NEEDLELESS INJECTOR
20220062555 · 2022-03-03
Assignee
Inventors
Cpc classification
A61M5/3137
HUMAN NECESSITIES
A61M5/3007
HUMAN NECESSITIES
A61M5/2053
HUMAN NECESSITIES
A61M5/30
HUMAN NECESSITIES
A61M5/2046
HUMAN NECESSITIES
International classification
A61M5/30
HUMAN NECESSITIES
A61M5/20
HUMAN NECESSITIES
Abstract
A needleless injector includes a first switch and a second switch that is provided to an injector enclosure for activation of a driving part. The first switch is arranged to be slidable in a predetermined direction different from a contact direction of a palm of the user, in a first region on a side surface that is a part of a surface of the injector enclosure positioned on side of the user, the first region being covered by the palm of the user in a holding state of the user, and the second switch has an upper side surface with at least a part inclined toward the side of the user to be visible from the user in a holding state of the user, and is arranged on an upper side of the injector enclosure to be able to be pressed.
Claims
1. A needleless injector that ejects an intended injection substance to a target region without using an injection needle, the needleless injector comprising: a housing part that includes an accommodating space in which the intended injection substance is accommodated, and defines a flow path through which the intended injection substance is ejected to the target region; a driving part that imparts an ejection energy for ejecting the intended injection substance; a pressurizing unit that, upon being imparted with the ejection energy, pressurizes the intended injection substance accommodated in the accommodating space; an injector enclosure that has a tubular shape, incorporates at least one of the housing part, the driving part, or the pressurizing unit, and is configured to be capable of being held by one hand of a user; a first switch and a second switch for activation of the driving part, the first switch and the second switch being provided to the injector enclosure; and a control unit, that controls the activation of the driving part, via a predetermined operation on the first switch and the second switch, wherein the first switch is arranged to be slidabie in a predetermined direction different from a contact direction of a palm of the user, in a first region on a side surface that is a part of a surface of the injector enclosure positioned on side of the user, the first region being covered by the palm of the user in a holding state of the user, and the second switch has an upper side surface with at least a part inclined toward the side of the user to be visible from the user in a holding state of the user, and is arranged on an upper side of the injector enclosure to be able to be pressed.
2. The needleless injector according to claim 1, wherein the second switch is arranged in a second region in the upper side surface of the injector enclosure, the second region being configured to be inclined similarly to the at least a part of the upper side surface of the second switch, toward the side of the user.
3. The needleless injector according to claim 2, wherein the second switch in the second region is arranged on a virtual straight line that is an extension, along the surface of the injector enclosure, of a slide straight line of the first switch along the predetermined direction, or in vicinity of the virtual straight line.
4. The needleless injector according to claim 1, wherein the control unit is configured to activate the driving part in response to a predetermined pressing operation on the second switch performed after a predetermined sliding operation on the first switch by the user.
5. The needleless injector according to claim 4, wherein the predetermined sliding operation is an operation of sliding the first switch in the predetermined direction and maintaining the sliding state for a predetermined period of time.
6. The needleless injector according to claim 1, wherein the driving part is an ignition device that generates the ejection energy through combustion of an ignition charge upon being supplied with ignition current, a power cable for supplying the ignition current from a power supply to the ignition device extends from the injector enclosure, and the injector enclosure is configured to have the power cable extending toward a direction away from the user in a holding state of the user with the first switch facing toward the user.
7. The needleless injector according to claim 6, wherein the injector enclosure has a side surface, on a side opposite to the first switch with the second switch provided in between, provided with a connector to which the power cable is connected, and the connector is attached to the injector enclosure to make the power cable extend along an inclined surface defined by the at least a part of the upper side surface of the second switch.
8. The needleless injector according to claim 7, wherein the connector is configured to enable the power cable to be detachably attached.
Description
BRIEF DESCRIPTION OF DRAWINGS
[0024]
[0025]
[0026]
[0027]
[0028]
[0029]
[0030]
[0031]
[0032]
[0033]
[0034]
DESCRIPTION OF EMBODIMENTS
[0035] With reference to the drawings, a needleless injector 1 according to an embodiment of the present disclosure (herein, simply referred to as “injector”) is described below. The injector 1 is a needleless injector that implements injection by ejecting an ejection solution, which corresponds to an intended injection substance in the present application, to a target region through use of a combustion energy of an explosive, that is, a device that injects the ejection solution to the target region without using an injection needle.
[0036] Note that each of the configurations, combinations thereof, and the like in each embodiment are an example, and various additions, omissions, substitutions, and other changes may be made as appropriate without departing from the spirit of the present disclosure. The present disclosure is not limited by the embodiments and is limited only by the claims. 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 later, 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 injector assembly 10 (see
Configuration of Injector 1
[0037] Here,
[0038] Note that, in the following description in the present application, the ejection solution ejected to the target region by the injector 1 is formed of a liquid medium including a predetermined substance, which exerts an effect or a function expected in the target region. In the ejection solution, the predetermined substance may be in a state of being dissolved in liquid being a medium, or may be in a state of being simply mixed, rather than being dissolved.
[0039] 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 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 as the medium of the ejection solution is only required to be a substance suitable for administering the predetermined substance as exemplified above to the target region, and may be aqueous or oleaginous, which is not limited. Further, viscosity of the liquid as the medium is not particularly limited as long as the predetermined substance can be ejected by the injector 1.
[0040] In the injector 1, the injector assembly 10 is freely attachable to and detachable from the housing 2. An accommodating space 75 (see
[0041] On the other hand, the housing 2 has a grip portion 2a formed to be gripped by a user of the injector 1 in use, and is provided with a plurality of switches for operating the injector 1 to eject the ejection solution. Note that the injector 1 is configured to be capable of being held and operated by one hand of the user. In this context, the housing 2 will be described with reference to
[0042] Considering such a way of holding by the user, the grip portion 2a is provided at a front side portion of the housing 2 such that the user can easily rest user's fingertips thereon. The grip portion 2a is provided with a plurality of dimples, making the user's fingertips even easier to be rested thereon. Furthermore, the grip portion 2a has gentle recesses and protrusions on the front side of its outer shell (see (b) in
[0043] Further, the housing 2 is provided with a first switch 5 and a second switch 6 that are two operating switches for operating the injector 1. The first switch 5 and the second switch 6 are connected to a control unit 90, formed by a microcomputer. The control unit 90 controls the supply of ignition current to the igniter 22 based on a signal transmitted from each switch, thereby controlling an operation of the injector 1. The first switch 5 is a sliding switch provided in a first region R1 in a side surface on the back side of the housing 2, the sliding direction of which being an upward and downward direction of the housing 2 (direction between the distal end and the base end, as indicated by a white arrow in
[0044] The first switch 5 is constantly biased in the upward direction. When the user continuously slides the first switch 5 downward (toward the distal end side) for a predetermined period of time against the biasing force, the control unit 90 detects the sliding state of the first switch 5 and can place the injector 1 in a standby state. The standby state is a state in which preparation for the injector 1 to eject the ejection solution has been completed. When a user makes an additional operation (an operation on the second switch 6 described later) in this state, the ejection is implemented. The first switch 5 configured as described above is an operation switch for placing the injector 1 in the standby state. The contact direction of the palm of the user to hold the housing 2 is different from the operation direction of the first switch 5. Thus, the first switch 5 can be prevented from receiving an unintentional sliding operation by the user who holds the housing 2.
[0045] The second switch 6 is a pressing switch provided in a second region R2 including an inclined surface 2b on the upper side of the housing 2. The user can press the second switch 6 in a direction toward the inner side of the housing 2. The second region R2 is a region that is exposed without being covered by the palm of the user who holds the housing 2. The second switch 6 has an upper side surface inclined toward the side of the user, together with the inclined surface 2b in the second region R2. Alternatively, the upper side surface of the housing 2 may form the inclined surface without the upper side surface of the second switch 6 inclining. When at least the upper side surface of the second switch 6 thus forms the inclined surface, the user who holds the housing 2 with one hand can more easily visually recognize the upper side surface, which may be the pressing portion of the second switch 6, and can perform the pressing operation on the second switch 6 in a natural holding state. The upper side surface of the second switch 6 is thus more easily recognizable by the user and the second switch 6 is thus able to be pressed in the natural holding state, which enables the user to stably operate the injector 1 while clearly recognizing the presence of the second switch such that erroneous operation can be prevented, and thus leads to more reproducible administration.
[0046] As described above, the control unit 90 supplies an ignition current to the igniter 22 in response to the pressing operation on the second switch 6 while the injector 1 is in the standby state as a result of the operation on the first switch 5 described above. As a result, the injector 1 ejects the ejection solution. In view of this, the second switch 6 may be regarded as the operation switch of the injector 1 for determining the ejection of the ejection solution. Thus, the configuration in which the upper side surface of the second switch 6 is formed by an inclined surface to be more visible to the user as described above may be regarded as an extremely effective configuration in terms of stable operation of the injector 1.
[0047] Now, a relative positional relationship between the first switch 5 and the second switch 6 will be described. As illustrated in
[0048] A connector 4 to which the power cable 3 is connected is provided on the front side of the inclined surface 2b on the upper side surface of the housing 2. In the present embodiment, the connector 4 is a USB connector, and the power cable 3 is freely attachable to and detachable the housing 2. Alternatively, the power cable 3 may be a cable that is not detachable from the housing 2.
[0049] As illustrated in
[0050] Note that, as described above, in the present embodiment, the power for actuating the igniter 22 is supplied from the outside through the power cable 3. Alternatively, a battery for supplying such power may be provided inside the housing 2. In this case, the housing 2 can be repeatedly used while replacing the injector assembly 10, until the battery runs out. When the battery runs out, the battery may be replaced.
[0051] A schematic configuration of the injector assembly 10 is illustrated in
[0052] First of all, the actuator 20 will be described with reference to
[0053] Herein, a combustion energy used in the igniter 22 for the ignition charge is an 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.
[0054] 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 described below. The effective lengths of the male thread portion 26 and the female thread portion 32 are determined to guarantee sufficient coupling 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. The piston 40 is made of metal, has a shaft member 41, is provided with a first flange 42 on the base end side thereof, and is further provided with a second flange 43 in the vicinity of the first flange 42, as illustrated in
[0055] Then, when the igniter 22 is activated and the combustion product is discharged into the combustion chamber 20a and thus the pressure therein rises, the first flange 42 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 second flange 43 has a larger diameter than the opening 27, the distance by which the piston 40 can slide is limited. Thus, the distance by which the shaft member 41 of the piston 40 can protrude from the distal end surface of the distal end portion 21b of the body 21 is limited. Further, the piston 40 may be formed of a resin, and in such case, metal may be used together for a part to which heat resistance and pressure resistance are required.
[0056] 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.
[0057] Next, the attachment 30 will be described based on
[0058] 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
[0059] The internal space of the body 31 further includes a second region 34 in communication with the first region 33. The second region 34 is a region in which the plunger 80 is generally disposed as illustrated in
[0060] 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
[0061] Next, the plunger 80 will be described based on
[0062] Further, in the plunger rod 50, a protrusion 56 is provided to a distal end side of the shaft member 51 with a neck portion 55 with a smaller diameter than the shaft member 51 provided in between. The protrusion 56 is shaped like a weight to have a diameter being greater than the diameter of the neck portion 55 near a portion to be connected with the neck portion 55 and reducing toward the distal end side. The maximum diameter of the protrusion 56 is smaller than the diameter of the shaft member 51. A stopper portion 60 formed of an elastic member such as rubber is attached to the neck portion 55 and the protrusion 56, whereby the plunger 80 is formed (see
[0063] Specific examples of materials of the stopper portion 60 include butyl rubber and silicon rubber. Further, there may be exemplified a styrene-based elastomer or a hydrogenated styrene-based elastomer, or a substance obtained by mixing a styrene-based elastomer or a hydrogenated styrene-based elastomer with polyolefin such as polyethylene, polypropylene, polybutene, and an a-olefin copolymer, oil such as liquid paraffin and process oil, or a powder inorganic substance such as talc, cast, and mica. Further, as the material of the stopper portion 60, a polyvinyl chloride-based elastomer, an olefin-based elastomer, a polyester-based elastomer, a polyamide-based elastomer, a polyurethane-based elastomer, various rubber materials (particularly, a vulcanized material) such as natural rubber, isoprene rubber, chloroprene rubber, nitrile butadiene rubber, and styrene butadiene rubber, or a mixture thereof may be employed. Furthermore, the stopper portion 60 pressurizes the ejection solution by sliding within the container 70 described below. Thus, a surface of the stopper portion 60 and an inner wall surface 75a of the accommodating space 75 of the container 70 may be coated or processed using various matters, to guarantee/adjust slidability between the stopper portion 60 and the inner wall surface 75a of the accommodating space 75 of the container 70. Examples of the coating agent may include polytetrafluoroethylene (PTFE), silicon oil, diamond-like carbon, nano diamond, and the like.
[0064] Next, the container 70 will be described based on
[0065] The container 70 includes an accommodating space 75, in which the stopper portion 60 of the plunger 80 are movable, accommodating the ejection solution, and a nozzle portion 71 including a flow path 76 connecting the accommodating space 75 to the outside of the container 70. The nozzle portion 71 has a columnar outer circumference on the distal end side. Note that in the injector assembly 10, as illustrated in
[0066] The flow path 76 provided in the container 70 has a diameter smaller than the inner diameter of the accommodating space 75. With this configuration, the ejection solution that has been applied with a high pressure is ejected to the outside through the ejection port 77. The male thread portion 74 for attaching the container 70 to the attachment 30 is formed on the base end side of the container 70. The male thread portion 74 is screwed with the female thread portion 36 of the attachment 30.
[0067] Note that the profile on the distal end side of the stopper portion 60 of the plunger 80 is shaped to substantially match the profile of the inner wall 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 wall surface 75a of the container 70 when the plunger 80 slides for 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.
[0068] Now, how the injector assembly 10 is assembled will be described. In a state where the stopper portion 60 of the plunger 80 is inserted to the deepest part of the accommodating space 75 of the container 70, the plunger 80 is retracted with the ejection port 77 of the container 70 in communication with the ejection solution. The stopper portion 60 and the inner wall surface 75a of the accommodating space 75 are suitably in close contact with each other, the retraction action will produce negative pressure in the accommodating space. Thus, the accommodating space 75 can be filled with the ejection solution through the ejection port 77. In this process, the plunger 80 is retracted to an extent enough for making the part of the plunger 80 (plunger rod 50) protruding from the container 70 pass through the second region 34 to reach the first region 33 (the region 33b illustrated in
[0069] After the container 70 filled with ejection solution in the accommodating space 75 is attached to the attachment 30, the actuator 20 is inserted to the attachment 30 from the side of the first region 33. The actuator 20 is inserted until the distal end surface of its distal end portion 21b comes into contact with a distal end surface 33c of the region 33b of the attachment 30 (see
[0070] Thus, when the actuator 20 is attached to the attachment 30 to which the container 70 and plunger 80 are attached as described above, the plunger 80 is pushed to move from the piston 40 toward the distal end side, whereby the plunger 80 is positioned at a predetermined position within the container 70. Note that, in response to pressing of the plunger 80, a part of the ejection solution is discharged from the ejection port 77.
[0071] When the plunger 80 is thus positioned at the final position as described above, formation of the injector assembly 10 is completed. In this injector assembly 10, the position of the stopper portion 60 of the plunger 80 in the accommodating space 75 of the container 70 is mechanically determined. The final position of the stopper portion 60 is a position uniquely determined in the injector assembly 10, and hence an amount of the ejection solution that is finally stored in the accommodating space 75 in the injector assembly 10 can be a predetermined amount determined in advance.
[0072] The injector assembly 10 thus configured can be loaded into the housing 2 with the ignition pin 22b of the igniter 22 fitted into the socket 7 on the housing 2, whereby the injector 1 is prepared to be usable (see
[0073] Then, in S104, the control unit 90 places the injector 1 in the standby state. In this process, the injector 1 may issue a predetermined notification with an indicator or the like using sound or an LED, and the user can recognize the standby state of the injector 1. The user then presses the second switch 6 with the ejection port 77 being in contact with the target region (process in S105). As a result, the igniter 22 is activated, and the ejection solution is pressurized via the piston 40 and the plunger 80. Thus, the ejection is implemented, and the ejection solution is injected into the target region (process in S106).
[0074] As described above, in the injector 1, the control unit 90 receives operations by the user, different from each other in content, on the first switch 5 and the second switch 6, determines whether the operation is appropriate, and controls the activation of the igniter 22. Furthermore, the switches are configured such that in a series of operations in the injector 1 for ejection of the ejection solution, an erroneous operation on the first switch 5 while the housing 2 is being held can be suppressed, and the second switch 6 is easily recognizable. Thus, the improvement in the safety and the stable operation of the injector 1 can both be favorably achieved.
[0075] Each aspect disclosed in the present specification can be combined with any other feature disclosed herein.
REFERENCE SIGNS LIST
[0076] 1 Injector [0077] 2 Housing [0078] 2a Grip portion [0079] 3 Power cable [0080] 4 Connector [0081] 5 First switch [0082] 6 Second switch [0083] 10 Injector assembly [0084] 20 Actuator [0085] 21 Body [0086] 22 Igniter [0087] 30 Attachment [0088] 31 Body [0089] 40 Piston [0090] 50 Plunger rod [0091] 51 Shaft member [0092] 52 Reduced diameter portion [0093] 60 Stopper portion [0094] 70 Container [0095] 71 Nozzle portion [0096] 75 Accommodating space [0097] 76 Flow path [0098] 77 Ejection port [0099] 80 Plunger [0100] 90 Control unit