EP2480272A2 - Appareil d'injection - Google Patents

Appareil d'injection

Info

Publication number
EP2480272A2
EP2480272A2 EP10757045A EP10757045A EP2480272A2 EP 2480272 A2 EP2480272 A2 EP 2480272A2 EP 10757045 A EP10757045 A EP 10757045A EP 10757045 A EP10757045 A EP 10757045A EP 2480272 A2 EP2480272 A2 EP 2480272A2
Authority
EP
European Patent Office
Prior art keywords
component
carpule
piston rod
injection device
housing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP10757045A
Other languages
German (de)
English (en)
Inventor
Joachim Keitel
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Haselmeier AG
Original Assignee
Haselmeier 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
Application filed by Haselmeier AG filed Critical Haselmeier AG
Publication of EP2480272A2 publication Critical patent/EP2480272A2/fr
Withdrawn legal-status Critical Current

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
    • A61M2005/2403—Ampoule inserted into the ampoule holder
    • A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
    • 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
    • A61M2005/2485—Ampoule holder connected to rest of syringe
    • A61M2005/2488—Ampoule holder connected to rest of syringe via rotation, e.g. threads or bayonet
    • 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
    • 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
    • A61M5/3146—Priming, e.g. purging, reducing backlash or clearance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31551—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member

Definitions

  • the invention relates to an injection device, which preferably serves, from a
  • Medication reservoir also referred to as a carpule, for making one or more injections, depending on the patient's need for medication.
  • the injections are made by a hypodermic needle, which is also called a cannula.
  • a carpule has a displaceable piston, usually made of an elastomer, and this piston is also called a plug.
  • the plug is pushed by a piston rod, which is also referred to as dosing, in the direction of the front, ie towards the patient to squeeze drug through the injection needle.
  • the desired movement of the piston can be set in increments of 0.14 mm.
  • the position of the plunger be accurately known at the beginning of an injection.
  • the carpule is replaceable, i.
  • a new one is inserted into the injection device.
  • the position of the piston in it is not known exactly. Even with cartridges that are filled mechanically with a constant volume, the position of the piston can fluctuate by about ⁇ 0.5 mm.
  • Pen injectors usually have a holder in which the carpule is inserted and which is attached to the pen injector. This holder, which can be described as a carpule container, is formed at its near-patient, front end so that an injection needle can be attached, for example by means of a bayonet connection or a screw thread.
  • Fig. 1 is an injection device 28 in the form of a so-called. Peninjektors, seen in the direction of
  • FIG. 2 the injection device of FIG. 1, seen in the direction of the arrow II of Fig. 1, wherein the
  • Fig. 3 the injection device of Fig. 1 and 2, in which the supply of drug
  • FIG. 7 the injection device of FIG. 6, wherein the carpule container on the housing of the
  • Karpulencontainers is brought to the piston in the new carpule and rests against this without play
  • FIG. 9 shows a representation analogous to FIG. 8, but on an enlarged scale; FIG. this figure serves for
  • 1 0 is a side view of a carpule container 44, seen in the direction of the arrow X of FIG. 1 1,
  • Fig. 1 1 is a longitudinal section, as seen along the line XI - XI of Fig. 10, wherein in the
  • Cartridge container 44 is a filled carpule 50
  • FIG. 12 is a perspective view of the carpule container 44 of FIG. 10 and 1 1,
  • FIG. 13 is a three-dimensional view of a first component 68, which is used to attach the
  • FIG. 14 is a perspective view of the component 68 of FIG. 13, but seen from the
  • Fig. 1 5 is a plan view of the component 68 of FIGS. 13 and 14, seen in the direction of
  • FIG. 14 is a three-dimensional view of a second component 92, which also carries three ramps, which with the ramps of the component of FIG. 13 to 1 fifth
  • Fig. 17 is a plan view from below of the second component 92, seen in the direction of the arrow
  • FIG. 19 is a plan view of the component 92 of FIG. 16, seen in the direction of the arrow XIX of FIGS. 16 and 18,
  • FIGS. 16 to 19 shows a three-dimensional representation of the second component 92 according to FIGS. 16 to 19 and a compression spring acting on this component
  • Fig. 21 is a view similar to Figure 20 but in side view. the representation of the second
  • Component 92 corresponds approximately to the representation of FIG. 18,
  • Fig. 22 is a plan view of the housing 34, seen in the direction of arrow XXII the
  • Fig. 23 is an exploded view for explaining the interaction of the in the
  • FIG. 24 is a perspective view analogous to FIG. 23; FIG.
  • FIG. 25 is an illustration which serves to explain the employment of the piston rod 38 (FIG. 9) against the piston 48 of a carpule 50 and the simultaneous locking of the second component 92 against rotation
  • FIG. FIG. 26 is an illustration showing the locked state of the second member 92, which also locks the piston rod 38 (FIG. 9) against rotation but can be moved in the axial direction.
  • Fig. 27 is an illustration showing the cancellation of the locking of the second member 92 before a change of the carpule;
  • the carpule container 44 is rotated in the direction of the arrow 58;
  • 29 is a longitudinal section, as seen in the direction of the arrows XXIX-XXIX of FIG. 26,
  • Fig. 30 is a plan view of the housing 34, seen in the direction of arrow XXX of
  • Fig. 31 is an exploded view of a simplified embodiment of the
  • FIG. 32 shows a representation analogous to FIG. 31, but in a three-dimensional representation
  • Fig. 33 shows a variant of FIG. 16 of the embodiment according to FIGS. 16 to 29, the
  • Fig. 34 is a plan view from below of the second component 92, viewed in the direction of the arrow
  • 35 is a side view, as viewed in the direction of the arrow XXXV of Fig. 34, 36 is a plan view of the component of FIGS. 33 to 35, seen in the direction of the arrow XXXVI of FIG. 35,
  • Fig. 37 shows a variant of the second component 92, with a reduced compared to FIG. 35
  • FIG. 38 shows a plan view of the part 92, seen in the direction of the arrow XXXVIII of FIG. 37, FIG.
  • Fig. 41 shows a process during the carpule change, in which the carpule container 44 in
  • Figs. 1 and 2 show an injection device 28, which is also referred to as a pen-injector because of its small size.
  • an adjustment knob 30 for setting a desired injection dose (by turning the knob 30), the set dose being displayed in a window 32.
  • the knob 30 When adjusting the knob 30 is rotated out of a housing 34, and in an injection, the patient presses in the direction of an arrow 36 on the button 30, so the patient.
  • a piston rod 38 which is provided with an external thread 40, displaced in the direction of an arrow 42 forward in the direction of the patient, which one must think in Figs. 1 to 12 and 23 to 32 above.
  • the external thread 40 is shown as a left-hand thread.
  • the piston rod 38 is in a carpule container 44 which is provided with two opposite windows 46.
  • Fig. 3 shows the pen-injector 28 with an empty carpule 50, whose shape is best seen in Fig. 1 1.
  • the injection liquid 52 ( Figures 2, 6, 7, 8, 9, 11) is consumed and the piston rod 38 is in its foremost position.
  • a fully filled carpule 50 can be inserted, as shown in FIG. 1 1, the piston rod 38 must be brought into their rearmost position.
  • this is done by unscrewing the carpule container 44 and then rotating the piston rod 38 back by turning it on a separate component called the return ring.
  • the piston rod 38 is simply pressed by hand into the housing 34 after removing the carpule container 44.
  • Cartridge container 44 screwed back, here by turning counterclockwise, see. the arrow 58 in Fig. 4. (The direction of rotation is indicated from view from the front side of the injector 28, so from a top view.)
  • the carpule container 44 can be removed (FIG. 5), and the empty carpule 50 can be replaced by a full one, cf. Fig. 6.
  • the carpule container 44 is then attached to the housing 34, see. Fig. 7.
  • the piston rod 38 is screwed forward, so here by a clockwise rotation, see. the arrow 60 of FIG. 8.
  • Torque can be rotated counterclockwise. This provides protection against the accidental initiation of a carpule change (Figure 4), in effect comparable to the protection that is common in comparable pen injectors.
  • the patient may begin the injections without having to specially prime the pen injector again. This results in a very obvious and easy to understand
  • Figs. 10 to 12 are used to explain the carpule container 44. This has at its distal end 63 a pin 64, the bayonet connection with a
  • a corresponding recess 66 of a first component 68 is used, which is shown in Figs. 13 to 15 and 23 to 32.
  • Recess 66 introduced and then brought by twisting (to the left) via a locking lug 74 along a path 72 in the detent position shown in Fig. 25, 26 and 27. -
  • a locking lug 74 along a path 72 in the detent position shown in Fig. 25, 26 and 27.
  • the lower boundary 7 8 (Fig. 26) of the recess 66 is resiliently resilient to allow a latching connection.
  • the component 68 has a hollow cylindrical outer wall 80, and in this elastically resilient guide members 82 are incorporated, which in the housing 34, an annular groove 84 (Fig. 20, 24, 28, 29) is associated.
  • annular groove 84 (Fig. 20, 24, 28, 29) is associated.
  • the guide members 82 engage in this annular groove 84, and the component 68 is then rotatably guided by the guide members 82 in the annular groove 84 of the housing 34, but can not move axially relative to the housing 34.
  • the component 68 in turn via the bayonet connection 64, 66 with the carpule container 44 fixed, but releasably connected.
  • the component 68 has, subsequent to the cylindrical outer wall 80, a bottom 86, in the center of which there is a recess 88 into which a collar 90 of a second component 92 protrudes, as shown in FIGS. 28, 29
  • Components 68 and 92 are rotatable relative to each other and also axially displaceable.
  • the collar 90 has an axially extending recess 94, which serves for the axial guidance of the piston rod 38 and is therefore adapted to the cross-sectional shape, as shown for example in FIGS. 16, 17 and 19, so that the piston rod 38 and the second component 92 only rotate together, but can move axially relative to each other.
  • first member 68 may rotate relative to the housing 34, but not axially displace. This then also applies to the carpule container 44 when it is engaged on part 68.
  • the first component 68 and the second component 92 together form a gear 98, whose function will be described below with reference to FIGS. 25 to 27. It serves to convert a relative rotation between the components 68 and 92 into an axial movement of the second member 92, which has the function of bracing the second member 92 and the piston rod 38 guided therein, e.g. by positive engagement of the component 92 with the housing 34, see. 21 to 23 and 25 to 27, or by the generation of a strong friction between the second member 92 and the housing 34, as shown in Figs. 32 to 36.
  • first component 68 and second component 92 are provided with ramps 104 and 118, respectively.
  • FIGS. 14 and 15 show by way of example three ramps 104 which are arranged on the bottom 86 of the first component 68 at equal intervals of 120 °.
  • a ramp-free section 106 with an angular extent of approximately 50 ° follows in the clockwise direction. This is followed by a section 108 (e.g., 30 °) having a ramp section 110, which usually rises to a maximum in section 108.
  • the first component 68 has three ramps 104, three shoulders 1 14, and three ramp sections 1 10. Following the shoulder 1 14 repeats the structure described, ie at an angular distance 106 from the shoulder 1 14, the rise of the next begins
  • the second component 92 (FIGS. 1 to 19) has a construction that is largely complementary thereto, as a comparison of FIGS. 15 and 19 shows. It also has three ramps 1 18.
  • a flat area 122 (eg 50 °), as seen in the clockwise direction, is followed by a rising area 124 of the lower ramp 1 18 in FIG followed.
  • Ramp area 1 24 has in this example an angular extent 126 of about 30 °, and it ends in a flat roof area with an angular extent 1 28 of e.g. 40 °, at the end of which there is again a shoulder 120.
  • the ramps 1 18 lie around the collar 90 around, and within the collar 90 is the recess 94 in which the piston rod 38 is guided.
  • the piston rod 38 also rotates, and this can move freely in the axial direction in the recess 94, as shown e.g. when priming is required.
  • the second component 92 On its side facing away from the ramps 1 1 8 side, the second component 92 has a coupling projection 130 which tapers frustoconically at its free end 132 and is provided with longitudinal grooves 134 for engagement in corresponding longitudinal grooves 136 of the housing 34, so that the projection 130 upon engagement is prevented in the longitudinal grooves 136 by a positive connection to a rotation. Possibly.
  • This effect according to FIGS. 30 to 36 can also be achieved without the projection in that the second component 92 is simply pressed against a surface 140 (FIG. 32) of the housing 34 and secured there against friction by friction.
  • the second component 92 is urged by a spring 142 in the direction of the first
  • Cartridge container 44 clockwise (arrow 60) rotates with the carpule container 44 and the first component 68 rotates with its ramps 104, and these ramps 104 engage as shown in FIG. 25 between the ramps 1 18 of the second component 92 and thereby transmit this rotational movement 60 also on the second component 92 and guided in this piston rod 38th
  • the latter is guided in the housing 34 in a threaded portion 1 50 (Fig. 28, 29), e.g. Part of the metering device of the injector may be and does not rotate when changing cartridges.
  • the piston rod 38 is therefore in Fig. 28 at a rotation 60 (Fig. 25) in an upward direction, so towards the patient, moved.
  • the piston rod 38 comes into abutment against the piston 48 in the carpule 50 by means of its plate 46 '.
  • the injector 28 is now primed, so properly prepared for an injection.
  • the piston rod 38 can not move further up, i.
  • the torque in the direction of arrow 60 (Figure 25) continues to function because the patient continues to rotate the carpule container 44, as shown in Figure 26, the rotation of the second member 92 is now blocked because the piston rod 38 is against the piston 48 is present, cf. Fig. 8.
  • the inclined surfaces 110 (FIGS. 14 to 16) of the ramps 104 of the first component 68 cause an axial force on the inclined surfaces 124 of the ramps 18 of the second component 92 and displace the latter, as shown in FIG. 26, against the force This results in a coupling between the projection 1 30 (FIG. 21) and the longitudinal grooves 136 in the housing 34 (FIG. 22), so that the second component 92 does not can continue to turn clockwise 60 clockwise.
  • the injection device 28 is now ready for use, ie the patient can normally adjust his individual injection dose and give himself injections until the contents of the carpule 50 is consumed. Thereafter, the carpule container 44 must be removed. For this purpose, this, as shown in FIG. 27, rotated in the counterclockwise direction 58. In this case, the previous coupling between the first component 68 and the second component 92, the latter is displaced by the spring 142 in the upward direction, and the shoulders 1 14 of the first component 68 come into abutment against the shoulders 120 of the second component 92, so that the latter is also driven in the counterclockwise direction 58.
  • the described procedure is then repeated to re-prime the new carpule 50 and to re-prepare the injection device 28 for safe use.
  • the slope of the ramps has also been changed.
  • Threads have a certain slope. This thread pitch is the distance from one thread to the next and is preferably about 10 to about 20 mm.
  • a ramp 124 here extends over an angle beta, e.g. 40 °.
  • h 360 36 ° * thread pitch ... (1). If the thread pitch is 1 5 mm, so h has about the value 1, 5 mm, which has proven in experiments as a favorable value.
  • the ramps 104 on the part 68 have the same shape as the ramps 124 'of the part 92 and are therefore only shown in FIGS. 39 to 41. There, the part 68 and its ramps 104 are highlighted in gray to facilitate understanding.
  • FIGS. 39 to 41 show highly schematic representations of the setting processes.
  • Fig. 39 shows the setting of the plate 46 'to the piston 48.
  • the ramps 1 18 are rotated in the direction of the arrow 60, so that they first move the plate 46' upwards in the direction of the piston 48.
  • Fig. 40 the plate 46 'has reached the piston 48. Therefore, now the upper ramps 1 10 are shifting relative to the lower ramps 124 'and moving the part 92 downwardly so that it now has the distance h' from the part 68 and the part 92 is blocked against rotation in the manner described , The injection device is now primed.
  • Fig. 41 shows the process of cartridge replacement.
  • the carpule container 44 is rotated in the direction of the arrow 58, whereby the ramps 104 detach from the ramps 124 'and the distance between the parts 68 and 92 is h again.
  • the part 92 is pressed by its spring 142 (see Fig. 31) toward the part 68.
  • the ramps 104 now press with their steep flanks 1 14 against the corresponding flanks 120 (FIG. 40) of the ramps 1 10.

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

L'invention concerne un appareil d'injection comportant un boîtier (34) et un contenant de carpule (44) destiné à recevoir une carpule (50) qui contient un liquide (52) à injecter et dans laquelle un piston (48) est monté coulissant. L'appareil comporte également une tige de piston (38) qui, lors d'une injection, sert à pousser le piston (48) d'une carpule (50) logée dans le contenant de carpule (44), faisant ainsi sortir le liquide (52) hors de la carpule (50). La tige de piston (38) présente un filet externe (40) qui est en prise avec le filet interne d'un élément (150) disposé dans le boîtier (34). L'appareil comprend en outre une transmission (98) présentant un premier élément (68), qui tourne relativement au boîtier (34) mais ne coulisse pas dans l'axe, et un deuxième élément (92) solidaire en rotation avec la tige de piston (38) et coulissant dans l'axe, de sorte que le premier élément (68), le deuxième élément (92) et la tige de piston (38) peuvent tourner ensemble relativement au boîtier (34) tant que la tige de piston (38) n'est pas gênée dans son coulissement axial, et que, lorsque la tige de piston (38) est gênée par le piston (48) d'une carpule (58) dans la progression de son coulissement en direction de ce piston (48), le premier élément (68) et le deuxième élément (92) se déplacent l'un par rapport à l'autre pour mettre le deuxième élément (92) dans une position dans laquelle ledit élément et la tige de piston (38) solidaire en rotation ne peuvent pas tourner relativement au boîtier (34).
EP10757045A 2009-09-26 2010-09-21 Appareil d'injection Withdrawn EP2480272A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102009048497A DE102009048497A1 (de) 2009-09-26 2009-09-26 Injektionsgerät
PCT/EP2010/005762 WO2011035877A2 (fr) 2009-09-26 2010-09-21 Appareil d'injection

Publications (1)

Publication Number Publication Date
EP2480272A2 true EP2480272A2 (fr) 2012-08-01

Family

ID=43662645

Family Applications (1)

Application Number Title Priority Date Filing Date
EP10757045A Withdrawn EP2480272A2 (fr) 2009-09-26 2010-09-21 Appareil d'injection

Country Status (6)

Country Link
US (1) US20130030383A1 (fr)
EP (1) EP2480272A2 (fr)
JP (1) JP2013505748A (fr)
CA (1) CA2773605A1 (fr)
DE (1) DE102009048497A1 (fr)
WO (1) WO2011035877A2 (fr)

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DE102009048497A1 (de) 2011-03-31
WO2011035877A3 (fr) 2011-06-23
WO2011035877A2 (fr) 2011-03-31
CA2773605A1 (fr) 2011-03-31
US20130030383A1 (en) 2013-01-31
JP2013505748A (ja) 2013-02-21

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