WO1994016752A1 - Dispositif d'auto-injection - Google Patents

Dispositif d'auto-injection Download PDF

Info

Publication number
WO1994016752A1
WO1994016752A1 PCT/EP1993/000180 EP9300180W WO9416752A1 WO 1994016752 A1 WO1994016752 A1 WO 1994016752A1 EP 9300180 W EP9300180 W EP 9300180W WO 9416752 A1 WO9416752 A1 WO 9416752A1
Authority
WO
WIPO (PCT)
Prior art keywords
sleeve
piston
cap
piston rod
rear end
Prior art date
Application number
PCT/EP1993/000180
Other languages
German (de)
English (en)
Inventor
Philippe Meyer
Original Assignee
Med-Plastic Ag
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
Priority to AT0003292A priority Critical patent/AT398037B/de
Priority claimed from AT0003292A external-priority patent/AT398037B/de
Application filed by Med-Plastic Ag filed Critical Med-Plastic Ag
Priority to US08/302,847 priority patent/US5616128A/en
Priority to PCT/EP1993/000180 priority patent/WO1994016752A1/fr
Priority to EP94905692A priority patent/EP0632733A1/fr
Priority to JP6516587A priority patent/JPH07505563A/ja
Publication of WO1994016752A1 publication Critical patent/WO1994016752A1/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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • 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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2459—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
    • 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
    • A61M5/32—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
    • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion

Definitions

  • the invention relates to a device for self-injection, with a tubular sleeve in which an .Ampoulle .axially arranged, which is closed at the front end by a membrane and at the rear end by a piston, and with one in the ampoule axially displaceable guided injection cannula, which is designed at the front end for piercing the membrane and for injection and at the rear end abuts the piston via an end flange.
  • the invention can also be applied to devices for self-injection, which have a tubular sleeve in which an ampoule is guided axially displaceably, which is closed at the front end by a membrane and at the rear end by a piston, and further have an injection cannula axially displaceably guided in the sleeve in front of the ampoule, which is designed at the front end for injection and at the rear end for piercing the membrane.
  • Devices of this type are used primarily for administering emergency medications, such as, for example, antidotes.
  • emergency medications such as, for example, antidotes.
  • the device must be ready for use immediately, work absolutely immune to malfunction and ensure the sterility of the medicament contained and the enclosed cannula for a long time.
  • US-PS 3,320,955, US-PS 4,624,660 and EP-PS 0 107 874 devices of the aforementioned types are known in which the advance of the injection cannula out of the sleeve and the advance of the piston in the ampoule is made by spring force.
  • a piston rod acts on the piston, which is suspended at the rear end of the device with a plurality of snap hooks in an axial opening of a rear sleeve wall and is pretensioned by a strong spring which is pushed onto the piston rod and strives to follow it to drive in front.
  • the spreading of the snap hooks of the piston rod at the rear end of the sleeve is ensured by a locking pin, which is inserted centrally from the rear between the clamping hooks that engage behind the edge of the hole in the rear wall of the sleeve.
  • the locking pin is first pulled axially backwards, and then the clamping hooks of the piston rod are forced together by slightly shifting an actuating sleeve which is pushed onto the sleeve and has corresponding projections on the inside. Since the tensioning hooks no longer reach behind the opening edges, the suspension of the piston rod in the sleeve is released and the biasing spring drives the piston rod forward.
  • the forward movement of the piston rod in the first type of device mentioned at the outset simultaneously pierces the injection cannula through the ampoule membrane and releases the medicament contained in the ampoule into the body during the advancement of the piston and the injection cannula.
  • the advance of the piston causes the entire ampoule and the injection cannula arranged in front of it to be advanced until it has penetrated into the body, and then the ampoule membrane is pierced through the rear end of the cannula and finally one Feed the plunger in the ampoule while simultaneously expelling the medication into the body via the cannula.
  • the injection process takes place fully automatically after removal of the locking pin, if the actuating sleeve is slightly displaced relative to the inner sleeve for triggering, ie when the actuating sleeve is gripped and pressed against a body part, as a result of which the inner sleeve contacts the body part comes and shifts slightly relative to the actuating sleeve.
  • the injection process runs like a shot.
  • This trigger mechanism has the disadvantage, however, that after removing the locking pin, the automatic injection is caused by slight vibrations, impacts or by a Dropping the device is triggered and the medication is wasted and the device becomes worthless.
  • the known devices therefore do not meet the requirements for an operation which is absolutely not susceptible to malfunctions under the harshest conditions, such as are typical for emergency use.
  • the invention sets itself the goal of developing devices of the type mentioned in such a way that an unintentional triggering can be excluded and that simple handling while maintaining the constant operational readiness and ensuring sterility is made possible.
  • This object is achieved according to the invention in that a tubular actuating cap is displaceably guided on the sleeve at the rear end of the sleeve and is secured against being pulled off, which has a piston rod which starts from the cap bottom and is inserted into the sleeve and acts on the piston, the cap bottom and the piston rod is penetrated by a central bore, into which a locking pin is inserted in the starting position with the cap partially pushed onto the sleeve and the piston rod engaging the piston, the locking pin having radially projecting resilient tongues at its inserted end which pass through lateral slots in the piston rod and rest on the rear face of the sleeve.
  • axially extending grooves are provided on the inside of the central bore, the number and circumferential distribution of which correspond to the number and circumferential distribution of the tongues on the locking pin. Both when inserting and when removing the locking pin, these grooves serve as sliding guides for the tongues, which facilitates both the assembly of the device and the intended use.
  • the tongues on the circumference of the locking pin extend in the axial direction in a first straight section and protrude beyond the locking pin and then run obliquely outwards in the radial-axial direction in a second straight section deflected at an obtuse angle. Since the tongues are made of elastic material, this configuration of the tongues enables the tongues to be forced together in an excellent manner, so that they can be inserted and removed via the central bore.
  • the end of the locking pin that is not inserted has a grip part whose diameter is larger than the diameter of the central bore.
  • the locking pin is further fixed, so that the locking pin in particular when using the recesses on the inside of the actuating cap is fixed in both directions.
  • the handle part enables easy handling.
  • the rear side walls of the slots of the piston rod are chamfered, the edges of the chamfered slot side walls lying further back being on the inside of the bore. This facilitates the engagement and disengagement of the tongues engaging in the slots.
  • a simpler construction and improved sterility compared to the known devices of the second type is obtained if the rear end of the injection cannula is guided in a manner known per se through a cannula guide piston which is displaceably mounted in the sleeve, projects beyond it and is fixed therein and if this protruding cannula end is covered by an elastic protective cap serving as a spacer spring or is sealingly connected to the ampoule by an elastic protective tube serving as a spacer spring.
  • FIG. 1 shows a longitudinal section of a device of the first type designed according to the invention
  • FIG. 2 shows a reduced view of the device according to FIG. 1;
  • FIG. 3 is a reduced view of the device of Figure 1 in two different operating positions, each half. 4 shows a device of the second type designed according to the invention in longitudinal section;
  • FIG. 5 shows a reduced view of the device according to FIG. 4;
  • FIG. 6 is a reduced view of the device according to FIG. 4 in two different operating positions, each half;
  • FIG. 8 shows the actuating cap according to FIG. 7 in longitudinal section
  • Figure 10 seen the actuating cap in front view from the front.
  • Figure 11 shows the locking pin with the handle part and the attached tongues in longitudinal section.
  • FIG. 12 shows a view of the locking pin with the handle part and the tongues in a position rotated by 90 ° with respect to FIG. 11;
  • Figure 13 shows the locking pin with the handle part and the tongues in front view from the front.
  • a first type of device for self-injection has a tubular sleeve 1 which has an opening 2 of small diameter at the front end for the passage of an injection cannula 3 and is essentially open at the rear end 4.
  • an ampoule 5 made of glass or metal, e.g. a standard glass ampoule.
  • the ampoule 5 is at the front end through a disc-shaped membrane 6 made of e.g. Rubber sealed, which is held by an aluminum cap 36 pressed onto the neck 7 of the ampoule with a central opening 37 on the ampoule neck.
  • a piston 8 e.g. a rubber stopper that can be sealed in the ampoule.
  • the ampoule 5 lies at the front end via the membrane 6.
  • On the inside of the front end wall of the sleeve 1 and is held in its rear end by an inwardly flanged edge 9 of the sleeve 1.
  • the injection cannula 3 is slidably mounted in the ampoule 5, etc. in a cannula guide 10, which fills the front part of the ampoule and a central one
  • the cannula bore is connected to the interior of the ampoule via a lateral opening 12 in the rear cannula part. Through this opening 12 when the plunger 8 penetrates into the ampoule 5, the medicament contained in the ampoule is expelled and injected via the cannula bore.
  • a tubular actuating cap 13 is guided so that it can be pushed on the sleeve 1 and secured against being pulled off by a projection 14 arranged on the inside of the cap, which cooperates with a corresponding projection 15 on the outside of the rear end of the sleeve 4.
  • the actuating cap 13 is shown in more detail in FIGS. 7 to 10. The length of the actuating cap 13 in relation to the length of the sleeve 1 and the arrangement of the projections 14, 15 is selected so that when the actuating cap is displaced from the position shown in the left half of FIG.
  • the outside of the actuating cap 13, as can be seen in FIGS. 2 and 3, is designed as a handle by ribbing.
  • the actuating cap 13 is fixedly connected to a piston rod 16 acting on the piston 8, which extends from the bottom 17 of the actuating cap 13 in the axial direction into the interior of the cap and has a diameter such that it can be inserted into the ampoule 5 from its rear end .
  • the piston rod 16 and the cap base 17 are penetrated by a common central axial bore 18, so that the piston rod 16 can also be regarded as a tube or the entire arrangement of the actuating cap 13 and the piston rod 16 as a double-jacket jacket closed on one side.
  • This locking pin is shown in more detail in FIGS. 11 to 13 and has two resilient tongues 20 on its circumference which are opposite one another and extend in the axial direction and which pass through lateral slots 21 in the piston rod 16 and at their end on the backward face 22 of the sleeve 1 abut.
  • the tongues 20 extend in a first straight section in the axial direction on the circumference of the locking pin 13 and beyond the locking pin, are then angled at an obtuse angle and run obliquely outward in the radial-axial direction in a second straight section.
  • the tongues are deflected outward in the radial direction and engage in recesses 23 on the inside of the actuating cap 13.
  • At least these tongues 20 of the locking pin 19 are made of elastic material and can therefore be squeezed together during insertion or removal of the locking pin into or out of the bore 18, spring apart when the slots 21 are reached and snap into place in the position shown in FIG. 1 in recesses 23 of the actuating cap 13.
  • the snap-in of the resilient tongues 20 in this position is facilitated by the fact that the rear side walls 24 of the slots 21 are chamfered, the edges 25 of these chamfered slot side walls 24 lying further back being those that lie on the inside of the bore 18.
  • the rear end of the locking pin 19 has a grip part 26, the diameter of which is larger than the diameter of the central bore 18.
  • the locking pin 19 is pulled back in the axial direction using the handle part 26, the ends of the tongues 20 first disengaging from the recesses 23 and then the entire tongues 20 being pressed against one another until they are approximately parallel lie and can be deducted together with the pin 19 through the bore 18.
  • Axial grooves 27 are provided on the inside of the central bore 18, the number and circumferential distribution of which correspond to the number and circumferential distribution of the tongues 20 on the locking pin 19. The tongues 20 therefore slide into this groove 27 during the insertion or removal of the locking pin 19.
  • the entire device is attached with its front end to a body part, normally the upper arm, and the actuating cap 13 is pushed forward, whereby the piston 8 and simultaneously the injection cannula 3 are pushed forward over the piston rod 16 becomes, which breaks through the membrane 6 and enables the injection of the medicament contained in the ampoule 5 through the opening 12 during penetration into the body.
  • the sleeve 1 is longer and contains the injection cannula 3 and the ampoule 5 in a row.
  • the sleeve 1 consists of two parts which are screwed together at their joint 28 via a thread.
  • the ampoule 5 is slidably mounted in the sleeve 1.
  • the ampoule 5 is closed at its front end by the membrane 6, which is held by the open aluminum cap 36 on the ampoule neck 7, and at the rear end, the ampoule is closed by the piston 8.
  • the injection cannula 3 In front of the ampoule 5 is the injection cannula 3, which is guided through and fixed in a cannula guide piston 29 which lies in the region of the rear end of the cannula 3.
  • the cannula guide piston 29 is over ⁇ in ⁇ n O-ring 30 guided on the inside of the sleeve 1 in a sliding seal.
  • the front opening 2 of the sleeve 1 is closed by a protective membrane 31.
  • the end of the cannula 3 protruding behind the cannula guide piston 29 is provided with a flange 34 and covered with a protective cap 32 made of soft rubber and placed over this flange.
  • a spacer spring 33 is arranged, which holds the cannula guide piston and thus the rear end of the cannula 3 at a distance from the membrane 6 which closes the ampoule 5 such that the spring 33 is not subjected to any force the rear, tapered end of the cannula 3 or its protective cap 32 penetrates so that the protective cap 32 touches the ampoule membrane 6.
  • the spacer spring 33 must also be dimensioned such that when the actuating cap 13 is actuated and thus the piston 8 is displaced by means of the piston rod 16, because of the friction between the piston 8 and the inside of the ampoule, the ampoule 5 is carried along by the piston 8 and advanced.
  • the ampoule 5 pushes the cannula guide piston 29 with the cannula 3 through the protective membrane 31 via the spacer spring 33 until the cannula guide piston 29 strikes the inside of the front wall of the sleeve 1. Only when the piston 8 continues to act is the distance spring 33 compressed, whereupon the rear end of the cannula penetrates the protective cap 32 and the cannula membrane 6.
  • the connection between the interior of the ampoule and the interior of the body is established and, finally, the piston 8 penetrates into the ampoule 5 when it is acted on further, and the medicament contained in the ampoule is expelled via the injection channel.
  • FIG. 14 shows a protective cap 32 'designed as a plastic bellows, which is welded or glued to the cannula guide piston 29 in a sealing manner and which bears against the ampoule membrane 6.
  • the protective cap 32 "shown in FIG.
  • FIG. 15 is made of silicone rubber and also has a corresponding deformation resistance which replaces the spacer spring 33.
  • FIG. 16 shows a particularly advantageous variant in which a protective tube 35 is attached to one instead of a protective cap Is sealingly connected at the end to the cannula guide piston 29 and at the other end to the ampoule neck 7. In this way, the membrane 6 of the ampoule 5 is also covered in a sterile manner.
  • the deformation and protection tube 35 is again selected so that it replaces the spring force of the spacer spring 33. It is understood that the deformation properties of the protective cap variants 32 'and 32 "and the protective tube 35 must be selected in the same way as the spring properties of the spacer springs 33.

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

Abstract

Dispositif d'auto-injection comprenant un manchon tubulaire (1), à l'intérieur duquel est disposée axialement une ampoule (5) fermée, à son extrémité avant, par une membrane (6) et, à son extrémité arrière, par un piston (8), ainsi qu'une canule d'injection (3) guidée de manière à se déplacer axialement à l'intérieur de l'ampoule, caractérisé en ce qu'il est prévu à l'extrémité arrière (4) du manchon (1), un capuchon d'actionnement de forme tubulaire (13) monté coulissant et comportant des moyens l'empêchant d'être retirée, présentant une tige de piston (16) s'étendant à partir de la base (17) dudit capuchon, guidée à l'intérieur du manchon et agissant sur le piston (8), en ce que la base du capuchon et la tige du piston sont traversées par un alésage central (18) dans lequel est introduite, en position de départ, une tige de verrouillage, le capuchon étant partiellement repoussé sur le manchon, et la tige de piston étant en contact avec le piston. Ladite tige de verrouillage (19) présente des languettes (20) formant des saillies élastiques radiales sur son extrémité d'insertion, ces saillies traversant les fentes latérales (21) dans la tige de piston et s'appliquant sur l'extrémité arrière (22) du manchon.
PCT/EP1993/000180 1992-01-10 1993-01-27 Dispositif d'auto-injection WO1994016752A1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
AT0003292A AT398037B (de) 1992-01-10 1992-01-10 Vorrichtung zur selbst-injektion
US08/302,847 US5616128A (en) 1992-01-10 1993-01-27 Self-injection device
PCT/EP1993/000180 WO1994016752A1 (fr) 1992-01-10 1993-01-27 Dispositif d'auto-injection
EP94905692A EP0632733A1 (fr) 1992-01-10 1993-01-27 Dispositif d'auto-injection
JP6516587A JPH07505563A (ja) 1992-01-10 1993-01-27 自己注射装置

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AT0003292A AT398037B (de) 1992-01-10 1992-01-10 Vorrichtung zur selbst-injektion
PCT/EP1993/000180 WO1994016752A1 (fr) 1992-01-10 1993-01-27 Dispositif d'auto-injection

Publications (1)

Publication Number Publication Date
WO1994016752A1 true WO1994016752A1 (fr) 1994-08-04

Family

ID=25591181

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1993/000180 WO1994016752A1 (fr) 1992-01-10 1993-01-27 Dispositif d'auto-injection

Country Status (1)

Country Link
WO (1) WO1994016752A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2764193A1 (fr) * 1997-06-09 1998-12-11 Sofic Seringue d'injection perfectionnee, comportant des moyens d'aspiration

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1342358A (fr) * 1961-10-07 1963-11-08 Penicillin Ges Dauelsberg & Co Seringue d'injection
DE1491818A1 (de) * 1963-10-18 1969-10-02 Sarnoff Stanley Jay Vorrichtung zum Einspritzen von Medikamenten od.dgl.

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1342358A (fr) * 1961-10-07 1963-11-08 Penicillin Ges Dauelsberg & Co Seringue d'injection
DE1491818A1 (de) * 1963-10-18 1969-10-02 Sarnoff Stanley Jay Vorrichtung zum Einspritzen von Medikamenten od.dgl.

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2764193A1 (fr) * 1997-06-09 1998-12-11 Sofic Seringue d'injection perfectionnee, comportant des moyens d'aspiration
WO1998056437A1 (fr) * 1997-06-09 1998-12-17 Sofic Seringue d'injection perfectionnee, comportant des moyens d'aspiration

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