The present invention relates to medical pumps, in particular to a medical pump which comprises a connection for a hose, in the interior of which a medium can be conveyed by means of the pump, and which has a seating into which a hose clamp which is separate from the pump can be received or installed without using any tool.
Further, the present invention relates to a hose clamp which can be attached to a pump according to aspects of the invention and by means of which a hose attached to the pump can be pinched off such that no medium can flow through the interior of the hose.
Finally, the present invention also relates to a system comprising a pump according to aspects of the invention and a hose clamp according to aspects of the invention.
In infusion technology, transfer systems are used for conveying medications into the body of a patient. These transfer systems achieve the transfer of medications in most cases by means of hoses or hose sets and usually have shut-off devices such as roller clamps for interrupting the delivery.
In applications with demands regarding a high dosing accuracy, infusions working solely by gravity are insufficient; this is why infusion pumps are used for administering in particular life-sustaining medications.
In an infusion pump system, precautions have to be taken to avoid—during handling a hose set attached to an infusion pump or upon opening the infusion pump for interrupting the medication delivery—any free-flow situation which is life-threatening for the patient and in which the medication is supplied to the patient in an uncontrolled manner and without any dosage particularly by gravity.
On the one hand, infusion pumps are known for instance from EP 2 716 312 A1 or US 2013/0253442 A1, comprising a pump-side safety clamp which prevents the occurrence of a free-flow situation during opening of the infusion pump even with an open roller clamp.
On the other hand, infusion systems are also known for instance from EP 2 583 716 A1 or EP 2 780 070 A1, which are equipped with a so-called set-side free-flow clamp. This clamp is directly located on the disposable item, for instance on the hose or hose set, and closes said disposable item upon opening a pump flap.
It is a disadvantage of this prior art that users rely on the function of the set-side free-flow clamp and hence regularly neglect to close the roller clamp.
In order to minimize the endangerment of patients, it is thus necessary in the light of this prior art to provide both a pump-side safety clamp and a set-side free-flow clamp.
It is thus an object of the present invention to provide a medical pump and/or a hose clamp which can improve the accustomed patient safety or ensure it with less expenditure, in particular during an infusion.
A medical pump according to aspects of the invention, in particular an infusion pump for conveying a medium, comprises a seating for a hose clamp which is separate from the pump and arranged on a hose that is flexible at least in sections. Two clamping portions of the hose clamp which are movable relative to each other can be brought into a closed and an opened relative position with respect to each other. In the closed relative position, the clamping portions pinch off the hose arranged therebetween such that no medium can flow through the interior of the hose. In the opened relative position, the clamping portions do not pinch off the hose arranged therebetween, so that a medium or medication and/or a body fluid such as blood can flow through the interior of the hose.
The pump according to aspects of the invention is distinguished in that a sensor is provided thereon, in particular in the seating for the hose clamp, said sensor detecting on the hose clamp provided in the seating at least whether their clamping portions are in the closed or the opened relative position.
This means that the sensor is capable of detecting at least two measured values, from which one measured value is unambiguously associated to the closed relative position of the clamping portions of the hose clamp received in the seating and the other measured value is unambiguously associated to the opened relative position of the clamping portions of the hose clamp received in the seating. If the hose clamp is not placed in the seating, the sensor detects the same measured value as in the opened relative position of the clamping portions of the hose clamp received in the seating. Optionally, the sensor could also be designed such that it detects an unambiguous third measured value if the hose clamp is not placed in the seating.
The seating for the hose clamp is designed such that the hose clamp or at least one of the two clamping portions can be installed on the pump without using a tool and can be removed from the pump in a destruction-free manner. In particular, the seating comprises undercuts where portions of the hose clamp can be clamped.
The sensor may be designed such that it is capable of sensing the closed and the opened relative position of two clamping portions, which can be swiveled relative to each other, of the hose clamp received in the seating. As an alternative or in addition, the sensor may also be designed such that it is capable of sensing the closed and the opened relative position of two clamping portions, which can be shifted relative to each other or which can be swiveled and shifted relative to each other, of the hose clamp received in the seating.
The sensor may be a tactile sensor which is responsive to a contact with the hose clamp or with a part of the hose clamp. As an alternative, the sensor may also make use of optical, electrical or magnetic effects in order to detect the closed relative position.
It is an advantage of the present invention that errors on the part of the set-side hose clamp or free-flow clamp can be detected prior to the occurrence of any endangerment of the patient and the user is able to react accordingly.
Optionally, errors can be detected which arise during the manufacturing of the hose clamp (e.g. warpage due to cooling) and/or arise when the hose clamp has been already put on the market (e.g. a mechanical overload due to incorrect operation).
In an advantageous way, hose clamps suitable for the pump according to aspects of the invention do not necessarily have to fulfil the requirement in terms of first-error security and the quality demands on a clamp according to aspects of the invention can be reduced to the level of an ordinary roller clamp. This allows to cut manufacturing costs, for instance by the waiver of tests in terms of complete tightness.
The hose clamp as a safety clamp takes substantially two positions during normal use: a closed position in which the hose is pinched off, and an opened position in which the hose is not pinched off. If both positions are explicitly detected by the sensor, a redundant verification logic is implemented in which the sensor always delivers a signal both during the closed state of the hose clamp and in the opened state of the hose clamp.
The medical pump may comprise an electronic data processing unit which detects the structural and/or functional integrity of the hose clamp received in the seating required for use of the hose clamp in that it compares the temporal actual course of the measurement carried out by the sensor during the transition of the clamping portions from the closed to the opened or from the opened to the closed relative position with a temporal target course of the measurement. If there are any deviations in this comparison between the actual dynamical behavior of the hose clamp and the expected dynamical behavior of the hose clamp, the data processing unit may issue an alarm signal.
The monitoring of the dynamical behavior of the clamping portions is advantageous, as it allows to detect gradually incipient damages on the hose clamp at an earlier point in time.
The medical pump may be provided with an actuator which is able to move the clamping portions of the hose clamp which is received in the seating from the closed to the opened and/or from the opened to the closed relative position. The actuator is in particular an element which can be moved by a stepper motor and which for opening the closed hose clamp penetrates between the clamping portions and thus increases the distance between the clamping portions. As an alternative, the actuator may act only on one of the clamping portions for opening a rocker-like or clothespin-like hose clamp. It would also be possible to build up the actuator of two elements, with one element serving for moving one of the clamping portions in one direction and the other element serving for moving the same clamping portion in the opposite direction.
The advantage of a controllable actuator is that the process of opening the hose clamp can always be carried out in the same way and hence damages due to an improper opening procedure can be better avoided.
In an advantageous way, the medical pump may comprise a pump flap which in a closed position covers the seating such that the hose clamp cannot be removed from the seating or cannot be inserted into the seating, and in an opened position releases the seating such that, the hose clamp can be removed from the seating or can be inserted into the seating.
Owing to the pump flap, the measurement of the relative position of the clamping portions of the hose clamp which is received in the seating carried out by the sensor can be protected against any external disturbance variables, allowing to ensure the quality of the measurement. Even any environmental factors damaging the hose clamp or the sensor can be shielded by the pump flap. Optionally, it is also possible to design the pump flap such that the state of the hose clamp is influenced by a motion of the pump flap. By way of example, it may be designed such that the hose clamp is opened upon closing the pump flap.
In an advantageous way, the actuator, in the closed position of the pump flap, can move the clamping portions of the hose clamp which is received in the seating from the closed to the opened and/or from the opened to the closed relative position. In this way, both the measurement carried out by the sensor and the opening and closing operation effected by the actuator can be shielded against detrimental disturbance variables.
The medical pump may also be designed such that the opened relative position of the clamping portions of the hose clamp which is received in the seating can be altered by the actuator such that a degree of openness of the interior of the hose and hence a volumetric flow of the medium flowing through the hose can be adjusted. The sensor according to aspects of the invention may also be designed such that it is capable of detecting several opened relative positions of the clamping portions of the hose clamp which is received in the seating, so that the sensor is able to detect the degree of openness of the interior of the hose and hence the volumetric flow of the medium flowing through the hose.
If the sensor is capable of sensing several opened relative positions of the clamping portions, the hose clamp according to aspects of the invention can not only meet the security function to a greater extent, but may also serve for metering the medium flowing through the hose. The improvement of the security function is due to the fact that the monitoring of several states which can be adopted by the hose clamp allows to more accurately determine the position of the clamping portions in the event of a malfunction. If the pump is provided with an actuator which is able to change the relative position of the clamping portions of the hose clamp, and if the sensor is capable of sensing said relative positions adjusted by the actuator, a metering by means of the hose clamp is possible and the pump may do without any valves or roller clamps otherwise necessary.
The sensor may be designed such that it detects the closed relative position of the two clamping portions by sensing the position of the first clamping portion. The seating is especially configured such that a second one of the two clamping portions can be fixed therein. This connection may be implemented by means of a clamping connection. The seating and the sensor may be positioned relative to each other such that the sensor delivers the signal for the closed relative position of the clamping portions only if the second clamping portion is connected to the seating, in particular in a predetermined, only possible way.
If the sensor is designed such that the closed relative position of the clamping portions is detected immediately by measuring the distance between the two clamping portions, the monitoring of the hose clamp can be implemented in an efficient way.
The pump may comprise a main body relative to which the pump flap can be moved. The seating may be provided on the main body or on the pump flap, and the first clamping portion may be movable by means of the pump flap.
The connection for the hose may be positioned below the pump flap, so that the pump flap has to be opened or closed for coupling and decoupling the hose. In particular, the pump flap may be formed such that the hose clamp located in the seating is closed by opening the pump flap and/or the hose clamp located in the seating is opened by closing the pump flap.
Due to providing a pump flap acting on the hose clamp, it can be ensured in an advantageous way that the hose clamp is inevitably closed if the hose is taken out from the pump or that a proper opening process of the pump and a removal of the hose are only possible if the process of closing the hose clamp has been performed without any complications.
Both the sensor and the seating may be arranged on the main body. As an alternative, it would also be possible to provide both on the pump flap. The sensor and the seating could also be distributed to the two pump parts (i.e. the sensor on the main body and the seating on the pump flap or the seating on the main body and the sensor on the pump flap).
The pump flap may be pivotally connected to the main body.
The sensor according to aspects of the invention may be a light sensor which is responsive to at least one of the clamping portions interrupting, changing and/or deflecting a light beam emitted from a light source arranged on the pump.
In case a light sensor or an optical sensor is used for the sensor, it is possible in an advantageous way to increase the number of the states of the hose clamp which are to be measured by refining the graduation of the value range which can be measured by the sensor. If a measurable wavelength range or illumination intensity range is divided in more than two parts, for instance, it is not only possible to detect the closed and the opened relative position of the clamping portions received in the seating, but also further intermediate positions can be detected.
As described above, a tactile sensor may be used for the sensor. The tactile, sensor is in particular responsive to the contact with the first clamping portion or with the protrusion on the first clamping portion.
If the sensor is implemented as a tactile sensor, the sensor's counterpart arranged on the hose clamp and detected by the sensor can be designed so as to be robust without having special optical characteristics or any other material properties.
A hose clamp according to aspects of the invention comprises two clamping portions which can be moved relative to each other and can be brought into a closed relative position with respect to each other in which the hose arranged between the clamping portions is pinched off such that no medium can flow through the interior of the hose, and which can be moved to an opened relative position with respect to each other in which the hose positioned between the clamping portions is not pinched off so that a medium can flow through the interior of the hose. At least one of the clamping portions can be connected to a medical pump according to aspects of the invention. A first one of the two clamping portions comprises a portion which covers an aperture provided on the second one of the clamping portions in the closed relative position of the clamping portions and at least partially releases said aperture or does not cover it in the opened relative position of the clamping portions.
In particular, the aperture is an opening or recess which is provided in the second clamping portion and through which a light beam can radiate in a first direction in the opened relative position of the clamping portions of the hose clamp which is received in a seating of a medical pump according to aspects of the invention and which in the closed relative position of the clamping portions of the hose clamp which is received in the seating is concealed by the first clamping portion such that at least in the first direction a light beam cannot radiate through the aperture or only in part.
The advantage of the hose clamp provided with an aperture is that its opening state can be determined by means of a light sensor in a contact-free manner.
As an alternative, a hose clamp according to aspects of the invention comprises two clamping portions which can be moved relative to each other and from which at least one is designed in such a manner that it can be connected to a medical pump according to the application without using any tool and in particular can be detached from a medical pump according to the application without using any tool. A latching element is provided on the hose clamp, by means of which the clamping portions of the hose clamp can be held in a closed relative position or the hose clamp can be held in a closed position. In their closed relative position, the clamping portions can pinch off a flexible hose, which is arranged between them and is flexible at least in sections, such that no medium can flow through the interior of the hose.
In addition to the latching element, a protrusion is provided on the hose clamp on a first one of the two clamping portions, said protrusion in the closed relative position protruding in such a manner toward the second of the two clamping portions that it extends up to a rear side of the second clamping portion facing away from the first clamping portion. If the hose clamp according to aspects of the invention is connected to the pump, the closed relative position of the clamping portions can be detected by means of a sensor arranged on the rear side of the second clamping portion on the medical pump.
The latching element may comprise parts from which one part is provided on the first clamping portion and the other part is provided on the second clamping portion. In the closed relative position of the clamping portions, the two parts of the latching element cooperate in particular in a form-fitting manner and thus prevent a relative movement of the two clamping portions.
If the hose clamp according to aspects of the invention is attached to a hose which is connected to a medical pump, the construction of the hose clamp according to aspects of the invention allows a simple monitoring of the state of the hose clamp. If the hose clamp is formed such that the second clamping portion is the one that can be connected to the seating of the pump, the sensor may be arranged in or on the seating of the pump, which allows an easy installation of the hose clamp in the seating.
The hose clamp may be designed such that the protrusion extends in the closed relative position through a continuous recess or a hole in the second clamping portion.
By providing a continuous recess in the second clamping portion, which is penetrated by the protrusion of the first clamping portion in the closed relative position, any warpage occurred during manufacturing of the hose clamp can be detected in an easier and more reliable way.
The clamping portions of the hose clamp according to aspects of the invention may be pivotally connected to each other by means of a hinge. As described above, the latching element may comprise two parts, with one of said parts being arranged on the first clamping portion and the second part being arranged on the second clamping portion. The parts of the latching element may each be integrally formed with the corresponding clamping portion. The parts of the latching element may each be arranged on the side of each of the two clamping portions facing away from the hinge. A hose seating, in particular a chute-shaped or groove-shaped hose seating, may be provided between the side of each clamping portion facing the latching element and facing the hinge, said hose seating having a surface where the hose to be pinched off may rest at least in sections. If the recess and the protrusion are each arranged between the hinge and the respective hose seating of the corresponding clamping element, the protrusion and the latching means allow to monitor the integrity of the hinge.
If the hose is placed in the hose seatings of the hose clamp and the clamping portions are moved toward each other to such an extent that the parts of the latching elements lock in place in each other, a user can perceive said locking process owing to the resulting locking noise. If the sensor of the medical pump determines that the protrusion does not enter the recess so far as it was to be expected in the closed relative position of the clamping portions, a production error of the hinge or a damage on the hinge can be diagnosed.
A medical system according to aspects of the invention comprises a medical pump according to at least one of the aspects described above and a hose clamp according to at least one of the aspects described above.
The advantage of the system according to aspects of the invention is that —following the metered administering of a medium by means of the pump to a patient and having shut down the pump—it can be ensured without any great effort that the hose clamp is closed and that there is no free-flow situation.
The invention is best understood from the following detailed description when read in connection with the accompanying drawings. Included in the drawings are the following figures:
A first end of the first clamping portion 4 is provided with a hinge 8 by means of which the first clamping portion is pivotally connected to a first end of the second clamping portion 6.
The two clamping portions 4 and 6 may be made from a thermoplastic polymer and the hinge 8 as a film hinge may be made in one piece with the two clamping portions 4 and 6.
As an alternative, the hinge 8 could also be realized by means of protrusions which are provided on the first ends of the clamping portions 4 and 6 and engage each other in the manner of pinnacles, or implemented by means of a separately manufactured, attached hinge.
At a second end opposite to its first end, the first clamping portion 4 comprises a first spring clamp 10. At a second end opposite to its first end, the second clamping portion 6 comprises a first spring clamp seating 12. The first spring clamp 10 and the first spring clamp seating 12 together form a latching element 14.
The first spring clamp 10 extends from the second end of the first clamping portion 4 substantially perpendicular to the first clamping portion 4 toward the second clamping portion 6 and comprises a ramp-shaped free end. If the two clamping portions 4 and 6 are moved toward each other starting from an open position shown in
If the two second ends of the clamping portions 4 and 6 are connected to each other through the positive form locking, the hose clamp 2 is in a closed position shown in
In order to release the positive form locking between the two second ends of the two clamping portions 4 and 6, the first spring clamp 10 has to be moved in the first swiveling direction, so that the undercut 16 on the first spring clamp 10 is disengaged from the first spring clamp seating 12.
The first spring clamp seating 12 is realized by means of a through-hole provided on the second end of the second clamping portion 6 and extending substantially perpendicular to the second clamping portion, comprising an edge 18 which can cooperate with the undercut 16 in a form-locking manner. At the side of the through-hole facing away from the first clamping portion 4, the rim of the through-hole is provided with an enclosure 20 which in the closed position of the hose clamp 2 shields the free end of the first spring clamp 12 from three sides and allows a lateral access to the first spring clamp 12 substantially only in the direction of the first swiveling direction.
The hinge 8 is designed such that it is tensioned in the closed position shown in
At a part of the first clamping portion 4 facing the first end of the first clamping portion 4, a feeler pin 22 is provided so as to extend substantially perpendicular to the first clamping portion 4 toward the second clamping portion 6.
At a part of the second clamping portion 6 facing the first end of the second clamping portion 6, a feeler pin seating 24 is provided so as to extend substantially perpendicular to the second clamping portion 6.
The circular cylindrical feeler pin 22 and the feeler pin seating 24 realized as a through-hole are dimensioned such that in the closed position of the hose clamp 2 the free end of the feeler pin 22 is situated at the side of the feeler pin seating 24 facing away from the first clamping portion 4, and the position of the free end of the feeler pin 22, as shown in
To be more precise, the feeler pin 22 is a protrusion in the form of a circular cylinder whose free end in the closed position of the hose clamp 2 is located within the feeler pin seating 24 in the form of a largely circular through-hole; here, a surface of the free end facing away from the first clamping portion 4 is coplanar (at least in sections) with the outer surface of the side of the second clamping portion 6 facing away from the first clamping portion 4 (see
If the hose clamp is in the open position shown in
A first, preferably chute-like hose seating 30 is provided on the first clamping portion 4 between the feeler pin 22 and the first spring clamp 10.
A second, preferably chute-like hose seating 32 is provided on the second clamping portion 6 between the feeler pin seating 24 and the first spring clamp seating 12.
The two hose seatings 30 and 32 are formed such that they are in contact at least in sections with a hose arranged between the clamping portions 4 and 6, if the clamping portions 4 and 6 are moved to the closed relative position.
As shown in
At least a second spring clamp 36 and at least a second spring clamp seating 38 are provided on the lateral borders of the second clamping portion 6.
If the hose clamp 2 is attached to a medical pump 40, the second clamping portion 6 is received in a pump-side clamping portion seating 42 whose outline is equal to the outline of the second clamping portion 6. The connection between the hose clamp 2 and the pump 40 is ensured by a form-fitting cooperation between protrusions 44 or spring clamps at the rim of the clamping portion seating 42 and the second spring clamp 36 and/or the second spring clamp seating 38.
As shown in
If a mechanical opening system of the pump flap is actuated (see step S1 in
If the tactile sensor 26 detects that the hose clamp 2 is properly closed (see step S2 in
If the tactile sensor 26 detects that the hose clamp 2 is not properly closed (see step S2 in
Said alarm signal can be realized by means of a visual indication (e.g. a flashlight) and/or a loudspeaker.
The mechanical opening system of the pump flap may be designed such that the process of opening the pump flap also results in the pump being switched off.
A hose clamp 2′ according to a second embodiment of the invention is shown in
At the end of the first clamping portion 4′ facing away from the film hinge 8′, a covering portion 48 is provided which in the closed relative position of the two clamping portions 4′ and 6′ extends toward the second clamping portion 6′.
At the end of the second clamping portion 6′ facing away from the film hinge 8′, an aperture 50 is provided which in the closed relative position of the two clamping portions 4′ and 6′ is concealed by the covering portion. In this context, “concealed” means that a light beam extending parallel to the main direction of extension of the second clamping portion 6′ goes through the aperture 50 if the hose clamp 2′ is open (see
Just like the hose clamp 2 according to the first embodiment, the hose clamp 2′ according to the second embodiment also comprises a first hose seating 30′ in the form of a chute-like recess (see
As shown in
In
Provided in the pump flap 66 is a first actuator element 56 in the form of a swiveling lever whose pivot axis extends substantially parallel to the hinge axis of the film hinge 8′. By means of the first actuator element 56, the first clamping portion 4′ can be swiveled from an opened relative position toward the second clamping portion 6′ into a closed relative position.
Provided in the main body 64 is a second actuator element 58 in the form of a linearly displaceable bolt whose direction of displacement extends transverse to the first spring clamp 10′. In the closed relative position of the two clamping portions 4′ and 6′, the second actuator element 58 is capable of moving the first spring clamp 10′ such that the undercut 16′ on the first spring clamp 10′ on the first clamping portion 4′ can be disengaged from the edge 18′ on the first spring clamp seating 12′ on the second clamping portion 6′. If the undercut 16′ and the edge 18′ are disengaged, the first clamping portion 4′ moves to the opened relative position as soon as there is a certain minimum pressure in the hose clamped by the hose clamp 2′. As an alternative, the hose clamp 2′ may also be designed such that the clamping portions 4′ and 6′ are in a tension-free state in the opened relative position.
In the main body 64, a light source 52 is provided at one side of the end of the second clamping portion 6′ facing away from the film hinge 8′, and at the other side of said end a light sensor 54 is provided. In the context of this description and the claims, the term ‘light’ is to be understood as any electromagnetic radiation which can be shielded by means of plastic or metallized plastic. Thus, the light sensor 54 is generally distinguished in that it is able to detect at least a change in properties or a property of the light, such as the intensity, for example. The light source 52 and the light sensor 54 are arranged in the main body 64 such that a light beam can radiate from the light source 52 through the aperture 50 to the light sensor 54, if the clamping portions 4′ and 6′ are in the opened relative position, and that a light beam from the light source 52 hits the covering portion 48 and cannot radiate up to the light sensor 54 if the clamping portions 4′ and 6′ are in the closed relative position.
The embodiments of the hose clamp according to aspects of the invention and of the medical pump according to aspects of the invention which are shown in
By way of example, the feeler pin 22 does not necessarily have a circularly cylindrical shape, but may be generally cylindrical or shaped like a rotation body. Accordingly, the cross-section of the feeler pin seating 24 may be polygonal or oval.
The hose clamp 2 is made in one piece. As an alternative, it is also possible to manufacture the hose clamp 2 by assembling a plurality of individual parts.
In the embodiment as described, the degree of openness of the hose clamp 2 is detected on the basis of the displacement of the feeler 46 in the axial direction of the feeler pin seating 24. As an alternative or in addition, it would be possible to use the feeler 46 for detecting the displacement of the feeler pin 22 relative to the feeler pin seating 24 transverse to the axial direction of the feeler pin seating 24 (determining the width of the gap 28).
Number | Date | Country | Kind |
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10 2015 117 493.6 | Oct 2015 | DE | national |
This application is the U.S. national phase application of PCT International Application No. PCT/EP2016/073791 filed Oct. 5, 2016, which claims priority to German Patent Application No. DE 10 2015 117 493.6 filed Oct. 14, 2015, the contents of each application being incorporated by reference herein.
Filing Document | Filing Date | Country | Kind |
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PCT/EP2016/073791 | 10/5/2016 | WO | 00 |