JP5520110B2 - Injection needle assembly and drug injection device - Google Patents

Description

  The present invention relates to an injection needle assembly and a drug injection device that are used to puncture a needle tip from the surface of the skin and inject a drug into an upper layer portion of the skin.

  In recent years, human infection with avian influenza has been reported, and there are concerns about many damages caused by a pandemic of human-to-human infection. Therefore, stockpiling of pre-pandemic vaccines that are likely to be effective against avian influenza is being carried out all over the world. In addition, in order to administer the prependemic vaccine to many humans, studies have been made to increase the production amount of the vaccine.

  The skin is composed of three parts: epidermis, dermis, and subcutaneous tissue. The epidermis is a layer of about 50 to 200 μm from the skin surface, and the dermis is a layer of about 1.5 to 3.5 mm continuing from the epidermis. Since influenza vaccine is generally administered subcutaneously or intramuscularly, it is administered in the lower layer of the skin or deeper than that.

  On the other hand, it is reported that by administering the influenza vaccine using the upper skin layer where many immunocompetent cells are present as the target site, the ability to acquire immunity equivalent to subcutaneous administration or intramuscular administration can be obtained even if the dose is reduced (Non-Patent Document 1). Therefore, since the dose can be reduced by administering the prepanemic vaccine to the upper layer of the skin, the prepanemic vaccine can be administered to more humans. The upper skin layer refers to the epidermis and dermis of the skin.

  Various methods using single needles, multiple needles, patches, gas, etc. have been reported as methods for administering drugs to the upper skin layer, but considering the stability, reliability, and production cost of administration, As an administration method to the upper layer part, a method using a single needle is most suitable. As a method of administering a vaccine to the upper skin layer using this single needle, the Manto method has been known for a long time. In the Manto method, generally, a needle having a short bevel with a size of 26 to 27 G is inserted about 2 to 5 mm from an oblique direction of about 10 to 15 ° with respect to the skin, and about 100 μl of the drug is administered. Is the method.

  However, since the administration of drugs by the Manto method is difficult, the success rate depends on the skill of the doctor performing the injection. In particular, it is difficult to administer influenza vaccine by the Manto method because children may move during administration. Therefore, development of a device that can easily administer a vaccine to the upper skin layer is required.

  Patent Document 1 describes an injection device in which a limiter having a skin contact surface is connected to a hub of a syringe. The limiter of the injection device described in Patent Document 1 is formed in a cylindrical shape that covers the periphery of the needle tube, and has a skin contact surface from which the injection needle protrudes. In this limiter, the length of the injection needle protruding from the skin contact surface (protrusion length) is regulated to 0.5 to 3.0 mm, and the drug injected from the injection needle is administered into the skin.

JP 2001-137343 A

R.T.Kenney et al. New England Journal of Medicine, 351, 2295-2301 (2004)

  However, in the injection device in which the length of the needle tube protruding is relatively short like the injection device described in Patent Document 1, when the syringe is slowly pressed against the skin or pressed with a weak force, the needle tip of the needle tube is The skin was not punctured or difficult to puncture. In addition, there is a problem that it is difficult for the user to recognize how much pressure the needle tube punctures the living body. As a result, the needle tip of the needle tube did not reach the desired position, and it was difficult to reliably administer the drug to the upper skin layer.

  The object of the present invention is to take the above-mentioned problems into consideration, and to ensure the necessary pressing force and the speed of puncture when puncturing the needle tube into the skin, and to ensure that the needle tip of the needle tube is positioned in the upper layer of the skin. It is an object of the present invention to provide a needle assembly and a medicine injection device that can perform the above-described operation.

In order to solve the above problems and achieve the object of the present invention, an injection needle assembly of the present invention covers a needle tube having a needle tip that can be punctured into a living body, a hub that holds the needle tube, and the periphery of the needle tube. And a stabilizing portion having an end face that comes into contact with the skin when the needle tube is punctured into the living body. A puncture speed securing member that is provided on the hub and contacts the skin prior to the needle tip of the needle tube when the needle tube is punctured into the living body, and secures the speed and pressing force when the needle tube is punctured into the living body; The puncture speed securing member includes a finger rest that is fixed to the outer periphery of the hub, and a sliding portion that is disposed on the radially outer side of the stable portion and is movable in the longitudinal direction of the needle tube along the outer peripheral surface of the stable portion. And a deforming portion interposed between the finger rest portion and the sliding portion .
Further, the injection needle assembly of the present invention has a needle tube having a needle tip that can puncture a living body, a hub that holds the recording tube, and a skin that is disposed so as to cover the periphery of the needle tube when the needle tube is punctured into the living body. Stabilizing part with end face to contact with the body, and provided in the hub, when the needle tube is punctured into the living body, contact the skin before the needle tip of the needle tube, ensuring the speed and pressing force when piercing the needle tube into the living body A puncture speed securing member that is disposed on a radially inner side of the stabilizing portion and a finger rest that is fixed to the outer periphery of the hub, and is arranged along the inner peripheral surface of the stable portion. It consists of a sliding part movable in the longitudinal direction and a deforming part interposed between the finger rest part and the sliding part.
The injection needle assembly of the present invention includes a needle tube having a needle tip that can puncture a living body, a hub that holds the needle tube, and a skin that is disposed so as to cover the periphery of the needle tube when the needle tube is punctured into the living body. A stabilizing portion having an end surface to be contacted, and a hub, when the needle tube is punctured into the living body, contact the skin before the needle tip of the needle tube, and ensure the speed and pressing force when puncturing the needle tube into the living body. A puncture speed securing member and an adjustment portion having a needle projecting surface from which the needle tip of the needle tube protrudes are provided around the needle tube, and the puncture speed securing member is adjusted with a finger contact portion fixed to the outer periphery of the hub. The sliding part which covers the outer peripheral surface of a part and is movable to the longitudinal direction of a needle tube along the outer peripheral surface of an adjustment part, and a deformation | transformation part interposed between a finger rest part and a sliding part.

Further, the drug injection device of the present invention includes a needle tube having a needle tip that can be punctured into a living body, a hub that holds the needle tube, a syringe connected to the hub, and a needle tube that is disposed so as to cover the periphery of the needle tube. A stabilizing portion having an end surface that comes into contact with the skin when puncturing the skin. A puncture speed securing member that is provided on the hub and contacts the skin prior to the needle tip of the needle tube when the needle tube is punctured into the living body, and secures the speed and pressing force when the needle tube is punctured into the living body; The puncture speed securing member includes a finger rest that is fixed to the outer periphery of the hub, and a sliding portion that is disposed on the radially outer side of the stable portion and is movable in the longitudinal direction of the needle tube along the outer peripheral surface of the stable portion. A syringe is connected to a hub provided in an injection needle assembly including a deforming portion interposed between the finger rest portion and the sliding portion .
The drug injection device of the present invention includes a needle tube having a needle tip that can puncture a living body, a hub that holds the recording tube, and a skin that is disposed so as to cover the periphery of the needle tube when the needle tube is punctured into the living body. A stabilizing portion having an end surface to be contacted, and a hub, when the needle tube is punctured into the living body, contact the skin before the needle tip of the needle tube, and ensure the speed and pressing force when puncturing the needle tube into the living body. A puncture speed securing member, and the puncture speed securing member is disposed on the radially inner side of the stabilizing portion and the finger rest portion fixed to the outer periphery of the hub, and the longitudinal direction of the needle tube along the inner peripheral surface of the stabilizing portion A syringe is connected to a hub provided in an injection needle assembly that includes a sliding portion that is movable in a direction, and a deformation portion that is interposed between the finger rest portion and the sliding portion.
In addition, the drug injection device of the present invention has a needle tube having a needle tip that can be punctured into a living body, a hub that holds the needle tube, and is disposed so as to cover the periphery of the needle tube so that the needle tube comes into contact with the skin when puncturing the living body. A stabilizing portion having an end surface that is provided on the hub, and a puncture that contacts the skin prior to the needle tip of the needle tube when the needle tube is punctured into the living body and ensures speed and pressing force when the needle tube is pierced into the living body A speed securing member, and an adjustment part having a needle projecting surface from which the needle tip of the needle tube projects around the needle tube, and the puncture speed securing member includes a finger pad part fixed to the outer periphery of the hub, and an adjustment part An injection needle assembly comprising a sliding portion that covers the outer peripheral surface of the adjusting portion and is movable in the longitudinal direction of the needle tube along the outer peripheral surface of the adjusting portion, and a deformable portion interposed between the finger rest portion and the sliding portion. A syringe is connected to a hub provided in the solid body.

  According to the injection needle assembly and the pharmaceutical injection device of the present invention, the puncture speed securing member can temporarily secure the speed and pressing force when puncturing the living body with the needle tube, and reliably secure the needle tip of the needle tube. It is possible to puncture a desired position on the upper skin layer. Furthermore, since the appropriate pressing force to the living body by the needle tube and the stabilizing part can be recognized, the user can use it without feeling uneasy.

It is sectional drawing which shows the 1st Embodiment of the pharmaceutical injection device of this invention. It is sectional drawing which shows the state in the middle of the puncture in the 1st Example of the pharmaceutical injection device of this invention. It is sectional drawing which shows the state which the puncture in the 1st Embodiment of the chemical injection device of this invention was completed. It is sectional drawing which shows the 2nd Embodiment of the chemical injection apparatus of this invention. It is sectional drawing which shows the state which the puncture in the 2nd Example of the pharmaceutical injection device of this invention was completed. It is sectional drawing which shows the 3rd Embodiment of the chemical injection apparatus of this invention. It is sectional drawing which shows the 4th Example of the chemical injection apparatus of this invention. It is sectional drawing which shows the 5th Example of the chemical injection apparatus of this invention. It is sectional drawing which shows the state which the puncture in the 5th example of the medicine injection apparatus of this invention was completed. It is sectional drawing which shows the 6th Example of the chemical injection apparatus of this invention.

Hereinafter, embodiments of an injection needle assembly and a drug injection device according to the present invention will be described with reference to FIGS. In addition, the same code | symbol is attached | subjected to the common member in each figure. The present invention is not limited to the following form.
The description will be given in the following order.
1. First embodiment example 1-1. Configuration example of injection needle assembly and drug injection device 1-2. 1. Method of using drug injection device Second embodiment example 3. FIG. 3. Third embodiment example 4. Fourth embodiment example 5. Fifth embodiment Sixth embodiment

<1. First Embodiment>
1-1. Configuration Example of Injection Needle Assembly and Drug Injection Device First, referring to FIGS. 1 to 3, the injection needle assembly and the drug according to the first embodiment of the present invention (hereinafter referred to as “this example”). The injection device will be described.
FIG. 1 is a cross-sectional view showing a drug injection device of this example, and FIG. 2 is a cross-sectional view showing a state during puncturing in the drug injection device of this example. FIG. 3 is a cross-sectional view showing a state where the puncture is completed.

  As shown in FIG. 1, the medicine injection device 1 includes an injection needle assembly 2 and a syringe 3 to which the injection needle assembly 2 is detachably connected. The syringe 3 may be one that is filled with a medicine when the medicine injection device is used, or may be a prefilled syringe that is filled with a medicine in advance. Moreover, as a medicine with which the syringe 3 is filled, a vaccine can be mentioned, but a medicine using a high-molecular substance such as a cytokine or a hormone may be used.

  The injection needle assembly 2 includes a hollow needle tube 5 having a needle hole, a hub 6 that holds the needle tube 5, and a puncture speed securing member 7.

[Needle tube]
The needle tube 5 has a size of 26 to 33 G (outer diameter 0.2 to 0.45 mm) based on the ISO medical needle tube standard (ISO9626: 1991 / Amd.1: 2001 (E)), preferably 30-33G is used. A blade surface 5 a for making the needle tip 8 have an acute angle is formed at the tip of the needle tube 5. The length of the blade surface 5a in the direction in which the needle tube 5 extends (hereinafter referred to as “bevel length B”) may be 1.4 mm (adult) or less, which is the thinnest thickness of the upper skin layer described later, Moreover, what is necessary is just about 0.5 mm or more which is a bevel length when a short bevel is formed in a 33G needle tube. That is, the bevel length B is preferably set in the range of 0.5 to 1.4 mm.

  Furthermore, the bevel length B is more preferable if the thinnest thickness of the upper skin layer is 0.9 mm (child) or less, that is, the bevel length B is in the range of 0.5 to 0.9 mm. In addition, a short bevel refers to the blade surface which makes 18-25 degrees with respect to the longitudinal direction of the needle generally used for the needle for injection.

  Examples of the material of the needle tube 5 include, but are not limited to, stainless steel, and aluminum, aluminum alloy, titanium, titanium alloy, and other metals can be used. The needle tube 5 may be a straight needle or a tapered needle at least partially having a tapered structure.

[Hub]
Next, the hub 6 will be described. The hub 6 includes a substantially cylindrical hub body 10, a fixing portion 11, an adjustment portion 12, and a stabilization portion 13. An adjustment portion 12 and a stabilization portion 13 are provided at one end portion of the hub body 10 in the axial direction, and a fixing portion 11 is provided at the other end portion. Examples of the material of the hub 6 include synthetic resins (plastics) such as polycarbonate, polypropylene, and polyethylene.

  The fixing portion 11 is provided with a cylindrical hole 11a into which the insertion portion 3a of the syringe 3 is fitted. The cylindrical hole 11a is set to a size corresponding to the insertion portion 3a of the syringe 3, and the diameter continuously decreases toward the adjustment portion 12 and the stabilization portion 13 side. In addition, you may provide the thread groove for screwing the insertion part 3a of the syringe 3 in the internal peripheral surface of this fixing | fixed part 11. FIG.

  The adjustment unit 12 is provided at the center of the one end surface 10 a of the hub body 10 and is configured as a protrusion that protrudes in the axial direction of the hub body 10. The axis of the adjusting portion 12 is coincident with the axis of the hub body 10. The needle tube 5 passes through the adjustment unit 12 and the hub body 10, and the axis of the needle tube 5 and the axis of the adjustment unit 12 coincide. An end surface of the adjustment unit 12 is a needle projecting surface 12a from which the needle tip 8 side of the needle tube 5 projects.

  The needle projecting surface 12 a is formed as a plane orthogonal to the axial direction of the needle tube 5. This needle protruding surface 12a defines the depth at which the needle tube 5 is punctured by contacting the surface of the skin when the needle tube 5 is punctured into the upper skin portion. That is, the depth at which the needle tube 5 is punctured into the upper skin layer is determined by the length of the needle tube 5 protruding from the needle protruding surface 12a (hereinafter referred to as “projection length L”).

  The thickness of the upper skin layer corresponds to the depth from the skin surface to the dermis layer, and is generally in the range of 0.5 to 3.0 mm. Therefore, the protrusion length L of the needle tube 5 can be set in the range of 0.5 to 3.0 mm.

  By the way, the vaccine is generally administered to the upper arm, but when it is considered to be administered to the upper layer of the skin, it is considered that the shoulder peripheral part where the skin is thick, particularly the deltoid part is suitable. Therefore, the thickness of the upper layer of the deltoid muscle was measured for 19 children and 31 adults. This measurement was performed by imaging the upper layer of the skin with high ultrasonic reflectivity using an ultrasonic measurement device (NP60R-UBM high-resolution echo for small animals, Nepagene). In addition, since the measured value was logarithmic normal distribution, the range of MEAN ± 2SD was obtained by geometric mean.

  As a result, the thickness of the upper skin layer of the deltoid muscle of children was 0.9 to 1.6 mm. In addition, the thickness of the upper skin layer in the deltoid muscles of adults was 1.4 to 2.6 mm at the distal part, 1.4 to 2.5 mm at the central part, and 1.5 to 2.5 mm at the proximal part. It was. From the above, it was confirmed that the thickness of the upper skin layer in the deltoid muscle was 0.9 mm or more in the case of children and 1.4 mm or more in the case of adults. Therefore, in the injection at the upper layer portion of the deltoid skin, the protruding length L of the needle tube 5 is preferably set in the range of 0.9 to 1.4 mm.

  By setting the protrusion length L in this way, the blade surface 5a of the needle tip 8 can be reliably positioned on the upper skin layer. As a result, the needle hole (chemical solution discharge port) that opens in the blade surface 5a can be located in the upper skin layer portion at any position in the blade surface 5a. Even if the drug solution outlet is located in the upper skin layer, if the needle tip 8 is deeply stabbed into the upper skin layer, the drug solution flows subcutaneously between the side surface of the end of the needle tip 8 and the cut skin. Therefore, it is important that the blade surface 5a is surely in the upper skin portion.

  Note that it is difficult to make the bevel length B 1.0 mm or less with a needle tube thicker than 26G. Therefore, in order to set the protruding length L of the needle tube 5 within a preferable range (0.9 to 1.4 mm), it is preferable to use a needle tube thinner than 26G.

  The needle protruding surface 12a is formed so that the distance S from the peripheral edge to the peripheral surface of the needle tube 5 is 1.4 mm or less, and preferably in the range of 0.3 to 1.4 mm. The distance S from the peripheral edge of the needle protruding surface 12a to the peripheral surface of the needle tube 5 is set in consideration of the pressure applied to the blisters formed by administering the drug to the upper skin layer. That is, the needle projecting surface 12a is set to a size that is sufficiently smaller than the blisters formed on the upper layer portion of the skin and does not hinder the formation of blisters. As a result, it is possible to prevent the needle protruding surface 12a from pressing the skin around the needle tube 5 and leaking the administered drug.

Next, the stabilizer 13 will be described.
The stabilizing portion 13 is provided on the end surface 10 a of the hub body 10. The stabilizing portion 13 is formed in a cylindrical shape that is continuous with the peripheral edge portion of the end surface 10a. The needle tube 5 and the adjustment unit 12 are disposed in the cylindrical hole of the stabilization unit 13. That is, the stable portion 13 is formed in a cylindrical shape that covers the periphery of the adjusting portion 12 through which the needle tube 5 passes. And the end surface 13a of the stable part 13 is located on the substantially same plane as the needle | hook protrusion surface 12a of the adjustment part 12. FIG.

  Further, when the living body is punctured with the needle tip 8 of the needle tube 5, the needle protruding surface 12 a contacts the surface of the skin and also contacts the end surface 13 a of the stabilizing portion 13. At this time, the drug injection device 1 is stabilized by the end surface 13a of the stabilizing portion 13 coming into contact with the skin, and the needle tube 5 can be maintained in a posture substantially perpendicular to the skin.

  Even if the end surface 13a of the stabilizing portion 13 is positioned on the same plane as the needle protruding surface 12a, or is positioned closer to the needle tip 8 side of the needle tube 5 than the needle protruding surface 12a, the needle tube 5 is skinned. It is possible to keep the posture substantially perpendicular to the angle. In consideration of the swelling of the skin when the stable portion 13 is pressed against the skin, the axial distance between the end surface 13a of the stable portion 13 and the needle protruding surface 12a is preferably set to 1.3 mm or less.

  Further, the inner diameter d of the stable portion 13 is set to a value equal to or larger than the diameter of the blister formed on the skin. Specifically, the distance T from the inner wall surface of the stable portion 13 to the peripheral edge of the needle protruding surface 12a is set to be in the range of 4 mm to 15 mm. Thereby, it can prevent that blister formation is inhibited by pressure being applied to the blister from the inner wall surface of the stable part 13.

  The shortest distance T from the inner wall surface of the stable portion 13 to the outer peripheral surface of the adjusting portion 12 is not particularly limited as long as it is 4 mm or more. However, when the distance T is increased, the outer diameter of the stable portion 13 is increased, so that it is difficult to bring the entire end surface 13a of the stable portion 13 into contact with the skin when the needle tube 5 is inserted into a thin arm like a child. . For this reason, the distance T is preferably set to 15 mm as a maximum in consideration of the thinness of the child's arm.

  Moreover, if the distance S from the periphery of the needle protrusion surface 12a to the peripheral surface of the needle tube 5 is 0.3 mm or more, the adjustment unit 12 does not enter the skin. Therefore, considering the distance T (4 mm or more) from the inner wall surface of the stable portion 13 to the periphery of the needle protruding surface 12a and the diameter (about 0.3 mm) of the needle protruding surface 12a, the inner diameter d of the stable portion 13 is 9 mm or more. Can be set.

  In addition, the shape of the stable part 13 is not limited to a cylindrical shape, For example, you may form in square tube shapes, such as a square column and a hexagonal column, which have a cylinder hole in the center.

  Next, the puncture speed ensuring member 7 will be described. The puncture speed ensuring member 7 is composed of a finger pad portion 15, a sliding portion 16, and a deforming portion 17. The finger pad 15 is fixed to the hub body 10. The finger pad 15 is formed in a flange shape that protrudes radially outward from the outer peripheral surface of the hub body 10. The sliding portion 16 includes a cylindrical portion 16a, a guide portion 16b that slides along the outer periphery of the fixed portion 11 of the hub 6 and the hub body 10, and a connection portion 16c that connects the cylindrical portion 16a and the guide portion 16b. Have.

  The guide portion 16b has a cylindrical shape and is supported by the hub body 10 so as to be movable along the axial direction thereof. Thereby, the cylindrical part 16a mentioned later can be slid along the outer peripheral surface of the stable part 13 without shaking.

  The cylindrical portion 16 a covers the outer peripheral surface of the stabilizing portion 13 and is movable along the axial direction of the hub 6. A connecting portion 16c is provided substantially vertically from the one end portion of the cylindrical portion 16a in the axial direction to the end portion of the guide portion 16b. Further, the end surface of the cylindrical portion 16a opposite to the connecting portion 16c is an abutting surface 18 that comes into contact with the skin when the needle tube 5 is punctured.

  In a state before the needle tube 5 is punctured into the living body, the cylindrical portion 16 a of the sliding portion 16 is disposed at a first position that covers the needle tip 8 and the adjustment portion 12 of the needle tube 5. Then, as shown in FIGS. 2 and 3, when the finger contact portion 15 is pressed and the hub 6 is pushed out, the sliding portion 16 slides along the axial direction of the hub 6. Therefore, the cylindrical portion 16 a of the sliding portion 16 moves to the second position where the needle tip 8 of the needle tube 5 is exposed and the abutting surface 18 is located substantially on the same plane as the end surface 13 a of the stabilizing portion 13.

  Further, the cylindrical portion 16a is provided with a guide portion 19 which is a pressing guide portion. The guide portion 19 is provided continuously along the circumferential direction of the outer peripheral surface of the cylindrical portion 16a, and is formed as a ring-shaped flange protruding outward in the radial direction of the cylindrical portion 16a. The guide portion 19 has a contact surface 19a that comes into contact with the skin. The contact surface 19a is a plane that is substantially parallel to the contact surface 18 of the cylindrical portion 16a.

  By pressing the stable portion 13 until the contact surface 19a of the guide portion 19 comes into contact with the skin, the force with which the stable portion 13 and the needle tube 5 press the skin can always be secured to a predetermined value or more. Thereby, the part (equivalent to protrusion length L) which protrudes from the needle | hook protrusion surface 12a of the needle tube 5 is punctured reliably in skin.

  The distance from the contact surface 19a of the guide portion 19 to the contact surface 18 of the sliding portion 16 is long enough so that the stable portion 13 and the needle tube 5 can be pressed with an appropriate pressing force and can puncture the skin. Is set (see FIG. 3). Hereinafter, this length is referred to as “guide height y”.

  In addition, the appropriate pressing force of the needle tube 5 and the stable part 13 is 0.5-20N, for example. As a result, the user can be guided by the guide portion 19 with the pressing force applied to the skin by the needle tube 5 and the stabilizing portion 13, and the needle tip 8 and the blade surface 5 a of the needle tube 5 can be reliably positioned on the upper skin portion. This is advantageous in that it can give the user a sense of security.

  Specifically, the inner diameter d of the stabilizing portion 13 is preferably set in a range of 11 to 14 mm, and the guide portion height y is set to the outer periphery of the cylindrical portion 16a of the sliding portion 16 from the protruding end surface of the guide portion 19. It is set as appropriate based on the length x to the surface (hereinafter referred to as guide portion length x). For example, when the inner diameter d of the stable portion 13 is 12 mm, the guide height y is set in the range of 2.3 to 6.6 mm when the guide length x is 3 mm, for example.

  Further, a deforming portion 17 is interposed between the sliding portion 16 and the finger rest portion 15. The deformable portion 17 includes a first elastic portion 17a, a second elastic portion 17b, and a connection portion 17c that connects the first elastic portion 17a and the second elastic portion 17b. The first elastic portion 17 a is formed in a cylindrical shape, and the end surface on one end side in the axial direction is fixed to the peripheral edge portion of the finger pad portion 15. The diameter of the first elastic portion 17 a is set to be approximately equal to the diameter of the finger pad portion 15. Further, a connecting portion 17c is continuously provided on the other end side in the axial direction of the first elastic portion 17a.

  The second elastic portion 17b is formed in a cylindrical shape having a larger diameter than the first elastic portion 17a. The diameter of the second elastic portion 17b is set to be approximately equal to the diameter of the cylindrical portion 16a. And the connection part 17c is continuously provided in the one end side of the axial direction of the 2nd elastic part 17b, and the end surface of the other end side is being fixed to the cylindrical part 16a.

  The connecting portion 17c has a continuously increasing diameter from the first elastic portion 17a to the second elastic portion 17b. When the cylindrical portion 16a is disposed at the first position, the connection portion 17c is inclined and connected to the first elastic portion 17a and the second elastic portion 17b. As shown in FIG. 2, when the finger pad 15 is pressed, the second elastic portion 17b and the connecting portion 17c are elastically deformed and extend outward in the radial direction. At this time, the connecting portion 17c is temporarily horizontal. As shown in FIG. 3, when a certain pressing force is applied to the finger pad 15, the connecting portion 17 c bends in the reverse direction from the state shown in FIG. 1. Note that the deforming portion 17 has a resistance force that attempts to return to the original state (see FIG. 1) even in the bent state (see FIG. 3), and maintains a pressing force of a certain level or more in order to maintain the deformation. There is a need. And when it stops pressing, the deformation | transformation part 17 will return to an initial state (refer FIG. 1).

  As a material of the deformable portion 17, for example, an elastomer such as silicone rubber or urethane rubber can be applied.

  In addition, the shape of the stable part 13 is not limited to a cylindrical shape, For example, you may form in square tube shapes, such as a quadratic prism and a hexagonal column which have a cylindrical hole in the center. The shape of the cylindrical portion 16 a of the sliding portion 16 is set corresponding to the shape of the stable portion 13.

1-2. Method of Using Drug Injection Device Next, a method of using the drug injection device 1 of this example will be described with reference to FIGS.

  First, the contact surface 18 of the sliding portion 16 in the puncture speed securing member 7 is opposed to the skin. Thereby, the needle tip 8 of the needle tube 5 is opposed to the skin to be punctured. As shown in FIG. 1, the sliding portion 16 is disposed at the first position, and the contact surface 18 protrudes from the hub 6 to the skin side of the needle tip 8 of the needle tube 5. That is, the needle tip 8 of the needle tube 5 and the side surfaces of the stabilizing portion 13 are covered with the cylindrical portion 16 a of the sliding portion 16.

  Next, the injection needle assembly 2 is moved substantially perpendicular to the skin, and the contact surface 18 of the cylindrical portion 16a is pressed against the skin. Then, the user presses the finger contact portion 15 of the puncture speed securing member 7 to push out the needle tip 8 of the needle tube 5 from the opening facing the skin in the cylindrical portion 16a. At that time, as shown in FIG. 2, the second elastic portion 17 b and the connecting portion 17 c of the deformable portion 17 constituting the puncture speed securing member 7 are elastically deformed.

  Specifically, the pressing force input to the finger pad 15 is transmitted to the connection portion 17c and the second elastic portion 17b via the first elastic portion 17a. The connecting portion 17c is inclined in advance with respect to the axial direction of the first elastic portion 17a and the second elastic portion 17b, and is connected to the first elastic portion 17a and the second elastic portion 17b. Therefore, the pressing force input to the connection portion 17c is divided into a vertical force along the axial direction of the second elastic portion 17b and a horizontal force orthogonal to the vertical direction. Then, by the lateral force, the end portion side of the second elastic portion 17b that is connected to the connecting portion 17c is elastically deformed such that its diameter is expanded.

  At this time, the drag generated when the deforming portion 17 is deformed is transmitted to the user via the finger rest 15. The drag transmitted to the user is a resistance force when the user presses the finger pad 15.

  As shown in FIG. 2, when the user presses the finger pad 15 with a pressing force stronger than the resistance transmitted through the finger pad 15, the connecting part 17c is against the first elastic part 17a. It bends substantially vertically and its main surface becomes parallel to the finger pad 15. Therefore, the force which goes to a horizontal direction among the forces input into the connection part 17c from the 1st elastic part 17a reduces. Therefore, the force applied to the second elastic portion 17b by the connecting portion 17c is reduced, and the resistance force becomes extremely small. As a result, since the resistance force when the user presses the finger pad 15 is reduced, a large pressing force is input to the hub 6 to which the finger pad 15 is fixed, and the speed for puncturing the needle tube 5 into the living body. Can be raised temporarily.

  Here, the pressing force secured when the needle tube 5 is punctured into the living body by the puncture speed securing member 7 is set to 3 to 20 N, for example. Further, the force for returning the deformed portion 17 from the deformed state to the original state is smaller than the pressing force secured at the time of puncturing.

  And as shown in FIG. 3, the connection part 17c bends in the reverse direction from an initial state. Further, the needle tip 8 of the needle tube 5 is vigorously pushed out from the opening of the cylindrical portion 16a, and the needle tip 8 of the needle tube 5 is punctured into the living body. Therefore, the sliding portion 16 of the puncture speed securing member 7 moves from the first position to the second position where the needle tip 8 of the needle tube 5 is exposed. At this time, the finger rest 15 abuts against the end surface of the guide portion 16b, and further movement is restricted, and the end surface 13a of the stabilizing portion 13 and the abutment surface 18 of the sliding portion 16 become the same plane. Note that when the connecting portion 17c bends in the opposite direction and the sliding portion 16 moves from the first position to the second position, a click feeling is generated, so the user punctures the needle tube 5 into the living body. It can be confirmed that the pressing force and speed of are temporarily increased.

  In this manner, the puncture speed ensuring member 7 can temporarily increase the speed and pressing force when the needle tube 5 is punctured into the living body, thereby ensuring the puncture speed. As a result, the needle tip 8 easily cuts the skin, and the user can puncture the needle tip 8 of the needle tube 5 to the upper skin layer easily and reliably.

  The guide portion 16b of the sliding portion 16 is slidably supported by the hub body 10. Therefore, the cylindrical portion 16a of the sliding portion 16 can be slid in the axial direction along the outer peripheral surface of the stabilizing portion 13 without shaking. Furthermore, the needle projecting surface 12a of the adjusting unit 12 can contact the skin to deform the skin flatly, and the needle tube 5 can be punctured into the skin by the projecting length L.

  Next, the finger pad 15 is pressed until the contact surface 19a of the guide 19 contacts the skin, and the hub 6 is pressed. Here, the length of the guide portion height y is set so that the needle tube 5 and the stable portion 13 can puncture the skin with an appropriate pressing force. Therefore, the force of pressing the skin by the hub 6 via the finger contact portion 15 of the puncture speed ensuring member 7 becomes a predetermined value.

  Further, the puncture speed securing member 7 ensures a pressing force when puncturing the living body with the needle tip 8 of the needle tube 5. As a result, the pressing force of the hub 6 can be guided to the user, and the hub 6 can be pressed against the skin with an appropriate pressing force, so that the needle tip 8 and the blade surface 5a of the needle tube 5 can be securely attached to the upper layer of the skin. In addition, the drug can be stably administered. As described above, the guide portion 19 serves as a mark for guiding the pressing force of the hub 6, so that an appropriate pressing force can be appealed to the user's vision.

  Further, since the stabilizing portion 13 comes into contact with the skin, the needle tube 5 can be stabilized and the needle tube 5 can be punctured straight into the skin. Therefore, the blurring which arises in the needle tube 5 can be prevented, and the medicine can be administered stably.

  For example, with a very short protruding length of about 0.5 mm, the skin may not stick into the skin even if the needle tip 8 is brought into contact with the skin. However, when the stable portion 13 is pressed against the skin and the skin is pushed down in the vertical direction, the skin inside the stable portion 13 is pulled and tension is applied to the skin. For this reason, the skin does not easily escape from the needle tip 8 of the needle tube 5, so that the stable portion 13 also has an effect that the needle tip 8 is more likely to pierce the skin. Further, the needle tip 8 of the needle tube 5 can be reliably punctured into the skin by temporarily increasing the puncture speed and the pressing force by the puncture speed securing member 7.

  Furthermore, since the protrusion length L is set in the range of 0.5 to 3.0 mm, the needle tip 8 and the blade surface 5a of the needle tube 5 are surely positioned in the upper skin layer. Thereafter, the drug is injected into the upper skin layer by the syringe 3 connected to the hub 6.

  The adjustment portion 12 of the injection needle assembly 2 is fixed in close contact with the periphery of the needle tube 5 so that no gap is generated between the adjustment portion 12 and a portion that penetrates the adjustment portion 12 of the needle tube 5. ing. Therefore, when the needle protruding surface 12a of the adjustment unit 12 is brought into contact with the skin, the skin around the needle tube 5 can be deformed flat. As a result, the needle tube 5 can be punctured into the skin by the protruding length L, and the needle tip 8 of the needle tube 5 can be reliably positioned in the upper layer portion of the skin.

  In addition, since the diameter of the needle projecting surface 12a of the adjusting unit 12 and the inner diameter d of the stabilizing unit 13 are set to appropriate sizes, the injected drug can be prevented from leaking out of the body, and the drug can be reliably contained in the upper skin layer. Can be administered.

  In this example, it is described that the finger pad 15 is pressed to the skin side when the pressing force is applied. However, the hub 6 that fixes the finger pad 15 or the syringe 3 coupled to the hub 6 is gripped. You may make it press.

  Further, since the puncture speed securing member 7 has a resistance to return to the original state even when the puncture is completed, the puncture speed ensuring member 7 can convey it sensuously to the user and apply a pressing force to prevent the return. You can force the user to keep adding. Thereby, it is possible to prevent the needle from coming off or the medicine from leaking due to the pressure being relaxed during the medicine administration. Furthermore, since the user can be informed that the pressing force can be maintained above a certain level even during drug administration, the user can be given a sense of security.

<2. Second Embodiment>
Next, a second embodiment of the drug injection device according to the present invention will be described with reference to FIGS.
4 and 5 are cross-sectional views showing a drug injection device according to the second embodiment.

  The drug injection device 21 according to the second embodiment is different from the drug injection device 1 according to the first embodiment in that the guide portion in the injection needle assembly 22 is not a sliding portion but a stable portion. It is a point provided. Therefore, here, the sliding portion, the stabilizing portion, and the guide portion will be described, and the same reference numerals are given to the portions that are common to the drug injection device 1, and the duplicate description will be omitted.

  As shown in FIG. 4, a plurality of slits 27 are formed in the cylindrical portion 26 a of the sliding portion 26. The plurality of slits 27 extend from the contact surface 28 of the cylindrical portion 26a to the other end portion in the axial direction of the cylindrical portion 26a.

  A guide portion 29 is provided on the outer peripheral surface of the stable portion 13. The guide portion 29 is formed in a flange shape protruding from the outer peripheral surface of the stabilizing portion 13. The guide portion 29 has a plurality of insertion holes through which the portion divided by the slit 27 of the cylindrical portion 26a is inserted. Further, as shown in FIG. 5, the guide portion 29 is movable along the longitudinal direction of the slit 27.

  Other configurations are the same as those of the pharmaceutical injection device 1 according to the first embodiment described above, and thus the description thereof is omitted. The drug injection device 21 having such a configuration can provide the same operations and effects as those of the drug injection device 1 according to the first embodiment described above.

<3. Third Embodiment>
Next, a third embodiment of the drug injection device of the present invention will be described with reference to FIG.
FIG. 6 is a cross-sectional view showing a drug injection device according to a third embodiment.

  The drug injection device 31 according to the third embodiment is provided with a sliding portion constituting the puncture speed securing member on the inner peripheral surface side of the stabilizing portion. Therefore, here, the sliding portion, the hub, and the guide portion will be described, and the same reference numerals are given to portions common to the drug injection device 1, and redundant description will be omitted.

  As shown in FIG. 6, a plurality of through holes 34 are formed at the end portion of the end surface 33 a of the hub body 33 on the stable portion 35 side. In the third embodiment, an example in which three through holes 34 are formed at substantially equal intervals will be described. The number of through holes is not limited to three, and two or less or four or more may be provided. The stabilizing portion 35 is provided with a flange-shaped guide portion 36.

  The cylindrical portion 37a of the sliding portion 37 is divided into a plurality of covering pieces 39 by cutting out a plurality of locations along the axial direction at substantially equal intervals. In the third embodiment, an example in which the cover is divided into three cover pieces will be described. The number of divisions of the cylindrical portion 37 a corresponds to the number of through holes 34 provided in the hub body 33. The plurality of cover pieces 39 in the cylindrical portion 37 a are slidably inserted into the plurality of through holes 34 of the hub body 33. Thereby, the cylindrical portion 37 a moves in the axial direction along the inner peripheral surface of the stabilizing portion 35.

The inner diameter d ₂ of the cylindrical portion 37a is either equal to the diameter of the blisters formed in the skin, and is set to a value greater than that. Specifically, the distance _{T 2} of the from the inner wall surface of the cylindrical portion 37a to the outer peripheral surface of the adjustment portion 12 is set to be in the range of 4Mm～15mm. Thereby, it can prevent that blister formation is inhibited by pressure being applied to a blister from the end face of cylindrical part 37a.

  Other configurations are the same as those of the pharmaceutical injection device 1 according to the first embodiment described above, and thus the description thereof is omitted. The drug injection device 31 having such a configuration can also obtain the same operations and effects as those of the drug injection device 1 according to the first embodiment described above.

<4. Fourth Embodiment>
Next, a fourth embodiment of the drug injection device of the present invention will be described with reference to FIG.
FIG. 7 is a cross-sectional view showing a drug injection device according to a fourth embodiment.

  The drug injection device 41 according to the fourth embodiment is provided with a second cylindrical portion that slides along the outer peripheral surface of the adjusting portion 12 at the tip of the cylindrical portion according to the third embodiment. Is. Therefore, here, the sliding portion will be described, and portions common to the drug injection device 1 and the drug injection device 31 according to the third embodiment are denoted by the same reference numerals, and redundant description is omitted.

  As shown in FIG. 7, the cylindrical portion 43a of the sliding portion 43 is divided into a plurality of covering pieces by cutting out a plurality of portions along the axial direction at substantially equal intervals. And the 2nd cylindrical part 45 is joined via the 2nd connection part 46 to the edge part which opposes the skin in this cylindrical part 43a. The diameter of the second cylindrical portion 45 is set to be slightly larger than the diameter of the adjusting portion 12. An end surface of the second cylindrical portion 45 opposite to the second connection portion 46 is a contact surface 47 that contacts the skin. The second cylindrical portion 45 slides in the axial direction along the outer peripheral surface of the adjusting portion 12.

  Other configurations are the same as those of the pharmaceutical injection device 1 according to the first embodiment described above, and thus the description thereof is omitted. The drug injection device 41 having such a configuration can also obtain the same operations and effects as those of the drug injection device 1 according to the first embodiment described above.

<5. Fifth embodiment>
Next, a fifth embodiment of the drug injection device of the present invention will be described with reference to FIGS.
8 and 9 are cross-sectional views showing a medicine injection device according to the fifth embodiment.

  The difference between the drug injection device 51 according to the fifth embodiment and the drug injection device 1 according to the first embodiment is the configuration of the deforming portion. Therefore, a deformation | transformation part is demonstrated here, the same code | symbol is attached | subjected to the part which is common in the pharmaceutical injection device 1, and the overlapping description is abbreviate | omitted.

  As shown in FIG. 8, the deforming portion 57 includes a plurality of leaf springs that are elastically deformed up to a predetermined pressing force and bend with a force equal to or greater than the predetermined pressing force, and the plurality of leaf springs are equally spaced on the circumference. Are lined up. It is. The deformed portion 57 has a bending point 57a. The pressing force at which the deformable portion 57 is bent is set, for example, in the range of 3 to 20N. Then, as shown in FIG. 9, when a force greater than a predetermined pressing force is input, the bending point 57a is bent. In this way, the bending force causes the resistance force applied to the user via the finger pad 15 to decrease rapidly.

  Other configurations are the same as those of the pharmaceutical injection device 1 according to the first embodiment described above, and thus the description thereof is omitted. The drug injection device 41 having such a configuration can also obtain the same operations and effects as those of the drug injection device 1 according to the first embodiment described above.

  The deformable portion 57 may be a material that yields a so-called yield, in which the bending point 57a changes from elasticity to plasticity by a force equal to or greater than a predetermined pressing force.

<6. Sixth Embodiment>
Next, a sixth embodiment of the pharmaceutical injection device of the present invention will be described with reference to FIG.
FIG. 10 is a cross-sectional view showing a drug injection device according to the sixth embodiment.

  The difference between the drug injection device 61 according to the sixth embodiment and the drug injection device 1 according to the first embodiment is the configuration of the deforming portion. Therefore, a deformation | transformation part is demonstrated here, the same code | symbol is attached | subjected to the part which is common in the pharmaceutical injection device 1, and the overlapping description is abbreviate | omitted.

As shown in FIG. 10, the deformable portion 67 is an elastomer made of synthetic rubber or the like formed in a cylindrical shape. The deformation portion 67 is elastically deformed and contracts along the axial direction when the pressing force input through the finger pad 15 is equal to or less than a predetermined force, or slightly deforms in the lateral direction perpendicular to the axial direction. Mu At this time, a drag force generated when the deformable portion 67 is elastically deformed is transmitted to the user via the finger pad 15 and the drag force becomes a resistance force.

  In addition, when a force greater than a predetermined force is input, the deforming portion 67 is greatly bent outward in the radius. As a result, the resistance transmitted to the user via the finger pad 15 is drastically reduced.

  Other configurations are the same as those of the pharmaceutical injection device 1 according to the first embodiment described above, and thus the description thereof is omitted. Also with the medicine injection device 61 having such a configuration, the same operations and effects as those of the medicine injection device 1 according to the first embodiment described above can be obtained.

  The present invention is not limited to the embodiment described above and shown in the drawings, and various modifications can be made without departing from the scope of the invention described in the claims. For example, the sliding part may be slid so as to cover the outer side in the radial direction of the guide part. In the above-described embodiment, the example in which the pressing guide portion is formed in a flange shape has been described. However, the embodiment is not limited thereto. For example, the pressing guide portion may be formed by cutting out the outer peripheral surface of the cylindrical portion or the stabilizing portion substantially vertically and providing a stepped portion.

  Further, in order to restrict the sliding portion of the puncture speed securing member from returning from the second position to the first position, a locking portion for fixing the sliding portion to the hub and the sliding portion at the second position is provided. It may be provided.

1, 21, 31, 41, 51, 61 ... Drug injection device, 2, 22 ... Injection needle assembly, 3 ... Syringe, 3 a ... Insertion part, 5 ... Needle tube, 5 a ... Blade surface, 6 ... Hub, 7 ... Puncture Speed securing member, 8 ... Needle tip, 10, 33 ... Hub body, 11 ... Fixing part, 12 ... Adjusting part, 12a ... Needle protruding surface, 13, 35 ... Stabilizing part, 13a ... End face, 15 ... Finger rest part, 16 , 26, 37, 43 ... sliding portion, 16a, 26a, 37a, 43a ... cylindrical portion, 16b ... guide portion, 16c ... connection portion, 17, 57, 67 ... deformation portion, 17a ... first elastic portion, 17b 2nd elastic part, 17c ... Connection part, 18, 28, 47 ... Abutting surface, 19, 29, 36 ... Guide part (pressing standard part), 19a ... Contact surface, 27 ... Slit, 34 ... Through-hole, 39 ... Covering piece, 45 ... Second cylindrical part, 46 ... Second connecting part, 57 ... inflection point, B ... bevel length, L ... projection length, S ... distance from the periphery of the needle protruding surface to the circumferential surface of the needle tube, T, T 2 _... outer periphery of the adjusting portion from the inner wall of the inner wall surface or the cylindrical portion of the stabilizer Distance to the surface, x: Guide part length, y: Guide part height, d, d ₂ ... Inner diameter

Claims (8)

A needle tube having a needle tip that can puncture a living body;
A hub for holding the needle tube;
A stabilizing portion that is arranged so as to cover the periphery of the needle tube and has an end surface that comes into contact with the skin when the needle tube is punctured into a living body;
A puncture speed securing member that is provided on the hub and contacts the skin prior to the needle tip of the needle tube when the needle tube is punctured into the living body, and secures a speed and a pressing force when the needle tube is punctured into the living body; ,
Equipped with a,
The puncture speed securing member is
A finger rest fixed to the outer periphery of the hub;
A sliding part that is arranged on the outer side in the radial direction of the stabilizing part and is movable in the longitudinal direction of the needle tube along the outer peripheral surface of the stabilizing part;
An injection needle assembly comprising: a deforming portion interposed between the finger rest portion and the sliding portion . A needle tube having a needle tip that can puncture a living body;
A hub for holding the needle tube;
A stabilizing portion that is arranged so as to cover the periphery of the needle tube and has an end surface that comes into contact with the skin when the needle tube is punctured into a living body;
A puncture speed securing member that is provided on the hub and contacts the skin prior to the needle tip of the needle tube when the needle tube is punctured into the living body, and secures a speed and a pressing force when the needle tube is punctured into the living body; ,
With
The puncture speed securing member is
A finger rest fixed to the outer periphery of the hub;
A sliding portion that is disposed inside the stabilizing portion in the radial direction and is movable in the longitudinal direction of the needle tube along the inner peripheral surface of the stabilizing portion;
A deformable portion interposed between the finger rest portion and the sliding portion.
A needle assembly characterized by that. The injection needle assembly according to claim 1 or 2 , wherein an adjustment portion having a needle projecting surface from which a needle tip of the needle tube projects is provided around the needle tube. A needle tube having a needle tip that can puncture a living body;
A hub for holding the needle tube;
A stabilizing portion that is arranged so as to cover the periphery of the needle tube and has an end surface that comes into contact with the skin when the needle tube is punctured into a living body;
A puncture speed securing member that is provided on the hub and contacts the skin prior to the needle tip of the needle tube when the needle tube is punctured into the living body, and secures a speed and a pressing force when the needle tube is punctured into the living body; ,
Around the needle tube, an adjustment unit having a needle projecting surface from which the needle tip of the needle tube projects,
With
The puncture speed securing member is
A finger rest fixed to the outer periphery of the hub;
A sliding portion that covers the outer peripheral surface of the adjusting portion and is movable in the longitudinal direction of the needle tube along the outer peripheral surface of the adjusting portion;
Note Iharigumi steric you characterized in that it consists of a deformable portion which is interposed between the sliding portion and the finger rest portion. Wherein the sliding portion or the outer peripheral surface of the stabilizing portion, as claimed in any one of claims 1 to 4, characterized in that pressing a guide portion having a step surface forming the outer peripheral surface substantially perpendicular is provided Needle assembly. The sliding portion is disposed at a first position where a contact surface that comes into contact with the living body projects to one side in the longitudinal direction from the needle tip of the needle tube in a state before the needle tube is punctured into the living body. The needle tip of the needle tube is exposed when the body is punctured with the living body, and the contact surface moves to a second position located substantially on the same plane as the end surface of the stabilizing portion. The injection needle assembly according to any one of 1 to 5 . The deforming portion is bent and deformed when a force equal to or greater than the pressing force secured by the puncture speed securing member is applied, the resistance is reduced, and a constant smaller than the pressing force is maintained to maintain the bent and deformed state. The injection needle assembly according to any one of claims 1 to 6 , wherein the injection needle assembly is made of a member that requires the following force. Drug injection apparatus characterized by syringe is connected to the hub with the needle assembly as claimed in any of claims 1 to 7.

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