WO2023181997A1 - Dispositif de médication continue - Google Patents

Dispositif de médication continue Download PDF

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Publication number
WO2023181997A1
WO2023181997A1 PCT/JP2023/009314 JP2023009314W WO2023181997A1 WO 2023181997 A1 WO2023181997 A1 WO 2023181997A1 JP 2023009314 W JP2023009314 W JP 2023009314W WO 2023181997 A1 WO2023181997 A1 WO 2023181997A1
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WO
WIPO (PCT)
Prior art keywords
confirmation
continuous administration
stopper
administration device
main body
Prior art date
Application number
PCT/JP2023/009314
Other languages
English (en)
Japanese (ja)
Inventor
弘樹 吉川
優 畑
拓心 密岡
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2023181997A1 publication Critical patent/WO2023181997A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin

Definitions

  • the present invention relates to a continuous administration device that continuously administers a substance to be administered, such as a drug solution, while remaining 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.
  • a semipermeable membrane liquid permeation part
  • 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 The piston is slid toward the distal end side as the internal pressure in the first space increases due to swelling, and the drug contained in the second space can be released into the living body.
  • Some of the drugs that can be selected for administration by continuous administration devices are expected to have therapeutic effects, but some may cause serious side effects if the prescribed dosage is not properly administered.
  • At least one embodiment of the present invention has been made in view of the above-mentioned circumstances, and specifically provides a continuous administration device whose driving state can be confirmed from outside the body while indwelling in the body. It's about doing.
  • the continuous administration device includes a main body having a lumen, a stopper that can slide liquid-tightly within the lumen, and a stopper disposed upstream of the stopper in the lumen.
  • a pressing part that presses the body downstream; a substance to be administered that is housed in the inner cavity downstream of the plug and is released into the living body by sliding the plug downstream; and the main body part.
  • a discharge part disposed on the distal end side of the body for releasing the substance to be administered into the living body after being pressed by the stopper, and the discharge part is indwelled in the living body to continuously release the substance to be administered in a sustained manner.
  • the present invention is a continuous administration device that includes a confirmation section that allows the driving state of the stopper to be confirmed from outside the living body.
  • the driving state of the stopper can be confirmed from outside the body, so even if an abnormality occurs in the device, immediate action can be taken and safe long-term sustained release can be achieved. can do.
  • the driving state of the stopper and the dose of the administered substance from outside the body even drugs that cause serious side effects can be used without fear, expanding the range of treatment options. I can do it.
  • the current size of the device can be maintained without increasing the size of the device.
  • FIG. 1 is a schematic cross-sectional view of the continuous administration device according to the first embodiment.
  • FIG. 2 is a schematic configuration diagram showing a state in which the stopper of the continuous administration device according to the first embodiment is moved. It is a schematic sectional view of the continuous administration device concerning a 2nd embodiment. It is a schematic sectional view showing the state where the stopper of the continuous administration device concerning a 2nd embodiment moved. It is a schematic sectional view of the continuous administration device concerning a 3rd embodiment. It is a schematic sectional view showing the state where the stopper of the continuous administration device concerning a 3rd embodiment moved.
  • the distal side (downstream side) is the side where the discharge part is arranged and the administered substance X is administered
  • proximal side refers to the side opposite to the distal end side, where the liquid permeable part is arranged and into which the liquid in the living body enters.
  • side upstream side
  • the distal end side is on the right side of the figure
  • the proximal end side is on the left side of the figure.
  • a continuous administration device 100A according to the first embodiment will be described with reference to FIGS. 1 and 2 as appropriate.
  • the continuous administration device 100A is indwelled in a living body and continuously administers (sustained release) the administered substance X such as a drug. Dose X can be released.
  • the continuous administration device 100A is capable of sustained release 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 continuous administration device 100A is a fluid composition that can be released in a sustained manner to the living body to which it is administered to achieve a predetermined effect, and can be continuously 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.
  • 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. .
  • drugs include peptides, proteins, polypeptides (e.g. enzymes, hormones, cytokines), nucleic acids, oligonucleotides, viruses, viral vectors, plasmids, nucleoproteins, polysaccharides, glycoproteins
  • the continuous administration device 100A generally includes a main body portion 10A, a liquid permeable portion 20A, a pressing portion 30A, a stopper 40A, and a discharge portion 50A. Further, the continuous administration device 100A includes a confirmation section 60A that allows confirmation of the driving state of the stopper 40A from outside the living body.
  • the main body portion 10A is composed of a hollow cylindrical member that has a lumen 11A and constitutes the casing of the continuous administration device 100A.
  • the liquid permeable part 20A, the pressing part 30A, the stopper 40A, and the discharge part 50A are arranged in this order from the base end to the distal end of the main body part 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 discharge part 50A (the space between the base end of the stopper 40A and the base end of the discharge part 50A), and the stopper 40A and the administered substance It is a space that is accommodated.
  • 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 driving the continuous administration device 100A. That is, when the continuous administration device 100A starts to drive, the first space Y1 gradually expands as the stopper 40A slides toward the downstream side by the pressing portion 30A. Further, when the continuous administration device 100A starts driving, the stopper 40A slides downstream by the pressing portion 30A, and the second space Y2 gradually becomes smaller.
  • the main body 10A expands due to the pressure of the pressing part 30A, and the liquid in the two chambers sandwiching the stopper 40A may leak from the sides of the stopper 40A, causing the stopper 40A to lose its function. Therefore, if the main body portion 10A has low rigidity, there is a possibility that the sliding movement of the plug body 40A may be inhibited.
  • the confirmation section 60A is made of a contrasting material
  • the main body section 10A needs to be made of a material that does not inhibit confirmation of the driving state of the stopper 40A from outside the living body using a modality.
  • At least a portion of the main body portion 10A can be made of a resin material so that the driving state of the stopper 40A by the confirmation portion 60A can be confirmed from outside the living body using modality.
  • a resin material having a Young's modulus of 0.1 GPa or more and 950 GPa or less is used as a material that is rigid enough to withstand the pressure of the pressing part 30A during normal operation and is non-invasive or minimally invasive to the living body. be able to.
  • Suitable resin materials for the main body 10A include, for example, curable polyurethane, perfluoroalkoxy fluororesin, polytetrafluoroethylene, ethylene-tetrafluoroethylene copolymer, polyethylene, polypropylene, acrylonitrile-butadiene-styrene copolymer, and cyclic resin.
  • examples include polyolefin, polymethyl methacrylate, polycarbonate, soft polyvinyl chloride, and polyacetal.
  • carbon reinforced fibers impregnated with resin can also be used for the main body portion 10A.
  • the Young's modulus of the resin material that can be used in the main body portion 10A is defined as follows.
  • the inner diameter of the main body part 10A which is the smallest size of the resin pipe that is assumed to be implanted, is about 4 mm in outer diameter and 2 mm in inner diameter when pressure to the extent that the plug body 40A is operated normally is applied.
  • the stopper 40A ceases to function when it expands by 10% or more of its original inner diameter
  • the Young's modulus when this phenomenon is realized was calculated based on material mechanics for the lumen.
  • the upper limit value if the main body portion 10A is made of a hard material, the above phenomenon will not occur, so there is no restriction in the present invention, but the upper limit value is set as the highest value among the materials that can be used. Among them, the value of pitch-based carbon fiber is set as a representative value of carbon reinforced fiber having a particularly high Young's modulus.
  • the main body portion 10A may be configured such that the moving distance of the stopper 40A can be measured from outside the living body based on the position of the confirmation portion 60A. Therefore, the main body part 10A may be entirely made of resin material, or at least only the measurement area for measuring the relative distance between the first confirmation part 61A and the second confirmation part 62A in the main body part 10A is made of resin material. It may be composed of
  • the constituent materials other than the measurement area of the main body 10A are metal materials that can be used in conventional continuous administration devices (stainless steel, titanium, nickel, aluminum, vanadium, platinum, tantalum, gold). , alloys thereof, gold-plated iron alloys, platinum-plated iron alloys, cobalt chromium alloys, titanium nitride-coated stainless steel, etc.) can be used.
  • the liquid permeable part 20A is arranged on the base end side of the main body part 10A, isolates the living body from the inside of the continuous 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.
  • PMMA polymethyl methacrylates
  • HEMA hydroxylethyl methacrylate
  • Semipermeable membranes constructed of materials such as elastomeric materials, such as thermoplastic copolyesters, or mixtures thereof can be applied.
  • the pressing portion 30A is located downstream of the liquid permeable portion 20A within the main body portion 10A, and presses the stopper 40A downstream.
  • the pressing portion 30A is an osmotic agent containing an osmotic agent (a swelling material containing a hydrophilic polymer or an osmotic substance) that swells and expands due to moisture that has passed through the liquid permeable portion 20A using the principle of osmotic pressure. It is a pressure engine.
  • 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 pressing part 30A is configured so that the pressing speed of the stopper 40A (i.e., the swelling speed of the pressing part 30A) is in accordance with the conditions of use (such as the sustained release period and dosage per unit time of the administered substance X).
  • the material, size, etc. can be determined as appropriate.
  • the sustained release period and dosage can be adjusted depending on the composition of the osmotic pressure engine that constitutes the pressing section 30A and the water absorption rate, water absorption rate, thickness, etc. of the semipermeable membrane that constitutes the liquid permeable section 20A. It is possible.
  • 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 discharge 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 parts 42A are provided on the outer circumferential surface of the base part 41A, and the apex part protruding most outwardly comes into contact with the inner circumferential surface of the inner cavity 11A of the main body part 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.
  • the number and position of the protrusions 42A are not particularly limited.
  • 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. This adjusts the frictional force between the plug body 40A and the inner circumferential surface of the main body portion 10A, allowing stable sliding.
  • 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.
  • styrenic elastomers such as polyethylene, polypropylene, polybutene, ⁇ -olefin copolymers, etc., liquid paraffin, process oils, and talc.
  • polyolefins such as polyethylene, polypropylene, polybutene, ⁇ -olefin copolymers, etc., liquid paraffin, process oils, and talc. Examples include mixtures of powdered inorganic materials such as , cast, and mica.
  • polyvinyl chloride elastomers, olefin elastomers, polyester elastomers, polyamide elastomers, polyurethane elastomers, and mixtures thereof can be used as constituent materials.
  • 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. Further, the surface of the plug body 40A may be coated with a coating having functions such as slipperiness, water repellency, corrosion resistance, and chemical resistance.
  • the discharge section 50A is arranged on the distal end side of the main body section 10A, and discharges the administered substance X pushed out by the stopper 40A into the living body.
  • the discharge part 50A has a through hole that penetrates a columnar member having a predetermined thickness along the axial direction in order to efficiently administer the substance X into the living body.
  • the discharge portion 50A allows the administered substance X to be diffused into the living body without congealing in one place.
  • the shape, size, and number of through-holes in the discharge section 50A are appropriately determined in consideration of the properties of the administered substance X, the ease of diffusion of the administered substance X at the indwelling location of the continuous administration device 100A, etc.
  • the shape of the through hole is not limited to a linear shape, and may be, for example, a spiral shape. Alternatively, it may penetrate in the axial direction to the central part of the discharge part 50A, and from there in the circumferential direction through the main body part 10A in a substantially V-shape outside the living body.
  • the confirmation unit 60A makes it possible to confirm from outside the living body whether the stopper 40A is operating normally.
  • the confirmation unit 60A is configured to be able to confirm the current position of the stopper 40A in the sliding region (the distance traveled from the movement start position of the stopper 40A).
  • the confirmation section 60A includes a first confirmation section 61A provided on the plug 40A, and a second confirmation section 62A provided at a position where the moving distance of the stopper 40A can be measured.
  • the first confirmation part 61A is arranged at a predetermined location on the stopper 40A.
  • the second confirmation part 62A is arranged at a position where the moving distance of the stopper 40A can be measured. Since the stopper 40A moves along the axial direction of the main body 10A, the second confirmation section 62A measures the moving distance with the first confirmation section 61A that is linked to the movement of the stopper 40A. It is fixedly arranged at any part of the components of the continuous administration device 100A except for the continuous administration device 100A.
  • the components of the continuous administration device 100A to which the second confirmation part 62A is fixed are the parts that are fixed in position so that the moving distance of the first confirmation part 61A can be measured.
  • the portion 50A is included.
  • the second confirmation part 62A may be disposed at a location where the moving distance of the stopper 40A from the initial position can be determined from the position of the first confirmation part 61A, and preferably it can be provided in the main body part 10A, and more preferably It can be provided in the liquid permeable part 20A or the discharge part 50A located on the axis of the main body part 10A.
  • the continuous administration device 100A shown in FIG. 1 has a configuration in which a second confirmation section 62A is provided in the discharge section 50A.
  • the moving distance of the stopper 40A can be confirmed during image confirmation by modality. It becomes easier to do.
  • the stopper 40A moves from the movement start position to the movement end position in the sliding region. Therefore, by measuring the relative distance between the first confirmation part 61A and the second confirmation part 62A, it is possible to confirm the current position and movement distance of the stopper 40A. For example, medical personnel such as doctors can determine whether or not the stopper 40A is properly driven by periodically plotting changes over time in the relative distance between the first checking section 61A and the second checking section 62A. can be easily determined.
  • the constituent material of the confirmation section 60A includes a material that can be confirmed from outside the living body (detected material).
  • the material to be detected is a material that can be detected by a predetermined means from outside the living body, and a contrast material can be used as an example.
  • a “contrast material” is a material that can function as a contrast agent for medical image capturing used in a medical image diagnostic apparatus (modality) capable of capturing medical images of a subject.
  • the modality is, for example, a medical device that images the examination area of a subject (patient), such as an FPD (Flat Panel Detector) device, a CT (Computed Tomography) device, an MRI (Magnetic Resonance Imaging) device, or an ultrasound diagnostic device. Based on the image for This is a device that performs predetermined diagnosis.
  • the contrast material has at least one of electromagnetic contrast properties (electromagnetic wave shielding properties), radiographic contrast properties (radio-opacity), and ultrasound contrast properties (ultrasound reflectivity) as a property that can be detected by the modality. has.
  • electromagnetic contrast properties electromagnetic wave shielding properties
  • radiographic contrast properties radio-opacity
  • ultrasound contrast properties ultrasound reflectivity
  • the contrast material it is possible to use a material that has contrast properties that are compatible with the contrast function of the modality used.
  • Contrast material is a radiopaque substance that exhibits contrast properties in FPD devices, for example, and is a mixture of metal materials such as platinum, tungsten, palladium, titanium, stainless steel, synthetic resin, etc., mixed with barium sulfate, iodine compounds, and gadolinium. Examples include.
  • the second confirmation section 62A only needs to have a configuration that can measure the movement distance of the first confirmation section 61A, so it can be configured, for example, as a marker section 621A for distance measurement as shown in FIG. 2.
  • the marker portion 621A can be provided on at least a portion of the outer surface of the main body portion 10A or the inner surface of the inner cavity 11A corresponding to the sliding region of the plug body 40A. Alternatively, it may be embedded in the main body portion 10A.
  • the marker section 621A can be configured with a scale having graduations at a predetermined pitch according to the measurement unit when measuring the moving distance of the first confirmation section 61A.
  • FIG. 2 shows a configuration in which a marker portion 621A functioning as a scale is provided on the outer surface of the main body portion 10A along the axial direction.
  • the intervals between the graduations of the scale may be configured so that the moving distance of the stopper 40A can be easily grasped from outside the living body.
  • the scale interval can be set according to a preset unit (length, number of days, etc.).
  • the scale interval may be set to a pitch width (for example, in 1 mm increments) that allows the actual moving distance of the stopper 40A to be confirmed, or the moving distance may be set according to the daily dose of the substance to be administered. It's okay.
  • the marker section 621A is not limited to a scale having graduations at a predetermined pitch, and may have any form as long as it can quantitatively measure the movement distance of the first confirmation section 61A.
  • the second confirmation part 62A is provided on the ejection part 50A, and a marker part 621A is further provided on the outer surface of the main body part 10A.
  • the second confirmation part 62A functions as a reference for measuring the amount of movement of the first confirmation part 61A provided on the stopper 40A
  • a configuration in which only the marker portion 621A is provided can be set as appropriate.
  • the continuous administration device 100A includes the confirmation section 60A for confirming the driving state of the stopper 40A from outside the living body.
  • the confirmation unit 60A is composed of a first confirmation unit 61A and a second confirmation unit 62A that contain a detection target material (contrast material) that can be confirmed from outside the living body, images can be confirmed using a predetermined modality.
  • the moving distance of the first confirmation section 61A in the continuous administration device 100A can be grasped. Therefore, if the continuous administration device 100A confirms the image using a predetermined modality, the moving distance of the stopper 40A can be measured by the confirmation unit 60A in the continuous administration device 100A, so the driving state of the stopper 40A and the administered amount can be measured.
  • the dosage of substance X, etc. can be confirmed from outside the living body.
  • the continuous administration device 100B includes a main body portion 10B, a liquid permeable portion 20B, a pressing portion 30B, a stopper 40B, and a discharge portion 50B. Further, the continuous administration device 100B includes a window section 80B for confirming the marker section 70B provided in the confirmation section 60B from outside the living body.
  • the continuous administration device 100B according to the second embodiment differs mainly in the configuration of the confirmation section 60B from the configuration of the confirmation section 60A of the first embodiment.
  • the constituent material of the main body portion 10B includes metal materials known in the medical field that are non-invasive or minimally invasive to living bodies (stainless steel, titanium, nickel, aluminum, vanadium, platinum, tantalum, gold, and alloys thereof, Gold-plated ferroalloys, platinum-plated ferroalloys, cobalt chromium alloys, titanium nitride-coated stainless steel, etc.) are applicable.
  • the main body portion 10B is made of a resin material (acrylonitrile polymers, halogenated polymers, , polyimide, polysulfone, polycarbonate, polyethylene, polypropylene, polyvinyl chloride-acrylic acid copolymer, polycarbonate-acrylonitrile-butadiene-styrene, polystyrene, etc.), and resin materials applicable to the main body portion 10A can also be used.
  • a resin material acrylonitrile polymers, halogenated polymers, , polyimide, polysulfone, polycarbonate, polyethylene, polypropylene, polyvinyl chloride-acrylic acid copolymer, polycarbonate-acrylonitrile-butadiene-styrene, polystyrene, etc.
  • the confirmation unit 60B makes it possible to confirm from outside the living body whether the stopper 40B is operating normally.
  • the confirmation section 60B is composed of a linear member that connects the liquid permeable section 20B and the stopper 40B. As shown in FIG. 3, the confirmation part 60B has one end connected to the liquid permeable part 20B and the other end connected to the stopper 40B, and has a length determined based on the movement distance of the stopper 40B from the movement start position to the movement end position. is specified.
  • a part of the confirmation part 60B is exposed to the space between the liquid permeable part 20B and the stopper 40B (accommodation area of the pressing part 30B), and the other part is exposed to the liquid permeable part 20B. It is accommodated in the formed accommodation recess 201B or the like.
  • the confirmation part 60B is gradually drawn out from the accommodation recess 201B along the axial direction of the main body part 10B as the stopper 40B moves.
  • the confirmation section 60B includes a marker section 70B for confirming the driving state of the stopper 40B from outside the living body.
  • the marker portion 70B is provided at a predetermined location on the outer surface of the confirmation portion 60B extending in the axial direction.
  • the marker portion 70B is preferably provided over the entire circumferential direction of the confirmation portion 60B in order to be able to be confirmed from outside the living body regardless of the indwelling posture of the continuous administration device 100B in the living body. There are no restrictions.
  • the marker portion 70B has a form that allows the driving state of the plug 40B to be confirmed from outside the living body.
  • the marker portion 70B may be configured with a marker that can identify the predetermined number of days (for example, one month) for administering the substance It may be configured with a scale having a width (for example, in 1 mm increments).
  • the shape of the marker section 70B is not particularly limited as long as it has a configuration that allows confirmation of the driving state of the confirmation section 60B.
  • the marker section 70B can be configured to include a detected material whose position can be confirmed from outside the living body.
  • the material to be detected is a material that can be detected from outside the living body, and as an example, a contrast material having at least one of electromagnetic contrast properties, radiographic contrast properties, and ultrasound contrast properties that can be imaged by a modality is used. be able to.
  • the window portion 80B is provided in at least a portion of the area in which the confirmation portion 60B extends in the main body portion 10B so that the marker portion 70B can be viewed from outside the living body.
  • the window part 80B can be made of a material (for example, a resin material) that allows imaging of the marker part 70B using a modality.
  • window portions 80B are not particularly limited as long as the confirmation portion 60B and the marker portion 70B are configured to be visible at least from outside the living body.
  • the window portion 80B is preferably provided over the entire circumferential direction of the main body portion 10B so that the marker portion 70B can be confirmed regardless of the indwelling posture of the continuous administration device 100B in the living body.
  • the continuous administration device 100B includes the confirmation section 60B for confirming the driving state of the stopper 40B from outside the living body.
  • the confirmation section 60B is composed of a linear member that connects the liquid permeable section 20B and the stopper 40B, and includes a marker section 70B composed of a detection material (contrast material) that can be confirmed from outside the living body.
  • the main body portion 10B is provided with a window portion 80B for confirming the marker portion 70B from outside the living body. Therefore, in the continuous administration device 100B, by confirming the image using a predetermined modality, it is possible to confirm the marker portion 70B of the confirmation portion 60B in the continuous administration device 100B.
  • the dosage of substance X, etc. can be confirmed from outside the living body.
  • the continuous administration device 100C according to the third embodiment is a modification of the continuous administration device 100B of the second embodiment. Therefore, constituent elements having the same functions as those in the second embodiment are given the same or related reference numerals, and detailed explanations are omitted. It may be similar to the embodiment.
  • the continuous administration device 100C includes a main body portion 10C, a liquid permeable portion 20C, a pressing portion 30C, a stopper 40C, and a discharge portion 50C. Further, the continuous administration device 100C includes a window section 80C for confirming the marker section 70C provided in the confirmation section 60C from outside the living body.
  • the continuous administration device 100C according to the third embodiment differs mainly in the configuration of the confirmation section 60C from the configuration of the confirmation section 60B of the second embodiment.
  • the confirmation unit 60C makes it possible to confirm from outside the living body whether the stopper 40C is operating normally.
  • the confirmation section 60C is composed of a linear member that connects the discharge section 50C and the stopper 40C. As shown in FIG. 5, the confirmation part 60C has one end connected to the proximal end side of the discharge part 50C, and the other end connected to the winding part 401C provided at the distal end side of the plug body 40C. The length is defined based on the movement distance from the movement start position to the movement end position.
  • the confirmation part 60C extends into the space between the winding part 401C and the discharge part 50C (the sliding area of the plug 40C) before the plug 40C moves.
  • the confirmation part 60C has a shape memorized such that it wraps around the winding part 401C, and gradually winds around the body of the winding part 401C as the stopper 40C moves.
  • the winding portion 401C can be provided on the plug body 40C or the discharge portion 50C located on the axis of the main body portion 10A.
  • a continuous administration device 100C shown in FIG. 5 has a structure in which a stopper 40C is provided with a winding portion 401C.
  • the winding part 60C is made of a shape memory alloy (such as a Ni-Ti alloy) as a constituent material. Any material may be used as long as it can impart a curl to the portion 401C.
  • a shape memory alloy such as a Ni-Ti alloy
  • the confirmation section 60C includes a marker section 70C for confirming the driving state of the stopper 40C from outside the living body.
  • the marker portion 70C is provided on the outer surface of the confirmation portion 60C extending in the axial direction, as shown in FIGS. 5 and 6.
  • the marker portion 70C is preferably provided over the entire circumferential direction of the confirmation portion 60C in order to be able to be confirmed from outside the living body regardless of the indwelling posture of the continuous administration device 100C in the living body. There are no restrictions.
  • the marker portion 70C has a form that allows the driving state of the plug body 40C to be confirmed from outside the living body.
  • the marker portion 70C may be configured with a marker that can identify a predetermined number of days (for example, one month) for administering the substance to be administered, or may be provided with a marker at a predetermined pitch so that the moving distance of the stopper 40C can be confirmed. It may be configured with a scale having a width (for example, in 1 mm increments).
  • the shape of the marker section 70C is not particularly limited as long as it has a configuration that allows confirmation of the driving state of the confirmation section 60C.
  • the marker section 70C can be configured to include a detected material whose position can be confirmed from outside the living body.
  • the material to be detected is a material that can be detected from outside the living body, and as an example, a contrast material having at least one of electromagnetic contrast properties, radiographic contrast properties, and ultrasound contrast properties that can be imaged by a modality is used. be able to.
  • the window portion 80C is provided in at least a portion of the region in which the confirmation portion 60C extends in the main body portion 10C so that the marker portion 70C can be viewed from outside the living body.
  • the window portion 80C can be made of a material (for example, a resin material) that allows imaging of the marker portion 70C using a modality.
  • the shape, material, and number of window portions 80C are not particularly limited as long as the confirmation portion 60C and marker portion 70C can be confirmed at least from outside the living body.
  • the window portion 80C is preferably provided over the entire circumferential direction of the main body portion 10C so that the marker portion 70C can be confirmed regardless of the indwelling posture of the continuous administration device 100C in the living body.
  • the continuous administration device 100C includes the confirmation section 60C for confirming the driving state of the stopper 40C from outside the living body.
  • the confirmation section 60C is composed of a linear member that connects the emitting section 50C and the stopper 40C, and includes a marker section 70C made of a detected material (contrast material) that can be confirmed from outside the living body.
  • the main body portion 10C is provided with a window portion 80C for confirming the marker portion 70C from outside the living body. Therefore, in the continuous administration device 100C, if the image is confirmed using a predetermined modality, it is possible to confirm the marker portion 70C of the confirmation portion 60C in the continuous administration device 100C.
  • the dosage of substance X, etc. can be confirmed from outside the living body.
  • the continuous administration devices 100A to 100C include the main body portions 10A to 10C having the lumens 11A to 11C, and the plug body 40A that can slide fluid-tightly inside the lumens 11A to 11C. - 40C, pressing parts 30A to 30C that are arranged upstream of the plugs 40A to 40C in the lumens 11A to 11C and press the plugs 40A to 40C downstream, and plugs 40A to 40C in the lumens 11A to 11C.
  • 40C which is housed downstream from the body parts 40A to 40C and is released into the living body by sliding the plugs 40A to 40C downstream; It is a device that is indwelled in a living body to continuously release the administered substance X, and includes discharge parts 50A to 50C that release the administered substance Confirmation units 60A to 60C are provided to enable confirmation of the driving state of 40C from outside the living body.
  • the continuous administration devices 100A to 100C stop driving the stoppers 40A to 40C due to some abnormality, it can be dealt with by checking the confirmation parts 60A to 60C from outside the body, allowing safe long-term sustained release. can be realized. Further, in the continuous administration devices 100A to 100C, the driving states of the stoppers 40A to 40C and the dose of the administered substance X can be confirmed from outside the living body by the confirmation units 60A to 60C, so that it is possible to confirm the driving state of the stoppers 40A to 40C and the dose of the administered substance X. It will now be possible to use it without any concerns even if it occurs, and the range of treatment options will be expanded. Further, since the continuous administration devices 100A to 100C do not need to be equipped with an electric device such as a drive detection sensor, the current size of the device can be maintained without increasing the size of the device.
  • the continuous administration device 100A includes a liquid permeable portion 20A disposed on the proximal end side of the main body portion 10A, and the pressing portion 30A includes an osmotic agent that swells with the liquid passing through the liquid permeable portion 20A.
  • the confirmation unit 60A is fixed to either the first confirmation unit 61A provided on the stopper 40A or any of the components of the continuous administration device 100A other than the stopper 40A.
  • the second confirmation unit 62A may also be configured.
  • the continuous administration device 100A can grasp the driving state of the stopper 40A sliding inside the lumen 11A from the moving distance of the first confirmation part 61A with the second confirmation part 62A as a reference. . Therefore, by checking the confirmation part 60A, medical personnel can easily check whether the continuous administration device 100A is operating normally in the living body, such as malfunction of the stopper 40A or the amount of administered substance X. can be learned.
  • the second confirmation section 62A may be provided in the discharge section 50A or the liquid permeation section 20A.
  • the second confirmation part 62A in the liquid transmission part 20A and the discharge part 50A at the end of the continuous administration device 100A and on the axis, it is easy to confirm the moving distance of the stopper 40A when checking images by modality. Become.
  • the second confirmation part 62A may be formed of a marker part 621A that is provided in at least a part of the sliding area of the plug 40A of the main body part 10A and is made of a scale having graduations at a predetermined pitch.
  • the second confirmation section 62A is configured with the marker section 621A, when an image is confirmed using a modality, the movement distance of the first confirmation section 61A can be easily quantitatively determined while grasping the driving status of the first confirmation section 61A. can be grasped.
  • the first confirmation section 61A and the second confirmation section 62A are made of a contrast material having characteristics that can be detected by an image test from outside the body using a modality
  • at least the measurement area for measuring the movement distance of the first confirmation part 61A may be made of a resin material.
  • the resin material constituting the main body portion 10A may have a Young's modulus of 0.1 GPa or more and 950 GPa or less.
  • the confirmation section 60A can be confirmed from outside the living body using a modality. Furthermore, if the main body part 10A is made of a resin material having a Young's modulus of 0.1 GPa or more and 950 GPa or less, the sliding area of the plug 40A can be secured to the extent that it can resist the pressing force from the surrounding tissues when it is indwelled in a living body. stiffness can be obtained. Therefore, even when the continuous administration device 100A is indwelled in a living body, the state of the confirmation part 60A can be confirmed using modality without ensuring a sliding area for the stopper 40A and inhibiting the sliding movement of the stopper 40A. Therefore, it is possible to easily know whether or not it is operating normally in the living body.
  • the continuous administration devices 100B and 100C include liquid permeable portions 20B and 20C disposed on the proximal end side of the main body portions 10B and 10C, and the confirmation portions 60B and 60C are connected to the stoppers 40B and 40C.
  • the main body parts 10B and 10C are equipped with marker parts 70B and 70C that allow the movement distance to be confirmed, and are composed of linear members connected to the stoppers 40B and 40C and the liquid permeable parts 20B and 20C or the discharge parts 50B and 50C. , it may be configured to include windows 80B, 80C that allow the marker parts 70B, 70C to be checked from the outside.
  • the continuous administration devices 100B, 100C can confirm the marker parts 70B, 70C provided in the confirmation parts 60B, 60C through the windows 80B, 80C, so that the continuous administration devices 100B, 100C can be connected to the confirmation parts 60B, 60C.
  • the driven state of the stoppers 40B and 40C can be confirmed from outside the living body. Therefore, by checking the confirmation parts 60B and 60C, medical personnel can check whether the continuous administration devices 100B and 100C are operating normally in the living body, such as malfunction of the stoppers 40B and 40C and the amount of administered substance X. It is possible to easily know whether the
  • the window portions 80B and 80C are made of a resin material, and the marker portions 70B and 70C have characteristics that can be detected by an image test from outside the body using a modality. Constructed of contrast material with
  • the confirmation parts 60B and 60C of the continuous administration devices 100B and 100C can be confirmed using the modality while indwelling in the living body, so that the driving state of the stopper 40C and the normal driving state in the living body can be confirmed. It is easy to know whether or not there are any.

Abstract

L'invention concerne un dispositif de médication continue qui est équipé : d'une partie corps principal (10A) possédant une cavité interne (11A) ; d'un corps de bouchon (40A) capable de glisser à l'intérieur de la cavité interne (11A) de manière étanche ; d'une partie pression (30A) disposée côté amont par rapport au corps de bouchon (40A) dans la cavité interne (11A), et exerçant une pression sur le corps de bouchon (40A) côté aval ; d'un produit à administrer (X) qui est admis côté aval par rapport au corps de bouchon (40A) dans la cavité interne (11A), et qui est libéré à l'intérieur d'un corps biologique par glissement du corps de bouchon (40A) côté aval ; et d'une partie libération (50A) qui est disposée côté extrémité avant de la partie corps principal (10A), et qui libère à l'intérieur d'un corps biologique le produit à administrer (X) subissant la pression du corps de bouchon (40A). Ce dispositif de médication continue est maintenu à l'intérieur du corps biologique afin de libérer de manière contrôlée et en continu le produit à administrer (X). Enfin, ce dispositif de médication continue est également équipé d'une partie vérification (60A) permettant de vérifier de l'extérieur du corps biologique les conditions d'entraînement du corps de bouchon (40A).
PCT/JP2023/009314 2022-03-25 2023-03-10 Dispositif de médication continue WO2023181997A1 (fr)

Applications Claiming Priority (2)

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JP2022049287 2022-03-25
JP2022-049287 2022-03-25

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999033513A1 (fr) * 1997-12-31 1999-07-08 Alza Corporation Methode et systeme de controle osmotique de l'administration de medicament
JP2013505932A (ja) * 2009-09-28 2013-02-21 インターシア セラピューティクス，インコーポレイティド 実質的な定常状態薬物送達の迅速な確立及び／又は停止

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999033513A1 (fr) * 1997-12-31 1999-07-08 Alza Corporation Methode et systeme de controle osmotique de l'administration de medicament
JP2013505932A (ja) * 2009-09-28 2013-02-21 インターシア セラピューティクス，インコーポレイティド 実質的な定常状態薬物送達の迅速な確立及び／又は停止

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