WO2014049887A1

WO2014049887A1 - Puncture device and medical fluid application device

Info

Publication number: WO2014049887A1
Application number: PCT/JP2012/075874
Authority: WO
Inventors: 内山　城司; 近藤　晃
Original assignee: テルモ株式会社
Priority date: 2012-09-28
Filing date: 2012-09-28
Publication date: 2014-04-03

Abstract

An objective of the present invention is to propose a puncture device and a medical fluid application device whereby it is possible, with a simple configuration, to reliably puncture with a dual structure puncture needle wherein an inner needle is an indwelling needle. When a push part (5A) is pushed, a central part (5D) having an outer needle (62) slides downward, and an inner needle pulling part (72) which is anchored to the push part (5A) pulls an inner needle (50), thereby puncturing the interior of a user's body with the outer needle (62) and the inner needle (50) which is inserted within the outer needle (62). When the push part (5A) is pushed to the utmost, hook-shaped stoppers (89A, 89B) of the central part (5D) are opened, returning only an outer needle slide part (80) of the central part (5D) to the original location by the restoring force of a coil spring (94), thereby retracting only the outer needle (62) within a medical fluid application device (1) while leaving the inner needle (50) within the body. Thus, it is possible to simplify the configuration, and to reliably puncture the interior of the user's body with the inner needle (50) together with the outer needle (62), without requiring a separate drive part, as an example.

Description

Puncture device and drug solution administration device

The present invention relates to a puncture device and a drug solution administration device, and is suitable for application when, for example, insulin is administered into the body.

2. Description of the Related Art Conventionally, as a device that administers medicinal solution (insulin), it is a portable device that is used by adhering to the user's skin and is administered into the body by pushing out the medicinal solution filled in the outer cylinder through a plunger. A so-called syringe pump type drug administration device has been proposed (see, for example, Patent Document 1).
In addition, in a chemical solution administration device, a chemical solution is administered through a puncture needle that is punctured into a user's body. Conventionally, as a structure of this puncture needle, a metal inner needle and a plastic outer needle are used. A double-structured puncture needle is proposed (see, for example, Patent Document 2).
This double puncture needle is inserted into the user's body with the metal inner needle protruding from the tip of the plastic outer needle, and then the metal inner needle is the plastic outer needle. The drug solution is administered through the outer needle in a state where only the outer needle is removed from the body and is left in the body of the user.

Special table 2010-501283 gazette JP 2002-58747 A

By the way, in the conventional double-structured puncture needle, it is made to function as an indwelling needle which indwells an outer needle in a user's body.
If the diameter of the indwelling needle is reduced, the pain of the user can be reduced. However, in the case of a conventional puncture needle, a metal inner needle is inserted inside the outer needle as the indwelling needle. The inner diameter of the outer needle had to be larger than the outer diameter of the metal inner needle, and it was difficult to reduce the diameter of the indwelling needle.
Here, if a puncture needle having an indwelling needle as an indwelling needle instead of an outer needle can be realized, the diameter of the indwelling needle can be easily reduced as compared to a conventional puncture needle using the outer needle as an indwelling needle, and the burden on the user is reduced. It is thought that this can be further reduced.
However, when puncturing with such a puncture needle, a new puncture mechanism is required for extracting only the outer needle while the inner needle is left in the user's body, and this new puncture mechanism is also simplified. It is required to ensure that the puncture needle can be punctured with a simple configuration.
The present invention has been made in consideration of the above points, and proposes a puncture device and a drug solution administration device capable of reliably puncturing a double puncture needle having an inner needle as an indwelling needle with a simple configuration. It is what.
In order to solve such a problem, in the puncture device of the present invention, a puncture needle having a double structure of an outer needle and an inner needle inserted into the outer needle, a housing portion for storing the puncture needle, The puncture needle is provided in the housing part and the puncture needle in a state where the distal end portion of the inner needle is inserted into the outer needle is projected from the housing part and punctured into the body of the user. A puncture mechanism that pulls back only the outer needle of the puncture needle into the housing while the inner needle is left in the body, and the puncture mechanism includes a pusher that can be pushed into the housing; and An outer needle slide portion having the outer needle that can slide in the housing portion, a fixing release portion that fixes or releases the pushing portion and the outer needle slide portion, and one end fixed to the housing portion And an elastic member whose other end is fixed to the outer needle slide portion and one end of the pushing portion The other end is fixed to the rear end portion of the inner needle, and has an inner needle pulling portion that pulls the inner needle as the pressing portion is pushed, and the pushing portion and the outer needle sliding portion When the push-in portion is pushed in with the fixed release portion being fixed, the outer needle slide portion slides in one direction and the inner needle is pulled by the inner needle pulling portion. When the needle protrudes from the housing portion together with the inner needle and is punctured into the user's body, and the outer needle slide portion slides to a predetermined position, the fixing release portion causes the push portion and the outer needle slide portion to The fixation was released, and only the outer needle slide portion was slid in the other direction by the elastic member, and only the outer needle was pulled back into the housing portion while the inner needle was left in the body.
Further, in the drug solution administration device of the present invention, a puncture needle having a double structure of an outer needle and an inner needle inserted into the outer needle, a housing portion for storing the puncture needle, and a housing portion The puncture needle with the tip of the inner needle inserted into the outer needle is protruded from the housing and punctured into the body of the user, and the inner needle of the puncture needle A puncture mechanism for pulling back only the outer needle of the puncture needle into the housing part, a medicinal solution storage part for storing a medicinal solution, and the medicinal solution stored in the medicinal solution storage part in the body. And a puncture mechanism that can be pushed into the casing, and an outer needle that is slidable within the casing and has the outer needle. A fixing part for fixing or releasing the sliding part, and the pushing part and the outer needle sliding part; One end is fixed to the housing part and the other end is fixed to the outer needle slide part, and one end is fixed to the pushing part and the other end is fixed to the rear end part of the inner needle. An inner needle pulling portion that pulls the inner needle as the pushing portion is pushed, and the pushing portion is pushed in a state where the pushing portion and the outer needle slide portion are fixed by the fixing release portion. When the outer needle slide portion slides in one direction and the inner needle is pulled by the inner needle pulling portion, the outer needle protrudes from the housing portion together with the inner needle, and the user's body. When the outer needle slide portion is further slid to a predetermined position, the fixation release portion releases the fixation between the push-in portion and the outer needle slide portion, and the elastic member removes only the outer needle slide portion. Slide in direction Te, while the inner needle was indwelled in the body, and to retract only the outer needle in the housing portion.
As described above, the mechanism that can perform from the puncture of the puncture needle to the return of the outer needle can be performed only by pushing the push portion, and for example, the configuration of the puncture mechanism is simplified without the need for a separate drive portion or the like. In addition, the outer needle slide part slides as the pushing part is pushed, and the inner needle pulling part pulls the inner needle, so that the inner needle together with the outer needle can be reliably punctured into the user's body. .
According to the present invention, a mechanism that can perform from the puncture of the puncture needle to the retraction of the outer needle only by the pushing operation with respect to the push-in portion, for example, does not require a separate drive unit, and the configuration of the puncture mechanism In addition, the outer needle slide part slides as the push-in part is pushed in, and the inner needle pulling part pulls the inner needle, so that the inner needle together with the outer needle is securely punctured into the user's body. Thus, it is possible to realize a puncture device and a drug solution administration device that can reliably puncture a double puncture needle having an inner needle as an indwelling needle with a simple configuration.

FIG. 1 is a schematic diagram illustrating a configuration of a drug solution administration device.
FIG. 2 is an exploded perspective view of the chemical liquid administration device.
FIG. 3 is a schematic diagram illustrating a configuration of a chemical solution storage unit.
FIG. 4 is a schematic diagram illustrating the configuration of the sending unit.
FIG. 5 is a schematic diagram showing a state of the piston moved to the pressing position.
FIG. 6 is a schematic diagram illustrating the configuration of the drive unit.
FIG. 7 is a schematic diagram illustrating the configuration of the drive unit.
FIG. 8 is a schematic diagram illustrating a configuration of a delivery unit and a drive unit including a film.
FIG. 9 is a schematic diagram showing the configuration of the puncture mechanism.
FIG. 10 is a schematic diagram showing the configuration of the puncture mechanism.
FIG. 11 is a schematic diagram illustrating the configuration of the base.
FIG. 12 is a schematic diagram illustrating the configuration of the inner needle fixing portion.
FIG. 13 is a schematic diagram illustrating the configuration of the central portion.
FIG. 14 is a schematic diagram for explaining the operation of the puncture mechanism.
FIG. 15 is a schematic diagram for explaining the return of the outer needle by the coil spring.
FIG. 16 is a schematic diagram for explaining the operation of the puncture mechanism.
FIG. 17 is a schematic diagram for explaining the operation of the puncture mechanism.
FIG. 18 is a schematic diagram for explaining the operation of the puncture mechanism.
FIG. 19 is a schematic diagram showing a configuration of a puncture needle (outer needle + inner needle).
FIG. 20 is a schematic diagram illustrating an electrical configuration of the drug solution administration device.
FIG. 21 is a schematic diagram illustrating a configuration of a sensor device according to another embodiment.
FIG. 22 is a schematic diagram illustrating a configuration of a puncture needle according to another embodiment.

Hereinafter, an embodiment of the present invention will be described in detail with reference to the drawings.
[1. Overall configuration of drug solution administration device]
As shown in FIG. 1 and FIG. 2, the drug solution administration device 1 is a portable device that is used by being attached to the skin of a user, and is a bottom device that is open on the upper side and has a space inside. A flat, substantially rectangular parallelepiped shape is formed by the casing 2 and the upper casing 3 that fits into the opening of the lower casing 2.
The size of the drug solution administration device 1 may be reduced to such an extent that it can be affixed to the user's skin, and examples thereof include a substantially rectangular parallelepiped shape having a width of 32 mm, a length of 44 mm, and a height of 11 mm.
The lower housing part 2 is provided with a sticking part 4 made of double-sided tape or the like on the bottom surface 2A. The medicinal-solution administration device 1 is held by the user when the affixing portion 4 is affixed to the user's skin.
The medicinal-solution administration device 1 is a puncture needle (not shown) that is punctured into the user's body in order to administer insulin filled therein to the front end of the bottom surface 2A of the lower housing part 2. Is provided with a puncture needle hole 2 B for allowing the puncture mechanism 5 to project from the space formed by the lower housing portion 2 and the upper housing portion 3. The puncture needle has a double structure including a metal outer needle and a resin inner needle, which will be described in detail later.
In addition, the medicinal solution administration device 1 is provided with a pushing portion 5 A capable of pushing operation at the front end of the upper housing portion 3. The pushing portion 5A is a part of the puncture mechanism 5 shown in FIG. 2, and the drug solution administration device 1 is punctured from the puncture needle hole 2B by operating the puncture mechanism 5 when the push portion 5A is pushed into the user. The puncture needle is punctured into the user's body by protruding the needle.
Furthermore, the chemical solution administration device 1 is provided with a chemical solution storage unit 6, a flow channel unit 7, a delivery unit 8, a drive unit 9, a substrate unit 10, and the like in a space formed by the lower casing unit 2 and the upper casing unit 3. .
As will be described in detail later, the chemical solution storage unit 6 is filled with a chemical solution from the outside in a cylindrical outer cylinder 11.
The flow path part 7 includes suction pipes 7A, a delivery pipe 7B, flow paths 22B, 23A, 24A formed in the delivery part 8 and an inner needle of a puncture needle of the puncture mechanism 5, and a chemical solution from the drug solution storage part 6 to the body. Forms a flow path through which. The suction pipe 7A allows the chemical solution storage unit 6 and the flow path 23A formed in the delivery unit 8 to communicate with each other. The delivery tube 7B allows the flow path 24A formed in the delivery unit 8 to communicate with the inner needle of the puncture needle of the puncture mechanism 5.
As will be described in detail later, the delivery unit 8 allows the chemical solution stored in the chemical solution storage unit 6 to flow through the flow path unit 7 when the piston 21 slides in the internal space 22A of the cylinder unit 22 (FIG. 4). To be delivered to the body.
The drive unit 9 drives the piston 21 based on the control of the CPU 101 (FIG. 18), and slides the piston 21 in the internal space 22 A of the cylinder unit 22.
The substrate unit 10 is provided with a power source unit 104 (FIG. 18) for supplying power and a circuit such as a CPU 101.
[2. (Composition of chemical storage part)
The chemical | medical solution storage part 6 inserts piston 12 from the open end side to the outer cylinder 11 formed in a cylindrical shape, as shown in FIG. The chemical liquid storage unit 6 stores the chemical liquid in a chemical liquid storage space 13 formed by the outer cylinder 11 and the piston 12.
The outer cylinder 11 is provided with a distal end portion 11B that closes the distal end of the cylindrical main body portion 11A, and the main body portion 11A and the distal end portion 11B are integrally formed.
The tip portion 11B is a surface (hereinafter referred to as an inscribed surface) that is in contact with the medicinal solution storage space 13 along a direction orthogonal to a direction along the axis of the main body portion 11A (hereinafter also referred to as a cylinder axis direction). A hollow protrusion 11D having an opening penetrating to the outside is provided at the center of 11C.
The distal end portion 11B communicates with the protruding portion 11D, and an external port 11E protrudes in a direction opposite to the protruding portion 11D. The suction pipe 7A is connected to the external port 11E.
The main body 11 A is provided with a regulating portion 11 F in which a portion longer than the length of the protruding portion 11 D protrudes inward from the inscribed surface 11 C on the inner peripheral surface in contact with the chemical solution storage space 13. That is, the main body portion 11A is formed such that the inner diameter of the restricting portion 11F is shorter than the inner diameter of the main body portion 11A other than the restricting portion 11F.
The piston 12 is inserted into the outer cylinder 11 from the end opposite to the distal end portion 11B, contacts the inner surface of the main body portion 11A along the circumferential direction, and is liquid-tight along the cylindrical axis direction of the main body portion 11A. It is slidably arranged. The piston 12 is formed with a diameter larger than the inner diameter of the restricting portion 11F.
The medicinal solution storage unit 6 is configured such that the medicinal solution stored in the vial from a predetermined injection port (not shown) enters the medicinal solution storage space 13 in a state where the piston 12 is positioned closest to the tip end part 11B and is in contact with the regulating unit 11F. Injected. At this time, in the chemical solution storage unit 6, a slight space is opened by the regulating unit 11 F between the inscribed surface 11 C of the outer cylinder 11 and the piston 12.
In the chemical solution storage unit 6, the piston 12 is moved to the end side as the chemical solution is injected, and a predetermined amount (for example, 2 ml) of the chemical solution is injected. At this time, bubbles that existed in the chemical solution storage space 13 remain as they are.
When the chemical solution is delivered into the body by the delivery unit 8, the chemical solution storage unit 6 sucks in through the protrusion 11 D and the external port 11 E while the piston 12 moves to the tip portion 11 B side by the chemical solution suction pressure by the delivery unit 8. The chemical solution is sent to the tube 7A. And the chemical | medical solution storage part 6 sends out a chemical | medical solution until the piston 12 contact | abuts to protrusion part 11D.
By the way, in the chemical | medical solution storage part 6, when the bubble exists in the chemical | medical solution storage space 13, most of this bubble adheres to a wall surface. Therefore, in the chemical solution storage unit 6, when the piston 12 moves and the chemical solution is delivered, the bubbles attached to the side surface of the main body portion 11A move while being pushed by the piston 12, and the piston 12 comes into contact with the regulating portion 11F. At this time, since the air bubbles are accumulated in the space provided between the piston 12 and the inscribed surface 11C, it is possible to prevent the air bubbles from being sent to the outside.
Further, since the chemical liquid storage unit 6 is provided with the protruding portion 11D protruding from the inscribed surface 11C on the chemical liquid storage space 13 side, bubbles attached to the side surface of the main body 11A when the chemical liquid is delivered. Can be prevented from being sent to the outside through the opening of the protrusion 11D.
[3. (Configuration of sending unit)
As shown in FIG. 4A, the delivery unit 8 includes a piston 21, a cylinder unit 22, lids 23 and 24, one-way valves 25 and 26, an X ring 27, an X ring fixing unit 28, and a fixing member 29. It is supposed to be configured.
The piston 21 has a diameter of, for example, 1.03 mm, and is slid with a predetermined stroke in an internal space 22 A formed in a hollow cylindrical shape formed in the cylinder portion 22 by being driven by the drive portion 9. Examples of the material of the piston 21 include stainless steel, copper alloy, aluminum alloy, titanium material, thermoplastic elastomer such as polypropylene and polycarbonate, and the like.
The cylinder portion 22 is provided with an internal space 22A in which the piston 21 is inserted from one end and slides. The cylinder portion 22 is provided such that a flow path 22B that is in contact with the other end of the internal space 22A and orthogonal to the internal space 22A penetrates between opposing side surfaces of the cylinder portion 22.
The cylinder part 22 is provided with an X ring 27 for preventing leakage of a chemical solution between the piston 21 and an X ring fixing part 28 for fixing the X ring 27 at one end where the piston 21 is inserted in the internal space 22A.
The X ring 27 is inserted into the cylinder portion 22 from the side of the cylinder portion 22 where the internal space 22A is provided, and is pressed and fixed by the X ring fixing portion 28. A part of the X ring fixing part 28 is fitted into the cylinder part 22 and the X ring 27 is fixed so that the remaining part is exposed to the outside.
As shown in FIG. 4B, the flow path 22B is formed in a rectangular cross section whose horizontal width is the same as the diameter of the internal space 22A and whose height is shorter than the horizontal width. Hydrophilic processing is performed on the surfaces of the internal space 22A and the flow path 22B. As the hydrophilic processing, for example, plasma treatment or application of a surfactant (sodium stearate) or the like is applied. Note that hydrophilic processing may also be performed on the tip surface (upper surface) of the piston 21.
In the cylinder portion 22, the diameter of the internal space 22A and the horizontal width of the flow path 22B are formed to have the same length, and the center position of the axis of the internal space 22A and the central position of the horizontal width of the flow path 22B are formed to coincide.
The cylinder portion 22 has lid portions 23 and 24 connected to the side surface on which the flow path 22B is formed via a fixing member 29, respectively. The lid portions 23 and 24 are provided with flow passages 23A and 24A penetrating along the flow passage 22B at positions facing the flow passage 22B of the cylinder portion 22.
One end of the flow path 23A is connected to the flow path 22B of the cylinder part 22, and the other end of the flow path 23A is connected to the suction pipe 7A to connect the suction pipe 7A and the flow path 22B.
In the lid 24, one end of the flow path 24A is connected to the flow path 22B of the cylinder part 22, and the other end of the flow path 24A is connected to the delivery pipe 7B, thereby communicating the flow path 22B and the delivery pipe 7B.
The delivery section 8 is provided with a one-way valve 25 between the flow path 23A of the lid section 23 and the flow path 22B of the cylinder section 22, and between the flow path 22B of the cylinder section 22 and the flow path 24A of the lid section 24. Is provided with a one-way valve 26.
The one-way valve 25 allows the chemical liquid flowing from the flow path 23A of the lid portion 23 to the flow path 22B of the cylinder portion 22 to pass, and does not allow the chemical liquid to pass from the flow path 22B of the cylinder portion 22 to the flow path 23A of the lid portion 23. For example, an umbrella valve is applied.
The one-way valve 26 allows the chemical liquid that flows from the flow path 22B of the cylinder portion 22 to the flow path 24AB of the lid portion 24 to pass, and does not allow the chemical liquid to pass from the flow path 22B of the cylinder portion 22 to the flow path 24A of the lid portion 24. For example, an umbrella valve is applied.
The delivery unit 8 is a position where the piston 21 is most retracted (hereinafter also referred to as a push-off position) when delivering a chemical solution from the chemical solution storage unit 6 into the living body (hereinafter also referred to as a withdrawal position). The chemical solution that has been moved by the drive unit 9 in the internal space 22A and stored in the chemical solution storage unit 6 is sucked into the internal space 22A.
And the delivery part 8 sends out the chemical | medical solution suck | inhaled by 22 A of internal spaces in the living body, when the piston 21 is moved by the drive part 9 from a retracted position to a pushing position.
The delivery unit 8 can administer about 1 to 2 μL of a chemical solution into the user's body by reciprocating the piston 21 once. By repeating this operation at a set cycle and interval, a desired administration rate and dosage can be obtained. The drug solution can be administered to the user.
By the way, the pressing position is set to a position where the tip of the piston 21 is on the same plane as the bottom surface of the flow path 22B (the surface to which the internal space 22A is connected) or a position within the flow path 22B. That is, as shown in FIG. 5, when the drive unit 9 moves the piston 21 to the pressing position, the position where the tip of the piston 21 is on the same plane as the bottom surface of the flow path 22B or within the flow path 22B from the position. Move to the position.
As a result, when air bubbles are present in the internal space 22A, the delivery unit 8 causes the air bubbles present in the internal space 22A to move into the flow path 22B at the tip surface (upper surface) of the piston 21 when the piston 21 moves to the push-off position. Since it can push out, when the piston 21 is moved to the retracted position thereafter, the possibility that the bubbles are pulled back into the internal space 22A can be greatly reduced.
On the other hand, in an apparatus that does not move the piston tip into the flow path, for example, bubbles adhere to the side surface of the cylinder part that contacts the internal space or the tip surface of the piston, and the air bubbles present in the internal space cause the piston to slide. In some cases, it may not be pushed into the flow path.
In this case, the bubble repeatedly expands and contracts due to a change in the internal pressure that changes according to the movement of the piston, thereby changing the amount of the drug solution sucked into the internal space, and sending the set drug solution amount into the living body. Can not do. Therefore, with such a device, there is a possibility that the drug solution cannot be administered with high accuracy.
On the other hand, since the drug solution administration device 1 pushes out the air bubbles existing in the internal space 22A into the flow path 22B when the piston 21 moves to the push-off position in the delivery unit 8, the piston 21 moves to the retract position thereafter. In doing so, only the chemical solution can be sucked into the internal space 22A. Thus, the drug solution administration device 1 can accurately administer the drug solution.
Further, in the drug solution administration device 1, since the hydrophilic processing is applied to the front end surface of the piston 21, and the surfaces of the internal space 22A and the flow path 22B, it is possible to prevent air bubbles from remaining in the internal space 22A and the flow path 22B. can do.
[4. (Configuration of drive unit)
As shown in FIG. 6, the drive unit 9 includes a base unit 31, a motor 32, a motor support unit 34, a motor fixing plate 35, a fixed plate support unit 36, a bearing unit 37, a coupling 38, and a bearing support unit 39. It is said.
Each part of the drive unit 9 is arranged on the base unit 31. The motor 32 is sandwiched between a motor support portion 34 and a motor fixing plate 35 supported by the fixing plate support portion 36 and fixed to the base portion 31.
The motor 32 is provided with a motor shaft 33 that protrudes from the side surface on the motor fixing plate 35 side. A screw groove 33 A is formed on the side surface of the motor shaft 33.
The bearing portion 37 has a substantially rectangular parallelepiped shape that is elongated along the axial direction of the motor 32 and has a hollow interior. The bearing portion 37 is provided with a screw hole 37A at the center of the side surface corresponding to the short side of the substantially rectangular parallelepiped shape, through which the motor shaft 33 of the motor 32 is inserted and screwed into the screw groove 33A.
In the bearing portion 37, the piston 21 is coaxially connected to the motor shaft 33 via a coupling 38 on a side surface facing a side surface provided with a screw hole 37 A corresponding to a short side of a substantially rectangular parallelepiped shape. The bearing portion 37 is supported by the bearing support portion 39. As the coupling 38, for example, a coupling that absorbs axial displacement between the motor shaft 33 and the piston 21 is applied.
As shown in FIGS. 6 and 7, the drive unit 9 rotates the motor shaft 33 when the motor 32 is driven, and the bearing unit 37 screwed to the motor shaft 33 in the axial direction is driven in accordance with the rotation. Move and reciprocate the piston 21 in the axial direction. As a result, the drive unit 9 slides the piston 21 in the internal space 22 A of the cylinder unit 22. 6A and 6B, the piston 21 is in the retracted position, and in FIG. 7, the piston 21 is in the push-off position.
Thus, since the motor shaft 33 of the motor 32 is arranged coaxially with the piston 21, the drive unit 9 has a force applied to the bearing portion 37 by the rotation of the motor shaft 33 and the force applied to the piston 21. The applied force is in the same direction, and the thrust loss of the piston 21 is eliminated.
Therefore, the drive unit 9 can slide the piston 21 with a stable stroke distance in the internal space 22 A of the cylinder unit 22. In addition, since the driving unit 9 can drive the piston 21 with a smaller force by eliminating the loss of thrust of the piston 21, the motor 32, the battery, and the like can be reduced, and the entire apparatus can be downsized. Can do. The side surface of the piston 21 may be coated with diamond-like carbon to reduce sliding resistance.
On the other hand, in a device in which the piston and the shaft portion of the motor are not arranged coaxially, the force applied to the bearing portion by the rotation of the shaft portion and the force applied to the piston by the force are offset, The loss of thrust of the piston increases, and the sliding resistance of the bearing portion and the piston increases due to the offset of the force, which not only stabilizes the stroke of the piston but also increases the size of the entire apparatus.
By the way, in the chemical solution administration device 1, as shown in FIG. 8, the space between the X ring fixing portion 28 and the coupling 38 is covered with a tube-like flexible film 40. As the material of the film 40, for example, polyethylene or the like is applied.
The film 40 is fixed to the X ring fixing portion 28 and the coupling 38 without gaps in the circumferential direction by film fixing portions 41 and 42 having both ends made of, for example, O-rings.
Since the film 40 has flexibility, the piston 21 is always in the range from the state where the piston 21 shown in FIG. 8A is in the retracted position to the state where the piston 21 shown in FIG. Can be kept covered.
Therefore, in the chemical solution administration device 1, the piston 21 can be slid within the internal space 22 A of the cylinder portion 22 without touching the air outside the film 40. Thereby, the chemical solution administration device 1 can further maintain the cleanliness of the piston 21 entering the internal space 22A.
[5. (Puncture mechanism configuration)
Next, the configuration of the puncture mechanism 5 will be described in detail. As shown in FIG. 9, the puncture mechanism 5 mainly includes a pushing portion 5A, a fixing plate portion 5B fixed to the inside of the front end side of the bottom surface 2A (FIG. 1) of the lower housing portion 2, and the fixing plate portion 5B. A base 5C projecting from the base 5C, a central portion 5D that can be slid in the vertical direction inside the base 5C in response to a pressing operation on the pressing portion 5A, and an inner needle 50 that guides the inner needle 50 from the rear of the base 5C to the inside of the base 5C. An inner needle guide portion 5E to be attached, and a lid portion 5F attached to the upper end of the base 5C. In FIG. 9, the lid 5F is indicated by a dotted line.
As shown in FIG. 10, the fixed plate portion 5 B has a substantially square plate shape, and a communication hole 51 that communicates with the puncture needle hole 2 B provided in the bottom surface 2 A of the lower housing portion 2 is provided at the center thereof. Yes.
Further, plate-like projections 52A and 52B are provided on the left and right sides of the communication hole 51 at a predetermined interval.
The fixing plate 5B may be provided separately from the lower casing 2 of the drug solution administration device 1 and fixed to the lower casing 2 or the lower casing 2 And may be provided integrally.
As shown in FIGS. 10 and 11, the base 5C has a substantially U-shaped cross section having three

walls

53A, 53B, and 53C on the left and right and rear sides, and the left wall 53A and the right wall 53B. On the outer side of each of these, fitting grooves 54A and 54B into which the protrusions 52A and 52B of the fixing plate portion 5B are fitted are provided at the center lower part thereof.
The base 5C is fixed at a predetermined position of the fixed plate portion 5B by fitting the projections 52A and 52B of the fixed plate portion 5B into these two fitting grooves 54A and 54B.
Further, on the outer side surfaces of the left side wall part 53A and the right side wall part 53B, the fitting parts 54F and 54B are fitted above the center of the fitting grooves 54A and 54B, that is, in the center upper part, respectively.

Grooves

54C and 54D are provided.
Here, the lower fitting grooves 54A and 54B are referred to as lower fitting grooves 54A and 54B, and the upper

fitting grooves

54C and 54D are referred to as upper

fitting grooves

54C and 54D.
Furthermore, a groove 55A and a groove 55B (FIG. 10) extending from the lower end to the upper end are provided on the inner side surfaces of the left wall portion 53A and the right wall portion 53B at positions close to the rear end.
These grooves 55A and 55B are grooves that serve as guides when the central portion 5D slides along the inner wall of the base 5C. Hereinafter, these grooves 55A and 55B are referred to as guide grooves 55A and 55B.
Further, recessed

portions

56A and 56B that are recessed outward are provided at the upper ends in front of the guide grooves 55A and 55B on the inner side surfaces of the left side wall portion 53A and the right side wall portion 53B, and the recessed

portions

56C and 56D are provided at the lower ends. Is provided.
Here, the

recesses

56A and 56B located at the upper end are called

upper recesses

56A and 56B, and the

recesses

56C and 56D located at the lower end are called

lower recesses

56C and 56D. These roles will be described later.
Although the base 5C has no front side wall portion, the front end portions of the left side wall portion 53A and the right side wall portion 53B are bent inward at a right angle so that the central portion 5D is separated from the base 5C. It is designed to prevent it from coming off.
Further, a U-shaped notch 57 into which the inner needle guide portion 5E is fitted is provided at the center of the upper end of the rear side wall portion 53C.
Further, on the inner side surface of the rear side wall portion 53C, a spring fixing portion 58 (FIG. 11) for fixing one end of a coil spring (described later) is projected at the lower end of the left side position.
Further, on the inner side surface of the rear side wall portion 53C, a spring folding portion 59 is provided so as to extend from the center of the lower end to a position immediately below the notch 57 (position near the center upper end). The spring folding portion 59 is for folding back the other end of a coil spring (not shown) whose one end is fixed to the spring fixing portion 58. Although the coil spring will be described in detail later, only the outer needle is pulled back into the drug solution administration device 1 after puncturing a puncture needle composed of a metal outer needle and a resin inner needle into the body of the user. belongs to.
As shown in FIG. 10, the center portion 5D is fixed to the lower end of the shaft 60 of the pushing portion 5A, and the inside of the base 5C is vertically moved along the guide grooves 55A and 55B by pushing the pushing portion 5A. It can slide.
In addition, the pushing portion 5A is provided with a button 61 on the upper end of the shaft 60 in a shape that is easy to push with a finger (for example, a substantially disc shape having the same size as the belly of the finger).
Further, as will be described in detail later, a part of the central portion 5D is an outer needle 62 of a puncture needle.
As shown in FIGS. 10 and 12, the inner needle guide portion 5 E includes a substantially columnar guide portion 63 that extends in the front-rear direction, and a plate that protrudes slightly forward from the center of the lower surface of the guide portion 63. It is comprised with the support part 64 of a shape.
The guide part 63 is provided with a passage 65 extending in the front-rear direction. Further, the guide portion 63 has a shape in which the front end portion of the lower surface is bent downward, and a downward opening 66 connected to the passage 65 is provided in front of the bent portion. Furthermore, the guide part 63 is provided with a rearward opening 67 connected to the passage 65 on the rear surface.
Here, the front opening 66 is referred to as a front opening 66, and the rear opening 67 is referred to as a rear opening 67.
The inner needle guide portion 5E is fitted to the notch 57 of the base 5C with the front end portion of the guide portion 63 protruding forward from the rear side wall portion 53C of the base 5C. Attached to.
At this time, the support portion 64 of the inner needle guide portion 5E comes into contact with the outer surface of the rear side wall portion 53C of the base 5C, thereby supporting the guide portion 63 so as to be orthogonal to the rear side wall portion 53C. To do.
Further, when the inner needle guide portion 5E is attached to the base 5C in this way, the front side opening 66 is positioned in front of the rear side wall portion 53C and the outer needle 62 of the center portion 5D attached to the base 5C. It is designed to be located directly above.
The passage 65 of the inner needle guide portion 5E has a linear shape in a portion from the rear opening 67 to the vicinity of the front end, and a curved portion in which a portion from the front opening 66 ahead to the front opening 66 is curved and curved downward. Yes.
The passage 65 includes a front passage 68 which is a front portion from the center and a rear passage 69 which is a rear portion from the center. The rear passage 69 is a single passage, whereas the front passage 68 is a front portion. The passage 68 is divided into two upper and

lower passages

68A and 68B.
Here, the upper passage 68A of the front passage 68 is referred to as an upper passage 68A, and the lower passage 68B is referred to as a lower passage 68B. These upper and lower passages 68 A and 68 B have leading ends connected to the front opening 66 and rear ends connected to the rear passage 69.
Of these, the upper passage 68A is a passage through which the inner needle 50 passes and is thicker than the lower passage 68B.
The inner needle 50 passes through the rear passage 69 and the upper passage 68A, is bent downward at the front end of the upper passage 68A, extends downward from the front opening 66, and is inserted into the outer needle 62 in the center portion 5D. It has become.
Further, in this passage 65, there is provided a slide portion 70 that can slide in the rear passage 69 and connects and fixes the rear end of the inner needle 50 and the front end of the delivery pipe 7B connected to the drug solution storage portion 6. It has been.
Actually, when the slide portion 70 slides forward in the rear passage 69 of the inner needle guide portion 5E, the inner needle 50 moves forward in the passage 65 and is pushed downward from the front opening 66. It is like that.
In addition, when the front end of the slide portion 70 comes into contact with the rear end of the boundary portion 71 between the upper passage 68A and the lower passage 68B, the slide portion 70 cannot slide further forward.
That is, the rear end of the boundary portion 71 functions as a stopper that restricts sliding of the slide portion 70, and this portion is hereinafter referred to as a slide stopper 71.
Furthermore, the rear end of the belt portion 72 made of a metal or resin belt is fixed to the lower end of the slide portion 70.
The belt portion 72 passes through the rear passage 69 and the lower passage 68B, is bent downward at the front end of the lower passage 68B and extends downward from the front opening 66, and the tip thereof is fixed to the center portion 5D. .
The center portion 5D and the slide portion 70 are connected by the belt portion 72, so that the slide portion 70 slides in conjunction with the slide of the center portion 5D.
Actually, when the center portion 5D slides downward by the pushing operation on the pushing portion 5A, the slide portion 70 is slid forward by the belt portion 72, and the inner needle 50 also moves.
As described above, the belt portion 72 and the slide portion 70 function as the inner needle pulling portion 73 that pulls the inner needle 50 along with the sliding of the central portion 5D by the pressing operation with respect to the pressing portion 5A.
As a result, when the center portion 5D slides downward, the outer needle 62 which is a part of the center portion 5D and the inner needle 50 whose tip is inserted into the outer needle 62 move together.
In addition, the inner needle guide part 5E can remove a part of the side surface, and the inside can be easily confirmed by removing this part.
The inner needle 50 has a tubular shape in which a portion on the rear end side of a portion inserted into the outer needle 62 of the center portion 5D can be inserted into the upper passage 68A and has an inner diameter larger than the outer diameter of the inner needle 50. It is also inserted into the inner needle bending prevention portion 74.
The inner needle bending prevention portion 74, which will be described in detail later, is a resin member that prevents the inner needle 50 from bending between the center portion 5D and the front opening 66 of the inner needle guide portion 5E. It has become.
As shown by a dotted line in FIG. 9, the lid 5F has a substantially rectangular plate shape covering the upper end of the base 5C, and a hole 75 through which the shaft 60 of the push-in part 5A passes is provided at a position near the center front end. Yes.
Further, the lid portion 5F is provided with plate-like projections 76A and 76B projecting downward at the left and right ends, respectively.
The lid portion 5F passes the shaft 60 of the push-in portion 5A through the hole 75, and the two left and right projections 76A and 76B are provided on the upper side of the left

side wall portions

53A and 53B of the base 5C. By being fitted into the

mating grooves

54C and 54D, it is fixed to the upper end of the base 5C.
The lid portion 5F may be provided separately from the upper housing portion 3 of the drug solution administration device 1 and fixed inside the front end side of the upper housing portion 3. It may be provided integrally with the body part 3.
The puncture mechanism 5 has such a configuration. Here, the central portion 5D will be described in more detail.
As shown in FIG. 13, the center portion 5D is mainly fixed to the outer needle slide portion 80 having the outer needle 62 of the puncture needle, and the shaft 60 of the push portion 5A, and further, the push portion 5A and the outer needle slide portion 80 And a slide fixing / releasing portion 81 for fixing or releasing the fixing.
The outer needle slide portion 80 is stacked on the slide fixing / releasing portion 81. The outer needle slide portion 80 has a substantially square U shape with the front side opened to the rear and the rear side opened rearward. Each part has a shape extending upward.
As for this outer needle slide part 80, convex part 82A and 82B are formed in the right-and-left both side surface part of the rear side.
Each of the convex portions 82A and 82B is a portion fitted into the guide grooves 55A and 55B of the base 5C, whereby the outer needle slide portion 80 slides up and down along the guide grooves 55A and 55B of the base 5C. It can be done.
Further, when the outer needle slide portion 80 is overlaid on the slide fixing / releasing portion 81, an arc-shaped recess 83 is provided at the center of the front end so as not to interfere with the shaft 60 of the pushing portion 5A.
Further, the outer needle slide portion 80 is provided with a cylindrical projection 84 projecting downward at the center of the bottom surface, which is thicker than the outer needle 62 and has the same diameter as the communication hole 51 of the fixed plate portion 5B.
A metal outer needle 62 extends downward from the lower end of the protrusion 84. The outer needle 62 is a hollow tubular needle having a length of 8 mm, an outer diameter of 0.4 mm, and an inner diameter of 0.2 mm.
Further, the outer needle slide portion 80 is provided with a plate-like protrusion 85 having a lower protruding amount than the protrusion 84 on the right side of the protrusion 84.
The protrusion 84 at the center of the bottom surface is referred to as a center protrusion 84, and the protrusion 85 located on the right side of the center protrusion 84 is referred to as a right protrusion 85.
A recess 86 is provided at the center of the upper surface of the outer needle slide portion 80, and a communication hole 87 that reaches the lower end of the central projection 84 and communicates with the outer needle 62 is provided at the center of the recess 86.
The inner needle 50 extending downward from the front opening 66 of the inner needle guide portion 5E is inserted into the outer needle 62 through the communication hole 87.
Further, the tip of the inner needle bending prevention portion 74 is attached to the recess 86. As a result, the inner needle 50 is inserted into the inner needle bending prevention portion 74 at a portion on the rear end side from the portion inserted into the outer needle 62.
The outer needle slide portion 80 configured as described above can slide in the vertical direction on the inner side of the base 5C between the inner needle guide portion 5E attached to the upper end of the base 5C and the fixed plate portion 5B. ing.
Actually, when the outer needle slide portion 80 is located at the uppermost position, the left and right side surfaces of the front end portion of the inner needle guide portion 5E are sandwiched between the left and right side surface portions on the rear side, and the front side of the inner needle guide portion 5E. A communication hole 87 is located immediately below the opening 66.
At this time, the inner needle bending prevention portion 74 is almost entirely contained in the upper passage 68A of the inner needle guide portion 5E.
Further, when the outer needle slide portion 80 is located at the lowermost position, the right projection 85 on the bottom surface abuts on the top surface of the fixed plate portion 5B, and the central projection 84 is formed in the communication hole 51 of the fixed plate portion 5B. Insert.
At this time, the central protrusion 84 does not protrude downward from the communication hole 51, and only the outer needle 62 protrudes from the communication hole 51.
At this time, the inner needle bending prevention portion 74 has a rear end portion left at the front end portion in the upper passage 68A of the inner needle guide portion 5E, and the remaining portion is exposed outside the upper passage 68A.
On the other hand, the slide fixing / releasing portion 81 is made of an elastic member, and includes a rectangular plate-shaped base 88 and U-shaped claw-shaped

stoppers

89A and 89B formed at the front ends of both the left and right sides of the base 88. The shaft 60 of the pushing portion 5 A is fixed to the center of the front end of the base portion 88.
Further, the tip of the belt portion 72 of the inner needle pulling portion 73 described above is fixed to the rear end of the base portion 88.
In this way, the base 88 of the slide fixing / releasing part 81 is fixed to the pushing part 5A and the inner needle pulling part 73. That is, the pushing portion 5A and the inner needle pulling portion 73 are fixed through the slide fixing / releasing portion 81.
Further, the base portion 88 is provided with a through-hole 90 penetrating in the vertical direction for passing the central protrusion 84 of the outer needle slide portion 80 and the outer needle 62 at a position near the rear end.
On the other hand, the left and right claw-shaped

stoppers

89A and 89B are respectively composed of a lower claw portion 91, a center portion 92, and an upper claw portion 93, and the lower claw portion 91 extends from the side surface of the base portion 88 and the base portion 88. It is integrally molded. The base 88, the claw-shaped

stoppers

89A and 89B, and the shaft 60 of the pushing portion 5A may be integrally molded.
The left and right claw-shaped

stoppers

89A and 89B are normally arranged such that the tip of the upper claw portion 93 is positioned outward from the tip of the lower claw portion 91. When added, the tip of each upper claw part 93 is deformed so as to approach each other.
Also, the left and right claw-shaped

stoppers

89A and 89B are elastic members, so that when the inner pressing force disappears, the upper claw portions 93 are deformed so as to move away from each other and return to their original shapes. Yes.
The left and right claw-shaped

stoppers

89A and 89B are deformed in the direction in which the upper claw portion 93 is brought closer, the claw-shaped

stoppers

89A and 89B are closed, and the claw-shaped

stoppers

89A and 89B are deformed in the away direction. Let it open.
When the claw-shaped

stoppers

89A and 89B are closed, the upper claw portion 93 is positioned above the upper surface of the base portion 88 by a predetermined length.
Here, it is assumed that the central protrusion 84 of the outer needle slide portion 80 is fitted into the communication hole 87 of the slide fixing / releasing portion 81 and the outer needle slide portion 80 is overlapped on the slide fixing / releasing portion 81.
Here, the thickness of the slide fixing / releasing portion 81 is formed to be thinner than the protruding amount of the central protruding portion 84 of the outer needle slide portion 80, so that the tip of the central protruding portion 84 when overlapped is formed. The part projects together with the outer needle 62 downward from the through hole 90 of the slide fixing / releasing part 81.
The tip end portion of the central projecting portion 84 projecting downward is a portion to be fitted into the communication hole 51 of the fixed plate portion 5B.
Further, when the left and right claw-shaped

stoppers

89A and 89B are closed in the state where the outer needle slide part 80 is overlapped on the slide fixing / releasing part 81 as described above, the upper claw parts of the left and right claw-shaped

stoppers

89A and 89B are closed. The outer needle slide portion 80 is fixed to the slide fixing / releasing portion 81 by the outer needle slide portion 80 being sandwiched between 93 and the upper surface of the base 88.
In this way, the outer needle slide portion 80 is fixed to the slide fixing / releasing portion 81. Here, since the slide fixing / releasing portion 81 is also fixed to the pushing portion 5A, the fact that the outer needle slide portion 80 is fixed to the slide fixing / releasing portion 81 means that the slide fixing / releasing portion 81 is fixed. It means that 5 A of pushing parts and the outer needle slide part 80 are fixed via.
Further, when the left and right claw-shaped

stoppers

89A and 89B are opened from this state, the fixation between the slide fixing / releasing portion 81 and the outer needle slide portion 80 is released (that is, the pressing portion 5A and the outer needle slide portion 80 are fixed to each other). Is fixed).
The central portion 5D configured as described above is configured such that the outer needle slide portion 80 is overlaid on the slide fixing / releasing portion 81, and the inner needle 50 is inserted into the outer needle 62 of the outer needle slide portion 80, and the base 5C. By fitting the convex portions 82A and 82B of the outer needle slide portion 80 into the inner guide grooves 55A and 55B, the guide grooves 55A and 55B are fitted inside the base 5C.
As shown in FIG. 14A, the center portion 5D is disposed at the inner upper end of the base 5C as an initial position. In FIG. 14, for convenience of explanation, a part of the puncture mechanism 5 (button 61, coil spring, etc.) is omitted.
At this time, the center portion 5D has the inner needle 50 bent downward by the inner needle guide portion 5E, with the communication hole 87 of the outer needle slide portion 80 positioned immediately below the front opening 66 of the inner needle guide portion 5E. Is inserted into the outer needle 62 through the communication hole 87.
At this time, the entire outer needle 62 is housed in the drug solution administration device 1, while the protruding amount of the push-in portion 5A from the drug solution administration device 1 is maximized.
Further, at this time, the center portion 5D is located at the upper ends of the left side wall portion 53A and the right side wall portion 53B of the base 5C, and as shown in FIG. 15 (A), outside the left and right claw-shaped

stoppers

89A and 89B. Since the

upper recesses

56A and 56B serving as open spaces are positioned, the left and right claw-shaped

stoppers

89A and 89B are open as shown in FIG. 14B. In FIG. 15, for convenience of explanation, a part of the puncture mechanism 5 (such as the pushing portion 5 A) is omitted and the shape of the outer needle slide portion 80 is deformed.
That is, when the center portion 5D is at the initial position, the outer needle slide portion 80 is not yet fixed to the slide fixing / releasing portion 81.
Further, when in this initial position, the outer needle slide portion 80 of the center portion 5D is positioned in front of the upper end of the spring folding portion 59 provided on the rear side wall portion 53C of the base 5C, as shown in FIG. It is supposed to be.
Here, the coil spring 94 having one end fixed to the spring fixing portion 58 provided at the lower left end of the rear side wall portion 53C of the base 5C is bent downward by the spring folding portion 59 into a J-shape. In this state, the other end is fixed to a predetermined position on the right side of the rear portion of the outer needle slide portion 80.
At this time, the coil spring 94 is in a natural length state that does not expand and contract. Then, from this state, it is assumed that the user pushes the pushing portion 5A into the drug solution administration device 1.
Then, at the center portion 5D, first, the left and right claw-shaped

stoppers

89A and 89B of the slide fixing / releasing portion 81 are released from the upper

concave portions

56A and 56B of the base 5C and are pressed inward by the left side wall portion 53A and the right side wall portion 53B. To close.
As a result, the outer needle slide portion 80 is fixed to the slide fixing / releasing portion 81, and the center portion 5D slides downward inside the base 5C as shown in FIG. 15B in this state. Go.
At this time, as the outer needle slide portion 80 of the central portion 5D slides downward, the entire coil spring 94 is extended so as to be deformed from the J shape to the U shape. Yes.
[6. Operation of puncture mechanism)
Here, the operation of the puncture mechanism 5 when actually puncturing the outer needle 62 and the inner needle 50, which are puncture needles, into the user's body will be described in detail.
First, as shown in FIG. 14A, the puncture mechanism 5 has the center portion 5D set at the initial position, the entire outer needle 62 is accommodated in the drug solution administration device 1, and the pushing portion 5A. The amount of protrusion from the liquid medicine administration device 1 is the maximum.
At this time, as shown in FIG. 15A, the center portion 5D has an upper recessed portion 56A provided at the upper ends of the left wall portion 53A and the right wall portion 53B on the outside of the left and right claw-shaped

stoppers

89A and 89B. 14B, the left and right claw-shaped

stoppers

89A and 89B are open, and the outer needle slide part 80 is not fixed to the slide fixing / releasing part 81.
Further, at this time, as shown in FIG. 19A, the inner needle 50 has its distal end kept substantially at the same position as the distal end of the outer needle 62 and does not protrude from the distal end of the outer needle 62. Is inserted inside.
Here, after the user attaches the drug solution administration device 1 to a predetermined position of the body, the pusher 5A is pushed into the drug solution administration device 1.
Then, as shown in FIGS. 15B and 16A, the central portion 5D slides downward inside the base 5C. Here, the left and right claw-shaped

stoppers

89A and 89B are removed from the upper

concave portions

56A and 56B, so that there is no space to open to the outside, and the left and right claw-shaped

stoppers

89A and 89B are closed by being pressed inward by the left wall portion 53A and the right wall portion 53B.
As a result, as shown in FIG. 16B, the outer needle slide portion 80 is fixed to the slide fixing / releasing portion 81, and the pushing portion 5A and the outer needle slide portion 80 are fixed. Thereafter, the outer needle slide portion 80 slides downward together with the slide fixing / releasing portion 81 as the push portion 5A is pushed.
Thus, the center portion 5D is provided at the initial position without fixing the outer needle slide portion 80 to the slide fixing / releasing portion 81, and when the pushing portion 5A is pushed in, first, the claw-like shape of the slide fixing / releasing portion 81 is provided. The

stoppers

89A and 89B are closed and the outer needle slide portion 80 is fixed to the slide fixing / releasing portion 81, and then the slide is moved downward with the outer needle slide portion 80 fixed to the slide fixing / releasing portion 81. It has become.
As the central portion 5D slides downward together with the pushing portion 5A in this way, the belt portion 72 fixed to the slide fixing / releasing portion 81 of the central portion 5D is slid in the inner needle guide portion 5E. The inner needle 50 is pulled by sliding the part 70 forward.
As a result, the inner needle 50 moves with the outer needle 62 reliably while maintaining the position where the tip of the inner needle 50 is substantially the same as the tip of the outer needle 62 and does not protrude from the tip of the outer needle 62.
Further, when the central portion 5D slides downward together with the pushing portion 5A in this way, the interval between the inner needle guide portion 5E and the central portion 5D is widened, and the inner needle 50 is exposed outside the inner needle guide portion 5E within this range. Will do.
Here, in the entire inner needle 50, the portion located between the inner needle guide portion 5E and the center portion 5D may be bent along with the slide of the center portion 5D if there is nothing to guide. .
Therefore, in this puncture mechanism 5 according to the present embodiment, this portion is protected by being inserted into the inner needle bending prevention portion 74.
In other words, the inner needle bending prevention portion 74 is configured to guide a portion of the entire inner needle 50 located between the inner needle guide portion 5E and the central portion 5D. Is prevented from bending.
Further, while the center portion 5D slides downward together with the pushing portion 5A in this way, as shown in FIG. 15B, the coil spring 94 having the other end fixed to the outer needle slide portion 80 of the center portion 5D extends. To go.
Here, the outer needle 62 of the center portion 5D slides downward while holding the inner needle 50 inside, and protrudes from the puncture needle hole 2B through the communication hole 51 of the fixed plate portion 5B. 50 is punctured into the user's body.
Further, when the pushing portion 5A is pushed and the entire shaft 60 of the pushing portion 5A is housed in the drug solution administration device 1 as shown in FIGS. 15C and 17A, at this time, the pushing portion 5A is The portion protruding from the drug solution administration device 1 is only the button 61, and the amount of protrusion is minimized.
When the pushing portion 5A is pushed to the end in this way, the central portion 5D reaches the lower end of the base 5C at this time. At this time, the outer needle 62 and the inner needle 50, which are puncture needles, are punctured deeply into the user's body as shown in FIG. 19B. In addition, in the chemical | medical solution administration apparatus 1, the length of the part punctured in a user's body is designed so that it may be 7 mm, for example.
At this time, the lower

concave portions

56C and 56D provided at the lower ends of the left

side wall portions

53A and 53B are positioned outside the claw-shaped

stoppers

89A and 89B of the central portion 5D, so that the claw-shaped

stoppers

89A and 89B are As shown in FIG. 17B, the force that is pressed inwardly disappears and opens.
As a result, the fixation between the slide fixing / releasing part 81 and the outer needle sliding part 80 at the center part 5D is released, and the fixing between the pushing part 5A and the outer needle sliding part 80 is released.
When the fixation is released in this manner, the outer needle slide portion 80 slides upward as shown in FIGS. 15D, 18A and 18B by the restoring force of the coil spring 94. Return to the original position.
As a result, the entire outer needle 62 is pulled out of the user's body and stored in the drug solution administration device 1. At this time, the position of the inner needle 50 is held by the inner needle pulling portion 73 fixed to the slide fixing / releasing portion 81, so that as shown in FIG. Detained.
Further, even when the outer needle slide portion 80 slides upward in this way, at least a portion of the entire inner needle 50 located between the inner needle guide portion 5E and the center portion 5D is prevented from bending the inner needle. Covered and guided by part 74.
Thus, this portion is prevented from bending as the outer needle slide portion 80 slides.
Further, as described above, the inner needle 50 is prevented from being bent between the inner needle guide portion 5E and the outer needle slide portion 80, so that the inner needle 50 comes off from the user's body or is used. It is also possible to prevent the portion placed in the body of the person from becoming shorter. That is, it can be said that the inner needle 50 can be punctured into the user's body more reliably.
In this manner, the puncture mechanism 5 punctures the inner needle 50 together with the outer needle 62 in the user's body in accordance with the pushing operation of the pushing portion 5A, and the pushing portion 5A is moved until the center portion 5D reaches the lower end of the base 5C. When pushed, that is, when the pushing portion 5A is pushed to the end, only the outer needle 62 is pulled back while the inner needle 50 is left in the body.
In the chemical solution administration device 1, when the pushing portion 5A is pushed to the end, the button 61 of the pushing portion 5A serves as a lid of the upper housing portion 3, and packing around the shaft 60 of the pushing portion 5A (not shown). Is provided with a waterproof structure that prevents water from entering the interior.
As explained so far, when the pushing portion 5A is pushed by the user, the medicinal solution administration device 1 slides the center portion 5D having the outer needle 62 downward and is fixed to the pushing portion 5A via the center portion 5D. When the inner needle pulling portion 73 thus pulled pulls the inner needle 50, the outer needle 62 and the inner needle 50 inserted into the outer needle 62 are caused to protrude from the drug solution administration device 1, so that the user's body. Puncture into.
Then, when the pushing portion 5A is pushed to the end, the medicinal solution administration device 1 opens the claw-shaped

stoppers

89A and 89B of the center portion 5D, and only the outer needle slide portion 80 of the center portion 5D is restored by the restoring force of the coil spring 94. By returning to the position, only the outer needle 62 is pulled back into the drug solution administration device 1 while the inner needle 50 is left in the body of the user.
Thereafter, the medicinal solution administration device 1 administers the medicinal solution stored in the medicinal solution storage unit 6 into the body of the user through the inner needle 50 by the delivery unit 8.
In this way, the drug solution administration device 1 uses the double needle puncture needle 50 as an indwelling needle, so that the diameter of the indwelling needle is smaller than that of a conventional puncture needle using the outer needle 62 as an indwelling needle. Can be easily reduced.
That is, the medicinal solution administration device 1 can narrow the inner needle 50 as an indwelling needle, which is a portion to be placed in the user's body, thereby reducing the burden on the user.
Incidentally, the inner needle 50 made of a resin material can be manufactured with a thin tube, and its inner diameter can be made larger than that of a metal needle having the same outer diameter.
Further, the medicinal solution administration device 1 can perform from the puncture of the puncture needle (the outer needle 62 and the inner needle 50) to the withdrawal of the outer needle 62 at a time only by pushing the pushing portion 5A.
Further, since the puncture mechanism 5 of the drug solution administration device 1 operates only by the pushing operation of the user as described above, a driving unit such as a motor is not required, the configuration can be simplified, and the size can be easily reduced.
The medicinal solution administration device 1 mainly includes functions necessary for the puncture mechanism 5 including the pushing portion 5A, the outer needle slide portion 80, the slide fixing / releasing portion 81, the inner needle pulling portion 73, and the coil spring 94 ( By realizing the puncture of the puncture needle and the return of the outer needle 62), the function required for the puncture mechanism 5 can be realized while suppressing the number of parts.
Further, when the puncture is performed, the medicinal solution administration device 1 causes the inner needle to be pulled by the inner needle pulling portion 73 fixed to the pushing portion 5A via the outer needle sliding portion 80 as the outer needle sliding portion 80 slides by pushing the pushing portion 5A. By pulling 50, the inner needle 50 can be reliably moved together with the outer needle 62.
Accordingly, for example, a situation where only the outer needle 62 moves and only the outer needle 62 is punctured into the user's body is prevented, and the inner needle 50 is reliably punctured into the user's body together with the outer needle 62. be able to.
Furthermore, when the pushing portion 5A is pushed to the end, the medicinal solution administration device 1 has a compact size with few protrusions as a whole, and improves the convenience in carrying.
[7. Electrical configuration of drug solution administration device]
As shown in FIG. 20, the chemical solution administration apparatus 1 includes a CPU (Central Processing Unit) 101, a ROM (Read Only Memory) 102, a RAM (Random Access Memory) 103, a power supply unit 104, an interface unit (I / F unit) 105. The notification unit 106 and the drive unit 9 are connected via a bus 107.
The CPU 101, ROM 102, RAM 103, power supply unit 104 and notification unit 106 are arranged on the substrate unit 10. A battery is applied to the power supply unit 104. The notification unit 106 is a speaker.
The interface unit 105 is arranged on the upper casing unit 3 or the lower casing unit 2 and is adapted with a button (not shown) for receiving a user input command.
The CPU 101 performs overall control by reading the basic program stored in the ROM 102 into the RAM 103 and executing it, and executes various processes by reading out and executing various application programs stored in the ROM 102 into the RAM 103.
When the CPU 101 administers the medicinal solution to the user, it reads out the medicinal solution administration program to the RAM 103 and executes the medicinal solution administration process. In addition, after the puncture needle is punctured into the user's skin by the puncture mechanism 5, parameters such as a dose and a dose rate input via the interface unit 105 are set.
Then, the CPU 101 controls the drive unit 9 based on the set parameters and starts administration of the drug solution.
[8. Other Embodiments]
[8-1. Other Embodiment 1]
In the above-described embodiment, the case where the present invention is applied to the drug solution administration device 1 that administers a drug solution into the user's body has been described. However, the present invention is not limited to this, and any device other than the drug solution administration device 1 may be used as long as the device is a puncture device that punctures a double puncture needle composed of an outer needle and an inner needle.
For example, you may make it apply to the sensor apparatus which inserts various sensors in a user's body, and acquires biometric information.
FIG. 21 shows the sensor device 200. This sensor device 200 has the same puncture mechanism 5 as the drug solution administration device 1, but does not have the drug solution storage unit 6, the delivery unit 8, and the drive unit 9, and instead acquires biological information from the sensor. It has a control unit 201 and a transmission unit 202 that wirelessly transmits this biological information to the outside.
As shown in FIG. 22, a sensor 203 is attached to the tip of the inner needle 50 of the sensor device 200, and the sensor 203 and the control unit 201 are electrically connected to the inner needle 50. A signal line 204 is inserted.
In the sensor device 200, the puncture mechanism 5 punctures the user's body with the outer needle 62 into which the inner needle 50 having the sensor 203 attached at the tip is inserted.
The sensor device 200 pulls only the outer needle 62 back into the sensor device 200 while the sensor 203 is left in the user's body.
Thereafter, the control unit 201 of the sensor device 200 acquires biological information obtained from the sensor 203 and wirelessly transmits the information to the outside via the transmission unit 202.
[8-2. Other Embodiment 2]
In the above-described embodiment, the puncture mechanism (outer needle 62 and inner needle 50) is punctured into the user's body by the puncture mechanism 5 shown in FIGS. 9 to 13, and only the outer needle 62 is pulled back. However, the puncture needle may be punctured and the outer needle pulled back by a puncture mechanism other than the puncture mechanism 5 shown in FIGS.
[8-3. Other Embodiment 3]
In the above-described embodiment, after the puncture needle composed of the metal outer needle 62 and the resin inner needle 50 is punctured into the body of the user, only the outer needle 62 is pulled back into the drug solution administration device 1. The coil spring 94 is used as the elastic member. However, the present invention is not limited to this, and an elastic member other than the coil spring 94 may be used as long as the elastic member functions in the same manner as the coil spring 94.
[8-4. Other Embodiment 4]
Furthermore, in the above-described embodiment, the puncture mechanism 5 is provided with the inner needle bending prevention portion 74 that covers the inner needle 50 between the central portion 5D and the front opening 66 of the inner needle guide portion 5E. Not limited to this, the puncture mechanism 5 may have a configuration in which the inner needle bending prevention portion 74 is omitted.
[8-5. Other Embodiment 5]
Further, in the above-described embodiment, the inner needle pulling portion 73 of the puncture mechanism 5 is configured by the belt-like belt portion 72 and the slide portion 70.
Instead of this, instead of the belt portion 72, for example, the inner needle pulling portion 73 may be configured by a wire portion made of a metal or resin wire and the slide portion 70.
In this case, the front end of the wire portion may be fixed to the slide fixing / releasing portion 81 and the rear end may be fixed to the slide portion 70.
Further, the present invention is not limited to this, and it can be bent freely like a belt or a wire, does not expand and contract, and the slide fixing / releasing part 81 and the slide part 70 can be connected so that their distance is always constant. Any member other than a belt or wire may be used.

The present invention can be applied to the medical field, for example.

DESCRIPTION OF SYMBOLS 1 ... Chemical solution administration apparatus, 2 ... Lower housing | casing part, 3 ... Upper housing | casing part, 4 ... Pasting part, 5 ... Puncture mechanism, 5A ... Pushing part, 5B ... Fixing plate part, 5C ... ... base, 5D ... center part, 5E ... inner needle guide part, 6 ... chemical storage part, 7 ... flow path part, 8 ... delivery part, 9 ... drive part, 10 ... substrate part, 50 …… Inner needle, 62 …… Outer needle, 73 …… Inner needle traction part, 74 …… Inner needle bending prevention part, 80 …… Outer needle slide part, 81 …… Slide fixing / release part, 89A, 89B …… Claw-shaped stopper, 94 ... coil spring, 200 ... sensor device, 201 ... control unit, 202 ... transmission unit, 203 ... sensor, 204 ... signal line

Claims

A puncture needle having a double structure of an outer needle and an inner needle inserted into the outer needle;
A housing for storing the puncture needle;
The puncture needle is provided in the housing portion and punctures into the user's body by projecting the puncture needle in a state where the distal end portion of the inner needle is inserted into the outer needle. A puncture mechanism that retracts only the outer needle of the puncture needle into the housing while the inner needle is left in the body,
The puncture mechanism is
A pushing portion capable of being pushed into the housing portion;
An outer needle slide part that is slidable in the housing part and has the outer needle;
A fixing release part for fixing or releasing the fixing of the pushing part and the outer needle slide part;
An elastic member having one end fixed to the housing and the other end fixed to the outer needle slide;
One end is fixed to the pushing portion and the other end is fixed to the rear end portion of the inner needle, and the inner needle pulling portion pulls the inner needle as the pushing portion is pushed.
When the pushing portion is pushed in a state where the pushing portion and the outer needle sliding portion are fixed by the fixing release portion, the outer needle sliding portion slides in one direction and the inner needle pulling portion causes the inner needle to move. When the outer needle protrudes from the housing portion together with the inner needle and is punctured into the body of the user, and when the outer needle slide portion slides to a predetermined position, the push-out is performed by the fixing release portion. And the outer needle slide part is released, and only the outer needle slide part is slid in the other direction by the elastic member, and only the outer needle is retained in the body while the inner needle is left in the body. A puncture device characterized by being pulled back into a body part.
The puncture mechanism is
The inner needle can be inserted, and has a tubular inner needle bending prevention portion for preventing the bending of the inner needle,
The inner needle is
The puncture device according to claim 1, wherein a portion on the rear end side of a portion inserted into the outer needle is inserted into the inner needle bending prevention portion.
The puncture mechanism is
An inner needle guide portion for guiding the inner needle;
The inner needle is
It passes through the inside of the inner needle guide part, is exposed to the outside of the inner needle guide part through an opening provided at the tip of the inner needle guide part, and is inserted into the outer needle of the outer needle slide part, and at least the The portion exposed to the outside of the inner needle guide portion between the opening of the inner needle guide portion and the outer needle is inserted into the inner needle bending prevention portion. Puncture device.
The fixing release part is
A pair of claw-shaped stoppers, and when a force is applied in a direction to close the pair of claw-shaped stoppers, by deforming the pair of claw-shaped stoppers to close, the pushing portion and the outer needle slide portion, When the applied force disappears, the pair of claw-shaped stoppers are opened and deformed to return to the original shape, thereby releasing the fixing of the pushing portion and the outer needle slide portion. The puncture apparatus according to claim 3, wherein
Until the outer needle slide portion reaches a predetermined position, the pair of claw-shaped stoppers are pressed inward by the wall portions positioned on the outer sides of the pair of claw-shaped stoppers. The stopper is closed and the push-in part and the outer needle slide part are fixed,
When the outer needle slide portion reaches a predetermined position, the wall portion located outside each of the pair of claw-shaped stoppers is provided with a recess for opening each of the pair of claw-shaped stoppers, The puncture apparatus according to claim 4, wherein the pair of claw-shaped stoppers are opened to release the fixation between the push-in portion and the outer needle slide portion.
A sensor attached to the tip of the inner needle of the puncture needle;
A controller that is connected to the sensor via the inner needle and acquires biological information from the sensor;
The puncture mechanism is
The puncture needle in a state where the inner needle with the sensor attached is inserted into the outer needle is projected from the housing portion and punctured into the body of the user, and then only the outer needle of the puncture needle is The puncture device according to claim 1, wherein the sensor is indwelled in the body by being pulled back into the housing.
A puncture needle having a double structure of an outer needle and an inner needle inserted into the outer needle;
A housing for storing the puncture needle;
The puncture needle is provided in the housing portion and punctures into the user's body by projecting the puncture needle in a state where the distal end portion of the inner needle is inserted into the outer needle. A puncture mechanism that retracts only the outer needle of the puncture needle into the housing while the inner needle is left in the body, a chemical solution storage unit that stores the chemical solution,
A delivery section for delivering the medicinal solution stored in the medicinal solution storage section into the body through the inner needle indwelled in the body,
The puncture mechanism is
A pushing portion capable of being pushed into the housing portion;
An outer needle slide part that is slidable in the housing part and has the outer needle;
A fixing release part for fixing or releasing the fixing of the pushing part and the outer needle slide part;
An elastic member having one end fixed to the housing and the other end fixed to the outer needle slide;
One end is fixed to the pushing portion and the other end is fixed to the rear end portion of the inner needle, and the inner needle pulling portion pulls the inner needle as the pushing portion is pushed.
When the pushing portion is pushed in a state where the pushing portion and the outer needle sliding portion are fixed by the fixing release portion, the outer needle sliding portion slides in one direction and the inner needle pulling portion causes the inner needle to move. When the outer needle protrudes from the housing portion together with the inner needle and is punctured into the body of the user, and when the outer needle slide portion slides to a predetermined position, the push-out is performed by the fixing release portion. And the outer needle slide part is released, and only the outer needle slide part is slid in the other direction by the elastic member, and only the outer needle is retained in the body while the inner needle is left in the body. A drug administration device characterized by being pulled back into the body.