EP3758774A1 - Pompe à perfusion - Google Patents

Pompe à perfusion

Info

Publication number
EP3758774A1
EP3758774A1 EP19703972.0A EP19703972A EP3758774A1 EP 3758774 A1 EP3758774 A1 EP 3758774A1 EP 19703972 A EP19703972 A EP 19703972A EP 3758774 A1 EP3758774 A1 EP 3758774A1
Authority
EP
European Patent Office
Prior art keywords
pump
pumping chamber
infusion pump
valve
infusion
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP19703972.0A
Other languages
German (de)
English (en)
Inventor
Torsten Van Venrooy
Michael Becker
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP3758774A1 publication Critical patent/EP3758774A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14212—Pumping with an aspiration and an expulsion action
    • A61M5/14224—Diaphragm type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804—Flow controllers
    • A61M5/16809—Flow controllers by repeated filling and emptying of an intermediate volume
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/36—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests with means for eliminating or preventing injection or infusion of air into body
    • A61M5/365—Air detectors
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
    • F04B43/00—Machines, pumps, or pumping installations having flexible working members
    • F04B43/02—Machines, pumps, or pumping installations having flexible working members having plate-like flexible members, e.g. diaphragms
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
    • F04B43/00—Machines, pumps, or pumping installations having flexible working members
    • F04B43/12—Machines, pumps, or pumping installations having flexible working members having peristaltic action
    • F04B43/14—Machines, pumps, or pumping installations having flexible working members having peristaltic action having plate-like flexible members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3334—Measuring or controlling the flow rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3375—Acoustical, e.g. ultrasonic, measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves

Definitions

  • the invention relates to an infusion pump.
  • syringe pumps and volumetric pumps with peristaltic tubing are known.
  • volumetric 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 (eg, parenteral nutrition) at higher delivery rates, the delivery rate accuracy being uncritical. Potent drugs are also 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, allowing for an approximately continuous flow rate and, especially in a short time interval, high delivery rate accuracy.
  • the disadvantage is that occlusions between the pump and the patient are difficult to recognize, as a corresponding pressure sensor is not integrated with the commonly used small and relatively rigid hoses.
  • syringe pumps are disadvantageous in that the drug is to be transferred into the syringe before administration and that a maximum delivery volume is limited to about 60 ml due to the capacity of the syringes present and consequently relatively frequent replacement 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 easy to detect because pressure sensors can be combined with the relatively large-caliber, soft infusion tubes.
  • a disadvantage of volumetric peristaltic pumps is the relatively large pumping volume per pump cycle (about 100-200mI_). Thus, these pumps are not suitable for use with potent drugs that require low flow rates and near-continuous flow. Peristaltic pumps provide a periodic sequence of drug boli, each with a volume of 100mI_ to 200mI_ and intervening pauses. For the application of potent drugs therefore syringe pumps are preferred that do not have these disadvantages.
  • peristaltic pumps for example from B. Braun, Fresenius, Carefusion, Baxter
  • an elastic hose segment made of silicone pump hose segment
  • the series has at least three but often a variety of plungers.
  • the effective pumping volume is defined by the resi- dual volume that forms between the first and last plungers as they squeeze the tubing segment.
  • a disadvantage of this type of pump is that the effective pumping volume per cycle is only defined very inaccurately and is influenced by external boundary conditions. That's how the effective changes Pump volume due to tolerances of the wall thickness of the pump tube segment and hardness tolerances of the tubing.
  • the pump tube segment is positioned relative to the peristalsis by means of suitable mechanical means and is held between it and a counter plate. Length tolerances of the pump tubing segment lead to longitudinal stretching or compression, which influences the effective pump chamber volume in the pump tubing segment. The mechanical interaction with the pump peristalsis also leads to position shifts of the pump tubing segment between peristaltic and the counter plate, which also alters the pumping chamber volume. In addition, temperature influences affect the hose hardness and also change the effective pump chamber volume. Variable upstream and downstream pressures in the infusion tube also affect the flow rates, which is usually no better than ⁇ 5% for peristaltic pumps.
  • EP 2 446 910 A1 describes a membrane pump with cassette part, which avoids the disadvantages of a hose peristaltic pump.
  • the diaphragm pump consisting of a pre-compression chamber, two valve chambers and a pump chamber with covering diaphragm.
  • the individual chambers are interconnected by connecting channels.
  • these connection channels form a residual volume that is incompressible by the peristaltic, with geometric tolerances and liquid filling states and pressures that are not clearly defined by the peristaltics, which negatively influences the aspiration behavior as well as the emptying of the pumping chamber, in particular if Stick air bubbles permanently in the connection channels or if deviations of the upstream and downstream pressures from the normal state occur.
  • WO 2014/207 596 A3 discloses a peristaltic pump with linear pump peristaltic, wherein the actual pump tube segment is fixed and guided in a profile plastic part. For the valve tappets and pump tappets access is provided in this plastic part. The profile plastic part facilitates the insertion of the pump segment into the pump.
  • the pump described in WO 2015/073 599 A1 comprises a pneumatically driven pump cassette with various valves and pressure measuring windows in conjunction with an electric / pneumatic drive unit.
  • the effective pumping chamber volume is very sensitive to variable downstream and upstream pressures in the infusion line. Therefore, this pump requires an integrated measuring method to measure the pump chamber pressure and to derive therefrom a control variable which compensates the external influence on the effective pump chamber volume.
  • the technical effort for this pump and disposable cassette is relatively expensive due to the necessary pneumatic components.
  • the infusion pump shown in US 5,378,126 A1 shows a disposable cassette with various input and output valves, valve switches for the time sequential Application of several medications and a pumping chamber.
  • the various valve chambers are separated from the actual pumping chamber but connected to each other by channels between the individual chambers. These connecting channels in turn form a disturbing residual volume with insufficiently defined filling states and pressures, with which the disadvantages already described above are associated, which leads to an inconclusive effective pumping chamber volume.
  • the pumps described in US Pat. No. 5,586,868 A1 have a cassette module consisting of a hard part and a flexible membrane, with passive valves being integrated as lamellae in the membrane, without disruptive residual volumes being present in the pumping chamber. According to the position and movement of a pumping ram, there is an overpressure or depression in a pumping chamber. In accordance with these variable pressure conditions, the lamellar valves open and close. As passive elements, however, the valve tappets are not operated by valve tappets.
  • the switching times of the valves therefore depend to a relatively great extent on the pressure conditions in the pump chamber and the upstream and downstream pressures in the infusion tube, as well as on undefined adhesions of the lamellae to the walls of the valve webs, which adversely affects the delivery rate accuracy .
  • Another disadvantage is that the pump cavity with its valve webs has a complicated geometry, with corresponding tolerances of the effective pump chamber volume and an increased probability that air bubbles can settle permanently in the pumping chamber, because they are not rinsed out, so that they Sustainably change the compression behavior of the pump and adversely affect the delivery rate accuracy.
  • An anti-free-flow valve is designed as a manually operated rocker arm.
  • 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.
  • EP 02 88 716 A1 and DE 43 36 336 A1 each describe cartridges 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.
  • Mobile infusion pumps which are also used outside of hospitals and ambulances, are also established products. Mobile infusion pumps are also used in particular for pain therapies with morphine, whereby the drug containers are particularly protected against unauthorized access.
  • Further potential for improvement consists in simplifying the operability and making the pump housings small and, in particular, flat, so that the mobile infusion pump can be carried in clothes or bags in order to provide the patient with a high level of flexibility without great impairment. permit. This also includes an extension of the autonomy times before a recharging of the batteries is necessary.
  • 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 indication-specific requirements for mobile infusion pumps in addition to the specific requirements for stationary syringe pumps and peristaltic pumps further increase the complexity in the area of logistics for infusion technology and workflows.
  • the invention has for its object to provide an infusion pump of the type mentioned, which has a reproducible delivery rate with a relatively large accuracy in a simple and inexpensive as well as robust and flat design and stationary and mobile can be used with a long autonomy period.
  • 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 is used for the delivery of large volumes.
  • This increases the capacity utilization of a pumping unit in a hospital, simplifies logistics and thus reduces costs.
  • the infusion pump includes a pump component that is supported relative to a pump drive that includes a pump ram that acts on the pump component to deliver a solution, and an electronic control module for Actuation of the pump drive, wherein the pump component comprises at least one receiving part with a delivery channel, which extends on the inlet side and outlet side in each case a hose connection, and a pump diaphragm made of a flexible material forming a pumping chamber.
  • the pump component can be detached from the pump drive and designed as a disposable module.
  • the pump component can be designed like a cassette and is therefore easy to handle as a separate unit and can be connected to the pump drive with high repeat accuracy of the positioning and released again.
  • the pump component can be made relatively small.
  • 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.
  • the miniaturized pump component transports a defined volume of the solution per unit of time through the flexible pumping chamber and the outlet-side hose connection via a further hose to the patient.
  • the pumping chamber is designed to actively switch the inlet and outlet valves and they are integrated into the pumping chamber so that there are no residual volumes that would be uncontrollable by peristalsis.
  • This design of the pumping chamber according to the invention leads to a significantly improved intake behavior in comparison to the prior art and to a significantly improved compression behavior during liquid ejection from the pumping chamber.
  • the pump chamber design according to the invention avoids that in particular variable upstream and downstream pressures act on the pumping chamber, it avoids that sustained air bubbles can accumulate in the pumping chamber.
  • the design ensures a well-defined, effective pumping chamber volume that reproducibly forms with high repeatability and thus ensures high delivery rate accuracy.
  • connection of the hoses with the hose connections can by gluing or welding, in particular by means of a laser beam, or by force simple plugging done.
  • the pumping of the solution ie the actual volumetric application, depends on the flexible pumping chamber and the pump drive, ie components of the infusion pump, and not on the hose used, in particular on a pump hose segment with all its disadvantages. whereby a good reproducibility and accuracy in the administration of the solution can be achieved.
  • the pump component can be designed like a cassette and is therefore easy to handle as a separate unit and can be detachably connected to the pump drive.
  • the cassette-like design ensures correct connection of the pump component with the pump drive, for example in a common housing.
  • the pump component can be mounted to the pump drive such that desired degrees of freedom are kept.
  • the storage can be carried out in the manner of a floating storage.
  • a storage with fixed and / or floating bearings is possible and a fixed clamping is not excluded.
  • the receiving part in which the delivery channel is formed on the side facing the pump membrane and thus also an intermediate part, is made of a rigid material, in particular a plastic, in order to give the pump component a sufficient stability against deformation.
  • the pump component 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 cavities on its upper side facing the pump membrane, which in turn are separated from the pump membrane, which is made of a flexible material. is, for example, a silicone sealed.
  • a flexible material is, for example, a silicone sealed.
  • Through vertical connecting 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, ie 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 eino in a peripheral frame of the receiving part.
  • 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, with the pump diaphragm being deformable with respect to the rigid intermediate part.
  • the inner surface of the pump membrane 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.
  • a cover plate rests on the pump membrane, 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 membrane protrudes.
  • the cover plate may have an outer contour congruent with the pump diaphragm and the intermediate part and also in the peripheral one Eino frame of the receiving part.
  • the cover plate is firmly connected to the intermediate part in sections by gluing or welding. This creates the necessary mechanical pressure on the intermediate pump diaphragm, which seals it by pressing and a suitable seal geometry around the cavities of the intermediate part.
  • 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. All movable functional elements of the pump module are united in a single flexible pump membrane.
  • the multilayer stack is small, very flat and relatively inexpensive to manufacture with low dimensional and dimensional tolerances.
  • the miniaturized pump component is removable from the pump drive, wherein at the latest with the removal of an anti-free-flow valve closing, which is achieved by means of an actuator associated with the pump drive, to correctly inserted or with the pump drive and / or a pump housing component coupled to release a flow for the solution.
  • an anti-free-flow valve closing which is achieved by means of an actuator associated with the pump drive, to correctly inserted or with the pump drive and / or a pump housing component coupled to release a flow for the solution.
  • the electronic drive unit which essentially comprises the pump drive
  • the control electronics and a monitoring sensor system preferably in a common housing or encapsulated by a membrane
  • the anti-free-flow valve closes ( AFF valve) automatically to prevent unwanted uncontrolled drug flow between the reservoir and the patient.
  • the AFF valve is already actively closed by the actuator as soon as the pump is stopped, and the AFF is not opened until the pump is started. Opening and closing of the AFF valve takes place with the pump cover closed. This avoids an undefined closure condition of the AFF valve during removal or insertion of the pump component.
  • the pump component comprises a mechanical or electronic coding, which is provided by the pump drive and / or the control module for definite Neten operation of the infusion pump can be detected and / or decoded 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.
  • a needs-based volume of the pumping chamber can also be selected which, for example, is between 10 ⁇ l and 200 ml, preferably between 15 ml and 150 ml, more preferably between 20 ml and 100 mI_, so that both small volumes delivered in neonatology at a quasi-continuous delivery rate and relatively large volumes can be delivered and administered by selecting and using the appropriate pump component, which of course is easily recognizable is coupled to the pump drive. In particular, errors in the operation of the infusion pump are reduced by the coding.
  • a pump tappet is expediently arranged between an inlet-side and an outlet-side valve tappet.
  • the pump plunger and the two valve tappets are connected to the pump drive for periodic, peristaltic deformation of the pump diaphragm in the area of the pumping chamber.
  • the pumping chamber is designed as an elongated cavity.
  • the functions of inlet and outlet valves are integrated into the pumping chamber having vertically aligned inlet and outlet ports which are opened and closed by locally depressing the soft pump diaphragm in the area of the pumping chamber through the outer valve tappets.
  • the shape of the cavity is chosen such that the membrane is fixed around the pumping chamber.
  • the inside of the membrane is supported in the inlet and outlet areas of the pumping chamber.
  • the membrane is biased and positioned so that the inner surface of the membrane forms, together with the cavity, a well-defined effective pumping chamber volume between the inlet and outlet channels.
  • the design of the pump Chamber is designed so that the effective pumping chamber volume is essentially due to the geometry and the geometrical tolerances of the pumping chamber cavity in the hard intermediate part. Other tolerances of the membrane geometry, hardness tolerances of the membrane and temperature influences on the membrane hardness have no or only insignificant effect on the effective pumping chamber volume.
  • the design of the pumping chamber also avoids residual volumes that would not be achievable by the peristalsis with undefined fill states and pressures that would degrade the delivery rate accuracy.
  • the volume of the pumping chamber is periodically changed by the third pusher, the pump plunger, acting from outside, whereby the flub of this pump plunger defines the so-called displacement.
  • 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 effective pump chamber volume immediately before the opening of the inlet valve is zero ml, because there are no residual volumes with undefined fill state and pressure in the pump chamber, and then with the opening of the inlet valve and by lifting of the pump stem to a volume defined only by the geometry of the cavity and the geometry of the membrane inner surface.
  • the momentary pumping chamber volume and thus the filling volume in this intake phase is greater than the effective pumping chamber volume.
  • the inlet valve closes. To a small extent, the aspirated liquid is again forced out of the pumping chamber through the inlet, because the volume of the pumping chamber is reduced to its effective pumping chamber volume only by closing the inlet valve.
  • the integration of the inlet valve in the pumping chamber thus ensures that the sucked-in volume of liquid in the pumping chamber over long pressure ranges only insignificantly depends on the current upstream pressure.
  • the sucked liquid in the pumping chamber after the closing of the inlet valve and the opening of the outlet side valve by the pump plunger from the pumping chamber pushed out. Only after the outlet valve has closed, this emptying process is completed, and the pumping chamber is again reduced to the volume 0 ml_. Since the outlet valve is also integrated into the pumping chamber, maximum compression of the pumping chamber is achieved. There is no residual volume with an undefined state of filling and undefined, due to changeable downstream pressures, pressures in the pumping chamber that would negatively affect the suction and discharge of the liquid at the next pumping cycle.
  • the pump plunger does not contact the membrane. In this case, thickness tolerances of the diaphragm in the area of the pump plunger do not affect the effective pumping chamber volume.
  • the plungers preferably have a flat contact surface with the outwardly convex shaped membrane.
  • the peristalsis in interaction with the membrane is insensitive to lateral tolerances of the fixed pump module.
  • its profile can be deformed by a suitably selected geometry of the outwardly convex membrane in such a way that a uniform contact pressure of the membrane in the region of the pumping chamber is produced, in order to ensure a sufficiently high compression pressure in the pump chamber Pumping chamber to produce.
  • the pump membrane has material weakenings. Due to the weakening of the material, the pretension and the shape of the membrane can be influenced by means of the associated valve tappets in such a way that preferably defined sections of the convex pump membrane are moved in the direction of the intermediate part in order to open the associated inlet or outlet opening in the intermediate part Close intermediate part.
  • the pump plunger is in permanent contact with the diaphragm to pre-bias it in addition to the valve lifters. and to increase the rigidity of the pumping chamber during the suction of liquid keit.
  • thickness tolerances of the membrane affect the effective pumping chamber volume is corrected by preferably measuring a stroke and an actuating force by means of a displacement sensor and / or a force measuring sensor on the pump tappet and the measurement data can be evaluated on the control module.
  • Manufacturing tolerances, in particular the thickness of the pump diaphragm or the depth of the pump cavity in the hard intermediate part generate fluctuations in the effective volume of the pump chamber, which can be detected and corrected by recording a force-displacement characteristic curve.
  • 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.
  • the air detection sensor preferably comprises a piezoelectric sensor, whose transmitter transmitting a sound wave and the receivers reflecting the reflected sound signals are arranged on the same side.
  • the air sensor is located in the area of the cylindrical hose connections, whereby the hose connection has a recess with a flat base. In the water base may be the central axis of the underlying river channel.
  • 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 selected such that the focus lies on the piezo sensor in order to increase the intensity of the receiving sound signal.
  • the received sound reflexes change their amplitude depending on the current filling state in the flow channel. Air in the flow channel increases the sound wave reflection at the cylindrical interior 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.
  • At least one pressure sensor is coupled to the control module, wherein the pump membrane has pressure membrane areas.
  • 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 transmitted from the pump membrane in the pressure membrane areas to the pressure sensor with minimal loss of information.
  • the sensitivity of the internal pressure measurement is influenced by the mechanical properties of the pump diaphragm in the pressure membrane areas.
  • the internal pressure prevailing in the pump component should be transferred to the pressure sensor with as little as possible stored deformation work in order 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.
  • the pressure sensor is in contact with the hose wall of the radially less elastic pump hose segment, so that this measurement approach is significantly less sensitive and less accurate than the pressure measurement on the elastic pump diaphragm.
  • occlusions in the upstream and downstream regions of the infusion tube can be detected with the pressure sensors.
  • pressure deviations with respect to reference pressures stored in the control module can also be measured.
  • the control module may calculate therefrom a correction quantity to determine the cycle frequency of the To change the drive so that the delivery rate is kept constant, regardless of the upstream or downstream pressures in the infusion tube.
  • 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, in addition to control devices and adjusting devices coupled to the control electronics, also has at least one fixing device for the pump component.
  • the pump component is preferably positionally positioned in a receptacle of the housing of the infusion pump or a correspondingly shaped cover and can be secured in position, for example, by a cover that can be closed with a simple lever.
  • the pump component is precisely aligned relative to the peristaltic nature of the 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.
  • the contact forces can vary due to tolerances between different drives.
  • the membrane is pressed into the cavity differently in interaction with various drives, in particular by the valve tappets, which has an influence on the effective pumping chamber volume.
  • corresponding calibration parameters of the respective drive can be stored in the control module in order to correctively switch off these residual influences on the diaphragm and its shape and thus on the effective pump chamber volume.
  • All interactions between the Pump component and the housing can be easily done on only one functional surface of the pump component, namely the cover plate. Since different layers of the pump component are made of hard parts, a very simple, preferably one-handed, insertion of the pump component into the cavity, ie the housing of the pump housing and, if appropriate, the securing of the pump component in the receptacle by closing the cover or a locking Lung element possible, wherein 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 in particular facilitates the handling of the infusion tube while maintaining sterile conditions.
  • a simple replacement of the disposable pump component while maintaining the remaining components of the infusion pump is ensured, for example, to use a specific, preferably correspondingly coded pump component with a smaller displacement volume with respect to certain indications, which is quasi-continuous even with small delivery rates River allows.
  • 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.
  • 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.
  • the design of the pump component in interaction with the electronic pump drive implements a volumetric infusion pump that 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 ⁇ l and thus about a factor of 2-4 smaller than the volume of conventional volumetric peristaltic pumps, it being apparent to the person skilled in the art that a volume in particular less than 20 ml or greater than 100 mI_ by a corresponding adjustment of the pumping chamber with the same stroke of the pump penst formulateels is adjustable.
  • the infusion pump With the infusion pump, a quasi-continuous flow rate can be generated, and high delivery rate accuracy can also be achieved, in particular at low delivery rates and with short application times.
  • 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 approx. 1000 - 1500 ml / h can be set, which are comparable to those of classic volumetric peristaltic pumps.
  • the inventive pump component together 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, make 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 preferred smaller than 25 mm, which provides ergonomic advantages in the application, during transport and in particular stowage of mobile usable infusion pump with itself.
  • the energy efficiency of the inventive pump peristalsis due to the fact that the deformation of the pump membrane requires less energy than the deformation of a hose, results in much greater autonomy of the electronic drive unit compared to conventional 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 diaphragm and thus simple and from one side, ie a functional level through which axially movable actuators and sensors in the electronic drive unit, which includes the pump drive and the control electronics with associated sensors, operable.
  • FIG. 1 is a schematic partial representation of an infusion pump according to the invention
  • FIG. 3 is a plan view of the pump drive of the infusion pump of FIG. 1,
  • FIG. 4 is a side view of the illustration of FIG. 3,
  • FIG. 10 is an exploded view of the sectional view of FIG. 9,
  • FIG. 11 is a sectional view along the line XI-XI of Fig. 1,
  • FIG. 12 is an exploded view of the sectional view of FIG. 11, 13 is a plan view of a cover plate of a pump component of the infusion pump according to Fig. 1,
  • FIG. 16 is a plan view of a pump diaphragm of the pump components of the infusion pump of FIG. 1,
  • FIG. 17 is a sectional view along the line XVII-XVII of FIG. 16,
  • FIG. 19 shows a plan view of an intermediate part of the pump component of the infusion pump according to FIG. 1,
  • 21 is a sectional view along the line XXI-XXI of FIG. 19,
  • FIG. 22 shows a plan view of a receiving part of the pump component of the infusion pump according to FIG. 1, FIG.
  • FIG. 24 is a sectional view according to the line XXIV-XXIV of FIG. 22 and FIG. 25 is an alternative partial view of the infusion pump according to FIG. 2.
  • the infusion pump essentially comprises a miniaturized pump component 1, a pump drive 2 and a control module 3, which are accommodated in a common housing 63 of the infusion pump.
  • the pump component 1 is constructed from a plurality of layers having a substantially rectangular base area and fixed relative to the pump drive 2 such that the pump component 1 can be removed from the pump drive 2 and removed from the housing.
  • a cover 68 which can be pivoted in the housing and can also be embodied as a type of retaining bracket or the like, can releasably fix the pump component 1.
  • the pump component 1 may be suitable for single use while retaining the remaining components of the infusion pump.
  • the pump component 1 comprises a receiving part 4 made of a dimensionally stable and essentially rigid material with an inlet-side hose connection 5 and an outlet-side hose connection 6. Between the two hose connections 5, 6 there extends a delivery channel 7 for the solution to be applied.
  • the conveying channel 7 is circumferentially provided with a groove 66 which corresponds to a spring 8 on the underside of an intermediate part 21 to seal the conveying channel 7 by gluing or welding, wherein the spring engages in the groove 66 in the assembled state of the pump component 1 ,
  • a groove 66 which corresponds to a spring 8 on the underside of an intermediate part 21 to seal the conveying channel 7 by gluing or welding, wherein the spring engages in the groove 66 in the assembled state of the pump component 1 .
  • the outlet-side hose connection 6 is to be coupled with an infusion hose for the patient.
  • the receiving part 4 is provided in one embodiment with a one-sided raised edge to align and seal layers arranged above.
  • a circumferentially closed first section 9 of the conveying channel 7 leads to a second section 10 extending perpendicularly thereto, which extends into the open at the front side. Furthermore, an open channel section 13 is arranged in a third section 11 of the conveying channel 7, which terminates 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 and corresponds to the inlet opening 28 and one Inlet of an inlet valve 19 forms.
  • a depression 67 in the receiving part 4 gives space for receiving a cavity 30 or bulge of the pump chamber 14 on the underside of the intermediate part 21, as a result of which the overall height of the stack can be minimized. From the other end of the pumping chamber
  • a fifth channel section 17 in the intermediate part 21 connects the vertical passages 22a, 22b in the sink 24 and opens into the sixth section 18 closed on the bypass side in the receiving part 4, the sixth section 18 of the conveying channel 7 leading to the outlet-side hose connection 6.
  • the likewise rectangular intermediate part 21 is sealed from a rigid plastic material.
  • the intermediate part 21 has the first passage 22a of an anti-free-flow valve 23, which extends through the thickness thereof and is arranged to prevent inadvertent flow of the fluid through the pump component 1 to the patient, through the passage 22a the solution of the fourth section 16 of the conveying channel 7 in a recess 24 and passes through the other passage 22b of the receiving part 4 in the sixth section 18 as soon as the anti-free-flow valve 23 is opened.
  • the depression 24 gives the overlying membrane 31 movement space in order to axially displace the valve attachment 36 connected to this membrane 31 by an externally acting force in the passage 22a.
  • the passage 22a is opened when the diaphragm 31 is deformed with an actuator into the recess 24 under tension.
  • the diaphragm 31 automatically returns to its relaxed initial state, it rises out of the recess 24 and closes with the valve lug 36 the passage 22 a. Furthermore, in the intermediate plate 21, an inlet-side passage 25, which is associated with the open channel section 13 of the third section 11 of the conveyor channel 7, and an outlet-side passage 26, which is associated with the open channel section 15 of the fourth section 16 of the conveyor channel 7, educated.
  • the spring 8 is designed in the form of a circumferential web which correspondingly dips into the groove 66 of the receiving part 4, encloses the associated channel section 15 and by gluing or sealing of groove 66 and spring 8 seals.
  • the concave cavity 30, which is a component of the pumping chamber 14, is associated at one end with an inlet 28 for the liquid associated with the inlet valve 19 and an outlet 29 associated with the outlet valve 20, which fluidically communicates with the open channel section 13 of the third Section 11 of the conveying channel 7 and the open channel section 15 of the fourth section 16 of the conveying channel 7 are in communication.
  • the pump diaphragm 31 has a convex curvature 32, which is part of the pumping chamber 14.
  • the elongated convex curvature 32 is provided with material weakenings 33 for forming the inlet valve 19 and the outlet valve 20, the end portions 34 of the bulge 32 of the pump membrane 31 sealingly on the inlet side and outlet side, respectively, when actuated toward the intermediate part 21 Passage 28, 29 come to rest to release or prevent flow. Furthermore, pressure membrane regions 35 are formed in the pump membrane 31, which extend above the inlet-side and outlet-side passages 25, 26.
  • valve seat 36 of the anti-free-flow valve 23 is formed on the pump diaphragm 31, which extends through the associated passage 22a in the intermediate part 21 and which is biased against the intermediate part 21 to be conically enlarged
  • an opening 37 is recessed.
  • a resting on the pump diaphragm 31 cover plate 38 of a rigid material has in the region of the convex curvature 32 and the pressure membrane portions 35 of the pump diaphragm 31 openings 39.
  • a projection 41 is provided, which engages in the opening 37 of the valve lug 36.
  • the cover plate 38 is convexly curved and, in a region adjacent to the projection 41, has a depression 40 in order to resiliently move the projection 41.
  • the convexity of curvature 23 in this area minimizes influences of lateral tolerances of the unspecified actuator mounted in a housing 63 relative to the central axis of the anti-free-flow valve 23, with the associated actuator being the anti-free-flow valve 23 opens by advancing.
  • the receptacle 65 in the housing 63 is designed so that the pump component 1 automatically aligns correctly after closing the lid 68 and is added to the pump. pen drive fixed 2 becomes. Then, in the region of its convex elevation, the cover plate 38 is contacted above the projection 41 of the anti-free-flow valve 23 by the rigid actuator, which is part of the housing 63 of the infusion pump, and is displaced in the direction of the receiving part 4. As a result, the projection 41 inserted into the opening 37 of the valve lug 36 will move the valve lug 36 towards the release of the passage 22a in the direction of the receiving part 4 and remain elastically biased.
  • the anti-free-flow valve 23 is closed and thereby an uncontrolled flow prevents the liquid to be applied from the reservoir through the pump component 1 to the patient.
  • the actuator is axially displaceable by a motor, which is part of the drive in the housing 63. Only when the pump component 1 is inserted correctly and secured, for example, by the lid 68 of the housing 63 or a headband or the like, the Infusi onspumpe can be started. Only then does the motor advance the actuator and open 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 biased pump diaphragm 31. This avoids an accidentally occurring free flow situation when inserting or removing the pump component 1.
  • the pump drive 2 used in the housing 63, to which the pump component 1 is fixed, essentially comprises an electric pump motor 42 which, via a toothed wheels 44 mounted on shafts 43, couples with a pump tappet 46 and two valve tappets 47, 48 is.
  • the pump tappet 46 and the two valve tappets 47, 48 each have a tappet head 49 and are mounted pivotably on a transmission housing 51 on a tappet foot 50 opposite the tappet head 49.
  • a camshaft 52 which is arranged in the gear housing 51 and driven by the pump motor 42, actuates the pump plunger 46 and the two valve plungers 47, 48 counter to the force with its cams 53 of tension springs 54, which are clamped between the pump plunger 46 and the two valve tappets 47, 48 on the one hand and the gear housing 51 on the other.
  • the camshaft 52 produces a periodic up and down movement of the plunger heads 49 of fixed phase relationship and well-defined amplitude.
  • the plunger heads 49 protrude beyond the gear housing 51 into the open.
  • the gear housing 51 is resiliently mounted relative to the housing 63 and the pump component 1 mounted in the receptacle 65 in order to compensate positional tolerances of the gear housing and thus of the plunger heads 46, 47, 48 relative to the pump component 1.
  • the resilient mounting of the gear housing 51 relative to the housing 63 can be realized, for example, by arranging at least one spring element 69 on the side facing the pump component 1 and at least one bearing element 70 on the side facing away from the pump component 1.
  • the plunger heads 49 or actuation projections 62 of the plunger heads 49 are connected to a flexible sealing element 64 which seals the housing 63.
  • this membrane-type sealing element 64 is fixed laterally to the actuating projections 62 of the plunger heads 49 which are made of a hard material.
  • the hard actuating lugs 62 of the plunger heads 49 are directly in contact with the flexible pump diaphragm 31 of the pump component 1.
  • the tappet heads 49 in contact with the curvature 30 of the pump diaphragm 31, wherein the valve tappets 47, 48 associated with the end portions 34 and on the one hand, the inlet valve 19 and the other outlet valve 20 form or components or actuators of the inlet valve 19 and of the exhaust valve 20 are.
  • the sprung mounting of the drive 2 together with the peristaltic movement of the three plungers 46, 47, 48 cause either the valve lifter 47 or the valve lifter 48 to close the inlet valve 19 or the outlet valve 20 to avoid a free-flow situation ,
  • the control module 3 For monitoring and controlling the pump component 1 and the pump drive 2 as well as the liquid to be administered within the pump component 1, the control module 3 is provided which, in addition to a computer module 55, comprises at least one memory module 56 and at least one data interface 57. Via the data interface 57, relevant data for the control of the pump drive 2 can be transmitted and stored, which relate, 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, the data input by means of any input device known to a person skilled in the art, for example in the form of a keyboard and / or a computer, in particular a mobile computer, inputted to the data interface 57 and stored on the control module 3.
  • the pump component 1 with a code that can be read or detected, and provides information for the control module 3 for the activation of the pump drive 2 in order to achieve a predetermined pumping rate with a specific pump component 1 , which is of course dependent on both the timing of the valve lifters 47, 48 and the pump plunger 46 and the size of the pumping chamber 14.
  • the control module 3 is connected to display elements 58.
  • the display elements 58 may, for example, provide an indication of operating states of the infusion pump, information on an applied volume, supply charge states of accumulators for mobile operation of the infusion pump, and the like.
  • the control module 3 is connected to the actual data acquisition and status evaluation with an air detection sensor 59 in the region of the inlet-side hose connection 5, 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 the region of which the central axis of the hose connection 5 extends.
  • the air detection sensor 59 includes a piezo transmitter for emitting a sound wave reflected from the inner wall of the hose fitting 5 to a receiver, the geometry of the hose fitting 5 acting as a cylindrical reflector transmitting the reflected sound along the cylinder axis to the receiver the Beererfas- sungssensors 59 back focused 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. Since transmitter and receiver are positioned on one side of the hose connection 5, the arrangement is simplified.
  • pressure sensors 60 coupled to the control module 3 are provided in the pressure membrane regions 35 of the pump membrane 31.
  • the internal pressure of the liquid in the pump component 1 is transferred from the pressure membrane regions 35 of the pump membrane 31 with minimal information losses to the corresponding pressure sensor 60, the sensitivity of the internal pressure measurement being influenced by the mechanical properties of the pressure membrane regions 35 of the pump membrane 31.
  • the internal pressure should be transferred to the pressure sensor 60 with as little as possible stored deformation work, wherein the pressure membrane regions 35 can be configured such that the pressure membrane regions 35 are prestressed in contact with the pressure sensors 60 and do not have to pass through a zero point with a minimum restoring force.
  • the pumping chamber 14 is designed as an elongated cavity.
  • the inlet and outlet valves 19, 20 are integrated in the pumping chamber 14.
  • the inlet 28 and the outlet 29 are opened and closed by locally depressing the end-side portions 34 of the soft pump diaphragm 31 by the outer valve lifters 47, 48.
  • the shape of the pumping chamber 14 is selected such that, with the inlet and outlet valves 19, 20 closed at the same time, an effective volume is still present between the inlet 28 and the outlet 29. 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 concave.
  • the volume in the pump chamber 14 is changed periodically with the externally acting pump plunger 46.
  • the present infusion pump is a volumetric, peristaltically operating infusion pump, in which a solid phase coupling between the two valve tappets 47, 48 and the central pump tappet 46 results in a periodic, peristaltic deformation of the arch 30 of the pump membrane 31 in the region of the pumping chamber 14 leads.
  • the pumping chamber 14 is filled by closing the outlet valve 20, opening the inlet valve 19, and moving the pumping plunger 46 away from the pumping chamber 14, wherein a vacuum develops in the increasing volume of the pumping chamber 14 to draw liquid into the pumping chamber 14. It is essential that the self-adjusting suppression is not disturbed by residual volumes with undefined filling state and undefined pressure in the region of the pumping chamber 14.
  • the volume of the pumping chamber 14 is reduced by closing the inlet valve 19, and liquid is expressed through the inlet valve 19 until it is completely closed. Only then has the effective volume of the pumping chamber 14 to be delivered adjusted.
  • the controlled overfilling of the pumping chamber 14 during the suction ensures a reproducible and optimal filling of the effective volume of the pumping chamber 14 after closing the inlet valve 19.
  • the effective volume of the pumping chamber 14 is defined only by the geometry of the cavity itself and by the internal shape of the biased pump diaphragm 31 supported on the inlet 28 and outlet 29. Other tolerances do not work.
  • This effect is essentially produced by the mechanism of the pump peristalsis and by the geometry of the effective pumping chamber 14 in that there is no residual volume with an undefined filling state and filling pressure between the inlet and outlet valves 19, 20 in which air bubbles persist could adversely affect the effective pumping chamber volume and thus the delivery rate accuracy.
  • the effective stiffness of the pump diaphragm 31 and thus of the pumping chamber 14 is substantially due to this Defined bias, so that membrane-specific properties or 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 profiled convexly on the outside in the region of the inlet and outlet valves 19, 20 and in the central region of the pumping chamber 14 in contact with the valve plungers 47, 48 and the pump plunger 46 and in the pressure membrane regions 35, so that the end faces Actuation approaches of the plunger heads 49 and the contact surfaces of the pressure sensors 60 NEN can be designed essentially flat. This avoids 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 do not become negative due to lateral tolerances affected.
  • the convex shape of the pumping membrane 31 is such that upon deformation by the peristaltic plunger 46, 47, 48 it comes to a uniformly distributed contact pressure of the pump diaphragm 31 on the inner surface of the concave shaped pumping chamber 14 to generate stati cal downstream pressures of up to 2 bar. This is advantageous in order to maintain the flow rate accuracy of the infusion pump when downstream pressures occurring through flow resistances should occur up to approximately 1 bar.
  • the peristaltically operating infusion pump comprises the disposable pump component 1, which is mounted relative to the pump drive 2.
  • the pump component 1 is removable from the pump drive 2 and constructed as a stack consisting of the receiving part 4, the intermediate part 21, the soft pump membrane 31 and the cover plate 38.
  • the intermediate part (21) has the cavity 30, which is elongated or elliptical, and the inlet 28 and outlet 29, which correspond with the conveying channels 7 of the receiving part 4.
  • the cavity 30, together with the pump diaphragm 31, forms the pumping chamber 14.
  • the inlet valve 19 and the outlet valve 20 are integrated in the pumping chamber 14 such that the pumping diaphragm 31 interacts with the valve plungers 47, 48 and the pumping plunger 46 applies in sections over the entire surface of the cavity 30 and the pumping chamber 14 is completely compressible without residual volumes.
  • the pump diaphragm 31 is supported by the interaction with the valve tappets 47, 48 in the region of the inlet 28 and the outlet 29 with the pump chamber 14 closed, so that a defined bias, shape and position of the inner surface of the pump diaphragm 31 relative to the intermediate part 21 is generated.
  • An effective pumping chamber volume is formed which, with the inlet valve 19 and the outlet valve 20 closed, is defined by the shape and position of the membrane inner surface and by the geometry of the cavity 30 of the intermediate part 21. reference numeral

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  • Reciprocating Pumps (AREA)

Abstract

La présente invention concerne une pompe à perfusion qui comprend un élément de pompe (1) qui est monté par rapport à un entraînement de pompe (2) comprenant un poussoir de pompe (46) agissant sur l'élément de pompe (1) pour acheminer une solution, et un module de commande électronique (3) pour commander l'entraînement de pompe (2), l'élément de pompe (1) comprenant au moins une partie de réception (4) avec un canal d'acheminement (7) qui s'étend côté admission et côté évacuation dans respectivement un raccord de tuyau (5, 6), et une membrane de pompe (31) en matériau flexible qui forme une chambre de pompe (14).
EP19703972.0A 2018-02-26 2019-02-01 Pompe à perfusion Pending EP3758774A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102018104229.9A DE102018104229B3 (de) 2018-02-26 2018-02-26 Infusionspumpe
PCT/EP2019/052545 WO2019162064A1 (fr) 2018-02-26 2019-02-01 Pompe à perfusion

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EP3758774A1 true EP3758774A1 (fr) 2021-01-06

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EP19703972.0A Pending EP3758774A1 (fr) 2018-02-26 2019-02-01 Pompe à perfusion

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EP (1) EP3758774A1 (fr)
DE (1) DE102018104229B3 (fr)
WO (1) WO2019162064A1 (fr)

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Publication number Priority date Publication date Assignee Title
CN116870296B (zh) * 2023-09-07 2023-11-21 广东宝莱特医用科技股份有限公司 基于泵秤联调的输注控制方法、装置、设备、存储介质

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL74236A (en) 1984-02-08 1990-07-12 Omni Flow Inc Infusion system having plural fluid input ports and at least one patient output port
US4759264A (en) * 1985-11-18 1988-07-26 Critikon, Inc. Parenteral solution diaphragm pump
DE4336336A1 (de) 1992-11-23 1994-05-26 Lang Volker Kasetteninfusionssystem
CA2145295A1 (fr) 1992-12-30 1994-07-21 Kent D. Abrahamson Membrane pour systeme de pompage de solution parenterale
JP3628699B2 (ja) 1994-05-13 2005-03-16 アボツト・ラボラトリーズ 押しボタン式流れストッパをその上に有する使い捨て注入ポンピングチャンバカセット
US6877713B1 (en) * 1999-07-20 2005-04-12 Deka Products Limited Partnership Tube occluder and method for occluding collapsible tubes
US8465454B2 (en) * 2010-07-23 2013-06-18 Carefusion 303, Inc. Matrix infusion pump and disposable set
EP2446910A1 (fr) 2010-10-27 2012-05-02 Fresenius Kabi Deutschland GmbH Pompe et procédé de transport d'un fluide et corps creux pour une pompe
EP2744533B1 (fr) * 2011-08-19 2019-12-11 ICU Medical, Inc. Système de reconnaissance de modèle, et procédé de détection de gouttelettes de fluide coincées dans une conduite d'administration de fluide d'un système de perfusion
WO2014193246A1 (fr) * 2013-05-31 2014-12-04 Adept Limited Appareil et système de mesure de fluide
US20140378901A1 (en) 2013-06-23 2014-12-25 Q-Core Medical Ltd. Mechanical pump to tube interfaces, systems including the interfaces and methods for producing same
EP3068461B1 (fr) 2013-11-15 2021-04-14 Ivenix, Inc. Chambre de pompe comprenant des modifications de surface interne

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DE102018104229B3 (de) 2019-05-16

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