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CN117861021A - Needleless injector with disposable medicine core for single-charge and multiple-injection and configuration method thereof - Google Patents

Needleless injector with disposable medicine core for single-charge and multiple-injection and configuration method thereof Download PDF

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Publication number
CN117861021A
CN117861021A CN202410220684.XA CN202410220684A CN117861021A CN 117861021 A CN117861021 A CN 117861021A CN 202410220684 A CN202410220684 A CN 202410220684A CN 117861021 A CN117861021 A CN 117861021A
Authority
CN
China
Prior art keywords
injection
assembly
needleless injector
impact
disposable
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN202410220684.XA
Other languages
Chinese (zh)
Other versions
CN117861021B (en
Inventor
支前锋
郭兴成
袁婧怡
戚雯
居志杰
白政忠
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Jiangsu Leju Pharmaceutical Technology Co ltd
Original Assignee
Jiangsu Leju Pharmaceutical Technology Co ltd
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Filing date
Publication date
Application filed by Jiangsu Leju Pharmaceutical Technology Co ltd filed Critical Jiangsu Leju Pharmaceutical Technology Co ltd
Priority to CN202410220684.XA priority Critical patent/CN117861021B/en
Publication of CN117861021A publication Critical patent/CN117861021A/en
Application granted granted Critical
Publication of CN117861021B publication Critical patent/CN117861021B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3114—Filling or refilling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/27—General characteristics of the apparatus preventing use
    • A61M2205/273—General characteristics of the apparatus preventing use preventing reuse, e.g. of disposables

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

The invention relates to a disposable medicine core single-charge multi-injection needleless injector and a configuration method thereof, wherein the disposable medicine core single-charge multi-injection needleless injector comprises: a housing having a mounting cavity; a strike assembly disposed within the mounting cavity of the housing, the strike assembly having a strike portion; and a disposable drug core assembly mounted to the housing, the disposable drug core assembly having a push rod; wherein the impact portion of the impact assembly is spaced a first predetermined distance from the push rod of the disposable cartridge assembly prior to each injection and the momentum of the impact assembly is in the range of 0.21 kg-m/s to 2 kg-m/s when each injection is administered. According to the embodiment of the invention, the impact assembly can impact the push rod of the disposable drug core assembly during each injection, and the impact momentum parameter is controlled, so that the depth of multiple injections is uniform, and the micro-dose injection can be realized.

Description

Needleless injector with disposable medicine core for single-charge and multiple-injection and configuration method thereof
Technical Field
The invention relates to the field of medical appliances, in particular to a disposable drug core needleless injector capable of filling drug for multiple injections once and a configuration method thereof.
Background
The needleless injector is an injector which does not need a needle, and high pressure is usually used for injecting injection into human tissues, so that the medicine administration is realized, and the injector is a safer, more sanitary and more comfortable injection mode.
In the treatment of some diseases, multi-point injection is needed, such as vitiligo treatment, scar treatment, some operation anesthesia and the like, and one-time medicine filling and multi-time injection are needed to facilitate the operation of medical staff.
Some needleless injectors can realize one-time medicine filling and multiple injection, and the cavity tube of the needleless injector for filling medicine liquid has a complex structure, needs to be disassembled, cleaned, sterilized and disinfected after each use, is reassembled before the next use, and is troublesome to operate; another needleless injector uses a disposable cartridge, which is convenient to inject, but has the problems of increasing depth from the first injection to the last injection (i.e., shallow depth of the front injection, deep depth of the rear injection, uneven depth of multiple injections) and inability to inject small doses.
Thus, there is a need for further improvement in existing single-charge multiple-injection needleless injectors.
The information disclosed in the background section of the invention is only for enhancement of understanding of the general background of the invention and should not be taken as an acknowledgement or any form of suggestion that this information forms the prior art already known to a person of ordinary skill in the art.
Disclosure of Invention
The invention aims to provide a needleless injector with a disposable drug core for single-charge multi-injection and a configuration method thereof, and the needleless injector with the disposable drug core for single-charge multi-injection can improve the phenomenon of uneven depth of multi-injection and realize micro-dose injection.
According to a first aspect of the present invention there is provided a method of configuring a disposable drug-filled multiple shot needleless injector comprising: a) Providing a housing having a mounting cavity; b) An impact assembly is arranged in the mounting cavity of the shell; c) Mounting a single-charge, multi-injection disposable cartridge assembly to the housing; d) Such that a first predetermined distance exists between the impact portion of the impact assembly and the push rod of the disposable cartridge assembly prior to each injection and the momentum of the impact assembly is in the range of 0.21 kg-m/s to 2 kg-m/s when each injection is administered.
Preferably, the first predetermined distance is greater than or equal to 1mm.
Preferably, the momentum of the striking assembly at the time of each injection is performed is in the range of 0.21 kg-m/s to 1 kg-m/s.
Preferably, the momentum of the striking assembly at the time of each injection is performed is in the range of 0.3 kg-m/s to 0.7 kg-m/s.
Preferably, a reset member is disposed within the mounting cavity of the housing, the reset member being mounted to the mounting cavity and capable of providing a resilient reset force to the ram assembly such that the ram assembly resets after each injection.
Preferably, the disposable cartridge single-charge multiple injection needleless injector further comprises: and the cavity tube is connected to the front end of the mounting cavity in a threaded manner, the front end of the impact part extends into the cavity tube, and the rear end of the push rod extends into the cavity tube.
Preferably, the disposable cartridge assembly further has a cartridge detachably connected to the front end of the lumen.
Preferably, the disposable cartridge single-charge multiple injection needleless injector further comprises: a spring positioning ball mounted to an inner sidewall of a front end of the housing; the outer side wall of the front end of the cavity tube is provided with a positioning groove, and the spherical end of the spring positioning collision bead can be elastically inserted into the positioning groove.
Preferably, the front end of the shell is provided with a mounting cylinder; the needleless injector further comprises: the front part of the screw sleeve wraps the cavity tube, and the rear part of the screw sleeve wraps the front part of the mounting cylinder; and a spacer disposed between the front of the screw sleeve and the lumen.
According to a second aspect of the present invention there is provided a disposable drug-filled multiple shot needleless injector comprising: a housing having a mounting cavity; a strike assembly disposed within the mounting cavity of the housing, the strike assembly having a strike portion; and a disposable drug core assembly mounted to the housing, the disposable drug core assembly having a push rod; wherein the impact portion of the impact assembly is spaced a first predetermined distance from the push rod of the disposable cartridge assembly prior to each injection and the momentum of the impact assembly is in the range of 0.21 kg-m/s to 2 kg-m/s when each injection is administered.
Preferably, the first predetermined distance is greater than or equal to 1mm.
Preferably, the momentum of the striking assembly at the time of each injection is performed is in the range of 0.21 kg-m/s to 1 kg-m/s.
Preferably, the momentum of the striking assembly at the time of each injection is performed is in the range of 0.3 kg-m/s to 0.7 kg-m/s.
Preferably, the disposable cartridge single-charge multi-injection needleless injector further comprises: a return member mounted to the mounting cavity and configured to provide a resilient return force to the impact assembly.
Preferably, the disposable cartridge single-charge multi-injection needleless injector further comprises: and the cavity tube is connected to the front end of the mounting cavity in a threaded manner, the front end of the impact part extends into the cavity tube, and the rear end of the push rod extends into the cavity tube.
Preferably, the disposable cartridge assembly further has a cartridge detachably connected to the front end of the lumen.
Preferably, the disposable cartridge single-charge multi-injection needleless injector further comprises: a spring positioning ball mounted to an inner sidewall of a front end of the housing; the outer side wall of the front end of the cavity tube is provided with a positioning groove, and the spherical end of the spring positioning collision bead can be elastically inserted into the positioning groove.
Preferably, the positioning grooves are provided in plurality and uniformly distributed along the circumferential surface.
Preferably, the front end of the shell is provided with a mounting cylinder; the disposable cartridge single-charge multiple-injection needleless injector further comprises: the front part of the screw sleeve wraps the cavity tube, and the rear part of the screw sleeve wraps the front part of the mounting cylinder; and a spacer disposed between the front of the screw sleeve and the lumen.
Preferably, the insert includes an insert body and a baffle extending radially inward from a front end of the insert body.
Preferably, the impact assembly further comprises; a piston slidably mounted in the mounting chamber, a rear end of the striking portion being fixedly secured to the piston; the rear end of the positioning sleeve is fixedly connected to the piston, the positioning sleeve is provided with a containing cavity penetrating through the positioning sleeve in the front-rear direction, the reset member is sleeved on the positioning sleeve, a second preset distance exists between the positioning sleeve and the front inner wall of the shell before each injection, and the second preset distance is larger than the first preset distance.
According to the embodiment of the invention, the impact component can impact the push rod of the disposable drug core component during each injection, and the impact momentum parameter is controlled, so that the depth of multiple injections is uniform, and each micro-dose injection during multiple injections can be realized.
The method and apparatus of the present invention have other features and advantages which will be apparent from or are set forth in detail in the accompanying drawings and the following embodiments, which are incorporated herein, and which together serve to explain the particular principles of the invention.
Drawings
FIG. 1 is a first cross-sectional view of a needleless injector of an embodiment of the present invention;
FIG. 2 is an enlarged schematic view of FIG. 1 at A;
FIG. 3 is a schematic structural view of a lumen;
FIG. 4 is a schematic structural view of a screw sleeve;
FIG. 5 is a schematic cross-sectional view of a threaded sleeve;
FIG. 6 is a schematic structural view of a gasket;
FIG. 7 is a schematic cross-sectional view of a gasket;
FIG. 8 is a schematic illustration of the fit of the sleeve, spacer and lumen;
FIG. 9 is a first cross-sectional view of a needleless injector of an embodiment of the present invention;
FIG. 10 is an enlarged schematic view of FIG. 9A;
FIG. 11 is a schematic cross-sectional view of an impact assembly;
fig. 12 is a schematic structural view of a disposable drug core assembly.
Reference numerals illustrate:
100: the housing 101: mounting cavity
102: mounting cylinder 103: front inner wall
200: impact assembly 201: impact part
202: piston 203: positioning sleeve
203A: the housing chamber 203B: front end face
206: front end face
300: disposable drug core assembly 301: medicine core tube
302: push rod 303: rear end face
400: reset component
500: lumen 501: positioning groove
601: spring positioning bump 602: screw sleeve
603: gasket 606: screw sleeve main body
607: baffle 608: rear part of gasket
609: gasket front 610: incision
700: handle portion 701: trigger
702: gas channel 703: an inlet.
It should be understood that the drawings are not necessarily to scale, presenting a simplified representation of various features illustrative of the basic principles of the invention. The particular design features disclosed herein (including, for example, particular dimensions, orientations, locations, and shapes) will be determined in part by the particular application and environment in which they are to be used.
In the drawings, like numerals refer to the same or equivalent parts of the invention throughout the several views of the drawings.
Detailed Description
Reference will now be made in detail to various embodiments of the invention, examples of which are illustrated in the accompanying drawings and described below. While the invention will be described in conjunction with the exemplary embodiments, it will be understood that the present description is not intended to limit the invention to these exemplary embodiments. On the contrary, the invention is intended to cover not only these exemplary embodiments, but also various alternatives, modifications, equivalents and other embodiments, which may be included within the spirit and scope of the invention as defined by the appended claims.
When an element is referred to as being "on" or "over" another element, it can be in contact with the other element or intervening elements may also be present.
The embodiments of the present invention are described by taking gun-type needleless injectors as an example, and the types of needleless injectors are not limited to gun-type, but may be pen-type or other types.
The power source of the embodiment of the invention adopts an air source. The power source may be spring driven, electric or otherwise, in addition to the air source.
A single-charge multiple injection needleless injector with a disposable cartridge according to an embodiment of the present invention is described below with reference to fig. 1 to 12.
FIG. 1 is a first cross-sectional view of a needleless injector of an embodiment of the present invention; FIG. 2 is an enlarged schematic view of FIG. 1 at A; FIG. 3 is a schematic structural view of a lumen; FIG. 4 is a schematic structural view of a screw sleeve; FIG. 5 is a schematic cross-sectional view of a threaded sleeve; FIG. 6 is a schematic structural view of a gasket; FIG. 7 is a schematic cross-sectional view of a gasket; FIG. 8 is a schematic illustration of the fit of the sleeve, spacer and lumen; FIG. 9 is a first cross-sectional view of a needleless injector of an embodiment of the present invention; FIG. 10 is an enlarged schematic view of FIG. 9A; FIG. 11 is a schematic cross-sectional view of an impact assembly; fig. 12 is a schematic structural view of a disposable drug core assembly.
As shown in fig. 1 to 2, the disposable cartridge single-charge multi-injection needleless injector of the embodiment of the present invention comprises: housing 100, impact assembly 200, and disposable cartridge assembly 300.
The housing 100 has a mounting cavity 101.
The impact assembly 200 is disposed within the mounting cavity 101 of the housing 100, the impact assembly 200 having an impact portion 201.
The disposable cartridge assembly 300 is mounted to the housing 100, the disposable cartridge assembly 300 having a push rod 302.
Wherein a first predetermined distance L1 exists between the impact portion 201 of the impact assembly 200 and the push rod 302 of the disposable cartridge assembly 300 prior to each injection and the momentum of the impact assembly 200 at the time of each injection is in the range of 0.21 kg-m/s to 2 kg-m/s.
Embodiments of the present invention can make the depth of multiple injections uniform and can achieve micro-dose injections by controlling the striker assembly 200 to strike the push rod 302 of the disposable cartridge assembly 300 at each injection and controlling the momentum parameters of the strike.
A large number of experiments show that the impact momentum of the drug core push rod is given to each single injection, the phenomenon of uneven depth of multiple injections of one drug charge can be obviously improved, and the injection can be realized by small dosage.
In an exemplary embodiment, the momentum of the impact assembly 200 at the time of each injection is in the range of 0.21 kg-m/s to 1 kg-m/s.
In an exemplary embodiment, the momentum of the impact assembly 200 at the time of each injection is in the range of 0.3 kg-m/s to 0.7 kg-m/s.
The striking part 201 is a striking rod.
In an exemplary embodiment, as shown in fig. 2, the first predetermined distance L1 is greater than or equal to 1mm. For a needleless injector having a single charge multiple injections of a disposable cartridge that has been configured, the first predetermined spacing L1 is constant.
In an exemplary embodiment, the first predetermined distance L1 is in the range of 2mm to 8 mm.
In a further embodiment, the first predetermined spacing L1 is in the range of 4mm to 6 mm.
The range of the first predetermined distance L1 may be appropriately set according to the mass of the impact assembly 200, the obtained urging force.
The first predetermined distance L1 is generally not more than 30mm.
In an exemplary embodiment, as shown in fig. 1, the disposable cartridge single-charge multi-injection needleless injector further comprises: reset member 400, reset member 400 is mounted to mounting cavity 101 and is configured to provide a resilient reset force to strike assembly 200 that is configured to move strike assembly 200 back to an initial position (i.e., reset) after each injection is completed.
In an exemplary embodiment, the reset member 400 may be a coil spring, and the kind of the reset member 400 is not limited thereto, and it may be any form of the prior art as long as the above-described functions can be achieved.
In an exemplary embodiment, as shown in fig. 1, the disposable cartridge single-charge multi-injection needleless injector further comprises: a lumen 500, the lumen 500 being threadably connected to the front end of the mounting cavity 101, the front end of the striking portion 201 of the striking assembly 200 extending into the lumen 500, the rear end of the push rod 302 extending into the lumen 500. By twisting the lumen 500, the position of the lumen 500 relative to the strike 201 can be changed for each single injection.
In an exemplary embodiment, as shown in fig. 1, the front end of the housing 100 has a mounting barrel 102.
Specifically, the rear end of the lumen 500 has an external thread, the front end of the installation cavity 101 (the front end of the installation tube 102) has an internal thread, and the rear end of the lumen 500 is screwed to the inner surface of the front end of the installation cavity 101 (the front end of the installation tube 102).
In an exemplary embodiment, as shown in fig. 1, the disposable cartridge single-charge multi-injection needleless injector further comprises: spring positioning spring 601, spring positioning spring 601 is mounted to the inside wall of the front end of housing 100.
Wherein, as shown in fig. 3, the outer sidewall of the front end of the lumen 500 has a positioning groove 501, and the ball end of the spring positioning ball 601 can be elastically inserted into the positioning groove 501.
In the embodiment of fig. 1 and 3, the positioning grooves 501 are provided in 2, and the 2 positioning grooves 501 are symmetrically distributed on the circumferential surface of the lumen 500.
The number of the positioning grooves 501 may be adjusted according to circumstances, and for example, may be set to any number of 1 to 6, and when the number of the positioning grooves 501 is 2 or more than 2, they may be uniformly distributed along the circumferential surface.
In an exemplary embodiment, an inner sidewall of a front end of the housing 100 (a front end of the mounting cylinder 102) is provided with a mounting hole into which the spring positioning spring ball 601 is mounted.
In an exemplary embodiment, as shown in fig. 1 and 12, the disposable cartridge assembly 300 further has a cartridge 301, and the cartridge 301 of the disposable cartridge assembly 300 is detachably coupled to the front end of the lumen 500, thereby detachably coupling the disposable cartridge assembly 300 to the mounting cylinder 102 of the front end of the housing 100.
In one embodiment, the front end of the lumen 500 has internal threads and the rear end of the cartridge 301 of the disposable cartridge assembly 300 has external threads such that the cartridge 301 can be removably attached to the front end of the lumen 500.
In another embodiment, the cartridge 301 and the lumen 500 may also be snap-fit such that the cartridge 301 may be removably attached to the front end of the lumen 500.
Other forms of connection besides threaded connection and snap-fit connection are possible to enable the cartridge 301 to be detachably connected to the front end of the lumen 500.
In an exemplary embodiment, as shown in fig. 1 and 2, the disposable cartridge single-charge multi-injection needleless injector further comprises: a sleeve 602 and a washer 603.
The front of the sleeve 602 encloses the lumen 500 and the rear of the sleeve 602 encloses the front of the mounting barrel 102.
A spacer 603 is disposed between the front of the sleeve 602 and the lumen 500.
The screw sleeve 602 and the spacer 603 prevent the lumen 500 from being unscrewed from the mounting cylinder 102 by a user's erroneous operation, and the spacer 603 also prevents the lumen 500 from being shaken by a screw gap.
Specifically, as shown in fig. 4 and 5, the insert 602 includes an insert body 606 and a baffle 607 extending radially inward from a front end of the insert body 606, the baffle 607 being adapted to block the washer 603 to prevent the washer 603 from falling off.
In an exemplary embodiment, as shown in fig. 6 and 7, the washer 603 includes a washer rear portion 608 and a washer front portion 609, wherein the washer rear portion 608 and the washer front portion 609 have the same inner diameter, and the washer rear portion 608 has an outer diameter that is greater than the washer front portion 609 so that the nut 602 catches the washer rear portion 608 to prevent the washer 603 from sliding forward.
As shown in fig. 6, the pad 603 has a cutout 610 for mounting the pad 603.
The material of the pad 603 may be a material that is easily elastically deformable, such as plastic.
As shown in fig. 8, the sleeve body 606 encloses a back portion 608 of the spacer, and a front portion 609 of the spacer is disposed between the bezel 607 and the lumen 500.
In an exemplary embodiment, as shown in fig. 1 and 11, the impact assembly 200 further includes: a piston 202 and a positioning sleeve 203.
The piston 202 is slidably mounted in the mounting chamber 101, the rear end of the striking portion 201 is fixed to the piston 202, and the rear end of the return member 400 abuts against the front end of the piston 202.
The rear end of the positioning sleeve 203 is fixed to the piston 202, the positioning sleeve 203 has a receiving chamber 203A penetrating in the front-rear direction, and the reset member 400 is fitted over the positioning sleeve 203. The front end surface 203B of the positioning sleeve 203 contacts the front inner wall 103 of the housing 100 and is blocked by the front inner wall 103, thereby realizing positioning.
Wherein the rear end of the striking portion 201 is fixed to the piston 202.
The high pressure gas provided by the gas source may contact and push the piston 202 to push the entire ram assembly 200 forward.
In an exemplary embodiment, as shown in fig. 1, the gun-type needleless injector further comprises a handle portion 700, the handle portion 700 comprising a trigger 701, a gas passage 702, and an inlet 703, the high pressure gas of an external gas source entering the gas passage 702 through the inlet 703, thereby imparting an impulse to the piston 202. The needleless injector may be activated by actuating the trigger 701.
By controlling the second predetermined distance L2 between the front end surface 203B of the positioning sleeve 203 and the front inner wall 103 of the housing 100 and the first predetermined distance L1 between the front end surface 206 of the striking part 201 and the rear end surface 303 of the push rod 302 by the dimensions of the above-mentioned components (where L2 > L1), the impact momentum of the striking assembly 200 is formed by moving the striking assembly 200 within the distance L1 by the power source, and the magnitude thereof can be controlled by adjusting the energy output by the power device, the moving first predetermined distance L1 and the quality of the striking assembly 200. The second predetermined distance for the entire movement of the strike assembly 200 at each injection is L2, the front face 203B of the positioning sleeve 203 stops when it contacts the front inner wall 103 of the housing 100, the strike 201 moves the push rod 302 a distance (L2-L1), and the entire mechanism outputs a dose that is the product of (L2-L1) and the cross-sectional area of the interior cavity of the cartridge 301. At this time, the pushrod 302 is moved forward (L2-L1) a distance.
If the next injection is required, the cavity 500 needs to be manually rotated, the spring positioning spring ball 601 slides out of the positioning groove 501, the cavity 500 drives the drug core barrel 301 and the push rod 302 to move (i.e. move backwards) towards the inside of the cavity, the spring positioning spring ball 601 stops rotating when falling into the next positioning groove 501, the moving distance depends on the thread pitch of the rear end thread of the cavity 500 and the number of positioning grooves 501 arranged on the cavity 500, in the embodiment of fig. 1 and 3, the cavity 500 is provided with two positioning grooves 501 which are symmetrical up and down, the cavity 500 can be positioned by the spring positioning spring ball 601, and the minimum distance of adjustment is half of the thread pitch of the rear end thread of the cavity 500.
In the case of N locating grooves 501, the minimum distance of adjustment is one-nth of the pitch of the rear end threads of the lumen 500.
If there is only one positioning groove 501, the lumen 500 is rotated one full revolution at a time.
Embodiments of the present invention also provide a method of configuring a single-charge multiple-injection needleless injector with a disposable cartridge, capable of configuring a single-charge multiple-injection needleless injector with a disposable cartridge as shown in fig. 1 to 12, the configuring method comprising:
a) A housing 100 is provided, the housing having a mounting cavity 101.
b) An impingement assembly 200 is disposed within the mounting cavity 101 of the housing 100.
c) A single charge, multiple injection, disposable cartridge assembly 300 is mounted to housing 100.
d) Such that a first predetermined distance exists between the impact portion 201 of the impact assembly 200 and the push rod 302 of the disposable cartridge assembly 300 prior to each injection and the momentum of the impact assembly 200 is in the range of 0.21 kg-m/s to 2 kg-m/s when each injection is administered.
The operation of the needleless injector according to the embodiments of the present invention will be described with reference to the accompanying drawings.
The disposable drug core assembly 300 filled with the dosage form is prepared and the disposable drug core assembly 300 is mounted to the front end of the lumen 500. At this time, the striker assembly 200 is positioned at the rearmost end (i.e., initial position) by the elastic restoring force provided by the restoring member 400, the second predetermined distance between the front end surface 203B of the positioning sleeve 203 and the front inner wall 103 of the housing 100 is L2, and the distance between the front end surface 206 of the striker 201 and the rear end surface 303 of the push rod 302 is L1 (see fig. 1 and 2 in cooperation).
Actuation of trigger 701 (i.e., actuation of the needleless injector) causes forward movement of strike assembly 200 and acquires impact momentum while overcoming the elastic return force of return member 400, such that strike assembly 200 moves forward, the momentum of strike assembly 200 being in the range of 0.21 kg-m/s to 2 kg-m/s.
When the striking part 201 moves forward (L2-L1), the front end surface 206 of the striking part 201 strikes against the rear end surface 303 of the push rod 302, and the push rod 302 is pushed forward, so that the liquid medicine in the disposable cartridge assembly 300 starts to be ejected until the front end surface 203B of the positioning sleeve 203 contacts the front inner wall 103 of the housing 100, at which time an injection is completed, at which time the push rod 302 moves forward (L2-L1) for a distance (see fig. 9 and 10 in cooperation). The front end surface 203B of the positioning sleeve 203 contacts the front inner wall 103 of the housing 100 and is blocked by the front inner wall 103, thereby realizing positioning.
After a single injection is completed, the trigger 701 is released to disconnect the power source, and the striker 201 can be moved back to the initial position, i.e., reset the striker assembly 200, by the elastic reset force provided by the reset member 400.
At this time, since the push rod 302 has moved forward a distance, the lumen 500 is rotated, so that the lumen 500 is rotated by 180 ° to the right along the rear end thread, and the position of the disposable drug core assembly 300 is adjusted, so that the next injection can be performed, accurate adjustment of the injection dosage can be achieved through the above steps, and the momentum of each single injection is ensured to be basically consistent. For the embodiment of fig. 1 and 3, the number of positioning grooves 501 is 2, which can be rotated to turn the lumen 500 right an integer multiple of 180 ° along the rear end thread, i.e., 180 °, 360 °, 540 °, 720 °, etc.
In the case of N locating grooves 501, it is possible to rotate (360/N) an integer multiple.
At the initial stage of this rotation process, the spring positioning spring 601 is further compressed such that the ball end of the spring positioning spring 601 slides from the bottom of the previously fitted positioning groove 501 to the outer circumferential surface of the lumen 500 along the side of the positioning groove 501.
In the middle stage of this rotation process, the ball end of the spring positioning spring 601 slides along the outer circumferential surface of the lumen 500 to the other positioning groove 501, and the spring positioning spring 601 maintains the same degree of compression (i.e., the maximum degree of compression).
At the end of this rotation process, the ball end of the spring positioning spring 601 slides from the outer circumferential surface of the lumen 500 along the side of the other positioning groove 501 to the bottom of the other positioning groove 501, at which stage the spring positioning spring 601 gradually returns to the original compressed degree. When the ball end of the spring positioning spring 601 slides to the bottom of the other positioning groove 501, the lumen 500 is locked again by the spring positioning spring 601.
The injection depth is related to the penetration ability of the jet, and the method for evaluating the injection depth comprises the following steps:
(1) Skin B-mode, for small doses of injections, the skin B-mode image display is not clear and therefore is less used. (2) The injection effect of the volunteers is observed and compared, and the skin has poor puncture capability and more leakage, skin hills are generated, the skin has strong puncture capability and less leakage, and no hills or Pi Qiuxiao even has micro bleeding. (3) The puncture capability is stronger, the number of layers penetrating through the plastic film is larger. For small-dose injection, the latter two methods are mainly used for judging the injection depth, and the two methods are combined.
The applicant has carried out a plurality of experiments on the needleless injector with the disposable drug core for single-charge and multiple injections, and the experimental data are shown in the following table:
TABLE 1
Experimental data illustrates:
1. momentum: the amount of momentum in the test data is controlled by changing the mass of the impact assembly and the impact spacing. The test uses special equipment, and the impact distance and the impact assembly quality can be conveniently adjusted.
2. Stagnation pressure: refers to the pressure generated in the liquid medicine in the injection process of the needleless injector, and the expression modes of liquid medicine pressure, stagnation pressure and stop pressure are provided. All the experimental data were tested at the same stagnation pressure, 20MPa.
3. Liquid-to-liquid ratio at injection: indicating the ratio of the volume of the drug solution at the time of injection within the disposable drug core assembly to the maximum volume that can be accommodated. The injection penetration depth is greatly affected when proper momentum is not used, and the penetration capability is different due to different liquid volumes, different liquid compression amounts and different drug core expansion.
4. Injection completion rate: indicating the ratio of the volume of liquid injected into the subject to the volume injected in a single injection, a larger value indicating a greater volume injected into the subject.
5. Number of plastic film puncture layers: the number of layers of plastic film that can be pierced when a certain combination of parameters is used. The more the number of piercing layers indicates the stronger the injection piercing capability, the deeper the piercing.
6. The same momentum puncture layer RSD: the larger the value of the relative standard deviation of the number of puncture layers of the plastic film under the same momentum, the worse the repeatability, the larger the number of puncture layers, and the more unstable.
7. The injection completion rate and the number of plastic film puncture layers in the table are the average values of a plurality of tests.
The relationship between the magnitude of the momentum P and the injection effect can be derived from the above table:
1. when 0 kg.m/s < P < 0.21 kg.m/s, injection cannot be completed even at a high stagnation pressure.
2. When P is less than or equal to 0.21 kg.m/s and less than or equal to 0.3 kg.m/s, the injection completion rate is relatively low, so that the waste of the injection liquid medicine is caused.
3. When P is more than or equal to 0.3 kg.m/s and less than or equal to 0.7 kg.m/s, the injection completion rate is more than 90%, the number of the plastic film puncture layers is not more than 10, the RSD value of the plastic film puncture layers is less than 10%, and the stability is good.
4. When 0.7 kg.m/s < P is less than or equal to 1.0 kg.m/s, the injection completion rate and the RSD value of the puncture layer number of the plastic film are good, but the puncture layer number of the plastic film exceeds 10 layers, the maximum is 15 layers, the injection effect is achieved, the injection depth is large, and the injection damage is large, so the injection effect is inferior to the injection effect with the momentum of 0.3 (containing) to 0.7 (containing) kg.m/s value.
5. When 1.0 kg.m/s < P.ltoreq.2.0 kg.m/s, the injection completion rate becomes relatively low, and the number of puncture layers RSD of the plastic film exceeds 20%, and the injection stability becomes poor. Because the momentum exceeds the stable value of the injection system, the leakage condition exists in the sealing structure inside the disposable injection core component, and although the injection can be completed, the stability is poor, and the stability of the injection depth is not as good as the range of 0.3-0.7 kg-m/s.
6. When P is more than 2.0 kg.m/s, the disposable injection core component cannot bear the momentum, and the push rod can be bent and deformed during injection, so that the liquid medicine cannot be sprayed.
Embodiments of the present invention merely provide an example of a gun-structured needleless injector that improves the depth non-uniformity of multiple injections of a single charge by imparting a certain impact momentum to the plunger 302 at each single injection, and achieves that small doses may be injected as well. This principle can equally be applied to spring powered injectors, pen-type pneumatic injectors, electric drives etc.
For convenience in explanation and accurate definition in the appended claims, the terms "upper", "lower", "inner", "outer", "upper", "lower", "upwardly", "downwardly", "front", "rear", "back", "inner", "outer", "inwardly", "outwardly", "inner", "outer", "outwardly", "forwardly", "rearwardly" are used to describe features of the exemplary embodiments with reference to the positions of such features as displayed in the figures.
The foregoing description of specific exemplary embodiments of the invention has been presented for the purposes of illustration and description. The foregoing description is not intended to be exhaustive or to limit the invention to the precise form disclosed, and obviously many modifications and variations are possible in light of the above teaching. The exemplary embodiments were chosen and described in order to explain the specific principles of the invention and its practical application to thereby enable others skilled in the art to make and utilize the invention in various exemplary embodiments and with various alternatives and modifications. The scope of the invention is defined by the appended claims and equivalents thereof.

Claims (21)

1. A method of configuring a disposable drug-filled single-charge multiple-injection needleless injector comprising:
a) Providing a housing having a mounting cavity;
b) An impact assembly is arranged in the mounting cavity of the shell;
c) Mounting a single-charge, multi-injection disposable cartridge assembly to the housing;
d) Such that a first predetermined distance exists between the impact portion of the impact assembly and the push rod of the disposable cartridge assembly prior to each injection and the momentum of the impact assembly is in the range of 0.21 kg-m/s to 2 kg-m/s when each injection is administered.
2. The method of configuring a single-charge multiple-injection needleless injector with a disposable drug core of claim 1, wherein the first predetermined spacing is greater than or equal to 1mm.
3. The method of configuring a single-charge multiple-injection needleless injector with a disposable cartridge of claim 1, wherein the momentum of the strike assembly is in the range of 0.21 kg-m/s to 1 kg-m/s at the time of each injection.
4. The method of configuring a single-charge multiple-injection needleless injector with a disposable cartridge of claim 1, wherein the momentum of the strike assembly is in the range of 0.3 kg-m/s to 0.7 kg-m/s at the time of each injection.
5. The method of configuring a single-charge multiple-injection needleless injector of claim 1, wherein a reset member is disposed within a mounting cavity of said housing, said reset member being mounted to said mounting cavity and capable of providing a resilient reset force to said strike assembly such that said strike assembly resets after each injection.
6. The method of configuring a single-charge multiple-injection needleless injector of claim 1, wherein the single-charge multiple-injection needleless injector of the single-charge further comprises:
and the cavity tube is connected to the front end of the mounting cavity in a threaded manner, the front end of the impact part extends into the cavity tube, and the rear end of the push rod extends into the cavity tube.
7. The method of configuring a single-charge multiple-injection needleless injector of claim 6 wherein the disposable cartridge assembly further has a cartridge detachably connected to a front end of the lumen.
8. The method of configuring a single-charge multiple-injection needleless injector of claim 6, wherein said single-charge multiple-injection needleless injector of said single-charge further comprises:
a spring positioning ball mounted to an inner sidewall of a front end of the housing;
the outer side wall of the front end of the cavity tube is provided with a positioning groove, and the spherical end of the spring positioning collision bead can be elastically inserted into the positioning groove.
9. The method of configuring a single-charge multiple-injection needleless injector with a disposable cartridge of claim 6, wherein a front end of said housing has a mounting barrel;
the needleless injector further comprises:
the front part of the screw sleeve wraps the cavity tube, and the rear part of the screw sleeve wraps the front part of the mounting cylinder; and
a spacer disposed between the front of the sleeve and the lumen.
10. A disposable drug-filled multiple shot needleless injector comprising:
a housing having a mounting cavity;
a strike assembly disposed within the mounting cavity of the housing, the strike assembly having a strike portion; and
a disposable drug core assembly mounted to the housing, the disposable drug core assembly having a push rod;
wherein the impact portion of the impact assembly is spaced a first predetermined distance from the push rod of the disposable cartridge assembly prior to each injection and the momentum of the impact assembly is in the range of 0.21 kg-m/s to 2 kg-m/s when each injection is administered.
11. The single-charge multiple-injection needleless injector of claim 10, wherein the first predetermined spacing is greater than or equal to 1mm.
12. The single-charge multiple injection needleless injector of claim 10, wherein the momentum of the ram assembly is in the range of 0.21 kg-m/s to 1 kg-m/s when each injection is administered.
13. The single-charge multiple injection needleless injector of claim 10, wherein the momentum of the ram assembly is in the range of 0.3 kg-m/s to 0.7 kg-m/s when each injection is administered.
14. The disposable drug-filled single-charge multiple-injection needleless injector of claim 10, further comprising:
a return member mounted to the mounting cavity and configured to provide a resilient return force to the impact assembly.
15. The disposable drug-filled single-charge multiple-injection needleless injector of claim 10, further comprising:
and the cavity tube is connected to the front end of the mounting cavity in a threaded manner, the front end of the impact part extends into the cavity tube, and the rear end of the push rod extends into the cavity tube.
16. The single-charge multiple-injection needleless injector of claim 15, wherein the disposable cartridge assembly further has a cartridge detachably connected to a front end of the lumen.
17. The disposable drug-filled multiple shot needleless injector of claim 15, further comprising:
a spring positioning ball mounted to an inner sidewall of a front end of the housing;
the outer side wall of the front end of the cavity tube is provided with a positioning groove, and the spherical end of the spring positioning collision bead can be elastically inserted into the positioning groove.
18. The single-charge multiple injection needleless injector of claim 17, wherein said positioning grooves are provided in a plurality and evenly distributed along the circumferential surface.
19. The disposable drug-filled single-charge multiple-injection needleless injector of claim 15, wherein a front end of said housing has a mounting barrel;
the disposable cartridge single-charge multiple-injection needleless injector further comprises:
the front part of the screw sleeve wraps the cavity tube, and the rear part of the screw sleeve wraps the front part of the mounting cylinder; and
a spacer disposed between the front of the sleeve and the lumen.
20. The single-charge multiple injection needleless injector of claim 19, wherein said barrel comprises a barrel body and a baffle extending radially inward from a forward end of the barrel body.
21. The disposable drug-filled single-charge multiple-shot needleless injector of claim 19, wherein said strike assembly further comprises;
a piston slidably mounted in the mounting chamber, a rear end of the striking portion being fixedly secured to the piston;
the rear end of the positioning sleeve is fixedly connected to the piston, the positioning sleeve is provided with a containing cavity penetrating through the positioning sleeve in the front-rear direction, the reset member is sleeved on the positioning sleeve, a second preset distance exists between the positioning sleeve and the front inner wall of the shell before each injection, and the second preset distance is larger than the first preset distance.
CN202410220684.XA 2024-02-27 2024-02-27 Needleless injector with disposable medicine core for single-charge and multiple-injection and configuration method thereof Active CN117861021B (en)

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