EP1558308A1 - Procede et dispositif d'affichage et de dosage pour l'administration d'un produit - Google Patents

Procede et dispositif d'affichage et de dosage pour l'administration d'un produit

Info

Publication number
EP1558308A1
EP1558308A1 EP03753197A EP03753197A EP1558308A1 EP 1558308 A1 EP1558308 A1 EP 1558308A1 EP 03753197 A EP03753197 A EP 03753197A EP 03753197 A EP03753197 A EP 03753197A EP 1558308 A1 EP1558308 A1 EP 1558308A1
Authority
EP
European Patent Office
Prior art keywords
dose
metering
dosing
administration
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Withdrawn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
EP03753197A
Other languages
German (de)
English (en)
Inventor
Beat Steffen
Julian Yeandel
Alessandro Sebaste
M'hamed Moulay Heniche
Alain Charles Boss
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 EP1558308A1 publication Critical patent/EP1558308A1/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Withdrawn legal-status Critical Current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
    • A61M5/31—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
    • A61M5/31525—Dosing
    • 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
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A61M15/0066—Inhalators with dosage or measuring devices with means for varying the dose size
    • 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
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
    • A61M15/008—Electronic counters
    • 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
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • 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
    • A61M5/31553—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe without axial movement of dose setting member
    • 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
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof

Definitions

  • the present invention relates to a method and a device for displaying and dosing a product that is administered from a reservoir, in which a desired administration dose is set with the aid of a dosing device.
  • administration devices such as. B. injection pen used.
  • Such administration devices have a reservoir, e.g. B. an ampoule in which the product is received.
  • the product is administered from the ampoule through an outlet, in which a piston arranged in the reservoir is moved by a drive device in the direction of the outlet by actuating a drive button J.
  • a dosing device is provided, by means of which the movement of the drive device when the drive button is actuated is regulated in accordance with a desired dose.
  • the metering device limits the distance that a drive device can cover when the drive button is actuated, and thus also the distance that the piston is advanced within the reservoir in the direction of the outlet.
  • the metering device in a metering direction z. B. movable relative to a housing of the injection pen, ie rotatable or displaceable.
  • the dosing device is moved from a starting position in the dosing direction over a dosing distance which corresponds to the desired dose and which determines a distance over which the plunger has to be advanced in order to administer the desired volume.
  • An electrical display on the administration device registers the movement of the dosing device and shows a selected dose.
  • the dose value is in Depends on the metering distance displayed, which was covered by the metering device in the metering direction from the starting position.
  • the movement of the metering device can z. B. be provided with a locking mechanism in which each locking position corresponds to a dose unit. Starting from the starting position, when the dosing device moves in the dosing direction, the display is increased by one dose unit each time a rest position is exceeded. After the selected dose has been administered, the display can be reset to zero using the reset button.
  • this section creates an empty dose section for the drive device. If the drive device or the piston is subsequently moved in the feed direction towards the outlet, no product is distributed over this empty dose path. This is commonly referred to as a "dry shot”.
  • a warning appears on the display.
  • the display can be turned back to the zero value and thus the metering device can be returned to the original position after the dose has been administered.
  • the dose display is counted up with a first movement in the dosing direction or when a stop position is exceeded for the first time.
  • the empty dose distance is counted as a metering distance for a desired dose.
  • no product is poured out when the plunger is advanced over this empty dose distance, so that a dose of product corresponding to the empty dose distance is missing in the dose, although the display shows the desired dose value.
  • a metering device and a display unit are used in a method for displaying and metering a product to be administered from a reservoir, the metering device being moved over a metering distance from a starting position in a metering direction to set a specific dose.
  • a reference point is determined by an initial position of the dosing device for a first dose to be administered or a position in which the dosing device is after the administration of a dose.
  • the dose value of this dose is displayed by the display unit as a function of the distance that the metering device has traveled in the metering direction from the reference point.
  • the reference point therefore represents a zero point, from which the distance covered by the dosing device in the dosing direction is measured when setting the dose. This is a relative zero point, since this zero point is determined anew each time the dose is administered.
  • the reference point for subsequent administration is thus shifted by a distance that the dosing device has traveled in the dosing direction since the reference point for the administered dose setting.
  • the metering device moves in the metering direction, d. H. If an empty dose distance was generated, this empty dose distance is taken into account when displaying the dose value according to the present invention and the correct value of the set dose is given.
  • the dose setting is accordingly displayed as a value which is produced by subtracting the empty dose section from a metering section covered by the metering device in the metering direction, i. H. if a user moves the dosing device from a starting position over a dosing section in the dosing direction, the distance that the dosing device has traveled against this direction before the movement in the dosing direction is subtracted from this dosing section. Incorrect operation in the dosing opposite direction is therefore automatically taken into account when a set dose value is displayed.
  • the reference point is preferably displayed by the display unit using an identifier. For this, z. B. the display "00" selected. If a user moves the dosing device over a distance in the opposite direction of dosing, ie if an empty dose distance is set, a marking of this process is preferably done, for. B. in the form of two minus signs as a warning for the user z. B. issued by the display unit. If the dosing device is then moved over a distance in the dosing direction, the identification of the reference point only appears on the display when the empty dose distance in the dosing direction has been overcome again by the dosing device and the reference point or the relative zero point has been reached. From this point on, the display starts to show the dose value when setting the dose.
  • an absolute zero point is preferably defined by certain positions of the metering device.
  • the absolute zero point can e.g. B. be determined by the position of the metering device, which it occupies when attaching a reservoir to the metering device, ie when replacing or reinserting an ampoule into an administration device, if necessary with NuUab Eisen.
  • the absolute zero point can be determined by a manual adjustment of the display unit, ie by a priming process.
  • An absolute zero point can be determined by the position of the metering device, which it assumes after covering a predetermined minimum distance in the counter-metering direction, the display unit registering a distance moved back and the distance preferably being significantly larger than a dose distance.
  • the position of the metering device can be defined as an absolute zero point, which it occupies after moving back by more than 15 dose units, a priming process then being carried out.
  • a position of the metering device in which it is retracted as far as possible in the administration device ie when the metering device is at a rear stop in the administration device be defined as an absolute zero point.
  • a button or a switch can be actuated by moving back in a rearmost position.
  • the user is required to manually adjust the NuU.
  • a manual readjustment also remains necessary if data of a setting of the device were lost due to extraordinary effects on the administration device, such as due to a too rapid twisting of the dose device, which cannot be detected by a scanning device, or due to mechanical influences.
  • the absolute zero point represents a starting point from which several doses can subsequently be set.
  • the relative zero point corresponds to the absolute zero point.
  • the relative zero point moves further away from the absolute zero point, namely by the distance traveled by the dosing device since the reference point for the administration.
  • the relative zero point and the absolute zero point are preferably stored in a memory in the display unit.
  • the method according to the invention is also intended for displays and metering devices in which it is possible to influence the display independently of the metering device.
  • Electronic displays are advantageously used.
  • a device for the metered administration of a product has a reservoir for the product, a display unit for displaying a set dose value and a dosing device, the dosing device being movable over a dosing path from a starting position in a dosing direction for setting a specific dose of the product.
  • the display unit shows the dose value as a function of a distance traveled by the dosing device in the dosing direction, the distance being determined starting from a reference point which is determined by an initial position of the dosing device for a first dose to be administered or by a position of the dosing device given a dose administration.
  • the dose value accordingly shows the dose corresponding to the distance traveled from the reference point or a relative zero point in the metering direction. Distances that were previously covered in the counter direction are not taken into account in the dose display. The dose value is therefore obtained by subtracting the distance traveled by the dosing device in the counter-dosing direction before a movement in the dosing direction from the metering distance traveled in the dosing direction for setting the dose.
  • the method steps of the previously described method for displaying and dosing a product to be administered are implemented according to the invention.
  • the display is preferably an electronic display and a memory for the relative and the absolute zero point is provided.
  • the idea of the invention was illustrated using the example of an injection pen. Of course, however, it is also possible to choose other forms of administration devices for the use of the method, such as, for example, infusion devices and inhalers.
  • FIG. 1 shows a partial section of a device for the metered administration of a
  • Product and Figure 2 is a diagram illustrating the method of the present invention.
  • FIG. 1 shows an administration device in the form of an injection pen, which illustrates the principle of dose administration, as is used in the prior art and the invention.
  • the injection pen has an ampoule 1 in a front area as a reservoir for a product to be administered, with an outlet 2.
  • a piston 3 is received in the ampoule and can be advanced by a drive device in the direction of the outlet 2.
  • the drive device comprises a piston rod 4 and a drive button 5, by means of which the piston rod 4 can be displaced in the feed direction.
  • a metering device is arranged in the rear area of the injection pen and has a rotatable sleeve 6.
  • a distance can be set over which the piston 4 is displaced in the direction of the outlet 2 when the drive button 5 is actuated when a dose is administered.
  • the dosing sleeve 6 is rotated in the opposite direction of the dosing, it is possible that an empty dose path is created for the piston rod 4, in which the piston rod 4 does not advance the piston 3 when the drive button 5 is actuated, and thus no product is displaced from the ampoule 1.
  • the setting of the metering section can, for. B. by a metering mechanism (not shown in Figure 1), in which by rotating the metering sleeve 6 a stop for the Drive device of the piston 4 is arranged such that it limits the drive distance for the piston according to the metering distance.
  • An electronic display unit 7 is arranged in the rear area of the injection pen.
  • the display 7 can e.g. B. display the dose value by actuating contacts arranged on its back when adjusting the dose, for example by means of a camshaft, which is connected to the dosing sleeve 6. According to the rotation of the dosing sleeve, the contacts are actuated by the camshaft and the dosing is displayed.
  • the display unit 7 further comprises a battery, a memory, a computing unit, a display and at least one button for manual actuation.
  • the effective distribution of a product to be administered ie the amount of product actually dispensed, is shown on the horizontal axis, starting from an absolute zero NP abS .
  • the distribution is shown on the vertical axis in accordance with a dose value displayed on the display unit.
  • the units on the axes correspond to the number of discrete dose units.
  • a first dose to be administered of ten units is set by moving the metering device in the metering direction.
  • the value 10 appears on the display unit, as can be seen from the vertical axis.
  • the metering device is moved in the opposite metering direction over a distance 2a of five dose units, as a result of which a "dry shot" is set, ie an empty dose section is created.
  • This movement in the dosing direction causes a warning on the display, e.g. B. a minus sign.
  • the user sets a new dose for administering the product, again using the metering device via a metering section 3 a moved in the dosing direction.
  • a dose of ten units is also set.
  • the display unit in the prior art begins to count up these ten units. This means that starting from the starting position A, counting continues by ten units. The next ten units are added to the first ten units on the vertical axis so that the value 20 is reached.
  • a distance corresponding to the empty dose distance 2a of five units is first overcome on the horizontal axis up to the value 10 already administered.
  • the further five units are then set along a distance 3 a 'up to the value 15 by moving in the metering direction.
  • the metering section 3a is therefore composed of the empty dose section 2a and the section 3a '.
  • the dosage and display according to the method of the present invention is shown as a dashed line.
  • a first dose is set and administered along a dosing path 1b starting from the absolute zero NP abs of ten dose units.
  • the position of the dosing device after the administration of this first dose determines a reference point, ie a relative zero point NP re -, which is stored in the memory of the display unit.
  • a reference point ie a relative zero point NP re -
  • the relative zero point NP rel would correspond to the absolute zero point NP abs defined by the manual zero adjustment.
  • the user improperly actuates the injection pen in the opposite direction of the dose by five dose units along the route 2b, which results in an empty dose route during the administration of a dose.
  • the starting position A that is reached it becomes Setting a second dose of ten units moves the metering device in the metering direction.
  • the empty dose section 3b which corresponds to section 2b, is traversed by five units in the metering direction. According to the present invention, during this movement in the metering direction, the value on the display unit is not counted up according to the movement by five units.
  • a value "0" is indicated on the display unit. Then, when the dosing device moves along the distance 3b 'of 5 units, the value " 0 "is counted up by 5 units so that it shows the value” 5 ".
  • the display unit therefore, in accordance with the present invention, indicates the dose value that is actually administered when the drive device is actuated with this metering position.
  • the distance 3b accordingly corresponds to one
  • the dosing route covered by the dosing device in the dosing direction is composed of the empty dose route 3b and the administration route 3b '. If a user actually wants to set a dose of ten units, he would have to move the dosing device another five units in the dosing direction for him easily by on the lower unit displayed.
  • the two metering sections la and 3a are summed with 3a 'according to the prior art, so that a value 20 results on the display unit and the vertical axis of FIG.
  • the first metering distance 1b covered in the metering direction and the second metering section covered in the metering direction which is composed of sections 3b and 3b ', are added and the value of the idle stroke section 2b or 3b, which was incorrectly set by the user , subtracted so that a value of 15 is set on the display in accordance with the total product quantity actually distributed.

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

Abstract

L'invention concerne un procédé d'affichage et de dosage d'un produit à administrer, contenu dans un récipient, au moyen d'un dispositif de dosage et d'une unité d'affichage. Lors du réglage d'une dose prescrite, ce dispositif de dosage est déplacé depuis une position initiale (NPabs ; A) dans un sens de dosage le long d'une section de dosage (1a ; 1b ; 3a, 3a' ; 3b, 3b'). Un point de référence (NPrel) est déterminé à partir d'une position initiale du dispositif de dosage pour une première dose à administrer ou d'une position de ce dispositif de dosage après l'administration d'une dose. Un réglage de cette dose est affiché comme valeur de dose par ladite unité d'affichage en fonction de la section (3b') parcourue dans le sens de dosage par le dispositif de dosage à partir du point de référence (NPrel).
EP03753197A 2002-10-30 2003-10-24 Procede et dispositif d'affichage et de dosage pour l'administration d'un produit Withdrawn EP1558308A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10250629 2002-10-30
DE10250629A DE10250629A1 (de) 2002-10-30 2002-10-30 Verfahren und Vorrichtung zur Anzeige und Dosierung bei der Verabreichung eines Produkts
PCT/CH2003/000693 WO2004039440A1 (fr) 2002-10-30 2003-10-24 Procede et dispositif d'affichage et de dosage pour l'administration d'un produit

Publications (1)

Publication Number Publication Date
EP1558308A1 true EP1558308A1 (fr) 2005-08-03

Family

ID=32114982

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03753197A Withdrawn EP1558308A1 (fr) 2002-10-30 2003-10-24 Procede et dispositif d'affichage et de dosage pour l'administration d'un produit

Country Status (7)

Country Link
US (1) US20050251103A1 (fr)
EP (1) EP1558308A1 (fr)
JP (1) JP2006504457A (fr)
CN (1) CN100594043C (fr)
AU (1) AU2003271488B2 (fr)
DE (1) DE10250629A1 (fr)
WO (1) WO2004039440A1 (fr)

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US9241753B2 (en) 2012-01-13 2016-01-26 Myoscience, Inc. Skin protection for subdermal cryogenic remodeling for cosmetic and other treatments
CA2861116A1 (fr) 2012-01-13 2013-07-18 Myoscience, Inc. Systeme de filtration de sonde cryogenique
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US9295512B2 (en) 2013-03-15 2016-03-29 Myoscience, Inc. Methods and devices for pain management
WO2014146122A1 (fr) 2013-03-15 2014-09-18 Myoscience, Inc. Méthodes et systèmes pour le traitement de la névralgie occipitale
CN105208954B (zh) 2013-03-15 2019-06-04 肌肉科技股份有限公司 低温钝性解剖方法和设备
US9610112B2 (en) 2013-03-15 2017-04-04 Myoscience, Inc. Cryogenic enhancement of joint function, alleviation of joint stiffness and/or alleviation of pain associated with osteoarthritis
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Also Published As

Publication number Publication date
CN1708324A (zh) 2005-12-14
AU2003271488B2 (en) 2009-04-09
DE10250629A1 (de) 2004-05-19
WO2004039440A1 (fr) 2004-05-13
AU2003271488A1 (en) 2004-05-25
JP2006504457A (ja) 2006-02-09
US20050251103A1 (en) 2005-11-10
CN100594043C (zh) 2010-03-17

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