NEEDLELESS INJECTOR
20230218828 · 2023-07-13
Inventors
Cpc classification
A61M5/30
HUMAN NECESSITIES
A61M5/31511
HUMAN NECESSITIES
A61M5/2046
HUMAN NECESSITIES
International classification
A61M5/30
HUMAN NECESSITIES
A61M5/20
HUMAN NECESSITIES
Abstract
A needleless injector includes an injector main body, a housing part including an accommodating space in which an injection substance is accommodated, the housing part defining a flow path to enable the injection substance to be ejected to a target region through an ejection port, and an attachment part configured to attach the housing part to the injector main body. The attachment part attaches the housing part to the injector main body, with a distal end side outer surface of the housing part corresponding to an inner surface of the housing part on a distal end side, where a communication portion where the flow path is in communication with the accommodating space is located, pressed in a direction opposite to a movement direction of a pressurizing unit that pressurizes the injection substance toward the ejection port.
Claims
1. A needleless injector configured to eject an injection substance to a target region without using an injection needle, the needleless injector comprising: an injector main body; a housing part including an accommodating space in which the injection substance is accommodated, the housing part defining a flow path to enable the injection substance to be ejected to the target region through an ejection port; an attachment part configured to attach the housing part to the injector main body; a driving part that is provided in the injector main body and imparts ejection energy for ejecting the injection substance; and a pressurizing unit that is disposed to be movable in a direction toward the ejection port in a predetermined region that is provided to be located inside both the injector main body and the housing part, and pressurizes the injection substance accommodated in the accommodating space, upon being imparted with the ejection energy, wherein the attachment part attaches the housing part to the injector main body, with a distal end side outer surface of the housing part corresponding to an inner surface of the housing part on a distal end side, where a communication portion where the flow path is in communication with the accommodating space is located, pressed in a direction opposite to a movement direction of the pressurizing unit toward the ejection port.
2. The needleless injector according to claim 1, wherein the housing part includes a base end portion radially expanded in a radial direction and including a base end surface, a distal end portion including the distal end side outer surface, and a body portion that connects the base end portion and the distal end portion to each other, and the attachment part is fastened to the injector main body with the base end portion sandwiched between the attachment part and the injector main body, to attach the housing part to the injector main body with the base end surface of the housing part on a side opposite to a distal end surface of the housing part where the ejection port is provided, brought into contact with a predetermined end surface that is part of a surface of the injector main body intersecting the predetermined region, and with the distal end side outer surface of the housing part pressed.
3. The needleless injector according to claim 1, wherein the housing part includes a base end portion where the attachment part is fastened to the housing part, the base end portion including a base end surface, a distal end portion including the distal end side outer surface, and a body portion that connects the base end portion and the distal end portion to each other, the attachment part is fastened to the housing part to make the attachment part be in contact with and press the distal end side outer surface of the distal end portion, and the housing part is attached to the injector main body with the attachment part to which the housing part is fastened being fastened to the injector main body.
4. The needleless injector according to claim 2, wherein the distal end portion includes a protruding portion that includes part of the flow path on a side of the ejection port; and a tapered portion that connects the protruding portion and the body portion to each other and includes the distal end side outer surface inclined with respect to a center axis along a longitudinal direction of the injector main body, and the attachment part has an opening formed, through which the protruding portion passes, to open the ejection port, and includes a contact portion that comes into contact with a region having a predetermined width from a connection portion where the tapered portion and the body portion are connected to each other in the distal end side outer surface.
5. The needleless injector according to claim 4, wherein a ratio of an area of the opening to a cross-sectional area of the body portion is from 0.10 to 0.74.
6. The needleless injector according to claim 1, wherein tensile strength of the attachment part is not lower than tensile strength of the housing part.
Description
BRIEF DESCRIPTION OF DRAWINGS
[0020]
[0021]
[0022]
[0023]
[0024]
[0025]
[0026]
[0027]
DESCRIPTION OF EMBODIMENTS
[0028] With reference to the drawings, a needleless injector 1 (hereinafter, simply referred to as “injector 1”) without an injection needle is described as an example of an administration device of the disclosure of the present application. Note that each of the configurations, combinations thereof, and the like in each embodiment described in the present application is an example, and additions, omissions, substitutions, and other changes of the configuration may be made as appropriate without departing from the spirit of the present invention. The present disclosure is not limited by the embodiment, but only by the claims.
First Embodiment
[0029] The injector 1 is a needleless injector that injects an ejection solution, which corresponds to an injection substance of the present application, into a target region, using the combustion energy of an explosive. In other words, the injector 1 is a device that injects the ejection solution into the target region without using an injection needle. Note that, in the present embodiment, as terms indicating a relative positional relationship in a longitudinal direction of the injector 1, “distal end side” and “base end side” are used. The “distal end side” indicates a side closer to the distal end of the injector 1 described below, that is, a position closer to an ejection port 77, and the “base end side” indicates a side in an opposite direction to the “distal end side” in a longitudinal direction of the injector 1, that is, a direction to an igniter 22 side of an actuator 20.
[0030] Here,
[0031] For example, examples of the predetermined substance included in the ejection solution include an organism-derived substance and a substance with a desired bioactivity, which can be ejected to the target region being an organism. For example, examples of the organism-derived substance include DNA, RNA, a nucleic acid, an antibody, and a cell. Examples of the substance with a desired bioactivity include various substances exerting pharmacological or therapeutic effects, which are exemplified by medicines composed of low molecular compounds, proteins, peptides, or the like, a vaccine, an inorganic substance such as metal particles for thermotherapy or radiotherapy, and a carrying body functioning as a carrier. Further, the liquid being the medium of the ejection solution is only required to be a substance suitable for administering the predetermined substance exemplified by those substances to the target region, and may be aqueous or oleaginous, which is not limited. Further, viscosity of the liquid being the medium is not particularly limited as long as the predetermined substance can be ejected by the injector 1.
[0032] In the injector 1, the igniter 22 is actuated upon by being supplied with ignition current from an external power source, to make the injector 1 inject the ejection solution. The ignition current may be supplied to the igniter 22, under various modes. For example, the power actuating the igniter 22 may be supplied from the outside through a power cable not illustrated. Alternatively, a battery for supplying the power may be provided inside the actuator 20.
[0033] Now, the actuator 20 will be described based on
[0034] Herein, combustion energy used in the igniter 22 for the ignition charge 22a is energy for the injector 1 to eject the ejection solution to the target region. Note that, examples of the ignition charge include an explosive containing zirconium and potassium perchlorate (ZPP), an explosive containing titanium hydride and potassium perchlorate (THPP), an explosive containing titanium and potassium perchlorate (TiPP), an explosive containing aluminum and potassium perchlorate (APP), an explosive containing aluminum and bismuth oxide (ABO), an explosive containing aluminum and molybdenum oxide (AMO), an explosive containing aluminum and copper oxide (ACO), an explosive containing aluminum and iron oxide (AFO), or an explosive composed of a combination of a plurality of these explosives. These explosives exhibit characteristics that, although the explosives generate high-temperature and high-pressure plasma during combustion immediately after ignition, when the combustion product condenses at room temperature, the explosives do not contain gaseous components and hence the pressure generated decreases abruptly. An explosive other than these may be used as the ignition charge as long as appropriate ejection of the ejection solution can be performed.
[0035] The internal space of the center portion 21a of the body 21 serves as a combustion chamber 20a into which a combustion product is discharged from the igniter 22. Furthermore, a male thread portion 26 is formed in a part of the outer surface of the center portion 21a. The male thread portion 26 is configured to mate with a female thread portion 32 of the attachment 30. The effective lengths of the male thread portion 26 and the female thread portion 32 are determined to secure sufficient fastening force therebetween. The internal space of the distal end portion 21b adjacent to the center portion 21a is formed in a cylindrical shape in which a piston 40 is slidably provided and O rings 25 serving as a sealing member are also provided. In a state where the piston 40 is disposed in the internal space of the distal end portion 21b before the actuation of the actuator 20, a flange surface on the base end side of the piston 40, which serves as a surface receiving pressure of the combustion product from the igniter 22, is exposed on the combustion chamber 20a side, and the distal end of the piston 40 is accommodated in the opening portion 27.
[0036] Then, when the igniter 22 is actuated and the combustion product is discharged into the combustion chamber 20a and thus the pressure therein rises, the flange surface on the base end side of the piston 40 receives the pressure, resulting in the piston 40 sliding toward the distal end side. Thus, the actuator 20 has a mechanism with the igniter 22 serving as an actuation source and the piston 40 serving as an output unit. Since the radially expanded flange surface of the piston 40 has a larger diameter than the opening portion 27, the distance by which the piston 40 can slide is limited. Thus, the distance by which the piston 40 can protrude from the distal end surface of the distal end portion 21b of the body 21 is limited. The piston 40 may be formed of a resin, and in such a case, metal may be used together for a part where heat resistance and pressure resistance are required.
[0037] Additionally, as an alternative mechanism to adjust the pressure applied to the piston 40, the combustion chamber 20a of the actuator 20 may be further provided with a gas generating agent that is burned by the combustion product from the igniter 22 to produce gas. The agent may be disposed, for example, at a location that may be exposed to the combustion product from the igniter 22. Further, as another method, the gas generating agent may be disposed in the igniter 22 as disclosed in WO 01-031282, JP 2003-25950 A, and the like. As one example of the gas generating agent, there may be exemplified a single base smokeless explosive formed of 98 mass % of nitrocellulose, 0.8 mass % of diphenylamine, and 1.2 mass % of potassium sulfate. Further, various types of gas generating agents used in a gas generator for an air bag and a gas generator for a seat belt pretensioner may be used. A combustion completion time period of the gas generating agent can be changed by adjusting a dimension, a size, a shape, and particularly, a surface shape of the gas generating agent at the time of being disposed in the combustion chamber 20a or the like. With this, the pressure applied to the piston 40 can be adjusted to a desired pressure.
[0038] Next, the attachment 30 will be described based on
[0039] The internal space of the body 31 includes a first region 33, extending from the base end side to the center, where the actuator 20 is disposed as illustrated in
[0040] Furthermore, in the internal space of the body 31, a second region 34 that is in communication with the first region 33 is formed. The second region 34 is a region in which the plunger 80 is generally disposed as illustrated in
[0041] The internal space of the body 31 further includes a third region 35 in communication with the second region 34. The third region 35 is a region in which a part of the container 70 is generally disposed as illustrated in
[0042] Next, attachment of the container 70 to the attachment 30 using the container holder 71 will be described based on
[0043] The container 70 includes an accommodating space 75 that is formed to enable the stopper portion 60 of the plunger 80 to be movable therein, and to accommodate the ejection solution, and a flow path 76 connecting the accommodating space 75 to the ejection port 77 facing the outside of the container 70. Specifically, the container 70 includes a body portion 70a having a hollow cylindrical shape defining the accommodating space 75, a base end portion 70b radially expanded to have a diameter larger than that of the body portion 70a and connected to the base end side of the body portion 70a; and a distal end portion 70c that is connected to the distal end side of the body portion 70a and defines the flow path 76. In addition, the distal end portion 70c is configured to include a protruding portion 70c2 including a part of the flow path 76 on the ejection port 77 side, and a tapered portion 70c1 that connects the protruding portion 70c2 and the body portion 70a to each other and includes a distal end side outer surface 70c3 inclined with respect to a center axis in the longitudinal direction of the attachment 30. The protruding portion 70c2 is formed to have a columnar outer circumference. The distal end side outer surface 70c3 that is the outer surface of the tapered portion 70c1 corresponding to the inner surface 75a on the distal end side of the container 70 where a communication portion at which the flow path 76 is in communication with the accommodating space 75 is located, is located more on the distal end side than the accommodating space 75 in the longitudinal direction of the attachment 30.
[0044] The container 70 itself thus formed does not have a male thread portion mating with the female thread portion 36 formed in the wall portion 38 of the attachment 30. Thus, the attachment of the container 70 to the attachment 30 is implemented using the container holder 71. The container holder 71 includes a body portion 71a defining a space incorporating the container 70, a mating portion 71b that has a male thread that mates with the female thread portion 36 formed, and is connected to the base end side of the body portion 71a, and a contact portion 71c that is connected to the distal end side of the body portion 71a, and has an inner surface 71c1 (see
[0045] The container 70 is accommodated with the protruding portion 70c2 passing through the opening 71c2 of the container holder 71 having such a configuration. At this time, the container 70 is in a state in which the accommodating space 75 is filled with the injection substance and the plunger 80 is loaded. In this accommodated state, the distal end side outer surface 70c3 of the container 70 and the inner surface 71c1 of the container holder 71 are in surface contact with each other on the distal end side, and the base end portion 70b of the container 70 and the mating portion 71b of the container holder 71 are in contact with each other on the base end side. While the container 70 is accommodated in the container holder 71, the male thread formed in the mating portion 71b of the container holder 71 and the female thread portion 36 of the attachment 30 are mated, until the base end side end surface of the base end portion 70b of the container 70 comes into contact with the end surface 35a of the third region 35 of the attachment 30. As a result, with the fastening force produced by the mating, the container 70 is attached to the attachment 30 with the distal end side outer surface 70c3 of the container 70 pressed by the container holder 71 from the distal end side toward the base end side, that is, in a direction opposite to the movement direction of the plunger 80. In this state, the plunger 80 is in a state of being located inside both the accommodating space 75 in the container 70 and in the second region 34 in the attachment 30.
[0046] The state illustrated in
[0047] Note that the profile on the distal end side of the stopper portion 60 of the plunger 80 is shaped to generally match the profile of the inner surface 75a near a portion where the accommodating space 75 and the flow path 76 are connected to each other (the deepest part of the accommodating space 75). With this configuration, a smallest possible gap can be formed between the stopper portion 60 and the inner surface 75a of the container 70 when the plunger 80 slides when ejecting the ejection solution and reaches the deepest part of the accommodating space 75, whereby the ejection solution can be prevented from wastefully remaining in the accommodating space 75. However, the shape of the stopper portion 60 is not limited to a particular shape as long as desired effects can be obtained with the injector 1 according to the present embodiment.
[0048] When the ejection solution is thus injected, the ejection solution is pressurized by the plunger 80 within an extremely short period of time, meaning that the container 70 receives a relatively large load. However, according to the attachment mode of the container 70 according to the present embodiment, the end surface of the base end portion 70b is in surface contact with and thus is supported on the end surface 35a of the attachment 30, and the distal end side outer surface 70c3 of the distal end portion 70c is in surface contact with and is pressed and supported on the inner surface 71c1 of the container holder 71. Thus, the initial deformation of the container 70 (deformation along the movement direction of the plunger 80) can be suppressed, whereby damage or the like to the container 70 can be reliably prevented.
[0049] For the sake of suppression of the initial deformation of the container 70, the tensile strength of the material forming the container holder 71 is preferably not lower than the tensile strength of the material forming the container 70. The tensile strength is a parameter indicating the breaking strength unique to a material, which is obtained through a tensile test according to a predetermined standard such as JIS.
Variation
[0050] A variation of the present embodiment, related to the relationship between the container 70 and the container holder 71 in the injector 1 of the disclosure of the present application will be described based on
Second Embodiment
[0051] Attachment of the container 70 to the attachment 30 using the container holder 71 according to a second embodiment will be described based on
[0052] Specifically, the container 70 illustrated in
[0053] Also in the present embodiment, the container 70 is accommodated in the container holder 71, with the protruding portion 70c2 of the container 70 passing through the opening provided in the container holder 71. Here, the male thread portion 70f of the container 70 and the female thread of the mating portion 71d of the container holder 71 are mated and fastened to each other. Thus, the container 70 and the container holder 71 are integrated, in a state where the distal end side outer surface 70c3 of the container 70 is in contact with and presses against the inner surface 71c1 of the contact portion 71c of the container holder 71. Here, the plunger 80 is incorporated in the container 70, in a state where the stopper portion 60 is accommodated in the container 70. With this state maintained, the male thread of the mating portion 71d of the container holder 71 and the female thread portion 36 of the attachment 30 are mated. As result, the container 70 is attached to the attachment 30 with the distal end side outer surface 70c3 of the container 70 pressed from the distal end side toward the base end side by the container holder 71, that is, in a direction opposite to the movement direction of the plunger 80.
[0054] Also in such an attachment mode of the container 70, the distal end side outer surface 70c3 of the distal end portion 70c is in surface contact with, and thus is pressed and supported on the inner surface 71c1 of the container holder 71. Thus, the initial deformation of the container 70 at the time of actuation of the igniter 22 can be suppressed, whereby damage or the like to the container 70 can be reliably avoided. Also in the present embodiment, the contact portion 71c of the container holder 71 is formed to be in contact with part of the distal end side outer surface 70c3 of the container 70 as illustrated in
Variation
[0055] A variation of the present embodiment related to the shape of the container holder 71 will be described based on
[0056] In the present variation, the body portion 710a of the container holder 71 defines a space incorporating the container 70, with no contact between the inner surface of the body portion 710a and the outer surface of the body portion 70a of the container 70, and with a predetermined gap formed therebetween. The contact portion 710c is formed to be in contact with a predetermined region that is part of the distal end side outer surface 70c3 of the container 70, that is, a region of a predetermined width not covering the entirety of the distal end side outer surface 70c3 from the connection portion between the body portion 70a and the distal end portion 70c.
[0057] Also in such an attachment mode of the container 70 using the container holder 71, the distal end side outer surface 70c3 of the distal end portion 70c is in surface contact with, and thus is pressed and supported on the inner surface of the container holder 710c. Thus, the initial deformation of the container 70 at the time of actuation of the igniter 22 can be suppressed, whereby damage or the like to the container 70 can be reliably avoided.
EXAMPLES
[0058] Now, a description will be given on a specific dimensional relationship between the container 70 and the container holder 71, for favorably suppressing the initial deformation of the container 70. The cross-sectional area A1 of the body portion 70a is an important parameter regarding the container 70. The area A2 of the opening 71c2 is an important parameter regarding the container holder 71. The inventor of the invention according to the present application has found that the initial deformation of the container 70 is favorably suppressed, when a ratio of the area A2 to the cross-sectional area A1 (hereinafter, referred to as “area ratio A2/A1”) is within a predetermined range.
[0059] Specifically, the area ratio A2/A1 is preferably a numerical value that falls within a range of from 0.10 to 0.74. Preferably, the area ratio A2/A1 is a numerical value that falls within a range of from 0.15 to 0.67. On the other hand, it has been further found that, when only the side surface of the body portion 71a of the container 70 is reinforced by the container holder 71 without pressing and reinforcing the distal end side outer surface 70c3 of the container 70 as in a known technique, that is, when the area ratio A2/A1 is approximately 1 with the container holder 71 not being provided with the inner surface 71c1, it is difficult to sufficiently suppress damage or the like to the container 70.
[0060] Each aspect disclosed in the specification of the present application can be combined with any other feature disclosed herein.
REFERENCE SIGNS LIST
[0061] 1 Injector (needleless injector) [0062] 20 Actuator [0063] 22 Igniter [0064] 30 Attachment [0065] 33 First region [0066] 34 Second region [0067] 35 Third region [0068] 35a End surface [0069] 40 Piston [0070] 70 Container [0071] 70a Body portion [0072] 70b Base end portion [0073] 70c Distal end portion [0074] 70c1 Tapered portion [0075] 70c2 Protruding portion [0076] 70c3 Distal end side outer surface [0077] 70e Base end portion [0078] 70f Male thread portion [0079] 71 Container holder [0080] 71a Body portion [0081] 71b Mating portion [0082] 71c Contact portion [0083] 71c2 Opening [0084] 71d Mating portion [0085] 710a Body portion [0086] 710c Contact portion [0087] 75 Accommodating space [0088] 76 Flow path [0089] 77 Ejection port [0090] 80 Plunger