JP2011212183A - Prefilled syringe - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a prefilled syringe which has attained a reduction in the manufacture processes thereof by being made siliconeless, prevents waste of a liquid medicine and facilitates quick preparation for administration of the liquid medicine.SOLUTION: The prefilled syringe 1 includes an outer cylinder 2, a liquid medicine container 3 filled with a liquid medicine in advance, a pressing part 16 for moving the liquid medicine container 3, a double ended needle 10, and a needle support part 15 for supporting the double ended needle 10. Also, the prefilled syringe 1 includes a holding part 8 and a sealing member 9 for holding the liquid medicine container 3 on the proximal end side of the outer cylinder 2 in an initial state. Upon use, when the pressing part 16 is pressed to move the liquid medicine container 3, the sealing member 9 and the holding part 8 are detached, and the liquid medicine container 3 is moved inside the outer cylinder 3 in such a state that the end face of the sealing member 9 and the inner peripheral surface of the outer cylinder 2 or the end face of the sealing member 9 and the outer peripheral surface of the liquid medicine container 3 are separated by the width of the holding part 8. Thus, since the liquid medicine container 3 is move almost without contacting the inner peripheral surface of the outer cylinder, there is no sliding operation when the liquid medicine container 3 is moved.

Description

  The present invention relates to a prefilled syringe in which a chemical solution is stored in advance in a syringe.

  In recent years, many prefilled syringes in which a medical solution is filled in advance have been used. Also, as a dental syringe, a type of syringe that is used with a chemical solution cartridge is known (Patent Document 1). In use, this syringe is used with a chemical cartridge and a double-ended needle attached to the syringe body. In addition, the syringe body is repeatedly used a plurality of times by performing sterilization, and the chemical cartridge and the double-ended needle are used only once and are disposable. For this reason, the syringe body does not need to have a structure capable of maintaining the sterility of the syringe body, and does not actually maintain the sterility.

  The conventional dental syringe is a type of syringe that is used with a chemical cartridge installed, so that waste of chemicals can be prevented, but it is necessary to install a double-ended needle on the syringe body during use. Have hassle and time.

Patent Document 2 describes a prefilled syringe capable of injecting medication by attaching a chemical liquid cartridge filled with a chemical liquid in advance to a syringe body and inserting the chemical liquid cartridge into the syringe body.
When the chemical cartridge is slid inside the syringe body, silicone is generally applied to the syringe body for the purpose of reducing sliding resistance between the outer periphery of the chemical cartridge and the inner periphery of the syringe body. .

  However, when it has the process of apply | coating silicone inside a syringe main body in this way, control of the process in silicone application | coating is complicated. Furthermore, in the manufacturing process of the syringe, if silicone adheres to the equipment of the press-fitting and fitting process, problems such as loosening of the press-fitting part / fitting part occur, so the silicone must be used under strict control. And the like. Therefore, it is required to make silicone-free between the chemical cartridge and the syringe body.

JP 2002-159575 A JP 2002-172166 A

  In view of the above-described points, the present invention provides a prefilled syringe that can reduce the number of manufacturing steps by eliminating silicone, can prevent waste of chemicals, and can easily and quickly prepare for administration of chemicals.

In order to solve the above problems and achieve the object of the present invention, a prefilled syringe of the present invention comprises an outer cylinder, a chemical solution container, a holding part, a seal member, a pressing part, a double-ended needle, and a needle support part. Is provided.
The outer cylinder has a distal end and a proximal end.
The chemical liquid container has a distal end and a proximal end, has an outer diameter smaller than the inner diameter of the outer cylinder, and is configured by a container having a distal end opening at the distal end. In this chemical liquid container, the tip opening is sealed with a sealing body, so that the chemical liquid is sealed inside the container and the inside of the outer cylinder is movable in the axial direction.
The holding portion is disposed between the inner peripheral surface of the outer cylinder and the outer peripheral surface of the chemical liquid container, and is fixed to the inner peripheral surface of the outer cylinder or the outer peripheral surface of the chemical liquid container.
Or while a chemical | medical solution container is sealed with the 1st sealing body and the 2nd sealing body inside a container, a chemical | medical solution is contained in the container pinched | interposed with a 1st sealing body and a 2nd sealing body. It is configured to be sealed.
The seal member is fixed in the circumferential direction of the outer peripheral surface of the chemical solution container facing the holding portion or the inner peripheral surface of the outer cylinder. In the initial state, the seal member seals between the holding portion and the outer peripheral surface of the chemical liquid container facing the holding portion or the inner peripheral surface of the outer cylinder, and the chemical liquid container is held on the proximal end side of the outer cylinder. The
The pressing part is used to move the chemical container.
The double-ended needle has a needle tip that can puncture a living body at one end and an end that can puncture a sealing body at the other end.
The needle support portion is provided on the distal end side of the outer cylinder and supports the double-ended needle.
In the prefilled syringe of the present invention, when the pressing portion is pressed in the distal direction, the chemical container moves in the distal direction with respect to the outer cylinder, and the end of the double-ended needle is pierced through the sealing body and provided at one end of the double-ended needle. The chemical is discharged from the needle tip.

  In the prefilled syringe of the present invention, in the unused state, the chemical solution container is held on the proximal end side of the outer cylinder by the holding portion and the seal member. In use, the chemical container moves to the distal end side by pressing the pressing portion toward the distal end side. At this time, when the seal member is removed from the holding portion, the seal member end surface and the outer peripheral surface of the outer cylinder, or the seal member end surface and the outer peripheral surface of the chemical container are separated by the width of the holding portion. The chemical container moves inside the outer cylinder. Thereby, since the chemical solution container moves in a substantially non-contact manner to the inner peripheral surface of the outer cylinder, there is no sliding operation when the chemical solution container is moved.

  According to the present invention, since there is no sliding operation when the chemical container moves in the outer cylinder, it is possible to eliminate the silicone between the outer cylinder and the chemical container. Thereby, the number of manufacturing processes can be reduced. In addition, since the chemical solution container that stores the required amount of the chemical solution is included, the waste of the chemical solution can be prevented, and preparation of the chemical solution administration can be easily and quickly performed.

It is a schematic sectional lineblock diagram of the prefilled syringe concerning a 1st embodiment of the present invention, and is a figure showing the state where a protection member was removed. It is a general | schematic cross-section block diagram at the time of use of the prefilled syringe which concerns on the 1st Embodiment of this invention. It is a schematic sectional block diagram of the prefilled syringe which concerns on the modification of 1st Embodiment. It is a general | schematic cross-section block diagram at the time of use of the prefilled syringe which concerns on a modification. It is a schematic sectional block diagram in the initial state of the prefilled syringe which concerns on the 2nd Embodiment of this invention. It is a schematic block diagram at the time of use of the prefilled syringe which concerns on the 2nd Embodiment of this invention. It is a general | schematic cross-section block diagram at the time of use of the prefilled syringe which concerns on the 2nd Embodiment of this invention. It is a schematic sectional block diagram which shows the initial state of the prefilled syringe which concerns on the modification of 2nd Embodiment. It is a general | schematic cross-section block diagram at the time of use of the prefilled syringe which concerns on the modification of 2nd Embodiment. It is a schematic sectional block diagram which shows the initial state of the prefilled syringe which concerns on the 3rd Embodiment of this invention. It is a schematic sectional block diagram at the time of use of the prefilled syringe which concerns on the 3rd Embodiment of this invention.

Below, an example of the prefilled syringe which concerns on embodiment of this invention is demonstrated, referring FIGS. 1-11. Embodiments of the present invention will be described in the following order. In addition, this invention is not limited to the following examples.
1. 1st Embodiment: Prefilled syringe 1-1 Structure 1-2 Usage method 1-3 Modification 2. Second Embodiment: Prefilled Syringe 2-1 Configuration 2-2 Usage Method 2-3 Modified Example 3. Third Embodiment: Prefilled Syringe 3-1 Configuration 3-2 Usage Method

<1. First Embodiment: Prefilled Syringe>
[1-1 Configuration]
FIG. 1 is a schematic cross-sectional configuration diagram of a prefilled syringe according to the first embodiment of the present invention. Moreover, FIG.2 and FIG.3 is a schematic cross-section block diagram of the prefilled syringe at the time of use.

  As shown in FIG. 1, the prefilled syringe 1 according to the present embodiment includes an outer cylinder 2, a chemical liquid container 3 that can be moved along the central axis of the outer cylinder 2, and a pressing unit that moves the chemical liquid container 3. 4, a double-ended needle 10, and a needle support portion 15 that supports the double-ended needle 10. Further, a holding part 8 for holding the chemical liquid container 3 on the proximal end side of the outer cylinder 2 in an unused state, a seal member 9 for sealing between the holding part 8 and the chemical liquid container 3, and unused It has a protective member (cap) 19 for maintaining a sterile condition in the state.

  The outer cylinder 2 has a cylindrical shape having a proximal end and a distal end, and is constituted by a cylindrical member in the present embodiment. In the following description, one end side of the outer cylinder 2 is referred to as a “base end” and the other end side is referred to as a “tip”.

  As a constituent material of the outer cylinder 2, for example, polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene-styrene copolymer, Various resins such as polyesters such as polyethylene terephthalate, butadiene-styrene copolymers, and polyamides (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12) can be used. Among them, it is preferable to use a resin such as polypropylene, cyclic polyolefin, polyester, or poly- (4-methylpentene-1) because it is easy to mold. In addition, it is preferable that the constituent material of the outer cylinder 2 is substantially transparent in order to ensure internal visibility.

  The chemical liquid container 3 has a cylindrical shape having a distal end and a proximal end, and is composed of a bottomed cylindrical member having a bottom portion 5 inside and a distal end opening portion 3a on the distal end side. The chemical solution container 3 is held on the proximal end side of the outer cylinder 2 in an unused state. Further, the outer diameter of the chemical liquid container 3 is made smaller than the inner diameter of the outer cylinder 2, and when the chemical liquid container 3 moves inside the outer cylinder 2 in use, the inner peripheral surface of the outer cylinder 2 and the chemical liquid container The outer peripheral surface 3 is in a non-contact state.

  Although it does not specifically limit as a constituent material of the chemical | medical solution container 3, For example, the thing similar to the constituent material of the outer cylinder 2 mentioned above can be used. In addition, it is preferable that the constituent material of the chemical | medical solution container 3 is substantially transparent in order to ensure internal visibility. Further, a scale not shown is formed on the outer peripheral surface of the chemical solution container 3. Thereby, the quantity of the chemical | medical solution accommodated in the chemical | medical solution container 3 can be grasped | ascertained.

  And the sealing body 6 which seals the front-end | tip opening part 3a is airtightly hold | maintained at the front end side inside the chemical | medical solution container 3. FIG. The sealing body 6 is provided so as to be movable along the inner peripheral surface of the chemical liquid container 3, and is configured so that a second needle tip 11 on the proximal end side of the double-ended needle 10 to be described later can communicate.

  The constituent material of the sealing body 6 provided in the tip opening 3a of the chemical liquid container 3 is not particularly limited, but is preferably composed of an elastic material in order to improve the liquid tightness with the chemical liquid container 3, For example, various rubber materials such as natural rubber, butyl rubber, isoprene rubber, isobutylene rubber, butadiene rubber, styrene-butadiene rubber, silicone rubber, and various thermoplastics such as polyurethane, polyester, polyamide, olefin, and styrene. An elastic material such as an elastomer or a mixture thereof can be used.

  In addition, the sealing body 6 should just have the outer peripheral part comprised with the elastic material as mentioned above, for example, has a core part (not shown) comprised with the resin material, The thing of the structure by which the elastic material mentioned above is arrange | positioned so that outer periphery may be covered may be sufficient.

  And the chemical | medical solution M is beforehand liquid-tightly accommodated in the space 7 inside the chemical | medical solution container 3 enclosed by the bottom part 5 and the sealing body 6 of the chemical | medical solution container 3. FIG. This space 7 is a sealed space hermetically sealed by the sealing body 6 and is maintained in a sterile state.

  Examples of the chemical solution M stored in the space 7 of the chemical solution container 3 include various vaccines for preventing various infectious diseases such as influenza in the present embodiment, but are not limited to vaccines. In addition to vaccines, for example, glucose injection solutions such as glucose, electrolyte correction injection solutions such as sodium chloride and potassium lactate, vitamin agents, antibiotic injection solutions, contrast agents, steroid agents, proteolytic enzyme inhibitors, fat Emulsions, anticancer agents, anesthetics, stimulants, narcotics, heparin calcium, antibody drugs and the like can be mentioned.

  Moreover, although the quantity (volume of the space 7) of the chemical | medical solution M accommodated in the space 7 is not specifically limited, For example, about 0.02-2.0 mL is preferable and about 0.05-0.8 mL is more preferable. That is, the prefilled syringe 1 is particularly suitable when such a small amount of drug solution is administered.

  The holding portion 8 is disposed between the inner peripheral surface of the outer cylinder 2 and the outer peripheral surface of the chemical liquid container 3, and is fixed to the inner peripheral surface of the outer cylinder 2, and in this embodiment example, It is formed in a bowl shape on the inner peripheral surface of the base end of the outer cylinder. As described above, when the chemical liquid container 3 of the present embodiment is used, the inner peripheral surface of the outer cylinder 2 and the outer peripheral surface of the chemical liquid container 3 are substantially the same when the chemical liquid container 3 moves inside the outer cylinder 2. It is set as the size which will be in a non-contact state. For this reason, a gap of a predetermined distance is formed between the inner peripheral surface of the outer cylinder 2 and the outer peripheral surface of the chemical solution container 3, and this gap is reduced by the holding portion 8.

  In this embodiment, the outer cylinder 2 and the holding part 8 are integrally formed. As a constituent material of the holding part 8, the same constituent material as that of the outer cylinder 2 described above can be used.

  The seal member 9 is provided to seal between the holding portion 8 and the chemical liquid container 3 and to hold the chemical liquid container 3 on the proximal end side of the outer cylinder 2 in an unused state. Fixed to the outer peripheral surface of the tip of the chemical solution container 3 facing the portion 8 over the entire circumference. Although it does not specifically limit as a constituent material of the sealing member 9, The thing similar to the constituent material of the bottom part 5 can be used, and it is comprised by the O-ring-shaped elastic member in this embodiment. Further, the seal member 9 may be formed by two-color molding.

  The inner peripheral surface of the outer cylinder 2 reduced by the holding part 8 and the chemical container are brought into close contact with the side of the outer cylinder 2 side of the sealing member 9 on the side surface of the bowl-shaped holding part 8 formed in the outer cylinder 2. 3 is completely sealed. And in the unused state (initial state), the chemical | medical solution container 3 is hold | maintained by the holding | maintenance part 8 and the sealing member 9 at the base end side of the outer cylinder 2. FIG.

  As described above, the seal member 9 is provided between the holding portion 8 formed in the outer cylinder 2 and the chemical liquid container 3, so that the distal end of the chemical liquid container 3 is stably held on the proximal end side of the outer cylinder 2. In addition, the inner peripheral surface of the outer cylinder 2 and the region (outer cylinder inner space 41) surrounded by the chemical solution container 3 are hermetically sealed.

  In this embodiment, the seal member 9 is provided on the distal end side of the chemical solution container 3 so that the distal end side of the chemical solution container 3 is held on the proximal end side of the outer cylinder 2 in the initial state. The position of the container 3 may be a position where the second needle tip 11 of the double-ended needle 10 described later does not puncture the sealing body 6. Therefore, the position where the seal member 9 is provided is not limited to the tip of the chemical solution container 3.

  The pressing portion 4 is formed in a disc shape, and is formed integrally with the chemical liquid container 3 so as to cover the base end surface of the chemical liquid container 3. In the present embodiment, the chemical liquid container 3 and the pressing part 4 are integrally formed. However, the present invention is not limited to this. For example, the chemical liquid container 3 and the pressing part 24 are configured as separate members, and these are bonded by an adhesive. Or you may join by melt | fusion etc. By pressing the pressing portion 4, the chemical liquid container 3 moves to the proximal end side with respect to the outer cylinder 2.

  The double-ended needle 10 has a sharp first needle tip 12 that can pierce a living body on the distal end side, and a sharp second needle tip 11 that can pierce the sealing body 6 of the drug solution container 3 on the proximal end side. have. The second needle tip 11 on the proximal end side of the double-ended needle 10 pierces the sealing body 6 so that the proximal end side of the double-ended needle 10 communicates with the inside of the drug solution container 3. .

  As the double-ended needle 10, an ISO medical double-ended needle standard (ISO9626: 1991 / Amd.1: 2001 (E)) having a size of 22 to 33G (outer diameter: 0.2 to 0.7 mm) is used. can do. In addition, when using for the administration to the upper skin part, the thing of 26-33G can be used, Preferably, the thing of the size of 30-33G can be used.

  The first needle tip 12 on the distal end side of the double-ended needle 10 is formed with a blade tip having a blade surface 12a. The axial length of the double-ended needle 10 on the blade surface 12a on the distal end side (hereinafter referred to as “bevel length”). B ”is preferably 1.4 mm (adult) or less, which is the thinnest thickness of the upper layer of the skin, and is about the bevel length when a short bevel is formed on a 33G double-ended needle. It is preferable that it is 0.5 mm or more. That is, the bevel length B is preferably set in the range of 0.5 to 1.4 mm. Here, the upper skin layer refers to the epidermis and dermis.

  Furthermore, the bevel length B is more preferably 0.9 mm (child) or less, which is the thinnest thickness of the upper skin layer. That is, the bevel length B is more preferably set within the range of 0.5 to 0.9 mm.

  The constituent material of the double-ended needle 10 is not particularly limited. For example, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, superelastic alloy such as Ni-Ti alloy, and various hard materials such as polyphenylene sulfide. Resin material etc. are mentioned.

  The needle support portion 15 includes a substantially disc-shaped needle support portion main body 20, an adjustment portion 17, a stabilization portion 13, and a guide portion 16 that is a pressing guide portion. The needle support portion 15 is disposed so as to close the opening on the distal end side of the outer cylinder 2 while holding the double-ended needle 10. At this time, the second needle tip 11 of the double-ended needle 10 penetrating the needle support portion 15 is disposed in the outer cylinder inner space 41 surrounded by the needle support portion 15 and the drug solution container 3 in the outer cylinder 2.

  The adjusting portion 17 and the stabilizing portion 13 are provided on the distal end side of the needle support portion main body 20. The material of the needle support portion 15 is not particularly limited. For example, the same material as that of the outer cylinder 2 described above can be used. Further, the needle support portion 15 may be formed integrally with the outer cylinder 2.

  Further, the needle support portion main body 20 is provided with a first vent hole 14 penetrating from the distal end side to the proximal end side. The first vent hole 14 communicates the outer cylinder inner space 41 with the outer side of the outer cylinder inner space 41. Furthermore, a filter may be provided in the first vent hole 14 in order to enhance the maintenance of the sterilized state of the outer cylinder inner space 41.

  In this example, the example in which the number of the first ventilation holes 14 is one has been described. However, the present invention is not limited to this, and a plurality of the first ventilation holes 14 are formed in the needle support body 20. May be.

  The adjustment portion 17 is provided at the center of one of the distal end surfaces 20a of the needle support portion main body 20, and is configured as a convex portion that protrudes in the axial direction of the needle support portion main body 20. The axis of the adjustment unit 17 coincides with the axis of the needle support body 20. And the double-ended needle 10 has penetrated this adjustment part 17. As shown in FIG. Moreover, the end surface of the adjustment part 17 is a needle projecting surface 17a from which the first needle tip 12 side of the double-ended needle 10 projects.

  The needle projecting surface 17 a is formed as a plane orthogonal to the axial direction of the double-ended needle 10. This needle projecting surface 17a defines the depth to puncture the double-ended needle 10 in contact with the surface of the skin when the double-ended needle 10 is punctured into the upper skin layer. That is, the depth at which the double-ended needle 10 is punctured into the upper skin portion of the skin is determined by the length of the double-ended needle 10 protruding from the needle protruding surface 17a (hereinafter referred to as “projecting 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 protruding length L of the double-ended needle 10 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 part, but in the case of administration to the upper skin part, it is considered that the shoulder peripheral part where the skin is thick, particularly the deltoid part is preferable. 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 muscle, it is preferable that the protruding length L of the double-ended needle 10 is set in the range of 0.9 to 1.4 mm.

  By setting the protrusion length L in this manner, the blade surface 12a of the first needle tip 12 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 12a can be located in the upper skin layer portion at any position within the blade surface 12a. In addition, even if the chemical solution discharge port is located in the upper skin portion, if the first needle tip 12 is deeply stabbed into the upper skin portion, the gap between the side surface of the end portion of the first needle tip 12 and the cut skin Since the chemical M flows under the skin, it is important that the blade surface 12a is surely in the upper skin layer.

  Note that it is difficult to set the bevel length B to 1.0 mm or less with a double-ended needle thicker than 26G. Therefore, in order to set the protruding length L of the first needle tip 12 in the double-ended needle 10 within a preferable range (0.9 to 1.4 mm), it is preferable to use a double-ended needle smaller than 26G.

  The needle projecting surface 17a is formed such that the distance S from the peripheral edge to the peripheral surface of the double-ended needle 10 is 1.4 mm or less, preferably in the range of 0.3 to 1.4 mm. The distance S from the peripheral edge of the needle projecting surface 17a to the peripheral surface of the double-ended needle 10 is set in consideration of the pressure applied to the blisters formed by administering the drug solution to the upper skin layer. That is, the needle projecting surface 17a 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 can be prevented that the needle protruding surface 17a presses the skin around the double-ended needle 10 and the administered drug solution leaks.

  The stabilizing portion 13 is provided on the distal end surface 20 a of the needle support portion main body 20. The stable portion 13 is formed in a cylindrical shape that is continuous with the peripheral edge portion of the distal end surface 20a. The first needle tip 12 and the adjustment unit 17 of the double-ended needle 10 are disposed in the cylindrical hole of the stabilizing unit 13. That is, the stable portion 13 is formed in a cylindrical shape that covers the periphery of the adjusting portion 17 through which the double-ended needle 10 passes.

  As shown in FIG. 2, when the first needle tip 12 of the double-ended needle 10 is punctured into the living body, the needle projecting surface 17a contacts the surface of the skin and the end surface 13a of the stabilizing portion 13 also contacts the surface of the skin. . At this time, the prefilled syringe 1 is stabilized by the end surface 13a of the stabilizing portion 13 coming into contact with the skin, and the double-ended needle 10 can be maintained in a posture substantially perpendicular to the skin.

  The end surface 13a of the stabilizing portion 13 may be positioned on the same plane as the needle protruding surface 17a, or may be positioned closer to the first needle tip 12 side of the double-ended needle 10 than the needle protruding surface 17a. The double-ended needle 10 can be maintained in a substantially vertical posture with respect to the skin. In consideration of the swelling of the skin when the stable portion 13 is pressed against the skin, the axial distance r between the end surface 13a of the stable portion 13 and the needle protruding surface 17a 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 17a 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 distance T from the inner wall surface of the stable portion 13 to the peripheral edge of the needle protruding surface 17a 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. Therefore, when the double-ended needle 10 is inserted into a thin arm like a child, it is difficult to bring the entire end surface 13a of the stable portion 13 into contact with the skin. Become. 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 peripheral edge of the needle projecting surface 17a to the peripheral surface of the double-ended needle 10 is 0.3 mm or more, the adjusting unit 17 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 17a and the diameter (about 0.3 mm) of the needle protruding surface 17a, the inner diameter d of the stable portion 13 is 9 mm or more. Can be set.

  Furthermore, a second ventilation hole 18 penetrating from the outer peripheral surface to the inner peripheral surface of the stable portion 13 is formed in the stable portion 13. By providing the second ventilation hole 18 in the stable portion 13, as shown in FIG. 2, when the stable portion 13 is brought into contact with the skin, the space surrounded by the stable portion 13 and the skin, and the stable portion The space outside 13 can be communicated. The first ventilation hole 14 and the second ventilation hole 18 constitute a ventilation means for opening the outer cylinder inner space 41 to the outside.

  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.

The guide portion 16 is provided on a side surface portion of the needle support portion main body 20. The guide portion 16 is formed as a flange in a ring shape protruding from the side surface portion of the needle support portion main body 20 in the radially outward direction of the needle support portion main body 20. The guide portion 16 protrudes substantially perpendicular to the outer peripheral surface of the stable portion 13.

  Furthermore, the guide part 16 has the contact surface 16a which contacts skin. The contact surface 16 a is a plane that is substantially parallel to the end surface 13 a of the stabilizing portion 13. By pressing the stable portion 13 until the contact surface 16a of the guide portion 16 comes into contact with the skin, the force with which the stable portion 13 and the double-ended needle 10 press the skin can always be secured above a predetermined value. Thereby, the part (equivalent to the protrusion length L) which protrudes from the needle protrusion surface 17a of the double-ended needle 10 is reliably punctured in the skin.

  The distance from the contact surface 16a of the guide portion 16 to the end surface 13a of the stable portion 13 is such that the double-ended needle 10, the stable portion 13 and the double-ended needle 10 can puncture the skin with an appropriate pressing force. Is set. Hereinafter, this length is referred to as “guide height y”.

  In addition, the suitable pressing force of the double-ended needle 10 and the stable part 13 is 3-20N, for example. As a result, the user can be guided by the guide portion 16 with the pressing force applied to the skin by the double-ended needle 10 and the stabilizing portion 13, and the first needle tip 12 and the blade surface 12 a of the double-ended needle 10 can be provided on the upper skin portion. Therefore, it is possible to provide the user with a sense of security.

  Specifically, when the inner diameter d of the stable portion 13 is in the range of 11 to 14 mm, the guide portion height y is the length x from the protruding end surface of the guide portion 16 to the outer peripheral surface of the stable portion 13 (hereinafter referred to as guide portion length). X). ) Is set as appropriate. 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 3.0 mm, for example.

  As shown in FIG. 2, the protection member 19 is a member that seals the space surrounding the first needle tip 12 on the side of the double-ended needle 10 that is punctured into the living body, and the needle support portion 15 in the unused state. It is attached to the stable part 13 of the detachable part.

  The protection member 19 is formed in a bottomed cylindrical shape having a bottom portion on the distal end side, in the present embodiment, a bottomed cylindrical shape. In an unused state, the side surface of the protection member 19 is attached to the outer peripheral portion of the needle support portion 15, whereby the outer cylinder surrounded by the protection member 19, the outer tube 2, the needle support portion 15, and the seal member 9. The inner space 41 is hermetically sealed, and the outer cylinder inner space 41 and the protection member 19 are sealed. Thereby, the aseptic condition inside the outer cylinder inner space 41 and the protection member 19 is maintained.

  When the prefilled syringe 1 is used, the protective member 19 is removed from the needle support portion 15 as shown in FIG. 1, and the sealing of the first needle tip 12 on the side where the double-ended needle 10 is punctured is released. The At this time, the space 41 in the outer cylinder is also released to the outside by the first vent hole 14 of the needle support portion 15.

  Although it does not specifically limit as a constituent material of the protection member 19, For example, the thing similar to the constituent material of the outer cylinder 2 mentioned above and the constituent material of the sealing body 6 can be used.

  In the prefilled syringe 1, the protective member 19 is attached to the distal end side of the needle support portion 15, and after the necessary portions are sterilized, the sterilized state inside the outer cylinder inner space 41 and the protective member 19 is as described above. And the aseptic condition of the double-ended needle 10 is maintained.

[1-2 Usage]
Next, an example of a method for using the prefilled syringe 1 of the present embodiment will be described. FIG. 3 shows a schematic cross-sectional configuration diagram in use.

  When using the prefilled syringe 1, first, the protective member 19 is removed from the distal end side of the needle support portion 15 of the prepared prefilled syringe 1. Thereby, the preparation for administering the drug solution is completed. As described above, the prefilled syringe 1 can easily and quickly prepare for the administration of the drug solution.

  Next, the end surface 13a of the stabilizing portion 13 is made to face the skin. Thereby, the first needle tip 12 of the double-ended needle 10 is opposed to the skin to be punctured. Next, as shown in FIG. 2, the prefilled syringe 1 is moved substantially perpendicular to the skin, the double-ended needle 10 is punctured into the skin, and the end surface 13a of the stabilizing portion 13 is pressed against the skin.

  Here, the needle projecting surface 17a of the adjusting portion 17 and the end surface 13a of the stabilizing portion 13 are located on the same plane. Thereby, the needle projecting surface 17a of the adjustment unit 17 can contact the skin and deform the skin flatly, and the first needle tip 12 of the double-ended needle 10 can be punctured into the skin by the projecting length L.

  Next, the stabilization part 13 is pressed until the contact surface 16a of the guide part 16 contacts skin. Here, the length of the guide portion height y is set so that the double-ended needle 10 and the stable portion 13 can puncture the skin with an appropriate pressing force. Therefore, the force that presses the skin by the stabilizing portion 13 becomes a predetermined value. Therefore, the pressing force of the stable portion 13 can be guided to the user, and the stable portion 13 can be pressed against the skin with an appropriate pressing force, so that the first needle tip 12 and the blade surface 12a of the double-ended needle 10 can be obtained. Can be reliably positioned in the upper layer of the skin.

  As described above, the guide portion 16 serves as a mark for guiding the pressing force of the stable portion 13, so that the first needle tip 12 of the double-ended needle 10 can be reliably positioned on the upper skin portion, and the upper skin portion can be positioned in the upper skin portion. It is possible to reliably administer the drug solution and improve the user's sense of security.

  In addition, since the stabilizing portion 13 contacts the skin, the double-ended needle 10 can be stabilized and the double-ended needle 10 can be punctured straight into the skin. Therefore, the blur which arises in the double-headed needle 10 can be prevented, and the chemical | medical solution can be administered stably.

  Furthermore, for example, with a very short protruding length of about 0.5 mm, even if the first needle tip 12 is brought into contact with the skin, it may not pierce 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. Therefore, the skin is less likely to escape with respect to the first needle tip 12 of the double-ended needle 10, so that the stabilizing portion 13 also has an effect that the first needle tip 12 is more likely to pierce the skin.

  Moreover, since the protrusion length L is set in the range of 0.5 to 3.0 mm, the first needle tip 12 and the blade surface 12a of the double-ended needle 10 are surely positioned in the upper skin layer. The adjusting portion 17 is fixed in close contact with the periphery of the double-ended needle 10 so that no gap is generated between the adjusting portion 17 and a portion of the double-ended needle 10 that passes through the adjusting portion 17.

  Therefore, when the needle projecting surface 17a of the adjustment unit 17 is brought into contact with the skin, the skin around the double-ended needle 10 can be deformed flat. As a result, the double-ended needle 10 can be punctured into the skin by the protruding length L, and the first needle tip 12 of the double-ended needle 10 can be reliably positioned in the upper skin layer.

  Next, the drug solution container 3 is moved and operated by placing a finger on the pressing portion 4 and pressing it in the distal direction. Thereby, the chemical | medical solution container 3 currently hold | maintained at the holding | maintenance part 8 with the sealing member 9 remove | deviates from the holding | maintenance part 8 with the sealing member 9, and holding | maintenance of the chemical | medical solution container 3 by the holding | maintenance part 8 is cancelled | released. And the chemical | medical solution container 3 moves to the front end side in the state which does not contact the outer cylinder 2 inside the outer cylinder 2 substantially. Thereafter, as shown in FIG. 2, the second needle tip 11 on the proximal end side of the double-ended needle 10 is pierced into the sealing body 6 of the drug solution container 3 moved to the distal end side along the central axis in the outer cylinder 2. Communicating with the inside of the chemical solution container 3. Thereby, the liquid passing through the double-ended needle 10 is completed.

  Since the chemical container 3 before pressing the pressing part 4 is tightly held by the holding part 8 by the elastic force of the seal member 9, the chemical container 3 can be held by the holding part 8 only by pressing the pressing part 4 with a predetermined force. Deviate from. Further, the outer cylinder 2 is sized so that the inner peripheral surface of the outer cylinder 2 and the outer peripheral surface of the chemical liquid container 3 are in a substantially non-contact state when the chemical liquid container 3 moves inside the outer cylinder 2. The portion 8 is separated from the end face of the seal member 9 by the reduced width. For this reason, after the chemical liquid container 3 is detached from the holding portion 8 together with the seal member 9, the chemical liquid container 3 moves in the outer cylinder 2 substantially in non-contact with the outer cylinder 2, and the chemical liquid is passed. Therefore, when the chemical liquid container 3 is moved, the chemical liquid container 3 provided with the seal member 9 does not slide inside the outer cylinder 2, and the space between the inner peripheral surface of the outer cylinder 2 and the outer peripheral surface of the chemical liquid container 3 is not affected. There is no resistance.

  When the pressing portion 4 is further pressed in the distal direction after the completion of liquid passing, the sealing body 6 slides relatively in the moving direction of the chemical liquid container 3 inside the chemical liquid container 3. Thereby, the chemical solution in the chemical solution container 3 passes through the double-ended needle 10 and is discharged from the first needle tip 12 on the distal end side, and the chemical solution is administered to the target site.

  In the prefilled syringe 1 of the present embodiment example, as described above, the outer periphery of the chemical liquid container 3 even when the chemical liquid container 3 and the seal member 9 do not contact or slightly contact the inner peripheral surface of the outer cylinder 2 when liquid is passed. Since the resistance between the surface and the inner peripheral surface of the outer cylinder 2 is low, there is no operation of sliding the chemical container 3 within the outer cylinder 2. For this reason, it is not necessary to apply silicone for reducing sliding resistance to the outer peripheral surface of the chemical solution container 3 or the inner peripheral surface of the outer cylinder 2. Thereby, compared with the syringe which requires the operation | movement which slides the conventional chemical | medical solution container 3 inside the outer cylinder 2, the process of apply | coating silicone can be skipped and a manufacturing process can be reduced. Moreover, since it is not necessary to apply silicone to the inner peripheral surface of the outer cylinder 2 and the outer peripheral surface of the chemical solution container 3, the silicone does not adhere to the equipment in the press-fitting process and the fitting process in the manufacturing process.

  Here, as shown in FIG. 1, the prefilled syringe 1 according to the present embodiment is provided with the first vent hole 14 and the second vent hole 18, so that the pressing portion 4 is moved in the distal direction. At this time, the air in the outer cylinder inner space 41 is discharged to the outside through the first vent hole 14 and the second vent hole 18. As a result, an increase in pressure in the outer cylinder inner space 41 can be prevented, and the moving operation of the pressing portion 4 can be performed easily and smoothly. Even if it releases | separates, it can prevent that the press part 4 moves to a base end direction.

  In addition, according to the prefilled syringe 1 of the present embodiment example, since the chemical liquid container 3 in which a necessary amount of chemical liquid is stored is provided, waste of the chemical liquid can be prevented, which is economical.

  Further, since the chemical solution container 3 and the double-ended needle 10 are installed in advance and the sterilized state of the outer cylinder inner space 41 in which the double-ended needle 10 is disposed is kept unused, the protective member 19 is removed. The preparation of the drug solution can be easily and quickly prepared by simple operation.

  Moreover, since the 1st ventilation hole 14 and the 2nd ventilation hole 18 are provided, the assembly of the prefilled syringe 1 can be performed easily. That is, when the first vent hole 14 and the second vent hole 18 are not provided, the outer cylinder inner space 41 is hermetically sealed, so that the chemical liquid container 3 provided with the seal member 9 is attached to the outer cylinder. 2 is required to decompress the outer cylinder inner space 41, but the prefilled syringe 1 of the present embodiment does not require such a decompression step, and does not require time and effort. Assembly can be performed.

  In the present embodiment, the prefilled syringe used for administering the drug solution to the subcutaneous upper layer is taken as an example, but it can be applied to various applications such as subcutaneous administration, intramuscular administration, and vascular administration. In that case, what is necessary is just to make protrusion length L etc. of the double-ended needle 10 respond | correspond to various uses, and you may abbreviate | omit the structure of the stabilization part 13, the adjustment part 17, and the guide part 16. FIG.

  By the way, in the prefilled syringe 1 of the present embodiment example, the resistance to the chemical solution container 3 suddenly disappears after the chemical solution container 3 is removed together with the seal member 9 from the holding portion 8, and therefore the chemical solution container 3 moves vigorously toward the distal end side. The needle tip of the double-ended needle 10 may be damaged. In order to prevent this, a member for preventing the second needle tip 11 of the double-ended needle 10 from bending can be provided. For example, the second needle tip 11 is damaged by providing an elastic member or the like around the second needle tip 11 so that the sealing body does not suddenly hit the second needle tip 11. Can be prevented.

[1-3 Modification]
Next, a prefilled syringe according to a modification of this embodiment will be described. FIG.3 and FIG.4 is a schematic cross-section block diagram of the prefilled syringe 21 which concerns on a modification. 3 and FIG. 4, the same reference numerals are given to the portions corresponding to FIG. 1 and FIG.

  The modified prefilled syringe 21 is an example in which the fixed portion 40 is configured on the proximal end side of the needle support portion 15 in the prefilled syringe 1 according to the first embodiment.

  The fixing portion 40 is provided at the central portion of the other proximal end surface 20b facing the distal end surface 20a of the needle support portion main body 20. The fixed portion 40 is configured as a convex portion that protrudes in a substantially cylindrical shape in the axial direction of the needle support portion main body 20. The double-ended needle 10 penetrates through the fixed portion 40, and the second needle tip 11 of the double-ended needle 10 protrudes from the end surface of the fixed portion 40.

  In this modified example, the axis of the double-ended needle 10 and the axes of the adjustment unit 17 and the fixing unit 40 coincide. However, the fixing portion 40 only needs to be formed along the axial direction of the double-ended needle 10, and the object can be achieved without matching the axial center of the double-ended needle 10 and the axial center of the fixing portion 40. Furthermore, although the example which formed the fixing | fixed part 40 in the substantially cylindrical shape was demonstrated, the shape of the fixing | fixed part 40 is not limited to a substantially cylindrical shape. The fixing | fixed part 40 should just be a shape which presses the sealing body 6, for example, may be formed in substantially semicircle shape or prismatic shape.

  The fixing portion 40 is disposed in the outer cylinder inner space 41 when the needle support portion 15 closes the opening on one end side of the outer cylinder 2.

  Also when using the prefilled syringe 21 of a modification, the protection member 19 is removed from the front end side of the needle support part 15 similarly to 1st Embodiment. Next, the first needle tip 12 on the distal end side of the double-ended needle 10 is inserted into a site such as an arm where a drug solution is administered, and the end surface 13a of the stabilizing portion 13 is pressed against the skin.

  And a finger | toe is applied to the press part 4 and it presses to a front-end | tip direction, and the chemical | medical solution container 3 is moved. As a result, the seal member 9 fixed to the chemical liquid container 3 is removed from the holding portion 8, and the chemical liquid container 3 moves to the tip side in the outer cylinder 2 in a non-resistance state. Then, the second needle tip 11 on the proximal end side of the double-ended needle 10 is pierced through the sealing body 6 of the drug solution container 3 moved to the distal end side along the central axis in the outer cylinder 2, and as shown in FIG. The fixed portion 40 contacts the sealing body 6 while communicating with the inside of the chemical liquid container 3.

  In the prefilled syringe 21 of the modified example, after the liquid passage is completed, by further pressing the pressing portion 4, the sealing body 6 in contact with the fixed portion 40 slides on the inner peripheral surface of the chemical liquid container 3, It moves to the base end side of the chemical solution container 3. Thereby, the chemical | medical solution in the chemical | medical solution container 3 is discharged | emitted from the 1st needle tip 12 of the double-ended needle 10, and is administered to a biological body.

  In the modified example, the fixing body 40 is formed, so that the sealing body 6 stably slides and moves in the chemical solution container 3. This stabilizes the discharge of the chemical solution. In addition, the same effects as those of the first embodiment can be obtained.

<2. Second Embodiment: Prefilled Syringe>
Next, a prefilled syringe according to a second embodiment of the present invention will be described. FIG. 5 is a schematic cross-sectional configuration diagram of the prefilled syringe 22 of the present embodiment. Moreover, FIG.6 and FIG.7 is a schematic sectional block diagram of the prefilled syringe 22 at the time of use. 5 to 7, parts corresponding to those in FIGS. 1 and 2 are denoted by the same reference numerals, and redundant description is omitted.

[2-1 Configuration]
The chemical solution container 27 has a cylindrical shape, and is configured by a cylindrical member in the present embodiment. The chemical solution container 27 is held on the proximal end side of the outer cylinder 2 and provided on the proximal end side of the outer cylinder 2 in an unused state. Is stored in the chemical container storage unit 26. The outer diameter of the chemical container 27 is smaller than the inner diameter of the outer cylinder 2, and the inner peripheral surface of the outer cylinder 2 is moved when the chemical container 27 moves inside the outer cylinder 2 in use. And the outer peripheral surface of the chemical solution container 27 are in a size that is substantially in a non-contact state.

  Although it does not specifically limit as a constituent material of the chemical | medical solution container 27, For example, the thing similar to the constituent material of the outer cylinder 2 mentioned above can be used. In addition, since the internal visibility can be ensured, the constituent material of the chemical solution container 27 is preferably substantially transparent. Further, a scale not shown is formed on the outer peripheral surface of the chemical solution container 27. Thereby, the quantity of the chemical | medical solution accommodated in the chemical | medical solution container 27 can be grasped | ascertained.

  A first sealing body 28 and a second sealing body 29 that seal the space inside the chemical liquid container 27 are formed inside the chemical liquid container 27. The first sealing body 28 is provided on the distal end side inside the chemical liquid container 27, the second needle tip 11 of the double-ended needle 10 is formed so as to be able to puncture, and is fixedly provided inside the chemical liquid container 27. Yes. On the other hand, the second sealing body 29 is provided on the base end side inside the chemical liquid container 27 and is formed to be slidable inside the chemical liquid container 27. In the space 7 surrounded by the first sealing body 28 and the second sealing body 29 inside the chemical liquid container 27, the chemical liquid M is held in a liquid-tight manner.

  Although the constituent material of the 1st sealing body 28 and the 2nd sealing body 29 is not specifically limited, The thing similar to the constituent material of the sealing body 6 of 1st Embodiment can be used.

  The chemical container storage unit 26 is a cylindrical member that has an outer diameter smaller than the inner diameter of the outer cylinder 2 at the upper part of the holding unit 8 formed in a bowl shape and can store the chemical container 27 inside when not in use. It is configured. The chemical container storage unit 26 is used to stably hold the chemical container 27 on the base end side of the outer cylinder 2 in an unused state, and moves (presses) a pressing unit 24 described later. In some cases, it serves as a guide for the pressing portion 24, so that the moving operation can be easily performed.

  In the present embodiment, the outer cylinder 2, the holding unit 8, and the chemical solution container storage unit 26 are integrally formed. As the constituent materials of the holding unit 8 and the chemical container storage unit 26, the same materials as those of the outer cylinder 2 described above can be used.

  The seal member 9 is provided to seal between the holding portion 8 and the chemical liquid container 27 and to hold the chemical liquid container 27 on the proximal end side of the outer cylinder 2 in an unused state. It is fixed to the outer peripheral surface of the tip of the chemical solution container 27 facing the portion 8 over the entire circumference. The constituent material of the seal member 9 is not particularly limited, but the same constituent materials as those of the first sealing body 28 and the second sealing body 29 can be used. In this embodiment, O-rings are used. It is comprised with the shape-like elastic member.

  The inner peripheral surface of the outer cylinder 2 reduced by the holding part 8 and the chemical container are brought into close contact with the side of the outer cylinder 2 side of the sealing member 9 on the side surface of the bowl-shaped holding part 8 formed in the outer cylinder 2. The gap between the outer peripheral surface of 27 is completely sealed. And in the unused state, the chemical | medical solution container 27 is hold | maintained at the base end side of the outer cylinder 2 with the holding | maintenance part 8 and the sealing member 9. FIG.

  As described above, the seal member 9 is provided between the holding portion 8 formed on the outer cylinder 2 and the chemical liquid container 27, so that the distal end of the chemical liquid container 27 is stably held on the proximal end side of the outer cylinder 2. In addition, the area surrounded by the inner peripheral surface of the outer cylinder 2 and the chemical solution container 27 is hermetically sealed.

  In this embodiment, the seal member 9 is provided on the distal end side of the chemical solution container 27 so that the distal end side of the chemical solution container 27 is held on the proximal end side of the outer cylinder 2 when not in use. The position of the chemical solution container 27 may be a position where the second needle tip 11 of the double-ended needle 10 to be described later does not puncture the first sealing body 28. Therefore, the position where the seal member 9 is provided is not limited to the tip of the chemical solution container 27.

  The pressing portion 24 has a cross-sectional shape, for example, a cross-shaped or circular shape, a rod-shaped main body portion 25 whose tip is fixed to the second sealing body 29, and a disc provided on the base end side of the main body portion 25. And a flange 32 having a shape. That is, the pressing portion 24 is connected to the chemical solution container 27 and provided at the proximal end of the chemical solution container 27. The method for fixing the second sealing body 29 to the main body portion 25 is not particularly limited. For example, a female screw is formed on the main body portion 25 and is screwed into the second sealing body 29 with the male screw. Examples include a method of forming a screw and screwing both of them together.

  Although it does not specifically limit as a constituent material of the press part 24, For example, the same thing as the constituent material of the outer cylinder 2 mentioned above can be used.

[2-2 Usage]
Also when using the prefilled syringe 22 of this embodiment example, the protection member 19 is removed from the front end side of the needle support portion 15 as in the first embodiment. Next, the first needle tip 12 on the distal end side of the double-ended needle 10 is inserted into a site such as an arm where a drug solution is administered, and the end surface 13a of the stabilizing portion 13 is pressed against the skin.

  And a finger | toe is applied to the flange 32 of the press part 24, the press part 24 is pressed to the front end direction, and the chemical | medical solution container 27 is moved. As a result, the seal member 9 formed in the chemical liquid container 3 is detached from the holding portion 8, and the chemical liquid container 27 moves to the front end side in the outer cylinder 2 in a non-resistance state. Then, the second needle tip 11 on the proximal end side of the double-ended needle 10 is pierced through the first sealing body 28 of the drug solution container 27 moved to the distal end side along the central axis in the outer cylinder 2, and FIG. As shown, it communicates with the inside of the chemical container 27. Thereby, the liquid passing through the double-ended needle 10 is completed.

  Thereafter, by further pressing the pressing portion 24 in the distal direction, the second sealing body 29 is slid and moved to the first sealing body 28 side, and the chemical solution is discharged. Thereby, administration of a chemical | medical solution is performed.

  In the prefilled syringe 22 of the present embodiment example, if the seal member 9 formed integrally with the chemical solution container 27 is detached from the holding portion 8, the chemical solution container 27 and the seal member 9 do not adhere to each other. Can be moved in a substantially non-contact state. For this reason, it is not necessary to apply silicone between the chemical solution container 27 and the outer cylinder 2.

  In addition, the same effects as those of the first embodiment can be obtained.

[2-3 Modification]
Next, the prefilled syringe which concerns on the modification of 2nd Embodiment mentioned above is demonstrated. FIG. 8 is a schematic cross-sectional configuration diagram illustrating an unused state of the modified pre-filled syringe 30, and FIG. 9 is a schematic cross-sectional configuration diagram illustrating a state of the modified pre-filled syringe 30 in use. 8 and 9, parts corresponding to those in FIGS. 5 to 7 are denoted by the same reference numerals, and redundant description is omitted.

  The prefilled syringe 30 according to the modification is an example in which a return prevention mechanism for the pressing portion 24 is provided in the prefilled syringe 22 according to the second embodiment. The return prevention mechanism of the pressing unit 24 is a mechanism for preventing the leaked medicinal liquid from returning after the pressing unit 24 returns after the pressing unit 24 is pressed to complete the medication.

  In the modified example, as shown in FIG. 8, the return prevention mechanism of the pressing portion 24 is provided on the distal end side of the main body portion 25 of the pressing portion 24 and the stopper portion 33 provided on the base end surface of the chemical liquid container storage portion 26. The latching claw 31 is configured.

  The stopper portion 33 is a flat member having an opening 23 through which the main body portion 25 of the pressing portion 24 is inserted in the center portion, and is provided on the base end surface of the chemical liquid container storage portion 26. Although the constituent material of the stopper part 33 is not specifically limited, the same material as the outer cylinder 2 etc. which were mentioned above can be used, and the stopper part 33 may be formed integrally with the chemical | medical solution container accommodating part 26. FIG.

  The locking claw 31 provided on the main body portion 25 of the pressing portion 24 is positioned on the distal end side of the stopper portion 33 in an unused state, and the second sealing body 29 slides to the end by the pressing portion 24. When it is done, that is, when the administration of the chemical solution is finished, it is provided so as to be located immediately below the stopper portion 33. In addition, the diameter of the portion of the main body 25 where the locking claw 31 is formed is larger than the diameter of the opening 23, and the opening 23 has the locking claw 31 when the pressing portion 24 is pressed. It is designed in such a size that the locking claw 31 is not inserted when the force to be inserted and pressed is stopped.

  In the case where the drug solution is administered using the prefilled syringe 30 having the above-described configuration, in the state in which the pressing portion 24 is pushed down and the second sealing body 29 is slid and moved all the way out, the drug solution is completely discharged. As shown in FIG. 9, the locking claw 31 provided in the pressing portion 24 is locked to the distal end surface of the stopper portion 33. For this reason, even if it removes the force which presses the press part 24 after pressing the press part 24, the press part 24 does not return to a base end side. Accordingly, the second sealing body 29 is fixed so as not to move from the pushed position. For this reason, for example, at the time of medication to the upper skin part, it is possible to prevent the pressing part 24 from being pushed back by the force of the upper skin part to discharge the chemical liquid, and it is possible to prevent the administered chemical liquid from leaking. .

<3. Third Embodiment: Prefilled Syringe>
Next, a prefilled syringe according to a third embodiment of the present invention will be described. FIG. 10 is a schematic cross-sectional configuration diagram showing an unused state of the prefilled syringe 36 of the present embodiment example, and FIG. 11 is a schematic cross-sectional configuration diagram showing a state in use. 10 and 11, the same reference numerals are given to the portions corresponding to those in FIGS. 5 and 6, and the duplicate description will be omitted.

[3-1 Configuration]
The prefilled syringe 36 of the present embodiment does not have the chemical solution container storage portion 26 in FIG. 5, and the chemical solution container 37 is exposed to the outside as shown in FIG. Further, the outer diameter of the chemical liquid container 37 is smaller than the inner diameter of the outer cylinder 2, and when the chemical liquid container 37 moves inside the outer cylinder 2 in use, the inner peripheral surface of the outer cylinder 2 and the chemical liquid container 37. It is set as the magnitude | size which becomes a non-contact state with the outer peripheral surface of this. Furthermore, the chemical liquid container 37 in the present embodiment is formed relatively longer in the axial direction than the chemical liquid container 27 in the first embodiment, and the second sealing body 29 in the chemical liquid container 37 is the It is arranged on the tip side from the center. The proximal end side of the chemical solution container 37 is used as a guide when operating the pressing portion 24. Thereby, when moving the pressing part 24, the chemical | medical solution container 37 of the 2nd sealing body 29 upper part becomes a guide of the pressing part 24, and the moving operation can be performed easily.

  In the present embodiment, the holding portion 39 is formed in a bowl shape on the outer peripheral surface of the proximal end of the chemical liquid container 37 so as to reduce the gap between the outer peripheral surface and the inner peripheral surface of the outer cylinder 2. Yes. The holding portion 39 is formed integrally with the chemical solution container 37.

  Further, the seal member 38 seals between the holding portion 39 provided at the distal end of the chemical liquid container 37 and the outer cylinder 2 in an unused state, and holds the chemical liquid container 37 on the base end side of the outer cylinder 2. Therefore, it is fixed over the inner peripheral surface of the base end of the outer cylinder 2 facing the holding portion 39.

  The seal member 38 is brought into close contact with the side surface of the bowl-shaped holding part 39 formed with the chemical liquid container 37, whereby the gap between the inner peripheral surface of the outer cylinder 2 reduced by the holding part 39 and the outer peripheral surface of the chemical liquid container 37. Is completely sealed. In this embodiment, the chemical liquid container 37 is held on the proximal end side of the outer cylinder 2 by the elastic force of the seal member 38.

  As described above, the seal member 38 is provided between the holding portion 39 formed in the chemical liquid container 37 and the outer cylinder 2, so that the distal end of the chemical liquid container 37 is stably held on the proximal end side of the outer cylinder 2. In addition, the area surrounded by the inner peripheral surface of the outer cylinder 2 and the chemical solution container 37 is hermetically sealed. Also in the present embodiment example, in the unused state, the chemical solution container 37 is located at a position where the first sealing body 28 of the chemical solution container 37 does not puncture the second needle tip 11 on the proximal end side of the double-ended needle 10. Is retained.

[3-2 Usage]
When using the prefilled syringe 36 of the present embodiment, the protective member 19 is removed from the distal end side of the needle support portion 15 as in the second embodiment. Next, the second needle tip 11 on the distal end side of the double-ended needle 10 is inserted into a site to which a drug solution such as an arm is administered. Then, a finger is applied to the flange 32 of the pressing portion 24, and the pressing portion 24 is pressed in the distal direction, that is, moved. As a result, the holding portion 39 formed in the chemical liquid container 37 is detached from the seal member 38, and the chemical liquid container 37 moves to the front end side in the outer cylinder 2 in a non-resistance state. Then, the second needle tip 11 on the proximal end side of the double-ended needle 10 is pierced through the first sealing body 28 of the drug solution container 37 moved to the distal end side along the central axis in the outer cylinder 2, and FIG. As shown, it communicates with the inside of the chemical container 37. Thereby, the liquid passing through the double-ended needle 10 is completed.

  Thereafter, the drug solution is administered in the same manner as in the second embodiment.

  Also in the present embodiment, by pressing the pressing portion 24, the holding portion 39 and the chemical solution container 37 formed integrally with the holding portion 39 can be easily removed from the sealing member 38 to the distal end side. Further, the outer cylinder 2 is sized so that the inner peripheral surface of the outer cylinder 2 and the outer peripheral surface of the chemical liquid container 37 are in a substantially non-contact state when the chemical liquid container 37 moves inside the outer cylinder 2. The end surface of the seal member 38 and the outer peripheral surface of the chemical solution container 37 are separated from each other by the width reduced by the portion 39. For this reason, after the site | part in which the holding | maintenance part 39 of the chemical | medical solution container 37 was formed remove | deviated from the sealing member 38, the chemical | medical solution container 37 moves in the outer cylinder 2 in a substantially non-contact with the outer cylinder 2, Is done. That is, when the chemical liquid container 37 is moved, the chemical liquid container 37 does not slide inside the outer cylinder 2, and there is no resistance between the inner peripheral surface of the outer cylinder 2 and the outer peripheral surface of the chemical liquid container 37. .

  Thus, in the prefilled syringe 36 of the present embodiment example, if the holding part 39 formed integrally with the chemical liquid container 37 is detached from the seal member 38, the chemical liquid container 37 and the seal member 38 do not adhere to each other. The inside of the outer cylinder 2 can be moved in a substantially non-contact state. For this reason, it is not necessary to apply silicone between the chemical solution container 37 and the outer cylinder 2.

  In addition, the same effects as those of the first embodiment can be obtained.

In addition, also in the above-mentioned 1st Embodiment, it is also possible to combine the structure of the modification based on 2nd Embodiment, and a various change is possible.
As described above, according to the present invention, in the prefilled syringe that is used by moving the chemical liquid container in the outer cylinder, it is possible to realize silicone-less between the inner peripheral surface of the outer cylinder and the peripheral surface outside the chemical liquid container. Can do. Moreover, the prefilled syringe by which the double-ended needle and the chemical | medical solution container were hold | maintained previously is realizable.
Therefore, according to the present invention, it is possible to obtain a prefilled syringe capable of reducing the number of manufacturing steps by eliminating silicone, preventing waste of chemicals, and preparing preparations for administration of chemicals easily and quickly.

  DESCRIPTION OF SYMBOLS 1 ... Prefilled syringe, 2 ... Outer cylinder, 3 ... Chemical solution container, 3a ... Tip opening part, 4 ... Press part, 5 ... Bottom part, 6 ... Sealing body, 7 ... space, 8 ... holding portion, 9 ... sealing member, 10 ... double-ended needle, 11 ... second needle tip, 12 ... first needle tip, 12a ... -Blade surface, 13 ... Stabilizing part, 13a ... End face, 14 ... First vent hole, 15 ... Needle support part, 16 ... Guide part, 16a ... Contact surface, 17 ... Adjustment part, 17a ... Needle protruding surface, 18 ... Second vent hole, 19 ... Protective member, 20 ... Needle support body, 21 ... Prefilled syringe, 22. -Prefilled syringe, 23 ... opening, 24 ... pressing part, 25 ... main body, 26 ... chemical container storage, 27 ... chemical container, 28 ... first Sealing body, 29 ... second sealing body, 30 ... prefilled syringe, 31 ... locking claw, 32 ... flange, 33 ... stopper portion, 34 ... prefilled syringe, 35 ... elastic member, 36 ... prefilled syringe, 37 ... chemical container, 38 ... sealing member, 39 ... holding part, 40 ... fixing part

Claims (10)

An outer cylinder having a distal end and a proximal end;
A container having a distal end and a proximal end and having an outer diameter smaller than an inner diameter of the outer cylinder, the distal end having a distal end opening, and the distal end opening being sealed with a sealing body; The chemical solution is sealed inside the container, and the chemical solution container is movable in the axial direction inside the outer cylinder; and
A holding part disposed between the inner peripheral surface of the outer cylinder and the outer peripheral surface of the chemical liquid container, and fixed to the inner peripheral surface of the outer cylinder or the outer peripheral surface of the chemical liquid container;
In an initial state, the space between the holding portion and the outer peripheral surface of the chemical liquid container facing the holding portion or the inner peripheral surface of the outer cylinder is sealed, and the chemical liquid container is placed on the proximal end side of the outer cylinder And a sealing member provided fixed in the circumferential direction of the outer peripheral surface of the chemical solution container facing the holding portion or the inner peripheral surface of the outer cylinder,
A pressing portion for moving and operating the chemical container;
A double-ended needle having a needle tip capable of puncturing a living body at one end and an end portion capable of puncturing the sealing body at the other end;
A needle support portion provided on the distal end side of the outer cylinder and supporting the double-ended needle;
When the pressing portion is pressed in the distal direction, the sealing member is removed from the holding portion, whereby the holding of the chemical solution container held on the proximal end side of the outer cylinder in the initial state is released, and the chemical solution container is It moves in the distal direction with respect to the outer cylinder, the end of the double-ended needle penetrates the sealing body, and the chemical solution is discharged from the needle tip provided at one end of the double-ended needle. Prefilled syringe. An outer cylinder having a distal end and a proximal end;
A container having a distal end and a proximal end and having an outer diameter smaller than the inner diameter of the outer cylinder, wherein the inside of the container is sealed with a first sealing body and a second sealing body, and A chemical solution sealed inside the container sandwiched between the first sealing body and the second sealing body, and movable in the axial direction inside the outer cylinder; and
A holding part disposed between the inner peripheral surface of the outer cylinder and the outer peripheral surface of the chemical liquid container, and fixed to the inner peripheral surface of the outer cylinder or the outer peripheral surface of the chemical liquid container;
In an initial state, the space between the holding portion and the outer peripheral surface of the chemical liquid container facing the holding portion or the inner peripheral surface of the outer cylinder is sealed, and the chemical liquid container is placed on the proximal end side of the outer cylinder And a sealing member provided fixed in the circumferential direction of the outer peripheral surface of the chemical solution container facing the holding portion or the inner peripheral surface of the outer cylinder,
While operating to move the chemical solution container, a pressing unit for operating to move the second sealing body to the first sealing body side,
A double-ended needle having a needle tip capable of puncturing a living body at one end and an end portion capable of puncturing the first sealing body at the other end;
A needle support portion provided on the distal end side of the outer cylinder and supporting the double-ended needle;
When the pressing portion is pressed in the distal direction, the sealing member is removed from the holding portion, whereby the holding of the chemical solution container held on the proximal end side of the outer cylinder in the initial state is released, and the chemical solution container is It moves in the distal direction with respect to the outer cylinder, the end of the double-ended needle penetrates the sealing body, and the chemical solution is discharged from the needle tip provided at one end of the double-ended needle. Prefilled syringe. The prefilled syringe according to claim 1, further comprising a fixing portion for fixing a position of the sealing body with respect to the double-ended needle in a state where an end portion of the double-ended needle is punctured into the sealing body. The prefilled syringe according to claim 3, wherein the fixing portion is formed along an axial direction of the double-ended needle. The protective member which seals the space surrounding the needle point which can puncture the living body is detachably attached to the surface side of the needle support part which has the needle point which can puncture the living body. The prefilled syringe as described in any one of these. The prefilled syringe according to any one of claims 1 to 5, wherein an elastic member is provided around the other end of the double-ended needle. The prefilled syringe according to any one of claims 1 to 6, wherein the holding portion is provided in a bowl shape on an inner peripheral surface of the outer cylinder. The prefilled syringe according to claim 7, wherein an inner diameter of the holding part is formed larger than an outer diameter of the chemical liquid container, and the chemical liquid container is held by the outer cylinder by the holding part. The prefilled syringe according to any one of claims 1 to 6, wherein the holding portion is provided in a bowl shape on the outer peripheral surface of the chemical solution container. The prefilled syringe according to claim 9, wherein an outer diameter of the holding part is formed smaller than an inner diameter of the outer cylinder, and the chemical solution container is held by the outer cylinder by the holding part.

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