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KR-20220082005-A - INJECTION END POINT SIGNALLING ASSEMBLY for Pre-Filled Syringes

KR20220082005AKR 20220082005 AKR20220082005 AKR 20220082005AKR-20220082005-A

Abstract

An injection endpoint signaling assembly mounted on a pre-filled syringe and adapted and configured for use with the syringe is provided. The infusion endpoint assembly is configured to prevent signaling of the infusion endpoint before the plunger of the pre-filled syringe reaches a limit of an acceptable degree of direction of infusion movement. The assembly is also configured to enable signaling of the injection endpoint when the plunger of the pre-filled syringe reaches a limit of an allowed degree of direction of injection movement and is prevented from moving in a direction of movement different from the direction of injection movement.

Inventors

  • MARCOZ ALAIN

Assignees

  • Biocorp Production SA

Dates

Publication Date
20220616
Application Date
20191017
Priority Date
20191017

Claims (20)

  1. An injection end point signaling assembly adapted and configured for use with and mounting on a pre-filled syringe, the injection end point signaling assembly comprising: The pre-filled syringe comprises: An elongated hollow syringe body having a proximal extremity and a distal extremity, the hollow syringe body having a first opening at the proximal end and around the first opening at the proximal end. the elongated syringe body having a collar projecting outward of the body; an injection needle mounted on, or mountable to, the distal end of the hollow elongate syringe body and closing a second opening of the hollow elongate syringe body at the distal end; an amount of injectable material introduced into the hollow body; a plunger configured and dimensioned to be inserted into the hollow elongate syringe body through a proximal end and a corresponding proximal opening of the hollow syringe body, the plunger body comprising a stopper positioned at the distal end of the plunger body; and a plunger having a plunger head positioned at a proximal end of the plunger body; the injection endpoint assembly is configured to prevent signaling of the injection endpoint before the plunger reaches a limit of an allowed degree of direction of injection movement; The injection endpoint assembly is also configured to enable signaling of the injection endpoint when the plunger reaches a limit of an allowed degree of direction of injection movement and prevent movement in a direction of movement different from the direction of injection movement , which is an injection endpoint signaling assembly.
  2. The method of claim 1, wherein the endpoint signaling assembly comprises a displaceable electrical contact configured to enable signaling of the injection point.
  3. The method of claim 1, wherein the endpoint signaling assembly comprises plunger movement locking means configured to prevent movement of the plunger in a direction of movement different from that of the injection movement upon reaching a limit of an allowed degree of direction of the injection movement.
  4. 4. The method according to any one of claims 1 to 3, wherein the displaceable electrical contact forms an electrical contact at the same time that the plunger movement locking means engages.
  5. 5. The method according to claim 3 or 4, wherein the plunger movement locking means comprises at least one radially outwardly projecting tine, or a plurality of radially outwardly projecting tines, connected to the plunger body.
  6. 6. The method of claim 5, and the one or plurality of radially outwardly projecting tines are connected to the plunger body via an elastically deformable arm, or a corresponding plurality of elastically deformable arms.
  7. 5. The method according to claim 3 or 4, wherein the plunger movement locking means comprises at least a pair of cooperating and opposite abutment surfaces.
  8. 8. The method of claim 7, and each of the at least one pair of cooperating and opposing abutment surfaces comprises a ridge portion of material.
  9. The method of claim 1, The displaceable electrical contact causes translational movement of the electrical contact applicator from a first non-contact position in which no electrical contact is established, to a second contact position establishing electrical contact, in a direction different from the direction of implantation movement. ) to establish electrical contact via the injection endpoint signaling assembly.
  10. 10. The method of claim 9, wherein the contact applicator is displaced through a translational motion generally parallel to the longitudinal axis of the plunger.
  11. 11. The method according to claim 9 or 10, wherein the contact applicator comprises an electrically conductive surface.
  12. 12. The method according to any one of claims 9 to 11, and the contact applicator is positioned within the plunger head.
  13. 13. The method according to any one of claims 9 to 12, and displacement means for engaging the contact applicator when the plunger is moved in a direction of injection movement and configured to cause displacement of the contact applicator in a direction different from the direction of injection movement.
  14. 14. The method of claim 13, wherein the displacement means is located at least partially on or integrated into the collar of the hollow syringe body.
  15. 14. The method of claim 13, wherein the displacement means is located on a syringe backstop removably mounted to a collar of the hollow syringe body.
  16. 16. The method according to any one of claims 13 to 15, wherein the displacement means comprises a raised arcuate profile.
  17. 17. The method of claim 16, and the raised arcuate profile is positioned coaxially about the longitudinal axis of the plunger, on a proximal surface of the collar, or on a proximal surface of the syringe backstop.
  18. 18. The method according to any one of claims 13 to 17, and anti-tamper means configured to prevent manipulation of the plunger head when electrical contact is established and when the plunger has reached a limit of an acceptable degree of direction of injection movement. .
  19. 19. The method of claim 18, wherein the tamper-resistant means is positioned radially outward of the displacement means about the longitudinal axis of the plunger and comprises a wall projecting proximally.
  20. 20. The method of claim 19, wherein the protruding wall has a proximal end positioned adjacent to or substantially flush with a proximal surface of the plunger head.

Description

INJECTION END POINT SIGNALLING ASSEMBLY for Pre-Filled Syringes FIELD OF THE INVENTION The present invention relates to pre-filled syringes and associated technology. In particular, the present invention relates to a signaling assembly for pre-filled syringes using near-field communication circuitry, generally abbreviated as NFC. Pre-filled syringes are known per se to the skilled person and are commonly used for administration of various fixed or unit doses of substances, which may be medicaments or other substances. For example, pre-filled syringes are commonly used for administration of drugs such as vaccines for immunization campaigns and programs, or for use with fixed, pre-measured and stored doses of drugs, eg, diabetes and diabetics. For the treatment of organ pathologies such as, or other disorders requiring management with administration of antidotes used, for example, in the treatment of snake or spider bites, or severe pain or trauma, myocardial infarction, anaphylaxis, bacterial or for emergency infusions for the treatment or outbreak of other potentially life-threatening conditions, such as toxic shock and the like. Applications for pre-filled syringes are therefore widespread and well known. These syringes are usually: An elongated hollow syringe body having a proximal end and a distal end having a first opening at the proximal end and a collar, or flange, projecting outwardly of the hollow syringe body around the first opening at the first proximal end; the elongated hollow syringe body; an injection needle mounted or mountable at the distal end of the hollow elongate syringe body and closing a second opening of the hollow elongate syringe body at the distal end; a controlled amount of injectable material introduced into the hollow body; and a plunger configured and dimensioned to be inserted into the hollow elongate syringe body through a proximal end and a corresponding proximal opening of the hollow syringe body, the plunger body comprising a stopper positioned at the distal end of the plunger body; and and a plunger having a plunger head positioned at a proximal end of the plunger body. One of the common problems with these pre-filled syringes is to avoid attempted re-use, or for tracking purposes, eg to know when and how much an injectable substance has been administered from the pre-filled syringe. , it is possible to know when the syringe was actually used. To this end, various tracking systems have been associated with these pre-filled syringes in an attempt to overcome this common problem. For example, the international patent application published as WO2014089086 relates to a method for using an electronic pharmaceutical device, such as an auto-injector, comprising a medicament such as epinephrine for treating anaphylactic shock. The device includes an ID tag, memory, display, and speaker, such as a sensor, RFID, NFC, or other tag for short-range wireless communications such as Bluetooth communications, as well as a processor and communication interfaces, the processor being one of the components interconnecting one or more, and the communication interface includes an interface for communication through wifi, a mobile carrier network, or a satellite. The processor is configured to communicate with the at least one remote system, such as a mobile phone, via a communication interface in response to the occurrence of an event, such as administration of the medicament and expiration of the medicament. The sensor detects activation of the device and includes a frangible element that completes or breaks an electronic circuit when the device is activated. The sensor provides a signal to an ID tag to perform an action in response to use of the auto-injector device, along with a log of time of use, changing memory to indicate that the device is being used. The ID tag also provides information from the auto-injector device to an NFC-enabled mobile device, such as a wireless reader such as a mobile phone. The mobile phone uses RFID, NFC, or other wireless communication to read medication information printed on the auto-injector device or stored in the auto-injector device memory. Similarly, a US patent application published as US2019038840 relates to two antennas: a first transmit antenna configured to transmit a control signal to an external device, and a transmit first antenna configured to provide instructions to the transmit antenna to transmit a control signal to an external device. A connected control electronics, and the control electronics prevent the control electronics from providing instructions to the transmit antenna when the bypass antenna is in the undisturbed position, and when the bypass antenna is displaced from the undisturbed position, the control electronics activate the transmit antenna Disclosed is a pre-filled syringe comprising a complex arrangement of a second, bypass antenna arranged and configured to permit providing instructions. A complex arrangement of two anten