Integrated injection system and communication device

Abstract

To collect data on injection events and patient physical characteristics. [Solution] An integrated system for injection is provided, including an injection device (10) in electrical connection with a communication device (A). The external communication device may be a handheld electronic device, such as a smartphone or dedicated reader, capable of reading information contained in an RFID tag. The injection device includes a needle (12) and a drug delivery portion (28) enclosed within an outer housing. Optionally, multiple sensors (16) are affixed to the needle surface to collect data regarding the patient's injection and physical characteristics. The data may be recorded in a data acquisition module (36). The electronic chip may be a readable / writable electronic chip, such as a non-volatile memory chip. The injection device may further include a data transmitter (42) that transmits information acquired from the data acquisition module to the external communication device.

Description

[Technical field]

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

[0002] It is generally accepted in the health care community that costs per capita must be reduced. In particular, as populations age and countries have less money to spend on health care, the amount of money available to pay for health care per capita will inevitably decrease. As a result, patients will perform more of their own treatments to eliminate the costs for simple (e.g., non-diagnostic) procedures associated with visiting a health care professional. This has already occurred for patients with diabetes, rheumatoid arthritis, or multiple sclerosis, and in the future may become the standard for other treatments, including contraceptives, cosmetics, or vaccines. Individuals who perform their own treatments have different needs and requirements than patients receiving treatment from trained professionals. Thus, the types of drug dispensing devices that appeal to untrained individuals will be different from the types of devices used by trained health care professionals.

[0003] Rapidly increasing healthcare costs require healthcare providers to reevaluate how they deliver medicines to patients and how they evaluate the effectiveness of prescribed drugs. For example, there is a need to have better control over the supply and demand of medicines. Also, there is a need to better manage chronic diseases, as chronic patients account for a large proportion of healthcare costs. In particular, overspending for chronic patients is common as a result of patients failing to comply with prescribed treatments. In addition, there is a need to focus on prediction and early detection of potential health risks.

[0004] Currently, a patient's adherence to prescribed treatment is generally based on information self-reported by the patient to a health care provider. The patient may keep a diary that includes information such as when medications are administered and some diagnostic information such as blood glucose levels in the case of diabetes. Note that in each of these examples, the patient bears significant responsibility for the treatment and possibly the diagnosis. Not only must the patient take the prescribed amount of medication at the correct time, but they must also document whether the medication was ingested or injected, perform tests (i.e., blood tests for insulin levels), record the results, and in some cases interpret the results to determine if additional medication must be taken. As the number of actions the patient must perform increases, so does the likelihood that the patient will not adhere to the instructions provided.

[0005] Alternatively, patients may visit medical facilities at various intervals to undergo tests that are performed during the course of a drug treatment plan. The need for additional visits to medical facilities for diagnostic procedures increases medical costs. In addition, patients often consider the costs of testing and diagnosis to be less important than treatment, and as a result, are not willing to bear the expense of such tests. Thus, patients will either forgo the prescribed tests while still taking the medication, or completely avoid optional treatments that require additional tests during the course of the treatment plan.

[0006] Therefore, there is a need for an injection device that can extract information from the patient to provide an indication of the patient's health status during the treatment process. The information should be available to medical professionals quickly and automatically to trigger ongoing diagnostics and to modify the treatment plan as necessary. Information about the patient's adherence to the prescribed treatment and physical condition should be able to be correlated with data from other patients to determine when the patient is most likely to comply with the treatment instructions and to understand why the patient may not be able to comply with the treatment instructions. The data may also be used to coach the patient on how to better comply with the prescribed treatment and, if necessary, to modify the treatment options to further encourage patient compliance. Summary of the Invention [Means for solving the problem]

[0007] An embodiment of the present invention is directed to an integrated system for injection, including an injection device electrically connected with 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 contained in an RFID tag. The injection device includes a needle, a drug delivery section, 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 the function of storing information about the injection and about the patient's physical condition. 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 readable 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 that includes a wireless antenna.

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

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

[0011] In another configuration of the drug delivery portion, the fluid contained in the reservoir includes a single dose of a therapeutic agent, and the drive mechanism releases the fluid from the reservoir as a single continuous dose delivered at a standard clinical dose rate, optionally 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. Moreover, once the activation element is engaged, the drive mechanism passively releases the fluid from the reservoir. The activation element may be disposed on the housing of the device. Alternatively, the activation element is triggered by an activation action performed by a user on an external device such as a smartphone or other remote location.

[0013] In another embodiment of the self-injection device, the device further includes an indicator that alerts the user when the fluid has been fully released 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 pierceable septum disposed in a wall of the reservoir for accessing the reservoir when filling the reservoir. Optionally, the pierceable septum is self-sealing.

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

[0016] In one configuration, the feedback mechanism includes an end-of-dose indication, hi another configuration, the feedback mechanism includes transmitting information about 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 with a drug delivery part, a data transmitter, and a data acquisition module including at least one sensor. The data acquisition module is configured to sense information about a patient's physical condition and / or behavior during an injection event. The data transmitter is configured to be in 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 portion may include a needle and the at least one sensor may be located on a portion of the needle that is intended to be located inside the patient's body during the injection event. The at least one sensor may be located inside the patient's body during the injection event.

[0019] In a particular configuration, the injection device further includes an outer housing enclosing the drug delivery portion and the data transmitter, the drug delivery portion including a reservoir containing a medicinal product to be delivered to the patient, and the needle is in fluid communication with the reservoir and can extend through at least a portion of the outer housing. The data transmitter may be configured to transmit a signal to the communication device when the medicinal product is fully released from the reservoir. In a particular configuration, the communication device is configured to provide an indication to alert a user that the medicinal product has been released from the reservoir in response to the signal. The drug delivery portion may include an actuation element configured to engage a drive mechanism configured to release medicinal product from the injection device, and the actuation element may be configured to be triggered by an actuation action performed by a user on the communication device.

[0020] In another configuration, the sensor is configured to measure a physical characteristic of the patient. The physical characteristic may be metabolism, body temperature, heart rate, blood pressure, or body fat composition. The communication device may be configured to analyze at least a portion of the sensed information to determine compliance with a predetermined treatment 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 treatment routine.

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

[0022] The data transmitter may include a wireless transmitter configured to wirelessly perform the electrical communication with the communication device. Alternatively, the data transmitter may include 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 occurs 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 other configurations, the injection system further includes a medicinal product in the drug delivery portion, and the sensor is configured to detect whether the medicinal product has been successfully injected into the patient's body. In certain configurations, the injection system further includes a receiving device configured to be placed 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 medicinal product 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 with a drug delivery part, a data transmitter, and a data acquisition module including at least one sensor. The data acquisition module is configured to sense information about a patient's physical condition and / or behavior during an injection event. The data transmitter is configured to be in 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 the step of delivering a medicinal product to a patient's body by an injection device. The method also includes the steps of sensing information about the patient's physical condition and / or behavior during the injection event by at least one sensor of a data acquisition module of the injection device, and establishing electrical communication with a communication device external to the injection device by a data transmitter of the injection device. The method further includes the step of transmitting at least a portion of the sensed information to the communication device by the data transmitter of the injection device.

[0027] For the purposes of facilitating an understanding of the invention, the accompanying drawings and description illustrate preferred embodiments thereof, from which the invention, various embodiments of its construction, arrangement and method of operation, and many of its advantages may be understood and appreciated. [Brief description of the drawings]

[0028] [Figure 1A] FIG. 1 is an exploded perspective view of a combined injection device and smartphone according to an embodiment of the present invention. [Figure 1B] FIG. 1B is a side view of the injection device and smartphone of FIG. 1A according to an embodiment of the present invention. [Diagram 2] FIG. 1B is a perspective view of the bottom of the injection device and smartphone of FIG. 1A according to an embodiment of the present invention. [Figure 3A] FIG. 1 is a perspective view of an injection device connected to a smartphone, according to an embodiment of the present invention. [Figure 3B] FIG. 3B is a perspective view of the injection device of FIG. 3A according to an embodiment of the present invention. [Figure 4] FIG. 3B is a perspective view of the injection device of FIG. 3A according to an embodiment of the present invention. [Figure 5A] FIG. 3B is a plan view of the injection device of FIG. 3A in accordance with an embodiment of the present invention. [Figure 5B] FIG. 3B is a side view of the injection device of FIG. 3A according to an embodiment of the present invention. [Figure 6A] FIG. 2 is a plan view of a fluid reservoir of an injection device according to an embodiment of the present invention. [Figure 6B] FIG. 6B is a side view of the fluid reservoir of FIG. 6A in accordance with an embodiment of the present invention. [Figure 7A] FIG. 6B is a partial enlarged plan view of the fluid reservoir of FIG. 6A in accordance with an embodiment of the present invention. [Figure 7B] FIG. 6B is an enlarged partial side view of the fluid reservoir of FIG. 6A in accordance with an embodiment of the present invention. [Figure 8A] FIG. 2 is a side view of a drug delivery portion of an injection device according to an embodiment of the present invention. [Figure 8B] FIG. 8B is an enlarged partial side view of the drug delivery portion of FIG. 8A according to an embodiment of the present invention. [Figure 9]FIG. 2 is an exploded perspective view of a drug delivery portion of an injection device according to an embodiment of the present invention. [Figure 10] FIG. 2 is an exploded perspective view of a drug delivery portion of an injection device according to an embodiment of the present invention. [Figure 11] FIG. 1 is a perspective view of an injection device according to an embodiment of the present invention, having a coating layer removed therefrom. [Figure 12A] FIG. 2 is a perspective view of a drug delivery portion of an injection device according to an embodiment of the present invention. [Figure 12B] FIG. 12B is a perspective view of the bottom of the drug delivery portion of FIG. 12A in accordance with an embodiment of the present invention. [Figure 13] FIG. 2 is a block diagram of a combined injection device and communication device according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[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 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 invention.

[0030] It should be noted that for purposes of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "transverse", "longitudinal" and their derivatives shall refer to the present invention as oriented in the drawings. However, it should be understood that the present invention is susceptible to alternative variations and sequences of steps unless otherwise specified. It should also be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following detailed description are merely exemplary embodiments of the present invention. Accordingly, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

[0031] 1A-5B and 13, the present invention relates to an integrated injection and communication device including an injection device 10. The injection device may include a drug delivery section 28, a data acquisition module 36 including at least one sensor 16, a receiver 38, an electronic chip 40, a data transmitter 42 in communication with a communication device A, and / or an internal power source 44. The communication device A may be a smartphone and includes a user interface display 46. The injection device 10 is capable of detecting and recording information regarding the patient's physical condition and behavior during the injection event. In particular, the needle 12 is inside the patient's body and is thus ideally positioned to access a tissue sample to obtain data regarding the patient's metabolism. In one non-limiting embodiment of the present invention, a sensor 16 is embedded in the distal end 14 of the needle 12 to measure metabolism and other physical characteristics. The sensor may be any type of commercially available sensor of suitable size that provides useful information for estimating metabolism, including but not limited to sensors that measure body temperature, heart rate, blood pressure, or body fat composition. The metabolic data can be used to draw general conclusions about the patient's behavior, such as compliance with prescribed treatment regimens, physical activity, overall health, and physical well-being. For patients who are regularly scheduled for injections, data can be collected consistently, thereby providing an indication of changes in physical parameters over time. Data can be acquired, stored, and correlated with evidence from other sources to draw further conclusions about the patient's behavior and physical condition. Inserting the needle 12 into the patient's body provides a convenient method of measuring physical characteristics, such as metabolism, without requiring the patient to undergo additional medical testing procedures. In particular, the injection device 10 can be used to collect data about patients suffering from chronic conditions, such as diabetes, rheumatoid arthritis, multiple sclerosis, or for patients suffering from conditions that require consistent administration of medication by injection, albeit more temporary.

[0032] In other configurations, the injection system of the present invention can be used to collect patient health data about generally healthy patients who would not otherwise submit to medical testing. For example, a healthy individual who receives an annual flu vaccination may have no other interactions with medical personnel throughout the year. Thus, the annual vaccination is the only time that data could potentially be collected without imposing additional requirements on the individual. Thus, collecting data at the time of vaccination provides an attractive way to ensure that an individual is adequately monitored without imposing additional requirements that the individual may simply ignore or fail to implement.

[0033] The needle 12 of the present invention is adapted for use with any known injection device 10 in which the needle enters the skin tissue of a patient, including, but not limited to, a stand-alone hypodermic needle, a pen needle, an autoinjector, a catheter, a miniaturized autoinjection device, or a drug delivery patch. The present invention focuses on utilizing the fact that the distal end 14 of the needle 12 is inserted into the patient for drug delivery as an opportunity to gather useful patient data that can be 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 available remotely after the injection is completed, either by simultaneously downloading the data directly to a data management system or by simultaneously transferring the data via a wired or wireless data transmission system. The data can be transferred to any number of interested parties with an interest in the patient's physical condition and compliance with treatment, including, but not limited to, caregivers (both family members and accountable medical practitioners), pharmacists, physicians, hospitals, clinics, accountable care organizations, pharmacy benefit managers, disease management companies, pharmaceutical companies, insurance companies, social service providers (such as Medicare and Medicaid in the United States or Caisse Nationale d'Assurance Maladie in France), or non-governmental organizations.

[0035] In one 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 capable of storing information about the injection, such as: type of injection device, lot and / or serial number of the device, manufacturer name, date, place of manufacture, type of drug, expiration date of the drug. In one embodiment, the information remains on the electronic chip even when the chip is not powered. An example of this type of electronic chip is a chip with an erasable programmable read-only memory (EEPROM). In this embodiment, data is stored as blocks that can be written / erased individually. It can further be understood that in this configuration, 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 certain configurations, the electronic chip can be either located on a surface of the injection system or embedded within a component of the injection system, such as a needle shield, a rigid needle shield, and / or a plastic rigid tip cap.

[0036] The patient or user can review the data collected by the needle 12 using smartphone A running a software application that serves as a dedicated user interface. The information can also be transmitted to selected stakeholders directly or to a remote data server using the smartphone's communication device. In one embodiment, smartphone A also hosts software for controlling the injection device 10. For example, the user may be required to press an electronic button on the screen of smartphone A to start the 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 medication intake schedules can be stored on smartphone A for the purpose of monitoring patient compliance.

[0037] 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, a top end 22 of the outer housing 20 is adapted to attach to a bottom surface of a portable electronic communication device, such as a smartphone A. Any commercially available data connection assembly, such as a Universal Serial Bus (USB) port or a Firewire port, can be used to establish an electrical connection between the injection device and the smartphone A. Both the power to power the injection device and the data from the sensor 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 can be a wireless connection. The battery of the injection device can be recharged via wireless magnetic induction. Any commercially available wireless protocol, such as WiFi, can be used to transfer data between the devices. WiFi is a wireless data transmission protocol for transmitting digital data using radio waves based on the IEEE 802.11 standard. 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 is more power consuming but 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 and establishes fluid access to the subcutaneous tissue. A user actuates the injection device 10 according to one of the actuation mechanisms described in more detail below, causing the medicinal product contained therein to be expelled from the injection device 10 through the cannula (not shown) of the needle 12.

[0038] 3A-4, a further non-limiting embodiment of an injection device is shown in conjunction with a smartphone A. The injection device includes a pin connector 18 extending from a side of the injection device 10 adapted for insertion into a corresponding port of the smartphone A. 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 is a pin arrangement adapted to be received in a port of a Universal Serial Bus (USB). To conserve space and to ensure that the injection device 10 is compatible with many commercially available mobile phones, the pin arrangement can be configured as a mini-USB or micro-USB plug.

[0039] The smartphone A can directly power the electronic chip and other elements of the injection device 10. Alternatively, the electronic chip can include an internal 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 provided by an energy harvesting device and is attached to the injection device 10. In an exemplary embodiment, the energy harvesting device is a motion generator that is powered by the moving parts of the injection device 10. Alternatively, body heat 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 portion of the injection device 10. Advantageously, a 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 an 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 categorizes and presents the recorded data in a format that is easily understood by the user. As with other embodiments of the integrated system described above, data can also be transmitted directly from the reader to selected stakeholders or to a remote data server for further utilization by interested third parties, such as family members, physicians, caregivers, or disease management companies.

[0041] In use, an integrated injection device according to any of the above configurations can also be used for inventory control to track a particular medicine from production to injection and to prevent counterfeiting of the injection device or medicine. For example, reading devices can be placed at key locations along the distribution chain, such as at the injection device manufacturer, the pharmaceutical company's filling plant, distributor warehouses, retailers, and at the actual user's locations. Throughout the distribution chain, authorized personnel can "write" additional information about the manufacturing and distribution process into the electronic chip using dedicated data entry devices with appropriate security features. The information can be read at a later point during the distribution chain and / or production, either by dedicated devices or by general-purpose handheld devices such as smartphones.

[0042] Generally, any entity in the production and distribution chain will be able to read the data contained in the electronic chip or RFID tag. To prevent counterfeiting and other security breaches, writing capabilities should be restricted to authorized parties using dedicated devices developed for that purpose. In one embodiment, "reading" may involve transmitting the reader's information (location, identification, date, time) to a selected party via any secure wireless or wired data communication protocol. For example, an originator (e.g., manufacturer) may ship a device to a distributor. When the device is "read" by a reader located at a distribution facility, a message is sent to the originator alerting it that the product has been received. In this manner, the system can be used to help monitor shipping lead times, thereby optimizing the distribution network.

[0043] Using the same system, one 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 allows users 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, such as for chronic disease management. Specifically, the system according to the present invention can be used to record and transmit data regarding device usage, including whether or not the pharmaceutical was successfully 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 located at the opening of the disposable container to record that the empty device has been properly placed. For non-disposable devices, activation of the device can trigger transmission of data to interested parties that an injection has occurred.

[0045] In some cases, merely recording that the medicine has been released from the device may not be enough to satisfy the interested parties. Instead, proof that the medicine 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 the electronic chip through the injection needle into the patient's body. As a result of the body's electrical 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 is complete. Upon indication of the completion of the injection, data related to the injection time, location, as well as other data, are transmitted to the interested parties using the data transmission capabilities of the injection device itself or the attached electronics.

[0046] By collecting this data on injections, the duration and frequency of injections can be compared with the prescribed amount to assess the overall adherence of the patient. For adherence monitoring purposes, the prescription and the medication intake schedule may be stored either in the memory of the reader or in the memory of the user's smartphone. Also, the application software included in the dedicated reader or the connected smartphone or tablet can be designed to send reminders to the patient before each scheduled injection. If a dose is missed, a more urgent reminder can be sent to the patient. If the patient does not respond to the reminder in a timely manner, additional reminders can be sent to other stakeholders, such as, for example, a family member, a caregiver, the medical professional who prescribed the medication, or a specialized adherence 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). Using the recorded data from the device, the DMC can personalize efforts toward members who are at least willing to comply with medical instructions. Thus, the DMC can better direct resources to those members who most need additional care or monitoring. For example, according to one embodiment of the system, the DMC and health insurance company would enroll their members in a program in which the use of such an integrated injection device is essential. As long as the patient maintains the required level of compliance, the member could be offered incentives such as better coverage or discounted rates.

[0048] In addition to monitoring patient adherence, information regarding patient adherence can be sent to pharmacies to improve inventory management and allow pharmacies to use this information to automatically refill patient prescriptions at the appropriate time, further reducing the amount of liability for ensuring patients receive the medications they need.

[0049] With continued reference 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 and the internal reservoir 30 that contains the medication of the injection device 10 is optimized to improve "human factors", such as factors that increase the user's confidence in using the device to perform an injection. Human factors can also include the ease of use of the device for individuals without medical training, the user's perception that an injection will not be error-free, the confidence at the end of the dose that the entire dose has been administered, and the confidence that the user will not miss a scheduled time for administering the medication. It is generally understood that devices should be designed to be more "intelligent", requiring less medical training and simpler administration protocols, so that injections can be performed by non-medical personnel without the assistance of a trained medical professional.

[0050] The present invention further demonstrates that the compatibility ratio is a useful indicator of the relationship between the drug delivery portion of the device and other parts of the device designed to enhance the user experience. The compactness ratio is defined as:

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

[0052] 6A-8B, a drug delivery portion 28 of an 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 in fluid communication with an internal reservoir 30 containing a fluid. Alternative structures for facilitating fluid delivery include an injection catheter, a straw for oral delivery, or a nozzle for nasal or pulmonary delivery. In the embodiment of FIGS. 8A and 8B, the needle 12 is a hollow miniaturized needle having a patient puncture end 24 on one end of the device and an opposite end 26 in association with a fluid-containing reservoir 30. A cannula (not shown) extends longitudinally through the needle forming a passage for fluid flow. The needle 12 can be formed from any material having suitable strength characteristics and capable of being sharpened to a tip sufficient to penetrate the skin of a user. Exemplary materials include metals, metal alloys, and medical grade high density polymers. Although the dimensions of the needle 12 will depend largely on the type of therapeutic agent or drug for which the device is being prepared for intradermal vaccination purposes, the needle 12 will be approximately 2 to 4 mm long with a cross-sectional diameter of approximately 0.3 to 0.5 mm. In use, according to one embodiment of the present invention, the needle 12 will extend approximately 1 to 2 mm from the base of the drug delivery portion 28 of the injection device 10, allowing the needle 12 to penetrate the user's skin to a depth of between 1-2 mm.

[0053] It is further understood that the needle 12 may be adapted to further reduce the pain of injection, thereby reducing the fear and anticipation often associated with receiving an injection. As discussed above, fear and anticipation are two of the "human factors" that prevent potential users from adopting self-injection devices and techniques. Generally, pain from injections is caused by the pH or ionic forces of the injection solution, rather than injury to the skin, as well as by disruption of internal tissues that "free" spaces within the internal tissues that can accommodate the volume of injected liquid. Thus, pain reduction methods can be used to counteract the forces of these solutions to effectively reduce pain. For example, an anesthetic or painkiller or pain reliever can be applied to the needle 12. The painkiller 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, dispersed, or emulsified in silicone oil, and the mixture is sprayed or dip-coated onto the needle. Also, the salts that are incorporated into the needle surface have a similar pain-reducing effect by countering the ionic forces of the injected solution. An analgesic or other local numbing agent such as lidocaine, prilocaine, tetracaine, ametop gel, or tramadol may be applied to the patient's skin before injection and / or vaccination to reduce the pain sensation associated with the needle penetrating the skin. In a further embodiment, the needle and skin contact zone may be impregnated with a numbing agent, e.g., ethyl chloride, which numbs the skin around the injection site as the material evaporates.

[0054] The delivery structure or 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 collapsible reservoir in a micro-infuser). According to other embodiments of the 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 draws the liquid from the reservoir.

[0055] In most areas of the body, injections 1-2 mm deep penetrate and extend through the epidermal layer of the skin, allowing delivery of drugs directly 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 epidermis depth varies, being as much as 1.5 mm thick. For injections intended to be delivered to thicker locations of the skin, the puncture depth must be increased to compensate for the increased skin thickness.

[0056] 6A and 6B, a reservoir 30 containing a therapeutic agent is formed in 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 in the surface of the substrate layer 32. The substrate is made of silicon or glass, or more generally, any material that can be lithographically patterned and etched to form the reservoir 30. The choice of material for the substrate layer 32 is mostly driven by the composition of the therapeutic agent contained in the reservoir 30. In particular, the substrate material must be non-reactive with the therapeutic agent. Glass, such as borosilicate-based 1 glasses, is often inert and non-reactive, making it an excellent substrate material for many applications. Glass is also impermeable to both water and oxygen. Alternatively, the reservoir may be a prefabricated 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 the dose of therapeutic agent to be delivered to the user. By configuring the reservoir 30 based on the dose volume, the fluid to be injected occupies the majority of the reservoir volume, leaving very little wasted space and reducing the overall size of the delivery portion 28 of the device. In contrast, with a conventional syringe, the fluid can only fill ⅓ or less of the total tank volume.

[0057] The above mentioned compaction ratio provides an indication of the relationship between the volume of fluid injected and the total volume of the device. Note that although the invention seeks to avoid wasted space within the reservoir itself, the volume of fluid must nevertheless be small compared to the total capacity of the infusion 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] 6A-8B, the drug delivery section 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 is automatically activated when a signal is sent from the smartphone A to the injection device 10. Fluid is released from the reservoir 30 for a material that is solid at room temperature and becomes flowable when exposed to heat. An exemplary material is paraffin wax. A 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 an electric current passes through them. The electric current is provided by a power source, such as one of the power sources described above. A release reservoir 52 containing a flowable 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 fluidic maze of the internal reservoir 30. The outlet channel 58 opens into the distal-most portion (ie, the beginning) of the internal reservoir 30 .

[0059] When the heating layer 54 is actuated, the material contained in the release reservoir 52 softens and becomes flowable, causing the material to flow downward through the exit channel 58. The flowable material enters the internal reservoir 30 at its most distal portion. As the flowable 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 a variety of structures or materials that maintain a separation between the flowable material and the fluid therapeutic. Of note, the material should not degrade in response to heat or adversely interact with either the fluid or the flowable 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 forced toward the center of the reservoir 30. The fluid exits the reservoir through the needle 12, which is located in the center of the reservoir 30, for delivery to the user.

[0060] Referring now to FIG. 9, according to a further non-limiting embodiment of the drug delivery portion 28 of the injection device 10, the release mechanism includes a release reservoir 52 with a labyrinth containing the actuation medium. expansion A possible gas layer 154 is located above the reservoir 52, so that the expanding gas teeth , release reservoir 52 in Press down but This allows fluid to be drawn from the release reservoir 52. Extrude As the gas contained in the gas layer 154 expands, the working fluid is forced through the labyrinth of the release reservoir 52. The release fluid passes from the release reservoir 52 to the reservoir 30 containing the pharmaceutical agent through a port located at the outer edge of the release reservoir 52. The release fluid enters the fluid reservoir 30 and forces the therapeutic agent through the labyrinth of the fluid reservoir 30 and out of the drug delivery device through the cannula of the needle. Therapeutic Agents The layer containing the release reservoir 52 and the layer containing the fluid reservoir 30 are separated by a permeable layer 156. overlayer 156 functions as a gas release layer that is permeable to air and shuts off gas actuation. Specifically, gas from the expandable gas layer 154 can diffuse out of the drug delivery portion 28 of the device through the permeable layer 156 such that the expanding gas does not exert pressure on the reservoir 30. Cut .

[0061] 10, a further embodiment of the drug delivery portion 28 of the injection device 10 is shown, which includes multiple release layers 252 and 254 containing an actuating substance and a fluid reservoir 30 with a double labyrinth. Each of the multiple layers includes an release port 260 such that once the device is actuated, wax flows through each port 260 into the fluid reservoir 30. Wax from each release port 260 flows through each release layer 252, 254 in an independent defined path of the labyrinth. Wax from separate release layers 252, 254 travel simultaneously through separate paths in the fluid reservoir 30. In this manner, the volume of therapeutic agent released at one time from the fluid reservoir 30 of the device is increased.

[0062] 11, according to a further non-limiting embodiment of the drug delivery portion 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, so that upon actuation, the pump 352 extracts the therapeutic agent from the reservoir 30 and releases the fluid through the needle 12. In one non-limiting embodiment, the pump 352 is a Bartels mp6 pump manufactured by Bartels Mikrotechnik, Dortmund, Germany. However, any micropump that can be adapted to fit within an outer housing can be used within the scope of the present invention. Additionally, the present invention can be configured to include multiple pumps to increase the fluid pressure and thus the rate at which fluid is released from the pump.

[0063] The drug delivery portion of the autoinjector described above is designed to hold small volumes of fluid, such as a single dose (0.1 milliliters) of an intradermal injection of influenza vaccine. Other applications requiring small volume injections include intradermal injections of other vaccines (e.g., HPV), allergy desensitization, and emergency pain medications (e.g., lidocaine). However, the drug delivery device of the present invention can also be applied to larger volume injections. The above-described embodiment of the drug delivery portion can be used for reservoir sizes up to about 0.5 milliliters. With minor modifications to the design, the reservoir can be adapted to accommodate fluid volumes even in the range of 100 milliliters. One configuration capable of accommodating larger volumes of fluid is obtained by stacking smaller volume drug delivery tips on top of each other to create a composite tip with a larger total reservoir capacity.

[0064] 12A and 12B, in one embodiment, the drug delivery device further includes a stopper 60 having a pierceable septum that is used to fill the fluid reservoir 30. In use, a needle is inserted into the reservoir through the stopper 60. The needle may be coupled to a syringe or other injection device. The user expels fluid into the reservoir 30 through the needle with the syringe. In this manner, the fluid reservoir 30 is filled and prepared for injection into the patient.

[0065] A further aspect of the invention is drawn to a method of manufacturing a miniaturized injection system, which involves placing the injection system in a housing and then filling the device with a therapeutic agent, such as a vaccine or drug. According to one non-limiting embodiment, the manufacturing method is based primarily on manufacturing processes developed for use in the semiconductor and electronics industries and which are typically used to make integrated circuits, electronic packages, and other microelectronic and MEMS devices. Other techniques used in the manufacturing method of the 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 invention can be formed in numerous other ways that do not rely on the principles of semiconductor manufacturing, but still fall within the scope of the device and method of the invention.

[0066] It is desired that the manufacturing method allow for large scale batch production of the injection devices to reduce costs as well as allow the reservoir to be filled at a rate that can meet market needs. Batch production is a manufacturing technique in which multiple items are prepared in parallel, rather than in an assembly line fashion where only a single device is run at a time. It is envisioned that batch manufacturing will increase the production rate of injection devices, thereby reducing the cost per device.

[0067] The manufacturing method of the present invention provides a substrate. Optionally, the substrate is a thin layer of glass produced by any acceptable method, including float and fusion processes (overflow downdraw). Float processes (also known as the Pilkington process) involve floating molten glass on a bed of molten metal to create a sheet of uniform thickness. In the fusion manufacturing method, molten glass is allowed to flow down both sides of a tapered trough forming 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 to produce flat glass. Advantageously, this technique produces a more pristine surface for the glass since there is no molten metal contacting the surface. Glass produced by this technique is widely available commercially 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 present method.

[0068] The substrate is provided as a large sheet on which a large number of drug delivery devices are formed. Recent advances in glass manufacturing technology, particularly in the area of ​​flat glass for flat panel displays, have significantly increased the size of commercially available flat glass panels. Panels encompassing several square meters are currently commercially available. In a preferred embodiment of the method of the present invention, square glass wafers measuring 8×8 to 17×17 inches, which can be manufactured to contain approximately 40 to 200 delivery devices, are used as the substrate material.

[0069] Once the substrate is provided, a reservoir or cavity is formed on the substrate. Those skilled in the art will recognize that there are many techniques for forming depressions in glass substrates that serve as fluid-containing cavities. According to one embodiment, the cavities are formed by wet etching, which exposes unprotected portions of the glass surface to a strong acid (e.g., hydrofluoric acid). The depth of the etched cavity can be substantially controlled by estimating the rate of decomposition of the substrate based on the composition of the reagent. It is understood that some reagents are isotropic, which causes the reagent to retract the substrate at an equal rate in all directions, resulting in a hemispherical depression. Anisotropic reagents only retract the substrate in the vertical (depth) direction, resulting in an essentially rectangular shaped depression. It is understood that other etching techniques may be used to form the reservoirs, including plasma (dry) etching, where a high velocity stream of plasma (e.g., discharge particle glow) on a suitable gas mixture is directed at the specimen to form the depression. Also, rather than forming the reservoir in the substrate, a preformed reservoir can be attached to the substrate. As mentioned above, the size of the cavity or reservoir should be as small as possible yet sufficient to hold a single dose of drug or vaccine. According to one embodiment of the invention, the reservoir employed for use with influenza vaccines is 100 microliters.

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

[0071] A top layer including one or more thin glass membrane layers surrounding the fluid reservoirs and isolating them from the rest of the delivery device, a top structural layer having similar dimensions and composition as the substrate layer, a drive mechanism, and an actuation element may be deposited onto the base layer and the fluid-containing reservoirs. These upper layers and mechanical structures are deposited using microfabrication techniques similar to the method used to deposit the microneedles within the reservoirs. As mentioned above, it is desirable to deposit the components in a batch protected manner, depositing 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 quickly and accurately make small cuts through the wafer. One cutting process that is 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 the 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 is purchased and shipped to a pharmaceutical company or pharmacy. In either case, filling can be achieved in several ways. The examples provided herein are, however, two of several available methods for filling an injection device. Those skilled in the art will appreciate that other filling methods are available as well.

[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 plug is penetrated by a filling needle. The filling needle is pressed through the plug, thereby providing a second source of access to the reservoir. Fluid is then forced through the injection needle and into the reservoir. Air is vented from the reservoir through the microneedle. 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 vacuum suction. According to the vacuum suction method, the injection device is placed in a vacuum chamber to evacuate the air from the reservoir cavity. Once the air is evacuated from the chamber, a needle from the filling machine can be placed into the reservoir, and fluid is injected through the needle into the reservoir. Notably, when the reservoir is evacuated, no venting is required since there is no air contained within the reservoir. Furthermore, as a result of the pressure difference between the reservoir and the filling machine, the fluid is drawn into the reservoir by suction, again without the need for a pump to introduce the fluid into the reservoir. Once the fluid is injected into the reservoir, the filling needle is removed and a film cap is placed over the injection site. Exemplary cap materials include thin hydrophobic films or UV-cured polymers.

[0076] According to one embodiment of the vacuum suction filling method, the microneedles are placed after the reservoirs are filled. After filling, the microneedles are inserted into the reservoirs through the film caps. The film caps then act as breakable septa to keep the fluid in the reservoirs until activation occurs. Once the device is activated, increased force on the cap or septum breaks the cap and allows fluid to flow from the reservoirs through the microneedles.

[0077] Once the injection device is fully assembled and filled, the injection portion of the device is placed into a housing. As mentioned above, it is necessary for the housing to be visually appealing so as to encourage the user to participate in optional medical procedures such as voluntary vaccination. The injection device is placed into the housing using a dedicated "pick and place" machine adapted for the purpose.

[0078] When considering a manufacturing process for an autoinjector device, it is understood that multiple steps involving micromachining can be performed together, for example, the step of dividing the devices by sawing the wafer and the step of placing the individual wafers into housings can be performed simultaneously in the same "pick and place" type machine.

Claims

1. 1. An integrated injection system comprising an injection device with a drug delivery unit and a data transmitter, and a communication device external to the injection device, comprising: the injection device comprises a data acquisition module including at least one sensor, the data acquisition module being configured to sense information regarding at least one of a patient's physical condition and a patient's behavior during an injection by means of the at least one sensor; the data transmitter configured to be in electrical communication with the communication device; and the data transmitter is configured to transmit at least a portion of the sensed information to the communication device; The injection device further comprises an outer housing enclosing the drug delivery portion and the data transmitter; the drug delivery portion includes an internal reservoir that contains a medicinal agent to be delivered to the patient; The internal reservoir is formed in a substrate layer of the drug delivery portion, the internal reservoir comprising a spiral labyrinth on a surface of the substrate layer; The drug delivery portion further includes (i) an release reservoir including a maze with an release fluid, and (ii) an expandable gas layer located above the release reservoir, whereby expansion of the gas in the gas layer causes the gas to enter the release reservoir from the gas layer and push the release fluid out of the release reservoir, and the release fluid travels from the release reservoir through the maze of the release reservoir to the internal reservoir containing the pharmaceutical agent through a port located at an outer end of the release reservoir, and the release fluid enters the internal reservoir and moves the pharmaceutical agent through the spiral maze of the internal reservoir, resulting in the pharmaceutical agent being released from the drug delivery portion. Integrated injection system.

2. 2. The integrated injection system of claim 1, wherein the substrate layer containing the release reservoir and the internal reservoir is separated by a permeable layer, the permeable layer being permeable to air and through which gas from the gas layer of the drug delivery portion is released.

3. 2. The integrated injection system of claim 1, wherein the drug delivery portion comprises a needle, the needle being in fluid communication with the internal reservoir and extendable through at least a portion of the outer housing, and the at least one sensor being disposed on a portion of the needle that is intended to be placed inside the patient's body during the injection.

4. The integrated injection system of claim 3 , wherein the at least one sensor is positioned within the patient's body during the injection.

5. The integrated injection system of claim 1 , wherein the data transmitter is configured to transmit a signal to the communication device when the medication is completely released from the internal reservoir.

6. 6. The integrated injection system of claim 5, wherein the communication device is configured to provide an indication to alert a user that the medication has been released from the internal reservoir in response to the signal.

7. The integrated injection system of claim 1 , wherein the at least one sensor is configured to measure a physical characteristic of the patient.

8. The integrated injection system of claim 7 , wherein the physical characteristic is metabolism, body temperature, heart rate, blood pressure, or body fat composition.

9. The integrated injection system of claim 1 , wherein the communication device is configured to analyze at least a portion of the sensed data to determine compliance with a predetermined treatment routine.

10. 10. The integrated injection system of claim 1, wherein the communication device is configured to analyze the sensed data in correlation with data obtained from other sources to determine compliance with a predetermined treatment routine.

11. 10. The integrated injection system of 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.

12. The integrated injection system of claim 1 , wherein the injection device further comprises an electronic chip configured to store the sensed data.

13. The integrated injection system of claim 1 , wherein the data transmitter comprises a wireless transmitter configured to wirelessly communicate with the communication device.

14. 2. The integrated injection system of claim 1, wherein the data transmitter comprises 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 occurs via the wired connection.

15. The integrated injection system of claim 1 , wherein the injection device further comprises an internal power source.

16. The integrated injection system of claim 1 , wherein the injection device is configured to receive power from the communication device.

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

18. 1. An integrated injection device comprising an injection device with a drug delivery unit and a data transmitter, and a communication device external to the injection device, comprising: the injection device comprising a data acquisition module including at least one sensor, the data acquisition module being configured to sense information regarding a patient's physical condition and behavior during an injection by means of the at least one sensor; the data transmitter configured to be in electrical communication with the communication device; and the data transmitter is configured to transmit at least a portion of the sensed data to the communication device; The injection device further comprises an outer housing enclosing the drug delivery portion and the data transmitter; the drug delivery portion includes an internal reservoir that contains a medicinal agent to be delivered to the patient; The internal reservoir is formed in a substrate layer of the drug delivery portion, the internal reservoir comprising a spiral labyrinth on a surface of the substrate layer; The drug delivery unit further includes (i) an release reservoir including a maze with an release fluid, and (ii) an expandable gas layer located above the release reservoir, wherein the expansion of the gas in the gas layer causes the gas to enter the release reservoir from the gas layer and push the release fluid out of the release reservoir, and the release fluid travels from the release reservoir through the maze of the release reservoir to the internal reservoir containing the pharmaceutical product through a port located at an outer end of the release reservoir, and the release fluid enters the internal reservoir and moves the pharmaceutical product through the spiral maze of the internal reservoir, resulting in the pharmaceutical product being released from the drug delivery unit.

19. 20. The integrated injection device of claim 18, wherein the substrate layer containing the release reservoir and the internal reservoir is separated by a permeable layer, the permeable layer being permeable to air and through which gas from the gas layer of the drug delivery portion is released.

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