Injection device.

p0001The invention relates to an injection device of the in the preamble of patent claim 1 is known.

p0002use diabetics for insulin delivery syringes or injection devices with controlled drug delivery. The injection devices are divided into two types: the infusion pump, in which the patient carries the dispenser in his clothes and the dispenser includes a continuously operating pump (continuous application of insulin), insulin promotes through a tube to a needle which in the patient's body is introduced, and a so-called Pen (discontinuous application of insulin). The insulin pump is due to the necessary metabolic control only for a very small proportion of people with diabetes into account. The constant wearing of a pump is annoying and is rejected by many patients. The pen is an injection device that is about the size and shape of a pen and is expressed by the fixed to the front housing end cannula in by manually pressing a button or rotary member part of the contents, the vial contained in the pen housing. The patient performs the puncture by the cannula of the pen, and then pressed the button for injection. It reaches a pre-settable amount of insulin in the body. In many patients, the exact dose adjustment of bolus is a big problem.

p0003The invention has for its object to provide an injection device that specified in the preamble of claim 1 is known, allows the timely injections precisely defined bolus amounts easily and without the risk of human error, but does not require the constant wearing of an infusion system to the body.

p0004This object is inventively with the features specified in the characterizing portion of claim 1.

p0005The injection device of the invention combines the advantages of computer-controlled insulin pump with those of pen-injector devices. The injection including puncture and of release of the medication itself is performed manually by the patient, whereby the wear an infusion system eliminates the body. On the other hand, the timing of the bolus and bolus amounts are monitored and controlled by the microprocessor. At the predetermined times, the microprocessor generates audible alarm signals. The patient then puts the needle on, guides them to the injection site and the injection is carried out by actuation of the actuating member, which is preferably designed as a pushbutton. The time course of injection and the bolus are controlled by the microprocessor. On a display provided on the housing, the fact can be shown that the injection is just done and not yet completed. After injection, the patient pulls the needle back out. The needle can then be covered with a protective cap or retracted into the housing and the device can be stored until the next injection or placed in clothes.

p0006In the injection device according to the invention no infusion takes place, but the injections are performed at time intervals by the patient. The injection process itself is monitored and controlled by the microprocessor.

p0007according to claim 2 it is provided that after the injection end, an acoustic signal is generated. The patient is thus a clear indication as to when he can pull out the needle.

p0008Preferably, the injection device according to claim 3 is programmable by a programming device. About This programmer has the doctor who is entering the injection times and the associated boluses. The microprocessor includes a timer to detect the injection times and to generate the alarm signal. The display information on the remaining battery power and the amount of the ampoule remaining drug supply may be further specified.

p0009With the features of claim 4, the device for different types of vials may be used. For each type ampoules A special interchangeable insert is provided which closes the receiving space for the ampoule. This change insert bears a coding which is recognized by a housing-side sensor. The microprocessor is communicated information about the type of change insert and thus on the corresponding vials type. The microprocessor can then feed the intervals at which the piston of the ampoule is advanced in the individual bolus doses vary according to the ampoule type and thus express the preset bolus at each bolus.

p0010A further possibility is to provide on the housing an input device through which the patient or the doctor can adjust the dosage of medication necessary. The adjusted data can be recalled at a keystroke.

p0011The injection device of the invention is particularly suitable for insulin dosage in diabetics, but it is also suitable, such as heparin, papaverine or for patient-controlled pain therapy for administration of other drugs. If the patient can adjust the dose on the device itself, a dose limit should the physician can be programmed.

p0012In the following an embodiment of the invention will be explained in more detail with reference to the drawings.

p0013Show it: <ul><li>FIG. 1 is a view of the injection device and</li><li>Fig. 2 is a view of the open housing of the injection device.</li></ul>

p0014The injection device has a flat housing 10 which has approximately the surface dimensions of a plug-in card and can be easily carried in a jacket pocket. Outside of the housing an LCD display 11 and a viewing window 12 are provided. Through the viewing window 12, the ampule 13 is visible, which contains the drug and which space is closed by the piston 14 which is also visible. Based on the position of the piston 14, the amount of which are still in the ampule 13 drug are detected.

p0015On the housing 10, the actuator 15 is also mounted in the form of a push button. This actuating element 15 is housed in a recess 16 of the housing so that it can not be accidentally actuated. In addition to the actuating element 15, a connector 17 is arranged for connecting an external programming device.

p0016Inside the housing 10 is the pump 18 which is composed of the electric motor 19, the pinion 20 driven by the electric motor and driven by the pinion rack 20 21st The front end of the rack 21 pushes against the back of the piston 14 and pushes this piston in the ampoule 13 for expressing the drug before.

p0017Further, the microprocessor MP and the battery B are accommodated in the housing 10th In addition, the housing includes an acoustic signal generator 23rd

p0018The receiving space 24 for the exchangeable cartridge 13 is closed at one end face of the housing 10 with a screwed-change insert 25th This change adapter has the form of a cap which is matched to the type of the respective vial. 13 The interchangeable insert 25 includes an opening 26, which projects through the neck of the ampoule. This ampoule neck is sealed with a septum 27 which can be pierced by the rear needle 28 of the double cannula 29th The forward needle 30 of the double needle is inserted into the patient's body. This needle 30 is covered by a needle cap 31, which is attached to the double needle 29 containing connector 32nd

p0019The interchangeable insert 25 is provided with a characteristic mark 33 that can be detected by a sensor provided on the housing 10 34th Sensor 34 tells the type of the case-mounted change insert with the microprocessor MP and this calculated taking into account the characteristics of the associated ampoule 13 those way the piston 14 need to travel to inject the bolus amount foreseen.

p0020The programming of the injection time and the bolus amounts is performed by the doctor. To the injection time of the microprocessor MP causes the generation of an alarm signal by the signal transmitter 23. The patient sets the double cannula on the vial 29, with the needle 28 pierces the septum 27th After removal of the needle cap 31, the needle is guided to the injection site. The injection is carried out by actuation of the actuating element 15, which was prepared by the microprocessor. Before the alarm signal was generated, an operation of the operating member 15 has no effect. After generation of the alarm signal, the pump is in operation of the actuator 15 18 is put into operation and the generation of the alarm signal is stopped. a display which indicates that the injection runs appears at the display eleventh After the injection is completed, is effected on the display 11 another display, indicating that the injection is completed, and further, an acoustic end signal is generated.

p0021In another embodiment of the injection apparatus, the metering device is designed so that it allows an intensified insulin therapy for type I diabetes. Given an input device is provided at the diabetic can adjust your insulin dosage required and retrieve a single key press, an audible confirmation of the input and visual inspection via the display is made possible.

p0022The injection device is distinguished in particular by an ease of operation, practically can not occur in the error.