Integrated injection system and injection device

Abstract

To provide an integrated injection system comprising an injection device that collects data about an injection event and physical characteristics of a patient and transmits the data to a receiver.SOLUTION: An integrated injection system comprises: an injection device comprising a drug delivery portion and a data transmitter; and a communication device that is external to the injection device. The injection device further includes a data capture module including at least one sensor, the module being configured to sense information about a physical condition and / or behavior of a patient during an injection by the at least one sensor. The data transmitter is configured to be in electronic communication with the communication device. The data transmitter is configured to transmit at least a part of the sensed information to the communication device. The injection device further comprises an external housing enclosing the drug delivery portion and the data transmitter.SELECTED DRAWING: Figure 10

Description

Technical Field

[0001] The present invention generally relates to an integrated injection system comprising an injection device that collects data regarding an injection event and a patient's physical characteristics and transmits the data to a receiver.

Background Art

[0002] In the healthcare community, it is generally recognized that the cost per capita must be reduced. In particular, as the population ages and countries spend less on healthcare, the amount of money available to pay for healthcare per capita will necessarily decrease. As a result, patients are becoming more self-administered in order to eliminate the costs associated with simple (e.g., non-diagnostic) procedures related to visiting a healthcare professional. This is already happening with patients suffering from diabetes, rheumatoid arthritis, or multiple sclerosis, and may become the norm for other treatments in the future, including contraceptives, cosmetics, or vaccines. Individuals who self-administer treatment have different needs and requirements than patients who receive treatment from trained professionals. Therefore, the types of attractive pharmaceutical dispensing devices for untrained individuals will differ from the types of devices used by trained healthcare professionals.

[0003] The rapidly increasing healthcare costs require healthcare providers to reevaluate how medications are provided to patients and how the effectiveness of prescription medications is evaluated. For example, it is necessary to have better control over the supply and demand of medications. Also, since chronic patients account for the majority of healthcare costs, it is necessary to better manage chronic diseases. Specifically, overspending for chronic patients is common as a result of patients failing to follow the prescribed treatment. In addition, it is necessary to focus on predicting and detecting potential health risks early.

[0004] Currently, compliance with a patient's prescribed treatment generally relies on information self-reported by the patient to the healthcare provider. The patient may keep a log that includes information such as when medications were taken and, in the case of diabetes, some diagnostic information such as blood glucose levels. In each of these examples, note that the patient has a significant responsibility for the treatment and, in some cases, the diagnosis. The patient must not only take the prescribed amount of medication at the correct time, but also document whether the medication was taken or injected, perform tests (i.e., blood tests for insulin levels), record the results, and, in some cases, interpret the results and determine whether additional medication needs to be taken. As the number of actions the patient must perform increases, so does the likelihood that the patient will not comply with the provided instructions.

[0005] Alternatively, the patient may visit a healthcare facility at various intervals to receive tests performed during the course of a medication treatment plan. The need for additional visits to the healthcare facility for diagnostic procedures increases the cost of healthcare. In addition, patients often consider the cost of tests and diagnostics to be less important than the treatment and, as a result, are reluctant to bear the expense of such tests. Therefore, the patient will either continue to take the medication and forgo the prescribed tests or completely avoid alternative treatments that require additional tests during the course of the treatment plan.

[0006] Accordingly, there is a need for an injection device that can extract information from a patient in order to provide an indication of the patient's health status during a treatment session. Medical professionals should be able to access the information quickly and automatically in order to trigger a continuous diagnosis and, if necessary, change the treatment plan. In order to determine when the patient is most likely to follow the treatment instructions and to understand why the patient is unable to follow the treatment instructions, it is necessary to correlate information regarding the patient's compliance with the prescribed treatment and physical state with data from other patients. The data may also be used to guide the patient on how to better comply with the prescribed treatment, and, if necessary, to change treatment options to further encourage the patient's compliance. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0007] Embodiments of the present invention are directed to an integrated system for injection, including an injection device electrically connected to a communication device. The external communication device may be a handheld electronic device such as a smartphone or a dedicated reader such as a reader capable of reading information included in an RFID tag. The injection device includes a needle, a drug delivery unit, and an outer housing. Optionally, a data acquisition module including a plurality of sensors is fixed to the surface of the needle. The injection device further includes an electronic chip having a function of storing information about the injection and about the patient's physical state. The electronic chip may be a readable and writable electronic chip such as a non-volatile memory chip, for example, an electrically erasable programmable read-only memory (EEPROM). Alternatively, the electronic chip can be a passively read RFID tag. The injection device may further include a data transmitter for transmitting information acquired from the data acquisition module to the external communication device.

[0008] In a particular configuration, the data transmitter is a wired connection such as a USB or FireWire port. Alternatively, the data transmitter can be a wireless communication module including a wireless antenna.

[0009] In a particular configuration, the injection device further includes a power source such as a battery. Alternatively, the injection device can be configured to receive power either directly or wirelessly from an external device such as a smartphone.

[0010] The present invention further includes a miniaturized drug delivery unit including a reservoir for containing a fluid to be delivered to a user, and a microneedle in fluid communication with the reservoir, the microneedle being capable of extending through at least a portion of the housing. According to an embodiment of the present invention, the microneedle of the drug delivery unit is configured for intradermal injection. Optionally, the microneedle is configured to extend from the housing by about 2 mm to enable an injection up to a depth of 2 mm. In another configuration, it is configured to extend from the housing by about 1 mm to enable an injection up to a depth of 1 mm.

[0011] In another configuration of the drug delivery unit, the fluid contained in the reservoir includes a single dose of a therapeutic agent. Further, the drive mechanism releases the fluid from the reservoir as a single continuous dose delivered at a standard clinical dose rate. Optionally, this clinical rate is about 10 seconds.

[0012] According to another embodiment of the present invention, the drug delivery element of the injection device further includes an activation element for engaging the drive mechanism. Further, once the activation element is engaged, the drive mechanism releases the fluid from the reservoir passively. The activation element may be disposed on the housing of the device. Alternatively, the activation element is triggered by an activation operation performed by the user on an external device such as a smartphone or other remote deployment.

[0013] In another embodiment of the self-injection device, the device further includes an indicator that warns the user when the fluid is completely discharged from the reservoir to complete the injection. Optionally, the indicator is an external indicator that appears on an external device such as a smartphone or other remote deployment.

[0014] In another configuration of the reservoir of the drug delivery portion of the device, the drug delivery portion further includes a penetrable partition disposed on the wall of the reservoir for accessing the reservoir when filling the reservoir. Optionally, the penetrable partition is self-sealing.

[0015] According to another embodiment of the present invention, an intradermal injection device includes a non-conventional actuation mechanism for initiating the release of fluid from a housing, a mechanism for reducing the perception of pain at the recipient of the released fluid from the housing, and a feedback mechanism for providing information regarding the completion of the release of the fluid from the housing to a patient.

[0016] In one configuration, the feedback mechanism includes an end-of-dose indication. In another configuration, the feedback mechanism includes the transmission of information regarding the completion of treatment to a third party.

[0017] According to an embodiment of the present invention, an integrated injection system includes an injection device having a drug delivery portion, a data transmitter, and a data acquisition module including at least one sensor. The data acquisition module is configured to sense information about the state and / or behavior of the patient's body during an injection event. The data transmitter is configured to make an electrical communication with a communication device external to the injection device, and the data transmitter is also configured to transmit at least a portion of the sensed information to the communication device.

[0018] The drug delivery part includes a needle, and the at least one sensor may be arranged at a part of the needle that is intended to be placed inside the patient's body during the injection event. The at least one sensor may be placed inside the patient's body during the injection event.

[0019] In a particular configuration, the injection device further includes an outer housing surrounding the drug delivery part and the data transmitter. The drug delivery part includes a reservoir for containing the pharmaceutical to be delivered to the patient, and the needle is in fluid communication with the reservoir and can extend through at least a part of the outer housing. The data transmitter may be configured to transmit a signal to the communication device when the pharmaceutical is completely released from the reservoir. In a particular configuration, the communication device is configured to provide an indicator to warn the user that the pharmaceutical has been released from the reservoir in response to the signal. The drug delivery part can include an activation element configured to engage a drive mechanism configured to release the pharmaceutical from the injection device, and the activation element may be configured to be triggered by an activation operation performed by the user on the communication device.

[0020] In other configurations, the sensor is configured to measure the physical characteristics of the patient. The physical characteristics may be metabolism, body temperature, heart rate, blood pressure, or body fat composition. The communication device may be configured to analyze at least a part of the sensed information to determine compliance with a predetermined processing routine. The communication device may also be configured to analyze the sensed information in correlation with data obtained from other sources to determine compliance with a predetermined processing routine.

[0021] At least one of the injection device and the communication device may be configured to store the sensed information from a plurality of different injection events. The injection device may also include an electronic chip configured to store the sensed information. The electronic chip may be further configured to store information identifying at least one of the type of injection device, the injection time of the injection event, or the injection location for the injection event. The electronic chip may also be configured to store additional information related to the manufacturing process or distribution process of the injection device.

[0022] The data transmitter may include a wireless transmitter configured to perform the electrical communication with the communication device wirelessly. Alternatively, the data transmitter may comprise a wired connection including a pin connector configured for insertion into a corresponding port of the communication device, such that the electrical communication with the communication device is performed via the wired connection. Optionally, the injection device further includes an internal power source. Alternatively, the injection device is configured to receive power from the communication device.

[0023] In certain embodiments, the communication device is configured to transmit at least a portion of the sensed information to at least one external system. The communication device may include a user interface display configured to provide at least a portion of the sensed information to a user.

[0024] In another configuration, the injection system further includes a pharmaceutical within the drug delivery portion, and the sensor is configured to detect whether the pharmaceutical has been properly injected into the patient's body. In a particular configuration, the injection system further includes a receiving device configured to be disposed in a region of the patient's body during the injection event. The injection device is configured to transmit an electrical signal of a predefined waveform through a needle into the patient's body, and the receiving device is configured to identify and process the predefined waveform to determine whether the pharmaceutical has been injected into the patient's body. Optionally, the communication device may be a smartphone.

[0025] According to another embodiment of the present invention, an integrated injection device includes an injection device having a drug delivery portion, a data transmitter, and a data acquisition module including at least one sensor. The data acquisition module is configured to sense information about the patient's body state and / or behavior during an injection event. The data transmitter is configured to make an electrical communication with a communication device external to the injection device, and the data transmitter is also configured to transmit at least a portion of the sensed information to the communication device.

[0026] According to another embodiment of the present invention, a method for monitoring an injection event includes delivering a pharmaceutical to a patient's body by an injection device. The method also includes sensing, by at least one sensor of the data acquisition module of the injection device, information about the patient's body state and / or behavior during the injection event, and establishing an electrical communication with a communication device external to the injection device by a data transmitter of the injection device. The method further includes transmitting, by the data transmitter of the injection device, at least a portion of the sensed information to the communication device.

[0027] For the purpose of facilitating the understanding of the present invention, the accompanying drawings and description show its preferred embodiments, from which the present invention, various embodiments of its structure, the configuration and method of operation, and many advantages can be understood and recognized.

Brief Description of the Drawings

[0028]

Figure 1A

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Figure 2

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Figure 6A

Figure 6B

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Figure 8A

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Figure 9

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Figure 12A

Figure 12B

Figure 13

Embodiments for Carrying Out the Invention

[0029] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the present invention. However, various modifications, equivalents, variations, and alternatives will remain readily apparent to those skilled in the art. Any or all of the modifications, equivalents, variations, and alternatives are included within the spirit and scope of the present invention.

[0030] For the purposes of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "upper part", "bottom part", "lateral", "longitudinal", and derivatives thereof are related to the present invention as oriented in the drawings. However, it should be understood that the present invention may take alternative variations and process sequences unless otherwise specified. Also, it should be understood that the specific devices and processes shown in the accompanying drawings and described in the following detailed description are merely exemplary embodiments of the present invention. Accordingly, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered as limitations.

[0031] Referring to FIGS. 1A - 5B and FIG. 13, the present invention relates to an integrated injection device and communication device including an injection device 10. The injection device can include a drug delivery unit 28, a data acquisition module 36 including at least one sensor 16, a receiver 38, an electronic chip 40, a data transmitter 42 communicating with a communication device A, and / or an internal power source 44. The communication device A can be a smartphone and includes a user interface display 46. The injection device 10 can detect and record information regarding the patient's body state and actions during an injection event. Specifically, the needle 12 is within the patient's body and as a result, is ideally positioned to access a tissue sample and obtain data regarding the patient's metabolism. In one non - limiting embodiment of the present invention, a sensor 16 is embedded at the tip 14 of the needle 12 to measure metabolism and other physical characteristics. The sensor can be of any type of commercially available sensor of appropriate size that measures, without limitation, body temperature, heart rate, blood pressure, or body fat composition and provides useful information for estimating metabolism. Using the metabolic data, general conclusions regarding the patient's actions such as compliance with a given treatment plan, physical activity, overall health status, and physical well - being can be drawn. For patients for whom injections are regularly scheduled, data can be consistently collected, thereby providing an indicator of the change in physical parameters over time. The data can be acquired, stored, and correlated with evidence obtained from other sources to draw even more conclusions regarding the patient's actions and physical state. Inserting the needle 12 into the patient's body provides a convenient way to measure physical characteristics such as metabolism without the patient having to undergo additional medical testing procedures. Specifically, using the injection device 10, data can be collected for patients suffering from chronic conditions such as diabetes, rheumatoid arthritis, multiple sclerosis, or patients suffering from conditions that require consistent administration of medications by injection, even if more temporary in nature.

[0032] In other configurations, the injection system of the present invention can be used to collect patient health data on generally healthy patients who otherwise do not respond to medical examinations. For example, healthy individuals who receive an annual influenza vaccination may have no other interactions with medical personnel throughout the year. Therefore, the annual vaccination is the only time when data can potentially be collected without imposing additional requirements on the individual. Thus, collecting data during vaccination provides an attractive way to ensure that individuals are adequately monitored without imposing additional requirements that they might simply ignore or fail to carry out.

[0033] The needle 12 of the present invention includes, without limitation, a stand-alone subcutaneous injection needle, pen needle, self-injector, catheter, miniaturized self-injection device, drug delivery patch, and is compatible for use in any known injection device 10 in which the needle enters the patient's skin tissue. The present invention focuses on taking advantage of the fact that the tip 14 of the needle 12 is inserted into the patient for drug delivery as an opportunity to collect useful patient data that is used for diagnosis, recorded for comparison with later values, or correlated to draw conclusions about the patient's behavior.

[0034] In some embodiments, the system further includes a communication mechanism configured to make the measured data remotely available after the injection is complete, either by downloading the data all at once directly to a data management system or by simultaneously transferring the data via a wired or wireless data transmission system. The data can be, without limitation, caregivers (both family and responsible medical staff), pharmacists, physicians, hospitals, clinics, accountable care organizations, pharmacy benefit managers, disease management companies, pharmaceutical companies, insurance companies, social service providers (Medicare and Medicaid in the United States or Caisse Na in France). It can be transferred to any stakeholder interested in the patient's physical condition and compliance with treatment, including, for example, the National Health Insurance (NHI), or non-governmental organizations.

[0035] In a non-limiting embodiment, the system further includes a data acquisition module that stores information about the injection device itself. In one embodiment, the data acquisition module is an electronic chip having the function of storing the following information regarding the injection: type of injection device, lot and / or serial number of the device, manufacturer name, date, manufacturing location, type of pharmaceutical, expiration date of the pharmaceutical. In one embodiment, the information remains on the chip even when the electronic chip is not powered. An example of this type of electronic chip is a chip having an electrically erasable programmable read-only memory (EEPROM). In this embodiment, the data is stored as individually writable / erasable blocks. Further, it can be understood that in this configuration, the data contained on the chip can be deleted, added, and read multiple times throughout the life cycle of the chip. In some embodiments of the electronic chip, data can be written to or read from the chip without the need to physically contact the chip. For example, the contents of the chip can be changed by magnetic induction. In a particular configuration, the electronic chip can be either placed on the surface of the injection system or embedded within components of the injection system, such as, for example, a needle shield, a rigid needle shield, and / or a plastic rigid tip cap.

[0036] The patient, i.e., the user, can view the data collected by the needle 12 using smartphone A that runs a software application functioning as a dedicated user interface. The information can also be transmitted directly to selected stakeholders or to a remote data server using the communication device of the smartphone. In one embodiment, smartphone A also hosts software for controlling the injection device 10. For example, the user may need to press an electronic button on the screen of smartphone A to initiate an injection. The user interface software can alert the user when the injection is complete by presenting an indicator on the screen of smartphone A. It will also be appreciated that in certain embodiments, prescriptions and pharmaceutical intake schedules can be stored on smartphone A for the purpose of monitoring patient compliance.

[0037] Referring now to FIGS. 1A - 2, the injection device 10 further includes an outer housing portion 20. The needle 12 extends through the outer housing portion 20. In one embodiment, the upper end portion 22 of the outer housing 20 is adapted to adhere to the bottom surface of a portable electronic communication device such as a smartphone A. An electrical connection can be established between the injection device and the smartphone A using any commercially available data connection assembly such as a Universal Serial Bus (USB) port or a FireWire port. Both the power to supply power to the injection device and the data from the sensors included in the needle can be transferred between the smartphone A and the injection device 10 via a wired connection. Alternatively, the connection between the injection device 10 and the smartphone A may be a wireless connection. The battery of the injection device can be recharged via wireless magnetic induction. Data can be transferred between the devices using any commercially available wireless protocol such as WiFi. WiFi is a wireless data transmission protocol for transmitting digital data based on the IEEE 802.11 standard using radio waves. Further exemplary commercially available wireless communication modules include Bluetooth®, Near Field Communication (NFC), Zigbee®, or a wireless antenna that transmits ANT signals. Generally, Bluetooth is suitable for low - power applications where data needs to be transmitted over short distances. WiFi consumes more power but also has a larger data transmission range. In use, the injection device 10 is adapted to be placed flat on the patient's skin such that the needle 12 penetrates the skin to establish access to the subcutaneous tissue for the fluid. The user operates the injection device 10 according to one of the operating mechanisms described in more detail below and causes the pharmaceutical product contained therein to be discharged from the injection device 10 via the cannula (not shown) of the needle 12.

[0038] Referring to FIGS. 3A - 4, a further non - limiting embodiment of the injection device is shown in connection with a smartphone A. The injection device includes a pin connector 18 extending from a side adapted for insertion into a corresponding port of the smartphone A of the injection device 10. The pin connector 18 is used to transfer data and instructions between the injection device 10 and the smartphone A. In a particular configuration, the pin connector 18 has a pin arrangement adapted to be received in a port of a Universal Serial Bus (USB). To save space and to ensure that the injection device 10 is compatible with a number of commercially available mobile phones, the pin arrangement can be configured as a mini - USB or a micro - USB plug.

[0039] The smartphone A can directly supply power to the electronic chip and other elements of the injection device 10. Alternatively, the electronic chip can include a built - in power source such as a thin - film battery. In a further embodiment, the electronic chip has an embedded rechargeable battery that can be wirelessly charged via an external device by electromagnetic induction. Alternatively, the electronic chip is powered by energy supplied by an energy harvesting device and is also mounted on the injection device 10. In an exemplary embodiment, the energy harvesting device is a motion generator powered from a movable part of the injection device 10. Alternatively, body temperature can be used to generate electricity to power the electronic chip.

[0040] In a further embodiment, the electronic chip is a passive RFID tag with a non-volatile memory fixed to a part of the injection device 10. Advantageously, the passive RFID tag does not need to receive power for operation. The RFID tag is read using an externally powered reader. A further advantage of RFID technology is that the RFID tag can be read without the need for physical contact between the tag and the external reader. Instead, the information contained in the chip or RFID tag is transmitted to the reader via magnetic induction. It is further understood that the reader may include a wireless communication transmitter such as Bluetooth, WiFi, NFC (Near Field Communication), Zigbee, or an ANT antenna. The data uploaded from the injection device 10 to the reader can be transmitted by the wireless transmitter to other external devices for storage, collection, and analysis. For example, the data can be transferred to a portable electronic device such as a smartphone, tablet, or laptop computer. The user, i.e., the patient, can use these electronic devices to review the collected data. The system can further include interface software that classifies and presents the recorded data in a form that is easily understandable by the user. Similar to other embodiments of the integrated system described above, the data can also be transmitted directly from the reader to selected stakeholders or a remote data server for further utilization by interested third parties such as family members, physicians, caregivers, or disease management companies.

[0041] In use, the integrated injection device configured according to any of the above-described configurations can also be used for inventory management to track a specific pharmaceutical product from production to injection and to prevent counterfeiting of the injection device or the pharmaceutical product. For example, the reading device can be placed at key locations along the distribution network, such as the manufacturer of the injection device, the filling factory of the pharmaceutical company, the warehouse of the sales agent, the retailer, and the location of the actual user. Throughout the distribution network, authorized persons can "write" additional information about the manufacturing and distribution processes to the electronic chip using a dedicated data input device with appropriate security features. The information can be read at a later point in time during the distribution network and / or manufacturing, either by a dedicated device or by any general-purpose handheld device such as a smartphone.

[0042] Generally, any entity within the production and distribution network will be enabled to read the data contained in the electronic chip or RFID tag. To prevent counterfeiting and other security breaches, the writing function should be restricted to authorized persons only using a dedicated device developed for that purpose. In one embodiment, "reading" may include transmitting the information (location, identification, date, time) of the reading device to the selected interested parties via any secure wireless or wired data communication protocol. For example, the originator (e.g., the manufacturer) may ship the device to the sales agent. When the device is "read" by a reading device located in the distribution facility, a message is sent to the originator warning it that the product has been received. In this way, the system can be used to help monitor the shipping lead time and thereby optimize the distribution network.

[0043] Using the same system, a person can quickly and easily locate an entire batch of products in the event of a product recall, thereby speeding up the recall operation. Most advantageously, the system enables the user to collect real-time data on manufacturing and distribution performance.

[0044] In an alternative embodiment, the system of the present invention can be used to improve compliance and monitoring of pharmaceutical distribution and administration, for example, for chronic disease management. Specifically, using the system according to the present invention, it is possible to record and transmit data regarding the use of the device, including data indicating whether the drug has been properly injected into the patient's body. In one embodiment, this usage information is collected by passing the injection device in proximity to a reader after the injection has occurred. For example, in the case of a disposable device, the reader can be positioned at the opening of the disposable container so as to record that the empty device has been properly placed. For non-disposable devices, activation of the device can trigger the transmission of data indicating that an injection has occurred to the relevant parties.

[0045] In some cases, simply recording that the drug has been released from the device may not be sufficient to satisfy the relevant parties. Instead, proof that the drug has been injected into the patient's body may be required. In that case, in one embodiment of the present invention, an electrical signal of a predefined waveform is transmitted from an electronic chip through an injection needle into the patient's body. As a result of the body's conductivity, this predefined signal can be identified and processed by a receiver placed in another area of the patient's body. If the waveform of the signal measured by the receiver is substantially similar to the reference injection signal waveform, it is presumed that the injection has been completed. Immediately upon indication of injection completion, data related to the injection time, location, and other data are transmitted to the relevant parties using the data transmission function of the injection device itself or an attached electronic device.

[0046] By collecting this data regarding injections, the overall compliance of patients can be evaluated by comparing the injection period and frequency with the prescribed dosage. For the purpose of compliance monitoring, the prescription and medication intake schedule may be stored either in the memory of the reading device or in the memory of the user's smartphone. Also, the application software included in a dedicated reader or a connected smartphone or tablet can be designed to send reminders to the patient before each scheduled injection. In the case of missed doses, more urgent reminders can be sent to the patient. If the patient does not respond to the reminders in a timely manner, additional reminders can be sent to other stakeholders such as a family member, a caregiver, a medical professional who prescribed the medication, or a special compliance monitoring service that can take additional steps to encourage the patient to follow the prescribed treatment plan.

[0047] In one embodiment, the system can be adopted for use by a disease management company (DMC). The DMC can use the recorded data from the device to personalize its efforts, at least, towards members who are willing to comply with medical instructions. Thus, the DMC can better allocate resources to those members who require more additional care and monitoring. For example, according to one embodiment of the system, the DMC and the health insurance company will enroll their members in a program where the use of such an integrated injection device is essential. As long as the patient maintains the required level of compliance, the members could have been provided with incentives such as better coverage or discounted rates.

[0048] In addition to monitoring the patient's compliance, information regarding the patient's compliance can be sent to the pharmacy to improve inventory management. Also, the pharmacy can use this information to automatically refill the patient's prescription at the appropriate time and further reduce the amount of responsibility for the patient to take the required medication.

[0049] Continuing to refer to FIGS. 1A - 5B, various injection devices 10 for use in an integrated drug delivery system are shown. In one embodiment, as shown in FIGS. 6B - 8A, the relationship between the size of the outer housing 20 of the injection device 10 and the size of the internal reservoir 30 that houses the pharmaceutical is optimized, for example, to improve "human factors" such as factors that enhance user confidence when performing an injection using the device. Human factors can also include the ease of use of the device for individuals without medical training, the user's perception that no errors will occur during injection, the confidence at the end of dosing that the full dose has been administered, and the confidence that the user will not miss the scheduled time for administering the pharmaceutical. Generally, it is understood that the device should be designed to be more "intelligent", requiring less medical training and a simpler dosing protocol, so that non - medical personnel can perform an injection without the assistance of a trained medical professional.

[0050] The present invention further recognizes that the Compacity ratio is an effective indicator of the relationship between the drug delivery portion of a device designed to improve the user experience and the other parts of the device. The Compacity ratio is defined as follows.

[0051] Compacity ratio = V° / V In the above formula, V° is the total volume of the injection device, including the actuator, reservoir, connection, or plunger. V is the volume of the liquid delivered to the patient. The Compacity ratio gives an indication of the optimization of the space within a micro - machine technology (MEMS) device, showing how close the volume of the MEMS is to the volume of the liquid available for delivery. The higher the Compacity ratio, the more likely it is that the device was designed based on human characteristics and considerations rather than functional considerations related to the size of the drug delivery portion of the device.

[0052] Referring now to FIGS. 6A - 8B, the drug delivery portion 28 of the injection device 10 is illustrated according to one non - limiting embodiment of the present invention. The drug delivery portion 28 includes a delivery structure such as a needle 12 that is in fluid communication with an internal reservoir 30 that holds fluid. Another structure for facilitating fluid delivery includes an injection catheter, a straw for oral delivery, or a nozzle for nasal or pulmonary delivery. In the embodiments of FIGS. 8A and 8B, the needle 12 is a hollow, miniaturized needle having a patient - piercing end 24 on one end of the device and an opposite end 26 associated with the fluid - containing reservoir 30. A cannula (not shown) extends longitudinally through the needle that forms a passage for the flow of fluid. The needle 12 can be formed from any material having suitable strength characteristics and that can be sharpened to a tip sufficient to penetrate the user's skin. Exemplary materials include metals, metal alloys, and medical - grade high - density polymers. The dimensions of the needle 12 depend largely on the type of therapeutic agent or drug for which the device is prepared for the purpose of intradermal vaccination, but the needle 12 has a diameter of cross - section of about 0.3 to 0.5 mm and a length of about 2 to 4 mm. In use, according to one embodiment of the present invention, the needle 12 extends approximately 1 to 2 mm from the base of the drug delivery portion 28 of the injection device 10, allowing the needle 12 to enter the user's skin to a depth between 1 and 2 mm.

[0053] It is further understood that the needle 12 can be adapted to further reduce the pain of injection, thereby reducing the fear and anticipation often associated with receiving an injection. As described above, fear and anticipation are two of the "human factors" that prevent potential users from adopting self-injection devices and techniques. Generally, the pain of injection is caused rather by the pH or ionic strength of the injection solution than by the damage to the skin, and also by the splitting of the internal tissue to make the space in the internal tissue "free" to accept the volume of the injected liquid. Therefore, pain reduction methods can be used to counteract the forces of these solutions to effectively reduce pain. For example, an anesthetic or analgesic or pain reliever can be applied to the needle 12. The analgesic may be in the form of a hydrophobic polymer coating on the surface of the needle 12 that diffuses into the patient's skin after injection to reduce the sensation of pain. In one embodiment, an analgesic or anesthetic such as lidocaine, prilocaine, tetracaine, ametop gel, or tramadol is dissolved or dispersed or emulsified in silicone oil, and the mixture is spray-coated or dip-coated onto the needle. Also, the salt that has entered the needle surface has a similar pain-reducing effect by counteracting the ionic strength of the injected solution. An analgesic or other local anesthetic such as lidocaine, prilocaine, tetracaine, ametop gel, or tramadol may be applied to the patient's skin before injection and / or before vaccination to reduce the sensation of pain associated with the needle penetrating the skin. In a further embodiment, the contact zone between the needle and the skin may be impregnated with a paralytic agent, such as ethyl chloride, that paralyzes the skin around the injection site when the material evaporates.

[0054] The delivery structure, i.e., the needle 12, establishes fluid communication between the reservoir 30 and the patient. The reservoir 30 is emptied by a release mechanism. According to one non-limiting embodiment of the device, the reservoir 30 plays an active role in the release of the fluid. For example, a plunger-type portion can push the liquid through the reservoir for release from the needle. Alternatively, a portion of the reservoir 30 may be deformable and can be pressed to release the liquid (e.g., a foldable reservoir in a micro-injector). According to other embodiments of the present invention, the reservoir 30 is passive and does not include or incorporate a structure for releasing the fluid. Instead, the reservoir simply contains the liquid and an external pumping mechanism withdraws the liquid from the reservoir.

[0055] In most areas of the body, an injection with a depth of 1-2 mm penetrates and extends through the epidermal layer of the skin, enabling direct drug delivery to the dermis. Advantageously, many therapeutic agents that cannot diffuse through the epidermis can diffuse through the dermal layer. However, it should be noted that in some areas of the skin, the depth of the epidermis varies and is 1.5 mm thick. For injections intended to be delivered to thicker areas of the skin, the penetration depth must be increased to compensate for the increased skin thickness.

[0056] Referring to FIGS. 6A and 6B, a reservoir 30 for containing a therapeutic agent is formed within a substrate layer 32 of the delivery portion 28 of the device. According to one non-limiting embodiment, the reservoir is a circular maze formed on the surface of the substrate layer 32. The substrate is made of silicon or glass, and more generally, can be made of any material obtained by patterning and etching by lithography to form the reservoir 30. The choice of material for the substrate layer 32 is largely dictated by the composition of the therapeutic agent contained within the reservoir 30. Specifically, the substrate material must be non-reactive with respect to the therapeutic agent. Glass, such as borosilicate glass 1, is often inert and non-reactive, making it an excellent substrate material for many applications. Glass also does not allow both water and oxygen to pass through. Alternatively, the reservoir may be a pre-manufactured structure that is fixed to the substrate layer 32. The needle 12 extends from the reservoir 30 through the substrate layer 32. The volume of the reservoir 30 is selected to closely correspond to a single dose of the therapeutic agent delivered to the user. By configuring the reservoir 30 based on the dosing volume, the injected fluid occupies most of the reservoir volume, leaving very little wasted space and reducing the overall size of the delivery portion 28 of the device. In contrast, in a conventional syringe, the fluid can only fill less than 1 / 3 of the total tank volume.

[0057] The above-described compatibility ratio provides an indication of the relationship between the volume of the injected fluid and the total volume of the device. It should be noted that although the present invention seeks to avoid wasted space within the reservoir itself, the volume of the fluid must still be small compared to the total volume of the injection portion of the device. In that way, human factors, rather than the configuration of the reservoir itself, can guide the design of the device.

[0058] Referring to FIGS. 6A-8B, the drug delivery unit 28 further includes an activation element (not shown) and a fluid release mechanism 50. The activation element may be a raised button extending from the housing 20 of the injection device 10. Alternatively, the activation element is an electrical switch that automatically activates when a signal is transmitted from the smartphone A to the injection device 10. The fluid is released from the reservoir 30 for materials that are solid at room temperature and become flowable when exposed to heat. An exemplary material is paraffin wax. The heating layer 54 is deposited on the reservoir including the substrate layer 32. Specifically, the heating layer 54 includes thin film resistors or resistive coils 56 that become hot when current flows through them. The current is provided by a power source such as one of the power sources described above. The release reservoir 52 containing the fluidic material (e.g., paraffin wax) is deposited on the heating layer 54. The release reservoir 52 includes an outlet channel 58 for establishing a fluid connection between the release reservoir 52 and the fluid labyrinth of the internal reservoir 30. The outlet channel 58 opens at the most distal portion (i.e., the tip) of the internal reservoir 30.

[0059] When the heating layer 54 is activated, the material contained in the release reservoir 52 softens and becomes flowable, causing the material to flow downward through the outlet channel 58. The fluidic material enters the internal reservoir 30 at its most distal portion. As the fluidic material enters the internal reservoir 30, it exerts a force on the stopper 60, thereby forcing the stopper 60 to advance through the internal reservoir 30. The stopper 60 can be of various structures or materials that maintain the separation between the fluidic material and the fluid therapeutic agent. It should be noted that the material should not degrade in response to heat or interact unfavorably with either the fluid or the fluidic material contained within the reservoir. In one non-limiting embodiment, the stopper 60 is a small amount of silicone oil. As the stopper 60 progresses through the reservoir 30, the fluid contained therein is pushed towards the center of the reservoir 30. The fluid exits the reservoir through the needle 12 located at the center of the reservoir 30 for delivery to the user.

[0060] Referring now to FIG. 9, in accordance with a further non-limiting embodiment of the drug delivery portion 28 of the injection device 10, the release mechanism includes a release reservoir 52 having a labyrinth containing a working fluid. An expandable gas layer 154 is located above the reservoir 52 such that the expanding gas pushes down on the release reservoir 52 to release fluid from the release reservoir 52. As the gas contained in the gas layer 154 expands, the working fluid is forced through the labyrinth of the release reservoir 52. The released fluid is passed from the release reservoir 52 to a reservoir 30 containing the pharmaceutical through a port located at the outer end of the release reservoir 52. The released fluid enters the fluid reservoir 30 and forces the therapeutic agent through the labyrinth of the fluid reservoir 30 to release the fluid through the needle cannula from the drug delivery device. The layer containing the release reservoir 52 and the layer containing the fluid reservoir 30 are separated by a permeable layer 156. The permeable gas layer 156 functions as a gas release layer that is permeable to air and stops the gas actuation. Specifically, the gas from the expandable gas layer 154 can diffuse through the permeable layer 156 from the drug delivery portion 28 of the device so that the expanding gas does not exert pressure on the reservoir 30, and the therapeutic agent is advanced prematurely from the drug delivery portion 28 of the device.

[0061] Referring to FIG. 10, a further embodiment of the drug delivery portion 28 of the injection device 10 is shown that includes a plurality of release layers 252 and 254 containing a working substance and a fluid reservoir 30 having a double labyrinth. Each of the plurality of layers includes a release port 260 such that once the device is actuated, wax flows through each port 260 into the fluid reservoir 30. The wax from each release port 260 flows through each release layer 252, 254 through an independent defined path of the labyrinth. The wax from the separate release layers 252, 254 proceeds simultaneously through separate paths of the fluid reservoir 30. In this way, the volume of the therapeutic agent released at one time from the fluid reservoir 30 of the device is increased.

[0062] Referring now to FIG. 11, in accordance with a further non-limiting embodiment of the drug delivery unit 28, the release mechanism is a piezoelectric pump 352. The pump 352 is in fluid communication with both the labyrinth reservoir 30 and the cannula of the needle 12, such that, in operation, the pump 352 extracts the therapeutic agent from the reservoir 30 and discharges the fluid through the needle 12. In one non-limiting embodiment, the pump 352 is a Bartels mp6 pump manufactured by Bartels Mikrotechnik of Dortmund, Germany. However, any micropump that can be adapted to fit within the outer housing can be used within the scope of the present invention. Also, the present invention can be configured to include multiple pumps in order to increase the fluid pressure and thus increase the rate at which fluid is discharged from the pump.

[0063] The drug delivery unit of the autoinjector described above is designed to hold a small volume of fluid, such as a single dose (0.1 milliliters) of an intradermal injection of an influenza vaccine. Other applications that require a small volume injection include intradermal injection of other vaccines (e.g., HPV, etc.), desensitization of allergies, and emergency analgesics (e.g., lidocaine). However, the drug delivery device of the present invention can also be applied to larger volume injections. The above-described embodiments of the drug delivery unit can be used with a reservoir size of up to about 0.5 milliliters. With minor modifications to the design, the reservoir can be adapted to accommodate fluid volumes within a further range of up to 100 milliliters. One configuration that enables accommodation of a larger volume of fluid is obtained by stacking smaller volume drug delivery chips on top of each other to create a composite chip with a larger total reservoir capacity.

[0064] Referring to FIGS. 12A and 12B, in one embodiment, the drug delivery device further includes a stopper 60 having a penetrable partition used to fill the fluid reservoir 30. In use, the needle is inserted into the reservoir through the stopper 60. The needle may be coupled to a syringe or other injection device. The user discharges fluid into the reservoir 30 through the needle using a syringe. In this way, the fluid reservoir 30 is filled and prepared for injection into the patient.

[0065] A further aspect of the present invention is drawn to a method of manufacturing a miniaturized injection system in which an injection system is placed within a housing and the device is filled with a therapeutic agent such as a vaccine or drug. According to one non-limiting embodiment, the manufacturing method is a manufacturing process developed for use in the semiconductor and electronics industries and is primarily based on manufacturing processes commonly used to make integrated circuits, electronic packages, and other microelectronics and MEMS devices. Other techniques used in the manufacturing method of the present invention are adapted from the field of microfabrication. However, the manufacturing method described below is intended only as a non-limiting, exemplary method for manufacturing an injection device. It is understood that the self-injection device of the present invention can be formed in a number of other ways that fall within the scope of the devices and methods of the present invention, even though it does not rely on the principles of semiconductor manufacturing.

[0066] It is desirable for the manufacturing method to enable large-scale batch manufacturing of injection devices to reduce costs and to enable filling of the reservoir at a rate that can meet market needs. Batch production is a manufacturing technique in which multiple articles are prepared in parallel rather than in the manner of an assembly line where only a single device is operated at a time. It is envisioned that batch manufacturing will increase the productivity of injection devices and thereby reduce the cost per device.

[0067] A substrate is provided by the manufacturing method of the present invention. Optionally, the substrate is a thin glass layer manufactured by any acceptable method including a float process and a fusion process (overflow down-draw method). The float process (also known as the Pilkington process) involves floating molten glass on a bed of molten metal to create a sheet of uniform thickness. In the fusion manufacturing method, the molten glass is allowed to flow down both sides of a tapered trough that forms two thin molten streams. The two glass streams recombine or fuse at the base of the trough to form a single sheet with excellent uniformity in depth and composition. The fusion process is a technique often used in the manufacture of flat panel displays for producing flat glass. Advantageously, since the molten metal does not contact the surface in this technique, the glass is produced with a more natural surface. The glass produced by this technique is widely commercially available and is produced by companies including Schott, Corning, Samsung, and Nippon Electric Glass Co., Ltd. Alternatively, substrate materials including medical grade polymers and silicon can be used within the scope of the method of the present invention.

[0068] The substrate is provided as a large sheet on which a number of drug delivery devices are formed. Recent advances in glass manufacturing technology (especially in the field of flat glass for flat panel displays) have led to a significant increase in the size of commercially available flat glass panels. Currently, panels enclosing several square meters are commercially available. In a preferred embodiment of the method of the present invention, a square glass wafer measuring 8×8 to 17×17 inches and capable of being manufactured to include about 40 to 200 delivery devices is used as the substrate material.

[0069] Once a substrate is provided, a reservoir or cavity is formed on the substrate. One of ordinary skill in the art will recognize that there are many techniques for forming a depression that serves as a fluid containment cavity in a glass substrate. According to one embodiment, the cavity is formed by wet etching the unprotected portion of the glass surface with a strong acid (e.g., hydrofluoric acid). The depth of the cavity to be etched can be substantially controlled by estimating the decomposition rate of the substrate based on the composition of the reagent. Some reagents are isotropic, and it is understood that the reagent etches the substrate at an equal rate in all directions to form a hemispherical depression. Anisotropic reagents only etch the substrate in the vertical (depth) direction, resulting in an essentially rectangular-shaped depression. It is understood that other etching techniques, including plasma (dry) etching, may be used to form the reservoir, where a high-speed stream of plasma (e.g., a discharge particle glow) is directed at the specimen on a suitable gas mixture to form a depression. Also, rather than forming the reservoir within the substrate, it is possible to attach a pre-formed reservoir to the substrate. As described above, the dimensions of the cavity or reservoir should be as small as possible while still being sufficient to hold a single dose of the drug or vaccine. According to one embodiment of the invention, the reservoir employed for use in an influenza vaccine is 100 microliters.

[0070] Once the reservoir is formed, the microneedles are placed within the reservoir. As described above, the microneedles are hollow needles formed from metal or other materials of suitable strength. The needles are placed using an automated "pick and place" machine similar to the machines used to place transistors on a circuit board. According to one embodiment of the method, it is further envisioned that multiple needles are placed simultaneously within separate reservoirs of a wafer. In this way, the time required to fabricate each delivery device and reservoir on the substrate can be significantly reduced. Optionally, the microneedles are fixed to the substrate using an adhesive material such as an adhesive. Also, the microneedle structure can further include a stopper material to prevent premature release of fluid from the reservoir. For example, a thin breakable film or membrane can be included within the lumen of the needle. The film or membrane must be strong enough and stable enough to prevent fluid from leaking from the reservoir. However, once the injection device is actuated, the discharge mechanism begins to reduce the chamber volume of the reservoir, increasing the force applied to the thin film. In response to the increasing force, the film or membrane breaks and the fluid can pass through the needle for delivery to the user.

[0071] An upper layer including one or more thin glass film layers surrounding the fluid reservoir and separating it from other parts of the delivery device, an upper structural layer having dimensions and composition similar to the substrate layer, a drive mechanism, and an activation element may be deposited over the substrate layer and the fluid containment reservoir. These upper layers and mechanical structures are placed using microfabrication techniques similar to the method of placing microneedles within the reservoir. As described above, it is desirable to place the components using a batch protection method that places the components for multiple injection devices simultaneously.

[0072] Once the layers and components for each reservoir are assembled on the wafer substrate, the wafer is divided into individual injection devices. The wafer can be divided by any suitable method that can make a small cut through the wafer quickly and accurately. One cutting process well-suited for this application is laser cutting. Mechanical cutting and plasma cutting techniques can also be adapted to divide larger wafers into individual injection devices.

[0073] At some point during the manufacturing or distribution process, the injection device is filled with a vaccine or drug to be delivered to the user. One possibility is that the reservoir can be filled during the manufacturing process, before the large wafer is separated into individual devices. In this case, the injection device is sold to the consumer as a pre-filled injection device. Alternatively, the injection device can be filled at a later time, such as after it has been purchased and shipped to a pharmaceutical company or pharmacy. In either case, filling can be accomplished in several ways. The examples provided herein, however, are two of the multiple available methods for filling an injection device. One of ordinary skill in the art will understand that other filling methods are equally available.

[0074] In one filling method, the injection device includes a second fluid channel formed in the substrate to allow access to the reservoir. This channel is closed by an elastomeric plug. The filling needle is adapted to penetrate the plug. The filling needle is pressed through the plug, thereby providing a second source of access to the reservoir. Fluid is then pushed into the reservoir through the injection needle. Air is vented from the reservoir through the micron needle (injection needle). The filling needle is then removed from the reservoir by pulling it away from the elastomeric plug. Once the filling needle is removed from the plug, the flexible elastomeric material reseals, thereby preventing fluid from leaking out of the reservoir.

[0075] Alternatively, the reservoir is filled by a vacuum suction method. According to the vacuum suction method, the injection device is placed in a vacuum chamber to exhaust air from the reservoir cavity. Once the air is exhausted from the chamber, the needle from the filling machine can be inserted into the reservoir, and the fluid is injected into the reservoir through the needle. In particular, when the reservoir is evacuated, there is no air in the reservoir, so ventilation is not necessary. Further, as a result of the pressure difference between the reservoir and the filling machine, the fluid is drawn into the reservoir by suction, and no pump is required to introduce the fluid into the reservoir without further ado. Once the fluid is injected into the reservoir, the filling needle is removed and a film cap is placed over the injection site. Representative cap materials include thin hydrophobic films or UV-curable polymers.

[0076] According to one embodiment of the vacuum suction filling method, the micro needle is installed after the reservoir is filled. After filling, the micro needle is inserted into the reservoir through the film cap. The film cap then serves as a frangible diaphragm to maintain the fluid within the reservoir until activation occurs. Once the device is activated, the increased force on the cap or diaphragm breaks the cap and allows the fluid to flow from the reservoir through the micro needle.

[0077] Once the injection device is fully assembled and filled, the injection part of the device is placed within the housing. As described above, it is necessary for the housing to be visually appealing to encourage the user to participate in optional medical procedures such as self-administered vaccinations. The injection device is placed within the housing using a dedicated "pick and place" machine adapted for that purpose.

[0078] Considering a manufacturing method for a self-injection device, it is understood that a plurality of steps that require a microfabrication machine can be performed together. For example, the step of dividing the device rather than cutting the wafer, and the step of placing the individual wafers into the housing can be performed simultaneously with the same "pick and place" type of machine.

Claims

**Claim 1** An integrated injection system, comprising an injection device having a drug delivery unit and a data transmitter, and an injection system having a communication device external to the injection device, wherein the injection device includes a data acquisition module including at least one sensor, the data acquisition module being configured to sense, by the at least one sensor, information regarding at least one of a patient's physical state and behavior during injection, wherein the data transmitter is configured to communicate electrically with the communication device, and wherein the data transmitter is configured to transmit at least a part of the sensed information to the communication device, wherein the injection device further includes an outer housing surrounding the drug delivery unit and the data transmitter, wherein the drug delivery unit includes an internal reservoir for containing a pharmaceutical to be delivered to the patient, the internal reservoir being formed within a substrate layer of the drug delivery unit, the internal reservoir including a circular maze on a surface of the substrate layer, the drug delivery unit further including a needle, the needle being in fluid communication with the internal reservoir and being extendable through at least a part of the outer housing. An integrated injection system. **Claim 2** The drug delivery unit further includes a piezoelectric pump, the piezoelectric pump being in fluid communication with the internal reservoir and a cannula of the needle such that, when actuated, the piezoelectric pump extracts the pharmaceutical from the internal reservoir and discharges the fluid through the needle. The integrated injection system according to claim 1. **Claim 3** The piezoelectric pump further includes a plurality of piezoelectric pumps, the plurality of piezoelectric pumps being in fluid communication with the internal reservoir and a cannula of the needle such that, when actuated, the piezoelectric pumps extract the pharmaceutical from the internal reservoir and discharge the fluid through the needle. The integrated injection system according to claim 2. **Claim 4** The drug delivery unit further includes a stopper having a penetrable partition, the partition being configured to fill the internal reservoir by passing a needle into the internal reservoir. The integrated injection system according to claim 1. **Claim 5** The drug delivery unit has a plurality of release layers, and each release layer of the plurality of release layers includes an actuating substance, a fluid reservoir having a double maze, and a release port. In response to actuation, the actuating substance of each release layer flows through the release port and through the individually defined passages of the fluid reservoir, and the actuating substances from the plurality of release layers flow simultaneously through the individually defined passages of the fluid reservoir. The integrated injection system according to claim 1.

6. The injection device is configured to transmit an electrical signal having a predefined waveform into the patient's body through a needle, and the receiving device is configured to identify and process the predefined waveform to determine whether the waveform of the signal measured by the receiving device is substantially similar to a reference injection signal waveform associated with successful injection of a drug into the patient's body, and to determine whether the pharmaceutical has been injected into the patient's body. The integrated injection system according to claim 1.

7. The integrated injection system according to claim 2, wherein the at least one sensor is disposed within the patient's body during the injection.

8. The data transmitter is configured to transmit a signal to the communication device when the pharmaceutical has been completely released from the internal reservoir, and the communication device is configured to provide an indicator warning the user that the pharmaceutical has been released from the internal reservoir in response to the signal. The integrated injection system according to claim 1.

9. The at least one sensor is configured to measure a physical characteristic of the patient, and the physical characteristic is metabolism, body temperature, heart rate, blood pressure, or body fat composition. The integrated injection system according to claim 1.

10. The communication device is configured to analyze at least a portion of the sensed data to determine compliance with a predetermined processing routine. The integrated injection system according to claim 1.

11. The communication device is configured to analyze the sensed data in correlation with data obtained from other sources to determine compliance with a predetermined processing routine. The integrated injection system according to claim 1.

12. The integrated injection system according to claim 1, wherein at least one of the injection device and the communication device is configured to store the sensed data from a plurality of different injections.

13. The integrated injection system according to claim 1, wherein the data transmitter includes a wireless transmitter configured to perform the electrical communication with the communication device wirelessly.

14. The integrated injection system according to claim 1, wherein the communication device is configured to transmit at least a part of the sensed data to at least one external system, the communication device includes a user interface display configured to provide at least a part of the sensed data to a user, and the communication device is a smartphone.

15. An integrated injection device, an injection device comprising a drug delivery unit and a data transmitter, and an integrated injection device comprising a communication device external to the injection device, wherein the injection device includes a data acquisition module including at least one sensor, the data acquisition module being configured to sense information regarding the state and behavior of a patient's body during an injection by the at least one sensor, the data transmitter is configured to perform electrical communication with the communication device, and the data transmitter is configured to transmit at least a part of the sensed data to the communication device, the injection device further includes an outer housing surrounding the drug delivery unit and the data transmitter, the drug delivery unit includes an internal reservoir for containing a pharmaceutical to be delivered to the patient, the internal reservoir being formed within a substrate layer of the drug delivery unit, the internal reservoir including a circular maze on a surface of the substrate layer, the drug delivery unit further including a needle, the needle being in fluid communication with the internal reservoir and configured to be extendable through at least a part of the outer housing.

16. The integrated injection device according to claim 15, wherein the drug delivery unit further includes a piezoelectric pump, and when actuated, the piezoelectric pump extracts the pharmaceutical from the internal reservoir and discharges the fluid through the needle, and is in fluid communication with the internal reservoir and a cannula of the needle.

17. The piezoelectric pump further includes a plurality of piezoelectric pumps, and when operating, the piezoelectric pumps extract the pharmaceutical from the internal reservoir and discharge the fluid through the needle, and are in fluid communication with the internal reservoir and the cannula of the needle. The integrated injection device according to claim 16.

18. The drug delivery unit further includes a stopper having a penetrable partition wall, and the partition wall is configured to fill the internal reservoir through the needle into the internal reservoir. The integrated injection device according to claim 15.

19. The drug delivery unit has a plurality of release layers, and each release layer of the plurality of release layers includes an actuating substance, a fluid reservoir having a double maze, and a release port. In response to actuation, the actuating substance of each release layer flows through the release port and through the individually defined passages of the fluid reservoir, and the actuating substances from the plurality of release layers flow simultaneously through the individually defined passages of the fluid reservoir. The integrated injection device according to claim 15.

20. The injection device is configured to transmit an electrical signal of a predefined waveform into the patient's body through the needle, and the receiving device is configured to identify and process the predefined waveform to determine whether the waveform of the signal measured by the receiving device is substantially similar to a reference injection signal waveform associated with successful injection of the drug into the patient's body, and to determine whether the pharmaceutical has been injected into the patient's body. The integrated injection device according to claim 15.

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