EP3787733A1 - Infusion device comprising a clamping device - Google Patents

Infusion device comprising a clamping device

Info

Publication number
EP3787733A1
EP3787733A1 EP19718699.2A EP19718699A EP3787733A1 EP 3787733 A1 EP3787733 A1 EP 3787733A1 EP 19718699 A EP19718699 A EP 19718699A EP 3787733 A1 EP3787733 A1 EP 3787733A1
Authority
EP
European Patent Office
Prior art keywords
clamping
infusion
lever
housing
infusion device
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
EP19718699.2A
Other languages
German (de)
French (fr)
Inventor
Damien Archat
Mathieu PAOLI
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.)
Fresenius Vial SAS
Original Assignee
Fresenius Vial SAS
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 Fresenius Vial SAS filed Critical Fresenius Vial SAS
Publication of EP3787733A1 publication Critical patent/EP3787733A1/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M39/28Clamping means for squeezing flexible tubes, e.g. roller clamps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps

Definitions

  • Infusion device comprising a clamping device
  • the invention relates to an infusion device according to the preamble of claim 1 and to a method for operating an infusion device.
  • An infusion device of this kind comprises a housing having a receptacle for receiving an infusion line, a pump mechanism for delivering a medical fluid through an infusion line received in the receptacle, and a clamping mechanism having a clamping element being pivotably connected to the housing and being movable with respect to the housing between a clamping position for acting onto an infusion line received in the receptacle to locally pinch off the infusion line and a release position for allowing a flow through the infusion line.
  • An infusion device in particular a volumetric (peristaltic) infusion device, serves to deliver a medical fluid, such as a medication or a nutritional solution for example for the enteral feeding, to a patient and for this, via its pump mechanism, acts onto an infusion line.
  • the infusion line on one end may be connected for example to a container containing the medical solution and on its other end to the patient, the pump mechanism exerting a pumping force for example in a peristaltic fashion on the infusion line such that the medical solution is transported through the infusion line towards the patient.
  • an infusion set comprising the infusion line is placed on the infusion device, the infusion line being received in the receptacle of the infusion device.
  • the infusion device comprises a clamping mechanism which shall stop a flow through the infusion line at the closing of a door of the infusion device (prior to the start of the actual infusion operation) to be able to perform an integrity check, in particular a so-called OCS (occlusivity check system) test with which the correct functioning of the system, in particular the pumping mechanism is tested.
  • OCS oxygen check system
  • a slide clamp acts onto an infusion line, the slide clamp being automatically closed for pinching off the infusion line when closing a door of the infusion device.
  • an opening mechanism by means of a finger acts onto the slide clamp, such that the pinching of the infusion line is released and a flow through the infusion line may take place.
  • an infusion device which is compatible with different infusion lines of different manufacturers. It furthermore is desirable to provide an infusion device having a clamping mechanism of simple structure and constitution, which is easy and intuitive to use for a user, in particular a nurse in a hospital environment, which furthermore provides for a reliable pinching of an infusion line to prevent a free flow condition even after opening the door of the infusion device, and which also is capable of preventing an unintentional removing of the infusion line from the infusion device.
  • the clamping mechanism comprises a first lever element pivotably connected to the housing and a second lever element connecting the first lever element to the clamping element, the second lever element being operative to act onto the clamping element for moving the clamping element into the clamping position and/or for holding the clamping element in the clamping position.
  • the clamping element of the clamping mechanism is placed on the housing and is pivotable with respect to the housing in order to, in the clamping position, act onto an infusion line received in the receptacle of the housing to locally pinch off the infusion line and, in the release position, allow a flow through the infusion line by releasing the pinching.
  • the movement of the clamping element herein is controlled by a combination of two lever elements, a first lever element being pivotably connected to the housing and a second lever element connecting the first lever element to the clamping element.
  • the movement of the clamping element hence mechanically is controlled by a lever gear, which may be actuated to move the clamping element between its clamping position and its release position.
  • the second lever element may in particular be pivotably connected to the clamping element at a first joint connection and pivotably connected to the first lever element at a second joint connection.
  • the first lever element and the second lever element in this way may form a toggle lever arrangement which may be acted on to move the clamping element for example towards the clamping position and which, in the clamping position, holds the clamping element in a stable fashion such that the clamping position may not be released without further ado, in particular not in an unintentional fashion.
  • the first lever element may for example be pivotable to the housing about a pivot axis.
  • the second joint connection may for example in the release position of the clamping element be located on a first side with respect to a virtual line connecting the pivot axis and the first joint connection in a plane perpendicular to the pivot axis, and in the clamping position of the clamping element may be located on a second side opposite the first side with respect to the virtual line.
  • the second joint connection at which the first lever element is pivotably connected to the second lever element hence, when moving the clamping element from the release position to the clamping position, changes sides with respect to a virtual line drawn in between the first joint connection (at which the clamping element is pivotably connected to the second lever element) and the pivot axis (about which the first lever element is pivotable with respect to the housing), such that a toggle function is provided causing the clamping element to be held in the clamping position in a stable fashion by the two lever elements.
  • the clamping mechanism comprises a spring element being formed and arranged to elastically pretension the first lever element with respect to the housing towards a position corresponding to the release position of the clamping element.
  • the spring element for example being formed by a leg spring, may for example be supported with one leg on the housing and with another leg on the first lever element to exert a force in between the housing and the first lever element towards the release position.
  • the movement of the first lever element towards the release position of the clamping element hence is elastically supported by means of the spring element, such that, once the second joint connection has crossed the virtual line (drawn in between the first joint connection and the pivot axis in said plane perpendicular to the pivot axis), the clamping element by action of the spring element is automatically moved towards the release position.
  • the clamping mechanism may be actuated to move the clamping element between the clamping position and the release position for example by acting onto the first lever element or the second lever element.
  • This in one embodiment, may take place manually by acting onto a handle element connected to the first lever element or the second lever element, such that a user may manually move the clamping element of the clamping mechanism for example into the clamping position or from the clamping position to the release position.
  • the movement of the clamping element to the clamping position may take place automatically when a closure element of the infusion device, also denoted as door, is closed.
  • the closure element is for example pivotably arranged on the housing and, in a closed position, at least partially covers the receptacle.
  • When closing the closure element it, in one embodiment, may act onto the first lever element or the second lever element in order to move the clamping element to its clamping position.
  • the clamping mechanism hence is actuated in order to transfer the clamping element from the release position towards the clamping position such that, when the closure element is closed, an infusion line received on the receptacle of the infusion device is automatically pinched off and a free flow condition through the infusion line is prevented.
  • a pre-test such as an integrity test to check the integrity of the pumping mechanism.
  • the clamping mechanism is opened by transferring the clamping element from the clamping position to the release position such that a medical solution may be delivered through the infusion line in a controlled fashion by means of the pump mechanism acting onto the infusion line.
  • the closure element comprises a body and an actuation element, for example in the shape of a cam, which is movably arranged on the body.
  • the actuation element may for example act onto one of the lever elements such that, by action of the actuation element, the clamping mechanism is actuated and the clamping element is moved to the clamping position.
  • the actuation element may for example be connected with a handle which a user actuates when closing the closure element.
  • the actuation element may be moved with respect to the body of the closure element, such that the actuation element when closing the closure element acts onto one of the lever elements for moving the clamping element from the release position to the clamping position.
  • the clamping mechanism may comprise an opening mechanism having for example a pin movable with respect to the housing by means of an electric motor or the like.
  • the opening mechanism may act onto the first lever element or the second lever element in order to move the first lever element or the second lever element and, with this, the clamping element to transfer the clamping element from the clamping position to the release position.
  • the clamping mechanism comprises a base element arranged on the housing.
  • the base element serves, together with the clamping element, to pinch off the infusion line, the infusion line being received in between the clamping element and the base element and the clamping element being movable with respect to the base element in order to pinch off the infusion line.
  • the base element may for example be received within a reception opening of the housing in a floating fashion such that the base element at least to some degree is movable with respect to the housing in the reception opening.
  • the base element in its position and orientation may automatically adjust, dependent for example on tolerances of the system or a shape and dimension of an infusion line received in the clamping mechanism, with respect to the clamping element such that a reliable pinching of the infusion line may be achieved.
  • the clamping mechanism may in particular be non-releasably arranged on the housing such that the clamping mechanism may act onto different infusion lines received in the receptacle of the housing.
  • the clamping element may be non-releasably connected to the housing, in contrast to arrangements in which a clamping mechanism is arranged on an infusion line and together with the infusion line is placed on an infusion device. This may allow the use of different infusion lines of different constitution and by different manufacturers on the infusion device.
  • the object is also achieved by a method for operating an infusion device, the method comprising:
  • the clamping mechanism comprises a first lever element pivotably connected to the housing and a second lever element connecting the first lever element to the clamping element, wherein the second lever element acts onto the clamping element for moving the clamping element into the clamping position and/or for holding the clamping element in the clamping position.
  • Fig. 1 shows a schematic drawing of an infusion device
  • Fig. 2 shows a schematic view of a clamping mechanism of an infusion device, in a release position of a clamping element of the clamping mechanism
  • Fig. 3 shows a schematic view of the clamping mechanism, in a clamping position of the clamping element
  • Fig. 4 shows a schematic view of the clamping mechanism, in the release position of the clamping element for conducting an actual infusion operation
  • Fig. 5 shows a schematic view of the clamping mechanism, in the clamping position of the clamping element, when actuating the clamping mechanism manually by a user;
  • Fig. 6 shows a detailed view of the clamping element and a base element of the clamping mechanism
  • Fig. 7 shows another detailed view of the clamping element and the base element.
  • Fig. 1 shows, in a schematic view, an infusion device 1 having a housing 10 forming a receptacle 100 to receive an infusion set 3 comprising an infusion line 30 and, possibly, a pumping module 31 in the shape of a pumping cassette or the like therein.
  • the infusion device 1 comprises a pump mechanism 12 to, in a manner known per se, exert a pumping action onto the infusion line 30 and to in this way force a flow of a medical solution through the infusion line 30 to administer the medical solution to a patient.
  • the infusion device 1 may be constituted to act on a pumping module 31 of an infusion line 30 or directly on an infusion line 30. In the latter case any conventional infusion line 30 without comprising a pumping module 31 may be used on the infusion device 1.
  • the infusion set 3 For conducting an infusion operation, the infusion set 3 s placed on the infusion device 1 such that it comes into operative connection with the pump mechanism 12. Upon placing the infusion set 3 on the infusion device 1 , a closure element 1 1 in the shape of a door pivotably connected about a pivot axis 1 10 to the housing 10 is closed such that the infusion set 3 is securely held within the receptacle 100. During an infusion operation, then, a pressure within the infusion line 30 is monitored via a pressure sensor 13, for example to monitor a correct functioning of the device during the infusion and to possibly detect an occlusion condition stemming from an occlusion of the infusion line 30.
  • one pressure sensor may be located upstream of the pumping mechanism 12, and another pressure sensor may be located downstream of the pumping mechanism 12 in order to detect the pressure within the infusion set 3 upstream and downstream of the pumping mechanism 12.
  • the infusion device 1 comprises a clamping mechanism, schematically indicated at reference numeral 2 in Fig. 1 , serving to pinch off the infusion line 30 upon placing the infusion line 30 in the receptacle 100 of the infusion device 1 in order to be able to for example perform a so-called occlusivity pre-test of the pumping mechanism 12..
  • the clamping mechanism of Figs. 2 to 5 comprises a clamping element 20 pivotably connected to a housing portion 102 of the housing 10 about a pivot axis 200 in a non- releasable fashion.
  • the clamping element 20 can be moved with respect to the housing portion 102 in between a release position (Fig. 2) and a clamping position (Fig. 3) in order to, in the release position according to Fig. 2, be able to place an infusion line 30 in between the clamping element 20 and a base element 24 of the clamping mechanism 2 and, in the clamping position according to Fig. 3, locally pinch off the infusion line 30 in order to occlude the infusion line 30 to prevent a free flow of a medical solution through the infusion line 30 towards a patient.
  • the clamping element 20 is operated by means of a toggle lever arrangement comprising two lever elements 21 , 22, a first lever element 22 being connected to the housing portion 102 pivotably about a pivot axis 220 and a second lever element 21 connecting the first lever element 22 to the clamping element 20.
  • the second lever element 21 at a first joint connection 210 is pivotably connected to an end 201 of the clamping element 20 and at a second joint connection 212 is pivotably connected to the first lever element 22.
  • the toggle lever arrangement of the lever elements 21 , 22 serves to actuate the clamping element 20 to move it in between its clamping position (Fig. 3) and its release position (Fig. 2).
  • the toggle lever arrangement of the lever element 21 , 22 furthermore serves to stably hold the clamping element 20 in the clamping position (Fig. 3) such that the clamping element 20 cannot unintentionally be moved out of the clamping position such that an infusion line 30 is securely held by the clamping element 20 in the clamping position.
  • the second joint connection 212 is placed at a first side with respect to a (virtual) line L drawn to connect the first joint connection 210 and the pivot axis 220 in a plane perpendicular to the pivot axis 220 (corresponding to the drawing plane of Figs. 2 and 3).
  • the second joint connection 212 is placed at a second side opposite the first side with respect to the line L, bringing it about that the second joint connection 212 of the toggle lever arrangement of the lever elements 21 , 22 must be moved across the line L to move the clamping element 20 from the release position (Fig. 2) to the clamping position (Fig. 3).
  • the first lever element 21 is tensioned towards the release position by means of a spring element 23, the spring element 23 being formed as a leg spring having one leg 230 supported on the housing portion 102 and another leg 231 supported on the lever element 22.
  • the spring element 23 in this way acts onto the lever element 22 to support the movement of the lever element 22 towards the release position of the clamping element 20.
  • the clamping mechanism 2 in an open position of the closure element 1 1 in the shape of the door of the infusion device 1 , for example is in the release position as illustrated in Fig. 2.
  • the closure element 1 1 In the open position the closure element 1 1 may for example be completely open (at an angle of about 90° to the housing 10).
  • an infusion set 3 can be placed on the infusion device 1 and the infusion line 30 can be received in between the clamping element 20 and the base element 24, as shown in Fig. 2.
  • the clamping mechanism 2 Upon closing the closure element 1 1 by pivoting it about its pivot axis 1 10 in a closing direction A the clamping mechanism 2 is automatically transferred to the clamping position of the clamping element 20, as shown in Fig. 3.
  • a user actuates a handle 1 13 connected to an actuation element 1 1 1 being pivotably arranged about a pivot axis 1 12 on a body 1 14 of the closure element 1 1 , as illustrated in Fig. 2, the handle 1 13 for example being constituted to actuate a locking mechanism for locking the closure element 1 1 in its closed position.
  • the handle 1 13 is moved in a moving direction B as shown in Fig.
  • a pre-test may be conducted while the clamping mechanism 2 with its clamping element 20 is in the clamping position.
  • a so-called pressure rise test may be conducted in order to test an occlusion detection functionality of the infusion device 1.
  • the clamping mechanism 2 is opened by means of an opening mechanism 25 comprising a pin 250 which, in an electric fashion, can be moved with respect to the housing portion 102 in order to act onto the lever element 21 with a tip 251 of the pin 250 and to in this way toggle the arrangement of the lever elements 21 , 22 to move the clamping element 20 to the release position of Fig. 4.
  • Liquid may hence flow through the infusion line 30 and may be delivered by the infusion device 1 towards a patient connected to the infusion line 30.
  • the opening of the clamping mechanism 2 is initiated by the opening mechanism 25 which, with its pin 250, serves to act onto the lever element 21 in order to move the joint connection 212 across the (virtual) line L connecting the joint connection 210 and the pivot axis 220, as indicated in Fig. 3.
  • the joint connection 212 at which the lever elements 21 , 22 are pivotably connected to each other
  • the further movement of the lever elements 21 , 22 and the clamping element 20 towards the release position is forced by the spring element 23 acting onto the lever element 22, the spring element 23 ensuring that the clamping element 20 is fully moved into the release position.
  • a user may again wish to open the closure element 1 1 , for which the user may grab the handle 1 13 to rotate the handle 1 13 together with the actuation element 1 1 1 about the pivot axis 1 12, such that the actuation element 1 1 1 in this way acts onto the lever element 22 to again move the clamping element 20 into the clamping position of Fig. 3.
  • This takes place by action of the end section 1 15 of the actuation element 1 1 1 onto the actuation nose 221 of the lever element 22, such that, when opening the closure element 1 1 , the clamping element 20 is again brought to its clamping position.
  • a user now wishes to remove the infusion line 30 from the infusion device 1 , the user, for example with a finger as illustrated in Fig.
  • the infusion line 30 may easily be removed from the receptacle 100.
  • the opening of the clamping mechanism 2 for removing the infusion line 30 from the infusion device 1 when the closure element 1 1 is opened may also be triggered by the opening mechanism 25.
  • a user may also pull on the infusion line 30 to remove it from the clamping mechanism 2, in which case the clamping mechanism 2 will automatically open due to the elastic pretensioning force of the spring element 23.
  • the base element 24 is floatingly received in a reception opening 103 of the housing portion 102, as it is shown in detail in Figs. 6 and 7.
  • the base element 24 is received movably in the reception opening 103, but is held within the reception opening 103 by fastening sections 241.
  • a support spring 242 supports the base element 24 with respect to the housing portion 102, a clamping face 240 facing a clamping face 202 of the clamping element 20 for receiving the infusion line 30 therebetween.
  • the base element 24 is floatingly arranged on the housing portion 102, tolerances in the system as well as differences in dimension and shape of different infusion lines 30 may be adapted to in an automatic fashion by a floating movement of the base element 24, as illustrated in Figs. 6 and 7.
  • the clamping mechanism In the absence of an infusion line the clamping mechanism automatically assumes its opened state (release position of the clamping element), due to the absence of the infusion line.
  • the actuation of the clamping mechanism requires little force, as it may be achieved by acting onto one of the lever elements.
  • the infusion device may be compatible with a large number of different infusion lines, possibly manufactured by different manufacturers.
  • the clamping mechanism may be designed to reliably resist an unintentional removal of an infusion line.

Abstract

An Infusion device (1), comprises a housing (10) having a receptacle (100) for receiving an infusion line (20), a pump mechanism (12) for delivering a medical fluid through an infusion line (20) received in the receptacle (100), and a clamping mechanism (2) having a clamping element (20) being pivotably connected to the housing (10) and being movable with respect to the housing (10) between a clamping position for acting onto an infusion line (20) received in the receptacle (100) to locally pinch off the infusion line (20) and a release position for allowing a flow through the infusion line (20). Herein, the clamping mechanism (2) comprises a first lever element (22) pivotably connected to the housing (10) and a second lever element (21) connecting the first lever element (22) to the clamping element (20), the second lever element (21) being operative to act onto the clamping element (20) for moving the clamping element (20) into the clamping position and/or for holding the clamping element (20) in the clamping position.

Description

Infusion device comprising a clamping device
Description
The invention relates to an infusion device according to the preamble of claim 1 and to a method for operating an infusion device.
An infusion device of this kind comprises a housing having a receptacle for receiving an infusion line, a pump mechanism for delivering a medical fluid through an infusion line received in the receptacle, and a clamping mechanism having a clamping element being pivotably connected to the housing and being movable with respect to the housing between a clamping position for acting onto an infusion line received in the receptacle to locally pinch off the infusion line and a release position for allowing a flow through the infusion line.
An infusion device, in particular a volumetric (peristaltic) infusion device, serves to deliver a medical fluid, such as a medication or a nutritional solution for example for the enteral feeding, to a patient and for this, via its pump mechanism, acts onto an infusion line. The infusion line on one end may be connected for example to a container containing the medical solution and on its other end to the patient, the pump mechanism exerting a pumping force for example in a peristaltic fashion on the infusion line such that the medical solution is transported through the infusion line towards the patient.
For delivering a medical solution to the patient, an infusion set comprising the infusion line is placed on the infusion device, the infusion line being received in the receptacle of the infusion device. Herein, when placing an infusion line on an infusion device it is to be avoided that a medical solution flows through the infusion line towards the patient in an uncontrolled fashion (so-called free flow condition). For this, the infusion device comprises a clamping mechanism which shall stop a flow through the infusion line at the closing of a door of the infusion device (prior to the start of the actual infusion operation) to be able to perform an integrity check, in particular a so-called OCS (occlusivity check system) test with which the correct functioning of the system, in particular the pumping mechanism is tested. For starting the infusion operation the clamping mechanism is opened such that a flow through the infusion line may take place controlled by the pump mechanism.
In an infusion device known from US 2010/0040481 A1 a slide clamp acts onto an infusion line, the slide clamp being automatically closed for pinching off the infusion line when closing a door of the infusion device. For opening the slide clamp for conducting an infusion operation an opening mechanism by means of a finger acts onto the slide clamp, such that the pinching of the infusion line is released and a flow through the infusion line may take place.
It is desirable to provide an infusion device which is compatible with different infusion lines of different manufacturers. It furthermore is desirable to provide an infusion device having a clamping mechanism of simple structure and constitution, which is easy and intuitive to use for a user, in particular a nurse in a hospital environment, which furthermore provides for a reliable pinching of an infusion line to prevent a free flow condition even after opening the door of the infusion device, and which also is capable of preventing an unintentional removing of the infusion line from the infusion device.
It is an object of the instant invention to provide an infusion device and a method for operating an infusion device which allow to provide for an easy and intuitive use for placing an infusion line on the infusion device, which may allow the use of different infusion lines on the infusion device and which enables a reliable pinching of the infusion line in order to prevent a free flow condition.
This object is achieved by means of an infusion device comprising the features of claim 1 .
Accordingly, the clamping mechanism comprises a first lever element pivotably connected to the housing and a second lever element connecting the first lever element to the clamping element, the second lever element being operative to act onto the clamping element for moving the clamping element into the clamping position and/or for holding the clamping element in the clamping position.
The clamping element of the clamping mechanism is placed on the housing and is pivotable with respect to the housing in order to, in the clamping position, act onto an infusion line received in the receptacle of the housing to locally pinch off the infusion line and, in the release position, allow a flow through the infusion line by releasing the pinching. The movement of the clamping element herein is controlled by a combination of two lever elements, a first lever element being pivotably connected to the housing and a second lever element connecting the first lever element to the clamping element. The movement of the clamping element hence mechanically is controlled by a lever gear, which may be actuated to move the clamping element between its clamping position and its release position.
The second lever element may in particular be pivotably connected to the clamping element at a first joint connection and pivotably connected to the first lever element at a second joint connection. The first lever element and the second lever element in this way may form a toggle lever arrangement which may be acted on to move the clamping element for example towards the clamping position and which, in the clamping position, holds the clamping element in a stable fashion such that the clamping position may not be released without further ado, in particular not in an unintentional fashion.
The first lever element may for example be pivotable to the housing about a pivot axis. For providing a toggle lever arrangement the second joint connection may for example in the release position of the clamping element be located on a first side with respect to a virtual line connecting the pivot axis and the first joint connection in a plane perpendicular to the pivot axis, and in the clamping position of the clamping element may be located on a second side opposite the first side with respect to the virtual line. The second joint connection at which the first lever element is pivotably connected to the second lever element hence, when moving the clamping element from the release position to the clamping position, changes sides with respect to a virtual line drawn in between the first joint connection (at which the clamping element is pivotably connected to the second lever element) and the pivot axis (about which the first lever element is pivotable with respect to the housing), such that a toggle function is provided causing the clamping element to be held in the clamping position in a stable fashion by the two lever elements. In one embodiment, the clamping mechanism comprises a spring element being formed and arranged to elastically pretension the first lever element with respect to the housing towards a position corresponding to the release position of the clamping element. The spring element, for example being formed by a leg spring, may for example be supported with one leg on the housing and with another leg on the first lever element to exert a force in between the housing and the first lever element towards the release position. The movement of the first lever element towards the release position of the clamping element hence is elastically supported by means of the spring element, such that, once the second joint connection has crossed the virtual line (drawn in between the first joint connection and the pivot axis in said plane perpendicular to the pivot axis), the clamping element by action of the spring element is automatically moved towards the release position. This in particular allows that a user may easily fit an infusion line into the clamping mechanism when placing the infusion line on the receptacle of the infusion device, making the placement of the infusion line on the infusion device easy and intuitive for the user.
The clamping mechanism may be actuated to move the clamping element between the clamping position and the release position for example by acting onto the first lever element or the second lever element. This, in one embodiment, may take place manually by acting onto a handle element connected to the first lever element or the second lever element, such that a user may manually move the clamping element of the clamping mechanism for example into the clamping position or from the clamping position to the release position.
In one embodiment, the movement of the clamping element to the clamping position may take place automatically when a closure element of the infusion device, also denoted as door, is closed. The closure element is for example pivotably arranged on the housing and, in a closed position, at least partially covers the receptacle. When closing the closure element it, in one embodiment, may act onto the first lever element or the second lever element in order to move the clamping element to its clamping position. By acting onto one of the lever elements the clamping mechanism hence is actuated in order to transfer the clamping element from the release position towards the clamping position such that, when the closure element is closed, an infusion line received on the receptacle of the infusion device is automatically pinched off and a free flow condition through the infusion line is prevented. Hence, when closing the closure element when closing a door of the infusion device, an infusion line received in the receptacle is automatically pinched off, in particular to conduct a pre-test such as an integrity test to check the integrity of the pumping mechanism.
To then conduct the infusion operation the clamping mechanism is opened by transferring the clamping element from the clamping position to the release position such that a medical solution may be delivered through the infusion line in a controlled fashion by means of the pump mechanism acting onto the infusion line.
In one embodiment, the closure element comprises a body and an actuation element, for example in the shape of a cam, which is movably arranged on the body. When closing the closure element the actuation element may for example act onto one of the lever elements such that, by action of the actuation element, the clamping mechanism is actuated and the clamping element is moved to the clamping position.
The actuation element may for example be connected with a handle which a user actuates when closing the closure element. By means of the handle the actuation element may be moved with respect to the body of the closure element, such that the actuation element when closing the closure element acts onto one of the lever elements for moving the clamping element from the release position to the clamping position.
In order to automatically open the clamping mechanism for an actual infusion operation
(for example after a pre-test prior to the infusion operation has been conducted) the clamping mechanism may comprise an opening mechanism having for example a pin movable with respect to the housing by means of an electric motor or the like. By means of the pin the opening mechanism may act onto the first lever element or the second lever element in order to move the first lever element or the second lever element and, with this, the clamping element to transfer the clamping element from the clamping position to the release position. By means of the opening mechanism in particular the stable position of the toggle lever arrangement of the two lever elements may be overcome by moving the two lever elements such that the second joint connection
(connecting the first lever element to the second lever element) crosses the virtual line connecting the first joint connection (at which the second lever element is pivotably connected to the clamping element) and the pivot axis (about which the first lever element is pivotable with respect to the housing). Once the second joint connection has crossed the virtual line, the further movement of the lever elements may then be induced by means of the action of the spring element tensioning the first lever element towards the release position of the clamping element.
In one embodiment, the clamping mechanism comprises a base element arranged on the housing. The base element serves, together with the clamping element, to pinch off the infusion line, the infusion line being received in between the clamping element and the base element and the clamping element being movable with respect to the base element in order to pinch off the infusion line.
The base element may for example be received within a reception opening of the housing in a floating fashion such that the base element at least to some degree is movable with respect to the housing in the reception opening. In this way and by for example supporting the base element with respect to the housing by means of a support spring, the base element in its position and orientation may automatically adjust, dependent for example on tolerances of the system or a shape and dimension of an infusion line received in the clamping mechanism, with respect to the clamping element such that a reliable pinching of the infusion line may be achieved.
The clamping mechanism may in particular be non-releasably arranged on the housing such that the clamping mechanism may act onto different infusion lines received in the receptacle of the housing. Hence, the clamping element may be non-releasably connected to the housing, in contrast to arrangements in which a clamping mechanism is arranged on an infusion line and together with the infusion line is placed on an infusion device. This may allow the use of different infusion lines of different constitution and by different manufacturers on the infusion device.
The object is also achieved by a method for operating an infusion device, the method comprising:
- receiving an infusion line in a receptacle of a housing of the infusion device for delivering a medical fluid through the infusion line received in the receptacle using a pump mechanism, and
- pivotably moving a clamping element of a clamping mechanism with respect to the housing between a clamping position for acting onto an infusion line received in the receptacle to locally pinch off the infusion line and a release position for allowing a flow through the infusion line.
Herein, the clamping mechanism comprises a first lever element pivotably connected to the housing and a second lever element connecting the first lever element to the clamping element, wherein the second lever element acts onto the clamping element for moving the clamping element into the clamping position and/or for holding the clamping element in the clamping position.
The advantages and advantageous embodiments described above for the infusion device equally apply also to the method, such that in this regard it shall be referred to the above.
The idea underlying the invention shall subsequently be described in more detail with respect to the embodiments shown in the figures. Herein:
Fig. 1 shows a schematic drawing of an infusion device;
Fig. 2 shows a schematic view of a clamping mechanism of an infusion device, in a release position of a clamping element of the clamping mechanism;
Fig. 3 shows a schematic view of the clamping mechanism, in a clamping position of the clamping element;
Fig. 4 shows a schematic view of the clamping mechanism, in the release position of the clamping element for conducting an actual infusion operation;
Fig. 5 shows a schematic view of the clamping mechanism, in the clamping position of the clamping element, when actuating the clamping mechanism manually by a user;
Fig. 6 shows a detailed view of the clamping element and a base element of the clamping mechanism; and
Fig. 7 shows another detailed view of the clamping element and the base element.
Fig. 1 shows, in a schematic view, an infusion device 1 having a housing 10 forming a receptacle 100 to receive an infusion set 3 comprising an infusion line 30 and, possibly, a pumping module 31 in the shape of a pumping cassette or the like therein. The infusion device 1 comprises a pump mechanism 12 to, in a manner known per se, exert a pumping action onto the infusion line 30 and to in this way force a flow of a medical solution through the infusion line 30 to administer the medical solution to a patient.
It shall be noted that the infusion device 1 may be constituted to act on a pumping module 31 of an infusion line 30 or directly on an infusion line 30. In the latter case any conventional infusion line 30 without comprising a pumping module 31 may be used on the infusion device 1.
For conducting an infusion operation, the infusion set 3 s placed on the infusion device 1 such that it comes into operative connection with the pump mechanism 12. Upon placing the infusion set 3 on the infusion device 1 , a closure element 1 1 in the shape of a door pivotably connected about a pivot axis 1 10 to the housing 10 is closed such that the infusion set 3 is securely held within the receptacle 100. During an infusion operation, then, a pressure within the infusion line 30 is monitored via a pressure sensor 13, for example to monitor a correct functioning of the device during the infusion and to possibly detect an occlusion condition stemming from an occlusion of the infusion line 30.
It shall be noted that additional pressure sensors may be present. For example, one pressure sensor may be located upstream of the pumping mechanism 12, and another pressure sensor may be located downstream of the pumping mechanism 12 in order to detect the pressure within the infusion set 3 upstream and downstream of the pumping mechanism 12.
The infusion device 1 comprises a clamping mechanism, schematically indicated at reference numeral 2 in Fig. 1 , serving to pinch off the infusion line 30 upon placing the infusion line 30 in the receptacle 100 of the infusion device 1 in order to be able to for example perform a so-called occlusivity pre-test of the pumping mechanism 12..
An embodiment of a clamping mechanism 2 shall subsequently be explained with reference to Figs. 2 to 5.
The clamping mechanism of Figs. 2 to 5 comprises a clamping element 20 pivotably connected to a housing portion 102 of the housing 10 about a pivot axis 200 in a non- releasable fashion. The clamping element 20 can be moved with respect to the housing portion 102 in between a release position (Fig. 2) and a clamping position (Fig. 3) in order to, in the release position according to Fig. 2, be able to place an infusion line 30 in between the clamping element 20 and a base element 24 of the clamping mechanism 2 and, in the clamping position according to Fig. 3, locally pinch off the infusion line 30 in order to occlude the infusion line 30 to prevent a free flow of a medical solution through the infusion line 30 towards a patient.
The clamping element 20 is operated by means of a toggle lever arrangement comprising two lever elements 21 , 22, a first lever element 22 being connected to the housing portion 102 pivotably about a pivot axis 220 and a second lever element 21 connecting the first lever element 22 to the clamping element 20. For this, the second lever element 21 at a first joint connection 210 is pivotably connected to an end 201 of the clamping element 20 and at a second joint connection 212 is pivotably connected to the first lever element 22.
The toggle lever arrangement of the lever elements 21 , 22 serves to actuate the clamping element 20 to move it in between its clamping position (Fig. 3) and its release position (Fig. 2). The toggle lever arrangement of the lever element 21 , 22 furthermore serves to stably hold the clamping element 20 in the clamping position (Fig. 3) such that the clamping element 20 cannot unintentionally be moved out of the clamping position such that an infusion line 30 is securely held by the clamping element 20 in the clamping position.
In particular, in the release position (Fig. 2) the second joint connection 212 is placed at a first side with respect to a (virtual) line L drawn to connect the first joint connection 210 and the pivot axis 220 in a plane perpendicular to the pivot axis 220 (corresponding to the drawing plane of Figs. 2 and 3). In the clamping position (Fig. 3), in contrast, the second joint connection 212 is placed at a second side opposite the first side with respect to the line L, bringing it about that the second joint connection 212 of the toggle lever arrangement of the lever elements 21 , 22 must be moved across the line L to move the clamping element 20 from the release position (Fig. 2) to the clamping position (Fig. 3). This provides for a toggle action of the toggle lever arrangement of the lever elements 21 , 22, because in the clamping position the lever elements 21 , 22 are held in a stable fashion, such that the clamping element 20 is secured in its interaction with the infusion line 30 received in between the clamping element 20 and the base element 24, as shown in Fig. 3.
The first lever element 21 is tensioned towards the release position by means of a spring element 23, the spring element 23 being formed as a leg spring having one leg 230 supported on the housing portion 102 and another leg 231 supported on the lever element 22. The spring element 23 in this way acts onto the lever element 22 to support the movement of the lever element 22 towards the release position of the clamping element 20.
In the clamping position (Fig. 3) the clamping element 20, by an elastic force of the (resilient) infusion line 30, is stably held due to the position of the lever elements 21 , 22 being in abutment with the housing portion 102, the elastic action of the infusion line 30 exceeding the pretensioning force of the spring element 23 such that the lever elements 21 , 22 cannot be moved (without actuation) towards the release position.
The clamping mechanism 2, in an open position of the closure element 1 1 in the shape of the door of the infusion device 1 , for example is in the release position as illustrated in Fig. 2. In the open position the closure element 1 1 may for example be completely open (at an angle of about 90° to the housing 10). In this state an infusion set 3 can be placed on the infusion device 1 and the infusion line 30 can be received in between the clamping element 20 and the base element 24, as shown in Fig. 2.
Upon closing the closure element 1 1 by pivoting it about its pivot axis 1 10 in a closing direction A the clamping mechanism 2 is automatically transferred to the clamping position of the clamping element 20, as shown in Fig. 3. Specifically, when closing the closure element 1 1 a user actuates a handle 1 13 connected to an actuation element 1 1 1 being pivotably arranged about a pivot axis 1 12 on a body 1 14 of the closure element 1 1 , as illustrated in Fig. 2, the handle 1 13 for example being constituted to actuate a locking mechanism for locking the closure element 1 1 in its closed position. Immediately prior to reaching the fully closed position of the closure element 1 1 , the handle 1 13 is moved in a moving direction B as shown in Fig. 3 (for example to lock the closure element 1 1 with respect to the housing 10), hence pivoting the actuation element 1 1 1 in the shape of a cam about its pivot axis 1 12. In this way the actuation element 1 1 1 acts with an end section 1 15 onto a protruding actuation nose 221 of the lever element 22 and in this way pushes the lever element 22 towards the clamping position of the clamping element 20.
When the closure element 1 1 is closed and the handle 1 13 is no longer actuated, the actuation element 1 1 1 with its end section 1 15 is moved past the actuation nose 221 into the position shown in Fig. 4. When the closure element 1 1 is closed, hence, the clamping mechanism 2 is automatically actuated such that the clamping element 20 assumes the clamping position of Fig. 3. When closing the closure element 1 1 , hence, the infusion line 30 received in the receptacle 100 of the infusion device 1 is pinched off as illustrated in Fig. 3, such that a free flow of liquid through the infusion line 30 is prevented.
Prior to starting an actual infusion operation, a pre-test may be conducted while the clamping mechanism 2 with its clamping element 20 is in the clamping position. In particular, a so-called pressure rise test may be conducted in order to test an occlusion detection functionality of the infusion device 1.
For conducting the actual infusion operation the clamping mechanism 2 is opened by means of an opening mechanism 25 comprising a pin 250 which, in an electric fashion, can be moved with respect to the housing portion 102 in order to act onto the lever element 21 with a tip 251 of the pin 250 and to in this way toggle the arrangement of the lever elements 21 , 22 to move the clamping element 20 to the release position of Fig. 4. Liquid may hence flow through the infusion line 30 and may be delivered by the infusion device 1 towards a patient connected to the infusion line 30.
The opening of the clamping mechanism 2 is initiated by the opening mechanism 25 which, with its pin 250, serves to act onto the lever element 21 in order to move the joint connection 212 across the (virtual) line L connecting the joint connection 210 and the pivot axis 220, as indicated in Fig. 3. Once the joint connection 212 (at which the lever elements 21 , 22 are pivotably connected to each other) has crossed the line L, the further movement of the lever elements 21 , 22 and the clamping element 20 towards the release position is forced by the spring element 23 acting onto the lever element 22, the spring element 23 ensuring that the clamping element 20 is fully moved into the release position.
After termination of the infusion operation a user may again wish to open the closure element 1 1 , for which the user may grab the handle 1 13 to rotate the handle 1 13 together with the actuation element 1 1 1 about the pivot axis 1 12, such that the actuation element 1 1 1 in this way acts onto the lever element 22 to again move the clamping element 20 into the clamping position of Fig. 3. This takes place by action of the end section 1 15 of the actuation element 1 1 1 onto the actuation nose 221 of the lever element 22, such that, when opening the closure element 1 1 , the clamping element 20 is again brought to its clamping position. If a user now wishes to remove the infusion line 30 from the infusion device 1 , the user, for example with a finger as illustrated in Fig. 5, may act onto a handle element 21 1 fixedly connected to the lever element 21 in order to toggle the arrangement of the lever elements 21 , 22 towards the release position of the clamping element 20. In the release position of the clamping element 20 the infusion line 30 may easily be removed from the receptacle 100.
The opening of the clamping mechanism 2 for removing the infusion line 30 from the infusion device 1 when the closure element 1 1 is opened may also be triggered by the opening mechanism 25.
In case of an emergency a user may also pull on the infusion line 30 to remove it from the clamping mechanism 2, in which case the clamping mechanism 2 will automatically open due to the elastic pretensioning force of the spring element 23.
In the embodiment illustrated in Figs. 2 to 5 the base element 24 is floatingly received in a reception opening 103 of the housing portion 102, as it is shown in detail in Figs. 6 and 7. In particular, the base element 24 is received movably in the reception opening 103, but is held within the reception opening 103 by fastening sections 241. A support spring 242 supports the base element 24 with respect to the housing portion 102, a clamping face 240 facing a clamping face 202 of the clamping element 20 for receiving the infusion line 30 therebetween. Because the base element 24 is floatingly arranged on the housing portion 102, tolerances in the system as well as differences in dimension and shape of different infusion lines 30 may be adapted to in an automatic fashion by a floating movement of the base element 24, as illustrated in Figs. 6 and 7.
The idea underlying the invention is not limited to the embodiments described above, but may be implemented in an entirely different fashion.
By means of an infusion device of the described type the placement of the infusion line on the infusion device may become simple and intuitive.
In the absence of an infusion line the clamping mechanism automatically assumes its opened state (release position of the clamping element), due to the absence of the infusion line. The actuation of the clamping mechanism requires little force, as it may be achieved by acting onto one of the lever elements.
Because of the floating arrangement of the base element the infusion device may be compatible with a large number of different infusion lines, possibly manufactured by different manufacturers.
The clamping mechanism may be designed to reliably resist an unintentional removal of an infusion line.
List of Reference Numerals
1 Infusion device
10 Housing
100 Receptacle
101 Front face
102 Housing portion
103 Reception opening
1 1 Closure element (door)
1 10 Pivot axis
1 1 1 Actuation element (cam)
1 12 Pivot axis
1 13 Handle
1 14 Body
1 15 End section
12 Pump mechanism 13 Sensor device
2 Clamp mechanism
20 Clamping element
200 Pivot axis
201 End
202 Clamping face
21 Lever element
210 Pivotable joint
21 1 Handle element
212 Pivotable joint
22 Lever element
220 Pivot connection
221 Actuation nose
23 Spring element
24 Base element
240 Clamping face
241 Fastening portion
242 Support spring
25 Opening mechanism 250 Pin 251 Tip
3 Infusion set
30 Line
31 Pumping cassette A Closing direction B Movement direction C Movement direction L Connecting line

Claims

Claims:
1. Infusion device (1 ), comprising:
- a housing (10) having a receptacle (100) for receiving an infusion line (20),
- a pump mechanism (12) for delivering a medical fluid through an infusion line (20) received in the receptacle (100), and
- a clamping mechanism (2) having a clamping element (20) being pivotably connected to the housing (10) and being movable with respect to the housing (10) between a clamping position for acting onto an infusion line (20) received in the receptacle (100) to locally pinch off the infusion line (20) and a release position for allowing a flow through the infusion line (20), characterized in that the clamping mechanism (2) comprises a first lever element (22) pivotably connected to the housing (10) and a second lever element (21 ) connecting the first lever element (22) to the clamping element (20), the second lever element (21 ) being operative to act onto the clamping element (20) for moving the clamping element (20) into the clamping position and/or for holding the clamping element (20) in the clamping position.
2. Infusion device (1 ) according to claim 1 , characterized in that the second lever element (21 ) is pivotably connected to the clamping element (20) at a first joint connection (210) and pivotably connected to the first lever element (22) at a second joint connection (212).
3. Infusion device (1 ) according to claim 2, characterized in that the first lever element (22) is pivotable to the housing (10) about a pivot axis (220), wherein, when viewed in a plane perpendicular to the pivot axis (220), the second joint connection (212) in the release position of the clamping element (20) is located on a first side with respect to a virtual line (L) connecting the pivot axis (220) and the first joint connection (210) in said plane perpendicular to the pivot axis (220), and in the clamping position of the clamping element (20) is located on a second side opposite the first side with respect to the virtual line (L).
4. Infusion device (1 ) according to one of claims 1 to 3, characterized in that the clamping mechanism (2) comprises a spring element (23) being formed and arranged to elastically pretension the first lever element (22) with respect to the housing (10) towards a position corresponding to the release position of the clamping element (20).
5. Infusion device (1 ) according to one of the preceding claims, characterized in that at least one of the first lever element (22) and the second lever element (21 ) comprises a handle element (211 ) for actuating the clamping mechanism (2).
6. Infusion device (1 ) according to one of the preceding claims, characterized by a closure element (1 1 ) being pivotably arranged on the housing (10) and being configured to, in a closed position, at least partially cover the receptacle (100), wherein the closure element (1 1 ) is operative to act onto one of the first lever element (22) and the second lever element (21 ) for moving the clamping element (20) to its clamping position when pivoting the closure element (1 1 ) towards the closed position.
7. Infusion device (1 ) according to claim 6, characterized in that the closure element (1 1 ) comprises a body (1 14) and an actuation element (1 1 1 ) movably arranged on the body (1 14), the actuation element (1 1 1 ) being configured to act onto one of the first lever element (22) and the second lever element (21 ) when pivoting the closure element (1 1 ) towards the closed position.
8. Infusion device (1 ) according to claim 7, characterized in that the closure element (1 1 ) comprises a handle (1 13) connected with the actuation element (1 1 1 ) for moving the actuation element (1 1 1 ) with respect to the body (1 14).
9. Infusion device (1 ) according to one of the preceding claims, characterized in that the clamping mechanism (2) comprises an opening mechanism (25) being configured to act onto one of the first lever element (22) and the second lever element (21 ) for moving the clamping element (20) to the release position.
10. Infusion device (1 ) according to claim 9, characterized in that the opening mechanism (25) comprises a pin (250) movable with respect to the housing (10) to act onto one of the first lever element (22) and the second lever element (21 ) for moving the clamping element (20) to the release position.
1 1. Infusion device (1 ) according to one of the preceding claims, characterized in that the clamping mechanism (2) comprises a base element (24) arranged on the housing (10), the clamping element (20) being movable with respect to the base element (24) for pinching the infusion line (20) in between the clamping element (20) and the base element (24) in the clamping position and for allowing a flow through the infusion line (20) in the release position.
12. Infusion device (1 ) according to claim 1 1 , characterized in that the base element (24) is movably received in a reception opening (103) of the housing (10).
13. Infusion device (1 ) according to claim 1 1 or 12, characterized in that the base element (24) is elastically supported on the housing (10) by a support spring (242).
14. Infusion device (1 ) according to one of the preceding claims, characterized in that the clamping element (20) is non-releasably arranged on the housing (10).
15. Method for operating an infusion device (1 ), comprising:
- receiving an infusion line (20) in a receptacle (100) of a housing (10) of the infusion device (1 ) for delivering a medical fluid through the infusion line (20) received in the receptacle (100) using a pump mechanism (12), and - pivotably moving a clamping element (20) of a clamping mechanism (2) with respect to the housing (10) between a clamping position for acting onto an infusion line (20) received in the receptacle (100) to locally pinch off the infusion line (20) and a release position for allowing a flow through the infusion line (20), characterized in that the clamping mechanism (2) comprises a first lever element (22) pivotably connected to the housing (10) and a second lever element (21 ) connecting the first lever element (22) to the clamping element (20), wherein the second lever element
(21 ) acts onto the clamping element (20) for moving the clamping element (20) into the clamping position and/or for holding the clamping element (20) in the clamping position.
EP19718699.2A 2018-05-04 2019-04-18 Infusion device comprising a clamping device Pending EP3787733A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP18305559 2018-05-04
PCT/EP2019/060163 WO2019211107A1 (en) 2018-05-04 2019-04-18 Infusion device comprising a clamping device

Publications (1)

Publication Number Publication Date
EP3787733A1 true EP3787733A1 (en) 2021-03-10

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Application Number Title Priority Date Filing Date
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EP (1) EP3787733A1 (en)
CN (1) CN112512620B (en)
WO (1) WO2019211107A1 (en)

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CN112717231A (en) * 2020-12-31 2021-04-30 深圳市好克医疗仪器股份有限公司 Infusion pump

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Publication number Priority date Publication date Assignee Title
JP4754917B2 (en) * 2004-10-19 2011-08-24 テルモ株式会社 Infusion device
FR2908176B1 (en) 2006-11-08 2008-12-19 Fresenius Vial Soc Par Actions DEVICE FOR MONITORING THE OPENING OR CLOSING OF A CLAMP IN A VOLUMETRIC PUMP
US9028456B2 (en) * 2008-04-30 2015-05-12 Namiki Seimitsu Houseki Kabushiki Kaisha Infusion pump
JP2011212112A (en) * 2010-03-31 2011-10-27 Terumo Corp Infusion pump
US10655779B2 (en) * 2011-12-21 2020-05-19 Deka Products Limited Partnership System, method, and apparatus for clamping
EP2832388B1 (en) * 2012-03-26 2016-11-16 Terumo Kabushiki Kaisha Infusion pump
WO2014077308A1 (en) * 2012-11-14 2014-05-22 並木精密宝石株式会社 Tubing pump

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WO2019211107A1 (en) 2019-11-07
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