Injection endpoint signalling 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 the treatment or onset of other life-threatening situations such as acute pain or trauma, myocardial infarction, anaphylaxis, bacterial or toxic shock, etc. for emergency injections. Thus, the uses of prefilled syringes are widespread and well-known.

[0003] Such prefilled syringes generally include an elongated hollow syringe body having a proximal end and a distal end, the elongated hollow syringe body having a first opening at the proximal end and a collar or flange protruding outwardly of the hollow syringe body around the first opening at the proximal end, 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 configured and dimensioned to be inserted into the elongated hollow syringe body through a proximal end of the hollow syringe body and a corresponding proximal opening, the plunger having a plunger body, the plunger body having a stopper disposed at a distal end of the plunger body and a plunger head disposed at a proximal end of the plunger body, the plunger, having.

[0004] One of the general problems with such prefilled syringes is being able to indicate when the syringe was actually used, either to avoid attempts at reuse or, for example, for tracking purposes, to know whether and how much of an injectable substance was administered from the prefilled syringe. To overcome this general problem, various tracking systems have been associated with such prefilled syringes.

[0005] For example, the international patent application published as WO 2014 / 089086 relates to a method of using an electronic drug device such as an autoinjector containing a drug such as epinephrine for treating anaphylactic shock. This device includes a sensor, an ID tag such as an RFID, NFC, or other tag for short-range wireless communication such as Bluetooth communication, a memory, a display, and a speaker, as well as a processor and a communication interface, where the processor interconnects one or more of the components and the communication interface includes an interface for communication via wifi, a mobile carrier network, or a 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 events such as drug administration and the occurrence of an expiration date of the drug. The sensor includes a vulnerability element that detects the activation of the device and completes or breaks an 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 autoinjector device and changes the memory to indicate that the device has been used, along with a log of the usage time. The ID tag also provides information from the autoinjector device to a wireless reader of an NFC-enabled mobile device, such as a mobile phone. The mobile phone reads drug information printed on the autoinjector device or stored in the autoinjector device memory using RFID, NFC, or other wireless communication.

[0006] Similarly, a U.S. patent application published as U.S. Patent No. 2019038840 discloses a prefilled syringe having a complex arrangement of two antennas, including a first transmission antenna configured to transmit a control signal to an external device, a control electronics connected to the first transmission antenna and configured to provide an instruction to the transmission antenna to transmit the control signal, and a second bypass antenna positioned and configured such that when the bypass antenna is in a non-disturbed position, the control electronics is blocked from providing an instruction to the transmission antenna, and when the bypass antenna is displaced from the non-disturbed position, the control electronics is permitted to provide an instruction to the transmission antenna. 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 such that when the push button is pressed by the user of the syringe, the electrical contacts are broken. Pressing the push button irreparably breaks the electrical contact 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 adapted to extrude a drug from a syringe, comprising a shaft sized and dimensioned to act on the piston of the syringe and a finger-operable head portion housing at least two sub-units of a wireless sensor. In a pre-operational configuration, the sub-units are separated from each other by a physical barrier and the wireless sensor is inoperative. In a post-operational configuration, the sub-units are connected to each other and the sensor operates to transmit a signal. The user operates the finger-operable head portion to reversibly move the physical barrier and transition the plunger rod from the pre-operational configuration to the post-operational 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 above-mentioned documents, many problems remain to be overcome for injection endpoint (injection endpoint) detection and signaling using short-range wireless communication. This is especially true for prefilled syringes that are specifically modified to function in a particular way. For example, there are also known prefilled syringes that incorporate a safety mechanism to protect the user from needle stick injuries when the injection is complete. Such prefilled 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

Patent Document 2

Patent Document 3

Summary of the Invention

Problems to be Solved by the Invention

[0010] Accordingly, according to one objective, the applicant provides an injection endpoint signaling device that is adapted and configured to be attached to a prefilled syringe having a needle safety mechanism and used with the prefilled syringe, 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 objectives will become apparent from the description below or from the specification that follows.

Means for Solving the Problems

[0012] Accordingly, one object of the present invention is an injection end-point signaling device adapted and configured to be attached to a prefilled syringe, the prefilled syringe having a post-injection needle shroud, the needle shroud moving from a first position where the shroud retracts and the needle of the prefilled syringe is exposed to a second position where the shroud extends and the needle of the prefilled syringe is completely surrounded by the shroud, in an injection end-point signaling device configured to translate (transfer). The injection end-point signaling device has a wireless injection end-point signaling system having a near-field communication (NFC) circuit and an activation switch. When attached to the prefilled syringe In the first shroud retracted position, the activation switch maintains the NFC circuit in an inactive state where the NFC circuit is off and the NFC circuit has no access to injection end-point information. In the second shroud extended position, the activation switch maintains the NFC circuit in an active state where the NFC circuit is on and the NFC circuit has access to injection end-point information. The activation switch is an injection end-point signaling device that is transitioned from an inactive state to an active state by mutual cooperative surface engagement between a part of the shroud and the activation switch.

[0013] The prefilled syringe is generally substantially as described above, namely An elongated hollow syringe body having a proximal end and a distal end, the elongated hollow syringe body having a first opening at the proximal end and a collar or flange protruding outwardly of the hollow syringe body around the first opening at the proximal end. An injection 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 configured and dimensioned to be inserted into the elongated hollow syringe body through the proximal end of the hollow syringe body and a corresponding proximal opening, the plunger having a plunger body, the plunger body having a stopper disposed at the distal end of the plunger body and a plunger head disposed at the proximal end of the plunger body. It should be understood from the present invention that it has.

[0014] Generally, most such prefilled syringes are for single use only, for example, when administering a vaccine or other single-dose drug, and after their use, they should be disposed of in accordance with current appropriate and desirable disposal practices.

[0015] The prefilled syringe has a post-injection needle shroud. For the purposes of this specification, the expression "post-injection needle shroud" is to be understood to refer to a prefilled syringe equipped with an active or passive needle shroud that operates upon completion or shortly after completion of the release of the substance contained within the syringe. In this context, the expressions "active" and "passive" with respect to the needle safety shroud are as follows, namely "Passive" - a needle shroud that automatically operates as a result of the movement of one or more components of the prefilled syringe with respect to the needle shroud, the operation of which is independent of any action by the user of the prefilled syringe other than the release of the substance from the syringe chamber. "Active" - a needle shroud that is actuated by a separate or intentional action performed by the user of the prefilled syringe at the end of the discharge operation with respect to the normal discharge of the injectable substance from the syringe chamber. It refers to.

[0016] As described above, the needle shroud is configured to translate from a first position where the shroud retracts and the needle of the prefilled syringe is exposed, to a second position where the shroud extends and the needle of the prefilled syringe is completely surrounded by the shroud. An example of a prefilled syringe that operates in this manner is available under the trade name BD Ultrasafe Passive(™) sold by Becton Dickinson, which relates to a passive needle guard mechanism for prefilled ISO standard glass syringes, for which injection can be performed with one hand. In this device, the needle safety shroud is in a first position where the needle is exposed at the start and throughout the injection movement, during which the plunger moves distally along the longitudinal central axis of the syringe until the plunger head of the syringe engages 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. Due to the elastic deformation of the needle shroud at the proximal end of the shroud, the bore of the shroud slightly expands along its length. The abutting sleeve is disposed within the bore of the shroud and is positioned by fixed axial engagement contact with the outer surface of the syringe barrel. A pre-constrained biasing spring is disposed between the distal end of the shroud and the distal-facing contact surface of the abutting sleeve within the bore of the shroud, and the spring abuts against the distal-facing contact surface of the abutting sleeve. The elastic deformation and expansion of the shroud caused by the plunger head interacting with the elastically deformable wings at the end of injection allows the pre-constrained biasing spring to expand axially along the central axis and simultaneously push against the distal-facing contact surface of the abutting sleeve, thereby driving the shroud distally. As the shroud moves distally from the shroud retracted position to the shroud extended position, it begins to cover the needle that was exposed during injection.

[0017] Furthermore, as the shroud moves distally, the elastic deformation of 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, and this recess 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 in which the circuit is off and the NFC circuit has no access to injection endpoint information. As used herein, the terms "inactive" and "off" refer to the inability of the NFC circuit to search for or find 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 in which the circuit is on and thus the NFC circuit has access to 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 injection endpoint information when such a circuit is energized in a known manner.

[0020] In this way, it is ensured that the end point information is available to the NFC circuit only when the activation switch is active, i.e., in the "on" state, and that only the actually completed injection can be communicated via the NFC circuit to a separate NFC reader or a suitable NFC-equipped 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 defines the functions of ID cards used to store information as found in NFC ID tags, and the latter defines the RFID communication used by NFC-equipped devices. The basis of NFC should be found in radio frequency identification, i.e., RFID technology, which provides suitably equipped hardware not only for powering but also for communicating with passive electronic tags that use radio waves and are otherwise unpowered or de-energized. Thus, the NFC circuit used in the present invention has a passive ID tag that stores an information set such as, for example, the type of injectable substance, unit dose, concentration, expiration date, and any other useful or necessary information that can be appropriately stored within the limitations of such NFC ID tags. The NFC circuit also has appropriate corresponding communication components that normally enable the exchange of said information with another NFC-compatible device such as a smartphone when the NFC circuit is energized. An antenna forming part of the NFC circuit is also provided to capture radio waves at a given operating frequency of the NFC protocol and thereby energize the circuit.

[0022] Furthermore, as described above, the activation switch of the near field communication circuit is moved from the inactive state to the active state by the mutual cooperative surface engagement between a part of the shroud and the activation switch when attached to the prefilled syringe as described above. Thus, the activation switch engages with a part of the safety shroud mechanism and is moved by physical interaction with this part.

[0023] Advantageously, according to another object, the interactive engagement between the actuating switch and the mating portion of the needle safety shroud is effected only when the shroud is positioned in its fully extended position. In other words, the short-range wireless communication circuit becomes active only when the shroud has reached its final extended position where it completely covers the needle of the prefilled syringe. In this way, the prefilled syringe is not only safe to dispose of, but also that the end of delivery and / or injection has been achieved, and thus that the NFC circuit incorporated in the end point signaling device is made accessible to the end point information, which can then be signaled to the NFC-equipped reader device in the normal manner by energizing the NFC circuit located within the injection point signaling device.

[0024] According to yet another object, the actuating switch is moved from its inactive state to its active state by the cooperative engagement between the proximal portion of the shroud and the actuating switch. A suitable proximal portion of the shroud can be a recess disposed within the shroud near the proximal end of the shroud, which recess, as described above, is disposed in the abutment sleeve and receives at least one radially projecting spool extending from the abutment sleeve. In such a configuration, the actuating switch is mounted to the shroud and, in its inactive state, is positioned to occupy the space provided by the recess above the recess facing the bore of the shroud. When injection is complete, the shroud moves axially in the proximal direction due to the interaction of the biasing spring with the abutment sleeve, such that the projecting spool of the abutment sleeve engages the recess of the shroud and presses against the actuating switch, shifting the switch from its inactive or “off” state to its active or “on” state.

[0025] According to a further object, the actuating switch is disposed 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 the needle safety shroud.

[0026] Thus, for yet a further purpose, the actuating switch is a displaceable or movable electrical contact.

[0027] For another purpose, 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. The displaceable or movable electrical contact is generally arranged to be movable or displaced from a first non-active or "off" position in which current or charge cannot pass through the circuit with which the electrical contact interacts, to a second active or "on" position in which charge or current can pass through the circuit with which the electrical contact interacts. When the conductive surface is implemented as a switch, such a conductive surface advantageously can have a conductive material distributed within or on such a surface by any of a range of techniques known to those skilled in the art, such as, for example, lamination, embedding, deposition whether chemical or physical, etching, engraving, doping, etc. In a particularly advantageous embodiment, the conductive surface disposed on the electrical contact applicator has carbon or metal particles. This conductive surface forms an electrical contact when the projecting spool of the abutment sleeve fits into a corresponding recess provided in the shroud when the shroud moves to the fully extended position. Until such a position is achieved, the conductive surface is configured and arranged to prevent the NFC circuit from accessing end point information by establishing the electrical contact.

[0028] For yet another purpose, the injection end point signaling device has a near field communication circuit holder body, and the circuit holder body is attached to the outer facing surface of the longitudinal body of the prefilled syringe.

[0029] For yet a further purpose, advantageously, the circuit holder body is attached to the outer facing surface of the needle safety shroud. It should be understood that the "outer facing surface" refers to the outer surface of the shroud, i.e., the surface facing outward, as opposed to the inner surface of the shroud, i.e., the inner facing surface, which faces inwardly into the bore of the shroud.

[0030] According to yet another object, the circuit holder body is attached to the prefilled syringe in a plane parallel to the longitudinal central axis.

[0031] Furthermore, and advantageously, according to yet another object, the circuit holder body is attached to the outer facing surface of the needle shroud and also engages at least a portion of the prefilled syringe, such 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 shroud retracted position to a second shroud extended position. The end result of such an attachment is that the circuit holder body is not only parallel to the longitudinal central axis of the syringe, but also extends on both sides thereof substantially orthogonally to the longitudinal central axis within the parallel longitudinal plane.

[0032] Furthermore, and according to yet another object, advantageously, the displaceable or movable electrical contact of the NFC circuit's activation switch establishes an active electrical contact by a translational movement of the shroud in a direction parallel to the longitudinal central axis from a first non-active position where the electrical contact is not established to a second contact position where the electrical contact is established. Thus, the shroud serves to move the activation switch, for example via a protruding spool of an abutment sleeve, directly or indirectly from an electrically gapped or electrically insulated area of the NFC circuit, thereby closing the circuit and allowing current or charge to flow, and thereby also allowing the NFC circuit to access end point information.

[0033] According to yet another object, the circuit holder body has a socket configured and dimensioned to receive and dispose the NFC microcontroller of the 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, for example when an injection end point signaling device is attached to the prefilled syringe.

[0034] Furthermore, for yet another purpose, the short-range wireless communication circuit is advantageously incorporated into a disc-shaped circuit board, the NFC microcontroller is disposed on a first surface of the circuit board, and the activation switch is disposed on a second surface opposite to the first surface of the circuit board. With such a configuration, on the one hand, due to the physical surface interaction between the microcontroller and the seating socket of the circuit holder body, the disc-shaped circuit board can be seated, and on the other hand, the activation switch is released for the corresponding cooperative surface engagement with the needle shroud.

[0035] For yet another purpose, the first surface of the disc-shaped circuit board is held against the inward-facing surface of the disc-shaped base of the circuit holder body by at least one or a plurality of retaining lugs. The retaining lugs serve to hold the disc-shaped circuit board within the circuit holder body and, together with the socket, properly position the circuit board, and thus the corresponding activation switch, with respect to the needle shroud when the device is attached to the prefilled syringe.

[0036] For a further purpose, 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 end-point signaling device is at least partially disc-shaped and that the disc, when attached to the prefilled syringe, is not only parallel to the longitudinal central axis of the syringe but also in a plane orthogonal to the plane parallel to the longitudinal central axis of the syringe. Thus, the axis of rotation of the disc-shaped base of the circuit holder body is perpendicular to a horizontal plane parallel to the longitudinal central axis.

[0038] According to another object, the circuit holder body has at least one or a plurality of walls that are arranged around a disc-shaped base and extend away from the base in the same direction. The walls are shaped and configured to engage at least a portion of a prefilled syringe and / or a needle shroud.

[0039] Accordingly, according to a further object, the at least one or a plurality of extending walls are arcuate in shape, and when the device is attached to a prefilled syringe and / or a needle safety shroud, the walls engage in an elastically deformable abutting manner with at least one side wall of the prefilled syringe and / or the needle safety shroud.

[0040] Thus, from the above, it will be appreciated that the circuit holder body advantageously preferably has a disc-shaped base, and that, for example, preferably, a pair of walls extending away from the base are provided around the base in a direction orthogonal to the plane of the base of the circuit holder body. Further, the walls advantageously 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 a needle shroud, preventing any lateral movement of the injection end point signaling device around the longitudinal central axis.

[0041] According to yet another object, each of the at least one or a plurality of extending walls has a capture shoulder that extends away from the longitudinal central axis substantially orthogonally to the longitudinal central axis from the proximal end of each respective extending wall. The capture shoulder is designed to engage and abut a finger stop, which is a finger top attached to the needle shroud and otherwise known as a backstop, and the shoulder provides a surface that can be pressed by a finger of one hand during use, while the plunger is pressed entirely by the thumb of the same hand.

[0042] According to a further object, the capture shoulder extends proximally from the radially distal end of the shoulder so as to form a curled lip configured to engage in an elastically deformable fastening engagement with a corresponding finger stop or backstop extending orthogonally outward from the shroud. The curled lip serves to clamp or fasten the circuit holder body to the backstop of the syringe, preventing any unwanted movement of the end point signaling device while the user is pressing the plunger with his thumb during injection.

[0043] According to yet another object, the capture shoulder is provided with one or more elastically deformable seating lugs extending proximally away from the shoulder to facilitate engagement with the finger stop or backstop. These seating lugs are elastically moved when the backstop engages the shoulder, moving the shoulder onto and elastically deforming it over the periphery of the backstop, and then returning it to its initial undeformed state when the edge of the backstop seats.

[0044] According to yet another object, the one or more extending walls, capture shoulder and curled lip 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 end point signaling device is substantially hermetically sealed to prevent, for example, tampering with the device by the user, which could interfere with the function of the NFC circuit, and / or accidental ingress of fluids, dust, etc.

[0045] According to another object, the back cover has a rotatable hinge to facilitate, for example, attaching the injection end point signaling device to a prefilled syringe and then closing the back cover after the device is attached to the prefilled syringe.

[0046] Accordingly, one further objective contemplates that the rotatable hinge is provided along one edge of the extending wall. Thus, in this way, the back cover is essentially configured as a panel or door having a hinge joint aligned with one of the edges of one of the extending walls. The back cover may also be provided with a corresponding opposing latch mechanism and a corresponding opposing recess provided at the opposing edge of the opposing wall to receive the latch in order to secure the back cover when it is moved from the open position at the time of attachment of the signaling device to the closed position after attachment to the prefilled syringe.

[0047] In short, the injection end signaling device is designed to function as follows.

[0048] The injection end-point signaling device is attached to the outer surface of a prefilled syringe having an axially translatable needle shroud, and translates the shroud from a first shroud retracted position prior to injection to a second shroud extended position at the completion of injection along the longitudinal central axis of the prefilled syringe, at which second position the needle of the prefilled syringe is completely covered, thereby rendering the prefilled syringe safe for subsequent disposal by the user. The signaling device has an actuating switch positioned in parallel alignment with the longitudinal central axis of the prefilled syringe, and this switch is further positioned within a recess provided near the proximal end of the shroud. The proximal recess of the shroud receives a projecting spool provided on an abutment sleeve disposed near the distal end of the syringe barrel and in fixed contact therewith. Upon completion of injection, the plunger head of the prefilled syringe actuates a release mechanism for the shroud, causing the shroud to move distally along the longitudinal central axis. Due to the relative movement of the shroud, the proximal recess moves proximally as part of the shroud until it contacts the projecting spool of the abutment sleeve. At this point, the projecting spool enters the recess and engages the actuating switch, shifting the actuating switch from an “off” position to an “on” position. Considering that any further axial movement of the shroud by the projecting spool is prevented, the actuating switch remains “on” or actuated in this position, and injection end-point information, whether it be separately stored data bits, electrical impulses, or simply the direction of current, is made accessible to an NFC circuit, which can be energized in a known manner, for example, by bringing the prefilled syringe closer to or away from an NFC-equipped smartphone or corresponding NFC reader. The appropriately energized NFC circuit of the end-point signaling device can then cause any tag information stored in the NFC circuit, including the just-accessible end-point information, to be revealed, and / or communicated, and / or received by the reader in a known manner, and / or by the functionality of the NFC circuit.

[0049] Here, the present invention will be further described in connection with the drawings provided for purposes of illustration of various embodiments of the present invention.

Brief Description of the Drawings

[0050]

Figure 1A

Figure 1B

Figure 2A

Figure 2B

Figure 3A

Figure 3B

Figure 4A

Figure 4B

Figure 5A

Figure 5B

Best Mode for Carrying Out the Invention

[0051] Referring now to the drawings, a prefilled syringe (1) equipped with a safety shroud is shown in FIGS. 1A and 1B in top perspective and bottom perspective views, respectively, and more particularly in the exemplary cross-sectional views of FIGS. 5A and 5B. The prefilled 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, at the proximal end (3), a collar (6) or flange projecting outwardly of the hollow syringe body (2) around the first opening (5). A hypodermic needle (7) covered by a removable or frangible needle cap (8) is attached to the distal end (4) of the elongated hollow syringe body (2), closing a second distal opening (7) of the elongated hollow syringe body (2) at the distal end (4). A controlled amount of injectable material (not shown), such as a liquid or foamed drug, is introduced into the hollow body (2) during assembly of the syringe components.

[0052] The plunger (9) is configured and dimensioned to be inserted into the elongated hollow syringe body (2) through the proximal end (3) of the hollow syringe body (2) and the corresponding proximal opening (5). The plunger (9) has a plunger body or rod (10), and the plunger body or rod (10) has a stopper (11) disposed at the distal end (12) of the plunger body (10). The stopper (11) can be connected to the plunger body (10) in a known manner, for example, by providing a threaded projection (13) at 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) disposed at the proximal end (16) of the plunger body (10). The plunger (9) and the syringe body (2) are substantially longitudinally aligned along the longitudinal central axis (17) of the syringe body (2). A needle shroud (18) extends around the outside of the syringe body (2) along its length and has a proximal end (19) and a distal end (20). Commercially available products having a safety needle shroud such as that illustrated are sold by Becton Dickinson under the trade name BD Ultrasafe Passive (TM).

[0053] As can be seen in more detail in FIGS. 5A and 5B, the needle shroud (18) is effective only at the completion of injection, from a first shroud retracted position (see FIG. 5A) where the needle (7) is exposed when the frangible or removable needle cap (8) is removed, and is configured to move to a second shroud extended position as shown in FIG. 5B where 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 the proximal end (19) disposed adjacent the proximal end (3) of the syringe (2) along the outside of the syringe (2) over the distal end (4) of the syringe (2) and beyond this distal end in the distal direction to the distal end (20) of the shroud (18). The shroud (18) engages the syringe (2) at the proximal end of the shroud via an elastically deformable portion (24). A compressed biasing spring (25) is disposed within the bore and seats against the distal end (20) of the shroud (18). The proximal end (26) of the spring (25) abuts against an abutment sleeve (27) which surrounds and seats in a fixed position on the outer surface (28) of the syringe (2) in the proximal direction adjacent the proximal end (4) of the syringe (2). The abutment sleeve (27) further has at least one projecting spool (29) which engages in sliding engagement with an inward facing 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 disposed in the distal direction adjacent the proximal end (19) of the shroud (18).

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

[0055] FIGS. 2A and 2B schematically show views of an injection end-point signaling device (33) when attached to a prefilled syringe equipped with a needle safety shroud. FIG. 2A shows a view from the distal ends (4, 20) along the longitudinal central axis (17) of the prefilled syringe, and FIG. 2B shows a view from the proximal end (3, 19) of the prefilled syringe equipped with a needle safety shroud. In conjunction with FIGS. 1A and 1B, and as is apparent from these figures, the injection end-point signaling device (33) extends across the width of the shroud (18) and lies in a plane that is not only orthogonal (A-A') but also parallel (B-B') to the longitudinal central axis, and furthermore, it can be seen to further engage each side wall (34) of the shroud parallel to the longitudinal central axis. As can be seen from FIGS. 2A and 2B, the injection end-point signaling device (33) rises slightly above the outer-facing surface (32) of the shroud (18) and resembles a button cap positioned across its width on the shroud (18).

[0056] FIGS. 3A, 3B, 4A and 4B represent more detailed exemplary views of the injection end-point signaling device (33), in particular perspective views of the relative component parts of the injection end-point signaling device (33).

[0057] Figures 3A and 3B show the circuit holder body (35) in a rear perspective view to show further details of the injection end 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 are known per se. The NFC circuit (36) has a disc-shaped printed circuit board (37), and incorporates an antenna (38) and an activation switch (40) on a first surface (39) of the disc-shaped printed circuit board (37). On a second surface (41) opposite to the circuit board (37), an NFC microcontroller (42, Figures 5A, 5B) for controlling the functions of the NFC circuit (36) is provided. The circuit holder body (35) has a disc-shaped or substantially disc-shaped base (43), which is configured and dimensioned 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 an NFC microcontroller (42) disposed on the second surface (41) opposite to the circuit board (37). The socket (44) further enables the activation switch (40) on the surface (41) opposite to the circuit board (37) to be properly positioned in parallel alignment with the longitudinal central axis (17) of the prefilled syringe (1) when the end signaling device (33) is attached to the shroud (18). As can be seen from Figures 1A and 1B, when the end signaling device (33) is attached to the shroud (18) and the shroud (18) is in its initial retracted position, the activation switch (40) penetrates from the outer surface (32), enters 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 around it from the periphery (46) of the base (43), and one or more radially spaced retaining lugs (47) are provided on the peripheral wall (45), and this retaining lug includes a head portion (48) protruding 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 portion, the lug (47) elastically deforms radially outward to allow a disk-shaped circuit board to pass through, and then returns to its original position to close over the circuit board, and the protruding head portion (48) engages with the first surface (39) of the circuit board (37) in a holding surface engagement.

[0058] As shown in FIGS. 3A, 3B, 4A and 4B, the circuit holder body (35) further has a pair of elastically deformable side walls (49, 50) that extend in the same direction orthogonally to the base (43) from around the base (43). The side walls (49, 50) each have a first end (51, 51') and a second end (52, 52'), and an outer edge (53, 53'). The side walls (49, 50) have an arcuate shape corresponding to an arc defined by and at least partially extending around the periphery of the disc-shaped base (43), with each first end (51, 51') and second end (52, 52') defining a space slightly narrower than the width of the shroud (18) therebetween, such that when the terminal signaling device (33) is attached, 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 capture shoulders, with each shoulder (54, 54') extending away from and substantially orthogonally to the longitudinal central axis (17) from the respective first or proximal end (51, 51') of the respective extending side wall (49, 50). The capture shoulders (54, 54') extend orthogonally outward from the body (2) of the prefilled syringe (1) and form curled lips (57, 57') configured to engage in an elastically deformable snap engagement with corresponding finger stops or back stops (58) attached to the shroud (18), extending from a first radially distal end (55, 55') of the shoulder (54, 54') to a second end (56, 56') spaced from the first end of the shoulder. Conveniently, the capture shoulders (54, 54') are provided with one or more elastically deformable seating lugs (59, 59') that extend away from the shoulder to assist in engagement with the 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 end-point signaling device (33), thereby moving the shoulder (54, 54’) over the periphery of the backstop (58), elastically deforming it, and then, when the edge of the backstop (58) seats on the shoulder (54, 54’), returning it to its initial undeformed state.

[0059] As can be seen, particularly from FIG. 1B, the circuit holder body (35) is shown as having no back, i.e., no back cover. However, although not shown, it can be useful to provide a back closure cover extending from the first edge (53) of at least one of the extending sidewalls (49) to the opposite edge (53’) of the other extending sidewall (50) on one or more of the extending walls, capture shoulders, and curled lips. The back cover can further be provided with a rotatable hinge, for example, arranged along one of the edges (53, 53’) of one of the extending sidewalls (49, 50). This is particularly advantageous, for example, to prevent any ingress of dust and / or liquid into the end-point signaling device (33), and in particular, to prevent any tampering by the user with the components of the end-point signaling device, such as the circuit board, antenna, NFC micro-controller, and / or actuation switch. Of course, such a hinged back cover is opened when attaching the end-point signaling device (33) to the shroud (18) and then closed when the attachment of the device (33) is complete. The closure of the back cover can be appropriately effected by a combination of a latch in the back cover and a corresponding receiving recess for the latch provided at the edge (53’) opposite to the edge (53) where the joint or hinge point is provided.

[0060] Here, with reference to FIGS. 5A and 5B again, the function of the end-point signaling device (33) will be described. At the shroud retracted position shown in FIG. 1A, which is the position of the shroud before and during injection, the shroud (18) exposes the needle (7) when the vulnerable or removable needle cap (8) is removed. The actuating switch of the end-point signaling device is parallel to the longitudinal central axis (17), engages the recess (31) of the shroud (18), and extends into the bore (21) of the shroud. As the injection progresses, the plunger (9) and the plunger head (15) are moved distally towards 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 point, by actuating the needle safety mechanism as described elsewhere in this specification, for example, the compressed biasing spring is expanded and pressed against the abutment sleeve (27) that is in fixed position contact with the outer surface of the syringe body (2). The abutment sleeve (27) and the syringe body (2) are moved in a direction opposite to the direction of the shroud (18) that is moved from the retracted position to the extended position covering the needle. The relative reverse translation movement of the shroud (18) along the longitudinal central axis (17) with respect to the syringe body (2) stops when the abutment sleeve (31) and the associated projecting spool (29) move along the inner surface of the shroud (18) to the point where the projecting spool (29) engages the recess (31). It is also at this point that the projecting spool (29) makes surface contact with the actuating switch (40). In the example shown in the drawings, the switch lifts out of the recess (31) as the projecting spool enters the recess, thereby moving the switch from the non-active or "off" state to the active or "on" state. The movement of the actuating switch from the "off" state to the "on" state enables the NFC circuit to see or access the injection end-point information that was previously inaccessible to the NFC circuit.The syringe (1) can at this point be brought close to an NFC-enabled device such as a smartphone or an NFC reader, which energizes the NFC circuit (36) within the end-point signaling device (33) and informs the NFC reader or the NFC-enabled smartphone device of any information stored in the NFC circuit that includes injection end-point information accessible at this point.

Claims

1. 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, the needle shroud being configured to translate from a first position where the shroud is retracted and the needle of the prefilled syringe is exposed to a second position where the shroud extends and the needle of the prefilled syringe is completely surrounded by the shroud, the injection endpoint signaling device having a wireless injection endpoint signaling system having a near field communication (NFC) circuit and an actuation switch, when attached to the prefilled syringe, in the first, shroud-retracted position, the actuation switch maintains the NFC circuit in a non-active state where the NFC circuit is off and injection endpoint information is inaccessible by the NFC circuit, in the second, shroud-extended position, the actuation switch maintains the NFC circuit in an active state where the NFC circuit is on and the injection endpoint information is accessible by the NFC circuit, the actuation switch being moved from the non-active state to the active state by an interactive surface engagement between a portion of the shroud and the actuation switch, an injection endpoint signaling device.

2. The injection endpoint signaling device according to claim 1, wherein the interactive surface engagement between the actuation switch and the needle shroud is provided when the shroud is positioned in the fully extended position.

3. The injection endpoint signaling device according to claim 1 or claim 2, having a near field communication circuit holder body, the circuit holder body being attached to an outer surface of the longitudinal body of the prefilled syringe.

4. The injection endpoint signaling device according to claim 3, wherein the circuit holder body is attached to an outer surface of the needle safety shroud.

5. The injection endpoint signaling device according to claim 3 or 4, wherein the circuit holder body is attached to the prefilled syringe in a plane parallel to the longitudinal central axis.

6. The injection end point signaling device according to any one of claims 3 to 5, wherein the circuit holder body has a socket configured and dimensioned to receive and position the microcontroller of the short-range wireless communication circuit.

7. The injection end point signaling device according to any one of claims 3 to 6, wherein the short-range wireless communication circuit is incorporated in a disk-shaped circuit board, the microcontroller is disposed on a first surface of the circuit board, and the actuating switch is disposed on a second surface opposite to the first surface of the circuit board.

8. The injection end point signaling device according to any one of claims 3 to 7, wherein the first surface of the disk-shaped circuit board is held by at least one or more holding lugs against the inward-facing surface of the disk-shaped base of the circuit holder body.

9. The injection end point signaling device according to claim 8, wherein the holding lugs are arranged radially around the axis of rotation of the disk-shaped base of the circuit holder body.

10. The injection end point signaling device according to claim 9, wherein the axis of rotation of the disk-shaped base is perpendicular to the longitudinal central axis of the prefilled syringe.

11. The injection end point signaling device according to claim 9 or claim 10, wherein the axis of rotation of the disk-shaped base is perpendicular to a horizontal plane parallel to the longitudinal central axis.

12. The injection end point signaling device according to any one of claims 3 to 11, wherein the circuit holder body has at least one or more walls disposed around the disk-shaped base and extending in the same direction away from the disk-shaped base.

13. The injection end point signaling device according to claim 12, wherein the at least one or more extending walls are arc-shaped, and when the device is attached to the prefilled syringe and / or the needle safety shroud, the walls engage in an elastically deformable abutment with at least one side wall of the prefilled syringe and / or the needle safety shroud.

14. The injection end point signaling device according to claim 12 or claim 13, wherein each of the at least one or more extending walls has a capture shoulder extending substantially perpendicular to the longitudinal central axis from the proximal end of each respective extending wall.

15. The capture shoulder extends proximally from the radially distal end of the shoulder so as to form a curled lip, and the curled lip is configured to engage in an elastically deformable snap engagement with a corresponding finger stop that extends orthogonally outward from the body of the prefilled syringe. The injection endpoint signaling device according to claim 14.

16. The one or more extending walls, the capture shoulder, and the curled lip are closed by a back cover that extends from the trailing edge of at least one extending wall to the trailing edge of another extending wall. The injection endpoint signaling device according to any one of claims 12 to 15.

17. The back cover has a rotatable hinge. The injection endpoint signaling device according to claim 16.

18. The rotatable hinge is provided along an edge of one of the extending walls. The injection endpoint signaling device according to claim 17.

19. The circuit board actuating switch is arranged parallel to and along the longitudinal central axis when the circuit holder body is attached to the prefilled syringe body and / or the needle safety shroud. The injection endpoint signaling device according to any one of claims 1 to 18.

20. The actuating switch is moved from the non-active state to the active state by a cooperating surface engagement between the proximal portion of the shroud and the actuating switch. The injection endpoint signaling device according to claim 1.

21. The actuating switch is a displaceable or movable electrical contact. The injection endpoint signaling device according to claim 1.

22. 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. The injection endpoint signaling device according to claim 21.

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