Injection endpoint signaling device for pre-filled syringes

Abstract

An injection endpoint signaling device for mounting on a pre-filled syringe comprising a needle shroud that translates from a first retracted position to a second extended position. The injection endpoint signaling device comprises a near-field communication (NFC) circuit and an activation switch, and when mounted on a pre-filled syringe, in the first retracted position, the activation switch maintains the NFC circuit in an inactive state where injection endpoint information cannot access the NFC circuit, and in the second shroud-extended position, the activation switch maintains the NFC circuit in an active state where injection endpoint information can access the NFC circuit. The activation switch is moved from the inactive state to the active state through mutually cooperating surface engagement between a portion of the shroud and the activation switch.

Description

Technology Field

[0001] The present invention relates to pre-filled syringes and related technology. In particular, the present invention relates to a signaling assembly for pre-filled syringes using a near field communications circuit, generally abbreviated as NFC. Background Technology

[0002] Pre-filled syringes are known to those skilled in the art and are commonly used for the administration of various fixed doses or unit doses of substances, medicates, or other materials. For example, pre-filled syringes are commonly used for the administration of drugs such as vaccines for immunization campaigns and programs, or for the treatment of long-term pathologies such as diabetes, for example, or for the treatment of other disorders requiring management through the administration of fixed, pre-measured, and stored doses of antivenom used for the treatment of snake bites or spider bites, for example, or for emergency injections for the treatment or onset of other potentially life-threatening situations such as acute pain or trauma, myocardial infarction, anaphylaxis, bacterial or toxic shock, etc. Thus, the applications for pre-filled syringes are extensive and well known.

[0003] These pre-filled syringes are generally

[0004] An elongated hollow syringe body having a proximal end and a distal end, the elongated hollow syringe body having a first opening and a collar or flange protruding outwardly from the proximal end around the first opening;

[0005] An injection needle that is mounted or capable of being mounted on the distal end of a hollow extended syringe body and closes a second opening of the hollow extended syringe body at the distal end;

[0006] A controlled amount of injectable material introduced into a hollow body; and

[0007] A plunger configured and dimensioned to be inserted into the hollow extended syringe body through the proximal end of the hollow syringe body and a corresponding proximal opening, wherein the plunger comprises a plunger body having a stopper located at the distal end of the plunger body, and a plunger head located at the proximal end of the plunger body.

[0008] One of the common problems with these pre-filled syringes is that, in order to prevent attempts at reuse or, alternatively, for tracking purposes—for example, to determine whether and how much injectable substance was administered from the pre-filled syringe—it is difficult to verify when the syringe was actually used. To address this, various tracking systems have been associated with these pre-filled syringes to overcome this common issue.

[0009] For example, an international patent application disclosed as WO2014089086 relates to a method of using an electronic pharmaceutical device, such as an auto-injector containing a medication such as epinephrine, to treat anaphylactic shock. The device comprises a sensor, an ID tag such as RFID or near field communication (NFC), or other tags for short-range wireless communication such as Bluetooth communication, memory, a display, and a speaker, as well as a processor and communication interfaces, wherein the processor interconnects one or more of the components, and the communication interface includes an interface for communication via Wi-Fi, a carrier network, or satellite. The processor is configured to communicate with at least one remote system, such as a mobile phone, via the communication interface in response to the occurrence of events such as the administration of the medication and the expiration of the medication. The sensor detects the activation of the device and includes a friable element that completes or blocks the electronic circuit when the device is activated. The sensor provides a signal to the ID tag to perform an action in response to the use of the auto-injector device and modifies the memory to indicate that the device is being used, along with a log of the usage time. The ID tag also provides information from the auto-injector device to a wireless reader, such as an NFC-enabled mobile device, for example, a mobile phone. The mobile phone reads pharmaceutical information printed on the auto-injector device or stored in the auto-injector device's memory using RFID, NFC, or other wireless communication.

[0010] Similarly, U.S. patent application disclosed in US2019038840 discloses a pre-filling syringe comprising two antennas, a first transmitting antenna configured to provide instructions to the transmitting antenna to transmit a control signal, an external device connected to the first transmitting antenna configured to transmit a control signal to a control electronics device, and a second bypass antenna positioned and configured to prevent the control electronics device from providing instructions to the transmitting antenna when the bypass antenna is in an unobstructed position and to cause the control electronics device to provide instructions to the transmitting antenna when the bypass antenna is displaced from the unobstructed position. The complex arrangement of the two antennas and the control electronics device is integrated into the proximal end of the syringe plunger and covered by a press button. The bypass antenna is configured as a physically destructible electrical switch, and the electrical contact of this switch is broken when the user of the syringe presses a press-button. Pressing the press-button causes the electrical contact to the bypass antenna to be irrecoverably destroyed, activates the primary antenna circuit, and signals the start of syringe use.

[0011] Furthermore, international patent application disclosed in WO2018111969A1 discloses a plunger rod adapted to push a drug from a syringe, comprising a finger actuated head portion comprising at least two sub-units of a shaft and a wireless sensor, the shaft being sized and dimensioned to act on a piston on the syringe. In a pre-activation configuration, the sub-units are separated from each other by a physical barrier and the wireless sensor is non-operational. In a post-activation configuration, the sub-units are connected to each other and the sensor can operate to transmit a signal. A user activates the finger actuated head portion to reversibly move the physical barrier and moves the plunger rod from the pre-activation configuration to the post-activation configuration. The signal transmitted by the sensor contains information regarding the ejection of the drug from the syringe and is received by a remote receiver.

[0012] Despite the solutions disclosed in the aforementioned literature, numerous challenges remain to be overcome regarding injection endpoint detection and signaling using near-field communication. This is particularly true for pre-filled syringes specifically modified to function in a particular manner. For example, pre-filled syringes are also known that incorporate safety mechanisms to protect the user from needle stick injury once the injection is completed. These pre-filled syringes often include systems that automatically protect the user from the needle or remove the needle after the injection is completed.

[0013] Accordingly, for one purpose, the applicant provides an injection endpoint signaling device adapted and configured to be mounted on and used with a pre-filled syringe comprising a needle safety mechanism, wherein information regarding the injection endpoint may be signaled only through a wireless communication circuit, such as a near-field communication circuit, once the needle safety mechanism is activated.

[0014] These and other purposes will be described below or will become apparent from the specifications below.

[0015] Accordingly, one object of the present invention is an injection endpoint signaling device adapted and configured to be mounted on a pre-filled syringe, wherein the pre-filled syringe comprises a post-injection needle shroud, and the needle shroud is configured to translate from a first position in which the shroud is retracted and the needle of the pre-filled syringe is exposed to a second position in which the shroud is extended and the needle of the pre-filled syringe is completely surrounded by the shroud, wherein

[0016] The scanning endpoint signaling device includes a wireless scanning endpoint signaling system comprising a near-field communication (NFC) circuit and an enable switch; and

[0017] When mounted on a pre-filled syringe,

[0018] In the first shroud-retracted position, the activation switch keeps the NFC circuit in an inactive state where the NFC circuit is off and scan endpoint information cannot access the NFC circuit; and

[0019] In the second shroud-extended position, the activation switch keeps the NFC circuit in an active state where the NFC circuit is on and scan endpoint information can access the NFC circuit;

[0020] Here, the activation switch is moved from an inactive state to an active state through mutually cooperating surface engagement between a part of the shroud and the activation switch.

[0021] The pre-filled syringe is substantially as generally described above, and

[0022] An extended hollow syringe body having a proximal end and a distal end, the extended hollow syringe body having a first opening and a collar or flange protruding outwardly from the proximal end around the first opening;

[0023] An injection needle that is mounted or capable of being mounted on the distal end of a hollow extended syringe body and closes a second opening of the hollow extended syringe body at the distal end;

[0024] A controlled amount of injectable material introduced into a hollow body; and

[0025] It should be understood from the present invention that the plunger is configured and dimensioned to be inserted into the hollow extended syringe body through the proximal end of the hollow syringe body and a corresponding proximal opening, wherein the plunger comprises a plunger body having a stopper located at the distal end of the plunger body, and a plunger head located at the proximal end of the plunger body.

[0026] Generally, most of these pre-filled syringes are intended for single use only, for example, when administering vaccines or other single-dose medications, and the syringes should be disposed of after use in accordance with current appropriate best practices.

[0027] Pre-filled syringes include a post-injection needle shroud. By means of the expression "post-injection needle shroud," it should be understood for the purposes of this specification to refer to pre-filled syringes equipped with a passive or active needle shroud that operates upon completion of or immediately after the release of the substance contained within the syringe. In this context, the expressions "passive" and "active" regarding the needle safety shroud are, respectively,

[0028] A "manual" needle shroud that is automatically activated as a result of the movement of one or more components of a pre-filled syringe with respect to the needle shroud, wherein this activation is independent of any action by the user of the pre-filled syringe other than causing the release of material from the syringe chamber;

[0029] It refers to "active" needle shrouds that are activated through a separate or intentional action for the normal expel of an injectable substance from a syringe chamber, and are initiated by the user of a pre-filled syringe at the end of the expel action.

[0030] As mentioned above, the needle shroud is configured to translate from a first position, in which the shroud is retracted and the needle of the pre-filled syringe is exposed, to a second position, in which the shroud is extended and the needle of the pre-filled syringe is completely enclosed by the shroud. An example of a pre-filled syringe operating in this manner is the trademark "BD Ultrasafe Passive," sold by Becton Dickinson, which relates to a manual needle guard mechanism intended for pre-filled ISO standard glass syringes that allow injection to be performed with one hand. TMIt is available as follows. In this device, when the plunger is moved distally along the central longitudinal axis of the syringe until the plunger head of the syringe is pushed radially outward from the central axis and eventually engages with a pair of elastically deformable release wings that support the elastically deformable portion of the needle shroud at the proximal end of the needle shroud, the needle safety shroud is in the first position where the needle is exposed at the start of the injection motion and throughout the injection motion. At the proximal end of the shroud, the elastic deformation of the needle shroud causes the bore of the shroud to expand somewhat along its length. An abutment sleeve is located within the bore of the shroud and is positioned at an axial engaging contact fixed to the outer surface of the syringe barrel. A pre-constrained biasing spring engages with the distal end of the shroud. The spring is positioned within the bore of the shroud between the distal contact surfaces of the sleeve and is bonded to the distal contact surfaces of the bonding sleeve. The elastically deformed extension of the shroud, induced by the plunger head interacting with the elastically deformable wings upon completion of injection, causes the pre-limited biasing spring to expand axially along the central axis and simultaneously push against the distal contact surfaces of the bonding sleeve, thereby driving the shroud distally. As the shroud moves distally from the shroud-retracted position toward the shroud-extended position, the shroud begins to cover the needle exposed during injection. Furthermore, as the shroud moves distally, the elastic deformation of the proximal end of the shroud is released, and the inner diameter of the shroud bore begins to return to normal.The shroud is prevented from extending distally beyond a predetermined axial limit by at least one recess located on the shroud adjacent to the proximal end of the shroud, and the recess is located on the bonding sleeve and accommodates at least one radially projecting spur extending from the bonding sleeve. The position of the proximal recess, the bonding sleeve, and the corresponding expansion of the biasing spring determine the degree of axial movement of the shroud from the first needle exposed position to the second needle shroud position, and to the shroud-extended position, respectively.

[0031] As mentioned above, the injection endpoint signaling device also includes a wireless injection endpoint signaling system comprising a near-field communication circuit and an enable switch. When the injection endpoint signaling device is mounted on a pre-charged syringe as described above, in a first shroud-retracted position, the enable switch keeps the near-field communication circuit in an inactive state where the circuit is turned off and injection endpoint information cannot be accessed by the NFC circuit. As used herein, the terms "inactive" and "off" relate to the NFC circuit being unable to retrieve or discover injection endpoint information. The endpoint information in question may be as simple as, for example, a single bit of data, an electrical pulse, or a simple state of an open or closed electrically conductive or semiconducting gate that allows the passage of charged particles such as electrons.

[0032] Conversely, in the second shroud-extended position, the activation switch keeps the NFC circuit in an active state where the circuit is on, and consequently, scan endpoint information can access the NFC circuit. Therefore, as used herein, the terms “active” and “on” relate to the NFC circuit being able to retrieve or discover scan endpoint information when such circuit is energized in a known manner.

[0033] In this way, it is ensured that when the activation switch is in an active or "on" state, endpoint information is available only to the NFC circuit, and that only scans that are actually completed can be communicated through the NFC circuit to a separate NFC reader or a smartphone device appropriately equipped with NFC.

[0034] Near Field Communication (NFC) technology, as a derivative or advancement 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 defining the function of ID cards used to store information such as that found in NFC ID tags, and the latter defining RFID communication used by NFC-equipped devices. The basis of NFC will be found in radio frequency identification, or RFID, technology, which uses radio waves to power passive electronic tags that are otherwise unpowered or unenergized, and provides hardware appropriately equipped to communicate with them. Accordingly, the NFC circuit used in the present invention comprises a passive ID tag that stores a set of information, such as, for example, the type of injectable material, unit capacity, concentration, expiry date, etc., and any other useful or necessary information that can be appropriately stored within the limitations of such NFC ID tags. The NFC circuit also includes appropriate and corresponding communication components that, when energized, enable the NFC circuit to exchange the information with another NFC-enabled device, such as a smartphone. An antenna forming part of the NFC circuit is also provided to capture radio waves of a predetermined functional frequency of the NFC protocol and energize the circuit accordingly.

[0035] Additionally, and as mentioned above, when mounted on a pre-filled syringe as described above, the activation switch of the near-field communication circuit is moved from an inactive state to an active state through surface engagement that cooperates between a part of the shroud and the activation switch. Thus, the activation switch engages with and is moved by physical interaction with a part of the safety shroud mechanism.

[0036] Advantageously, and for other purposes, mutually cooperative surface engagement between the activation switch and the corresponding part of the needle safety shroud is provided only when the shroud is positioned in a fully extended position. That is, the near-field communication circuit is activated only when the shroud reaches the final, extended position that completely covers the needle of the pre-charged syringe. In this way, it can be assured that the pre-charged syringe is not only safe to dispose of, but additionally reaches the release and / or injection endpoint, and thus the endpoint information becomes accessible to the NFC circuit integrated within the endpoint signaling device, and that this endpoint information can be signaled to an NFC-equipped reader device through the energization of the NFC circuit located in the injection point signaling device in a conventional manner.

[0037] For another purpose, the activation switch is moved from an inactive state to an active state by cooperative surface engagement between the proximal part of the shroud and the activation switch. A suitable proximal part of the shroud may be a recess located within the shroud near the proximal end of the shroud, which is positioned on the bonding sleeve as described above and accommodates at least one radially protruding spur extending from the bonding sleeve. In this configuration, when the activation switch is mounted on the shroud and, in the inactive state, is positioned to occupy the space provided by the recess from a position on the recess facing into the bore of the shroud. When the injection is completed, the shroud is moved axially in the proximal direction as described above due to the interaction of the biasing spring with the bonding sleeve, so that the protruding spur of the bonding sleeve engages with the recess of the shroud and pushes against the activation switch to move the switch from an inactive or "off" state to an active or "on" state.

[0038] For other purposes, the activation switch is positioned parallel to and along the central longitudinal axis when the circuit holder body is mounted on the pre-fill syringe body and / or needle safety shroud.

[0039] Therefore, depending on another purpose, an activation switch is a displaceable or movable electrical contact.

[0040] Depending on another purpose, a displaceable or movable electrical contact is selected from the group consisting of a microswitch, a biased or restricted electrically conductive metal strip, and a movable electrically conductive surface. The displaceable or movable electrical contact is generally positioned to be movable or displaceable from a first inert or "off" position, in which current or charge may pass through the circuit in which the electrical contact interacts, to a second active or "on" position, in which the electrical contact is made so that charge or current flows through the circuit in which the electrical contact interacts. Where the electrically conductive surface is implemented as a switch, such electrically conductive surface may usefully comprise a conductive material distributed within or on the surface by any range of techniques known to those skilled in the art, such as layering, embedding, chemical or physical deposition, etching, engraving, doping, etc. In a particularly advantageous embodiment, an electrically conductive surface positioned on an electrical contact applicator comprises carbon particles or metal particles. This electrically conductive surface will form an electrical contact once the shroud moves to a fully extended position, at which point the protruding spur of the bonding sleeve recesses into the corresponding recess provided on the shroud. Until this position is achieved, the electrically conductive surface is configured and organized to prevent the establishment of any electrical contact, thereby sending endpoint information accessible to the NFC circuit.

[0041] For another purpose, the injection endpoint signaling device includes a near-field communication circuit holder body, and the circuit holder body is mounted on a surface facing outwardly of the longitudinal body of a pre-filled syringe.

[0042] For another purpose, advantageously, the circuit holder body is mounted on the outwardly facing surface of the needle safety shroud. It should be understood that "outwardly facing" refers to the outer surface of the shroud, that is, the surface facing outwardly opposite the inner surface of the shroud, or the inwardly facing surface of the shroud facing inwardly into the bore of the shroud.

[0043] For another purpose, the circuit holder body is mounted on the pre-filled syringe in a plane placed parallel to the central longitudinal axis.

[0044] Additionally, and advantageously for another purpose, the circuit holder body is mounted on the surface facing outwardly of the needle shroud and also engages with at least a portion of the pre-filled syringe so that the circuit holder body cannot be removed from the shroud, but the shroud can be moved axially along the central longitudinal axis from a first shroud-retracted position to a second shroud-extended position. The end result of this mounting is that the circuit holder body is positioned not only parallel to the central longitudinal axis of the syringe, but also extends in both directions substantially orthogonally to the central longitudinal axis in the parallel longitudinal plane.

[0045] Furthermore, for another purpose, advantageously, the displaceable or movable electrical contact of the activation switch of the NFC circuit establishes an active electrical contact through a translational movement of the shroud in a direction parallel to the central longitudinal axis from a first inactive position where no electrical contact is established to a second contact position where an electrical contact is established. Thus, the shroud serves to move the activation switch directly or indirectly, for example, from an electrically gapped or electrically insulated region of the NFC circuit through a protruding spur of the junction sleeve, thereby closing the circuit and allowing current or charge to flow and thereby also making endpoint information accessible to the NFC circuit.

[0046] For another purpose, the circuit holder body includes a socket configured and dimensioned to accommodate and position 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 body holder, for example, when mounting an injection endpoint signaling device on a pre-filled syringe.

[0047] Additionally, and for other purposes, a near-field communication circuit is advantageously integrated into a disk-shaped circuit board, an NFC microcontroller is located on the first side of the circuit board, and an activation switch is located on the opposite, second side of the circuit board. This configuration allows the disk-shaped circuit board to be seated on one side through physical surface interaction between the microcontroller and the seating socket of the circuit body holder, while on the other side, the activation switch is left without corresponding cooperative surface engagement with the needle shroud.

[0048] For another purpose, a first side of the disc-shaped circuit board is held against the inwardly facing surface of the disc-shaped base of the circuit holder body by at least one retaining lug. The retaining lugs help hold the disc-shaped circuit board within the circuit holder body and, together with the socket, properly position the circuit board and thus position the corresponding activation switch for the needle shroud when the device is mounted on a pre-filled syringe.

[0049] For other purposes, retaining lugs are distributed radially around the axis of rotation of the disc-shaped base of the circuit holder body.

[0050] For another purpose, the rotation axis of the disc-shaped base of the circuit holder body is positioned perpendicular to the central longitudinal axis of the pre-filled syringe. From this, and as mentioned elsewhere in this specification, it will be understood that the endpoint signaling device is at least partially disc-shaped, and when mounted on the pre-filled syringe, the disc is positioned in a plane orthogonal to the central longitudinal axis of the syringe, in a plane that is entirely parallel and within a parallel plane. Accordingly, the rotation axis of the disc-shaped base of the circuit holder body is positioned perpendicular to a horizontal plane parallel to the central longitudinal axis.

[0051] For another purpose, the circuit holder body comprises at least one wall positioned on the periphery of a disc-shaped base and extending in the same direction away from the disc-shaped base. The walls are formed and configured to engage with at least a portion of a pre-filled syringe and / or needle shroud.

[0052] Accordingly, for other purposes, at least one extending wall is arc-shaped, and when the device is mounted on a pre-fill syringe and / or needle safety shroud, said walls engage with at least one side wall of the pre-fill syringe and / or needle safety shroud with an elastically deformable abutment.

[0053] Accordingly, it will be understood from the foregoing that the circuit holder body advantageously comprises a base, preferably in the shape of a disc, and that the base is provided with a pair of walls extending, for example, from the periphery of the base and preferably extending away from the base in a direction orthogonal to the plane of the base of the circuit holder body. Furthermore, the walls extend in a direction substantially parallel to the rotational axis of the base of the circuit holder body to form an elastically deformable engagement surface when mounted on a pre-filled syringe and / or needle shroud, thereby preventing any lateral movement of the injection endpoint signaling device about the central longitudinal axis.

[0054] For other purposes, each of at least one extending wall comprises a prehensile shoulder extending substantially perpendicular to the central longitudinal axis and away from the central longitudinal axis from the proximal end of each of the extending walls. The prehensile shoulders are designed to engage and abut a finger stop, known as a backstop, mounted on the needle shroud, and the shoulder provides a surface to be supported by the fingers of one hand during use, while the plunger is generally pressed by the thumb of the same hand.

[0055] Depending on the purpose, the graspable shoulder extends from a radially spaced end of the shoulder proximally to form a curled lip configured to engage with a corresponding finger stop or backstop extending orthogonally outward from the shroud and an elastically deformable clasping engagement. The curled lip serves to clamp or clasp the circuit body holder onto the backstop of the syringe and prevents any unwanted movement of the endpoint signaling device when the user presses the plunger with the thumb during injection.

[0056] For another purpose, the grasping shoulder is provided with one or more elastically deformable seating lugs extending proximally from the shoulder to assist in engaging with a finger stop or backstop. These seating lugs are elastically moved when the backstop engages with the shoulders, causing the shoulders to move over the surrounding edges of the backstop, be elastically deformed, and then return to an initial undeformed state when the edges of the backstop are engaged.

[0057] For other purposes, one or more extending walls, graspable shoulders, and curled lips are closed by a rear covering extending from the rear edge of at least one extending wall to the rear edge of another extending wall. In this configuration, the endpoint scanning signaling device is essentially completely closed to prevent, for example, tampering of the device by a user, and / or accidental ingress of fluids, dust, etc., which could potentially interfere with the function of the NFC circuit.

[0058] For another purpose, the rear covering includes a rotatable hinge to facilitate, for example, mounting an injection endpoint signaling device onto a pre-filled syringe and subsequently closing the rear covering once the device is mounted onto the pre-filled syringe.

[0059] Accordingly, another objective anticipates that a rotatable hinge is provided along the edge of one of the extending walls. In this way, the rear cover is essentially configured as a panel or door having a hinged articulation aligned with one of the edges of one of the extending walls. The rear cover is also provided with a corresponding opposing latch mechanism and a corresponding opposing recess provided on the opposite edge of the opposite wall to accommodate the latch, so as to secure the rear cover when moved from an open position during mounting of the signaling device to a closed position after mounting on the pre-filled syringe.

[0060] In brief, scan endpoint signaling devices are designed to function as follows:

[0061] An injection endpoint signaling device is mounted on the outer surface of a pre-filled syringe having an axially translational needle shroud that translates the shroud along the central longitudinal axis of the pre-filled syringe from a first shroud-retracted position before injection to a second shroud-extended position at the completion of injection, which is a second position where the needle of the pre-filled syringe is completely covered, thereby securing the pre-filled syringe for subsequent disposal by the user. The signaling device has an activation switch positioned in alignment parallel to the central longitudinal axis of the pre-filled syringe and also positioned within a recess provided near the proximal end of the shroud. The proximal recess of the shroud receives a protruding spur provided on a bonding sleeve located nearby and fixedly contacting the distal end of the syringe barrel. When the injection is completed, the plunger head of the pre-charged syringe activates a release mechanism for the shroud, and the shroud moves distally along the central longitudinal axis. The relative movement of the shroud compared to the fixed position of the bonding sleeve causes the proximal recess to move proximally as part of the shroud until it comes into contact with the protruding spur of the bonding sleeve. At this point, the protruding spur enters the recess and engages with the activation switch, causing it to move from the "off" position to the "on" position. Considering that the protruding spur prevents any further axial movement of the shroud, the activation switch remains in the "on" or active state in this position, and the injection endpoint information, which is the detection of a separately stored data bit, an electrical impulse, or a simple current flow, becomes accessible to an NFC circuit that can be energized in a known manner, for example, by bringing the pre-charged syringe close to an NFC-equipped smartphone or a corresponding NFC reader, or vice versa.A suitably energized NFC circuit of an endpoint signaling device can subsequently cause any tag information stored in the NFC circuit, including recently accessible endpoint information, to be broadcast and / or communicated and / or received by a reader in a known manner and function of the NFC circuit. Brief explanation of the drawing

[0062] The present invention will now be described further in connection with the drawings provided for exemplary purposes of various embodiments of the present invention: FIGS. 1a and 1b show schematic perspective views of the upper and lower portions of a pre-filled syringe equipped with a passive needle safety shroud mechanism fitted with an endpoint signaling device according to the present invention. FIGS. 2a and 2b show schematic axial views of the front and rear of the pre-filled syringe of FIG. 1, equipped with an endpoint signaling device according to the present invention. FIGS. 3a and 3b show schematic perspective views of an endpoint signaling device according to the present invention, viewed from below, illustrating details regarding the location of a short-range communication circuit. FIGS. 4a and FIGS. 4b show schematic perspective views of additional details of an endpoint signaling device according to the present invention. FIGS. 5A and 5B show schematic cross-sectional views of a pre-filled syringe having a manual needle safety shroud mechanism as shown in FIG. 1, illustrating two main positions of the needle shroud and the corresponding endpoint signaling device according to the present invention. Specific details for implementing the invention

[0063] Now, referring to the drawings, a pre-filled syringe (1) equipped with a safety shroud is illustrated in more detail in the top and bottom perspective views in FIG. 1a and FIG. 1b and in the exemplary cross-sectional views in FIG. 5a and FIG. 5b. The pre-filled syringe (1) is an extended hollow syringe body (2) having a proximal end (3) and a distal end (3), and has a first opening (5) and a collar (6) or flange protruding outwardly from the hollow syringe body (2) at the proximal end (3) around the first opening (5). An injection needle (7) covered by a removable or frangible needle cap (8) is mounted at the distal end (4) of a hollow extended syringe body (2) and closes the second distal opening (7) of the hollow extended syringe body (2) at the distal end (4). A controlled amount of injectable material (not shown), such as a liquid or form of drug, is introduced into the hollow body (2) during the assembly of the syringe components.

[0064] The plunger (9) is configured and dimensioned to be inserted into the hollow extended syringe body (2) through the proximal end (3) and the corresponding proximal opening (5) of the hollow syringe body (2), and the plunger (9) has a plunger body or rod (10) comprising a stopper (11) located at the distal end (12) of the plunger body (10). The stopper (11) may be connected to the plunger body (10) in a known manner, for example, by providing a screw-threaded projection (13) at the distal end (12) of the plunger body (9) and a corresponding screw-threaded bore (14) provided 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 the syringe body (2) are substantially longitudinally aligned along the central longitudinal axis (17) of the syringe body (2). The needle shroud (18) extends along the outside of the syringe body (2) and around the perimeter of the syringe body (2) and has a proximal end (19) and a distal end (20). A commercial product having a safety needle shroud like the one illustrated is the BD Ultrasafe Passive by Becton Dickinson. TM It is sold as.

[0065] As can be seen in more detail in FIGS. 5a and 5b, the needle shroud (18) is configured to move from a first shroud-retracted position (see FIG. 5a) where the needle (7) is exposed once the brittle or removable needle cap (8) is removed, to a second shroud-extended position where the needle (7), which is effective only at the completion of the injection, is completely covered by the needle shroud (18), as illustrated in FIG. 5b. 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) located adjacent to the proximal end (3) of the syringe (2) so that the syringe (2) is held within the bore (21) of the shroud (18), along the outside of the syringe (2), over the distal end (4) of the syringe (2), and distally beyond the distal end (4) 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 through an elastically deformable portion (24). A compressed biasing spring (25) is located within the bore and is seated against the distal end (20) of the shroud (18). The proximal end (26) of the spring (25) is adjacent to the distal end (4) of the syringe (2), but is joined to an abutment sleeve (27) that surrounds the outer surface (28) of the syringe (2) proximally from the distal end (4) and is seated in a fixed position on the outer surface (28). The abutment sleeve (27) further includes at least one projecting spur (29) that engages with a groove aligned longitudinally with the central longitudinal axis (17) and the inwardly facing surface (30) of the shroud, for example, in sliding engagement.The shroud (18) is further provided with a recess (31) or orifice extending from the outwardly facing surface (32) of the shroud (18) to the inwardly facing surface (30) of the shroud (18), and the recess or orifice (31) is located adjacent to but distal to the proximal end (19) of the shroud (18).

[0066] As illustrated in more detail in FIGS. 5a and 5b, the scan endpoint signaling device (33) is mounted and engaged on the outwardly facing surface (32) of the shroud (18). In the first shroud-retracted position (Fig. 5a), the scan endpoint signaling device (33) is positioned near the proximal end (19) of the shroud (18), as will be described in more detail below.

[0067] FIGS. 2a and 2b schematically illustrate a drawing of an injection endpoint signaling device (33) when mounted on a pre-filled syringe equipped with a needle safety shroud. FIG. 2a shows a drawing from the distal ends (4, 20) along the central longitudinal axis (17) of the pre-filled syringe, and FIG. 2b shows a drawing from the proximal ends (3, 19) of the pre-filled syringe equipped with a needle safety shroud. As is evident from these drawings taken together with FIGS. 1a and 1b, the injection endpoint signaling device (33) spans the width of the shroud (18), lies in a plane (B-B') that is orthogonal to the central longitudinal axis and parallel to (A-A'), and additionally engages with each side wall (34) of the shroud parallel to the central longitudinal axis. As can be seen from FIGS. 2a and 2b, the scanning endpoint signaling device (33) resembles a button cap positioned on and across the width of the shroud (18), slightly raised from its outwardly facing surface (32).

[0068] FIGS. 3a, FIGS. 3b, FIGS. 4a and FIGS. 4b show more detailed exemplary drawings of the scanning endpoint signaling device (33), in particular perspective views of relative component parts of the scanning endpoint signaling device (33).

[0069] FIGS. 3A and 3B illustrate a circuit holder body (35) in a rear perspective view to expose additional details of a scan endpoint signaling device (33). The circuit holder body (35) is molded and configured to accommodate and hold a near-field communication (NFC) circuit (36) of which its type and function are known. The NFC circuit (36) comprises a disk-shaped printed circuit board (37) and incorporates an antenna (38) and an activation switch (40) on a first side (39) of the disk-shaped circuit board (37). On a second side (41) opposite the circuit board (37), an NFC microcontroller (42, FIGS. 5A, 5B) is provided to control the function of the NFC circuit (36). The circuit holder body (35) includes a disc-shaped, or substantially disc-shaped, base (43) configured and dimensioned to receive and hold a disc-shaped circuit board (37). To this end, the base (43) of the circuit holder body (37) is provided with a socket (44) dimensioned and positioned to receive and seat an NFC microcontroller (42) positioned on a second opposite side (41) of the circuit board (37). The socket (44) allows an activation switch (40) on the opposite side (41) of the circuit board (37) to be accurately positioned parallel to the central longitudinal axis (17) of the pre-charge syringe (1) when the endpoint signaling device (33) is mounted on the shroud (18). As can be seen from FIG. 1a and FIG. 1b, when the endpoint signaling device (33) is mounted on the shroud (18), when the shroud (18) is in an initial, retracted position, the activation switch (40) is placed inside the recess (31) so as to penetrate from the outer surface (32) and extend 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) and includes a head portion (48) protruding into an internal volume defined by the base (43) and the peripheral wall (46). When a circuit board (37) is inserted into this internal volume, the lugs (47) are elastically deformed radially outward to allow passage of the disc-shaped circuit board and then moved backward to close over the circuit board, and the protruding head portions (48) engage in maintaining surface engagement with the first face (39) of the circuit board (37).

[0070] As illustrated in FIGS. 3a, 3b, 4a, and 4b, the circuit holder body (35) further comprises a pair of elastically deformable side walls (49, 50) extending in the same direction from the periphery of the base (43) and orthogonally to the base (43). Each of the side walls (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 arched shape corresponding to an arc defined by the periphery of the disc-shaped base (43) and also extend at least partially around the periphery of the base (43), and the first end (51, 51') and the second end (52, 52') define a space between them that is slightly smaller than the width of the shroud (18), so that when the endpoint signaling device (33) is mounted, the side walls are elastically deformed through the first end (51, 51') and the second end (52, 52') and engage frictionally and elastically with the corresponding side walls (34, 34') of the shroud (18) which are on both sides of the central longitudinal axis (17). The circuit holder body (35) further includes a pair of gripping shoulders (prehensile shoulders), each of which extends substantially orthogonally from the central longitudinal axis (17) and from the first or proximal end (51, 51') of each of the extending side walls (49, 50) to the central longitudinal axis (17).The graspable shoulders (54, 54') extend outwardly and orthogonally from the body (2) of the pre-filled syringe (1) and extend from the first radially spaced end (55, 55') of the shoulder (54, 54') to the second end (56, 56') spaced from the first end of the shoulder to form a curled lip (57, 57') configured to engage with a corresponding finger stop or backstop (58) mounted on the shroud (18) and an elastically deformable clasping engagement. One or more elastically deformable seating lugs (59, 59') extending away from the shoulders are provided to assist in engaging with the finger stop or backstop, advantageously for the graspable shoulders (54, 54'). These seating lugs (59, 59') are elastically moved when the backstop (58) engages with the shoulders during mounting of the endpoint signaling device (33), causing the shoulders (54, 54') to move over the surrounding edges of the backstop (58), elastically deform, and then return to their original undeformed state when the edges of the backstop (58) are seated on the shoulders (54, 54').

[0071] As can be seen from the drawings, particularly from FIG. 1b, the circuit holder body (35) appears backless, that is, it does not have a rear cover. However, although not illustrated, it may be useful to provide one or more of extending walls, graspable shoulders, and curled ribs having a rear covering extending from the first edge (53) of at least one extending side wall (49) to the opposite facing edge (53') of the other extending side wall (50). The rear covering may further be provided with a rotatable hinge positioned, for example, along one of the edges (53, 53') of one of the extending side walls (49, 50). This is particularly advantageous, for example, in preventing some ingress of dust and / or liquids into the endpoint signaling device (33), but is particularly advantageous in preventing tampering by a user of any components of the endpoint signaling device, for example, circuit boards, antennas, NFC microcontrollers and / or activation switches. This articulated rear covering will, of course, be opened when mounting the endpoint signaling device (33) onto the shroud (18), and then closed when mounting of the device (33) is completed. Closing of the rear covering can be appropriately provided through a combination of a latch on the rear covering and a corresponding receiving recess for a latch provided on the edge (53') opposite to the edge (53) where the articulated or hinge point is provided thereon.

[0072] Referring again to FIGS. 5a and 5b, the function of the endpoint signaling device (33) will now be described. In the shroud-retracted position exemplified in FIG. 1a, which is the position adopted by the shroud before and during injection, the shroud (18) exposes the needle (7) once the brittle or removable needle cap (8) is removed. The activation switch of the endpoint signaling device is positioned parallel to the central longitudinal axis (17), engages with the recess (31) of the shroud (18), and extends into the bore (21) of the shroud. As the injection proceeds, the plunger (9) and the plunger head (15) are moved distally toward the proximal end (3) of the syringe. When the injection is completed, the plunger (9) and the 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 time, for example, as described elsewhere in this specification, the needle safety mechanism is activated, causing the compressed biasing spring to extend and push against the bonding sleeve (27) which is in fixed position contact with the outer surface of the syringe body (2). The bonding sleeve (27) and the syringe body (2) are moved in the opposite direction to the direction of the shroud (18), which moves from a retracted position to an extended position covering the needle. When the bonding sleeve (31) and the associated protruding spur (29) move along the inner surface of the shroud (18) to the point where the protruding spur (29) engages with the recess (31), relative opposing translational movements along the central longitudinal axis (17) of the shroud (18) relative to the syringe body (2) are prevented. At this time, the protruding spur (29) also comes into surface contact with the activation switch (40).In the example illustrated in the drawings, the switch is moved up and out of the recess (31) as the protruding spur enters the recess, thereby moving the switch from an inactive, or “off” state to an active, or “on” state. The movement of the activation switch from the “off” to the “on” state makes scan endpoint information, which was previously inaccessible to the NFC circuit, visible or accessible to the NFC circuit. The syringe (1) can now be brought close to an NFC-equipped device, such as a smartphone or an NFC reader, which will energize the NFC circuit (36) within the endpoint signaling device (33) and allow any information stored in the NFC circuit, including the now accessible scan endpoint information, to be communicated to the NFC reader or the NFC-equipped smartphone device.

Claims

Claim 1 An injection endpoint signaling device adapted and configured to be mounted on a pre-filled syringe, wherein the pre-filled syringe comprises a post-injection needle shroud, said shroud configured to translate from a first position in which the shroud is retracted and the needle of said pre-filled syringe is exposed to a second position in which the shroud is extended and the needle of said pre-filled syringe is completely enclosed by said shroud, and the injection endpoint signaling device comprises a wireless injection endpoint signaling system comprising a near field communications (NFC) circuit and an activation switch; and when mounted on said pre-filled syringe, in the first shroud-retracted position, said activation switch maintains the NFC circuit in an inactive state in which the NFC circuit is off and injection endpoint information cannot access said NFC circuit; A scanning endpoint signaling device, wherein in a second shroud-extended position, the activation switch maintains the NFC circuit in an active state in which the NFC circuit is on and the scanning endpoint information can access the NFC circuit; the activation switch is moved from the inactive state to the active state through mutually cooperating surface engagement between a part of the shroud and the activation switch, wherein in a first shroud-retracted position, the activation switch is disposed within a recess formed in the shroud, and in a second shroud-extended position, the activation switch forms the mutually cooperating surface engagement by contacting a protruding spur of a bonding sleeve disposed within a bore of the shroud. Claim 2 In claim 1, the mutual cooperation surface engagement between the activation switch and the shroud is provided when the shroud is positioned in a fully extended position, a scanning endpoint signaling device. Claim 3 An injection endpoint signaling device according to claim 1, comprising a near-field communication circuit holder body, wherein the circuit holder body is mounted on a surface facing outwardly of the longitudinal body of the pre-filled syringe. Claim 4 In claim 3, the circuit holder body is mounted on a surface facing outwardly of the shroud, a scanning endpoint signaling device. Claim 5 In claim 3, the circuit holder body is an injection endpoint signaling device mounted on the pre-filled syringe in a plane parallel to the central longitudinal axis of the pre-filled syringe. Claim 6 In claim 3, the scanning endpoint signaling device comprising a circuit holder body configured to accommodate and position a microcontroller of the near-field communication circuit and including a dimensioned socket. Claim 7 A scanning endpoint signaling device according to claim 6, wherein the near-field communication circuit is integrated into a disk-shaped circuit board, the microcontroller is located on a first surface of the disk-shaped circuit board, and the activation switch is located on a second surface opposite the disk-shaped circuit board. Claim 8 In claim 7, the scanning endpoint signaling device wherein the first surface of the disk-shaped circuit board is held against the inwardly facing surface of the disk-shaped base of the circuit holder body by at least one retaining lug. Claim 9 In claim 8, the scanning endpoint signaling device, wherein the retaining lugs are radially distributed around the rotation axis of the disk-shaped base of the circuit holder body. Claim 10 In claim 9, the rotation axis of the disk-shaped base is positioned perpendicular to the central longitudinal axis of the pre-filled syringe, an injection endpoint signaling device. Claim 11 In claim 9, the rotation axis of the disk-shaped base is positioned perpendicular to a horizontal plane parallel to the central longitudinal axis of the pre-filled syringe, in an injection endpoint signaling device. Claim 12 A scanning endpoint signaling device according to any one of claims 8 to 11, wherein the circuit holder body comprises at least one wall positioned on the periphery of the disk-shaped base and extending in the same direction away from the disk-shaped base. Claim 13 In claim 12, the injection endpoint signaling device wherein at least one wall is arc-shaped, and when the device is mounted on the pre-filled syringe and / or the shroud, the at least one wall engages with at least one side wall of the pre-filled syringe and / or the shroud via an elastically deformable abutment. Claim 14 An injection endpoint signaling device according to claim 12, wherein each of the at least one wall comprises a prehensile shoulder extending substantially orthogonally to the central longitudinal axis of the pre-filled syringe from the proximal end of each of the walls. Claim 15 In claim 14, the injection endpoint signaling device, wherein the graspable shoulder extends proximally from a radially distant end of the shoulder to form a curled lip configured to engage with a corresponding finger stop extending orthogonally outward from the body of the pre-filled syringe and an elastically deformable clasping engagement. Claim 16 In claim 15, one or more of the at least one wall, the graspable shoulder, and the curled lip are closed by a rear covering extending from the rear edge of at least one extending wall of the at least one wall to the rear edge of another extending wall of the at least one wall, in a scanning endpoint signaling device. Claim 17 In claim 16, the scanning endpoint signaling device, wherein the rear covering comprises a rotatable hinge. Claim 18 In claim 17, the rotatable hinge is provided along the edge of one of the at least one wall, a scanning endpoint signaling device. Claim 19 In claim 3, the activation switch is an injection endpoint signaling device positioned parallel to the central longitudinal axis of the pre-charge syringe and along the central longitudinal axis when the circuit holder body is mounted on the pre-charge syringe and / or the shroud. Claim 20 In claim 1, the activation switch is a scanning endpoint signaling device that is moved from the inactive state to the active state by the mutually cooperative surface engagement between the proximal part of the shroud and the activation switch. Claim 21 In claim 1, the activation switch is a scan endpoint signaling device that is a displaceable or movable electrical contact. Claim 22 In claim 21, the displaceable or movable electrical contact is selected from the group consisting of a microswitch, a biased or restricted electrically conductive metal strip, and a movable electrically conductive surface, for a scanning endpoint signaling device.

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