Ingestible capsule

Abstract

In one aspect the present disclosure relates to an ingestible capsule (50) configured for ingestion into a lumen of a patient, the ingestible capsule (50) comprising: - a housing (51), - an electronic circuit (54) inside the housing (51) and comprising a processor (55) and an interface (57), wherein the processor (55) is selectively operable in an inactive mode and in an operation mode, - a machine-readable identifier (30; 40), which is readable by an electronic device (80), - wherein the interface (57) is operable to receive an approval signal from the electronic device (80) and to relay the approval signal to the processor (55), which in response to receive the approval signal is operable to switch into the operation mode.

Description

[0001] Ingestible Capsule

[0002] Description

[0003] Field

[0004] The present disclosure relates to the field of ingestible capsules and in particular to the safe, precise and reliable use of such capsules. The disclosure further relates to aspects of activating ingestible capsule and to the approval of ingestible capsules before ingestion or intake by a user or patient.

[0005] Background

[0006] Ingestible capsules or pills for introduction into a bodily lumen are as such known in the art. They may serve to provide drug release and / or diagnosis of the gastrointestinal tract in the human or animal body. Ingestible capsules or respective swallowable electronic devices typically comprise a housing made from a bio-compatible material that houses electronic components in order to analyze the direct environment of the ingestible capsule, to collect or to acquire physiological parameters and / or to release or to inject a drug or medicament.

[0007] Since ingestible capsules may provide a rather effective means of depositing a drug or medicament in a lumen of a body of a patient particular care should be taken to prevent misuse or incorrect use of such ingestible capsule.

[0008] It is therefore desirable to prevent misuse as well as unauthorized or unintended use of ingestible capsule to thereby enhance patient safety.

[0009] Summary

[0010] In one aspect the present disclosure relates to an ingestible capsule, which is configured for ingestion into a lumen of a patient. The ingestible capsule comprises a housing, e.g., a housing made of a biocompatible material. The ingestible capsule further comprises an electronic circuit inside the housing. The electronic circuit comprises a processor and an interface. The processor is selectively operable in an inactive mode and in an operation mode. In the inactive mode, the processor may be in a sleep mode. In the inactive mode, the processor and / or the electronic circuit may provide a limited functionality. When and as long as in the inactive mode the electronic circuit and / or the processor may be inoperable to release or to inject a substance into the lumen of the patient while the ingestible capsule is located inside the lumen of the patient.

[0011] It may be only in the operation mode, e.g., also denoted as an active mode, in which the electronic circuit and / or the processor is / are operable to provide and / or to conduct or execute an electronically implemented function, such as collecting or measuring of physiological parameters and / or releasing, injecting or dispensing a dose of a medicament or drug from the ingestible capsule.

[0012] The ingestible capsule further comprises a machine-readable identifier, which is readable by an electronic device. The electronic device may be implemented as an external electronic device. It may be provided separate and independent from the ingestible capsule. The electronic device may comprise a portable electronic device. The electronic device may comprise one of a handheld, wearable or portable electronic device, such as a smartphone, a smartwatch, a tablet computer or other computing device operable to read the machine-readable identifier of the ingestible capsule.

[0013] The interface of the ingestible capsule is operable to receive an approval signal from the electronic device and to relay the approval signal to the processor. In response to receive the approval signal from the electronic device, e.g., via the interface, the processor is operable to switch into the operation mode.

[0014] In this way switching of the processor of the ingestible capsule in to the operation mode may require reading of the machine-readable identifier and / or processing of the approval signal from the electronic device. Hence, for activating the electronic circuit, the processor and hence for setting the ingestible capsule into an active mode or operation mode it may be required to generate and to submit an approval signal to the ingestible capsule. In turn, the approval signal may be only generatable on the basis of a prior reading of the machine-readable identifier as provided in or on the ingestible capsule. In this way, the machine-readable identifier, which may be individual for each ingestible capsule, may serve to identify each ingestible capsule and thus allows to conduct an authorization procedure, e.g., by making use of a separate electronic device, which may evaluate or verify the machine-readable identifier and which may then approve or disapprove use of the ingestible capsule by a patient requesting to activate the respective ingestible capsule, e.g., via the electronic device. In case that the electronic device disapproves use of the ingestible capsule processing, evaluation or verification of the machine-readable identifier may prevent or may block generation of the approval signal. Insofar, the approval signal cannot be generated or must not be generated and the electronic circuit and / or the processor cannot be switched or transferred from the inactive mode into the operation mode.

[0015] According to a further example the processor and / or the electronic circuit is in the inactive mode per default. In this way it is indispensable to switch or transfer at least one of the processor and the electronic circuit of the ingestible capsule from the inactive mode into the operation mode in order to use the ingestible capsule. Activation of the ingestible capsule may take place prior to an ingestion into the lumen or prior to an intake or swallowing by a patient. In some examples, activation, i.e. switching of the electronic circuit and / or of the processor from the inactive mode into the operation mode may take place when the ingestible capsule is already located inside the lumen of the patient.

[0016] However, operation of the ingestible capsule, e.g., for detecting or measuring physiological parameters inside the patient and / or for releasing or injecting a medicament into the lumen of the patient always requires a verification or authorization, which verification or authorization procedure is conducted on the basis of a readout of the machine-readable identifier of the respective ingestible capsule.

[0017] According to a further example the processor and / or the electronic circuit of the ingestible capsule is exclusively switchable or transferable from the inactive mode into the operation mode by receiving and / or processing the approval signal from the electronic device. Hence, for operating the ingestible capsule and in order to make use of its electronically implemented function(s), e.g. for the purpose of detecting or measuring physiological data of the patient and / or for releasing or injecting a dose of a medicament into the lumen of the patient it is indispensable to generate the approval signal, typically by evaluating or verifying the machine- readable identifier, to generate the approval signal by or through the electronic device, to submit the approval signal from the electronic device to the ingestible capsule, wherein the approval signal, upon receipt by the interface and / or by the processor is effective to switch or to transfer the processor and / or the electronic circuit from the inactive mode into the operation mode.

[0018] Hence, it may be only upon generation and receipt of the approval signal that a full functionality of the ingestible capsule can be deployed. Otherwise, the ingestible capsule remains inactive and stays in the inactive mode, in which the ingestible capsule might be inoperable to conduct at least one or all of its electronically implemented functions, for which it has been designed and / or implemented for.

[0019] According to another example the machine-readable identifier of the ingestible capsule comprises a machine-readable code containing information about the ingestible capsule. The machine-readable code may be extractable by the electronic device upon or in response to a reading of the machine-readable identifier. The machine-readable code may be indicative of information being specific about the ingestible capsule. The machine-readable code may have to be interpreted or translated into the code information being indicative about the respective ingestible capsule. Code interpretation or code translation may be provided by the electronic device. The code interpretation or code translation may be provided by the electronic device in a standalone mode or by way of communication with at least one of a provider and a database being operable to translate or to interpret the code contained in or provided by the machine- readable identifier.

[0020] Providing the code information by a database or provider, e.g., by a provider of the ingestible capsule, may be beneficial in that information about the ingestible capsule may be updated regularly and that a code interpretation or code translation may be indicative of actual developments of the information regarding the machine-readable identifier and / or regarding the ingestible capsule.

[0021] Moreover, reading of the machine-readable identifier by or through the electronic device and transmitting the machine-readable identifier and / or the machine-readable code to a database and / or to provider may indicate to the provider or database, that the specific machine-readable identifier, which may be unique for each ingestible capsule has been read by an electronic device.

[0022] In some examples, generation of the approval signal may be exclusively provided by an external database or provider, such as a health care provider (HCP). In this way, the respective database provider of healthcare provider is provided with information, that a specific ingestible capsule is allowed to become activated or is about to be switched or transferred from the inactive mode into the operation mode.

[0023] Specifically and when the ingestible capsule is provided with a unique machine-readable identifier or with a machine-readable identifier containing a unique machine-readable code, the healthcare provider or database provider is given the possibility to approve a use or activation of a specific ingestible capsule. A repeated request of switching an ingestible capsule from the inactive mode into the operation mode, e.g., by using the machine-readable identifier and the respective machine-readable code repeatedly may immediately indicate to the database provider of healthcare provider of an attempt of misuse of the ingestible capsule.

[0024] Moreover, an exclusive generation of an approval signal by an external database or by a healthcare provider gives the database or the healthcare provider the possibility to control, i.e. to remotely control each and every individual activation attempt of an ingestible capsule. In case that an ingestible capsule has a certain expiry date, e.g., indicated by at least one of the machine-readable identifier and the machine-readable code, generation of the approval signal may be dismissed or denied if a respective request of generating and submitting an approval signal is received by the database provider or healthcare provider at a time that is after the expiry date of the ingestible capsule. In this way patient safety in combination with the use of ingestible capsules can be enhanced and misuse or unauthorized use of ingestible capsules can be effectively prevented.

[0025] In a further example, the machine-readable code contains information including at least one of a drug name, a drug concentration, a total amount of a drug, and expiry date, a production date, a production site and a LOT number of a drug or drug container, e.g. located or arranged inside the ingestible capsule.

[0026] Accordingly, the machine-readable code and / or the machine-readable identifier is provided with or contains information being indicative about important properties, details or prescribed use of the medicament to be administered into the lumen by the ingestible capsule. In some examples, numerous or at least some of the above-mentioned information may be decoded by at least one of the electronic device and a database or healthcare service provider upon a readout of the machine-readable identifier and / or upon decoding of the machine-readable code contained in the machine-readable identifier.

[0027] According to another example the machine-readable code comprises one of an optical code and an electronically readable digital code. Generally, the machine-readable code may be implemented in a variety of different ways. In some examples the machine-readable code is an optical code to be captured or to be read by an optical reader of the electronic device. The optical reader may comprise a camera or the like imaging system, which is configured for operable to acquire a one-dimensional or two-dimensional image of the optical code. In other examples the machine-readable identifier comprises an electronically readable digital code. Here, the code may be provided by a sequence of digital information.

[0028] The electronically readable code may be stored or provided in an electronic storage, e.g., in a digital storage. The electronically-readable digital code may be stored in a read-only memory (ROM) or in an erasable programmable read-only memory (EPROM). The electronically- readable digital code may be stored in a non-volatile memory of the ingestible capsule. The memory or digital storage of the ingestible capsule may be implemented as a part of the electronic circuit. In some examples the digital storage containing the electronically-readable digital code may be provided in the processor of the electronic circuit of the ingestible capsule.

[0029] When in the inactive mode the electronic circuit and / or the processor of the ingestible capsule will provide readout or gathering of digital information stored in the machine-readable digital code of the machine-readable identifier. Accordingly, a digital readout of the electronically- readable digital code of the machine-readable identifier may be a minimum functionality of the electronic circuit and / or of the processor, which is available even if the ingestible capsule, e.g. the electronic circuit and / or the processor thereof, is in the inactive mode. Hence, readout of the electronically-readable digital code is always provided even if the electronic circuit and / or the processor is in the inactive mode.

[0030] According to a further example the optical code comprises a one-or two-dimensional code pattern. In some examples the optical code is a barcode. In other examples the optical code is a matrix code or QR code or the like two-dimensional code pattern.

[0031] According to a further example the electronic circuit comprises a digital storage coupled to the processor. The digital storage may comprise a non-volatile storage. In this way, digital information stored in the digital storage can be persistently stored even in the absence of electric power or energy. According to a further example the electronically readable code comprises a digital code stored in the digital storage of the electronic circuit.

[0032] In some examples the electronic circuit comprises one of an active or passive RFID circuit. When implemented as an active RFID circuit the ingestible capsule, in particular the electronic circuit may comprise an own electric power supply, which is operable to provide sufficient electrical energy for operating the electronic circuit and / or the processor and eventually even an electronically implemented function of the ingestible capsule by way of which there can be acquired, measured or captured at least one physiological parameter and / or by way of which there can be administered, released or delivered a medicament into the lumen of the patient.

[0033] In further examples the electronic circuit comprises a passive RFID circuit, which is void of an own power supply. Here, the ingestible capsule may be entirely void of an own electric power supply. It may retrieve or harvest electrical power from an interrogating RF field, e.g., provided by a code reader and / or provided by the electronic device. Here, electric energy required for a readout of the machine-readable code may be provided by the electronic device. The electronic device may be operable to generate a reading RF field by way of which the electronic circuit may be provided with electric power that is sufficient to provide or to conduct an electronic readout of the electronically readable digital code of the machine-readable identifier.

[0034] According to a further example the machine-readable identifier is provided on an outside surface of the housing. This is particularly suitable and applicable when the machine-readable identifier is provided as an optical code or contains an optical code. The machine-readable identifier may be printed on the outside surface of the housing of the ingestible capsule. This way, the machine-readable code may be universally readable by an optical reader of the electronic device or by the patient or user of the ingestible capsule himself.

[0035] In other examples and when the machine-readable identifier comprises a machine-readable digital code that is it electronically readable the machine-readable identifier does not have to be provided on the outside surface of the housing of the ingestible capsule. Here, the electronically-readable digital code may be provided or arranged anywhere inside the housing of the ingestible capsule. Typically, the housing of the ingestible capsule is non-absorbent for RF-radiation that may be required to provide an electronic readout of the electronically-readable digital code.

[0036] According to a further example the interface of the ingestible capsule comprises a wireless near field communication interface. The interface may be implemented as one of an active or passive RFID circuit. In some examples the interface may comprise a near field communication interface and hence a so-called NFC communication interface with a limited transmission range.

[0037] The near field communication interface of the ingestible capsule may use a communication protocol for communication between two respective electronic devices over a distance of only a few centimeters or less. The transmission range of the near field communication interface may be less than or equal to 4 cm, less than or equal to 3 cm, less than or equal to 2 cm. The near field communication interface may be based on inductive coupling between two so-called antennas present on NFC-enabled devices communicating in one or both directions, using a frequency of 13.56 MHz in the globally available unlicensed radio frequency ISM band using the ISO / IEC 18000-3 air interface standard at data rates ranging from 106 to 424 kbit / s.

[0038] With a near field communication interface, e.g., implemented as a co-called NFC communication interface it can be ensured, that the machine-readable identifier can only be captured or read by the electronic device when the electronic device is within a predefined maximum distance from the ingestible capsule. Here, the electronic device has to be in close vicinity, e.g., closer than 0.5 m, closer than 0.25 m, closer than 0.1 m to the ingestible capsule in order to read or to obtain the machine-readable identifier, e.g., via a wireless near field communication interface of the electronic circuit of the ingestible capsule.

[0039] Of course, and for such wireless communication the electronic device is correspondingly equipped with a complementary configured or correspondingly configured reading interfaces.

[0040] Typically, the electronic device comprises at least one of a wireless near field communication interface and one of a short range communication interface and wide range communication interface. The wide range communication interface may be implemented as a mobile phonebased communication interface, such as USM, LTE, 4G, 5G, 6G or any other telecommunication standards. The wide range communication interface may be implemented to communicate in a wireless wide area network (WANW). Such networks are created through the use of mobile phone signals typically provided and maintained by specific mobile phone (cellular) service providers.

[0041] The short range communication interface may be implemented as a wireless local area network (WLAN) interface. Such networks are wireless networks that use radio waves. The backbone network usually uses cables, with one or more wireless access points connecting the wireless users to the wired network. The transmission range of such WLAN network can be anywhere from a single room to an entire campus. The short range communication interface may be also implemented to communicate with a wireless personal area network (WPAN), typically implemented as a short-range network that uses Bluetooth or Bluetooth low energy (BLE). The short range communication interface may provide a transmission range of several meters.

[0042] In some examples, the short range wireless communication interface may comprise one of a Bluetooth interface and a Bluetooth low energy interface.

[0043] According to a further example the processor of the ingestible capsule is switchable or transferable from the operation mode into an actuation mode. When in the actuation mode the ingestible capsule is operable to conduct at least one of the following actions: attaching the ingestible capsule to biological tissue, e.g., inside the lumen of the patient, acquiring at least one physiological parameter from inside of the lumen and / or releasing or injecting a medicament into the lumen. Here, the electronic circuit and / or the processor may be selectively operable in at least one of an inactive mode, an operation mode and an actuation mode. In some examples, the ingestible capsule may be or may remain in the inactive mode when and as long as the ingestible capsule is subject to shipment, retail or storage. Prior to a use of the ingestible capsule the electronic circuit and / or the processor has to be switched from the inactive mode into the operation mode so that the ingestible capsule operates in a well-defined manner. Typically, the ingestible capsule should be ingested only and exclusively when in the operation mode. Switching from the inactive mode into the operation mode requires evaluation or verification of the machine- readable identifier as provided by or on the ingestible capsule. In this way, authorization to use the ingestible capsule can be either granted or dismissed for a particular patient aiming to ingest or swallow the ingestible capsule.

[0044] When in the operation mode, the ingestible capsule is generally operable to conduct at least one of the following actions of attaching the ingestible capsule to biological tissue, e.g., inside the lumen of the patient, to acquire at least one physiological parameter from inside the lumen, to communicate or to transmit such a parameter to an external electronic device, e.g., by a wireless data transmission, and / or to release or to inject a medicament into the lumen.

[0045] Switching or transferring the ingestible capsule into the actuation mode may be triggered according to a predefined schedule, e.g. after lapse of a predefined time interval proceeding the switching into the operation mode. Moreover, witching the processor and / or the electronic circuit and hence the entire ingestible capsule from the operation mode into the actuation mode may be also triggered by detection of a well-defined or predefined environmental condition, such as a pH value, temperature, pressure or presence of an actuating electromagnetic signal.

[0046] Hence, switching of the ingestible capsule from the operation mode into the actuation mode may be either autonomously or externally triggered, e.g., by the electronic device. In some examples the ingestible capsule should transfer or switching into the actuation mode only when it can be ensured or guaranteed that the ingestible capsule is located inside a predefined or intended lumen of a patient.

[0047] According to another example the processor is switchable into the actuation mode in response to receive an actuation signal from the electronic device via the interface. In this way, the processor and hence the entire ingestible capsule may be transferred or switched into the actuation mode exclusively by the electronic device via the interface. Hence, the electronic device may be required and may be indispensable for transferring the ingestible capsule into the actuation mode. In this way, the operability of the ingestible capsule of its processor and / or of its electronic circuit can be remotely controlled, e.g., by the electronic device.

[0048] In another aspect the present disclosure relates to an electronic device configured for use with an ingestible capsule as described above. The electronic device comprises a housing and a device processor inside the housing. The electronic device further comprises a device interface, which is operable to transmit an approval signal to the interface of the ingestible capsule. The electronic device is particularly configured and / or operable to cooperate with the ingestible capsule as described above. Insofar, all features, effects and benefits as described above in connection with the ingestible capsule may equally apply to the electronic device and / or to a combination of the electronic device and the ingestible capsule.

[0049] In some examples the electronic device is a portable electronic device. It may comprise a display and may be operable or configured for communication with a user or patient. The device interface is particularly operable to communicate and / or to exchange data with the interface of the ingestible capsule.

[0050] Specifically, the device processor of the electronic device may be operable to extract the machine-readable code from the machine-readable identifier of the ingestible capsule and to conduct an authorization procedure on the basis of the machine-readable code that has been obtained or extracted from the machine-readable identifier of a specific ingestible capsule. The device processor may be particularly configured to approve or to disapprove use of the ingestible capsule by a specific patient for owning or possessing the respective electronic device. In case that the verification or evaluation of the machine-readable code reveals that the ingestible capsule can or should be used by a particular patient the device processor of the electronic device will be operable to generate and to transmit a respective approval signal to the interface of the ingestible capsule via the device interface of the electronic device.

[0051] In this way, the ingestible capsule in turn may switch from the inactive mode into the operation mode.

[0052] According to a further example of the electronic device the electronic device comprises a reader coupled to the device processor. The reader is operable to read the machine-readable identifier as provided in or on the housing of the ingestible capsule. At least one of the reader and the device processor is operable to extract a code, e.g., either an optical or an electronically readable digital code from the machine-readable identifier. By way of the reader, the electronic device is operable to obtain and to extract a code and respective code information of the machine-readable identifier. According to a further example the device processor is further operable to verify the code and to generate the approval signal in response to a positive verification of the code. Verification of the code may comprise at least one of numerous verification schemes, so as to verify if a user, e.g., identified by a patient ID or provided with a prescribed medication is entitled or authorized to make use of the ingestible capsule.

[0053] Moreover, verification of the code may also comprise a verification of an expiry date as extracted from the machine-readable code. If the electronic device should detect that the expiry date as provided by the machine-readable identifier has already expired the device processor may be operable to prevent, deny or dismiss operation of the ingestible capsule. In such a case, and when the verification of the code reveals that the ingestible capsule should not be used by a particular patient the processor may be operable to dismiss generation of an approval signal and / or to generate a refusal signal or denial signal instead.

[0054] According to a further example the device processor of the electronic device is operable to acquire a patient identifier from at least one of a device storage and an external database by another communication interface. The device processor is further operable to generate the approval signal when the patient identifier matches with the code or when the patient as identified by the patient identifier is entitled to use an ingestible capsule, which in turn is identified by the machine-readable code as provided by the machine-readable identifier.

[0055] In other situations and when the device processor conducts an authorization procedure or when the device processor verifies the machine-readable code, e.g., in view of a patient identifier and when the patient identifier should not match with the machine-readable code or any of the code information, the device processor may be in turn operable to dismiss generation of an approval signal or may be operable to generate a refusal or denial signal, which can be likewise transferred or transmitted to the interface of the ingestible capsule.

[0056] Concurrent with the generation and / or submission of at least one of an approval signal and a denial or refusal signal at least one of the ingestible capsule and the electronic device may further provide a confirmation or feedback signal, e.g. one of a visual signal, an audible signal or haptically discernible signal by way of which the user may be intuitively informed about approval or disapproval of a use of the ingestible capsule. Such a feedback signal may be generated by a feedback generator. Typically, such feedback generator may comprise at least one of a noiseproducing device or arrangement, such as a speaker or beeper, and an optical signal generating device, such as a light source, e.g., implemented as a LED. In further examples or in addition the feedback generator may comprise a kind of a buzzer, which may be operable to generate a vibration signal that is haptically and / or acoustically discernible by a user.

[0057] According to a further example the reader of the electronic device comprises one of a camera and a wireless code reader. The camera is operable to capture or to scan an optical code of the machine-readable identifier. The wireless code reader is operable to read a digital code of the machine-readable identifier, which is typically stored in a digital storage of the ingestible capsule. The digital storage of the ingestible capsule may belong or may form part of the electronic circuit of the ingestible capsule. In some examples the digital storage may be implemented or integrated into the processor of the electronic circuit of the ingestible capsule.

[0058] When the reader of the electronic device comprises a camera the machine-readable code of the ingestible capsule may comprise the optical code as mentioned above. The optical code may comprise a one-or two-dimensional code pattern, such as a barcode or a data matrix-code or QR-code. The wireless code reader may comprise or may be implemented as a RFID reader, e.g., operable to read-out data of the digital storage of the ingestible capsule. The digital storage of the ingestible capsule may be provided or integrated into the interface, e.g., into the communication interface of the ingestible capsule. It may be integrated into a RFID Chip of the ingestible capsule, wherein the RFID Chip may comprise or may constitute the machine- readable identifier. Insofar, the digital storage of the ingestible capsule may be provided by or integrated in at least one of the electronic circuit, the processor, the interface and / or the machine-readable identifier of the ingestible capsule.

[0059] According to an aspect the present disclosure also relates to a system. The system comprises an ingestible capsule or several ingestible capsules as described above and at least one electronic device as described above. Typically, the system comprises a combination of an ingestible capsule as described above and an electronic device as described above. Insofar, all features, effects and benefits as described above in connection with at least one of the ingestible capsule and the electronic device equally apply to the system; and the vice versa.

[0060] In a further example the system may comprise a first ingestible capsule and a second ingestible capsule as described above and may further comprise the electronic device as described above. Here, the first and the second ingestible capsule may distinguish by their machine- readable identifier, e.g. by the information or code stored or provided in or by the machine- readable identifier. Here, the electronic device may be operable to selectively switch only one of the first and the second ingestible capsules from the inactive mode into the operation mode at a time. Here, the approval signal as generated and provided by the electronic device may be processable by only one of the first and the second ingestible capsules. In this way, the electronic device can be used to cooperate with only one of a plurality of ingestible capsules. In this way, a patient may be provided with numerous ingestible capsules, which may provide and serve the same or different purpose. By way of the machine-readable identifier the distinguishing features of the ingestible capsule can be communicated to an electronic device, which upon conducting or executing an authorization, evaluation of verification procedure may then selectively transfer only one of a plurality of ingestible capsules from an inactive mode into the operation mode and / or into the actuation mode later-on.

[0061] According to a further aspect the present disclosure also relates to a method of authorizing use of an ingestible capsule as described above. The method comprises the steps of reading of a machine-readable identifier as provided by the ingestible capsule by an electronic device. In a further step a code is extracted from the machine-readable identifier. Extraction of the code may be typically conducted by the electronic device, e.g. by a device processor and / or by a device interface of the electronic device. Then, the extracted code is verified, e.g., by a database query or by an inquiry with a healthcare provider (HCP), or locally by the electronic device itself.

[0062] Thereafter an approval signal is generated and submitted to the ingestible capsule in case that the extracted code is positively verified and / or in case that the extracted code is approved. Thereafter and when receiving the approval signal the processor of the electronic circuit of the ingestible capsule is switched or transferred into the operation mode. In other cases, and when the verification or evaluation of the extracted code reveals that the user, e.g., the user of the electronic device, is not authorized to use the ingestible capsule switching of the electronic circuit and / or of the processor of the electronic circuit of the ingestible capsule from the inactive mode into the operation mode may be effectively prevented.

[0063] The electronic circuit and / or the processor and / or the entire ingestible capsule may then be locked in the inactive mode at least until verification of a code as obtainable or extractable from the machine-readable identifier of the ingestible capsule matches with predefined approval conditions by way of which use of the ingestible capsule is authorized and allowed. The method as described herein is typically to be conducted and executed by making use of an ingestible capsule and / or by making use of an electronic device as described above. Insofar, all features, effects and benefits as described above in connection with any of the ingestible capsule, the electronic device, the system comprising the ingestible capsule and the electronic device, equally apply to the method of authorizing use of an ingestible capsule; and vice versa. According to a further aspect there is also provided a computer program for authorizing use of an ingestible capsule as described above. The computer program comprises computer- readable instructions, which when executed by the processor of the ingestible capsule cause the processor to execute the steps of switching the processor of the electronic circuit of the ingestible capsule into the operation mode in response to receive the approval signal from an electronic device as described above. Typically, the computer program is to be executed by the processor of the ingestible capsule as described above in order to execute the method of authorizing use of an ingestible capsule. Insofar, all features, effects and benefits as described above in connection to any of the ingestible capsule, the electronic device and the method of authorizing use of the ingestible capsule equally apply to the computer program; and vice versa.

[0064] According to another aspect there is provided a further computer program for authorizing use of an ingestible capsule as described above. The computer program comprising computer- readable instructions, which when executed by a device processor of an electronic device as described above cause the device processor to execute the steps of reading of the machine- readable identifier by a reader of the electronic device, extracting a code from the machine- readable identifier, verifying the extracted code and generating an approval signal and submitting the approval signal to the ingestible capsule.

[0065] In some examples executing of the method of authorizing use of an ingestible capsule requires installation and deploying of a computer program in or with the ingestible capsule as well as implementing or deploying another computer program in or with the electronic device. Insofar, the computer programs are particularly configured for the processor of the ingestible capsule and for the device processor of the electronic device, respectively. They may be configured to mutually interact so as to conduct or to execute the method of authorizing use of the ingestible capsule. Insofar and since the computer programs are configured to be executed by the processor of the ingestible device and by the device processor of the electronic device, all features, effects and benefits as described above in connection to any of the ingestible capsule, the electronic device, the system and the method of authorizing use of the ingestible capsule equally apply to the computer program configured for execution by the processor and / or apply to the further computer program configured for execution by the device processor; and vice versa.

[0066] Generally, the scope of the present disclosure is defined by the content of the claims. The disclosure is not limited to specific embodiments or examples but comprises any combination of elements of different embodiments or examples. Insofar, the present disclosure covers any combination of claims and any technically feasible combination of the features disclosed in connection with different examples or embodiments.

[0067] In the present context the term ‘distal’ or ‘distal end’ relates to an end of the injection device that faces towards an injection site of a person or of an animal. The term ‘proximal’ or ‘proximal end’ relates to an opposite end of the injection device, which is furthest away from an injection site of a person or of an animal.

[0068] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0069] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0070] The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., shorter long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dualchamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0071] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders.

[0072] Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0073] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide. Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0074] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); 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; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega- carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(w- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0075] Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC- 1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211 , CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701 , MAR709, ZP- 2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA- 15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide- XTEN and Glucagon-Xten.

[0076] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom. Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0077] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin. Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

[0078] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0079] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art. The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0080] Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

[0081] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0082] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

[0083] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0084] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).

[0085] As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

[0086] Brief description of the drawings

[0087] In the following, some examples of ingestible capsules and ways of use or authorize use thereof will be illustrated in greater detail by making reference to the drawings, in which:

[0088] Fig. 1 is a schematic illustration of numerous ingestible capsules provided in an outer packaging,

[0089] Fig. 2 schematically illustrates scanning of a machine-readable identifier by an electronic device,

[0090] Fig. 3 is a block diagram of the electronic device and the ingestible capsule,

[0091] Fig. 4 schematically shows a use scenario of data exchange between the electronic device when the ingestible capsule is located inside the body of a patient, and

[0092] Fig. 5 is a flowchart of a method of authorizing use of the ingestible capsule.

[0093] Detailed description

[0094] In Fig. 1 there is shown an example of numerous ingestible capsules 50, 50', 50" as they might be delivered to a patient or user. There is provided a packaging 10 providing an accommodation space 11 for numerous ingestible capsule 50, 50', 50". The packaging 10 comprises or forms an enclosure 12 for numerous ingestible capsule 50, 50',". The packaging 10 may comprise a surrounding sidewall 14 and a bottom 15 forming or enclosing the accommodation space 11 , which is sized to receive numerous ingestible capsules 50, 50', 50". The packaging 10 may comprise a foldable lid 16 by way of which the packaging 10 may be selectively opened or closed.

[0095] The ingestible capsule 50 comprises a capsule housing 51 with an outside surface 53. On the outside surface 53 there may be provided a machine-readable identifier 30. A further ingestible capsule 50' may be likewise provided with another machine-readable identifier 30'. The machine-readable identifier 30, 30' may distinguish from each other or may be substantially identical. As schematically illustrated in Fig. 2 the machine-readable identifier 30 may comprise a substrate 31 , e.g., a code carrying substrate 31. On the substrate 31 of the identifier 30 there may be provided a code 32. In the example of Fig. 2 the code 32 is an optical code 33. The optical code 33 may comprise a one- or two-dimensional code pattern. There is further provided or proposed an electronic device 80 as also shown in Fig. 2.

[0096] The electronic device 80 comprises a housing 81 and a display 82, e.g. implemented as a two- dimensional electronic display. The electronic device 80 further comprises a code reader 87, which is operable to read the machine-readable code 32, e.g., the optical code 33 of the machine-readable identifier. In the example as shown in Fig. 2 the code reader 87 comprises a camera 83, e.g. provided on a backside of the device housing 81. The backside is opposite to the side of the housing 81 of the electronic device that is provided with the display 82.

[0097] The internal structure and functionality of the ingestible capsule 50 is explained in greater detail, e.g. with regards to Figs. 3-5. The ingestible capsule 50 comprises the machine-readable identifier 30, e.g. on an outside surface 53 of the housing 51 of the ingestible capsule 50. With other examples or in addition to the machine-readable identifier 30 there may be provided another machine-readable identifier 40, which may be located or arranged inside the housing 51 of the ingestible capsule 50. The further machine-readable identifier 40 may also comprise a substrate 41 and a machine-readable code 42. Here, the machine-readable code 42 may comprise an electronically readable digital code 43, which is readable by the electronic device 80, e.g. in a wireless way.

[0098] The machine-readable identifier 40 may comprise a wirelessly readable machine-readable code 42. The machine-readable identifier 40 may comprise a wirelessly readable tag, such as a RFID tag or NFC tag, which is readable by the reader 87 of the electronic device 80. Here, the reader 87 may comprise a wireless communication interface 84, 86 operable read information stored in a digital storage of the machine-readable identifier 40.

[0099] The ingestible capsule 50 further comprises a power source 52, e.g. implemented as a battery. The ingestible capsule 50 further comprises a circuit 54 located inside a housing 51. The electronic circuit 54 comprises a processor 55, e.g., implemented as a microcontroller. The electronic circuit 54 may comprise a digital storage 58 readable and / or writable by the processor 55. The electronic circuit 54 may further comprise a communication interface 57, which may be operable to communicate, i.e. to receive and / or to transmit signals from the electronic device 80 and / or to the electronic device 80. Optionally, the electronic circuit 54 may comprise a clock 56 operably connected to the processor 55. In some examples, the clock 56, the digital storage 58 and the communication interface 57 may be located on a common chip and their generic functions maybe integrated into or provided by the processor 55.

[0100] In some examples the ingestible capsule 50 comprises a delivery unit 60. The delivery unit 60 may be configured to release or to inject a dose of a medicament into a lumen 4 of a patient when the ingestible capsule 50 is located inside such a lumen 4, e.g., after the ingestible capsule 50 has been swallowed or ingested by a patient.

[0101] The delivery unit 60 may comprise a drive unit 61. The drive unit 61 may be controllable by the processor 55. It may receive power from the power source 52. The drive unit 61 may be operable to expel or to release a dose of a medicament. Further, the delivery unit 60 may also comprise an injector 63, e.g., a pointed needle or pointed needle cannula by way of which a dose of a liquid medicament could be injected into the tissue enclosing the lumen 4 of the patient.

[0102] Optionally, the ingestible capsule 50 comprises an anchoring member 65. The anchoring member 65 may be operable to pierce or to penetrate tissue adjoining or enclosing at least a portion of the lumen 4 of the patient. By way of the anchoring member 65, the ingestible capsule 50 may be attached to a dedicated portion of the lumen of the patient and / or to a dedicated portion of a tissue or tissue portion of the body 8 of the patient or user of the ingestible capsule 50.

[0103] Once the anchoring member 65 is deployed or triggered by the processor 55 it may serve to fix the ingestible capsule 50 to a sidewall of the lumen 4 of the patient. In this way, the ingestible capsule 50 can be attached to a dedicated lumen of the patient.

[0104] Furthermore, the ingestible capsule may comprise a first and / or a second seonsor 66, 67. The sensors 66, 67 may be operable to detect and / or to quantitatively measure a physiological parameter of the patient from inside the lumen 4 of the patient or user of the ingestible capsule 50. In some examples the sensor 66 may be operable to detect or to measure the pH value in the immediate vicinity of the ingestible capsule. The further sensor 67 may be operable to monitor, to detect or to quantitatively measure another physiological parameter of the patient, such as a temperature inside the lumen of the patient. Capturing of respective physiological parameters may be beneficial to autonomously detect or to autonomously determine if and in how far the ingestible capsule 50 is located within a dedicated or selected lumen 4 of a patient.

[0105] For instance, and when the ingestible capsule 50 is designed and configured to release or to inject a medicament in the gastrointestinal tract 5 of a patient the position or allocation of the ingestible capsule 50 inside such a lumen 4 may be detectable or determinable by measuring a pH value or other biological markers or physiological parameters that can be electronically detected or quantitatively measured by any of the sensors 66, 67.

[0106] When the respective sensors 66, 67 provide respective sensor signals being indicative of the presence of the ingestible capsule 50 in a dedicated or specific lumen 4 inside a body 8 of a patient or user the respective signal as provided by any of the sensors 66, 67 can be adequately processed by the processor 55, which may then be operable to trigger operation of at least one of the anchoring member 65 and the delivery unit 60 so as to fasten or to fix the ingestible capsule 50 to biological tissue and / or to inject or to release a dose of a medicament in such issue.

[0107] Capturing of physiological parameters by way of the sensors 66, 67, deploying or triggering the anchoring member 65 as well as inducing or triggering of a medicament release or medicament injection action by making use of the delivery unit 60 may be exclusively conducted or triggered by the processor 55 when the processor 55 and / or the electronic circuit 54 is in an actuation mode or operation mode.

[0108] In some examples the ingestible capsule 50 is switchable or transferable from an inactive mode, which may also be a default or initial mode, into an operation mode. In the operation mode the electronic circuit 54 is in a so-called wake up mode or normal operation mode, in which the sensors 66, 67, the anchoring member 65 and / or the delivery unit 60 as such are operable to provide a dedicated function or functionality. A respective or dedicated action, e.g. fastening of the ingestible capsule 50 to the issue of the patient as well as delivery of a medicament from the delivery unit 60 may be triggered by the processor 55 exclusively when the ingestible capsule 50 is in the operation mode or actuation mode.

[0109] The processor 55 and / or the electronic circuit 54 of the ingestible capsule 50 may be further switchable into the actuation mode, wherein at least one of the sensors 66, 67, the anchoring member 65 and the delivery unit 60 are actively operated and provide a respective dedicated functionality, of e.g., measuring a physiological parameter, fixing the ingestible capsule 50 to dedicated tissue of the patient and / or releasing or injecting a dose of the medicament. The ingestible capsule 50 is further operable in an inactive mode. In the inactive mode the ingestible capsule 50 is inoperable to release or to inject a dose of the medicament and / or is inoperable to activate the anchoring member 65. In the inactive mode operation of and / or data acquisition from the sensors 66, 67 may be also disabled. The inactive mode may be also regarded as a sleep mode, in which the electronic circuit 54 provides only a limited functionality in order to save energy and / or to avoid consumption of energy as provided by the power source 52.

[0110] However, in the inactive mode the processor 55 may at least provide a limited functionality, namely to process an approval signal that may be generated and transmitted by the external electronic device 80 and which approval signal may be received by the interface 57. The processor 55 and / or the electronic circuit 54 may be operable to switch from the inactive mode into the operation mode upon receipt of the approval signal received of from or via the communication interface 57. The processor 55 and / or the electronic circuit 54 may be operable to process the approval signal even when in the inactive mode.

[0111] Hence, in the inactive mode the functionality of the electronic circuit 54, the interface 57 and the processor 55 may be limited to the processing and receiving of the approval signal. Once the approval signal has been received by the communication interface 57 and has been forwarded or relayed to the processor 55, the processor 55 is operable to switch into the operation mode so as to power up the genuine functions of the ingestible capsule 50 and / or to terminate a sleep mode.

[0112] In some examples the processor 55 is in the inactive mode per default. In this way energy as provided and stored in the power source 52 can be saved over a comparatively long time interval and the shelf life of the ingestible capsule 53 effectively prolonged and / or extended. In some examples the processor 55 is exclusively switchable from the inactive mode into the operation mode only and / or exclusively by receiving and / or processing the approval signal from the electronic device.

[0113] Insofar, the approval signal as generated and provided by the electronic device 80 may provide an unlocking or unlocking key suitable to transfer the electronic device into a normal operation mode.

[0114] The external electronic device 80 may be implemented as a smartphone, as a smartwatch, as a handheld tablet computer or the like wearable electronic device. The electronic device 80 comprises a device processor 85 as well as a device interface 84, which is operable to communicate, e.g. to transmit the approval signal to the interface 57 of the ingestible capsule 50. Optionally, the electronic device 80 is provided with a further communication interface 86, which may be operable to exchange data and / or to communicate with a database 92, e.g., of a healthcare provider, via a communication network 90.

[0115] The electronic device 80 further comprises a reader 87. The reader 87 is operable to read the machine-readable identifier 30, 40 as provided on or inside the housing 51 of the ingestible capsule 50. The reader 87 may comprise a camera 83 or may comprise a device interface 84. Also, the electronic device 80 may comprise a storage 88, e.g., in form of a digital storage 88. The digital storage 88 may store patient specific information, such as a patient identifier, patient name, date of birth, a medication history, a medication schedule, prescribed medicaments, an anamnesis of the patient as well as one or numerous identifiers being specific about a medicament that should be taken or administered by the patient.

[0116] In some examples the electronic device 80 is operable to read the code 32, 42 of the machine- readable identifier 30, 40. The electronic device 80, specifically a device processor 85 may be further configured to evaluate or to verify the code information as obtained by the readout of the machine-readable identifier 30, 40. The code information may be used to conduct a database query in order to check if the patient actually using the electronic device 80 and intending to use a specific ingestible capsule 50 is authorized to do so. For this, respective code information may be transmitted to the database 92 via the communication interface 86 and the communication network 90.

[0117] In return the communication interface 86 and / or in the device processor 85 may either receive one of a return signal, the approval signal and a refusal or denial signal by way of which use of the ingestible capsule by a specific patient is either authorized and approved or by way of which a respective use is denied or prevented. Only in case that there is provided a positive feedback, e.g. from the database 92, the device processor 85 is operable to generate an approval signal and on the basis of the return signal and / or to transmit the approval signal via the device interface 84 to the interface 57 and hence to the processor 55 of the ingestible capsule 50.

[0118] Upon receipt of the approval signal via the interface 57 the processor 55 is operable to switch into the operation mode. Then and only then the ingestible capsule 50 may be configured to become swallowed or ingested by a patient. It may be then, e.g. based on the approval that the ingestible capsule 50 switches into or transfers into the actuation mode, in which actuation mode the functionality of the sensors 66, 67, of the anchoring member 65 and / or of the delivery unit 60 may be actively deployed. Alternative to a database query by or through a communication network 90 it is also conceivable that patient specific data required for conducting an evaluation or verification of the use of the ingestible capsule 50 are stored locally, e.g., in the local storage 88 of the electronic device 80. Then, the device processor 85 may simply conduct a respective query on the basis of data contained in the electronic storage 88. A comparison of extracted code information with patientspecific data stored in the local storage 88 of the electronic device 80 may likewise lead to an approval or denial of use of the ingestible capsule 50.

[0119] In case that a patient could not be authorized to make use or to ingest a particular ingestible capsule 50 the evaluation or verification as conducted by the device processor 85 will not lead to the generation of the approval signal. Rather, there may be generated a refusal signal or denial signal, which may be optionally transmitted to the processor 55 via the interface 57. Upon receipt of such a denial signal or refusal signal the electronic circuit 54 and / or the processor 55 may be locked in the inactive mode, at least for a predefined time intervail . In this way, the ingestible capsule may remain inactive at least during the predetermined time interval after an unsuccessful attempt to authorized use of the ingestible capsule 50.

[0120] When in the operation mode and after having been swallowed or ingested by a patient the ingestible capsule 50 may find its way into a lumen 4 of the patient, such as the gastrointestinal tract 5. Also here, and by way of a wireless data transmission between the device interface 84 and the interface 57 the external electronic device 80 may be further used to control a functionality or operability of the ingestible capsule while located inside the lumen 4 of the body 8 of the patient.

[0121] Here, wireless signals may be transmitted between the device interface 84 and the interface 57 of the ingestible capsule 50 through the skin 6 or through respective biological tissue of the patient or user of the ingestible capsule, e.g. in order to trigger a specific function of the ingestible capsule 50 or to exchange data between the ingestible capsule 50 and the electronic device 80. in the flowchart according to Fig. 5 there is illustrated one example of authorizing use of an ingestible capsule 50 as described herein. In a first step 100 the electronic device 80 is used to scan or to capture the machine-readable identifier 30, 40. In a subsequent step 102 the code information stored in the machine-readable identifier 30, 40 is extracted from the machine- readable identifier 30, 40 and the respective code information is decoded from the readable code 33, 43 as provided by the machine-readable identifier 30, 40. In a subsequent step 104 the respective code 33, 34 may be directly checked and verified. In step 110 a decision will be made depending on the preceding code verification or code evaluation. If in step 104 the evaluation or verification of the code 33, 43 reveals that the ingestible capsule 50 should not be used by that particular patient actually using the electronic device 80, then, in step 110 the procedure proceeds with step 112, in which the authorization procedure terminates. Termination of the authorization procedure will leave the electronic circuit 54 and / or the processor 55 of the ingestible capsule 50 in the inactive mode. Then, the ingestible capsule 50 cannot be used or cannot provide a desired functionality, e.g., in terms of collecting or measuring physiologic data, fixing or attaching to a tissue portion of the patient and / or releasing or injecting of a dose of a medicament.

[0122] However, if in step 110 it is confirmed that the evaluation or verification as conducted in step 104 is approved thereby indicating that the ingestible capsule 50 can or should be used by the respective patient, then the procedure proceeds with steps 114.

[0123] In step 104 evaluating of verifying the code information is conducted locally by comparing the code information with respective matching information that is stored locally in the storage 88 of the electronic device 80.

[0124] Alternative to step 104 and in case that the relevant data about a patient or user of the ingestible capsule may not be present with the electronic device 80 there may be submitted a database query in step 106 to the database 92, e.g. via the communication network 90. Then, the database 92 or a respective healthcare provider operating the database 92 may conduct the evaluation or verification of the machine-readable identifier and the code information, e.g. with regards to a patient or patient ID actually requesting or inquiring use of the ingestible capsule. Such verification or evaluation is conducted by the database 92 or by a respective healthcare provider in step 108.

[0125] Once the evaluation or verification provides a positive feedback or positive result the approval signal will be generated in step 114. The approval signal will either be generated locally by the device processor 85 or may be provided by the database 92 or healthcare provider and may be submitted via the communication network 90 to the electronic device 80. Irrespective on the location of generation of the approval signal in step 114 the approval signal will be submitted to the ingestible capsule 55 via the device interface 84 in step 116. Upon receiving of the approval signal in step 118 the electronic circuit 54 and / or the processor 55 of the ingestible capsule 50 will be switched into the operation mode in step 118. The ingestible capsule 50 may then be swallowed or ingested by a user or patient.

[0126] Thereafter and in step 120 there may be optionally started a timer, e.g., on the basis of a clock signal as provider by the clock 56. The timer may be operable to keep the electronic circuit 54 and / or processor 55 in the operation mode even after intake or ingestion by the patient before the processor 55 and / or the electronic 54 switches or transfers into an actuation mode. Here, the lapse of the timer or lapse of a predefined time interval, which may coincide with completion of step 120 may trigger switching of the ingestible capsule 50 into the actuation mode in step 122. Thereafter and in step 124 operation of the anchoring member 65 and / or operation of the delivery unit 60 may be triggered to dispense or to release a medicament and / or to fix the ingestible capsule to a dedicated portion of the body 8 inside a lumen 4.

[0127] Alternative to the timer routine as conducted in step 120 the ingestible capsule 50 may be operable to monitor and / or to detect electric signals that may be provided by one of the sensors 66, 67 when the capsule is the operation mode. Here, and in step 126 localization or the presence of the ingestible capsule 50 in a dedicated portion of a lumen 4 of a patient can be detected. For instance, and when the detector 66 detects a predefined range of a pH value in the immediate vicinity of the ingestible capsule 50 such a detection may be indicative of a localization of the ingestible capsule 50 in a predefined portion of e.g., the gastrointestinal tract 5 of the body 8 of the patient.

[0128] In response to such a localization in step 126 the procedure may proceed with step 122 in which step 122 the ingestible capsule 50 is switched into the actuation mode which will be which switching will be followed by triggering a further function of the ingestible capsule 50 in step 124.

[0129] Reference Numbers

[0130] 4 lumen

[0131] 5 gastrointestinal tract

[0132] 6 skin

[0133] 8 body

[0134] 10 packaging

[0135] 11 accommodation space

[0136] 12 enclosure

[0137] 14 sidewall

[0138] 15 bottom

[0139] 16 lid

[0140] 30 identifier

[0141] 31 substrate

[0142] 32 code

[0143] 40 identifier

[0144] 41 substrate

[0145] 42 code

[0146] 50 ingestible capsule

[0147] 51 capsule housing

[0148] 52 power source

[0149] 53 outside surface

[0150] 54 electronic circuit

[0151] 55 processor

[0152] 56 clock

[0153] 57 interface

[0154] 58 storage

[0155] 60 delivery unit

[0156] 61 drive unit

[0157] 62 medicament container

[0158] 63 injector

[0159] 65 anchoring member

[0160] 66 sensor

[0161] 67 sensor

[0162] 80 electronic device

[0163] 81 housing

[0164] 82 display 83 camera

[0165] 84 device interface

[0166] 85 device processor

[0167] 86 communication interface 87 reader

[0168] 88 storage

[0169] 90 network

[0170] 92 database

Claims

PAT23317-WO-PCTClaims1. An ingestible capsule (50) configured for ingestion into a lumen of a patient, the ingestible capsule (50) comprising: a housing (51), an electronic circuit (54) inside the housing (51) and comprising a processor (55) and an interface (57), wherein the processor (55) is selectively operable in an inactive mode and in an operation mode, a machine-readable identifier (30; 40), which is readable by an electronic device (80), wherein the interface (57) is operable to receive an approval signal from the electronic device (80) and to relay the approval signal to the processor (55), which in response to receive the approval signal is operable to switch into the operation mode.

2. The ingestible capsule (50) according to claim 1 , wherein the processor (55) is in the inactive mode per default.

3. The ingestible capsule (50) according to any one of the preceding claims, wherein the processor (55) is exclusively switchable from the inactive mode into the operation mode by receiving and / or processing the approval signal from the electronic device (80).

4. The ingestible capsule (50) according to any one of the preceding claims, wherein when in the inactive mode the functionality of the electronic circuit (54), the interface (57) and the processor (55) is limited to the processing and receiving of the approval signal.

5. The ingestible capsule (50) according to any one of the preceding claims, wherein the machine-readable identifier (30; 40) comprises a machine-readable code (32; 42) containing information about the ingestible capsule (50).

6. The ingestible capsule (50) according to claim 5, wherein the machine-readable code (32; 42) comprises one of an optical code (33) and an electronically readable digital code (43).

7. The ingestible capsule (50) according to any one of the preceding claims, wherein the machine-readable identifier (30) is provided on an outside surface (53) of the housing (51).

8. The ingestible capsule (50) according to any one of the preceding claims, wherein the interface (57) comprises a wireless near field communication interface.

9. The ingestible capsule (50) according to any one of the preceding claims, wherein the processor (55) is switchable from the operation mode into an actuation mode, wherein when in the actuation mode the ingestible capsule (50) is operable to conduct at least one of the following actions: attaching the ingestible capsule (50) to biological tissue, acquiring at least one physiological parameter from inside of the lumen (4), releasing or injecting a medicament into the lumen (4).

10. The ingestible capsule (50) according to claim 9, wherein the processor (55) is switchable into the actuation mode in response to receive an actuation signal from the electronic device (80) via the interface (57).

11. An electronic device (80) configured for use with an ingestible capsule (50) according to any one of the preceding claims, the electronic device (80) comprising: a housing (81), a device processor (85) inside the housing (81) and a device interface (84) operable to transmit an approval signal to the interface (57) of the ingestible capsule (50).

12. The electronic device (80) according to claim 11 , further comprising: a reader (87) coupled to the device processor (85), wherein the reader (7) is operable to read the machine-readable identifier (30), and wherein at least one of the reader (87) and the device processor (85) is operable to extract a code (32, 42) from the machine-readable identifier (30).

13. The electronic device (80) according to claim 12, wherein the device processor (85) is operable to verify the code (32, 42) and to generate the approval signal in response to a verification of the code (32, 42).

14. The electronic device (80) according to claim 12 or 13, wherein the reader (87) comprises one of: a camera (83) to capture or to scan an optical code (33) of the machine-readable identifier (30), anda wireless code reader (87) operable to read a digital code (43) of the machine-readable identifier (40) stored in a digital storage (58) of the ingestible capsule.

15. The electronic device (80) according to any one of the preceding claims 11-14, wherein the electronic device (80) is implemented as one of a smartphone, a smartwatch and a handheld tablet computer.

16. A system (20) comprising: an ingestible capsule (50) according to any one of the preceding claims 1 - 10, and an electronic device (80) according to any one of the preceding claims 11 - 15.

17. A method of authorizing use of an ingestible capsule (50) according to any one of the preceding claimsl - 10 , the method comprising the steps of: reading of the machine-readable identifier (30, 40) by an electronic device (80), extracting a code (32, 43) from the machine-readable identifier (30, 40), verifying the extracted code (32, 43), generating the approval signal and submitting the approval signal to the ingestible capsule (50), and switching the processor (55) of the electronic circuit (54) of the ingestible capsule (50) into the operation mode when the processor (55) receives the approval signal.

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