Injection end point signaling device for pre-filled syringes

Abstract

An injection end point signaling device for mounting on a pre-filled syringe comprising a needle guard, wherein the guard translates from a first retracted position to a second extended position. The injection end point 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 of the guard, the activation switch maintains the NFC circuit in an inactive state in which injection end point information is inaccessible to the NFC circuit, and in the second extended position of the guard, the activation switch maintains the NFC circuit in an active state in which injection end point information is accessible to the NFC circuit. The activation switch moves from the inactive state to the active state via an interfacing surface engagement between a portion of the guard and the activation switch.

Description

Technical Field

[0001] This invention relates to pre-filled syringes and related technologies. In particular, this invention relates to a signal component for a pre-filled syringe using near-field communication circuitry (commonly abbreviated as NFC). Background Technology

[0002] Pre-filled syringes are known to technicians and are commonly used for the administration of various fixed or unit doses of substances, whether pharmaceuticals or other substances. For example, pre-filled syringes are commonly used for the administration of medications (such as vaccines in immunization campaigns and programs), for the treatment of chronic conditions (such as diabetes or other illnesses requiring the administration of fixed, predictable, and stored doses of medication, e.g., antivenom for snake or spider bites), or for emergency injections to treat or manage other potentially life-threatening situations (such as acute pain or trauma, myocardial infarction, anaphylactic shock, bacterial or toxic shock, etc.). Therefore, the use of pre-filled syringes is widespread and well-known.

[0003] This type of pre-filled syringe typically includes:

[0004] A slender hollow syringe body having a proximal end and a distal end, a first opening at the proximal end, and a collar or flange protruding outward from the hollow syringe body around the first opening at the proximal end;

[0005] An injection needle, which is mounted or can be mounted at the distal end of a hollow, elongated syringe body, and closes a second opening of the hollow, elongated syringe body at the distal end;

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

[0007] A plunger, sized to be inserted into the hollow elongated syringe body via a proximal end and a corresponding proximal opening, the plunger having a plunger body including a stop at the distal end of the plunger body and a plunger head at the proximal end of the plunger body.

[0008] One of the general problems with these pre-filled syringes is being able to know when the syringe was actually used to avoid attempts to reuse it, or for tracking purposes, such as to know whether an injectable substance has been administered from the pre-filled syringe and the amount administered. To address this, various tracking systems have been associated with these pre-filled syringes in an attempt to overcome this general problem.

[0009] For example, international patent application WO2014089086 discloses a method of using an electronic pharmaceutical device (e.g., an autoinjector) comprising a drug, such as adrenaline for treating anaphylactic shock. The device includes sensors, ID tags (e.g., RFID, NFC, or other tags for short-range wireless communication, such as Bluetooth), memory, a display, a speaker, and a processor and communication interface. The processor interconnects one or more of these components, and the communication interface includes interfaces for communication via Wi-Fi, mobile operator networks, or satellite. The processor is configured to communicate with at least one remote system (e.g., a mobile phone) via the communication interface in response to events such as drug administration and drug expiration. The sensors are used to detect activation of the device and include a fragile element that completes or disconnects electronic circuitry when the device is activated. The sensors provide signals to the ID tag to perform actions in response to the use of the autoinjector device and update the memory to indicate that the device has been used and the duration of use. The ID tag also provides information from the autoinjector device to a wireless reader, such as an NFC-enabled mobile device, like a mobile phone. Using RFID, NFC, or other wireless communication, a mobile phone reads drug information, which is then printed on the auto-injector or stored in the auto-injector's memory.

[0010] Similarly, US Patent Application US2019038840 discloses a pre-filled syringe comprising a complex arrangement of two antennas (a first transmitting antenna and a second bypass antenna). The first transmitting antenna is configured to transmit control signals to an external device, and control electronics connected to the first transmitting antenna are configured to provide instructions to the transmitting antenna to transmit control signals. The second bypass antenna is positioned to prevent the control electronics from providing instructions to the transmitting antenna when the bypass antenna is in an undisturbed position, and to allow the control electronics to provide instructions to the transmitting antenna when the bypass antenna is displaced from its undisturbed position. The complex arrangement of the two antennas and the control electronics is integrated into the proximal end of the syringe plunger and covered by a button. The bypass antenna is configured as a physically destructible electrical switch that disconnects electrical contacts when the syringe user presses the button. Pressing the button causes irreparable damage to the electrical contacts of the bypass antenna, thereby activating the primary antenna circuitry and signaling the start of syringe use.

[0011] Furthermore, international patent application WO2018111969A1 discloses a plunger rod suitable for ejecting medication from a syringe. The plunger rod includes a shaft sized and dimensionally adapted to act as a piston on the syringe, and a finger-actuated head comprising at least two subunits containing wireless sensors. In a pre-activated configuration, the subunits are physically separated from each other, and the wireless sensors are inoperable. In a post-activated configuration, the subunits are interconnected, and the sensors are operable to transmit signals. The user activates the finger-actuated head to reversibly move the physical barriers and move the plunger rod from the pre-activated configuration to the post-activated configuration. The signals transmitted by the sensors include information related to ejecting medication from the syringe and are received by a remote receiver.

[0012] Despite the solutions disclosed in the aforementioned documents, several challenges remain to be overcome regarding injection endpoint detection and signaling using near-field communication. This is particularly true for pre-filled syringes that are specifically modified to function in a particular manner. For example, pre-filled syringes with integrated safety mechanisms are also known to protect users from needle pricks after injection. Such pre-filled syringes typically include a system that automatically protects the user from needle pricks or removes the needle after injection. Summary of the Invention

[0013] According to one purpose, the applicant provides an injection endpoint signaling device adapted and configured to be mounted on and used with a prefilled syringe, the prefilled syringe including a needle safety mechanism, wherein, once the needle safety mechanism has been activated, information relating to the injection endpoint can only be signaled via a wireless communication circuit (e.g., a near-field communication circuit).

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

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

[0016] The injection endpoint signaling device includes a wireless injection endpoint signaling system, which comprises near-field communication (NFC) circuitry and an activation switch; and

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

[0018] In the first retracted position of the shield, the activation switch keeps the NFC circuit in an inactive state. In the inactive state, the NFC circuit is disconnected, and the injection endpoint information is inaccessible to the NFC circuit.

[0019] At the second extended position of the shield, the activation switch keeps the NFC circuit in an active state. In the active state, the NFC circuit is turned on, and the injection endpoint information is accessible to the NFC circuit.

[0020] The activation switch moves from the inactive state to the active state via a surface engagement between a portion of the cover and the activation switch.

[0021] As can be understood from the present invention, the pre-filled syringe is essentially as described above and includes:

[0022] A slender hollow syringe body having a proximal end and a distal end, a first opening at the proximal end, and a collar or flange protruding outward from the hollow syringe body around the first opening at the proximal end;

[0023] An injection needle, which is mounted or can be mounted at the distal end of a hollow, elongated syringe body, and closes a second opening of the hollow, elongated syringe body at the distal end;

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

[0025] A plunger, sized to be inserted into the hollow elongated syringe body via a proximal end and a corresponding proximal opening, the plunger having a plunger body including a stop at the distal end of the plunger body and a plunger head at the proximal end of the plunger body.

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

[0027] The pre-filled syringe includes a post-injection needle guard. For the purposes of this specification, the term "post-injection needle guard" should be understood as referring to a pre-filled syringe equipped with a passive or active needle guard that is operable upon or immediately thereafter the dispensing of the substance contained in the syringe. In this document, the terms "passive" and "active" regarding the needle safety guard refer to:

[0028] "Passive" - ​​The needle guard is automatically activated by the movement of one or more parts of the prefilled syringe relative to the needle guard, and this activation is independent of any action by the user of the prefilled syringe, except to achieve the ejection of material from the syringe cavity;

[0029] "Active" - ​​The needle guard is used by a single or intentional operation to properly expel injectable material from the syringe cavity, and is activated by the user of the pre-filled syringe after the expulsion operation is completed.

[0030] As described above, the needle shield is configured to translate from a first position to a second position. In the first position, the shield retracts and the needle of the pre-filled syringe is exposed; in the second position, the shield extends and the needle of the pre-filled syringe is completely surrounded by the shield. An example of a pre-filled syringe operating in this manner is the trademarked "BD Ultrasafe Passive" sold by Becton Dickinson. TM The syringe relates to a passive needle protection mechanism for pre-filled ISO standard glass syringes, allowing for single-handed injection. In this device, the needle safety guard is in a first position in which, at the start of the injection movement and throughout its duration, the needle is exposed as the plunger moves distally along the central longitudinal axis of the syringe until the plunger head engages with a pair of resiliently deformable release flaps, thereby radially pushing the release flaps outward from the central axis. The release flaps then press against the resiliently deformable portion of the needle guard proximal to the needle guard. The resilient deformation of the needle guard proximal to the guard causes the orifice of the guard to widen slightly along its length. A support sleeve is located within the orifice of the guard and positioned to make fixed axial engagement contact with the outer surface of the syringe barrel. A pre-constrained bias spring is located within the orifice of the guard, abutting against the distally facing contact surface of the support sleeve between the distal end of the guard and the distally facing contact surface of the support sleeve. Upon completion of the injection, the widening elastic deformation of the shield caused by the interaction between the plunger head and the elastically deformable vane allows the pre-constrained bias spring to expand axially along the central axis, simultaneously pushing against the distally facing contact surface of the support sleeve, thereby driving the shield in the distal direction. As the shield moves distally from its retracted position toward its extended position, it begins to cover the needle exposed during the injection.

[0031] Furthermore, as the shield moves distally, the elastic deformation at the proximal end of the shield is released, and the inner diameter of the shield's aperture begins to return to normal. The shield is prevented from extending distally beyond a predetermined axial limit by at least one recess located on the shield adjacent to its proximal end; this recess receives at least one radially projecting tooth located on and extending from the support sleeve. The positions of the proximal recess, the support sleeve, and the corresponding expansion of the bias spring determine the axial travel range of the shield from the first needle exposure position to the second needle coverage position and the shield extension position, respectively.

[0032] As described above, the injection endpoint signaling device also includes a wireless injection endpoint signaling system comprising near-field communication circuitry and an activation switch. When the injection endpoint signaling device is mounted on a pre-filled syringe such as described above, in a first retracted position of the sheath, the activation switch keeps the near-field communication circuitry in an inactive state, in which the circuitry is disconnected, and in this inactive state, the injection endpoint information is inaccessible to the NFC circuitry. As used herein, the terms “inactive” and “disconnected” refer to situations where the NFC circuitry cannot retrieve or discover the injection endpoint information. For example, the endpoint information in question can be as simple as a single bit of data, or an electrical pulse, or the simple state of an open or closed conductive or semiconductive gate that allows charged particles (e.g., electrons) to pass through.

[0033] Conversely, at the second extended position of the shield, the activation switch keeps the NFC circuitry in an active state, in which the circuitry is turned on, and therefore, in this active state, the injection endpoint information is accessible to the NFC circuitry. Thus, as used herein, the terms “active” and “on” refer to the NFC circuitry being able to retrieve or discover the injection endpoint information in a known manner when powered on.

[0034] In this way, it can be ensured that the NFC circuit can obtain the endpoint information only when the activation switch is in the active or "on" state, and only the injection that has actually been completed can be transmitted through the NFC circuit to a separate NFC reader or a smartphone device that is properly equipped with NFC.

[0035] 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 international standards ISO / IEC 14443 and ISO / IEC 18000-3, the former defining the functionality of ID cards for storing information, such as information found in NFC ID tags, and the latter defining RFID communication used by NFC-enabled devices. The basis of NFC can be found in radio frequency identification (RFID) technology, which provides suitably equipped hardware to power and communicate with passive electronic tags that are not powered or not powered, using radio waves. Therefore, the NFC circuit used in this invention includes a passive ID tag that stores a set of information, such as the type, unit dose, concentration, expiration date, etc., of an injectable substance, as well as any other useful or necessary information that can be suitably stored within the scope of such an NFC ID tag. The NFC circuit also includes corresponding suitable communication components that typically enable the NFC circuit to exchange said information with another NFC-enabled device (e.g., a smartphone) when powered on. An antenna forming part of the NFC circuit is also provided to capture radio waves at specific functional frequencies of the NFC protocol, thereby powering the circuit.

[0036] Furthermore, as described above, the activation switch of the near-field communication circuit, when mounted on the pre-filled syringe as described above, moves from an inactive state to an active state through a mating surface engagement between a portion of the shield and the activation switch. Therefore, the activation switch engages with and moves through a physical interaction with a portion of the safety shield mechanism.

[0037] Advantageously, for another purpose, the mating surface engagement between the activation switch and the corresponding portion of the needle safety shield is provided only when the shield is positioned in its fully extended position. In other words, the near-field communication circuitry is activated only when the shield reaches its final extended position, completely covering the needle of the pre-filled syringe. In this way, it can be determined not only that the pre-filled syringe can be safely handled, but also that the injection and / or dispensing endpoint has been reached, and that the NFC circuitry integrated into the endpoint signaling device can accordingly access the endpoint information, which can then be transmitted to an NFC-equipped reader device in the usual manner by energizing the NFC circuitry located in the injection point signaling device.

[0038] According to another objective, the activation switch moves from an inactive state to an active state through mating surface engagement between the proximal portion of the shield and the activation switch. A suitable proximal portion of the shield may be a recess located in the shield, near the proximal end of the shield, which receives at least one radially projecting tooth located on and extending from the support sleeve, as described above. In such a configuration, when the activation switch is mounted on the shield and is in the inactive state, the activation switch is positioned to occupy the space provided by the recess from above the recess facing the aperture of the shield. When injection is complete, due to the interaction of the bias spring against the support sleeve, the shield moves axially in the proximal direction as described above, such that the projecting tooth of the support sleeve engages in the recess of the shield and pushes the activation switch to move the switch from an inactive or "off" state to an active or "on" state.

[0039] For another purpose, when the circuit support body is mounted on the prefilled syringe body and / or needle safety guard, the activation switch is positioned parallel to and along the central longitudinal axis.

[0040] For another purpose, the activation switch is a replaceable or movable electrical contact.

[0041] According to another purpose, replaceable or movable electrical contacts are selected from the group consisting of microswitches, biased or constrained conductive metal strips, and movable conductive surfaces. Replaceable or movable electrical contacts are typically configured to be movable or replaceable from a first inactive or "off" position to a second active or "on" position. In the first inactive or "off" position, no current or charge can pass through the circuit interacting with the electrical contacts; in the second active or "on" position, the electrical contacts allow charge or current to flow through the circuit interacting with the electrical contacts. When the conductive surface is implemented as a switch, such conductive surface can effectively comprise conductive material distributed in or on such surface, for example by any of a 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, the conductive surface located on the electrical contact applicator comprises carbon or metal particles. When the shroud is moved to the fully extended position, the conductive surface forms an electrical contact once the protruding teeth of the support sleeve are recessed into corresponding recesses provided on the shroud. Before reaching such a position, the conductive surface is configured to prevent the establishment of any electrical contacts, thus preventing the NFC circuitry from accessing the destination information.

[0042] According to another purpose, the injection endpoint signaling device includes a near-field communication circuit support body, wherein the circuit support body is mounted on the outward surface of the longitudinal body of the pre-filled syringe.

[0043] For another purpose, advantageously, the circuit support body is mounted on the outward surface of the needle safety shield. The term "outward" can be understood as referring to the outer surface of the shield, that is, the surface facing outwards, as opposed to the inner or inward surface of the shield, where the inward surface faces the hole into the shield.

[0044] For another purpose, the circuit support body is mounted on the pre-filled syringe in a plane parallel to the central longitudinal axis.

[0045] Furthermore, advantageously, according to another objective, the circuit support body is mounted on the outer surface of the needle sheath and also engages with at least a portion of the pre-filled syringe, such that the circuit support body cannot be removed from the sheath, but the sheath can be axially moved along its central longitudinal axis from a first retracted position to a second extended position. The end result of this mounting is that the circuit support body is not only parallel to the central longitudinal axis of the syringe, but also substantially orthogonal to the central longitudinal axis in the parallel longitudinal plane and extends on both sides of the central longitudinal axis.

[0046] Furthermore, for another purpose, advantageously, the replaceable or movable electrical contact of the NFC circuit's activation switch is activated by translating the shield 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 shield is used to directly or indirectly, for example via the protruding teeth of the support sleeve, remove the activation switch from the electrical gap or electrical isolation region of the NFC circuit, thereby closing the circuit and allowing the flow of current or charge, thereby enabling the NFC circuit to access the endpoint information.

[0047] For another purpose, the circuit support body includes a socket configured to receive and position an NFC microcontroller for near-field communication circuitry. The socket within the circuit support body serves to prevent movement of the NFC microcontroller relative to the circuit support body, for example, when mounting an injection endpoint signaling device on a pre-filled syringe.

[0048] Furthermore, for another purpose, the near-field communication circuitry is advantageously integrated onto a disc-shaped circuit board, with the NFC microcontroller located on the first side of the board and the activation switch on the opposite second side. This configuration allows the disc-shaped circuit board to be secured by the physical surface interaction between the microcontroller and the socket of the circuit support body, while also allowing the activation switch to freely engage with the corresponding mating surface of the needle cover.

[0049] For another purpose, the first surface of the disc-shaped circuit board is held against the inward surface of the disc-shaped base of the circuit support body by at least one or more retaining lugs. The retaining lugs help to secure the disc-shaped circuit board in the circuit support body and, together with the socket, properly position the circuit board so that, when the device is mounted on a pre-filled syringe, the corresponding activation switch is properly positioned relative to the needle guard.

[0050] For another purpose, the fixed lugs are radially distributed around the rotation axis of the disc-shaped base of the circuit support body.

[0051] For another purpose, the axis of rotation of the disc-shaped base of the circuit support body is perpendicular to the central longitudinal axis of the pre-filled syringe. It can be understood, and as mentioned elsewhere in this specification, that the endpoint signaling device is at least partially disc-shaped, and when the disc is mounted on the pre-filled syringe, it lies in a plane that is both parallel to the central longitudinal axis of the syringe and orthogonal to the central longitudinal axis of the syringe within a parallel plane. Therefore, the axis of rotation of the disc-shaped base of the circuit support body is perpendicular to a horizontal plane parallel to the central longitudinal axis.

[0052] According to another purpose, the circuit support body includes at least one or more walls located on the outer periphery of a disc-shaped base and extending in the same direction away from the disc-shaped base. The walls are shaped and configured to engage at least a portion of a pre-filled syringe and / or needle sheath.

[0053] For another purpose, at least one or more extended walls are arcuate, and when the device is mounted on a prefilled syringe and / or needle safety shield, the walls are elastically deformably engaged with at least one side wall of the prefilled syringe and / or needle safety shield.

[0054] Therefore, it can be understood from the above that the circuit support body advantageously includes a base, preferably disc-shaped, and the base is provided with, for example, a pair of walls extending from the outer periphery of the base and away from the base, preferably extending in a direction orthogonal to the base plane of the circuit support body. Furthermore, the walls advantageously extend in a direction substantially parallel to the axis of rotation of the base of the circuit support body to form a mating surface that is elastically deformable when mounted on a pre-filled syringe and / or needle sheath, and that the mating surface prevents any lateral movement of the injection endpoint signaling device about a central longitudinal axis.

[0055] According to another purpose, at least one or more extension walls each include a grippable shoulder that extends substantially orthogonal to and away from the central longitudinal axis from the proximal end of each of the respective extension walls. The grippable shoulder is designed to engage and abut against a finger stop (also called a support) mounted on the needle sheath, and the shoulder provides a surface on which the fingers of one hand press during use, while the plunger is typically pressed by the thumb of the same hand.

[0056] For another purpose, a grippable shoulder extends proximally from the radially distal end of the shoulder to form a curled lip, which is configured to engage in a resiliently deformable snap-fit ​​manner with a corresponding finger stop or support extending orthogonally outward from the shield. The curled lip serves to clamp or lock the circuit support body onto the syringe support and prevents any unwanted movement of the endpoint signaling device during injection when the user presses the plunger with their thumb.

[0057] For another purpose, the grippy shoulder is provided with one or more elastically deformable lugs extending proximally away from the shoulder to assist engagement with a finger stop or support. When the support engages with the shoulder, these lugs elastically move, causing the shoulder to move past the outer periphery of the support, elastically deforming, and then returning to their initial undeformed state when the edge of the support is fixed.

[0058] For another purpose, one or more extended walls, a grippable shoulder, and a curled lip are sealed by a back cover extending from the rear edge of at least one extended wall to the rear edge of another extended wall. In such a configuration, the endpoint injection signal device is essentially fully enclosed to prevent, for example, user tampering with the device, and / or accidental ingress of fluids, dust, etc., which could potentially interfere with the operation of the NFC circuitry.

[0059] For another purpose, the back cover includes a rotatable hinge, for example, to facilitate the mounting of an injection endpoint signal device on a pre-filled syringe, and then to close the back cover once the device has been mounted on the pre-filled syringe.

[0060] Therefore, for a further purpose, the rotatable hinge is provided along the edge of one of the extension walls. In this way, the rear cover is thus essentially configured as a panel or door, having a hinged hinge aligned with the edge of one of the extension walls. The rear cover may also be provided with corresponding opposing latching mechanisms, and corresponding opposing recesses provided in the opposing edges of the opposing walls to receive the latch, so that the rear cover is secured when moved from an open position during the installation of the signal device to a closed position after installation into the pre-filled syringe.

[0061] In short, the injection endpoint signaling device is designed to have the following functions:

[0062] An injection endpoint signaling device is mounted on the outer surface of a pre-filled syringe with an axially translatable needle guard that moves along the central longitudinal axis of the pre-filled syringe from a first retracted position before injection to a second extended position after injection, in which the needle of the pre-filled syringe is fully covered, thus ensuring the pre-filled syringe is safe for subsequent user handling. The signaling device has an activation switch positioned parallel to the central longitudinal axis of the pre-filled syringe and also positioned in a recess near the proximal end of the guard. The proximal recess of the guard receives protruding teeth that are fixedly contacted with the distal end of the syringe barrel and located on a support sleeve near the distal end of the syringe barrel. Upon injection completion, the plunger head of the pre-filled syringe activates a release mechanism of the guard, causing the guard to move distally along the central longitudinal axis. This relative movement of the guard compared to the fixed position of the support sleeve causes the proximal recess, as part of the guard, to move proximally until it contacts the protruding teeth of the support sleeve. At this point, the protruding teeth enter the recess and engage with the activation switch, moving it from the "off" position to the "on" position. Assuming the protruding teeth prevent any further axial movement of the shield, the activation switch remains in the "on" or active state, and the injection endpoint information, whether individually stored data bits, an electrical pulse, or simple current detection, can be accessed by the NFC circuitry, which can be energized in a known manner, for example, by bringing a pre-filled syringe close to an NFC-enabled smartphone or corresponding NFC reader, and vice versa. The properly energized NFC circuitry of the endpoint signaling device can then enable any tag information stored in the NFC circuitry, including recently presented accessible endpoint information, to be broadcast and / or communicated and / or received by the reader in a known manner and function of the NFC circuitry. Attached Figure Description

[0063] The invention will now be described further with reference to the accompanying drawings, which are provided to illustrate various embodiments of the invention:

[0064] Figure 1A and Figure 1B A schematic perspective view showing the top and bottom of a pre-filled syringe equipped with a passive needle safety shield mechanism, on which an endpoint signal device according to the invention has been mounted.

[0065] Figure 2A and Figure 2B express Figure 1A and Figure 1B A schematic axial view of the front and rear portions of a pre-filled syringe equipped with an endpoint signaling device according to the invention;

[0066] Figure 3A and Figure 3B A schematic perspective view of the endpoint signaling device according to the invention, as seen from below, shows details related to the location of the near-field communication circuit;

[0067] Figure 4A and Figure 4B A schematic perspective view showing further details of the endpoint signal device according to the present invention;

[0068] Figure 5A and Figure 5B Indicates having as Figure 1A and Figure 1B The schematic cross-sectional view of the pre-filled syringe with the passive needle safety guard mechanism shown illustrates two main positions of the needle guard and the corresponding endpoint signal device according to the invention. Detailed Implementation

[0069] Referring now to the attached diagram, the pre-filled syringe (1) equipped with a safety shield is respectively in... Figure 1A 3D top view and Figure 1B This is illustrated in the three-dimensional bottom view, and in Figure 5A and Figure 5B The schematic cross-sectional view illustrates this in more detail. The pre-filled syringe (1) has an elongated hollow syringe body (2) with a proximal end (3) and a distal end (4), a first opening (5) at the proximal end (3), and a collar (6) or flange protruding outward from the hollow syringe body (2) around the first opening (5) at the proximal end (3). An injection needle (7), covered by a removable or fragile needle cap (8), is mounted at the distal end (4) of the hollow elongated syringe body (2) and closes the second distal opening (7) of the hollow elongated syringe body (2) at the distal end (4). During the assembly of the syringe components, a controlled amount of injectable material (not shown) (e.g., a liquid or dosage form of drug) is introduced into the hollow body (2).

[0070] The plunger (9) is sized to be inserted into the hollow, elongated syringe body (2) via a proximal end (3) and a corresponding proximal opening (5). The plunger (9) has a plunger body or plunger rod (10) including a stop (11) located at the distal end (12) of the plunger body (10). The stop (11) can be connected to the plunger body (10) in a known manner, for example, by providing a threaded protrusion (13) at the distal end (12) of the plunger body (9) and a corresponding threaded hole (14) within the stop (11). The plunger body (10) also 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 shield (18) extends along and around the outside of the syringe body (2) and has a proximal end (19) and a distal end (20). For example, Becton Dickinson uses the trademark BD UltrasafePassive. TM Commercial products sold with safety needle guards.

[0071] exist Figure 5A and Figure 5B As can be seen in more detail, the needle shield (18) is configured from the first retracted position of the shield (see [reference]). Figure 5A Move to the second extension position of the shield (e.g.) Figure 5BAs shown), in the first retracted position of the shield, the needle (7) is exposed once the fragile or removable needle cap (8) is removed; the second extended position of the shield is only effective when the injection is complete, in which the needle (7) is completely covered by the needle shield (18). The needle shield (18) defines an orifice (21) and has a proximal end (19) and a distal extension (20). The shield (18) extends from the proximal end (19) located adjacent to the proximal end (3) of the syringe (2) along the outside of the syringe (2), across the distal end (4) of the syringe (2) and distally to the distal end (20) of the shield (18), such that the syringe (2) is held within the orifice (21) of the shield (18). The shield (18) engages against the syringe (2) at the proximal end (19) of the shield by a resiliently deformable portion (24). A compressed bias spring (25) is located within the bore and fixed against the distal end (20) of the shield (18). The proximal end (26) of the spring (25) abuts against a support sleeve (27) which surrounds and is mounted on the outer surface (28) of the syringe (2) in a fixed position near the proximal end (4) of the syringe (2), but adjacent to the proximal end (4) of the syringe (2). The support sleeve (27) also includes at least one protruding tooth (29) that engages in a sliding engagement with the inward surface (30) of the shield, for example, a groove longitudinally aligned with the central longitudinal axis (17). The shield (18) is also provided with a recess (31) or an opening that extends from the outer surface (32) of the shield (18) to the inner surface (30) of the shield (18), and the recess or opening (31) is located on the far side of the proximal end (19) of the shield (18), but adjacent to the proximal end (19) of the shield (18).

[0072] like Figure 5A and Figure 5B In more detail, the injection endpoint signal device (33) is mounted on and engages with the outward surface (32) of the shield (18). In the initial retracted position of the shield (… Figure 5A The injection endpoint signal device (33) is located near the proximal end (19) of the shield (18), which will be described in more detail below.

[0073] Figure 2A and Figure 2B The diagram schematically shows a view of the injection endpoint signal device (33) mounted on a pre-filled syringe equipped with a needle safety guard. Figure 2A The image shows a view taken from the distal end (4, 20) along the central longitudinal axis (17) of the pre-filled syringe. Figure 2B This shows a view from the proximal end (3, 19) of a pre-filled syringe equipped with a needle safety shield. From these combined... Figure 1A and Figure 1BAs can be clearly seen in the view, the injection endpoint signal device (33) spans the width of the shield (18), lies in a plane orthogonal (A-A') and parallel (B-B') to the central longitudinal axis, and engages with the corresponding sidewall (34) of the shield parallel to the central longitudinal axis. Figure 2A and Figure 2B As can be seen, the injection endpoint signal device (33) is similar to a button cap, located on the width of the shield (18) and spanning the width of the shield (18), and slightly protruding from the outward surface (32) of the shield (18).

[0074] Figure 3A , Figure 3B , Figure 4A and Figure 4B A more detailed schematic diagram of the injection endpoint signal device (33), particularly a perspective view of the components related to the injection endpoint signal device (33).

[0075] Figure 3A and Figure 3B A rear perspective view of the circuit support body (35) is shown to reveal further details of the injection endpoint signal device (33). The circuit support body (35) is shaped and configured to receive and hold near-field communication (NFC) circuitry (36), the type and function of which are known in themselves. The NFC circuitry (36) includes a disc-shaped printed circuit board (37), and an antenna (38) and an activation switch (40) are integrated on the first side (39) of the disc-shaped circuit board (37). On the opposite second side (41) of the circuit board (37), an NFC microcontroller (42, ...) is provided. Figure 5A , Figure 5B The circuit support body (35) includes a disc-shaped or basically disc-shaped base (43) configured to receive and hold the disc-shaped circuit board (37). For this purpose, the base (43) of the circuit support body (37) is provided with a socket (44) configured to receive and hold the NFC microcontroller (42) located on the opposite second side (41) of the circuit board (37). When the endpoint signal device (33) is mounted on the housing (18), the socket (44) also allows the activation switch (40) on the opposite side (41) of the circuit board (37) to be correctly positioned parallel to the central longitudinal axis (17) of the pre-filled syringe (1). Figure 1A and Figure 1BAs can be seen, when the endpoint signal device (33) is mounted on the cover (18) and the cover (18) is in the initial, retracted position, the activation switch (40) penetrates from the outer surface (32) and engages in the recess (31), extending into the hole (21) of the cover (18). The base (43) is also provided with a peripheral wall (45) extending from and surrounding the outer periphery (46) of the base (43), the peripheral wall (45) being provided with one or more radially spaced fixing lugs (47), the fixing lugs (47) including heads (48) protruding into the internal volume defined by the base (43) and the peripheral wall (46). When the circuit board (37) is inserted into the internal volume, the lugs (47) elastically deform radially outward to allow the disc-shaped circuit board to pass through, and then move inward again to close the circuit board, the protruding heads (48) engaging with the first surface (39) of the circuit board (37) in a manner that maintains surface engagement.

[0076] like Figure 3A , Figure 3B , 4A and Figure 4BAs shown, the circuit support body (35) also includes a pair of elastically deformable sidewalls (49, 50) that extend from the outer periphery of the base (43) in the same direction and are orthogonal to the base (43). Each sidewall (49, 50) has a first end (51, 51') and a second end (52, 52'), as well as an outer edge (53, 53'). The sidewalls (49, 50) have an arcuate shape corresponding to the arcuate shape defined by the outer periphery of the disc-shaped base (43) and also extend at least partially around the outer periphery of the base (43). The corresponding first ends (51, 51') and second ends (52, 52') define a space between them that is slightly smaller than the width of the shield (18), such that when the end signal device (33) is installed, the sidewalls elastically deform and engage frictionally and elastically with the corresponding sidewalls (34, 34') of the shield (18) on either side of the central longitudinal axis (17) through their respective first ends (51, 51') and second ends (52, 52'). The circuit support body (35) also includes a pair of grippable shoulders, each shoulder (54, 54') extending from the first end or proximal end (51, 51') of its respective extending sidewall (49, 50) away from and substantially orthogonal to the central longitudinal axis (17). A grippable shoulder (54, 54') extends from a first radially distal end (55, 55') of the shoulder (54, 54') to a second end (56, 56') spaced apart from the first end of the shoulder to form a curled lip (57, 57'), configured to engage with a corresponding finger stop or support (58) in a resiliently deformable snap-fit ​​manner, the finger stop or support (58) extending orthogonally outward from the body (2) of the prefilled syringe (1) and mounted on the shield (18). The grippable shoulder (54, 54') advantageously has one or more resiliently deformable lugs (59, 59') extending away from the shoulder to assist engagement with the finger stop or support. During the installation of the endpoint signal device (33), when the support (58) engages with the shoulder, these seat lugs (59, 59') elastically move, causing the shoulder (54, 54') to move over the outer peripheral edge of the support (58), elastically deform, and then return to their initial undeformed state when the edge of the support (58) is mounted on the shoulder (54, 54').

[0077] As can be seen from the graph, especially from Figure 1BIn the diagram, the circuit support body (35) is shown as backless, i.e., it has no back cover. However, although not shown, it is useful to provide a rear closure for one or more extended walls, a grippable shoulder, and a curled lip, which extends from a first edge (53) of at least one extended sidewall (49) to the opposite edge (53') of another extended sidewall (50). The back cover may further be provided with a rotatable hinge, for example located along one edge (53, 53') of one of the extended sidewalls (49, 50). This is particularly advantageous, for example, to prevent dust and / or liquid from entering the endpoint signaling device (33), but especially to prevent the user from tampering with any part of the endpoint signaling device, such as the circuit board, antenna, NFC microcontroller, and / or activation switch. Such a hinged back cover is, of course, open when the endpoint signaling device (33) is mounted onto the housing (18), and closes once the installation of the device (33) is complete. Closure of the rear cover can be appropriately provided by a combination of a latch on the rear cover and a corresponding receiving recess for latching, the receiving recess being disposed on the opposite edge (53') of the edge (53) providing the hinge or hinge point.

[0078] Refer again Figure 5A and Figure 5B The function of the endpoint signal device (33) will now be explained. Figure 1AThe retracted position of the shroud (18) is shown, which is the position the shroud (18) is in before and during injection, exposing the needle (7) once the fragile or removable needle cap (8) is removed. The activation switch of the endpoint signal device is parallel to the central longitudinal axis (17) and engages in the recess (31) of the shroud (18) and extends into the hole (21) of the shroud (18). As injection proceeds, the plunger (9) and plunger head (15) move toward the proximal end (3) of the syringe in the distal direction. When injection is complete, the plunger (9) and plunger head are located at the proximal end of the syringe, and the stopper (11) of the plunger (9) is located at the distal end (4) of the syringe. At this point, the needle safety mechanism is activated, for example, as described elsewhere in this specification, causing the compressed bias spring to expand and push the support sleeve (27) into fixed contact with the outer surface of the syringe body (2). The direction of movement of the support sleeve (27) and the syringe body (2) is opposite to the direction of movement of the shield (18), which moves from a retracted position to an extended position covering the needle tip. When the support sleeve (31) and the associated protruding tooth (29) have moved along the inner surface of the shield (18) to the point where the protruding tooth (29) engages in the recess (31), the opposite translational movement relative to the syringe body (2) along the central longitudinal axis (17) of the shield (18) is prevented. It is at this point that the protruding tooth (29) also contacts the surface of the activation switch (40). In the example shown, as the protruding tooth enters the recess, the switch moves upward and out of the recess (31), thereby moving the switch from an inactive or "off" state to an active or "connected" state. The activation switch moving from the "off" state to the "connected" state makes injection endpoint information, previously unavailable to the NFC circuitry, visible or obtainable by the NFC circuitry. The syringe (1) can now be brought close to an NFC-enabled device, such as a smartphone or NFC reader, which will power the NFC circuit (36) within the endpoint signaling device (33) and allow any information stored in the NFC circuit, including the now-accessible injection endpoint information, to be transmitted to the NFC reader or NFC-enabled smartphone device.

Claims

1. An injection endpoint signaling device adapted to be mounted on a pre-filled syringe, the pre-filled syringe including a post-injection needle safety shield configured to translate from a first position to a second position, in the first position, the shield retracts and the needle of the pre-filled syringe is exposed, and in the second position, the shield extends and the needle of the pre-filled syringe is completely surrounded by the shield, wherein: The injection endpoint signaling device includes a wireless injection endpoint signaling system, which includes a near-field communication (NFC) circuit and an activation switch. The NFC circuit includes a microcontroller and a passive ID tag configured to store a set of information. When mounted on the pre-filled syringe: In the first retracted position of the shield, the activation switch keeps the NFC circuit in an inactive state. In the inactive state, the NFC circuit is disconnected, and in the inactive state, the injection endpoint information stored in the passive ID tag is inaccessible to the NFC circuit. as well as At the second extended position of the shield, the activation switch keeps the NFC circuit in an active state, in which the NFC circuit is turned on, and in which the injection endpoint information stored in the passive ID tag is accessible to the NFC circuit. The activation switch moves from the inactive state to the active state via a surface engagement between a portion of the shield and the activation switch.

2. The injection endpoint signal device according to claim 1, wherein, When the shield is positioned in the fully extended position, a mating surface engagement is provided between the activation switch and the needle safety shield.

3. The injection endpoint signal device according to claim 1 or 2, comprising a near-field communication circuit support body, wherein, The circuit support body is mounted on the outward surface of the longitudinal body of the pre-filled syringe.

4. The injection endpoint signal device according to claim 3, wherein, The circuit support body is mounted on the outer surface of the needle safety shield.

5. The injection endpoint signal device according to claim 3, wherein, The circuit support body is mounted on the pre-filled syringe in a plane parallel to the central longitudinal axis.

6. The injection endpoint signal device according to claim 3, wherein, The circuit support body includes a socket, the size of which is configured to receive and position the microcontroller of the near-field communication circuit.

7. The injection endpoint signal device according to claim 6, wherein, The near-field communication circuit is integrated onto a disk-shaped circuit board, with the microcontroller located on the first side of the circuit board and the activation switch located on the opposite second side of the circuit board.

8. The injection endpoint signal device according to claim 7, wherein, The first surface of the disc-shaped circuit board is held against the inward surface of the disc-shaped base of the circuit support body by at least one or more fixed lugs.

9. The injection endpoint signal device according to claim 8, wherein, The fixed lugs are radially distributed around the rotation axis of the disc-shaped base of the circuit support body.

10. The injection endpoint signaling device according to claim 9, wherein, The rotation axis of the disc-shaped base is perpendicular to the central longitudinal axis of the pre-filled syringe.

11. The injection endpoint signaling device according to claim 10, wherein, The rotation axis of the disc-shaped base is perpendicular to the horizontal plane, and the horizontal plane is parallel to the central longitudinal axis.

12. The injection endpoint signaling device according to claim 10, wherein, The circuit support body includes at least one or more extending walls located on the outer periphery of the disc-shaped base and extending in the same direction away from the disc-shaped base.

13. The injection endpoint signaling device according to claim 12, wherein, The at least one or more extension walls are arc-shaped, and when the device is mounted on the prefilled syringe and / or the needle safety shield, the extension walls are elastically deformably engaged with at least one sidewall of the prefilled syringe and / or the needle safety shield.

14. The injection endpoint signaling device according to claim 12, wherein, Each of the at least one or more extension walls includes a grippable shoulder that extends substantially orthogonal to the central longitudinal axis from the proximal end of the respective extension wall.

15. The injection endpoint signaling device according to claim 14, wherein, The grippable shoulder extends from the radially distal end of the shoulder in a proximal direction to form a curled lip, which is configured to engage with a corresponding finger stop in a resiliently deformable snap-fit ​​manner, the finger stop extending orthogonally outward from the body of the prefilled syringe.

16. The injection endpoint signaling device according to claim 12, wherein, The one or more extended walls, the grippy shoulder, and the curled lip are closed by a rear cover that extends from the rear edge of at least one extended wall to the rear edge of the other extended wall.

17. The injection endpoint signaling device according to claim 16, wherein, The rear cover includes a rotatable hinge.

18. The injection endpoint signaling device according to claim 17, wherein, The rotatable hinge is positioned along the edge of one of the extended walls.

19. The injection endpoint signaling device according to claim 10, wherein, When the circuit support body is mounted on the prefilled syringe body and / or the needle safety guard, the circuit board activation switch is parallel to and positioned along the central longitudinal axis.

20. The injection endpoint signal device according to claim 1, wherein, The activation switch moves from the inactive state to the active state through the mating surface between the proximal portion of the shield and the activation switch.

21. The injection endpoint signal device according to claim 1, wherein, The activation switch is a replaceable or movable electrical contact.

22. The injection endpoint signaling device according to claim 21, wherein, The replaceable or movable electrical contacts are selected from the group consisting of microswitches, biased or constrained conductive metal strips, and movable conductive surfaces.

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