a space partitioned between the stopper 20 and the opening/closing control unit 70 (the space between the tip of the stopper 20 and the base end of the release port 12). The second region S2 can accommodate the substance A to be administered. The second region S2 also constitutes a sliding region in which the stopper 20 slides along the axial direction of the main body 10.

The axial lengths of the first region S1 and the second region S2 expand or contract as the stopper 20 slides when the administration device 100 is in an operating state (meaning the state before and after administration of the substance A, or the state during administration). In other words, the volumes of the first region S1 and the second region S2 are variable depending on the operating state of the administration device 100. More specifically, when the administration device 100 starts operating and the stopper 20 slides toward the tip side due to the swelling agent 30, the volume of the space corresponding to the first region S1 gradually expands, while the volume of the space corresponding to the second region S2 gradually contracts.

The main body 10 is preferably configured to prevent the main body 10 from being crushed by buckling or the like in the range in which the plug 20 slides, causing the shape of the lumen 11 (for example, the cross-sectional shape intersecting the axial direction) to deform into an unintended shape, thereby preventing the plug 20 from decreasing in slidability. In addition, since the main body 10 is intended to be used in a state in which it is placed in a living body, it is preferable that the material of the main body 10 is non-invasive or minimally invasive to the living body. In consideration of these points, the material of the main body 10 may be, for example, a resin material known in the medical field (acrylonitrile polymers, halogenated polymers, polyimide, polysulfone, polycarbonate, polyethylene, polypropylene, polyvinyl chloride-acrylic acid copolymer, polycarbonate-acrylonitrile-butadiene-styrene, polystyrene, etc.), a metal material (stainless steel, titanium, nickel, aluminum, vanadium, platinum, tantalum, gold, and alloys thereof, as well as gold-plated ferrous alloys, platinum-plated ferrous alloys, cobalt chromium alloys, and titanium nitride-coated stainless steel, etc.).

(Liquid permeable portion 40)
The liquid-permeable portion 40 is disposed at the base end of the main body portion 10, and separates the living body from the inner cavity 11 of the main body portion 10. In addition, the liquid-permeable portion 40 has a function of selectively allowing only liquid components contained in bodily fluids in the living body to pass therethrough.

The liquid-permeable portion 40 can be made of a known material that has a solid-liquid separation function that allows only the liquid component (water) in bodily fluids to pass through. The liquid-permeable portion 40 can be made of a semipermeable membrane made of materials such as plasticized cellulose-based materials, reinforced polymethyl methacrylates (PMMA) such as hydroxyethyl methacrylate (HEMA), and elastomeric materials such as polyurethanes, polyamides, polyether-polyamide copolymers, and thermoplastic copolyesters, or mixtures thereof.

(Swelling Agent 30)
The swelling agent 30 is disposed in the lumen 11 of the main body 10 on the distal side of the liquid permeable portion 40. The swelling agent 30 functions as a pressing portion that presses the plug 20 toward the distal side by non-electrical continuous driving using the principle of an osmotic engine.

The swelling agent 30 gradually swells due to the liquid components that have permeated the liquid-permeable portion 40. As the swelling agent 30 swells, it increases the internal pressure of the first region S1. The swelling agent 30 can slide the plug 20 toward the tip side by the pressing effect caused by the increase in internal pressure of the first region S1.

The swelling agent 30 is not particularly limited in its specific form as long as it has a property that allows it to be discharged from the inner cavity 11 of the main body 10 and to be filled (filled) into the inner cavity 11 of the main body 10. For example, a material that can flow as a whole when pressure is applied, such as granules, a gel, a fluid, etc., can be used as the swelling agent. In addition, the swelling agent 30 may have a property that can at least cause a flow during the discharge operation and the inflow operation as described above. For example, the swelling agent 30 does not have to have a property that can cause a flow as described above when it swells in the inner cavity 11 of the main body 10 upon contact with a liquid component and functions as a pressing part. For example, a substance that shows high viscosity after swelling, such as a water-absorbent polymer, and thus is practically difficult to discharge from the inner cavity 11, can be excluded from the swelling agent 30 (osmotic agent) in this specification.

For example, the swelling agent 30 can be composed of a chloride that can swell when it comes into contact with a liquid component. The chloride is a solute that can be refilled into the lumen 11, and can be selected from any solute that can swell when it comes into contact with a liquid component in a body fluid. Specific types of chloride include, for example, sodium chloride, magnesium chloride, potassium chloride, sodium sulfate, magnesium sulfate, potassium sulfate, sodium phosphate, potassium phosphate, mannitol, urea, inositol, raffinose, sucrose, glucose, lactose, sorbitol, tartrates, succinates, and mixtures thereof.

The constituent materials and the volume in the initial filled state of the swelling agent 30 can be arbitrarily set so as to achieve a predetermined pressing speed (i.e., the swelling speed of the swelling agent 30) according to the administration conditions of the administered substance A.

In addition, the administration device 100 can adjust the administration interval and administration amount by adjusting the composition of the osmotic engine that constitutes the swelling agent 30 and the shape of the semipermeable membrane that constitutes the liquid permeable portion 40.

(Plug 20)
As described above, plug 20 is pressed and moves toward the tip side as swelling agent 30 swells, and pushes out substance A contained in second region S2 toward opening/closing control section 70.

The plug 20 is located in the lumen 11 of the main body 10, closer to the tip than the swelling agent 30. The outer circumferential surface of the plug 20 is in liquid-tight contact with the inner circumferential surface of the main body 10, and the plug 20 is arranged to be able to slide within the lumen 11.

There are no particular limitations on the specific shape of the plug 20. For example, the plug 20 can be configured to have multiple protrusions 21 for adjusting the liquid-tightness and sliding properties against the inner surface of the main body 10, and a base 22 equipped with multiple protrusions 21.

The plug 20 can be made of a material that maintains adhesion (liquid-tightness) with the inner circumferential surface of the lumen 11 of the main body 10 and has a certain degree of flexibility. The flexible material is preferably an elastic material. Examples of such elastic materials include various rubber materials (especially those that have been vulcanized), such as natural rubber, isoprene rubber, butyl rubber, chloroprene rubber, nitrile-butadiene rubber, styrene-butadiene rubber, and silicone rubber, as well as styrene-based elastomers, hydrogenated styrene-based elastomers, and mixtures of these styrene-based elastomers with polyolefins, such as polyethylene, polypropylene, polybutene, and α-olefin copolymers, oils, such as liquid paraffin and process oil, and powdered inorganic materials, such as talc, cast, and mica. Furthermore, polyvinyl chloride-based elastomers, olefin-based elastomers, polyester-based elastomers, polyamide-based elastomers, polyurethane-based elastomers, and mixtures thereof can also be used as the constituent materials.

In particular, it is preferable to select diene rubber, styrene elastomer, etc. as the constituent material of the plug body 20 from the viewpoint of having elastic properties and being capable of being sterilized by gamma rays, electron beams, and high-pressure steam.

The plug 20 only needs to have a configuration that allows it to slide liquid-tightly within the lumen 11. Therefore, when the plug 20 is configured to have a protrusion 21 and a base 22, both parts may be made of any of the materials exemplified above (elastic materials, etc.), or only the protrusion 21, which is required to have a sealing ability against the inner surface of the main body 10, may be made of any of the materials exemplified above (elastic materials, etc.), and the base 22 may be made of a hard material that has no elasticity.

(Opening/Closing Control Unit 70)
As shown in Figures 1, 4, and 5, the opening/closing control unit 70 is arranged at the tip side of the main body 10 and has a valve body 71 that is capable of opening and closing the release port 12, and a holding portion 72 that holds the valve body 71.

The opening/closing control unit 70 has pressure responsiveness according to the internal pressure of the cavity 11. Specifically, the opening/closing control unit 70 has a function of switching the discharge port 12 between an open state and a closed state according to the internal pressure of the cavity 11. In this embodiment, the opening/closing control unit 70 is configured to have a function equivalent to that of a known umbrella valve, which is a pressure-responsive one-way valve.

The valve body 71 has a shaft portion 73 that extends in the axial direction of the discharge port 12, and an umbrella-shaped closure portion 74 formed around the tip side of the shaft portion 73.

The valve body 71 can be made of, for example, an elastic material.

The blocking portion 74 is configured to cover the discharge port 12 located at the tip of the main body portion 10 when in the blocked state shown in FIG. 4.

When the stopper body 20 advances toward the tip side as the swelling agent 30 swells and the internal pressure of the second region S2 reaches a predetermined release pressure, the valve body 71 separates a part of the blocking portion 74 from the release port 12 as shown in FIG. 5, thereby opening the release port 12. Furthermore, when the release of a predetermined amount of the administered substance A is completed and the internal pressure of the lumen 11 falls below the release pressure, the valve body 71 returns the blocking portion 74 to its original position (the shape shown in FIG. 4) to block the release port 12.

The above-mentioned "release pressure" can be considered as a pressure value for intermittently releasing a predetermined amount of the administered substance A at a predetermined administration interval when the stopper body 20 pressed by the swelling agent 30 (pressing portion) moves toward the tip side. In other words, the valve body 71 of the opening/closing control portion 70 is configured so that at least a portion of it moves to open the release port 12 when the internal pressure of the lumen 11 (internal pressure of the second region S2) reaches a predetermined release pressure. The release pressure can be set arbitrarily depending on the administration conditions of the administered substance A used (type and properties of the administered substance, target organ of the living body, etc.).

The holding portion 72 is fixed to the inner cavity 11. The holding portion 72 holds the shaft portion 73 of the valve body 71. The holding portion 72 can be configured to have one or more through holes through which the substance A to be administered can pass. The shape and number of through holes provided in the holding portion 72 can be set as desired, taking into consideration the amount of substance A to be administered per time, the viscosity of substance A, etc.

The specific configuration of the opening/closing control unit 70 is not particularly limited as long as it can control the opening and closing of the release port 12 in response to changes in the internal pressure of the lumen 11 of the main body 10. The opening/closing control unit 70 can be configured to have, for example, a structure such as a duckbill valve or any other structure for controlling the release of the administered substance A.

(First port portion 50)
1 and 2, the first port portion 50 can be disposed at a position corresponding to the first region S1 of the main body portion 10. As described above, the volume (range in the axial direction) of the first region S1 is variable depending on the amount of the substance A released from the lumen 11. Taking this into consideration, the first port portion 50 can be disposed at any position corresponding to the first region S1 in which the swelling agent 30 is accommodated in the initial filling state.

The first port portion 50 allows the flow of the swelling agent 30 inside and outside the first region S1 (inside and outside the main body portion 10). The first port portion 50 can be configured, for example, as an opening that connects the inside and outside of the lumen 11.

The first port portion 50 can be configured to include a valve mechanism for preventing the swelling agent 30 filled in the first region S1 from accidentally leaking out through the first port portion 50 and for preventing bodily fluids from flowing into the lumen 11 through the first port portion 50. The first port portion 50 includes a first septum 51 that functions as the above-mentioned valve mechanism.

As shown in FIG. 2, the first septum 51 has a configuration that allows the first puncture member 211 having an inner cavity 212 to be punctured. The first septum 51 can be disposed, for example, near the first port portion 50 so as to seal the opening that constitutes the first port portion 50. The first septum 51 can be fixed to the main body portion 10, for example, by adhesion, fitting, etc.

The first septum 51 can be made of elastic materials such as various rubber materials, such as natural rubber, butyl rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, and silicone rubber, various thermoplastic elastomers, such as polyurethane-based, polyester-based, polyamide-based, olefin-based, and styrene-based elastomers, or mixtures of these.

The first puncture member 211 can be configured, for example, as a needle provided in a first syringe 210 that is well known in the medical field. There are no particular limitations on the specific configuration or material of the first puncture member 211, and it can be any type depending on the material and structure of the first septum 51.

As shown in FIG. 1, the first septum 51 keeps the first port portion 50 closed when the first puncture member 211 is not inserted.

As shown in Figures 2 and 7, the surgeon can connect the cavity 11 to the outside of the main body 10 via the first port 50 and the first puncture member 211 by penetrating the first septum 51 of the first port 50 with the tip (needle tip) of the first puncture member 211 in the first region S1. With the first puncture member 211 penetrating the first septum 51, the surgeon can operate the syringe 210 outside the body to remove the swelling agent 30 filled in the cavity 11 of the main body 10 to the outside of the cavity 11, or fill the swelling agent 30 into the cavity 11 of the main body 10.

In this embodiment, a configuration in which a first septum 51 is disposed in the first port portion 50 is exemplified, but the specific configuration of the first port portion 50 is not particularly limited as long as it is possible to at least manipulate the flow of the swelling agent 30 inside and outside the main body portion 10. For example, the first port portion 50 may be configured to include a fluid valve that is configured to be able to switch between open and closed in response to pressure from the outside, or may be configured to include a mechanism that allows the connection of a tube or the like that is constantly or optionally connected to the first port portion 50.

In this embodiment, the administration device 100 is configured to be able to fill (inject) the swelling agent 30 into the cavity 11 and discharge the swelling agent 30 from the cavity 11 through one first port portion 50. However, the administration device 100 may be provided with a dedicated port (swelling agent introduction port) for filling (injecting) the swelling agent 30 into the cavity 11 and a dedicated port (swelling agent discharge port) for discharging the swelling agent 30 from the cavity 11 separately. In other words, there is no particular limit to the number of first port portions 50 provided in the administration device 100. However, when the administration device 100 is configured to have one first port portion 50 that enables the injection and discharge of the swelling agent 30, as in the administration device 100, the structure of the main body portion 10 can be simplified. In addition, as described later, it becomes possible to smoothly and easily move the swelling agent 30 inside and outside the main body portion 10 using two syringes 210 and 220.

(Second port portion 60)
1 and 3, the second port portion 60 can be disposed at a position corresponding to the second region S2 of the main body portion 10. As described above, the volume (range in the axial direction) of the second region S2 is variable depending on the amount of the substance A released from the lumen 11. In consideration of this, the second port portion 60 can be disposed at any position corresponding to the second region S2 in which the substance A is contained in the initial filling state.

The second port portion 60 allows the passage of the substance A to be administered between the inside and outside of the second region S2 (the inside and outside of the main body portion 10). The second port portion 60 can be configured, for example, as an opening that communicates between the inside and outside of the lumen 11.

The second port portion 60 can be configured to include a valve mechanism for preventing the substance A filled in the second region S2 from accidentally leaking out through the second port portion 60 and for preventing bodily fluids from flowing into the lumen 11 through the second port portion 60. The second port portion 60 includes a second septum 61 that functions as the valve mechanism described above.

As shown in FIG. 3, the second septum 61 has a configuration that allows the second puncture member 221 having an inner cavity 222 to be punctured. The second septum 61 can be disposed, for example, near the second port portion 60 so as to seal the opening that constitutes the second port portion 60. The second septum 61 can be fixed to the main body portion 10, for example, by adhesion, fitting, etc.

The second septum 61 may be made of, for example, the same material as that exemplified above as the material for the first septum 51.

The second puncture member 221 can be configured, for example, as a needle provided in a second syringe 220 that is well known in the medical field. There are no particular limitations on the specific configuration or material of the second puncture member 221, and it can be any type depending on the material and structure of the second septum 61.

In this specification, the puncture member used to puncture the first septum 51 is referred to as the first puncture member 211, and the puncture member used to puncture the second septum 61 is referred to as the second puncture member 221. However, these members may have substantially the same configuration, or each may have a different configuration to suit the structure of each septum 51, 61.

As shown in FIG. 1, the second septum 61 keeps the second port portion 60 closed when the second puncture member 221 is not inserted.

As shown in Figures 3, 7, etc., the surgeon can connect the cavity 11 to the outside of the main body 10 via the second port 60 and the second puncture member 221 by penetrating the second septum 61 of the second port 60 with the tip (needle tip) of the second puncture member 221 in the second region S2. The surgeon can remove the substance A filled in the cavity 11 of the main body 10 to the outside of the cavity 11 or fill the substance A into the cavity 11 of the main body 10 by operating the syringe 220 outside the body with the second puncture member 221 penetrating the second septum 61.

In this embodiment, a configuration in which a second septum 61 is disposed in the second port portion 60 is exemplified, but there are no limitations on the specific configuration of the second port portion 60 as long as it is at least capable of manipulating the flow of the administered substance A inside and outside the main body portion 10. For example, the second port portion 60 may be configured to include a fluid valve that is configured to be able to switch between open and closed in response to pressure from the outside, or may be configured to include a mechanism that allows connection of a tube or the like that is constantly or arbitrarily connected to the second port portion 60.

In this embodiment, the administration device 100 is configured to be able to fill (inject) the subject A into the cavity 11 and discharge the subject A from the cavity 11 through one second port 60. However, the administration device 100 may be provided with a dedicated port (substance introduction port) for filling (injecting) the subject A into the cavity 11 and a dedicated port (substance discharge port) for discharging the subject A from the cavity 11 separately. In other words, there is no particular limit to the number of second port sections 60 provided in the administration device 100. However, when configured to have one second port section 60 that enables the injection and discharge of the subject A as in the administration device 100, the structure of the main body 10 can be simplified. In addition, as described later, it becomes possible to smoothly and easily move the subject A inside and outside the cavity 11 using two syringes 210 and 220.

<Usage example>
An example of a method of using the administration device 100 will now be described with reference to Figures 1 and 6-9.

FIG. 1 shows the initial filling state before the administration of the substance A. In this state, the administration device 100 is placed (embedded) in a specific biological organ to which the substance A is to be administered.

In the initial filling state shown in FIG. 1, the position where the plug 20 is positioned is referred to as the first position P1.

The opening/closing control unit 70 keeps the discharge port 12 closed during the initial filling state.

When the administration device 100 is placed in a living organ, a predetermined amount of liquid components flows into the inner cavity 11 via the liquid permeable portion 40, causing the swelling agent 30 to swell. As shown in FIG. 6, the opening/closing control portion 70 opens the release port 12, and the administered substance A is released from the release port 12.

As shown in FIG. 7, when a predetermined amount of the substance A to be administered is released through the release port 12 as the swelling agent 30 swells, the internal pressure of the cavity 11 of the main body 10 on the tip side of the plug 20 drops. When this internal pressure falls below the release pressure of the opening/closing control unit 70, the opening/closing control unit 70 closes the release port 12. After that, when the initially planned amount of the substance A to be administered has been released, the balance between the internal pressures of the first region S1 and the second region S2 results in a state in which the release of the substance A does not proceed. The position where the plug 20 is positioned in this state is referred to as the second position P2.

If the surgeon or other person wishes to further administer the substance A into the living body, as shown in FIG. 7, the surgeon or other person punctures the first septum 51 of the first port portion 50 with the first puncture member 211, and punctures the second septum 61 of the second port portion 60 with the second puncture member 221.

In this usage example, two syringes are prepared as the first syringe 210 equipped with the first puncture member 211: a "syringe 210A for discharging swelling agent" (see Figures 7 and 8) in which the syringe body (cylinder) 213 is empty, and a "syringe 210B for injecting swelling agent" (see Figure 9) in which a predetermined amount of swelling agent 30 is filled inside the syringe body (cylinder) 213. In addition, a "syringe for injecting substance to be administered" is prepared as the second syringe 220 equipped with the second puncture member 221, in which a predetermined amount of substance to be administered A is filled inside the syringe body (cylinder) 223.

As shown in FIG. 8, the surgeon punctures the first septum 51 of the first port portion 50 with the first puncture member 211 of the syringe 210A for discharging the swelling agent, and punctures the second septum 61 of the second port portion 60 with the second puncture member 221 of the syringe 220 for injecting the substance to be administered. Then, the surgeon aspirates the swelling agent 30 filled in the cavity 11 of the main body portion 10 through the cavity 212 of the first puncture member 211 (see FIG. 2).

When the swelling agent 30 is discharged to the outside of the lumen 11, the internal pressure on the base end side of the plug 20 in the lumen 11 decreases, and the plug 20 moves toward the base end. When the plug 20 moves toward the base end as described above, the internal pressure on the tip side of the plug 20 decreases. As a result, the substance A filled in the syringe body 223 of the syringe 220 for injecting the substance is refilled into the lumen 11 via the lumen 222 of the second puncture member 221 that is connected to the lumen 11 of the main body 10.

After refilling the lumen 11 with the substance A, the surgeon adjusts the amount of substance A to be administered using the syringe 210B for injecting the swelling agent and the syringe 220 for injecting the substance to be administered in order to return the plug 20 to the first position P1 of the initial filling state.

Specifically, as shown in FIG. 9, the surgeon removes syringe 210A for discharging swelling agent that was connected to first port portion 50, and connects syringe 210B for injecting swelling agent to first port portion 50. The surgeon inserts first puncture member 211 of syringe 210B for injecting swelling agent into first septum 51 of first port portion 50, thereby connecting lumen 11 with syringe body 213 of syringe 210B for injecting swelling agent. Next, the surgeon uses syringe 220 for injecting substance to discharge a predetermined amount of substance A to the outside of lumen 11. This reduces the internal pressure at the tip side of plug 20, causing plug 20 to start moving towards the tip side. When the plug 20 moves toward the tip, the internal pressure of the lumen 11 on the base side of the plug 20 decreases, and the swelling agent 30 filled in the syringe body 213 of the syringe 210B for injecting the swelling agent moves into the lumen 11 via the lumen 212 of the first puncture member 211 that is connected to the lumen 11 of the main body 10, and is refilled.

When refilling the swelling agent 30 as described above, the surgeon operates the discharge of the administered substance A so that the internal pressure on the distal side of the stopper 20 remains below the discharge pressure of the opening/closing control unit 70. This makes it possible to properly position the stopper 20 in the first position P1 while preventing the release of the administered substance A due to inadvertent opening of the opening/closing control unit 70.

As described above, the administration device 100 according to this embodiment can administer the substance A intermittently by repeatedly moving and stopping the movement of the stopper body 20 toward the tip side of the main body 10 in response to an increase in the volume of the swelling agent 30.

In addition, since the administration device 100 includes the first port section 50 and the second port section 60, it can be refilled with the substance A while it is indwelled in the living body, and the volume of the swelling agent 30 can be adjusted (the swelling agent 30 can be replaced) so as to generate an appropriate pressing force for releasing the substance A. Therefore, when administering the substance A again after administration of a predetermined amount of the substance A filled in the administration device 100 has been completed, it is possible to omit the procedure of removing the administration device 100 from the living body and re-inserting the administration device 100 that has been removed from the living body in the living body. This makes it possible to significantly reduce the burden on the patient using the administration device 100.

Second Embodiment
Next, an administration device 300 according to a second embodiment will be described with reference to FIGS.

The administration device 300 according to the second embodiment is a device intended to administer the subject A in a living body for a predetermined period of time, similar to the administration device 100 according to the first embodiment described above. Furthermore, the administration device 300 according to the second embodiment has a configuration capable of filling and discharging the subject A and the swelling agent 30, similar to the administration device 100 according to the first embodiment.

In the description of the administration device 300, some of the description, including illustrations, of components that have the same functions as the administration device 100 according to the first embodiment described above will be omitted. In addition, configurations, members, and methods of use that are not specifically mentioned can be the same as those of the first embodiment described above.

Administration Device 300
10 and 11, the administration device 300 has a main body 310 provided with a plurality of reservoirs 380, 390 for controlling the administration of the substance A to be administered, and a plurality of flow paths 321, 322, 323.

(Main body portion 310)
The main body 310 can be configured as a housing having a box-shaped structure with flat upper surface 301 and bottom surface 302. Since the upper surface 301 and the bottom surface 302 of the main body 310 of the administration device 300 have a flat shape, the administration device 300 can be placed in a state where the upper surface 301 and the bottom surface 302 of the main body 310 are in surface contact with a predetermined biological organ to which the substance A is to be administered. Therefore, the administration device 300 can be placed in a desired position in the living body in a stable state (stable posture) for a long period of time.

The main body 310 is formed by combining two members: a first member 310A including a top surface 301 and a second member 310B including a bottom surface 302. Note that the top surface 301 and the bottom surface 302 are referred to for convenience and do not limit the up-down direction of the administration device 300 when in use.

The first member 310A and the second member 310B are connected with their inner surfaces facing each other to form the main body 310. The inner surfaces of the first member 310A and the second member 310B are provided with concave shapes that form spaces and flow paths for arranging each component. In other words, when the members 310A, 310B are connected with their inner surfaces facing each other, the main body 310 has a structure in which each component of the administration device 300 is housed inside the box-shaped structure. The members 310A, 310B can be connected by, for example, fitting the members together, fixing them via fastening members, or fixing them using adhesives.

In this specification, for the convenience of explanation using drawings, as shown in Figures 10 and 11, reference numerals are used to indicate the components at corresponding locations on the second member 310B side. The function and structure of the administration device 300 will be explained through the explanation of the second member 310B.

The main body 310 does not have to be composed of two members such as the first member 310A and the second member 310B. For example, the main body 310 can be composed of a single member with a predetermined flow path or space defined therein.

The main body 310 has an outlet 312 through which the substance A to be administered can be released into the living body.

The administration device 300 includes an opening/closing control unit 370 disposed at the discharge port 312. The opening/closing control unit 370 is configured to open the discharge port 312 to allow the substance A to be administered to be discharged when the internal pressure of the main body unit 310 reaches a predetermined discharge pressure. The material and configuration of the opening/closing control unit 370 can be the same as those of the opening/closing control unit 70 described in the first embodiment, for example.

The main body 310 (first member 310A, second member 310B) can be made of, for example, the same materials as those exemplified as the constituent materials of the main body 10 according to the first embodiment described above. It is more preferable that the main body 310 be made of a metal material or a resin material with a predetermined rigidity (hardness) in order to ensure reliable and smooth ejection of the administered substance A by the swelling agent 330 filled in the first reservoir 380 described below.

The administration device 300 has a first reservoir 380, a second reservoir 390, a liquid permeable portion 340, a first port portion 350, a second port portion 360, a first flow path 321, a second flow path 322, and a third flow path 323.

(First reservoir 380)
The first reservoir 380 holds a swelling agent 330 that swells upon contact with a liquid component contained in bodily fluids in a living body. As the swelling agent 330, for example, the same swelling agent as that exemplified in the first embodiment can be used.

The first reservoir 380 can be configured as a space partitioned between the inner surface of the first member 310A and the inner surface of the second member 310B. As described below, in this embodiment, the first reservoir 380 is configured as a reservoir holding portion 314 that forms a space that partially or entirely surrounds the periphery of the second reservoir 390.

The swelling agent 330 is filled in the reservoir holding portion 314 that constitutes the first reservoir 380. The swelling agent 330 can be arranged so as to surround the periphery of the second reservoir 390 that is disposed in the reservoir holding portion 314.

(Second reservoir 390)
The second reservoir 390 has a function of retaining the substance A to be administered and discharging the substance A as the swelling agent 330 swells.

The second reservoir 390 can be placed in a reservoir holding portion 314 defined between the inner surface of the first member 310A and the inner surface of the second member 310B. A positioning protrusion 314a can be arranged in the reservoir holding portion 314 to prevent the second reservoir 390 from shifting out of position.

As shown in Figures 12 and 13, the second reservoir 390 includes a support 391 having a predetermined rigidity, a deformation portion 392 attached to the support 391, and a tube 393 connected to communicate between the inside and outside of the deformation portion 392.

The inside of the deformable portion 392 can be filled with the substance A to be administered. The deformable portion 392 can be made of, for example, a membrane-like member that is flexible and can be deformed when pressure is applied from the surroundings.

FIG. 13 shows the second reservoir 390 in an initial filled state before the administration of the substance A to be administered. As shown in FIG. 14, the second reservoir 390 is placed in the reservoir holding section 314 in a state where it is surrounded by the first reservoir 380 filled with a swelling agent 330. When the swelling agent 330 comes into contact with the liquid components of the body fluids in the living body and swells, the deformation section 392 of the first reservoir 380 is pressed from the periphery and deforms so as to contract. When the deformation section 392 contracts, the substance A to be administered filled inside the deformation section 392 is pushed out and discharged via the tube 393.

In the above operation for ejecting the administered substance A, the main body 310 (first member 310A and second member 310B) made of a material with a predetermined rigidity is less likely to deform due to the swelling of the swelling agent 330. Therefore, when the swelling agent 330 swells, the administration device 300 can apply an appropriate pressing force from the swelling agent 330 to the deformed portion 392 of the first reservoir 380 to eject the administered substance A.

As shown in FIG. 11, the tip of the tube 393 of the second reservoir 390 can be positioned in the third flow path 323 located between the reservoir holding portion 314 and the discharge port 312.

The first reservoir 380 and the second reservoir 390 are not limited in their specific configurations, so long as they are configured to be capable of releasing the administered substance A held in the second reservoir 390 to the outside of the main body 310 as the swelling agent 330 swells. For example, the first reservoir 380 can be configured not as a space provided in the main body 310, but as a member that holds the swelling agent 330 and is configured to expand partially or entirely as the swelling agent 330 swells. Also, for example, the second reservoir 390 does not have a structure like the support 391, and the entire second reservoir 390 may be configured as a flexible member that can expand and contract.

(Liquid transmission section 340)
The administration device 300 has a liquid permeable portion 340 that allows liquid components contained in bodily fluids in a living body to permeate to the first reservoir 380 side.

The liquid permeable portion 340 is disposed in the inlet portion 315, which is an opening disposed so as to be in constant communication with the bodily fluids in the living body. The material and configuration of the liquid permeable portion 340 can be, for example, the same as the liquid permeable portion 40 described in the first embodiment.

(First port portion 350)
The administration device 300 has a first port portion 350 that allows the flow of the swelling agent 330 between the first reservoir 380 and the outside of the main body portion 310. The first port portion 350 is configured as an opening portion provided at a predetermined position of the main body portion 310.

A first septum 351 is disposed in the first port portion 350 to prevent the swelling agent 330 from accidentally flowing out from the first port portion 350 and the inflow of bodily fluids through the first port portion 350. The material and configuration of the first septum 351 can be, for example, similar to the first septum 51 described in the first embodiment.

(Second port portion 360)
The administration device 300 has a second port portion 360 that allows the substance A to flow between the second reservoir 390 and the outside of the main body portion 310. The second port portion 360 is configured as an opening portion provided at a predetermined position of the main body portion 310.

A second septum 361 is disposed in the second port portion 360 to prevent the substance A from accidentally flowing out from the second port portion 360 and the inflow of bodily fluids through the second port portion 360. The material and configuration of the second septum 361 can be, for example, similar to the second septum 61 described in the first embodiment.

In addition, modifications to the number of ports 350, 360 (construction associated with providing separate inflow and outflow ports) and modifications to the configuration of each septum 351, 361 can be made as desired, as in the first embodiment.

The main body 310 has a first flow path 321 extending between the first port 350 and the first reservoir 380, a second flow path 322 extending from the second port 360 toward the second reservoir 390, a third flow path 323 that moves the substance A discharged from the second reservoir 390 toward the discharge port 312, and a fourth flow path 324 that connects the liquid permeable section 340 and the reservoir holding section 314 in which the reservoirs 380, 390 are disposed.

As shown in FIG. 10, the second member 310B has a fixed portion 313 that can be used to fix the main body portion 310 to a biological organ. The fixed portion 313 can be provided with a fixing hole portion (screw hole, etc.) that can be used to fix the main body portion 310 to a biological organ via a fastening member, etc.

An example of the operation of the administration device 300 is described below.

When placed in a living body, the administration device 300 can allow liquid components of bodily fluids in the living body to flow into the inside of the main body 310 via the liquid permeable section 340. The liquid components that pass through the liquid permeable section 340 flow via the fourth flow path 324 into the first reservoir 380 (reservoir holding section 314) in which the swelling agent 330 is held.

When the swelling agent 330 held in the first reservoir 380 comes into contact with the liquid component, it swells within the first reservoir 380. When the swelling agent 330 swells, the deformation portion 392 of the second reservoir 390, which is surrounded by the swelling agent 330, is pressed. This causes the second reservoir 390 to eject the substance A to be administered via the tube 393 (see FIG. 14).

The tip of the tube 393 of the first reservoir 380 is disposed in the third flow path 323 that is connected to the release port 312. Therefore, the administered substance A discharged from the tube 393 moves to the release port 312 via the third flow path 323. When the swelling agent 330 swells, the internal pressure of the main body 310 (the internal pressure of the space partitioned between the inner surface of the first member 310A and the inner surface of the second member 310B) increases. When the internal pressure of the main body 310 reaches a predetermined release pressure, the opening/closing control unit 370 opens the release port 312. As a result, the administered substance A that has been guided to the release port 312 via the tube 393 and the third flow path 323 is administered into the living body via the release port 312.

The administration device 300 can intermittently administer the substance A filled in the second reservoir 390 by repeatedly causing the swelling agent 330 to swell and stop swelling as a result of contact with the liquid components that permeate the liquid permeable section 340 and flow in.

Here, FIG. 14 shows the second reservoir 390 in a state after a predetermined amount of the substance A to be administered has been administered. When refilling the second reservoir 390 with the substance A to be administered, the surgeon etc. punctures the first septum 351 of the first port portion 350 with the first puncture member 211 of the syringe 210A for discharging the swelling agent, and punctures the second septum 361 of the second port portion 360 with the second puncture member 221 of the syringe 220 for injecting the substance to be administered, in the same manner as the procedure described in the first embodiment above (see FIG. 7).

The surgeon, with the puncture members 211, 221 puncturing the ports 350, 360, aspirates the swelling agent 330 filled in the first reservoir 380 through the inner cavity 212 of the first puncture member 211. The swelling agent 330 is guided to the first port 350 via the first flow path 321.

15, when the swelling agent 330 is discharged to the outside of the main body 310, the internal pressure of the first reservoir 380 of the administration device 300 decreases. When the internal pressure of the first reservoir 380 decreases, the deformation portion 392 of the second reservoir 390, which is surrounded by the first reservoir 380, expands. With the expansion of the deformation portion 392 of the second reservoir 390, the administration device 300 can refill the second reservoir 390 with the substance A prefilled in the syringe body 223 of the syringe 220 for injecting the substance. The refilled substance A is guided through the second port portion 360 and the second flow path 322 to the third flow path 323 in which the tip of the tube 393 is located.

After refilling the second reservoir 390 with the substance A, the surgeon adjusts the amount of substance A filled in by operating the syringe 210B for injecting the swelling agent and the syringe 220 for injecting the substance to be administered in order to return the internal pressure of the first reservoir 380 and the second reservoir 390 to their initial filling state.

Specifically, the surgeon removes the swelling agent discharge syringe 210A that was connected to the first port portion 350, and connects the swelling agent injection syringe 210B to the first port portion 350. With the swelling agent injection syringe 210B connected to the first port portion 350 as described above, when the surgeon uses the injection syringe 220 to discharge a predetermined amount of the administration subject A to the outside of the main body portion 310, the internal pressure of the second reservoir 390 decreases, and the swelling agent 330 that has been pre-filled in the syringe body 213 of the swelling agent injection syringe 210B moves into the second reservoir 390 via the inner cavity 212 of the first puncture member 211 of the swelling agent injection syringe 210B that is connected to the first reservoir 380, and is refilled.

When refilling the swelling agent 330 as described above, the surgeon can adjust the internal pressure of the first reservoir 380 and the second reservoir 390 to be similar to the initial filling state while preventing the release of the administered substance A due to the inadvertent opening of the opening/closing control unit 370 by controlling the discharge of the administered substance A so that the internal pressure of the main body 310 is maintained below the release pressure of the opening/closing control unit 370.

As described above, the administration device 300 according to this embodiment can intermittently administer the substance A held in the second reservoir 390 by repeatedly causing the swelling agent 330 held in the first reservoir 380 to swell and stop swelling due to the liquid components that have flowed into the main body 310.

Furthermore, since the administration device 300 includes the first port portion 350 and the second port portion 360, it is possible to refill the subject A while it is placed in the living body, and it is possible to adjust the volume of the swelling agent 330 (replace the swelling agent 330) so as to generate an appropriate pressing force for releasing the subject A. Therefore, when administering the subject A again after administration of a predetermined amount of the subject A filled in the administration device 300 has been completed, it is possible to omit the procedure of removing the administration device 300 from the living body and re-placing the administration device 300 removed from the living body in the living body. This makes it possible to significantly reduce the burden on the patient using the administration device 300.

<Modification of the second embodiment>
Fig. 17 shows a modified example of the administration device 300 according to the second embodiment described above. In the administration device 300A according to the modified example shown in Fig. 17, the same reference numerals are used for the parts corresponding to the parts of the administration device 300. Also, some components (ports 350, 360, etc.) are not shown.

As in the modified administration device 300A shown in FIG. 17, the main body 310 can be configured to have a curved outer shape.

The main body 310 in the modified example is configured to have a curved top surface 301 and bottom surface 302. Because the main body 310 has such a curved shape, the administration device 300A can be placed in a stable state within a living body by abutting the top surface 301 or bottom surface 302 against the surface of a biological organ (e.g., an eyeball) that has a curved outer shape. There are no particular limitations on the curvature of the top surface 301 and bottom surface 302.

Furthermore, the administration device 300, 300A according to the second embodiment and the modified example is not particularly limited in other configurations as long as it is possible to realize administration of the substance A filled in the second reservoir 390, refilling of the substance A filled in, and refilling of the swelling agent 330 filled in the first reservoir 380 by including the first reservoir 380, the second reservoir 390, the liquid permeable portion 340, the first port portion 350, and the second port portion 360, etc. For example, the arrangement of each flow path, the arrangement of each port portion, the arrangement of other components, etc. can also be changed as desired.

This application is based on Japanese Patent Application No. 2023-055136, filed on March 30, 2023, the disclosure of which is incorporated by reference in its entirety.

10 Main body 11 Inner cavity of main body 12 Release port 20 Stopper 30 Swelling agent 40 Liquid permeable portion 50 First port 51 First septum 60 Second port 61 Second septum 70 Opening/closing control portion 100 Administration device 210 First syringe 210A Syringe for discharging swelling agent 210B Syringe for injecting swelling agent 211 First puncture member 212 Inner cavity of first puncture member 213 Syringe body 220 Second syringe 221 Second puncture member 222 Inner cavity of second puncture member 223 Syringe body 300 Administration device 300A Administration device 301 Top surface 302 of main body Bottom surface 310 of main body 310 Main body 310A First member 310B Second member 312 Release port 314 Reservoir holding portion 315 Inflow portion 321 First flow path 322, second flow path 323, third flow path 324, fourth flow path 330, swelling agent 340, liquid permeable portion 350, first port portion 351, first septum 360, second port portion 361, second septum 370, opening/closing control portion 380, first reservoir 390, second reservoir 391, support 392, deformation portion 393, tube S1, first region S2, second region P1, first position P2, second position A, substance to be administered

Claims (14)

a main body having an inner cavity capable of accommodating an administration substance to be released while the device is placed in a living body, and a release port formed at a tip thereof;
A plug capable of sliding fluid-tightly within the inner cavity;
a swelling agent that is filled in a first region defined on the proximal side of the plug in the lumen and swells upon contact with a liquid component contained in a body fluid in the living body, thereby moving the plug toward the distal side;
The substance to be administered is filled in a second region defined on the distal end side of the inner cavity relative to the plug body and is released from the release port as the plug body advances;
a liquid permeable portion disposed on a proximal end side of the first region and capable of allowing a liquid component contained in a body fluid in a living body to permeate to the first region side in response to an osmotic pressure;
a first port portion disposed in the main body portion and enabling the passage of the swelling agent between the first region and an exterior of the main body portion;
An administration device having a second port portion disposed in the main body portion and enabling the passage of the administered substance between the second region and the outside of the main body portion. The first port portion has a first septum configured to be puncturable by a first puncture member having an internal cavity,
the second port portion has a second septum configured to be puncturable by a second puncture member having an internal cavity;
2. The administration device of claim 1, wherein, in a state in which the first region is connected to the outside of the main body portion via the first puncture member punctured into the first septum and the second region is connected to the outside of the main body portion via the second puncture member punctured into the second septum, the swelling agent filled in the first region can be sucked in through the first puncture member, thereby moving the stopper toward the base end side of the main body portion and allowing the substance to be administered to flow into the second region through the second puncture member. the first port portion has a swelling agent discharge port for discharging the swelling agent from the inner cavity of the main body portion, and a swelling agent introduction port for filling the swelling agent into the inner cavity of the main body portion,
2. The administration device of claim 1, wherein the second port portion has a substance discharge port for discharging the substance from the inner cavity of the main body portion, and a substance introduction port for filling the substance into the inner cavity of the main body portion. The administration device according to any one of claims 1 to 3, further comprising an opening/closing control unit disposed at the release port, which opens the release port to allow the substance to be administered to be released when the internal pressure of the cavity reaches a predetermined release pressure. the liquid permeable portion is configured to selectively allow permeation of a liquid component contained in a body fluid in a living body by osmotic pressure;
The administration device according to claim 1 , wherein the substance to be administered is a liquid or gel-like drug. The administration device according to claim 1, wherein the main body has a cylindrical outer shape with a predetermined length along the longitudinal direction. A main body portion having an outlet through which an object to be administered can be released into a living body;
a first reservoir disposed in the main body portion and holding a swelling agent that swells upon contact with a liquid component contained in a body fluid in a living body;
a second reservoir disposed in the main body portion, for holding the substance to be administered and discharging the substance to be administered as the swelling agent swells;
a liquid permeable portion that is arranged to communicate with the first reservoir and that is capable of allowing a liquid component contained in a body fluid in a living body to permeate to the first reservoir;
a first port portion that allows the swelling agent to flow between the first reservoir and the outside of the main body portion;
A second port portion that allows the substance to be administered to pass between the second reservoir and the outside of the main body portion;
a first flow passage extending between the first port portion and the first reservoir;
a second flow passage extending from the second port portion toward the second reservoir;
and a third flow path that moves the substance discharged from the second reservoir toward the outlet. The first port portion has a first septum configured to be puncturable by a first puncture member having an internal cavity,
the second port portion has a second septum configured to be puncturable by a second puncture member having an internal cavity;
8. The administration device according to claim 7, wherein, in a state in which the first reservoir is connected to the outside of the main body via the first puncture member punctured into the first septum and the second reservoir is connected to the outside of the main body via the second puncture member punctured into the second septum, the swelling agent filled in the first reservoir is sucked in through the first puncture member, thereby contracting the first reservoir and allowing the substance to be administered to flow into the second reservoir through the second puncture member. the first port portion has a swelling agent discharge port for discharging the swelling agent from inside the main body portion, and a swelling agent introduction port for filling the swelling agent into the main body portion,
8. The administration device of claim 7, wherein the second port portion has a substance discharge port for discharging the substance from within the main body portion, and a substance introduction port for filling the substance into the main body portion. The administration device according to any one of claims 7 to 9, further comprising an opening/closing control unit disposed at the release port, which opens the release port to allow the substance to be administered to be released when the internal pressure of the main body reaches a predetermined release pressure. the liquid permeable portion is configured to selectively allow permeation of a liquid component contained in a body fluid in a living body by osmotic pressure;
The administration device according to claim 7 , wherein the substance to be administered is a liquid or gel-like medicine. The administration device according to claim 7, wherein the main body has a box-shaped structure with flat top and bottom surfaces, or a box-shaped structure with curved top and bottom surfaces. The first reservoir is formed of a space partitioned by the main body portion,
The administration device of claim 7 , wherein the second reservoir is disposed within the space that defines the first reservoir. The first reservoir is disposed in the main body portion and is configured as a member containing the swelling agent therein,
8. The administration device of claim 7, wherein the second reservoir is disposed inside the first reservoir and is surrounded by the swelling agent.