WO2023181996A1

WO2023181996A1 - Administration device

Info

Publication number: WO2023181996A1
Application number: PCT/JP2023/009313
Authority: WO
Inventors: 拓心密岡; 陽一郎岩瀬; 学有延
Original assignee: テルモ株式会社
Priority date: 2022-03-25
Filing date: 2023-03-10
Publication date: 2023-09-28

Abstract

[Problem] To administer a substance to be administered in a non-electric and intermittent manner while being placed in a living body. [Solution] An administration device 100A comprises: a body portion 10A that has a lumen 11A capable of containing a substance X to be administered that is to be released into a living body, the body portion 10A having a release opening 12A formed in the tip thereof for the substance X to be administered; a plug 40A that can slide in the lumen 11A in a liquid-tight manner; a pressing portion 30A that is disposed upstream of the plug 40A in the lumen 11A and that is continuously driven in a non-electric manner to press the plug 40A downstream; and an open/close control portion 50A that is disposed on the tip side of the body portion 10A, and that, when the internal pressure of the lumen 11A reaches a predetermined release pressure, opens the release opening 12A to permit the release of the substance X to be administered. When a predetermined amount of the substance X to be administered has been released and the internal pressure of the lumen 11A drops below the release pressure, the open/close control portion 50A closes the release opening 12A to limit the release of the substance X to be administered.

Description

dosing device

TECHNICAL FIELD The present invention relates to an administration device that intermittently administers a substance to be administered, such as a drug solution, while being left in a living body.

Patent Document 1 discloses an osmotic delivery device that is a continuous administration device that continuously releases a drug as an administered substance over a long period of time while being implanted in a living body.

The device of Patent Document 1 includes a hollow container (body part), a piston (stopper body) slidably held within the container, and an osmotic pressure engine (pressing part) that serves as a driving source for pressing the piston. , a semipermeable membrane (liquid permeation part) placed at the proximal end of the container that allows liquid components in the body fluid (extracellular fluid) to pass through to the osmotic pressure engine, and a drug pressed by a piston placed at the tip end of the container. and a delivery orifice (emission section) for emitting. The container is divided into two spaces by the piston: a drug storage space (second space) located on the distal end side of the container with the piston as the boundary, and a proximal end side of the container that is on the opposite side of the second space with the piston as the boundary. an osmotic agent storage space (first space) located at It is configured to be able to slide toward the distal end and release the drug contained in the second space into the living body.

JP 2017-57212 Publication

Incidentally, there are some substances to be administered, such as nucleic acid medicines, for which it is more appropriate to administer a small amount intermittently during the administration period (an administration method that repeats administration and stoppage) rather than continuous administration. However, conventional continuous administration devices, including the device of Patent Document 1, cannot handle intermittent administration because they are devices intended to continuously administer (sustained release) a substance to be administered over a predetermined period of time.

In order to achieve intermittent administration of the substance to be administered, it is also possible to consider a configuration in which the conventional continuous administration device is improved and the stopper is intermittently driven by an electric drive mechanism such as a small motor. However, from a manufacturing standpoint, it is difficult to manufacture and mount an electric mechanism for intermittent dosing in a size that can be accommodated in a continuous dosing device as small as several centimeters.

At least one embodiment of the present invention has been made in view of the above-mentioned circumstances, and specifically, an administration device that can non-electrically intermittently administer a substance to be administered while indwelling in a living body. Our goal is to provide the following.

The administration device according to the present embodiment includes a main body portion that has a lumen capable of accommodating a substance to be administered to be released into a living body, and a main body portion having a discharge port for the substance to be administered at the tip, and a plug body that can slide in a fluid-tight manner; a pressing portion that is disposed upstream of the plug body in the inner cavity and that is continuously driven in a non-electrical manner to press the plug body downstream; When the internal pressure of the lumen reaches a predetermined release pressure, the release port is opened to allow the release of the administered substance, and a certain amount of the administered substance is released to release the administered substance. The device further includes an opening/closing control unit that closes the discharge port to restrict release of the administered substance when the internal pressure of the cavity falls below the discharge pressure.

According to at least one embodiment of the present invention, it is possible to non-electrically intermittently administer a substance to be administered while it is left in a living body. Therefore, it is possible to intermittently administer a drug that is preferably administered intermittently at appropriate dosing intervals without installing an electrical drive mechanism.

It is a schematic sectional view of the administration device concerning a 1st embodiment. FIG. 2 is a schematic cross-sectional view of the vicinity of the tip of the administration device according to the first embodiment. FIG. 3 is a conceptual diagram showing the operation of the administration device according to the first embodiment. FIG. 3 is a conceptual diagram showing the operation of the administration device according to the first embodiment. FIG. 3 is a conceptual diagram showing the operation of the administration device according to the first embodiment. It is a schematic sectional view of the administration device concerning a 2nd embodiment. It is a schematic sectional view of the tip part vicinity of the administration device concerning a 2nd embodiment. It is a conceptual diagram which shows the operation|movement of the administration device based on 2nd Embodiment. It is a conceptual diagram which shows the operation|movement of the administration device based on 2nd Embodiment. It is a conceptual diagram which shows the operation|movement of the administration device based on 2nd Embodiment. It is a schematic sectional view of the administration device concerning a 3rd embodiment. It is a schematic sectional view of the tip part vicinity of the administration device concerning a 3rd embodiment. It is a conceptual diagram which shows the operation|movement of the administration device based on 3rd Embodiment. It is a conceptual diagram which shows the operation|movement of the administration device based on 3rd Embodiment. It is a conceptual diagram which shows the operation|movement of the administration device based on 3rd Embodiment. It is a schematic sectional view of the administration device concerning a 4th embodiment. It is a schematic sectional view of the tip part vicinity of the administration device concerning a 4th embodiment. It is a conceptual diagram which shows the operation|movement of the administration device based on 4th Embodiment. It is a conceptual diagram which shows the operation|movement of the administration device based on 4th Embodiment. It is a conceptual diagram which shows the operation|movement of the administration device based on 4th Embodiment.

Hereinafter, embodiments for carrying out the present invention will be described in detail with reference to the drawings. The embodiments shown here are exemplified to embody the technical idea of the present invention, and are not intended to limit the present invention. In addition, all other possible embodiments, examples, operational techniques, etc. that can be considered by those skilled in the art without departing from the gist of the present invention are included within the scope and gist of the present invention, and are described in the claims. inventions and their equivalents.

Furthermore, for the convenience of illustration and ease of understanding, the drawings attached to this specification may be represented schematically by changing the scale, vertical/width dimensional ratio, shape, etc. from the actual thing as appropriate, but these are merely examples. However, this does not limit the interpretation of the present invention.

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

In the administration devices according to the first to fourth embodiments described below, the "tip side (downstream side)" refers to the side where the opening/closing control section is arranged in the axial direction of the main body (where the object to be administered is administered). The "proximal side (upstream side)" is the side opposite to the distal end side where the liquid permeable part is arranged (the side where the liquid in the living body enters the main body part). For example, in FIG. 1, the distal end side is on the right side of the figure, and the proximal end side is on the left side of the figure.

[First embodiment]
An administration device 100A according to the first embodiment will be described. The administration device 100A is indwelled in a living body, and enables intermittent administration of the substance to be administered based on predetermined administration conditions while being continuously driven non-electrically.

The administration device 100A releases (administers) the substance )can do. The administration device 100A can perform intermittent administration over a long period of time (at least several weeks to several months, or even several years).

The administered substance X to be administered from the administration device 100A is a fluid composition that can be administered to a living body to be administered to produce a predetermined effect, and can be intermittently released from the device. The administered substance X is, for example, a drug (liquid) for the purpose of treating a predetermined disease. Medications include drugs. A drug can be any physiologically or pharmacologically active substance, especially one known to be delivered to the human or animal body. Drugs affect peripheral nerves, adrenergic receptors, cholinergic receptors, skeletal muscle, cardiovascular system, smooth muscle, vascular system, synaptic sites, neuroexchanger junction sites, endocrine and hormonal systems, immune system, reproductive organs. the skeletal system, the local hormonal system, the digestive and excretory system, the histamine system, or the 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 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. .

As shown in FIG. 1, the administration device 100A generally includes a main body portion 10A, a liquid permeable portion 20A, a pressing portion 30A, a stopper 40A, and an opening/closing control portion 50A.

The main body portion 10A is composed of a hollow cylindrical member that has an inner cavity 11A and constitutes a housing of the administration device 100A. A discharge port 12A from which the substance to be administered X is discharged is formed at the tip of the main body portion 10A. The liquid permeable portion 20A, the pressing portion 30A, the plug body 40A, and the opening/closing control portion 50A are arranged in this order from the base end to the distal end of the main body portion 10A.

The main body portion 10A has a first space Y1 and a second space Y2 with the stopper 40A as a boundary. The first space Y1 is a space defined by the liquid permeable part 20A and the stopper 40A (the space between the attached end of the liquid permeable part 20A and the base end of the stopper 40A in the main body part 10A), and is a space defined by the liquid permeable part 20A and the stopper 40A. It is a space that accommodates. The second space Y2 is a space defined by the stopper 40A and the opening/closing control section 50A (space between the base end of the stopper 40A and the base end of the opening/closing control section 50A), and is a space defined by the stopper 40A and the opening/closing control section 50A. This is the space where X is accommodated. Moreover, the second space Y2 constitutes a sliding area of the stopper 40A.

The first space Y1 and the second space Y2 expand or contract as the stopper 40A slides before and after the administration device 100A is driven. That is, when the administration device 100A starts driving, the stopper 40A slides downstream by the pressing portion 30A, and the first space Y1 gradually expands. Further, when the administration device 100A starts driving, the stopper 40A slides downstream by the pressing portion 30A, and the second space Y2 gradually becomes smaller.

In order to maintain the release accuracy of the administered substance X by sliding the stopper 40A, the main body 10A is configured such that at least the lumen 11A in the sliding area of the stopper 40A is collapsed due to buckling or the like and the shape of the lumen 11A (axis It is necessary to prevent the sliding movement of the stopper 40A from being obstructed due to deformation of the cross-sectional shape (crossing the direction). The constituent materials of the main body 10A include resin materials that are non-invasive or minimally invasive to living organisms and known in the medical field (acrylonitrile polymers, halogenated polymers, polyimide, polysulfone, polycarbonate, polyethylene, polypropylene, polychloride). vinyl-acrylic acid copolymer, polycarbonate-acrylonitrile-butadiene-styrene, and polystyrene), metal materials (stainless steel, titanium, nickel, aluminum, vanadium, platinum, tantalum, gold, and alloys thereof, and gold plating) Applicable materials include iron alloys, platinum-plated iron alloys, cobalt chromium alloys, and titanium nitride-coated stainless steel.

The liquid permeable part 20A is arranged on the proximal end side of the main body part 10A, isolates the living body from the inside of the administration device 100A, and allows only the liquid component contained in the body fluid in the living body to pass therethrough. The liquid permeable portion 20A is made of a member having a solid-liquid separation function that allows only moisture in body fluids to permeate therethrough.

The liquid permeable portion 20A is made of, for example, a plasticized cellulose material, reinforced polymethyl methacrylates (PMMA) such as hydroxylethyl methacrylate (HEMA), polyurethanes, polyamides, and polyether-polyamide copolymers. Semipermeable membranes constructed of materials such as elastomeric materials, such as thermoplastic copolyesters, or mixtures thereof can be applied.

The pressing part 30A is located downstream of the liquid permeable part 20A in the main body part 10A, and uses an osmotic pressure engine that uses the principle of osmotic pressure to swell and expand with water that has passed through the liquid permeable part 20A. The stopper 40A is pushed downstream by non-electrical continuous driving. The pressing portion 30A gradually swells with the water that has passed through the liquid permeable portion 20A, and slides the stopper 40A downstream by a pressing action caused by an increase in internal pressure in the first space Y1 due to this swelling.

The constituent material, size, etc. of the pressing part 30A can be determined as appropriate so that the pressing speed of the stopper 40A (i.e., the swelling speed of the pressing part 30A) corresponds to the administration conditions of the substance to be administered. In the dosing device 100A, the dosing interval and dose due to intermittent dosing can be adjusted depending on the composition of the osmotic engine constituting the pressing section 30A and the shape of the semipermeable membrane constituting the liquid permeable section 20A.

The pressing unit 30A is not limited to an osmotic pressure engine, but may employ other configurations as long as it can be continuously driven non-electrically to press the stopper 40A toward the downstream side.

The plug body 40A has a columnar base 41A extending in the longitudinal direction of the main body 10A, and an annular protruding protrusion 42A protruding from the radial outer circumference of the base 41A. The stopper 40A is pressed by the pressing portion 30A, moves downstream, and pushes out the object X accommodated in the second space Y2 toward the opening/closing control portion 50A. The plug body 40A is located downstream of the pressing part 30A in the main body part 10A, and its outer circumferential surface is in fluid-tight contact with the inner circumferential surface of the inner cavity 11A of the main body part 10A, and the plug body 40A slides into the inner cavity 11A. Possibly located.

A plurality of protruding portions 42A are provided on the outer surface of the base portion 41A, and the apex portion that protrudes most outwardly contacts the inner circumferential surface of the inner cavity 11A of the main body portion 10A. The protrusion 42A seals with the inner circumferential surface of the lumen 11A so that the administered substance X does not leak upstream from the stopper 40A.

Note that the number and position of the protrusions 42A are not particularly limited. Moreover, the stopper 40A may have a configuration without the protruding portion 42A, that is, a configuration in which the outer circumferential surface of the base portion 41A directly contacts the inner circumferential surface of the inner cavity 11A to be liquid-tight.

The plug body 40A is made of a flexible material that maintains close contact (liquid tightness) with the inner circumferential surface of the lumen 11A of the main body portion 10A. The flexible material is preferably an elastic material, and examples of the elastic material include various rubber materials such as natural rubber, isoprene rubber, butyl rubber, chloroprene rubber, nitrile-butadiene rubber, styrene-butadiene rubber, and silicone rubber. sulfur-treated), styrenic elastomers, hydrogenated styrene elastomers, and polyolefins such as polyethylene, polypropylene, polybutene, α-olefin copolymers, etc., liquid paraffin, process oils, and talc. Examples include mixtures of powdered inorganic materials such as , cast, and mica. Further, polyvinyl chloride elastomers, olefin elastomers, polyester elastomers, polyamide elastomers, polyurethane elastomers, and mixtures thereof can be used as constituent materials. As the constituent material, diene rubber, styrene elastomer, etc. can be used, especially from the viewpoint that they have elastic properties and can be sterilized by gamma rays, electron beams, or high-pressure steam. In addition, the stopper 40A only needs to have a structure that allows it to slide liquid-tightly within the inner cavity 11A. Therefore, in the plug body 40A, the base portion 41A and the protruding portion 42A may be made of a flexible material or an elastic material, or, for example, only the protruding portion 42A that contacts the inner cavity 11A may be made of an elastic material, and the base portion 41A may be made of an elastic material. It may be made of a hard material that does not have elasticity.

As shown in FIG. 2, the opening/closing control section 50A includes a valve body 51A that is disposed on the distal end side of the main body section 10A and is capable of opening and closing the discharge port 12A, and a holding section 52A that holds the valve body 51A. Prepared and configured. The opening/closing control unit 50A has pressure responsiveness and opens or closes the discharge port 12A depending on whether the internal pressure in the inner cavity 11A reaches a predetermined discharge pressure. The opening/closing control section 50A can be configured to have the same function as an umbrella valve, which is a pressure-responsive one-way valve.

The valve body 51A includes a shaft portion 511A extending in the axial direction of the discharge port 12A, and an umbrella-shaped closing portion 512A formed around the distal end side of the shaft portion 511A and closing the discharge port 12A so as to cover the discharge port 12A. It consists of:

The valve body 51A is made of an elastic member, and when the internal pressure in the lumen 11A reaches the release pressure due to movement of the stopper 40A, a part of the closing portion 512A separates from the discharge port 12A to open the discharge port 12A. (See Figure 3B). Furthermore, when the release of a certain amount of the administered substance X is completed and the internal pressure within the lumen 11A becomes lower than the release pressure, the separated portion of the closing portion 512A returns to its original position (shape) and releases the object. Close outlet 12A (see Figure 3C). Note that the white arrows in FIGS. 3B and 3C indicate the internal pressure inside the lumen 11A, and in FIG. 3B, the internal pressure has reached the discharge pressure, and in FIG. 3C, the internal pressure is below the discharge pressure. It is expressed as.

The "discharge pressure" is a pressure value for intermittently discharging a predetermined amount of the administered substance X at predetermined dosing intervals when the stopper 40A pressed by the pressing part 30A moves downstream. The valve body 51A of the opening/closing control section 50A is designed to at least partially move to open the discharge port 12A when the internal pressure in the inner cavity 11A reaches the discharge pressure. Therefore, in the opening/closing control unit 50A, when the internal pressure of the lumen 11A reaches the release pressure, at least a portion of the valve body 51A opens the release port 12A and can release the administered substance X. Note that the discharge pressure can be appropriately set according to the administration conditions of the substance to be administered X to be used.

The holding portion 52A is fixed to the inner cavity 11A and holds the shaft portion 511A of the valve body 51A. The holding portion 52A is provided with one or more through holes 521A through which the object to be administered X can pass. The shape and number of the through-holes 521A can be appropriately set in consideration of the amount of the administered substance X per dose, the viscosity of the administered substance X, and the like.

As shown in FIG. 2, the holding portion 52A can be fixed by cutting a part of the inner cavity 11A into a groove shape and fitting into this groove-shaped portion. The holding portion 52A may be adhesively fixed to the inner cavity 11A using an adhesive or the like.

The administration device 100A according to the first embodiment described above is percutaneously introduced into a living body lumen after being filled with the substance to be administered X to be administered. FIG. 3A shows the state immediately after the administration device 100A is placed in the living body.

In the administration device 100A, as shown in FIG. 3B, when the internal pressure in the lumen 11A reaches the release pressure due to movement of the stopper 40A, the valve body 51A is pushed by the substance X and air in the lumen 11A. A portion is separated, opening the discharge port 12A. At this time, a certain amount of the administered substance X is administered into the living body from the opened discharge port 12A.

Then, as shown in FIG. 3C, in the administration device 100A, when the administration of a certain amount of the substance The body 51A returns to its original position and closes the discharge port 12A. In the administration device 100A, administration of the substance to be administered X is stopped until the internal pressure within the lumen 11A reaches the discharge pressure again. By repeatedly performing the series of operations described above, the administration device 100A can intermittently administer the substance to be administered X while being left in the living body.

[Second embodiment]
Next, the administration device 100B according to the second embodiment will be described with reference to FIGS. 4 to 6 as appropriate.

In addition, in the administration device 100B according to the second embodiment, components having the same functions as those in the first embodiment described above are given the same or related symbols, detailed explanations are omitted, and configurations that are not particularly mentioned. The members, method of use, etc. may be the same as those in the first embodiment described above.

As shown in FIG. 4, the administration device 100B includes a main body portion 10B, a liquid permeable portion 20B, a pressing portion 30B, a stopper 40B, and an opening/closing control portion 50B.

In the administration device 100B according to the second embodiment, as shown in FIGS. 4 and 5, the configuration of the opening/closing control section 50B is different from the configuration of the opening/closing control section 50A of the first embodiment. In addition, in the administration device 100B of the second embodiment, as in the administration device 100A of the first embodiment, the pressing part 30B is continuously driven non-electrically to press the stopper 40B, but it remains indwelled in the living body. The device has a configuration that allows for intermittent administration of the substance to be administered based on predetermined administration conditions.

As shown in FIG. 5, the opening/closing control section 50B is disposed on the distal end side of the main body section 10B, and is provided with a valve body 51B that can open and close the discharge port 12B, and is fixed to the inner cavity 11B. a base 52B, a slit 53B provided at the tip of the valve body 51B, a liquid passage port 54B provided on the side into which the administered substance X flows, and a channel 55B connecting the liquid passage port 54B to the slit 53B. , consists of. The opening/closing control section 50B has pressure responsiveness and opens or closes the discharge port 12B depending on whether the internal pressure in the inner cavity 11B reaches a predetermined discharge pressure. The opening/closing control section 50B can be configured to have the same function as a duckbill valve, which is a pressure-responsive one-way valve.

The valve body 51B is made of an elastic member, and is made up of a pair of valve members that extend in the axial direction of the discharge port 12B and are inclined so as to gradually converge at the axial center toward the tip. The base end of the valve body 51B is connected to the base 52B. The tip of the valve body 51B is arranged to face the tip of the other valve body 51, and is configured to be able to approach and separate. The slit 53B is formed at the tip of the valve body 51B.

When the internal pressure in the lumen 11B reaches the release pressure due to the movement of the stopper 40B, the valve body 51B deforms and opens the slit 53B to open the discharge port 12B (see FIG. 6B). Further, when the release of a certain amount of the administered substance X is completed and the internal pressure in the lumen 11B becomes lower than the release pressure, the tip of the valve body 51B returns to its original posture (shape) before deformation. to close the slit 53B and block the discharge port 12B (see FIG. 6C). Note that the white arrows in FIGS. 6B and 6C indicate the internal pressure inside the lumen 11B, and in FIG. 6B, the internal pressure has reached the discharge pressure, and in FIG. 6C, the internal pressure is below the discharge pressure. It is expressed as.

The base portion 52B is fixed to the inner cavity 11B, and the base end of the valve body 51B is connected to the base portion 52B. The base 52B is provided with a liquid passage port 54B through which the substance to be administered X can pass. The liquid passage port 54B is connected to the slit 53B via a flow path 55B formed inside the valve body 51B. The shape and number of the liquid passage ports 54B can be appropriately set in consideration of the amount of the substance to be administered per time, the viscosity of the substance to be administered, and the like.

As shown in FIG. 5, the base 52B can be fixed by cutting a part of the inner cavity 11B into a groove and fitting into the groove. The base portion 52B may be adhesively fixed to the inner cavity 11B using an adhesive or the like.

Similarly to the first embodiment, the administration device 100B according to the second embodiment described above is percutaneously introduced into a living body lumen after being filled with the substance X to be administered. FIG. 6A shows the state immediately after the administration device 100B is placed in the living body.

In the administration device 100B, as shown in FIG. 6B, when the internal pressure in the lumen 11B reaches the release pressure due to movement of the stopper 40B, the valve body 51B is pushed by the object X and air in the lumen 11B. The tip portions are deformed and separated, opening the discharge port 12B. At this time, a certain amount of the administered substance X is administered into the living body from the opened discharge port 12B.

Then, as shown in FIG. 6C, in the administration device 100B, when the administration of a certain amount of the substance It weakens, the valve body 51B returns to its original position, and the tip of the valve body 51B closes, thereby closing the discharge port 12B. In the administration device 100B, administration of the substance to be administered X is stopped until the internal pressure within the lumen 11B reaches the discharge pressure again. By repeatedly performing the series of operations described above, the administration device 100B can intermittently administer the substance to be administered X while being left in the living body.

[Third embodiment]
Next, an administration device 100C according to the third embodiment will be described with reference to FIGS. 7 to 9 as appropriate.

In addition, in the administration device 100C according to the third embodiment, constituent elements having the same functions as those in the first embodiment and the second embodiment described above are given the same or related numerals, and detailed explanations are omitted. Configurations, members, usage methods, etc. that are not particularly mentioned may be the same as those in the first embodiment described above.

As shown in FIG. 7, the administration device 100C includes a main body portion 10C, a liquid permeable portion 20C, a pressing portion 30C, a stopper 40C, and an opening/closing control portion 50C.

In the administration device 100C, the configuration of the opening/closing control section 50C is different from the configuration of the opening/closing control section 50A of the first embodiment and the opening/closing control section 50B of the second embodiment. In addition, in the administration device 100C of the third embodiment, as in the administration devices 100A and 100B of the first and second embodiments, the pressing portion 30C is continuously driven non-electrically to press the stopper 40C. The device has a device configuration that allows for intermittent administration of the substance to be administered based on predetermined administration conditions while it remains in the body.

As shown in FIG. 8, the opening/closing control section 50C is disposed on the distal end side of the main body section 10C, and is provided with a valve body 51C that can open and close the discharge port 12C, and a liquid passage port 53C for the administered substance X. The valve body 52C is configured to include a base 52C, and a tensioning portion 54C, which has one end connected to the valve body 51C and the other end connected to the base 52C, and which pulls the valve body 51C toward the discharge port 12C with a tensile force weaker than the discharge pressure. Ru. The opening/closing control section 50C opens or closes the discharge port 12C depending on whether the internal pressure in the inner cavity 11C reaches a predetermined discharge pressure.

The valve body 51C is composed of a plate-like member that covers and closes the discharge port 12C. The valve body 51C is connected to the tension portion 54C and is pulled toward the discharge port 12C with a tensile force that is weaker than the discharge pressure. When the internal pressure in the inner cavity 11C has not reached the release pressure, the valve body 51C covers the release port 12C and maintains the closed state due to the tensile action of the tension portion 54C. The shape and material of the valve body 51C are not particularly limited as long as the valve body 51C has properties that can cut off communication between the inner cavity 11C and the outside when closed.

When the internal pressure within the lumen 11C reaches the release pressure, the valve body 51C moves in a direction away from the release port 12C against the tensile force of the tensioning portion 54C to open the release port 12C (see FIG. 9B). ). Further, when the discharge of a certain amount of the administered substance X is completed and the internal pressure in the inner cavity 11C becomes lower than the discharge pressure, the valve body 51C is pulled by the tensioning action of the tension portion 54C, and the discharge port 12C is pulled. (see Figure 9C). Note that the white arrows in FIGS. 9B and 9C indicate the internal pressure in the inner cavity 11C, and in FIG. 9B, the internal pressure has reached the discharge pressure, and in FIG. 9C, the internal pressure is below the discharge pressure. It is expressed as.

The base portion 52C is fixed to the inner cavity 11C and connected to the valve body 51C via the tension portion 54C. The base 52C is provided with a liquid passage port 53C through which the object X pressed by the stopper 40C can pass. The shape and number of the liquid passage ports 53C can be appropriately set in consideration of the amount of the administered substance X per dose, the viscosity of the administered substance X, and the like.

As shown in FIG. 8, the base 52C can be fixed by cutting a part of the inner cavity 11C into a groove and fitting into the groove. The base portion 52C may be adhesively fixed to the inner cavity 11C using an adhesive or the like.

The tension portion 54C has one end connected to the valve body 51C, the other end connected to the base portion 52C, and is made of an elastic member that can be elastically contracted like a torsion coil spring. The tensioning portion 54C pulls the valve body 51C toward the discharge port 12C with a tensile force (elastic contraction force) that is weaker than the pressing force due to the discharge pressure. When the internal pressure in the inner cavity 11C reaches the release pressure, the valve body 51C pulled by the tensioning part 54C is pressed in a direction away from the outlet 12C to open the outlet 12C, and the internal pressure in the inner cavity 11C is released. When the pressure drops below the pressure, the tensioning force of the tensioning portion 54C pulls the discharge port 12C toward the discharge port 12C, thereby closing the discharge port 12C.

Similarly to the first and second embodiments, the administration device 100C according to the third embodiment described above is percutaneously introduced into a living body lumen after being filled with the substance X to be administered. FIG. 9A shows the state immediately after the administration device 100C is placed in the living body.

In the administration device 100C, as shown in FIG. 9B, when the internal pressure in the lumen 11C reaches the release pressure due to the movement of the stopper 40C, the valve body 51C is pushed by the object X and air in the lumen 11C. It moves in a direction away from the discharge port 12C against the tensile force of the tension portion 54C to open the discharge port 12C. At this time, a certain amount of the administered substance X is administered into the living body from the opened discharge port 12C.

Then, as shown in FIG. 9C, in the administration device 100C, when the administration of a certain amount of the substance Therefore, the valve body 51C is pulled toward the discharge port 12C by the tensioning action of the tension portion 54C, thereby closing the discharge port 12C. In the administration device 100C, administration of the substance to be administered X is stopped until the internal pressure in the lumen 11C reaches the discharge pressure again. By repeatedly performing the series of operations described above, the administration device 100C can intermittently administer the substance to be administered X while being left in the living body.

[Fourth embodiment]
Next, an administration device 100D according to a fourth embodiment will be described with reference to FIGS. 10 to 12 as appropriate.

The administration device 100D according to the fourth embodiment is a modification of the third embodiment described above, and the operation mode during intermittent administration is the same. Therefore, constituent elements having the same functions as those in the third embodiment are given the same or related reference numerals, and detailed explanations are omitted. It may be similar to the embodiment.

As shown in FIG. 10, the administration device 100D includes a main body portion 10D, a liquid permeable portion 20D, a pressing portion 30D, a stopper 40D, and an opening/closing control portion 50D.

In the administration device 100D, the configuration of the opening/closing control section 50D is different from the configuration of the opening/closing control section 50C of the third embodiment. Also, in the administration device 100D of the fourth embodiment, the pressing portion 30D is continuously driven non-electrically to press the stopper 40D, as in the administration devices 100A to 100C of the first to third embodiments. The device has a device configuration that allows for intermittent administration of the substance to be administered based on predetermined administration conditions while it remains in the body.

As shown in FIG. 11, the opening/closing control section 50D is disposed on the distal end side of the main body section 10D, and is provided with a valve body 51D that can open and close the discharge port 12D, and a liquid passage port 53D for the administered substance X. The valve body 52D is configured to include a base 52D, and a tensioning portion 54D, which has one end connected to the valve body 51D and the other end connected to the base 52D, and which pulls the valve body 51D toward the discharge port 12D with a tensile force weaker than the discharge pressure. Ru. The opening/closing control unit 50D opens or closes the discharge port 12D depending on whether the internal pressure within the lumen 11D reaches a predetermined discharge pressure.

The valve body 51D is composed of a plate-like member that covers and closes the discharge port 12D. The valve body 51D is connected to the tensioning portion 54D and is pulled toward the discharge port 12D with a tensile force that is weaker than the discharge pressure. When the internal pressure within the lumen 11D has not reached the release pressure, the valve body 51D covers the release port 12D and maintains the closed state due to the tensile action of the tension portion 54D. Like the valve body 51C, the shape and constituent material of the valve body 51D are not particularly limited as long as the valve body 51D has properties that can cut off communication between the inner cavity 11D and the outside when closed.

When the internal pressure in the lumen 11D reaches the release pressure, the valve body 51D moves in a direction away from the release port 12D against the tensile force of the tensioning portion 54D to open the release port 12D (see FIG. 12B). ). Further, when the discharge of a certain amount of the administered substance X is completed and the internal pressure in the inner cavity 11D becomes lower than the discharge pressure, the valve body 51D is pulled by the tensioning action of the tensioning portion 54D, and the discharge port 12D is pulled. (see Figure 12C). Note that the white arrows in FIGS. 12B and 12C indicate the internal pressure inside the lumen 11D, and in FIG. 12B, the internal pressure has reached the discharge pressure, and in FIG. 12C, the internal pressure is below the discharge pressure. It is expressed as.

The base portion 52D is fixed to the inner cavity 11D and connected to the valve body 51D via the tension portion 54D. The base 52D is provided with a liquid passage port 53D through which the object X pressed by the stopper 40D can pass. The shape and number of the liquid passage ports 53D can be appropriately set in consideration of the amount of the administered substance X per dose, the viscosity of the administered substance X, and the like.

As shown in FIG. 11, the base 52D can be fixed by cutting a part of the inner cavity 11D into a groove and fitting into the groove. The base portion 52D may be adhesively fixed to the inner cavity 11D using an adhesive or the like.

The tension portion 54D is composed of a first magnetic body 541D connected to the valve body 51D and a base portion 52D. The base 52 functions as a second magnetic body 542D. The first magnetic body 541D is fitted into a non-magnetic support portion 521D extending from the base 52D to the distal end side, and is arranged so as to be relatively movable along the axial direction of the inner cavity 11D. The first magnetic body 541D and the second magnetic body 542D have different magnetic poles (N pole or S pole), and generate a tensile force (magnetic attractive force) that is weaker than the discharge pressure. When the internal pressure in the inner cavity 11D reaches the release pressure, the valve body 51D pulled by the tensioning part 54D is pressed in a direction away from the outlet 12D to open the outlet 12D, and the internal pressure in the inner cavity 11D is released. When the pressure drops below the pressure, the tensioning force of the tensioning portion 54D pulls the discharge port 12D toward the discharge port 12D, thereby closing the discharge port 12D.

Similarly to the first to third embodiments, the administration device 100D according to the fourth embodiment described above is percutaneously introduced into a living body lumen after being filled with the substance to be administered X to be administered. FIG. 12A shows the state immediately after the administration device 100D is placed in the living body.

In the administration device 100D, as shown in FIG. 12B, when the internal pressure in the lumen 11D reaches the release pressure due to the movement of the stopper 40D, the valve body 51D is pushed by the substance X and air in the lumen 11D, The discharge port 12D is opened by moving in a direction away from the discharge port 12D against the tensile force of the tension portion 54D. At this time, a certain amount of the administered substance X is administered into the living body from the opened discharge port 12D.

Then, in the administration device 100D, as shown in FIG. 12C, when the administration of a certain amount of the object X is finished and the internal pressure in the lumen 11D becomes lower than the discharge pressure, the pressing force of the air in the lumen 11D weakens. Therefore, the valve body 51D is pulled toward the discharge port 12D by the tensioning action of the tension portion 54D, thereby closing the discharge port 12D. In the administration device 100D, administration of the substance to be administered X is stopped until the internal pressure within the lumen 11D reaches the discharge pressure again. By repeatedly performing the above-described series of operations, the administration device 100D can intermittently administer the substance to be administered while the administration device 100D is left in the living body.

[Effect]
As explained above, the administration devices 100A to 100D according to the present embodiment have internal cavities 11A to 11D that can accommodate the administered substance X to be released into the living body, and have a discharge port for the administered substance X at the tip. 12A to 12D are formed, plugs 40A to 40D that can slide liquid-tightly inside the lumens 11A to 11D, and plugs 40A to 40D that are upstream of the plugs 40A to 40D in the lumens 11A to 11D. Pressing parts 30A to 30D are arranged and continuously driven non-electrically to push the stoppers 40A to 40D downstream, and pressure parts 30A to 30D are arranged at the distal ends of the main bodies 10A to 10D to maintain the internal pressure of the lumens 11A to 11D at a predetermined level. When the discharge pressure reaches the discharge pressure, the discharge ports 12A to 12D are opened to allow the discharge of the administered substance , opening/closing control units 50A to 50D that close the discharge ports 12A to 12D to restrict release of the administered substance X.

The administration devices 100A to 100D utilize the structure of a conventional continuous administration device, and have opening/closing control sections 50A to 50D arranged on the distal end side of the main body sections 10A to 10D instead of the ejection section. The pressing parts 30A to 30D of the administration devices 100A to 100D are configured to be non-electrically driven continuously, and the opening/closing control parts 50A to 50D have pressure responsiveness, so that the internal pressure within the lumens 11A to 11D is controlled by the administered body. It is activated when a release pressure set according to the administration conditions of the substance X is reached, and the substance to be administered can be intermittently released into the living body. Therefore, the administration devices 100A to 100D are capable of intermittently administering a substance to be administered which is preferably administered intermittently at appropriate administration intervals without being equipped with an electrical drive mechanism. In addition, the administration devices 100A to 100D are effective from a manufacturing point of view because they utilize the conventional device configuration and require only a partial change in the tip portion.

In addition, in the administration device 100A according to the present embodiment, the opening/closing control unit 50A is formed around a shaft portion 511A extending in the axial direction of the discharge port 12A and a distal end side of the shaft portion 511A, and covers the discharge port 12A. When the internal pressure of the lumen 11A reaches the release pressure, a part of the occlusion part 512A separates from the ejection port 12A to open the ejection port 12A, and the object to be administered X is released. When the internal pressure of the lumen 11A becomes lower than the release pressure due to release, a part of the closing portion 512A may approach the release port 12A and close the release port 12A.

With such a configuration, in the administration device 100A, when the internal pressure in the lumen 11A reaches the release pressure, a part of the closing part 512A opens the release port 12A to allow the release of the administered substance X, and the internal pressure is reduced. When the discharge pressure is lower than the discharge pressure, the separated portion of the closing portion 512A can close the discharge port 12A and restrict the discharge of the administered substance X. Therefore, although the administration device 100A is configured to be continuously driven non-electrically, it is possible to intermittently administer the substance to be administered X while remaining in the living body.

In addition, in the administration device 100B according to the present embodiment, the opening/closing control unit 50B includes a pair of valve bodies 51B that extend in an inclined manner so as to gradually converge at the axial center toward the distal end, and a distal end of the valve body 51B. It includes an openable and closable slit 53B formed by contacting each other, a liquid passage port 54B provided on the side into which the administered substance X flows, and a flow path 55B connecting the liquid passage port 54B to the slit 53B. When the internal pressure of the cavity 11B reaches the discharge pressure, the slit 53B opens due to the deformation of the valve body 51B, opening the discharge port 12B. When the internal pressure of the cavity 11B falls below the discharge pressure due to the discharge of the administered substance X, the valve body It may be configured such that 51B returns to its pre-deformed shape and slit 53B closes to close discharge port 12B.

With such a configuration, in the administration device 100B, when the internal pressure in the lumen 11B reaches the release pressure, the distal end portion of the valve body 51B is separated, the slit 53B is opened, the release port 12B is opened, and the administered material X is released. When the internal pressure becomes lower than the release pressure, the tip of the valve body 51B returns to the shape before deformation, the slit 53B closes, and the release port 12B is closed to restrict the release of the administered substance X. Can be done. Therefore, although the administration device 100B is configured to be continuously driven non-electrically, it is possible to intermittently administer the substance to be administered X while remaining in the living body.

In addition, in the administration devices 100C and 100D according to the present embodiment, the opening/closing control units 50C and 50D include valve bodies 51C and 51D that close to cover the discharge ports 12C and 12D, a liquid passage port 53C for the administered object X, 53D are provided, one end is connected to the valve body 51C, 51D, the other end is connected to the base 52C, 52D, and the valve body 51C, 51D is connected to the discharge port 12C, with a tensile force weaker than the discharge pressure. When the internal pressure of the inner cavities 11C and 11D reaches the discharge pressure, the valve bodies 51C and 51D are separated from the discharge ports 12C and 12D, and the valve bodies 51C and 51D are separated from the discharge ports 12C and 12D. When the internal pressure of the inner cavities 11C and 11D becomes lower than the discharge pressure due to release of the administered substance X, the valve bodies 51C and 51D approach the discharge ports 12C and 12D to close the discharge ports 12C and 12D. Good too.

With such a configuration, in the administration devices 100C and 100D, when the internal pressure in the lumens 11C and 11D reaches the release pressure, the valve bodies 51C and 51D are separated from the release port 12A to allow the release of the administered substance X. When the internal pressure is lower than the release pressure, the release ports 12C and 12D can be closed by the valve bodies 51C and 51D due to the tensioning action of the tension portions 54C and 54D, thereby restricting the release of the administered substance X. Therefore, although the administration devices 100C and 100D are configured to be continuously driven non-electrically, they can intermittently administer the substance to be administered while remaining in the living body.

This application is based on Japanese Patent Application No. 2022-049285 filed on March 25, 2022, the disclosure content of which is incorporated by reference in its entirety.

10A, 10B, 10C, 10D main body 11A, 11B, 11C, 11D lumen,
12A, 12B, 12C, 12D outlet,
20A, 20B, 20C, 20D liquid transmission part,
30A, 30B, 30C, 30D pressing part,
40A, 40B, 40C, 40D plug body,
50A, 50B, 50C, 50D opening/closing control section,
51A, 51B, 51C, 51D valve body,
52C, 52D base,
53B slit,
54B, 53C, 53D liquid port,
54C, 54D tension part,
55B flow path,
X administered substance,
Y1 first space,
Y2 2nd space.

Claims

a main body portion having a lumen capable of accommodating a substance to be administered to be released into a living body, and a discharge port for the substance to be administered is formed at the tip;
a plug that can slide fluid-tightly within the lumen;
a pressing part that is disposed upstream of the plug in the inner cavity and continuously drives the plug in a non-electrical manner to press the plug downstream;
Disposed on the distal end side of the main body, when the internal pressure of the lumen reaches a predetermined release pressure, the discharge port is opened to allow release of the administered substance, and a predetermined amount of the administered substance is released. an opening/closing control unit that closes the discharge port to limit release of the administered substance when the internal pressure of the inner cavity becomes lower than the discharge pressure;
A dosing device comprising:
The opening/closing control section is
a shaft portion extending in the axial direction of the discharge port;
a closing part formed around the distal end side of the shaft part and closing the discharge port so as to cover it;
including;
When the internal pressure of the lumen reaches the discharge pressure, a part of the blocking part separates from the discharge port to open the discharge port;
The administration device according to claim 1, wherein when the internal pressure of the lumen becomes lower than the discharge pressure due to discharge of the administration object, the separated portion of the closing portion approaches the discharge port and closes the discharge port.
The opening/closing control section is
a pair of valve bodies extending at an angle so as to gradually converge at the axial center toward the tip;
an openable and closable slit formed by the tips of the valve bodies coming into contact with each other;
a liquid passage port provided on the side into which the substance to be administered flows;
a flow path connecting the liquid passage port to the slit,
When the internal pressure of the inner cavity reaches the discharge pressure, the slit opens due to deformation of the valve body and opens the discharge port;
The administration according to claim 1, wherein when the internal pressure of the lumen becomes lower than the release pressure due to release of the administered substance, the valve body returns to the shape before deformation, the slit closes, and the release port is closed. Device.
The opening/closing control section is
a valve body that closes to cover the discharge port;
a base portion provided with a liquid passage port for the administered substance;
a tensioning part, one end of which is connected to the base, the other end of which is connected to the valve body, and which pulls the valve body toward the discharge port side with a tensile force that is weaker than the discharge pressure;
When the internal pressure of the inner cavity reaches the discharge pressure, the valve body separates from the discharge port to open the discharge port;
The administration device according to claim 1, wherein when the internal pressure of the inner cavity becomes lower than the discharge pressure due to discharge of the administration object, the valve body approaches the discharge port and closes the discharge port.