EP3525847A1 - Dispositif de commande pour un dispositif de distribution de médicament - Google Patents

Dispositif de commande pour un dispositif de distribution de médicament

Info

Publication number
EP3525847A1
EP3525847A1 EP17777303.3A EP17777303A EP3525847A1 EP 3525847 A1 EP3525847 A1 EP 3525847A1 EP 17777303 A EP17777303 A EP 17777303A EP 3525847 A1 EP3525847 A1 EP 3525847A1
Authority
EP
European Patent Office
Prior art keywords
medicament
controller
delivery device
plunger rod
resilient member
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.)
Withdrawn
Application number
EP17777303.3A
Other languages
German (de)
English (en)
Inventor
Christian Keller
Pei Chi HU
Shih Hsun TU
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.)
SHL Medical AG
Original Assignee
SHL Medical AG
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 SHL Medical AG filed Critical SHL Medical AG
Priority claimed from PCT/EP2017/075367 external-priority patent/WO2018069150A1/fr
Publication of EP3525847A1 publication Critical patent/EP3525847A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof
    • A61M5/3157—Means providing feedback signals when administration is completed
    • 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
    • A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver

Definitions

  • the present invention is directed to a controller for a medicament delivery device, in particular, is directed to a controller configured to detect a completion of a medicament delivery.
  • Advanced medicament delivery devices have been developed in a user-friendly way featured with automatic mechanism.
  • the advanced automatic medicament delivery devices are designed mechanically to achieve an audible, tactile or visual confirmation such that users could use them more intuitively and ergonomically with less risk of human errors.
  • Document EP 258371 OA describes such an advanced automatic medicament delivery device.
  • An automatic injection is initialized while a user presses the proximal end of the medicament delivery device, enabling the needle to penetrate the injection area and then this user may be noticed by a mechanical sound that the injection is completed.
  • the advanced automatic medicament delivery device allows a user to easily accomplish the process of the injection.
  • a mechanical medicament delivery device may not be very precise and adaptive.
  • an audible confirmation of this mechanical medicament delivery device may not correspond to precise timing of injection completion and also may not be adjustable/ customizable for indication of a progress of medicament delivery.
  • the present invention is directed to a controller for a medicament delivery device.
  • the medicament delivery device comprises a medicament container, a plunger rod and a resilient member.
  • the plunger rod is in contact with a slidable stopper within the medicament container for expelling a medicament.
  • the resilient member is used for applying a force to the plunger rod upon a delivery of the medicament.
  • the controller is configured to detect a completion of a delivery stroke of the plunger rod according to an inductive property of the resilient member.
  • the inductive property is derived by the frequency variation of the resilient member during the delivery of the medicament.
  • the frequency variation is regarding a resonance frequency derived from a LC circuit including the resilient member.
  • the resilient member is coil shaped and corresponds to an inductive element of the LC circuit.
  • a monitoring of a resonance frequency value of the LC circuit is activated at a time when the delivery of the medicament begins and the resonance frequency value is continuously monitored in order to determine the completion of the stroke of the plunger rod.
  • the completion of the stroke of the plunger rod is determined when the resonance frequency value is detected to be equal to or more than a predetermined frequency value.
  • a monitoring of a resonance frequency difference per unit time of the LC circuit is activated at a time when the delivery of the medicament begins and the resonance frequency difference per unit time is continuously monitored until the completion of the stroke of the plunger rod.
  • the completion of the stroke of the plunger rod is determined at a time when the resonance frequency difference per unit time is substantially equal to 0.
  • the controller controls an indicator to indicate a progress of the medicament delivery.
  • the controller is configured to send a signal to the indicator for indicating the completion of the stroke of the plunger rod and wherein the indicator is configured to indicate the completion of the delivery of the medicament after a predetermined delay time.
  • the medicament delivery device further includes a communication unit configured to communicate with the controller and with an external unit.
  • the indicator is located within the medicament delivery device and/ or the external unit.
  • the predetermined delay time is customizable.
  • the provided medicament delivery device could be customizable to precisely detect the completion of the delivery of the medicament and the controller of the medicament delivery device could be configured to control an indicator to indicate the entire progress of the medicament delivery.
  • Fig. 1 shows a cross section view of a medicament delivery device in an initial state having a controller, an indicator and a communication unit according to an embodiment of the invention.
  • Fig. 2 shows an exemplary schematic LC circuit implemented in the medicament delivery device of Fig. 1 for the detection of the delivery stroke of the plunger rod based on the inductive property of the resilient member, according to an embodiment of the invention.
  • Fig. 3 illustrates a plot of the resonance frequency difference per unit time versus the length of the resilient member.
  • Fig. 4 illustrates an indicator implemented with a medicament delivery device to indicate several phases of a progress of a medicament delivery, according to an embodiment of the invention.
  • Fig. 5 shows a functional block diagram of a controlling circuit implemented in the medicament delivery device of Fig. 1 according to an embodiment of the invention.
  • Fig. 1 shows a cross section view of a medicament delivery device 1 in an initial state having a controller 11, an indicator 13 and a communication unit 12 according to an embodiment of the invention.
  • the medicament delivery device 1 mainly includes a medicament container 80, a plunger rod 90, a slidable stopper 83, a resilient member 91.
  • the medicament container 80 is arranged within the medicament delivery device 1 and has a predetermined volume to contain a medicament.
  • the plunger rod 90 has a proximal end in contact with the slidable stopper 83 and encloses the resilient member 91 which is adapted to apply a force to the plunger rod 90 in the proximal direction.
  • the slidable stopper 83 is disposed within the medicament container 80 for expelling the medicament.
  • the medicament delivery device 1 further includes a cap 10, a tubular activation member 30, a spring 34, a needle 61 and housing members (not shown).
  • a user removes the cap 10 and presses the tubular activation member 30against a delivery area (e.g., against the arm skin of the user)
  • the spring 34 is compressed, the needle 61 is penetrated and the housing members are cooperated with the components 80, 90, 83 and 91 to achieve an automatic injection.
  • the resilient member 91 applies a force to the plunger rod 90 upon the delivery of the medicament.
  • the controller 11 could be configured or programmed to detect the completion of the delivery stroke of the plunger rod 90.
  • the resilient member 91 may be coil shaped or may be a spring and thus the resilient member 91 could be served as an inductor while being implemented in a circuit, i.e., the resilient member 91 has an inductive property.
  • the controller 11 could be configured to detect the completion of the delivery stroke of the plunger rod 90 according to the inductive property of the resilient member 91.
  • the controller 91 could be any available controller which is programmable or configurable.
  • Fig. 2 shows an exemplary schematic LC circuit 15 implemented in the medicament delivery device 1 of Fig. 1 for the detection of the delivery stroke of the plunger rod 90 based on the inductive property of the resilient member 91, according to an embodiment of the invention.
  • the resilient member 91 could be served as an inductor, the resilient member 91 could correspond to an inductive element of an inductance-capacitance (LC) circuit, wherein a capacitor CI could be provided and coupled with the resilient member 91 to form a LC circuit 15.
  • the controller 11 may be coupled to the LC circuit 15 and detect a resonance frequency derived from the LC circuit 15.
  • the controller 11 may be configured to always monitor the resonance frequency value of the LC circuit 15. According to another embodiment, the controller 11 may start to monitor the resonance frequency value of the LC circuit 15 at the time when the delivery of the medicament begins; that is, monitoring the resonance frequency value of the LC circuit 15 is triggered or activated when a user presses the proximal end of the medicament delivery device and starts to inject a medicament.
  • the controller 11 may be continuously monitoring the resonance frequency value of the LC circuit 15 during the delivery of the medicament. In other words, the controller 11 keeps detecting the LC circuit 15 when the medicament is being injected. Subsequently, the controller 11 may determine the completion of the stroke of the plunger rod 90 based on a frequency variation of the resilient member 91.
  • Fig. 3 illustrates a plot of the resonance frequency difference per unit time versus the length of the resilient member 91.
  • the resilient member 91 is in a pre-tensioned state, i.e., the resilient member 91 is compressed with a length LI .
  • the plunger rod 90 is released and the resilient member 91 is increasing length so as to apply forces to the slidable stopper 83 to move, causing the medicament to be delivered.
  • the resilient member 91 stops relaxing and has a length L2.
  • the resilient member 91 is coil shaped with a plurality of helical coils.
  • the resilient member 91 may change length from LI to L2 upon relaxing. Meanwhile, each adjacent pair of the coils of the resilient member 91 may be stretched by a distance, causing the inductance variation of the resilient member 91. Consequently, increasing the distance between each adjacent pair of coils may cause reducing the inductance derived from the resilient member 91 so as to cause the resonance frequency of the LC circuit 15 to vary.
  • a predetermined frequency value could be defined by the capacitance of the capacitor CI and the inductance of the resilient member 91 in the relaxing state with length L2. Accordingly, the controller 11 could determine the completion of the stroke of the plunger rod 90 when the resonance frequency value is detected to be substantially equal to or more than the predetermined frequency value.
  • the controller 11 may initiate monitoring the resonance frequency difference per unit time Af of the LC circuit 15 at the time when the delivery of the medicament begins. Subsequently, the controller 11 could keep monitoring the resonance frequency difference per unit time Af while the plunger rod 90 is moving and the resilient member 91 is relaxing. Consequently, the controller 11 may determine the completion of the stroke of the plunger rod 90 if the resonance frequency difference per unit time Af is detected to be substantially equal to 0, i.e., the resonance frequency of the LC circuit 15 stops varying and becomes a constant value.
  • the controller 11 may be wiredly or wirelessly coupled to an indicator. As shown in Fig. 1, the controller 11 may control the indicator 13 to indicate a progress of the medicament delivery of the medicament delivery device 1.
  • the indicator 13 may be located within the medicament delivery device.
  • the indicator 13 which is wiredly coupled to the controller may be, but not limited to, a LED device, a vibration device, a buzzer or speaker or any device which is tangible for a human.
  • an indicator (not shown) which is wirelessly coupled to the controller 11 may be external to the medicament delivery device 1.
  • an external indicator may be a simple device, such as an external buzzer or speaker, an external vibration device or an external LED device or the like.
  • an external indicator may be an external electronic device, such as a mobile phone, a smart watch, a smart bracelet or the like.
  • an external indicator of the invention is not limited to those devices mentioned above. Any device which could receive indicating signals wirelessly from the controller 11 may also be used as an external indicator for the medicament delivery device 1.
  • the medicament delivery device 1 may further includes a communication unit 12 (as shown in Fig. 1), which may be configured to communicate with the controller 11 and to communicate with an external unit. In this way, the controller 11 may send a signal to an external indicator (not shown) through the communication unit 12.
  • Fig. 4 illustrates an indicator 13 implemented with a medicament delivery device 1 to indicate several phases of a progress of a medicament delivery, according to an embodiment of the invention.
  • the medicament delivery device 1 of Fig. 4 shows an exterior appearance of the medicament delivery device 1 of Fig. 1 that a user may see, wherein the indicator 12 may be e.g., a LED device 12.
  • the medicament delivery device 1 is lidded with a cap in an initial phase. After the cap is removed, the LED device 12 may emit light for a while to indicate that the medicament delivery device 1 is ready for use (a phase of ready-for-use). After the delivery of the medicament is activated, the LED device 12 of the medicament delivery device 1 may start to blink; and the LED device 12 may keep blinking during the delivery of the medicament/dose (a phase of injection). Until the completion of the stroke of the plunger rod (not shown) of the medicament delivery device 1 is determined as mentioned above, the LED device 12 may stop blinking but still emit light for a delay time (a phase of time delay).
  • the LED device 12 may emit light with a different color after the delay time has passed to indicate the real completion of the delivery of the medicament (a phase of finish). After the medicament delivery device 1 is removed (e.g., from a human body), the LED device 12 may stop emitting light.
  • the injection time may depend upon the power source (e.g., battery) of the medicament delivery device 1, properties of the syringe of the medicament delivery device 1 (such as size or material), an amount of medicament/drug, viscosity of medicament/drug, the needle gauge of the medicament delivery device 1 and/or combination thereof. Accordingly, a normal condition of injection time could be determined within a predetermined range before injection. Thus, the controller of the medicament delivery device 1 could also determine a failure condition of injection. For example, if the injection time is too short, the controller of the medicament delivery device 1 may determine that the medicament delivery device 1 is mal- functioned (or jammed). On the other hand, if the injection time is too long, the controller of the medicament delivery device 1 may determine that the plunger rod of the medicament delivery device 1 is moving too slow due to e.g., wear-out.
  • the power source e.g., battery
  • the delay time may be predetermined depending upon human body (who is the target subjected to be injected) properties, medicament parameters, the medicament delivery device design and/or external condition.
  • the human body properties may be, but not limited to, blood pressure, injection site, injection temperature, skin pressure/ resistance, body fat percentage, hydration condition, age and etc.
  • the medicament parameters may be, but not limited to, viscosity, dosage and etc.
  • the medicament device design may be, but not limited to, needle gauge, needle length, injection spring power and etc.
  • the external environmental condition may be, but not limited to, storage temperature and etc.
  • the predetermined delay time is customizable for each individual human body under each individual injection environment.
  • Fig. 5 shows a functional block diagram of a controlling circuit 50 implemented in the medicament delivery device of Fig. 1 according to an embodiment of the invention. Referring to Fig.
  • the controlling circuit 50 includes a power source 56, a controller 11, a detector 57, a resilient member (spring) 91 and an indicator (LED device) 13. While the medicament delivery device is powered on, the controller 11 receives power from the power source 56, which may be e.g., a battery. According to an embodiment of the invention, the controller 11 may control the detector 57 to detect an inductive property (such as resonance frequencies) of the resilient member 91 and the controller 1 1 could control the indicator 13 to indicate the progress of the usage of the medicament delivery device according to the inductive property of the resilient member 91.
  • the power source 56 which may be e.g., a battery.
  • the controller 11 may control the detector 57 to detect an inductive property (such as resonance frequencies) of the resilient member 91 and the controller 1 1 could control the indicator 13 to indicate the progress of the usage of the medicament delivery device according to the inductive property of the resilient member 91.
  • the present invention provides a medicament delivery device with a controller therefor.
  • the medicament delivery device includes a medicament container, a plunger rod and a resilient member.
  • the controller of the medicament delivery device could be configured to sense the inductive property of the resilient member to determine the completion of the delivery stroke of the plunger rod and further to determine the completion of the delivery of the medicament with a customizable delay time.
  • the controller also could control an indicator to indicate the entire progress of the delivery of the medicament. As a result, a precise, customizable and more intuitive medicament delivery device is achieved.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention porte sur un dispositif de distribution de médicament et sur un dispositif de commande. Le dispositif de distribution de médicament comprend un récipient de médicament, une tige de piston et un élément élastique. La tige de piston est en contact avec un bouchon coulissant à l'intérieur du récipient de médicament pour expulser un médicament. L'élément élastique est utilisé pour appliquer une force à la tige de piston lors d'une distribution du médicament. De plus, le dispositif de commande est configuré de sorte à détecter un achèvement d'une course de distribution de la tige de piston en fonction d'une propriété inductive de l'élément élastique.
EP17777303.3A 2016-10-13 2017-10-05 Dispositif de commande pour un dispositif de distribution de médicament Withdrawn EP3525847A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP2016193794 2016-10-13
PCT/EP2017/075367 WO2018069150A1 (fr) 2016-10-13 2017-10-05 Dispositif de commande pour un dispositif de distribution de médicament

Publications (1)

Publication Number Publication Date
EP3525847A1 true EP3525847A1 (fr) 2019-08-21

Family

ID=67251148

Family Applications (1)

Application Number Title Priority Date Filing Date
EP17777303.3A Withdrawn EP3525847A1 (fr) 2016-10-13 2017-10-05 Dispositif de commande pour un dispositif de distribution de médicament

Country Status (1)

Country Link
EP (1) EP3525847A1 (fr)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015187793A1 (fr) * 2014-06-03 2015-12-10 Amgen Inc. Système d'administration de médicament et son procédé d'utilisation

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015187793A1 (fr) * 2014-06-03 2015-12-10 Amgen Inc. Système d'administration de médicament et son procédé d'utilisation

Similar Documents

Publication Publication Date Title
CN118490934A (zh) 具有倾注探测功能的自动注射器
US10653852B2 (en) Medicament delivery device
KR102165552B1 (ko) 진동 센서를 구비한 약물 전달 장치
CN108136121B (zh) 用于附接到注射装置的装置
JP6726751B2 (ja) 薬剤送達デバイス
US11357924B2 (en) Controller for a medicament delivery device
EP3349828B1 (fr) Dispositif d'administration de médicaments
US12109401B2 (en) State estimation for drug delivery systems
US20250099687A1 (en) Smart syringe using nfc communication and capacitance detection
EP3525847A1 (fr) Dispositif de commande pour un dispositif de distribution de médicament
US10960132B1 (en) Clutched delivery device
WO2024110745A1 (fr) Système d'actionnement pour un auto-injecteur

Legal Events

Date Code Title Description
STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: UNKNOWN

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE

PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE

17P Request for examination filed

Effective date: 20190327

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

AX Request for extension of the european patent

Extension state: BA ME

DAV Request for validation of the european patent (deleted)
DAX Request for extension of the european patent (deleted)
STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: EXAMINATION IS IN PROGRESS

17Q First examination report despatched

Effective date: 20210305

P01 Opt-out of the competence of the unified patent court (upc) registered

Effective date: 20230425

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION HAS BEEN WITHDRAWN

18W Application withdrawn

Effective date: 20251222