EP2125073A1 - Système d'administration modulaire - Google Patents

Système d'administration modulaire

Info

Publication number
EP2125073A1
EP2125073A1 EP07701913A EP07701913A EP2125073A1 EP 2125073 A1 EP2125073 A1 EP 2125073A1 EP 07701913 A EP07701913 A EP 07701913A EP 07701913 A EP07701913 A EP 07701913A EP 2125073 A1 EP2125073 A1 EP 2125073A1
Authority
EP
European Patent Office
Prior art keywords
cartridge
base unit
transmission element
hydraulic
plug
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.)
Pending
Application number
EP07701913A
Other languages
German (de)
English (en)
Inventor
Jürg Clavadetscher
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 EP2125073A1 publication Critical patent/EP2125073A1/fr
Pending 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
    • A61M5/1413—Modular systems comprising interconnecting elements
    • 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
    • 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
    • A61M5/14526—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons the piston being actuated by fluid pressure
    • 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
    • A61M2005/14264—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with means for compensating influence from the environment
    • 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
    • A61M2205/18—General characteristics of the apparatus with alarm
    • 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
    • A61M5/14566—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for receiving a piston rod of the pump
    • 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
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies

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 medication such as heparin over a long period of time.
  • a medicine container is usually provided in such administration devices a carpule, i. a glass container with a plug movable therein.
  • the carpule (often referred to as ampoule) is connected to an infusion set, the cannula flows into the body tissue of the patient.
  • a suitable drive e.g. a spring drive or an electric motor, the plug is advanced in the carpule and thus expelled the drug from the carpule. Once the carpule is emptied, it is removed from the delivery device and replaced with a new carpule.
  • the plug is fed into the carpule via a threaded rod which acts as a piston rod for the plug.
  • a rotatably and non-displaceably mounted nut runs on the threaded rod and is driven by an electric motor. By turning the nut, the threaded rod is advanced.
  • the electric motor is arranged next to the carpule in order to limit the length of the administering device and to simplify the replacement of the carpule.
  • US 6,248,093 an administering device is disclosed in which the drive motor and the transmission are arranged coaxially with the medicament reservoir.
  • the reservoir of the drug reservoir is advanced by a sleeve-like advancing element which is connected via an internal thread with a drive screw driven by the motor and thereby linearly advanced.
  • the feed element In its initial position, the feed element at least partially surrounds the gearbox of the engine.
  • the feed element is part of the base unit, while the plug is part of the exchangeable medicament reservoir.
  • the feed element and the plug are therefore configured separable from each other.
  • the advancing element and the plug are connected so that the connection can also absorb tensile forces during operation of the administering device.
  • the plug forcibly follows the movement of the feed element and can not be further advanced by pressure fluctuations, as dictated by the position of the feed element.
  • the feed element is then returned to its original position by the engine.
  • This arrangement requires on the one hand a relatively complicated connection of the plug with the feed element. On the other hand, it is necessary to retract the feed element after the end of the administration. In addition, special measures must be taken in the event that a not completely filled drug reservoir is used.
  • Such a device comprises a reusable base unit having a drive means and an interchangeable cartridge detachably connectable to the base unit with a product container for the fluid product, i. the device is modular.
  • a rotational movement is transferable between the base unit and the cartridge.
  • the base unit on a driver, which is displaceable by the drive means in a rotational movement about an axis of rotation.
  • the cartridge has a complementary rotatable transfer member formed so that rotation of the transfer member causes ejection of the fluid product from the product container.
  • the driver and the transmission element are releasably connected to each other for transmitting the rotational movement.
  • the present invention is thus between the base unit and transmit a rotational movement to the cartridge.
  • the connection between the cartridge and the base unit can be made in a very simple manner, since a coupling of two rotatable elements for transmitting a rotary movement is much easier to implement than a pressure and tension-resistant connection between a piston rod and a plug.
  • the cartridge change is greatly simplified. When the cartridge is to be changed, it can simply be removed from the base unit, and a new cartridge can be used without having to reset the drive device beforehand.
  • the driver and the transmission element along the axis of rotation are designed to be displaceable relative to one another.
  • the driver and the transmission element can be connected in a simple manner by sliding into one another.
  • this allows an axial movement of the transmission element during operation.
  • regions of the driver and of the transmission element preferably surround each other.
  • regions of the driver and of the transmission element preferably surround each other.
  • the transmission element can be guided by a thread in such a way that a rotational movement of the transmission element leads to a screw movement of the transmission element in the cartridge.
  • a rotational movement of the transmission element leads to a screw movement of the transmission element in the cartridge.
  • the transmission element can also perform a pure rotary motion, which leads in another way to an ejection of the product from the product container.
  • a simple and elegant construction results when the transmission element is designed as a sleeve, which in the assembled state at least partially surrounds the driver and engages on its inside with the driver.
  • the transmission element preferably extends substantially around the circumference of the driver (viewed in a plane perpendicular to the axis of rotation).
  • one or more longitudinal grooves or longitudinal ribs are preferably formed on the inside of the sleeve, which extend substantially parallel to the axis of rotation, and the driver has on its outer side to a complementary structure, ie, a structure which is suitable, with the longitudinal grooves or longitudinal ribs to engage.
  • the structure may be, for example, one or more radially outwardly projecting noses or longitudinal ribs. This construction allows a simple way of relative movement between the transmission element and driver in the axial direction.
  • the transmission element between an initial position, which occupies the transmission element before the beginning of the emptying of the product container, and an end position which occupies the transmission element after emptying of the product container be movable.
  • a particularly good use of space is achieved when the transmission element surrounds at least a part of the drive device, at least in the initial position.
  • the transmission element extends substantially around the circumference of a part of the drive means (viewed in a plane perpendicular to the rotation axis).
  • the drive device preferably comprises an electric motor and a gear connected thereto, which transmits the drive movement of the motor in a rotational movement of the driver.
  • the engine and the transmission are arranged one behind the other along the axis of rotation, and the transmission element surrounds at least part of the transmission, at least in the initial position.
  • the drive device can be accommodated at least partially in a finger-like region of the base unit extending along the rotation axis, the cartridge in the assembled state at least partially surrounding the finger-like region of the base unit.
  • the base unit preferably has a holding area that extends laterally offset from the finger-like area such that the cartridge, when it is attached to the base unit, has an area that is in the lateral direction is arranged between the finger-like area and the holding area.
  • the cartridge and the base unit surround each other, and a stable connection between these units is achieved.
  • other components such as e.g. a E- nergie provoke, in particular in the form of a battery, and a control electronics are housed.
  • the cartridge has a fluid reservoir with a movable plug.
  • the transmission element is then connected to the plug in such a way that rotation of the transmission element leads to an advance of the plug.
  • This may be a pure translational movement of the plug or a combined translation and rotation, in particular a screw movement, of the plug.
  • the plug and the transmission element can be made in one piece with each other.
  • the fluid reservoir may be directly the product container.
  • there is a hydraulic that indirectly transfers the advance of the plug to the product container and the fluid reservoir is then a hydraulic reservoir for the hydraulic fluid.
  • the cartridge comprises a hydraulic connection between the hydraulic reservoir and a hydraulic connection with the product container.
  • the hydraulic reservoir, the hydraulic connection and the Verschiebereservoir are arranged such that the hydraulic fluid passes through the advancing movement of the plug from the hydraulic reservoir through the hydraulic connection in the Verschiebereservoir and thereby causes an ejection of the fluid product from the product container.
  • Fig. 1 is a longitudinal section through a base unit of an administering device
  • Figure 2 is a side view of the base unit of Figure 1, viewed in the direction to the right in FIG. 1.
  • FIG. 3 shows a side view of the base unit of FIG. 1, viewed in the direction of view to the left;
  • Figure 5 shows a side view of the cartridge, viewed in the direction to the right in FIG. 4;
  • Figure 6 is a longitudinal section through an administering device, as it results from a compound of the filled cartridge with the base unit.
  • Fig. 7 is a plan view of the administering device of Fig. 6;
  • FIG. 8 shows a side view of the administration device of FIG. 6, looking in the direction of view to the right;
  • Fig. 9 is a side view of the administering apparatus in the viewing direction of Fig. 8 after the terminal unit has been removed;
  • FIG. 10 is a side view of the administering device of FIG. 8, looking to the left as seen;
  • FIG. 11 is a cross-section through the cartridge of FIG. 4 in the plane A -
  • FIG. 12 shows a longitudinal section through the administering device of FIG. 6, FIG. after a portion of the medicament contained therein has been administered, partially schematically and enlarged in section in the plane BB of Fig. 11;
  • FIG. 13 shows an enlarged detail of FIG. 12;
  • FIG. Figure 14 is a longitudinal section through a cartridge in an alternative embodiment. such as
  • FIG. 15 shows a longitudinal section through an administration device with the cartridge of FIG. 14.
  • the administration device comprises a reusable base unit 100, which is shown alone in FIGS. 1 to 3, and a complementary, replaceable cartridge 200, which is shown alone in FIGS. 4 and 5.
  • Figures 6 to 13 show the administering device composed thereof.
  • the distal direction is understood in each case to be the direction in which the movable elements of the administering device move in the course of the administration of the medicament. As will be described in more detail below, this movement is reversed by 180 degrees inside the administering device.
  • the distal direction therefore corresponds to different absolute spatial directions for different parts of the administering device.
  • the proximal direction is correspondingly defined as the direction opposite to the distal direction.
  • a lateral direction is a direction perpendicular thereto.
  • the base unit comprises a housing 110.
  • This has an elongated, substantially rounded cuboid or prism-shaped holding portion 111. From one end of the holding region, a support region 112 for the cartridge protruding substantially perpendicularly from it extends into one lateral direction.
  • the housing in the longitudinal section of FIG. 1 initially has a substantially L-shaped basic shape.
  • a substantially circular-cylindrical, finger-like structure 114 which will be described in more detail below, extends from the support region 112 in a distal direction parallel to the holding region 111. This is laterally flanked on both sides by two wing regions 113, 113 ', which are particularly clearly visible in FIG. 3.
  • the holding region 111, the support region 112 and the wing regions 113, 113 'thus delimit a receiving region 115 for the cartridge, into which the finger-like structure 114 extends.
  • the finger-like structure 114 includes a drive motor 140, the shaft 141 is out at both ends out of the motor housing to the outside. Connected to the distal end of the shaft is a gear 150 which is also coaxial with the motor in the finger-like structure 114.
  • the gearbox suppresses the rotation of the motor shaft 141 and transmits the thus reduced rotational movement to a driver 160 disposed at the distal end of the finger-like portion 114.
  • the driver 160 consists essentially of a wheel, on whose peripheral surface two diametrically opposite driver fingers 161 are arranged.
  • the housing 110 is also an electric battery 120 and a control electronics not shown in the drawing included.
  • the control electronics are used to control the motor 140 so that its shaft performs a predetermined number of revolutions per unit time.
  • the control electronics receive signals from an encoder 144, which cooperates with an encoder wheel 143 mounted on the proximal end of the motor shaft 141.
  • the encoder wheel rotates, the encoder generates electrical signals that allow it to determine the angle of rotation traveled or the number of revolutions of the motor shaft. This can be done, for example, optically.
  • Such encoders are known and commercially available.
  • the base unit 100 can be used to connect the replaceable cartridge 200, which is shown in FIGS. 4 and 5.
  • the cartridge 200 comprises a cartridge housing 210 whose outer shape is configured complementary to the housing 110 of the base unit 100. As a result, the cartridge can be inserted into the receiving region 115 of the base unit 100, as will be described below.
  • the cartridge 200 is divided into two areas, which are shown in Fig. 4 above and below.
  • the housing is open.
  • a closing element 240 is inserted, which defines together with the cartridge housing 210 a fluid channel 241, which connects the two regions of the cartridge.
  • a product container 250 in the form of a carpule with a cylindrical side wall region 251 and product plug 252 displaceable therein is accommodated.
  • the product container 250 is held in a sealing ring 242 while fixed at its distal end by a retainer insert 260 which abuts an inner annular flange 261 against the side wall of the product container which tapers in this region.
  • the product container is closed at its distal end by a closure 254 with septum 255.
  • the region of the cartridge housing 210 arranged at the top in FIG. 4 delimits a cylindrical cavity in which a hydraulic plug 230 can be displaced.
  • the head of the hydraulic plug 230 is sealed against the wall of the cartridge housing 210 at its periphery by an elastic seal 232, which is preferably integrally molded on the head in a two-component injection molding process.
  • the cartridge housing 210, the hydraulic plug 230 and the closing element 240 jointly delimit a hydraulic reservoir 231 in which a hydraulic fluid, eg colored, deionized water or a suitable oil, is arranged.
  • the hydraulic fluid also fills the fluid channel 241 and an adjoining Verschiebereservoir 243 completely.
  • the displacement reservoir is limited by the side wall of the product container 250, the product plug 252 and the end element 240.
  • An elongated, cylindrical hollow-spindle-like sleeve 233 adjoins the head of the hydraulic plug 230 in the proximal direction, on the outside of which an external thread is formed.
  • a plurality of longitudinal ribs 234 are formed, which extend parallel to the longitudinal direction of the sleeve. These can be seen in particular in FIG. 5.
  • the external thread of the sleeve 233 is in threaded engagement with an internal thread of a spindle nut 270.
  • the spindle nut 270 is rotationally fixed, but axially displaceable, held in the cartridge housing 210.
  • the spindle nut 270 By a biased coil spring 280, the spindle nut 270 is axially displaced in the distal direction, i. in the direction of the hydraulic reservoir, pressed against a stop 213. Normally, this is the spindle nut 270 fixed to the cartridge housing 210. However, as soon as an axial counterforce in the proximal direction on the spindle nut 270 acts, which exceeds an adjustable by the biasing force of the coil spring 280 threshold, the spindle nut 270 moves axially in the proximal direction , As long as the spindle nut 270 is stationary, the sleeve 233 is guided by the spindle nut 270 with respect to the housing 210.
  • the spindle nut 270 will therefore also be referred to more generally below as a guide element.
  • the cartridge 200 is first connected to the base unit 100.
  • the region of the cartridge arranged at the top in FIG. 4 is accommodated in the receiving area 115 of the base unit.
  • Fig. 6 the so-compounded administration device is shown.
  • the finger-like region 114, in which the motor 140 and the gear 150 are accommodated now protrudes into the interior of the sleeve 233.
  • the driver fingers 161 of the driver 160 engage in the intermediate space between in each case two longitudinal ribs 234 and thus effect a rotationally fixed, but longitudinally displaceable connection between the driver 160 and the sleeve 233.
  • the cartridge 200 is fixed by a sliding latch 116 to the base unit 100.
  • the latch 116 is laterally bevelled, so that it slides back automatically when inserting the cartridge.
  • the latch is spring loaded in the latching position so that it is automatically pushed into the latching position after assembly and prevents inadvertent release of the cartridge from the base unit.
  • the adapter 300 to which a catheter 302 of an infusion set then attaches, is then placed on the cartridge.
  • the adapter 300 includes a hollow needle 301 which pierces the septum 254 of the closure 255 and thus connects the product container 250 to the catheter 302.
  • the basal rate of the drug to be administered is set on a multi-stage rotary switch 131, which is particularly well recognizable in FIG.
  • the device will now be switched on and initially performs a self-test. Subsequently, by actuating a "priming" switch (not shown in the drawing), a first release of a certain amount of product takes place in order to completely fill the infusion set with the drug to be administered and to displace any existing air into it ("priming")
  • This switch is prevented by the fact that this switch is difficult to access and can be actuated only with a needle or ballpoint pen tip, for example, or priming automatically when the adapter is put in.
  • the device goes into normal operation, in which continuous or in predetermined intervals (eg, once or several times every hour) a certain amount of product is delivered During all these operations, two light-emitting diodes 133, 134 indicate the operating state of the device.
  • the motor 140 via the gear 150, the driver 160 in a rotary motion.
  • This rotation is due to the engagement of the driver 160 with the longitudinal ribs 234th transferred to the sleeve 233 and on the thus integrally connected head of the hydraulic plug 230.
  • the sleeve 233 is guided with its external thread in the spindle nut 270, the rotational movement of the sleeve 233 also causes a feed movement in the axial direction.
  • the hydraulic plug 230 thus performs a screw movement.
  • the volume V 2 of the hydraulic reservoir decreases, so that hydraulic fluid is forced through the fluid channel 241 into the displacement reservoir 243 and leads here to a feed of the product plug in the distal direction.
  • the fluid product through the hollow needle 301 and the catheter 302 from the now also decreasing volume Vi ejected.
  • a rotation of the sleeve 233 causes a feed of the hydraulic plug 230 and so indirectly an ejection of the fluid product from the product container.
  • the hydraulic plug 230 with the sleeve 233 can therefore also be referred to more generally as a transmission element which transmits the rotary motion generated by the motor into a feed movement.
  • This transmission element is guided in the spindle nut 270 as a guide element.
  • between the base unit 100 and the cartridge 200 only torques are transmitted to the feed direction, but no axial forces.
  • This makes it possible to design the connection between base unit 100 and cartridge 200 very simply and to provide a relatively simple latch 116 which does not have to absorb any significant axial forces.
  • a secure recording of the torques between base unit 100 and cartridge 200 is achieved in a simple manner by the complementary shaping of these units.
  • Fig. 12 shows the administering device after a certain period of operation.
  • the hydraulic plug 230 has now covered about a quarter of its way.
  • the sleeve 233 surrounds the gear 150 and a portion of the motor 140.
  • the product plug 252 was also about a quarter advanced way and ejected a corresponding amount of the drug from the product container 250.
  • the base unit 100 preferably has a suitable counter which registers the number of cartridge changes made and prevents further operation after a predetermined number of changes. In this way it can be ensured that only a predetermined number of cartridge changes can be made before the battery 120 must be replaced or the entire base unit 100 must be renewed.
  • a lever 220 which transmits the proximal (axial) displacement of the spindle nut 270 in a lateral (radial) movement of the lever and actuates a switch 132 in the base unit. Actuation of the switch 132 shuts down the drive and triggers an alarm warning the user that a malfunction has occurred.
  • an elongated, longitudinally extending recess is provided laterally offset from the longitudinal axis.
  • the lever 220 is arranged, which is integrally formed with the cartridge housing.
  • the pivot axis of this lever is formed by a taper 222 near the distal end of the recess. Both lever arms of the lever are arranged on the same side of this pivot axis.
  • the first "long" lever arm extends substantially parallel to the housing wall within the recess to near its proximal end, starting from the taper 222.
  • the second, "short" lever arm starting from the taper 222, first falls with the first lever arm together, but ends in a nose 223, which extends from the first lever arm laterally into the interior of the cartridge 200. Because this arm is considerably shorter than If the first lever arm 221 is already leading a small lateral displacement of the nose in the direction of the exterior of the housing to a relatively large lateral displacement of the free end of the first lever arm.
  • the nose 223 cooperates with the spindle nut 270 so that a proximal (axial) displacement of the spindle nut 270 leads to a lateral (radial) pivoting of the lever 220.
  • both the exterior of the spindle nut 270 and the nose 223 are bevelled so that a proximal displacement of the spindle nut 270 causes a lateral evasive movement of the nose 233.
  • the switch 132 is mounted in the base unit 100 adjacent to the free end of the long lever arm 221. Lateral pivoting of the lever 220 thus results in actuation of the switch 132.
  • the switch 132 may be e.g. a simple mechanical switch or a suitable type of proximity sensor, e.g. operates on a capacitive or inductive path, as a pressure sensor or optically.
  • the switch is preferably formed liquid-tight, so that penetration of water or other liquids is avoided in the base unit.
  • the cartridge By arranging the switch in the base unit 100 and providing only a purely mechanical arrangement in the cartridge 200, the cartridge can be manufactured inexpensively. In addition, no electrical connections between the cartridge and the base unit are necessary.
  • the administering device has an innovative sealing concept.
  • the interior of the base unit 100 as well as the liquid-carrying areas of the cartridge 200 are each sealed liquid and preferably also gas-tight against the environment.
  • no sealing measures are intentionally provided between the base unit 100 and the cartridge 200.
  • This further simplifies cartridge replacement since, when inserting a new cartridge, the patient does not have to pay attention to a correct sealing.
  • a very reliable seal of the individual units (base unit and cartridge) is taken individually This is achieved because the sealing already takes place at the factory, where this is possible with far greater reliability than would be possible for the patient in daily use. Another important advantage becomes apparent when one becomes aware of how the hydraulic stopper, together with the sleeve, moves in the cartridge housing.
  • the volume trapped between the cartridge and the base unit increases during operation as the hydraulic plug moves into the cartridge. If the cartridge and the base unit were sealed against each other, so would create a vacuum that would counteract further advancement of the hydraulic stopper. By no sealing is provided between the cartridge and base unit, ambient air can penetrate into this gap.
  • the increasing volume is often located in an area that is sensitive to the ingress of fluids. Therefore, special sealing measures are frequently taken there with liquid-tight, but gas-permeable membranes. The relevant effort can be omitted in the present sealing concept.
  • the present sealing concept allows greater flexibility in the design of the base unit and the cartridge, since no consideration must be given to a mutual seal. Due to the design of the proposed delivery device this is also insensitive to air pressure fluctuations.
  • Figures 14 and 15 show a variant of the administering device in which the bias of the spring 280 is relatively low, as long as the cartridge is not yet connected to the base unit, and is only increased when the Kartu- see is connected to the base unit.
  • the cartridge has a bearing ring 290 which can be displaced in the distal direction as a support for the proximal end of the spring 280. So the spring is between the ring and the Spindle nut 270 is arranged.
  • the support ring is pressed by the spring in the proximal direction against a housing stop, as shown in FIG. 14 can be seen.
  • FIG. 14 shows a variant of the administering device in which the bias of the spring 280 is relatively low, as long as the cartridge is not yet connected to the base unit, and is only increased when the Kartu- see is connected to the base unit.
  • the cartridge has a bearing ring 290 which can be displaced in the distal direction as a support for the proximal end of the spring 280. So the
  • the base unit 100 has an annular projection 117, extending in the distal direction, of the housing, which is dimensioned such that when the cartridge 200 is inserted into the space between the outer wall of the cartridge housing 210 and the sleeve 233.
  • the support ring 290 is thereby displaced in the distal direction, thus compressing the spring 280.
  • the displacement path is designated as X in FIG. In the present example, it is relatively small, but can easily be chosen larger.
  • This arrangement has the advantage that in this way an increase in volume can be compensated by a rise in temperature, as can occur during storage of the cartridge. Since the spindle nut 270 can escape in the proximal direction at a pressure increase against the still relatively small spring force, it allows for an increase in volume in the product container and hydraulic reservoir with only a slight back pressure. For example, in aqueous solutions, a temperature increase of 20 0 C leads to an increase in volume of about 6 per thousand. If this volume increase could not be compensated, a considerable internal pressure in the hydraulic reservoir and in the product container would accordingly result. Such a pressure increase is particularly well avoided in the present arrangement.
  • the embodiment described above has a lever mechanism and a cooperating switch to transmit and detect a proximal displacement of the spindle nut 270.
  • detecting the displacement of the spindle nut can be arranged at a small distance proximal to the spindle nut, which is closed when the spindle nut shifts.
  • an electrical connection between the cartridge and the base unit is necessary, for example via a contact pair.
  • a proximity sensor for example a capacitive, inductive or optical sensor, which is accommodated directly in the cartridge.
  • the head of the hydraulic plug 230 and the sleeve 233 form a rigid unit.
  • the entire plug is made in one piece, in particular in a two-component injection molding process.
  • the sleeve with the thread and the longitudinal ribs is made of a hard, torsion-resistant plastic, while the head of the hydraulic plug 230 consists wholly or partly of a soft, elastically deformable plastic, in particular a thermoplastic elastomer.
  • a soft, elastically deformable plastic in particular a thermoplastic elastomer.
  • the hydraulic plug and the sleeve can also be made in two parts.
  • the sleeve can be rotatable relative to the stopper. In this way, the screw movement of the sleeve can be converted into a purely translatory feed movement of the plug.
  • the engine 140 is disposed coaxially with the transmission 150.
  • the engine may be be arranged with its shaft parallel to the feed direction in the holding portion 111 of the base unit.
  • Gear wheels can then be used to transmit the drive movement.
  • the transmission of rotational movement could be carried out by bevel gears.
  • motors can be used, the shaft is guided only one side of the motor housing.
  • the encoder can then be arranged between the engine and the gearbox.
  • a motor various types of commercially available electric motors be used, for example, a DC motor, a stepper motor or a piezoelectric drive.
  • the battery which serves to supply power to the control electronics and the drive motor, is accommodated in the reusable base unit. Therefore, the same battery is usually used for administering the contents of a larger number of cartridges.
  • the battery can not be replaced. It will then supply power throughout the life of the device.
  • this requires a relatively large and heavy battery.
  • two or more electrical contacts are provided to establish an electrical connection between the base unit and the cartridge. As a result, a certain weight and space savings is achieved. Since the battery is already factory-installed in the cartridge, this also ensures that there is always a fresh battery.
  • a modern Li-battery which is sufficient for the administration of about 50 cartridges with 3 ml of drug, typically weighs about 20 g.
  • a simple silver oxide battery as it could be used in the cartridge, weighs only about 4 g. This corresponds to only about one fifth of the weight of the Li-battery.
  • the battery can be housed in a drawer easily removable from the outside.
  • the drawer with the battery could in this case only be used shortly before delivery to the patient or even by the patient himself, if desired.
  • the product container can also be designed as a container which is compressible as a whole.
  • the container may e.g. have a bellows-like side wall or simply be formed as a bag.
  • the product plug may be substituted for the hydraulic plug of the embodiment illustrated above, that is, the product plug is then advanced directly through the sleeve 233.
  • the product plug may be substituted for the hydraulic plug of the embodiment illustrated above, that is, the product plug is then advanced directly through the sleeve 233.
  • this requires a different design, but on the other hand represents a structural simplification dar.

Abstract

La présente invention concerne un appareil d'administration modulaire comprenant une unité de base réutilisable (100) qui comporte un dispositif d'entraînement (140, 150), ainsi qu'une cartouche remplaçable (200) qui est reliée de façon amovible à l'unité de base et qui comporte un réservoir à produit (250). Un mouvement de rotation est transmis entre l'unité de base et la cartouche. A cette fin, l'unité de base présente un entraîneur (160) qui peut être déplacé par le dispositif d'entraînement selon un mouvement de rotation autour d'un axe de rotation, et la cartouche présente un élément de transmission rotatif (233) qui est conçu de manière qu'une rotation de l'élément de transmission entraîne la sortie d'un médicament à administrer. Dans un mode de réalisation préféré, l'élément de transmission entoure au moins partiellement le dispositif d'entraînement.
EP07701913A 2007-03-02 2007-03-02 Système d'administration modulaire Pending EP2125073A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CH2007/000113 WO2008106806A1 (fr) 2007-03-02 2007-03-02 Système d'administration modulaire

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EP2125073A1 true EP2125073A1 (fr) 2009-12-02

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EP07701913A Pending EP2125073A1 (fr) 2007-03-02 2007-03-02 Système d'administration modulaire

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US (1) US8679070B2 (fr)
EP (1) EP2125073A1 (fr)
CN (1) CN101678166B (fr)
WO (1) WO2008106806A1 (fr)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1476210B1 (fr) 2002-02-11 2008-09-24 Antares Pharma, Inc. Injecteur intradermique
JP5216328B2 (ja) 2005-01-24 2013-06-19 アンタレス ファーマ インコーポレイテッド あらかじめ充填された針補助シリンジジェット式注射器
US9144648B2 (en) 2006-05-03 2015-09-29 Antares Pharma, Inc. Injector with adjustable dosing
US8251947B2 (en) 2006-05-03 2012-08-28 Antares Pharma, Inc. Two-stage reconstituting injector
EP3636301A1 (fr) 2008-03-10 2020-04-15 Antares Pharma, Inc. Dispositif de sécurité d'injecteur
WO2009140782A1 (fr) * 2008-05-23 2009-11-26 Tecpharma Licensing Ag Surveillance de la pression dans un appareil d'administration modulaire
JP5611208B2 (ja) 2008-08-05 2014-10-22 アンタレス・ファーマ・インコーポレーテッド 多数回服用量の注射装置
CH700630A1 (de) * 2009-03-18 2010-09-30 Tecpharma Licensing Ag Verabreichungsvorrichtung mit hydraulischer Kraftübertragung.
EP2453956A1 (fr) * 2009-07-15 2012-05-23 Sanofi-Aventis Deutschland GmbH Ensemble d'entraînement pour injecteur de type stylo et injecteur de type stylo avec ensemble d'entraînement
CH702075A1 (de) 2009-10-16 2011-04-29 Tecpharma Licensing Ag Okklusionserkennung in einem Verabreichungsgerät.
WO2012171572A1 (fr) 2011-06-16 2012-12-20 Tecpharma Licensing Ag Dispositif pour administrer un produit fluide
US9220660B2 (en) 2011-07-15 2015-12-29 Antares Pharma, Inc. Liquid-transfer adapter beveled spike
US8496619B2 (en) 2011-07-15 2013-07-30 Antares Pharma, Inc. Injection device with cammed ram assembly
PT2822618T (pt) 2012-03-06 2024-03-04 Antares Pharma Inc Seringa pré-cheia com característica de força de rutura
KR20150011346A (ko) 2012-04-06 2015-01-30 안타레스 팔마, 인코퍼레이티드 테스토스테론 조성물의 바늘-보조식 젯 주입 투여 장치 및 방법
US9364610B2 (en) 2012-05-07 2016-06-14 Antares Pharma, Inc. Injection device with cammed ram assembly
EP4349383A2 (fr) 2013-02-11 2024-04-10 Antares Pharma, Inc. Dispositif d'injection par jet assisté par aiguille ayant une force de déclenchement réduite
EP2968792B1 (fr) 2013-03-11 2019-05-15 Antares Pharma, Inc. Injecteur de dose avec système à pignon
US9498575B2 (en) * 2013-03-14 2016-11-22 MRI Interventions, Inc. Substance delivery devices, systems and methods
EP2803376A1 (fr) * 2013-05-16 2014-11-19 Georg Fischer Nouvelle soupape d'alimentation d'urgence active
US10751470B2 (en) 2014-02-10 2020-08-25 E3D A.C.A.L Ltd Semi disposable auto injector
KR101666715B1 (ko) 2014-02-19 2016-10-17 가부시끼 가이샤 구보다 암레스트 장치
EP3341054B1 (fr) 2015-08-27 2021-04-14 E3D Agricultural Cooperative Association Ltd. Dispositif d'injection automatique réutilisable
CN114191646A (zh) * 2022-01-10 2022-03-18 阳上争 一种全自动输液仪

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3964482A (en) * 1971-05-17 1976-06-22 Alza Corporation Drug delivery device
DE3314664C2 (de) * 1983-04-22 1985-02-21 B. Braun Melsungen Ag, 3508 Melsungen Verfahren zur Auslösung von Voralarm bei einem Druckinfusionsapparat
US5279544A (en) * 1990-12-13 1994-01-18 Sil Medics Ltd. Transdermal or interdermal drug delivery devices
GB9815819D0 (en) * 1998-07-22 1998-09-16 Secr Defence Transferring materials into cells and a microneedle array
DK1124608T3 (da) * 1998-10-29 2006-04-03 Medtronic Minimed Inc Reservoirkonnektor
US20050197626A1 (en) * 1998-10-29 2005-09-08 Medtronic Minimed Inc. Fluid reservoir for use with an external infusion device
CN1191872C (zh) * 1999-01-28 2005-03-09 塞托·帕尔斯科技公司 运送大分子进入细胞的装置
US6743211B1 (en) * 1999-11-23 2004-06-01 Georgia Tech Research Corporation Devices and methods for enhanced microneedle penetration of biological barriers
US6256533B1 (en) * 1999-06-09 2001-07-03 The Procter & Gamble Company Apparatus and method for using an intracutaneous microneedle array
US6565532B1 (en) * 2000-07-12 2003-05-20 The Procter & Gamble Company Microneedle apparatus used for marking skin and for dispensing semi-permanent subcutaneous makeup
US6638246B1 (en) * 2000-11-28 2003-10-28 Scimed Life Systems, Inc. Medical device for delivery of a biologically active material to a lumen
US20020099356A1 (en) * 2001-01-19 2002-07-25 Unger Evan C. Transmembrane transport apparatus and method
US6854620B2 (en) * 2001-04-13 2005-02-15 Nipro Diabetes, Systems, Inc. Drive system for an infusion pump
US7537579B2 (en) * 2002-09-26 2009-05-26 Covidien Ag Safety interlock system for an enteral feeding pump
US20060015066A1 (en) * 2004-05-17 2006-01-19 Turieo Melanie J Intraosseous infusion device
DE502005002757D1 (de) 2005-03-24 2008-03-20 Disetronic Licensing Ag Vorrichtung für die dosierte Verabreichung eines fluiden Produkts
CH699723B1 (de) * 2005-04-25 2010-04-30 Tecpharma Licensing Ag Vorrichtung zur Verabreichung eines fluiden Produkts.

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
None *
See also references of WO2008106806A1 *

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US20100152661A1 (en) 2010-06-17
CN101678166A (zh) 2010-03-24
WO2008106806A1 (fr) 2008-09-12
US8679070B2 (en) 2014-03-25
CN101678166B (zh) 2012-08-22

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