Dose capture attachment for handheld syringes

Abstract

A handheld dose capture device configured and adapted to be releasably attached to a handheld syringe, the handheld dose capture device comprising: a support body adapted and configured to releasably engage with a slender body of the syringe, the slender body being aligned parallel to a central longitudinal axis of the syringe; a displacement replicator system adapted and configured to replicate a translational movement of a syringe plunger parallel to the longitudinal axis; a coupling device adapted and configured to couple a proximal end of the plunger to a proximal end of the displacement replicator system; the dose capture device comprising at least one sensor and a processing system adapted and configured to correlate the translational movement of the displacement replicator system with a dose of injectable substance selected and / or injected by a user through a translational movement of the plunger along the longitudinal axis.

Description

Technical Field

[0001] The present invention generally relates to the field of handheld syringes, and methods and devices for obtaining a dose of an injectable substance set by a user of the syringe, and / or determining a dose of an injectable substance actually injected and / or administered from the handheld syringe. Background Art

[0002] The patent application with PCT patent application publication number WO2018136901A1 describes an example of a system and device for capturing a dose administered or injected by a handheld syringe. The document discloses a handheld syringe for use in a teaching system or training system for teaching people how to perform an injection. The system includes a hypodermic syringe with a needle and a plunger, wherein the plunger shaft has a spiral or substantially spiral groove along the longitudinal axis of the plunger shaft. The spiral groove is configured to rotate approximately 270 degrees along a length of about 50 mm to about 100 mm, in other words, its length is approximately 76 mm for every 360 degrees of rotation. The signal processing system is mounted on a finger-shaped lug at the proximal end of the syringe body and includes a keyed rotation sensor or potentiometer, such as a hollow shaft type sensor. The rotation sensor has a fixed housing and a bearing. The bearing has a generally D-shaped opening, and the opening is configured to slidably accommodate a D-shaped plunger shaft, and during the linear advancement of the plunger shaft, the bearing rotates along the spiral groove of the plunger shaft while the housing remains stationary. As the plunger advances in a linear motion toward the needle tip to deliver the drug, the rotation sensor detects the angular position relative to the housing bearing. The rotation sensor calculates the distance of the linear motion based on the amount of rotation of the spiral groove measured by the rotation sensor. The amount of rotation of the spiral groove, i.e., the angular position of the bearing, is determined based on the change in resistance of the rotation sensor due to the rotation of the bearing.

[0003] The Applicant has noticed that existing technical solutions, such as the above-mentioned solution, are not able to be configured sufficiently easily, accurately and / or simply for use when it comes to setting, and / or injecting, and / or administering a dose by a user in a handheld syringe containing a particularly small volume, such as only a few milliliters to tens of milliliters of injectable substance. This is particularly true, for example, in a handheld hypodermic syringe containing a maximum of 30 milliliters of injectable substance. For example, the above-mentioned technical solution previously described, even assuming that it is effective for such a small volume of handheld syringes, requires significant modifications to the shape and function of the plunger, which significantly complicates the overall functioning of the device and requires the provision of a whole separate production and assembly line in order to effectively carry out the required changes in the plunger.

[0004] Therefore, an object of the present application is to provide a device for obtaining a dose of an injectable substance set by a user from a handheld syringe, and / or determining the dose of an injectable substance actually injected and / or administered from the handheld syringe, which device does not require modification of existing commercially available handheld syringes.

[0005] Therefore, another object of the present application is to provide a system and / or method for obtaining a dose of an injectable substance set by a user from a handheld syringe and / or determining the dose of an injectable substance actually injected and / or administered from the handheld syringe.

[0006] The above and other objects will become clear through the description, drawings and claims of the present application. Summary of the invention

[0007] According to one object, the present application provides a handheld dose capture device adapted and configured to be releasably attached to a handheld syringe comprising an elongated body having a longitudinal bore defining a central longitudinal axis, the elongated body having a proximal end and a distal end, and a syringe plunger located within and movable along the central longitudinal axis of the bore, the syringe plunger extending beyond the proximal end;

[0008] wherein the releasably attachable dose capture device comprises:

[0009] a support body adapted and configured to at least releasably engage an outer surface of an elongated body of a hand-held injector, aligned parallel to a central longitudinal axis of the elongated body;

[0010] a displacement replicator system adapted and configured to replicate the translational motion of the plunger parallel to the longitudinal axis;

[0011] a coupling device adapted and configured to couple the proximal end of the plunger to the proximal end of the displacement replicator system; and

[0012] Wherein, the handheld dose capture device comprises at least one sensor and processing system, and the at least one sensor and processing system is adapted and configured to associate the translational movement of the displacement replicator system with the dose of injectable substance selected and / or injected by the user through the translational movement of the plunger along the longitudinal axis.

[0013] The above-mentioned hand-held syringes are common in trade and commerce, and their structure is known per se. It should be noted that the additional device envisaged in the present application does not change the structure or function of such commercially available hand-held syringes, such as hypodermic syringes. The hand-held syringes usually contain an injectable substance in the central hole of the syringe body. However, the present application also envisages the possibility that the unsealed syringe does not contain an injectable substance, and when the distal end of the syringe body is already connected to a supply container (e.g., a vial) of the injectable substance, or after reassembly in a separate storage and / or reassembly device, for example, the user can extract this substance into the central longitudinal hole by moving the plunger in the proximal direction. This usage is also common in hand-held syringes.

[0014] The handheld dose capture device is adapted and configured to be releasably attached to the handheld syringe. "Releasably attached", "releasably connected", "releasably mounted" and other similar expressions that may be found in this application should be understood to mean that the dose capture device is attached to the handheld syringe in some temporary manner, which allows the dose capture device to be easily removed once the dose capture device has served its purpose, or in other words, when the user has completed the injection or otherwise used up the injectable substance contained in the syringe. Therefore, in this aspect, the dose capture device is both releasable from and attachable to the handheld syringe.

[0015] The releasably attachable dose capture device comprises a support body adapted and configured to at least releasably attach, clip or otherwise engage with an outer surface of an elongated body of a handheld injector, aligned parallel to a central longitudinal axis of the elongated body.

[0016] According to one object, a support body of the dose capture device is releasably attached at least one or more locations along the length of the elongated body of the hand-held syringe. For example, the support body may be provided with one or more removable or otherwise activated clips extending around the outer surface of the elongated body of the syringe and engaging with the outer surface of the elongated body of the syringe at a plurality of locations along the length of the syringe body. For example, one, two or more clips may be provided extending outwardly from the support body and extending around the circumference of the outer surface of the syringe body.

[0017] Alternatively, according to yet another object, the support body advantageously comprises a bracket for releasably attaching to at least one outer surface of the elongated body of the hand-held syringe. The bracket may extend along substantially at least a portion of the length of the syringe body, or substantially the entire length, although typically it will extend along only a portion of the length of the syringe body to allow positioning of the finger-shaped lugs and the proximal end of the syringe body, the finger-shaped lugs protruding outwardly from the syringe body, and the proximal end of such a syringe body typically has a wider diameter than the remainder of the syringe body, thereby requiring a bracket fork of different and corresponding size, the bracket fork having a radius of curvature of an appropriately sized radius to accept the radius of curvature of the outer surface of the proximal end of the syringe body. Typically, the bracket is configured as an outwardly protruding concave curved wall, for example, the wall substantially matches the radius of curvature of the outer surface of the syringe body, or has a radius of curvature slightly narrower than the outer surface of the syringe body, and the bracket wall forms a longitudinally oriented hollow portion or groove, which is shaped to receive and fix the syringe body during use of the syringe. The support wall of the support body is advantageously made of an elastically deformable material so that when the syringe body is pushed toward the support, it snaps or pushes into the longitudinally formed groove due to the elastic deformation of the support wall. Once the syringe body is located in the longitudinal groove, the elastic deformation force of the support wall material forces the support wall to engage with the outer surface of the syringe body and firmly fix it to the outer surface. Similarly, when the syringe is used and the syringe body is removed from the support, the syringe body can be loosened or pulled out by the elastic deformation of the support wall and released from the support body.

[0018] According to yet another object, the support body comprises a tubular body having a longitudinal central hole defining a longitudinal axis, the longitudinal axis of the tubular body being positioned parallel to the longitudinal axis of the elongated body of the syringe when the dose capture device is mounted on the handheld syringe. The tubular body and the support wall are attached to each other by any suitable means, but preferably and advantageously, the support and the tubular body are made of the same material, such as a suitable plastic or polymeric material, for example by injection and / or blow molding. Such a suitable polymeric material may be a polycarbonate (PC) / acrylonitrile-butadiene-styrene (ABS) resin blend, which combines the known high deformability of ABS copolymers with the known excellent mechanical properties, impact resistance and heat resistance of polycarbonate.

[0019] According to a further object, the tubular body extends along at least a portion of the length of the elongated body of the hand-held syringe. Preferably however and advantageously, when the tubular body is mounted to the syringe body, for example by a bracket, it extends in parallel along the entire length of the syringe body, such that the support body and the syringe body have the same or substantially the same length. When the syringe body is mounted to the support body of the dose capture device, the longitudinal axis of the syringe body and the longitudinal axis of the aperture of the support body are aligned in parallel but spaced apart from each other.

[0020] According to another object, the support body includes a base adapted and configured to receive at least a portion of the displacement replicator system. The base is sized and shaped to accommodate at least a portion of the displacement replicator system, as will be described in more detail below. The base is also configured to allow at least a portion of the displacement replicator to move within the base along the central longitudinal axis of the support body and through the base. Because the base is advantageously located within the hole of the support body.

[0021] To this end, according to yet another object, the base is a fixed nut having an internally threaded hole. The nut is fixed in the hole of the tubular support by rotation or by translation along the length of the hole of the tubular support, for example by pressing, gluing, bonding or ultrasonic welding, or any other suitable fixing means capable of preventing the nut from moving in the hole. Therefore, the nut cannot move. The nut includes a hole with a surface facing inward (i.e., into the hole) provided with threads configured for engagement with the displacement replicator system.

[0022] The nut is advantageously made of a material with a low or relatively low friction coefficient in order to reduce friction with the displacement replicator system as much as possible, as will be described in more detail below. Typically, the nut is made of a plastic or polymeric material with a relatively high hardness and a low friction coefficient. The selection of an appropriate hardness and friction coefficient of the nut is considered to be within the common sense of the skilled person. However, as a non-limiting, illustrative example of a suitable material for the nut, one may cite the IGUS company of France, which is known as Those materials which are commercially available under the designation J350, for example, the sleeve bearing series identified by the reference number J350.

[0023] As mentioned above, the dose capture device also includes a displacement replicator system adapted and configured to replicate the translational movement of the plunger parallel to the longitudinal axis of the syringe body. Such a system is designed to replicate any translational displacement movement generated by the syringe plunger, whether in the proximal or distal direction.

[0024] Therefore, in another object, the displacement replicator system includes a shaft having an external thread on its outer surface. The external thread of the shaft is configured and dimensioned to engage and cooperate with the internal thread of a nut disposed in a support. The shaft can be made of any suitable material, such as metal or a suitable corrosion resistant plastic material, but advantageously the shaft is made of metal, preferably stainless steel. Illustrative, non-limiting examples of suitable threaded shafts are commercially available from IGUS (France), for example Lead Screw Product. From the above it will be appreciated that the displacement replicator system is also configured to rotate about the longitudinal axis of the support while performing translational movement along the axis of the support.

[0025] For the reasons stated above, and in accordance with yet another object, the shaft of the displacement replicator system is at least partially accommodated within the central bore of the tubular body of the support body. For example, when the dose capture device is used with an unfilled syringe, the displacement replicator system is configured such that when the dose capture device is first mounted on the syringe body, the shaft is substantially or almost completely accommodated within the bore of the tubular support body, and vice versa. However, the proximal end of the shaft of the displacement replicator system extends beyond the proximal end of the tubular support body. Optionally, for example, when the dose capture device is used with a prefilled syringe, for example, initially the shaft is only partially accommodated within the central bore of the tubular body of the support body, and in particular, only the distal end portion of the shaft including the distal end is accommodated in the tubular body of the support body.

[0026] According to another object of the present application, the displacement replicator system also includes a magnetic field generating device. Various devices for generating magnetic fields are known, for example, conventional magnets, electromagnets and hybrid material magnets. Such magnets are generally made of magnetizable materials with magnetic or paramagnetic properties, whether natural materials or materials that generate or induce magnetic fields in the material when an electric current or other excitation flow passes through or affects the material. Suitable materials can be appropriately selected from:

[0027] - ferrite magnets, in particular sintered ferrite magnets, such as crystalline compounds containing iron, oxygen and strontium;

[0028] - Composite materials consisting of a thermoplastic matrix and isotropic NdFeB powder;

[0029] - a composite material consisting of a thermoplastic matrix and a strontium-based hard ferrite powder, the magnets thus obtained may contain ferrite particles which may be isotropic, ie independent of orientation, or anisotropic, ie dependent on orientation;

[0030] - Composite materials made of a thermosetting plastic matrix and isotropic NdFeB powder;

[0031] - magnetic elastomers, for example made from heavily charged strontium ferrite powder mixed with synthetic rubber or PVC and subsequently extruded into the desired shape or pressed into sheets;

[0032] -Flexible calendered composites, which usually have the appearance of brown sheets, are more or less flexible depending on their thickness and composition. These composites are not as flexible as rubber, and their Shore hardness tends to be in the 60 to 65 Shore D range specified by the American National Standards Institute (ANSI). This composite is usually formed from a synthetic elastomer filled with strontium ferrite particles. The resulting magnets can be anisotropic or isotropic, and the various sheet materials usually have magnetic particle alignment due to the calendering process;

[0033] - Laminated composite materials, usually comprising a flexible composite material as described above, in a lamination process with soft iron plates;

[0034] - Neodymium Iron Boron magnets;

[0035] -Steel made of Alnico and magnetized;

[0036] -Samarium-Cobalt alloy.

[0037] Among the magnetic field generating devices listed above that are suitable for the present invention, preferably selected from NdFeB permanent magnets, magnetic elastomers, composite materials made of thermoplastic matrix and strontium-based hard ferrite powder, and composite materials made of thermosetting plastic matrix and isotropic NdFeB powder. Such magnets that can be manufactured in relatively small sizes while maintaining relatively high magnetic field strength are known.

[0038] Although the magnetic field generating means may be of any suitable general shape, such as a disk, including a circular, elliptical, or any other suitable polygonal shape, a single magnet advantageously has only a single dipole. Although the magnetic field generating means may be substantially disk-shaped, such a disk shape may also include a magnet having a hole substantially located in the center of the disk to form a ring or annulus.

[0039] Therefore, according to another object of the present application, the magnetic field generating device includes at least one of a ring-shaped dipole magnet, a disk-shaped dipole magnet, or at least one pair of radially positioned NS dipole magnets.

[0040] According to an advantageous purpose of the present application, the magnetic field generating device includes two radially aligned single dipole magnets, wherein the magnets are radially aligned at relative positions of their diameters. The term "alignment" or "alignment" used herein refers to the alignment of the magnetic poles of the magnets along the longitudinal axis of each magnet. The implementation of this magnet structure can be, for example, by using a disk-shaped, rod-shaped or cylindrical magnet having a first end and a second end, the first pole being substantially located at the first end of the magnet, and the opposite second pole being substantially located at the second end of the magnet. Then, each magnet is located at a relative position on the circumference of its diameter so that the two poles of the magnet are aligned with each other along the longitudinal axis of the magnet. The magnetic poles of each magnet can be placed in reverse relative to each other, for example in a NS / SN arrangement or a SN / NS arrangement, but it is preferred and advantageous that the magnetic poles are placed in a repeated configuration, wherein the magnetic poles are aligned in a NS / NS or SN / SN arrangement along the longitudinal axis of the magnet.

[0041] According to a further object, the magnetic field generating device is mounted to be fixedly co-rotating with the shaft. In other words, when the shaft rotates, the magnetic field generating device rotates together with the shaft in the same rotational direction and at the same rotational angle. Advantageously, the magnetic field generating device is mounted at or near the proximal end of the shaft, in particular adjacent to the proximal end of the shaft, which protrudes beyond the proximal end of the tubular support in the proximal direction. The length dimension of the shaft corresponds to the maximum possible axial movement distance of the plunger head of the syringe and remains functionally effective, however, a shorter shaft length can also be foreseen in case the dose capture device is used only for measuring a more limited degree of translational axial movement of the plunger head in the proximal or distal direction.

[0042] As described above, the magnetic field generating device is mounted on the shaft. According to another purpose of the present application, for example, when the shaft is made of metal, in order to avoid and / or limit the possibility of magnetization of part or all of the shaft, the magnetic field generating device can advantageously further include a magnet holder body, for example, made of a suitable plastic or polymer material, such as a polycarbonate (PC) / acrylonitrile-butadiene-styrene (ABS) resin mixture. As described herein, the magnet holder body is provided with at least one receiving portion, which is configured to receive the magnet and orient it to the correct spatial orientation around the shaft. Optionally, if the shaft is made of non-metallic material, the magnet can be directly mounted on the shaft, or optionally, the magnet can also be located in the magnet holder body. Preferably and advantageously, the magnet holder body is a sleeve with a hole, the size of the hole is designed to allow the shaft to pass through and be inserted therein, depending on the material used for the magnet holder body and the shaft, and can be attached to the magnet holder body by any suitable fixing method, such as press-fit insertion, gluing, adhesion or attachment, such as welding, such as ultrasonic welding. In particular, in one contemplated configuration, the magnet holder body includes two diametrically opposed recesses, each recess being sized to accommodate a single dipole magnet, the magnet being positioned in the recess such that the polar axis of the magnet passing through the magnet is aligned radially between the magnet holder body and the shaft, such as NS / NS or SN / SN. Alternatively, a first dipole magnet is positioned in a first recess of the magnet holder body with a first polarity orientation, and a second dipole magnet is positioned in a second recess diametrically opposite the first recess with a second polarity orientation, the second polarity orientation being opposite to the first polarity orientation, such as NS / SN or SN / NS.

[0043] As can be understood from the above, by the engagement of the threaded surface of the shaft with the threaded surface of the nut, the shaft moves in the proximal or distal direction and accordingly moves out of or into the tubular support body, and the shaft rotates around the longitudinal axis of the tubular body. During the rotation of the shaft, due to the fixed rotational relationship between the magnetic field generating device and the shaft, the magnetic field generating device including the magnet and the magnet holder body rotate to the same angle as the shaft. In this way, one or more magnetic fields are generated around the longitudinal axis of the tubular body, and the axis is parallel to the longitudinal axis of the elongated body of the syringe.

[0044] According to another purpose, at least one sensor is a magnetometer. This magnetometer is different from a GMR, AMR or TMR sensor in that it can directly measure the magnetic field strength. Magnetometers measure magnetic fields mainly in two ways: vector magnetometers measure the vector components of the magnetic field, and total field magnetometers or scalar magnetometers measure the magnitude of the vector magnetic field. Another type of magnetometer is an absolute magnetometer, which uses the internal calibration of the magnetic sensor or known physical constants to measure the absolute magnetic field amplitude or vector magnetic field. Relative magnetometers measure the magnetic field amplitude or vector magnetic field with reference to a fixed uncalibrated baseline, also known as magnetic variometers, for measuring magnetic field changes. Therefore, the preferred magnetometer for the dose capture device according to the present invention is an ultra-low power, high-performance three-axis Hall effect magnetometer. Therefore, the magnetometer is correspondingly configured to measure the magnetic field on two or three mutually perpendicular or orthogonal axes.

[0045] According to another object of the present invention, the sensor, such as a magnetometer, is positioned along the central longitudinal axis of the support body. In this way, the sensor is aligned relative to the center of the rotating magnetic field provided by the magnetic field generating device, which forms a multi-dimensional magnetic field around the central longitudinal axis of the tubular support body, preferably at least a two-dimensional magnetic field, and even more preferably a three-dimensional magnetic field.

[0046] According to yet another object, at least one sensor is an accelerometer. Such sensors are known in the art per se and also include single-axis and multi-axis accelerometers. Although there are many different types of accelerometers on the market, a suitable accelerometer contemplated herein is a low-g triaxial accelerometer. The accelerometer is responsible for detecting and / or measuring the change in acceleration caused by the relative movement of a dose capture device mounted on the drug delivery device relative to a set of predetermined and preprogrammed reference positions. The relative movement can be from a horizontal position held by the user to a vertical position, or any position in between. The intensity and frequency of the relative movement of the acceleration transmitted from the accelerometer to the processing system are used to determine the type of operation that the user has implemented. In particular, the accelerometer is configured to detect the position orientation of the syringe equipped with the dose capture device, which is selected from at least one or more of the injection start position, the syringe emptying position and the injection discharge position. The injection start position is the position of the syringe ready for injection, which is generally a substantially horizontal position, at which the user has selected the dose of the injectable substance to be injected. The syringe evacuation position is a position in which the syringe body is ready or has been evacuated of any residual air, which position is typically a substantially vertical position of the needle or the distal end of the syringe body pointing upward, although the processing system typically considers the maximum angle from the vertical to be in this position, such as a maximum angle of about 30° to 45° from the vertical. The injection discharge position refers to a position in which the syringe body is pointed generally downward, with the distal end of the syringe and / or the needle downwardly directed toward the injection site and / or injection site of the injectable substance, thereby enabling the injectable substance to be injected into or onto the subject.

[0047] As described above, the dose capture device includes at least one sensor, such as a magnetometer and an accelerometer, and a processing system. According to another object, the processing system and the at least one sensor communicate with each other, and the processing system is configured to process signals received from the at least one sensor. In the case of operation of the magnetic sensor as described herein, when the magnetic field generating device rotates around the central longitudinal axis of the tubular support and moves in the proximal or distal direction thereof, the magnetic sensor detects the magnetic field generated by the magnetic field generating device and transmits the measured magnetic field changes to the processing system. The processing system includes an integrated control and data processing unit, such as at least one microcontroller, which is electrically connected to the magnetic sensor for processing information received from the magnetic sensor. The processing system and the at least one sensor can be integrated into an electronic component board, such as a printed circuit board with correspondingly adapted dimensions, which will vary according to the desired position of the electronic component board in the dose capture device. The integrated control and data processing unit, including at least one microcontroller, handles all electrical communications and signal transmissions between different electronic components from the processing system and the magnetic sensor. The at least one microcontroller is in electrical communication with at least one of a memory, an independent power supply and a communication unit.

[0048] The processing system is also responsible for performing calculations that allow the precise positioning of the magnetic field generating means to be calculated and determined, as well as processing signals from an independent power supply and communication means, the latter being configured to optionally communicate with another local or remote data processing system, such as on a smartphone. By means of at least one microcontroller, the processing system can be remotely programmed or receive information and updates when first used, in a manner similar to other electronic devices today that contain integrated control and data processing units. Such integrated control and data processing units are known per se and are typically integrated as a central processing unit, a real-time clock, one or more storage device systems, and optionally a communication system or subsystem, as well as other desired components.

[0049] The processing system is powered by an independent power source, such as a removable and / or rechargeable power source. Both types of batteries are well known to those skilled in the art, and the removable independent power source may usefully be, for example, a lithium-ion battery that can be easily replaced when the power is exhausted, or alternatively a rechargeable battery that can be recharged when exhausted, for example, via a corresponding charging port (e.g., a USB charging port) provided in the dose capture device and connected to the rechargeable battery.

[0050] The communication unit may be any suitable radio frequency transmission unit, such as a Bluetooth communication unit, and advantageously a Bluetooth Low Energy circuit (BLE), enabling the processing system to send and receive data to and from a remote terminal device, respectively, which may be a suitably equipped smartphone, a remote computing system or a distributed computing system.

[0051] At least one sensor and a processing system as described above are located within the dose capture device. Advantageously, in the case where the sensor is a magnetic sensor and the magnetic field generating means are located around the axis of the displacement replicator system, at least one sensor and a processing system are located somewhere along the longitudinal axis of the tubular support and advantageously at either end of the longitudinal axis of the tubular support in order to obtain the most accurate results from the processing system. Thus, in an advantageous configuration, at least one sensor and a processing system can be housed within the coupling means. According to an optional purpose, at least one sensor and a processing system can be housed within the support.

[0052] The coupling device will be described in more detail below. The coupling device is used to couple the syringe plunger to the displacement replicator system. Therefore, ideally, the coupling device includes a first receiving portion that is adapted and configured to receive at least a portion of the plunger head located at the proximal end of the plunger. The receiving portion of the coupling device is sized to allow at least a portion of the plunger head to be inserted and received therein, while surrounding the at least a portion of the plunger head so that the coupling device can directly move at least a portion of the plunger head when the coupling device is pushed in the distal direction or pulled in the proximal direction. In this regard, the receiving portion of the coupling device includes an engagement surface that tightly surrounds and engages the at least a portion of the plunger head to transmit any proximal or distal movement of the coupling device to the plunger head.

[0053] According to yet another object, the coupling device further comprises a second receiving portion adapted and configured to receive at least a portion of the proximal end of the displacement device. Similar to the first receiving portion, the second receiving portion is dimensioned to receive and engage with the proximal end of the shaft so that any movement of the plunger head in the proximal or distal direction is transmitted to the proximal end of the shaft of the displacement replicator system through the coupling device. In this way, the proximal end of the displacement replicator system moves in the proximal or distal direction, depending on the direction of the plunger movement. As already mentioned elsewhere in the present application, the distal or proximal movement of the shaft causes the magnetic field generating device to rotate around the central longitudinal axis of the tubular support until the extent of its rotation is the same as the extent of rotation of the shaft of the displacement replicator.

[0054] Furthermore, in an optional embodiment, in which the magnetic sensor is, for example, located on or within a support and measurements are taken along or on the longitudinal axis of the support, any movement of the magnet towards the magnetic sensor will appear as an increase in the measured magnetic field strength, while movement away from the magnetic sensor will appear as a decrease in the measured magnetic field strength.

[0055] Advantageously, in a preferred embodiment, the sensor is configured to report magnetic field measurements for any given rotation angle, which means that even if the magnetic field generating device and the magnetic sensor are maintained at a fixed length distance from each other, for example when the sensor is located within a coupling device, the number of rotations of the magnet around the axis of the tubular support can still be detected.

[0056] Therefore, all the above corresponding measurements are processed by the processing system and used to correlate the distance moved by the displacement replicator system with the distance moved by the plunger or plunger head. The processing system then converts the correlated distance moved by the plunger into a dose selected and / or injected by the user.

[0057] According to another object, the second receiving portion of the coupling device is also configured to receive a magnetic field generating device of the displacement replicator system. This feature allows the magnetic field generating device to be received in the second receiving portion. Therefore, the size of the second receiving portion is not only suitable for receiving and engaging the proximal end of the displacement replicator shaft, but also, according to another object, it can provide sufficient space for the magnetic field generating device to allow the magnetic field generating device to rotate freely around the longitudinal axis of the support body in the second receiving portion. The term "free rotation" should be understood here to mean that the size, shape and dimensions of the receiving portion allow the magnetic field generating device to rotate freely in the second receiving portion with minimal friction as much as possible. Appropriate selection of materials for the magnetic field generating device and the receiving portion of the coupling device can bring about the desired results. For example, as already mentioned elsewhere in this application, the magnetic field generating device includes a magnet holder body, and the body is made of PC / ABS, and the second receiving portion of the coupling device can also be made of PC / ABS.

[0058] Therefore, it can be understood from the above that according to another object of the present application, the coupling device is configured as:

[0059] Correlating translational motion of a plunger of a hand-held syringe in a proximal or distal direction to a displacement replicator system, and

[0060] The displacement replicator system is allowed to rotate freely parallel to the central longitudinal axis of the elongated body.

[0061] The coupling device can generally be represented as a proximal body of a material, such as a suitably molded PC / ABS material, having corresponding first and second receiving portions. For example, the first receiving portion of the coupling device can be provided by a slot of appropriate size and orientation in the body, which receives the plunger head and includes at least one engagement surface that cooperates and engages with the corresponding engagement surface of the plunger head. For example, the first receiving portion of the coupling device can be provided by a slot of appropriate size and orientation in the body. Similarly, the proximal body of the coupling device can be provided with a groove defining the second receiving portion, which groove is parallel to the axis of the syringe and is aligned and spaced so that when the proximal end of the displacement replicator system enters the second receiving portion, the axis of the syringe body and the axis of the tubular support are parallel and spaced and aligned. Optionally, the coupling device body can be provided with suitable partition walls and protrusions, which are intended to contain each plunger head and magnetic field generating device in their first and second receiving portions, respectively.

[0062] In addition, as described elsewhere herein, at least one sensor and processing system are mounted within the coupling device. To this end, the coupling device includes a third receiving portion, which is configured and sized to receive the at least one sensor and processing system. The third receiving portion is typically formed as part of the body of the coupling device, for example it may form a well defined by corresponding side walls extending from the substrate in a proximal direction, the well receiving at least one sensor and processing system, wherein at least one sensor is positioned to be axially aligned with the central longitudinal axis of the tubular support body. Typically, the third receiving portion is axially positioned at the proximal end of the second receiving portion so that the magnetic field generating device rotates around the magnetic sensor together with the axis of the displacement locator, and the magnetic sensor is correspondingly axially positioned at the proximal end of the rotation axis. In this way, even if the magnetic field generating device maintains a constant axial distance from the magnetic sensor, changes in the axial proximal movement or distal movement of the plunger head can still be recorded as a rotation of the magnetic field generating device around the magnetic sensor.

[0063] In yet another object of the present invention, there is provided a method for capturing a dose selected or injected by a user of a hand-held syringe, the hand-held syringe comprising an elongated body having a longitudinal bore defining a central longitudinal axis, the elongated body having a proximal end and a distal end, and a syringe plunger positioned within the bore and movable along the central longitudinal axis, the syringe plunger extending beyond the proximal end, the method comprising:

[0064] attaching a handheld dose capture device as described herein to a handheld injector, the coupling means of the dose capture device receiving at least a portion of the plunger head of the proximal end of the plunger in a first receiving portion of the coupling means;

[0065] moving a plunger tip of the handheld syringe in a distal and / or proximal direction;

[0066] Replicating the motion of the plunger head through a displacement replicator system;

[0067] Detecting the replicating movement of the displacement replicator system by means of at least one sensor located in the coupling device and / or in the support;

[0068] Correlating, by a processing system connected to at least one sensor, the detected repetitive displacement movement to provide a captured dose corresponding to a dose set and / or expelled by a user;

[0069] The captured dose is stored within the processing system for one of dose recording, communication with a remote receiver, and display of the captured dose.

[0070] According to another object of the present application, the method is further defined, wherein:

[0071] The detection of the repetitive motion includes detecting a change in the magnetic field produced by the rotation of a magnetic field generating device provided by the displacement replicator system and correlating the change in the magnetic field to a distance moved by the plunger; and

[0072] The dose of the handheld injector set and / or injected by the user is calculated from the associated movement distance. BRIEF DESCRIPTION OF THE DRAWINGS

[0073] The present invention will now be described in more detail with reference to the accompanying drawings, which are provided for illustrative purposes of one or more embodiments, in which:

[0074] Figure 1 is a schematic exploded perspective view of a handheld dose capture device for a handheld injector;

[0075] Figure 2 Yes Figure 1 A schematic cross-sectional view of a handheld dose capture device shown when mounted on a syringe with a needle;

[0076] Figure 3 Yes Figure 1 A schematic cross-sectional view of a displacement replicator system of a dose capture device is shown;

[0077] Figure 4 Yes Figure 1 A schematic cross-sectional view of a coupling device of a handheld dose capture device is shown;

[0078] FIG. 5A to FIG. 5E Shows that when Figure 1 Schematic cross-sectional views showing the relative positions of the various components of the handheld dose capture device at different stages of use when mounted on a syringe. DETAILED DESCRIPTION

[0079] refer to Figure 1 and Figure 2 , a schematic exploded perspective view of a handheld dose capture device (1) according to the present invention ( Figure 1 ) and Section View ( Figure 2), the device being adapted to be releasably attached to a hand-held syringe (2), such as a hypodermic syringe. The hypodermic syringe (2) is of a commonly known type of syringe available commercially, and comprises an elongated syringe body (3) having a longitudinal bore (4) defining a central longitudinal axis (5), the elongated body (3) having a proximal end (6) and a distal end (7), and a syringe plunger (8) located in the bore (4) and movable along the central longitudinal axis (5), the syringe plunger (8) extending beyond the proximal end (6) of the elongated body (3). The plunger (8) is terminated at its proximal end (9) by a plunger head (10), and the syringe body (3) is closed at its distal end (7) by a hypodermic needle (11) or cannula and covered by a protective cap (12). At the proximal end (6) of the syringe body (3), the body is provided with an annular skirt (13) protruding radially outwards, an annular wall (14) extending from the periphery of the annular skirt (13) in the proximal direction, and together they define a well (15). The well (15) defined by the skirt (13) and the annular wall (14) is of such size that the plunger head (10) can be completely accommodated in the well (15), or the proximal end (16) of the annular wall can serve as a stop abutment for any distal movement of the plunger head.

[0080] The dose capture device (1) comprises a support (17) configured to releasably connect, clamp or otherwise engage at least one outer surface (18) of an elongated body (3) of a hand-held injector (2) in parallel alignment with a central longitudinal axis (5) of the elongated body (3). Figure 2As shown, the support body (17) includes a bracket (19) for releasably engaging at least one outer surface of the elongated body of the hand-held syringe, the bracket extending substantially along at least a portion of the length of the body (3) of the syringe, thereby allowing the positioning of the finger-shaped lug formed by the annular skirt (13) protruding radially outward. In addition, the support body (17) is provided with a bracket fork (20) of corresponding size, which has a radius of curvature of appropriate size to engage the radius of curvature of the outer surface of the protruding proximal end formed by the annular skirt (13) and the annular wall (14) of the body (3) of the syringe. The bracket (19) is configured with an outwardly protruding concave curved wall (21) extending from the support body (17), for example, which is substantially matched with the radius of curvature of the outer surface (18) of the syringe body (3), or optionally has a slightly narrower radius of curvature than the outer surface (18) of the syringe body (3). The support wall (21) forms a longitudinally positioned hollow portion or groove (22) shaped to receive and hold the body (3) of the syringe (2) during use of the syringe. The support wall (21) of the support body (17) is advantageously made of an elastically deformable material so that when the syringe body is pushed against the support, it snaps or pushes into the longitudinally formed groove (22) by elastic deformation of the support wall (21). Once the syringe body is located in the longitudinal groove (22), the elastic restoring force of the support wall (21) material forces the support wall (21) to engage with and firmly hold the outer surface (18) of the syringe body (3). Similarly, when the syringe is finished using, the syringe body can be removed from the support again by elastically deforming the wall (21) of the support (19) so that the syringe body (3) is relaxed or pulled out and released from the support body (17).

[0081] The support body further comprises a tubular body (23) having a longitudinal central hole (24) defining a longitudinal axis (25) which is parallel to the longitudinal axis (5) of the elongated body (3) of the hand-held syringe (2) when the dose capture device (1) is mounted on the hand-held syringe (2). The tubular body (23) and the support wall (21) are connected to each other by any suitable means, for example made of a same material, for example a suitable plastic or polymeric material, for example a material obtained by injection and / or blow molding. A suitable polymer material for the support (21) and the tubular body (23) is a polycarbonate (PC) / acrylonitrile-butadiene-styrene (ABS) resin blend, which combines the high deformability known for ABS copolymers with the excellent mechanical properties, impact resistance and heat resistance known for polycarbonate.

[0082] The tubular body (23) extends along at least a portion of the length of the elongated body (3) of the hand-held syringe (2). Figure 2As shown, when mounted on the syringe body (3), the tubular body extends in parallel along the entire length of the syringe body (3), so that the support body (17) and the syringe body (3) have the same or substantially the same length. Therefore, when the syringe body (3) is mounted on the support body (17) of the dose capture device, the longitudinal axis (5) of the syringe body and the longitudinal axis (25) of the hole of the support body (17) are aligned in parallel, but spaced apart from each other. Preferably, but not necessarily, the hole (24) of the tubular body (23) is closed at its distal end (26) by a material wall (27) of the tubular support body (17).

[0083] The proximal end (28) of the bore (24) of the tubular body (23) is open and includes a base (29) sized and configured to receive at least a portion of a displacement replicator system (30). In this example, the base (29) is an internally threaded nut that is located in a fixed position within the bore (24) at the proximal end (28) of the bore (24). The base (29) is also configured to allow at least a portion of the displacement replicator system (30) to move within the base (29) along the central longitudinal axis (25) of the tubular body (23) of the support (17) and through the base (29). The base (29) as shown, which is composed of an internally threaded nut, also includes a bore (31) sized and configured to receive a portion of the displacement replicator system (30).

[0084] The nut base (29) is fixed in the hole (24) of the tubular body (23) of the support (17) by rotation or by translation along the length of the hole (24) of the tubular body (23), for example by pressing, gluing, adhering or ultrasonic welding, or any other suitable fixing means capable of preventing the nut from moving in the hole (24). In this way, the nut base (29) cannot move. The internal thread of the nut base (29) is a facing surface facing inwards, i.e. into the hole, which is configured for corresponding engagement with the displacement replicator system (30).

[0085] The displacement replicator system (30) is adapted and configured for replicating the translational movement of the plunger parallel to the longitudinal axis (5) of the syringe body (3). Such a system (30) is configured to replicate any translational movement, whether in the proximal or distal direction, produced by the plunger (8) of the syringe (3). Figure 1 , Figure 2 and Figure 3As shown, the displacement replicator system includes a shaft (32) having an external thread (33) located on an outer surface (34) of the shaft. The external thread (33) of the shaft (32) is configured and dimensioned to engage and cooperate with an internal thread (31) of a nut base (29) disposed in a tubular body (23) of a support body (17). The shaft (32) may be made of any suitable material, such as metal or a suitable corrosion-resistant plastic material, but advantageously, the shaft is made of metal, preferably stainless steel. The shaft (32) is at least partially received in a central hole (24) of the tubular body (23) of the support body (17). As shown Figure 2 As shown, when the dose capture device (1) is first attached to the syringe body (3), the displacement replicator system (30) is configured so that the shaft (32) is substantially or almost completely accommodated in the hole (24) of the tubular body (23) of the support body (17), or vice versa. The proximal end (35) of the shaft (32) of the displacement replicator system (30) extends beyond the proximal end (28) of the tubular body (23), while the distal end (36) of the shaft (32) is accommodated in the hole (24) of the tubular body (23) of the support body (17) and is prevented from extending beyond the distal end (26) of the tubular body (23) by the distal end wall (27).

[0086] As shown, the displacement replicator system (30) further comprises a magnetic field generating device (37), which is mounted at or near the proximal end of the shaft (32), in particular adjacent to the proximal end (35) of the shaft (32), which protrudes in the proximal direction beyond the proximal end (28) of the tubular body (23) of the support body (17). The length dimension of the shaft (32) corresponds to the maximum possible axial movement distance of the plunger head (10) of the syringe (3) and remains functionally effective, however, a shorter length of the shaft (32) can also be envisaged in case the dose capture device (1) is used only for measuring a limited degree of translational axial movement of the plunger head (10) in the proximal or distal direction.

[0087] As described elsewhere herein, typically the magnetic field generating means (37) will be provided by one or more magnets, electromagnets and / or hybrid material magnets. Figure 1 , Figure 2 and Figure 3As shown, the magnetic field generating device is represented by a pair of single dipole disk or rod-shaped magnets (38a, 38b). The magnets (38a, 38b) are mounted on the shaft (32) so that when the shaft (32) moves in the proximal or distal direction through the interaction of the external thread (33) of the shaft (32) and the internal thread (31) of the nut base (29), the rotation of the shaft (32) causes the magnets (38a, 38b) to rotate with the shaft (32) around the longitudinal axis (25). As described elsewhere herein, in order to avoid and / or limit the possibility of magnetization of a portion or all of the shaft, for example, when the shaft is made of metal, the magnetic field generating device (37) also includes a magnet holder body (39), for example, made of a suitable molded plastic or polymer material, such as a polycarbonate (PC) / acrylonitrile-butadiene-styrene (ABS) resin mixture. The magnet holder body (39) is provided with at least one receiving portion (40) configured to receive and orient one or more magnets (38a, 38b) into a correct spatial orientation around the shaft. If the shaft is made of a non-metallic material, the one or more magnets (38a, 38b) can be mounted directly to the shaft, or can also be located within the magnet holder body (40). As shown, the magnet holder body (39) is a sleeve having a hole (41), the size of which is designed to allow the shaft to pass through and be inserted therein, such as by press-fit insertion, or attached to the magnet holder body (39) by gluing, adhesion or any suitable fixing means, such as welding, such as ultrasonic welding, which depends on the materials used for the magnet holder body (39) and the shaft (32), respectively. As shown, the magnet holder body (39) is configured with a receiving portion (40) including two diametrically opposed grooves (40a, 40b), each groove being sized to receive a single dipole magnet (38a, 38b), the magnets (38a, 38b) being positioned in the grooves such that the polar axes of the magnetic poles passing through the magnets (38a, 38b) are aligned on the diameter of the magnet holder body (39) and the shaft (32), such as in a NS / NS polar alignment configuration, or a SN / SN polar alignment configuration. Optionally, a first dipole magnet (38a) is positioned in the first groove (40a) of the magnet holder body with a first polarity orientation, and a second dipole magnet (38b) is positioned in a second groove (40b) diametrically opposite the first groove (40a) with a second polarity orientation, the second polarity orientation being opposite to the first polarity orientation, such as NS / SN or SN / NS.

[0088] As can be understood from the above, when the shaft (32) moves in the proximal or distal direction through the engagement of the threaded surface (33) of the shaft (32) with the threaded surface (31) of the nut base (29), and accordingly moves out of or into the tubular body (23), the shaft (32) will rotate around the longitudinal axis (25) of the tubular body (23). During the rotation of the shaft, due to the fixed rotational relationship between the magnetic field generating device (37) and the shaft (32), the magnetic field generating device (37) including one or more magnets (38a, 38b) and the magnet holder body (39) also rotates to the same rotation angle as the shaft (32). In this way, one or more magnetic fields are generated around the longitudinal axis (25) of the tubular body (23) parallel to the longitudinal axis (5) of the elongated body (3) of the syringe (2).

[0089] The dose capture device (1) also includes a coupling device (42) for coupling the syringe plunger (8) to the displacement replicator system (30). The coupling device (42) includes a first receiving portion (43) adapted and configured to receive at least a portion of the plunger head (10). The first receiving portion (43) of the coupling device (42) is sized to allow at least a portion of the plunger head to be inserted and received therein, but at the same time surrounds at least a portion of the plunger head so that when the coupling device (42) is pushed in the distal direction or pulled in the proximal direction, the coupling device (42) directly moves at least a portion of the plunger head (10) along the longitudinal axis (5) of the syringe body (3). Therefore, the first receiving portion (43) of the coupling device (42) includes an engagement surface (44, 45) that closely surrounds and engages with at least a portion of the plunger head (10) to transmit any proximal or distal movement of the coupling device to the plunger head. For example, as Figure 1 and Figure 2 As shown, the coupling device (42) is represented by a body (46), such as a molded body of a plastic or polymer material PC / ABS resin mixture, having a first receiving portion (43) represented by a T-shaped slot including a proximal wall (44) and a distal wall (45). The proximal wall (44) and the distal wall (45) define an engagement surface of the first receiving portion (43), and when a user applies a force in the proximal or distal direction through the coupling device (42), such as when the user pushes or pulls the coupling device in the distal or respectively proximal direction, the proximal wall and the distal wall act on or cooperate with the plunger head (10).

[0090] In addition, if Figure 1 , Figure 2 and Figure 4As shown, the coupling device also includes a second receiving portion (46) configured and adapted to receive the proximal end (35) of the shaft (32) and at least a portion of the magnetic field generating device (37). The second receiving portion (46) is sized to receive and engage the proximal end of the shaft (32) so that any proximal or distal movement of the plunger head (10) is transmitted to the proximal end (35) of the shaft (32) of the displacement replicator system (30) via the coupling device (42). In this way, the proximal end (35) of the displacement replicator system (30) also moves in the proximal or distal direction depending on the corresponding movement direction of the plunger (8). As already mentioned elsewhere in this application, the proximal or distal movement of the shaft causes the magnetic field generating device (37) to rotate around the central longitudinal axis (25) of the tubular body (23) of the support body (17) to the same extent as the rotation of the displacement replicator shaft (32). The second receiving portion (46) of the coupling device (42) is also configured to receive the magnetic field generating device (37) of the displacement replicator system (30). Therefore, the size of the second receiving portion (46) is not only configured to receive and engage the proximal end (35) of the displacement replicator shaft (32), but also to provide sufficient space for the magnetic field generating device (37) to allow the magnetic field generating device to rotate freely or substantially freely within the second receiving portion (46) around the longitudinal axis (25) of the tubular support (23) of the support body (17). The term "freely rotating" or "substantially freely rotating" should be understood here as: the size, shape and dimensions of the second receiving portion (46) allow the magnetic field generating device (37) to rotate freely within the second receiving portion (46) with as little friction as possible. Appropriate selection of materials for the magnetic field generating device (37) and the receiving portion (46) of the coupling device will result in acceptable results and functions. For example, as already mentioned elsewhere in this document, where the magnetic field generating device (37) comprises a magnet holder body (39), and the body is made of PC / ABS, the second receiving part (46) of the coupling device can also be made of PC / ABS.

[0091] As shown, the dose capture device further comprises at least one sensor (47) and a processing system (48), and the at least one sensor (47) and the processing system (48) are adapted and configured to correlate the translational movement of the displacement replicator system (30) with the dose of injectable substance selected and / or injected by the user through the operation of the translational movement of the plunger (8) along the longitudinal axis (5). For example, the processing system (48) and the at least one sensor (47) communicate with each other via an electrical connection, and the processing system (48) is configured to process signals received from the at least one sensor (47). As already described elsewhere in the present application, the magnetic sensor (47) detects the magnetic field generated by the magnetic field generating device (37), and when the magnetic field generating device rotates around the central longitudinal axis (25) of the tubular body (23), and / or moves proximally or distally along the central longitudinal axis (25), the magnetic sensor (47) transmits the measured magnetic field changes to the processing system (48). The processing system (48) comprises an integrated control and data processing unit, such as at least one microcontroller, which is electrically connected to the magnetic sensor (47) for processing information received from the magnetic sensor (47). The processing system (48) and the at least one sensor (47) may be integrated into an electronic component board (52), such as a printed circuit board of corresponding appropriate dimensions, the dimensions of which will vary depending on the desired location of the electronic component board (52) within the dose capture device. The integrated control and data processing unit, including at least one microcontroller, handles all electrical communications and signal transmissions between the different electronic components from the processing system (48) and the magnetic sensor (47).

[0092] At least one sensor (47) is positioned along the longitudinal axis (25) of the tubular body (23) of the support (17). Figure 1 , Figure 2 and Figure 4In the example shown, the sensor (47) and the processing system (48) are housed in a coupling device (42) which includes a third receiving portion (49). The third receiving portion (49) is configured and dimensioned to receive at least one sensor (47) and the processing system (48). Typically, the third receiving portion (49) is formed as part of the body of the coupling device (42), such as a well (49) defined by a corresponding annular side wall (50) extending in a proximal direction from a base plate (51), the well (49) receiving at least one sensor (47) and the processing system (48), wherein at least one sensor (47) is positioned axially aligned with the central longitudinal axis of the tubular support. Typically, the third receiving portion is axially positioned proximal to the second receiving portion, so that the magnetic field generating device rotates with the axis of the displacement locator around the magnetic sensor, which is correspondingly axially positioned proximal to the axis of rotation. In this way, even if the magnetic field generating device maintains a constant axial distance from the magnetic sensor, changes in the axial proximal or distal movement of the plunger head can still be recorded as a rotation of the magnetic field generating device around the magnetic sensor.

[0093] The processing system also includes at least one of a memory, an independent power supply (53) and a communication unit, whereby the at least one microcontroller is in electrical communication with these components so as to receive power from the independent power supply (53) on the one hand, and to be able to communicate data with the processing system using a remote receiver (e.g. a smart phone) or other telecommunication network (e.g. a telephone network). The processing system (48) is also responsible for performing calculations of the precise position of the magnetic field generating device (37) to be calculated and determined, and for processing signals from the independent power supply (53) and the communication means. By means of the at least one microcontroller, the processing system (48) can be remotely programmed when first used, or receive information and updates, in a manner similar to other electronic devices today that contain integrated control and data processing units. Such integrated control and data processing units are known per se and typically integrate a central processing unit, a real-time clock, one or more memory storage systems, and optionally also a communication system or subsystem, as well as other desired components.

[0094] As mentioned above, the processing system (48) is powered by an independent power source (53), such as a removable and / or rechargeable power source. Such a removable independent power source may usefully consist of, for example, a lithium-ion battery that can be easily replaced when the power is exhausted, or alternatively a rechargeable battery that can be recharged when the power is exhausted, for example, via a corresponding charging port (54) provided in the dose capture device (1), such as a USB charging port connected to the rechargeable battery, both types of batteries being well known to those skilled in the art. Figure 1 , Figure 2 and Figure 4As shown, the independent power supply (53) can be suitably received within or adjacent the slot of the third receiving portion (49), for example, proximal to and above the electronic component board.

[0095] The communication unit may be any suitable radio frequency transmission unit, such as a Bluetooth communication unit, and advantageously a Bluetooth Low Energy circuit (BLE), enabling the processing system to send and receive data to and from a remote terminal device, such as a suitably equipped smartphone, a remote computing system or a distributed computing system, respectively, via, for example, a telecommunications network or any other suitable communication network infrastructure.

[0096] The processing system may also include a visual or audible signaling device that is controlled by the microcontroller and whose output can be heard and / or seen outside the dose capture device. For example, when the sensor and processing system are housed in the coupling device (42), the visual or audible signaling device may be provided with an outlet in the body of the coupling device (42). Figure 4 As shown, such visible signal outlet means is provided by an optical fiber (55), for example for transmitting light from a light emitting diode included in the processing system to the exterior of the dose capture device (1). The optical fiber (55) may be conveniently located in the outer wall (50) of the well (49), or alternatively, in the wall of a well cap (56) covering the proximal opening of the well (49), and is sized and configured to enclose the proximal wellhead and to enclose the independent power supply (53), the processing system (48) and the magnetic sensor (47).

[0097] As shown, the sensor (47) aligned with the longitudinal axis (25) of the tubular body (23) will report the magnetic field measurement at any given rotation angle of the magnetic field generating means (37), which means that even if the magnetic field generating means (37) and the magnetic sensor (47) are kept at a fixed length distance from each other, the number of rotations of the magnet around the axis of the tubular support body can still be detected. All of these measurements are processed by the processing system (48) and used to correlate the distance moved by the displacement replicator system with the distance moved by the plunger or plunger head. Since the pitch of the shaft (32) is known in advance, which is stored in the memory of the processing system (48) and stored by the execution of a corresponding program by the processing system (48), and the translation distance moved by the displacement replicator system (30) is directly correlated to the distance moved by the plunger head (10) in the proximal or distal direction, each time the plunger head (10) moves in the proximal or distal direction, the processing system converts the relevant distance moved by the plunger head (10) into a dose selected and / or injected by the user. Similarly, in the case where the syringe does not yet contain an injectable substance, moving the plunger head (10) in the proximal direction to extract the injectable substance from the substance container (e.g., a vial) will cause the displacement replicator system to replicate the proximal movement and cause the magnet to rotate about the longitudinal axis (25). The dose of the substance extracted from the vial into the syringe will be calculated by the magnetic field change information detected by the magnetic sensor contained in the coupling device (42). When the plunger is actuated in the opposite direction, i.e., in the distal direction, to expel the injectable substance, the change in the magnetic field will be detected in a similar manner and used to calculate the expelled or injected dose of the injectable substance by the processing system (48). The device (a suitably equipped smartphone or mobile device or a remote server) can then transmit the calculated set, injected or expelled dose externally thereof via a communication unit (e.g., via a Bluetooth communication protocol), execute program code for processing, and / or display the captured dose to the user.

[0098] Based on the above content, the following will be given as FIG. 5A to FIG. 5E A brief description of the functionality of the device shown. Figure 5A A schematic diagram of a dose capture device (1) according to the invention is shown, attached to a hypodermic syringe (2) with a volume of 30 ml by means of a bracket (18) and ready for use. In this example, the syringe (2) already contains an injectable substance, such as a drug, such as an injectable insulin product for the treatment of diabetes. In this schematic diagram, the plunger head (10) is secured by the engagement surfaces (44, 45) of the first receiving portion (43) of the coupling device (42). Figure 5B In the embodiment of the present invention, the user of the syringe has already started to withdraw the plunger by pulling or moving the plunger head, for example by pulling the coupling device (42) in the proximal direction. Figure 5BIt can be seen that the displacement replicator system (30), in particular the axis (32), is now visible below the syringe plunger (8), and it can also be seen that the axis (32) of the displacement replicator system (30) is aligned parallel to the longitudinal axis (5) of the syringe. Figure 5C As shown, the user continues to move the plunger head (10) in the proximal direction, i.e., generally toward the hand manipulating the coupling device (42), until a position satisfactory to the user is reached, which is the appropriate dose of injectable substance that has been selected, i.e., the maximum proximal movement range of the plunger head (10) is reached. At the same time, the shaft (32) rotates about the longitudinal axis (25), thereby causing the magnetic field generating device (not shown) to rotate within the second receiving portion of the coupling device (42). When the rotation of the magnetic field generating device (37) causes changes in the magnetic field measured by the magnetic sensor (47), these changes are transmitted to the processing system (48), which associates the changes with the distance moved by the plunger so that the selected dose can be calculated. When the desired volume or expected dose of the injectable substance has been selected, the user can begin to discharge and / or inject. This step is as shown in FIG. Figure 5D As shown in , wherein the coupling device (42) and the plunger head (10) are as shown in Figure 5C The distal end of the corresponding position in . Figure 5D As shown, moving the coupling device (42) in the distal direction causes the coupling device to push the plunger head (10) and the proximal end of the shaft (32) to the same extent. The movement of the shaft (32) in the distal direction causes the shaft (32) to rotate, thereby rotating the magnetic field generating device (37) around the longitudinal axis (25), thereby rotating the magnetic field generating device in the second receiving part of the coupling device. Even if the axial distance between the magnetic field generating device (37) and the magnetic sensor (47) remains unchanged, the rotation of the magnetic field generating device (37) will cause the magnetic field measured at the magnetic sensor (47) to change. By the user pushing the coupling device (42) in the distal direction, the further distal movement of the plunger head causes the plunger head (10) to move the plunger to inject or expel the injectable substance from the syringe body (3). Once the injectable substance has been expelled, that is, as shown Figure 5EA further position of the dose capture device of the invention is shown, in which the coupling means have been returned to the initial position of the various components before the device is used. The plunger head has moved a certain distance, which has been replicated by the displacement replicator system (30), so that the shaft is re-accommodated in the tubular body (23) of the support body (17). In the displacement replicator system (30), the shaft (32) rotates the magnetic field generating means (37) around the longitudinal axis (25) until the translational movement of the longitudinal axis stops, thereby stopping the rotational movement of the magnetic field generating means (37) around the axis (25). Therefore, the processing system is able to process information from the magnetic sensor (47), which no longer detects changes in the magnetic field. Thereby, the processing system is programmed to determine that the injection has been completed and calculate the injected dose of the injectable substance, reporting the captured injected dose to an external receiver system (e.g. a smartphone running a corresponding application or program to display such information) through a communication unit contained in the processing system.

Claims

1. A handheld dose capture device adapted and configured to be releasably attached to a handheld syringe, the handheld syringe comprising an elongated body having a longitudinal bore defining a central longitudinal axis, the elongated body having a proximal end and a distal end, and a syringe plunger located within the bore and movable along the central longitudinal axis, the syringe plunger extending beyond the proximal end; in, A releasably attachable dose capture device comprising: a support body adapted and configured to at least releasably engage an outer surface of an elongated body of said hand-held injector, aligned parallel to said central longitudinal axis of said elongated body; a displacement replicator system adapted and configured to replicate translational motion of said syringe plunger parallel to said central longitudinal axis; a coupling device adapted and configured to couple the proximal end of the syringe plunger to the proximal end of the displacement replicator system; and wherein said handheld dose capture device comprises at least one sensor and processing system adapted and configured to correlate translational movement of said displacement replicator system with a dose of injectable substance selected or injected by a user through translational movement of said syringe plunger along said central longitudinal axis; wherein the coupling device comprises a first receiving portion and a second receiving portion, the first receiving portion being configured and adapted to receive at least a portion of a plunger head at a proximal end of the syringe plunger, and the second receiving portion being configured and adapted to receive at least a portion of a proximal end of the displacement replicator system and a magnetic field generating device of the displacement replicator system; Wherein, the support body includes a base, which is suitable and configured to receive at least a portion of the displacement replicator system, the base is a fixing nut with an internal threaded hole, and the displacement replicator system includes a shaft with an external thread located on its outer surface.

2. The handheld dose capture device according to claim 1, wherein: The support is releasably attached at least one or more locations along the length of the elongated body of the handheld injector.

3. The handheld dose capture device according to claim 1, wherein: The support body comprises a tubular body having a longitudinal central bore defining a longitudinal axis which is parallel to a longitudinal axis of the elongated body of the handheld syringe when the dose capture device is mounted on the handheld syringe.

4. The handheld dose capture device according to claim 1, wherein: The support body includes a tubular body extending along at least a portion of the length of the elongated body of the handheld injector.

5. The handheld dose capture device according to claim 1, wherein: The support body includes a bracket for releasably attaching to at least one outer surface of the elongated body of the hand-held injector.

6. The handheld dose capture device according to claim 1, wherein: The shaft of the displacement replicator system is at least partially housed in the central hole of the tubular body of the support.

7. The handheld dose capture device according to claim 1, wherein: The magnetic field generating device is mounted for fixed common rotation with the shaft.

8. A handheld dose capture device according to any one of claims 1, 6 and 7, wherein: The magnetic field generating device includes at least one of a ring-shaped dipole magnet, a disk-shaped dipole magnet, or at least one pair of radially positioned NS dipole magnets.

9. The handheld dose capture device of claim 1, wherein: The at least one sensor is a magnetometer.

10. A handheld dose capture device according to claim 3 or 9, wherein: The at least one sensor is a magnetometer and the sensor is positioned along a central longitudinal axis of the support body.

11. The handheld dose capture device of claim 1, wherein: The at least one sensor and the processing system are housed within the coupling device.

12. The handheld dose capture device of claim 1, wherein: The at least one sensor and the processing system are housed within the support body.

13. The handheld dose capture device of claim 1, wherein: The processing system and at least one sensor are in communication with each other, and the processing system is configured to process signals received from the at least one sensor.

14. The handheld dose capture device of claim 1, wherein: The processing system includes at least one microcontroller in electrical communication with at least one of a memory, an independent power supply, and a communication unit.

15. The handheld dose capture device of claim 1, wherein: The second receiving portion is configured to allow the magnetic field generating means of the displacement replicator system to rotate freely within the second receiving portion around the longitudinal axis of the support body.

16. The handheld dose capture device of claim 1, wherein: The coupling device is configured as follows: associating translational movement of the plunger of the hand-held syringe in the proximal or distal direction with a displacement replicator system, and The displacement replicator system is allowed to rotate freely parallel to the central longitudinal axis of the elongated body.

17. The handheld dose capture device of claim 1, wherein: The at least one sensor is an accelerometer.

18. The handheld dose capture device of claim 17, wherein: The accelerometer is configured to detect a position orientation of a syringe mounted with the dose capture device, the position orientation being selected from at least one or more of an injection start position, a syringe empty position and an injection expelling position.

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