JP5366196B2 - Injection needle assembly and drug injection device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To surely position a needle point of a needle tube that punctures the skin, to a skin upper layer part. <P>SOLUTION: This injection needle assembly 1 includes the needle tube 2 having the needle point that can puncture a living body; a hub 3 holding the needle tube 2; a skin deforming part 4; and a distance recognizing part 8. The skin deforming part 4 is formed in cylindrical shape to surround the needle tube 2 and forms a bulge of the skin punctured by the needle tube 2, inside a cylinder hole 6a by pressing an end face 6b to the skin. The distance recognizing part 8 is provided at the skin deforming part 4 to recognize a distance x of the skin deforming part 4 being pushed into the skin. <P>COPYRIGHT: (C)2010,JPO&amp;INPIT

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 may be effective against avian influenza is taking place worldwide. In addition, in order to administer the prependemic vaccine to many humans, studies are being made to expand the production amount of the vaccine.

  The skin is composed of the epidermis, the dermis, and a part of the 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. Influenza vaccines are generally administered subcutaneously or intramuscularly, and are therefore administered in the lower layer of the skin or deeper.

  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 avian influenza vaccine to the upper skin layer, there is a possibility that the avian influenza vaccine can be administered to more humans. The upper skin layer refers to the epidermis and dermis of the skin.

  Methods for using a single needle, multiple needles, patches, gas, and the like have been reported as methods for administering drugs to the upper skin layer. In consideration of the stability of administration, reliability, and production cost, the method using a single needle is the most suitable as the method of administration to the upper skin layer. 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, the Manto method is difficult to perform and is left to 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 for an upper skin portion in which a limiter having a skin contact surface is connected to a needle hub. 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 gap between the needle tube and the needle tube. By defining the length (protrusion length) of the needle tube protruding from the surface of the limiter in contact with the skin to 0.5 to 3.0 mm, the drug is administered into the skin.

Patent Document 2 describes a puncture adjusting tool for an injection needle that prevents the injection needle from being punctured deeper than a target depth. The injection needle puncture adjusting device described in Patent Document 2 is formed in a cylindrical shape that covers the injection needle, and has a gap between the injection needle and the injection needle. In some embodiments of the puncture adjusting device for an injection needle, there is one formed at a position where the needle tip of the injection needle does not protrude from the end.
When the puncture adjustment tool for an injection needle formed in this way is pressed firmly against the skin, the skin inside the puncture adjustment tool for an injection needle swells and the injection needle is inserted into the skin.

JP 2001-137343 A JP 2000-037456 A

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

  However, the injection device described in Patent Document 1 has a limiter having a skin contact surface around the needle tube, and a space of a predetermined size is provided between the limiter and the periphery of the needle tube. It was done. For this reason, when the limiter is pressed against the skin, the skin rises in the space between the limiter and the periphery of the needle tube.

  The thickness of the upper skin layer (epidermis and dermis) varies depending on the administration site, sex, race, and age, but the depth from the surface of the skin is in the range of about 0.5 to 3.0 mm. Patent Document 1 describes that the most preferable protruding length of the needle (the length protruding from the skin contact surface of the limiter) is 1.5 mm. On the other hand, it has been reported that the upper layer of the deltoid muscle, which is a general vaccine administration site, is about 1.5 mm in a thin human. Therefore, when the skin rises in the space between the limiter and the periphery of the needle tube, there is a concern that the tip of the needle tube reaches the subcutaneous tissue.

  The epidermis and dermis are composed of dense fibrous connective tissue and are harder than subcutaneous tissue. For this reason, when the tip of the needle tube reaches the subcutaneous tissue, a drug such as an administered vaccine moves from the dermal tissue to the subcutaneous tissue, and the expected effect cannot be obtained.

  In addition, in the puncture adjusting tool for an injection needle described in Patent Document 2, the height of the skin raised inside the puncture adjusting tool for an injection needle is the depth of insertion of the injection needle. However, the swelling of the skin that occurs inside the injection needle puncture adjustment tool varies depending on the pressing force when the injection needle puncture adjustment tool is pressed against the skin. Therefore, it has been difficult to always position the needle tip and the blade surface of the injection needle punctured on the skin in the upper layer portion of the skin.

  The present invention has been made in view of such a situation, and is intended to reliably position the needle tip and the blade surface of a needle tube punctured on the skin at a predetermined part of a living body including the upper skin portion. Objective.

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, a skin deformation portion, and a distance recognition portion. The skin deforming portion is formed in a cylindrical shape so as to surround the periphery of the needle tube, and an end surface is pressed against the skin to form a skin swell that is punctured into the needle tube within the tube hole. Distance identification unit is a stepped portion provided on the outer peripheral surface of the skin deformation part has an end abutment surface parallel to the surface of the skin deformation portion, skin to skin by contact surface is in contact with the skin Recognize the distance to which the deformed part is pushed. Then, the skin deforming portion is pressed against the skin until the skin contacts the contact surface of the distance recognition 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 needle tube, a syringe connected to the hub, a skin deformation portion, and a distance recognition portion. The skin deforming portion is formed in a cylindrical shape so as to surround the periphery of the needle tube, and an end surface is pressed against the skin to form a skin swell that is punctured into the needle tube within the tube hole. Distance identification unit is a stepped portion provided on the outer peripheral surface of the skin deformation part has an end abutment surface parallel to the surface of the skin deformation portion, skin to skin by contact surface is in contact with the skin Recognize the distance to which the deformed part is pushed. Then, the skin deforming portion is pressed against the skin until the skin contacts the contact surface of the distance recognition portion.

  In the injection needle assembly and the pharmaceutical injection device of the present invention, the distance recognition unit can recognize the distance by which the skin deformation portion is pushed into the skin. Therefore, the distance to which the skin is pushed when the end face of the skin deforming portion is pressed against the skin is constant, and the height of the skin swell formed in the cylindrical hole of the skin deforming portion can be always constant. A needle tube is punctured into the raised portion of the skin.

  According to the injection needle assembly and the pharmaceutical injection device of the present invention, the height of the skin swell formed by the skin deforming portion can be made constant at all times, and the needle tip and the blade surface of the needle tube can be reliably placed in the upper skin portion. Can be located.

It is a block diagram which shows 1st Embodiment of the injection needle assembly of this invention. It is a perspective view which shows 1st Embodiment of the injection needle assembly of this invention. It is explanatory drawing which shows the state which punctured the skin of the needle tube of the chemical injection device of this invention. It is explanatory drawing which shows the measuring apparatus for measuring the distance equivalent to the height of the skin rise in a cylinder | tube formed by the skin deformation part which concerns on the injection needle assembly of this invention, and a recognition part height. The height of skin swell (skin protrusion length) when the diameter of the cylindrical hole of the skin deformed portion is changed using the measured values shown in FIG. 4, and the distance corresponding to the height of the recognition portion (movement distance of the outer tube) It is a graph which shows the result of having measured. It is a graph which shows the result of having measured the height of the swelling of the skin at the time of changing the diameter of the cylindrical hole of a skin deformation part using the measured value shown in FIG. It is a graph which shows the result of having measured the height of the skin swell and the distance (movement distance of an outer cylinder) equivalent to recognition part height at the time of changing recognition part length using the measured value shown in FIG. It is a graph which shows the height of the swelling of a skin at the time of changing the recognition part length and the movement distance of the outer cylinder corresponded to recognition part height using the measured value shown in FIG. It is a graph which shows the relationship between recognition part height and the height of the swelling of skin. It is a block diagram which shows 2nd Embodiment of the injection needle assembly of this invention. It is a perspective view which shows 3rd Embodiment of the injection needle assembly of this invention.

The best mode for carrying out the injection needle assembly and drug injection device of the present invention will be described below with reference to the drawings. In addition, the same code | symbol is attached | subjected to the common member in each figure.
The description will be given in the following order.
1. 1. First embodiment 2. Second embodiment Third embodiment

1. First Embodiment [Configuration Example of Needle Assembly and Drug Injection Device]
First, a first embodiment of an injection needle assembly and a drug injection device according to the present invention will be described with reference to FIGS. 1 and 2.
FIG. 1 is a configuration diagram showing a first embodiment of the injection needle assembly of the present invention. FIG. 2 is a perspective view showing a first embodiment of the injection needle assembly of the present invention.

  The injection needle assembly 1 includes a hollow needle tube 2 having a needle hole 2a, a hub 3 that holds the needle tube 2, and a skin deformation portion 4 that is fixed to the hub 3. By connecting a syringe 9 (see FIG. 3) to the hub 3 of the injection needle assembly 1, the drug injection device of the present invention is configured.

  The needle tube 2 has a size of 26 to 33 G (outer diameter 0.2 to 0.45 mm) according to the standard of ISO medical needle tube (ISO9626: 1991 / Amd.1: 2001 (E)), preferably 30-33G is used. A blade surface 2 b for making the needle tip an acute angle is formed at the tip of the needle tube 2. The length of the blade surface 2b in the direction in which the needle tube 2 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.

  Further, the bevel length B is further preferable if the thinnest thickness of the upper skin portion is 0.9 mm (child) or less. That is, the bevel length B is more preferably set in the range of 0.5 to 0.9 mm. The “short bevel” refers to a blade surface that is generally used for injection needles and forms 18 to 25 ° with respect to the longitudinal direction of the needle.

  As a material of the needle tube 2, for example, stainless steel, aluminum, aluminum alloy, titanium, titanium alloy, and other metals can be used. The needle tube 2 can be a straight needle or a tapered needle having at least a part of a tapered structure. As the taper needle, the outer diameter of the proximal end portion fixed to the hub 3 may be made larger than the outer diameter of the distal end portion including the needle tip, and the intermediate portion may have a tapered structure.

  The needle hole 2 a of the needle tube 2 communicates with the hub 3. The hub 3 includes a hub body 3a that holds the needle tube 2 and a flange 3b that is continuous with the hub body 3a. The hub body 3a has a tapered structure such that the diameter decreases toward the tip. The proximal end portion of the needle tube 2 is fixed to the distal end portion of the hub body 3a. The flange 3b is provided at the proximal end portion of the hub body 3a. The skin deforming portion 4 is abutted and fixed to the flange 3b.

  The syringe 9 may be a medicine filled when using a medicine injection device or a prefilled syringe filled with a medicine in advance. Moreover, as a medicine with which the syringe 9 is filled, a vaccine can be mentioned, but a medicine using a macromolecular substance such as cytokine or a hormone may be used.

  The skin deforming part 4 is formed in a cylindrical shape, and has a fixed cylinder part 5 that forms one end part, and a contact cylinder part 6 that is continuous with the fixed cylinder part 5 and forms the other end part. ing. As a material of the skin deforming portion 4, a synthetic resin (plastic) such as polycarbonate, polypropylene, or polyethylene may be used, or a metal such as stainless steel or aluminum may be used.

  The fixed tube portion 5 of the skin deforming portion 4 is formed of a cylindrical body having a tube hole 5a. One end of the fixed cylinder portion 5 is continuous with the contact cylinder portion 6. The other end portion of the fixed cylinder portion 5 is fixed to the flange 3b of the hub 3 by a fixing method such as an adhesive. The hub body 3 a of the hub 3 is accommodated in the tube hole 5 a of the fixed tube portion 5.

  The contact tube portion 6 of the skin deforming portion 4 is formed of a cylindrical body having a diameter larger than that of the fixed tube portion 5, and has a tube hole 6 a communicating with the tube hole 5 a of the fixed tube portion 5. The diameter of the cylinder hole 6 a of the contact cylinder part 6 is larger than the diameter of the cylinder hole 5 a of the fixed cylinder part 5. The needle tube 2 held by the hub 3 is disposed in the tube hole 6 a of the contact tube portion 6. Further, the center line of the tube hole 6 a coincides with the axis of the needle tube 2.

  The end surface 6b of the contact tube portion 6 is pressed against the surface of the skin when the needle tube 2 is punctured into the upper layer portion of the skin. When the end surface 6b of the contact tube portion 6 is pressed against the skin, a skin swell is formed in the tube hole 6a of the contact tube portion 6. And the needle tube 2 is punctured by the rise of the skin formed in the cylinder hole 6a.

  A distance recognition unit 8 is integrally formed on the outer peripheral surface of the contact tube unit 6. The distance recognition unit 8 protrudes in the radial direction of the contact tube portion 6 and is formed in a circular ring shape that is continuous in the circumferential direction of the contact tube portion 6. That is, the distance recognition unit 8 is a flange that protrudes from the outer peripheral surface of the contact cylinder unit 6. The distance recognition unit 8 has a contact surface 8 a parallel to the end surface 6 b of the contact cylinder unit 6. By pressing the contact tube portion 6 until the contact surface 8a comes into contact with the skin, the distance that the contact tube portion 6 pushes the skin can always be constant.

  As a result, the height of the skin swell formed in the tube hole 6a of the contact tube portion 6 can be made substantially constant. The depth at which the needle tube 2 is punctured into the skin is equal to a value obtained by adding the distance from the end surface 6b of the contact tube portion 6 to the needle tip of the needle tube 2 to the height of the skin swell. Therefore, the depth at which the needle tube 2 is stabbed in the skin can be made substantially constant by making the height of the skin swell substantially constant.

  In this embodiment, the skin deformation part 4 and the distance recognition part 8 are formed by integral molding. However, the distance recognition unit according to the present invention may be formed separately from the skin deformation unit. In this case, the distance recognition unit is fixed to the skin deforming unit by a fixing method such as a screw or an adhesive.

  Hereinafter, the distance from the end surface 6b of the contact tube portion 6 to the tip of the needle hole 2a in the needle tube 2 is referred to as “needle protruding length L”. Further, the height of the bulge from the skin end face 6b is called “skin protrusion length y” (see FIG. 3), and the length obtained by adding the needle protrusion length L and the skin protrusion length y is “puncture length P”. Call. Furthermore, the length of the contact surface 8a of the distance recognition unit 8 in the direction orthogonal to the outer surface of the contact cylinder part 6 is referred to as “recognition part length k”, and the contact of the distance recognition unit 8 from the end surface 6b of the contact cylinder part 6 The distance to the surface 8a is referred to as “recognition unit height x”.

  The recognition part length k can be said to be the length by which the distance recognition part 8 protrudes from the contact cylinder part 6. The recognition unit length k is set in consideration of the recognition unit height x. This is because the distance to push the contact surface 8a of the distance recognition unit 8 into the skin increases unless the recognition unit length k is increased as the recognition unit height x increases.

  The needle protrusion length L is a positive value when the needle tip of the needle tube 2 protrudes from the end surface 6 b of the contact tube portion 6, and is negative when the needle tip of the needle tube 2 is in the tube hole 6 a of the contact tube portion 6. It becomes the value of. This needle protrusion length L can be appropriately set by changing the length of the needle tube 2, the length of the hub 3 that holds the needle tube 2, and the like. In order to reduce the risk of a sudden needle stick accident, it is preferable that the needle tip of the needle tube 2 does not protrude beyond the end face 6b.

  Needle protrusion length L is determined based on puncture length P and skin protrusion length y (L = P−y). Puncture length P is set within the thickness range of the upper skin layer. On the other hand, it was found by experiments described later that the skin protrusion length y changes depending on the recognition part length k and the recognition part height x. Therefore, the needle protrusion length L can be determined by setting the skin protrusion length y based on the recognition part length k and the recognition part height x.

  Here, the thickness of the upper skin portion will be described. As described above, the upper skin portion refers to the epidermis and dermis of the skin. The thickness of the upper skin portion is generally in the range of 0.5 to 3.0 mm. Therefore, the puncture length P is preferably set in the range of 0.5 to 3.0 mm.

  By the way, the administration site of influenza vaccine is generally the deltoid muscle. 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 in the upper layer portion of the deltoid skin, the puncture length P is preferably set in the range of 0.9 to 1.4 mm at the maximum.

  Moreover, by setting in this way, the blade surface 2b can be reliably positioned in the upper skin layer. As a result, the needle hole 2a (chemical solution discharge port) that opens in the blade surface 2b can be located in the upper skin layer portion at any position in the blade surface 2b. Even if the drug solution outlet is located in the upper skin part, if the needle tip is deeply stabbed into the upper skin part, the drug solution flows subcutaneously between the side surface of the needle tip and the cut skin. It is important to ensure that the needle tip 2 and the blade surface 2b are in the upper skin layer.

  The bevel portion is preferably in the skin when punctured, but 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 puncture length P within a preferable range (0.9 to 1.4 mm), it is preferable to use a needle tube thinner than 26G.

  Next, the diameter of the cylinder hole 6a in the contact cylinder part 6 will be described. Hereinafter, the diameter of the cylinder hole 6a is referred to as “cylinder hole diameter d”.

  Usually, when a drug of about 100 μL is injected into the upper skin layer, blisters having a diameter of about 9 to 12 mm are formed in the skin. Therefore, considering that the skin deformed portion 4 does not inhibit blister formation, the tube hole diameter d is preferably 12 mm or more that does not inhibit blister formation when the contact tube portion 6 is pressed against the skin and a drug is administered. Even if the diameter is 8 mm, which is smaller than the diameter of the blister, a blister is formed inside the cylindrical hole 6a and administration is possible. In addition, if the cylinder hole diameter d is 8 mm or more, there is no upper limit in particular. However, when the cylinder hole diameter d is increased, the outer diameter of the skin deforming portion 4 and the outer diameter of the distance recognition portion 8 are increased.

  When the outer diameter of the skin deforming part 4 and the outer diameter of the distance recognizing part 8 are increased, for example, when the needle tube 2 is punctured into the arm, it becomes difficult to make the distance recognizing part 8 contact the skin. Therefore, it is preferable that the outer diameter of the distance recognition unit 8 is about 30 mm at the maximum in consideration of the smallness of the child's arm. Here, assuming that the width of the end face of the contact cylinder portion 6 is 0.5 mm and the recognition portion length k is 0.5 mm considered to be the minimum, the cylinder hole diameter d is 28 mm at the maximum.

  The outer diameter of the distance recognition unit 8 is determined by the width of the end surface of the contact tube unit 6, the tube hole diameter d, and the recognition unit length k. In the present embodiment, the width of the end surface of the contact cylinder portion 6 is set to 0.5 mm. And the cylinder hole diameter d was set to the range of 11-14 mm, and the recognition part length k was set to the range of 0.5-6.0 mm. Therefore, the outer diameter of the distance recognition unit 8 is in a range of 13 to 27 mm, and the contact surface 8a of the distance recognition unit 8 can be brought into contact with the skin.

[How to use drug injection device]
Next, a method of using the drug injection device to which the injection needle assembly 1 is applied will be described with reference to FIG.
FIG. 3 is an explanatory view showing a state where the needle tube 2 of the injection needle assembly 1 in the drug injection device is punctured into the skin.

  First, the end surface 6b of the contact cylinder part 6 in the skin deformation part 4 is made to oppose skin. Thereby, the needle tip of the needle tube 2 is opposed to the punctured skin. Next, the drug injection device is moved substantially perpendicularly to the skin, and the end surface 6b of the contact tube portion 6 is pressed against the skin.

  At this time, if the needle tip of the needle tube 2 protrudes from the end surface 6b of the contact tube portion 6, the needle tip hits the skin before the end surface 6b. It is pushed and becomes a little depressed. On the other hand, if the needle tip of the needle tube 2 is in the tube hole 6a of the contact tube portion 6, the needle tip of the needle tube 2 contacts the skin after the end surface 6b of the contact tube portion 6 contacts the skin.

  Furthermore, when the end surface 6b of the contact tube portion 6 is pressed against the skin, a skin swell is formed in the tube hole 6a of the contact tube portion 6. That is, the skin punctured by the needle tube 2 is raised. At this time, the needle tip of the needle tube 2 punctures the skin. And if the contact cylinder part 6 is pressed until the distance recognition part 8 contacts skin, the distance by which the skin was pushed in by the contact cylinder part 6 will become a predetermined value. Therefore, by bringing the distance recognition unit 8 into contact with the skin, the distance of the contact cylinder portion 6 pushed into the skin can always be made constant, and the skin protrusion length y can be made substantially constant.

  By making skin protrusion length y substantially constant, the depth at which needle tube 2 is punctured into the skin can be made substantially constant. Therefore, if the needle protrusion length L is set in consideration of the skin protrusion length y, the needle tip of the needle tube 2 and the tip of the needle hole 2a can be reliably positioned in the upper skin layer. For example, when the skin protrusion length y is approximately 0.8 mm, the needle protrusion length L is set to 0.4 mm. As a result, the puncture length P becomes 1.2 mm, and the tip of the needle hole 2a in the needle tube 2 can be positioned within the range of the thickness of the upper skin layer.

  Thereafter, the medicine is discharged from the needle hole 2 a of the needle tube 2 by the syringe 9 connected to the hub 3. As a result, the drug is injected into the upper skin layer.

[Experimental example]
Next, the height of the skin swell formed in the tube hole 6a of the contact tube portion 6 (skin protrusion length y) and the distance that the contact tube portion 6 is pushed into the skin (corresponding to the recognition portion height x) An experimental example in which measurement is performed will be described with reference to FIGS.

  FIG. 4 is an explanatory diagram showing a measuring device for measuring the skin protrusion length y and the recognition unit height x. FIG. 5 is a graph showing measured values of the skin protrusion length y and the recognition unit height x when the tube hole diameter d is changed. FIG. 6 is a graph showing measured values of the skin protrusion length y and the recognition unit height x when the recognition unit length k is changed.

  First, the measuring apparatus 100 used for this experiment will be described. The measuring device 100 was formed by cutting synthetic resin (plastic). The measuring apparatus 100 includes an outer cylinder 101 formed in a circular cylindrical shape, and a pressing member 102 slidably fitted in a cylindrical hole 101a of the outer cylinder 101.

  A flange 103 protruding in the radial direction of the outer cylinder 101 is provided at one end (lower end) of the outer cylinder 101. The bottom surface 103 a of the flange 103 forms the same plane as the end surface of the outer cylinder 101. The flange 103 corresponds to the distance recognition unit 8 of the injection needle assembly 1 (see FIG. 1). The length from the outer surface of the flange 103 to the inner surface of the outer cylinder 101 corresponds to the recognition portion length k in the injection needle assembly 1.

  The pressing member 102 is formed of a cylindrical body having a diameter substantially equal to the diameter of the cylinder hole 101a of the outer cylinder 101, and has an upper surface 102a and a bottom surface 102b. A circular recess 104 is provided on the bottom surface 102 b of the pressing member 102. The diameter of the recess 104 corresponds to the cylinder hole diameter d in the injection needle assembly 1. A measuring member 105 is slidably fitted in the recess 104. The measuring member 105 is formed of a cylindrical body having a diameter substantially equal to the diameter of the recess 104, and has an upper surface 105a and a bottom surface 105b.

  On the other hand, the bottom surface 102b of the pressing member 102 is formed in a circular ring shape by providing the recess 104. The bottom surface 102 b of the pressing member 102 corresponds to the end surface 6 b of the contact cylinder portion 6 in the injection needle assembly 1. In the measurement apparatus 100 used in this experiment, the width of the bottom surface 102b of the pressing member 102 is set to 0.5 mm.

  In order to measure the skin protrusion length y and the recognition unit height x using the measuring apparatus 100 having such a configuration, first, the measuring apparatus 100 is placed on the skin as shown in FIG. At this time, the bottom surface 103a of the flange 103 provided on the outer cylinder 101, the bottom surface 102b of the pressing member 102, and the bottom surface 105b of the measuring member 105 are in contact with the skin.

  Next, as shown in FIG. 4B, the upper surface 102a of the pressing member 102 is pressed. As a result, the pressing member 102 moves in the tube hole 101a of the outer tube 101, and the bottom surface 102b is pressed against the skin. As a result, the outer cylinder 101 and the pressing member 102 have the same form as the skin deforming portion 4 in a state where the contact cylinder portion 6 is pressed against the skin.

  When the bottom surface 102 b of the pressing member 102 is pressed against the skin, a skin swell is formed in the recess 104. As a result, the measuring member 105 is pushed up by the skin swell. In this state, the distance from the bottom surface 102b of the pressing member 102 to the bottom surface 105b of the measuring member 105 corresponds to the height of the skin swell (skin protrusion length y) formed by the skin deforming portion 4 of the injection needle assembly 1. To do. Therefore, by measuring the distance from the bottom surface 102b of the pressing member 102 to the bottom surface 105b of the measuring member 105, the skin protrusion length y can be measured.

  The distance from the bottom surface 102 b of the pressing member 102 to the bottom surface 103 a of the flange 103 corresponds to the recognition unit height x in the injection needle assembly 1. Therefore, by measuring the distance from the bottom surface 102b of the pressing member 102 to the bottom surface 103a of the flange 103, the recognition unit height x can be measured.

  In this experiment, skin protrusion length y and recognition part height x in the skin of deltoid muscles of 10 adults were measured. In this experiment, first, the skin protrusion length y and the recognition part height x were measured using four measuring devices 100 in which the diameters of the recesses 104 (cylinder hole diameter d) were 11 mm, 12 mm, 13 mm, and 14 mm, respectively. The recognition unit length k was 0.5 mm. And the force which presses the press member 102 made 20 N considered the maximum value applicable in practical use to the upper limit. By this measurement, it can be confirmed whether or not the skin protrusion length y changes depending on the difference in the diameter of the tube hole diameter d. The experimental results are shown in FIG.

  As shown in FIG. 5, when the skin was pressed against the pressing member 102 with 20N, the skin protrusion length y was in the range of 1.0 to 1.3 mm. For example, when the tube hole diameter d is 11 mm, the skin protrusion length y is about 1.1 mm. From this result, it was found that the tube hole diameter d hardly affects the skin protrusion length y in the range of 11 to 14 mm. The recognition part height x was shifted by about 2.6 mm when the cylinder hole diameter d was 11 mm, and was shifted by about 1.5 mm when the cylinder hole diameter d was 12 to 14 mm.

  Next, the skin protrusion length y when pressed until the recognition part height x was 1 mm and 2 mm was measured. The result is shown in FIG. When the recognition part height x was 1 mm, the skin protrusion length y was in the range of 0.5 to 0.7 mm when the cylinder hole diameter d was 11 to 14 mm. The skin protrusion length y was the largest when the tube hole diameter d was 12 mm, and the skin protrusion length y was about 0.7 mm. When the cylinder hole diameter d was 11 m and the recognition part height x was 2 mm, the skin protrusion length y was about 0.8 mm.

  Next, since the skin protrusion length y at 20N is about 1.2 mm even if the tube hole diameter d is changed, the tube hole diameter d is set to 12 mm and the recognition portion length k is set to 0.5 to 5 mm. The skin protrusion length y and the recognition part height x when changing were measured. The experimental results are shown in FIG.

  First, the force for pressing the pressing member 102 was set to 20N, and the skin protrusion length y and the recognition part height x were measured. As shown in FIG. 7, the recognition unit height x increased as the recognition unit length k increased. The skin protrusion length y was in the range of about 1.0 to 1.2 mm.

  Next, the skin protrusion length y when the recognition part height x was changed to 1 to 8 mm was measured. The result is shown in FIG. As the recognition part height x increased, the skin protrusion length y increased. Thereby, it turned out that the skin protrusion length y is substantially proportional to the recognition part height x (refer FIG. 9). Therefore, the skin protrusion length y can be set based on the recognition unit height x.

FIG. 9 is a graph showing the relationship between the recognition unit height x and the skin protrusion length y (height of skin swell). As shown in FIG. 9, for example, when the recognition part length k is 3 mm, it has been found that the skin protrusion length y and the recognition part height x satisfy the following relationship.
y = 0.104x + 0.097 (correlation coefficient 0.99)
Moreover, when the recognition part length k was 5 mm, it turned out that the skin protrusion length y and the recognition part height x satisfy | fill the following relationship.
y = 0.090x + 0.090 (correlation coefficient 0.98)

It can be said that the two relational expressions described above have substantially the same constants. That is, when the second decimal place of each constant is rounded off, it can be said that the skin protrusion length y and the recognition part height x satisfy the following relationship.
y = 0.1x + 0.1
Therefore, it is possible to apply this relational expression when the recognition section length k is in the range of 3.0 to 5.0 mm.

  When the recognition unit length k is 0.5 mm, the recognition unit height x can be set to 1 mm, but the recognition unit height x cannot be changed to 2 mm or more. That is, even if the pressing member 102 is pressed against the skin until the recognition unit height x becomes 2 mm, the bottom surface 103a of the flange 103 is not in contact with the skin. Therefore, it was found that when the recognition part length k is set to 0.5 mm, the recognition part height x should be within 1 mm. Similarly, when the recognition unit length k is set to 1.0 mm, it has been found that the recognition unit height x should be within 2 mm.

  From the above experimental results, it was found that the puncture length P (see FIG. 3) can be defined by changing the recognition unit height x. For example, if the recognition part length k is set to 0.5 mm and the recognition part height x is set to about 1.5 mm, the skin protrusion length y is about 1.2 mm. Therefore, if the needle protrusion length L is set to 0.2 mm, the puncture length P can be set to 1.4 (1.2 + 0.2 = 1.4) mm, and the tip of the needle tube 2 is connected to the upper layer of the adult skin. Can be reliably positioned. Further, if the needle protrusion length L is set to -0.3 mm, the puncture length P can be set to 0.9 (1.2-0.3 = 0.9) mm, and the needle is placed on the upper skin portion of the child. The tip can be positioned reliably.

  In the case where the range of the recognition part length k is 3.0 to 5.0 mm and the range of the cylinder hole diameter d is 11 to 14 mm, the recognition part height x and the skin protrusion length y are y = 0. It was found that the relational expression of 1x + 0.1 was satisfied. Therefore, the skin protrusion length y can be defined according to this relational expression. The needle protrusion length L can be determined from the defined skin protrusion length y and puncture length P (L = P−y).

2. Second Embodiment [Configuration Example of Needle Assembly and Drug Injection Device]
Next, a second embodiment of the needle assembly and drug injection device of the present invention will be described with reference to FIG.
FIG. 10 is a block diagram showing a second embodiment of the injection needle assembly of the present invention.

  The injection needle assembly 11 has the same configuration as that of the injection needle assembly 1 of the first embodiment, and the difference is a skin deformation portion 14 and a distance recognition portion 18. Therefore, here, the skin deforming part 14 and the distance recognizing part 18 will be described, and the same reference numerals are given to the parts common to the injection needle assembly 1, and redundant description will be omitted.

  The drug injection device of the present invention is configured by connecting a syringe 9 (see FIG. 3) to the hub 3 of the injection needle assembly 11.

  The skin deforming part 14 is formed in a cylindrical shape, and has a fixed cylinder part 15 that forms one end part, and a contact cylinder part 16 that is continuous with the fixed cylinder part 15 and forms the other end part. ing. As the material of the skin deforming portion 14, a synthetic resin (plastic) such as polycarbonate, polypropylene, or polyethylene may be used, or a metal such as stainless steel or aluminum may be used.

  The fixed cylinder part 15 of the skin deforming part 14 has the same shape as the fixed cylinder part 5 of the first embodiment, and is formed of a cylindrical body having a cylinder hole 15a. One end portion of the fixed cylinder portion 15 is fixed to the flange 3b of the hub 3 by a fixing method such as an adhesive. The other end of the fixed cylinder 5 is continuous with the contact cylinder 16. The hub body 3 a of the hub 3 is accommodated in the tube hole 15 a of the fixed tube portion 5.

  The contact cylindrical portion 16 of the skin deforming portion 14 is made of a cylindrical body having a diameter larger than that of the fixed cylindrical portion 15 and has a cylindrical hole 16 a communicating with the cylindrical hole 15 a of the fixed cylindrical portion 15. The diameter of the cylinder hole 16 a is larger than the diameter of the cylinder hole 15 a of the fixed cylinder portion 15. The needle tube 2 held by the hub 3 is disposed in the tube hole 16 a of the contact tube portion 16. Further, the center line of the cylindrical hole 16 a coincides with the axis of the needle tube 2.

  The end surface 16b of the contact tube portion 16 is pressed in contact with the surface of the skin when the needle tube 2 is punctured into the upper skin portion. When the end face 16b is pressed against the skin, a skin swell is formed in the cylindrical hole 6a of the contact cylindrical portion 16. The needle tube 2 is punctured by the swell of the skin formed in the cylindrical hole 16a.

  A distance recognition unit 18 is provided at the end of the contact cylinder unit 6. This distance recognition part 18 is formed by notching the end surface 16b of the contact cylinder part 16, and providing a step part, and has the contact surface 18a and the wall surface 18b.

  The contact surface 18 a of the distance recognition unit 18 is a plane parallel to the end surface 16 b of the contact cylinder part 16, and is formed in a circular ring shape continuous in the circumferential direction of the contact cylinder part 16. The distance from the contact surface 18a to the end surface 16b of the contact cylinder portion 16 corresponds to the “recognition portion height x” in the first embodiment. The wall surface 18 b is a curved surface that is continuous in the circumferential direction of the contact cylinder portion 16. The distance from the wall surface 18b to the outer surface of the contact cylinder portion 16 corresponds to the “recognition portion length k” in the first embodiment. In other words, the length of the contact surface 18a in the direction orthogonal to the outer surface of the contact cylinder portion 16 corresponds to the “recognition portion length k”.

  Also with the injection needle assembly 11 having such a configuration, the same operations and effects as those of the injection needle assembly 1 of the first embodiment described above can be obtained. That is, by pressing the contact tube portion 16 until the contact surface 18a of the distance recognition portion 18 contacts the skin, the distance that the contact tube portion 6 pushes the skin can be always constant.

  As a result, the height of the skin swell formed in the tube hole 16a of the contact tube portion 16 can be made substantially constant. The depth at which the needle tube 2 is punctured into the skin is equal to a value obtained by adding the distance from the end surface 16b of the contact tube portion 16 to the needle tip of the needle tube 2 to the height of the skin swell. Therefore, the depth at which the needle tube 2 is punctured into the skin can be made substantially constant by making the height of the skin swell substantially constant.

3. Third Embodiment [Configuration Example of Injection Needle Assembly and Drug Injection Device]
Next, a third embodiment of the injection needle assembly and drug injection device of the present invention will be described with reference to FIG.
FIG. 11 is a perspective view showing a third embodiment of the injection needle assembly of the present invention.

  The injection needle assembly 21 has the same configuration as that of the injection needle assembly 1 of the first embodiment, and a difference is a distance recognition unit 28. Therefore, here, the distance recognizing unit 28 will be described, and the same reference numerals are given to portions common to the injection needle assembly 1 and redundant description will be omitted.

  The injection needle assembly 21 includes the same hub 3 (see FIG. 1) as that in the first embodiment. The drug injection device of the present invention is configured by connecting a syringe 9 (see FIG. 3) to the hub 3 of the injection needle assembly 21.

  The distance recognition part 28 of the injection needle assembly 21 is a scale provided on the contact cylinder part 6. The distance recognition unit 28 is formed by printing or painting the contact cylinder unit 6. In addition, the site | part which performs printing or coating may be the outer surface of the contact cylinder part 6, and may be an inner surface. The distance recognizing part 28 is formed continuously in the circumferential direction of the contact cylinder part 6 and can be recognized from any direction. The distance from this distance recognition part 28 to the end surface 6b of the contact cylinder part 6 is equivalent to the "recognition part height x" of 1st Embodiment.

  Also with the injection needle assembly 21 having such a configuration, the same operations and effects as those of the injection needle assembly 1 of the first embodiment described above can be obtained. That is, by pressing the contact cylinder 6 against the skin until the distance recognition unit 18 (scale) matches the skin surface around the contact cylinder 6, the distance that the contact cylinder 6 pushes the skin is always constant. Can do.

  As a result, the height of the skin swell formed in the tube hole 6a of the contact tube portion 6 can be made substantially constant. The depth at which the needle tube 2 is punctured into the skin is a value obtained by adding the distance from the end surface 6b of the contact tube portion 6 to the needle tip of the needle tube 2 to the height of the skin formed in the tube hole 6a. Will be equal. Therefore, the depth at which the needle tube 2 is punctured into the skin can be made substantially constant by making the height of the skin swell substantially constant.

  In the present embodiment, the distance recognition unit 28 is formed by printing or painting on the contact cylinder unit 6, but the distance recognition unit 28 may be formed by other methods. The distance recognition unit 28 may be formed, for example, by providing a groove in the contact cylinder unit 6 or by attaching a sheet.

  In the present embodiment, one distance recognition unit (scale) 28 is provided. However, as the injection needle assembly according to the present invention, two or more distance recognition units (scale) can be provided. For example, a distance recognition unit (scale) for children and a distance recognition unit (scale) for adults may be provided. In this case, the recognition unit height x of the adult distance recognition unit is set higher (larger) than the recognition unit height x of the child distance recognition unit, and the depth at which the needle tube 2 is punctured into the upper layer of the child's skin. In addition, the depth at which the needle tube 2 is punctured into the upper skin portion of the adult is deepened. Thereby, the depth at which the needle tube 2 is punctured can be changed according to the thickness of the upper skin layer portion, and the needle tip of the needle tube 2 can be reliably positioned in the upper skin layer portion.

  The injection needle assembly and the drug injection device of the present invention are not limited to the above-described embodiment, and various modifications and changes can be made without departing from the configuration of the present invention in terms of other materials and configurations. Needless to say.

  In the first to third embodiments, the skin deforming portion 4 (14) is fixed to the hub 3. However, as the skin deforming portion according to the present invention, for example, it may be fixed to a syringe constituting a drug injection device. Good. Moreover, as a skin deformation part which concerns on this invention, it can also integrally mold with a hub or a syringe.

DESCRIPTION OF SYMBOLS 1,11,21 ... Injection needle assembly 2 ... Needle tube 2a ... Needle hole 2b ... Blade surface 3 ... Hub 4,14 ... Skin deformation part 5,15 ... Fixed cylinder part 6,16 ... Contact cylinder part 6a, 16a ... Tube Hole 6b, 16b ... End face 8, 18, 28 ... Distance recognition part 9 ... Syringe B ... Bevel length L ... Needle protrusion length P ... Puncture length d ... Tube hole diameter k ... Recognition part length x ... Recognition part height y ... Skin Protrusion length

Claims (8)

A needle tube having a needle tip that can puncture a living body;
A hub for holding the needle tube;
A skin deforming part that is formed in a cylindrical shape so as to surround the periphery of the needle tube, and an end surface is pressed against the skin, thereby forming a skin swell that is punctured into the needle tube in a cylindrical hole;
A step provided on an outer peripheral surface of the skin deforming portion, having a contact surface parallel to the end surface of the skin deforming portion, and the skin contacting the skin by the contact surface contacting the skin; A distance recognizing unit for recognizing a distance into which the deforming unit is pushed ,
The injection needle assembly , wherein the skin deforming portion is pressed against the skin until the skin contacts the contact surface of the distance recognition portion .   The needle assembly according to claim 1, wherein the distance recognizing part is a flange protruding from an outer surface of the skin deforming part. The distance the contact surface of the recognition unit, the continuous outside peripheral surface of the skin deforming portion, and a length which recognition unit length in a direction perpendicular to the outer surface of the skin deforming section 0.5-5. The needle assembly according to claim 1 or 2 , wherein the needle assembly is 0 mm. The injection needle assembly according to any one of claims 1 to 3, wherein the cylindrical hole of the skin deforming portion is formed in a circular shape. The needle assembly according to claim 4 , wherein a diameter of the cylindrical hole of the skin deforming portion is 8 to 28 mm. The injection needle assembly according to claim 5 , wherein the diameter of the cylindrical hole of the skin deforming portion is 11 to 14 mm. When the recognition part length is set to 3.0 to 5.0 mm, y is the height of the skin swell, and x is the distance from the end face of the skin deformation part to the distance recognition part. And x are
y = 0.1x + 0.1
The injection needle assembly according to claim 6 , wherein the relationship is satisfied. A needle tube having a needle tip that can puncture a living body;
A hub for holding the needle tube;
A skin deforming part that is formed in a cylindrical shape so as to surround the periphery of the needle tube, and an end surface is pressed against the skin, thereby forming a skin swell that is punctured into the needle tube in a cylindrical hole;
A step provided on an outer peripheral surface of the skin deforming portion, having a contact surface parallel to the end surface of the skin deforming portion, and the skin contacting the skin by the contact surface contacting the skin; A distance recognition unit for recognizing the distance to which the deformation unit is pushed;
A syringe connected to the hub ,
The drug injection device , wherein the skin deforming portion is pressed against the skin until the skin contacts the contact surface of the distance recognition portion .

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