DE102018104229B3 - infusion pump - Google Patents

Abstract

An infusion pump comprises a pump component (1) which is mounted relative to a pump drive (2), which comprises a pump plunger (46) acting on the pump component (1) for conveying a solution, and an electronic control module (3) for activating the pump drive ( 2), wherein the pump component (1) comprises at least one receiving part (4) with a delivery channel (7) which extends into a respective tube connection (5, 6) on the inlet side and outlet side, and a pump membrane (31) made of a flexible material, which forms a pumping chamber (14).

Description

The invention relates to an infusion pump.

The EP 2 446 910 A1 describes a diaphragm pump with a cassette part. The membrane pump, includes a Vorkompressionskammer, two valve chambers and a pumping chamber with covering membrane. The individual chambers are interconnected by connecting channels. These connection channels form a non-compressible by the peristaltic residual volume, with geometric tolerances and not clearly defined by the peristaltic liquid filling conditions and pressures that adversely affect the intake and the emptying of the pumping chamber, especially if permanently settle air bubbles in the connecting channels , or if deviations of the upstream and downstream pressures from the normal state adjust.

In addition, the Die shows US 5,378,126 A1 an infusion pump with a disposable cassette with various input and output valves, valve switches for the time sequential application of several drugs and a pumping chamber. The various valve chambers are separated from the actual pumping chamber but connected by channels between the individual chambers. These connection channels in turn form a disturbing residual volume with insufficiently defined filling states and pressures, which is associated with disadvantages which lead to an ambiguously defined effective pumping chamber volume.

In the following describe the EP 02 88 716 B1 and the DE 43 36 336 A1 each cartridge for an infusion pump system, which are composed of hard plastic parts and membranes. The designs show various inlet / outlet valves, pumping chambers and sensor windows integrated in the cassettes. The individual functional elements are in turn connected to one another via flow channels, the residual volumes with volume tolerances and with undefined filling states and pressures change the intake behavior and the compression behavior and thus the flow rate of the pump.

In practice, syringe pumps and volumetric pumps with peristaltic tubing are known. Syringe pumps usually have a delivery accuracy of ± 3% with a confidence interval of Cl = 95% and volumetric pumps have a delivery accuracy of ± 5% with a confidence interval of Cl = 95%. Because of their precision, syringe pumps are preferred in administering potent drugs to achieve accurate dosing. Volumetric pumps are preferably used for the administration of larger volumes of medical fluids (e.g., parenteral nutrition) at higher delivery rates, with delivery rate accuracy being uncritical. Potent drugs will also be administered with volumetric pumps if a sufficient dilution of the drug has previously been made.

Syringe pumps are advantageous in that they have a high delivery accuracy regardless of the fluid pressure in the infusion tube between the pump and the patient. Syringe pumps administer drugs in very small bolus volumes by shifting a syringe plunger in small increments, so that an approximately continuous flow rate and, especially in a short time interval, high delivery rate accuracy can be achieved. The disadvantage, however, is that occlusions between the pump and the patient are difficult to recognize, since a corresponding pressure sensor is not integrated in the usually used small and relatively stiff tubes. In addition, syringe pumps are disadvantageous in that the drug is to be filled into the syringe before administration and that a maximum delivery volume is limited to about 60 ml due to the capacity of the existing syringes and therefore a relatively frequent change is required.

Volumetric peristaltic pumps are advantageous in that they are used with relatively simple spike transfer systems, and therefore drugs can be applied in bags, plastic or glass bottles. Drugs can often be used in their primary packaging without the need for transfer and drug preparation is easy in this primary packaging. Volume restrictions usually do not exist. Possible occlusions are relatively easily recognizable, because pressure sensors can be combined with the relatively large-caliber, soft infusion tubes. A disadvantage of volumetric peristaltic pumps, the relatively large pumping volume per pumping cycle (about 100-200μL), and that the pumping volume by the pump peristalsis and the associated pump hose segment is mechanically defined only relatively inaccurate and very sensitive to variable hose Internal pressures before and after the pump reacts. In particular, due to the large pumping volume per cycle, it is not possible to produce an approximately continuous flow at low flow rates. Tolerances in the geometry of the pump tubing segment (inside and outside diameter) as well as length tolerances lead to buckling or pulling effects when the pump tubing segment is inserted into the pump. In addition, tolerances in the degree of hardness of the hose and temperature influences on the hose adversely affect the effective Pump chamber volume off. These factors reduce the delivery rate accuracy so that it is usually not better than ± 5%.

The WO 2014/207 596 A3 discloses a pump designed as a peristaltic pump with an annular linear pump peristaltic pump, wherein the actual pumping segment is guided in a U-shaped profile part. This facilitates the insertion of the pump segment into the pump. However, it can not avoid the sensitivity of the pump to variable upstream and downstream pressures. In addition, an anti-free-flow valve must be pushed as an additional part of the hose. The relatively large distance of the peristaltic plunger to each other leaves room for permanently settling air bubbles, which degrade the flow rate accuracy.

The in the WO 2015/073 599 A1 described pump includes a pneumatically driven pump module in conjunction with an electric / pneumatic drive unit. This concept is comparable in accuracy to volumetric infusion pumps. However, due to the pneumatic drive, its flow rate accuracy is sensitive to variable upstream and downstream pressures in the infusion line. Therefore, this pump needs an integrated measure of effective pump volume per cycle to achieve 5% accuracy (Cl = 95%). This pump is relatively expensive due to the complex pneumatic components.

The pump according to the US 5 586 868 A1 has a cassette module consisting of a hard part and a flexible membrane, wherein valves are integrated as lamellae in the membrane. According to the position and movement of a pump plunger, there is an overpressure or underpressure in a pumping chamber. According to these variable pressure conditions open and close the lamellar valves. An anti-free-flow valve is designed as a manually operated rocker arm. The switching times of the valves depend relatively strongly on the pressure conditions in the pumping chamber, undefined adhesions of the fins on the walls of the valve webs and on the current upstream and downstream pressures, which adversely affects the delivery rate accuracy. Another disadvantage is that the pump cavity with its valve webs has a complicated geometry that traps air bubbles with high probability permanently, whereby the delivery rate accuracy is further negatively affected. A disadvantage of the anti-free-flow valve is its only manual operation. If the user forgets to close the anti-free-flow valve when the pump cassette is removed from the pump, this leads to a patient-endangering free-flow situation.

In practice, the known infusion pumps proved due to their complex structure as a hospital or physician practice suitable. For use in a mobile environment, however, robust, easy-to-use and very compact infusion pumps are necessary. Mobile infusion pumps, which are also used outside of hospitals and ambulances, are established products. However, there is room for improvement to simplify operability and to make the pump housings small and particularly flat, so that the mobile infusion pump can be carried in garments or bags to allow the patient a high degree of mobility without great harm. This also includes an extension of the autonomy times before a recharging of the batteries is necessary. In addition, the need for mobile infusion pumps with long autonomy time becomes increasingly larger, as patients should be able to mobilize quickly even after major interventions.

The invention has for its object to provide an infusion pump of the type mentioned, which has a reproducible delivery rate with a relatively high accuracy in a simple and inexpensive and robust and flat design and which is also mobile and can be used with great autonomy.

In addition, the infusion pump according to the invention is intended to serve all applications with the broad spectrum of the patient population in which today either a syringe pump due to the required accuracy or a volumetrically operated pump for the promotion of large volumes is used. This increases the utilization of a pumping unit in a hospital, it simplifies logistics and thus reduces costs.

According to the invention the object is achieved by the features of the independent claim.

The subclaims represent advantageous embodiments of the invention.

The infusion pump includes a pump component supported relative to a pump drive including a pump plunger engaging the pump component for delivering a solution, and an electronic control module for driving the pump drive, the pump component including at least one receiving portion having a delivery channel located on the inlet and outlet sides extends into a respective hose connection, and a pump diaphragm of a flexible material which forms a pumping chamber, wherein the pump component is removable from the pump drive, and wherein at the latest with the removal closing of an anti-free-flow valve takes place, which is openable by means of an actuator associated with the pump drive to release a flow for the solution.

The pump component can be detached from the pump drive and designed as a disposable module. In particular, the pump component can be designed to be relatively small, ie miniaturized in comparison with pump components known from the prior art. The solution to be administered is provided in a reservoir and transported from the reservoir through a hose to the inlet-side hose port in the pump component. From the miniaturized pump component, the transport of a defined volume of the solution per unit time through the flexible pumping chamber and the outlet-side hose connection via a further hose to the patient. The connection of the hoses with the hose connections can be made by gluing or welding, in particular by means of a laser beam, or non-positively by simply plugging. The pumping of the solution, ie the actual volumetric application, is dependent on the flexible pumping chamber and the pump drive, ie on components of the infusion pump, and not on the tube used, whereby a good reproducibility and accuracy in the administration of the solution can be achieved. The pump component can be designed cassette-like and is therefore easy to handle as a separate unit and detachably connectable to the pump drive. The cartridge-like design ensures correct connection of the pump component with the pump drive, for example in a common housing. Of course, the pump component may be mounted to the pump drive such that desired degrees of freedom are maintained. For example, the storage can be carried out in the manner of a floating storage. Of course, however, a storage with fixed and / or floating bearings is possible and a fixed clamping is not excluded. Removable pump component of the pump drive, wherein the removal is carried out closing of an anti-free-flow valve, which is achieved by means of an actuator associated with the pump drive to flow with correctly inserted or coupled to the pump drive and / or a common housing pump component to release for the solution. As soon as the preferably miniaturized pump component from the electronic drive unit, which essentially comprises the pump drive, the control electronics and a monitoring sensor system, preferably encapsulated in a common housing or enclosed by a membrane, is removed, the anti-free-flow valve (AFF Valve) automatically to prevent unwanted uncontrolled drug flow between the reservoir and the patient. The receiving part, in which on the pump diaphragm and thus also an intermediate part facing side of the delivery channel is formed, made of a rigid material, in particular a plastic, made to give the pump component a sufficient stability against deformation.

In a preferred embodiment, the pump component, as explained in more detail below, consists of a receiving part, a substantially plate-shaped intermediate part, a membrane and a cover plate. The structure is therefore formed of the stacked components stacked and is also referred to as a stack. The previously described components of the pump component are connected to each other under release or to form the delivery channels, for example by gluing or welding, in particular laser welding.

The intermediate part closes the conveyor channels in the underlying receiving part by a tongue and groove connection, which can be glued or welded. The intermediate part has, on its upper side facing the pump membrane, cavities which, in turn, are sealed by the pump membrane, which is made of a flexible material, for example a silicone. Through vertical connection channels in the intermediate part, the liquid from the delivery channels of the receiving part passes into the cavities of the intermediate part. All essential functions integrated in the pump component are realized in the intermediate part and the overlying pump diaphragm. The cover plate is used for mechanical fixation of the stack, so the entire pump component in the housing of the infusion pump. The designated parts of the stack or the pump component may have a rectangular base and they may einliegen in a peripheral frame of the receiving part.

In a preferred embodiment, the pump membrane in the region of the pumping chamber convex to the outside and inwardly facing the intermediate part, just shaped. The flat intermediate part has a plurality of cavities, wherein a cavity associated with the pumping chamber or the cavity forming the pumping chamber together with the pumping membrane is elongated or has an elliptical base surface. The cavities form quasi concave curvatures in the intermediate part. The pump diaphragm and the associated cavity in the substantially plate-shaped intermediate part form the pumping chamber, wherein the pump diaphragm is deformable with respect to the rigid intermediate part. Alternatively, of course, the inner surface of the pump diaphragm facing the intermediate part may also be concave-shaped and the surface of the intermediate part may be flat or concave in order to form the cavity of the pumping chamber.

The intermediate part is provided in the region of the pumping chamber, which rests directly on the receiving part, with an inlet and an outlet opening, which correspond to the delivery channels of the receiving part.

Conveniently, a cover plate rests on the pump diaphragm, which has recesses in the region of the pumping chamber and the other cavities formed in the intermediate part, into which the convex curvature of the outer surface of the pump diaphragm protrudes. The cover plate may have a congruent to the pump diaphragm and the intermediate part outer contour and also einliegen in the peripheral frame of the receiving part. The cover plate is firmly connected to the intermediate part in sections by gluing or welding. Thus, the necessary mechanical pressure is generated on the intermediate pump membrane, which seals by pressing and a suitable seal geometry around the cavities of the intermediate part around. Overall, the pump component has a sandwich-type construction with a relatively small number of individual parts. The flow channels and the other functional cavities are distributed over several levels of the stack. However, all movable functional elements of the pump module are combined in a single flexible pump membrane. Thus, the multilayer stack is small, very flat and relatively inexpensive to manufacture with low dimensional and dimensional tolerances.

In an embodiment, the pump component comprises a mechanical or electronic coding, which can be detected and / or decoded by the pump drive and / or the control module for defined operation of the infusion pump in order to set a predetermined delivery rate. The coding / decoding can be realized, for example, by means of switching cams which act on corresponding switches or by means of a preferably non-contact-readable electronic component. As a result, for example, a rotational speed of a motor of the pump drive or a stroke moving the pump diaphragm can be adjusted. In this context, in addition to a suitable coding of the pump component and a need-based volume of the pumping chamber can be selected, for example, between 10 .mu.l and 200 .mu.l, preferably between 15 .mu.l and 150 .mu.l, more preferably between 20 .mu.L and 100 .mu.L sized so that both small volumes administered in neonatology at a quasi-continuous delivery rate and relatively large volumes can be delivered and administered by selecting and coupling the corresponding pump component, which of course is easily recognizable, to the pump drive. The coding reduces errors in the operation of the infusion pump in particular.

Conveniently, a pump tappet is arranged between an inlet-side and an outlet-side valve tappet. The pump plunger and the two valve tappets are connected to a periodic, peristaltic deformation of the pump diaphragm in the region of the pumping chamber with the pump drive. The pumping chamber is designed as an elongated cavity. The functions of inlet and outlet valves are integrated in the pumping chamber having vertically aligned inlet and outlet ports which are opened and closed by local depression of the soft pump diaphragm in the area of the pumping chamber through the outer valve tappets. In this case, the shape of the cavity is selected such that, while the inlet and outlet valves are closed at the same time, an effective pumping chamber volume between the inlet and outlet channels is still maintained by the valve tappets and a prestressing of the pump membrane generated by the pump tappet. The pumping chamber volume is essentially defined by these geometric boundary conditions. Delivery rate inaccuracies are thus caused only by the geometrical tolerances of the pumping chamber cavity in the hard intermediate part and by tolerances of the membrane thickness in the region of the pump tappet. Other tolerances of the membrane geometry, hardness tolerances of the membrane as well as temperature influences on the membrane hardness only have an insignificant effect on the effective pumping chamber volume.

The volume of the pumping chamber is periodically changed with the third plunger acting from the outside, the pump plunger, wherein the stroke of this pump plunger defines the so-called displacement. In the volumetric, peristaltic infusion pump, a fixed phase coupling between the two valve lifters and the central pump plunger results in a periodic, peristaltic deformation of the pump membrane in the area of the pumping chamber. The filling of the effective volume of the pumping chamber is achieved after opening the inlet valve and lifting the pumping plunger. The sucked liquid in the pumping chamber is pushed out of the pumping chamber by the pump plunger after closing the inlet valve and opening the outlet side valve. The plungers preferably have a flat contact surface with the outwardly convex shaped membrane. As a result, the peristalsis in interaction with the membrane is insensitive to lateral tolerances of the fixed pump module. In addition, a uniform contact pressure of the membrane in the region of the pumping chamber can be generated by a suitably selected geometry of the outwardly convex membrane to a sufficient to generate large compression pressure in the pumping chamber.

In order to form an effective inlet valve and outlet valve together with the valve tappets and the corresponding inlets and outlets in the area of the pumping chamber, the pump membrane has material weakenings. Due to the weakening of the material, a defined section of the convex pump diaphragm can be moved in the direction of the intermediate part by means of the associated valve tappet in order to close the associated inlet or outlet opening in the intermediate part.

Preferably, a stroke and an actuating force by means of a displacement sensor and / or a force measuring sensor can be measured on the pump tappet and the measured data can be evaluated on the control module. Due to manufacturing tolerances, in particular the thickness of the pump diaphragm concerning or the depth of the pump cavity in the hard intermediate part, fluctuations in the effective volume of the pumping chamber can result, which can be detected and corrected by the recording of a force-displacement curve. Based on the evaluated sensor data, which relate to the stroke of the pump plunger and its actuation force, a correction factor of the effective pumping chamber volume for each pump component used, which is of course also produced as a disposable component due to their relatively inexpensive construction, calculable and its tolerances on the control module correctable.

According to a development, at least one air detection sensor is arranged in the region of one of the hose connections and coupled to the control module for the evaluation of sensor data. Preferably, the air detection sensor comprises a piezoelectric sensor, whose transmitter transmitting a sound wave and the receiver detecting the reflected sound signals are arranged on the same side. The air sensor is arranged in the region of the cylindrical hose connections, wherein the hose connection has a recess with a flat base. In this base, the central axis of the underlying river channel may lie. The piezo sensor emits a sound wave, which is reflected by the inner wall of the flow channel. The selected geometry of the flow channel acts as a cylindrical sound wave reflector, which focuses the reflected sound along the cylinder axis back to the piezo sensor. The curvature of the cylindrical sound wave reflector is preferably chosen so that the focus is on the piezo sensor in order to increase the intensity of the receiving sound signal. The received sound reflexes change their amplitude as a function of the current filling state in the flow channel. Air in the flow channel increases the sound wave reflection on the cylindrical inner wall of the flow channel, liquid in the flow channel reduces the reflection behavior. It is advantageous that the sound wave does not have to pass the hose walls, which avoids additional disturbing reflections. Since the transmitter and the receiver are positioned on one side of the flow channel, the pump component and its arrangement in the infusion pump is simplified.

In a further embodiment, at least one pressure sensor is coupled to the control module, the pump diaphragm having pressure membrane areas. Preferably, a pressure sensor between the inlet-side hose connection and the pumping chamber and a pressure sensor between the pumping chamber and the outlet-side hose connection are arranged. The pressure membrane areas are in contact with the pressure sensors in the electronic drive unit of the infusion pump. The internal pressure of the solution in the miniaturized pump component is transferred from the pump membrane in the pressure membrane areas to the pressure sensor with minimal information loss. The sensitivity of the internal pressure measurement is influenced by the mechanical properties of the pump membrane in the pressure membrane areas. The prevailing in the pump component internal pressure should be transferred with the least possible deformation work stored on the pressure sensor to increase the sensitivity. The profile of the pressure membrane areas should in particular also be designed in such a way that the pump membrane in the pressure membrane areas in contact with the associated pressure sensors is always biased and does not have to pass through a zero point with a minimum restoring force. If pretension prevails, the force transmitted through the pump membrane will change monotonically with the internal pressure of the pump module. In classical peristaltic pumps, the pressure sensor is in contact with the hose wall of the radially less elastic pump hose segment, so that this measurement approach is much less sensitive and less accurate than the pressure measurement on the elastic pump diaphragm.

Expediently, the electronic control module comprises at least one computer module, at least one memory module connected to the computer module and at least one data interface. Accordingly, the control module for controlling the pump drive is suitably via the interface of predetermined data suitable. The data relating, for example, to the volume of the solution to be administered and / or a specific period in which the infusion pump is to be operated can be input to the interface, for example by means of a suitable input unit, and stored on the control module.

The pump drive and the control electronics are installed in a common housing, which also has at least one fixing device for the pump component in addition to control electronics and control devices coupled to the control electronics.

The pump component is preferably positioned accurately positioned in a receptacle of the housing of the infusion pump or a correspondingly shaped lid and can be secured in position, for example, by a closable with a simple lever lid in position. Thus, the pump component is precisely aligned relative to the peristaltic drive and to the sensors in the housing. The pump drive is mounted sprung relative to the pump housing and thus also relative to the pump component in order to achieve a defined contact pressure of the pump and valve plunger on the diaphragm of the pump component. All interactions between the pump component and the housing can easily be done via only one functional surface of the pump component, namely the cover plate. Since different layers of the pump component consist of hard parts, is a very simple, preferably one-handed, inserting the pump component into the cavity, so the inclusion of the pump housing and possibly securing the pump component in the receptacle by closing the lid or a locking element possible, with a Locking device between the housing and the pump component can be effective. The pump component can be handled in the manner of a cassette. One-handed insertion of the pump component is easily possible and facilitates in particular the handling of the infusion tube while maintaining sterile conditions. In particular, a simple replacement of the disposable pump component while maintaining the other components of the infusion pump is ensured, for example, to use with respect to certain indications a specific, preferably correspondingly coded pump component with smaller displacement, which allows a quasi-continuous flow even at low flow rates.

The control devices can be displays which provide the patient and / or a doctor with visually and / or acoustically perceptible information about the operation of the infusion pump. Of course, in the housing, a power supply, for example in the form of at least one accumulator, be provided, which allows a self-sufficient and especially mobile operation of the infusion pump.

With the design of the pump component interacting with the electronic pump drive, a volumetric infusion pump is realized which achieves a flow rate accuracy of ± 3% (confidence interval 95%), which is equivalent to the accuracy of syringe pumps. The volume of the pumping chamber is typically about 50 μL and thus about a factor 2 - 4 smaller than the volume of conventional volumetric peristaltic pumps, it being apparent to those skilled in the art that a volume in particular less than 20 μL or greater 100 μL is adjustable by a corresponding adjustment of the pumping chamber with the same stroke of the pump plunger. With the infusion pump, a quasi-continuous flow rate can be generated, and it can also be a high delivery rate accuracy, especially at low flow rates and short application times can be achieved.

The pumping chamber peristalsis requires much less deformation work in comparison with the peristaltic pumps known from the prior art. As a result, the inventive peristalsis can be operated at higher cycle frequencies than is possible with conventional peristaltic pumps. As a result, despite the smaller volume of the pumping chamber, delivery rates of about 1000 to 1500 ml / h can be set, which are comparable to those of classical volumetric peristaltic pumps.

The inventive pump component, along with the electric pump drive, which of course includes a pump motor and associated gearbox, combines the advantages of high flow rate accuracy of syringe pumps with the large flow rate dynamics of volumetric pumps. The flat geometry of the pump component and the necessarily laterally positionable flat drive unit, namely the pump drive with the associated components, makes it possible for the outer housing of the infusion pump to be very flat, in particular with a thickness of less than 50 mm, preferably less than 35 mm and particularly preferably less than 25 mm, which provides ergonomic advantages in the application, during transport and in particular stowage of mobile usable infusion pump with it.

The energy efficiency of the inventive pumping peristalsis, due to the fact that the deformation of the pumping membrane requires less energy than the deformation of a hose, results in much greater autonomy of the electronic drive unit compared to traditional syringes or volumetric pumps.

All essential functions of the pump component, the pressure sensor diaphragms, the valve functions of the pumping chamber, the pumping chamber and the anti-free-flow valve are combined on a membrane surface, namely the pump membrane and thus simple and from one side, so a functional level through the axially movable Actuators and sensors in the electronic drive unit, which includes the pump drive and the control electronics with associated sensors, operable.

It goes without saying that the features mentioned above and those yet to be explained below can be used not only in the respectively specified combination but also in other combinations. The scope of the invention is defined only by the claims.

The invention will be explained in more detail below with reference to an embodiment with reference to the accompanying drawings.

• 1 eine schematische Teildarstellung einer erfindungsgemäßen Infusionspumpe,
• 2 einen Querschnitt durch die 1
• 3 eine Draufsicht auf den Pumpenantrieb der Infusionspumpe nach 1,
• 4 eine Seitenansicht der Darstellung nach 3,
• 5 Darstellungen der Pump-Peristaltik bis 8
• 9 eine Schnittdarstellung gemäß der Linie IX-IX nach 1,
• 10 eine Explosionsdarstellung der Schnittdarstellung gemäß 9,
• 11 eine Schnittdarstellung gemäß der Linie XI-XI nach 1,
• 12 eine Explosionsdarstellung der Schnittdarstellung gemäß 11,
• 13 eine Draufsicht auf eine Deckplatte einer Pumpenkomponente der Infusionspumpe nach 1,
• 14 eine Schnittdarstellung gemäß der Linie XIV-XIV nach 13,
• 15 eine Schnittdarstellung gemäß der Linie XV-XV nach 13,
• 16 eine Draufsicht auf eine Pumpenmembran der Pumpenkomponenten der Infusionspumpe nach 1,
• 17 eine Schnittdarstellung gemäß der Linie XVII-XVII nach 16,
• 18 eine Schnittdarstellung gemäß der Linie XV-XV nach 13,
• 19 eine Draufsicht auf ein Zwischenteil der Pumpenkomponente der Infusionspumpe nach 1,
• 20 eine Schnittdarstellung gemäß der Linie XX-XX nach 19,
• 21 eine Schnittdarstellung gemäß der Linie XXI-XXI nach 19,
• 22 eine Draufsicht auf ein Aufnahmeteil der Pumpenkomponente der Infusionspumpe nach 1,
• 23 eine Schnittdarstellung gemäß der Linie XXIII-XXIII nach 22,
• 24 eine Schnittdarstellung gemäß der Linie XXIV-XXIV nach 22 und
• 25 eine alternative Teildarstellung der Infusionspumpe nach 2.

It shows:

• 1 a schematic partial view of an infusion pump according to the invention,
• 2 a cross section through the 1
• 3 a plan view of the pump drive of the infusion pump after 1 .
• 4 a side view of the illustration 3 .
• 5 Representations of pump peristalsis up 8th
• 9 a sectional view according to the line IX - IX to 1 .
• 10 an exploded view of the sectional view according to 9 .
• 11 a sectional view according to the line XI - XI to 1 .
• 12 an exploded view of the sectional view according to 11 .
• 13 a plan view of a cover plate of a pump component of the infusion pump according to 1 .
• 14 a sectional view according to the line XIV - XIV to 13 .
• 15 a sectional view according to the line XV -XV after 13 .
• 16 a plan view of a pump diaphragm of the pump components of the infusion pump according to 1 .
• 17 a sectional view according to the line XVII - XVII to 16 .
• 18 a sectional view according to the line XV - XV to 13 .
• 19 a plan view of an intermediate part of the pump component of the infusion pump according to 1 .
• 20 a sectional view according to the line XX - XX to 19 .
• 21 a sectional view according to the line XXI - XXI to 19 .
• 22 a plan view of a receiving part of the pump component of the infusion pump according to 1 .
• 23 a sectional view according to the line XXIII - XXIII to 22 .
• 24 a sectional view according to the line XXIV - XXIV to 22 and
• 25 an alternative partial view of the infusion pump after 2 ,

The infusion pump essentially comprises a miniaturized pump component 1 , a pump drive 2 and a control module 3 in a common housing 63 the infusion pump are housed.

The pump component 1 is composed of a plurality of layers having a substantially rectangular base area and relative to the pump drive 2 fixed so that the pump component 1 from the pump drive 2 removable and removable from the housing. For example, a lid pivotable in the housing 68 which may also be formed as a kind of headband or the like, the pump component 1 releasably fix. Accordingly, the pump component 1 be suitable for a single use while maintaining the other components of the infusion pump.

Specifically, the pump component includes 1 a made of a dimensionally stable and substantially rigid material receiving part 4 with an inlet-side hose connection 5 and an outlet side hose connection 6 , Between the two hose connections 5 . 6 runs a conveyor channel 7 for the solution to be applied. The conveyor channel 7 is circumferential with a groove 66 provided with a spring 8th on the underside of an intermediate part 21 Corresponds to the conveyor channel by gluing or welding 7 seal, wherein the spring in the assembled state of the pump component 1 in the groove 66 intervenes. To the inlet-side hose connection 5 one end of a hose can be connected, the other end of which is coupled to a supply of the solution to be applied. The outlet side hose connection 6 should be paired with an infusion tube for the patient. The peripheral side is the receiving part 4 provided in one embodiment with a one-sided raised edge to align and seal layers arranged above it. From the inlet-side hose connection 5 leads a circumferentially closed first section 9 of the conveyor channel 7 to a perpendicularly extending second section 10 which extends frontally into the open air. Below are in a third section 11 of the conveyor channel 7 an open channel section 13 arranged in the area below the pumping chamber 14 of the intermediate part 21 in the region of the one end of the pumping chamber 14 ends and with the inlet opening 28 corresponds and an inlet of an inlet valve 19 forms. A sink 67 in the recording section 4 gives room to a vault 30 the pumping chamber 14 on the underside of the intermediate part 21 absorb, whereby the overall height of the stack can be minimized. From the other end of the pumping chamber 14 and the outlet opening 29 to the exhaust valve 20 goes an open channel section 15 a fourth section 16 of the conveyor channel 7 starting in an open cross-sectional enlargement 12 flows and with a vertical passage 22a in a valley 24 of the intermediate part 21 corresponds. A fifth channel section 17 in the middle part 21 connects the vertical passages 22a . 22b in the valley 24 and flows into the sixth closed section 18 in the recording section 4 , the sixth section 18 of the conveyor channel 7 to the outlet side hose connection 6 leads.

On the receiving part 4 is also the rectangular intermediate part 21 sealed from a rigid plastic material. The intermediate part 21 has the first passage extending through the thickness thereof 22a an anti-free-flow valve 23 on, to prevent inadvertent flow of the liquid through the pump component 1 is arranged to the patient, passing through the passage 22a the solution of the fourth section 16 of the conveyor channel 7 into a depression 24 and through the other passage 22b of the receiving part 4 in the sixth section 18 arrives once the anti-free-flow valve 23 is open. The depression 24 gives the overlying membrane 31 Movement space to the with this membrane 31 connected valve lug 36 by an external force in the passage 22a to move axially. By the axial movement of the valve lug 36 becomes the passage 22a opened when the membrane 31 with an actuator in the recess 24 is deformed under tension. Once the bias of the membrane 31 is taken away, the membrane goes 31 automatically returns to its relaxed initial state, it rises from the depression 24 out and closes with the valve neck 36 the passage 22a , Furthermore, in the intermediate plate 21 an inlet-side passage 25 which is the open channel section 13 of the third section 11 of the conveyor channel 7 is assigned, and an outlet-side passage 26 which is the open channel section 15 of the fourth section 16 of the conveyor channel 7 is assigned trained. In the area of the depression 24 is on the opposite side of the intermediate plate 21 the spring 8th formed in the form of a circumferential ridge, which is in the groove 66 of the receiving part 4 corresponding immersed, the associated channel section 15 includes and by gluing or welding of groove 66 and spring 8th seals. The concave curvature 30 that are part of the pumping chamber 14 is at the one end to the inlet valve 19 assigned inlet 28 for the liquid and an outlet valve 20 associated outlet 29 assigned, the fluidically with the open channel section 13 of the third section 11 of the conveyor channel 7 or the open channel section 15 of the fourth section 16 of the conveyor channel 7 stay in contact.

A pump diaphragm 31 made of an elastic material, for example an elastomeric material, extends above the intermediate part 21 and has a convex curvature 32 on, the part of the pumping chamber 14 is. The elongated convex curvature 32 is with material weakening 33 for forming the inlet valve 19 and the exhaust valve 20 provided, wherein the end-side sections 34 the vault 32 the pump diaphragm 31 upon actuation in the direction of the intermediate part 21 sealing on the respective inlet-side and outlet-side passage 28 . 29 come to rest to release or prevent flow. Furthermore, in the pump diaphragm 31 Pressure membrane regions 35 formed above the inlet-side and outlet-side passages 25 . 26 extend. In addition, a valve lug 36 of the anti-free-flow valve 23 at the pump diaphragm 31 formed, extending through the associated passage 22a in the intermediate part 21 extends and the so against the intermediate part 21 is biased that its conically enlarging free end on the receiving part 4 facing side of the intermediate part 21 the passage 22a sealingly applied. In the valve neck 36 is an opening 37 admitted.

One on the pump diaphragm 31 Overlying cover plate 38 made of a rigid material points in the area of the convex curvature 32 and the pressure membrane areas 35 the pump diaphragm 31 breakthroughs 39 on. In the following is an approach 41 provided in the opening 37 of the valve lug 36 intervenes. Above the neck 41 is the cover plate 38 convex and conveys in one to the approach 41 adjacent area a recess 40 on to the approach 41 to move resiliently. The convex curvature 23 In this area minimizes influences of lateral tolerances of the actuator, not shown, in a housing 63 is mounted relative to the central axis of the anti-free-flow valve 23 wherein the associated actuator is the anti-free-flow valve 23 opens by advancing.

Is the miniaturized pump component 1 correctly in the housing 63 the infusion pump used and to the pump drive 2 fixed, then the cover plate 38 in the area of their convex elevation above the neck 41 of the anti-free-flow valve 23 through the rigid actuator, which is part of the case 63 the infusion pump is contacted, and in the direction of the receiving part 4 postponed. This will be the opening 37 of the valve lug 36 used approach 41 the valve lug 36 to release the passage 22a in the direction of the receiving part 4 move while remaining elastically biased. Is the pump component 1 not correctly in the housing 63 the infusion pump used and to the pump drive 2 fixed, or the pump component 1 is out of the case 63 taken, then the anti-free-flow valve 23 closed and thereby an uncontrolled flow of the liquid to be applied from the reservoir through the pump component 1 prevented to the patient. In a further embodiment, the actuator is by a motor, which is part of the drive in the housing 63 is axially displaceable. Only when the pump component 1 correctly inserted and, for example, through the lid 68 of the housing 63 or a headband or the like is secured, the infusion pump can be started. Only then does the motor drive the actuator forward and open the anti-free-flow valve 23 , Once the infusion pump is stopped, the motor-driven actuator returns and the anti-free-flow valve 23 closes automatically due to the prestressed pump diaphragm 31 , This avoids an accidental free flow situation when inserting or removing the pump component 1 ,

The in the case 63 used pump drive 2 to which the pump component 1 is fixed, essentially comprises an electric pump motor 42 that one over on waves 43 mounted gears 44 comprehensive transmission 45 with a pump tappet 46 and two valve lifters 47 . 48 is coupled. The pump tappet 46 and the two valve tappets 47 . 48 each have a plunger head 49 on and are at one of the plunger head 49 opposite plunger foot 50 pivotable on a gearbox 51 stored. One in the gearbox 51 arranged and by the pump motor 42 driven camshaft 52 operated with their cams 53 the pump tappet 46 and the two valve tappets 47 . 48 against the force of tension springs 54 between the pump plunger 46 and the two valve tappets 47 . 48 on the one hand and the transmission housing 51 on the other hand are clamped.

The camshaft 52 generates a periodic up and down movement of the plunger heads 49 with fixed phase relationship and well-defined amplitude. The plunger heads 49 protrude over the gearbox 51 into the open. In a preferred embodiment, the transmission housing 51 resilient relative to the housing 63 and in the recording 65 stored pump component 1 stored to tolerate tolerances of the gear housing and thus the plunger heads 46 . 47 . 48 relative to the pump component 1 compensate. The resilient mounting of the gear housing 51 relative to the housing 63 For example, by the arrangement of at least one spring element 69 on the pump component 1 facing side and at least one bearing element 70 on the pump component 1 be turned away side. This ensures that with correctly inserted and fixed pump components1 always at least one plunger head 46 . 47 . 48 in the area of the pumping chamber 14 supported with a defined contact force. The reference plane of the peristalsis is then through this base in the intermediate part 21 and the overlying membrane 31 defined, and the Pumpperistaltik is independent of position tolerances of the pump drive 2 relative to the pump component 1 ,

In a further preferred embodiment, the plunger heads 49 or actuarial approaches 62 the plunger heads 49 with a the housing 63 sealing, flexible sealing element 64 connected. It is advantageous that this membrane-like sealing element 64 laterally to the existing of a hard material actuation approaches 62 the plunger heads 49 is fixed. The hard approach to action 62 the plunger heads 49 are in direct contact with the flexible pump diaphragm 31 the pump component 1 , As a result, the stroke of the plunger heads 49 precisely defined, which increases the delivery rate accuracy.

Is the cartridge-type pump component 1 correctly in the housing 63 the infusion pump used and to the pump drive 2 with the lid 68 fixed, are the plunger heads 49 in contact with the vault 30 the pump diaphragm 31 where the valve tappets 47 . 48 the end sections 34 are assigned and on the one hand, the inlet valve 19 and on the other hand, the exhaust valve 20 form or components or actuator of the inlet valve 19 or the exhaust valve 20 are. The sprung storage of the drive 2 along with the peristaltic movement of the three pestles 46 . 47 . 48 cause either the valve lifter 47 or the valve lifter 48 the inlet valve 19 or the outlet valve 20 closes to avoid a free-flow situation.

For monitoring and controlling the pump component 1 and the pump drive 2 as well as the liquid to be applied within the pump component 1 is the control module 3 provided, in addition to a computer module 55 , at least one memory module 56 and at least one data interface 57 includes. Via the data interface 57 can be used for controlling the pump drive 2 transmit and store relevant data, for example, concern the volume of the solution to be administered and / or a certain period in which the infusion pump is operated, the data input by means of any known to those skilled input device, for example in the form of a keyboard and or a computer, in particular a mobile computer, generated at the data interface 57 entered and on the control module 3 get saved. Alternatively, it is possible to use the pump component 1 be provided with a coding that is readable or detectable, and information for the control module 3 for controlling the pump drive 2 providing to a particular pumping component 1 to achieve a predetermined delivery rate, of course, depending on both the timing of the valve lifter 47 . 48 and the pump plunger 46 as well as the size of the pumping chamber 14 is.

To provide control, the control module is 3 with display elements 58 connected. The display elements 58 For example, it may provide an indication of operating conditions of the infusion pump, information about an applied volume, charge states of batteries for mobile operation of the infusion pump, and the like.

The control module 3 stands for actual data acquisition and status evaluation with an air detection sensor 59 in the area of the inlet-side hose connection 5 in connection, wherein the air sensor is located in the region of the hose connections. The cylindrical hose connection 5 has a recess with a flat base on which an air detection sensor 59 is mounted, in whose area the central axis of the hose connection 5 runs. The air detection sensor 59 includes a piezo transmitter for emitting a sound wave coming from the inner wall of the hose connector 5 is reflected to a receiver, the geometry of the hose connection 5 acts as a cylindrical reflector, which reflects the reflected sound along the cylinder axis to the receiver of the air detection sensor 59 focused back and thus increases the intensity of the receiving sound signal. The received sound reflexes change their amplitude as a function of the current filling state within the hose connection 5 , Air in the hose connection 5 increases the sound wave reflection, liquid in the hose connection 5 reduces the reflection behavior. Because transmitter and receiver on one side of the hose connection 5 are positioned, the arrangement is simplified.

Furthermore, with the control module 3 coupled pressure sensors 60 in the pressure membrane areas 35 the pump diaphragm 31 intended.

The internal pressure of the liquid in the pump component 1 is from the pressure membrane areas 35 the pump diaphragm 31 with minimal information losses on the corresponding pressure sensor 60 the sensitivity of the internal pressure measurement by the mechanical properties of the pressure membrane areas 35 the pump diaphragm 31 is affected. The internal pressure should be with as little as possible stored deformation work on the pressure sensor 60 be transferred, wherein the pressure membrane areas 35 be designed such that the pressure membrane areas 35 in contact with the pressure sensors 60 are biased and must pass through zero point with minimal restoring force.

The pumping chamber 14 is designed as an elongated cavity. The intake and exhaust valves 19 . 20 are in the pumping chamber 14 integrated. The inlet 28 and the outlet 29 are done by pushing down the end-side sections locally 34 the soft pump diaphragm 31 through the outer valve lifters 47 . 48 opened and closed. It is essential that the shape of the pumping chamber 14 is chosen so that at the same time closed inlet and outlet valve 19 . 20 another effective volume between the inlet 28 and the outlet 29 is available. In the present embodiment, this requirement is solved such that the baseline of the pumping chamber 14 between the inlet 28 and the outlet 29 is formed concave. The volume in the pumping chamber 14 becomes with the externally acting pump plunger 46 changed periodically. The present infusion pump is a volumetric, peristaltic infusion pump, with a fixed phase coupling between the two valve tappets 47 . 48 and the central pump plunger 46 to a periodic, peristaltic deformation of the curvature 30 the pump diaphragm 31 in the area of the pumping chamber 14 leads. The pumping chamber is filled 14 by removing the exhaust valve 20 is closed, the inlet valve 19 is open and the pump tappet 46 away from the pumping chamber 14 removed, wherein in the increasing volume of the pumping chamber 14 a negative pressure develops, the liquid in the pumping chamber 14 sucks. The filling of the effective volume to be pumped will be after closing the inlet valve 19 and opening the exhaust valve 20 through the pump tappet 46 from the pumping chamber 14 pushed out.

Another important feature of the mechanism of pump peristalsis is that there is no dead volume between the intake and exhaust valves 19 . 20 and the effective pumping chamber 14 exist. This avoids that air bubbles permanently in the pumping chamber 14 which could adversely affect the effective pumping chamber volume and thus the delivery rate accuracy.

When the pump diaphragm 31 through the valve tappets 47 . 48 and the pump tappet 46 is biased over the entire stroke-way, especially in upper reversal points, the effective stiffness of the pump diaphragm 31 and thus the pumping chamber 14 increases, so that variable upstream and downstream pressures can not adversely affect the effective pumping chamber volume and thus the flow rate accuracy.

The pump diaphragm 31 is on the outside in the area of the inlet and outlet valve 19 . 20 and in the central area of the pumping chamber 14 in contact with the valve lifters 47 . 48 and the pump tappet 46 and in the pressure membrane areas 35 Profiled convex, so that end-side actuation approaches of the plunger heads 49 and the contact surfaces of the pressure sensors 60 essentially can be interpreted just. Thus, the influence of lateral tolerances between the plungers 46 . 47 . 48 , the electronic pump drive 2 and the disposable pump component 1 with regard to the valve functions and the effective pumping chamber volume, and in particular the flow rate accuracy and pressure measurements are not adversely affected by lateral tolerances. The convex shape of the pump diaphragm 31 is such that when deformed by the peristaltic plunger 46 . 47 . 48 it to a uniformly distributed contact pressure of the pump diaphragm 31 on the inner surface of the concave pumping chamber 14 comes to produce static downstream pressures of up to 2 bar. This is advantageous for maintaining the flow rate accuracy of the infusion pump when downstream pressures due to flow resistances should occur to about 1 bar.

LIST OF REFERENCE NUMBERS

1.

pump component

Second

pump drive

Third

control module

4th

receiving part

5th

hose connection

6th

hose connection

7th

delivery channel

8th.

edge

9th

first section

10th

second part

11th

third section

12th

Cross-sectional enlargement

13th

channel section

14th

pumping chamber

15th

channel section

16th

fourth section

17th

fifth section

18th

sixth section

19th

intake valve

20th

outlet valve

21st

intermediate part

22nd

passage

23rd

Anti-free-flow valve

24th

deepening

25th

passage

26th

passage

27th

flow channel

28th

inlet

29th

outlet

30th

bulge

31st

pump diaphragm

32nd

bulge

33rd

material weakening

34th

section

35th

Pressure membrane area

36th

valve approach

37th

opening

38th

cover plate

39th

breakthrough

40th

deepening

41st

approach

42nd

pump motor

43rd

wave

44th

gear

45th

transmission

46th

pump plunger

47th

tappet

48th

tappet

49th

ram head

50th

Stößelfuß

51st

gearbox

52nd

camshaft

53rd

cam

54th

mainspring

55th

computer module

56th

memory module

57th

Data Interface

58th

display element

59th

Air detection sensor

60th

pressure sensor

61st

cavity

62nd

actuating extension

63rd

casing

64th

sealing element

65th

admission

66th

groove

67th

depression

68th

cover

69th

spring element

70th

bearing element

Claims (22)

Infusion pump with a pump component (1) which is mounted relative to a pump drive (2) which comprises a pump plunger (46) acting on the pump component (1) for conveying a solution, and an electronic control module (3) for controlling the pump drive (2 ), wherein the pump component (1) comprises at least one receiving part (4) with a delivery channel (7) which extends on the inlet side and outlet side into a respective hose connection (5, 6), and a pump membrane (31) made of a flexible material which a pumping chamber (14) is formed, wherein the pump component (1) from the pump drive (2) is removable, and wherein no later than the removal closing of an anti-free-flow valve (23) takes place by means of the pump drive (2) Actuator is openable to release a flow for the solution. After infusion pump Claim 1 characterized in that the pump membrane (31) is convexly shaped in the region of the pumping chamber (14) and is spaced from a plate-shaped intermediate part (21) which is concavely curved in the region of the pumping chamber (14), After infusion pump Claim 2 , characterized in that the convex curvature (30) of the pump diaphragm (31) in the direction opposite to the intermediate part (21) direction and the pump diaphragm (31) in the region of the pumping chamber (14) on the intermediate part facing side (21) flat or is concave. After infusion pump Claim 1 or 2 , characterized in that the intermediate part (21) has a plurality of cavities, the cavity assigned to the pumping chamber (14) being elongate or elliptical and having an inlet (28) and outlet (29) corresponding to conveying channels (7) of the receiving part (4). having. After infusion pump Claim 1 or 2 , characterized in that on the pump diaphragm (31) a cover plate (38) rests, which has at least in the region of the pumping chamber (14) has a recess into which the convex curvature (32) of the pump diaphragm (31) protrudes. After infusion pump Claim 1 , characterized in that the pump component (1) comprises a mechanical or electronic coding detectable by the pump drive (2) and / or the control module (3) for defined operation of the infusion pump and / or decodable to set a delivery rate. After infusion pump Claim 1 , characterized in that the pump plunger (46) is arranged between an inlet-side and an outlet-side valve plunger (47, 48). After infusion pump Claim 1 or 2 , characterized in that the pump plunger (46) and the two valve tappets (47, 48) to a periodic, peristaltic deformation of the pump diaphragm (31) in the pump chamber (14) are connected to the pump drive (2). Infusion pump according to one of Claims 1 to 5 , characterized in that on the pump tappet (46) a stroke and an actuating force by means of a displacement sensor and / or a force measuring sensor can be measured and at the control electronics, the measured data can be evaluated. After infusion pump Claim 1 , characterized in that the pump drive (3) in a closed housing (63) with the release of the pump diaphragm (31) acting on actuation lugs (62) of the pump plunger (46) and the two valve tappets (47, 48) is housed. After infusion pump Claim 10 , characterized in that between the housing (63) and the actuating lugs (62) of the pump plunger (46) and the two valve tappets (47, 48) elastic or flexible sealing elements (64) are arranged. After infusion pump Claim 10 , characterized in that the housing (63) has a receptacle (65) for the pump component (1). Infusion pump according to one of Claims 1 to 5 , characterized in that the pump diaphragm (31) in the region of the pumping chamber (14) for forming an inlet valve (19) and an outlet valve (20) material weakenings (33). After infusion pump Claim 1 , characterized in that at least one air detection sensor (59) in the region of one of the hose connections (5, 6) is arranged and coupled to the evaluation of sensor data with the control electronics. After infusion pump Claim 11 , characterized in that the air detection sensor (59) comprises a piezoelectric sensor whose one sound wave emitting receiver and the reflected sound signals detecting receiver are arranged on the same side. After infusion pump Claim 11 or 12 , characterized in that the flow channel formed by the air inlet sensor (59) has a geometry as a cylindrical sound wave reflector which focuses the reflected sound along the cylinder axis back onto the piezo air detection sensor (59), the curvature of the cylindrical Sound wave reflector is selected such that the focus is on the piezo air detection sensor (59). After infusion pump Claim 1 , characterized in that at least one pressure sensor (60) is coupled to the control electronics, wherein the pump diaphragm (31) pressure membrane regions (35). After infusion pump Claim 17 , characterized in that a pressure sensor (60) between the inlet-side hose connection (5) and the pumping chamber (14) and a pressure sensor (60) between the pumping chamber (14) and the outlet-side hose connection (6) is arranged. Infusion pump according to one of Claims 1 to 18 , characterized in that the control electronics at least one computer module (55), at least one connected to the computer module (55) memory module (56) and at least one data interface (57). Infusion pump according to one of Claims 1 to 19 , characterized in that the housing (63) accommodates the pump component (1), the pump drive (2), the control electronics as well as with the control electronics coupled control devices and adjusting devices and at least one fastening device. Infusion pump according to one of Claims 1 to 20 , characterized in that all the functions of the pump component (1) are integrated in a pump diaphragm (31) and lie in one plane and can be operated or read from one side of the pump component (1) from the housing (63). Infusion pump according to one of Claims 1 to 21 , characterized in that the anti-free-flow valve (23) in the pump component (1) integrated and operated by simple forward and backward movement of an actuator in contact with the pump component (1) without fixing with elements of the pump component (1) is.

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