EP1515764A1 - Dispositif et procede de dosage d'une substance - Google Patents

Dispositif et procede de dosage d'une substance

Info

Publication number
EP1515764A1
EP1515764A1 EP03722173A EP03722173A EP1515764A1 EP 1515764 A1 EP1515764 A1 EP 1515764A1 EP 03722173 A EP03722173 A EP 03722173A EP 03722173 A EP03722173 A EP 03722173A EP 1515764 A1 EP1515764 A1 EP 1515764A1
Authority
EP
European Patent Office
Prior art keywords
coding
positions
rotational position
rotational
generated
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Withdrawn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
EP03722173A
Other languages
German (de)
English (en)
Inventor
Stefan Jost
Julian Yeandel
Beat Steffen
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 EP1515764A1 publication Critical patent/EP1515764A1/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Withdrawn legal-status Critical Current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
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/31556—Accuracy improving means
    • 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
    • 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
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3306—Optical measuring means
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated
    • A61M2205/8212—Internal energy supply devices battery-operated with means or measures taken for minimising energy consumption
    • 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
    • A61M5/31—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
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31578—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
    • A61M5/3158—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod performed by axially moving actuator operated by user, e.g. an injection button

Definitions

  • the present invention relates to a device and a method for dosing, in particular for the dosed delivery of a preferably injectable substance from an injection or infusion device.
  • the present invention relates to an apparatus and a method for setting and / or measuring a dose of the substance to be delivered or delivered.
  • the direction of rotation can, for example, be interpreted incorrectly if the first bit remains incorrectly at the value 0.
  • a transition from the intermediate state bc (coding: 001) to position C (correct coding: 101; incorrect coding: 001) is not recognized.
  • a further transition to the intermediate state cd (correct coding: 111; incorrect coding: 011) is interpreted as a transition from the intermediate state bc to position B.
  • the exemplary encodings shown in FIGS. 4 and 5 can thus lead, by means of a single faulty bit, that a direction of rotation opposite to the actual direction of rotation is determined and thus, for example, the increase in a set dose is incorrectly interpreted as a decrease in the dose amount and thus, for example, incorrectly no warning is given if the dose set is too high.
  • This object is achieved by a device and a method according to the independent claims.
  • Advantageous embodiments result from the subclaims.
  • the device according to the invention for dosing a substance can be contained in an infusion or an injection device, a movable, for example rotatable element being provided, via the position or rotational position of which the amount of a substance to be dispensed, for example, with an injection device or the amount of a substance dispensed by an infusion device is set or measured.
  • a movable, for example rotatable element being provided, via the position or rotational position of which the amount of a substance to be dispensed, for example, with an injection device or the amount of a substance dispensed by an infusion device is set or measured.
  • the substance is dispensed by pressing on a trigger element, which is often also the adjusting element.
  • At least one coding element is provided on the rotatable element, which enables detection of the rotational position, the coding being able to be designed, for example, in such a way that four different rotational positions offset by 90 ° to the respective neighboring positions can be detected.
  • two, three, five or more rotational positions can be distinguished by the coding, depending on the number of differentiating elements or bits available and the selected coding, so that, for example, eight rotational positions can also be distinguished from one another.
  • the rotational positions can either be fixed positions or rotational angles or angular ranges, that is to say, for example, that the rotation of the rotatable element from a starting position by 85 ° to 95 ° is recorded as a quarter turn with a tolerance range of 5 °.
  • at least one reference element is provided, which can be attached to the rotatable element, for example, or can be integrated into the rotatable element or separated from the rotatable element and can interact with an element or part of the rotatable element, the reference element only providing a signal at least one and preferably two, three, four or more predetermined positions are generated.
  • the reference element can, for example, be designed such that a signal is generated in an initial state of the rotatable element and in each of which a rotational position offset by a multiple of 90 °, so that, for example, a signal upon rotation of 0 °, 90 °, 180 ° , 270 ° and 360 ° in each direction.
  • the reference element according to the invention can also be used for other movements, such as. B. a longitudinal or rectilinear movement can be used to generate corresponding reference signals.
  • the reference element is preferably designed such that a reference signal is only generated when the rotatable element is positioned as precisely as possible, ie. H. for example, no or only a very slight deviation of, for example, up to 1 ° from the respective position is tolerated in order to output the reference signal.
  • a larger tolerance range can also be predetermined, which allows the rotational position of the rotatable element to deviate from a predetermined position by, for example, up to 10 ° or up to 30 ° or 45 ° in order to output the reference signal.
  • the reference element can only be used to generate a reference signal when there are predetermined changes in position, for example before and / or after a defined position or a defined state.
  • a reference signal can thus be generated, which can be used to read out a coding for determining the rotational position of the rotatable element only at predetermined, defined rotational positions, in order to achieve increased security when coding or reading out a coding and thus Detect errors or, for example, reject errors that occur in intermediate states.
  • the reference element according to the invention can be used to rule out that such intermediate states are detected and interpreted as errors or as incorrect rotational positions which do not correspond to an actual rotational position of the rotary element.
  • the at least one reference element for generating at least one reference signal can preferably be designed such that not only an error detection but also an error correction is possible. So z. B. a coding with predetermined valid codes or states can be selected, in which z. B. a faulty bit can be recognized and corrected. For this purpose, the codes should be at a sufficient distance from one another.
  • the reference signal can preferably also be used to switch energy-consuming elements, such as. B. the electronics of an infusion device .Z.
  • the electronics can only be activated when the reference element indicates that a relevant change in position has occurred, so that no energy is consumed in intermediate states of no interest.
  • the coding elements used to detect the rotational position and / or the reference element can advantageously be designed as mechanical elements, as shown by way of example in FIGS. 1 to 3.
  • a two-digit or multi-digit code for coding a rotational position can be generated by a rotating body which has a disk element for each individual bit, which is dependent on the respective rotational position has a protruding element, for example to press an adjacent switch at a certain rotational position and thus to make a contact.
  • no protruding element is provided, so that an adjacent switch is not pressed.
  • the individual disk elements assigned to the respective bits can have protruding elements at mutually offset or rotated positions, so that multi-digit coding can be implemented, the individual bits being able to change independently of one another depending on the respective rotational position.
  • the elements used for coding and / or the at least one reference element can also be based on optical principles, for example light barriers or photodiodes, which detect emitted light signals and detect the presence or interruption of light signals by means of corresponding light-emitting or reflecting elements used for coding or referencing can.
  • Optical elements enable contactless scanning and can be used over a longer period of time due to the wear that is essentially non-existent compared to mechanical elements.
  • the coding elements and / or the reference element using a combination of the variants described above, i. that is, for example, the coding of the rotational position is implemented by mechanical elements, while the reference element is implemented by optical elements.
  • the code used for coding the rotational position can advantageously be a Gray code, it being possible to provide a coding with two, three, four or more bits in order to code the desired number of different rotational positions.
  • a display element in connection with the device according to the invention is advantageously provided on an infusion or injection device in order to display a rotational position detected by the coding and the reference element or a corresponding set or dispensed dose quantity and to indicate possible errors in the coding.
  • a reset switch can preferably also be provided, which can be actuated separately, for example to initiate a new measuring process.
  • the present invention relates to a method for setting and / or measuring the dose or amount of a substance to be dispensed or dispensed, a two-digit or multi-digit code being read out or evaluated only in the case of positions or position changes specified by a reference element. Incorrect coding in the case of undefined intermediate states cannot therefore lead to incorrect recognition of an actual rotational position.
  • an error that occurs is advantageously recognized, for example, by permissible transitions from predefined coding states and / or permissible codes and comparing codes that have actually been detected and changes in the coding with the permissible codes and code changes.
  • Figure 1 is a side view of a mechanical embodiment of an element according to the invention for adjusting a dose of an infusion device with an associated switching arrangement;
  • Figure 2 shows the device shown in Figure 1 in plan view
  • FIG. 3 cross sections at the positions shown in FIG. 1;
  • Figures 4 and 5 known encodings of rotary positions with two and three bits
  • FIG. 6 shows a two-bit Gray coding with a reference
  • FIG. 7 shows the schematic representation of the angle-dependent switching processes of an exemplary implementation of the code shown in FIG. 6;
  • FIG. 8 shows an exemplary two-bit coding scheme with a reference bit according to the invention for defining measurement positions
  • FIG. 9 shows an example of non-separable coding using a three-bit
  • Figure 10 is a functional diagram of a mechanical implementation of the encoding shown in Figure 9;
  • FIG. 11 shows a three-bit coding scheme with an additional reference bit
  • Figure 12 is a schematic for the mechanical implementation of the one shown in Figure 11
  • Figure 13 shows an injection device with a coding and reference element according to the invention.
  • FIG. 1 shows a camshaft 1 which, in the installed state, is opposite switching elements 2 in an infusion device, the four cams of the camshaft 1 denoted by the respective cross sections A to D each opposing a switching element of a switching mat 3 which, depending on the rotational position of the camshaft 1 are pressed onto the printed circuit board 4 in order to make an electrical contact.
  • FIG. 2 shows the arrangement shown in FIG. 1 in a plan view, it being possible to see that the camshaft 1 has on its inside four projections, each offset by 90 ° from one another, so that the camshaft 1 is secured against rotation on an adjusting and pushbutton (not shown) ) can be postponed in order to enable a dose to be set by turning the button and then the dose to be dispensed by pressing the button while simultaneously pushing the button through the camshaft 1.
  • the cross-sectional views A to D shown in FIG. 1 are shown in FIG.
  • Sections B-B to D-D show the partial elements of the camshaft 1 which are used to implement a three-digit coding and with which different codes can be generated depending on the rotational position of the camshaft 1.
  • the position shown in FIG. 3 is coded, for example, by "101" if a pressed switching element corresponds to the state "1" and a code is defined in the sequence section B-B to D-D.
  • the associated switching connection is first interrupted by the reference element 6 and it is only closed again by a further rotation of approximately 90 ° in order to indicate the presence of a valid code.
  • the position rotated 90 ° clockwise is coded by the code "011".
  • FIG. 6 shows a coding of four rotational positions with a two-digit Gray code and a reference bit, which indicates position transitions. If, for example, it is assumed that the second bit remains faulty at "0", a transition from position A to position B is not recognized if only the first two bits are taken into account. However, if the third additional reference bit is taken into account according to the invention, it can be determined by changing the reference bit that a position transition has taken place and the code "001" is output. Because this code "001" is not provided, it can be determined that an error has occurred. The further transition from position B to position C generates the code "100", which can also be recognized as invalid and thus indicates an error that has occurred.
  • the additional reference bit can also be used for show a change in position and used to check the accuracy of a code.
  • FIG. 7 schematically shows a diagram of a mechanical implementation of the coding shown in FIG. 6, the points drawn on the circles defining the change in state of the respective bit.
  • the innermost circle is assigned to the first bit, while the outer circle is assigned to the last bit used as the reference bit.
  • the implementation shown in FIG. 7 is particularly suitable for a metering device which can only be rotated in one direction, since the change in the reference bit occurs immediately before and preferably at the same time as a new position is reached, so that the previously occurring changes in the first both bits have been performed stably.
  • FIG. 8 schematically shows an example of a mechanical implementation of a further embodiment of the invention, the reference bit only assuming the value “1” at the specific rotational positions offset by 90 °.
  • the reference bit has the value "0" between the defined rotary positions, so that intermediate states of the two bits used for coding the rotary position are not recorded.
  • the coding scheme shown in FIG. 8 can be realized with the device shown by way of example in FIGS. 1 to 3.
  • FIG. 9 shows the coding of four states, position A to position D, adjacent codes differing in each case by a change of two bits. If the first bit remains incorrectly at the value "0", for example the change from position B to position C is recognized because the second bit changes and an error is output because the code "001" is invalid. With a further transition to position D, the code "010" is generated, so that an error can also be displayed here.
  • FIG. 10 schematically shows an exemplary implementation of the code shown in FIG. 9 with exemplary angle-dependent positions of the bit change, it being possible for this coding scheme to be used in conjunction with a reference element according to the invention for generating a reference bit, as shown for example in FIG. 8
  • FIG. 11 shows a Gray coding of four positions A to D, which are separated from one another by four intermediate states.
  • the last bit is a reference bit and assumes the value "1" in intermediate positions, while it assumes the value "0" in the defined positions A to D. If, for example, the first bit is incorrectly set to the value "0", a transition from the intermediate position bc to the position C can be recognized due to the change in the last reference bit, although the position coding "001" does not change.
  • FIG. 12 schematically shows a mechanical implementation of the example shown in FIG. 11, the reference bit being set to the value "1" only in the four defined positions shown by way of example and being set to the value "0" immediately before and after the defined positions becomes. Because the distance of the code is 2 in this exemplary embodiment, any change in a single bit will be recognized as an invalid code and thus as an error.
  • FIG. 13 shows an example of an injection device 10 with a built-in device 1, 2 according to the invention for generating and removing a code using a reference element.

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

Abstract

La présente invention concerne un dispositif de dosage d'une substance comprenant au moins un élément rotatif (1) et au moins un élément de codage (b, c, d) qui est associé à l'élément (1) et qui permet de reconnaître la position de rotation de l'élément rotatif (1). L'invention est caractérisée en ce qu'au moins un élément de référence (6) qui génère un signal de référence uniquement pour des positions données ou des modifications de positions ainsi qu'un procédé permettant de déterminer la position de rotation d'un élément rotatif (1) permettant de régler une dose. La position de rotation est déterminée par un codage qui ne peut être lu ou évalué qui si un signal de référence est généré dans le cas de positions de rotation données ou de transitions de positions.
EP03722173A 2002-06-10 2003-06-05 Dispositif et procede de dosage d'une substance Withdrawn EP1515764A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10225707A DE10225707A1 (de) 2002-06-10 2002-06-10 Vorrichtung und Verfahren zum Dosieren einer Substanz
DE10225707 2002-06-10
PCT/CH2003/000359 WO2003103753A1 (fr) 2002-06-10 2003-06-05 Dispositif et procede de dosage d'une substance

Publications (1)

Publication Number Publication Date
EP1515764A1 true EP1515764A1 (fr) 2005-03-23

Family

ID=29594354

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03722173A Withdrawn EP1515764A1 (fr) 2002-06-10 2003-06-05 Dispositif et procede de dosage d'une substance

Country Status (7)

Country Link
US (1) US8128604B2 (fr)
EP (1) EP1515764A1 (fr)
JP (1) JP4504807B2 (fr)
CN (1) CN100463702C (fr)
AU (1) AU2003229472B2 (fr)
DE (1) DE10225707A1 (fr)
WO (1) WO2003103753A1 (fr)

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EP1827537B1 (fr) 2004-10-21 2019-08-14 Novo Nordisk A/S Dispositif de délivrance d'un médicament avec un détecteur délivrant un signal indicatif d'une dose éjectée.
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AU2003229472B8 (en) 2003-12-22
JP4504807B2 (ja) 2010-07-14
CN100463702C (zh) 2009-02-25
AU2003229472A1 (en) 2003-12-22
DE10225707A1 (de) 2003-12-24
AU2003229472B2 (en) 2007-05-24
US8128604B2 (en) 2012-03-06
JP2005528959A (ja) 2005-09-29
US20050182360A1 (en) 2005-08-18
WO2003103753A1 (fr) 2003-12-18
CN1688354A (zh) 2005-10-26

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