Sensor, cartridge and drug delivery device
By using planar flexible foil to arrange measuring electrodes and contact electrodes in a drug delivery device, the problem of positioning capacitance measuring electrodes is solved, realizing a low-cost sensor for frequent measurement of cartridge parameters, suitable for reusable drug delivery devices.
Patent Information
- Application Number
- CN202511250287.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2015-07-31
- Filing Date
- 2016-07-26
- Publication Date
- 2026-02-17
AI Technical Summary
In existing drug delivery devices, the positioning and electrical contact requirements of the capacitance measurement electrodes are high, which is difficult to achieve in low-cost production. Furthermore, passive sensor systems have limited functionality, cannot frequently measure cartridge parameters, and rely on external energy sources.
A planar flexible foil is used as the sensor substrate, which includes measuring electrodes and contact electrodes. The electrodes are separately arranged on the outer periphery of the drug cartridge, and the contact electrodes are connected to the power supply in the drug delivery device to provide stable electrical contact and signal transmission. The sensor assembly is reusable, and the processor and transceiver realize data processing and communication within the device.
The sensor, which enables low-cost production, can frequently measure cartridge parameters, is independent of external devices, provides large storage capacity and rotationally constant electrical contact, and is suitable for reusable drug delivery devices.
Smart Images

Figure CN121534262A_ABST
Abstract
Description
[0001] This application is a divisional application of the application patent application with the application date of 26 July 2016, the application number of 201680044442.3 (the international application number of PCT / EP2016 / 067815), and the name of "Sensor, Cartridge and Drug Delivery Device". TECHNICAL FIELD
[0002] The present application relates to the field of measuring at least one physical or chemical parameter of a cartridge filled with a liquid substance, typically filled with a medicament. Furthermore, the present application relates to a cartridge provided with such a sensor. In another aspect, the present application relates to a drug delivery device, in particular to an injection device for setting and dispensing a dose of a liquid medicament. BACKGROUND
[0003] Drug delivery devices for setting and dispensing one or more doses of a liquid medicament are generally well known in the art. Typically, such devices have a function which is essentially similar to that of an ordinary syringe.
[0004] Drug delivery devices like pen-type injectors have to meet a number of user-specific requirements. For example, the patient can be physically infirm or can have impaired vision or dexterity. Due to these limitations, particular needs can exist for suitable drug delivery devices, particularly for home medication. Appropriate drug delivery devices therefore need to be robust in construction yet easy to use. Furthermore, the manipulation of the device and its components should be intelligible and easy to understand. Such an injection device should provide for setting a variable size of a dose of a medicament and for dispensing the set dose subsequently. Moreover, the dose setting and the dose dispensing procedure must be easy to operate and must be unambiguous.
[0005] Typically, such devices comprise a housing or a specific cartridge holder which is adapted to accommodate a cartridge which is at least partially filled with a medicament to be dispensed. The device further comprises a drive mechanism which usually has a movable piston rod to operably engage with a piston of the cartridge. By means of the drive mechanism and its piston rod, the piston of the cartridge can be moved in a distal or dispensing direction and, thus, a predetermined amount of the medicament can be expelled via a piercing member which is releasably connected with a distal portion of the housing of the drug delivery device.
[0006] The medicament to be dispensed by the drug delivery device is provided and accommodated in a multi-dose cartridge. Such a cartridge usually comprises a glass barrel which is sealed in the distal direction by means of a pierceable seal and further sealed in the proximal direction by a piston. In case of a reusable drug delivery device, the empty cartridge can be replaced by a new one. In contrast thereto, a disposable drug delivery device is to be discarded completely when the medicament within the cartridge is dispensed or used up.
[0007] It is generally desirable to determine the amount of drug remaining in a cartridge while the cartridge is arranged inside a drug delivery device. It is generally known in the art to perform a capacitance measurement or capacitance determination of a filled level of a cartridge. At least two electrodes are provided either on the cartridge itself or inside a cartridge holder portion of the drug delivery device. Since the dielectric properties of the liquid substance inside the cartridge are significantly different from the dielectric properties of other surrounding substances, e.g. glassy materials, the cartridge is made of a rubber-based material forming a proximal piston of the cartridge, the capacitance between the electrodes located on diametrically opposed side wall portions of the cartridge is measured and correlates with the filling level of the cartridge and / or the axial position of the piston inside the cartridge. The measurable capacitance between the electrodes is thus a direct measure of the axial position of the piston of the cartridge. In this way, the measured capacitance directly indicates the filling level of the cartridge.
[0008] For example, the document WO 2014 / 052997 A1 discloses a corresponding dispensing device having at least one pair of capacitive measuring electrodes arranged in an outer region of a drug container for determining the dielectric constant of a corresponding medium in an intermediate region between the measuring electrodes. Furthermore, a shield is described which is arranged around the container and surrounds the measuring material in a sheath-like manner.
[0009] The correct arrangement of the capacitive electrodes on the outer circumference of such a container or cartridge is rather delicate and cumbersome. The electrodes have to be correctly positioned and arranged relative to the cartridge. Once the electrodes have been correctly assembled, they need to be in electrical contact with a processor to provide for the measurement and data processing of the measured capacitance values. Only slight changes or deviations in the relative positioning of the at least two electrodes relative to each other and / or relative to the cartridge as well as only slight deviations or changes in the electrical contact with the processor can have severe consequences on the measurement results. In a mass production environment for low-cost production of cartridges and / or drug delivery devices, such high requirements on positioning accuracy and electrical contact are difficult to achieve.
[0010] For the measurement of physical or chemical parameters of a cartridge on the basis of capacitive electrodes, electrical energy has to be provided. Passive solutions, e.g. on the basis of RFID transponder technology, are rather complex and can be rather susceptible to electromagnetic or mechanical disturbances. Furthermore, the measurement or monitoring of the relevant parameters can only be performed if a suitable energy source, usually in the form of an RFID reader, is in close proximity to the cartridge or to a drug delivery device equipped with such a cartridge. In addition, the functionality of such a passive sensor system with wireless transmission of electromagnetic energy is rather limited in terms of its processing power and storage capacity, e.g. for series storage of physical or chemical parameters.
[0011] It is therefore an object of the present application to provide an improved sensor for measuring at least one physical or chemical parameter of a cartridge, wherein the cartridge is filled with a liquid substance. The sensor should be producible at low costs and should be configured as a disposable entity. Furthermore, the sensor and its interaction with the drug delivery device should provide a large number of functions as well as a considerable storage capacity for capturing and storing electronic data representing the measured physical or chemical parameter. Moreover, the sensor and its interaction with the drug delivery device should enable continuous or frequent measurements of the physical or chemical parameter of the cartridge according to a predetermined schedule and independent of an external reader or some other external electronic device configured to communicate with the sensor and / or the drug delivery device. SUMMARY
[0012] In a first aspect, a sensor for measuring at least one physical or chemical parameter of a cartridge or syringe is provided, wherein the cartridge or syringe is filled with a liquid substance. Typically, the cartridge is filled with a liquid drug.
[0013] The sensor comprises a planar flexible foil, which can be arranged at the outer circumference of the barrel of the cartridge or syringe. Furthermore, the sensor comprises at least a first and a second measuring electrode arranged on the foil. The electrodes are typically spatially separated from each other in order to enable an arrangement of the first electrode and the second electrode at diametrically opposite portions of the cartridge's sidewall. Typically, the measuring electrodes can be of arbitrary shape. The first and the second measuring electrode are separated from each other when arranged or connected to the outer circumference of the barrel's sidewall such that at least a portion of the cartridge and the liquid substance contained therein is located between the first and the second measuring electrode. Furthermore, the sensor also comprises at least a first and a second contact electrode arranged on the foil. The first contact electrode is electrically connected with the first measuring electrode and the second contact electrode is electrically connected with the second measuring electrode. In this way, the two contact electrodes provide a clear electrical contact to an electrical energy supply and a processor or further signal processing means, such as a transceiver arranged within the drug delivery device, to provide wireless communication of the processor with an external device.
[0014] The first and the second contact electrode provide a wired energy supply for the first and the second measuring electrode, respectively. In addition, the first and the second contact electrode also provide a wired transmission of electrical signals derived or generated by the first and / or the second measuring electrode.
[0015] The first and the second contact electrode provide a clear electrical interface between the measuring electrodes and at least one electrical energy supply. Typically, the electrical energy supply is located outside and remote from the sensor. The electrical energy supply is typically arranged within the drug delivery device or is typically connected to an externally facing portion thereof. When the sensor is connected or assembled to the cartridge and when the cartridge is placed inside the drug delivery device, the first and the second contact electrodes are electrically contacted with the electrical energy supply in order to enable a measurement of the physical or chemical parameter of the cartridge.
[0016] According to one embodiment, the sensor consists exactly of the planar flexible foil, the first and second measuring electrodes, and the first and second contact electrodes. In this way, all further components in the sensor assembly that are needed for the actual measurement of the physical or chemical parameter of the cartridge are located remotely, for example in or on the drug delivery device. Especially for reusable drug delivery devices, the sensor can thus be easily implemented as a permanently fastened or fixed sensor with a single use cartridge. Upon emptying of the cartridge, the entire cartridge with the connected sensor is discarded. Since the sensor only comprises the planar flexible foil and the number of electrodes, due to the sensor not having any further semiconductor structures or materials, a rather environmentally friendly disposal and a rather efficient production can be provided.
[0017] The rather expensive and relatively bulky components in the sensor assembly can be provided remotely from the sensor, but in the interior or connected to the drug delivery device. Due to the reusable nature of such a device, the usual components of the sensor assembly like an electrical energy supply, a transceiver for data transmission, and a processor for signal processing of the signals obtained by the measuring electrodes can be arranged in and permanently connected to the drug delivery device and can be used sequentially with a plurality of sensors or cartridges equipped with such a sensor.
[0018] According to another embodiment, the first and second contact electrodes are arranged at longitudinal ends of the foil. Generally, the planar flexible foil extends in a plane defined by a longitudinal direction (z) and a transversal or circumferential direction (u). The longitudinal and transversal directions generally extend perpendicular with respect to each other. The planar flexible foil is arranged to surround or connected to the outer circumference of the cartridge's barrel side wall. When arranged around or connected to the cartridge, the longitudinal direction of the foil generally extends parallel to the longitudinal or axial direction of the axially elongated cartridge, while the transversal or circumferential direction of the planar flexible foil extends along the tubular or circular circumference of the cartridge side wall.
[0019] By arranging the first and second contact electrodes at longitudinal ends of the foil, the contact electrodes form the distal or proximal end of the planar flexible foil. When connected or arranged at the outer circumference of the cartridge's barrel, the first and second contact electrodes are arranged at or near the distal end of the tubular cartridge or at or near the proximal end of the tubular cartridge. In this way, only the distal or proximal end of the planar flexible foil is occupied by the first and second contact electrodes. Thus, the remaining and major part of the planar flexible foil can be used for the arrangement of at least the first and second measuring electrodes.
[0020] According to a further embodiment, the first and second contact electrodes are arranged at a common longitudinal end of the foil. For example, both the first and second contact electrodes are arranged at or near the distal end of the foil. Alternatively, the first and second contact electrodes are arranged at or near the proximal end of the foil.
[0021] The terms proximal and distal refer to the intended orientation of the planar flexible foil and the respective cartridge inside the drug delivery device. The distal direction denotes the dispensing end of the drug delivery device. When the drug delivery device is implemented as an injection device, the distal end of the drug delivery device is directed towards the injection site of a patient. The proximal end or proximal direction faces the opposite direction. When implemented as an injection device like a pen-injector, the proximal end of the drug delivery device is operable by the hand of a user to configure, set and perform an injection procedure.
[0022] In another embodiment, the first and second contact electrodes are arranged at opposite longitudinal end portions of the foil. In this embodiment, it is conceivable that, for example, the first contact electrode is located at the proximal end of the planar flexible foil, while the second contact electrode is located at the distal end of the planar flexible foil. Here, the at least two contact electrodes form a longitudinal delimitation of the planar flexible foil, wherein the at least first and second measurement electrodes are located between the at least two contact electrodes. The specific arrangement and position of the first and second contact electrodes on the foil depends on the specific implementation of the entire sensor assembly and the specific configuration of the cartridge and the respective drug delivery device. Generally, the first and second contact electrodes are arranged on the planar flexible foil at such a position that an electrical contact between the contact electrodes and the electrical energy supply is formed when the cartridge equipped with the planar flexible foil is properly assembled inside the drug delivery device.
[0023] According to another embodiment, the first and second contact electrodes are separated in longitudinal direction and extend substantially parallel in a transverse or circumferential direction. By separating the first and second contact electrodes in longitudinal direction, each contact electrode can be electrically connected to the electrical energy supply, for example by means of first and second contact elements which are respectively positioned and arranged at a respective axial distance at the drug delivery device. Furthermore, since the first and second contact electrodes extend substantially parallel to each other in the transverse or circumferential direction, an annular contact electrode structure can be formed on the outer circumference of the cartridge when the planar flexible foil is wrapped around the side wall of the cartridge body.
[0024] Generally, the wrapping of the planar flexible foil and the transverse or circumferential extension of the first and second contact electrodes is such that each electrode forms a closed loop along the outer circumference of the cartridge body, wherein the loop lies in a single transverse plane which extends substantially perpendicular to the longitudinal or axial direction of the wrapping of the flexible foil or the cartridge body. In this way, each of the first and second contact electrodes forms a specific axial contact structure which is rotationally invariant when the cartridge is located in an arbitrary orientation within the drug delivery device.
[0025] According to a further embodiment, the first and second electrodes extend almost across the entire lateral dimension of the foil. Typically, the entire lateral dimension of the foil almost perfectly matches and corresponds to the outer periphery of the cartridge body. Typically, a planar flexible foil can be wrapped around the outer periphery of the cartridge without overlapping, but almost completely covers the outer periphery of the cartridge. When the first and second electrodes extend almost across the entire lateral dimension of the foil, a substantially closed first and second electrode structure can be obtained. In this way, a rotationally invariant contact electrode structure can be provided on the outer periphery of the cartridge.
[0026] In other embodiments (where, for example, at least one of the first and second contact electrodes is wound around the cartridge such that a small gap is left between the lateral ends of the contact electrodes that are positioned relative to each other), the lateral extension of the corresponding contact element of the drug delivery device exceeds the size of the lateral gap. In this way, the electrical contact between the contact element and the contact electrode always provides arbitrary rotational orientation of the cartridge relative to the contact element inside the drug delivery device.
[0027] In another embodiment, the foil is substantially transparent. Furthermore, at least one of the first and second measuring electrodes or at least one of the first and second contact electrodes includes a conductive structure printed or coated on or in the foil.
[0028] The foil itself is typically electrically insulating. In this way, the foil effectively serves as a flexible planar substrate or as a mechanical support for at least the first and second measuring electrodes and at least the first and second contact electrodes. By printing or coating all the electrodes onto or within the planar flexible foil, the various electrodes—namely, the first and second measuring electrodes and the first and second contact electrodes—are inherently correctly positioned relative to each other. The relative positions and / or relative orientations of the first and second measuring electrodes and the first and second contact electrodes are permanent and may only undergo explicit modifications because the initial planar flexible foil is wound around the outer periphery of the cartridge body.
[0029] Electrodes may comprise suitable conductive materials, such as aluminum, gold, silver, or mixtures and alloys thereof. Electrodes may be printed onto a flexible foil, for example by screen printing. Alternatively, they may be coated onto a planar flexible foil using any suitable thin-film deposition technique, such as sputtering, spraying, or by means of various chemical vapor deposition techniques. The foil typically comprises or is made of a transparent polymer. The foil may contain at least one or a combination of the following materials: polycarbonate, polyamide, or polyvinyl chloride (PVC).
[0030] According to a further embodiment, the first and second measuring electrodes and the first and second contact electrodes are located on a common side of the foil. Alternatively, the first and second measuring electrodes are located on one side of the foil, and the first and second contact electrodes are located on opposite sides of the foil.
[0031] The first and second measuring electrodes are always located on the same side of the foil. Furthermore, the first and second contact electrodes are always located on the same side of the flexible foil.
[0032] When the foil is wrapped or wound around the outer periphery of the cartridge body, the first and second contact electrodes are typically arranged on the outer side of the planar flexible foil. In such an arrangement, it is generally conceivable that the measuring electrode is also located on the outer side of the wrapped or wound foil. When implemented as a capacity measuring electrode, the planar flexible foil is dielectric or permeable to dielectric charges.
[0033] In another embodiment, it is conceivable that at least the first and second contact electrodes are located on the outer portion of the wound foil, while at least the first and second measuring electrodes are located on the inner portion of the wound foil. In this embodiment, it is conceivable that the planar flexible foil comprises a multilayer structure, wherein at least one conductor electrically connecting the first measuring electrode to the first contact electrode extends through the planar flexible foil.
[0034] In another embodiment, at least two measuring electrodes are configured as capacitance measuring electrodes or temperature measuring electrodes. When implemented as capacitance measuring electrodes, the first and second measuring electrodes typically extend entirely along the longitudinal extension of the cartridge when the foil is wound around the tube. The measuring electrodes may comprise a generally rectangular structure having a transverse or circumferential extension less than half the circumference of the tubular tube. Typically, the first and second measuring electrodes have substantially the same geometry.
[0035] In addition to the basic rectangular structure, the measuring electrode may also include a tapered structure in the axial direction. Furthermore, the electrode can be trapezoidal, triangular, or may include a combination of rectangles and triangles. In particular, by using electrodes with a geometry that continuously changes in the axial direction, a correspondingly linearly varying capacitance signal can be obtained, since, for example, the piston of a cartridge undergoes linear axial displacement during dispensing. Therefore, the geometry of the electrode can improve the accuracy and precision of capacitance measurement. Furthermore, it is conceivable that multiple measuring electrodes are arranged along the longitudinal extension of a planar flexible foil, wherein pairs of measuring electrodes located at the same or overlapping longitudinal positions can be connected in pairs to a specific processor. By means of multiple pairs of first and second measuring electrodes, wherein these pairs are arranged at different longitudinal positions along the outer periphery of the cartridge body, the spatial resolution of capacitance measurement, and therefore a considerably high spatial resolution of the piston position, can be measured and determined by a processor connectable to each pair of measuring electrodes.
[0036] When implemented as a temperature measuring electrode, the electrode may comprise pairs of heaters and thermistors arranged alternately along the longitudinal direction and in pairs along the sidewall of the cartridge. Typically, the first measuring electrode may comprise multiple parallel-oriented but longitudinally separated heaters, while the second electrode may comprise a corresponding arrangement of thermistors placed longitudinally between the heaters of the first measuring electrode. With the aid of the first electrode, heat energy can be deposited onto the sidewall of the cartridge, and with the aid of the various thermistors, and thus with the aid of the second electrode, temperature irregularities caused by the piston's position within the cartridge can be measured and determined. Typically, each branch of the first and second electrodes forming the heaters or thermistors can be individually connected to the processor of the sensor assembly. In this way, thermal excitation and heat transfer on the cartridge sidewall can be monitored with spatial resolution based on the distance between adjacent branches of the first and second electrodes. When configured and implemented as a temperature measuring electrode, the measuring electrode functions as a thermal induction array or, as in a heat flow sensor.
[0037] The implementation of such a temperature measuring device is particularly beneficial when the power supply is sufficient. By implementing a power supply in the drug delivery device, for example in the form of batteries, solar cells, or a combination thereof, sufficient power for temperature measurement can be easily provided in a fairly cost-effective manner.
[0038] According to another aspect, the present invention relates to a cartridge comprising a tubular tube filled with a liquid substance (typically a liquid drug). The cartridge further comprises a sensor as described above, said sensor being wound around the outer periphery of the side wall of the tube.
[0039] The cartridge to which the sensor can be disposed or connected may include a tubular tube, made of, for example, glass or some other material substantially inert to the liquid substance contained therein. The cartridge may include a distally located, punctureable outlet sealed by a punctureable diaphragm, allowing access to the interior of the cartridge by means of a puncturing component, such as a double-ended needle, through puncture of the distal seal. Opposite to the distal outlet of the cartridge, particularly its tubular portion, is typically a piston that can slide within the cartridge. The piston can slide distally relative to the cartridge under the action of a distally driven force, typically applied by a plunger or piston rod of a drug delivery device to advance distally, thereby applying distally pressure to the piston. Sensors are specifically designed for such cartridges, but may also be used in other ways, such as for other types of drug containers, including vials, ampoules, bottles, or flexible bags.
[0040] The cartridge and sensor components can be configured as disposable units, completely discarded after the contents of the cartridge are consumed or dispensed. Typically, because the flexible foil of the sensor is substantially transparent, the cartridge fill level is visually inspectable even when the sensor and therefore the flexible foil with electrodes thereon are attached to the cartridge. The electrodes can also be transparent. For example, the electrodes may comprise conductive and substantially transparent indium tin oxide (ITO) or may be made of indium tin oxide (ITO). Visual inspectability of the cartridge interior is particularly beneficial even when the sensor completely covers the sidewalls of the cartridge, allowing for intuitive control of the cartridge contents, especially whether liquid drugs may be subject to coagulation, flocculation, or other harmful effects or phenomena.
[0041] In another embodiment, the sensor is permanently attached to the cartridge and covers its entire tubular sidewall portion. This configuration can be particularly advantageous when the sensor, especially the planar flexible foil, provides a visual scale that can be permanently printed on the upper or lower side of the flexible foil. The scale can include various symbols, numbers, or other symbols to visually display the instantaneous fill level of the cartridge. By providing a scale, it is no longer necessary to provide such scale items directly on the outer periphery of, for example, a number of equidistantly arranged rulers typically separated along the axial or longitudinal direction of the flexible foil. By providing a visual scale on the sensor, especially on the flexible foil of the sensor, and by attaching the sensor to the outer periphery of the cartridge in a clear, precise, and highly reproducible manner, a fairly cost-effective, direct, and easy way to set visually perceptible scale items on the glass cartridge is provided.
[0042] According to a further embodiment, the sensor, in particular its planar flexible foil, is adhesively attached to the cartridge. As the foil is wound around the tubular cartridge, an adhesive for adhering the sensor and the cartridge can be provided on the radially inward-facing side of the foil.
[0043] The adhesive can be located on the side of the foil opposite to the first and second measuring electrodes. In this configuration, when the foil is wound around the cartridge, the measuring electrodes are located on the outward-facing side of the foil facing radially outward. Alternatively, it is conceivable that the measuring electrodes are located on the inward-facing portion of the wound foil. The adhesive can then be located longitudinally and / or circumferentially between the measuring electrodes. It is also conceivable that when the sensor is wound around the cartridge, the adhesive is located radially between the outer periphery of the cartridge body and the measuring electrodes of the sensor.
[0044] According to another embodiment, when the sensor is wound around the tubular cartridge, the sensor's contact electrodes are located on the outward-facing side of the foil. In this way, the contact electrodes can be easily accessed from the outside of the cartridge to establish electrical connections between the first and second measuring electrodes and at least the power supply, processor, and / or transceiver of the sensor assembly.
[0045] According to another aspect, the invention further relates to a drug delivery device for administering a dose of liquid medicine. The drug delivery device includes a housing containing a cartridge as described above, wherein the cartridge is filled with liquid medicine and includes a piston slidably housed within the cartridge. The drug delivery device further includes a drive mechanism, typically having a piston rod or plunger, to apply a distally directed driving force to the piston of the cartridge for discharging a dose of liquid medicine via a distally positioned outlet of the cartridge. The outlet of the cartridge can be connected to a puncture component, typically including a double-ended injection needle through which a fluid delivery channel within the cartridge is provided, allowing the drug discharged from the cartridge to be directly injected into biological tissue.
[0046] Typically, drug delivery devices are configured as injection devices, such as pen syringes, which provide individual and variable settings for variable and user-configurable drug doses and subsequent dispensing.
[0047] Furthermore, the drug delivery device includes a power supply that is electrically connected to the first and second contact electrodes of the sensor when the sensor connected to the cartridge is located within the drug delivery device. The drug delivery device further includes a processor connected to the power supply. The processor is configured to acquire and process electrical signals available from the sensor when the sensor makes electrical contact with the power supply to supply power. For example, the processor, configured as a microcontroller, includes a memory or storage device for storing a series of measurement data. Additionally, the processor is typically programmable to automatically execute various measurement programs, such as according to a predetermined schedule. For example, the processor can be programmed to perform and initiate temperature and / or contents measurements of the cartridge at fixed time intervals (e.g., several times a day, e.g., every two hours). In this way, environmental parameters, such as the temperature to which the cartridge is exposed, can be continuously monitored.
[0048] Additionally, the drug delivery device also includes a transceiver connected to the processor. The transceiver is configured for wireless communication with external devices such as computers, tablets, mobile phones, smartphones, or smartwatches or similar personal electronic devices. The transceiver can be implemented as a radio frequency (RF) repeater to communicate with external electronic devices via standardized communication protocols such as Bluetooth, Wi-Fi, or NFC. Alternatively, the transceiver can be implemented as an optical transmitter, operating, for example, in the infrared spectrum. In this configuration, the transceiver may include an IRDA interface. The arrangement of the transceiver and processor can constitute or form an active RFID chip or active RFID tag powered by an electrical supply.
[0049] According to another embodiment, the housing of the drug delivery device includes a cartridge holder in which a cartridge is assembled. When implemented as a reusable device, the housing of the drug delivery device typically includes a proximal body detachably connected to a distal cartridge holder. The cartridge can be assembled inside the cartridge holder by releasing or removing the cartridge holder and the body. Since the drug contained in the cartridge has been fully dispensed, the cartridge can be replaced with a new cartridge. For this purpose, the cartridge holder can be released or removed from the housing.
[0050] After replacing an empty cartridge with a new one from the proximal end of the cartridge holder, the cartridge holder can be reinstalled or reassembled to the housing body. Furthermore, according to a further embodiment, the drug delivery device is configured as a disposable device. Here, the cartridge for connecting the sensor is readily and initially arranged inside the cartridge holder, which is non-removably and therefore permanently connected to the housing body. In the context of this application, a non-removable connection means a connection that cannot be separated except by force and by compromising the integrity of at least one of the cartridge holder and the housing of the drug delivery device.
[0051] When implemented as a disposable device, it is particularly advantageous that the electronic components of the sensor assembly, and therefore the processor, power supply, and transceiver, are housed in a separate accessory unit, which is detachably connected to the housing of the drug delivery device. In this way, the sensor assembly can be reused on demand and connected to a variety of disposable drug delivery devices.
[0052] In another embodiment, the transceiver and processor are configured as passive RFID chips or passive RFID tags. Here, the transceiver is operable and configured to be withdrawable and to draw power from a nearby RF field to power the processor and / or electrodes for measuring and / or processing measurement data obtained from the contact electrodes and / or transmitting the measured or processed data to another electronic device.
[0053] In practice, the sensor component can be implemented as a hybrid active and passive RFID NFC component. It can be continuously powered by an electrical supply, for example, for periodically storing data at predetermined time intervals, and is independent of the presence of an adjacent RF field. Furthermore, the sensor component can be configured to acquire and extract electrical energy via a transceiver when exposed to an RF field provided and generated by an external electronic device such as a smartphone. This passive behavior can be particularly useful for saving energy and optimizing device power management. Battery life can be extended in this way.
[0054] This is particularly advantageous when the processor and transceiver are configured to default to passive mode and operate for as long as possible based on power derived from the applied RF field. In the absence of a suitable RF field, the processor can perform or trigger measurement programs based on power derived from a power supply, such as a battery. It is also conceivable that a power supply, and thus a battery, continuously powers the processor, for example, to monitor the status or dosage history of cartridges or syringes. The processor and transceiver then only communicate wirelessly with external electronic devices when additional power is drawn from the RF field. This approach is highly energy efficient, thereby extending battery life.
[0055] According to a further embodiment, the drug delivery device also includes at least one operating element electrically connected to a processor or transceiver to initiate sensor-based measurements or communication with external electronics via the transceiver. The operating element is user-actuable. It may include user-actuable buttons or dials to trigger measurements or communication, such as data exchange with external electronic equipment. Alternatively or concurrently, the operating element may also be software implemented in the external electronic equipment. Once a communication link is established between the external electronic equipment and the processor of the sensor assembly, the operating element can be presented as a user-selectable menu item, for example, on the display of the external electronic equipment.
[0056] With the aid of an operating element, manual and user-actuable measurements of at least one physical or chemical parameter of a cartridge, particularly of the liquid substance contained therein, can be triggered and initiated as needed.
[0057] According to another embodiment, the power supply device includes a chamber housing a battery and first and second contact elements, each electrically connected to the battery. The first and second contact elements further extend through a through-hole in the housing to electrically connect to first and second contact electrodes of a sensor, respectively. Typically, the chamber can be accessed from the outside via a removable or detachable closure. Opening or removing the closure provides access to the interior of the chamber. In this way, an empty battery can be exchanged for or replaced with a new battery. Alternatively or additionally, the battery can be a rechargeable battery, and the power supply may be further equipped with solar cells or other types of charging devices to accumulate, generate, and store electrical energy in the battery.
[0058] In a further embodiment, the chamber is integrated into a cartridge holder within a protective cap that detachably covers at least the distal end of the cartridge holder, or the chamber is integrated into an accessory detachably connected to the housing. Typically, the accessory may include at least one fastening clip via which the accessory is detachably connected to a specific portion of the housing of the drug delivery device. The accessory may be connected to the housing body of the drug delivery device. Here, the accessory may extend toward and radially overlap the cartridge holder of the housing of the drug delivery device. Thus, when the chamber is integrated into the cartridge holder or into the accessory, the cartridge holder includes a through-opening in a sidewall portion, thereby providing electrical contact between the first and second contact electrodes of a sensor connected to the cartridge and the first and second contact elements of a power supply.
[0059] In an alternative embodiment, the chamber is integrated into a protective cap that detachably covers at least the distal end of the cartridge holder. Here, both the protective cap and the cartridge holder include through openings through which electrical contacts can be established between first and second power supply contact elements and first and second contact electrodes of the sensor, respectively.
[0060] As used in this application, the term 'sensor assembly' defines a system comprising a sensor having measuring electrodes and contact electrodes, a power supply, a processor, and a transceiver. When a cartridge equipped with the sensor is assembled inside a drug delivery device, the operation and completion of the sensor assembly are achieved, thereby establishing electrical contact between the first and second contact electrodes and the power supply.
[0061] Typically, at least a planar flexible foil is assembled and permanently fixed to the cartridge along with the first and second measuring electrodes and at least the first and second contact electrodes, while other electronic components of the sensor assembly are assembled in the drug delivery device, or wherein such electronic components are connected to the drug delivery device. In this way, the sensor assembly can be disassembled and separated from the various components of the drug delivery device, namely the housing of the drug delivery device and the replaceable or replaceable cartridge.
[0062] The sensor and its planar flexible foil can be implemented as a tag that, in addition to measuring at least one physical or chemical parameter of the cartridge, can operatively mark or distinguish the cartridge from other identical cartridges. Since the power supply is integrated into the drug delivery device, it is not necessary to provide power to the tag itself. In this way, the tag can be kept small, requiring minimal space. Driving the sensor with a power supply located remotely from the sensor allows for relatively complex and multifunctional sensor implementations.
[0063] A remote power supply (e.g., including a battery) provides and enables sensor functions, such as creating dose history that can be stored in a processor or in a separate recording unit connected to the processor. The captured or recorded dose history can be transmitted to an external electronic device, such as a smartphone or computer, via a transceiver from the sensor assembly, if needed.
[0064] Generally, it is mentioned that the sensor can not only determine the fill level of the cartridge, but its electrodes can also be configured to perform light transmission measurements to check for turbidity, aggregate formation, or the mixing state of the lyophilized material contained inside the cartridge. In this embodiment, it is conceivable that at least one of the first and second measuring electrodes includes a photodetector, while the other of the first and second electrodes is implemented as a light transmission device.
[0065] By arranging the power supply and transceiver within or on the drug delivery device, the power supply and transceiver can be reusable, while the sensor connected to the cartridge can be disposable. By establishing electrical contact between the power supply and the sensor on components of the cartridge within the drug delivery device, the processor can be permanently or frequently powered as long as the cartridge is inside the drug delivery device. In this way, the processor and sensor can operate throughout the cartridge's entire lifespan to permanently collect and permanently or frequently capture or store cartridge-related data. This data can include the cartridge's dosage history and temperature history. Wireless transmission of the collected data can be performed upon external request or periodically according to a predefined schedule, for example, by storing it in the processor.
[0066] As used in this application, the terms "drug" or "pharmaceutical preparation" refer to a pharmaceutical formulation containing at least one pharmaceutically active compound.
[0067] In one embodiment, the pharmaceutically active compound has a molecular weight of up to 1500 Da and / or is a peptide, protein, polysaccharide, vaccine, DNA, RNA, enzyme, antibody or fragment thereof, hormone or oligonucleotide, or a mixture of the above pharmaceutically active compounds.
[0068] In one further embodiment, the pharmaceutically active compound can be used to treat and / or prevent diabetes or diabetes-related complications, such as diabetic retinopathy, thromboembolic diseases such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis.
[0069] In one further embodiment, the pharmaceutically active compound comprises at least one peptide for treating and / or preventing diabetes or diabetes-related complications, such as diabetic retinopathy.
[0070] In one further embodiment, the pharmaceutically active compound comprises at least one human insulin or human insulin analog or derivative, glucagon-like peptide-1 (GLP-1) or its analog or derivative, or sarcoptide exopeptide-3 or sarcoptide exopeptide-4 or sarcoptide exopeptide-4 analog or derivative.
[0071] Insulin analogs include, for example, Gly(A21), Arg(B31), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala, and at position B29, Lys can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.
[0072] Insulin derivatives include, for example, B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl-LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; and B30-N-myristoyl-ThrB2 9LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin; B29-N-(N-fucochoyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.
[0073] For example, scorpion exopeptide-4 refers to scorpion exopeptide-4(1-39), which is a peptide with the following sequence: H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.
[0074] Venomous lizard exopeptide-4 derivatives are selected from the following compounds:
[0075] H-(Lys)4-desPro36,desPro37 venomous lizard exopeptide-4(1-39)-NH2,
[0076] H-(Lys)5-desPro36,desPro37 venomous lizard exopeptide-4(1-39)-NH2,
[0077] des Pro36 Venomous Lizard Exopeptide-4(1-39),
[0078] des Pro36[Asp28] Venomous Lizard Exopeptide-4(1-39),
[0079] des Pro36[IsoAsp28] Venomous Lizard Exopeptide-4(1-39),
[0080] des Pro36[Met(O)14,Asp28]exotropic peptide-4(1-39),
[0081] des Pro36[Met(O)14,IsoAsp28]exotropic peptide-4(1-39),
[0082] des Pro36[Trp(O2)25,Asp28]exotropic peptide-4(1-39),
[0083] des Pro36[Trp(O2)25,IsoAsp28]exotropic peptide-4(1-39),
[0084] des Pro36[Met(O)14Trp(O2)25,Asp28] scorpion exopeptide-4(1-39),
[0085] des Pro36[Met(O)14Trp(O2)25,IsoAsp28] lizard exopeptide-4(1-39); or
[0086] des Pro36[Asp28] Venomous Lizard Exopeptide-4(1-39),
[0087] des Pro36[IsoAsp28] Venomous Lizard Exopeptide-4(1-39),
[0088] des Pro36[Met(O)14,Asp28]exotropic peptide-4(1-39),
[0089] des Pro36[Met(O)14,IsoAsp28]exotropic peptide-4(1-39),
[0090] des Pro36[Trp(O2)25,Asp28]exotropic peptide-4(1-39),
[0091] des Pro36[Trp(O2)25,IsoAsp28]exotropic peptide-4(1-39),
[0092] des Pro36[Met(O)14Trp(O2)25,Asp28] scorpion exopeptide-4(1-39),
[0093] des Pro36[Met(O)14Trp(O2)25,IsoAsp28] Lizard Exopeptide-4(1-39),
[0094] Among them, group-Lys6-NH2 can bind to the C-terminus of the sarcophagus exopeptide-4 derivative;
[0095] Or a venomous lizard exopeptide-4 derivative with the following sequence
[0096] des Pro36 venomous lizard exopeptide-4(1-39)-Lys6-NH2(AVE0010),
[0097] H-(Lys)6-desPro36[Asp28]exotropic peptide-4(1-39)-Lys6-NH2,
[0098] des Asp28 Pro36,Pro37,Pro38 Venomous Lizard Exopeptide-4(1-39)-NH2,
[0099] H-(Lys)6-des Pro36,Pro38[Asp28]exotropic peptide-4(1-39)-NH2,
[0100] H-Asn-(Glu)5des Pro36,Pro37,Pro38[Asp28]exotropic peptide-4(1-39)-NH2,
[0101] des Pro36,Pro37,Pro38[Asp28] Venomous Lizard Exopeptide-4(1-39)-(Lys)6-NH2,
[0102] H-(Lys)6-des Pro36,Pro37,Pro38[Asp28] Venomous Lizard Exopeptide-4(1-39)-(Lys)6-NH2,
[0103] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2,
[0104] H-(Lys)6-desPro36[Trp(O2)25,Asp28]exotropic peptide-4(1-39)-Lys6-NH2,
[0105] H-des Asp28 Pro36,Pro37,Pro38[Trp(O2)25]exotropic peptide-4(1-39)-NH2,
[0106] H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]exotropic peptide-4(1-39)-NH2,
[0107] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]exotropic peptide-4(1-39)-NH2,
[0108] des Pro36,Pro37,Pro38[Trp(O2)25,Asp28] Venomous Lizard Exopeptide-4(1-39)-(Lys)6-NH2,
[0109] H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2,
[0110] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2,
[0111] H-(Lys)6-desPro36[Met(O)14,Asp28]exotropic peptide-4(1-39)-Lys6-NH2,
[0112] des Met(O)14Asp28 Pro36,Pro37,Pro38 Venomous Lizard Exopeptide-4(1-39)-NH2,
[0113] H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Asp28]exotropic peptide-4(1-39)-NH2,
[0114] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Asp28]exotropic peptide-4(1-39)-NH2,
[0115] des Pro36,Pro37,Pro38[Met(O)14,Asp28] venomous lizard exopeptide-4(1-39)-(Lys)6-NH2,
[0116] H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2,
[0117] H-Asn-(Glu)5des Pro36,Pro37,Pro38[Met(O)14,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2,
[0118] H-Lys6-des Pro36[Met(O)14,Trp(O2)25,Asp28]exotropic peptide-4(1-39)-Lys6-NH2,
[0119] H-des Asp28 Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25]exotropic peptide-4(1-39)-NH2,
[0120] H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Asp28]exotropic peptide-4(1-39)-NH2,
[0121] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]exotropic peptide-4(1-39)-NH2,
[0122] des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2,
[0123] H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]exotropic peptide-4(S1-39)-(Lys)6-NH2,
[0124] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2;
[0125] Or a pharmaceutically acceptable salt or solvate of any of the aforementioned lizard exopeptide-4 derivatives.
[0126] Hormones are, for example, pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, as listed in Chapter 50 of Rote Liste, 2008, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, fertility-stimulating hormone), somatropin (growth hormone), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.
[0127] The polysaccharide is, for example, glucosamine, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or a sulfated form, such as a polysulfated form of the above polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium.
[0128] Antibodies are globular plasma proteins (~150 kDa), also known as immunoglobulins with a basic structure. They are glycoproteins because they have sugar chains added to amino acid residues. The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit); secreted antibodies can also be dimers with two Ig units, such as IgA, tetramers with four Ig units such as bony fish IgM, or pentamers with five Ig units such as mammalian IgM.
[0129] Ig monomers are Y-shaped molecules composed of four polypeptide chains; two identical heavy chains and two identical light chains are linked by disulfide bonds between cysteine residues. Each heavy chain is approximately 440 amino acids long; each light chain is approximately 220 amino acids long. Both the heavy and light chains contain intrachain disulfide bonds that stabilize their folding. Each chain consists of domains called Ig domains. These domains contain approximately 70–110 amino acids and are categorized into different classes (e.g., variable or V, constant or C) based on their size and function. They exhibit the characteristic immunoglobulin folding, where two β-sheets create a “sandwich” shape, held together by interactions between conserved cysteine residues and other charged amino acids.
[0130] There are five types of mammalian Ig heavy chains, denoted by α, δ, ε, γ, and μ. The current heavy chain types define antibody isotypes; these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.
[0131] Different heavy chains differ in size and composition; α and γ contain approximately 450 amino acids and δ contain approximately 500 amino acids, while μ and ε contain approximately 550 amino acids. Each heavy chain has two regions, a constant region (C... H) and variable region (V H Within a species, the constant region is substantially the same across all antibodies of the same isotype, but differs across antibodies of different isotypes. Heavy chains γ, α, and δ have a constant region consisting of three tandem Ig domains and a hinge region for increased flexibility; heavy chains μ and ε have a constant region consisting of four immunoglobulin domains. The variable region of the heavy chain differs among antibodies produced by different B cells, but is identical for all antibodies produced by a single B cell or a B cell clone. The variable region of each heavy chain is approximately 110 amino acids long and consists of a single Ig domain.
[0132] In mammals, there are two types of immunoglobulin light chains, denoted by λ and κ. The light chain has two continuous domains: a constant domain (CL) and a variable domain (VL). The approximate length of the light chain is 211 to 217 amino acids. Each antibody contains two identical light chains; in mammals, each antibody possesses only one type of light chain, either κ or λ.
[0133] Although the general structures of all antibodies are very similar, as mentioned above, the unique properties of a given antibody are determined by variable (V) regions. More specifically, variable loops, three each of the light chain (VL) and heavy chain (VH), are responsible for binding the antigen, i.e., antigen specificity. These loops are called complementarity-determining regions (CDRs). Because the CDRs from the VH and VL domains contribute to the antigen-binding site, it is the combination of the heavy and light chains, rather than either the heavy or light chain alone, that determines the final antigen specificity.
[0134] The “antibody fragment” contains at least one antigen-binding fragment as defined above and exhibits substantially the same function and specificity as the intact antibody from which the fragment originates. Restrictive proteolytic digestion with papain cleaves the Ig prototype into three fragments. Two identical N-terminal fragments are antigen-binding fragments (Fab), each containing a complete L chain and approximately half of the H chain. The third fragment is a crystallizable fragment (Fc), similar in size but containing carboxyl-termini of two heavy chains linked by interchain disulfide bonds. Fc contains carbohydrate, complement-binding, and FcR binding sites. Restrictive pepsin digestion yields a single F(ab')2 fragment containing the Fab fragment and a hinge region comprising the HH interchain disulfide bonds. F(ab')2 is divalent for antigen binding. The disulfide bonds of F(ab')2 can be cleaved to obtain Fab'. Furthermore, the variable regions of the heavy and light chains can fuse together to form a single-chain variable fragment (scFv).
[0135] Pharmaceutically acceptable salts include, for example, acid addition salts and basic salts. Acid addition salts include, for example, HCl or HBr salts. Basic salts include, for example, salts containing a cation selected from alkali metals or alkaline earth metals, such as Na. + 、or K+ , or Ca 2+ or ammonium ion N + (R1)(R2)(R3)(R4), where R1 to R4 independently refer to: hydrogen, optionally substituted C1-C6 alkyl, optionally substituted C2-C6 alkenyl, optionally substituted C6-C10 aryl, or optionally substituted C6-C10 heteroaryl. Further examples of pharmaceutically acceptable salts are described in: "Remington's Pharmaceutical Sciences," 17th edition, edited by Alfonso R. Gennaro, Mark Publishing Company, Easton, Pa., USA, 1985, and Encyclopedia of Pharmaceutical Technology.
[0136] Pharmaceutically acceptable solvates are, for example, hydrates.
[0137] It will further become apparent to those skilled in the art that various modifications and variations can be made to the invention without departing from the spirit and scope of the invention as defined by the claims. Furthermore, it should be noted that any reference numerals used in the appended claims should not be construed as limiting the scope of the invention.
[0138] Specifically, the present invention includes, but is not limited to, the following:
[0139] 1. A sensor for measuring at least one physical or chemical parameter of a cartridge (10) or syringe filled with a liquid substance, said sensor comprising:
[0140] - A planar flexible foil (101), which can be arranged on the outer periphery of the cartridge (10) or the syringe barrel (11),
[0141] - At least first and second measuring electrodes (102, 104), said at least first and second measuring electrodes (102, 104) are arranged on the foil (101), and
[0142] - At least first and second contact electrodes (106, 108), said at least first and second contact electrodes (106, 108) are arranged on the foil (101),
[0143] - wherein the first contact electrode (106) is connected to the first measuring electrode (102), and the second contact electrode (108) is connected to the second measuring electrode (104).
[0144] 2. The sensor according to item 1, wherein the first and second contact electrodes (106, 108) are arranged at the longitudinal end (103) of the foil (101).
[0145] 3. The sensor according to item 1 or 2, wherein the first and second contact electrodes (106, 108) are separated in the longitudinal direction (z) and extend substantially parallel in the transverse or circumferential direction (u).
[0146] 4. The sensor according to any one of the preceding items, wherein the first and second electrodes (106, 108) extend across almost the entire lateral dimension of the foil (101).
[0147] 5. The sensor according to any one of the preceding claims, wherein the foil is substantially transparent, and wherein at least one of the first and second measuring electrodes (102, 104) or at least one of the first and second contact electrodes (106, 108) comprises a conductive structure printed or coated on or within the foil (101).
[0148] 6. The sensor according to any one of the preceding items, wherein the first and second measuring electrodes (102, 104) and the first and second contact electrodes (106, 108) are located on a common side (101b) of the foil (101) or on opposite sides (101a, 101b) of the foil (101).
[0149] 7. A cartridge comprising a tubular body (11) filled with a liquid substance, and comprising a sensor (100; 300) according to any one of the preceding items, said sensor (100; 300) being wound around the outer periphery of the sidewall (12) of the body (11).
[0150] 8. The cartridge according to item 7, wherein the sensor (100; 300) is bonded to the body (11) of the cartridge (10).
[0151] 9. The cartridge according to item 7 or 8, wherein the contact electrodes (106, 108) of the sensor (100; 300) are located on the outward-facing side of the foil (101).
[0152] 10. A drug delivery device for administering a measured dose of a liquid drug, comprising:
[0153] - A housing (4) for receiving a cartridge (10) according to any one of items 7 to 9 above, wherein the cartridge (10) is filled with the liquid medicine and includes a piston (14) slidably received in the cylinder (11).
[0154] - A drive mechanism (5) for applying a distal driving force to the piston (14) to displace a dose of the liquid agent.
[0155] - A power supply (36; 66; 76), which is electrically connected to the first and second contact electrodes (106; 108) of the sensor (100; 300).
[0156] - A processor (110), the processor (110) being connected to the power supply (36; 66; 76), and
[0157] - Transceiver (120), which is connected to the processor (110).
[0158] 11. The drug delivery device according to item 10, wherein the housing (4) includes a cartridge holder (30; 40) therein in which the cartridge (10) is assembled.
[0159] 12. The drug delivery device according to item 10 or 11, wherein the transceiver (120) is operable or configured to be withdrawn, and to obtain electrical power from an external RF field and to supply electrical power at least to the processor (110).
[0160] 13. The drug delivery device according to any one of claims 10 to 12, further comprising at least one operating element (112) electrically connected to at least one of the power supply (36; 66; 76), the processor (110), and the transceiver (120) to initiate sensor-based measurements or to initiate communication with an external electronic device (200) via the transceiver (120).
[0161] 14. The drug delivery device according to any one of items 10 to 13 above, wherein the power supply (36; 66; 76) comprises a chamber (37; 67; 77) that houses a battery (130) and first and second contact electrodes (132, 134) electrically connected to the battery (130), and extends through an opening (37; 69, 79) in the housing (4) to be electrically connected to the first and second contact electrodes (102, 104) of the sensor (100; 300), respectively.
[0162] 15. The drug delivery device according to any one of items 10 to 14 above, wherein the chamber (37; 67; 77) is integrated into a cartridge holder (30) in a protective cap (60) or an accessory (70), the protective cap (60) being detachably covering at least the distal end of the cartridge holder (40), the accessory (70) being detachably connected to the housing (4). Attached Figure Description
[0163] The embodiments of the display device, drive mechanism, and drug delivery device are described in detail below with reference to the accompanying drawings, wherein:
[0164] Figure 1 This schematically illustrates one implementation of the drug delivery device as a pen-type syringe.
[0165] Figure 2 The cartridge and the sensor to be connected are shown schematically.
[0166] Figure 3 For separate description of the sensor,
[0167] Figure 4 An enlarged view of the longitudinal end of the sensor is shown.
[0168] Figure 5 Showing according to Figure 1 An exploded view of a drug delivery device.
[0169] Figure 6 The diagram shows the basis for the partial cutting off of the distal housing portion. Figure 1 The device,
[0170] Figure 7 yes Figure 6 A magnified image of a portion.
[0171] Figure 8 By according to Figure 1 Longitudinal cross-sectional view of the device,
[0172] Figure 9 It is based on Figure 8 An enlarged view of the middle section.
[0173] Figure 10 Another implementation of the sensor is shown.
[0174] Figure 11 This illustrates an alternative method for connecting the sensor to the cartridge.
[0175] Figure 12 This is a separate perspective view of a cartridge equipped with a sensor wrapped around its perimeter.
[0176] Figure 13 An exploded perspective view showing another embodiment of the drug delivery device is shown.
[0177] Figure 14 The diagram shows the basis for the partial cutting off of the distal housing component. Figure 13 Drug delivery device,
[0178] Figure 15 yesFigure 14 A magnified image of a portion.
[0179] Figure 16 By according to Figure 14 The longitudinal cross-sectional view of the device, and
[0180] Figure 17 yes Figure 16 A magnified view of the distal portion.
[0181] Figure 18 Another embodiment of the drug delivery device equipped with auxiliary devices is shown.
[0182] Figure 19 Showing according to Figure 18 An exploded view of a drug delivery device.
[0183] Figure 20 The basis for showing a chamber with an opening Figure 18 Drug delivery device,
[0184] Figure 21 The basis for showing that the auxiliary device is separated from the main body of the drug delivery device is illustrated. Figure 18 The device,
[0185] Figure 22 The diagram shows that the distal housing portion of the device has been partially cut off. Figure 18 The device,
[0186] Figure 23 yes Figure 22 A magnified image of a portion.
[0187] Figure 24 Shown by according to Figure 22 The longitudinal section of the device, and
[0188] Figure 25 It is based on Figure 24 An enlarged view of the aforementioned portion. Detailed Implementation
[0189] For example Figure 1 The drug delivery device 1 shown is implemented as a pen-type syringe. The drug delivery device 1 is a handheld drug delivery device. It includes a housing 4, which comprises various components. (Example...) Figure 5 As shown, the housing 4 actually includes or contains a cartridge holder 30 and a body 20. Both the cartridge holder 30 and the body 20 are generally tubular. As shown in the figures, the proximal end of the cartridge holder 30 can be connected to the distal end of the body 20. The cartridge holder 30 includes a window 31 located in the sidewall to allow visual inspection of the cartridge 10 assembled therein.
[0190] The cartridge holder 30 includes a threaded socket 32 at its distal end. The cartridge holder 30 further includes a through opening 33 on its distal surface, through which the proximal tip of a double-pointed injection needle extends to pierce the distal seal 13 of the cartridge 10. Figure 5 In this context, the proximal direction is denoted as P, and the distal direction as D. For example... Figure 2 The illustrated cartridge 10 includes a tubular tube 11 having tubular sidewalls 12 that extend in a distal direction D into a stepped neck portion 15. A punctureable seal 13 is provided at the distal end of the stepped neck portion 15, typically implemented as a punctureable diaphragm.
[0191] The proximal end of cartridge 10 is sealed by piston 14, such as Figure 8 As shown. The piston 14 frictionally engages with the inward portion of the side wall 12 of the cartridge body 11. The piston 14 is slidably accommodated within the cartridge body 11. When assembled inside the cartridge holder 30, the glass tube 11 of the cartridge 10 can be visually inspected through the window 31 of the cartridge holder 30. The cartridge 10 is axially fixed or axially fastened inside the cartridge holder 30, and its axial abutment is achieved by the radially narrowed neck 15 against a correspondingly shaped reduced-diameter socket 32 of the cartridge holder 30. The threaded socket 32 can be threadedly engaged with a correspondingly threaded needle seat, which is releasably and detachably connected to the cartridge holder 30 for dispensing a dose of the drug 16 located inside the cartridge.
[0192] Since the cartridge 10 is arranged and fixed inside the cartridge holder 30, when the cartridge holder 30 is connected to the body 20, the drive mechanism 5 of the drug delivery device 1 located inside the body 20 can be operated to apply a directional thrust to the piston 14, so that a specific dose of liquid substance or drug 16 can be discharged from the cartridge 10 through an injection needle or puncture component that is in fluid communication with the inside of the cartridge 10.
[0193] Typically, the drive mechanism 5 includes at least one piston rod that advances in a distal direction D. The drive mechanism 5 can be implemented in many different ways. It can be implemented entirely mechanically, such that the driving force acting on the piston 14 is provided, for example, by the user's thumb actually pressing down on a proximal dispensing button 21 located on the proximal end face of the body 20. Alternatively, a dose dial 22 can be provided, by which the user can individually set a variable dose. Furthermore, the drive mechanism 5 typically includes a dose indication window through which a rotatable dose indicator scale can be viewed.
[0194] Other embodiments of the drive mechanism 5 may include assisted dispensing. Here, the driving force for advancing the piston rod in the distal direction D may be provided or supported by a mechanical energy storage device (e.g., a spring), which may be pre-tensioned during the final assembly of the drug delivery device 1. It is also conceivable that, during dosage setting, the mechanical energy storage device implies repeated biasing, much like a spring. In this case, actuating the dosage dial 22 is used to bias or compress the dispensing spring. Other embodiments of the drive mechanism 5 may include electromechanical devices, such as electric actuators, operable to assist or aid the forward movement of the piston rod. Alternatively, the dispensing force acting on the piston or the corresponding piston rod may be provided entirely by the corresponding electric actuator.
[0195] from Figure 2 and 5 Obviously, a sensor 100 is provided having a planar flexible foil 110 that can be wound around the outer periphery of the cartridge 10's body 11. The sensor 100 is part of a sensor assembly 140 for measuring at least one physical or chemical parameter of the cartridge 10. Typically, the sensor 100 is implemented as a fill level sensor to measure the fill level of the cartridge by determining and measuring the actual axial position of the piston 14 inside the cartridge 10. Alternatively or alternatively, the sensor 100 is implemented as a temperature sensor.
[0196] The sensor 100 includes at least first and second measuring electrodes 102, 104. The measuring electrodes 102, 104 extend generally parallel along the longitudinal direction (z). They are separated along the circumferential direction (u) by a predetermined distance corresponding to the circumference of the sidewall 12 of the cartridge 10. Typically, the lateral or circumferential distance between the parallel-oriented first and second measuring electrodes 102, 104 is selected such that when the sensor 100 is wound around the tubular portion of the sidewall 12 of the cartridge 10, the first and second measuring electrodes 102, 104 are radially opposite to each other on the outer circumference of the sidewall 12 of the cartridge 10.
[0197] In this manner, the cartridge 10 and the liquid substance 16 therein are slightly sandwiched between the first and second measuring electrodes 102, 104. The planar flexible foil 101 is generally transparent. It is also conceivable that the first and second measuring electrodes 102, 104 are substantially transparent. In this way, visual inspection of the vitreous transparent cartridge 10 is not obstructed when the sensor 100 is wrapped around it. In addition to at least the first and second measuring electrodes 102, 104, the sensor 100 also includes first and second contact electrodes 106, 108, which are also arranged on the planar flexible foil 101.
[0198] like Figure 4As shown in detail, the first and second contact electrodes extend substantially perpendicular to the first and second measuring electrodes 102, 104. Furthermore, the first and second contact electrodes 106, 108 extend along the longitudinal end 103 of the planar flexible foil 101. The first and second contact electrodes 106, 108 are practically separated by a small axial gap. Additionally, the first and second contact electrodes 106, 108 comprise a longitudinally linear extension. When the sensor 100 is wound around the outer periphery of the sidewall 12 of the cartridge 11, the first contact electrode 106 and the second contact electrode 108 form a substantially closed annular structure. This annular structure allows the cartridge 10 to be rotated invariably within the cartridge holder 30 while ensuring electrical contact with the power supply 36, for example... Figure 5 , 7 Or as shown in 9.
[0199] A planar flexible foil 101 can be adhered to the outer periphery of the sidewall 12 of the cartridge 10. When attached to the cartridge 10, the first and second contact electrodes 106, 108 are located on the outer side 101b of the foil 101, thereby providing electrical contact from outside the sensor 100. Measuring electrodes 102, 104 may be located on the same side as the contact electrodes 106, 108. Alternatively, it is conceivable that at least the first and second measuring electrodes 102, 104 are located on the inner side 101a of the foil 101. In this embodiment, the measuring electrodes 102, 104 will have direct mechanical contact with the outer periphery of the sidewall 12 of the cartridge 10.
[0200] When the contact electrodes 106, 108 and the measuring electrodes 102, 104 are located on the common side 101b of the foil 101, the manufacture and production of the sensor 100 can be carried out in a fairly simple and cost-effective manner. For example, all conductive structures such as the first and second measuring electrodes 102, 104 and the first and second touch electrodes 106, 108, as well as the various conductors 105 extending therebetween, can be printed or coated onto the planar flexible foil 101 in a single step.
[0201] Sensor 100 is a component of sensor assembly 140. Sensor assembly 140 includes sensor 100, power supply 36, processor 110, and transceiver 120. In all embodiments shown in the various figures, sensor 100 includes only first and second measuring electrodes 102, 104, and at least first and second contact electrodes 106, 108. All remaining components of sensor assembly 140 are located and arranged within the housing 4 of drug delivery device 1. In some embodiments, the remaining components of sensor assembly 140 are connected to or can be connected to the housing 4 of drug delivery device 1. The remaining components may be arranged inside or near accessory device 70, which can be accessed via, for example... Figure 18 and 19 The fastening clip 72 shown is fixed to the housing 4 of the drug delivery device 1.
[0202] At least the power supply 36 is located on or within the housing 4 of the drug delivery device 1. Typically, the power supply 36 includes at least one battery 130, currently illustrated as a button cell battery.
[0203] When the cartridge 10 equipped with sensor 100 is correctly assembled inside the drug delivery device 1, particularly inside the cartridge holder 30, the sensor assembly 140 is completed and becomes operable. The power supply 36 is then electrically connected to the sensor 100. At least two contact elements 132, 134 disposed in or on the housing 4 of the drug delivery device 1 extend through the through opening 39 of the housing 4, making direct electrical contact with contact electrodes 106, 108 on the outer periphery of the cartridge 10, for example... Figure 7 As shown. Here, the contact element 134, implemented as a contact spring, extends through the through opening 39 in the side wall of the cartridge holder 30, and makes direct mechanical and electrical contact with the first contact electrode 106.
[0204] The additional contact element 132 will make corresponding electrical contact with the second contact electrode 108. Since the first and second contact electrodes 106, 108 are separated along the axial or longitudinal direction (z), the radially inwardly projecting portions of the contact springs of the first and second contact elements 132, 134 will also be located at positions axially offset relative to each other. The axial positions of the contact elements 132, 134 directly match and correspond to the axial positions of the first and second contact electrodes 106, 108 on the outer periphery of the cartridge 10.
[0205] When the contact elements 132, 134 are in electrical contact with the battery 130, the sensor 100 can supply electrical energy when establishing the electrical contact between the contact elements 132, 134 and the corresponding contact electrodes 106, 108.
[0206] The sensor assembly 140 further includes a processor 110, wherein in this embodiment, the sensor 100 is located within or on the housing 4 of the drug delivery device 1. Additionally, the sensor assembly 140 includes a transceiver 120, which is located and arranged within or on the housing 4 of the drug delivery device 1. In this embodiment, the transceiver 120 is permanently connected to the processor 110 and optionally also permanently connected to the battery 130 of the power supply 36. This establishes electrical contact between the measuring electrodes 120, 104 and the processor 110 when the cartridge 10 is properly assembled inside the housing 4. The processor 110 may be permanently electrically connected to the transceiver and / or the battery 130.
[0207] In any case, since the battery 130 of the power supply 36 is located on or inside the housing 4, it is located away from the sensor 100. Therefore, the design of the sensor 100 can be simplified and a low-cost sensor can be implemented, while providing a large number of functions that could potentially be performed by the battery-powered processor 110.
[0208] like Figure 5 As further shown, the power supply 36 includes a chamber 37 located on the outer periphery of the proximal portion of the cartridge holder 30. The chamber 37 actually houses the battery 130, contact elements 132, 134, processor 110, and transceiver 120. The chamber 37 can be closed by a closure 38, implemented as a removable or pivotable cover. Upon user request, the closure 38 can be opened, providing access to the interior of the chamber 37. In this way, an empty battery 130 can be replaced with a new battery. The use of a separate chamber 37 for at least a portion of the electrical components of the sensor assembly 140 further allows for a wired interface to be provided on the outer periphery of the housing 4 of the drug delivery device 1.
[0209] Instead of the wireless transceiver 120, it is conceivable to provide a standardized wired connector through which wired data transmission can be established to the external electronic device 200. The sensor assembly 140 may be further equipped with, for example... Figure 1 The operating element 112 shown can be accessed from outside the drug delivery device 1. The operating element 112 can be electrically connected to the processor 110, transceiver 120, or battery 130, or can be permanently electrically connected to these components. Actuating the operating element 112 can trigger a measurement process performed by the processor 110 and / or a data transmission operated by the transceiver 120. Although not explicitly shown, the operating element 112 can also be implemented with drug delivery devices 2 and 3, such as... Figures 13 to 25 As shown.
[0210] Transceiver 120 is typically implemented as a wireless transceiver or transponder that is operable to exchange data and communicate with external electronic devices 200 such as mobile phones, smartphones, smartwatches, tablets, or any other type of computer or communication system.
[0211] For example Figure 2 and 3The sensor 100 shown is typically implemented as a capacitance measurement sensor. For this purpose, at least the first and second measuring electrodes 102, 104 extend almost along the entire longitudinal extension of the flexible foil 101. When wound around the cartridge 10, the capacitance measured between these two measuring electrodes 102, 104 depends on the axial position of the piston 14, which exhibits a different polarization or capacitance than that of the liquid substance 16 located inside the cartridge 10.
[0212] like Figure 10 An alternative embodiment of the sensor 300 shown is implemented as a temperature sensor. Here, the first measuring electrode 102 includes various heaters 102a, and the second measuring electrode 104 includes a plurality of thermistors 104a. Figure 10 As shown, various heaters 102a and thermistors 104a are arranged alternately in the longitudinal direction (z) to form an alternating array of heaters 102a and thermistors 104a in the longitudinal or axial direction. In this way, sensor 300 is implemented as a heat flow sensor. When connected to an electrical supply 36, the heaters 102a can selectively or simultaneously cause small but noticeable heating of corresponding portions of the sidewall 12 of the cartridge 10. This temperature change can be detected by the array of thermistors 104a. In this way, and due to the different thermal conductivity properties of the piston 14 and the liquid substance 16 contained therein, the longitudinal position of the piston 14 inside the cartridge 10 can also be determined by temperature measurement. Alternatively and additionally, the temperature level of the entire cartridge 10 exposed can be determined even without using a series of heaters 102a.
[0213] Figure 11 Another embodiment is shown where the sensor 100 is connected to the cartridge 10. Here, with Figure 2 In the opposite embodiment shown, the sensor 100 is flipped 180° so that the first and second contact electrodes 106, 108 are located near the distal end of the cartridge 10. This configuration of the sensor 100 and the cartridge 10 is specifically designed for... Figures 13-17 The embodiment of the drug delivery device 2 shown is provided. (Compared to...) Figure 5 Compared to the embodiment of the drug delivery device 1 shown, only the protective cap 50 of the housing 4 and the cartridge holder 30 are modified, while the remaining parts, especially the main body 20 of the drug delivery devices 1 and 2, remain unchanged.
[0214] from Figure 5 and 13 The drug delivery device 2 is clearly equipped with a protective cap 60 containing an electrical supply 66. For example... Figure 13 As shown, a chamber 67 is provided on the outer periphery near the distal end of the protective cap 60. The power supply 36 of the drug delivery device 1 is integrated with... Figures 13-17As shown in the drug delivery device 2, chamber 37 houses battery 130 and first and second contact elements 132, 134 extending through opening 69 through the sidewall of protective cap 60. Cartridge holder 40 also includes a window 41 on its sidewall. Window 41 extends longitudinally and spans almost the entire longitudinal extension of tubular cartridge holder 40.
[0215] Furthermore, the distal end of the cartridge holder 40 includes a threaded stepped socket 42, which, when assembled within the cartridge holder 40, serves as an axial abutment against the radially narrowed shoulder of the cartridge 10. Figure 14 and 15 As shown in detail, the cartridge holder 40 also includes a distal through-hole 43 through which the punctureable and distal seal 13 of the cartridge 10 can enter. For example... Figures 13-17 In the illustrated embodiment, the first and second contact electrodes 106, 108 of the sensor 100 can enter through the window 41 of the cartridge holder 40. For this purpose, the window 41 is configured as a recess in the sidewall of the cartridge holder 40.
[0216] Because the first and second contact electrodes 106, 108 form a nearly closed annular structure on the outer periphery of the sidewall 12 of the cartridge 10, the cartridge 10 can be arranged at any angle with respect to its longitudinal axis, which serves as the axis of rotation, inside the cartridge holder 40. In order to provide a defined electrical contact between the batteries 130, and therefore between the contact elements 132, 134 and the sensor 100, the protective cap 60 needs to be arranged in a defined orientation on the cartridge holder 40.
[0217] When the cartridge holder 40 and the protective cap 60 are equipped with at least one symmetrical breaking feature, as according to Figure 5 This is particularly advantageous, as shown in the embodiment of the drug delivery device 1. Here, the protective cap 50 includes a recess 51 at its proximal end for receiving a radially outwardly projecting chamber 37 located on the outer periphery of the proximal portion of the cartridge holder 30. Similar symmetry-breaking features are also implemented by the cartridge holder 40 and the protective cap 60 of the drug delivery device 2, as... Figures 13-17 As shown. Apart from this, the electrical contact through the through opening 69 between the first and second contact elements 132, 134 is substantially the same as that described in the drug delivery device 1.
[0218] With the help of the closure 68, the chamber 67 is closable or sealable. Therefore, the interior of the chamber 67 and the interior of the protective cap 60 can be effectively protected from environmental influences such as dust or humidity.
[0219] Figures 18-25 In a further embodiment of the drug delivery device 3 shown, a basic and... Figures 1-9The same cartridge holder 40 and the same protective cap 50 are described in the drug delivery device 1. Here, at least some of the electronic components of the sensor assembly 140, namely the battery 130, contact elements 132, 134, processor 110 and transceiver 120, are located in or on the accessory device 70, which is detachably connected to the outer periphery of the tubular body 20 of the drug delivery device 3.
[0220] The auxiliary device 70 serves as a power supply 76. It includes a chamber 77 to at least house the battery 130. In the illustrated embodiment, the chamber 77 also houses the processor 110, transceiver 120, and electrical contact elements 132, 134. The auxiliary device 70 includes a fastening clip 72 that provides forced engagement of the tubular body 20 of the drug delivery device 3 with the auxiliary device 70. In addition to the chamber 77, the auxiliary device 70 also includes a longitudinal extension 71 extending in a distal direction D. The contact elements 132, 134 are located at the distal end of the extension 71. Figure 21 As shown, the distal end of the accessory device 70 can be arranged radially overlappingly on the proximal portion of the cartridge holder 30.
[0221] like Figure 25 As shown, the cartridge holder 30 includes a through opening 39 near its distal end, through which radially inwardly extending contact elements 132, 134 of the accessory 70 extend to establish electrical contact with contact electrodes 106, 108 of the sensor 100 connected to the cartridge 10. The geometry of the extension 71 is configured to match the recess 51 of the protective cap 50. Figure 23 and 25 As shown, the first and second contact elements 132 are located on the lower side 79 of the extension 71 of the accessory device 70 so as to extend through the through opening 39 of the cartridge holder 30 when the drug delivery device 3 is fully assembled. In this way, the contact elements 132, 134 make electrical contact with the first and second contact electrodes 106, 108 of the sensor 100.
[0222] Because the extension 71 of the accessory device 70 extends longitudinally or axially through the interface between the body 20 and the cartridge holder 30, the body 20 remains completely unchanged compared to conventional drug delivery devices without the sensor assembly 140. Only minor modifications are required to the cartridge holder 30 to establish electrical contact between the sensor 100 located inside the drug delivery device 3 and the accessory device 70 detachably arranged on the outer periphery of the body 20. Through the accessory device 70, at least some or all of the electronic components of the sensor assembly 140 can be housed in a separate device, thus keeping the structure of the drug delivery device 3 substantially unchanged. Since the accessory device 70 is detachably connected to the housing 4 of the drug delivery device 3, multiple drug delivery devices 3 can be reused, and these drug delivery devices 3 can be implemented as disposable devices.
[0223] The rather expensive or bulky electronic components of the sensor assembly 140, such as the battery 130, transceiver 120 and / or processor 110, are actually specifically arranged in the accessory device 70, so that the production cost of the sensor 100 and the space required for the sensor 100 can be effectively minimized.
[0224] List of reference numerals
[0225] 1. Drug delivery device
[0226] 2. Drug delivery device
[0227] 3. Drug delivery device
[0228] 4. Shell
[0229] 5. Drive mechanism
[0230] 10 medicine cartridges
[0231] 11. Cylinder
[0232] 12 sidewalls
[0233] 13. Seals
[0234] 14 Pistons
[0235] 15. Neck
[0236] 16 Liquid substances
[0237] 20 body
[0238] 21 Assign Button
[0239] 22 Dosage scale
[0240] 30 cartridge holder
[0241] 31 windows
[0242] 32 sockets
[0243] 33 Through-opening
[0244] 36. Power Supply
[0245] Room 37
[0246] 38. Enclosure
[0247] 39 Through-opening
[0248] 40 cartridge holder
[0249] 41 windows
[0250] 42 sockets
[0251] 43 Through-opening
[0252] 50 Protective Cap
[0253] 51 recess
[0254] 60 Protective Helmet
[0255] 66. Power Supply
[0256] Room 67
[0257] 68. Enclosure
[0258] 69 Through-opening
[0259] 70 Auxiliary devices
[0260] 71 Extension
[0261] 72 Fastening Clip
[0262] 76. Power Supply
[0263] Room 77
[0264] 78. Enclosure
[0265] 79 Lower side
[0266] 100 sensors
[0267] 101 Flexible Foil
[0268] 101a side
[0269] 101b side
[0270] 102 Measuring Electrode
[0271] 102a heater
[0272] 103 Longitudinal end
[0273] 104 Measuring Electrode
[0274] 104A thermistor
[0275] 105 conductor
[0276] 106 Contact Electrode
[0277] 108 Contact Electrode
[0278] 110 processor
[0279] 112 Operating elements
[0280] 120 transceiver
[0281] 130 battery
[0282] 132 Contact element
[0283] 134 Contact elements
[0284] 140 Sensor Assembly
[0285] 200 electronic devices
Claims
1. A sensor for measuring at least one physical or chemical parameter of a cartridge (10) or syringe filled with a liquid substance, the sensor comprising - a planar flexible foil (101) which is arrangeable to the outer circumference of a barrel (11) of the cartridge (10) or syringe, - at least a first and a second measuring electrode (102, 104) arranged on the foil (101), and - at least a first and a second contact electrode (106, 108) arranged on the foil (101), - wherein the first contact electrode (106) is connected with the first measuring electrode (102), and wherein the second contact electrode (108) is connected with the second measuring electrode (104).
2. The sensor according to claim 1, wherein the first and second measuring electrodes (102, 104) are configured as capacitive measuring electrodes.
3. The sensor according to claim 2, wherein the planar flexible foil (101) is dielectric or permeable to dielectric charges.
4. The sensor according to any of the preceding claims, wherein one of the first and second measuring electrodes (102, 104) comprises a photodetector, and wherein the other one of the first and second measuring electrodes (102, 104) comprises a light source.
5. The sensor according to claim 4, wherein the first and second measuring electrodes (102, 104) are configured to perform a light transmission measurement of the barrel.
6. The sensor according to any of the preceding claims, wherein the planar flexible foil (101) is transparent.
7. The sensor according to any of the preceding claims, wherein the electrodes (102, 104, 106, 108) are transparent.
8. The sensor according to any of the preceding claims, wherein the planar flexible foil is configured to surround or be connected to the outer circumference of a sidewall of the barrel.
9. The sensor according to any of the preceding claims, wherein the first and second measuring electrodes are located on a common side of the flexible foil.
10. The sensor according to any of the preceding claims, wherein at least one of the first and second measuring electrodes (102, 104) comprises a printed or coated electrically conductive structure on or in the planar flexible foil.
11. A drug container comprising a tubular barrel (11) filled with a liquid substance, and comprising a sensor (100; 300) according to any of the preceding claims surrounding the outer circumference of a sidewall (12) of the barrel (11).
12. The drug container according to claim 11, comprising one of a syringe, a cartridge, a vial or an ampoule.
13. The drug container according to claim 12, wherein the cartridge is filled with a liquid drug.
14. A drug delivery device for administering a dose of a liquid drug, comprising: - a housing (4) for accommodating a cartridge (10) according to claim 12 or 13, wherein the cartridge (10) is filled with the liquid drug and comprises a piston (14) slidably accommodated in the cartridge body (11), - a drive mechanism (5) for exerting a distally directed drive force on the piston (14) to expel a dose of the liquid drug, - an electrical energy supply (36; 66; 76) electrically connectable with the first and second contact electrodes (106; 108) of the sensor (100; 300), - a processor (110) connected with the electrical energy supply (36; 66; 76), and - a transceiver (120) connected with the processor (110).
15. Drug delivery device according to claim 14, wherein the electrical energy supply (36; 66; 76) is configured to form an electrical contact with the first and second contact electrodes (106, 108) of the sensor (100; 300) when the cartridge (10) is properly assembled in the drug delivery device.
Citation Information
Patent Citations
Dispensing device for medications
WO2014052997A1