WO2014042930A1 - Injecteur hypodermique sans aiguille et procédé associé - Google Patents

Injecteur hypodermique sans aiguille et procédé associé Download PDF

Info

Publication number
WO2014042930A1
WO2014042930A1 PCT/US2013/058013 US2013058013W WO2014042930A1 WO 2014042930 A1 WO2014042930 A1 WO 2014042930A1 US 2013058013 W US2013058013 W US 2013058013W WO 2014042930 A1 WO2014042930 A1 WO 2014042930A1
Authority
WO
WIPO (PCT)
Prior art keywords
ampule
injector
spring
elongated body
elongated
Prior art date
Application number
PCT/US2013/058013
Other languages
English (en)
Inventor
Masayoshi Fukushima
Original Assignee
Hns International, Inc.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Hns International, Inc. filed Critical Hns International, Inc.
Publication of WO2014042930A1 publication Critical patent/WO2014042930A1/fr

Links

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
    • 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
    • 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
    • A61M5/3129—Syringe barrels
    • A61M2005/3142—Modular constructions, e.g. supplied in separate pieces to be assembled by end-user
    • 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
    • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • 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
    • A61M5/3129—Syringe barrels
    • A61M5/3135—Syringe barrels characterised by constructional features of the proximal end

Definitions

  • Needleless hypodermic drug delivery systems are generally discussed with particular discussions on spring actuated jet injection devices that avoid piercing the skin by utilizing a high pressure liquid stream to pass a medicament or other liquid through the skin. Jet injection devices having easy release mechanism for separating the power source from the injector body are also disclosed. Quick release ampules for use with spring injectors and ampules with reinforcement mechanisms are also disclosed. BACKGROUND
  • Jet injection devices administer intramuscular and subcutaneous medications without the use of needles.
  • Many advantages of jet injection are the reduction of pain and apprehension associated with needles, the elimination of needle stick injuries and the reduction of environmental contamination associated with needle disposal. Jet injection devices are useful in a wide range of drug therapies including immunization vaccines, hormones and local anesthetics, as well as the administration of insulin to the diabetic population, where individuals may require a number of daily injections.
  • drug therapies including immunization vaccines, hormones and local anesthetics, as well as the administration of insulin to the diabetic population, where individuals may require a number of daily injections.
  • their use has become of increasing interest, particularly by persons of limited physical ability such as the elderly, or the very young.
  • Injectable medications fall into two different categories; namely, unit dose drugs such as vaccines and analgesics and variable dose drugs such as insulin where the dose size must be adjusted to meet the immediate needs of the individual at the time of administration.
  • unit dose drugs such as vaccines and analgesics
  • variable dose drugs such as insulin where the dose size must be adjusted to meet the immediate needs of the individual at the time of administration.
  • Insulin doses are typically marketed in 3 ml and 5 ml syringe cartridges, as well as provided in bulk in a standard 10 ml medication vial.
  • Injectors, injection drivers,or drive ends for imparting pressure to ampules filled with a fluid medicament may be equipped with a gas cartridge, such as a C0 2 cartridge, or a spring source for driving a piston to generate the needed pressure.
  • a gas cartridge such as a C0 2 cartridge
  • a spring source for driving a piston to generate the needed pressure.
  • the cartridge and/or the spring source makes recycling the injector a difficult task, if not impossible.
  • an ampule comprising: a body, a proximal opening at one end of the body, and a discharge end comprising a discharge tip having a nozzle in communication with an interior wall surface defining an interior cavity.
  • a plunger is disposed at least partially within the interior cavity of the body, the plunger comprising a plunger tip in dynamic sealing arrangement with the interior wall surface of the body.
  • a quick connect engagement mechanism is provided on the body. The quick connect comprising at least two spaced apart tapered engagement surfaces formed exteriorly of body; and wherein the body is made from a cyclo-olefin-copolymer material.
  • a further aspect of the present disclosure includes a drive end for a needleless injector device.
  • the drive end comprising: an elongated body comprising a distal end comprising a distal opening, a proximal end comprising a proximal opening, an interior surface defining an interior cavity, and a channel disposed exteriorly adjacent the proximal opening, a trigger pivotably disposed about an exterior of the elongated body comprising a latch pin holding a piston against an expansion force of a spring, said piston comprising a shoulder in contact with the spring; an end cap engaging the channel of the elongated body to close the proximal opening; and wherein the spring exerts a spring force against an interior face of the end cap.
  • the injector device can further comprise an ampule attached to the distal opening of the elongated body.
  • the injector device can further comprise a plurality of spaced apart tines at the distal opening of the elongated body for connecting with an ampule.
  • the injector device wherein the end cap can comprise a flange for engaging the channel and a second flange for engaging a second channel disposed exteriorly adjacent the proximal opening of the elongated body.
  • the injector device wherein the channel and the second channel can be tapered so that the flange and the second flange are loosely held therein and are pivotable therein.
  • the injector device can further comprise a boss and a pin for securing the cap to the elongated body.
  • the injector device wherein the pin can be located on the elongated body.
  • the injector device can further comprise an outer layer disposed around the ampule.
  • the injector device wherein the outer layer can comprise an end wall comprising an opening and wherein the opening on the end wall is disposed around a nozzle on the ampule.
  • a still further aspect of the present disclosure is a needleless injector device.
  • the needleless injector device comprising an ampule and a drive end.
  • the ampule comprising a body made from a cyclo-olefin-copolymer material, a proximal opening at one end of the body, and a discharge end comprising a discharge tip having a nozzle in communication with an interior wall surface defining an interior cavity; a plunger disposed at least partially within the interior cavity of the body, the plunger comprising a plunger tip in dynamic sealing arrangement with the interior wall surface of the body of the ampule.
  • the drive end comprising an elongated body comprising a distal end comprising a distal opening having the plunger projecting theretlirough, a proximal end comprising a proximal opening, an interior surface defining an interior cavity, and a channel disposed exteriorly adjacent the proximal opening, a trigger pivotably disposed about an exterior of the elongated body comprising a latch pin holding a piston against an expansion force of a spring, said piston comprising a shoulder in contact with the spring; an end cap engaging the channel of the elongated body to close the proximal opening; and wherein the spring exerts a spring force against an interior face of the end cap.
  • a needleless injector assembly comprising: an ampule and a drive end.
  • the ampule comprises a body, a proximal opening at one end of the body, and a discharge end comprising a discharge tip having a nozzle in communication with an interior wall surface defining an interior cavity.
  • a plunger is disposed at least partially within the interior cavity of the body of the ampule.
  • the plunger comprising a plunger tip in dynamic sealing arrangement with the interior wall surface of the body.
  • a quick connect engagement mechanism is located at a proximal end of the body comprising a flange engaged to a connection mechanism on the drive end, which comprises a spring.
  • the connection mechanism can comprise a plurality of spaced apart tines.
  • the drive end comprises an end cap removably engaged to an exterior surface a housing body of the drive end, the spring applying a first force against the end cap when cocked and applying a second lower force against the end cap when no longer cocked.
  • the needleless injector assembly can further comprise a sleeve mounted over the discharge end of the ampule.
  • the needleless injector assembly wherein the sleeve extends proximally over the body of the ampule.
  • the needleless injector assembly wherein the sleeve can further comprise a body sleeve mounted over the body of the ampule and spaced from the sleeve.
  • a further aspect of the assembly comprises closing ring for closing the tines over the quick connect engagement mechanism on the body.
  • a further aspect of the present device, system, and method include a drive end for a needleless injector device comprising an elongated body comprising a distal end comprising a distal opening and a plurality of spaced apart tines, a proximal end comprising a proximal opening, an interior surface defining an interior cavity, and a channel disposed exteriorly adjacent the proximal opening.
  • a trigger can be mounted pivotably to the elongated body and disposed about an exterior of the elongated body comprising a latch pin or trigger finger holding a piston against an expansion force of a spring.
  • the piston can comprise a shoulder in contact with the spring and an end cap can engage the channel of the elongated body to close the proximal opening; and wherein the spring exerts a spring force against an interior face of the end cap.
  • the drive end can further comprise an ampule comprising a flange mechanically coupled to the plurality of tines.
  • a still further aspect of the present disclosure is a method for separating metallic from thermoplastic components in a needleless injector device or assembly comprising the steps of sliding an end cap radially relative to a longitudinal length of a drive end; exposing a proximal opening of the drive end; and removing the spring from the drive end.
  • Yet another aspect of the present disclosure is a method for manufacturing a needleless injector assembly.
  • the method can comprise the steps of forming an ampule from a first material, the ampule comprising an elongated body having an exterior surface, an interior surface, an open proximal end, and a distal wall comprising a nozzle having a lumen passing through the distal wall and placing a plunger comprising a plunger tip in dynamic sealing arrangement with the interior surface of the ampule.
  • the method can further include the steps of forming an injector body comprising an elongated injector body comprising a distal end comprising a distal opening having the ampule attached thereto, a proximal end comprising a proximal opening, an interior surface defining a bore with an interior cavity, and a channel disposed exteriorly adjacent the proximal opening; placing a piston and a spring inside the bore of the elongated injector body; mounting a trigger to the elongated injector body, the trigger comprising a latch pin for holding the piston against an expansion force of the spring; and placing an end cap at the proximal end of the elongated injector body to close the proximal opening; wherein the end cap is pivotable about a lengthwise axis of the injector body when not under full biasing force of the spring.
  • an outer layer having an elongated body made of a second material can be disposed over the elongated body of the ampule and wherein the outer layer comprises a
  • the method can further comprise pushing the piston to compress the spring prior to attaching the ampule to the elongated injector body.
  • the method can further comprise heating the elongated body of the outer layer to shrink the length or the inside diameter.
  • the cap can have two inside flanges for engaging two corresponding channels on the elongated injector body.
  • a still yet further feature of the present disclosure include an impact resistant ampule for use in a needleless injection.
  • the impact resistant ampule comprises a body comprising an interior surface and an exterior surface, a proximal end comprising a proximal opening at one end of the body, and a discharge end comprising a discharge tip having a nozzle in
  • the ampule can include a connect engagement mechanism at the proximal end for connecting to a spring injector.
  • An outer layer comprising an elongated body having a length and a bore made from a second material is disposed over and tightly fitting around the exterior surface of the body so as not to slip off of the body.
  • the first material is more rigid than the second material.
  • the impact resistant ampule wherein the connect engagement mechanism can comprise at least two spaced apart tapered engagement surfaces formed exteriorly of the body.
  • the impact resistant ampule wherein the outer layer can be made from a shrink wrap material having an inside diameter that is larger than an outside diameter of the body prior to being subject to heat.
  • the impact resistant ampule wherein the outer layer can include an elongated body comprising an open proximal end and an open distal end.
  • the impact resistant ampule wherein the outer layer can have an elongated body comprising an open proximal end and a distal wall comprising a distal opening having a perimeter that is smaller in dimension than an inside diameter of the elongated body.
  • the impact resistant ampule can further comprise an injector end connected to the ampule, the injector end comprising an injector body defining a bore having a piston pushing against a spring located therein to compress the spring and wherein a latch pin operatively mounted to the injector body abuts the piston to hold the spring in a compressed state.
  • the impact resistant ampule can further comprise a trigger having a push end for triggering to release the spring; wherein the push end of the trigger faces a proximal end of the injector body and away from a distal end of the injector body to facilitate triggering by a user.
  • the impact resistant ampule wherein a blister pack comprising a cavity having a peelable cover can be placed around the ampule.
  • the ampule can be packaged inside a blister pack.
  • FIG. 1 is a schematic side view of a needleless injector device provided in accordance with aspects of the present disclosure.
  • FIG. 2 is a perspective exploded view of the needleless injector device of FIG. 1 , which shows the discharge end separated from the drive end.
  • FIG. 3 is a schematic partial cross-sectional side view of the needleless injector device of FIG. 1, which shows a motive force in a ready to use state to propel a piston.
  • FIG. 4 is a schematic partial cross-sectional side view of the needleless injector device of
  • FIG. 3 with the safety lock released so that the trigger may be pressed to deliver a fluid.
  • FIG. 5 is a schematic partial cross-sectional side view of the needleless injector device of FIG. 4 with the trigger depressed to release the spring and the spring released to propel the piston.
  • FIG. 6 is an expanded view of the proximal end of the drive end, which shows the end cap engaged to the elongated body and a secure pin projecting into a secure boss when the spring is compressed.
  • FIG. 7 is an expanded view of the proximal end of the drive end, similar to FIG. 6, which shows the end cap engaged to the elongated body and a secure pin projecting into a secure boss when the spring is released.
  • FIG. 8 is a schematic partial cross-sectional side view of the needleless injector device of FIG. 5 with the end cap partially removed from the proximal end of the elongated body of the drive end.
  • FIG. 9 is a schematic partial cross-sectiofial side view of the needleless injector device of FIG. 5 with the end cap completely removed from the proximal end of the elongated body of the drive end.
  • FIG. 10 is a perspective exploded view of an alternative needleless injector device, which shows a discharge end separated from a drive end.
  • FIG. 1 1 is an exploded perspective view of a drive end of a needleless injector assembly provided in accordance with further aspects of the present disclosure.
  • FIG. 1 1 A is a perspective view of a piston provided in accordance with the present disclosure.
  • FIG. 12 is an assembled view of the drive end of FIG. 1 1.
  • FIG. 13 is a further assembled view of the drive end of FIG. 1 1.
  • FIG. 14 is a completed assembled view of the drive end of FIG. 11.
  • FIG. 15 is a perspective view of an ampule with plunger in the process of being mounted to the drive end of FIG. 14.
  • FIG. 16 is an assembled perspective view of a needleless injector assembly provided in accordance with aspects of the present disclosure.
  • FIG. 17 is a perspective view of an ampule and plunger with different sleeve
  • FIG. 18 is a perspective view of the ampule of FIG. 17 with a discharge end sleeve and body sleeve positioned over the body of the ampule.
  • FIG. 19 is a perspective view of the ampule of FIG. 17 with one-piece sleeve positioned over the body of the ampule.
  • FIG. 20 is a perspective view of an alternative outer layer for placing over an ampule.
  • FIG. 21 is a perspective view of another alternative outer layer for placing over an ampule.
  • FIG. 22 is a perspective view of a roll of shrink wrap sheet or stretch wrap sheet for use with an ampule.
  • FIG. 23 is a cross-sectional side view of a needleless injector assembly provided in accordance with further aspects of the present disclosure in a ready to use position.
  • FIG. 24 is a cross-sectional side view of the needleless injector assembly of FIG. 23 with the spring being released or following released of the spring.
  • FIG. 1 is a schematic side view of a needleless injector device or needleless injector assembly provided in accordance with aspects of the present system, device and method, which is generally designated 10.
  • the needleless injector device 10 comprises a drive end component 12, or drive end for short, and a discharge end component 14, or discharge end for short.
  • the drive end 12 also sometimes refers to as an injection driver, injector end, spring end or simply injector, comprises an elongated body or housing 16 comprising a trigger 18 for holding back and subsequently releasing a motive force located inside the elongated body 16 when discharged to propel a piston (See 56 of FIGs. 3 and 4), also located inside the elongated body, to then propel a plunger (70 of FIG.
  • the drive end 12 comprises a safety mechanism or safety lock 20 that is displaceable to allow the trigger 18 to be activated.
  • the safety lock 20 is a ring that is slidable about the elongated body 16 to unlock the trigger, such as to provide space for the trigger to be depressed.
  • the safety lock 20 is rotatable or pivotable to unlock the trigger, such as to provide space for the trigger to move, pivot or rotate.
  • the safety lock 20 is both slidable and rotatable to unlock the trigger.
  • the safety feature comprises a frangible tab that is removable to provide space for the trigger 18 to be depressed or released.
  • the discharge end 14 is configured to hold a volume of fluid, such as a fluid medicament, vaccine, flu shot, insulin, local anesthesia, lidocaine, tetanus shot, etc., for subcutaneous delivery to a patient.
  • a volume of fluid such as a fluid medicament, vaccine, flu shot, insulin, local anesthesia, lidocaine, tetanus shot, etc.
  • the discharge end 14 is an ampule comprising a discharge head 22 having a discharge tip 24 and a discharge base 25 having a flange 26 and a coupling end 28 (FIG. 2), which in the present embodiment comprises a threaded end.
  • the discharge head 22 is shown relatively larger in cross-sectional dimension than the body 21. In other examples, the two are the same or the body is larger.
  • the coupling end 28 is a quick release end without threads.
  • the discharge end 14 is configured to threadedly engage with or to the drive end 12.
  • the ampule has a quick release cam surface for engaging a mating surface on the discharge end, as further discussed below.
  • the drive end 14, for example an ampule has an elongated body 21 of a size and dimension for sufficiently holding a desired volume of fluid medicament for subcutaneous delivery to a patient.
  • the assembly 10 is sized for use in dental applications, such as for delivering local anesthesia to the gum or mouth.
  • the discharge end 14 is made from a cyclo-olefin-copolymer (COC) material, such as from TOPAS and APEL Mitsui Chemical of Japan. It is believed that fluid medicament may be stored in the ampule made from COC for a much longer period than for ampules made from other thermoplastic or engineered plastic materials. This allows for the ampules to be pre-filled and stored with different fluid medicaments and refrigerated so that they may be readily available for use with drive ends of the present disclosure.
  • the discharge end 14 is made from a plastic material, such as a thermoplastic material, selected to have impact resistant characteristics.
  • the discharge end may be made from plastic injection molding using an acrylic-based polymer, such as ACRYLITE® and HYGARD®, the latter being made from a multi-layer of polycarbonate and acrylic.
  • the discharge end 14 may be made from plastic injection molding using a polycarbonate (PC)- based material, such as LEXAN®, MAR OLON®, SAFEGUARD®, and SAFEGUARD HARDCOAT®.
  • the discharge end 14 may be made from plastic injection molding using a polyethylene (PE)-based material, such as POLYSTONE® PG100, POLYSTONE® 500, and POLYSTONE® MATROX.
  • PC polycarbonate
  • PE polyethylene
  • the drive end 12 is preferably made from a hard plastic, such as high density polyethylene (HDPE), polycarbonate (PC), polyvinyl chloride (PVC), COC or other comparable hard plastic.
  • the elongated body 16 is made from two separate housing halves, such as by plastic injection molding two different opaque sections, that are joined together along an lengthwise seam by welding, gluing, detents, or combinations thereof.
  • the elongated body 16 may comprise a plurality of ribs 30, such as elongated ribs, that extend at least partially along the length of the elongated body.
  • the body has a smooth outer surface contour, a plurality of bumps or projections, or combinations thereof.
  • a pair of mounting flanges 32a, 32b are provide near the distal end 34 of the drive end 12 with each comprising a cradle 36 for receiving or accommodating a pivot pin or shaft 38.
  • the pivot shaft 38 is operatively connected to the trigger 18 so that when the trigger is pushed, it rotates about the pivot shaft 38.
  • the trigger 18 is shown with a plurality of exterior gripping features 33, which are ribs, projections, or bumps formed on the outer surface to facilitate gripping.
  • a pin is connected or mounted with the body 16 of the discharge end 12 and the trigger 18 is equipped with a pair of cradles (similar to cradle 36) for snapping onto the pin mounted to the injector body 16.
  • FIG. 2 is an exploded perspective view of the assembly 10 of FIG. 1.
  • the drive end 12 comprises a distal opening 40 comprising a threaded bore 42 for receiving the threaded end 28 of the discharge end 14, such as the ampule.
  • a rail or track 41 at the distal end 34 of the drive end 12 for accommodating a channel 44 formed in the interior bore of the safety lock 20 to ride therealong and for rotational alignment.
  • the track 41 ensures the ring is rotationally aligned so that a protrusion or raised bump 46 formed on the exterior surface of the safety ring 20 aligns with the trigger 18 so as to provide a physical presence under the trigger to prevent the trigger from triggering until the obstruction is removed.
  • An end cap 50 is provided at the proximal end 48 of the drive end 12.
  • the end cap 50 is provided to cover or close-off the proximal opening 49 (FIG. 5) of the elongated body 16 after installation of various injector components.
  • the end cap 50 is threadedly engaged to threads located on the elongated body 16.
  • the end cap 50 is provided with a slidable mechanism for engaging
  • the end cap 50 can comprise an end wall and a rim having an open passage through the rim so that the cap can slide over the proximal opening via the passage through the rim.
  • Flanges are formed on the rim of the cap to then engage tracks or channels on the elongated body 16 to secure the cap thereto from axial displacement.
  • a detent such as a pin and a boss, may be used to secure the cap to the elongated body from being displaced radially relative to the lengthwise axis of the body 16.
  • the slidable mechanism permits easy subsequent removal of the end cap 50 from the elongated body 16 to expose the proximal opening 49 to facilitate optional removal of the motive force located inside the elongated body 16.
  • the ampule 14 includes an enlarged discharge head 22, which is larger in outside diameter than the outside diameter of the elongated body 21.
  • the enlarged discharge head 22 has a generally constant outside diameter along a length of about 10% to about 35% of the total length of the ampule 14.
  • the wall thickness is constant and the enlarged discharge head is omitted.
  • the discharge head 22 comprises a plurality of generally parallel fins 52 to facilitate gripping when mounting the discharge end 14 onto the drive end 12.
  • at least one outlet nozzle is provided at the discharge tip 24.
  • the outlet nozzle which can have a diameter or bore size in the range of four thousandths to twelve thousandths, is sized and shaped to allow fluid inside the ampule to be discharged therethough to subcutaneously deliver an injection to a patient.
  • a plunger 70 is provided in the interior cavity of the ampule (See also FIGs. 23 and 24). When the plunger 70 is advanced, it pushes fluids inside the ampule out the discharge nozzle.
  • the plunger 70 has a plunger tip (FIGs. 23 and 24, 285) for dynamically sealing against the interior surface of the ampule to discharge fluid out the nozzle, similar to a plunger inside a barrel of a syringe.
  • FIG. 3 shows a schematic partial cross-sectional side view of the needleless injector assembly 10 of FIGs. 1 and 2 with a helical spring 54 and a piston 56 positioned inside the interior cavity or bore 58 of the elongated body 16 of the drive end 12.
  • the piston 54 is shown with a piston head 53 and a piston stem 55 defining a shoulder therebetween.
  • the length of the stem 55 can vary.
  • the spring 54 which is made from a metal, such as from carbon steel, is shown in a compressed state with the piston 56 moved proximally of the latch pin 60 located on the trigger 18, which abuts the piston face 61 to hold the piston which then holds the spring 54 in compression.
  • the spring 54 may be compressed or set to compress in the manner shown and described in the '911 , ⁇ 89 and '972 patents.
  • the latch pin 60 is a projection formed integrally or unitarily with the trigger 18. In another example, the latch pin is separately formed and subsequently attached to the trigger 18.
  • the compressed spring 54 exerts a high spring force against both the shoulder 62 on the piston 56 and the interior surface 64 of the end cap 50.
  • the spring force causes a secure pin 66 located at the proximal end 48 of the body 16 and a secure boss 68, similar to a bore or a recess, located on the end cap 50 to engage. This engagement prevents the cap from sliding radially to separate from the engagement between the flanges on the cap and the channels on the elongated body 16. This feature allows the end cap 50 to latch onto the elongated body 16 and held at the proximal end 48 of the elongated body.
  • the cap has two channels and the elongated body 16 has two flanges that engage the channels to secure the cap to the body 16.
  • the spring force acting on the end cap 50 provides added resistance against potential unlatching between the secure pin 66 and the boss 68.
  • the spring force causes the pin 66 to engage the secure 68 to prevent sliding the cap radially relative to the lengthwise axis of the body until the spring force is reduced or removed.
  • the cap 50 has a pin and the elongated body 16 has a secure boss 68.
  • FIG 3 does not show a plunger 70 (FIG. 2) located inside the ampule for clarity.
  • the piston 56 is configured to push a proximal end of the plunger 70 when the trigger 18 is depressed to release the spring 54, which then forces the piston 56 to propel the plunger 70.
  • FIG. 4 depicts the assembly of FIG. 3 with the safety lock 20 moved forward or distally to move the exterior protrusion 46 (FIG. 2) on the safety lock 20 away from the trigger 18 and provide clearance for triggering.
  • FIG. 5 depicts the assembly of FIG. 4 with the trigger 18 depressed at the push end 364 to release or separate the latch pin 60 from the piston face 61.
  • the push end 364 of the trigger 18 is arranged to face or point in the distal direction, i.e., points towards the ampule.
  • This pushing of the trigger 18 releases the spring 54 and allows it to rapidly expand to propel the piston 56 into the plunger 70 (FIG. 2) to then propel the plunger into the interior of the discharge end component 14 to expel fluid out the nozzle at the discharge tip 24 of the discharge end or ampule 14. Consequently, an injection can be made by placing the discharge tip 24 of the injection assembly 10 against the body of a patient, pulling or depressing the trigger 18 to push on the plunger 70 (FIG. 2) and releasing fluid medicament held inside the hollow cylinder 21 of the discharge end 14 into the patient.
  • FIGs. 6 and 7 are expanded views of FIG. 5 taken at "A" without the spring 54 and shown under two different situations, when biased by the spring to cause engagement and when the bias force is reduced or removed.
  • the expanded spring 54 after fluid discharge, exerts a lower spring force on interior surface 64 of the end cap 50 than when in the compressed state in FIGs. 1 and 3. Consequently, less pressure is exerted on the end cap 50 by the spring and the cap is less torqued or slanted about its upper end 72, which is shown in the expanded view of FIG. 7. This less slanted position may further be facilitated by pushing on the cap near 72.
  • the cap 50 engages the body 16 using a slidable mechanism is further discussed below with reference to FIGs. 8 and 9.
  • the cap 16 is positioned generally square or vertical relative to the end edge of the body 16.
  • the spring 54 when the spring 54 is compressed as shown in FIGs. 3 and 4 and ready to be released when the trigger 18 is activated, the spring force exerts a greater outward force on the end cap 50 and causes it to slant to force the secure pin 66 and the secure boss 68 to engage, which is shown in the expanded view of FIG. 6.
  • the lower load on the end cap 50, after the spring expands, will allow a user to manipulate the cap to separate it from the drive end 12.
  • Removal of the end cap 50 allows the spring 54 to be removed from the elongated body 16 through the proximal opening 49 of the elongated body.
  • the remaining components of the needleless injector 10, after the spring 54 has been removed, are all or are mostly non-metallic and therefore can easily be placed into a recycling bin for recycling.
  • the separated spring 54 may be re-used, if desired, otherwise discarded in an appropriate bin for disposal or recycling.
  • the end cap 50 may be pushed in the distal direction near the upper end 72 of the cap with a finger or a thumb to further facilitate separating the secure pin 66 from the secure boss 68.
  • a finger and pushing the cap 50 near point 72 can reduce the slanting to separate the secure pin 66 from the retaining boss 68.
  • the ability of the cap to cant or slant is provided by an engagement between a flange inside a tapered channel.
  • the tapered channel which is wider at one end than the other, provides room for flange to move within the channel.
  • FIG. 8 is a schematic side view of the device of FIG.
  • FIG. 9 is a schematic cross-sectional side view of FIG. 8 with the cap further removed from the elongated body 16.
  • the end cap 50 incorporates two engagement flanges 78 (one shown) for mating engagement with respective channels 80 formed at the proximal end 48 of the elongated body 16.
  • the flanges 78 are formed on the rim 69 of the cap 50.
  • the channels 80 are each tapered by having a relatively large width at an end or edge of the body 16 with the trigger 18 and tapers inwardly as it proceeds downwardly towards the other edge of the injector body 16.
  • the parting line 77 defines a vertical plane running lengthwise with the injector assembly 10, one channel 80 is located on an outer surface of the body 16 on each side of the vertical plane.
  • the cap 50 has a corresponding flange 78 located on the inside or interior of the cap 50 for engaging the exteriorly located channels 80.
  • the tapered channel 80 narrows as it extends towards the terminal end or closed end 82 of the channel.
  • the end cap 50 closes off the proximal opening 49 of the elongated body 16 and the secure boss 68 and secure pin 66 cooperate to prevent the end cap 50 from being displaced therefrom, in addition to the spring force acting on the end cap to bias the pin and the secure boss to engage.
  • the tapered channels 80 provide a degree of freedom by allowing the engagement flanges 78 on the cap to move within the confines of the channels, as discussed above with reference to FIGs. 6 and 7. This is especially true after the spring 54 has released and a lower spring force is acting on the end cap 50, as shown in FIG. 5.
  • FIG. 9 shows the end cap 50 completely separated from the elongated body 16 and the spring 54 extending partially out of the proximal opening 49.
  • a user can easily remove the spring 54 and safely discard it, such by pulling the spring out of the elongated body with a hand or rotating the device 10 and pointing the proximal end down so that the spring 54 drops out of the proximal opening 49 under its own weight.
  • the cap 50 allows for an environmental friendly device that facilitates separating metallic components from non-metallic components for recycling.
  • the piston 56 is preferably incorporated with features to prevent it from coming out the proximal opening 49 when the spring is being removed.
  • the piston 56 is incorporated with a notch (not shown) on the enlarged drum or head 53 to prevent it from moving proximally of a plate or flange near the proximal opening.
  • a notch not shown
  • Other means for preventing the piston 56 from being displaced out of the proximal opening 49 may be used without deviating from the spirit of the present disclosure.
  • the present device, system, and method are understood to include a needleless injector comprising an ampule and a plunger located in an interior cavity thereof connected to an injector driver comprising an elongated body, a piston, a trigger, a compression spring, and an end cap; wherein the end cap is pivotable or cant-able from a more vertical position to a more slanted position relative to the lengthwise axis of the elongated body.
  • the cap may define a plane that is at about 65 to 85 degrees from perpendicular with the lengthwise axis of the elongated body when the spring is held compressed.
  • the cap 50 can then slant less from about 80 degrees to a generally vertical position at about 90 degrees with the lengthwise axis of the elongated body 16 when the spring 54 is no longer held compressed by any part of the trigger 18, whether directly or indirectly, such as when the spring expands following an injection.
  • a secure pin 66 and a secure boss 68 engage one another at the proximal end 48 of the elongated body 16 to secure the end cap 50 to the elongated body 50.
  • the end cap 50 being removable from the elongated body 16 by separating the secure pin 66 from the secure boss 68.
  • the end cap can slide radially relative to longitudinal length or axis of the elongated body 16 to separate the end cap 50 from the elongated body. This allows the user to readily remove various injector components from the elongated body to then recycle, re-use, and/or dispose.
  • the present disclosure is further understood to include an all elastic and/or thermoplastic needleless injector, other than for the spring, which is made from a metal.
  • the needleless injector may be placed inside a recycling bin for non-metallic materials to be recycled.
  • features of the present disclosure are understood to include an environmentally friendly device that is readily capable of recycling by allowing easy access to the components of the assembly to separate metallic from plastic components. In an example, this is facilitate by incorporating a cap with easy installation and removable to facilitate separation of the cap from the injector body for removal of metallic components from non-metallic components.
  • an alternative needleless injector 86 is shown with the discharge end 88 separated or spaced from the drive end 90.
  • the needleless injector 86 is substantially the same as the needleless injector 10 of FIG. 1 except for the engagement mechanism between the discharge end 88 and the drive end 90.
  • the engagement mechanism may be understood as a quick connect engagement mechanism to enable quick mounting of the discharge end 88 onto the drive end 90.
  • the discharge end 88 comprises a pair of engagement wings 90a, 90b for mating engagement with the pair of corresponding mating wings 92a, 92b on the drive end 90.
  • the engagement wings 90a, 90b on the discharge end each comprises a ramp 94 for sliding engagement with a tapered fm 96 formed on the mating wings 92a, 92b of the drive end 90.
  • the ramp 94 and the tapered fin 96 act like a cam and axially load the two surfaces when the proximal end 98 of the discharge end 88 is placed into the drive end 90 and rotated to engage the engagement wings 90a, 90b with the mating wings 92a, 92b.
  • the discharge end 88 is shown without a plunger to better show the engagement mechanism.
  • a plunger (similar to "70" in FIG. 2) would be disposed inside the discharge end 88 and partially extends outwardly of the proximal end 98.
  • Other alternatives may be used to engage the discharge end 88 with the drive end 90.
  • notches and/or other matching features may be incorporated on the discharge end 88 and the drive end 90 to ensure compatibility before they can be connected.
  • the present disclosure is understood to include a discharge end, such as an ampule, comprising a quick connect engagement mechanism.
  • the present disclosure is further understood to include a pair of spaced apart engagement wings disposed about a proximal opening of the ampule for engaging with a pair of mating wings.
  • three spaced apart engagement wings are provided, which are evenly spaced about the proximal opening of the ampule.
  • an injector end comprising a mating engagement mechanism is configured to quickly engage the engagement mechanism of the discharge end.
  • two mating wings are provided at a distal end of the elongated body of the drive end for engaging spaced apart engagement wings on the discharge end.
  • Other quick connect engagement mechanisms are contemplated, such as threads, detents, tongue and groove combination, etc.
  • FIG. 11 is a schematic exploded perspective view of a drive end 200 of an alternative needleless injector device or needleless injector assembly provided in accordance with further aspects of the present system, device and method.
  • the drive end 200 which may also be referred to as an injection driver, injector, power end, or spring end, comprises a multi-part housing 202, a motive force device 204, such as a metallic helical coil spring, a piston 206, and an end cap 208 for closing the proximal end 210 of the drive end 200.
  • a motive force device 204 such as a metallic helical coil spring
  • piston 206 a piston 206
  • end cap 208 for closing the proximal end 210 of the drive end 200.
  • internal engagement flanges 212 on the end cap 208 engages the external channel 214 on each of the two housing halves 202a, 202b, as discussed above.
  • FIG. 1 1 A shows a perspective view of the piston 206, which comprises a piston head 216 and a piston stem 218 having a stem length that can vary and having a shoulder located therebetween.
  • a piston stopper 220 is formed near the distal end 224 of the housing.
  • the piston stopper 220 defines an annular bore to permit cocking of the piston 206, such as by allowing a cocking tool to reach through the annular bore to compress the motive force device 204.
  • a trigger finger 240 on the trigger 242 (FIG. 3) is positioned distally of the piston head 216 to hold the motive force device in the compresses position, such as holding the distal face of the piston head.
  • connection mechanism 244 is formed at the distal end 224 of the drive end 200.
  • the connection mechanism 244 comprises spaced apart latching tines 246 each with internal gripping ridges or fingers 248 for gripping a discharge end component, such as an ampule.
  • the fingers are located interiorly on the latching tines 246 and ramped projections 250 are located exteriorly to enable a locking ring (FIG. 13, 272) to ride thereover to close the tines 246 over the discharge end component, such as an ampule, as further discussed below.
  • the tines 246 are molded with an outward bias so that the locking ring is needed to force the tines inward to close against the discharge end component.
  • a gap 252 is provided between two adjacent tines 246 to receive flanged sections of the discharge end component of ampule for alignment purposes.
  • the channels are reduced or omitted as the ampule can be provided as a round structure to eliminate alignment issue.
  • FIG. 12 is a perspective view of the drive end 200 assembled together and the seam 260 either welded or glued.
  • the end cap 208 can now slide over the proximal end 210 with the engagement flanges 212 sliding into the channels 214 located on either side of the housing 202 at the proximal end.
  • the drive end 200 is now ready to receive a trigger and a closing ring, as shown with reference to FIGs. 13 and 14, discussed below.
  • FIG. 13 shows a trigger 242 comprising a trigger finger 240 for projecting into the trigger hold slot 262 to hold the piston 206 and the motive force device 204 in the cocked or ready to use positioned.
  • the trigger 242 is assembled to the cradle 264 by pushing the two pivot pins 266 on either side of the trigger into the slotted receptacles 268 of the two cradles 264, one on each housing half. The relative dimensions of the slotted receptacles hold the pins 266 in place after they are pushed therein.
  • a rocker spring 270 is provided between the trigger 242 and the housing 202 to pivot the trigger about the two pivot pins 266. In on example, the rocker spring 270 may be omitted. In yet other examples, a compressible or elastic material, a leaf spring, or a V-spring may be used.
  • a closing ring 272 is shown for closing the tines 246.
  • the closing ring 272 may be placed over the tines 246 by temporarily biasing the tines inwardly towards a longitudinal axis of the housing 202 so that the opening of the closing ring 272 can fit over and slide onto the housing.
  • the closing ring 272 can further incorporate a trigger lock 274 that sits under the lock landing 276 on the trigger to provide a physical barrier against rocking or pivoting by the trigger, which prohibits the trigger from pivoting about the pivot pins.
  • the closing ring 272 and the connection mechanism 244 can further incorporate notches and detents for alignment purposes and for thwarting the closing ring 272 from being displaced off of the connection mechanism.
  • FIG. 14 shows the drive end 200 in the fully assembled position except for the end cap
  • the housing 202 may be assembled as shown and then the piston 206 and the spring 204 slid into the housing 202 via the proximal opening 280 at the proximal end 210 of the housing.
  • the end cap 208 is thereafter placed into engagement with the housing to close off the proximal opening 280.
  • the end cap 208 may be removed to enable separation of the metallic spring 204 from the other components of the injector end 200. This allows the drive end 200 and the discharge end component, such as an ampule, to be recycled without any metallic parts.
  • the trigger 242 may be removed from the housing 202 to enable removable of the rocker spring 270, if incorporated. If the rocker spring 270 is not incorporated, the drive end 202 may be recycled after the drive spring 204 is removed through the proximal opening 280.
  • FIG. 15 shows an ampule 282 with a plunger 284 positioned for mounting onto the drive end 200.
  • the ampule may be made from a cyclo-olefin-copolymer material (COC).
  • COC cyclo-olefin-copolymer material
  • the ampule 282 comprises a discharge end 286 comprising a discharge nozzle 287 and a mounting end 288 comprising a mounting flange 290 and a plurality of flange projections 292.
  • the flange projections 292 are sized and shaped to slide between the gaps 252 located between the plurality of tines 246 of the connection mechanism 244.
  • the flange 290 is sized and shaped to sit within the gripping ridges 248 formed interiorly of the tines. Distal movement of the closing ring 272 once the mounting end 288 is placed into the connection mechanism 244 will force the tines 246 to close down on the flange and secure the ampule 282 to the drive end 200.
  • FIG. 16 shows the ampule 282 attached to the drive end 200 to form a needleless injector device or assembly 300 capable of delivering a dosage of medicinal fluid subcutaneously when the closing ring 272 is moved distally out from under the trigger 242 and the trigger is pressed at the triggering end 302.
  • the assembly 300 can deliver a dosage subcutaneously without a needle.
  • FIG. 17 shows an ampule 282 with different optional outer sleeves or outer layers.
  • a discharge end sleeve 310 may be mounted over the discharge end 286 of the ampule 282.
  • the discharge end sleeve 310 may be made from a transparent or semi-translucent elastomeric or rubber material and placed over the discharge end 286 to cushion the contact between the ampule and the recipient of the fluid to be delivered.
  • the discharge and sleeve 310 has an end wall 375 and a skirt section 377.
  • a distal opening 312 is provided on the end wall 375 of the discharge end sleeve 310 to provide the needed opening for the discharge nozzle 288.
  • a body sleeve 314 comprising an elongated body section 379 for placement over the body 316 of the ampule 282.
  • both the discharge end sleeve 310 and the body sleeve 314 are placed over the ampule 282.
  • the combination discharge end sleeve and the body sleeve may be referred to as an outer layer, generically referred to as outer layer 330.
  • the discharge end component 282 may be made from a rigid plastic material and having an outer layer 330 placed thereover or thereon.
  • the outer layer 330 is made from a different material than the discharge end component 282.
  • the outer layer 330 is made or formed from two separate pieces while in other embodiments from a single piece, as further discussed below.
  • the body sleeve 314 of the outer layer 330 should extend more than half the length of the ampule. In a particular example, the length of the body sleeve should extend to the mounting flange 290, such as contact with or nearly contact with the mounting flange.
  • the length of the outer layer 330 can extend to around the half-way point of the length of the ampule and up to the mounting flange 290. If there is no mounting flange, then up to about the interface of the ampule and the injector end. It is believed that the impulse of force from the initial release of the motive force or spring 204 and subsequent rapid movement of the plunger into the ampule, such as upon releasing the spring of FIG. 9, can be dampened by the use of the outer layer 330. Thus, the outer layer 330 should have a tight formfitting configuration around the body 316 of the ampule to dampen some of the initial shock experienced by the ampule upon releasing the spring.
  • FIG. 17 also shows the outer layer 330 as a one-piece sleeve 318 for mounting over the ampule 282.
  • the one-piece sleeve 318 can be thought of as a combination of the discharge end sleeve 310 and the body sleeve 314.
  • the sleeve 318 has an end wall 375 and an elongated body section 379.
  • the sleeve 318 is preferably sized and shaped to firmly wrap over the outside surface of the ampule but not so rigid or tight so as to deter or make assembling or mounting the sleeve over the ampule difficult.
  • the outer layer 330 only has an elongated body section without a distal wall, such as an open cylinder.
  • FIG. 18 shows an ampule 282 having an outer layer 330 mounted thereon, which comprises a discharge end sleeve 310 and a body sleeve 314.
  • FIG. 19 shows an ampule 282 having an outer layer 330 mounted thereon, the outer layer comprising a one-piece sleeve 318.
  • the ampules of FIGs. 18 and 19 may be mounted for use with any one of the injector ends discussed elsewhere herein.
  • FIG. 20 shows another embodiment of an outer layer 330. As shown, a shrink wrap bag 332 is provided for mounting over an ampule.
  • the slirink wrap bag 330 has an elongated body section 338 with a length, an inside diameter, and a distal opening 334 formed on a distal end, distal wall, or end wall 336 of the bag.
  • the inside diameter of the shrink wrap bag 330 is sized sufficiently larger than the outside diameter of an ampule for which the outer layer is to be used with and the distal opening 334 has a perimeter that is sufficiently larger than the nozzle on the ampule so as not to obstruct fluid flow passing through the nozzle.
  • the shrink wrap bag 332 may be slid over the body of an ampule and then subjected to heat so that the outer layer 330 shrinks to form a tight fitting around the ampule.
  • Heat may be provided from electricity or from a gas source and may be part of a heated tunnel or an oven. Heated lamps may also optionally be used to shrink the outer layer 330.
  • the shrink wrap bag 332 may be made from a polymer material.
  • Preferred polymers used for the shrink wrap bag 332 include polyolefm, polyvinyl chloride (PVC), and polyethylene.
  • the materials may be cross-linked or non-cross-linked.
  • the shrink wrap bag 332 may be formed to shrink in one direction (i.e., unidirectional or mono-directional) or in two directions (bidirectional).
  • the shrink wrap bag 332 of FIG. 20 may be configured to only shrink in diameter but not length.
  • the slirink wrap bag may be configured to shrink both in diameter and along its length.
  • the final length should extend at least to a half-way point of the length of the ampule and up to the mounting flange on the ampule, if any. If there is no mounting flange, then up to about the interface of the ampule and the injector end.
  • FIG. 21 shows another embodiment of an outer layer 330.
  • the outer layer comprises a shrink wrap open cylindrical section 340 and a discharge end sleeve 310, similar to the end sleeve 310 of FIG. 17.
  • the open cylindrical section 340 has an elongated body section 338 with two open ends 342, 344.
  • the elongated body section 338 is sized and shaped to slid over an ampule and the first open end 342 is sized and shaped to let the discharge end of the ampule left exposed.
  • Other characteristics of the layer 340 are the same as that of the embodiment of FIG. 20.
  • the discharge end sleeve 310 may be placed over the end of the ampule.
  • the combination has at least three different materials - one being from the ampule itself, the second from the shrink wrap material, and the third being from the discharge end sleeve.
  • FIG. 22 shows yet another embodiment of an outer layer 330, which is shown as a roll 346 of shrink wrap sheet or layer 348.
  • the layer 348 may be cut down to a working size sheet 350, applied over an ampule, and then subjected to heat to set over the ampule.
  • the working size sheet 350 may be rectangular in shape having a length and a width.
  • the roll 346 may be made as a stretch wrap layer or material.
  • Stretch wrap materials are highly stretchable plastic films. The elastic recovery of each film keeps the item that the film is applied against tightly bound.
  • the layer 348 may be cut down to size, stretched and applied over an ampule to keep a tight fit over the ampule.
  • the outer layers 330 of FIGs. 20-22 look similar to that shown in FIGs. 18 and 19.
  • the ampules with the outer layers 330 of FIGs. 20-22 may be used with any of the injector ends discussed elsewhere herein.
  • the assembly 360 comprises an injector end component 362 and a discharge end component 282, which are similar or comparable to components previously discussed elsewhere herein.
  • the assembly is understood to include an ampule body 316, a plunger 284 with a plunger tip 285, a piston 206 with a piston head 216 and a piston stem 218, a spring or motive force 204 for propelling the piston head 216 into the plunger 284, a safety lock 20, and an end cap 50 for closing off the proximal opening of the elongated housing body 16.
  • the cap 50 is removable following use to enable removable of the internal components, as previously discussed.
  • the assembly 360 is shown in a ready to use position in FIG. 23 with the latch pin or trigger finger 240 of the trigger 362 in contact with the piston head 216 to hold the spring 204 in a compressed position.
  • the trigger 362 has a push end 364 that is pointed in the proximal direction, towards the end cap 50. in the other embodiments, the push end of the triggers point distally towards the ampule. This may be arranged by changing the location of the cradle for holding the pivot pin that allows the trigger 362 to rotate to release the spring.
  • the assembly 360 of FIG. 23 is ideally suited for use in applications that require the user to reach into a closed or confined space.
  • the user can still have access to the push end 364 of the trigger 362 to perform an injection.
  • the direction of the push end 364 allows the clinician to insert the ampule into the mouth to inject the gum near the molars while still allowing for easy reach or access to the trigger to release the spring and perform the injection.
  • the size of the assembly 360 may be modified for different applications. For example, for dental applications or for small dosage applications, the size of the discharge end and injector end may be reduced. Furthermore, while the assembly 360 is described for use with confined space, it is not so limited and may be used in any wide open space application where subcutaneous delivery of medication is desired.
  • FIG. 24 is a cross-sectional side view of the injector assembly 360 of FIG. 23 following release of the spring 204.
  • the safety lock 20 has been moved proximally to the right of FIG. 24, which provides space for the trigger 362 to be depressed at the push and 364. This causes the latch pin or trigger finger 242 to separate from the piston head 216. This in turn allows the spring 204 to expand and push the piston 206 forward to then push the plunger 284 forward to push medication or fluids inside the ampule out of the discharge nozzle 288 of the ampule 282.
  • the present needleless injector assemblies are also ideally suited for being pre-filled and packaged inside a blister pack or package so that a user simply has to pry open the package, placed the discharge end of the nozzle against the skin, and squeeze the trigger to deliver a dosage of fluid subcutaneously. In another example, only the ampule end is pre-filled and packaged inside a blister pack.

Landscapes

  • 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

La présente invention concerne un injecteur sans aiguille présentant une extrémité d'évacuation et une extrémité d'entraînement. L'extrémité d'évacuation présente une buse relativement petite par laquelle est évacué le liquide administré par voie sous-cutanée à un patient sans aiguille et l'extrémité d'entraînement présente un piston retenu par un déclencheur, un ressort étant poussé contre le piston pour entraîner le piston pour ensuite entraîner un plongeur par l'intermédiaire de l'ampoule pour évacuer le médicament liquide. L'extrémité d'entraînement peut comprendre un bouchon amovible pour faciliter le retrait rapide du ressort.
PCT/US2013/058013 2012-09-17 2013-09-04 Injecteur hypodermique sans aiguille et procédé associé WO2014042930A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201261701824P 2012-09-17 2012-09-17
US61/701,824 2012-09-17
US201361814576P 2013-04-22 2013-04-22
US61/814,576 2013-04-22

Publications (1)

Publication Number Publication Date
WO2014042930A1 true WO2014042930A1 (fr) 2014-03-20

Family

ID=50278611

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2013/058013 WO2014042930A1 (fr) 2012-09-17 2013-09-04 Injecteur hypodermique sans aiguille et procédé associé

Country Status (1)

Country Link
WO (1) WO2014042930A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105413023A (zh) * 2016-01-04 2016-03-23 苏州肯美威机械制造有限公司 一种无针注射器
WO2017176910A1 (fr) * 2016-04-05 2017-10-12 H.N.S. International, Inc. Combinaison d'injecteur hypodermique sans aiguille et de feuille de couverture et procédés associés
WO2019094827A1 (fr) * 2017-11-09 2019-05-16 Aijex Pharma International Inc. Ensembles injecteur sans aiguille et procédés associés

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6558348B2 (en) * 2000-04-07 2003-05-06 Equidyne Systems, Inc. Low cost disposable needleless injector system for variable and fixed dose applications
US6673034B2 (en) * 1995-10-10 2004-01-06 Penjet Corporation Gas power sources for a needle-less injector and needle-less injectors incorporating the same
US20060270972A1 (en) * 2003-08-21 2006-11-30 Istvan Lindmayer Needleless injection device and cartridges
US7235063B2 (en) * 2001-08-21 2007-06-26 D'antonio Consultants International, Inc. Hypodermic injection system
US20080214996A1 (en) * 2003-06-20 2008-09-04 Kimmell Steven D Needleless injectors

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6673034B2 (en) * 1995-10-10 2004-01-06 Penjet Corporation Gas power sources for a needle-less injector and needle-less injectors incorporating the same
US6558348B2 (en) * 2000-04-07 2003-05-06 Equidyne Systems, Inc. Low cost disposable needleless injector system for variable and fixed dose applications
US7235063B2 (en) * 2001-08-21 2007-06-26 D'antonio Consultants International, Inc. Hypodermic injection system
US20080214996A1 (en) * 2003-06-20 2008-09-04 Kimmell Steven D Needleless injectors
US20060270972A1 (en) * 2003-08-21 2006-11-30 Istvan Lindmayer Needleless injection device and cartridges

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105413023A (zh) * 2016-01-04 2016-03-23 苏州肯美威机械制造有限公司 一种无针注射器
WO2017176910A1 (fr) * 2016-04-05 2017-10-12 H.N.S. International, Inc. Combinaison d'injecteur hypodermique sans aiguille et de feuille de couverture et procédés associés
WO2019094827A1 (fr) * 2017-11-09 2019-05-16 Aijex Pharma International Inc. Ensembles injecteur sans aiguille et procédés associés
JP2021502218A (ja) * 2017-11-09 2021-01-28 アイジェックス ファーマ インターナショナル インコーポレイテッドＡｉｊｅｘ Ｐｈａｒｍａ Ｉｎｔｅｒｎａｔｉｏｎａｌ Ｉｎｃ． 無針注射器アセンブリ及び関連方法
US11338091B2 (en) 2017-11-09 2022-05-24 Aijex Pharma International Inc. Needleless injector assemblies and related methods

Similar Documents

Publication Publication Date Title
AU2019202852B2 (en) Plunger-driven auto injectors
US10166336B2 (en) Auto-injector for retractable prefilled syringe
AU2001251739B2 (en) Low cost disposable needleless injector system for variable and fixed dose applications
CN109966594B (zh) 药物输送装置
US7247151B2 (en) Injector with shielded needle
US20060089594A1 (en) Needle-free injection device
MX2007000146A (es) Jeringa de un solo uso.
AU2001251739A1 (en) Low cost disposable needleless injector system for variable and fixed dose applications
TW201404419A (zh) 驅動控制機構及用於可注射匣之自動注射器
BRPI0407060B1 (pt) Conjunto de agulha retrátil acionável para uso com um conjunto de cilindro de seringa
EP2079502A1 (fr) Seringue rétractable
AU2013362425B2 (en) Prefillable auto-retractable safety syringe
AU2013362425A1 (en) Prefillable auto-retractable safety syringe
WO2014042930A1 (fr) Injecteur hypodermique sans aiguille et procédé associé
US20060116631A1 (en) Needleless injector
US20190125973A1 (en) Combination needleless hypodermic injector and cover sheet and related methods
AU2012101441A4 (en) Syringe Safety Prefillable
US20220409816A1 (en) Needleless injectors and related methods
AU2007231844B2 (en) Retractable Syringe
WO2005011777A1 (fr) Appareil d'aiguille medicale

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 13837011

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 13837011

Country of ref document: EP

Kind code of ref document: A1