WO2024054430A1 - Auto-injecteur - Google Patents

Auto-injecteur Download PDF

Info

Publication number
WO2024054430A1
WO2024054430A1 PCT/US2023/031975 US2023031975W WO2024054430A1 WO 2024054430 A1 WO2024054430 A1 WO 2024054430A1 US 2023031975 W US2023031975 W US 2023031975W WO 2024054430 A1 WO2024054430 A1 WO 2024054430A1
Authority
WO
WIPO (PCT)
Prior art keywords
auto
injector
sleeve
syringe
housing
Prior art date
Application number
PCT/US2023/031975
Other languages
English (en)
Inventor
Jeffrey Richard Held
Steven Michael Madland
John Bartholomew
Original Assignee
University Hospitals Cleveland Medical Center
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 University Hospitals Cleveland Medical Center filed Critical University Hospitals Cleveland Medical Center
Publication of WO2024054430A1 publication Critical patent/WO2024054430A1/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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the 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
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006—Having specific accessories
    • A61M2005/2013—Having specific accessories triggering of discharging means by contact of injector with patient body
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3267—Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3267—Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
    • A61M2005/3268—Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body having cantilever elastically spreadable arms, e.g. to accumulate energy during needle uncovering movement for urging protection sleeve to return to needle covering position

Definitions

  • the present disclosure relates to auto-injectors used to deliver medication through the skin of a patient through a needle.
  • medications are commonly administered via auto-injection devices by parents or caregivers.
  • insulin is administered for the treatment of diabetes.
  • Another common medication administered by parents or caregivers includes epinephrine for treating severe allergic reactions.
  • the present disclosure relates to auto-injection devices.
  • the auto-injectors include multiple components that work together to deliver medication.
  • An activation sleeve extends from the housing in an initial state.
  • a drive spring sleeve is released from a locked position, and a syringe assembly extends from the housing into the patient and releases the medication.
  • the activation sleeve is then pushed out from the housing again to act as a needle shield.
  • the auto-injectors comprise a housing, a syringe support, a syringe assembly, an activation sleeve, a lower compression spring, a drive spring sleeve, and an upper compression spring.
  • the housing has an orifice at a lower end thereof.
  • the syringe support is fixed in place in the lower end of the housing, and includes an upper tube, a support ledge and a lower tube.
  • the syringe assembly has an upper end surrounded by a syringe carrier, a plunger rod extending through the syringe carrier, and a lower end located within the syringe support.
  • the activation sleeve is located within the lower tube of the syringe support.
  • the activation sleeve includes a lower end extendable through the orifice of the housing and an upper end having a plurality of hooks thereon.
  • the lower compression spring is biased against the activation sleeve and the syringe support.
  • the drive spring sleeve has an upper end which engages the plunger rod and a lower end with a plurality of hooks.
  • the upper compression spring is biased against an upper end of the housing and the drive spring sleeve.
  • each hook of the activation sleeve engages a hook of the drive spring sleeve and the hooks of the drive spring sleeve rest on the support ledge of the syringe support, such that the drive spring sleeve is pushed against an upper end of the housing.
  • the syringe support may further comprise a plurality of circumferential slots in the support ledge, vertical passages in the lower tubular sidewall aligned with the circumferential slots that form lower stop surfaces, and vertical ribs on either side of each vertical passage.
  • the syringe assembly may further comprise a barrel having a flange which is located within the syringe carrier, a piston within the barrel, and a needle.
  • the plunger rod may also be located within the barrel, engaging the piston.
  • the syringe assembly may further comprise a rigid needle shield surrounding the needle.
  • the activation sleeve further comprises an annular channel between an inner tube and an outer tube in which the lower compression spring is located.
  • the activation sleeve may further comprise a shaft through the lower end of the sleeve.
  • each hook of the activation sleeve is also vertically aligned with an alignment member and a lower ramp.
  • the span between the alignment member and the lower ramp may be sized to receive a hook of the drive spring sleeve.
  • the drive spring sleeve further comprises an annular support surface which engages the upper compression spring.
  • the drive spring sleeve may further comprise a plurality of holes for engaging tabs at an upper end of the housing.
  • the housing comprises a baseplate and an exterior body.
  • the baseplate includes the orifice and engages the syringe support.
  • the exterior body may be formed from a cylindrical sidewall and a top end plate.
  • the top end plate may further comprise a plurality of tabs that pass through the drive spring sleeve and engage the syringe carrier in the initial state.
  • the drive spring sleeve and the housing may each further comprise dowel holes that are aligned with each other.
  • the auto-injector may further comprise a safety cap that engages the lower end of the activation sleeve.
  • the safety cap may include a rigid needle shield puller for removing a rigid needle shield from the syringe assembly.
  • the syringe carrier comprises an upper piece and a lower piece which interlock with each other.
  • the upper piece has an opening
  • the lower piece has an opening
  • the lower piece opening has a diameter that is greater than a diameter of the upper piece opening.
  • the lower end of the activation sleeve may extend out the orifice at the lower end of the housing.
  • the lower end of the activation sleeve may be pressed into the housing.
  • the drive spring sleeve is pushed against the lower end of the housing and the lower end of the activation sleeve extends out the orifice at the lower end of the housing.
  • the exterior body may include windows through which the drive spring sleeve is visible in the final state.
  • An auto-injector is received.
  • An activation sleeve of the autoinjector is placed against a user's limb.
  • the auto-injector is pressed downwards, pushing the activation sleeve into the auto-injector, and a needle to extend and penetrate into the user and deliver the dose of medication.
  • the auto-injector is then lifted from the limb, causing the activation sleeve to extend and cover the needle.
  • FIG. 1 is a cross-sectional view of one embodiment of an auto-injector of the present disclosure, in a first or initial state.
  • FIGS. 2A-2F are different views of a syringe support used in the auto-injector.
  • FIG. 2A is a perspective view.
  • FIG. 2B is a front exterior view.
  • FIG. 2C is a front cross- sectional view across line A-A of FIG. 2A.
  • FIG. 2D is a side exterior view.
  • FIG. 2E is a top plan view.
  • FIG. 2F is a bottom plan view.
  • FIGS. 3A-3E are different views of an activation sleeve used in the autoinjector.
  • FIG. 3A is a perspective view.
  • FIG. 3B is a front exterior view.
  • FIG. 3C is a front cross-sectional view across line B-B of FIG. 3A.
  • FIG. 3D is a top plan view.
  • FIG. 3E is an exterior view of an alternative embodiment of an auto-injector that includes a shaped endplate.
  • FIGS. 4A-4F are different views of a drive spring sleeve 400 used in the autoinjector.
  • FIG. 4A is a perspective view.
  • FIG. 4B is a front exterior view.
  • FIG. 4C is a front cross-sectional view across line C-C of FIG. 4A.
  • FIG. 4D is a side exterior view.
  • FIG. 4E is a top plan view.
  • FIG. 4F is a bottom plan view.
  • FIG. 5A and FIG. 5B are different views of a syringe assembly used in the auto-injector.
  • FIG. 5A is a cross-sectional view of the entire assembly.
  • FIG. 5B is an exterior view with some parts of the assembly removed so that other details are more visible.
  • FIG. 6A and FIG. 6B are different views of a plunger rod used in the syringe assembly.
  • FIG. 6A is a perspective view.
  • FIG. 6B is a front view.
  • FIGS. 7A-7E are different views of a syringe carrier used in the syringe assembly.
  • FIG. 7A is a perspective view of the syringe carrier, which is assembled from an upper piece and a lower piece.
  • FIG. 7B is a perspective view of the upper piece.
  • FIG. 7C is a top plan view of the upper piece.
  • FIG. 7D is a perspective view of the lower piece.
  • FIG. 7E is a top plan view of the lower piece.
  • FIG. 8A and FIG. 8B are different views of a baseplate used to form a housing for the auto-injector.
  • FIG. 8A is a perspective view of the baseplate.
  • FIG. 8B is a bottom view of the baseplate.
  • FIGS. 9A-9F are different views of an exterior body used together with the baseplate to form the housing.
  • FIG. 9A is a perspective view.
  • FIG. 9B is a front exterior view.
  • FIG. 90 is a front cross-sectional view across line D-D of FIG. 9A.
  • FIG. 9D is a side exterior view.
  • FIG. 9E is a front cross-sectional view across line E-E of FIG. 9A.
  • FIG. 9F is a bottom plan view.
  • FIG. 10 is a perspective view of a clip used in the auto-injector.
  • FIGS. 11A-11 E are views of two different embodiments of a safety cap 900 used with the auto-injector, in accordance with the present disclosure.
  • FIG. 11A is a perspective view of a rigid needle shield (RNS) puller that is part of the safety cap.
  • RNS rigid needle shield
  • FIG. 11 B is a perspective view of a first embodiment of the safety cap.
  • FIG. 11C is a cross- sectional view of the first embodiment.
  • FIG. 11D is a perspective view of a second embodiment of the safety cap.
  • FIG. 11E is a cross-sectional view of the second embodiment.
  • FIGS. 12A-12G illustrate various views for assembly of the auto-injector.
  • FIGS. 13A-13G are modified cross-sectional views showing various states during operation of the auto-injector.
  • FIGS. 14A-14C are illustrations of different variations of the auto-injector.
  • FIG. 14A is a cross-sectional view of a first variation.
  • FIG. 14B is an exterior view of a second variation.
  • FIG. 14C is an exterior view of a third variation.
  • the term “comprising” may include the embodiments “consisting of” and “consisting essentially of.”
  • the terms “comprise(s),” “include(s),” “having,” “has,” “can,” “contain(s),” and variants thereof, as used herein, are intended to be open-ended transitional phrases, terms, or words that require the presence of the named components/steps and permit the presence of other components/steps.
  • such description should be construed as also describing devices or methods as “consisting of and “consisting essentially of” the enumerated components/steps, which allows the presence of only the named components/steps, and excludes other components/steps.
  • the term “about” can be used to include any numerical value that can vary without changing the basic function of that value. When used with a range, “about” also discloses the range defined by the absolute values of the two endpoints, e.g. “about 2 to about 4” also discloses the range “from 2 to 4.” The term “about” may refer to plus or minus 10% of the indicated number.
  • the terms “upper” and “lower” are relative to each other in location, i.e. an upper component is located at a higher elevation than a lower component in a given orientation.
  • the terms “top” and “bottom” or “base” are also relative to each other, as are the terms “upward” and “downward”.
  • the terms “inlet” and “outlet” are relative to a direction of flow, and should not be construed as requiring a particular orientation or location for a device.
  • upstream and “downstream” are relative to the direction in which a fluid flows through various components, i.e. the fluid flows through an upstream component prior to flowing through the downstream component.
  • the present disclosure relates to autoinjection devices, also known as syringes, injectors, or auto-injectors.
  • the auto-injector is operated using a pressing motion along an axis generally normal to the patient.
  • the auto-injector includes a syringe support, an activation sleeve, a syringe assembly, a drive spring sleeve, and two springs which are all contained within a housing.
  • FIG. 1 is a cross-sectional illustration of an auto-injector 100 of the present disclosure in a first or initial state, in accordance with some embodiments.
  • the auto-injector 100 includes a housing 110, which is illustrated as being made from a baseplate 700 and an exterior body 800.
  • the housing has an upper end 112 and a lower end 114.
  • An orifice (not visible) is present at the lower end of the housing, in the baseplate 700.
  • An activation sleeve 300 is present at the lower end of the housing.
  • the upper end 302 of the activation sleeve is located within, and surrounded by, a syringe support 200.
  • the lower end 304 of the activation sleeve is covered by a safety cap 900.
  • a lower compression spring 130 is biased against the activation sleeve 300 and the syringe support 200.
  • a syringe assembly 500 is shown.
  • the lower end 504 of the syringe assembly is located within the syringe support 200.
  • a drive spring sleeve 400 is located above the syringe assembly.
  • the syringe assembly includes a plunger rod 550 which is attached to the upper end 402 of the drive spring sleeve.
  • An upper compression spring 120 is biased against the drive spring sleeve 400 and the upper end 112 of the housing. The upper compression spring will act as the drive spring for injecting the medication into the patient or user.
  • FIGS. 2A-2F are different views of the syringe support 200 in isolation.
  • FIG. 2A is a perspective view.
  • FIG. 2B is a front exterior view.
  • FIG. 2C is a front cross- sectional view across line A-A of FIG. 2A.
  • FIG. 2D is a side exterior view.
  • FIG. 2E is a top plan view.
  • FIG. 2F is a bottom plan view.
  • the syringe support 200 can be described as being formed from the combination of an upper tube 210 and a lower tube 220, which are joined together by a horizontal surface or support ledge 230.
  • the syringe support has an upper end 202 and a lower end 204.
  • the upper tube 210 includes a tubular sidewall 212.
  • the lower tube 220 also includes a tubular sidewall 222, into which recesses have been made on each side. As seen in FIG. 2B, the upper tube has height 213, and the lower tube has height 223. As illustrated here, the lower tube height 223 is greater than the upper tube height 213.
  • the interior of these two tubes is hollow, and a shaft 206 runs vertically through the syringe support 200.
  • the upper tube 210 extends below the support ledge 230, such that an annular channel 270 is created around the upper tube.
  • One end of the lower compression spring is held in this annular channel.
  • two vertical passages 240 have been made in the sides of the lower tube 220. Those two vertical passages are aligned with two circumferential slots 232 made in the support ledge 230.
  • the circumferential slot 232 has a greater arc length than the vertical passage 240, or put another way, the circumferential slot 232 subtends a larger angle than the vertical passage 240 measured from the central axis.
  • the circumferential slots 232 are located outside of the annular channel 270.
  • two vertical ribs 242 are present on the exterior surface of the lower tube 220 on either side of each vertical passage 240, for a total of four vertical ribs.
  • the lower end of the vertical passage is also shaped to create lower stop surfaces 244.
  • the upper tube 210 has an inner diameter 215 and an outer diameter 217, thus creating an upper annular surface 216 at the top of the syringe support.
  • the lower tube 220 has an outer diameter 227, and the support ledge 230 is an annular surface.
  • the two circumferential slots 232 define two internal travel passages 260.
  • the combination of the lower tube 220 and the vertical ribs 242 define two external travel passages 262.
  • the activation sleeve 300 travels through the internal travel passages 260
  • the drive spring sleeve 400 travels through the external travel passages 262.
  • a plurality of joints 250 are present at the bottom of the syringe support. These joints are used to attach the syringe support to the baseplate 700 (which is described further herein). More generally, the joints on the syringe support and the baseplate will be complementary to each other (e.g. male and female). Four rotating snap-fit joints are illustrated here.
  • FIGS. 3A-3E are different views of the activation sleeve 300 in isolation.
  • FIG. 3A is a perspective view.
  • FIG. 3B is a front exterior view.
  • FIG. 3C is a front cross- sectional view across line B-B of FIG. 3A.
  • FIG. 3D is a top plan view.
  • FIG. 3E is an exterior view of an alternative embodiment of an auto-injector that includes a shaped endplate.
  • the activation sleeve 300 has an upper end 302 and a lower end 304.
  • the activation sleeve 300 can be described as being formed from the combination of an inner tube 310 and an outer tube 320, which are joined together by an annular base 330 along the bottom of the outer tube 320.
  • the lower end 304 of the activation sleeve is at the bottom of the inner tube 310.
  • the inner tube 310 includes a tubular sidewall 312.
  • the outer tube 320 also includes a tubular sidewall 322.
  • the inner tube has height 313, and the outer tube has height 323.
  • the inner tube height 313 is greater than the outer tube height 323.
  • the interior of these two tubes is hollow, and a shaft 306 runs vertically through the inner tube 310 and the overall activation sleeve.
  • the inner tube 310 and the outer tube 320 overlap, such that an annular channel 332 is created.
  • the annular channel faces upwards.
  • a plurality of arcuate arms 340 extend upwards from opposite sides of the outer tube 320.
  • An upper hook 342 is present at the end of each arcuate arm.
  • Each upper hook faces outward from the outer tube, and faces downward.
  • the outer face 344 of each upper hook is sloped to angle outwards.
  • An alignment member 350 and a lower ramp 360 are also vertically aligned with each upper hook 342.
  • the alignment member is located between the upper hook 342 and the lower ramp 360.
  • the alignment member 350 also includes an upper face 352 that is sloped to angle outwards.
  • the lower ramp includes a sloped surface 362 and a horizontal surface 364.
  • the horizontal surface is above the sloped surface, and the sloped surface is angled inwards towards the inner tube.
  • the upper hook 342, alignment member 350, and lower ramp 360 have approximately the same width.
  • the vertical distance between the alignment member 350 and the lower ramp 360 is referred to as a span 355.
  • the inner tube 310 has an inner diameter 315 and an outer diameter 317.
  • the outer tube 320 also has an inner diameter 325 and an outer diameter 327.
  • the annular channel 332 is present between the two tubes.
  • FIGS. 4A-4F are different views of the drive spring sleeve 400 in isolation.
  • FIG. 4A is a perspective view.
  • FIG. 4B is a front exterior view.
  • FIG. 4C is a front cross- sectional view across line C-C of FIG. 4A.
  • FIG. 4D is a side exterior view.
  • FIG. 4E is a top plan view.
  • FIG. 4F is a bottom plan view.
  • the drive spring sleeve 400 has an upper end 402 and a lower end 404.
  • the drive spring sleeve 400 can be described as being formed from an inner tube 410 and an upper end plate 420 that closes off the top end of the inner tube.
  • the upper end 402 of the drive spring sleeve is defined by the top of the inner tube 410.
  • the inner tube 410 is formed from a tubular sidewall 412, and has height 413.
  • annular support surface 430 extends outwards from the bottom of the inner tube 410.
  • the annular support surface has height 433.
  • a set of vertical ribs 432 may extend upwards from the annular support surface 430. Eight vertical ribs are illustrated here.
  • the annular support surface provides a support surface for the upper compression spring.
  • a plurality of arcuate legs 440 extend downwards from opposite sides of the inner tube 410.
  • two legs are illustrated.
  • the interface between the inner tube and an arcuate leg is labeled as a root 441 of the arcuate leg.
  • a lower hook 442 is present at the end of each arcuate leg.
  • Each lower hook faces inward from the inner tube, and faces upward.
  • the outer face 444 of each lower hook is flat.
  • the drive spring sleeve 400 may also include an outer tube 450, which extends downward from the annular support surface 430.
  • the outer tube is formed from a tubular sidewall 452 and has height 453.
  • the inner tube height 413 is greater than the lower tube height 453.
  • the interior of both tubes 410, 450 is hollow.
  • the area between the outer tube 450 and the arcuate legs 440 may be considered an annular channel 456, which faces downwards.
  • dowel holes 406 may be present on opposite sides of the drive spring sleeve. Here, they are illustrated as extending through the outer tube 450. However, if the outer tube is not present, the dowel holes may be present in the annular support surface 430. Their use will be explained further herein.
  • the upper end plate 420 includes a set of circular holes 422 and arcuate holes 424 which extend entirely through the upper end plate.
  • the upper end plate also includes a plunger hole 426 in its center, which also extends entirely through the upper end plate.
  • a set of horizontal ribs 428 may also extend upwards from the upper end plate.
  • the inner tube 410 has an outer diameter 415.
  • the annular support surface 430 also has an outer diameter 435, which matches the outer diameter of the outer tube.
  • the outer faces 444 of the lower hooks are visible. Also visible are the plunger hole 426 and the circular holes 422.
  • the arcuate holes 424 are slightly obscured by the outer faces of the lower hooks.
  • FIG. 5A and FIG. 5B are different views of the syringe assembly 500 in isolation.
  • FIG. 5A is a cross-sectional view of the entire assembly.
  • FIG. 5B is an exterior view with some parts of the assembly removed so that other details are more visible.
  • the syringe assembly has an upper end 502 and a lower end 504.
  • the syringe assembly includes a barrel 510 having a flange 512 on the upper end of the barrel and a hub/adapter 514 and a needle 516 at the lower end of the barrel.
  • a rigid needle shield (RNS) 518 surrounds the needle, .
  • a piston I stopper I head 520 is located within the barrel 510, and is connected to the plunger rod 550.
  • Fluid 530 is illustrated within the barrel, located between the piston 520 and the needle 516.
  • a syringe carrier 600 surrounds the flange 512.
  • the flange 512 and an O-ring or washer 532 are located within the syringe carrier, which is formed from an upper piece 610 and a lower piece 620.
  • the barrel 510 has a diameter 511
  • the flange 512 has a diameter 513
  • the syringe carrier 600 has a diameter 605.
  • the barrel diameter 511 is less than the flange diameter 513.
  • the flange diameter 513 is less than the syringe carrier diameter 605.
  • the upper surface 602 and the lower surface 604 of the syringe carrier 600 each act as a stop surface.
  • FIG. 6A and FIG. 6B are different views of the plunger rod 550 in isolation.
  • FIG. 6A is a perspective view.
  • FIG. 6B is a front view.
  • the plunger rod includes a pole 552 which has an upper end 554 and a lower end 556.
  • the upper end of the pole includes a drive sleeve engagement member 560.
  • the lower end of the pole includes a piston engagement member 562, which attaches to the piston I stopper I head 520 within the barrel (see FIG. 5A).
  • the length 555 of the plunger rod is indicated, which does not include the two engagement members.
  • the plunger rod 550 also includes a horizontal surface which is provided by a horizontal plate 570 at the lower end of the pole.
  • a plurality of vertical ribs 572 may extend upwards from the horizontal plate upwards against the pole.
  • three vertical ribs are illustrated.
  • the horizontal plate 570 and the vertical ribs 572 are optional, and any other suitable structure may be used.
  • the diameter 557 of the plunger rod is measured at the lower end of the plunger rod, and is sufficient to close off the barrel 510.
  • FIGS. 7A-7E are different views of the syringe carrier 600 in isolation.
  • FIG. 7A is a perspective view of the syringe carrier, which is assembled from an upper piece and a lower piece.
  • FIG. 7B is a perspective view of the upper piece.
  • FIG. 7C is a plan view of the upper piece.
  • FIG. 7D is a perspective view of the lower piece.
  • FIG. 7E is a plan view of the lower piece.
  • the syringe carrier 600 is made up of an upper piece 610 and a lower piece 620.
  • the upper piece 610 includes an upper plate 612 having an upper surface 602.
  • An opening 614 is present in the upper plate 612.
  • a plurality of joints 616 are located around the circumference of the upper plate, and extend below the upper plate 612.
  • the upper plate opening 614 has a diameter 615.
  • the syringe carrier itself has a diameter 605.
  • the lower piece 620 includes a lower plate 622.
  • An opening 624 is present in the lower plate 622.
  • the lower plate opening 624 has a diameter 625.
  • a plurality of joints 626 are located around the circumference of the lower plate, and extend above the lower plate 622.
  • the lower plate opening diameter 625 is greater than the upper plate opening diameter 615.
  • the joints 616, 626 engage each other to form the syringe carrier.
  • the joints 626 in the lower piece 620 rotate clockwise when viewed from above
  • the joints 616 in the upper piece 610 rotate counter-clockwise when viewed from above.
  • the joints of the upper piece and the lower piece will be complementary to each other.
  • the joints are illustrated as circumferential snap-fit joints.
  • FIG. 8A and FIG. 8B are different views of the baseplate 700 in isolation.
  • FIG. 8A is a perspective view of the baseplate
  • FIG. 8B is a bottom view of the baseplate.
  • the baseplate 700 includes a cylindrical sidewall 702 and a bottom wall 704 that is normal to the sidewall and closes off one end of the sidewall.
  • a plurality of vertical ribs 706 may extend upwards from the bottom wall along the cylindrical sidewall.
  • three ribs are illustrated, offset 90 degrees from each other and are used for orientation.
  • a plurality of cantilever joints 708 are arranged vertically in the cylindrical sidewall, and are used to interlock the baseplate with the exterior body.
  • four cantilever joints are illustrated.
  • the bottom wall 704 includes a central orifice 712, through which the needle will be deployed.
  • a plurality of internal rotational slots 710 are also present along the interior of the sidewall 702. These slots engage the snap-fit joints 250 of the syringe support 200 (see FIG. 2A), to fix the syringe support in place at the lower end of the housing.
  • Four slots are illustrated. It is noted that the bottom wall of the baseplate could be flat or could be curved to conform to the shape of a limb.
  • the central orifice 712 is visible in the center of the baseplate.
  • the central orifice has a diameter 713, which is sized to permit the lower end of the activation sleeve to pass through (see FIG. 3A).
  • the four rotational slots 710 are also visible.
  • Four circumferential slots 714 are also visible, which are located below the cantilever joints 708.
  • FIGS. 9A-9F are different views of the exterior body 800 in isolation.
  • FIG. 9A is a perspective view.
  • FIG. 9B is a front exterior view.
  • FIG. 9C is a front cross-sectional view across line D-D of FIG. 9A.
  • FIG. 9D is a side exterior view.
  • FIG. 9E is a front cross-sectional view across line E-E of FIG. 9A.
  • FIG. 9F is a bottom plan view. Together, the baseplate and the exterior body form a housing of the auto-injector.
  • the exterior body is formed from a cylindrical sidewall 810 and a top end plate 820, with the interior of the exterior body being visible only from the bottom.
  • the exterior body has an upper end 802 and a lower end 804.
  • a plurality of lower recesses 812 are present along the lower end, which extend through the exterior body. These recesses engage with the cantilever joints 708 of the baseplate (see FIG. 8A) to form the housing.
  • a plurality of windows 814 may be present on the exterior body, extending through the sidewall 810. The windows may be of any size or shape, and be oriented horizontally or vertically as desired.
  • a plurality of dowel holes 816 are also present on opposite sides of the exterior body. These dowel holes 816 will align with the dowel holes 406 of the drive spring sleeve (see FIG. 4D).
  • the exterior body has a height 803 and a diameter 805.
  • the height is about 100 millimeters (mm).
  • the diameter is about 40 mm.
  • a plurality of tubular tabs 822 and a plurality of arcuate tabs 824 extend downwards from the top end plate 820. As best seen in FIG. 9F, the tubular tabs are located on opposite sides from each other, and the arcuate tabs are located on opposite sides from each other. These tabs 822, 824 will enter the holes 422, 424 present on the upper end plate 420 of the drive spring sleeve 400 (see FIG. 4E).
  • An optional plurality of posts 826 are also present around the exterior of the top end plate 820. These posts may be used for orienting the upper compression spring 120, but are optional.
  • a plurality of vertical recesses 828 are present on the interior surface of the exterior body. They are offset at 90 degrees from each other, and engage with the vertical ribs 706 of the baseplate for orientation of the parts.
  • the exterior body has a diameter 805.
  • the arcuate tabs 824 are located along the circumference of an imaginary circle having a tab diameter 825.
  • the tab diameter 825 is less than the syringe carrier diameter 605 (see FIG. 7C), preventing the syringe carrier from rising to the top of the drive spring sleeve.
  • FIG. 10 is a perspective view of a clip 140 which is used to secure the plunger rod 550 in place relative to the drive spring sleeve 400, as will be described later.
  • FIGS. 11A-11E are different views of various embodiments of a safety cap 900, in accordance with the present disclosure.
  • the safety cap is used initially to cover the lower end of the syringe and protect the patient or user from accidental discharge or needle stick.
  • FIG. 11A is a perspective view of a rigid needle shield (RNS) puller that is part of the safety cap.
  • RNS rigid needle shield
  • FIG. 11 B is a perspective view of a first embodiment of the safety cap
  • FIG. 11C is a cross-sectional view of the first embodiment.
  • FIG. 11D is a perspective view of a second embodiment of the safety cap
  • FIG. 11E is a cross-sectional view of the second embodiment.
  • the RNS puller 950 is used to remove the RNS 518 from the needle (see FIG. 5A).
  • the RNS puller is made from a cylindrical sidewall 952 that has barbs 954 therein. Both ends of the RNS puller are open. As illustrated here, barbs 954 are present on both ends, although only one end will engage the RNS.
  • the RNS puller has a diameter 955.
  • the first embodiment of the safety cap 900 is formed from an exterior cylindrical sidewall 910 and a lower end plate 920.
  • the exterior sidewall may be textured for easier grip.
  • An interior post 922 is located in the center of the lower end plate 920, and is used to engage the RNS puller.
  • the interior post can be solid or hollow, and is illustrated as being hollow.
  • the interior post has a diameter 923, which is substantially equal to or slightly greater than the RNS puller diameter 955.
  • the safety cap itself has an inner diameter 905. In this embodiment, the safety cap inner diameter 905 is about equal to the outer diameter 317 of the inner tube 310 of the activation sleeve 300 (see FIG. 3C).
  • An annular channel 924 is present between the exterior sidewall 910 and the interior post 922.
  • the second embodiment of the safety cap 900 includes the same components. As illustrated, the shape of the exterior cylindrical sidewall 910 is slightly different. Also, in this embodiment, the safety cap inner diameter 907 is about equal to the diameter 805 of the exterior body 800 (see FIG. 9F), or in other word is greater than the RNS puller diameter, in addition, the safety cap 900 includes a handle 930, which provides an alternate means for handling of the safety cap. A wider cap may be desirable, for example if the activation sleeve 300 includes an endplate 370.
  • the various components can be made of any suitable material, such as plastic, a polymeric material, a metal, or the like.
  • the springs 120, 130 and the RNS puller 950 may be made of metal, and/or the barrel 510 can be made of glass, while the other components can be made of plastic or a polymeric material.
  • the various components can be made using suitable processes such as injection molding, 3-D printing, and the like.
  • FIGS. 12A-12G provide various views of the assembly steps.
  • the syringe assembly 500 of FIG. 5A is made.
  • the barrel 510, hub 514, needle 516, and rigid needle shield 518 are usually provided together as an integrated component.
  • the barrel is filled with the desired medication or fluid 530, and the piston 520 is inserted.
  • An o-ring 532 is slid up from the bottom of the barrel to sit underneath the flange 512.
  • the syringe barrel 510 is inserted through the opening 624 of the lower piece 620 of the syringe carrier so the o-ring 532 abuts the lower piece.
  • the plunger rod 550 is then inserted into the syringe barrel.
  • the upper piece 610 of the syringe carrier is then slid over the plunger rod down to the lower piece, and the two pieces are rotated together.
  • the plunger rod 550 extends through the opening 614 in the upper piece 610 of the syringe carrier.
  • the plunger rod may a;sp be described as extending through the syringe carrier.
  • a lockout subassembly is made.
  • the activation sleeve 300 is placed into the orifice in the baseplate 700.
  • the lower compression spring 130 is inserted into the annular channel of the activation sleeve, and the syringe support 200 is then placed onto the lower compression spring.
  • the syringe support 200 is then pushed downwards to compress the lower compression spring 130.
  • the syringe support is then rotated so that the snap-fit joints 250 of the syringe support 200 engage the internal rotational slots (not visible) of the baseplate.
  • the engagement of the joints can be checked by looking up through the bottom of the baseplate (see FIG. 8B).
  • the syringe assembly 500 is attached to the drive spring sleeve 400.
  • the drive sleeve engagement member 560 of the plunger rod is inserted through the plunger hole of the drive spring sleeve, and the clip 140 is used to secure the plunger rod in place.
  • the upper compression spring 120 is inserted into the exterior body 800.
  • the drive spring sleeve 400 (with the attached syringe assembly) is then placed into the center of the upper compression spring 120, and pushed down into the exterior body.
  • dowel pins (not shown) are inserted into the dowel holes to lock these components into place.
  • the resulting structure is referred to herein as a drive subassembly.
  • at least the arcuate tabs 824 pass through the upper end plate of the drive spring sleeve 400 and engage the syringe carrier 600.
  • the lockout subassembly is then attached to the drive subassembly.
  • the lockout subassembly is inserted into the exterior body.
  • the arcuate legs 440 of the drive spring sleeve should be pushed outwards by the arcuate arms 340 of the activation sleeve until the hooks snap and lock together. If needed, the internal volume of the exterior body can be accessed through the windows 814.
  • the cantilever joints 708 of the baseplate 700 engage the lower recesses 812 of the exterior body 800.
  • the safety cap 900 is added.
  • the RNS puller 950 is mounted onto the interior post 922 of the safety cap.
  • the safety cap and RNS puller are then inserted into the activation sleeve 300.
  • the safety cap should be pushed in until flush against the baseplate 700.
  • the auto-injector is thus assembled.
  • the dowel pins can then be removed from the dowel holes, and the auto-injector is armed.
  • An exterior view of the final structure 100 is seen in FIG. 12D.
  • the auto-injector is ready for use, and can be considered an “initial” state for the auto-injector.
  • FIG. 12E shows some aspects of the interaction between the syringe support 200, the activation sleeve 300, and the drive spring sleeve 400.
  • the arcuate arms 340 of the activation sleeve will travel vertically through the circumferential slots and the internal travel passages 260 of the syringe support 200.
  • the upper hook 342, alignment member 350, and lower ramp 360 will travel vertically through a vertical passage 240 in the lower tube 220 of the syringe support.
  • the arcuate legs 440 of the drive spring sleeve will travel vertically between the vertical ribs 242 of the syringe support 200, through the external travel passages 262.
  • FIG. 12F is a cross-sectional view showing the interaction between certain parts of the syringe support 200 and the syringe assembly 500.
  • the lower end 504 of the syringe assembly is located within or surrounded by the upper tube 220 of the syringe support.
  • the barrel 510 engages the upper tube 210 of the syringe support.
  • FIG. 12G shows how some components interact near the lower end of the auto-injector.
  • the safety cap 900, RNS puller 950, baseplate 700, activation sleeve 300, and the lower compression spring 130 are illustrated.
  • the RNS puller 950 is mounted to the interior post 922, and extends upwards past the annular channel 332 of the activation sleeve almost to the end of the lower compression spring 130, for engaging the RNS of the syringe assembly.
  • the lower end of the activation sleeve 300 fits into the annular channel 924 of the safety cap.
  • FIGS. 13A-13G are modified cross-sectional views that illustrate the auto-injector in operation.
  • FIG. 13A shows the auto-injector 100 in an initial state. As can be seen here, the safety cap 900 is in place, with the RNS puller engaging the RNS (not visible).
  • the activation sleeve 300 is located within the lower tube of the syringe support 200. The upper hooks 342 of the activation sleeve 300 and the lower hooks 442 of the drive spring sleeve 400 are interlocked.
  • the lower hooks 442 are secured between the upper hooks 342 and the support ledge 230 of the syringe support, and rest on the support ledge.
  • the drive springe sleeve 400 is pushed against the upper end 112 of the housing 110.
  • the upper compression spring 120 is compressed between the upper end 112 of the housing and the drive spring sleeve 400.
  • the lower end 504 of the syringe assembly 500 is located within the upper tube 210 of the syringe support 200.
  • the syringe carrier 600 is pushed up against the arcuate tabs 824 extending from the top of the housing.
  • FIG. 13B the safety cap has been removed.
  • the needle 516 is now exposed.
  • the lower end 304 of the activation sleeve extends through the orifice 712.
  • FIG. 13E illustrates an intermediate state of the auto-injector 100.
  • the drive spring sleeve 400 has now been pushed down as far as possible by the upper compression spring 120.
  • the upper end plate 420 rests against the syringe carrier 600.
  • the syringe carrier 600 is resting upon the upper annular surface of the upper tube 210.
  • the arcuate legs 440 are no longer pushed outwards, and snap back into place.
  • the lower hooks 442 engage the lower stop surface 244 of the syringe support.
  • the outer tube 450 of the drive spring sleeve rests upon the cylindrical sidewall 702 of the baseplate.
  • the lower compression spring 130 is compressed between the syringe support 200 and the activation sleeve 300.
  • the needle 516 still extends out of the orifice 712.
  • the lower compression spring 130 now begins to extend, pushing the activation sleeve 300 downwards.
  • the lower ramps 360 push the lower hooks 440 of the drive spring sleeve outwards, away from the lower stop surface 244.
  • the upper compression spring 120 continues to hold the drive spring sleeve down in place.
  • FIG. 13G shows the auto-injector in a final state.
  • the lower hooks snap back into the span 355 between each lower ramp 360 and alignment member 350 of the activation sleeve (see FIG. 3C). This locks the activation sleeve 300 in place, and prevents the activation sleeve from being depressed again.
  • the lower end 304 covers the needle 516. The needle is not retracted into the housing. It is noted that the drive spring sleeve 400 is still held down in place near the lower end of the housing. A window aligned with the drive spring sleeve in this location could be used to indicate whether the auto-injector has been used or not.
  • the auto-injectors of the present disclosure do not contain any electronic components that may require battery power. Variations on the structure of the autoinjector are expected, and several such variations are expressly contemplated. For example, the structure may change depending on the desired fluid volume to be delivered, the viscosity of the fluid, and the injection depth. For example, the length of the plunger rod, the barrel diameter, the needle length, or the heights of the tubes of the syringe support could be changed.
  • FIGS. 14A-14C Some variations on the auto-injector are illustrated in FIGS. 14A-14C.
  • the housing 110 includes a window 814 which is oriented vertically.
  • the safety cap 900 includes a handle 930 which extends off to one side.
  • the housing 100 includes a window 814 which is circular.
  • the safety cap 900 includes a handle 930 which extends downwards.
  • the activation sleeve includes a shaped endplate 370.

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

Abstract

La présente invention concerne un auto-injecteur. L'auto-injecteur comprend un corps, un support de seringue, un ensemble seringue, un manchon d'activation, un ressort de compression inférieur, un manchon de ressort d'entraînement et un ressort de compression supérieur. Dans un état initial, le manchon d'activation et le manchon de ressort d'entraînement viennent en prise l'un avec l'autre par l'intermédiaire de crochets et maintiennent l'ensemble seringue à l'intérieur du corps. Lorsque le manchon d'activation est poussé dans le corps, les crochets se séparent et le ressort de compression supérieur pousse le manchon de ressort d'entraînement et l'ensemble seringue vers le bas pour exposer l'aiguille et injecter le médicament. Le ressort de compression inférieur est comprimé, puis s'étend pour pousser le manchon d'activation vers l'extérieur afin de recouvrir l'aiguille. Les crochets sur le manchon de ressort d'entraînement verrouillent ensuite le manchon d'activation en place.
PCT/US2023/031975 2022-09-06 2023-09-05 Auto-injecteur WO2024054430A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263404018P 2022-09-06 2022-09-06
US63/404,018 2022-09-06

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WO2024054430A1 true WO2024054430A1 (fr) 2024-03-14

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200009323A1 (en) * 2017-03-13 2020-01-09 University Of Cape Town An Auto-Injector
US20200108211A1 (en) * 2017-05-23 2020-04-09 Merck Patent Gmbh Auto injector with recap prevention
US20200139046A1 (en) * 2017-05-23 2020-05-07 Merck Patent Gmbh Auto injector with hollow plunger rod
US10765809B2 (en) * 2011-09-09 2020-09-08 Merck Patent Gmbh Auto-injector for epinephrine injection
US11260176B2 (en) * 2015-12-30 2022-03-01 Novo Nordisk A/S Autoinjector having needle shield triggering

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10765809B2 (en) * 2011-09-09 2020-09-08 Merck Patent Gmbh Auto-injector for epinephrine injection
US11260176B2 (en) * 2015-12-30 2022-03-01 Novo Nordisk A/S Autoinjector having needle shield triggering
US20200009323A1 (en) * 2017-03-13 2020-01-09 University Of Cape Town An Auto-Injector
US20200108211A1 (en) * 2017-05-23 2020-04-09 Merck Patent Gmbh Auto injector with recap prevention
US20200139046A1 (en) * 2017-05-23 2020-05-07 Merck Patent Gmbh Auto injector with hollow plunger rod

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