WO2008080237A1 - Device for automated delivery of a liquid medicament - Google Patents

Device for automated delivery of a liquid medicament Download PDF

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Publication number
WO2008080237A1
WO2008080237A1 PCT/CH2007/000540 CH2007000540W WO2008080237A1 WO 2008080237 A1 WO2008080237 A1 WO 2008080237A1 CH 2007000540 W CH2007000540 W CH 2007000540W WO 2008080237 A1 WO2008080237 A1 WO 2008080237A1
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WO
WIPO (PCT)
Prior art keywords
unit
operating unit
operating
infusion
infusion unit
Prior art date
Application number
PCT/CH2007/000540
Other languages
French (fr)
Inventor
Heiner Kaufmann
Original Assignee
F. Hoffmann-La Roche Ag
Roche Diagnostics Gmbh
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 F. Hoffmann-La Roche Ag, Roche Diagnostics Gmbh filed Critical F. Hoffmann-La Roche Ag
Publication of WO2008080237A1 publication Critical patent/WO2008080237A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1413Modular systems comprising interconnecting elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4836Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3546Range
    • A61M2205/3569Range sublocal, e.g. between console and disposable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3576Communication with non implanted data transmission devices, e.g. using external transmitter or receiver

Definitions

  • the present invention relates to a device for automated delivery of a liquid medicament in accordance with the preamble of Patent Claim 1.
  • BACKGROUND ART Devices for automated delivery of liquid medicaments are preferably used in patients who have a continuous requirement, varying over the course of the day, for a medicament that can be administered exclusively by the subcutaneous route.
  • a medicament that can be administered exclusively by the subcutaneous route.
  • analgesic therapies and the treatment of diabetes in which use is made of computer-controlled medicament pumps, for example insulin pumps, that can be worn on the body and that often contain, in a reservoir, a quantity of medicament sufficient for several days and that convey the liquid medicament, according to a pre-programmed daily profile, from the reservoir into the patient's body via an infusion cannula.
  • the object is therefore to make available a device, for automated delivery of a liquid medicament, which does not have the disadvantages of the prior art or at least avoids some of these .
  • the device according to the invention for automated delivery of a liquid medicament comprises an infusion " unit, which is designed to receive a medicament reservoir or contains a medicament reservoir and has a medicament-conveying device for conveying the liquid medicament out of the medicament reservoir to be received therein or the medicament reservoir contained therein.
  • the device comprises an operating unit for operating same, by means of which bolus doses, for example, can be dispensed.
  • the infusion unit and the operating unit each have a separate housing and have mutually adapted coupling means with which they can alternately be joined together, to form a mechanically coherent overall unit, or can be separated from each other, in both cases preferably without using tools.
  • the device can be operated via the operating unit at least in a state in which the operating unit is separated from the infusion unit.
  • the device With the device according to the invention, it is now possible for the first time to carry the infusion unit, without operating unit, unseen under ones clothing and to carry and operate the operating unit separately and inconspicuously, for example in ones trouser pocket, or, alternatively, to carry infusion unit and operating unit as a mechanically coherent overall unit, depending on what is desired in each particular situation.
  • the device is designed in such a way that the device can be operated with the aid of the operating unit both in the assembled state and also when the operating unit is separated from the infusion unit. This affords the advantage that the device can be operated via the operating unit in each state, thereby increasing the flexibility of use.
  • the coupling means with which the infusion unit and the operating unit can be joined together mechanically to form a coherent overall unit or can be separated, are designed on the infusion unit and on the operating unit such that they cannot be removed without using tools, e.g. by being designed integrally with their housings or being screwed onto these. This affords the advantage that the coupling means are formed captively on both units and are therefore available at all times.
  • these coupling means on the infusion unit and/or on the operating unit are formed by one or more elements that can be removed without using tools or can be exchanged without using tools.
  • the coupling means are replaced by other coupling means which not only allow the infusion unit and the operating unit to be connected to each other to form a coherent unit, but additionally allow the latter to be connected to a patient's body or to a suitable support system.
  • the coupling means of the infusion unit are formed by a component part that can be exchanged without using tools, this component part preferably additionally having means for securing it to the body of a patient or for coupling it to a support device or to an item of clothing on the body of a patient, preferably a suspension loop, an adhesive surface for fixing to the skin, a belt clip or a passage for a belt.
  • this component part preferably additionally having means for securing it to the body of a patient or for coupling it to a support device or to an item of clothing on the body of a patient, preferably a suspension loop, an adhesive surface for fixing to the skin, a belt clip or a passage for a belt.
  • the coupling means comprise safety means with which the infusion unit and the operating unit, in the correctly assembled state, can be secured, preferably automatically, against accidental separation.
  • the safety means require a manoeuvre that is different than the manoeuvre required for separating the operating unit from the infusion unit, for example they require a release button to be pressed, whereas the separation of operating unit and infusion unit requires a rotational movement .
  • the coupling means are designed in such a way that infusion unit and operating unit can be joined together by moving them relative to each other along rigid guides, in particular by pushing them together along linear guides, for example linear dovetail guides, or by a bayonet catch formed by the two units.
  • This type of coupling permits exact positioning of the two units relative to each other in the assembled state and additionally makes it easier to join the infusion unit and operating unit together, particularly using just one hand, at locations that are difficult to access and to see, for example when the infusion unit is secured at the side on a belt.
  • the coupling means are designed in such a way that infusion unit and operating unit are joined together by expansion of one or more rubber-elastic shaped elements which are formed by one unit and which, in the assembled state, form an elastically pretensioned form fit with associated rigid shaped elements of the other unit, preferably by enclosure of or engagement in contours.
  • the coupling means are designed in such a way that infusion unit and operating unit are joined together by locking of catch elements, in particular of press-buttons.
  • Such coupling means permit short coupling paths and generally do not require additional safety means.
  • the coupling means are designed in such a way that infusion unit and operating unit are joined together with a force fit, preferably by clamping, adhesive bonding or magnetic force, or by a velcro-type pairing.
  • the operating unit and the infusion unit in the separated state can communicate with each other in a first operating mode via a wireless connection, in particular via an infrared interface or a radio connection, either in one direction or in two directions.
  • the device additionally has means, for example switches or contacts with associated electronics, which, when the operating unit and infusion unit are correctly assembled to form a mechanically coherent overall unit, detect the assembled state and as a result automatically activate a second operating mode, which differs from the first operating mode in that less energy is used up for the same communication than in the first operating mode.
  • This increases the lifetime of the batteries of the operating unit and, in the case of bidirectional communication between operating unit and infusion unit, also considerably increases the lifetime of the batteries of the infusion unit.
  • the operating unit and the infusion unit in the first operating mode can communicate with each other via a radio connection with a first transmission power and, in the second operating mode, communicate with each other via a radio connection with a second transmission power that is less than the first transmission power.
  • the operating unit and the infusion unit in the first operating mode can communicate with each other via a radio connection and, in the second operating mode, can communicate with each other via another type of connection, preferably via an infrared interface formed between them or via an electrical connection, for example via electrical contacts.
  • a second aspect of the invention concerns a set comprising a device for automated delivery of a liquid medicament according to the first aspect of the invention, preferably an insulin pump, and a separate measurement module, preferably a blood sugar measurement module.
  • the operating unit (BE) of the device and the measurement module are provided with mutually adapted coupling means with which they can alternately be joined together to form a mechanically coherent overall unit or can be separated from each other, in both cases preferably without using tools.
  • the measurement module can be operated by means of the operating unit (BE) at least when the operating unit
  • Fig. 1 shows a side view of a first device according to the invention, with the infusion unit and operating unit joined together to form a mechanically coherent overall unit;
  • Figures Ia to Id each show a cross section along the line A-A in Fig. 1 through different embodiment variants of the device from Fig. 1 ;
  • Fig. 2 shows a view, as in Fig. 1, of a second device according to the invention
  • Figures 2a and 2b each show a cross section along the line B-B in Fig. 2 through different embodiment _ Q variants of the device from Fig. 2 ;
  • Fig. 3 shows a view, as in Fig. 1, of a third device according to the invention, with the infusion unit and operating unit being joined together;
  • Figures 3a and 3b each show a cross section along the line C-C in Fig. 3 through different embodiment variants of the device from Fig. 3 ;
  • Fig. 4 shows a view, as in Fig. 1, of a fourth device according to the invention.
  • Fig. 4a shows a plan view of the device from Fig. 4 ;
  • Fig. 5 shows a view, as in Fig. 1, of a fifth device according to the invention
  • Fig. 5a shows a cross section along the line D-D in Fig. 5;
  • Fig. 6 shows a view, as in Fig. 1, of a sixth device according to the invention
  • Fig. 6a shows a cross section along the line E-E in Fig . 6 ;
  • Fig. 7 shows a view, as in Fig. 1, of a seventh device according to the invention.
  • Fig. 7a shows a cross section along the line F-F in Fig. 7;
  • Fig. 8 shows a view, as in Fig. 1, of an eighth device according to the invention.
  • Fig. 8a shows a plan view of the device from Fig. 8 ;
  • Figures 8b and 8c each show a cross section along the line G-G in Fig. 8 through different embodiment variants of the device from Fig. 8 ;
  • Fig. 9 shows a view, as in Fig. 1, of a ninth device according to the invention.
  • Fig. 9a shows a plan view of the device from Fig. 9;
  • Fig. 10 shows a view, as in Fig. 1, of a tenth device according to the invention
  • Fig. 10a shows a longitudinal section through the device from Fig. 10;
  • Fig. 11 shows a view, as in Fig. 1, of an eleventh device according to the invention.
  • Fig. 11a shows a longitudinal section through the device from Fig. 11;
  • Fig. 12 shows a plan view of a twelfth device according to the invention.
  • Fig. 12a shows a cross section along the line I -I in Fig. 12.
  • FIG. 1 A first preferred embodiment of the device according to the invention for automated delivery of a liquid medicament, in the form of an insulin pump, is shown in side view in Fig. 1.
  • the insulin pump is composed of an operating unit BE, which has the keys necessary for operating and setting the pump, and also a display (neither of which are shown) , and of an infusion unit IE, these being joined together in Fig. 1 to form a mechanically coherent overall unit.
  • Operating unit BE and infusion unit IE have an identical configuration and, in the illustrated state in which they are correctly joined together in mirror symmetry, they form a closed overall contour, which is rounded off on all sides.
  • both the operating unit BE and the infusion unit IE have magnets 1, which are at directly opposite locations and by means of which the two units BE, IE are joined together to form a mechanically coherent overall unit .
  • the magnets 1 have been connected fixedly and inseparably to the units BE, IE by plastic encapsulation during production of the housings of the two units BE, IE.
  • the infusion unit IE has centring shoulders 2 which interact with corresponding matching contours of the operating unit BE and thereby ensure that, when infusion unit IE and operating unit BE are joined together, the magnets 1 of the two units BE, IE come to lie directly on each other.
  • Fig. Ib shows another embodiment of the insulin pump according to the invention from Fig. 1, in which the operating unit BE and the infusion unit IE are connected to each other across a large surface area by a velcro-type connection 3, for example by the operating unit BE carrying the loop part and the infusion unit IE the hook part.
  • the loop and hook parts are each connected by an adhesive connection to the housing of the operating unit or infusion unit supporting them.
  • a velcro-type connection an adhesive connection that can be used once or several times would also be conceivable in this embodiment.
  • Fig. Ic shows a further embodiment of the insulin pump in which the operating unit BE and the infusion unit IE are connected to each other with a form fit via two linear slide guides 4 that extend in the longitudinal direction along the sides of the insulin pump.
  • the slide guides 4 are each designed in one piece with the housing part supporting them.
  • the operating unit BE has, on its underside, a projection 5 which engages resiliently in a corresponding depression 6 on the top face of the infusion unit IE and thus forms, together with this depression 6, the claimed safety means with which the two units BE, IE are secured against accidental separation in the state illustrated.
  • a catch element which locks automatically in place and has to be unlocked by actuating a release button.
  • Fig. Id shows yet another embodiment of the insulin pump according to the invention in which the operating unit BE and the infusion unit IE are connected to each other via a bayonet connection 7, which is formed by the housings of the two units BE, IE and which can be released by rotation about the axis X and subsequent separation in the direction of the axis X.
  • the halves of the bayonet connection are each formed in one piece with the housing supporting them.
  • the elements 1, 2, 4, 5, 6, 7, which form the claimed coupling means are connected to the housings of the two units BE, IE such that they cannot be removed without using tools.
  • Fig. 2 shows a second insulin pump according to the invention, likewise in side view.
  • the operating unit BE and the infusion unit IE have substantially the same shape as the insulin pump in Fig. 1. However, they are not connected to each other via coupling elements arranged in spatial terms between the units BE, IE, but instead via external coupling means 8, 9, which at least partially engage around the infusion unit IE.
  • the two folding brackets are replaced by an elastic tensioning band 9 which is secured on the operating unit BE and, in the state shown, encloses the infusion unit IE with pretensioning .
  • Fig. 3 shows a further device according to the invention for automated delivery of liquid medicaments in an intermediate state during joining-together of the infusion unit IE and operating unit BE by pushing the infusion unit IE in the direction Z onto the operating unit BE.
  • the infusion unit IE and operating unit BE differ in configuration here but are designed such that, when correctly joined together, they provide an overall contour like the device shown in Fig. 1.
  • the operating unit BE has a thickness corresponding to the total thickness of the device according to the invention. This is in contrast to the two preceding devices according to the invention, in which the total thickness is obtained only when infusion unit IE and operating unit BE are joined together.
  • the operating unit BE and the infusion unit IE are here connected to each other via claimed coupling means that are designed as dovetail guides 11 extending along the sides in the longitudinal direction (Fig. 3a) or centrally in the longitudinal direction (Fig. 3b) .
  • the dovetail guides 11 are formed in one piece by the housings of the two units BE, IE.
  • the operating unit BE has a resilient projection with a locking lug 12 which, when the operating unit BE and infusion unit IE are pushed together, automatically locks into an associated undercut (not shown) in the infusion unit IE and can be unlocked, by pressing on a release button (also not shown) arranged on the outside of the operating unit BE, in the event that the infusion unit IE is to be uncoupled from the operating unit BE.
  • Fig. 4 shows a side view of a fourth insulin pump according to the invention when the operating unit BE and infusion unit IE have been coupled together.
  • the infusion unit IE in the present case is inserted, in a direction of insertion E extending transverse to the longitudinal extent of the device, into a recess in the operating unit BE, which recess partially surrounds the device and thereby matches its outer contour, and is thereby connected to the latter.
  • the infusion unit IE simply has to be removed from the operating unit BE counter to the direction of insertion E.
  • the boundary walls 13 of the recess receiving the infusion unit IE are formed by a rubber-elastic material, in such a way that the infusion unit IE is received free of play in the recess, with slight elastic deformation of these walls 13, and is thus held by friction therein. Provision is also made for the aforementioned boundary walls 13 to be made of a rigid material and for the infusion unit IE to be secured in the recess in the operating unit BE by means of a locking mechanism. As can be seen from Fig. 4, the operating unit BE in the present case has two battery covers 26, which can be removed in order to permit replacement of the batteries and can be installed again.
  • Fig. 5 shows a side view of a fifth insulin pump according to the invention, with the operating unit BE and infusion unit IE coupled together.
  • Fig. 5a which shows a cross section along the line D-D in Fig. 5
  • the operating unit BE in this embodiment is pushed over the infusion unit IE and thus encloses the latter on five of six sides.
  • the housing of the operating unit BE is made of a rubber-elastic material and on each long side is coupled by means of a push-button 14 (indicated by broken lines in Fig. 5) to the long side of the infusion unit IE.
  • the two push-button connections 14 are released by pulling out the housing areas of the operating unit BE that support them, and the operating unit BE is lifted from the infusion unit IE.
  • Fig. 6 shows a side view of a further insulin pump according to the invention, with the operating unit BE and infusion unit IE coupled together.
  • the operating unit BE and infusion unit IE in the present case are connected to each other via a hinge 15 on one long side and via a locking hook 16 arranged on the other long side opposite the hinge 15.
  • the locking hook 16 itself is formed by a free end of a rocker arranged on the operating unit BE and engages resiliently in an undercut formed on the infusion unit IE.
  • the locked connection can be released, whereupon the operating unit BE can be pivoted about the hinge 15 relative to the infusion unit IE in order to free the operating elements (e.g. keys and display) arranged on its inside.
  • the hinge 15 is designed in such a way that the hinge shaft is locked from underneath onto the hinge part formed by the operating unit BE. If the operating unit BE is to be separated from the infusion unit IE, the hinge shaft arranged fixedly on the infusion unit IE can be released from the hinge part on the operating unit BE after the locking hook 16 has been unlocked, and the operating unit BE can be removed. Joining the two units BE and IE together to form a mechanically coherent overall unit is possible in the reverse sequence.
  • Fig. 7 shows a side view of yet another insulin pump according to the invention, with the operating unit BE and infusion unit IE coupled together.
  • the operating unit BE and infusion unit IE in this embodiment have an identical outer shape and, for the purpose of connecting them to each other with slight pretensioning, are arranged in receiving apertures which are each formed in mirror symmetry by a rubber- elastic coupling element 27 and are adapted to the housing shape of the units BE, IE, and from which they can be removed without using tools, by elastic expansion of those areas of the coupling element . 27 that engage round the respective unit BE, IE.
  • the coupling element 27 either remains on the infusion unit IE or on the operating unit BE or can also be removed from both.
  • FIG. 8 shows a side view
  • Fig. 8a shows a plan view of yet another device according to the invention, with the operating unit BE and infusion unit IE coupled together.
  • the operating unit BE and the infusion unit IE in this embodiment too have an identical outer shape.
  • Their housings each form, on their outer periphery, a circumferential securing flange 17 which, for the purpose of connecting the two units BE, IE to each other to form a mechanically coherent overall unit, is enclosed by a resiliently elastic frame element 18, which is open at one end.
  • one of the units BE, IE is to be removed from the frame element 18 in order to separate said units, it can be pulled out of the frame element 18 by means of elastic spreading of the branches of the frame element 18 at the open end.
  • the frame element 18 is designed with a C-shaped cross section and for the operating unit BE and infusion unit IE to be connected to each other directly lying one upon the other (Fig. 8b) , or for the frame element 18 to be designed with an E-shaped cross section, in which case the central finger of the "E" merges into a rubber- elastic intermediate element 19 passing through between the two units BE, IE (Fig. 8c) .
  • Fig. 9 shows a side view and Fig. 9a a plan view of yet another device according to the invention, with the operating unit BE and infusion unit IE coupled together, which device differs from the one shown in Figures 8, 8a and 8c only in that the resiliently elastic frame element 18 has, on its open end, a closure flap 20 by means of which it can be closed to form a circumferentially enclosed frame.
  • the closure flap 20 in the closed state engages with a catch projection 21 formed in the edge area on the top face of the intermediate element 19, in order to safely prevent the closure flap 20 from coming open accidentally.
  • Fig. 10 shows a side view of yet another device according to the invention, with the operating unit BE and infusion unit IE coupled together.
  • Fig. 10a which shows a longitudinal section through the device from Fig. 10
  • the infusion unit IE and the operating unit BE are in this case connected to each other by a frame 22 which is made of a rubber- elastic material and encloses the infusion unit IE with slight elastic expansion, said frame 22 engaging with a circumferential lug 23 into a circumferential groove in the infusion unit IE.
  • the coupling between the frame 22 and the operating unit BE in the present case is achieved by magnets 1, which are mounted on opposite locations on the operating unit BE and the frame 22.
  • the orientation between operating unit BE and frame 22 is effected here by means of the operating unit BE having a rectangular outer shape which is rounded off on all sides, and the frame 22 provides a matching contour for the edge area of the operating unit BE. If the operating unit BE is to be separated from the infusion unit IE, it can simply be removed from the latter counter to the magnetic force. If the infusion unit IE is to be separated from the frame 22, the operating unit BE first has to be removed. The infusion unit can then be removed from the frame 22 by means of elastic radial expansion of the latter.
  • Figures 11 and 11a show views, similar to Figures 10 and 10a, of another device according to the invention, which differs from the one shown in Figures 10 and 10a in that, instead of the frame 22, which has the sole task of connecting operating unit BE and infusion unit IE to each other, a support element 24 is now provided which, on the one hand, forms a corresponding rubber- elastic frame 22 for connecting the infusion unit IE and operating unit BE and, on the other hand, can carry a belt clip 25 with which the device as a whole can be carried on a belt .
  • the frame 22 here, in contrast to the preceding illustrative embodiment, has a rear wall 26 that is likewise made from a rubber- elastic material .
  • Figures 12 and 12a show yet another device according to the invention, in a plan view (Fig. 12) and in longitudinal section (Fig. 12a), and specifically during joining or separating of the infusion unit IE and the operating unit BE.
  • the operating unit BE in the present case is made up of two housing parts 27, 28, which are connected to each other via guide rods 29 in such a way that they can be pulled apart along these guide rods 29 or, starting from the pulled-apart state shown here, can be pushed together in the direction Y.
  • Fig. 12 the operating unit BE in the present case is made up of two housing parts 27, 28, which are connected to each other via guide rods 29 in such a way that they can be pulled apart along these guide rods 29 or, starting from the pulled-apart state shown here, can be pushed together in the direction Y.
  • the two housing parts 27, 28 form a receiving aperture for the infusion unit IE
  • their boundary walls 31, 32 oriented in or counter to the direction Y form the matching contour for the outer contour of the infusion unit IE and, when the two housing parts 27, 28 are pushed together (not shown) , engage in such a way that the infusion unit IE is held with a form fit in the operating unit BE.
  • this receiving aperture is widened in such a way that the infusion unit IE can be removed from it.
  • the infusion unit IE arranged in the receiving aperture is surrounded by the boundary walls 31, 32 and thus secured with a form fit.
  • the guide rods 29 engage with locking means (not shown) , such that the housing parts 27, 28 are safely prevented from being accidentally pulled apart again.
  • the two release buttons 30 have to be pressed and, at the same time, the two housing parts 27, 28 have to be pulled apart until the receiving aperture formed by them is widened in such a way that the infusion unit IE can be removed.

Abstract

The invention relates to a device for automated delivery of a liquid medicament. The device comprises an infusion unit (IE), which contains a medicament reservoir and a medicament-conveying device for conveying the liquid medicament out of the medicament reservoir, and an operating unit (BE) for operating same. Infusion unit (IE) and operating unit (BE) have coupling means (11, 12), which are adapted to each other and with which they can alternatively be joined together, to form a mechanically coherent overall unit, or can be separated from each other. By means of the invention, it is possible for the first time to wear the infusion unit (IE), without operating unit (BE), unseen under ones clothing and to carry the operating unit around and operate it separately and inconspicuously, for example in ones trouser pocket, or, alternatively, to carry infusion unit and operating unit (IE, BE) around as a mechanically coherent overall unit, depending on the particular requirement.

Description

Device for automated delivery of a liquid medicament
TECHNICAL FIELD The present invention relates to a device for automated delivery of a liquid medicament in accordance with the preamble of Patent Claim 1.
BACKGROUND ART Devices for automated delivery of liquid medicaments are preferably used in patients who have a continuous requirement, varying over the course of the day, for a medicament that can be administered exclusively by the subcutaneous route. Concrete examples are, for instance, certain analgesic therapies and the treatment of diabetes, in which use is made of computer- controlled medicament pumps, for example insulin pumps, that can be worn on the body and that often contain, in a reservoir, a quantity of medicament sufficient for several days and that convey the liquid medicament, according to a pre-programmed daily profile, from the reservoir into the patient's body via an infusion cannula. There is an increasing need to allow the patient, depending on the particular situation, either to carry and operate the pump unseen, for example in public, or to carry it as conveniently as possible and unconcealed, for example in private. Whereas, in the first case, a medicament pump with a separate, wireless remote control has to be used in practice, in order to permit inconspicuous operation and reasonable wearing comfort, the second case requires, for maximum comfort, a medicament pump with an integrated operating unit that cannot be mislaid and is therefore available at all times. If the patient opts for a medicament pump with separate wireless remote control, he always runs the risk of losing the latter or permanently accepts increased coordination efforts to ensure that the operating unit does not go missing and is to hand at all times. If, by contrast, he opts for a medicament pump with integrated operating unit, he loses the possibility of operating it inconspicuously.
DISCLOSURE OF THE INVENTION The object is therefore to make available a device, for automated delivery of a liquid medicament, which does not have the disadvantages of the prior art or at least avoids some of these .
This object is achieved by the device according to Patent Claim 1.
Accordingly, the device according to the invention for automated delivery of a liquid medicament comprises an infusion" unit, which is designed to receive a medicament reservoir or contains a medicament reservoir and has a medicament-conveying device for conveying the liquid medicament out of the medicament reservoir to be received therein or the medicament reservoir contained therein. Moreover, the device comprises an operating unit for operating same, by means of which bolus doses, for example, can be dispensed. The infusion unit and the operating unit each have a separate housing and have mutually adapted coupling means with which they can alternately be joined together, to form a mechanically coherent overall unit, or can be separated from each other, in both cases preferably without using tools. The device can be operated via the operating unit at least in a state in which the operating unit is separated from the infusion unit.
With the device according to the invention, it is now possible for the first time to carry the infusion unit, without operating unit, unseen under ones clothing and to carry and operate the operating unit separately and inconspicuously, for example in ones trouser pocket, or, alternatively, to carry infusion unit and operating unit as a mechanically coherent overall unit, depending on what is desired in each particular situation. In a preferred embodiment of the device, the device is designed in such a way that the device can be operated with the aid of the operating unit both in the assembled state and also when the operating unit is separated from the infusion unit. This affords the advantage that the device can be operated via the operating unit in each state, thereby increasing the flexibility of use.
In another preferred embodiment of the device, the coupling means, with which the infusion unit and the operating unit can be joined together mechanically to form a coherent overall unit or can be separated, are designed on the infusion unit and on the operating unit such that they cannot be removed without using tools, e.g. by being designed integrally with their housings or being screwed onto these. This affords the advantage that the coupling means are formed captively on both units and are therefore available at all times.
In an alternative preferred embodiment of the device, these coupling means on the infusion unit and/or on the operating unit are formed by one or more elements that can be removed without using tools or can be exchanged without using tools. In this way it is possible, for example, when the device is used exclusively with the operating unit separated from the infusion unit, to easily remove the coupling means, which in this case are unnecessary and may also get in the way. Depending on the structural design, there is also the possibility of the coupling means being replaced by other coupling means which not only allow the infusion unit and the operating unit to be connected to each other to form a coherent unit, but additionally allow the latter to be connected to a patient's body or to a suitable support system.
Accordingly, in a preferred embodiment of the device, the coupling means of the infusion unit are formed by a component part that can be exchanged without using tools, this component part preferably additionally having means for securing it to the body of a patient or for coupling it to a support device or to an item of clothing on the body of a patient, preferably a suspension loop, an adhesive surface for fixing to the skin, a belt clip or a passage for a belt. In this way, it is easy to adapt the device to different situations of use or to different support systems by exchanging the component part that forms the coupling means and the securing means .
In yet another preferred embodiment of the device, the coupling means comprise safety means with which the infusion unit and the operating unit, in the correctly assembled state, can be secured, preferably automatically, against accidental separation.
It is preferable if, in order to cancel the safety effect, the safety means require a manoeuvre that is different than the manoeuvre required for separating the operating unit from the infusion unit, for example they require a release button to be pressed, whereas the separation of operating unit and infusion unit requires a rotational movement .
In this way, it is possible to achieve a high degree of safety against accidental separation and loss of the operating unit.
In yet another preferred embodiment of the device, the coupling means are designed in such a way that infusion unit and operating unit can be joined together by moving them relative to each other along rigid guides, in particular by pushing them together along linear guides, for example linear dovetail guides, or by a bayonet catch formed by the two units. This type of coupling permits exact positioning of the two units relative to each other in the assembled state and additionally makes it easier to join the infusion unit and operating unit together, particularly using just one hand, at locations that are difficult to access and to see, for example when the infusion unit is secured at the side on a belt.
In yet another preferred embodiment of the device, the coupling means are designed in such a way that infusion unit and operating unit are joined together by expansion of one or more rubber-elastic shaped elements which are formed by one unit and which, in the assembled state, form an elastically pretensioned form fit with associated rigid shaped elements of the other unit, preferably by enclosure of or engagement in contours. This represents a simple and inexpensive way of coupling the operating unit to the infusion unit mechanically and free of play.
In yet another preferred embodiment of the device, the coupling means are designed in such a way that infusion unit and operating unit are joined together by locking of catch elements, in particular of press-buttons. Such coupling means permit short coupling paths and generally do not require additional safety means.
In yet another preferred embodiment of the device, the coupling means are designed in such a way that infusion unit and operating unit are joined together with a force fit, preferably by clamping, adhesive bonding or magnetic force, or by a velcro-type pairing.
In yet another preferred embodiment of the device, the operating unit and the infusion unit in the separated state can communicate with each other in a first operating mode via a wireless connection, in particular via an infrared interface or a radio connection, either in one direction or in two directions. The device additionally has means, for example switches or contacts with associated electronics, which, when the operating unit and infusion unit are correctly assembled to form a mechanically coherent overall unit, detect the assembled state and as a result automatically activate a second operating mode, which differs from the first operating mode in that less energy is used up for the same communication than in the first operating mode. This increases the lifetime of the batteries of the operating unit and, in the case of bidirectional communication between operating unit and infusion unit, also considerably increases the lifetime of the batteries of the infusion unit.
It is preferable if the operating unit and the infusion unit in the first operating mode can communicate with each other via a radio connection with a first transmission power and, in the second operating mode, communicate with each other via a radio connection with a second transmission power that is less than the first transmission power. This has the effect that the same transmission and reception units of the device can be used for both operating modes, with the result that the outlay in terms of equipment for such a solution can be reduced to a minimum.
Alternatively, it is also preferable if the operating unit and the infusion unit in the first operating mode can communicate with each other via a radio connection and, in the second operating mode, can communicate with each other via another type of connection, preferably via an infrared interface formed between them or via an electrical connection, for example via electrical contacts. This permits solutions which, when the operating unit and infusion unit are joined together to form a coherent overall unit, require a minimum of energy for the communication between these units and accordingly permit long lifetimes for the batteries.
A second aspect of the invention concerns a set comprising a device for automated delivery of a liquid medicament according to the first aspect of the invention, preferably an insulin pump, and a separate measurement module, preferably a blood sugar measurement module. The operating unit (BE) of the device and the measurement module are provided with mutually adapted coupling means with which they can alternately be joined together to form a mechanically coherent overall unit or can be separated from each other, in both cases preferably without using tools.
The measurement module can be operated by means of the operating unit (BE) at least when the operating unit
(BE) is coupled thereto. In this way, it is possible to use the operating unit both to operate the device according to the invention and also to operate a measurement module with which, for example, it is possible to determine a parameter that defines the amount of liquid medicament to be delivered by the device .
BRIEF DESCRIPTION OF THE DRAWINGS
Further preferred embodiments of the invention will become evident from the dependent claims and from the following description of the figures, in which:
Fig. 1 shows a side view of a first device according to the invention, with the infusion unit and operating unit joined together to form a mechanically coherent overall unit;
Figures Ia to Id each show a cross section along the line A-A in Fig. 1 through different embodiment variants of the device from Fig. 1 ;
Fig. 2 shows a view, as in Fig. 1, of a second device according to the invention;
Figures 2a and 2b each show a cross section along the line B-B in Fig. 2 through different embodiment _ Q variants of the device from Fig. 2 ;
Fig. 3 shows a view, as in Fig. 1, of a third device according to the invention, with the infusion unit and operating unit being joined together;
Figures 3a and 3b each show a cross section along the line C-C in Fig. 3 through different embodiment variants of the device from Fig. 3 ;
Fig. 4 shows a view, as in Fig. 1, of a fourth device according to the invention;
Fig. 4a shows a plan view of the device from Fig. 4 ;
Fig. 5 shows a view, as in Fig. 1, of a fifth device according to the invention;
Fig. 5a shows a cross section along the line D-D in Fig. 5;
Fig. 6 shows a view, as in Fig. 1, of a sixth device according to the invention;
Fig. 6a shows a cross section along the line E-E in Fig . 6 ;
Fig. 7 shows a view, as in Fig. 1, of a seventh device according to the invention;
Fig. 7a shows a cross section along the line F-F in Fig. 7;
Fig. 8 shows a view, as in Fig. 1, of an eighth device according to the invention;
Fig. 8a shows a plan view of the device from Fig. 8 ;
Figures 8b and 8c each show a cross section along the line G-G in Fig. 8 through different embodiment variants of the device from Fig. 8 ;
Fig. 9 shows a view, as in Fig. 1, of a ninth device according to the invention;
Fig. 9a shows a plan view of the device from Fig. 9;
Fig. 10 shows a view, as in Fig. 1, of a tenth device according to the invention;
Fig. 10a shows a longitudinal section through the device from Fig. 10;
Fig. 11 shows a view, as in Fig. 1, of an eleventh device according to the invention;
Fig. 11a shows a longitudinal section through the device from Fig. 11;
Fig. 12 shows a plan view of a twelfth device according to the invention; and
Fig. 12a shows a cross section along the line I -I in Fig. 12.
MODES FOR CARRYING OUT THE INVENTION
A first preferred embodiment of the device according to the invention for automated delivery of a liquid medicament, in the form of an insulin pump, is shown in side view in Fig. 1. As will be seen, the insulin pump is composed of an operating unit BE, which has the keys necessary for operating and setting the pump, and also a display (neither of which are shown) , and of an infusion unit IE, these being joined together in Fig. 1 to form a mechanically coherent overall unit. Operating unit BE and infusion unit IE have an identical configuration and, in the illustrated state in which they are correctly joined together in mirror symmetry, they form a closed overall contour, which is rounded off on all sides.
As will be seen from comparison with Figures Ia to Id, which each show a cross section along the line A-A in Fig. 1 through different embodiment variants of the device from Fig. 1, the operating unit BE and the infusion unit IE are connected to each other via coupling means that can be separated without using tools and that are formed by both units BE, IE.
Thus, in the insulin pump shown in Fig. Ia, both the operating unit BE and the infusion unit IE have magnets 1, which are at directly opposite locations and by means of which the two units BE, IE are joined together to form a mechanically coherent overall unit . The magnets 1 have been connected fixedly and inseparably to the units BE, IE by plastic encapsulation during production of the housings of the two units BE, IE. In the present case, the infusion unit IE has centring shoulders 2 which interact with corresponding matching contours of the operating unit BE and thereby ensure that, when infusion unit IE and operating unit BE are joined together, the magnets 1 of the two units BE, IE come to lie directly on each other.
Fig. Ib shows another embodiment of the insulin pump according to the invention from Fig. 1, in which the operating unit BE and the infusion unit IE are connected to each other across a large surface area by a velcro-type connection 3, for example by the operating unit BE carrying the loop part and the infusion unit IE the hook part. The loop and hook parts are each connected by an adhesive connection to the housing of the operating unit or infusion unit supporting them. Instead of a velcro-type connection, an adhesive connection that can be used once or several times would also be conceivable in this embodiment. Fig. Ic shows a further embodiment of the insulin pump in which the operating unit BE and the infusion unit IE are connected to each other with a form fit via two linear slide guides 4 that extend in the longitudinal direction along the sides of the insulin pump. The slide guides 4 are each designed in one piece with the housing part supporting them. Moreover, the operating unit BE has, on its underside, a projection 5 which engages resiliently in a corresponding depression 6 on the top face of the infusion unit IE and thus forms, together with this depression 6, the claimed safety means with which the two units BE, IE are secured against accidental separation in the state illustrated. Alternatively, provision is also made for a catch element which locks automatically in place and has to be unlocked by actuating a release button.
Fig. Id shows yet another embodiment of the insulin pump according to the invention in which the operating unit BE and the infusion unit IE are connected to each other via a bayonet connection 7, which is formed by the housings of the two units BE, IE and which can be released by rotation about the axis X and subsequent separation in the direction of the axis X. The halves of the bayonet connection are each formed in one piece with the housing supporting them.
In all the variants set out above, the elements 1, 2, 4, 5, 6, 7, which form the claimed coupling means, are connected to the housings of the two units BE, IE such that they cannot be removed without using tools.
Fig. 2 shows a second insulin pump according to the invention, likewise in side view. As will be seen, the operating unit BE and the infusion unit IE have substantially the same shape as the insulin pump in Fig. 1. However, they are not connected to each other via coupling elements arranged in spatial terms between the units BE, IE, but instead via external coupling means 8, 9, which at least partially engage around the infusion unit IE.
As will be seen from a comparison with Figures 2a and 2b, which each show a cross section along the line B-B in Fig. 2 through two different embodiment variants of the insulin pump, provision is made, for example, for the infusion unit IE to be connected to the operating unit BE via two folding brackets 8 which are secured on the operating unit BE and which partially engage round the infusion unit IE and are locked to the latter in the state shown in Fig. 2a. As will be seen, provision is also made in this variant, with the infusion unit IE separated, for the folding brackets 8 to fold into depressions 10 which are formed for this purpose on the operating unit BE, such that they do not form protrusions .
In the variant shown in Fig. 2b, the two folding brackets are replaced by an elastic tensioning band 9 which is secured on the operating unit BE and, in the state shown, encloses the infusion unit IE with pretensioning . Provision is also made for a further such tensioning band 9 to be arranged in the longitudinal direction, such that the two tensioning bands 9 intersect on the underside of the infusion unit IE in a central area. Provision is additionally made for the tensioning bands 9 to be able to be removed without using tools.
Fig. 3 shows a further device according to the invention for automated delivery of liquid medicaments in an intermediate state during joining-together of the infusion unit IE and operating unit BE by pushing the infusion unit IE in the direction Z onto the operating unit BE. As will be seen, the infusion unit IE and operating unit BE differ in configuration here but are designed such that, when correctly joined together, they provide an overall contour like the device shown in Fig. 1. In an area in which it contains the medicament reservoir (not shown) , the operating unit BE has a thickness corresponding to the total thickness of the device according to the invention. This is in contrast to the two preceding devices according to the invention, in which the total thickness is obtained only when infusion unit IE and operating unit BE are joined together.
As will be seen from a comparison with Figures 3a and 3b, which each show a cross section along the line C-C in Fig. 3 through two different embodiment variants of the device from Fig. 3, the operating unit BE and the infusion unit IE are here connected to each other via claimed coupling means that are designed as dovetail guides 11 extending along the sides in the longitudinal direction (Fig. 3a) or centrally in the longitudinal direction (Fig. 3b) . The dovetail guides 11 are formed in one piece by the housings of the two units BE, IE.
As can also be seen in Fig. 3, the operating unit BE has a resilient projection with a locking lug 12 which, when the operating unit BE and infusion unit IE are pushed together, automatically locks into an associated undercut (not shown) in the infusion unit IE and can be unlocked, by pressing on a release button (also not shown) arranged on the outside of the operating unit BE, in the event that the infusion unit IE is to be uncoupled from the operating unit BE.
Fig. 4 shows a side view of a fourth insulin pump according to the invention when the operating unit BE and infusion unit IE have been coupled together. As will be seen from a comparison with Fig. 4a, which shows a plan view of the device, the infusion unit IE in the present case is inserted, in a direction of insertion E extending transverse to the longitudinal extent of the device, into a recess in the operating unit BE, which recess partially surrounds the device and thereby matches its outer contour, and is thereby connected to the latter. For removal, the infusion unit IE simply has to be removed from the operating unit BE counter to the direction of insertion E. The boundary walls 13 of the recess receiving the infusion unit IE are formed by a rubber-elastic material, in such a way that the infusion unit IE is received free of play in the recess, with slight elastic deformation of these walls 13, and is thus held by friction therein. Provision is also made for the aforementioned boundary walls 13 to be made of a rigid material and for the infusion unit IE to be secured in the recess in the operating unit BE by means of a locking mechanism. As can be seen from Fig. 4, the operating unit BE in the present case has two battery covers 26, which can be removed in order to permit replacement of the batteries and can be installed again.
Fig. 5 shows a side view of a fifth insulin pump according to the invention, with the operating unit BE and infusion unit IE coupled together. As can be seen from a comparison with Fig. 5a, which shows a cross section along the line D-D in Fig. 5, the operating unit BE in this embodiment is pushed over the infusion unit IE and thus encloses the latter on five of six sides. The housing of the operating unit BE is made of a rubber-elastic material and on each long side is coupled by means of a push-button 14 (indicated by broken lines in Fig. 5) to the long side of the infusion unit IE. To separate operating unit BE and infusion unit IE, the two push-button connections 14 are released by pulling out the housing areas of the operating unit BE that support them, and the operating unit BE is lifted from the infusion unit IE.
Fig. 6 shows a side view of a further insulin pump according to the invention, with the operating unit BE and infusion unit IE coupled together. As can be seen from a comparison with Fig. 6a, which shows a cross section along the line E-E in Fig. 6, the operating unit BE and infusion unit IE in the present case are connected to each other via a hinge 15 on one long side and via a locking hook 16 arranged on the other long side opposite the hinge 15. The locking hook 16 itself is formed by a free end of a rocker arranged on the operating unit BE and engages resiliently in an undercut formed on the infusion unit IE. By applying a pressure to the end of the rocker opposite the locking hook 16, the locked connection can be released, whereupon the operating unit BE can be pivoted about the hinge 15 relative to the infusion unit IE in order to free the operating elements (e.g. keys and display) arranged on its inside. The hinge 15 is designed in such a way that the hinge shaft is locked from underneath onto the hinge part formed by the operating unit BE. If the operating unit BE is to be separated from the infusion unit IE, the hinge shaft arranged fixedly on the infusion unit IE can be released from the hinge part on the operating unit BE after the locking hook 16 has been unlocked, and the operating unit BE can be removed. Joining the two units BE and IE together to form a mechanically coherent overall unit is possible in the reverse sequence.
Fig. 7 shows a side view of yet another insulin pump according to the invention, with the operating unit BE and infusion unit IE coupled together. As can be seen from a comparison with Fig. 7a, which shows a cross section along the line F-F in Fig. 7, the operating unit BE and infusion unit IE in this embodiment have an identical outer shape and, for the purpose of connecting them to each other with slight pretensioning, are arranged in receiving apertures which are each formed in mirror symmetry by a rubber- elastic coupling element 27 and are adapted to the housing shape of the units BE, IE, and from which they can be removed without using tools, by elastic expansion of those areas of the coupling element .27 that engage round the respective unit BE, IE. The coupling element 27 either remains on the infusion unit IE or on the operating unit BE or can also be removed from both.
Fig. 8 shows a side view and Fig. 8a shows a plan view of yet another device according to the invention, with the operating unit BE and infusion unit IE coupled together. As can be seen from a comparison with Figures 8b and 8c, which each show a cross section along the line G-G in Fig. 8 through different embodiment variants of the device from Fig. 8, the operating unit BE and the infusion unit IE in this embodiment too have an identical outer shape. Their housings each form, on their outer periphery, a circumferential securing flange 17 which, for the purpose of connecting the two units BE, IE to each other to form a mechanically coherent overall unit, is enclosed by a resiliently elastic frame element 18, which is open at one end. If one of the units BE, IE is to be removed from the frame element 18 in order to separate said units, it can be pulled out of the frame element 18 by means of elastic spreading of the branches of the frame element 18 at the open end. As can be seen from Figures 8b and 8c, provision is made, for example, for the frame element 18 to be designed with a C-shaped cross section and for the operating unit BE and infusion unit IE to be connected to each other directly lying one upon the other (Fig. 8b) , or for the frame element 18 to be designed with an E-shaped cross section, in which case the central finger of the "E" merges into a rubber- elastic intermediate element 19 passing through between the two units BE, IE (Fig. 8c) .
Fig. 9 shows a side view and Fig. 9a a plan view of yet another device according to the invention, with the operating unit BE and infusion unit IE coupled together, which device differs from the one shown in Figures 8, 8a and 8c only in that the resiliently elastic frame element 18 has, on its open end, a closure flap 20 by means of which it can be closed to form a circumferentially enclosed frame. In the present case, the closure flap 20 in the closed state engages with a catch projection 21 formed in the edge area on the top face of the intermediate element 19, in order to safely prevent the closure flap 20 from coming open accidentally.
Fig. 10 shows a side view of yet another device according to the invention, with the operating unit BE and infusion unit IE coupled together. As can be seen from Fig. 10a, which shows a longitudinal section through the device from Fig. 10, the infusion unit IE and the operating unit BE are in this case connected to each other by a frame 22 which is made of a rubber- elastic material and encloses the infusion unit IE with slight elastic expansion, said frame 22 engaging with a circumferential lug 23 into a circumferential groove in the infusion unit IE. The coupling between the frame 22 and the operating unit BE in the present case is achieved by magnets 1, which are mounted on opposite locations on the operating unit BE and the frame 22. The orientation between operating unit BE and frame 22 is effected here by means of the operating unit BE having a rectangular outer shape which is rounded off on all sides, and the frame 22 provides a matching contour for the edge area of the operating unit BE. If the operating unit BE is to be separated from the infusion unit IE, it can simply be removed from the latter counter to the magnetic force. If the infusion unit IE is to be separated from the frame 22, the operating unit BE first has to be removed. The infusion unit can then be removed from the frame 22 by means of elastic radial expansion of the latter.
Figures 11 and 11a show views, similar to Figures 10 and 10a, of another device according to the invention, which differs from the one shown in Figures 10 and 10a in that, instead of the frame 22, which has the sole task of connecting operating unit BE and infusion unit IE to each other, a support element 24 is now provided which, on the one hand, forms a corresponding rubber- elastic frame 22 for connecting the infusion unit IE and operating unit BE and, on the other hand, can carry a belt clip 25 with which the device as a whole can be carried on a belt . To safely avoid damage to the infusion unit IE caused by rubbing against the belt, and to ensure a secure hold of the device by means of defined rubbing on the belt, the frame 22 here, in contrast to the preceding illustrative embodiment, has a rear wall 26 that is likewise made from a rubber- elastic material .
Figures 12 and 12a show yet another device according to the invention, in a plan view (Fig. 12) and in longitudinal section (Fig. 12a), and specifically during joining or separating of the infusion unit IE and the operating unit BE. As will be seen, the operating unit BE in the present case is made up of two housing parts 27, 28, which are connected to each other via guide rods 29 in such a way that they can be pulled apart along these guide rods 29 or, starting from the pulled-apart state shown here, can be pushed together in the direction Y. As will be seen in particular from Fig. 12a, the two housing parts 27, 28 form a receiving aperture for the infusion unit IE, and their boundary walls 31, 32 oriented in or counter to the direction Y form the matching contour for the outer contour of the infusion unit IE and, when the two housing parts 27, 28 are pushed together (not shown) , engage in such a way that the infusion unit IE is held with a form fit in the operating unit BE. In the pulled-apart situation shown in Figures 12 and 12a, by contrast, this receiving aperture is widened in such a way that the infusion unit IE can be removed from it. If, starting from the situation shown here, the smaller housing part 28 is pushed in the direction Y towards the larger housing part 27, until it abuts the latter, the infusion unit IE arranged in the receiving aperture is surrounded by the boundary walls 31, 32 and thus secured with a form fit. At the same time, the guide rods 29 engage with locking means (not shown) , such that the housing parts 27, 28 are safely prevented from being accidentally pulled apart again. If the infusion unit IE is to be separated again from the operating unit BE, the two release buttons 30 have to be pressed and, at the same time, the two housing parts 27, 28 have to be pulled apart until the receiving aperture formed by them is widened in such a way that the infusion unit IE can be removed.

Claims

1. Device for automated delivery of a liquid medicament, comprising an infusion unit (IE) for receiving a medicament reservoir or which contains a medicament reservoir and which has a medicament- conveying device for conveying the liquid medicament out of the medicament reservoir to be received or the contained medicament reservoir, and an operating unit (BE) for operating the device, wherein the infusion unit (IE) and the operating unit (BE) having separate housings and mutually adapted coupling means (1, 2, 3, 4, I1 8, 9, 11, 12, 13, 14, 15, 17, 18, 20, 21, 22, 23, 24, 27) with which they can alternatively be joined .. together, to form a mechanically coherent overall unit, or can be separated from each other, in both cases particularly without using tools.
2. Device according to Claim 1, characterized in that the device is designed in such a way that the device can be operated via the operating unit (BE) both in the assembled state and also in the separated state of infusion unit (IE) and operating unit (BE) .
3. Device according to one of the preceding claims, characterized in that the coupling means (1, 2, 3, 4, 7, 8, 9, 11, 12, 13, 14, 15, 17) are designed on the infusion unit (IE) and on the operating unit (BE) such that they cannot be removed without using tools.
4. Device according to one of Claims 1 to 3, characterized in that the coupling means (18, 20, 21, 22, 23, 24, 27) are formed, at least on one of the two units (IE, BE) , by one or more component parts that can be removed without using tools or can be exchanged without using tools.
5. Device according to Claim 4, characterized in that the coupling means of the infusion unit (IE) are formed by a component part that can be exchanged without using tools, and in particular in that this component part (24) additionally has means
(25) for securing it to the body of a patient or for coupling it to a support device or to an item of clothing on the body of a patient, in particular a suspension loop, an adhesive surface for fixing to the skin, a belt clip (25) or a passage for a belt.
6. Device according to one of the preceding claims, characterized in that the coupling means comprise safety means (5, 6, 12, 21) with which the two units (IE, BE) , in the correctly assembled state, can be secured against accidental separation. ►,
7. Device according to Claim 6, characterized in that, in order to cancel the safety effect, the safety means (5, 6, 12, 21) require a manoeuvre that is different than the manoeuvre required for separating the two units (IE, BE) .
8. Device according to one of the preceding claims, characterized in that the coupling means (4, 7, 11, 15) are designed in such a way that infusion unit (IE) and operating unit (BE) can be joined together by moving them relative to each other along rigid guides (4, 7, 11, 29), in particular by pushing them together along linear guides (4, 11, 29) or by a bayonet catch (7) formed by the two units (IE, BE) .
9. Device according to one of the preceding claims, characterized in that the coupling means are designed in such a way that infusion unit (IE) and operating unit (BE) are joined together by expansion of one or more rubber-elastic shaped elements (22, 27) which, in the assembled state, form an elastically pretensioned form fit with associated rigid shaped elements, in particular by enclosure of or engagement in contours .
10. Device according to one of the preceding claims, characterized in that the coupling means are designed in such a way that infusion unit (IE) and operating unit (BE) are joined together by locking of catch elements, in particular of press-buttons (14) .
11. Device according to one of the preceding claims, characterized in that the coupling means are designed in such a way that infusion unit (IE) and operating unit (BE) are joined together with , a force fit, in particular by clamping, adhesive bonding or magnetic force, or by a velcro-type pairing (3) .
12. Device according to one of the preceding claims, characterized in that the operating unit (BE) and the infusion unit (IE) in the separated state can communicate with each other in a first operating mode via a wireless connection, in particular via an infrared interface or a radio connection, and have means which, when the units are correctly assembled to form a mechanically coherent overall unit, automatically activate a second operating mode which differs from the first operating mode in that less energy is used up for the same communication.
13. Device according to Claim 12, characterized in that the operating unit and the infusion unit in the first operating mode can communicate with each other via a radio connection with a first transmitting power and, in the second operating mode, communicate with each other via a radio connection with a second transmitting power that is less than the first transmitting power.
14. Device according to Claim 12, characterized in that the operating unit and the infusion unit in the first operating mode can communicate with each other via a radio connection and, in the second operating mode, can communicate with each other via another type of connection, in particular via an infrared interface formed between them or via an electrical connection formed between them, in particular electrical contacts.
15. Set comprising a device according to one of the preceding claims and a measurement module, in particular a blood sugar measurement module, wherein the operating unit (BE) of the device and the measurement module have mutually adapted coupling means with which they can alternately be joined together, to form a mechanically coherent overall unit, or can be separated from each other, in both cases particularly without using tools, and wherein the measurement module can be operated by means of the operating unit (BE) at least when the operating unit (BE) is coupled thereto.
PCT/CH2007/000540 2006-12-28 2007-11-01 Device for automated delivery of a liquid medicament WO2008080237A1 (en)

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