EP1667754A1 - Dispositif d'administration comportant un systeme d'insertion et un systeme de distribution - Google Patents

Dispositif d'administration comportant un systeme d'insertion et un systeme de distribution

Info

Publication number
EP1667754A1
EP1667754A1 EP04761905A EP04761905A EP1667754A1 EP 1667754 A1 EP1667754 A1 EP 1667754A1 EP 04761905 A EP04761905 A EP 04761905A EP 04761905 A EP04761905 A EP 04761905A EP 1667754 A1 EP1667754 A1 EP 1667754A1
Authority
EP
European Patent Office
Prior art keywords
piercing
dispensing
administration
pressure element
product
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Withdrawn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
EP04761905A
Other languages
German (de)
English (en)
Inventor
Edgar Hommann
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.)
Tecpharma Licensing AG
Original Assignee
Tecpharma Licensing 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 Tecpharma Licensing AG filed Critical Tecpharma Licensing AG
Publication of EP1667754A1 publication Critical patent/EP1667754A1/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Withdrawn legal-status Critical Current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
    • A61M5/20—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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206—With 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock

Definitions

  • the present invention relates to a device for administering an injectable product, in particular an auto-injection device, with an injection device for inserting an injection needle and a dispensing device for dispensing the injectable product.
  • Administration devices for the automatic administration of an injectable product, such as insulin, growth hormones and the like, with just one hand movement or push of a button are known in various embodiments. They generally have an insertion device for inserting an injection needle into a body tissue and a dispensing device which, after inserting the injection needle, dispenses the injectable product from a product container of the administration device.
  • the piercing and dispensing device can be triggered by a trigger z. B. be operated by hand, so that first a puncturing movement of the injection needle and then a dispensing movement for dispensing the product.
  • both the piercing device and the dispensing device with a drive means, for. B. a coil spring, provided between the puncturing or dispensing device and an abutment, for. B. are clamped on the housing of the administration device.
  • the puncturing and dispensing device can be fixed in a tensioned state of the drive means and released by the trigger. By triggering the puncturing or dispensing device, these are driven in the puncturing direction, ie generally along the longitudinal axis of the device towards the body tissue.
  • an injection pistol is known in which an injection needle is attached to a cylinder movable relative to the housing in a housing, which can be driven by a coil spring and brought into a preloaded position.
  • a piston which is movable relative to the housing is arranged within the cylinder and can be driven by a second spiral spring and can also be brought into a prestressed position.
  • the plunger and the cylinder interact such that when the injection gun is triggered, the cylinder is triggered first to cause the injection needle to be inserted, and then the piston is triggered to cause a dose of product to be spilled into a tissue.
  • the first and second coil springs are arranged coaxially along the longitudinal axis of the injection gun. When triggered, the spring driving the cylinder with the needle is triggered first, and the second spring engaging the piston and the piston initially remain at rest with respect to the housing. After the cylinder has covered a predetermined distance, the cylinder releases the second spring, so that a distribution takes place.
  • both springs are arranged in a fixed position with respect to one another and with respect to the housing.
  • the plunging cylinder on the one hand and the plunger for spouting on the other, there is a relative movement between the plunging cylinder movement and the plunger spouting movement when plunging in, so that plunging and spilling are not completely independent of one another.
  • the object of the invention is achieved according to the invention by an administration device according to claim 1.
  • a puncturing device for inserting an injection needle into a tissue with a first pressure element and a dispensing device for dispensing the injectable product from a product container can be driven by a second pressure element.
  • the pressure elements are preferably given by coil springs, but can also by other pressure-generating elements, such as. B. gas springs are formed.
  • the springs preferably generate pressure by compressing the springs. However, it would also be conceivable to generate pressure by stretching the springs.
  • the design of the administration device along the longitudinal axis of the device, e.g. B. with regard to the points of attack of the springs and a trigger for the springs, is then to be coordinated with such pressure generation.
  • a trigger is arranged on the administration device to trigger the puncturing and dispensing device.
  • a single trigger is preferably provided, the actuation of which triggers both the piercing device and the dispensing device. This enables automatic administration of the product with just one hand. In principle, however, it is also conceivable to provide a separate trigger for each of the devices.
  • the piercing device When the piercing and pouring device is triggered, the piercing device is moved by the first pressure element from a starting position in the piercing direction to a piercing position.
  • the piercing device moves relative to a housing of the administration device along the longitudinal axis of the device in the direction of the tissue surface until the injection needle has penetrated the tissue surface and the piercing device is thus in a piercing position.
  • the piercing position of the piercing device can e.g. B. be determined by a puncture of the puncturing device, for example on a housing part.
  • the dispensing device remains until the Piercing position of the piercing device at rest relative to the piercing device.
  • the dispensing device therefore moves simultaneously with the puncturing device relative to the housing of the administration device.
  • the second pressure element for driving the dispensing device remains at rest, ie in its pretensioned position, during the drive of the piercing device, ie during the action of the first pressure element.
  • the dispensing device After reaching the piercing position of the piercing device, the dispensing device is moved in the piercing direction relative to the piercing device into a dispensing position by means of the second pressure element.
  • the dispenser therefore moves towards the tissue to dispense the injectable product along the longitudinal axis of the administering device and thereby moves relative to the puncturing device and the housing of the administering device.
  • the dispensing device is moved as a whole during the piercing movement of the piercing device, so that no changes occur in the dispensing device due to the piercing of the injection needle.
  • the entire dispenser remains at rest during the piercing process.
  • the dispensing device is only triggered and the injectable product is dispensed after the piercing process has been completed. There is a complete separation of the piercing and dispensing process. The two processes can therefore not adversely affect each other. For example, the setting of a product dose size remains completely unaffected by the piercing process.
  • the administration device according to the present invention can therefore be used for reliable and simple administration of the injectable product.
  • the piercing device comprises an injection needle and at least one drive sleeve, in which at least the dispensing device, but also the product container and the second pressure element, are accommodated.
  • the drive sleeve can be formed from several sleeves, which are put together and interact. In an initial position of the piercing device, the injection needle and the drive sleeve are inside a housing Dispensing device arranged.
  • the injection needle is arranged at a front end of the drive sleeve, which is opposite a tissue surface when a product is administered, and at the opposite rear end, which is remote from the tissue surface, the first pressure element acts in the form of a spiral spring on the drive sleeve and is supported against a housing part.
  • the discharge device comprises a drive member, e.g. B. in the form of a piston rod which engages a piston in the product container.
  • the drive member of the dispensing device is movable relative to the drive sleeve of the piercing device in the longitudinal direction of the administration device.
  • the second pressure element in the form of a spiral spring acts on the drive member and on the rear end of the drive sleeve.
  • the product container is stored at the front end inside the drive sleeve. The second pressure element is therefore mounted together with the discharge device within the drive sleeve and is movable with it.
  • the dispensing device is fixed to the piercing device by a locking device.
  • z. B. between the drive member of the dispensing device and the drive sleeve of the piercing device blocking segments are provided, which cooperate in a piercing position of the piercing device to release the dispensing device with a release device.
  • the release device for releasing the blocking segments is arranged on the piercing stop of the piercing device. The latching device is therefore only released after the piercing process of the piercing device has been completed.
  • the drive member of the dispensing device In an initial position of the administering device, the drive member of the dispensing device is held by a trigger which is supported in relation to the housing of the administering device.
  • the first and second pressure elements are held in a prestressed position.
  • the first pressure element of the piercing device can exert force on the drive sleeve.
  • the drive sleeve is moved relative to the housing of the administration device in the piercing direction until it touches the Puncture stop strikes.
  • the injection needle is displaced out of the front end of the housing and sticks into the tissue when the administration device is placed on a tissue.
  • the administration device is then in a piercing position.
  • the second pressure element remains at rest since the drive member is fixed in relation to the drive sleeve.
  • the locking device between the drive sleeve and the drive member is released at the insertion stop and the drive member moves in the insertion direction relative to the drive sleeve and drives the piston within the product container, so that the injectable product from the container is administered through the injection needle. It is possible to pour out the entire product from the product container or to deliver only a predetermined product dose.
  • the delivery device is in a dispensing position after the product has been dispensed.
  • the thickness of the first and second pressure element can be adapted to the respective use.
  • the first spring for the piercing device can be selected to be significantly stronger than the second spring for pouring out the product.
  • the delivery device according to the present invention is reusable, i. H. it can be returned to an initial state with a tensioned first and second pressure element, and a new filled product container can be inserted after the emptying of a product container.
  • FIG. 1 shows a longitudinal section through an administration device according to the invention in a starting position
  • FIG. 2 shows a longitudinal section through an administration device according to the invention in a piercing position
  • FIG. 3 shows a longitudinal section through an administration device according to the invention in a dispensing position.
  • Figure 1 shows an administration device according to the present invention with a housing 1, in which a drive sleeve 2 is housed, which is composed of the sleeve parts 2 ', 2 "and 2'".
  • a product container 3 in the form of an ampoule is inserted in the sleeve part 2 '", which is followed by an injection needle 4 such that it protrudes from the sleeve part.
  • a drive member 5 in the form of a piston rod is arranged inside the sleeve parts 2' and 2", which is connected to a piston 6 in the ampoule 3.
  • a needle protection sleeve 7 is arranged, which serves to protect the needle after product administration and is slidably mounted along the housing.
  • a trigger 8 for triggering the drive sleeve 2 and the piston rod 5 is provided, which protrudes laterally from the housing of the administration device and can be secured by a safety cap 9.
  • the functioning of the trigger 8 and the safety cap 9 are described in detail in a parallel application by the applicants in the title “administration device for an injectable product with a trigger protection”, to which reference is hereby made.
  • the sleeve part 2 'of the drive sleeve 2 has a projection 10.
  • a first spring 11 as the first pressure element is mounted between the projection 10 and a wall 12 fixed to the housing. The drive sleeve 2 and the first spring 11 together with the injection needle 4 form the piercing device.
  • the piston rod 5 has in its rear region, located in the sleeve part 2 ', a recess 13 which is open from the rear end face of the piston rod and runs annularly to the axis of the administration device and extends in the longitudinal direction of the administration device into the interior of the piston rod 5 and in the front region the piston rod 5 ends.
  • a second spring 14 is inserted within the recess 13 and is supported at one end on the bottom of the recess 13 and at another end on an end wall 15 of the drive sleeve 2. The inner, from the second The spring 14 surrounding part of the piston rod 5 projects as an extension 16 beyond the outer part of the piston rod 5 lying outside the second spring 14.
  • the extension 16 projects through an opening in the end wall 15 of the drive sleeve and an opening in the wall 12 fixed to the housing and is fixed by the trigger 8.
  • the first spring 11 and the second spring 14 are in a prestressed state.
  • One or more blocking segments 17 are mounted between the sleeve part 2 'and the sleeve part 2 "of the drive sleeve 2.
  • the blocking segments 17 engage in a groove 18 which is arranged on the piston rod 5 in the circumferential direction and are engaged in this by an inner wall of the
  • the blocking segments 17, together with the groove 18, form a latching device which fixes the piston rod 5 with respect to the drive sleeve 2.
  • the blocking segments 17 can, for. B. be given by a prestressed ring. However, they are preferably formed by a plurality of balls or edge-shaped segments. In the case of balls, there is a point pressure between the piston rod 5 and the housing 1 and in the case of edge-shaped segments, a surface pressure. On the sleeve parts 2 'and 2 ", small aprons are provided adjacent to the blocking segment, which hold the blocking segments in position.
  • the administration device is shown in a piercing position.
  • the trigger 8 was actuated, thereby releasing the extension 16 of the piston rod 5.
  • the force of the first spring 11 moves the drive sleeve 2 relative to the housing 1 in the piercing direction and the injection needle 4 is inserted into a tissue 19.
  • the administration device was placed on the tissue 19 and the needle protection sleeve 7 was moved back into the housing 1.
  • the drive sleeve 2 is displaced relative to the housing 1 until it abuts with a shoulder 20 on an insertion stop 21 on the housing 1.
  • the blocking segments 17 come against one in the circumferential direction circumferential recess 22 to lie in an inner wall of the housing 1.
  • the recess 22 forms a release device for releasing the pouring device.
  • the fixing of the piston rod 5 with respect to the drive sleeve 2 is thereby released and the force of the second spring 14 drives the piston rod 5 relative to the drive sleeve 2 in the piercing direction.
  • the piston 6 is displaced within the ampoule 3 and the product is administered through an outlet in the ampoule and the injection needle.
  • the administration device is shown in a dispensing position.
  • the piston rod 5 is in an advanced position, in which the piston 6 is in a front position in the ampoule 3. It is also conceivable to provide a metering device within the administration device, by means of which a stop for the piston rod 5 can be adjusted in the longitudinal direction of the administration device such that the distance covered by the piston rod 5 is limited in accordance with a desired product dose.
  • the delivery device is reusable.
  • the drive sleeve 2 and the piston rod 5 can be returned to their rear position, in this case pretensioning the first spring 11 and the second spring 14 and being fixed in this initial position by the trigger 8.
  • This can e.g. B. together with the insertion of a new ampoule into the administration device.
  • the blocking segments 17 and the aprons on the sleeve parts 2 'and 2 are advantageously designed such that when the piston rod 5 moves back, the blocking segments 17 engage again in the groove 18, so that the piston rod 5 is locked with the drive sleeve 2.
  • an administration device of the present invention is possible without departing from the principle of the invention. It is Z. B. conceivable to fix the first and the second spring at their points of attack on the housing, the drive sleeve and the piston rod and a bias of the springs to generate by stretching the springs by z. B. the housing is moved relative to the drive sleeve and the piston rod. Furthermore, in a reversed variant of the drive sleeve and piston rod, a rod for driving the piercing device and a sleeve or a cylinder could be provided as the drive member of the dispensing device.

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 dispositif servant à administrer un produit injectable. Le dispositif selon l'invention comprend: un système d'insertion (2) permettant d'insérer une aiguille d'injection (4) dans un tissu au moyen d'un premier élément de pression (11); un système de distribution (5) destiné à distribuer le produit se trouvant dans un contenant à produit (3) au moyen d'un deuxième élément de pression (14), et; un déclencheur (8) conçu pour déclencher les systèmes d'insertion et de distribution. Le déclenchement des systèmes d'insertion et de distribution entraîne le déplacement du système d'insertion (2) par le premier élément de pression (11), d'une position de départ dans une direction d'insertion jusqu'à une position d'insertion, le système de distribution (5) restant inactif par rapport au système d'insertion (2) jusqu'à ce que la position d'insertion soit atteinte.
EP04761905A 2003-09-11 2004-09-08 Dispositif d'administration comportant un systeme d'insertion et un systeme de distribution Withdrawn EP1667754A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10342059A DE10342059B4 (de) 2003-09-11 2003-09-11 Verabreichungsvorrichtung mit Einstech- und Ausschütteinrichtung
PCT/CH2004/000565 WO2005023342A1 (fr) 2003-09-11 2004-09-08 Dispositif d'administration comportant un systeme d'insertion et un systeme de distribution

Publications (1)

Publication Number Publication Date
EP1667754A1 true EP1667754A1 (fr) 2006-06-14

Family

ID=34258582

Family Applications (1)

Application Number Title Priority Date Filing Date
EP04761905A Withdrawn EP1667754A1 (fr) 2003-09-11 2004-09-08 Dispositif d'administration comportant un systeme d'insertion et un systeme de distribution

Country Status (7)

Country Link
US (1) US7749195B2 (fr)
EP (1) EP1667754A1 (fr)
JP (1) JP2007504867A (fr)
CN (1) CN100496628C (fr)
AU (1) AU2004269839B2 (fr)
DE (1) DE10342059B4 (fr)
WO (1) WO2005023342A1 (fr)

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DE10342059A1 (de) 2005-04-28
JP2007504867A (ja) 2007-03-08
CN100496628C (zh) 2009-06-10
AU2004269839A1 (en) 2005-03-17
US20080009807A1 (en) 2008-01-10
WO2005023342A1 (fr) 2005-03-17
CN1849148A (zh) 2006-10-18
AU2004269839B2 (en) 2008-12-04
DE10342059B4 (de) 2007-03-01
US7749195B2 (en) 2010-07-06

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