NEEDLELESS INJECTION APPARATUS
20170340822 · 2017-11-30
Inventors
Cpc classification
A61M2005/2013
HUMAN NECESSITIES
A61M5/34
HUMAN NECESSITIES
A61M5/2053
HUMAN NECESSITIES
A61M5/30
HUMAN NECESSITIES
International classification
A61M5/30
HUMAN NECESSITIES
A61M5/20
HUMAN NECESSITIES
Abstract
A needleless injection apparatus is provided which forms a suitable contact state between an injection opening and an injection object. The needleless injection apparatus is provided with an expansible bag body, a needleless syringe including no injection needle, and a gas supply unit for supplying the expansion gas to the bag body. Here, the needleless syringe has a nozzle portion for injecting an injection objective substance toward the injection object surrounded by the bag body. Then, the bag body includes a first bag portion arranged at any of locations except an arrangement location of the needleless syringe so as to pressurize the injection object by expansion, and a second bag portion arranged at a location at which the nozzle portion is sandwiched between the second bag portion and the injection object so as to push the injection opening to an injection object side by expansion.
Claims
1. A needleless injection apparatus comprising: an expansible bag body that is adapted to be arranged so as to surround an outer peripheral surface of an injection object; a needleless syringe including no injection needle that comprises a nozzle portion for injecting an injection objective substance in said needleless syringe toward said injection object surrounded by said bag body, said nozzle portion including an injection opening which is in a state opposed to said injection object when said bag body is mounted on said injection object; and a gas supply unit that supplies an expansion gas to said bag body, wherein said bag body includes: a first bag portion that is a bag portion adapted to expand by said expansion gas from said gas supply unit, said first bag portion being arranged at any of locations in said bag body except an arrangement location of said needleless syringe, in such a manner as to pressurize said injection object by expansion thereof; and a second bag portion that is a bag portion adapted to expand by said expansion gas from said gas supply unit, and is formed separately from said first bag portion, said second bag portion being arranged at a location at which said nozzle portion is sandwiched between said second bag portion and said injection object, in such a manner as to push said injection opening toward said injection object by expansion thereof.
2. The needleless injection apparatus according to claim 1, further comprising: a pressure detection unit that is arranged at a location which is in the vicinity of said injection opening and at which a pressure applied to said injection opening from said injection object can be detected in a state where said expansion gas is supplied to said first bag portion and said second bag portion.
3. The needleless injection apparatus according to claim 2, wherein said pressure detection unit is arranged between said injection object and said second bag portion in such a manner as to be pushed, upon expansion of said second bag portion, against said injection object together with said injection opening by the expansion of said second bag portion.
4. The needleless injection apparatus according to claim 2, further comprising: a controller comprising at least one processor configured to control injection of said injection objective substance in said needleless syringe, wherein said controller is configured to carry out the injection of said injection objective substance when said expansion gas is supplied from said gas supply unit and the pressure detected by said pressure detection unit reaches a predetermined pressure.
5. The needleless injection apparatus according to claim 4, wherein said controller is further configured to control supply of said expansion gas in said gas supply unit, and wherein after said controller supplies said expansion gas to said first bag portion and said second bag portion at predetermined timing, said controller carries out the injection of said injection objective substance.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0020]
[0021]
[0022]
[0023]
[0024]
[0025]
[0026]
[0027]
[0028]
EMBODIMENTS
[0029] Hereinafter, reference will be made to a needleless injection apparatus 40 according to embodiments of the present disclosure, while referring to the accompanying drawings. In addition, the needleless injection apparatus 40 is provided with a needleless syringe 20 (hereinafter, referred to simply as a “a syringe 20”). Here, note that the structure or construction of the following embodiments is only example, but the present disclosure is not limited to such structure or construction of the embodiments.
First Embodiment
[0030] Here,
[0031] The needleless injection apparatus 40 has a casing 41 of a cylindrical shape, and its surface is formed of a relatively easily deformable member such as cloth fiber, resin or the like, and so, when bag portions 42, 43 to be described later expand, the surface of the casing 41 is also caused to expand and deform in conformity with the expansion of the bag portions. In addition, a through space 41b extending through the casing 41 in the axial direction thereof is formed in the central portion of the casing 41. This through space 41b is to allow an arm of the user in the form of the injection object to pass therethrough, as shown in
[0032] Here, a space in the inside of the casing 41 other than the through space 41b is formed as a closed space which is closed by the member of the casing 41 (hereinafter, referred to simply as a “closed space”), and in the closed space, there are arranged a first bag portion 42, a second bag portion 43, the syringe 20, a pressure sensor (or pressure control unit) 44, and a control unit 50. The first bag portion 42 is a bag-shaped member which is expanded by air supplied from an air supply unit (or gas supply unit) 51 arranged in the outside of the casing 41, wherein the first bag portion 42 is arranged inside the casing 41 in such a manner as to substantially occupy, in the closed space, a space other than a central accommodation space 41a (refer to
[0033] Then, the syringe 20 is arranged at the side of the through space 41b in the central accommodation space 41a, wherein in such an arrangement state, the injection opening of the nozzle portion 12 for injecting the injection solution by means of the syringe 20 is exposed to the through space 41b. That is, although a large portion of the syringe 20 is accommodated in the central accommodation space 41a, the above-mentioned exposed state is formed in a state where the injection opening of the nozzle portion 12 is in opposition to the user's arm inserted in the through space 41b so as to be contactable therewith. Here, note that the detailed structure of the syringe 20 including the nozzle portion 12 will be described later. In addition, a pressure sensor 44 is arranged in the central accommodation space 41a in the vicinity of the injection opening of the nozzle portion 12, so as to perform the detection of pressure onto the arm, which is the injection object, generated in the injection opening.
[0034] Then, when the user's arm is inserted in the through space 41b, the second bag portion 43 is arranged at a location in the central accommodation space 41a at which the nozzle portion 12 is sandwiched between the second bag portion 43 and the arm in the through space 41b. This second bag portion 43 is a bag-shaped member which is expanded by the air supplied from the air supply unit 51, as in the case of the first bag portion 42. When the second bag portion 43 is expanded by this expansion air, it acts on the nozzle portion 12 so as to bring the injection opening thereof close to the user's arm in the through space 41b. Here, note that the syringe 20 is constructed such that it has a through hole 9 formed in its interior so as to enable a piston 7 to slide therein, as will be described later. For that reason, in
[0035] Further, the control unit 50 is also accommodated in the central accommodation space 41a. This control unit 50 has an arithmetic unit, a memory and so on incorporated therein, and achieves predetermined processing of the needleless injection apparatus 40 by executing a control program stored in the memory. In addition, the above-mentioned pressure sensor 44 is electrically connected to the control unit 50, and a pressure value measured by this sensor is handed over to the control unit 50, and is utilized for the predetermined processing, etc. Moreover, the syringe 20 and the air supply unit 51 are also electrically connected to the control unit 50, so that the injection of the injection solution in the syringe 20, and the supply and discharge of the expansion air by the air supply unit 51, are made controllable by means of the control unit 50. Accordingly, the control unit 50 corresponds to a controller according to the present disclosure.
[0036] Here, the structure of the syringe 20 will be explained.
[0037] In addition, the syringe 20 has a syringe main body 1, and in the central portion of the syringe main body 1, there is formed the through hole 9 which extends in the axial direction thereof, and which has a fixed diameter along the axial direction. Then, as will be described later, one end of the through hole 9 reaches the side of a pressure generation portion 6 (pressurization portion) which applies pressure to the injection solution filled in the syringe 20, and the other remaining end thereof reaches the side of a nozzle holder 2 (a holding member, hereinafter referred to simply as a “holder 2”) in which the nozzle flow passages 3 are formed which serve as an injection path for the injection solution to the injection object. The nozzle portion 12 is formed by the holder 2 and the nozzle flow passages 3.
[0038] Here, the filled state of the injection solution in the through hole 9 will be explained. As shown in
[0039] In order to achieve the above structure, materials for the upstream side plug member 8 and the downstream side plug member 10 are decided in such a manner that the injection solution may not leak out at the time of filling the injection solution, and that the injection solution can smoothly move in the interior of the through hole 9 accompanying the transmission of the driving force from the piston 7. For example, butyl rubber and silicone rubber can be adopted. Further, examples of the material include styrene-based elastomer, hydrogenated styrene-based elastomer, and the styrene-based elastomer and the hydrogenated styrene-based elastomer added with polyethylene, polypropylene, polybutene, polyolefin such as α-olefin copolymer, liquid paraffin, oil such as process oil, and powder inorganic matters such as talc, cast, and mica. Further, polyvinyl chloride-based elastomer, olefin-based elastomer, polyester-based elastomer, polyamide-based elastomer, and polyurethane-based elastomer, various rubber materials (in particular, those subjected to vulcanization) such as natural rubber, isoprene rubber, chloroprene rubber, nitrile-butadiene rubber, and styrene-butadiene rubber, mixtures of the kinds of elastomer and the kinds of rubber, and the like can be adopted.
[0040] Here, the pressure generation portion 6 will be explained. As one specific embodiment thereof, there can be adopted a pressure generation mode making use of combustion of propellant or pyrotechnic charge. For example, there can be utilized an initiator which combusts an ignition charge by electrical energization. The ignition charge is preferably exemplified by a propellant containing zirconium and potassium perchlorate (ZPP), a propellant containing titanium hydride and potassium perchlorate (THPP), a propellant containing titanium and potassium perchlorate (TiPP), a propellant containing aluminum and potassium perchlorate (APP), a propellant containing aluminum and bismuth oxide (ABO), a propellant containing aluminum and molybdenum oxide (AMO), a propellant containing aluminum and copper oxide (ACO), a propellant containing aluminum and iron oxide (AFO), or a propellant composed of a combination of a plurality of the foregoing propellants. These propellants exhibit such characteristics that, although the propellants generate hot and high-pressure plasma during combustion immediately after ignition, when combustion products condense at a room temperature, the propellants do not contain gaseous components and the pressure generated decreases abruptly. It is also allowable that any propellant or pyrotechnic charge other than the above is used as the ignition charge, provided that the injection can be performed appropriately.
[0041] Then, by transferring the inflammation or fire of the combustion products generated by the combustion of the ignition charge by means of the initiator to a gas generating agent which is separately arranged, the driving force to be transmitted from the pressure generation portion 6 to the piston 7 can be made more suitable. As for an example of the gas generating agent, it is possible to exemplify a single base smokeless propellant including 98% by mass of nitrocellulose, 0.8% by mass of diphenylamine, and 1.2% by mass of potassium sulfate. Further, it is also possible to use various gas generating agents used for a gas generator for airbags and a gas generator for seat belt pretensioners. With these gas generating agents, a predetermined gas generated at the time of combustion thereof contains a gas component even in room temperature, unlike the above-mentioned ignition charge, and hence, a relatively long combustion period of time can be ensured, thus making it possible to produce a sufficient driving force necessary for injection of the injection solution, as the pressure generation portion 6.
[0042] Here, at the tip end side of the syringe 20 (at the left side of
[0043] Next, the detailed structure of the holder 2 will be explained. The holder 2 is mounted on the syringe main body 1, and in the holder 2, there is formed a concave portion 5 in which the downstream side plug member 10 moving with the injection solution under pressurization to the upstream side plug member 8 by the pressure generation portion 6 is finally accommodated. Specifically, the concave portion 5 is formed at the downstream side in the direction in which the downstream side plug member 10 is moved by the pressurization of the pressure generation portion 6 in the state where the holder 2 is mounted on the syringe main body 1, and the concave portion 5 has substantially the same diameter as the downstream side plug member 10, and has substantially the same depth as the length of the downstream side plug member 10. Then, there is formed a movement passage 4 between the initial position of the downstream side plug member 10 before the pressurization is carried out, i.e., the position of the downstream side plug member 10 shown in
[0044] As constructed in this manner, when pressure is applied to the piston 7 by the pressure generation portion 6 so that the injection solution is moved to the tip end side of the syringe 20 together with the upstream side plug member 8 and the downstream side plug member 10, the downstream side plug member 10 is accommodated in the concave portion 5. When the downstream side plug member 10 is accommodated in the concave portion 5, the injection solution filled therein will be released, while also being accompanied by the pressurization from the upstream side plug member 8 to the injection solution, so that the injection solution will be injected from the injection openings of the nozzle flow passages 3 to the injection object outside the syringe through the movement passage 4.
[0045] Here, as shown in
[0046] A relative position of an opening portion of this most downstream side nozzle flow passage 3 with respect to the downstream side plug member 10 is decided in such a manner that the opening is not closed by the downstream side plug member 10 in a state where the downstream side plug member 10 is accommodated in the concave portion 5. In addition, a chamfer 10a is formed on the peripheral edge portion of a surface of the downstream side plug member 10 which is in opposition to the upstream side plug member 8. By ensuring passage of the injection solution into a substantially annular space formed by this chamfer 10a between the peripheral edge portion of the downstream side plug member 10 and the movement passage 4, a circulation state of the injection solution through the inlet of the most downstream side nozzle flow passage 3 is held, even in a state where the downstream side plug member 10 is accommodated in the concave portion 5. Moreover, when the downstream side plug member 10 is accommodated in the concave portion 5, the upstream side plug member 8 further pressurized comes closer to the downstream side plug member 10, so that it is finally placed in contact therewith. As a result, the injection solution filled between the downstream side plug member 10 and the upstream side plug member 8 flows into the three nozzle flow passages 3 opening there through the movement passage 4. Then, immediately before the upstream side plug member 8 contacts the downstream side plug member 10, the inlets of the other nozzle flow passages 3 excluding the most downstream side nozzle flow passage 3 will be closed by the upstream side plug member 8. However, even in the state where the upstream side plug member 8 is in contact with the downstream side plug member 10, by means of the above-mentioned chamfer 10a, the opening portion of the most downstream side nozzle flow passage 3 will not be in a state where it is closed by the downstream side plug member 10 and/or the upstream side plug member 8, but the inflow of the injection solution into the most downstream side nozzle flow passage through its inlet is held possible.
[0047] Thus, by the provision of the most downstream side nozzle flow passage 3 which has the inlet directly opening to the movement passage 4, and which is held in such a manner that the inflow of the injection solution from the movement passage 4 into this nozzle flow passage through the inlet thereof always becomes possible during the time after the downstream side plug member 10 is accommodated in the concave portion 5 until the upstream side plug member 8 contacts the downstream side plug member 10, it becomes possible to suppress or reduce the amount of the injection solution remaining in the syringe 20, in particular in the movement passage 4. In addition, the inlet of the most downstream side nozzle flow passage 3 opens directly to the movement passage 4, and the direction of injection of the injection solution defined by the inlet and the outlet (injection opening) (i.e., a direction from the interior of the syringe toward the side thereof, in the case of this embodiment) is nonparallel (in a direction in which the injection direction becomes orthogonal with respect to the direction of movement in
[0048] In addition, among the three nozzle flow passages 3, also in the other nozzle flow passages 3 except the most downstream side nozzle flow passage 3, their inlets open directly to the movement passage 4, and hence, the injection of the injection solution to the injection object is achieved, while eliminating the formation of the liquid reservoir space, as described above. However, at the time of the completion of injection, the inlets of the other nozzle flow passages 3 will be directly closed by the upstream side plug member 8, or will be located at the upstream side of the upstream side plug member 8, as shown in
[0049] Moreover, in the above-mentioned embodiment, the inflow of the injection solution into the most downstream side nozzle flow passage 3 is held by the chamfer 10a of the downstream side plug member 10, but instead of this, a chamfer may be formed on the peripheral edge portion of a surface of the upstream side plug member 8 which is in opposition to the downstream side plug member 10, so that the inflow of the injection solution into the most downstream side nozzle flow passage 3 may be held by this chamfer, or a chamfer may be formed on the peripheral edge portion of the inlet of the most downstream side nozzle flow passage 3, so that the inflow of the injection solution into the most downstream side nozzle flow passage 3 may be held by this chamfer. Furthermore, the inflow of the injection solution into the most downstream side nozzle flow passage 3 may be held, by combining these chamfers in a suitable manner.
[0050] Here, note that in the above-mentioned embodiment, the three nozzle flow passages are formed in the holder 2 in a line along the direction of movement of the injection solution, but they are not limited to this and may be arranged in a plurality of lines. However, if the number of the nozzle flow passages increases, the residue (remaining amount) of the injection solution in the interior may increase, so it is preferable that the number of the nozzle flow passages be appropriate.
[0051] Here, the control with respect to the injection using the needleless syringe 20 in the needleless injection apparatus 40 will be explained based on
[0052] In step S102, according to an instruction from the control unit 50, a predetermined amount of air is supplied to the first bag portion 42 from the air supply unit 51. This predetermined amount of air is an amount of air which can apply such pressure as to lightly fix the arm in the through space 41b by the expansion of the first bag portion 42. Here, note that the volume occupied by the user's arm in the through space 41b differs from person to person, so the predetermined amount of air is to generate a certain pressure under which the user's arm does not move easily in the through space 41b, and at this point in time, the pressure applied to the syringe 20 is not adjusted strictly. After the processing of step S102 is terminated by completing the supply of the predetermined amount of air, the routine goes to step S103.
[0053] In step S103, in the state where the predetermined amount of air has been supplied to the first bag portion 42, the supply of air to the second bag portion 43 is started. This supply of air in step S103 is to gradually expand the second bag portion 43, and is carried out at such a speed or rate that the pressure applied to the injection opening of the nozzle portion 12 does not go up rapidly so as not to cause the user to feel displeasure or discomfort. Then, in step S104, the pressure applied to the injection opening of the nozzle portion 12 at that point in time is measured by the pressure sensor 44. The pressure sensor 44 is located at a side surface of the nozzle portion 12 (the holder 2), and is also located in the vicinity of the injection opening thereof, and hence, the pressure measured by the pressure sensor 44 can be rationally assumed as the pressure applied to the injection opening of the nozzle portion 12. After the processing of step S104 ends, the routine goes to step S105.
[0054] In step S105, it is determined whether the pressure measured in step S104 has reached a reference pressure. This reference pressure is a pressure in the case where a state of contact between the injection opening of the nozzle portion 12 and the surface (skin) of the arm, which is formed by the nozzle portion 12 being pushed out to the arm side, which is the injection object, by the expanded second bag portion 43, can be assumed as a suitable contact state for injection of the injection solution by the needleless syringe 20. That is, when the reference pressure is applied to the injection opening of the nozzle portion 12, it is assumed that the injection opening of the nozzle portion 12 is in contact with the surface of the arm with no gap, and that there is formed a contact state in which the user does not feel displeasure such as a pain, etc. When an affirmative determination is made in step S105, the routine goes to step S106, whereas when a negative determination is made, the processing in and after step S103 is carried out.
[0055] Subsequently, in step S106, when the measured pressure has reached the reference pressure, the supply of air to the second bag portion 43 is stopped. In this state, the arm in the through space 41b is subjected to pressure by means of the first bag portion 42 to which the predetermined amount of air is supplied, so that the arm is pushed up toward the injection opening of the nozzle portion 12 of the syringe 20. Then, by the air being supplied to the second bag portion 43, the nozzle portion 12 is pushed in toward the arm, and as a result, a state is formed where the injection opening of the nozzle portion 12 is in contact with the surface of the arm in a suitable manner. Accordingly, in the processing of step S107, the injection of the injection solution in the syringe 20 is carried out. Specifically, according to an instruction from the control unit 50, an ignition electric current is supplied to the ignition charge of the initiator in the pressure generation portion 6, whereby the pressurization of the injection solution and the injection thereof will be carried out.
[0056] Thereafter, in step S108, the air supplied to the first bag portion 42 and the second bag portion 43 is discharged. With this, the user's arm is released from the pressurization state caused by the expansion of the individual bag portions, so that it becomes possible to pull out the arm from the through space 41b.
[0057] Thus, according to this injection control, the injection of the injection solution by the syringe 20 is carried out, after the contact between the injection opening of the nozzle portion 12 and the surface of the user's arm is brought into a suitable state, by the action of the first bag portion 42 and the second bag portion 43. For that reason, the injection solution is injected under an injection support environment suitable for the syringe 20 including no injection needle, and it becomes easy to deliver the injection solution to a tissue which is at a desired position in the arm.
[0058] Here, note that in the above-mentioned injection control, the first bag portion 42 and the second bag portion 43 are made to expand sequentially in this order, but the first bag portion 42 and the second bag portion 43 may be made to expand at the same time, as long as the contact state of the nozzle portion 12 can be formed appropriately. In this case, in a situation where air is supplied to both the bag portions at the same time, the supply of the air to both the bag portions need only be stopped at the time when the measured pressure of the pressure sensor 44 reaches a reference pressure. Also, as another mode or method, the second bag portion 43 may first be made to expand, and the first bag portion 42 may then be made to expand. In this case, while expanding the first bag portion 42, the timing to stop the supply of air to the first bag portion 42 may be determined based on the measured value of the pressure sensor 44.
[0059] Further, the needleless injection apparatus 40 may also be provided with a plurality of syringes 20 in the casing 41. In that case, the user mounts on his or her arm the needleless injection apparatus 40 including the plurality of the syringes 20. Then, the injection execution timing for each of the syringes 20 is set in the control unit 50, whereby at the time of arrival of the injection execution timing for each syringe 20, the control unit 50 drives the air supply unit 51, and supplies air to the individual bag portions so that the contact between the injection opening of the nozzle portion 12 and the surface of the arm is brought into a suitable state, after which the injection of the injection solution in each syringe 20 is carried out in an automatic manner. In such a mode, only by mounting the needleless injection apparatus 40 on the arm, the user can be sequentially subjected to injections by the syringes 20 in a suitable manner.
First Modified Embodiment
[0060] A modification of the needleless injection apparatus will be explained based on
Second Modified Embodiment
[0061] Another modification of the needleless injection apparatus 40 will be explained based on
Other Embodiments
[0062] According to the needleless injection apparatus 40 of the present disclosure, for example, cultured cells, stem cells, and the like may be seeded or inoculated into injection target cells or scaffold tissues (scaffolds) in the field of the regenerative medicine of human, in addition to the case where the injection liquid is injected into the skin structure. For example, as described in Japanese Patent Application Publication No. 2008-206477, the syringe 20 may inject cells which may be appropriately determined by those skilled in the art depending on a transplantation portion and the purpose of the cell regeneration, for example, endothelial cells, endothelial precursor cells, myeloid cells, preosteoblast, chondrocytes, fibroblast, skin cells, muscle cells, liver cells, kidney cells, intestinal tract cells, and stem cells, as well as all cells considered in the field of the regenerative medicine.
[0063] Further, the needleless injection apparatus 40 may be also used for delivering DNA or the like to cells or scaffold tissues (scaffolds) as described in Japanese Translation of PCT Application No. 2007-525192. In this case, it is possible to suppress an adverse effect on cells themselves or scaffold tissues (scaffolds) themselves when the needleless injection apparatus 40 is used, as compared with when the delivery is performed using a needle. Therefore, it can be said that the use of the needleless injection apparatus 40 is more desirable.
[0064] Further, the needleless injection apparatus 40 is ideally useful, for example, when various genes, cancer inhibiting cells, lipid envelops, and the like are directly delivered to target tissues and when antigen genes are administered to enhance the immunity against pathogens. In addition to the above, the needleless injection apparatus 40 can be also used, for example, in the field of medical treatment for various diseases (for example, see Japanese Translation of PCT Application No. 2008-508881 and Japanese Translation of PCT Application No. 2010-503616) and the field of immunological medical treatment (for example, see Japanese Translation of PCT Application No. 2005-523679). The field, in which the needleless injection apparatus 40 is usable, is not intentionally limited.