JP2011055860A - Substance supply device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a substance supply device capable of being easily handled and capable of continuously supplying a small quantity of a substance into a living body for a long period of time. <P>SOLUTION: A drug solution bag 16 in which a drug solution including a drug as the substance to be supplied is sealed is stored in a storage space 28 within a container 18. The drug solution bag 16 is broken by a bag breaking projection 44 disposed in a movable plate 32 which is a part of the bottom surface of the container 18. A drive liquid is fed into the storage space by a liquid feeder pump mounted outside. The fed drive liquid presses the drug solution bag, so that the drug solution of the same amount as the amount of the drive liquid fed into the container 18 is delivered and supplied to the living body from micro-needles 20. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a substance supply apparatus that is attached to the skin of a living body and supplies a predetermined substance percutaneously, and relates to a substance supply apparatus that supplies a substance by inserting a fine needle into the skin.

  Subcutaneous injection using a syringe is well known as a method for transdermally supplying a substance such as a drug. In order to alleviate, intradermal or subcutaneous injection using a fine needle instead of injection has been proposed (see Patent Document 1 below). Here, the term “intradermal” refers to the granular layer, the winged layer, the basal layer and the dermis layer below the stratum corneum in the epidermis layer of the skin. The following Patent Document 1 describes an instrument having a housing and fine needles arranged in an array. A dry medicine and a diluent contained in a bag are contained in the housing. The housing is provided with a flexible cover, and the volume in the housing is reduced by pushing the cover. When the instrument is attached to the skin surface and the cover is pushed, the bag abuts against the cannula in the housing and the bag is punctured. As a result, the diluent is released from the bag into the housing to dilute the drug, and the diluted drug is supplied to the skin through the fine needle.

JP-T-2004-503341

  According to the above device, the supply of the diluent in which the medicine is dissolved is limited to a short time while the cover is pushed or while the medicine diluted by the cover deformed by being pushed is supplied. Thus, the supply of diluted drug can be intermittent or transient. On the other hand, there is a desire to continuously supply a diluted drug for a long time. There is also a demand to supply a very small amount quantitatively.

  The present invention provides a substance supply device for supplying a substance transcutaneously with a fine needle, supplying a substance continuously over a long period of time, and supplying a trace amount of substance quantitatively over a long period of time. At least one purpose.

  A substance supply apparatus according to the present invention is a supply apparatus that supplies a substance to a living body through a fine needle pierced in the skin, and includes a container having a storage space in a liquid-tight state, and a container in the storage space. A liquid bag disposed on the bottom side and containing a liquid containing a supply substance; a fine needle formed on the bottom surface of the container toward the outside of the container and having a passage connecting the housing space and the outside; and a bottom surface of the container The driving liquid is sent to a space on the opposite side of the housing space from the bottom surface side where the liquid bag is disposed, and a bag breaking projection that contacts the liquid bag and breaks the bag. A liquid feeding device that feeds the liquid containing the supply substance to the living body from the accommodation space by the pressure of the supplied driving liquid.

  Furthermore, the container may have an air venting mechanism that vents air remaining in the accommodation space when the driving liquid is fed by the liquid feeding device.

  Furthermore, the bottom surface of the container has a substrate portion and a moving portion that is movable with respect to the substrate portion and is provided with a fine needle and a bag breaking projection, and the moving portion is close to a surface defined by the substrate portion. It can move between a position and a distant position, and when it is in a close position, the bag breaking protrusion abuts on the liquid bag and can break it.

  The supply amount of the chemical liquid can be controlled by the supply amount of the driving liquid into the housing, and the supply over a long time can also be controlled.

It is a perspective view showing a schematic structure figure of a medicine supply device of this embodiment. It is sectional drawing of the injection apparatus of a chemical | medical agent supply apparatus. It is sectional drawing which shows the state which opened the cover of the air vent mechanism. It is sectional drawing which shows the detailed structure of a chemical | medical solution bag. It is sectional drawing which shows the detailed shape of a fine needle | hook. It is the schematic of the internal structure of a liquid feeding apparatus. It is explanatory drawing at the time of breaking a chemical | medical solution bag.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. In the following, a drug will be described as an example of a substance to be supplied. Moreover, the liquid containing a chemical | medical agent is described as a chemical | medical solution. FIG. 1 is a perspective view showing a schematic configuration of the medicine supply device 10. The drug supply device 10 is mounted on the surface of a living body such as a human body, and includes an injection device 12 that injects the drug into the living body, and a liquid feeding device 14 that sends a driving liquid for pushing out the drug solution containing the drug to the injection device 12. . The injection device 12 includes a container 18 that contains a drug solution bag 16 in which a drug solution containing a drug is enclosed, and a fine needle 20 that supplies the drug solution to a living body (see FIG. 2). Furthermore, the injection device 12 includes an adhesive sheet 22 for attaching the container 18 to the surface of the living body. The driving liquid sent out from the liquid feeding device 14 is sent into the container 18 of the injection device via the tube 23. The driving liquid in the container 18 presses the drug solution bag 16 (see FIG. 2), pushes out the drug solution, and supplies the drug solution into the living body through the fine needle 20 percutaneously.

  FIG. 2 is a cross-sectional view of the injection device 12. The container 18 includes a base 24 and a cap 26. A space is formed in the interior by the base and the cap, and a chemical solution bag 16 in which a chemical solution is sealed is accommodated in the space. The space inside the container that accommodates the drug solution bag 16 is hereinafter referred to as an accommodation space 28. The base 24 includes a substrate 30, a movable plate 32 movable with respect to the substrate 30, and a flexible portion 34 that connects the substrate 30 and the movable plate 32. The substrate 30, the moving plate 32, and the flexible portion 34 form the bottom surface of the container. Further, at the edge of the substrate 30, a base side wall 36 is erected so as to surround the inside, and a flange 38 extending outward is provided so as to extend the substrate 30. The substrate 30 has an annular shape, and a movable plate 32 and a flexible portion 34 block a portion that is inside the annular shape. The shape of the outer edge of the substrate 30 is not limited to a circle but may be an ellipse or a polygon. The base side wall 36 is circularly disposed on the substrate 30 and has a cylindrical shape. The base side wall 36 is a part involved in the connection between the base 24 and the cap 26. As will be described later, when the cap is screwed into the base, the shape of the base side wall 36 is a cylindrical shape, but other shapes may be used depending on the coupling method. The flange 38 may be provided over the entire circumference of the base 24, or may be composed of two parts extending in the opposite direction from the center of the container 18, for example, the center of the container 18. The adhesive sheet 22 is fixed to the flange 38, and the injection device 12 is fixed by sticking the adhesive sheet 22 to the surface of the living body.

  A fine needle 20 is provided on the moving plate 32 toward the outside of the container 18. One fine needle 20 may be provided, or a plurality of fine needles 20 may be provided. In the case of providing a plurality of lines, they may be provided in one row, or may be arranged in an array in the vertical and horizontal directions. A through hole 40 is opened in the fine needle 20, and the through hole 40 passes through the fine needle 20 and the moving plate 32, and communicates the container accommodation space 28 with the outside of the container. A cover 42 for protecting the fine needle 20 is attached to the moving plate 32. On the side of the accommodation space 28 of the moving plate 32, a bag breaking projection 44 is provided. The bag breaking protrusion 44 has a conical shape, but may have another shape as long as the bag is torn when it comes into contact with the drug solution bag 16. For example, it can be a plate shape with a sharp tip, or a shape in which a circular tube is cut obliquely. The movable plate 32 can be moved from the position shown in FIG. 2 into the plane formed by the substrate 30 as the flexible portion 34 is bent (see FIG. 7). By this movement, the bag breaking protrusion 44 comes into contact with the chemical solution bag 16, and a hole is made in the bag.

  The cap 26 includes a cap side wall 46 and an upper surface 48 covering the upper side of the cap side wall. The cap side wall 46 has a cylindrical shape that matches the cylindrical shape of the base side wall 36, and an insertion portion 50 that is inserted inside the base side wall 36 is provided at the lower end thereof. Note that the shapes of the cap side wall 46 and the insertion portion 50 can be determined in accordance with the shape of the base side wall. In this embodiment, a female screw is formed on the base side wall 36 and a male screw is formed on the cap side wall 46, whereby the base 24 and the cap 26 are screwed together. The cap side wall 46 is provided with a connection pipe 52 for coupling the tube, and the driving liquid is sent into the accommodation space 28 through the connection pipe 52.

  The upper surface 48 can be dome-shaped, and a transparent portion 54 is provided on the top. Further, the entire upper surface 48 and further the entire cap 26 may be transparent. An air vent mechanism 56 is provided at the top of the upper surface 48 to allow residual air in the accommodation space 28 to escape to the outside. The air vent mechanism 56 is disposed at the top of the upper surface 48 and is disposed at a position where the gas permeable film 58 that allows gas to permeate but does not allow liquid to pass therethrough and the gas permeable film 58 are disposed so as to connect the inside of the container and the outside. A membrane backup portion 62 having a vent hole 60 provided is included. The membrane backup unit 62 is a portion for preventing the gas permeable membrane 58 from being bent by the pressure in the container 18 and has a structure that allows the air that has passed through the gas permeable membrane 58 to be released to the outside. The structure for allowing air to pass therethrough may be provided with a ventilation hole formed by making a hole in the upper surface 48, or may be formed by fitting a lattice-like member into the opening formed in the upper surface 48. . Further, the air vent mechanism 56 includes a lid 64 positioned so as to cover the membrane backup unit 62. When the air inside the accommodation space 28 is vented, the lid 64 is opened as shown in FIG.

  FIG. 4 is a diagram showing a detailed configuration of the drug solution bag 16. The chemical solution bag 16 can include a bag body 66 in which a chemical solution is enclosed, and a base plate 68 to which a part of the bag body 66 is fixed. The base plate 68 has an annular plate shape having an outer diameter that fits inside the base side wall 36 of the base 24. The opening inside the annular ring is provided at a position facing the moving plate 32, particularly the bag breaking protrusion 44. The bag body 66 is fixed to a surface on one side around the opening of the base plate 68 by a technique such as sticking. A sealing material 72 is provided on the outer periphery of the base plate 68 without interruption. The sealing material 72 is made of a deformable material such as rubber and is sandwiched between the lower end of the insertion portion 50 of the cap 26 and the substrate 30 to seal the gap.

  The space surrounded by the bag body 66 corresponding to the opening 70 of the base plate 68, the moving plate 32 and the flexible portion 34 of the base 24 is a space where the chemical solution flows and accumulates when the chemical solution bag 16 breaks. Hereinafter, this space in the accommodation space 28 is referred to as a chemical reservoir 74.

  FIG. 5 is a cross-sectional view showing the detailed shape of the fine needle 20. FIG. 5A is a front view, and FIG. 5B is a side view. The fine needle 20 has a substantially conical shape whose bottom surface is a circle having a diameter (b) of 250 to 350 μm, and the tip is cut obliquely. The connection portion between the base of the fine needle 20 and the moving plate 32 is smoothly connected by a curved surface. The tip diameter (a) is 10 to 60 μm, and the needle length (h) is 100 to 1000 μm. The diameter (d) of the through hole 40 is 50 μm or less. These dimensions are appropriately changed according to the target living body. Moreover, it changes according to the depth from the biological surface which the front-end | tip of a needle | hook reaches | attains. For example, when a drug is supplied to the dermis part below the epidermis layer for the human body, the needle length is preferably 500 to 1000 μm, the tip diameter is 60 μm, and the passage hole diameter is approximately 50 μm. The fine needles 20 can be arranged in a two-dimensional array, for example, in a 1 cm square with a pitch of about 1 mm. Due to the dimensions of the fine needle 20 described above, the needle can be inserted with no pain or slight pain.

  The fine needle 20 may be integrally formed of resin, and is preferably a biocompatible material. A biocompatible material refers to a material that dissolves or decomposes even if it remains in a living body. More specifically, for example, polylactic acid, a material made of a mixture of polylactic acid and polyethylene glycol, and the like can be mentioned. The molecular weight of polyethylene glycol can be selected in the range of 10,000 to 35,000. The mixing ratio of polyethylene glycol can be selected in the range of 10 to 50% by weight concentration. By forming the fine needle 20 using such a material, safety is improved when the needle 20 breaks and remains subcutaneously. Polyethylene glycol is mixed in order to increase the fluidity of the material, so that the processability during production is improved and the production yield is improved. Furthermore, polylactic acid and polyethylene glycol can be incinerated at a temperature comparable to that of general combustible waste, and disposal after use becomes easy. As the material of the fine needle 20, other biocompatible materials such as hyaluronic acid can be used, and further, metals such as stainless steel and titanium, and inorganic materials such as silicon can be used.

  FIG. 6 is a diagram schematically showing an internal configuration of the liquid feeding device 14. The case 76 of the liquid feeding device 14 contains a liquid bag 78 containing a driving liquid, a battery 80, a micropump 82, and a control board 84. The micropump 82 is manufactured by a semiconductor processing technique, drives a diaphragm by a piezoelectric element or the like, and sends out liquid at a very small flow rate. A circuit for driving the micropump is mounted on the control board 84, and an operation unit for setting the flow rate of the micropump 82 and for starting and stopping the operation is provided. In addition, the operation unit is provided apart from the liquid feeding device 14, and signal transmission can be performed between these by wireless communication. In this case, the control board 84 is mounted with a transmission / reception circuit for wireless communication. The micropump 82 sends out the driving liquid from the liquid bag 78 at a controlled flow rate.

  In use, the lid 64 at the top of the cap 26 is opened, and the liquid feeding device 14 is driven to feed the driving liquid into the accommodating space 28 in the container 18. In the storage space 28, the chemical solution bag 16 is positioned on the bottom surface side of the container, that is, on the base substrate 30 side, and the driving liquid is sent into a space on the opposite side of the storage solution 28 from the bottom surface side. That is, it is fed into the space between the drug solution bag 16 and the upper surface 48 of the cap. Hereinafter, this space is referred to as a back space 86. The back space 86 is blocked from the chemical liquid reservoir 74 by the chemical liquid bag 16. The base plate 68 and the bag body 66 are in close contact with each other around the opening 70, and the sealing material 72 provided on the outer edge of the base plate 68 seals between the base 24 and the cap 26. Thus, the driving liquid in the back space 86 is prevented from flowing into the chemical liquid reservoir 74. At the initial stage when the driving liquid is fed into the storage space 28, air remains in the storage space 28. The air is discharged from the air vent mechanism 56 by the inflow of the driving liquid. The inflow of the driving liquid is monitored from the transparent portion 54, and when the air is completely removed, the liquid feeding is stopped and the lid 64 is closed.

  Next, with the cover 42 attached, the movable plate 32 is pushed and moved as shown in FIG. At the position where the moving plate 32 is pushed in, the bag breaking protrusion 44 comes into contact with and breaks through the bag body 66 of the drug solution bag. The chemical solution is discharged from the hole made by the bag breaking protrusion 44 into the chemical solution reservoir 74. The cover 42 is removed, the fine needle 20 is directed upward, the liquid feeding device 14 is driven again, and it is confirmed that the chemical liquid flows out from the tip of the fine needle 20. When the outflow is confirmed, the liquid feeding is stopped, the force is applied so that the bottom surface of the injection device 12 is applied to the skin and then pressed against the body, the fine needle 20 is punctured into the skin, and the injection device 12 is made to move the injection device 12 by the adhesive sheet Secure to the surface. The liquid feeding device 14 is set to a prescribed flow rate, and the operation is started. When the operation is started, the driving liquid is sent from the liquid feeding device 14 into the accommodation space 28, the chemical liquid bag 16 is pressed by the driving liquid, and as a result, the same amount of the chemical liquid as the fed driving liquid is discharged from the fine needle 20. . Since the liquid is incompressible, the supply amount of the chemical liquid can be accurately controlled by controlling the liquid feed amount of the driving liquid.

  In the above-described drug supply device 10, the base 24 and the cap 26 are coupled by a female screw and a male screw provided to each, but other coupling structures such as a luer lock structure and a sliding structure are employed. Can do. Further, the chemical solution bag 16 can be attached to and detached from the base 24. However, the bag body 66 is not bonded to the base plate 68 but can be directly bonded or bonded to the base 24 to be integrally formed. Further, the tube 23 may be eliminated, and the injection device 12 and the liquid delivery device 14 may be integrated.

  In the medicine supply device 10 of the present embodiment, since the medicine is supplied via the driving liquid, the configuration relating to the liquid feeding of the driving liquid, specifically, the liquid feeding device 14 and the flow path of the liquid feeding. Since the tube 23 does not touch the chemical solution, the material constituting the liquid feeding device 14 and the structure thereof are not limited by the chemical solution, and can be reused without sterilizing them. In particular, when injecting a chemical solution containing a substance with a large molecular weight (for example, insulin), clogging is likely to occur at locations where the flow path is narrowed or at the retention portion in parts with complicated structures such as pumps. In the form, this problem does not occur. Further, the arrangement of the liquid delivery device 14 with respect to the injection device 12 is not limited. In the drip, the drug solution bag is hung at a high position and the drug is supplied using gravity. However, in this device, the position of the solution delivery device is not limited because a pump is used.

  DESCRIPTION OF SYMBOLS 10 Drug supply apparatus, 12 Injection apparatus, 14 Liquid supply apparatus, 16 Chemical liquid bag, 18 Container, 20 Fine needle, 22 Adhesive sheet, 24 Base, 26 Cap, 28 Storage space, 30 Substrate, 32 Moving plate, 34 Flexible part , 36 base side wall, 40 through hole, 44 bag breaking projection, 46 cap side wall, 56 air vent mechanism, 74 chemical reservoir, 86 back space.

Claims (3)

A substance supply device for supplying a substance to a living body through a fine needle piercing the skin,
A container having a storage space in a liquid-tight state;
A liquid bag disposed in the storage space on the bottom side of the container and enclosing a liquid containing a supply substance;
A fine needle formed on the bottom surface of the container toward the outside of the container and having a passage connecting the housing space and the outside;
A bag breaking protrusion formed on the bottom surface of the container toward the housing space, contacting the liquid bag and breaking the bag;
A liquid-feeding device that feeds the driving liquid to a space on the opposite side of the housing space from the bottom side where the liquid bag is disposed;
Have
A substance supply device that supplies a liquid containing a supply substance from a storage space to a living body by the pressure of the supplied driving liquid.   2. The substance supply apparatus according to claim 1, wherein the container has an air venting mechanism that vents air remaining in the accommodation space when the driving liquid is supplied by the liquid supply apparatus. The substance supply device according to claim 1,
The bottom surface of the container has a substrate portion, and a movable portion that is movable with respect to the substrate portion and is provided with a fine needle and a bag breaking projection,
The moving part is movable between a position close to and far from the surface defined by the substrate part. When the moving part is in the close position, the bag breaking protrusion abuts on the liquid bag and breaks it.
Substance supply device.

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