The present invention relates to a method for detecting occlusion and pulling out of a tubing designed for the administration, by enteral pathway, of physiological liquids, as well as the apparatus designed for the implementation of the aforementioned method.
Equipment for administration, via enteral pathway, of physiological liquids, is known, this equipment being of the type including:
a) a pump, particularly the linear or rotary peristaltic type;
b) a tubing designed for the administration of the aforesaid liquids;
c) an occlusion detection device, comprised:
d) a computer programmed to measure the intensity the electromagnetic wave received at the aforementioned receiver in order to detect the presence of the aforementioned fluid in the aforementioned detection zone when the intensity of the electromagnetic wave reaches a predefined threshold and trigger, in the latter case, an alarm.
Such devices are essentially described in patents FR2945475 and GB6183437.
They all present principal disadvantages related to:
a) the detection of occlusion after the fluid enters the detection zone after a first occlusion: in fact, the characteristics of radiation received at the means of detection are disrupted since the sensing zone was moistened by the fluid, causing a change in surface tension due to traces that can stagnate in front of the means of detection, requiring the changing of the tube at each occlusion, which is not practical;
b) the pulling out of the tri-route tubular structure as well as the second part of the administration tubing, which has the effect of rendering the pump inoperable;
c) the lack of adjustment means, other than to move the receiver and emitter assembly, to vary the threshold for triggering the alarm.
The invention is directed toward developing a method and realizing a device for its implementation that eliminates the disadvantages mentioned above.
To accomplish this, the method according to the invention is essentially characterized in that it comprises:
To accomplish this, the device designed for the implementation of the aforementioned method is characterized essentially in that it includes
In the absence of occlusion, the fluid pressure is such that it passes through the tubing without entering the detection zone.
In case of occlusion of the tubing, for example if the patient pliers or twists it or coughs strongly but in this case there is no mechanical occlusion but temporary reflux during the fit of coughing or if the probe is clamped or blocked, the pressure will increase within the tubing, and in response to this increased pressure, the fluid will enter the detection zone. When the meniscus of the liquid passes, for example, the axis of the detection threshold, the electromagnetic receiver will record a change of the received wave enabling the detection of the occlusion.
The detection zone is in this case substantially transparent to the aforementioned electromagnetic radiation, the aforementioned fluid being substantially opaque to the aforementioned radiation, so that the occlusion detection can be carried out by measuring the intensity at the aforementioned receiver.
Preferably, the aforementioned means of detection defines a detection axis, the aforementioned detection zone traversing the aforementioned detection axis. In this way, the fluid can be detected when it crosses the detection axis.
The aforementioned detection zone can be arranged along a direction substantially perpendicular to the flow direction of the aforementioned fluid between the aforementioned fluid inlet zone and the aforementioned fluid outlet zone. In this way, the detecting zone can easily be positioned along a detection axis at the means of connection. To ensure that the measures of radiation intensity can be accurate even if the detection zone has already been crossed by fluid, the method can also include a calibration step of measuring the intensity of the aforementioned electromagnetic radiation received at the aforementioned receiver so as to define a calibration value of the aforementioned intensity, the aforementioned predefined threshold depending on the aforementioned calibration value of the aforementioned intensity.
In normal operation, the pressure in the air stopper is stronger than the pressure inside the fluid inlet and outlet zones near the occlusion detection zone and the meniscus fluid does not reach the detection axis. The electromagnetic radiation emitted by the emitter is received by the receiver after crossing the detection zone containing the air.
In case of occlusion of the downstream section of the tubing, the pressure at the detection zone increases and the meniscus of fluid enters into the aforementioned zone beyond the detection axis by compressing the air situated in it. In this case, the radiation received by the receiver is changed.
The emitter and receiver are, for example, coupled to a computer, possibly integrated with the pump, which calculates the radiation intensity received by the receiver by processing the received signal.
The computer is programmed to then emit an alarm in case of change of radiation received at the receiver.
It will be noted that the programming of the computer depends on the characteristics of the fluid distributed and on the type of detection used. According to a mode of implementation, for example, nutrients that are opaque to the chosen electromagnetic radiation are distributed and a transceiver-receiver pair adapted to emit and detect the aforementioned radiation is used. In this case, when the meniscus of fluid penetrates to the detection axis of the detection zone, the signal emitted by the emitter is blocked by the nutrients and is no longer received by the receiver. The computer then detects this change of the received signal and triggers the alarm.
The characteristics and advantages of the invention will appear more clearly upon reading the following detailed description of a preferred mode of implementing it given by way of non-limiting example and represented in the attached drawings.
Of these drawings:
The apparatus represented in the figures, designed for the administration, by enteral pathway, of physiological liquids (A), particularly nutritional, medical or hybrids, essentially includes:
a) a pump (1), or a pumping system, particularly the linear or rotary peristaltic type, fixed rate or programmable;
b) an administration tubing (2, 3);
c) an occlusion detection device (4, 5, 7) comprised:
d) a computer (14) programmed to measure the intensity of the aforementioned electromagnetic wave received at the aforementioned receiver in order to detect the presence of the aforementioned fluid in the detection zone when the intensity of the electromagnetic wave reaches a predefined threshold and trigger, in the latter case, an alarm.
The self-parameterizable method of detecting occlusion and pulling out of the tubing (2, 3) comprises:
The represented apparatus also includes:
The meniscus of the liquid column in the occlusion detection zone (7), bears the reference mark (13).
The detection device including the detection zone (7), the fluid inlet zone (4), and the fluid outlet zone (5), may be connected to a tubing, or may be composed of one piece within the tubing itself.
It includes means of connecting, at the inlet and outlet zones, adapted to the tubing used and known in the medical field.
Tubing used in association with the occlusion detection device are, for example, PVC tubes, with or without phthalate, or tubes based on styrenic material of the SEBS type or silicone.
The occlusion detection device can be made of flexible or rigid material, but a rigid molded material is preferred.
The type of material used for the occlusion detection device 1 is for example a rigid polymer of the ABS type, or of the 30 Terlux type (registered trademark) designating a material of the MABS (Methylmethacrylate-Acrylonitrile-Butadiene-Styrene) type. The material used for the occlusion detection device is also chosen so that it can be glued to PVC tubings.
The person of skill in the art will also understand that the means of detection (8) and (9) can be positioned at the distribution pump (1) to achieve a compact device. In this case, the computer (14) may be the computer coupled to the aforementioned pump. It is also possible to use means of detection separated from the pump and having a dedicated computer.
The means of detection may also serve to fix the detection zone (7) so that it does not leave the radiation zone. Various means of fixing the means of detection may also be considered in order to clamp the detection zone (7) between the emitter part (8) and the receiver part (9). In particular, the occlusion detection zone (7) may have a square shape designed to fit perfectly between the forks (19) supporting the emitter (8) and receiver (9) of the electromagnetic wave and include two wings (20) adapted to being positioned in support on the aforementioned emitter and receiver in order to ensure its correct placement on the path of the aforementioned wave and a means (21) having an effect of a magnifying glass adapted to visually verify that the alarm generated by the computer (14) was caused by an occlusion, pulling out, or improper positioning of the tri-route tubing (4, 5, 7). Finally, it is noted that the invention can be used with any type of fluid traversing a flexible tubing for which an occlusion is possible.
The computer data can be stored locally to be used in real-time or deferred or be transmitted at a distance to a central treatment element. In this case, the local alarms can be inhibited.
We have described the present invention in the context of a medical use for which an occlusion may have very negative consequences, but it is understood that the present invention depends neither on the fluid circulated in the flexible tubing, nor the type of detection used.
The person of skill in the art is indeed capable of adapting the means of detection depending on the circulated fluid and will be able to choose the emitters and the receivers throughout the electromagnetic spectrum, depending on the fluid and constraints of field of application.
Number | Date | Country | Kind |
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0511610 | Nov 2005 | FR | national |
0609671 | Nov 2006 | FR | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/FR2006/002488 | 11/7/2006 | WO | 00 | 10/6/2008 |