HK1203860B - Puncture device and drug solution administration device - Google Patents

Description

Puncture device and drug delivery device

Technical Field

The present invention relates to a puncture device and a medication administering device, and is a technique suitable for injecting insulin into a body, for example.

Background

Conventionally, as a device for injecting a drug solution (insulin), a portable device used by being attached to the skin of a user, that is, a so-called syringe pump type drug delivery device which injects a drug solution filled in an outer tube into the body by pushing the drug solution out through a plunger has been proposed (for example, see patent document 1).

In addition, in a medication administering device, a medical fluid is injected through a puncture needle that punctures the body of a user, and as a structure of the puncture needle, a puncture needle having a double structure of a metal inner needle and a plastic outer needle has been proposed (for example, see patent document 2)

In the puncture needle having such a double structure, after the metal inner needle is inserted into the body of the user in a state of protruding from the distal end of the plastic outer needle, the metal inner needle is pulled out from the plastic outer needle, and the drug solution is injected through the outer needle in a state of being left in the body of the user.

Patent document 1: japanese Kohyo publication No. 2010-501283

Patent document 2: japanese laid-open patent publication No. 2002-58747

However, in the conventional double structure puncture needle, the outer needle functions as an indwelling needle which is indwelling in the body of the user.

However, in the conventional puncture needle, since the metal inner needle is inserted into the inner side of the outer needle as the indwelling needle, the inner diameter of the outer needle as the indwelling needle has to be made larger than the outer diameter of the metal inner needle, and it is difficult to reduce the diameter of the indwelling needle.

Therefore, it is considered that in the puncture needle having the double structure, if the diameter of the indwelling needle can be reduced, the burden on the user can be further reduced.

Disclosure of Invention

The present invention has been made in view of the above problems, and provides a puncture device and a medication administering device that can further reduce the burden on the user.

In order to solve the above problem, a puncture device according to the present invention includes: a puncture needle having a double structure of a metal outer needle and a resin inner needle inserted into the outer needle; a housing portion that houses the puncture needle; and a puncture mechanism provided in the housing portion, the puncture mechanism being configured to, after the puncture needle in a state in which the inner needle is inserted into the outer needle is caused to protrude from the housing portion and to puncture a body of a user, return only the outer needle of the puncture needle into the housing portion while keeping a state in which the inner needle of the puncture needle is left in the body, and further comprising: a push-in portion that can be pushed in relative to the housing portion; an outer needle sliding portion which is slidable in the housing portion and has the outer needle; a stopper which fixes the push-in portion and the outer needle sliding portion and fixes an inner needle inserted into the outer needle to the outer needle sliding portion; an elastic member having one end fixed to the housing portion and the other end fixed to the outer needle sliding portion; and a fixation releasing section for releasing fixation of the pushing section and the outer needle sliding section and fixation of the outer needle sliding section and the inner needle by the stopper, and sliding by the outer needle sliding section when the pushing section is pushed in a state where the pushing section and the outer needle sliding section, and the outer needle sliding section and the inner needle are fixed by the stopper, so that the outer needle inserted with the inner needle protrudes from the housing part and penetrates into the body of the user, and when the outer needle sliding part slides to a predetermined position, the fixation between the pushing portion and the outer needle sliding portion and the fixation between the outer needle sliding portion and the inner needle are released, and the outer needle sliding portion is slid in the other direction by the elastic member, thereby keeping the inner needle in a state of being left in the body and returning only the outer needle into the housing portion.

Further, the medication administering device of the present invention includes: a puncture needle having a double structure of a metal outer needle and a resin inner needle inserted into the outer needle; a housing portion that houses the puncture needle; a puncture mechanism provided in the housing portion, for returning only the outer needle of the puncture needle to the inside of the housing portion while keeping the inner needle of the puncture needle in a state of being left in the body after the puncture needle in a state of being inserted into the outer needle is protruded from the housing portion and punctured in the body of the user; a drug solution storage unit for storing a drug solution; and a delivery unit that delivers the medical fluid stored in the medical fluid storage unit into the body through the inner needle indwelling in the body, wherein the puncture mechanism includes: a push-in portion that can be pushed in relative to the housing portion; an outer needle sliding portion which is slidable in the housing portion and has the outer needle; a stopper which fixes the push-in portion and the outer needle sliding portion and fixes an inner needle inserted into the outer needle to the outer needle sliding portion; an elastic member having one end fixed to the housing portion and the other end fixed to the outer needle sliding portion; and a fixation releasing section for releasing the fixation of the pushing section and the outer needle sliding section and the fixation of the outer needle sliding section and the inner needle by the stopper, wherein the outer needle sliding section slides when the pushing section is pushed in with the pushing section and the outer needle sliding section, and the outer needle sliding section and the inner needle fixed by the stopper, so that the outer needle inserted with the inner needle protrudes from the housing part and penetrates into the body of the user, and when the outer needle sliding part slides to a predetermined position, the fixation between the pushing portion and the outer needle sliding portion and the fixation between the outer needle sliding portion and the inner needle are released, and the outer needle sliding portion is slid in the other direction by the elastic member, thereby keeping the inner needle in a state of being left in the body and returning only the outer needle into the housing portion.

In this way, by using the inner needle of the puncture needle composed of the double structure of the outer needle and the inner needle as the indwelling needle, the diameter of the indwelling needle can be easily reduced as compared with the conventional puncture needle using the outer needle as the indwelling needle, and the puncture from the puncture needle to the return of the outer needle can be realized only by the pushing-in operation of the pushing-in portion 1 time.

According to the present invention, by using the inner needle of the puncture needle having a double structure of the outer needle and the inner needle as the indwelling needle, the diameter of the indwelling needle can be easily reduced as compared with the conventional puncture needle having the outer needle as the indwelling needle, and the puncture from the puncture needle to the return of the outer needle can be realized only by the pushing-in operation of the pushing-in portion 1 time. In this way, a puncture device and a medication administering device that can further reduce the burden on the user can be realized.

Drawings

Fig. 1 is a schematic diagram showing the structure of a medication administering device.

Fig. 2 is an exploded perspective view of the drug delivery device.

Fig. 3 is a schematic diagram showing the structure of the chemical liquid storage unit.

Fig. 4 is a schematic diagram showing the configuration of the feeding unit.

Fig. 5 is a schematic diagram showing a state of the piston moved to the thrust position.

Fig. 6 is a schematic diagram showing the structure of the driving unit.

Fig. 7 is a schematic diagram showing the structure of the driving unit.

Fig. 8 is a schematic diagram showing a configuration including a film feeding section and a driving section.

Fig. 9 is a schematic diagram showing the structure of the puncture mechanism.

Fig. 10 is a schematic diagram showing the configuration of the puncture mechanism ((a) left side surface, (B) front surface, (C) right side surface, (D) back surface, (E) upper surface, and (F) lower surface).

Fig. 11 is a schematic diagram showing the structure of the puncture mechanism.

Fig. 12 is a schematic diagram showing the structure of the center portion.

Fig. 13 is a schematic view showing the center portion of the stopper rod in a closed state.

Fig. 14 is a schematic view showing the fixing (a) and the releasing (B) of the inner needle by the inner needle fixing/releasing portion and the stopper rod.

Fig. 15 is a schematic diagram for explaining the operation of the engagement puncturing mechanism.

Fig. 16 is a schematic view of an explanation of returning the outer needle based on the coil spring.

Fig. 17 is a schematic diagram showing the structure of the puncture needle (outer needle + inner needle).

Fig. 18 is a schematic diagram showing the electrical configuration of the drug delivery device.

Fig. 19 is a schematic diagram showing a configuration of a sensor device according to another embodiment.

Fig. 20 is a schematic view showing the structure of a puncture needle according to another embodiment.

Fig. 21 is a schematic diagram showing a configuration of a puncture mechanism in another embodiment.

Fig. 22 is a schematic diagram showing a structure of a center portion in another embodiment.

Fig. 23 is a schematic view showing the state of the inner needle fixing (a) and the state of the inner needle releasing (B) in another embodiment.

Fig. 24 is a schematic diagram for explaining the operation of the puncture mechanism according to another embodiment.

Fig. 25 is a schematic diagram showing a configuration of a puncture mechanism in another embodiment.

Fig. 26 is a schematic diagram showing a structure of a center portion in another embodiment.

Fig. 27 is a schematic diagram for explaining the operation of the puncture mechanism according to another embodiment.

Detailed Description

Hereinafter, an embodiment of the present invention will be described in detail with reference to the drawings.

[ 1. integral construction of drug delivery device ]

As shown in fig. 1 and 2, the medication administering device 1 is a portable device that is held and used by being stuck to the skin of a user, and is formed in a flat substantially rectangular parallelepiped shape by a lower case portion 2 having an upper side opened and a space provided therein, and an upper case portion 3 fitted to the opening of the lower case portion 2.

The size of the medication administering device 1 may be reduced to such an extent that it can be attached to the skin of the user, and is, for example, a substantially rectangular parallelepiped shape having a lateral dimension of 32mm, a longitudinal dimension of 44mm, and a height of 11 mm.

A bonding portion 4 made of a double-sided tape or the like is provided on the bottom surface 2A of the lower case 2. The medication administering device 1 is held on the user by the attachment portion 4 being attached to the skin of the user.

The medication administering device 1 is provided with a puncture needle hole 2B at the tip of the bottom surface 2A of the lower case portion 2, and a puncture needle (not shown) for puncturing the body of a user to inject insulin filled therein into the body of the user is projected from a space formed by the lower case portion 2 and the upper case portion 3 by the puncture mechanism 5. The puncture needle has a double structure of a metal outer needle and a resin inner needle, which will be described in detail later.

The medication administering device 1 is provided with a push-in portion 5A that can be pushed in at the front end of the upper case portion 3. The pushing portion 5A is a part of the puncture mechanism 5 shown in fig. 2, and the drug delivery device 1 is configured such that the pushing portion 5A is pushed into the user to operate the puncture mechanism 5, whereby the puncture needle protrudes from the puncture needle hole 2B and the puncture needle punctures the body of the user.

The medication administering device 1 is provided with a liquid medicine storage portion 6, a flow path portion 7, a delivery portion 8, a drive portion 9, a substrate portion 10, and the like in a space formed by the lower case portion 2 and the upper case portion 3.

In the chemical liquid storage 6, the cylindrical syringe outer tube 11 is filled with the chemical liquid from the outside, which will be described in detail later.

The channel section 7 includes a suction tube 7A, a delivery tube 7B, channels 22B, 23A, and 24A formed in the delivery section 8, and an inner needle of a puncture needle of the puncture mechanism 5, and forms a channel through which the drug solution flows from the drug solution storage section 6 into the body. The suction tube 7A communicates the chemical solution storage unit 6 with a flow path 23A formed in the delivery unit 8. The delivery tube 7B communicates the flow path 24A formed in the delivery portion 8 with the inner needle of the puncture mechanism 5.

The delivery unit 8 is configured to deliver the chemical liquid stored in the chemical liquid storage unit 6 into the body through the flow path unit 7 by sliding the piston 21 in the internal space 22A of the cylinder unit 22 (fig. 4), as will be described in detail later.

The driving unit 9 drives the piston 21 based on the control of the CPU91 (fig. 18), and slides the piston 21 in the internal space 22A of the cylinder unit 22.

The circuit board portion 10 includes a power supply portion 94 (fig. 18) for supplying power, a CPU91, and the like.

[ 2. Structure of chemical liquid storage section ]

As shown in fig. 3, the piston 12 of the chemical liquid storage unit 6 is inserted into the outer cylinder 11 formed in a cylindrical shape from the open end side. The chemical liquid storage 6 stores a chemical liquid in a chemical liquid storage space 13 formed by the outer cylinder 11 and the piston 12.

The outer cylinder 11 has a distal end portion 11B that closes a distal end of a cylindrical body portion 11A, and the body portion 11A and the distal end portion 11B are integrally molded.

The distal end portion 11B has a hollow protruding portion 11D protruding from the center of a surface (hereinafter, also referred to as an inner contact surface) 11C that contacts the chemical solution storage space 13 side in a direction perpendicular to the direction along the axis of the body portion 11A (hereinafter, also referred to as a cylinder axis direction).

Further, the distal end portion 11B is provided with an external port 11E communicating with the projection 11D and projecting in the direction opposite to the projection 11D, and the suction pipe 7A is connected to the external port 11E.

The body portion 11A is provided with a regulating portion 11F, and the regulating portion 11F is formed by a portion of the body portion 11A protruding inward from an inner contact surface 11C of the inner peripheral surface in contact with the chemical liquid storage space 13 by a length longer than the protruding portion 11D. That is, the main body 11A is formed such that the inner diameter of the restricting portion 11F is smaller than the inner diameter of the portion of the main body 11A other than the restricting portion 11F.

The piston 12 is inserted into the outer tube 11 from the end opposite to the distal end portion 11B, abuts against the inner surface of the body portion 11A in the circumferential direction, and is slidable in a liquid-tight manner in the axial direction of the body portion 11A. The piston 12 is formed to have a diameter larger than the inner diameter of the restriction portion 11F.

In the chemical liquid storage portion 6, the chemical liquid stored in the vial is injected from a predetermined injection port (not shown) into the chemical liquid storage space 13 in a state where the piston 12 is positioned on the distal end portion 11B side and is in contact with the regulating portion 11F. At this time, in the chemical liquid storage portion 6, a slight space is left between the inner contact surface 11C of the outer cylinder 11 and the piston 12 by the restriction portion 11F.

The piston 12 moves to the distal end side as the chemical liquid is injected into the chemical liquid storage unit 6, and a predetermined amount (for example, 2ml) of the chemical liquid is injected. At this time, the pre-existing air bubbles remain in the chemical liquid storage space 13 as they are.

When the chemical liquid is discharged into the body through the discharge portion 8, the chemical liquid storage portion 6 discharges the chemical liquid to the suction tube 7A through the protrusion 11D and the external port 11E while moving the piston 12 toward the distal end portion 11B side by the chemical liquid suction pressure of the discharge portion 8. The chemical liquid storage unit 6 delivers the chemical liquid until the piston 12 comes into contact with the projection 11D.

However, in the chemical liquid storage unit 6, when bubbles are present in the chemical liquid storage space 13, most of the bubbles adhere to the wall surface. Therefore, in the chemical liquid storage unit 6, when the piston 12 moves to deliver the chemical liquid, the air bubbles adhering to the side surface of the body portion 11A are pushed and moved by the piston 12, and after the piston 12 abuts on the restriction portion 11F, the air bubbles accumulate in the space provided between the piston 12 and the inner contact surface 11C, and therefore, the air bubbles can be prevented from being delivered to the outside.

Further, since the chemical liquid storage portion 6 is provided so that the protrusion 11D protrudes toward the chemical liquid storage space 13 with respect to the inner contact surface 11C, bubbles adhering to the side surface of the main body portion 11A when the chemical liquid is delivered can be prevented from being delivered to the outside through the opening of the protrusion 11D.

[ 3. Structure of delivery section ]

As shown in fig. 4(a), the delivery unit 8 includes a piston 21, a cylinder 22, caps 23 and 24, check valves 25 and 26, an X-ring 27, an X-ring fixing unit 28, and a fixing member 29.

The piston 21 has a diameter of, for example, 1.03mm, and is driven by the driving unit 9 to slide with a predetermined stroke in an internal space 22A formed in a hollow cylindrical shape in the cylinder unit 22. Examples of the material of the piston 21 include thermoplastic elastomers such as stainless steel, copper alloy, aluminum alloy, titanium material, polypropylene, and polycarbonate.

The cylinder portion 22 is provided with an internal space 22A, and the piston 21 is inserted from one end and slides in the internal space 22A. The cylinder portion 22 is provided so that a flow path 22B, which is in contact with the other end of the internal space 22A and is orthogonal to the internal space 22A, penetrates between the opposing side surfaces of the cylinder portion 22.

At one end of the cylinder portion 22 in the internal space 22A, into which the piston 21 is inserted, an X-ring 27 for preventing leakage of the chemical liquid between the cylinder portion 22 and the piston 21 and an X-ring fixing portion 28 for fixing the X-ring 27 are provided.

The X-ring 27 is inserted into the cylinder portion 22 from the surface of the cylinder portion 22 where the internal space 22A is provided, and is pressed and fixed by the X-ring fixing portion 28. The X-ring fixing portion 28 is partially fitted in the cylinder portion 22, and the remaining portion is exposed to the outside to fix the X-ring 27.

As shown in fig. 4(B), the flow path 22B has a rectangular cross section having a width equal to the diameter of the internal space 22A and a height shorter than the width. The surfaces of the internal space 22A and the flow path 22B are subjected to hydrophilic processing. As the hydrophilic processing, for example, plasma treatment, coating with a surfactant (sodium stearate), or the like is applied. The distal end surface (upper surface) of the piston 21 may be subjected to hydrophilic processing.

In the cylinder portion 22, the diameter of the internal space 22A is formed to be the same length as the lateral width of the flow passage 22B, and the center position of the axis of the internal space 22A is formed to coincide with the center position of the lateral width of the flow passage 22B.

The lid portions 23 and 24 are connected to the side surface of the cylinder portion 22 on which the flow passage 22B is formed, respectively, via a fixing member 29. The covers 23 and 24 are provided with flow paths 23A and 24A that penetrate along the flow path 22B of the cylinder portion 22 at positions facing the flow path 22B.

The cover 23 has one end of the flow path 23A connected to the flow path 22B of the cylinder 22, and the other end of the flow path 23A connected to the suction pipe 7A, so that the suction pipe 7A communicates with the flow path 22B.

The cover 24 has one end of the flow path 24A connected to the flow path 22B of the cylinder 22, and the other end of the flow path 24A connected to the delivery pipe 7B, so that the flow path 22B communicates with the delivery pipe 7B.

The delivery unit 8 is provided with a check valve 25 between the flow passage 23A of the cap 23 and the flow passage 22B of the cylinder 22, and a check valve 26 between the flow passage 22B of the cylinder 22 and the flow passage 24A of the cap 24.

The check valve 25 allows the chemical liquid flowing from the flow passage 23A of the cover 23 to the flow passage 22B of the cylinder 22 to pass therethrough, but does not allow the chemical liquid to pass from the flow passage 22B of the cylinder 22 to the flow passage 23A of the cover 23, and an umbrella valve, for example, is used.

The check valve 26 allows the chemical liquid flowing from the flow path 22B of the cylinder 22 to the flow path 24A of the lid 24 to pass therethrough, but does not allow the chemical liquid to pass from the flow path 22B of the cylinder 22 to the flow path 24A of the lid 24, and for example, an umbrella valve is used.

When the chemical liquid is to be discharged from the chemical liquid storage 6 into the living body, the delivery unit 8 moves the piston 21 from a position of maximum push-in (hereinafter also referred to as a push-out position) to a position of maximum pull-back (hereinafter also referred to as a pull-back position) in the internal space 22A by the drive unit 9, and sucks the chemical liquid stored in the chemical liquid storage 6 into the internal space 22A.

The delivery unit 8 then delivers the chemical liquid sucked into the internal space 22A into the living body by moving the piston 21 from the retracted position to the pushed position by the driving unit 9.

The delivery unit 8 can inject about 1 to 2 μ L of the drug solution into the body of the user by one reciprocating operation of the piston 21, and can inject the drug solution into the user at a desired administration rate and injection amount by repeating the operation at predetermined cycles and intervals.

However, the pushing position is set such that 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 is located further inside the flow path 22B than this position. That is, as shown in fig. 5, when the piston 21 is moved to the pushed-out position, the driving unit 9 moves the piston 21 to a position where the tip of the piston 21 is on the same plane as the bottom surface of the flow passage 22B or a position inside the flow passage 22B from the position.

Accordingly, when the air bubbles are present in the internal space 22A, the delivery unit 8 can push the air bubbles present in the internal space 22A into the flow path 22B by the distal end surface (upper surface) of the piston 21 when the piston 21 moves to the push-out position, and therefore, the possibility that the air bubbles are pulled back into the internal space 22A again when the piston 21 moves to the pull-back position after that can be significantly reduced.

In contrast, in the device that does not move the distal end of the piston into the flow path, for example, bubbles may adhere to the side surface of the cylinder portion that is in contact with the internal space and the distal end surface of the piston, and bubbles present in the internal space may not be pushed out to the flow path when the piston slides.

In this case, the amount of the liquid chemical sucked into the internal space changes due to repeated expansion and contraction of the air bubbles caused by a change in the internal pressure that changes in accordance with the movement of the piston, and the set amount of the liquid chemical cannot be delivered into the living body. Therefore, in such a device, there is a possibility that the drug cannot be administered with high accuracy.

In contrast, in the medication administering device 1, the air bubbles present in the internal space 22A are pushed out into the flow path 22B when the piston 21 moves to the push-out position in the delivery portion 8, and therefore only the medical fluid can be sucked into the internal space 22A when the piston 21 moves to the pull-back position thereafter. Thus, the medication administering device 1 can inject the medical fluid with high accuracy.

In the medication administering device 1, the distal end surface of the piston 21, the surfaces of the internal space 22A and the flow path 22B are subjected to hydrophilic processing, and therefore, it is possible to further prevent air bubbles from remaining in the internal space 22A and the flow path 22B.

[ 4. Structure of Driving part ]

As shown in fig. 6, the driving unit 9 includes a base unit 31, a motor 32, a motor support unit 34, a motor fixing plate 35, a fixing plate support unit 36, a bearing unit 37, a coupling unit 38, and a bearing support unit 39.

The driving unit 9 has components disposed on the base portion 31. The motor 32 is sandwiched between the motor support portion 34 and a motor fixing plate 35 supported by the fixing plate support portion 36 and is fixed to the base portion 31.

The motor 32 is provided with a motor shaft 33 protruding from a side surface on the motor fixing plate 35 side. A screw groove 33A is formed in a side surface of the motor shaft 33.

The bearing portion 37 is formed in a substantially rectangular parallelepiped shape elongated in the axial direction of the motor 32 and is hollow inside. The bearing portion 37 has a screw hole 37A, through which the motor shaft 33 of the motor 32 is inserted and screwed into the screw groove 33A, in the center of a side surface corresponding to a short side of a substantially rectangular parallelepiped shape.

The bearing portion 37 connects the piston 21 and the motor shaft 33 coaxially via a coupling portion 38 at a side surface corresponding to a short side of a substantially rectangular parallelepiped shape and facing a side surface provided with the screw hole 37A. Further, the bearing portion 37 is supported by the bearing support portion 39. Further, the coupling portion 38 is, for example, a member for damping the axial displacement of the motor shaft 33 from the piston 21.

As shown in fig. 6 and 7, the driving unit 9 drives the motor 32 to rotate the motor shaft 33, and moves the bearing 37 screwed with the motor shaft 33 in the axial direction in accordance with the rotation to reciprocate the piston 21 in the axial direction. Thereby, the driving unit 9 slides the piston 21 in the internal space 22A of the cylinder unit 22. In fig. 6(a) and 6(B), the piston 21 is in the retracted position, and in fig. 7, the piston 21 is in the pushed position.

In this way, since the motor shaft 33 of the motor 32 is disposed coaxially with the piston 21, the force applied to the bearing 37 by the rotation of the motor shaft 33 and the force applied to the piston 21 by the force are in the same direction, and the thrust loss of the piston 21 is avoided.

Therefore, the driving unit 9 can slide the piston 21 within the internal space 22A of the cylinder unit 22 by a stable stroke distance. Further, the driving unit 9 can drive the piston 21 with a smaller force by avoiding a loss of the thrust force of the piston 21, and therefore, the motor 32, the battery, and the like can be reduced, and the entire device can be downsized. In addition, in order to reduce the sliding resistance, a diamond-like carbon film may be coated on the side surface of the piston 21.

On the other hand, in an apparatus in which the piston and the shaft portion of the motor are not coaxially arranged, a force applied to the bearing portion due to rotation of the shaft portion and a force applied to the piston due to the force are offset, so that a thrust loss of the piston is increased, and sliding resistance of the bearing portion and the piston is increased due to the offset of the force, so that not only is the stroke of the piston unstable, but also the apparatus as a whole is increased in size.

However, in the medication administering device 1, as shown in fig. 8, the space between the X-ring fixing portion 28 and the coupling portion 38 is covered with a tubular flexible film 40. As a material of the film 40, for example, polyethylene or the like is used.

The film 40 is fixed to the X-ring fixing portion 28 and the coupling portion 38 at both ends thereof without a gap in the circumferential direction by film fixing portions 41 and 42 made of, for example, O-rings.

Since the film 40 is flexible, the state of covering the piston 21 can be maintained from the state in which the piston 21 is at the retracted position shown in fig. 8(a) to the state in which the piston 21 is at the pushed position shown in fig. 8 (B).

Therefore, in the medication administering device 1, the piston 21 can be slid in the internal space 22A of the cylinder portion 22 without bringing the piston 21 into contact with the air outside the film 40. Thereby, the medication administering device 1 can further maintain the cleanliness of the piston 21 that enters the internal space 22A.

[ 5. Structure of the puncture mechanism ]

Next, the structure of the puncture mechanism 5 will be described in detail. As shown in fig. 9 to 11, the puncture mechanism 5 mainly includes a push-in portion 5A, a fixing plate portion 5B fixed to the inside of the front end side of the bottom surface 2A of the lower casing portion 2, a base portion 5C provided protruding from the fixing plate portion 5B, and a central portion 5D configured to allow the push-in portion 5A to slide in the vertical direction inside the base portion 5C in accordance with a push-in operation of the push-in portion 5A.

The inner needle groove 62, the inner needle 68, and the inner needle guide 84 shown in fig. 9 will be described later.

As shown in fig. 11, the fixing plate portion 5B is formed in a substantially square plate shape, and has a communication hole 50 provided at the center thereof to communicate with a puncture needle hole 2B provided in the bottom surface 2A of the lower case portion 2, and two protrusions 51A and 51B are provided to protrude to the left and right of the communication hole 50 at a predetermined interval.

Screw holes 52A and 52B serving as attachment positions of the base 5C are provided at predetermined positions outside the two projections 51A and 51B.

The base portion 5C has 3 wall portions 53A, 53B, and 53C on the left, right, and rear sides, and is formed in an コ shape in cross section, and lower protrusions 54A and 54B protruding outward are provided on the outer side surfaces and lower ends of the left side wall portion 53A and the right side wall portion 53B, respectively.

The lower protrusions 54A and 54B are provided with through holes 55A and 55B, respectively, which penetrate in the vertical direction.

The base portion 5C is fixed to a predetermined position of the fixing plate portion 5B by positioning the two through holes 55A and 55B directly above the screw holes 52A and 52B of the fixing plate portion 5B and fitting screws (not shown) into the screw holes 52A and 52B of the fixing plate portion 5B through the two through holes 55A and 55B.

Further, upper protrusions 56A and 56B protruding outward are provided on the outer side surfaces and the upper ends of the left side wall 53A and the right side wall 53B, respectively. The upper protrusions 56A and 56B are also provided with through holes 57A and 57B, respectively. The through holes 57A and 57B are holes used when the base portion 5C is fixed to a predetermined position of the upper case portion 3 with screws.

Further, a groove 58A and a groove 58B extending from the lower end to the upper end are provided on the inner side surfaces of the left side wall portion 53A and the right side wall portion 53B at positions closer to the rear. The grooves 58A and 58B are grooves that serve as guides when the central portion 5D slides along the inner wall of the base portion 5C, and the grooves are hereinafter also referred to as guide grooves 58A and 58B.

Further, recesses 59A and 59B are provided on the inner surfaces of the left side wall portion 53A and the right side wall portion 53B, respectively, and at the lower ends thereof in the front direction. The function of the concave portions 59A and 59B will be described later.

A spring fixing portion 60 for fixing one end of a coil spring (described later) is provided in a projecting manner on the lower left end of the inner surface of the rear side wall portion 53C.

A spring folding portion 61 is provided on the inner surface of the rear side wall portion 53C so as to protrude upward from the center, and the spring folding portion 61 is configured to fold the other end side of a coil spring (not shown) having one end fixed to the spring fixing portion 60. The coil spring is a member for pulling back only the outer needle into the medication administering device 1 after the puncture needle composed of the metal outer needle and the resin inner needle has been inserted into the body of the user, and will be described in detail later.

Further, an inner needle groove 62 for passing an inner needle is formed in the center of the upper surface of the rear side wall portion 53C.

The central portion 5D is partially fixed to the lower end of the shaft 63 of the pushing portion 5A, and slides inside the base portion 5C due to the pushing operation of the pushing portion 5A. The pushing portion 5A is provided with a push button 64 having a shape (for example, a substantially disk shape having the same size as the finger pad) that can be easily pushed in by a finger at the upper end of the shaft 63.

Here, the center portion 5D will be described in more detail. As shown in fig. 12, the central portion 5D mainly has: an outer needle sliding portion 66 having an outer needle 65 of the puncture needle, a slide fixing/releasing portion 67 fixed to the shaft 63 of the pushing-in portion 5A and fixing or releasing the outer needle sliding portion 66, and 1 inner needle fixing/releasing portions 69A and 69B for fixing or releasing an inner needle 68 of the puncture needle.

The slide fixing/releasing portion 67 is formed in a plate shape having a front side in a substantially T shape and a rear side in a substantially コ shape opened rearward, and the shaft 63 of the pushing portion 5A is attached to the center of the front end.

In the slide fixing and releasing portion 67, concave portions 70A and 70B are formed at positions closer to the front of both the left and right side surfaces, and convex portions 71A and 71B are formed at positions closer to the rear of both the left and right side surfaces.

The left and right protrusions 71A and 71B are fitted into the guide grooves 58A and 58B of the base portion 5C, respectively, so that the slide fixing and releasing portion 67 can slide in the vertical direction along the guide grooves 58A and 58B of the base portion 5C.

In the left and right recesses 70A and 70B, stopper rods 72A and 72B each having an コ -shaped cross section are rotatably supported so that the openings face each other.

Specifically, the lower pawl portions 73A and 73B of the stopper rods 72A and 72B are pivotally supported by the recesses 70A and 70B, respectively, via a front-rear rotational shaft (not shown).

Thus, the stopper rods 72A and 72B can rotate the upper claws 74A and 74B in the approaching direction and the separating direction about the lower claws 73A and 73B.

Here, the stopper rods 72A and 72B are closed by rotating the upper pawls 74A and 74B in the approaching direction, and the stopper rods 72A and 72B are opened by rotating the upper pawls 74A and 74B in the separating direction.

After the stopper rods 72A and 72B are closed, the upper claw portions 74A and 74B are located above the upper surface of the slide fixing/releasing portion 67 by a predetermined length.

After the closing, the stopper rods 72A and 72B are housed in the slide fixing/releasing portion 67 so as not to have a step difference from both left and right side surfaces of the slide fixing/releasing portion 67. That is, after the stopper rods 72A and 72B are closed, the slide fixing and releasing portion 67 is formed in a state where only the convex portions 71A and 71B protrude from both the left and right side surfaces.

A through hole 75 penetrating in the vertical direction for passing the outer needle 65 therethrough is provided in the central portion of the slide fixing and releasing portion 67.

The outer needle sliding portion 66 can be overlapped on the slide fixing/releasing portion 67, and is formed in a shape in which the front side is substantially T-shaped, the rear side is substantially コ -shaped which is opened rearward, the substantially T-shaped portion of the front side is plate-shaped, and both left and right side surface portions of the rear side extend upward.

The outer needle sliding portion 66 has concave portions 76A and 76B formed at positions closer to the front of both the left and right side surfaces, and has convex portions 77A and 77B formed at positions closer to the rear of both the left and right side surfaces.

The convex portions 77A and 77B are portions that are fitted into the guide grooves 58A and 58B of the base portion 5C, respectively, whereby the outer needle sliding portion 66 can slide in the vertical direction along the guide grooves 58A and 58B of the base portion 5C.

The outer needle sliding portion 66 is provided with a recess 78 at the center of the tip so as not to interfere with the shaft 63 of the pushing portion 5A after being overlapped on the slide fixing and releasing portion 67.

Further, a metal outer needle 65 is provided in the outer needle sliding portion 66 so as to protrude downward at the bottom center portion. The outer needle 65 is formed as a hollow tubular needle, for example, having a length of 8mm, an outer diameter of 0.4mm, and an inner diameter of 0.2 mm.

A recess 79 is provided in the center of the upper surface of the outer needle sliding portion 66, and a communication hole 80 communicating with the outer needle 65 on the bottom surface is provided in the center of the recess 79. Then, the inner needle 68 having an outer diameter equal to or smaller than the inner diameter of the outer needle 65 is inserted into the outer needle 65 by passing the inner needle 68 through the communication hole 80.

Further, recesses 81A and 81B shallower than the recess 78 are provided on the front surface of the outer needle sliding portion 66 on both left and right sides with the recess 78 interposed therebetween.

The outer shape of the bottom surface of the outer needle sliding portion 66 is formed to be substantially the same shape and size as the upper surface of the slide fixing/releasing portion 67 except for the recessed portions 78, 81A, and 81B at the distal end.

Thus, when the outer needle sliding portion 66 is overlapped on the slide fixing/releasing portion 67 so that the outer needle 65 is inserted through the through hole 75 of the slide fixing/releasing portion 67, the convex portions 77A and 77B provided on both the left and right side surfaces are connected to the convex portions 71A and 71B provided on both the left and right side surfaces of the slide fixing/releasing portion 67 without a step.

The inner needle fixing/releasing portions 69A and 69B are elastic members and have a substantially zigzag shape in which front portions 82A and 82B are laterally symmetrical and the front portions project outward, and rear portions 83A and 83B project inward.

The front portions 82A and 82B of the inner needle fixing/releasing portions 69A and 69B project downward and project downward further than the rear portions 83A and 83B.

The inner needle fixing/releasing portions 69A and 69B are held in opposition to the outer needle sliding portion 66 by the front portions 82A and 82B being fitted into the left and right recesses 81A and 81B provided in the front surface of the outer needle sliding portion 66, and the rear portions 83A and 83B being inserted into the recess 79 provided in the central portion of the upper surface of the outer needle sliding portion 66.

At this time, the rear parts 83A and 83B of the inner needle fixing/releasing parts 69A and 69B face each other with an interval equal to or larger than the outer diameter of the inner needle 68, and the inner needle 68 of the outer needle 65 inserted into the outer needle sliding part 66 is positioned between the rear parts 83A and 83B.

Here, as shown in fig. 13, in a state where the outer needle sliding portion 66 is overlapped on the sliding fixing and releasing portion 67, the inner needle 68 is inserted into the outer needle 65 of the outer needle sliding portion 66, and the inner needle fixing and releasing portions 69A and 69B are disposed on the outer needle sliding portion 66, the left and right stopper rods 72A and 72B of the sliding fixing and releasing portion 67 are closed.

In this way, the outer needle sliding portion 66 is held between the upper claw portions 74A and 74B of the left and right stopper rods 72A and 72B and the upper surface of the slide fixing/releasing portion 67, whereby the outer needle sliding portion 66 is fixed to the slide fixing/releasing portion 67.

At this time, the upper claws 74A and 74B of the left and right stopper rods 72A and 72B press the outer side surfaces of the left and right inner needle fixing/releasing portions 69A and 69B inward, respectively.

Thus, as shown in fig. 14(a), the inner needle fixing/releasing portions 69A and 69B are deformed so that the intervals between the rear portions 83A and 83B are close to each other. As a result, the inner needle 68 positioned between the rear portions 83A and 83B of the inner needle fixing/releasing portions 69A and 69B is pressed from both left and right sides by the rear portions 83A and 83B, and is fixed to the inner needle fixing/releasing portions 69A and 69B.

Here, since the inner needle fixing/releasing portions 69A and 69B are held by the outer needle sliding portion 66, the fixation of the inner needle 68 to the inner needle fixing/releasing portions 69A and 69B means that the inner needle 68 is fixed to the outer needle sliding portion 66.

On the other hand, from this state, the left and right stopper rods 72A and 72B are opened. Thus, the outer needle sliding portion 66 is released from being fixed to the sliding fixing/releasing portion 67. As shown in fig. 14(B), at this time, the inner needle fixing/releasing portions 69A and 69B are deformed so as to return the interval between the rear portions 83A and 83B to the original interval, and the fixing of the inner needle 68 to the inner needle fixing/releasing portions 69A and 69B is also released.

In a state where the outer needle sliding portion 66 is overlapped on the sliding fixing and releasing portion 67, the inner needle 68 is inserted into the outer needle 65 of the outer needle sliding portion 66, and the inner needle fixing and releasing portions 69A and 69B are disposed on the outer needle sliding portion 66, the convex portions 71A and 71B of the sliding fixing and releasing portion 67 are fitted into the convex portions 77A and 77B of the outer needle sliding portion 66 in the guide grooves 58A and 58B inside the base portion 5C, and the central portion 5D of this structure is slidably fitted into the inside of the base portion 5C.

As shown in fig. 9, the inner needle 68 passes through the inner needle groove 62 formed in the center of the upper surface of the rear side wall portion 53C of the base portion 5C from the rear of the puncture mechanism 5, is bent downward from the inner needle guide portion 84 fixed to the inner upper end portion of the rear side wall portion 53C, and is inserted into the outer needle 65 of the outer needle sliding portion 66.

As shown in fig. 15(a), the central portion 5D is disposed at the inner upper portion of the base portion 5C as the initial position, and at this time, the entire outer needle 65 is housed in the medication administering device 1, while the amount of projection of the pushing portion 5A from the medication administering device 1 is maximized.

At this time, the left and right stopper rods 72A and 72B of the central portion 5D are pressed inward by the left side wall portion 53A and the right side wall portion 53B of the base portion 5C, and the stopper rods 72A and 72B are closed.

That is, at this time, the outer needle sliding portion 66 is fixed to the sliding fixing and releasing portion 67, and the inner needle 68 is fixed to the outer needle sliding portion 66 by the inner needle fixing and releasing portions 69A and 69B, with respect to the central portion 5D.

As shown in the lower diagram of fig. 15(a), when the center portion 5D is located at the initial position, the center portion is located forward of the spring fold-back portion 61 provided at a position near the center and above the rear side wall portion 53C of the base portion 5C.

Here, as shown in fig. 16(a), one end of the coil spring 85 is fixed to the spring fixing portion 60 provided at the left lower end of the rear side wall portion 53C of the base portion 5C, and the other end of the coil spring 85 is fixed to a predetermined position on the right of the rear portion of the outer needle sliding portion 66 in a state where the other end side is bent downward in a J-shape from the spring folded portion 61. For convenience of explanation, fig. 16 omits a part of the puncture mechanism 5, and deforms the shape of the outer needle sliding portion 66.

At this time, the coil spring 85 is in an unstretched, natural length state. When the user pushes the pushing portion 5A into the medication administering device 1 from this state, the central portion 5D slides downward inside the base portion 5C as shown in fig. 16(B), and at this time, the outer needle sliding portion 66 of the central portion 5D also slides downward and deforms from the J shape to the U shape, so that the coil spring 85 is expanded as a whole.

[ 6 action of the puncturing mechanism ]

Here, the operation of the puncture mechanism 5 when the outer needle 65 and the inner needle 68 as puncture needles are actually punctured into the body of the user will be described in detail.

As shown in fig. 15(a), the puncture mechanism 5 is configured such that the central portion 5D is set at the initial position, the entire outer needle 65 is housed in the medication administering device 1, and the amount of projection of the pushing portion 5A from the medication administering device 1 is maximized.

At this time, in the central portion 5D, the left and right stopper rods 72A and 72B are closed as described above, the outer needle sliding portion 66 is fixed to the sliding fixing/releasing portion 67, and the inner needle 68 is fixed to the outer needle sliding portion 66 by the inner needle fixing/releasing portions 69A and 69B.

At this time, as shown in fig. 17(a), the inner needle 68 is held inside the outer needle 65 so that the tip of the inner needle 68 and the tip of the outer needle 65 are held at substantially the same position and do not protrude from the tip of the outer needle 65.

Then, the user attaches the medication administering device 1 to a predetermined position of the body and then pushes the pushing portion 5A into the medication administering device 1.

As shown in fig. 15(B) and 16(B), the central portion 5D of the puncture mechanism 5 slides downward inside the base portion 5C, and the coil spring 85 having the other end fixed to the outer needle sliding portion 66 of the central portion 5D extends.

At this time, the outer needle 65 of the central portion 5D slides downward while holding the inner needle 68 inside, passes through the communication hole 50 of the fixed plate portion 5B, and protrudes from the puncture needle hole 2B, thereby puncturing the body of the user together with the inner needle 68.

When the pushing portion 5A is pushed in, and the entire shaft 63 of the pushing portion 5A is housed in the medication administering device 1 as shown in fig. 15(C) and 16(C), the portion of the pushing portion 5A protruding from the medication administering device 1 at this time is only the push button 64, and the amount of protrusion of the pushing portion 5A is minimized.

When the pushing portion 5A is pushed completely in this way, the center portion 5D reaches the lower end of the base portion 5C at this time. At this time, as shown in fig. 17(B), the outer needle 65 and the inner needle 68, which are puncture needles, puncture the deepest into the body of the user. In the medication administering device 1, the length of the portion that penetrates the body of the user is designed to be, for example, 7 mm.

At this time, the concave portions 59A and 59B provided at the lower ends of the left side wall portions 53A and 53B are positioned outside the stopper rods 72A and 72B of the center portion 5D. Thus, the stopper rods 72A and 72B are not pressed inward, and can be opened.

At this time, the two projections 51A and 51B provided on the fixed plate portion 5B abut on the distal end portions of the lower claw portions 73A and 73B of the stopper rods 72A and 72B, respectively, and push up the distal end portions of the lower claw portions 73A and 73B, thereby opening the stopper rods 72A and 72B to rotate outward.

As a result, in the central portion 5D, the fixation of the outer needle sliding portion 66 and the inner needle 68 by the inner needle fixing/releasing portions 69A and 69B is released while the fixation of the slide fixing/releasing portion 67 and the outer needle sliding portion 66 is released.

In other words, the two projecting portions 51A and 51B of the fixed plate portion 5B function as releasing portions that release the fixation of the sliding fixation/release portion 67 and the outer needle sliding portion 66 and the fixation of the outer needle sliding portion 66 and the inner needle 68 by the stopper rods 72A and 72B by coming into contact with the stopper rods 72A and 72B.

When the fixation is released in this way, the outer needle sliding portion 66 slides upward together with the inner needle fixation/release portions 69A and 69B as shown in fig. 15(D) and 16(D) by the restoring force of the coil spring 85, and returns to the original position.

Thereby, the entire outer needle 65 is pulled out from the body of the user and stored in the medication administering device 1. At this time, since the fixing by the inner needle fixing/releasing portions 69A and 69B is released and the inner needle 68 is not fixed to the outer needle sliding portion 66, the inner needle 68 is left in the body of the user without moving as shown in fig. 17 (C).

In this way, the puncture mechanism 5 punctures the inner needle 68 into the body of the user together with the outer needle 65 in accordance with the pushing operation of the pushing portion 5A, and pulls back only the outer needle 65 while keeping the inner needle 68 in the body when the pushing portion 5A is pushed until the central portion 5D reaches the lower end of the base portion 5C, that is, when the pushing portion 5A is completely pushed in.

In the medication administering device 1, after the push-in portion 5A is completely pushed in, the push button 64 of the push-in portion 5A serves as a cover of the upper case portion 3, and a packing (not shown) is provided around the shaft 63 of the push-in portion 5A, whereby a waterproof structure is formed in which water cannot enter the inside.

As described so far, in the medication administering device 1, when the user pushes the pushing portion 5A, the central portion 5D of the puncture mechanism 5 slides downward, and the outer needle 65 into which the inner needle 68 is inserted is punctured into the body of the user.

In the medication administering device 1, when the pushing-in portion 5A is completely pushed in, the stopper rods 72A and 72B of the central portion 5D are opened, and only the outer needle sliding portion 66 of the central portion 5D is returned to the original position by the restoring force of the coil spring 85, so that only the outer needle 65 is pulled back into the medication administering device 1 while keeping the inner needle 68 in the body of the user.

Then, the medication administering device 1 injects the medical fluid stored in the medical fluid storage 6 into the body of the user through the inner needle 68 by the delivery unit 8.

In this way, the medication administering device 1 can easily reduce the diameter of the indwelling needle compared to a conventional puncture needle in which the outer needle 65 is used as the indwelling needle by using the inner needle 68 of the puncture needle having a double structure as the indwelling needle.

That is, the medication administering device 1 can reduce the burden on the user by making the inner needle 68 as an indwelling needle thin in the portion to be indwelling in the body of the user.

The resin inner needle 68 can be made of a thin tube, and can have a larger inner diameter than a metal needle having the same outer diameter.

Further, the medication administering device 1 can complete the puncture from the puncture needle (the outer needle 65+ the inner needle 68) to the retraction of the outer needle 65 at a time only by the pushing operation of the pushing portion 5A.

Further, since the puncturing mechanism 5 of the medication administering apparatus 1 is operated only by the pushing operation of the user, a driving unit such as a motor is not required, and the size can be easily reduced, and as a result, the space occupied by the puncturing mechanism 5 in the medication administering apparatus 1 can be reduced.

Further, in the medication administering device 1, when the push-in portion 5A is pushed in completely, the entire device is formed in a compact size with few projecting portions, and the convenience in carrying is also improved.

[ 7. Electrical Structure of the drug delivery device ]

As shown in fig. 18, the medication administering apparatus 1 is connected to a cpu (central processing unit)91, a rom (rom) (readonly memory)92, a ram (random access memory)93, a power supply unit 94, an interface unit (I/F unit) 95, a report unit 96, and a drive unit 9 via a bus 97.

The CPU91, ROM92, RAM93, power supply unit 94, and report unit 96 are disposed on the substrate unit 10. The power supply section 94 employs a battery. The report section 96 employs a speaker.

The interface unit 95 is provided with buttons (not shown) that are disposed on the upper case 3 or the lower case 2 and receive an input command from a user.

The CPU91 performs overall control by reading a basic program stored in the ROM92 into the RAM93 for execution, and reads various application programs stored in the ROM92 into the RAM93 for execution to execute various processes.

When the CPU91 injects a drug solution into a user, the CPU reads a drug administration program into the RAM93 to execute a drug administration process, and sets parameters such as an injection amount and an injection speed, which are input via the interface unit 95, after the drug solution is filled into the drug solution storage unit 6 from the outside, the attachment unit 4 is attached to the skin of the user, and the puncture mechanism 5 punctures the skin of the user with the puncture needle.

Then, the CPU91 controls the drive unit 9 to start the injection of the chemical liquid based on the set parameters.

[ 8 ] other embodiments ]

[ 8-1 ] other embodiments 1 ]

In the above-described embodiment, the case where the present invention is applied to the medication administering device 1 for injecting a medical fluid into the body of a user is described. However, the present invention is not limited to this, and any puncture device may be used as long as it punctures a puncture needle having a double structure of an outer needle and an inner needle, and the present invention is applicable to devices other than the medication administering device 1.

For example, the present invention can also be applied to a sensor device that obtains biological information by inserting various sensors into the body of a user.

The sensor device 100 is shown in fig. 19. The sensor device 100 has the same puncture mechanism 5 as the medication administering device 1, does not have the chemical liquid storage unit 6, the delivery unit 8, and the drive unit 9, and instead has a control unit 101 that acquires biological information from the sensor and a transmission unit 102 that wirelessly transmits the biological information to the outside.

As shown in fig. 20, a sensor 103 is attached to the tip of the inner needle 68 of the sensor device 100, and a signal line 104 for electrically connecting the sensor 103 and the control unit 101 is inserted into the inner needle 68.

In the sensor device 100, the outer needle 65 into which the inner needle 68 having the sensor 103 attached to the distal end portion thereof is inserted is punctured into the body of the user by the puncturing mechanism 5.

In the sensor device 100, only the outer needle 65 is returned to the inside of the sensor device 100 in a state where the sensor 103 is left in the body of the user.

Then, the control unit 101 of the sensor device 100 acquires the biological information obtained from the sensor 103 and wirelessly transmits the biological information to the outside via the transmission unit 102.

[ 8-2 ] other embodiments 2 ]

In the above-described embodiment, the puncture needle (the outer needle 65 and the inner needle 68) is punctured into the body of the user by the puncture mechanism 5 shown in fig. 9 to 12, and only the outer needle 65 is pulled back, but the puncture of the puncture needle and the pulling back of the outer needle may be performed by a puncture mechanism other than the puncture mechanism 5 shown in fig. 9 to 12.

For example, the puncture mechanism 110 as shown in fig. 21 may be used. The puncture mechanism 110 mainly includes a fixed plate portion 110A, a base portion 110B provided to protrude from the fixed plate portion 110A, and a center portion 110C slidable in the vertical direction inside the base portion 110B. The puncture mechanism 110 has the same pushing section 5A as the puncture mechanism 5, but is omitted in fig. 21.

The fixing plate portion 110A has a communication hole 111 at the center thereof, which communicates with a puncture needle hole 2B provided in the bottom surface 2A of the lower case 2, and two projecting portions 112A and 112B projecting upward at a predetermined interval from each other are provided on the left and right sides of the communication hole 111.

The base 110B is formed in a shape obtained by removing the recesses 59A and 59B from the base 5C of the puncture mechanism 5.

As shown in fig. 22, the center portion 110C includes: an outer needle sliding portion 113 having an outer needle 65, a shaft 63 (not shown) fixed to the pushing portion 5A, a slide fixing/releasing portion 114 (a portion shown by oblique lines in the drawing) for fixing or releasing the outer needle sliding portion 113, and an inner needle fixing/releasing portion 115 for fixing or releasing the inner needle 68 of the puncture needle.

The slide fixing/releasing portion 114 is made of an elastic member, and has through holes 116A and 116B at the front portion thereof at a predetermined interval in the left-right direction for allowing the protrusions 112A and 112B of the fixing plate portion 110A to pass through, and a through hole (not shown) at a central portion 117 between the left and right through holes 116A and 116B for allowing the outer needle of the outer needle sliding portion 113 to pass through.

The slide fixing/releasing portion 114 is provided with 1 pair of splayed claw stoppers 118A and 118B extending upward from outer edges of the left and right through holes 116A and 116B, respectively.

As shown in fig. 22 and 23, the outer needle sliding portion 113 is provided with through holes 119A and 119B at the distal end portion thereof with a predetermined distance in the left-right direction for passing the left and right claw stoppers 118A and 118B of the sliding fixing and releasing portion 114, and a through hole (not shown) for passing the inner needle 68 is provided at a central portion 120 between the left and right through holes 119A and 119B.

The outer needle sliding portion 113 has a metal outer needle 65 that is provided on the bottom surface of the central portion 120 so as to protrude downward and communicates with the through hole.

Further, although not shown, the other end of the coil spring 85 is also fixed to the outer needle sliding portion 113 in the same manner as the outer needle sliding portion 66 of the puncture mechanism 5 described above.

The inner needle fixing/releasing portion 115 is formed of an elastic member, and as shown in the lower drawing of fig. 23, includes a columnar front end portion 122 provided with a through hole 121 at the center thereof for passing an inner needle therethrough, and claw portions 123A and 123B extending downward from the lower left end and the lower right end of the front end portion 122 at predetermined intervals, respectively, and the left and right claw portions 123A and 123B are formed in an eight-letter shape in which the lower end side is opened outward from the upper end side.

The inner needle fixing/releasing portion 115 is disposed in the central portion 120 of the outer needle sliding portion 113. The inner needle 68 is inserted into the outer needle 65 from a through hole (not shown) of the outer needle sliding portion 113 through the through hole 121 of the inner needle fixing/releasing portion 115 and between the left and right claw portions 123A and 123B.

A plate stopper 124 having substantially the same shape as the central portion 120 of the outer needle sliding portion 113 is fitted to the inner needle fixing/releasing portion 115.

The plate stopper 124 has a through hole 125 formed at the center thereof and having substantially the same diameter as the outer diameter of the distal end portion 122 of the inner needle fixing/releasing portion 115, and the inner needle fixing/releasing portion 115 is fitted into the through hole 125 by inserting the inner needle fixing/releasing portion 115 into the through hole.

Further, a coil spring 126 is fitted between the plate stopper 124 and the central portion 120 of the outer needle sliding portion 113 so as to surround the outer periphery of the inner needle fixing/releasing portion 115, whereby the plate stopper 124 is biased upward so as to be positioned on the side of the distal end portion 122 of the inner needle fixing/releasing portion 115.

Here, the inner needle 68 is inserted into the outer needle 65 of the outer needle sliding portion 113 through the inner needle fixing/releasing portion 115, and the outer needle sliding portion 113 is disposed on the sliding fixing/releasing portion 114.

As shown in fig. 22, the central portion 120 of the outer needle sliding portion 113 and the plate stopper 124 are sandwiched between the distal end portions and the central portion 117 of the left and right claw stoppers 118A and 118B of the slide fixing and releasing portion 114, whereby the outer needle sliding portion 113 and the plate stopper 124 are fixed to the slide fixing and releasing portion 114.

At this time, by pushing the plate stopper 124 downward of the inner needle fixing/releasing portion 115, as shown in fig. 23(a), the left and right claw portions 123A and 123B are pushed inward by the plate stopper 124, and the inner needle fixing/releasing portion 115 is deformed so as to reduce the interval between the left and right claw portions 123A and 123B.

As a result, the inner needle 68 is pressed from both left and right sides by the left and right claw portions 123A and 123B and fixed to the inner needle fixing/releasing portion 115, and as a result, the inner needle 68 and the outer needle sliding portion 113 are fixed.

As shown in fig. 24(a), the central portion 110C is disposed above the base portion 110B in a state where the outer needle sliding portion 113 is fixed to the sliding fixing/releasing portion 114 and the inner needle 68 is fixed to the outer needle sliding portion 113.

Here, when the user pushes the pushing portion 5A (not shown), the center portion 110C slides downward inside the base portion 110B.

At this time, the outer needle 65 of the central portion 110C slides downward while holding the inner needle 68 inside, passes through the communication hole 111 of the fixing plate portion 110A, and protrudes from the puncture needle hole 2B, thereby puncturing the body of the user together with the inner needle 68.

As shown in fig. 24(B), when the pushing portion 5A is completely pushed in and the center portion 110C reaches the lower end of the base portion 110B, the left and right protrusions 112A and 112B of the fixing plate portion 110A are inserted into the left and right through holes 116A and 116B of the slide fixing/releasing portion 114.

The left and right protrusions 112A and 112B of the fixing plate portion 110A abut against the inner surfaces of the left and right claw stoppers 118A and 118B of the slide fixing/releasing portion 114, and push them up. As a result, the left and right claw stoppers 118A and 118B open outward. Thus, the fixing of the slide fixing/releasing portion 114 and the outer needle sliding portion 113 is released.

At this time, as shown in fig. 23(B), the plate stopper 124, which is opened outward by the left and right claw stoppers 118A and 118B and loses its downward pressure, moves toward the distal end side of the inner needle fixing/releasing portion 115 by the biasing force of the coil spring 126.

Thus, the inner needle fixing/releasing portion 115 is deformed so that the left and right claw portions 123A and 123B return to their original shapes, and the interval between the left and right claw portions 123A and 123B is widened. As a result, the inner needle 68 held and fixed between the left and right claw portions 123A and 123B is released from being fixed.

In this way, in the puncture mechanism 110, when the push-in portion 5A is completely pushed in, the fixation of the slide fixing/releasing portion 114 and the outer needle sliding portion 113 is released, and the fixation of the outer needle sliding portion 113 and the inner needle 68 is also released.

In other words, the left and right projecting portions 112A and 112B of the fixing plate portion 110A function as releasing portions for releasing the fixing of the slide fixing/releasing portion 114 and the outer needle sliding portion 113 and the fixing of the outer needle sliding portion 113 and the inner needle 68 by the left and right claw stoppers 118A and 118B abutting on the slide fixing/releasing portion 114.

As shown in fig. 24(C), the outer needle sliding portion 113 slides upward together with the inner needle fixing/releasing portion 115 due to the restoring force of the coil spring 85 and returns to the original position.

Thereby, the entire outer needle 65 is pulled out from the body of the user and stored in the medication administering device 1 while keeping the inner needle 68 indwelling in the body of the user.

The puncture mechanism 110 is not limited to this, and may be, for example, a puncture mechanism 130 shown in fig. 25. The puncture mechanism 130 mainly includes a fixed plate portion 130A, a base portion 130B provided to protrude from the fixed plate portion 130A, a center portion 130C slidable in the vertical direction inside the base portion 130B, and a pushing portion 5A.

The fixing plate portion 130A has a communication hole 131 at the center thereof, which communicates with a puncture needle hole 2B provided in the bottom surface 2A of the lower housing portion 2.

The base 130B is formed in a shape obtained by removing the recesses 59A and 59B from the base 5C of the puncture mechanism 5.

As shown in fig. 26, the center portion 130C has: an outer needle sliding portion 132 having an outer needle 65; and a shaft 63 for supporting the pushing portion 5A, and a fixing/releasing portion 133 (a portion shown by oblique lines in the drawing) for fixing or releasing the outer needle sliding portion 132 and the inner needle 68.

The outer needle sliding portion 132 has a cubic shape having a predetermined thickness, and the outer needle 65 is provided in a central portion of the bottom surface so as to protrude downward.

Further, although not shown, the outer needle sliding portion 132 is also attached to the coil spring 85 in the same manner as the outer needle sliding portion 66 of the puncture mechanism 5 described above.

The outer needle sliding portion 132 has a notch 134 formed in the center of the upper surface at a larger interval than the outer diameter of the inner needle 68, and a through hole (not shown) for passing the inner needle 68 is provided in the bottom of the notch 134 so as to communicate with the outer needle 65. The inner needle 68 is inserted into the outer needle 65 through the through hole by passing between the cut-out portions 134.

The outer needle sliding portion 132 is provided with a groove (referred to as a shaft groove) 135 through which the shaft 63 of the pushing portion 5A passes, extending from the upper end to the lower end of the front surface center portion.

A groove (referred to as a stopper groove) 137 into which the stopper 136 is fitted is provided on the front surface of the outer needle sliding portion 132 from the upper end to the lower end of the shaft groove 135 on the outer side (for example, the right side).

A rod-shaped stopper 136 longer than the stopper groove 137 is slidably fitted into the stopper groove 137 in the vertical direction. The stopper 136 has a claw 138 projecting rearward at an upper end thereof.

Further, the outer needle sliding portion 132 has a fixing/releasing portion 133 having an L-shaped cross section slidably fitted therein in the left-right direction.

The fixing/releasing portion 133 slides with its upper end portion exposed from the upper surface of the outer needle sliding portion 132, and a recess 139 that fits in the claw portion 138 of the stopper 136 is provided at its upper end portion.

As shown in fig. 26(a) and (B), when the fixing/releasing portion 133 is positioned on the side (right side) abutting against the stopper 136, the tip end portion of the fixing/releasing portion 133 enters the shaft groove 135 of the outer needle sliding portion 132 to close the shaft groove 135. At this time, the fixing/releasing portion 133 is partially brought close to the side surface of the notch portion 134 of the outer needle sliding portion 132, thereby sandwiching and fixing the inner needle 68 located between the notch portions 134 and the side surface of the notch portion 134.

On the other hand, as shown in fig. 26(C), when the needle is positioned on the reverse side (left side), the distal end portion of the fixing/releasing portion 133 is separated from the axial groove 135 and does not close the axial groove 135, and is separated from the side surface of the cutout portion 134 and does not fix the inner needle 68.

The fixing/releasing portion 133 is biased to a side (left side) away from the stopper groove 137 by a compression spring (not shown) provided in the outer needle sliding portion 132.

The stopper 136 fixes and holds the fixing and releasing portion 133 to the right side by fitting the claw portion 138 to the recess 139 of the fixing and releasing portion 133 from above in a state where the fixing and releasing portion 133 is fixed and held to the right side, specifically, the fixing and releasing portion 133 is pushed into the right side.

After the fixing and holding/releasing portion 133 is fixed, the lower end of the stopper 136 protrudes downward from the bottom surface of the outer needle sliding portion 132.

Thus, the central portion 130C is disposed above the base portion 130B as shown in fig. 27(a) in a state where the fixing/releasing portion 133 is fixedly held on the right side in the outer needle sliding portion 132 and the inner needle 68 is fixed to the outer needle sliding portion 132.

At this time, the lower end of the shaft 63 of the pushing-in portion 5A abuts on the upper surface of the distal end portion of the fixing/releasing portion 133 that closes the shaft groove 135 of the outer needle sliding portion 132.

Here, when the user pushes the pushing portion 5A, the upper surface of the distal end portion of the fixing/releasing portion 133 is pushed downward with respect to the shaft 63 of the pushing portion 5A, and the entire central portion 130C is pushed downward and slides downward inside the base portion 130B.

At this time, the outer needle 65 of the central portion 130C slides downward while holding the inner needle 68 inside, passes through the communication hole 131 of the fixing plate portion 130A, protrudes from the puncture needle hole 2B, and is punctured into the body of the user together with the inner needle 68.

As shown in fig. 27(B), when the pushing portion 5A is pushed completely, the center portion 130C reaches the lower end of the base portion 130B.

At this time, the lower end of the stopper 136 protruding downward from the bottom surface of the outer needle sliding portion 132 comes into contact with the fixed plate portion 130A before the bottom surface of the outer needle sliding portion 132 comes into contact with the lower end of the stopper 136, and then the outer needle sliding portion 132 slides with respect to the stopper 136 that is stopped.

As shown in fig. 26(B), the claw 138 of the stopper 136 fitted in the recess 139 of the fixing/releasing portion 133 is separated upward of the recess 139, and the fixing/releasing portion 133 is released from being fixed to the right side.

As a result, as shown in fig. 26(C), the fixing/releasing portion 133 slides leftward in the outer needle sliding portion 132 by the action of the compression spring.

Thus, the distal end portion of the fixing/releasing portion 133 is separated from the shaft groove 135 and is no longer in contact with the shaft 63, thereby releasing the downward pushing of the central portion 130C. At this time, a part of the fixing/releasing portion 133 is separated from the side surface of the notch portion 134 of the outer needle sliding portion 132, and the fixing of the inner needle 68 sandwiched therebetween is also released.

In this way, in the puncture mechanism 130, when the pushing portion 5A is completely pushed in, the fixation of the central portion 130C to the shaft 63 of the pushing portion 5A is released, and the fixation of the central portion 130C to the inner needle 68 is also released.

In other words, in the case of the puncture mechanism 130, the fixing plate portion 130A functions as a release portion that releases the fixing of the central portion 130C to the shaft 63 and the fixing of the central portion 130C to the inner needle 68 by the stopper 136 abutting on the central portion 130C.

Thus, as shown in fig. 27(C), the central portion 130C slides the shaft 63 of the pushing portion 5A in the shaft groove 135 by the restoring force of the coil spring 85, and slides upward to return to the original position.

Thereby, the entire outer needle 65 is pulled out from the body of the user while keeping the state in which the inner needle 68 is left in the body of the user, and the inner needle 68 is housed in the medication administering device 1.

Further, the two puncture mechanisms 110 and 130 as described above are explained here, but the present invention is not limited to this, and any other puncture mechanism may be used as long as it can achieve puncture of the puncture needle and retraction of the outer needle by the pushing operation of the pushing unit 5A.

[ 8-3 ] other embodiments 3 ]

In the above-described embodiment, the coil spring 85 is used as an elastic member for returning only the outer needle 65 to the inside of the medication administering device 1 after the puncture needle composed of the metal outer needle 65 and the resin inner needle 68 is punctured into the body of the user, but the present invention is not limited to this, and an elastic member other than the coil spring 85 may be used as long as it functions similarly to the coil spring 85.

Feasibility of industrial utilization

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

Description of reference numerals:

1 … drug delivery device; 2 … lower housing part; 3 … an upper housing part; 4 … pasting part; 5. 110, 130 … piercing mechanisms; 5a … push-in part; 5B, 110A, 130A … fixed plate part; 5C, 110B, 130B … base; 5D, 110D, 130D … center portion; 6 … medicinal liquid storage part; 7 … flow path section; 8 … delivery unit; 9 … a drive part; 10 … a base plate part; 65 … outer needle; 66. 113, 132 … outer needle sliding part; 67. 114 … sliding fixing/releasing part; 68 … inner needle; 69A, 69B, 115 … inner needle fixing/releasing parts; 72A, 72B … stop levers; 85. 126 … a coil spring; 100 … sensor device; 101 … control unit; 102 … sending part; 103 … sensor; 104 … signal lines; 118A, 118B … claw stops; 124 … plate stopper; 133 … fixing/releasing part; 136 … stop.

Claims (6)

1. A puncture device, comprising:

a puncture needle having a double structure including a metal outer needle and a resin inner needle inserted into the outer needle;

a housing portion that houses the puncture needle; and

a puncture mechanism provided in the housing portion, the puncture mechanism being configured to cause the puncture needle to protrude from the housing portion and puncture a body of a user in a state where the inner needle is inserted into the outer needle, and to return only the outer needle of the puncture needle to the housing portion while keeping the inner needle of the puncture needle in a state where the inner needle is left in the body,

the puncture mechanism further has:

a push-in portion that can be pushed in relative to the housing portion;

an outer needle sliding portion slidable in the housing portion and having the outer needle;

a stopper which fixes the push-in part and the outer needle sliding part and fixes the inner needle inserted into the outer needle to the outer needle sliding part;

an elastic member having one end fixed to the housing portion and the other end fixed to the outer needle sliding portion; and

a fixation releasing section for releasing the fixation of the pushing-in section and the outer needle sliding section and the fixation of the outer needle sliding section and the inner needle by the stopper,

when the pushing portion is pushed in with the pushing portion and the outer needle sliding portion, and the outer needle sliding portion and the inner needle fixed by the stopper, the outer needle inserted with the inner needle is projected from the housing portion by sliding of the outer needle sliding portion and is punctured into the body of the user,

further, when the outer needle sliding portion slides to a predetermined position, the fixing of the push-in portion and the outer needle sliding portion and the fixing of the outer needle sliding portion and the inner needle are released, and the outer needle sliding portion is slid in the other direction by the elastic member, so that only the outer needle is returned into the housing portion while keeping the inner needle in a state of being left in the body.

2. The lancing device of claim 1,

the fixation releasing section releases the fixation of the pushing section and the outer needle sliding section by the stopper and the fixation of the outer needle sliding section and the inner needle by abutting the stopper.

3. The lancing device of claim 2,

when the outer needle sliding portion slides to a predetermined position, the stopper abuts against the fixation releasing portion, the fixation between the pushing-in portion and the outer needle sliding portion and the fixation between the outer needle sliding portion and the inner needle are released, and the outer needle sliding portion slides in the other direction by the elastic member, so that the inner needle is kept in the body, and only the outer needle is returned into the housing portion.

4. The lancing device of claim 1,

when the push-in portion is pushed in, the front end portion of the push-in portion becomes a cover of the case portion, thereby closing the case portion to have a waterproof structure.

5. The lancing device of claim 1, having:

a sensor attached to a tip of an inner needle of the puncture needle; and

a control unit connected to the sensor through the inner needle to acquire biological information from the sensor,

the piercing mechanism is formed such that,

after the puncture needle is inserted into the body of the user with the inner needle to which the sensor is attached being projected from the housing, only the outer needle of the puncture needle is returned into the housing, and the sensor is left in the body.

6. A drug delivery device, comprising:

a puncture needle having a double structure including a metal outer needle and a resin inner needle inserted into the outer needle;

a housing portion that houses the puncture needle;

a puncture mechanism provided in the housing, for, after the puncture needle in a state where the inner needle is inserted into the outer needle is projected from the housing and punctured into a body of a user, returning only the outer needle of the puncture needle into the housing while keeping the inner needle of the puncture needle in a state where the inner needle is left in the body;

a drug solution storage unit for storing a drug solution; and

a delivery unit that delivers the medical fluid stored in the medical fluid storage unit into the body through the inner needle indwelling in the body,

the puncture mechanism further has:

a push-in portion that can be pushed in relative to the housing portion;

an outer needle sliding portion slidable in the housing portion and having the outer needle;

a stopper which fixes the push-in part and the outer needle sliding part and fixes the inner needle inserted into the outer needle to the outer needle sliding part;

an elastic member having one end fixed to the housing portion and the other end fixed to the outer needle sliding portion; and

a fixation releasing section for releasing the fixation of the pushing-in section and the outer needle sliding section and the fixation of the outer needle sliding section and the inner needle by the stopper,

when the pushing portion is pushed in with the pushing portion and the outer needle sliding portion, and the outer needle sliding portion and the inner needle fixed by the stopper, the outer needle sliding portion slides, and the outer needle into which the inner needle is inserted protrudes from the housing portion and penetrates into the body of the user,

further, when the outer needle sliding portion slides to a predetermined position, the fixing of the push-in portion and the outer needle sliding portion and the fixing of the outer needle sliding portion and the inner needle are released, and the outer needle sliding portion is slid in the other direction by the elastic member, so that only the outer needle is returned into the housing portion while keeping the inner needle in a state of being left in the body.