WO2013004308A1 - Dispositif pour injection automatique et détection d'occlusion - Google Patents

Dispositif pour injection automatique et détection d'occlusion Download PDF

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Publication number
WO2013004308A1
WO2013004308A1 PCT/EP2011/061442 EP2011061442W WO2013004308A1 WO 2013004308 A1 WO2013004308 A1 WO 2013004308A1 EP 2011061442 W EP2011061442 W EP 2011061442W WO 2013004308 A1 WO2013004308 A1 WO 2013004308A1
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WO
WIPO (PCT)
Prior art keywords
force
occlusion
injection device
offset value
measurements
Prior art date
Application number
PCT/EP2011/061442
Other languages
English (en)
Inventor
Roger Hänggi
Original Assignee
F. Hoffmann-La Roche Ag
Roche Diagnostics Gmbh
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 F. Hoffmann-La Roche Ag, Roche Diagnostics Gmbh filed Critical F. Hoffmann-La Roche Ag
Priority to PCT/EP2011/061442 priority Critical patent/WO2013004308A1/fr
Publication of WO2013004308A1 publication Critical patent/WO2013004308A1/fr

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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
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • 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
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14566—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for receiving a piston rod of the pump
    • 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
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M5/16854—Monitoring, detecting, signalling or eliminating infusion flow anomalies by monitoring line pressure
    • 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
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M2005/16863—Occlusion detection
    • 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
    • A61M2205/332—Force measuring means

Definitions

  • the present invention relates to an injection device for injecting automatically a medicament, and a method for detecting an occlusion in the injection device. Specifically, the present invention relates to an automatic injection device and a method for detecting an occlusion in the injection device using a force measurement unit for measuring an injection force. It is generally insulin that is injected into the body of a patient, although other medicaments to be injected over a long period of time can also be injected by the device, e.g. analgesics, pain killers or cancer drugs.
  • Automatically operating injection devices inject a predefined volume of a medicament into the body of a patient at predefined time intervals or delivery rates, respectively, in a continuous or quasi-continuous way.
  • the delivery rate varies according to an individual schedule, e.g. according to a preprogrammed circadian profile.
  • Some devices allow the additional injection of larger drug boli on demand.
  • This volume is withdrawn from a reservoir, generally an exchangeable ampoule, via a pump mechanism and is injected through an injection needle placed in the patient's body.
  • Automatically operating injection devices may be designed according to the syringe-driver principle.
  • a plunger that is received in a cartridge or ampule is linearly displaced in a controlled way via a typically motor driven pump mechanism with a piston rod that contacts and pushes the piston during operation.
  • a typically motor driven pump mechanism with a piston rod that contacts and pushes the piston during operation.
  • the pump unit operates automatically at predefined time intervals, the pressure in the ampoule and in the feed lines to the patient's body increases, which could cause damage to the injection device.
  • a still greater problem is that, with increasing pressure, the occlusion may eventually break up abruptly and the patient may then receive too large a quantity of the medicament. With a measurement unit that determines an injection force necessary for discharging the medicament, it is possible to ascertain whether an occlusion is present.
  • US 6,659,980 for example, describes such an injection device in which the volume to be injected is discharged by a piston that can be advanced by a spindle driven by an electric motor. I n order to detect an occlusion during injection, US 6,659,980 teaches a first method in which a maximum force threshold is predefined and, if it is exceeded, an occlusion alarm is triggered. In a second method, a force increase in a plurality of force values for discharging the injection volume is recorded.
  • WO 2009/53032 discloses an automatically operating injection device with a measurement unit for measuring and storing force values associated with injections of a medicament.
  • an evaluation unit determines an injection occlusion from the measurement values, whereby a switching unit modifies automatically the time interval between individual force measurements depending on evaluation results provided by the evaluation unit.
  • WO 2009/53032 teaches that the time interval between the basal releases is maintained constant, e.g . three minutes, independently of the time intervals for recording the force values. Initially, the force measurements are taken every three minutes in sync with the basal releases and stored over 30 minutes, and only if the evaluation unit determines based on these force measurements a potential occlusion, there is an extension of the time interval for measuring the force values.
  • the time interval between the single basal releases has to be increased for typical devices due to a limited injection volume resolution .
  • the time interval between basal releases may, e.g., be extended to 30 minutes for a smallest basal delivery rate of 0.02 l U/h (International Units per hour) .
  • the interval between basal releases is longer than the time interval for measuring the force values, resulting in multiple substantially identical measurements between consecutive injections, rather than measurements being in sync with the injections. As a consequence, an occlusion is not detected in this situation .
  • some infusion systems provide a check valve or pressure valve between the ampule and the feed line that only opens at a certain opening pressure.
  • the opening pressure After insertion of an ampule into the injection device, the opening pressure has to be built up in the fluidic system by advancing the piston before the feed line can be filled with medicine in a so-called priming phase and injection can start. Once, built up, the fluidic pressure in the ampule is maintained substantially at the opening pressure. Until the opening pressure is built up, the force values, as determined by the measurement unit, continuously increase in a similar way as in case of an occlusion during regular operation. Therefore, an occlusion detection as disclosed in WO 2009/53032 needs to be deactivated for the time before the actual injections starts.
  • an ampule with connected valve and feed line is removed from the device during operation for some time and subsequently reinserted.
  • the opening pressure of the valve present before, is released.
  • the opening pressure has to be built-up again. Since the device is in a regular operation mode and the occlusion detection is activated, the force increase while building-up the opening pressure may result in a false occlusion alarm.
  • the ampule When inserting an ampule into the device, the ampule is typically fully filled with the plunger being in an end position. This however, is not necessarily the case, for example, if an ampule is filled by a device user only partly, or if readily filled ampules of different filling volumes are commercially available. This is also the case, if an ampule is removed from the device and subsequently re-inserted as described above.
  • a piston rod of the drive mechanism When inserting a new cartridge, a piston rod of the drive mechanism may first be moved forward in a delivery direction, until it contacts the piston of the ampule and building-up the opening pressure of the pressure valve and priming can start.
  • This phase of device operation is referred to as "sniffing phase".
  • the occlusion detection is favourably deactivated . If, however, an ampule is removed during operation and subsequently reinserted, building up the opening pressure and subsequent medicine delivery start immediately without sniffing phase and with the occlusion detection being activated.
  • Detecting occlusions based on force measurements having an offset value deducted therefrom makes it possible to consider in the detection process various sources with a falsifying influence on the detection of occlusions and, thus, to avoid or at least reduce incorrect occlusion alarms.
  • deducting the force offset makes it possible to avoid incorrect occlusion alarms caused by an increase of pressure in the ampoule through regular basal insulin delivery before the opening pressure of a pressure valve is reached as discussed above.
  • reducing the force measurements by the force offset makes it possible to avoid incorrect occlusion alarms which may occur without the force measurement reduction and be caused by pressure fluctuations resulting from a drop in temperature and subsequent increase of pressure resulting from basal delivery.
  • the force offset value is determined based on an opening pressure required for opening a pressure valve arranged at an injection outlet of the injection device. In a further embodiment, the force offset value is determined based on an estimated range of friction of a piston arranged in the injection device for generating the injection force.
  • the force offset value is determined based on an estimated range of friction of a seal, particularly an X-ring, arranged in the injection device.
  • the force offset value is determined based on an estimated measurement error in the force measurements.
  • the force offset value is determined based on an estimated range of temperature variation .
  • the force measurement is set to zero in case deducting the force offset value from the force measurement results a negative value.
  • detecting occlusions comprises taking force measurements at a first measurement rate by a first occlusion detector and generating a first occlusion indicating signal based on a set of force measurements taken at the first measurement rate; taking force measurements at a second measurement rate by a second occlusion detector and generating a second occlusion indicating signal based on a set of force measurements taken at the second measurement rate; and generating an occlusion alarm signal in cases where the first occlusion indicating signal is generated by the first occlusion detector or the second occlusion indicating signal is generated by the second occlusion detector.
  • an injection device for injecting automatically a medicament which comprises a force measurement unit configured to measure an injection force and an occlusion detection system configured to detect occlusions based on force measurements provided by the force measurement unit, the occlusion detection system is further configured to deduct from the force measurements a force offset value, and to detect the occlusions based on the force measurements having the force offset value deducted therefrom.
  • Figure 1 shows an exemplary cross section of an injection device for injecting automatically a medicament into a body of a patient.
  • Figure 2 shows a block diagram illustrating schematically an automatically operating injection device with an occlusion detection system having a force measurement unit, two independent occlusion detectors, and an alarm generator.
  • Figure 3 shows a block diagram illustrating schematically an occlusion detector for an occlusion detection system of an automatically operating injection device.
  • Figure 4 shows a flow diagram illustrating an exemplary sequence of steps for detecting an occlusion in an automatically operating injection device.
  • Figure 5 shows graphs illustrating an example of occlusion detection including the temporal course of force measurements, and different dot products generated by occlusion detectors from force measurements taken at different measurement rates.
  • reference numeral 1 refers to an injection device for injecting automatically a medicament, e.g . insulin, through a catheter 8 under a patient's skin.
  • Figure 1 shows an example of the structural configuration of the injection device 1 .
  • the injection device 1 has a pump mechanism accommodated in a housing 6, a reservoir 2 in which the medicament is stored, and an exchangeable energy supply unit (not shown ) .
  • the pump unit has a piston 3 which comes to lie in the reservoir 2 and which, via a rod-shaped drive member 4, is driven by an electric motor 5 and toothed wheels 7a and 7b.
  • the electric motor 5 and force transmission elements - toothed wheels 7a and 7b that act on a sleeve-shaped, further drive member 9 meshing via a thread 1 4 with the drive member 4 - are arranged on a "free-floating" base 1 3 , which acts on a force sensor 1 1 operating as force measurement unit for determining, as measurement values or force measurements Fn, the injection force F applied for injection .
  • the injection device 1 further comprises a control unit (not shown ) with a controller for the electric motor 5.
  • the control unit comprises a processor as well as data and program memory.
  • the injection device 1 further comprises a one-way (unidirectional) pressure valve 1 5, indicated only schematically in Figure 1 , arranged at the injection outlet of the injection device 1 .
  • the injection device 1 comprises an occlusion detection system DD configured to detect occlusions on the basis of the injection force F measured by the force measurement unit 1 1 .
  • the occlusion detection system DD comprises several functional modules, including two occlusion detectors D 1 , D2 configured to take force measurements by sampling in parallel at different measurement rates SRI , SR2 the injection force F measured by the force measurement unit 1 1 .
  • the occlusion detectors D 1 , D2 are configured to generate occlusion indicating signals Oi l , Oi2 based on a set of force measurements Fn taken at the respective measurement rates SRI , SR2 .
  • TM2 ( ⁇ - ⁇ ) ⁇ — , respectively.
  • sampling times are
  • the sampling times 7S1 and TS2 are set to correspond to the longest and the shortest time interval between consecutive basal releases that may occur for the device.
  • This time interval may, for example, be fixed to 3 minutes for high delivery rates down to a threshold rate below which the interval is extended up to a maximum value of 30 minutes.
  • the occlusion detection system DD comprises a further functional module.
  • the alarm generator 1 2 is configured to generate an occlusion alarm signal OA, if either or both of the occlusion detectors D 1 , D2 generate an occlusion indicating signal Oi l , Oi 2.
  • the occlusion alarm signal OA is used to control, e.g . stop, the motor 5, and/or generate a visual and/or audible alarm.
  • the occlusion detectors D 1 , D2 can each be individually activated or deactivated so that the occlusion detection system DD operates with either one or both of the occlusion detectors D 1 , D2 in parallel.
  • the occlusion detection system DD further comprises a force adjustment module 1 6 configured to calculate an adjusted force measurement F adjusted by subtracting from the force measurements F , in each case a defined force offset value
  • the adjustment module 1 6 is implemented as part of the force measurement unit 1 1 or the occlusion detectors D 1 , D2, or as a separate functional module of the occlusion detection system DD arranged between the force measurement unit 1 1 and one or more occlusion detectors D 1 , D2.
  • Table 1 shows examples of minimum, maximum, and nominal values for the friction force F piston of the piston 3 , the friction force associated with the seal F seal , the force F valve opening for opening the pressure valve 1 5, and the measurement error F error in the force measurement s measurement t ,' whereby J all sig z ) ma values are calculated based on the assumption of a CPK-value of 4 (i.e. assuming a symmetrical distribution of +/- 4 sigma) .
  • the nominal force offset value to be deducted is 7.55 N .
  • the standard variation sigma based on CPK-value of 4 is 0.94 N for the force offset.
  • the valve operates according to specifications.
  • the occlusion detectors D 1 , D2, the alarm generator 1 2, and/or the force adjustment module 1 6 are implemented as programmed software modules comprising computer program code for controlling one or more processors (microcontrollers) of the injection device 1 , or fully or partly by way of hardware components. It should be pointed out that the force adjustment module 1 6 can be implemented in an injection device 1 with an occlusion detection system DD comprising and operating with either one or both of the occlusion detectors D 1 , D2, or with even further occlusion detectors.
  • reference numeral D refers to an embodiment of the occlusion detectors D 1 , D2.
  • embodiment D of the occlusion detectors D 1 , D2 comprises several functional modules including a sampling module S and a control module 1 0 with a computing module C and an analyzing module A.
  • the embodiment D of the occlusion detectors D 1 , D2 further comprises a memory unit SR for storing the current measurement (sampling) rate SRI , SR 2 , an array of memory units F0-F1 0 for storing the set of force measurements Fn taken by the sampling module S at the current measurement rates SRI , SR2 , an array of memory units K0-K1 0 for storing a set of weighting factors Kn, and memory units for storing values of an upper limit L and a lower limit L LOW .
  • the computing module C is configured to calculate from the set of force measurements Fn and the vector of weighting factors Kn the scalar or dot product
  • the analyzing module A is configured to compare the calculated scalar or dot product P to the current values of the upper limit L and the lower limit L low and to generate an occlusion indicating signal Oi, Oi l , Oi2 depending on the result of that comparison, as will be described below.
  • the sampling module S and/or the control module 1 0 with the computing module C and analyzing module A are implemented as programmed software modules comprising computer program code for controlling one or more processors (microcontrollers) of the injection device 1 , or fully or partly by way of hardware components.
  • processors microcontrollers
  • step SO the injection force F is measured continuously or periodically by the force sensor 1 1 operating as force measurement unit.
  • operation of the occlusion detection system DD or the occlusion detectors D 1 , D2, respectively, is delayed by a defined time delay T delay after the priming phase.
  • the time delay T dday is implemented by the control module 1 0 based on a set delay parameter Delay and ensures that there will be no incorrect alarms after the sniffing phase, if there is no priming phase.
  • the delay parameter Delay is expressed in [I II] ; this means that the occlusion detection system DD or the occlusion detectors D 1 , D2, respectively, are not active after the sniffing phase as long as the amount of I lls, indicated by the delay parameter Delay , has not been administered .
  • the control module 1 0 is configured to determine the time delay T del based on the set basal rate BasalRate , defined in [U l/h] and the delay parameter Delay using equation ( 2), where T s , , B , can be set to zero:
  • steps S 1 -S 1 2 are performed for detecting occlusions in the injection device 1 .
  • step S 1 at the set current measurement rate SRI , SR2 , the occlusion detector D 1 , D2 takes a force measurement Fn from the force measurement unit 1 1 .
  • the force measurements Fn are taken in sync with the injection of the medicament, preferably at a defined duration of time, e.g . one second, before an injection.
  • the injection force F is sampled in sync with the injection of the medicament.
  • the force measurement Fn is stored in the memory units F0-F 1 0.
  • the first or oldest force measurement of the current measurement period TMl , TM2 is stored in memory unit F 1 0 ("8.0"), whereas the last or newest force measurement of the current measurement period TMl , TM2 is stored in memory unit F0 ("9.0") .
  • step S3 the computing module C calculates from the current set of force measurements Fn and the vector of weighting factors Kn the scalar or dot product
  • step S4 the analyzing module A checks whether the value of the calculated dot product P is greater than the upper limit P > L If the dot product P is greater than the upper limit P > L up , processing continues in step S 1 2 with generating an occlusion indicating signal Oi. Otherwise, if the dot product P is not greater than the upper limit P ⁇ L up , processing continues instep S5.
  • step S5 the analyzing module A checks whether the value of the calculated dot 5 product P is lower than the lower limit P ⁇ L low . If the dot product P is lower than the lower limit P ⁇ L low , processing continues in step S9; otherwise, if the dot product P is not lower than the lower limit, i.e. the dot product is within the range of the upper and lower limits L low ⁇ P ⁇ L up , processing continues in step S9
  • step S6 the control module 1 0 increases the measurement period TMl , TM2 for the respective occlusion detector D 1 , D2 that had a dot product within the value range of upper and lower limits L l0W ⁇ P ⁇ L up .
  • the respective measurement period TMl , TM2 and sample time TSl , TS2 are doubled, and the corresponding measurement rate SRI , SR2 is halved accordingly.
  • Respective i s modes “Mode l “, “Mode2”, “Mode4", “Mode8”, and “Mode l 6" indicate how many times the respective measurement period TMl , TM2 or sample time TSl , TS2 have been multiplied, e.g. "Mode 1 " indicates that the current measurement period TMl , TM2 or sample time TSl , TS2 corresponds to the initial measurement period TMl , TM2 or sample time TSl , TS2 , respectively; whereas
  • Mode 8 indicates that the current measurement period TMl , TM2 or sample time TSl , TS2 corresponds to an eightfold of the initial measurement period TMl , TM2 or sample time TSl , TS2 , respectively.
  • the control module 1 0 rearranges the set of force measurements stored in the memory units F0-F 1 0 in accordance with the extended measurement period TMl , TM2 and corresponding measurement rate SRI , SR2 .
  • Table 3 illustrates the adjustment and rearrangement of the set of force measurements stored in the memory units F0-F 1 0 when the initial measurement period TMl , TM2 (“Mode 1 ") is doubled (“Mode 2”), quadrupled (“Mode 4”) and octuplicated (“Mode 8”) in length, respectively.
  • step S8 the control module 1 0 adjusts the values of upper limit L and the lower limit L low that are applicable to the current length of the measurement period TMl , TM2 . Subsequently, processing continues in step S 1 by sampling the injection force F at the new sample time TSl , TS2 or sampling rate SRI , SR2 , respectively.
  • Table 4 shows examples of defined values for the upper limit L and the lower limit L low as well as the corresponding sample times TSl , TS2 for the measurement periods TM 1 , TM2 according to Modes 1 , 2, 4, 8 and 1 6, respectively.
  • step S9 the control module 1 0 resets the measurement period TM ⁇ , TM2 for the respective occlusion detector D 1 , D2 that had a dot product below the lower limit L low . Specifically, the respective measurement period TMl , TM2 and sample time TSl , TS2 , and accordingly the corresponding measurement rate SRI , SR2 , are reset to their initial values of "Mode 1 ". In step S 1 0, the control module 1 0 resets the set of force measurements Fn stored in the memory units F0-F 1 0 to zero.
  • step S 1 1 the control module 1 0 resets the values of upper limit L up and the lower limit L low to their initial values of "Mode 1 ". Subsequently, processing continues in step S 1 by sampling the injection force F at the reset sample time TSl , TS2 or sampling rate SRI , SR2 , respectively.
  • step S 1 2 the control module 1 0 generates an occlusion indicating signal Oi, Oi l , Oi2 for the respective occlusion detector D 1 , D2 that had a dot product above the upper limit L .
  • the alarm generator 1 2 Responsive to an occlusion indicating signal Oi, Oi l , Oi2 from either or both of the occlusion detectors D 1 , D2, the alarm generator 1 2 generates an occlusion alarm signal OA.
  • Figure 5 shows an example of occlusion detection by the occlusion detection system DD for a basal delivery rate of 0.02 [l U/h], a basal delivery interval of 2 [h], a priming volume of 0 [I U] , and a delay parameter of 0.5 [I II] .
  • the occlusion detector D 1 is set to a take force measurements Fn at a measurement rate SRI corresponding to a sampling time TSl of 3 minutes.
  • the occlusion detector D2 is set to a take force measurements Fn at a measurement rate SR2 corresponding to a sampling time TS2 of 30 minutes.
  • Figure 5 illustrates in the top graph the temporal course of the force measurements F n in [N] (depending on the embodiment adjusted or not adjusted by the force offset) after a time delay.
  • the top graph further shows the occlusion indicating signal Oi2 generated by the occlusion detector D2.
  • Figure 5 illustrates the dot product P 1 generated by the occlusion detector D 1 operating at the sampling time TSl of 3 minutes and the dot product P2 generated by the occlusion detector D2 operating at the sampling time TS2 of 30 minutes.
  • the occlusion detector D 1 operating at the sampling time TSl of 3 minutes always stays in the 30 minute evaluation period and is, therefore, not configured to detect an occlusion.
  • the occlusion detector D2 operating at the sampling time TS2 of 30 minutes is configured to detect an occlusion and, thus, generate a corresponding occlusion indicating signal Oi2 at the detection time t detection for which the alarm generator 1 2 will generate a corresponding occlusion alarm signal OA.
  • an occlusion would be detected by occlusion detector D 1 , but not by occlusion detector D2.
  • the arrangement of more than one occlusion detector allows the detection of occlusions over a large range of basal delivery rates.
  • a further occlusion detector with a fixed force threshold value may be present as fallback for situations where the somewhat more sophisticated occlusion detectors fail to correctly detect the presence of an occlusion due to a data artefact or the like.
  • the occlusion detectors D 1 , D2 were each associated with an array of eleven array elements for measuring, recording, and processing a set of eleven force measurements Fn over a measurement period TM 1 , TM2 including ten times the sample time TSl , TS2 ; however, one skilled in the art will understand that the occlusion detectors D 1 , D2 and the array can alternatively be configured for different numbers of force measurements Fn and measurement periods TMl , TM2 , e.g . an array with nine or seventeen elements for recording and processing a corresponding number of force measurements Fn over a measurement period TMl , TM2 including eight or sixteen times the respective sample time TSl , TS2 .
  • the initial sampling times TSl , TS2 are set to correspond to the defined lower delivery rate limit (minimum delivery rate) and the defined upper delivery rate limit (maximum delivery rate) of three and thirty minutes, respectively, but one skilled in the art will understand that different values for the initial sampling times TSl , TS2 or corresponding minimum and maximum delivery rates are possible.
  • the computer program code has been associated with specific functional modules and the sequence of the steps has been presented in a specific order, one skilled in the art will understand, however, that the computer program code may be structured differently and that the order of at least some of the steps could be altered, without deviating from the scope of the invention .

Abstract

Selon la présente invention, pour détecter une occlusion dans un dispositif d'injection pour injecter automatiquement un médicament, une force d'injection est mesurée (SO), une valeur de décalage de force est déduite (SO') à partir de mesures de la force d'injection, et des occlusions sont détectées (BD) sur la base des mesures à partir desquelles la valeur de décalage de force est déduite. Par exemple, la valeur de décalage de force est déterminée sur la base d'une pression d'ouverture requise pour ouvrir une valve de pression agencée à une sortie d'injection du dispositif d'injection. La valeur de décalage de force est en outre déterminée sur la base d'une friction estimée d'un piston agencé dans le dispositif d'injection pour générer la force d'injection, une friction estimée d'un joint d'étanchéité, en particulier un joint X-Ring, agencé dans le dispositif d'injection, et/ou une erreur de mesure estimée dans les mesures de force (Fn). La détection d'occlusions sur la base des mesures de force à partir desquelles une valeur de décalage est déduite rend possible la réduction d'alarmes d'occlusion erronées.
PCT/EP2011/061442 2011-07-06 2011-07-06 Dispositif pour injection automatique et détection d'occlusion WO2013004308A1 (fr)

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WO2015172962A1 (fr) * 2014-05-14 2015-11-19 Meamedical Ag Dispositif de dosage pour l'administration d'un fluide médicamenteux depuis un réservoir, comprenant une tige à broche destinée à la translation du piston
WO2016078697A1 (fr) * 2014-11-18 2016-05-26 Meamedical Ag Dispositif de dosage pour la distribution d'un fluide médicamenteux
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WO2015172962A1 (fr) * 2014-05-14 2015-11-19 Meamedical Ag Dispositif de dosage pour l'administration d'un fluide médicamenteux depuis un réservoir, comprenant une tige à broche destinée à la translation du piston
WO2016078697A1 (fr) * 2014-11-18 2016-05-26 Meamedical Ag Dispositif de dosage pour la distribution d'un fluide médicamenteux
WO2016180011A1 (fr) * 2015-05-14 2016-11-17 深圳市科曼医疗设备有限公司 Procédé et dispositif d'identification pour le blocage d'appareil de perfusion
US10314971B2 (en) 2015-11-13 2019-06-11 Fresenius Vial Sas Method for detecting an occlusion in an infusion line
WO2017081034A1 (fr) * 2015-11-13 2017-05-18 Fresenius Vial Sas Procédé de détection d'une obstruction dans une ligne de perfusion
CN108348681A (zh) * 2015-11-13 2018-07-31 费森尤斯维尔公司 用于检测输注管线中的阻塞的方法
EP3167923A1 (fr) * 2015-11-13 2017-05-17 Fresenius Vial SAS Procédé pour détecter une occlusion dans une ligne de perfusion
CN108348681B (zh) * 2015-11-13 2019-11-15 费森尤斯维尔公司 用于检测输注管线中的阻塞的方法
WO2017162447A1 (fr) * 2016-03-23 2017-09-28 Fresenius Vial Sas Dispositif de perfusion et procédé d'administration d'un fluide médical à un patient
CN108883229A (zh) * 2016-03-23 2018-11-23 费森尤斯维尔公司 用于向患者施用医用流体的输注装置及方法
US10881791B2 (en) 2016-03-23 2021-01-05 Fresenius Vial Sas Infusion device and method for administering a medical fluid to a patient
CN108883229B (zh) * 2016-03-23 2021-08-24 费森尤斯维尔公司 用于向患者施用医用流体的输注装置及方法
WO2018041708A1 (fr) 2016-09-02 2018-03-08 Roche Diabetes Care Gmbh Identification d'un type de cartouche de médicament fluide
US11129932B2 (en) 2016-09-02 2021-09-28 Roche Diabetes Care, Inc. Fluid drug cartridge type identification
WO2022125272A1 (fr) * 2020-12-09 2022-06-16 Smiths Medical Asd, Inc. Pompe à perfusion à détection d'occlusion

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