Infusion endpoint signaling device for pre-filled syringes

Abstract

To provide an injection endpoint signalling device.SOLUTION: There is provided an injection endpoint signalling device for mounting on a pre-filled syringe comprising a needle shroud in which the shroud translates from a first, retracted position to a second, extended position. The injection endpoint signalling device comprises a near field communications (NFC) circuit and an activation switch, and when mounted on the pre-filled syringe, in the first, shroud-retracted position, the activation switch maintains the NFC circuit in an inactive state in which injection endpoint information is inaccessible to the NFC circuit, and in the second, shroud-extended position, the activation switch maintains the NFC circuit in an active state in which the injection endpoint information is accessible to the NFC circuit. The activation switch is moved from the inactive state to the active state via mutually cooperating surface engagement between a part of the shroud and the activation switch.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] The present invention relates to prefilled syringes and related technologies. Specifically, the present invention relates to a signaling assembly for a prefilled syringe that uses a short-range wireless communication circuit generally abbreviated as NFC (near field communications).

Background Art

[0002] Prefilled syringes are themselves known to those skilled in the art and are generally used for the administration of various fixed-dose or unit-dose substances, whether pharmaceutical or other substances? For example, prefilled syringes are generally used for the administration of drugs such as vaccines for vaccination campaigns and programs, or for the treatment of long-term medical conditions such as diabetes, or for the administration of fixed, pre-measured and stored doses of drugs such as antivenoms used in the treatment of snake or spider bites, or for emergency injections for the treatment or onset of other life-threatening situations such as acute pain or trauma, myocardial infarction, anaphylaxis, bacterial or toxic shock. Thus, the uses of prefilled syringes are widespread and well known?

[0003] Such prefilled syringes generally an elongated hollow syringe body having a proximal end and a distal end, the proximal end having a first opening and a collar or flange protruding outwardly of the hollow syringe body around the first opening at the proximal end, an elongated hollow syringe body; a hypodermic needle attached to or attachable to the distal end of the elongated hollow syringe body and closing a second opening of the elongated hollow syringe body at the distal end; a controlled amount of injectable material introduced into the hollow body; A plunger having a plunger body, configured and sized to be inserted into the elongated hollow syringe body via the proximal end of the hollow syringe body and a corresponding proximal opening, wherein the plunger body has a stopper located at the distal end of the plunger body and a plunger head located at the proximal end of the plunger body, It has.

[0004] One common challenge with such pre-filled syringes is the need to indicate when the syringe was actually used, for example, to know whether and how much of an injectable substance was administered from the pre-filled syringe, in order to avoid attempts at reuse or for tracking purposes. For this reason, various tracking systems have been associated with such pre-filled syringes in an attempt to overcome this common challenge.

[0005] For example, an international patent application published as International Publication No. 2014089086 relates to a method for using an electronic drug device, such as an auto-injector, containing drugs such as epinephrine for treating anaphylactic shock. The device includes a sensor, an ID tag such as RFID, NFC, or other tag for short-range wireless communication such as Bluetooth, memory, a display, and a speaker, as well as a processor and a communication interface, the processor interconnecting one or more of the components, and the communication interface including an interface for communication via Wi-Fi, a mobile carrier network, or satellite. The processor is configured to communicate with at least one or more remote systems, such as a mobile phone, via the communication interface in response to the occurrence of events such as drug administration and drug expiration. The sensor detects the activation of the device and includes a vulnerability element that completes or destroys the electronic circuit when the device is activated. The sensor provides a signal to the ID tag to take action in response to the use of the auto-injector device and modifies the memory to indicate that the device has been used, along with a log of usage time. The ID tag also provides information from the auto-injector device to an NFC-enabled mobile device, such as a mobile phone, which is a wireless reader. The mobile phone uses RFID, NFC, or other wireless communication to read the drug information printed on the auto-injector device or stored in the auto-injector device's memory.

[0006] Similarly, a U.S. Patent Application published as U.S. Patent No. 2019038840 discloses a pre-filled syringe having a complex arrangement of two antennas: a first transmitting antenna configured to transmit control signals to an external device; control electronics connected to the first transmitting antenna configured to provide commands to the transmitting antenna for transmitting control signals; and a second bypass antenna positioned and configured to prevent the control electronics from providing commands to the transmitting antenna when the bypass antenna is in an undisturbed position, and to allow the control electronics to provide commands to the transmitting antenna when the bypass antenna is displaced from an undisturbed position. The complex arrangement of the two antennas and the control electronics is incorporated at the proximal end of the syringe plunger and covered by a push button. The bypass antenna is configured as a physically destructive electrical switch so that when the push button is pressed by the user of the syringe, the electrical contacts are disconnected. Pressing the push button irreparably destroys the electrical contacts with the bypass antenna, activating the primary antenna circuit and signaling the start of use of the syringe.

[0007] Furthermore, an international patent application published as International Publication No. 2018111969(A1) discloses a plunger rod designed to dispense a drug from a syringe, comprising a shaft sized and dimensioned to act on the piston of a syringe, and a finger-operated head portion housing at least two subunits of a wireless sensor. In the pre-operated configuration, the subunits are separated from each other by a physical barrier, and the wireless sensor is inactive. In the post-operated configuration, the subunits are connected to each other, and the sensor is activated to transmit a signal. A user operates the finger-operated head portion to reversibly move the physical barrier, transitioning the plunger rod from the pre-operated configuration to the post-operated configuration. The signal transmitted by the sensor contains information regarding the release of the drug from the syringe and is received by a remote receiver.

[0008] Despite the solutions disclosed in the aforementioned literature, many challenges remain to be overcome for injection endpoint detection and signaling using short-range wireless communication. This is especially true for pre-filled syringes that are specifically modified to function in particular ways. For example, pre-filled syringes are known to incorporate safety mechanisms to protect the user from needlestick injury once the injection is complete. Such pre-filled syringes often have a system that automatically protects the user from the needle or removes the needle after the injection is complete. [Prior art documents] [Patent Documents]

[0009] [Patent Document 1] International Publication No. 2014089086 [Patent Document 2] U.S. Patent No. 2019038840 [Patent Document 3] International Publication No. 2018111969(A1) [Overview of the project] [Problems that the invention aims to solve]

[0010] Therefore, in one objective, the applicant provides an injection endpoint signaling device that is fitted to and configured for use with a prefilled syringe having a needle safety mechanism, wherein information regarding the injection endpoint can be signaled via a wireless communication circuit, such as a short-range wireless communication circuit, only when the needle safety mechanism is activated.

[0011] These and other purposes will be described below or become apparent from the specification that follows. [Means for solving the problem]

[0012] Therefore, one object of the present invention is an injection endpoint signaling device adapted and configured to be attached to a prefilled syringe, wherein the prefilled syringe has a post-injection needle shroud, and the needle shroud is configured to translate (transition) from a first position in which the shroud retracts and the needle of the prefilled syringe is exposed to a second position in which the shroud extends and the needle of the prefilled syringe is completely surrounded by the shroud, in the injection endpoint signaling device, The injection endpoint signaling device has a wireless injection endpoint signaling system that includes a near-field communication (NFC) circuit and an actuation switch. When attached to a pre-filled syringe, In the first shroud retracted position, the operating switch maintains the NFC circuit in an inactive state, where the NFC circuit is off and cannot access the injection endpoint information. At the second shroud extension position, the operating switch maintains the NFC circuit in an active state where the NFC circuit is on and can access the injection endpoint information. The actuation switch is an injection endpoint signaling device that transitions from an inactive state to an active state through the mutual cooperative surface engagement between a portion of the shroud and the actuation switch.

[0013] Prefilled syringes are essentially as described above, and the following, namely An elongated hollow syringe body having a proximal end and a distal end, the proximal end having a first opening and a collar or flange that protrudes outward from the hollow syringe body around the first opening at the proximal end, An injection needle is attached to or can be attached to the distal end of a long, slender hollow syringe body, and closes a second opening of the long, slender hollow syringe body at the distal end; A controlled amount of injectable material is introduced into the hollow body, A plunger having a plunger body, configured and sized to be inserted into the elongated hollow syringe body via the proximal end of the hollow syringe body and a corresponding proximal opening, wherein the plunger body has a stopper located at the distal end of the plunger body and a plunger head located at the proximal end of the plunger body, It should be understood from the present invention that it has [this characteristic].

[0014] Generally, most such pre-filled syringes are intended for single use, for example, when administering vaccines or other single-dose medications, and should be disposed of after use according to current appropriate and desirable disposal practices.

[0015] Prefilled syringes have a post-injection needle shroud. For the purposes of this specification, the expression “post-injection needle shroud” should be understood to mean a prefilled syringe equipped with an active or passive needle shroud that operates upon completion of the release of the substance contained in the syringe or immediately thereafter. In this context, the expressions “active” and “passive” with respect to the needle safety shroud are, respectively, as follows: "Passive" - ​​A needle shroud that acts automatically as a result of the movement of one or more components of a prefilled syringe with respect to the needle shroud, and whose actuation is independent of any action by the user of the prefilled syringe other than releasing material from the syringe chamber. "Active" - ​​In contrast to the normal discharge of injectable material from the syringe chamber, the needle shroud is activated by a separate or intentional action performed by the user of the pre-filled syringe at the end of the discharge operation. It refers to.

[0016] As described above, the needle shroud is configured to translate from a first position in which the shroud retracts and the needle of the prefilled syringe is exposed to a second position in which the shroud extends and the needle of the prefilled syringe is completely enclosed by the shroud. An example of a prefilled syringe operating in this manner is available from Becton Dickinson under the trade name BD Ultrasafe Passive™, which relates to a passive needle guard mechanism for prefilled ISO standard glass syringes, with which injection can be performed with one hand. In this device, the needle safety shroud is in the first position in which the needle is exposed at the start and throughout the injection movement, and during the injection movement, the plunger moves distally along the longitudinal central axis of the syringe until the plunger head of the syringe engages with a pair of elastically deformable release wings, thereby pushing the release wings radially outward from the central axis, and then compressing the elastically deformable portion of the needle shroud at the proximal end of the needle shroud. The elastic deformation of the needle shroud at the proximal end of the shroud causes the shroud's bore to expand slightly along its length. The contact sleeve is positioned within the shroud's bore and secured by fixed-axis engagement contact with the outer surface of the syringe barrel. A pre-constrained biasing spring is positioned within the shroud's bore between the distal end of the shroud and the distal contact surface of the contact sleeve, and the spring contacts the distal contact surface of the contact sleeve. The elastic deformation of the shroud, caused by the plunger head interacting with the elastically deformable wings upon completion of injection, allows the pre-constrained biasing spring to expand axially along its central axis and simultaneously press against the distal contact surface of the contact sleeve, thereby driving the shroud distally. As the shroud moves distally from the retracted position to the extended position, it begins to cover the needle exposed during injection.

[0017] Furthermore, as the shroud moves distally, the elastic deformation at the proximal end of the shroud is released, and the inner diameter of the bore of the shroud begins to return to its normal state. The shroud is prevented from extending distally beyond a predetermined axial limit by at least one recess disposed in the shroud adjacent to the proximal end of the shroud, which receives at least one radially projecting spool disposed in and extending from the abutment sleeve. The position of the proximal recess, the abutment sleeve, and the corresponding expansion of the biasing spring determine the extent of the axial movement of the shroud from the first needle exposure position to the second needle enclosure position, i.e., the shroud extension position.

[0018] As described above, the injection endpoint signaling device also has a wireless injection endpoint signaling system having a short-range wireless communication circuit and an activation switch. When the injection endpoint signaling device is attached to a prefilled syringe such as that described above, in the first shroud retracted position, the activation switch maintains the short-range wireless communication circuit in an inactive state where the circuit is off and the NFC circuit has no access to the injection endpoint information. As used herein, the terms "inactive" and "off" refer to the inability of the NFC circuit to search for or find the injection endpoint information. The endpoint information can be, for example, a single bit of data, or an electrical pulse, or a simple on-off conductive or semiconductive gate that allows the passage of charged particles such as electrons.

[0019] Conversely, in the second shroud extended position, the activation switch maintains the NFC circuit in an active state where the circuit is on and thus the NFC circuit has access to the injection endpoint information. Thus, as used herein, the terms "active" and "on" refer to the ability of the NFC circuit to search for or find the injection endpoint information when such a circuit is energized in a known manner.

[0020] In this way, it is ensured that the endpoint information is available to the NFC circuit only when the activation switch is active, i.e., in the "on" state, and that only actually completed injections can be communicated via the NFC circuit to a separate NFC reader or a suitable NFC-enabled smartphone device.

[0021] Near-field communication (NFC) technology, as a derivative or evolution of RFID technology, is well known to those skilled in the art. It is described in detail in the international standards ISO / IEC 14443 and ISO / IEC 18000-3, the former specifying the function of an ID card used to store information such as that found in an NFC ID tag, and the latter specifying RFID communication used by NFC-enabled devices. The basis of NFC should be found in radio frequency identification, i.e., RFID technology, which provides appropriately equipped hardware for communicating with passive electronic tags that use radio waves, not only for power supply but also otherwise unpowered or unenergized. Therefore, the NFC circuit used in this invention has a passive ID tag that stores, for example, a set of information such as the type of substance that can be injected, unit dose, concentration, and expiration date, and any other useful or necessary information that can be appropriately stored within the limitations of such an NFC ID tag. The NFC circuit also has appropriate corresponding communication components that typically enable the exchange of the information with another NFC-enabled device, such as a smartphone, once the NFC circuit is powered. An antenna is also provided that forms part of the NFC circuit, capturing radio waves of a given functional frequency of the NFC protocol and thereby energizing the circuit.

[0022] Furthermore, as described above, when the operating switch of the short-range wireless communication circuit is attached to the pre-filled syringe as explained above, it is moved from the inactive state to the active state by the mutual cooperative surface engagement between a part of the shroud and the operating switch. Thus, the operating switch engages with a part of the safety shroud mechanism and is moved by physical interaction with this part.

[0023] Conveniently, for another purpose, the cooperative surface engagement between the operating switch and the corresponding portion of the needle safety shroud is achieved only when the shroud is positioned in its fully extended position. In other words, the near-field communication circuit is activated only when the shroud has reached its final extended position, completely covering the needle of the pre-filled syringe. In this way, the pre-filled syringe is not only safe to dispose of, but it can also be assured that the discharge and / or injection endpoint has been achieved, and therefore the endpoint information is accessible to an NFC circuit incorporated in the endpoint signaling device, which can then signal that endpoint information to an NFC-enabled reader device in the usual manner by energizing the NFC circuit located within the injection point signaling device.

[0024] For yet another purpose, the actuating switch is moved from an inactive state to an active state by cooperative surface engagement between the proximal portion of the shroud and the actuating switch. A suitable proximal portion of the shroud can be a recess located within the shroud near the proximal end of the shroud, which receives at least one radially projecting spool located in and extending from the contact sleeve, as described above. In such a configuration, when the actuating switch is mounted on the shroud, and also in the inactive state, it is positioned above the recess facing the bore of the shroud, occupying the space provided by the recess. Once injection is complete, the shroud moves axially in the proximal direction as described above due to the interaction of the biasing spring with the contact sleeve, so that the projecting spool of the contact sleeve engages with the recess in the shroud and presses against the actuating switch, transitioning the switch from an inactive, or "off," state to an active, or "on" state.

[0025] For further purposes, the operating switch is positioned along the longitudinal central axis parallel to the longitudinal central axis when the circuit holder body is attached to the prefilled syringe body and / or needle safety shroud.

[0026] Therefore, and according to further purposes, the operating switch is a displaceable or movable electrical contact.

[0027] For another purpose, displaceable or movable electrical contacts are selected from the group consisting of microswitches, biased or constrained conductive metal strips, and movable conductive surfaces. Displaceable or movable electrical contacts are generally arranged to be movable or displaceable from a first inactive, or "off," position in which no current or charge can pass through the circuit in which the electrical contacts interact, to a second active, or "on," position in which charge or current can pass through the circuit in which the electrical contacts interact. Where the conductive surface is implemented as a switch, such a conductive surface may, for the benefit of the art, have conductive material distributed in or on such a surface by any of the techniques known to those skilled in the art, such as lamination, embedding, deposition whether chemical or physical, etching, engraving, doping, etc. In particularly advantageous embodiments, the conductive surface placed on an electrical contact applicator has carbon or metal particles. This conductive surface forms an electrical contact when the shroud moves to the fully extended position and the protruding spool of the contact sleeve is fitted into a corresponding recess provided in the shroud. Until such a position is reached, the conductive surface is configured and arranged to prevent the establishment of electrical contacts from allowing the endpoint information to be accessed by the NFC circuit.

[0028] For yet another purpose, the injection endpoint signaling device has a short-range wireless communication circuit holder body, which is attached to the outward-facing longitudinal surface of the prefilled syringe body.

[0029] For further purposes, and for convenience, the circuit holder body is attached to the outward-facing surface of the needle safety shroud. It should be understood that "outward-facing surface" refers to the outer surface of the shroud, i.e., the outward-facing surface, as opposed to the inner surface of the shroud, i.e., the inward-facing surface, which faces inward into the bore of the shroud.

[0030] For yet another purpose, the circuit holder body is mounted on the pre-filled syringe in a plane parallel to the longitudinal central axis.

[0031] Furthermore, and also conveniently for another purpose, the circuit holder body is attached to the outward-facing surface of the needle shroud and engages with at least a portion of the pre-filled syringe, so that the circuit holder body cannot be removed from the shroud and allows the shroud to move axially along the longitudinal central axis from a first retracted position to a second extended position. The final result of such mounting is that the circuit holder body is not only parallel to the longitudinal central axis of the syringe, but also extends on both sides of it substantially perpendicular to the longitudinal central axis in the parallel longitudinal plane.

[0032] Furthermore, for another purpose, conveniently, the displaceable or movable electrical contacts of the NFC circuit's activation switch establish active electrical contacts by translational motion of the shroud parallel to the longitudinal central axis, from a first inactive position where no electrical contacts are established to a second contact position where electrical contacts are established. Thus, the shroud acts to move the activation switch directly or indirectly from an electrically gapped or electrically isolated area of ​​the NFC circuit, for example, via a protruding spool of a contact sleeve, thereby closing the circuit, allowing current or charge to flow, and thereby making the endpoint information accessible to the NFC circuit.

[0033] For another purpose, the circuit holder body has a socket configured and sized to receive and accommodate an NFC microcontroller of a near-field communication circuit. The socket provided in the circuit holder body serves to prevent the NFC microcontroller from moving relative to the circuit holder body when, for example, an injection endpoint signaling device is attached to a pre-filled syringe.

[0034] Furthermore, for a further purpose, the near-field communication circuit is conveniently integrated into a disc-shaped circuit board, with the NFC microcontroller positioned on a first surface of the circuit board and the actuation switch positioned on a second, opposite surface of the circuit board. Such a configuration allows the disc-shaped circuit board to be seated, on the one hand, through physical surface interaction between the microcontroller and the seating socket of the circuit holder body, while on the other hand, the actuation switch is kept open for corresponding cooperative surface engagement with the needle shroud.

[0035] For yet another purpose, the first surface of the disc-shaped circuit board is held by at least one or more retaining lugs against the inward-facing surface of the disc-shaped base of the circuit holder body. The retaining lugs help to hold the disc-shaped circuit board within the circuit holder body, and together with the socket, properly position the circuit board, and therefore the corresponding actuation switch, relative to the needle shroud when the device is mounted on a pre-filled syringe.

[0036] For further purposes, the retaining lugs are arranged radially around the axis of rotation of the disc-shaped base of the circuit holder body.

[0037] For yet another purpose, the axis of rotation of the disc-shaped base of the circuit holder body is perpendicular to the longitudinal central axis of the prefilled syringe. From this, as described elsewhere in this specification, it will be understood that the endpoint signaling device is at least partially disc-shaped, and that when the disc is attached to the prefilled syringe, it lies not only parallel to the longitudinal central axis of the syringe but also in a plane that is orthogonal within a parallel plane. Thus, the axis of rotation of the disc-shaped base of the circuit holder body is perpendicular to the horizontal plane that is parallel to the longitudinal central axis.

[0038] For another purpose, the circuit holder body has at least one or more walls positioned around a disc-shaped base and extending away from the base in the same direction. The walls are shaped and configured to engage with at least a portion of the prefilled syringe and / or needle shroud.

[0039] Therefore, according to a further objective, at least one or more extending walls are arc-shaped, and when the device is attached to a prefilled syringe and / or needle safety shroud, the walls engage with at least one side wall of the prefilled syringe and / or needle safety shroud in an elastically deformable contact.

[0040] Therefore, from the above, it will be understood that the circuit holder body preferably has a disc-shaped base, and that this base is provided with, for example, preferably a pair of walls extending away from the base in a direction perpendicular to the plane of the base of the circuit holder body. Furthermore, the walls preferably extend in a direction substantially parallel to the axis of rotation of the base of the circuit holder body so as to form an engagement surface that is elastically deformable when attached to a prefilled syringe and / or needle shroud, thereby preventing any lateral movement of the injection endpoint signaling device around the longitudinal central axis.

[0041] For yet another purpose, at least one or more extending walls each have a capturing shoulder extending from each proximal end of each extending wall substantially perpendicular to the longitudinal central axis and away from the longitudinal central axis. The capturing shoulder is a finger top attached to the needle shroud, designed to engage with and abut against a finger stop, otherwise known as a backstop, the shoulder providing a surface that is pressed by the fingers of one hand during use, while the plunger is pressed overall by the thumb of the same hand.

[0042] To further objective, the capturing shoulder extends proximal from the radially distal end of the shoulder to form a curled lip configured to engage with a corresponding finger stop or back stop extending orthogonally outward from the shroud in an elastically deformable retaining engagement. The curled lip acts to clamp or secure the circuit holder body to the syringe back stop, preventing any undesirable movement of the endpoint signaling device while the user is pressing the plunger with their thumb during injection.

[0043] For yet another purpose, the capture shoulder is provided with one or more elastically deformable seating lugs that extend proximal to the shoulder to facilitate engagement with a finger stop or back stop. These seating lugs move elastically when the back stop engages with the shoulder, causing the shoulder to move over the periphery of the back stop, causing it to elastically deform, and then return to its initial undeformed state when the edge of the back stop is seated.

[0044] For yet another purpose, one or more extending walls, capture shoulders, and curled lips are closed by a back cover extending from the trailing edge of at least one extending wall to the trailing edge of the other extending wall. In such a configuration, the injection endpoint signaling device is essentially sealed all around to prevent user tampering with the device and / or accidental ingress of fluids, dust, etc., which could interfere with the function of the NFC circuit.

[0045] For another purpose, the back cover has a rotatable hinge to facilitate, for example, attaching the injection endpoint signaling device to a pre-filled syringe, and then closing the back cover once the device is attached to the pre-filled syringe.

[0046] Therefore, one further objective is assumed to be that a rotatable hinge is provided along one edge of the extending wall. Thus, the back cover is essentially configured as a panel or door having a hinge joint aligned with one of the edges of the extending wall. The back cover may also be provided with a corresponding opposing latch mechanism and corresponding opposing recesses provided on the opposing edges of the opposing wall to receive the latch in order to secure the back cover when it moves from the open position when the signaling device is mounted to the closed position after mounting to the prefilled syringe.

[0047] In short, injection terminal signaling devices are designed to function as follows:

[0048] The injection endpoint signaling device is mounted on the outer surface of a prefilled syringe having an axially translatable needle shroud, translating the shroud along the longitudinal central axis of the prefilled syringe from a first retracted position before injection to a second extended position upon completion of injection, at which point the needle of the prefilled syringe is completely covered, thereby making the prefilled syringe safe for subsequent disposal by the user. The signaling device has an operating switch positioned parallel to the longitudinal central axis of the prefilled syringe, which is further positioned in a recess located near the proximal end of the shroud. The proximal recess of the shroud receives a protruding spool provided in a contact sleeve located near the distal end of the syringe barrel in fixed contact with the distal end. Once the injection is complete, the plunger head of the prefilled syringe activates a release mechanism for the shroud, causing the shroud to move distally along its longitudinal central axis. Due to the relative movement of the shroud compared to the fixed position of the contact sleeve, the proximal recess moves proximal as part of the shroud until it contacts the protruding spool of the contact sleeve. At this point, the protruding spool enters the recess and engages with the actuating switch, moving the actuating switch from the "off" position to the "on" position. Given that the protruding spool prevents any further axial movement of the shroud, the actuating switch remains "on" or actuated in this position, and injection endpoint information, whether separately stored as data bits, electrical impulses, or simply current direction, is made accessible to the NFC circuit, which can be energized in known ways, for example, by bringing the prefilled syringe close to an NFC-enabled smartphone or a corresponding NFC reader, or vice versa. Subsequently, a properly energized NFC circuit of a destination signaling device can, in a known manner, allow any tag information stored in the NFC circuit, including the destination information that has just been made accessible, to be made explicit and / or communicated and / or received by a reader and by the functions of the NFC circuit.

[0049] The present invention will now be further described in reference to drawings provided to illustrate various embodiments of the invention. [Brief explanation of the drawing]

[0050] [Figure 1A] This is a schematic perspective view of the top surface of a pre-filled syringe equipped with a passive needle safety shroud mechanism and to which the endpoint signaling device according to the present invention is attached. [Figure 1B] This is a schematic perspective view of the underside of a pre-filled syringe equipped with a passive needle safety shroud mechanism and to which the endpoint signaling device according to the present invention is attached. [Figure 2A] Figure 1 is a schematic axial view of the front of a pre-filled syringe equipped with the endpoint signaling device according to the present invention. [Figure 2B] Figure 1 is a schematic axial view of the rear surface of a pre-filled syringe equipped with the endpoint signaling device according to the present invention. [Figure 3A] This is a schematic perspective view of the endpoint signaling device according to the present invention, viewed from below, showing details regarding the location of the short-range wireless communication circuit. [Figure 3B] This is a schematic perspective view of the endpoint signaling device according to the present invention, viewed from below, showing details regarding the location of the short-range wireless communication circuit. [Figure 4A] This is a schematic perspective view showing further details of the endpoint signaling device according to the present invention. [Figure 4B] This is a schematic perspective view showing further details of the endpoint signaling device according to the present invention. [Figure 5A] Figure 1 shows a schematic cross-sectional view of a pre-filled syringe with a passive needle safety shroud mechanism, indicating one of two main positions for the needle shroud and the corresponding endpoint signaling device according to the present invention. [Figure 5B] Figure 1 shows a schematic cross-sectional view of a pre-filled syringe with a passive needle safety shroud mechanism, indicating one of two main positions for the needle shroud and the corresponding endpoint signaling device according to the present invention. [Modes for carrying out the invention]

[0051] Referring here to the drawings, a pre-filled syringe (1) equipped with a safety shroud is shown in a top perspective view and a bottom perspective view in Figures 1A and 1B, respectively, and in more detail in exemplary cross-sectional views in Figures 5A and 5B. The pre-filled syringe (1) has an elongated hollow syringe body (2) having a proximal end (3) and a distal end (4), the proximal end (3) having a first opening (5) and a collar (6) or flange that protrudes outward from the hollow syringe body (2) around the first opening (5) at the proximal end (3). An injection needle (7) covered by a removable or fragile needle cap (8) is attached to the distal end (4) of the elongated hollow syringe body (2), and the distal end (4) closes a second distal opening (7) of the elongated hollow syringe body (2). A controlled amount of injectable material (not shown), such as a liquid or foamy drug, is introduced into the hollow body (2) during the assembly of the syringe components.

[0052] A plunger (9) is configured and sized to be inserted into an elongated hollow syringe body (2) via the proximal end (3) and a corresponding proximal opening (5) of the hollow syringe body (2). The plunger (9) has a plunger body or rod (10), the plunger body or rod (10) having a stopper (11) located at the distal end (12) of the plunger body (10). The stopper (11) can be connected to the plunger body (10) in known ways, for example, by providing a threaded projection (13) on the distal end (12) of the plunger body (9) and a corresponding threaded bore (14) inside the stopper (11). The plunger body (10) further has a plunger head (15) located at the proximal end (16) of the plunger body (10). The plunger (9) and syringe body (2) are substantially aligned longitudinally along the longitudinal central axis (17) of the syringe body (2). The needle shroud (18) extends around the outside of the syringe body (2) and has a proximal end (19) and a distal end (20). A commercially available product with a safety needle shroud like the one illustrated is sold by Becton Dickinson under the trade name BD Ultrasafe Passive®.

[0053] As can be seen in more detail in Figures 5A and 5B, the needle shroud (18) is configured to move from a first shroud retracted position (see Figure 5A), in which the needle (7) is exposed when the fragile or removable needle cap (8) is removed, to a second shroud extended position, as shown in Figure 5B, which is effective only upon completion of the injection and in which the needle (7) is completely covered by the needle shroud (18). The needle shroud (18) defines a bore (21) and has a proximal end (19) and a distal end (20). The shroud (18) extends from a proximal end (19) adjacent to the proximal end (3) of the syringe (2) so as to hold the syringe (2) within the bore (21) of the shroud (18), along the outside of the syringe (2), across the distal end (4) of the syringe (2), and beyond this distal end distally to the distal end (20) of the shroud (18). The shroud (18) engages with the syringe (2) at the proximal end (19) of the shroud via an elastically deformable portion (24). A compressed biasing spring (25) is positioned within the bore and seated against the distal end (20) of the shroud (18). The proximal end (26) of the spring (25) abuts against the contact sleeve (27), which surrounds the outer surface (28) of the syringe (2) adjacent to the proximal end (4) and is fixedly seated on the outer surface (28). The contact sleeve (27) further has at least one protruding spool (29), which engages by sliding engagement with the inward surface (30) of the shroud, for example, a groove aligned longitudinally with the longitudinal central axis (17). The shroud (18) is further provided with a recess (31) or orifice extending from the outward-facing surface (32) of the shroud (18) to the inward-facing surface (30) of the shroud (18), the recess or orifice (31) being positioned adjacent to the proximal end (19) of the shroud (18) in the distal direction.

[0054] As shown in more detail in Figures 5A and 5B, the injection endpoint signaling device (33) is attached to and engages with the outward-facing surface (32) of the shroud (18). In the initial shroud retracted position (Figure 5A), the injection endpoint signaling device (33) is positioned near the proximal end (19) of the shroud (18), as will be described in more detail below.

[0055] Figures 2A and 2B schematically show the injection endpoint signaling device (33) when attached to a pre-filled syringe equipped with a needle safety shroud. Figure 2A shows a view from the distal end (4, 20) along the longitudinal central axis (17) of the pre-filled syringe, and Figure 2B shows a view from the proximal end (3, 19) of the pre-filled syringe equipped with a needle safety shroud. As can be seen from these figures in conjunction with Figures 1A and 1B, the injection endpoint signaling device (33) extends across the width of the shroud (18) and lies in a plane that is not only perpendicular (A-A') but also parallel (B-B') to the longitudinal central axis, and can be seen to further engage with each side wall (34) of the shroud parallel to the longitudinal central axis. As can be seen in Figures 2A and 2B, the injection endpoint signaling device (33) is slightly elevated from the outward-facing surface (32) of the shroud (18) and resembles a button cap positioned on the shroud (18) across its width.

[0056] Figures 3A, 3B, 4A, and 4B show more detailed illustrative diagrams of the injection endpoint signaling device (33), in particular perspective views of the relative component parts of the injection endpoint signaling device (33).

[0057] Figures 3A and 3B show a rear perspective view of the circuit holder body (35) to show further details of the injection endpoint signaling device (33). The circuit holder body (35) is shaped and configured to receive and hold a near-field communication (NFC) circuit (36), the type and function of which is known. The NFC circuit (36) has a disc-shaped printed circuit board (37), and incorporates an antenna (38) and an actuation switch (40) on the first surface (39) of the disc-shaped printed circuit board (37). An NFC microcontroller (42, Figures 5A and 5B) that controls the function of the NFC circuit (36) is provided on the second surface (41) opposite the circuit board (37). The circuit holder body (35) has a disc-shaped or substantially disc-shaped base (43), which is configured and sized to receive and hold the disc-shaped circuit board (37). Therefore, a socket (44) is provided in the base (43) of the circuit holder body (37), and this socket is dimensioned and positioned to receive and seat the NFC microcontroller (42) located on the second surface (41) opposite to the circuit board (37). The socket (44) further enables the actuation switch (40) on the opposite surface (41) of the circuit board (37) to be properly aligned parallel to the longitudinal central axis (17) of the prefilled syringe (1) once the endpoint signaling device (33) is mounted on the shroud (18). As can be seen in Figures 1A and 1B, the endpoint signaling device (33) is mounted on the shroud (18), and when the shroud (18) is in its initial retracted position, the actuating switch (40) penetrates from the outer surface (32), enters into the recess (31), and extends into the bore (21) of the shroud (18). The base (43) is also provided with a peripheral wall (45) extending from and around the periphery (46) of the base (43), and the peripheral wall (45) is provided with one or more radially spaced retaining lugs (47), which include a head portion (48) that projects into the internal volume defined by the base (43) and the peripheral wall (46).When the circuit board (37) is inserted into this internal volume, the lug (47) elastically deforms radially outward to allow the disc-shaped circuit board to pass through, then returns to its original shape and closes on the circuit board, and the protruding head portion (48) engages with the first surface (39) of the circuit board (37) by retaining surface engagement.

[0058] As shown in Figures 3A, 3B, 4A, and 4B, the circuit holder body (35) further has a pair of elastically deformable side walls (49, 50) extending from around the base (43) in the same direction perpendicular to the base (43). Each side wall (49, 50) has a first end (51, 51') and a second end (52, 52'), and an outer edge (53, 53'). The side walls (49, 50) have an arc shape corresponding to an arc defined by the circumference of the disc-shaped base (43) and also extending at least partially around the base (43), with their respective first ends (51, 51') and second ends (52, 52') defining a space between them that is slightly narrower than the width of the shroud (18), so that when the terminal signaling device (33) is mounted, the side walls elastically deform and frictionally and elastically engage with the corresponding side walls (34, 34') of the shroud (18) on both sides of the longitudinal central axis (17) via their respective first ends (51, 51') and second ends (52, 52'). The circuit holder body (35) further has a pair of capturing shoulders, each shoulder (54, 54') extending away from the respective first ends, i.e., proximal ends (51, 51'), of the respective extending sidewalls (49, 50) and therefrom substantially perpendicular to the longitudinal central axis (17). The capturing shoulders (54, 54') extend from the first radially distal ends (55, 55') of the shoulders (54, 54') to the second ends (56, 56') spaced apart from the first ends of the shoulders, so as to form a curled lip (57, 57') which extends perpendicularly outward from the body (2) of the prefilled syringe (1) and is configured to engage in an elastically deformable retaining engagement with a corresponding finger stop or back stop (58) attached to the shroud (18). The capturing shoulder (54, 54') is conveniently provided with one or more elastically deformable seating lugs (59, 59') extending away from the shoulder to facilitate engagement with a finger stop or back stop.These seating lugs (59, 59') are elastically moved when the backstop (58) engages with the shoulder during the attachment of the endpoint signaling device (33), causing the shoulder (54, 54') to move onto the periphery of the backstop (58), causing it to elastically deform, and then return to its initial undeformed state when the edge of the backstop (58) seats on the shoulder (54, 54').

[0059] As can be seen in the drawings, particularly Figure 1B, the circuit holder body (35) is depicted as having no back, i.e., no back cover. However, although not shown, it may be useful to provide a back closing cover on one or more of the extending walls, capturing shoulders, and curled lips, extending from the first edge (53) of at least one extending side wall (49) to the opposite edge (53') of the other extending side wall (50). The back cover may further be provided with a rotatable hinge, for example, positioned along one of the edges (53, 53') of the extending side walls (49, 50). This is particularly advantageous, for example, to prevent any ingress of dust and / or liquid into the endpoint signaling device (33), and especially to prevent user tampering with any of the components of the endpoint signaling device, such as the circuit board, antenna, NFC microcontroller, and / or operating switch. Naturally, such a joint back cover is opened when the endpoint signaling device (33) is attached to the shroud (18), and then closed when the attachment of the device (33) is complete. Closing the back cover can be properly performed by a combination of a latch on the back cover and a corresponding receiving recess for the latch provided on the edge (53') opposite to the edge (53) where the joint or hinge point is located.

[0060] The function of the endpoint signaling device (33) will now be described again with reference to Figures 5A and 5B. In the shroud retracted position shown in Figure 1A, which is the position the shroud takes before and during injection, the shroud (18) exposes the needle (7) when the fragile or removable needle cap (8) is removed. The activation switch of the endpoint signaling device is parallel to the longitudinal central axis (17), engages with a recess (31) in the shroud (18), and extends into the bore (21) of the shroud. As injection progresses, the plunger (9) and plunger head (15) are moved distally toward the proximal end (3) of the syringe. When injection is complete, the plunger (9) and plunger head are positioned at the proximal end of the syringe, and the stopper (11) of the plunger (9) is positioned at the distal end (4) of the syringe. At this point, the needle safety mechanism is activated, for example, as described elsewhere in this specification, to expand the compressed biasing spring and press it against the contact sleeve (27), which is in fixed contact with the outer surface of the syringe body (2). The contact sleeve (27) and the syringe body (2) are moved in the opposite direction to the direction in which the shroud (18) moves from the retracted position to the extended position covering the needle. The relative counter-translational motion of the shroud (18) along the longitudinal central axis (17) with respect to the syringe body (2) stops when the contact sleeve (31) and the associated projection spool (29) move along the inner surface of the shroud (18) to the point where the projection spool (29) engages with the recess (31). It is also at this point that the projection spool (29) makes surface contact with the actuation switch (40). In the example shown in the drawing, the switch lifts up and exits the recess (31) as the protruding spool enters the recess, thereby moving the switch from an inactive, or "off," state to an active, or "on" state. The movement of the operating switch from the "off" state to the "on" state makes the injection endpoint information, which was previously inaccessible to the NFC circuit, visible to or accessible by the NFC circuit.At this point, the syringe (1) can be brought near an NFC-enabled device such as a smartphone or NFC reader, which energizes the NFC circuit (36) in the endpoint signaling device (33) and informs the NFC reader or NFC-enabled smartphone device of any information stored in the NFC circuit, including injection endpoint information that is accessible at this point.

Claims

1. It is a pre-filled syringe, The aforementioned pre-filled syringe is A post-injection needle shroud, configured such that the shroud is retracted and the needle of the pre-filled syringe is exposed, and then extends to translate to a second position in which the needle of the pre-filled syringe is completely surrounded by the shroud. The device includes an injection endpoint signaling device that is attached to the pre-filled syringe, The injection endpoint signaling device has a wireless injection endpoint signaling system that includes a near-field communication (NFC) circuit and an operating switch. In the first shroud retracted position, the actuation switch maintains the Near Field Communication (NFC) circuit in an inactive state, where the NFC circuit is off and injection endpoint information is inaccessible to the NFC circuit. In the second shroud extension position, the operating switch maintains the Near Field Communication (NFC) circuit in an active state in which the NFC circuit is on and the injection endpoint information is accessible by the NFC circuit. A pre-filled syringe, wherein the actuation switch is moved from the inactive state to the active state by mutual cooperative surface engagement between a recess located within the shroud near the proximal end of the shroud and the actuation switch, causing a protruding spool, which is located in a contact sleeve located within the bore of the shroud and extends from the contact sleeve, to engage with the recess and press against the actuation switch located within the recess.

2. The prefilled syringe according to claim 1, wherein the mutual cooperative surface engagement between the operating switch and the shroud is provided when the shroud is positioned in the fully extended position.

3. The pre-filled syringe according to claim 1 or 2, wherein the circuit holder body is attached to the outward-facing surface of the shroud.

4. The prefilled syringe according to claim 3, wherein the circuit holder body has a socket configured and sized to receive and position the microcontroller of the near-field communication (NFC) circuit.

5. The pre-filled syringe according to claim 4, wherein the near-field communication (NFC) circuit is incorporated into a disc-shaped circuit board, the microcontroller is located on a first surface of the circuit board, and the operating switch is located on a second surface opposite to the circuit board.

6. The prefilled syringe according to claim 5, wherein the first surface of the disc-shaped circuit board is held by at least one retaining lug against the inward-facing surface of the disc-shaped base of the circuit holder body.

7. The prefilled syringe according to claim 6, wherein the retaining lugs are arranged radially around the axis of rotation of the disc-shaped base of the circuit holder body.

8. The prefilled syringe according to claim 7, wherein the axis of rotation of the disc-shaped base is perpendicular to the longitudinal central axis of the prefilled syringe.

9. The prefilled syringe according to claim 7 or 8, wherein the axis of rotation of the disc-shaped base is perpendicular to a horizontal plane parallel to the longitudinal central axis of the prefilled syringe.

10. The prefilled syringe according to any one of claims 6 to 9, wherein the circuit holder body has at least one extending wall arranged around the disc-shaped base, and at least one extending wall extending in the same direction away from the disc-shaped base.

11. The prefilled syringe according to claim 10, wherein the at least one extending wall is arc-shaped, and when the device is attached to the outward-facing surface of the shroud and engages with the outward-facing surface, the extending wall engages with the prefilled syringe and / or at least one side wall of the shroud in an elastically deformable contact.

12. The prefilled syringe according to claim 10 or 11, wherein each of the at least one extending walls has a capturing shoulder extending substantially perpendicular to the longitudinal central axis of the prefilled syringe from the respective proximal end of each of the extending walls.

13. The prefilled syringe according to claim 12, wherein the capturing shoulder extends proximal from the radially distal end of the capturing shoulder to form a curled lip, and the curled lip is configured to engage with a corresponding finger stop extending orthogonally outward from the longitudinal body of the prefilled syringe by an elastically deformable retaining engagement.

14. The pre-filled syringe according to claim 13, wherein the at least one extending wall, the capturing shoulder, and the curled lip are closed by a back cover extending from the trailing edge of the at least one extending wall to the trailing edge of another extending wall.

15. The pre-filled syringe according to claim 14, wherein the back cover has a rotatable hinge.

16. The prefilled syringe according to claim 15, wherein the rotatable hinge is provided along one edge of the extending wall.

17. The prefilled syringe according to any one of claims 4 to 7, wherein the operating switch is positioned parallel to and along the longitudinal central axis of the prefilled syringe when the circuit holder body is attached to the outward-facing surface of the shroud and engages with a portion of the prefilled syringe.

18. The pre-filled syringe according to claim 1, wherein the operating switch is a displaceable or movable electrical contact.

19. The prefilled syringe according to claim 18, wherein the displaceable or movable electrical contact is selected from the group consisting of a microswitch, a biased or constrained conductive metal strip, and a movable conductive surface.

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