Ingestible capsules and associated packaging

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 power source (52) - an electronic circuit (54) connectable or connected to the power source (52) and - an operation mode controller (70) operable to transfer or to switch the ingestible capsule (50) from a sleep mode into an operation mode, wherein the operation mode controller (70) is configured to detect a presence of the ingestible capsule (50) within an accommodation space (11) of a packaging (10).

Description

[0001] I ngestible Capsules and Associated Packaging

[0002] Description

[0003] Field

[0004] The present disclosure relates to the field of ingestible capsules and in particular to the power management of ingestible capsules. The disclosure further relates to aspects of prolonging the shelf life of ingestible capsules and to reduce power consumption during shelf life. In further aspects the present disclosure relates to packagings for ingestible capsules as well as to the interaction between ingestible capsules and their corresponding packaging. Furthermore the disclosure relates to methods of preparing an ingestible capsule before intake.

[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 to or in dedicated portions of the body, e.g. in the gastrointestinal tract in the human or animal body. Ingestible capsules or respective swallowable electronic devices typically comprise a housing made from a biocompatible 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] Numerous functions of such ingestible capsules may consume electrical power. Therefore, the ingestible capsule has to be equipped with a power source, e.g. with a battery.

[0008] At least in some scenarios of use a time span between manufacturing, shipping or retailing of an ingestible capsule and use of the ingestible capsule by a patient or consumer may be comparatively long. Therefore, the power source of the ingestible capsule or pill has to be sufficiently dimensioned in order to provide a sufficient and rather long shelf life of the ingestible capsule.

[0009] Providing of a comparatively large battery for such ingestible capsules may not only increase production costs but may also impose a significant burden to the environment when the ingestible capsule will be discarded after use. It is therefore desirable to improve an improved power management for ingestible capsules, to prolong the shelf life of such ingestible capsules and / or to reduce the size or capacity of energy sources used or integrated in such swallowable capsules without imposing a negative impact on the usability or functionality of such ingestible capsules.

[0010] Summary

[0011] In one aspect there is provided an ingestible capsule configured for ingestion into a lumen of a patient. The ingestible capsule comprises a power source and an electronic circuit or connectable or connected to the power source. The ingestible capsule further comprises an operation mode controller, which is operable to transfer or to switch the ingestible capsule from a sleep mode into an operation mode. The operation mode controller is configured or operable to detect a presence of the ingestible capsule within an accommodation space of a packaging.

[0012] The operation mode controller may be operable to keep or to maintain the ingestible capsule and / or the electronic circuit in the sleep mode when and as long as a presence of the ingestible capsule inside an accommodation space of a packaging is detected. The detection may be conducted actively or passively. In some examples the operation mode controller may be configured to keep the ingestible capsule and / or the electronic circuit in the sleep mode by default. It may be then only and upon removal of the ingestible capsule from the accommodation space of the packaging or upon a physical modification of the accommodation space that the operation mode controller switches or transfers the ingestible capsule from the sleep mode into the operation mode.

[0013] In the sleep mode power consumption of the ingestible capsule, e.g. power consumption of the electronic circuit, may be smaller than a power consumption when the ingestible capsule and / or the electronic circuit is in the operation mode. In this way, power consumption and hence energy taken or withdrawn from the power source can be kept at a rather low level when and as long as the ingestible capsule is located inside a predefined accommodation space of a packaging.

[0014] The operability of the operation mode controller to transfer or to switch the ingestible capsule from the sleep mode into the operation mode may be triggered by removing of the ingestible capsule from the accommodation space and / or by modifying the physical constitution or configuration of the accommodation space. Both scenarios, namely the removal from the accommodation space or the physical modification of the accommodation space may typically take place directly before use or intake of the ingestible capsule by a patient or user. In this way, the ingestible capsule may be and remain in the sleep mode as long as it is duly contained or accommodated in the accommodation space of the packaging. It may automatically switch or transfer into the operation mode, e.g. upon removal from the packaging and / or by physically modifying the accommodation space, e.g. by opening or disintegrating of the packaging.

[0015] In some examples the operation mode controller is operable to conduct or to trigger switching of the ingestible capsule and / or the electronic circuit from the sleep mode into the operation mode when the packaging is opened or disintegrated and / or when the ingestible capsule is taken out of the packaging or out of the accommodation space. In this way, electric power consumption during shelf life can be reduced and / or minimized.

[0016] Thanks to a minimizing of the power consumption during transportation, delivery and shipment as well as storage with a patient the shelf life of such ingestible capsules can be prolonged. At the same time a capacity or dimension of the power source can be reduced because the amount of electrical energy withdrawn from the power source during shipment, delivery and shelf life can be reduced to a minimum.

[0017] In some examples the ingestible capsule may not consume any power at all when and as long as it is in the sleep mode.

[0018] Detection of the presence of the ingestible capsule within the accommodation space may be conducted actively or passively. When implemented in an active way the operation mode controller may be constantly or regularly powered by the power source and may consume a well-defined but comparatively small amount of electrical power. Here, the electrically operated operation mode controller may actively check or detect if the ingestible capsule is still located inside the accommodation space.

[0019] In other examples, wherein the operation mode controller is implemented in a passive way, the operation mode controller as well as the electronic circuit may be rather inactive as long as the ingestible capsule is retained or located inside the accommodation space of the packaging. Here, the process of removing of the ingestible capsule from the accommodation space or packaging may trigger a transfer or switching of the ingestible capsule and / or of its electronic circuit from the sleep mode into the operation mode. According to a further example the operation mode controller is configured to transfer or to switch the ingestible capsule from the sleep mode into the operation mode in response to detect at least one of a removal of the ingestible capsule from the accommodation space and a physical modification of the accommodation space. A physical modification of the accommodation space may include an opening of the accommodation space or disintegration or destroying of the accommodation space such that the ingestible capsule may be removed from the accommodation space or from the packaging.

[0020] A physical modification of the accommodation space may include opening of the accommodation space or to form or to establish a through opening in the enclosure formed by the accommodation space that allows to remove or to withdraw the ingestible capsule from the accommodation space or packaging. Both, the physical removal of the ingestible capsule from the accommodation space and hence moving of the ingestible capsule relative to the accommodation space of the packaging and / or a preceding physical modification of the accommodation space may rather autonomously trigger a switching or transferring of the electronic circuit or ingestible capsule from the sleep mode into the operation mode.

[0021] According to a further example of the ingestible capsule the electronic circuit is disconnected from the power source when the ingestible capsule is in the sleep mode. The operation mode controller may be then operable to connect the electronic circuit to the power source upon detection of at least one of a removal of the ingestible capsule from the accommodation space and a physical modification of the accommodation space.

[0022] Disconnecting the electronic circuit from the power source may drastically reduce a sleep mode power consumption of the ingestible capsule. In some examples and when and as long as in the sleep mode, the electrical power consumption of the electronic circuit may be as small as 0 Watt. In this way, battery lifetime as well as shelf life of the ingestible capsule can be prolonged significantly. Here, the operation mode controller may be implemented electromechanically or mechanically. Then, the process of removing the ingestible capsule from the accommodation space may induce a mechanical motion of at least a component of the operation mode controller, which motion establishes an electrical connection between the electronic circuit and the power source.

[0023] In other examples the operation mode controller may be implemented electronically and may consume electrical power, which is significantly less than an electric power consumption of the electronic circuit in the operation mode. An electronically implemented operation mode controller may be operable to detect or to quantitatively determine at least one of a removal of the ingestible capsule from the accommodation space and a physical modification of the accommodation space. It may be further operable to trigger a switching or transferring of the ingestible capsule and / or of the electronic circuit into the operation mode. With an electronically implemented operation mode controller there can be used a large variety of trigger mechanisms, which may be implemented electrically or electro mechanically. Here, the operation mode controller may consume a small amount of electric power during shelf life of the ingestible capsule.

[0024] According to a further example the operation mode controller comprises a controller electric circuit connected to at least one of an electrical contact element, a mechanical contact detector and a sensor. Any or all of these elements, detectors or sensors will be operable to detect the presence of the ingestible capsule within the accommodation space.

[0025] Here, the controller electronic circuit be operated in a passive or active way to detect the presence of the ingestible capsule within the accommodation space and / or to detect removal of the ingestible capsule from the accommodation space and / or to detect a physical modification of the accommodation space. An electrical contact element may be operable to electrically connect to a complementary or corresponding electrical counter contact element as provided in or on the packaging. A mechanical contact detector may be in mechanical contact with the accommodation space, e.g. with a bottom and / or sidewall of an enclosure of the packaging. Here, the mechanical contact detector may detect a modification of a mechanical contact between the ingestible capsule and the packaging upon removal of the ingestible capsule from the accommodation space and / or a physical modification of the accommodation space.

[0026] Moreover, a sensor, e.g. an electronic sensor may be used to detect at least one of a removal of the ingestible capsule from the accommodation space and a physical modification of the accommodation space. The sensor may be operable to generate or to modify an electric sensor signal, which can be processed by the controller electronic circuit in order to determine at least one of the removal of the ingestible capsule from the accommodation space and the physical modification of the accommodation space.

[0027] In either way, the controller electronic circuit may consume electrical power that is substantially smaller than electric power consumed by the electronic circuit of the ingestible capsule when in the operation mode.

[0028] In some examples the electronic circuit of the ingestible capsule comprises a processor, which controls operation of the electronic circuit and hence operation of the ingestible capsule when located inside the lumen of a patient. In some examples the controller electronic circuit and the electronic circuit may be implemented on one and the same printed circuit board. A processor of the operation mode controller and a processor of the electronic circuit may be either provided as separate processors that consume different levels of electric power.

[0029] In other examples, both, a processor of the electronic circuit and a processor of the controller electronic circuit may be integrated in one and the same hardware component. Here, the respective hardware component, e.g. a processor or microcontroller may be operable in a sleep mode with a limited electronic functionality and may be operable in an operation mode with an increased operability, wherein in the operation mode the power consumption of the processor or microcontroller is significantly larger compared to situations where the processor is in the sleep mode.

[0030] According to a further example the electrical contact element is configured to establish an electrical contact with at least one corresponding electrical counter contact element provided in or on the packaging. In this way there may be provided an electrical contact between the electrical contact element of the ingestible capsule and the electrical counter contact element of the packaging when and as long as the ingestible capsule is located inside the accommodation space of the packaging.

[0031] Here, a removal of the ingestible capsule from the accommodation space and / or a physical modification of the accommodation space may immediately lead to a disconnection of the electrical contact between the electrical contact element of the ingestible capsule and the electrical counter contact element of the packaging. This disconnection may be detectable by the operation mode controller, which in response to the disconnection may be operable to switch or to transfer the electronic circuit and hence the ingestible capsule from the sleep mode into the operation mode.

[0032] The interruption or disintegration of the electrical contact between the ingestible capsule and the packaging may also inherently trigger switching of the electronic circuit and / or the ingestible capsule from the sleep mode into the operation mode.

[0033] According to a further example the electrical contact element is electrically connected to the power source and is operable to electrically charge the power source when electrically connected to the electrical counter contact element. Here, the packaging may be provided with a packaging power source and the at least one or several ingestible capsules may be connected to the respective packaging power source when and as long as located inside the accommodation space of the packaging.

[0034] It may be only upon removal of the ingestible capsules from the packaging that the connection between the power source of the ingestible capsule(s) and the power source of the packaging is interrupted or disconnected. In this way and as long as accommodated inside the accommodation space the power source of the ingestible capsules may be constantly or regularly charged by the packaging power source. In this way, the capacity of the local power source of the respective ingestible capsule may be reduced while the packaging may provide sufficient electrical power for the ingestible capsule during the entire shelf life of the ingestible capsule.

[0035] In some examples the packaging for the ingestible capsule may be configured to receive numerous, e.g., 4, 6 or even more than 10 ingestible capsules. Here, each and every ingestible capsule may be electrically connected with its power source to the packaging power source. In this way, the packaging may provide a kind of a power board or power bank for numerous ingestible capsules. During storage and shelf life the individual ingestible capsules may be in electrical contact with the packaging power source and their respective local power sources may be constantly or frequently charged by the packaging power source.

[0036] It may be only upon removal of the ingestible capsule from the packaging or due to a physical modification of the accommodation space of the packaging that the electrical connection between the power source of an ingestible capsule and the packaging power source of the packaging is interrupted or disconnected. Such a disconnection may take place immediately before use of the ingestible capsule. Here, the power source of the ingestible capsule may be charged to a sufficient degree that is suitable to operate the electronic circuit when the ingestible capsule is located inside the lumen of the patient.

[0037] According to a further example the operation mode controller is connected to a first electrical contact element and to a second electrical contact element. The first electrical contact element is connectable to a first electrical counter contact element provided in or on the packaging. The second electrical contact element is connected to a second electrical counter contact element provided in or on the packaging. With first and second contact elements to detachably connect to respective first and second electrical counter contact elements the first and second electrical contact elements may be suitably connected to an external power source, such as a packaging power source by way of which there may be provided electrical power to the power source of the ingestible capsule. Disconnecting of only one of the first and second electrical contact element from one of the complementary first and second electrical counter contact element may be sufficient to detect removal of the ingestible capsule from the accommodation space or to detect a physical modification of the accommodation space. Both scenarios may be used to trigger or to automatically trigger switching or transferring of the ingestible capsule from the sleep mode into the operation mode.

[0038] In a further example of the ingestible capsule the mechanical contact detector comprises an electrical switch connected to or integrated into the controller electronic circuit and switchable by a mechanical counter contact element provided in or on the packaging. Upon a correct assembly and storage of the ingestible capsule inside the accommodation space of the packaging the mechanical contact detector of the ingestible capsule is mechanically coupled and / or is mechanically engaged with the mechanical counter contact element provided in or on the packaging.

[0039] It may be upon removal of the ingestible capsule from the accommodation space and / or upon a physical modification of the accommodation space, that the mechanical contact detector is subject to a detectable movement relative to the mechanical counter contact element of the packaging. This movement may lead to a modification, e.g. to a switching of the electrical switch of the mechanical contact detector. A switching operation of the electrical switch, e.g. induced by a movement of the mechanical contact detector relative to the mechanical counter contact detector may then trigger switching or transferring of the ingestible capsule and / or of its electronic circuit from the sleep mode into the operation mode.

[0040] In a further example the sensor of the ingestible capsule and hence the sensor connectable or connected to the controller electronic circuit of the operation mode controller comprises one of a magnetic sensor, an optical sensor, an acceleration sensor or a force sensor, a temperature sensor and a pressure sensor. The controller electronic circuit is further operable to detect at least one of a variation of: a magnetic field, a brightness, a mechanical force or acceleration, a temperature and variations of an atmospheric pressure to which the ingestible capsule is exposed to.

[0041] By way of the magnetic sensor a surrounding magnetic field can be detected. Moreover, variations of the magnetic field can be detected which may be indicative of a physical modification of the accommodation space and / or of a removal of the ingestible capsule from the accommodation space. The optical sensor, e.g. a photodiode or the like brightness sensor, may be operable to detect any variations of a brightness in the surrounding of the ingestible capsule. Here, a modification of the brightness detectable and / or quantitatively measurable by the optical sensor may be used to detect at least one of a removal of the ingestible capsule from the accommodation space and a physical modification of the accommodation space of the packaging. Hence, opening of the packaging may immediately increase the detectable brightness in direct vicinity of in the direct surrounding of the ingestible capsule. By detecting such variations of the brightness, e.g. by way of the optical sensor, such brightness variations can be used to trigger a transfer or switching of the ingestible capsule from the sleep mode into the operation mode.

[0042] By way of the acceleration sensor any mechanical forces to which the ingestible capsule is exposed to can be detected or quantitatively measured. By way of an acceleration sensor, a movement or movement pattern of the ingestible capsule, e.g. relative to the accommodation space, may be monitored, detected or quantitatively analyzed. Such modifications of a mechanical force or acceleration may then accordingly trigger transferring or switching of the electronic circuit and hence of the ingestible capsule from the sleep mode into the operation mode. Likewise, a raise or drop of a surrounding temperature, which is measurable by a temperature sensor, may likewise trigger a transfer or switching of the ingestible capsule from the sleep mode into the operation mode.

[0043] Moreover, and by way of a pressure sensor a surrounding atmospheric pressure, to which the ingestible capsule is exposed to, can the detected or quantitatively measured. Here, it is conceivable that the ingestible capsule is wrapped or provided in a gas tight enclosure as provided by the accommodation space or by the packaging. The gas tight enclosure may be subject to an over pressure or under pressure and may establish an atmospheric pressure in the direct vicinity or environment of the ingestible capsule inside the accommodation space. When the inside pressure, e.g. inside the gas tight enclosure of the accommodation space, differs from an outside atmospheric pressure a pressure variation can be detected immediately during or after opening of the packaging or by disrupting or destroying the gas tight enclosure of the ingestible capsule.

[0044] A measurable or detectable pressure variation may then trigger switching of the ingestible capsule and / or of its electronic circuit from the sleep mode into the operation mode.

[0045] In some examples the sensor comprises a magnetic sensor and when the packaging or parts thereof may be provided with a permanently magnetized section or portion. Upon removal of the ingestible capsule from the accommodation space and / or upon a physical modification of the accommodation space the magnetic sensor may detect or quantitatively measure a respective variation of the magnetic field, which detectable variation may then trigger a transfer or switching of the electronic circuit from the sleep mode into the operation mode.

[0046] Accordingly and in further examples the operation mode controller is configured to transfer or to switch the ingestible capsule and / or its electronic circuit from the sleep mode into the operation mode in response to detect at least one of a variation of a magnetic field, a variation of the brightness, a variation of a mechanical force or acceleration, a variation of a surrounding temperature and / or a variation of an atmospheric pressure to which the ingestible capsule is exposed to.

[0047] According to a further example the ingestible capsule comprises at least one electrical consumer connected or connectable to the power source of the ingestible capsule. The at least one electrical consumer comprises one of an injector to inject a medicament into the lumen or tissue of the patient, a dispenser to dispense a medicament into the lumen of the patient, an anchoring member to attach the ingestible capsule to biological tissue, e.g. to a wall of the gastrointestinal tract of the patient, and a physiological sensor operable to detect or to measure a physiological parameter of the patient.

[0048] The electrical consumer is inoperable or inactive as long as the ingestible capsule is in the sleep mode. The electrical consumer may be inoperable or inactive as long as the electronic circuit of the ingestible capsule is in the sleep mode. In some examples the ingestible capsule comprises a medicament reservoir, which is coupled or connected to at least one of the injector and the dispenser. This way, and when activated the injector or dispenser may be operable to inject or to dispense a well-defined amount of the medicament, e.g. a dose, into the lumen or tissue of the patient while and when the ingestible capsule is inside a lumen of the patient.

[0049] The anchoring member may be operable to attach the ingestible capsule at least temporarily to biological tissue, e.g. to a a portion of the gastrointestinal tract of the patient. This way, the anchoring member may serve to keep the ingestible capsule at a well-defined portion or section inside the human or animal body in order to conduct collection or gathering of physiological parameters from that particular region or section and / or to dispense or to inject the medicament over a respective time interval.

[0050] By keeping the ingestible capsule in the sleep mode the electrical consumer as mentioned above may be inoperable or inactive. Accordingly, their respective power consumption may be at a minimum. In this way, the overall power consumption of the ingestible capsule during shelf life, storage or shipment can be reduced to a minimum. The overall shelf life may be expanded or prolonged.

[0051] According to another aspect the present disclosure relates to a packaging for at least one ingestible capsule as described above. The packaging comprises an accommodation space to receive the at least one ingestible capsule. Insofar and since the packaging is particularly designed for storage of at least one or several of the above-mentioned ingestible capsules the same features, effects and benefits as described above in connection with the ingestible capsule equally apply to the packaging; and vice versa.

[0052] The accommodation space may be particularly configured and designed for receiving at least one or several of the above-mentioned ingestible capsules. The packaging may be configured and designed to allow and to support detection of a removal of the ingestible capsule from the accommodation space and / or to detect a physical modification of the accommodation space, which may precede removal of the ingestible capsule from the accommodation space.

[0053] According to a further example the packaging further comprises at least one of an electrical counter contact element to establish electrical contact with an electrical contact element of the ingestible capsule and a mechanical counter contact elements to mechanically engage with a mechanical contact detector of the ingestible capsule.

[0054] The mechanical counter contact element may be simply provided by a sidewall or by a bottom or bottom section of the packaging. The mechanical counter contact element may serve to interact with the mechanical contact detector of the ingestible capsule. Here and upon removal of the ingestible capsule from the accommodation space the mechanical contact detector may detect a loss of contact with the mechanical counter contact element of the packaging and may directly or indirectly trigger switching of the electronic circuit of the ingestible capsule from the sleep mode into the operation mode.

[0055] In some examples the mechanical counter contact element may protrude from an inside surface of the sidewall or bottom of the packaging and may mechanically engage with the mechanical contact detector of the ingestible capsule. Moving of the ingestible capsule relative to the packaging may disintegrate or abrogate the mechanical contact between the mechanical counter contact element of the packaging and the mechanical contact detector of the ingestible capsule. Switching or transferring of the ingestible capsule and / or of its electronic circuit from the sleep mode into the operation mode may be then likewise triggered.

[0056] In the same way or similarly, the electrical counter contact element may be in electrical contact with the electrical contact element of the ingestible capsule. Also here, removal or a respective removing movement of the ingestible capsule relative to the packaging may disconnect the electrical contact between the electrical counter contact element of the packaging and the electrical contact element of the ingestible capsule. Loss of electrical contact between the electrical counter contact element and the electrical contact element may either be detected by the operation mode controller or may directly trigger switching of the electronic circuit and / or of the ingestible capsule from the sleep mode into the operation mode.

[0057] According to a further example the accommodation space for the at least one ingestible capsule provides a gas tight enclosure. The gas tight enclosure is either destroyable, openable or destructible for a removal of the ingestible capsule from the accommodation a. Here, there may be provided only one ingestible capsule inside the gas tight enclosure. Inside the gas tight enclosure there may be provided an inside pressure that distinguishes from an outside atmospheric pressure. Hence, the interior of the gas tight enclosure may be provided at an upper pressure or at an under pressure compared to the surrounding atmospheric pressure.

[0058] Opening of the gas tight and closure may then lead to a measurable variation of the surrounding atmospheric pressure in direct vicinity of the ingestible capsule. This pressure variation may be detected by a pressure sensor and may be further processed by the operation mode controller to switch or to transfer the electronic circuit and hence the ingestible capsule from the sleep mode into the operation mode.

[0059] By way of a gas tight enclosure, the ingestible capsule may be also protected against other environmental influences, such as dust and humidity.

[0060] According to a further example the ingestible capsule is accommodated inside the gas tight enclosure wherein the gas tight enclosure comprises an inside pressure that differs from an outside atmospheric pressure. The inside pressure may be an under pressure or an overpressure compared to the outside atmospheric pressure. In either way and by opening the gas tight enclosure or by destroying the gas tight enclosure the inside pressure will adopt the outside atmospheric pressure. Insofar, a pressure sensor of the ingestible capsule may detect a variation of the pressure surrounding the ingestible capsule, which may then trigger transferring or switching of the electronic circuit and hence of the entire ingestible capsule from the sleep mode into the operation mode.

[0061] Wrapping or packaging the ingestible capsule in a gas tight enclosure, wherein the gas tight enclosure comprises an inside pressure that differs from an outside atmospheric pressure, may also provide an immediate feedback to a user of the ingestible capsule, namely in that opening of the gas tight enclosure is typically accompanied by an escape or intake of air from or inside the gas tight enclosure, which is perceptible or noticeable by a user. Hence, a user opening a gas tight enclosure without perceiving or noticing a respective pressure equalization or pressure compensation will be immediately warned, that the packaging may be damaged or harmed and that the ingestible capsule may not be used.

[0062] According to a further example the at least one ingestible capsule is arranged inside the accommodation space. Hence, the packaging comprises or constitutes an accommodation space to receive the at least one ingestible capsule and the packaging further comprises the at least one ingestible capsule arranged, wrapped or packed inside the accommodation space.

[0063] According to a further aspect the present disclosure also relates to a method of preparing an ingestible capsule for intake by a user or patient. The method comprises the steps of providing an ingestible capsule as described above in a sleep mode inside a packaging as described above. Thereafter, at least one of a removal of the ingestible capsule from the accommodation space and a physical modification of the accommodation space is detected. This detection may be conducted by the ingestible capsule itself. Here, the operation mode controller of the ingestible capsule may be operable to detect at least one of a removal of the ingestible capsule from the accommodation space and a physical modification of the accommodation space. Both events typically take place immediately before the ingestible capsule will be swallowed or ingested by the patient or user.

[0064] Upon detecting of at least one of a removal of the ingestible capsule from the accommodation space and a physical modification of the accommodation space the ingestible capsule and / or the electronic circuit of the ingestible capsule is transferred or switched from the sleep mode into an operation mode.

[0065] The method of preparing an ingestible capsule is to be conducted by an ingestible capsule as described above, typically in combination with a packaging as described above. Insofar, all features, effects and benefits as described above in connection with the ingestible capsule and / or in connection with the packaging equally apply to the method of preparing the ingestible capsule.

[0066] In general and by making use of the ingestible capsule, the packaging and the method of preparing the ingestible capsule as described above, the overall shelf life of the ingestible capsule can be prolonged, the dimensions of the power source to be implemented or used with the ingestible capsule can be reduced and the ecological footprint of the ingestible capsule as well as the geometric size of the ingestible capsule can be minimized.

[0067] 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.

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] 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. 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.

[0074] 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.

[0075] 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.

[0076] 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.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] 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).

[0081] 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.

[0082] 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.

[0083] 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).

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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). 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).

[0088] Brief description of the drawings

[0089] In the following, numerous examples of ingestible capsules and ways to reduce power consumption during shelf life are illustrated in greater detail by making reference to the drawings, in which:

[0090] Fig. 1 is a schematic illustration of numerous ingestible capsules provided in an outer packaging,

[0091] Fig. 2 schematically illustrates withdrawal of ingestible capsules from the packaging according to Fig. one,

[0092] Fig. 3 schematically shows an example of a mechanical interaction between an ingestible capsule and the packaging,

[0093] Fig. 4 schematically shows an example of an electrical coupling between an ingestible capsule and the packaging,

[0094] Fig. 5 shows a mechanical interaction between the ingestible capsule and the packaging in a first configuration,

[0095] Fig. 6 shows the interaction between the ingestible capsule and the packaging of Fig. 5 in a second configuration,

[0096] Fig. 7 shows an electrical interaction between the ingestible capsule and the packaging in a first configuration,

[0097] Fig. 8 shows the interaction between the ingestible capsule and the packaging of Fig. 7 in a second configuration,

[0098] Fig. 9 shows another example of an ingestible capsule in an outer packaging in a first configuration,

[0099] Fig. 10 shows the example of Fig. 9 in a second configuration, Fig. 11 shows another example of an ingestible capsule in an outer packaging in a first configuration,

[0100] Fig. 12 shows the example of Fig. 11 in a second configuration,

[0101] Fig. 13 schematically shows a block diagram of an example of the ingestible capsule and Fig, 14 is a flowchart of a method of managing electric power consumption of an ingestible capsule.

[0102] Detailed description

[0103] In Figs. 1-13 there are shown numerous examples of an ingestible capsule 50 configured for ingestion into a lumen of a patient in combination with a packaging 10. In the perspective illustration of Fig. 1 there is shown a packaging 10 providing an accommodation space 11 for numerous ingestible capsules 50. The ingestible capsules 50, 50', 50" are individually arranged and fastened inside the accommodation space 11 as may become apparent from Fig. 2. There, each one of the ingestible capsules 50 is provided with a contact detector 76 to make mechanical contact with a counter contact element 29 as provided e.g. on one of a sidewall 14 and a bottom 15 of the packaging 10.

[0104] Upon removal of ingestible capsule 50', 50" from the accommodation space 11 as e.g. shown in Fig. 2, the mechanical contact between the contact detector 76 and the counter contact element 29 may be abrogated or disconnected. This disconnection between the contact detector 76 and the packaging 10 may be detected by an operation mode controller 70 of the ingestible capsule 50. In response to a detection of a mechanical disconnection from the packaging 10 the operation mode controller 70 of the ingestible capsule 50 may be operable to switch or to transfer the ingestible capsule 50 and / or an electronic circuit 54 of the ingestible capsule 50 from a sleep mode into an operation mode.

[0105] In the operation mode the ingestible capsule 50 may start to operate and may start to consume electrical power provided by a power source 52. During and when in the sleep mode electrical power consumption of the ingestible capsule 50 may be either zero or may be at a minimum. Here, electrical power consumption may be limited to the operation of an e.g. electrically implemented operation mode controller 70.

[0106] In some examples, the operation mode controller 70 may be implemented purely mechanically and may not consume any electrical power during the sleep mode of the ingestible capsule 50.

[0107] In the example of Figs. 3, 5 and 6, the ingestible capsule 50, 50' comprises a contact detector 76 which may establish a mechanical contact with the counter contact element 29 as provided on the bottom 15 or sidewall 14 of the packaging. Here, the mechanical counter contact element 29 may comprise a pin protruding outwardly from the bottom 15. The pin of the counter contact element 29 may establish electrical contact with a complementary-shaped recess of a contact detector 76 as provided on an outside of a capsule housing 51 of the ingestible capsule 50, 50'.

[0108] The ingestible capsule 50 as shown in Fig. 3 may be still in mechanical contact with the counter contact element 29. Here, the ingestible capsule 50 may be and remain in the sleep mode. The ingestible capsule 50' may be detached from a respective counter contact element 29 during or upon removal from the accommodation space 11. This kind of disconnection may be electrically and / or electromechanically detected by the operation mode controller 70 as will be explained in greater detail with regard to Figs. 5 and 6.

[0109] In Fig. 5, the ingestible capsule 50 is located in a predefined storage position inside the accommodation space 11 as provided by the packaging 10. Here, the contact detector 76 of the operation mode controller 70 comprises an electrical switch 79, which in the configuration according to Fig. 5, interrupts an electronic circuit 54 of the ingestible capsule 50. Here and in the open configuration of the switch 79 the electronic circuit 54 of the ingestible capsule 50 is effectively disconnected from the power source 52.

[0110] Upon removal of the ingestible capsule 50 from a storage position inside the accommodation space 11 as indicated in Fig. 6, the counter contact element 29 as provided on or inside the packaging 10, e.g. at the bottom 15 of the packaging 10, gets out of engagement from the electrical switch 79 of the controller electronic circuit 71 of the operation mode controller 70. In this way, the switch 79 may establish an electrical interconnect between the electronic circuit 54 and the power source 52. The switch 79 may be biased by a spring and may tend to automatically transfer into the closed configuration as shown in Fig. 6.

[0111] Here and in the example of Figs. 3, 5 and 6 the operation mode controller 70 may be implemented all mechanically. The operation mode controller 70 may be operable to disconnect an electrical connection between the electronic circuit 54 of the ingestible capsule 50 from the power source 52 when and as long the ingestible capsule 50 is located at a predefined position inside the accommodation space 11 of the packaging 10. It may be due to a removal or due to a movement of the ingestible capsule 50 relative to the packaging 10 that the electrical switch 79 and hence the mechanical contact detector 76 of the operation mode controller 70 comes out of engagement with the counter contact element 29 as provided on or inside the accommodation space 11. As a consequence, the switch 79 may transfer into a closed configuration thereby establishing an electrical connection between the electronic circuit 54 and the power source 52. This way, the ingestible capsule 50 and / or it electronic circuit 54 may be switched into the operation mode from the sleep mode upon removal of the ingestible capsule 50 from the accommodation space 11 of the packaging 10.

[0112] In the further example as shown in connection with Figs. 4 with Figs. 7 and 8, the ingestible capsule 50 comprises a first electrical contact element 72 and a second electrical contact element 73, which may establish electrical contact with first and second electrical counter contact elements 27, 28 as provided on or inside the accommodation space 11 of the packaging 10. Here, the first counter electrical contact element 27 may be connected to a first terminal of a packaging power source 13. The second electric counter contact element 28 may be connected to a second terminal of a packaging power source 13.

[0113] As becomes further apparent From Fig. 13 in combination with Fig. 4 and when the first and second electrical contact elements 72, 73 are electrically connected to respective first and second electrical counter contact elements 27, 28 the power source 52 of the ingestible capsule 50 may be connected to the packaging power source 13. Accordingly, the power source 52 may be charged by the packaging power source 13. The capacity of the packaging power source 13 may be larger than the capacity of the local power source 52 of the individual ingestible capsules 50.

[0114] In this way and as long as the ingestible capsule 50 is duly stored inside the accommodation space 11 the local power source 52 of the respective ingestible capsules 50 may be electrically connected to a packaging power source 13 that may be subject to a constant, temporary and / or regular charging. In this way, the shelf life of the ingestible capsule 50 can be prolonged and extended. It is only upon removal of the ingestible capsule 50 from the packaging 10, that the electrical contact between the electrical contact elements 72, 73 with the corresponding electrical counter contact element 27, 28 is abrogated.

[0115] In the example of Figs. 7 and 8 there may be provided a mechanical and / or electrical counter contact element 29 at or inside the packaging 10. Here, the counter contact element 29 comprises an electrically conducting counter contact 30, e.g. implemented as a bridging contact. In a storage configuration of the ingestible capsule 50 inside the packaging 10 as illustrated in Figs. 7 the electrical conducting counter contact 30 may establish an electrical contact between the first and second electrical contact elements 72, 73 of the controller electronic circuit 71 of the operation mode controller 70 of the ingestible capsule 50.

[0116] In the storage configuration as shown in Fig. 7, the electrical contact between the contact element 72, 73 is closed by the electrical counter contact 30 thus providing a bridging contact between the first and second electric contact elements 72, 73. Upon removal of the ingestible capsule 50 from the accommodation space 11 the electrical contact between the first and second contact elements 72, 73 is abrogated. This change in the electrical conductivity between the first and the second electrical contact element 72, 73 may be detectable by a controller processor 75, which is connected to or integrated into the controller electronic circuit 71 of the operation mode controller 70.

[0117] Here and due to a detectable modification or change of electrical conductivity or connectivity between the first electrical contact element 72 and the second electrical contact element 73 the controller processor 75 of the controller electronic circuit 71 of the operation mode controller 70 may switch or trigger a transfer of the electronic circuit 54 and / or of the entire ingestible capsule 50 from the sleep mode into the operation mode.

[0118] The block diagram of the ingestible capsule 50 as shown in Fig. 13 is indicative of numerous possible implementations of an operation mode controller 70 to transfer or to switch the electronic circuit 54 of the ingestible capsule 50 from the sleep mode into the operation mode. Generally, the ingestible capsule 50 may comprise a biocompatible capsule housing 51.

[0119] The ingestible capsule 50 may further comprise a delivery unit 60 with a drive unit 61 that is operable by electrical power obtained or provided by the power source 52. The delivery unit 60 may be further provided or may comprise a medicament container 62, which is connected with an injector 63 or dispenser. Operation of the delivery unit 60 may be electronically controlled by the electronic circuit 54. For this, the electronic circuit 54 may comprise a respective processor 55, e.g. implemented as a microcontroller.

[0120] In order to control operation of the delivery unit 60 the electronic circuit 54 is further connected or coupled to at least one sensor 56, 57. In some examples the electronic circuit 54 may be further operable to control operation of an anchoring member 58, which is operable to attach the ingestible capsule 50 to a dedicated portion inside the body or lumen of a patient. One of the sensors 56, 57 may be implemented as a pH sensor. In this way, the electronic circuit 54 may be operable to detect or to determine if the ingestible capsule is located e.g. inside a stomach or inside the small or large intestine of a patient. In some examples, one of the sensors 56, 57 may be operable to measure certain enzymes or concentration of enzymes in order to determine if the ingestible capsule is located in a predefined region of a lumen of a body of a patient.

[0121] Depending on the sensor signals obtainable from at least one of the sensors 56, 57 the electronic circuit 54, specifically the processor 55, may decide to activate the anchoring member 58 and / or to trigger dispensing or injection of the medicament by operating the drive unit 61 of the delivery unit 60.

[0122] Operation of the sensors 56, 57 as well as operation of the processor 55 may consume significant electrical power provided by the power source 52.

[0123] During shelf life, operation and power consumption of the electronic circuit 54 may be expendable. Insofar, the ingestible capsule 50 is equipped with the operation mode controller 70, e.g. comprising a controller electronic circuit 71 , which is driven by the power source 52 but which consumes significantly less power compared to the power consumption of the electronic circuit 54 and / or of the delivery unit 60.

[0124] The operation mode controller 70 may comprise a controller electronic circuit 71. The operation mode controller 70 may be equipped with a controller processor 75, which is operable to process signals obtainable from at least one of the sensors 77, 78, the contact detector 76 and / or from a detectable element 74. The contact detector 76 may be implemented as described above, e.g. in connection with at least one of the examples according to Figs. 3-8. The contact detector 76 may be operable to detect a mechanical contact between the ingestible capsule 50 and the packaging 10.

[0125] The sensors 77, 78 may be implemented as a magnetic field sensor, as an optical sensor, as an acceleration sensor, as a temperature sensor or as a pressure sensor. Likewise, the sensor 78 may be implemented as one of a magnetic sensor, an optical sensor, an acceleration sensor, a temperature sensor and a pressure sensor.

[0126] The detectable element 74 may comprise a permanent magnet or a magnetic field located at or integrated into the packaging 10. Here, removal of the ingestible capsule 50 from the packaging 10 may increase a distance between the detectable element 74, which is detectable or measurable by at least one of the sensors 77, 78. Typically, a magnetic sensor may be operable to detect a variation of the magnetic field, which variation arises due to a movement or removal of the ingestible capsule 50 from the packaging 10.

[0127] Sensor signals of a respective magnetic sensor may be processed by the controller processor 75 and may be used to switch or transfer the electronic circuit 54 and hence the ingestible capsule 50 from the sleep mode into the operation mode.

[0128] As further indicated in Fig. 13 the operation mode controller 70 may be operable to disconnect an electrical connection between the power source 52 and at least one or both of the electronic circuit 54 and the delivery unit 60. In this way, power consumption during the shelf life can be reduced to a minimum.

[0129] In some examples, the controller processor 75 of the operation mode controller 70 and the processor 55 of the electronic circuit 54 are provided and implemented as separate microcontrollers. Here, the controller processor 75 is intended for low-power operation over a longer period of time, e.g. during the entire shelf life of the ingestible capsule 50. The processor 55 of the main electronic circuit 54 may be configured and intended for high complexity calculations and / or data or signal transmission to external electronic devices. It may be operable for high complexity calculations and numerical calculations and may include inter alia a digital signal processor, data heuristics, cryptography operations for communication, checksum calculation and other digital processing units. In some examples, the processor 55 has a higher power consumption than the controller processor 75 and may be therefore used or activated only when the ingestible capsule 50 is inside the bodily lumen of the patient. Generally, such concepts can be realized with discrete microcontroller units connected by a data bus or by using a system-on-chip (SoC) implementing multiple cores of different type.

[0130] In the example of Figs. 1-8, the packaging 10 may comprise a card box -like packaging. The packaging 10 may comprise a button 15, a sidewall 14 surrounding one side of the button 15 and further comprising a movable lid 16 by way of which the enclosure 12 formed by the bottom 15 and the sidewall 14 can be selectively closed or opened.

[0131] In some examples, the packaging 10 may be made of a non-transparent or opaque material. Insofar and when in a closed configuration, e.g. with a closed lid 16, the interior of the packaging 10 and hence the accommodation space 11 may be dimmed or darkened. Opening of the packaging 10, e.g. by pivoting the lid 16 into an open configuration as shown in Fig. 1 may expose the individual ingestible capsules 50 to a significant brightness, which change in brightness may be detected by one of the sensors 77, 78, e.g. implemented as an optical sensor. Hence, by opening of the packaging 10 the ingestible capsule 50 may be switched from the sleep mode into the operation mode.

[0132] In the example as illustrated in Figs. 9 and 10 the packaging 10 comprises a gas tight enclosure 12, which may be formed or established by a pliable shell 17. The shell 17 may comprise a first shell part 18 and a second shell part 19, which are mutually connected along a seam 20. In an initial configuration the interior of the packaging 10, hence the enclosure 12 as confined by the shell 17 may be exposed to an inside atmospheric pressure pi, which is larger than an outside pressure po. Upon opening and upon establishing an opening 32 or through opening in the packaging 10 as shown in Fig. 10, the inside pressure pi may adapt to the outer pressure po. Here, the sensor 77 of the operation mode controller 70, which may be implemented as a pressure sensor may detect or quantitatively measure a respective pressure modification. This pressure modification may then be used to trigger switching or transferring of the electronic circuit 54 from the sleep mode into the operation mode.

[0133] Also here, the shell 17 may be made of a non-transparent or opaque material. By opening of the shell 17 and / or by removing the ingestible capsule 50 from the shell 17 or enclosure 12 them ingestible capsule 50 may be exposed to an increase of a surrounding brightness, which may be detected by an optical sensor to trigger switching or transferring of the ingestible capsule 50 from the sleep mode into the operation mode.

[0134] In a similar way and as shown in Figs. 11 and 12 the packaging 10 may comprise numerous individual compartments 24, 24', 24", each of which forming or establishing an accommodation space 11 , 11', 11". Here, each accommodations space 11, 11', 11" and hence each compartment 24, 24', 24" is provided with a single ingestible capsule 50, 50', 50". The ingestible capsules 50 comprise at least one sensors 77, which may be implemented as a pressure sensor, as a magnetic sensor, as an optical sensor, as an acceleration sensor or the like sensors.

[0135] The compartment 24, 24', 24" may be sealed and closed by a closure 25, e.g. comprising a rupturable foil 26, e.g. an aluminum foil. Insofar, the packaging 10 as shown in Figs. 11 and 12 may comprise a kind of a blister packaging.

[0136] Upon withdrawal or removal of the ingestible capsule 50 out of a compartment 24, the sensor 77 may detect a respective withdrawal event, e.g. by detecting a variation of the brightness, by a variation of the mechanical force applied to the ingestible capsule 50, by monitoring or detecting a variation of the temperature answers or by detecting or monitoring a variation of at least one of an atmospheric pressure and a magnetic field in the surrounding of the ingestible capsule 50.

[0137] Each one of these variations of such measurable parameters may be used to trigger switching or transferring of the electronic circuit 54 and hence of the entire ingestible capsule 50 from the sleep mode into the operation mode.

[0138] In the flowchart of Fig. 14 a method of preparing an ingestible capsule for intake by a user is schematically described. Here and in a first step 100 and ingestible capsule 50 as described herein is provided in a sleep mode inside a packaging 10 as described above. In step 102 it is detected if the ingestible capsule is either removed from the accommodation space 11 of the packaging 10 and / or if a physical modification of the accommodation space 11 takes place.

[0139] In step 104 the result of this detection is evaluated. If in step 104 a removal of the ingestible capsule from the accommodation space or a physical modification of the accommodation space 11 is detected the method continues with step 106, where the ingestible capsule and / or its electronic circuit 54 is switched or transferred from the sleep mode into the operation mode.

[0140] In other situations and when the evaluation of step 104 reveals that the ingestible capsule 50 still remains inside the accommodation space 11 and that the accommodation space is not subject to a physical modification the procedure returns to step 102, in which the presence of the ingestible capsule 50 within the accommodation space is detected again.

[0141] Detection of the ingestible capsule within the accommodation space can be conducted either actively, e.g. by an electronically implemented controller electronic circuit 71 of the operation mode controller 70. Alternatively, it can be detected passively as e.g. shown and described above, e.g. with regards to Figs. 3-6.

[0142] Reference Numbers

[0143] 10 packaging

[0144] 11 accommodation space

[0145] 12 enclosure

[0146] 13 power source

[0147] 14 sidewall

[0148] 15 bottom

[0149] 16 lid

[0150] 17 shell

[0151] 18 shell part

[0152] 19 shell part

[0153] 20 seam

[0154] 21 elastic foil

[0155] 24 compartment

[0156] 25 closure

[0157] 26 foil

[0158] 27 counter contact element

[0159] 28 counter contact element

[0160] 29 counter contact element

[0161] 30 counter contact

[0162] 32 opening

[0163] 50 ingestible capsule

[0164] 51 capsule housing

[0165] 52 power source

[0166] 54 electronic circuit

[0167] 55 processor

[0168] 56 sensor

[0169] 57 sensor

[0170] 58 anchoring member

[0171] 60 delivery unit

[0172] 61 drive unit

[0173] 62 medicament container

[0174] 63 injector

[0175] 70 mode controller

[0176] 71 electronic circuit

[0177] 72 contact element 73 contact element

[0178] 74 detectable element

[0179] 75 processor

[0180] 76 contact detector 77 sensor

[0181] 78 sensor

[0182] 79 electrical switch

Claims

Claims1. An ingestible capsule (50) configured for ingestion into a lumen of a patient, the ingestible capsule (50) comprising: a power source (52) an electronic circuit (54) connectable or connected to the power source (52) and an operation mode controller (70) operable to transfer or to switch the ingestible capsule (50) from a sleep mode into an operation mode, wherein the operation mode controller (70) is configured to detect a presence of the ingestible capsule (50) within an accommodation space (11) of a packaging (10).

2. The ingestible capsule (50) according to claim 1, wherein the operation mode controller (70) is configured to transfer or to switch the ingestible capsule (50) from the sleep mode into the operation mode in response to detect at least one of: a removal of the ingestible capsule (50) from the accommodation space (11), a physical modification of the accommodation space (11).

3. The ingestible capsule (50) according to any one of the preceding claims, wherein electronic circuit (54) is disconnected from the power source (52) when the ingestible capsule (50) is in the sleep mode and wherein the operation mode controller (70) is operable to connect the electronic circuit (54) to the power source (52) upon detecting of at least one of: a removal of the ingestible capsule (50) from the accommodation space (11), a physical modification of the accommodation space (11).

4. The ingestible capsule (50) according to any one of the preceding claims, wherein the operation mode controller (70) comprises a controller electronic circuit (71) connected to at least one of: an electrical contact element (72, 73), a mechanical contact detector (76) and a sensor (77, 78) to detect the presence of the ingestible capsule (50) within the accommodation space (11).

5. The ingestible capsule (50) according to claim 4, wherein the electrical contact element (72, 73) is configured to establish an electrical contact with at least one complementary - shaped electrical counter contact element (27, 28) provided in or on the packaging (10).

6. The ingestible capsule (50) according to claim 5, wherein the electrical contact element (72, 73) is electrically connected to the power source (52) and is operable to electrically charge the power source (52) when electrically connected to the electrical counter contact element (27, 28).

7. The ingestible capsule according to claim 6, wherein the operation mode controller (70) connected to a first electrical contact element (72) and to a second electrical contact element (73) and wherein the first electrical contact element (72) is connectable to a first electrical counter contact element (27) provided in or on the packaging (10) and wherein the second electrical contact element (73) is connectable to a second electrical counter contact element (28) provided in or on the packaging (10).

8. The ingestible capsule (50) according to any one of the preceding claims 4-7, wherein the mechanical contact detector (76) comprises an electrical switch (79) connected to or integrated into the controller electronic circuit (71) and switchable by a mechanical counter contact element (29) provided in or on the packaging (10).

9. The ingestible capsule (50) according to any one of the preceding claims 4-8, wherein the sensor (77, 78) comprises one of: a magnetic sensor, an optical sensor, an acceleration sensor, a temperature sensor, and a pressure sensor, and wherein the controller electronic circuit (71) is operable to detect at least one of a variation of: a magnetic field, a brightness, a mechanical force, a temperature and an atmospheric pressure to which the ingestible capsule (50) is exposed to.

10. The ingestible capsule (50) according to claim 9, wherein the operation mode controller (70) is configured to transfer or to switch the ingestible capsule (50) from the sleep mode into the operation mode in response to detect at least one of variation of: a magnetic field,a brightness, a mechanical force, a temperature and an atmospheric pressure to which the ingestible capsule (50) is exposed to.

11. The ingestible capsule (50) according to any one of the preceding claims, wherein the ingestible capsule (50) comprises at least one electrical consumer (53) connected or connectable to the power source (52), wherein the at least one electrical consumer (53) comprises one of: an injector (63) to inject a medicament into the lumen of the patient, a dispenser to dispense a medicament into the lumen of the patient, an anchoring member (58) to attach the ingestible capsule (50) to biological tissue of the patient, and a physiological sensor (56, 57) operable to detect or to measure a physiological parameter of the patient, and wherein the electrical consumer (53) is inoperable or inactive as long as the ingestible capsule (50) is in the sleep mode.

12. A packaging (10) for at least one ingestible capsule (50) according to any one of the preceding claims, the packaging (10) comprising: an accommodation space (11) to receive the at least one ingestible capsule (50).

13. The packaging (10) according to claim 12, further comprising at least one of: an electrical counter contact element (27, 28) to establish electrical contact with an electrical contact element (72, 73) of the ingestible capsule (50), a mechanical counter contact element (29) to mechanically engage with a mechanical contact detector (76) of the ingestible capsule (50).

14. The packaging (10) according to any one of the preceding claims 12 or 13, wherein the accommodation space (11) for the at least one ingestible capsule (50) is provided in a gas tight enclosure (12), which is destroyable for a removal of the ingestible capsule (50) from the accommodation space (11).

15. The packaging (10) according to claim 14, wherein when the ingestible capsule (50) is accommodated inside the gas tight enclosure (12), and wherein the gas tight enclosure (12) comprises an inside pressure (pi) that differs from an outside atmospheric pressure (po).

16. The packaging (10) according to any one of the preceding claims 12 to 15, wherein the at least one ingestible capsule (50) is arranged inside the accommodation space (11).

17. A method of preparing or deploying an ingestible capsule (50) for intake by a user or patient, the method comprising the steps of: providing an ingestible capsule (50) according to any one of the preceding claims 1-11 in a sleep mode inside a packaging (10) according to any one of the preceding claims 12-16, detecting of at least one of a removal of the ingestible capsule (50) from the accommodation space (11) and a physical modification of the accommodation space (11), and transferring or switching of the ingestible capsule (50) from the sleep mode into an operation mode upon detection of at least one of the removal of the ingestible capsule (50) from the accommodation space (11) and the physical modification of the accommodation space (11).

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