Method of injection controlled by an infusion pump

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

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604 65, 604131, 604151, 604154, 128DIG1, 128DIG12, A61M 500, A61M 5172

Patent

active

056954646

DESCRIPTION:

BRIEF SUMMARY
TECHNICAL FIELD

The present invention involves a procedure for the controlled injection of liquid in a tube used in a system of the type comprising a source of liquid to be injected connected by way of an upstream part of the tube to a pump which acts by means of pressure exerted on the tube so as to inject the liquid deriving from the source of the liquid towards a downstream part of the tube, a rotary motor under continuous current to actuate the pump and obtain a quantity of liquid injected as a function of the angle at which the motor rotates, and a motor control unit, with the motor transmitting to the control unit pulses, the frequency of which is proportional to the angle through which the motor rotates.


STATE OF THE TECHNIQUE

More and more human diseases are treated using the injection of a medicamentous substance into the patient's body. Thus, in the treatment of diabetes, it is necessary to carry out regular injections of insulin to the patients. Other diseases such as cancer are also treated by means of the injection of medicamentous substances. However, regular injection via needle and syringe present numerous problems, such as the regularity with which the injections must be respected, and especially the problem raised by the cutaneous damage caused by the multiple injections given.
The solution was thus for the patient to have a continuous treatment using an infusion needle permanently positioned through the entry of the catheter implanted in the patient, usually by means of an implanted chamber connected to a pump.
The improvement provided by this technique was that the patient wore the pump on his person in a pocket, or attached to a belt. The pump, actuated by an electric motor, injects, in a continuous manner, the medicamentous substance into the catheter, and thus provides the chemotherapy necessary to the patient without having to carry out continual injections via needle and syringe.
Regardless of the mechanical system used by pumps for the injection of a medicamentous substance (peristaltic, nutation, fingers, cams . . . ), a continuous injection means a fragmentation of the volume to be delivered in small quantities, injected at regular intervals. This fragmentation technique is necessary, since the volumes injected are small for generally long durations, especially when it involves ambulatory and portable systems. In order to get close to continuous functioning, the process is always the same: the pump injects into the tube connected to the infusion needle a quantity of medicamentous substance called bolus, which is always identical, for example, 25 ul or 50 ul. Only the period of fragmentation may be modified so as to obtain a treatment over a longer or shorter period.
The above method has the advantage of requiring a relatively simple motor control management. However, it has the disadvantage that pharmacokinetic results are not always adapted to the treatment. In effect, since the minimal bolus is fixed, a small volume injection (50, 100 ml) of medicamentous substance having to be given over a long duration (4 or 5 days) necessarily requires long fragmentation periods. Thus, if the treatment requires an injection of 100 ml for 5 days, the theoretical flow is 0.83 ml/h or 13.88 ul/mn. However, since the system supplies a bolus of 50 ul, a period of 3 mn 36 sec is necessary, that is, the system will deliver 50 ul every 3 mn 36 sec.
This kind of control does not provide good results from the pharmaco-kinetic point of view, since the infusion leads to a considerable fluctuation in the concentration of the product injected between two injections, as is illustrated in FIG. 1. With each injection represented on the first graphic by pulses separated in time by a fragmentation period, the concentration of the medicamentous substance injected into the patient's organism increases up to a maximal concentration, Cmax. Subsequent to this injection and until the following injection, the concentration decreases to a minimal concentration, Cmin.
In order to decrease maximally the Cmax/Cmin r

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