JPS6153068B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a drug administration device comprising a controllable infusion device and its control device, in particular a programming device which can be separated from the infusion device if necessary.

Devices of the type mentioned at the beginning include, for example, heparin,
Known for continuously injecting liquid drugs such as painkillers, insulin and other hormones. In this case, the infusion rate is constant or possibly preprogrammed over a period of time (daily infusion schedule) that is repeated periodically. Alternatively, the injection rate can be adjusted as needed by appropriate operating elements or by means of sensors to the immediate requirements. Such devices may be bedside devices or body-borne devices from which a catheter is introduced into the body. The device may also be implantable within the human body, in which case it typically requires an extracorporeal control or programming device to control and/or program the injection rate. Devices of this type are currently known from various manufacturers.

Controlled or programmed continuous infusion therapy modalities provide greater precision in drug infusion and make drug infusion more consistent with time-constant or variable drug requirements than traditional therapy modalities or oral drug administration or injections. It has the advantage of being well matched.

In some cases, however, they also have the disadvantage that, compared to conventional forms of treatment, the drug supply to the human body cannot be automatically limited to a predetermined infusion volume. This creates the risk of over-infusion, which may be dangerous for the patient. It may be dangerous for the patient, especially if the infusion rate is set too high and the necessary reduction or stop of the infusion rate is not possible due to impaired consciousness, sleep, or lack of attention. There is a risk that some over-infusion may occur.

Devices for programmed or controlled drug infusions are installed, for example, to provide continuous insulin infusions in diabetes treatment. The infusion rate can be preprogrammed over a relatively long period of time (for example, by a 24-hour program that is repeated periodically), or it can be adapted to the immediate need by the patient by actuating appropriate operating elements. Can be matched. For example, a time-limited additional rate is added at each mealtime over a time-constant basal or basic rate or a programmed basal or basic rate according to the daily scheduled infusion. . This addition rate takes into account the increased insulin requirements during carbohydrate digestion.

For example, there is a risk of overinfusion of insulin when the insulin requirement is incorrectly estimated or there is an unexpected change in the insulin requirement due to illness, mental agitation, abnormal physical activity, etc. In some cases, a hypoglycemic state leading to impaired consciousness or syncope develops. This type of hypoglycemic condition is particularly dangerous if it occurs during sleep. This is because during sleep, corrective measures (reduction or cessation of insulin infusion, glucose supply) cannot be taken or cannot be taken in a timely manner. In the worst case scenario, it can lead to irreparable brain damage or death to the patient. With conventional injections, the amount of insulin in the body is limited to the injected amount and is therefore consumed after a predetermined time, whereas with continuous infusions, the insulin supply is limited to the amount that is injected and is therefore consumed after the patient is incapacitated or faints. I can continue even if I do. Although this is a drawback of automatic infusion devices, such drawbacks are not limited to insulin infusions, but may also occur when injecting other drugs that are dangerous to inject in a similar manner.

The aim of the invention is to eliminate these drawbacks in drug administration devices of the type mentioned at the outset. In particular, when a patient is incapacitated for a certain period of time, certain safety measures are automatically taken, which allows the use of self-operating infusion devices with an extremely high degree of safety. It is necessary to do so.

This purpose is achieved according to the invention by, for example, stopping the infusion device or reducing the rate of administration (so-called This is accomplished by providing means for taking safety measures such as switching to an "emergency rate" and/or issuing an alarm.

According to the present invention, it becomes possible to prevent continued excessive infusion even in an automatic drug administration device. In that case, the above-mentioned advantages of automatic drug infusion compared to conventional administration forms can be maintained.

The idea of the invention can be implemented in practice in three advantageous embodiments:

(a) a predetermined, fixed or similarly configurable period of time (hereinafter referred to as a “grace period”) after a regularly scheduled control operation has been carried out;
Programmed injections are performed over a period of time (referred to as .). If no further control operation is performed before the grace period expires, the safety measures according to the invention are automatically taken.

(b) after the regularly scheduled control operations have been carried out, a predetermined fixedly limited infusion volume or a similarly configurable limited infusion volume (hereinafter referred to as a “limited infusion volume”) A programmed injection is performed for the specified amount (referred to as "Infusion Volume"). If no further control operations are carried out before the limiting infusion volume is reached, the safety measures according to the invention are automatically taken.

(c) A time-dependent “standby time” is preset, compatible with regularly scheduled control operations. If a scheduled control operation is performed within the waiting period, programmed injections are carried out until the next waiting period. If, on the other hand, no scheduled control operation takes place, the safety measures according to the invention are automatically taken after the waiting time has elapsed.

The embodiments (a), (b), (c) described above can also be combined in an advantageous manner.

The control operation in question according to the invention may be the same as the normally required operation, for example the operation of a call switch in the case of a call-controlled insulin infusion device. In that case no auxiliary operating elements are required. However, the control operation that is problematic according to the invention is limited, for example, in the case of devices with a constant or periodically programmed injection rate, which does not require periodic operation for rate control. , can also be carried out by means of auxiliary operating elements.

In a special embodiment of the invention, an auxiliary signal transmitter is activated simultaneously with the start of a preprogrammable waiting period, so that the patient can, for example, perform the meal and the control operations scheduled for this mealtime. You are reminded to do so. Immediately at a preprogrammed moment, for example representing the start of a waiting period for breakfast, lunch or dinner, a signal is emitted which prompts the patient to carry out a series of control operations. This control operation, particularly in the case of automatic call-controlled insulin administration, is initiated by actuating the call switch for the additional insulin infusion before the start of food intake.

In accordance with the spirit of the invention, a safety circuit is activated if a waiting period elapses without the scheduled sequence of operations being initiated despite the generation of a warning signal. Preferably, the signal emitted by the signal transmitter is different for the signal emitted at the beginning of the time limit and the signal emitted after the end of the grace period. For example, initially a single or periodic acoustic signal may be generated as a reminder to the patient, while after a grace period a continuous strong tone may be generated, possibly to alert the patient to his surroundings. Allow an alarm signal to be sent. The signal transmitter and the alarm transmitter can be constructed into one unit. In that case, the alerting signal and the alarm signal can be different by different volume, continuous frequency and/or other parameters.

Next, the present invention will be described in detail based on embodiments shown in the drawings.

Figure 1 shows an external program or control device 2.
A patient P is shown having a drug infusion device 1 and a drug infusion device 1 implanted in the abdomen. Such an infusion device is disclosed, for example, in DE-A-2920976. Of course, this type of infusion device can also be installed outside the body and connected to the patient's body via a catheter. In that case,
The control unit can be combined with the infusion device into one functional unit.

FIG. 2 shows an example of a typical scheduled injection amount for so-called controlled-call insulin infusion in the treatment of diabetes. The horizontal axis shows the time axis, and the vertical axis shows the injection rate. This planned injection amount is
Illustrated on a 24 hour period. The numeral 10 represents the constant base rate of injection. This constant base rate is, for example, the amount of international insulin units per hour (IE/h). On top of the base rate 10, additional infusion amounts 11, 12, 13 are added, for example at mealtimes. This additional infusion amount is adjusted to the carbohydrate content of the current diet. The shaded area indicates the total insulin infusion amount.

In order to inject additional doses, corresponding control actions must be carried out by the patient, which are respectively indicated by arrows in FIG. In the illustrated example, this control operation is performed at 7 o'clock, 12 o'clock, and 19 o'clock. Corresponding to the embodiment of the safety circuit, the example shown has a grace period of about 13 hours, a limited infusion of about 20 units of insulin, or waiting times from 6:00 to 8:00, from 11:00 to 13:00 and from 18:00 to 20:00. Be taken.
In the illustrated example, since the time between dinner and breakfast is long, the grace period or limited infusion amount must be selected to be relatively large. provides stricter limits throughout the day. A narrower definition of the limiting infusion is possible if only the base rate for the integration of the limiting infusion is considered. In the example of Figure 2, a limited infusion of about 13 insulin units would be appropriate in that case.

FIG. 3 schematically shows an embodiment of a safety circuit with a grace period or standby time transmitter. In normal operation, a rate transmitter 20 to which a unit 21 with operating elements is attached provides a control for controlling the infusion pump 22 on the basis of a pregiven or differently settable infusion program. A signal is generated and routed via the transfer switch to the infusion pump 22 or its associated drive unit. Associated with this basic circuit is a grace period transmitter 30 which has a counter and can be reset to zero by actuating a suitable operating element. As already mentioned, the generation of the reset pulse can be associated with a normally necessary operating process, or an auxiliary operating key, such as key 23, can be used for the generation of the reset pulse. In a simple case, the grace period transmitter 30 is set to a fixed time, for example a few hours. When a grace period has elapsed before a new reset signal appears, the output of grace period transmitter 30 activates alarm transmitter 28 on the one hand and transfer switch 24 on the other hand. The transfer switch 24 then switches the infusion pump control lead to zero rate or emergency rate. The rate is defined by circuit 25. Switching to a lower, non-hazardous emergency rate is sometimes more effective than stopping completely, for example to avoid occlusion of the infusion catheter. If necessary, the grace period transmitter 30 can be equipped with an adjustment element 33 for adjusting or programming the length of the grace period.

If the grace period transmitter 30 is associated with an auxiliary start point transmitter 32, the grace period transmitter 30 can be designed as a standby time transmitter. The time measurement is then not started on the basis of each reset signal, but only after a suitably programmed or set start pulse has been emitted. Adjustment element 3
3 is used in this embodiment for adjusting or programming the length of the wait time.

FIG. 4 schematically shows an embodiment of a safety circuit with a limited infusion volume transmitter. Element 20~
28 is the same as elements 20-28 in FIG. The grace period transmitter 30 of FIG. 3 has been replaced by a limited infusion transmitter 40. The reset pulse for the limited infusion volume transmitter 40 is generated by actuation of the call switch 21, which in this embodiment according to the invention is provided for injecting a supplemental drug infusion volume. The limited infusion volume transmitter 40 begins integrating the rate signal provided by the rate transmitter circuit 20 based on each reset signal. This integration is performed, for example, by pulse counting if the rate control is designed as a pulse frequency control. When the set infusion limit is reached before a new reset signal is generated, the output of limit infusion transmitter 40 again activates alarm transmitter 28 and transfer switch 24.
The limited infusion volume transmitter can be equipped with an auxiliary adjustment element 43 for adjusting or programming the limited infusion volume.

For pulse counting, the grace period transmitter, waiting time transmitter or limited infusion transmitter can have a conventional resettable counter. The counter can be equipped with an adjustable or programmable timing element.

FIG. 5 schematically shows an embodiment of a safety circuit with a standby time transmitter and an auxiliary alarm transmitter. The safety circuit of FIG. 5 is based on the safety circuit of FIG. 3, so that the standby time transmitter 30 has a counter that can be reset to zero by operating a suitable operating element 23. are doing. A programmable start time oscillator 32 generates a time-related start signal for the counter. Particularly for the administration of insulin in the context of diabetes treatment, the starting time is set, for example, at a normal mealtime with a certain duration. When this time has been reached, ie giving the counter a starting point for counting the set waiting time, in this embodiment the auxiliary signal transmitter 29 is activated. This signal transmitter 29 is used to alert the patient to the aforementioned actuation of the call switch (i.e. the operating element 23), for example in order to draw attention to the intake of food and in connection therewith, if appropriate. It sends out a signal that can make a significant impression on people. A signal of this type may be a short-duration acoustic signal that repeats periodically and gradually increases in volume, as is known from alarm clocks, for example. By means of such a signal, the patient is usually reminded at this time to carry out the necessary operations on the infusion device or to carry out such operations with a special operating element, for example the key 23. Now, if the waiting time has elapsed without a reset signal being received and the patient has been warned, the waiting time transmitter 30 is activated in a known manner.
On the one hand, the output of the alarm transmitter 28 causes
On the other hand, the changeover switches 24 are respectively actuated. Transfer switch 24 switches the control leads of infusion pump 22 to zero rate or emergency rate. The rate is generated by circuit 25.

The alarm transmitter 28 and the signal transmitter 29 can be combined into one construction unit. This component is then capable of supplying a discernible signal and, in particular, is configured such that an alarm signal can be generated by the alarm transmitter 28, possibly alerting those around the patient. can be designed. It is especially important when the patient is incapacitated to be able to generate an alarm signal that alerts those around the patient.

For example, a grace period transmitter or a limited infusion volume transmitter may be provided to ensure that the safety circuit responds as soon as a grace period or limited infusion volume expires before a scheduled control operation occurs. It will be appreciated that the safety circuits described above can be assembled into one functional unit. This functionality can be specifically adapted to each situation.

The operation will be described below with respect to an example in which a "standby time" depending on time is set in advance and the auxiliary operation key 23 is used (see embodiment (c) of the present invention and FIG. 3).

Patients are scheduled to eat at 7:00, 12:00 and 19:00, each with a grace period of ±30 minutes. The device according to the invention is automatically switched to the corresponding rate 11, 12, 13 (FIG. 2) at these times.

The patient is required to press key 23 at the beginning of the meal period. If the patient fails to actuate this key, for example due to fainting, the circuit 25 must switch to a lower emergency rate and the alarm transmitter 28 must issue an alarm. Alarm and emergency rates are aborted as soon as key 23 is pressed. The length of the grace period is set by the doctor using an adjustment element (short time timer) 33 to be one hour (30 minutes before and after) around a predefined meal time. Start point transmitter 32
are programmed at times 6.30, 11.30 and 18.30. The signal pulses are formed in the circuit of FIG. 3a, which shows the safety circuit of FIG. 3 in more detail. here 5
0 and 53 are flip-flops, 33 is an adjustment element (short timer for grace period), 52 is an AND circuit, and 51 is a differential element. Figures 3b and 3
Figure c shows the case where the patient presses the key 23 at the correct time (Figure 3b) and the case where the patient does not press it at the correct time (at the time of alarm transmission) as an example for the first set time (7 o'clock).
The pulse train appearing on each conductor a-g of (FIG. 3c) is shown. Alarm transmission and transfer switch 24 (this can be configured as a relay)
Switching to the emergency rate occurs when a pulse signal occurs on conductor g (FIG. 3c).

In the circuit of FIG. 4a which shows the safety circuit of FIG. 4 in more detail, 60 is a discriminator, and the call switch 2
The switching position of 1a is monitored and a pulse is emitted when it is displaced (this is done by periodically recalling the switching position, storing it in an intermediate memory, comparing it with the new position, and emitting a pulse when there is a discrepancy). . This device switches the switch 21 when the mealtime profile is called up.
a is switched, the high rate starts, and is automatically reset to the basic rate after a predetermined period of time. The changeover switch 24 remains in its initial position until the next call.

The doctor sets the basic infusion volume using the infusion volume counter. This is essentially done by adding drive pulses of a step motor (infusion pump) 22 formed by a circuit (rate transmitter) 20 (each pulse of the step motor corresponds to a predetermined infusion volume).

FIG. 4b shows a pulse train when the device is operated normally, and FIG. 4c shows a pulse train for an alarm transmission event in the earliest possible situation, such as a patient fainting in the early morning.

[Brief explanation of the drawing]

FIG. 1 is a schematic diagram of a patient equipped with a remotely programmable implantable infusion device; FIG. 2 is a schematic diagram illustrating an example of a scheduled daily dose for call-controlled insulin infusion; FIG. 3 is a schematic diagram of a patient equipped with a remotely programmable implantable infusion device; A block diagram of the first embodiment of the safety circuit, FIG. 4 is a block diagram of the second embodiment of the safety circuit in the present invention, and FIG. 5 is a block diagram of the third embodiment of the safety circuit in the present invention. Figure 3a is a detailed diagram of a part of the safety circuit in Figure 3, Figures 3b and 3c are diagrams for explaining the operation of the circuit, Figure 4a is a detailed diagram of the safety circuit in Figure 4, and Figure 4a is a detailed diagram of the safety circuit in Figure 4. 4b and 4c are diagrams for explaining the operation of the circuit. DESCRIPTION OF SYMBOLS 1... Drug infusion device, 2... Program or control device, 20... Rate transmitter, 21... Unit with operating elements, 22... Infusion pump, 23... Key, 24... Changeover switch, 25
...Circuit for generating rate, 28...Alarm transmitter, 29...Signal transmitter, 30...Grace period transmitter, 32...Start point transmitter, 33
... Adjustment element, 40 ... Limited infusion amount transmitter, 43
...Adjustment element, P...patient.

Claims (1)

[Claims] 1. Infusion device 1 including a controllable infusion pump 22
and a rate transmitter 20 that generates a control signal for the infusion pump 22, in which: (a) a changeover switch 24 is provided, the input side of which is in a first switching position, the rate transmitter 20;
In the second switching position, it is connected to the emergency rate generation circuit 25, and the output side is connected to the infusion pump 22.
(b) so that an activation signal appears on the output side of the safety circuit 30, 40 connected to the operating element 23, 21; 32 if the intended operation of the operating element 23; 21a does not take place. and the actuation signal is guided to the changeover switch 24 to change from the first changeover position to the second changeover position. 2. The safety circuit 30; 40 has a grace period transmitter 30, on the output side of which the operating element 23;
2. The device according to claim 1, wherein an activation signal appears when a predetermined period of time has elapsed without operation of step a; 32. 3. The safety circuit 30; 40 has a grace period transmitter 30, on the output side of which the operating element 23;
3. The device according to claim 1, wherein the activation signal appears when a predetermined time-dependent standby time has elapsed without any operation at step 32. 4 Safety circuit 30; 40 is limited infusion amount transmitter 40
and has an operating element 23; 21 on its output side.
The device according to any one of claims 1 to 3, characterized in that an activation signal appears when a predetermined amount of drug is injected without the operation of step 32. 5. The device according to any one of claims 1 to 4, characterized in that the activation signal of the safety circuit 30; 40 is guided to the alarm transmitter 28. 6. Device according to any one of claims 1 to 5, characterized in that the operating element 23 is a separately provided key. 7. The device according to any one of claims 1 to 5, characterized in that a functionally existing operating element 21a of the infusion device 1 is provided as the operating element. 8. Claim No. 8, characterized in that the infusion device is an insulin infusion device that operates with a constant base rate 10 and an auxiliary call program 11, 12, 13, and has a call program switch 21a as an operating element. The device according to item 7. 9. The grace period transmitter 30 has a resettable counter, which counter is connected to the operating element 23;
9. The device according to claim 2, wherein the device is configured to be reset and restarted by operating the device 21a. 10. The device according to claim 9, characterized in that the counter is a time counter. 11 The limited infusion amount transmitter 40 has a resettable counter, which counter is connected to the operating element 2.
3; The device according to any one of claims 4 to 8, characterized in that it is configured to be reset and restarted by operation 21a. 12. The device according to claim 11, wherein the counter is an infusion amount counter. 13. characterized in that the onset of the time-dependent waiting period activates the signal transmitter 29, thereby reminding the patient of the meal time and the actuation of the operating elements 23; 21a; 32 scheduled for this purpose. Claims 3 to 12
Apparatus according to any of paragraphs. 14 Signal transmitter 29 and alarm transmitter 28
14. The device according to claim 13, wherein the signals are distinguishable from each other.