EP2175912A2 - Appareil d'administration à utilisation perfectionnée - Google Patents

Appareil d'administration à utilisation perfectionnée

Info

Publication number
EP2175912A2
EP2175912A2 EP08757262A EP08757262A EP2175912A2 EP 2175912 A2 EP2175912 A2 EP 2175912A2 EP 08757262 A EP08757262 A EP 08757262A EP 08757262 A EP08757262 A EP 08757262A EP 2175912 A2 EP2175912 A2 EP 2175912A2
Authority
EP
European Patent Office
Prior art keywords
base unit
adapter
locking
cartridge
bolus
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Withdrawn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
EP08757262A
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 EP2175912A2 publication Critical patent/EP2175912A2/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Withdrawn legal-status Critical Current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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M2005/1401—Functional features
    • A61M2005/1405—Patient controlled analgesia [PCA]
    • 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
    • A61M2205/27—General characteristics of the apparatus preventing use
    • A61M2205/276—General characteristics of the apparatus preventing use preventing unwanted use
    • 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
    • A61M2205/586—Ergonomic details therefor, e.g. specific ergonomics for left or right-handed users
    • 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
    • A61M5/31546—Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons

Definitions

  • the present invention relates to a device for administering a fluid product, in particular a medicament in liquid form.
  • a device for administering a fluid product, in particular a medicament in liquid form.
  • Such a device is referred to below as an administering device.
  • a liquid-form medicament e.g. To administer an insulin preparation or a blood-thinning drug such as heparin over a longer period of time.
  • a blood-thinning drug such as heparin
  • the device dispenses, on the one hand continuously or at regular intervals (for example every 20 minutes) a predetermined basal rate of the drug, which covers the normal basic requirement of the drug.
  • the device can be operated by the patient at an increased need of the drug so that a bolus dose is delivered.
  • the targeted delivery of insulin bolus be provided after meals.
  • Such a device can have a modular design, ie it can contain a reusable base unit with a drive and a disposable cartridge with the medicament that can be connected to it.
  • a modular design ie it can contain a reusable base unit with a drive and a disposable cartridge with the medicament that can be connected to it.
  • a device for administering a fluid product comprising a product container and (preferably electrically operable) drive components for expelling the fluid product from the product container.
  • the device is designed on the one hand to administer a basal rate quasi-continuously (ie either continuously or at predetermined time intervals which ensure a uniform supply to the patient with the medicament) and, on the other hand, to allow the additional targeted administration of a bolus dose.
  • the direction adjusting means for adjusting the bolus dose and a triggering device for triggering the administration of the bolus dose which preferably both operate electrically, ie have corresponding electrical components.
  • the adjusting device comprises a setting element rotatable about a rotation axis, in particular a setting wheel / rotary knob or a rotary knob, which serves in particular for operating a rotary switch, and the triggering device comprises a central release button which can be pressed concentrically with the adjusting element and can be pressed along the axis of rotation to operate one or more electrical switches.
  • the product container arranged in the device When the product container arranged in the device has an elongate shape, it thereby defines a longitudinal axis of the device.
  • the axis of rotation of the adjusting element then preferably extends at an angle to the longitudinal axis, which is not equal to 0, 90, 180 or 270 degrees in order to be accessible from different directions.
  • the angle between the axis of rotation and the longitudinal axis is preferably between about 30 degrees and about 60 degrees, more preferably about 45 degrees.
  • the axis of rotation preferably extends substantially in the device plane or parallel thereto. This, in combination with the above-mentioned angle range, ensures optimum accessibility and readability of the setting device.
  • the device when administering a bolus, only allows a very specific sequence of states to prevent misuse.
  • the adjusting element is rotatable between an initialization position and a plurality of dose setting positions.
  • the triggering element is displaceable along the axis of rotation at least between an extended position and an inserted position.
  • a bolus is administered only when the following sequence of states has been passed: an initialization state in which the adjustment element initiates its initialization.
  • the triggering element is therefore movable only in the extended position that the adjusting element is rotated to the initialization position. Only by turning the adjusting element into this position and subsequent setting of the dose can therefore bolus administration be made at all.
  • the triggering element is preferably spring loaded along the axis of rotation to the extended position so as to permit automatic deployment of the triggering element in the initialization position of the adjustment element.
  • the triggering element preferably has at least one latching element which cooperates in the dose setting positions of the adjusting element with a retaining element fixed to the housing at least in the axial direction such that it merely protrudes the extended position in the direction of the retracted position is movable and locked in the retracted position with the retaining element.
  • the latching element and thus the triggering element is released with respect to an axial displacement along the axis of rotation of the inserted to the extended position.
  • the holding element may be a housing-fixed, part-ring-shaped element which is interrupted in such a way that the latching element comes out of engagement with the holding element in the initialization position.
  • the triggering device can also be designed to be additionally pushed beyond the inserted position against an elastic spring force in a depressed position and to actuate a further electrical contact in this position.
  • the device can be designed to initiate a bolus administration only when the triggering device has been moved beyond the inserted position into the depressed position in the bolus triggering state and has been held in this position for a predetermined time against the spring force.
  • the triggering device can serve to acknowledge warnings or alarms.
  • the device comprises a warning device, which is designed to monitor the operating state of the device and in an abnormal operating state, e.g. to give audible and / or visual and / or vibratory warning signals.
  • the triggering device then interacts with the warning device in such a way that warning signals can be acknowledged by depressing the triggering device from the inserted position into the depressed position to the warning device, thus changing the warning device in accordance with its state and optionally terminating or interrupting the delivery of the warning signals.
  • an apparatus for administering a fluid product comprising a product container and drive components for expelling the fluid product from the product container.
  • the device is normally worn on the body with a belt or shoulder strap.
  • a pillow-like sheath made of a cushioning material is provided for use with the administering device and is capable of fully completing the device take.
  • the shell has a preferably frontally mounted opening through which the device is inserted into the shell. If the device has a display for displaying a set basal rate, it is advantageous for the reliability, if the display is arranged on the device that in a state in which the device is inserted into the shell, the display through the opening is readable.
  • a catheter can be connectable to the device.
  • the catheter In a state in which the device is pushed into the sheath, the catheter then preferably points directly from the device in the direction of the opening, so that the catheter is not bent.
  • the basal rate indicator is then preferably located on the same side as the catheter, i. on that side of the device, which faces in this state to the opening, preferably on a short end side of the elongated and flat formed device.
  • the sheath preferably has an opening which, through a hook-and-loop fastener, is at least in places, e.g. central, closable. Instead, but also a push button, a zipper, etc. may be provided.
  • the shell is sufficiently thick to ensure a good cushioning effect.
  • it points everywhere, e.g. a thickness of at least 5 mm.
  • the shell contains a foam. This can be surrounded at least to the outside by a skin-friendly tissue.
  • a device for administering a fluid product in particular a fluid medicament, which comprises a base unit with a drive device and an adjustment device for setting a basal rate to be delivered, in particular in the case of an electronically controlled device with a control device cooperates for the drive device; such as a locking device for locking on the base unit a replaceable cartridge detachably connectable to the base unit to a product container and / or an adapter detachably connectable to the base unit for connection to an infusion set or catheter, the locking device being designed to between a locking position, in which the cartridge and / or the adapter is locked to the base unit, and a release position, in which the cartridge and / or the adapter is removable from the base unit to be moved.
  • the locking device is designed such that it allows a setting of the basal rate in the release position, while it prevents a setting of the basal rate in the locking position.
  • the locking device in the locking position, the setting at least partially cover or block the adjustment for the basal rate.
  • the base unit usually has a display device for the set basal rate.
  • the display device is then preferably read in both the locked position and in the release position.
  • the locking device comprises a flat bolt, which is arranged displaceable on the base unit, wherein the adjusting device and the display device are arranged on the base unit, that the bolt on the adjusting device and the display device is displaceable.
  • the bolt then has a recess or opening which releases both the display device and the setting device in the release position, but only releases the display device in the locking position.
  • the adjusting device can be designed as follows in a very simple but effective embodiment: It comprises a rotary switch, which can preferably be operated only with a tool such as a screwdriver, which is provided at its periphery with a rotatable with the rotary switch or its control scale.
  • the scale together with a housing-fixed marking, for example with a part of the scale releasing window, a display device for the set basal rate.
  • an apparatus for administering a fluid product, in particular a fluid medicament which is of modular design and which comprises: a base unit (a "reusable" module) having drive means; a removable cartridge connectable to the base unit (a disposable module) having a product container; and an adapter detachably connectable to the base unit for connection to an infusion set or catheter.
  • the device has a locking device to lock both the Kartu- see and the adapter to the base unit.
  • the locking device is adapted between a locking position in which both the cartridge and the adapter is locked to the base unit, a partial locking position in which only the cartridge with the base unit is locked, and a release position in which the cartridge and the Adapters from the base unit are removable to be moved.
  • a simple locking of three components with a single device, preferably a single locking element can be achieved.
  • the locking device also preferably serves to prevent setting of the basal rate, at least in the first locking position.
  • the locking device is spring-loaded from the partial locking position into the locking position and designed such that the locking device is movable from the locking position to the partial locking position when the adapter is connected to the cartridge by the adapter, and then automatically into the partial locking position after the adapter has been connected to the cartridge Return to the locked position and locked with the adapter. In this way it is achieved that the adapter automatically locks with the base unit while the cartridge remains locked to the base unit.
  • the locking device here also comprises an operating element in the form of a flat bolt, which is arranged displaceably on the base unit.
  • This latch or a differently configured control element is preferably arranged on an end face of the (preferably flat and elongated) base unit which, in a state in which the adapter is locked to the base unit, points in the same direction as that side of the adapter on which the catheter is connected. In this way, a locking of the adapter can be easily achieved, while at the same time the operation is simplified, since both the locking and the connection of the catheter take place from the same side.
  • Fig. 1 is a schematic view of an administering device
  • Fig. 2 is a schematic view of a shell
  • Fig. 3 is an illustration of how the delivery device of Fig. 1 is inserted into the sheath of Fig. 2;
  • Fig. 4 is an opening-side view of the envelope with it received
  • FIG. 5 is a schematic view of the administering device with the cartridge removed and without needle adapter
  • Fig. 6 is a schematic view of the fully assembled
  • FIG. 7 is a schematic diagram of a bolt
  • FIG. 8 shows a schematic view of a bolus button in a first position
  • FIG. 9 is a schematic view of the bolus button of FIG. 8 in a second position;
  • FIG. 10 is a central longitudinal section in the plane XX through parts of a
  • FIG. 11 is a schematic view of the parts shown in Figure 10 from below.
  • FIG. 12 shows a central longitudinal section in the plane XII-XII through the parts of FIG. 10 in a second orientation;
  • FIG. Fig. 13 is a schematic view of the parts shown in Fig. 12 from below; such as
  • Fig. 14 is a schematic plan view of a contact arrangement.
  • FIG. 1 shows a schematic view of an administration device according to the invention.
  • the device is of modular construction and includes a reusable base unit 100, a disposable cartridge 200, and an adapter 300 mounted on the cartridge for connection to an infusion set with catheter 310 and one not illustrated cannula for piercing the skin.
  • the base unit 100 has a housing 110, in which inter alia an electric battery, an electronic control unit, an engine, a transmission and a driver are arranged for transmitting the rotary motion generated by the engine and geared by the transmission.
  • a suitably designed base unit is described in the international application PCT / CH 2007/000113 of 2 March 2007, which is referred to with regard to a possible closer design of the base unit and the power transmission between the base unit and the cartridge.
  • two light-emitting diodes 120, 121 are provided, which are particularly clearly visible in FIG.
  • a basal rate selection switch 160 which can be recognized in FIG. 5 and described in more detail below is present.
  • a bolus button 140 is also present, which has an adjusting wheel 145 as an adjusting element and a triggering element along the axis of rotation of the setting wheel 145.
  • Rally depressible trigger button 149 includes.
  • the bolus button 140 is slanted on the base unit for ease of use.
  • the axis of rotation of the setting wheel 145 extends at an angle of 45 degrees to the longitudinal axis of the device, which is defined by the longitudinal axis of the carpule, and is located in the central plane of the substantially flat device.
  • the wheel is very accessible, even for large fingers, even if the device itself is kept very compact.
  • the set dose is better readable from different directions.
  • the cartridge 200 has a housing 210 in which a product container is housed, e.g. in the form of a carpule, i. a cylindrical, ampoule-like container, which is usually made of glass, with a slide therein plug. At its end opposite the plug, the container is closed with a puncturable septum.
  • a liquid drug to be administered e.g. Insulin, a blood thinning agent, a pain medication or similar, available.
  • the housing 210 is preferably transparent, at least in the region of the container, so that the filling level of the container can be read through the housing wall.
  • a scale 220 is mounted on the housing.
  • the cartridge accommodates components which serve to convert the drive motion generated by the base unit to result in expulsion of the medicament.
  • a hydraulic system can be provided for deflecting and translating the forces.
  • the cartridge 200 is first connected to the base unit 100.
  • the adapter 300 is then pushed onto the cartridge - in FIG. 1 from above.
  • the adapter comprises a hollow needle which pierces the septum of the product container and thus connects the product container to the catheter 310.
  • Cartridge 200 and adapter 300 are fixed to the base unit 100 together by a displaceable latch, not visible in FIG.
  • the device preferably turns on automatically.
  • a predetermined amount of product preselected by the basal dial selector is delivered during normal operation at predetermined intervals (eg, three times an hour) so that the patient receives a predetermined basal rate substantially continuously.
  • the basal rate selector will normally be set to a patient-specific value by the physician or pharmacist, and possibly even by the patient, when the device is first put into service. If the patient requires an additional dose, a so-called bolus, he can adjust the desired dose by turning the setting wheel 145 on the bolus button 140 and triggering the administration of the bolus by pressing the release button 149.
  • Such a delivery device is usually carried over a longer period of time both during the day and at night constantly on the body. During the day it is e.g. fastened to a belt with a belt clip or worn under clothing with a special strap and / or a loop. So that the device can also be left comfortably close to the body at night, a pillow-type bag or sheath 400, shown in FIG. 2, is provided, into which the device is inserted at night or during rest periods.
  • the sheath 400 has internal dimensions that approximately correspond to the external dimensions of the composite delivery device.
  • the delivery device can be inserted into this through an opening 401 in an end face of the shell, as illustrated in FIG. 3, and can be fixed in the shell by means of a hook-and-loop fastener 402 in order to prevent it from slipping out.
  • Fig. 3 also illustrates the orientation in which the delivery device is inserted into the sheath.
  • the adapter 300 is at the end of the device arranged at the fully inserted into the shell device to the opening 401 points.
  • the catheter 310 points directly towards the opening and can be led out of the sheath without deflection and without the risk of kinking.
  • the latch 130 also points to the same side as the catheter.
  • This latch 130 is particularly clearly visible in FIGS. 4 to 6. It has a flat control element, which is displaceably accommodated in a displacement region formed by a shallow depression of the front-side housing wall and with which the latch 130 is displaceable between a release position shown in FIG. 5 and a locking position shown in FIG , In order to prevent slippage, surface structures 133 are also formed on the operating element of the bolt 130. In the release position, the latch allows unhindered removal of the adapter 300 in the direction in which the catheter 310 faces, as well as unimpeded withdrawal of the cartridge 200 in the opposite direction. In contrast, in the locked position, the latch holds the cartridge 200 on the base unit.
  • the latch is spring-loaded in this position and designed so that the adapter initially pushes the latch a little in the direction of the releasing position when it is pushed onto the cartridge in this situation. As soon as the adapter has reached its end position, the bolt then engages in a corresponding recess on the adapter. As a result, the latch 130 locks both the cartridge 200 and the adapter 300 to the base unit 100.
  • FIG. 7 illustrates in a highly schematic manner how in principle such a functioning of the bolt can be achieved.
  • the latch has two lugs 134, 135 which project through openings of the housing wall 110 of the base unit 100.
  • the first lug 134 serves to lock the cartridge 200 shown here only very schematically, while the second lug 135 serves to lock the adapter 300.
  • the first nose is longer than the second nose.
  • the latch is shown in the locked position. He is spring loaded in by a spring force 136.
  • the cartridge 200 is locked by the positive engagement with the nose 134 already on the base unit, ie, they can not be deducted in the downward direction of FIG. 7. Now, the adapter 300 is pushed in the direction 137.
  • FIG. 7 is only a highly schematized schematic diagram, and that multiple modifications of the principle illustrated there are possible.
  • the latch 130 is disposed on the housing 110 so as to cover the basal rate selector switch 160 in the lock position. This will prevent the basal rate from being accidentally altered during operation of the device.
  • the latch releases the view of a display 161 for the set basal rate.
  • the control element of the bolt on a keyhole-shaped, elongated opening 132.
  • the display 161 is easily realized as a ring on which numbers are printed and which is connected to the basal rate selection switch.
  • the Basalrateninfolschalter is in this simple embodiment, a rotary switch (Codierschalter) with a predetermined number (eg sixteen) defined switching positions and engages in each case in the switching positions.
  • one switching position corresponds to a specific basal rate, with insulin, for example, from 12 to 22 iu per day in steps of two iE, from 22 to 38 iE in steps of four iE, from 38 to 56 iE in steps of six iE and from 56 to 80 iE in increments of eight iE
  • the scaling of the administering rates relative to the switch position does not need to be linear.
  • the basal dial can only be adjusted with a suitable tool such as a screwdriver.
  • a bolus button is provided, the operation of which will be explained in more detail with reference to FIGS. 8 to 14.
  • the bolus button of FIGS. 8 and 9 has a base plate 141 which is provided with contacts 142. On the base plate 141 a multi-stage (eg twelve-stage) rotary switch 143 and a resilient switch button 144 are mounted with three switch positions.
  • the shaft of the rotary switch 143 is connected to a rotatable adjusting element in the form of a setting wheel 145, on which a scale 146 is mounted, which can be read through a window 148 of a housing-fixed cover 147.
  • the setting wheel is rotatable between an initialization position (scale display "S") and a plurality of dose setting positions (scale displays 0 to 16).
  • a release button 149 is arranged, which is axially displaceable along the axis of rotation of the setting wheel 145 from an extended position shown in FIG. 8 in an inserted position shown in FIG. 7.
  • the release button beyond the inserted position against a spring force can be pressed into a depressed position.
  • the trigger button is connected to an annular transmission element 150. Depending on the position of the release button, this pushes the spring-loaded button 144 by a specific amount: in the extended position of FIG. 8, the button is completely released and assumes a first switching state. In the retracted position of FIG. 7, the key is depressed by a first amount and assumes a second switching state.
  • the key In the additionally depressed position, the key assumes a third switching state. As a result, the position of the release button is detected by electrical means. Of course, this can also be achieved by providing two separate switching elements for this purpose.
  • the bolus button 140 and associated controller are designed to undergo a very specific sequence of conditions to administer a bolus:
  • a dose to be administered can be adjusted on the setting wheel by bringing the setting wheel into a corresponding dose setting position.
  • the release button continues to assume the extended position. This may be referred to as a "bolus adjustment condition”.
  • the trigger button against the spring force is first brought to the retracted position and beyond in the depressed position and held there until the device acoustically and / or visually acknowledges the administration of the bolus. This can be referred to as a "bolus triggering condition".
  • the release button is then released and remains in the inserted position. The wheel indicates by his position to the now administered bolus.
  • steps (e) through (d) are repeated.
  • This sequence of steps ensures that a bolus can not be accidentally administered. In addition, it allows a positive function receipt during bolus administration and a later reading of the last administered bolus.
  • the release button can take on additional functions. In particular, it can be used to provide warnings or alarms from the device acknowledge if the device detects an abnormal condition, such as an occlusion, too low a battery, etc.
  • the bolus button as a whole can also be used to initiate venting of the priming set after the cartridge has been replaced. To do this, after commissioning, the device waits for the sequence listed above to be performed once to pump a priming-required amount of the product through the infusion set.
  • FIGS. 10 to 14 illustrate an advantageous mechanical realization of the aforementioned functionality of the bolus button.
  • 10 and 12 show a central longitudinal section through the relevant components of the bolus button in two different rotational positions of the setting wheel 145:
  • the setting wheel assumes one of the dose setting positions, while in FIG. 12 the initialization position "S" of FIG Figures 8 and 9 occupies.
  • two different positions of the trigger button 149 are illustrated in FIG. 12 (upper half of the drawing: inserted position, lower half: extended position).
  • FIGS. 11 and 13 show the corresponding components schematically from below and indicate the sectional planes of FIGS. 10 and 12.
  • the setting wheel 145 is guided on a housing-fixed holding element 151.
  • the trigger button 149 is axially displaceably connected to the setting wheel 145 and is rotatably relative to the setting wheel, so rotates with the setting wheel.
  • the release button is spring-loaded by means of a spring loaded on pressure coil spring 157 against a likewise rotatably connected to the thumbwheel and axially movable contactor element 154 axially outwardly.
  • the release button is prevented by two axially opposite latching hooks 153 from jumping through this spring force in the extended position.
  • the latching hooks 153 are elastically bendable radially inwards. As a result, the latching hooks can be moved away from the extended position when the trigger button 149 is moved. driving position in the retracted position on an inner inclined surface of an inwardly extending, part-annular flange 157 of the holding member 151 slide while they are locked in the retracted position with the flange 157.
  • the latching hooks 153 come to rest in recesses 158 of the partially annular inner flange 157. As a result, the latching hooks 153 are no longer held axially, and the trigger button 149 can now jump due to the spring force of the spring 152 from the retracted position shown in the upper half of FIG. 12 in the extended position shown in the lower half.
  • the setting wheel can be rotated back into a dose setting, but now, unlike in Fig. 10, the locking hooks 153 come to lie right from the inclined surfaces of the flange 157.
  • the trigger button 149 is now depressed, the latching hooks 153 slide over the inclined surfaces and are thereby pressed elastically radially inward.
  • the latching hooks again jump radially outward.
  • the position of Fig. 10 is reached again, and the trigger button is held back in the retracted position.
  • Fig. 14 illustrates how the contacts are arranged in the rotary switch 143.
  • twelve contacts 159 are arranged concentrically in uniform angular intervals on two different radii.
  • a contact bridge 155 of the contactor element 154 is moved by the setting wheel over the contacts 159 and thus connects two of the contacts. Due to the spring force of the spring 152, the contactor element is pressed onto the contacts and additionally engages with a detent 156 in the slightly recessed contacts 159.
  • the product container can also be designed as a container which as a whole is compressible.
  • the container may e.g. have a bellows-like side wall or simply be formed as a bag.

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

Abstract

L'invention concerne un appareil d'administration d'un médicament liquide, tel que l'insuline, comprenant un commutateur de sélection de débit basal (160) pour le réglage d'un débit basal, et un bouton dit bouton "bolus" (140), présentant une roue de réglage pour l'ajustement d'une dose bolus, et un bouton déclencheur pour le déclenchement de l'administration de cette dose. Le bouton déclencheur est disposé au centre de la roue de réglage, et le bouton bolus est prévu incliné sur le boîtier, afin de simplifier l'utilisation. En vue d'augmenter la sécurité du fonctionnement, un bolus n'est administré que si l'on procède à une séquence bien déterminée d'états du bouton bolus. Le bouton bolus est utilisé en outre pour la confirmation d'alarmes. Lors du fonctionnement, le commutateur de sélection de débit basal est recouvert par un système de verrouillage (130) qui verrouille à la fois une cartouche (200) et un adaptateur (300) pour un cathéter (310) sur une unité de base (100). Une enveloppe du genre coussin (400) permet un emploi confortable de l'appareil, y compris durant le sommeil.
EP08757262A 2007-06-25 2008-06-13 Appareil d'administration à utilisation perfectionnée Withdrawn EP2175912A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH10142007 2007-06-25
PCT/CH2008/000269 WO2009000095A2 (fr) 2007-06-25 2008-06-13 Appareil d'administration à utilisation perfectionnée

Publications (1)

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EP2175912A2 true EP2175912A2 (fr) 2010-04-21

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EP08757262A Withdrawn EP2175912A2 (fr) 2007-06-25 2008-06-13 Appareil d'administration à utilisation perfectionnée

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US (1) US20100191214A1 (fr)
EP (1) EP2175912A2 (fr)
WO (1) WO2009000095A2 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9352095B2 (en) 2012-04-06 2016-05-31 Baxter International, Inc. Container system
US9931469B2 (en) 2013-08-19 2018-04-03 Dr. Reddy's Laboratories Ltd. Selectable single dose auto-injector and methods of making and using same

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3571205D1 (en) * 1985-04-11 1989-08-03 Becton Dickinson Co Reusable injection catheter
US5830187A (en) * 1995-12-22 1998-11-03 Science Incorporated Fluid delivery device with conformable ullage and fill assembly
EP1386626A1 (fr) * 2002-07-31 2004-02-04 Novo Nordisk A/S Dispositif d'administration pour le traitement de diabète mellitus
US6936035B2 (en) * 2002-12-31 2005-08-30 I-Flow Corporation Patient controlled drug administration device

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2009000095A3 *

Also Published As

Publication number Publication date
WO2009000095A3 (fr) 2009-02-26
WO2009000095A2 (fr) 2008-12-31
US20100191214A1 (en) 2010-07-29

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