Device for the intermittent pulsatory application of fluid medicaments

A device for the intermittent pulsatory application of fluid medicaments, particular for the application of LH-RH for initiating ovulation in women having hypothalamic and hyperprolactinamic amenorrhea. Said device has a reservoir for the medicament and a hose connected to said reservoir for delivering said medicament to a patient, which reservoir and which hose are a prefabricated unit which can be inserted into the device and removed when the content of the reservoir is exhausted. Furthermore, said device has a roller-type pump acting onto said hose when it is stretched onto the needle-like rollers of said roller-type pump, and a D.C. motor for driving said pump and further control means for controlling said motor, said control means having a timer for pulse and pause times so that the motor is energized only for short periods not longer than several minutes while it is between each two of such running periods stopped for more than one hour. At least one battery is provided as energy source for the D.C. motor.

FIELD OF THE INVENTION 
The invention relates to a device for the intermittent pulsatory 
application of fluid medicaments, particularly for the application of 
LH-RH for initiating ovulation in women having hypothalamic and 
hyperprolactinamic amenorrhea. 
BACKGROUND OF THE INVENTION 
In patients having hypothalamic and hyperprolactinamic amenorrhea the best 
treatment results are obtained when the pulsation of the natural secretion 
of LH-RH is simulated at intervals of 90 minutes between the individual 
doses of the medicament to initiate ovulation. 
It is known to feed metered quantities of fluid and/or gaseous medicaments 
by means of devices which are driven by electric motors and which are 
provided with means for interchangeable programmes. A mechanically 
controlled device for continuous infusion of medicaments is disclosed in 
Austrian Pat. No. 210 558. Furthermore, German Auslegeschrift No. 1 491 
747 discloses an injection device for single injection of a roentgen 
contrast agent, wherein the injected quantity, the rate and, if required, 
a time delay can be controlled by means of an electrical programme 
transmitter. 
For performing diabetes therapy an application device is known from German 
Auslegeschrift No. 2 451 424 which comprises a programmable control of an 
electric motor for actuating a syringe over a longer time period. Another 
infusion device for diabetes therapy described in German 
Offenlegungsschrift No. 2 758 368 is provided with an external programming 
device, an electrical control means and a micro-metering unit. These two 
known devices operate with a long-term programme and have, if required, 
infusion rate switches. 
Furthermore, portable infusion devices for the infusion of fluids are known 
which comprise a removable reservoir for the fluid and a roller-type pump 
as feeding and metering unit for feeding the infusion fluid from the 
reservoir to the discharge opening of a catheter (compare German 
Offenlegungsschriften DE-OS Nos. 29 20 975, 26 52 026 and 26 51 962). 
These known devices are for instance very small and have such low weight 
that they are implantable or, alternatively, can be carried on the 
patient's body without hindering the patient. Since they are to be used 
for diabetes therapy, the quantity of fluid infused is programmable in 
different rates and is programmable in cycles of days, the flow rates 
being in the order of magnitude of microliters per hour (10.sup.-6 l/h). 
Also, switching means for monitoring and/or connecting the volume of fluid 
fed from the roller-type pump to the discharge end of the catheter are 
provided. However, exchanging the reservoir is complicated, especially 
because it is difficult to position that part of the catheter or hose 
which cooperates with the roller-type pump between the head portion of the 
pump and a fixed jaw. Therefore, these known infusion devices are in the 
praxis not suitable for the intermittent pulsatory application of fluid 
medicaments, especially of fluid LH-RH medicaments. 
OBJECT OF THE INVENTION 
The object of the invention is to provide a device for the intermittent 
application of fluid medicaments which feeds the medicament and especially 
LH-RH medicament impulses of predetermine intervals by means of an 
electrically driven roller-type pump from a removable reservoir through a 
discharge catheter for instance into the vein of a patient's forearm. 
Preferably, the reservoir should be removable and insertable in simple and 
quick manner. 
DETAILS OF THE INVENTION 
The device of the present invention comprises a prefabricated reservoir of 
certain dimensions having a flexible hose for discharging the fluid 
medicament from said reservoir, wherein the control means for the motor 
driving the roller-type pump has a timer for impulse and pause times. The 
motor is a D.C. motor, and at least one battery is provided as energy 
source for said motor. The timer for the impulse and pause times comprises 
preferably of a timing generator, a frequency divider and a driver stage 
which are connected in series. 
By means of such control the drive of the D.C. motor is adjusted to pause 
times in the order of hours and to running times in the order of minutes, 
so that for instance each ninety minutes a single dose of the medicament 
can be applicated to the patient. By means of a special switching contact 
the drive motor can be energized at every desired time arbitrarily, while 
the control means can be set to zero by a reset button. 
In this system the operation cycle for the impulse sequence cannot be 
varied. It is sufficient that the treatment can be extented over various 
periods of time. 
It is a certain feature of the present invention that the hose for feeding 
the fluid medicament is provided between the reservoir and the discharge 
end in a predetermined distance with two stretching elements like two 
collars or two sockets, the portion between these two stretching elements 
being that portion of the hose which is passing the head portion of said 
roller-type pump. The two stretching elements can be positioned behind 
openings or the fixed wall so that the flexible hose or flexible catheter 
can be stretched over said head portion so that the needle-like rollers of 
said head portion act onto the hose as pumping means when the pump is 
operated and its head portion rotated around its axis. Therefore, no fixed 
jaw for cooperating with the head portion of the roller-type pump is 
necessary as in the known devices of this kind so that the flexible hose 
or flexible catheter is easily and quickly to be inserted and can also be 
removed easily and quickly. 
The advantages obtained by the invention reside in the fact that the 
quantity of medicament, particularly the LH-PH dissolved in a carrier or 
vehicle, prescribed by the physician can be administered ambulantly to a 
patient in the rhythm recognised to be natural. The device is portable on 
the patient's body and can be used repeatedly because the medicament is 
provided in a removeable closed container-hose system so that there are no 
medical objections with respect to the sterility of the medicament during 
administration.

The device is illustrated in FIG. 1 in an enlarged scale to clearly show 
the details thereof while it is illustrated in FIG. 2 smaller than in its 
actual size. 
In a block-like frame 1 a roller-type pump 16, an electronic controlling 
means 7 for controlling the roller-type pump 16 and electric batteries for 
feeding D.C. as energy source for driving the roller-type pump 16 are 
provided. The block-like frame 1 is inserted into the lower portion 15 of 
a box-like housing 17, the cover portion 18 of said housing being 
removable so that the upper portion of the block-like frame 1 can be 
exposed. 
The roller-type pump 16 has a D.C. driven motor 2 with a driven shaft 3 on 
which a head portion 19 is fixed so that it is rotated with shaft 3. 
Parallel to the axis of head portion 19 and shaft 3 are arranged within 
head portion 19 needle-like rollers 20 which extend between a disk 21 and 
a cover disk 22 so that these rollers 20 are provided in a guiding slot 
23. 
In a recess 24 of the block-like frame 1 is inserted a removable flexible 
reservoir 11 of standardized size (i.e. a size available in the trade) to 
which as discharging means a flexible hose 4 is connected, which hose 
extends through the slot 23 of the head portion 9 of the roller-type pump 
16. At the discharge end of hose 4 a catheter 14 with a connection piece 
13 is provided. Hose 4 extends through a hose-like elastic sleeve 25 which 
is shown in FIG. 1 only partly. On the outer surface of sleeve 25 are 
fixed in a predetermined mutual distance to nipple-like collars 5 and 6. 
These collars 5 and 6 are positioned behind an upstanding wall 26 of frame 
1, which wall is provided at its opposing sides with lateral horizontal 
slots 27 into which the elastic extensible hose 4 and sleeve 25 are 
inserted so that their portion between the collars 5 and 6 is laid around 
the head portion 19 of the roller-type pump 16 and is stretched against 
the needle-like rollers 20. Therefore, in operation the individual rollers 
20 cooperate with the stretched hose 4 as pumping means. 
The catheter 14 which is the one end of hose 4, is clamped into a groove 28 
which is provided in the front side of frame 1 so that it cannot be 
displaced if not desired. On the other hand, the groove 28 is wide enough 
to avoid that the lumen of the inserted catheter 14 is reduced. 
Even though the hose-like sleeve 25 is shown in FIG. 1 only partly it is to 
be understood that this sleeve can extend nearly over the entire length of 
hose 4 so that it effectively protects the very fine hose 4 against 
damages. 
Motor 2 is a D.C. motor which is energized by the batteries 10 and 
controlled by an electronic control means 7 which is a control circuit. By 
means of a press button switch 8 motor 2 can be energized independent of 
the programme of control means 7 at any time when desired. By actuating a 
reset button 9 the electronic control means 7 can at any time be set to 
zero so that the programme sequence starts again from the beginning. 
A contact slide 12 cooperates with the upper ends of four batteries 10 
under operational conditions. This tongue-like contact slide 12 is made 
preferably of spring steel. If it is removed, the circuit is interrupted 
so that no electric current is delivered from the batteries and the 
batteries are not exhausted unnecessarily. 
In FIG. 2 is shown that the device is attached to the outer side of a belt 
29 so that it is easily portable on the body of a patient. 
The electronic control means 7 comprises, as shown in FIG. 3, a timer 30 
which measures pause or interruption times in hours and which can be set 
for interruption time between 1 to 99 hours. Furthermore, the timer 30 
measures impulse times and thus also infusion times, which times can be 
set between one to nine minutes. The timer 30 comprises of a timing 
generator 31, a frequency divider 32 and a driver stage 33 which are 
connected in series and serve as the timing unit so that the electric 
current flows from the batteries 10 through this timing unit to motor 2 
for driving the roller-type pump 16. 
The device operates as follows: 
First of all, a reservoir 11 which contains a fluid medicament is inserted 
into the recess 24, and hose 4 is laid around the head portion of the 
roller-type pump 16 and is stretched against this head portion. Then, 
reset button 9 is pressed to set the electronic control means 7 to zero. 
To test the function of the roller-type pump 16 the press button switch 8 
is now actuated. Thus, motor 2 is switched on and runs as long as press 
button switch 8 is pressed down. By the rotation of the driven shaft 3 of 
motor 2 within this impulse time the needle-like rollers 20 circulate so 
that the fluid within the stretched part of hose 4 is fed into catheter 14 
and to the connection piece 13 where it is discharged for instance into 
the vein in one forearm of the patient. 
Reservoir 11, hose 4 and catheter 14 with its connection piece 13 are a 
prefabricated sterile disposable unit of predetermined standardized size 
which is disposed of or discarded when the medicament in reservoir 11 is 
exhausted. Those parts of this unit which come into contact with the 
medicament are made of polyethylene while hose 4 is preferably made of 
silicon. This sterile unit is supplied in a sterile form to the physician 
who inserts it to the device and starts operation of the device to 
administer the medicament to the patient. 
The housing 17 is for instance a rectangular box with a base area of 
100.times.20 mm and a height of 50 mm. Therefore, it is easily portable by 
means of a belt 29 on a patient's body. 
The timer 30 of the electronic control means 7 measures pause times of the 
device in hours which are set for instance for one and a half hours, and 
also measures the pulse times which are set for example to one minute. In 
this operational cycle the control means 7 controls the operation of motor 
2 during the relatively short pulse times of for instance one minute while 
between two of those pulse times the operation of the motor is interrupted 
for long periods of for instance one and a half hours.