Medical fluid injection device and method with removable patch and monitoring

Abstract

Provided herein are systems and methods for monitoring one or more health or physiological parameters of a subject. The systems and methods may include a patch coupled to a syringe. The data may be transmitted to a mobile device or remote server where it may be processed. The processed data may be used to inform the subject of their health or physiological condition.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 848,511, filed May 15, 2019, and U.S. Provisional Patent Application No. 62 / 788,589, filed January 4, 2019, the entire contents of each of which are incorporated herein by reference in their entirety. Background Art

[0003] Due to the extensive clinical history of bottle and the record of long-term stability with multiple medicaments, bottle is one of the preferred reservoirs or container closure systems used by the pharmaceutical industry. The medicine comprising biological products is provided in standard containers (such as, bottle). In addition, the industry has also made a large investment in the capital equipment of aseptic bottle filling. However, the bottle needs to be transferred from the bottle to the injection device (such as, syringe, automatic syringe, infusion set etc.) to be delivered to the patient. New container closure systems have been introduced, such as pre-filled syringes and cartridges, which allow the medicament to be directly transferred to the patient from the syringe or cartridge. Injection devices such as automatic syringes and pens have been developed to utilize these newer forms of container closures. Due to the uncertainty of long-term medicament stability, and a large amount of existing manufacturing resources, compared with the device of the medicament container that needs customized form, the pharmaceutical industry prefers to combine standard container closure systems (such as, the device of bottle, pre-filled syringe or cartridge).

[0004] In the present invention, bottle, pre-filled syringe and cartridge are the best container of medicine delivery device.But bottle, pre-filled syringe and cartridge are not necessarily the best container of medicine delivery device.This is especially true in the case of the conveying device of conveying relatively high capacity (2-50cc) or high viscosity (surpassing 15cP and up to about 100cP) medicament. Bottle, pre-filled syringe and cartridge are almost completely cylinders made of glass, and this has brought design constraint to force and geometry. Typical syringe and automatic syringe are limited to the viscosity of the medicament that can be conveyed and the power that can be applied to glass container closure system. Developed new injection device, it comprises the insulin delivery pump that uses customized container closure, but these systems are very expensive, can not produce high force or pressure, and are normally reusable and / or refillable.

[0005] In efforts to develop injection devices and methods, on-body injection devices have been the subject of ongoing development that provide benefits such as greater comfort and less pain while providing effective subcutaneous injections. Summary of the Invention

[0006] It is recognized herein that there is a need for new and / or improved devices, systems, and methods for injecting a drug (e.g., a medicament) from a reservoir (e.g., one or more source vials) into and into a subject. Furthermore, it is recognized herein that there is a need for devices, systems, and methods for monitoring health or physiological parameters before, during, and / or after the injection of a drug into a subject. Such devices or systems may be useful, for example, in regulatory procedures and patient monitoring.

[0007] The present disclosure provides devices, systems, and methods that can be used for medical fluid delivery and injection, as well as methods for administering a substance (e.g., a drug) to a subject and monitoring one or more physical parameters or properties of the subject before, during, and / or after administration of the substance.

[0008] In one aspect, the present invention provides a system for measuring a health or physiological parameter of a subject, comprising: (a) a patch comprising a first shell having a sensor configured to: (i) measure the health or physiological parameter from the subject when the patch is affixed to the subject's body, and (ii) provide one or more outputs corresponding to the health or physiological parameter from the subject, wherein the first shell comprises an opening; and a syringe having a second shell comprising a cannula in fluid communication with a fluid flow path, wherein the second shell is coupled to the first shell such that when the patch is affixed to the body, the cannula is guided through the opening and into contact with the subject's body, wherein the syringe is configured to (i) guide a substance from a reservoir to the fluid flow path in fluid communication with the reservoir, and (ii) guide the substance from the fluid flow path through the cannula into the subject.

[0009] In some embodiments, the system further includes a pump integrated with the cannula, wherein the pump is configured to direct a substance from the fluid flow path through the cannula into the subject. In some embodiments, the cannula is configured to extend toward or retract away from the subject's body. In some embodiments, the opening includes a pierceable membrane. In some embodiments, the pierceable membrane is pierced by the cannula to create the opening. In some embodiments, the reservoir is secured to the syringe. In some embodiments, the reservoir is removable from the syringe. In some embodiments, the reservoir is part of the syringe. In some embodiments, the substance is a medication. In some embodiments, the medication is used to treat one or more diseases selected from the group consisting of cardiovascular disease, musculoskeletal disease, gastrointestinal disease, skin disease, immune disease, ophthalmic disease, blood disease, neurological disease, oncological disease, endocrine disease, metabolic disease, and respiratory disease. In some embodiments, the syringe includes a reservoir, wherein the reservoir is configured to hold a formulation comprising the substance. In some embodiments, the first housing is removably coupled to the second housing. In some embodiments, the patch includes a communication interface for transmitting data corresponding to a plurality of health or physiological parameters to an electronic device that communicates with the communication interface. In some embodiments, the communication interface comprises a wireless communication interface. In some embodiments, the communication interface comprises a Wi-Fi interface. In some embodiments, the communication interface comprises a near-field communication interface. In some embodiments, the communication interface comprises a Bluetooth interface. In some embodiments, the communication interface comprises an optical wireless interface. In some embodiments, the communication interface comprises a direct electrical contact digital or analog interface. In some embodiments, the input transducer / sensor in the plurality of sensors is selected from the group consisting of: a conductivity sensor, an impedance sensor, a capacitance sensor, a charge sensor, a humidity sensor, a temperature sensor, a heart rate sensor, a gap pressure sensor, a resistance sensor, an optical sensor, a swelling sensor, an acoustic sensor, a vibration sensor, a blood pressure sensor, a color sensor, a chemical sensor, and a substance tracking sensor. In some embodiments, the system further comprises a second sensor, wherein the second sensor is configured to measure one or more device parameters selected from the group consisting of: a dose of the administered substance, a dispensing flow rate of the substance, a volume of the administered substance, obstruction of the cannula, and contact of the cannula with the subject's body. In some embodiments, the patch or syringe comprises the second sensor. In some embodiments, the patch further comprises one or more transducers. In some embodiments, one or more transducers are configured to generate an output signal, wherein the output signal comprises a vibration signal, an audio signal, or a visual signal. In some embodiments, the output transducer in the plurality of transducers is selected from the group consisting of: a tactile (vibration) transducer, an audio transducer, a visual transducer, and direct electrical stimulation (e.g., transcutaneous electrical nerve stimulation / TENS).

[0010] On the other hand, disclosed herein is a method for measuring multiple health or physiological parameters of a subject, the method comprising: (a) providing: (i) a patch comprising a first shell having a plurality of sensors and comprising an opening, and (ii) a syringe having a second shell comprising a cannula in fluid communication with a fluid flow path, wherein the second shell is coupled to the first shell of the patch, and wherein the syringe comprises a reservoir containing a substance and a fluid flow path in fluid communication with the reservoir; (b) securing the patch to the body of the subject; (c) when the patch is secured to the body of the subject, guiding the cannula through the opening to (i) guide the substance from the reservoir to the fluid flow path, and (ii) guide the substance from the fluid flow path through the cannula into the subject; and (d) using the plurality of sensors to (i) measure multiple health or physiological parameters from the subject, and (ii) provide one or more outputs corresponding to the multiple health or physiological parameters from the subject.

[0011] In some embodiments, the method further comprises using a pump integrated with the cannula to direct a substance from the fluid flow path through the cannula into the subject. In some embodiments, the cannula is configured to extend toward or retract away from the subject's body. In some embodiments, the opening comprises a pierceable membrane. In some embodiments, the pierceable membrane is pierced by the cannula to create the opening. In some embodiments, the reservoir is secured to the syringe. In some embodiments, the reservoir is removable from the syringe. In some embodiments, the reservoir is part of the syringe. In some embodiments, the substance is a medication. In some embodiments, the medication is used to treat one or more diseases selected from the group consisting of cardiovascular disease, musculoskeletal disease, gastrointestinal disease, skin disease, immune disease, ophthalmic disease, blood disease, neurological disease, oncological disease, endocrine disease, metabolic disease, and respiratory disease. In some embodiments, the syringe comprises a reservoir, wherein the reservoir is configured to hold a formulation comprising the substance. In some embodiments, the first housing is removably coupled to the second housing. In some embodiments, the patch comprises a communication interface for transmitting data corresponding to a plurality of health or physiological parameters to an electronic device that communicates with the communication interface. In some embodiments, the communication interface is a wireless communication interface. In some embodiments, the communication interface is a Wi-Fi interface. In some embodiments, the communication interface is a near-field communication interface. In some embodiments, the communication interface is a Bluetooth interface. In some embodiments, the communication interface is an optical wireless interface. In some embodiments, the input transducer / sensor in the plurality of sensors is selected from the group consisting of: a conductivity sensor, an impedance sensor, a capacitance sensor, a charge sensor, a humidity sensor, a temperature sensor, a heart rate sensor, a gap pressure sensor, a resistance sensor, an expansion sensor, an acoustic sensor, a vibration sensor, a blood pressure sensor, a color sensor, a chemical sensor, and a substance tracking sensor. In some embodiments, the output transducer in the plurality of transducers is selected from the group consisting of: a tactile (vibration) transducer, an audio transducer, a visual transducer, and direct electrical stimulation (e.g., transcutaneous electrical nerve stimulation / TENS).

[0012] In some embodiments, the second sensor of the plurality of sensors is selected from the group consisting of: a temperature sensor, a humidity sensor, a flow rate sensor, a button position sensor, a vibration sensor, an auditory sensor, a skin sensor.

[0013] In yet another aspect, the present invention provides a syringe comprising: a housing; (b) a drug reservoir disposed in the housing; (c) an injection cannula movable within the housing between a pre-dispensing position and a dispensing position in fluid communication with the reservoir; (d) a syringe transducer / sensor mounted on or within the housing; (e) a skin attachment layer attached to the housing, the skin attachment layer comprising an adhesive configured to secure the housing to the user's skin with a first retaining force; (f) a patch removably secured to the housing with a second retaining force, the patch comprising: a sensor adhesive layer configured to secure the patch to the user's skin with a third retaining force; a patch input transducer / sensor; an output transducer; and a circuit configured to receive data from the syringe transducer / sensor and the patch transducer / sensor and to transmit the received data to a remote receiver; (g) wherein the third retaining force is greater than the second retaining force.

[0014] In some embodiments, the second retaining force is greater than the first retaining force and the patch is removably attached to the skin attachment layer. In some embodiments, the patch is removably attached to the skin attachment layer by a perforation. In some embodiments, the patch is removably secured to the housing by a magnet. In some embodiments, the magnet is positioned within or on the housing of the syringe and the patch includes a metal portion configured to engage with the magnet. In some embodiments, the skin attachment layer includes an opening and the patch is positioned within the opening when the patch is removably secured to the housing of the syringe. In some embodiments, the opening is located in the center of the skin attachment layer and when in the dispensing position, the injection cannula of the syringe passes through the opening in the skin attachment layer and the orifice of the patch. In some embodiments, the patch includes an extension, the extension including an orifice through which the injection cannula of the syringe passes when in the dispensing position, the extension being configured to compress the user's skin around the injection site. In some embodiments, the patch includes a printed circuit board on which the circuitry is located, and to which the sensor adhesive layer and patch transducer / sensor are attached, the sensor adhesive layer including a central window through which the extension passes.

[0015] In some embodiments, the extension is generally conical. In some embodiments, the patch includes a printed circuit board, the circuitry is positioned on the printed circuit board, and the sensor adhesive layer and patch sensor are attached to the printed circuit board. In some embodiments, the patch's circuitry includes a microcontroller / microprocessor and a transmitter. In some embodiments, the syringe's sensor includes a transmitter, and the patch's circuitry also includes a receiver, via which data is wirelessly transmitted from the syringe's transducer / sensor and transmitted to the transducer via the receiver. In some embodiments, the microcontroller / microprocessor, transmitter, and receiver are combined into a single component. In some embodiments, the syringe further includes a wire connection between the syringe's transducer / sensor and the patch's circuitry, the wire connection being configured to disconnect upon or after the syringe is removed from the patient. In some embodiments, the microcontroller / microprocessor and transmitter are combined into a single component. In some embodiments, the transmitter is a Bluetooth transmitter. In some embodiments, the syringe sensor includes multiple input transducers / sensors and an output transducer. In some embodiments, the patch sensor includes multiple input transducers / sensors and an output transducer. In some embodiments, a patch sensor includes a plurality of input transducers / sensors and an output transducer.

[0016] On the other hand, the present invention provides a method for collecting data from a syringe and a patient, the method comprising (a) attaching a syringe including a syringe sensor and a patch including a patch sensor, an output transducer, and a circuit to a patient; (b) receiving data from the syringe sensor and the patch sensor using the patch circuit; (c) transmitting the received data to a remote receiver using the patch circuit; (d) removing the syringe from the patient; (e) after removing the syringe from the patient, receiving additional data from the syringe sensor using the patch circuit; and (f) transmitting the additional received data to a remote receiver using the patch circuit.

[0017] In some embodiments, the syringe and the patch are attached to the patient at the same time. In some embodiments, (a) includes attaching the patch before the injection, and before attaching the syringe to the patient, further includes the steps of receiving data from the patch sensor using the patch circuit and transmitting the received data to a remote receiver using the patch circuit. In some embodiments, the data collected from the patient includes measurable attributes that may be affected by the medicament administered by the syringe and / or the use of the syringe to inject the medicament. In some embodiments, the data collected from the patient includes measurable attributes that may affect or indicate the safety and / or effectiveness of the medicament administered by the syringe and / or the use of the injection.

[0018] In yet another aspect, provided herein is a method for monitoring an injection site reaction at an injection site in a patient, the method comprising the steps of: (a) attaching a syringe comprising a patch to a patient, the patch comprising a patch sensor and a circuit, wherein the patch sensor comprises a skin temperature transducer / sensor and a skin color monitor; (b) receiving data from the patch sensor using the patch circuit; and (c) transmitting the received data to a remote receiver using the patch circuit, wherein the data comprises an indication of an increase in temperature or a change in skin color so that an injection site reaction can be identified.

[0019] In another aspect, disclosed herein is a syringe comprising (a) a housing; (b) a drug reservoir disposed in the housing; (c) an injection cannula movable within the housing between a pre-dispensing position and a dispensing position in fluid communication with the reservoir; (d) a patch sensor configured to receive and transmit data, the patch sensor being removably secured to the housing with a first retaining force; (e) an attachment layer attached to the patch sensor, the attachment layer comprising an adhesive configured to secure the patch sensor to the user's skin with a second retaining force; and (f) wherein the second retaining force is greater than the first retaining force such that the patch sensor remains attached to the user's skin when the housing is removed from the patch sensor.

[0020] In some embodiments, the subject's body is skin. In some embodiments, the patch is configured to receive data from a syringe. In some embodiments, the data is used to adjust device parameters of the patch or syringe. In some embodiments, the device parameters include one or more device parameters selected from the group consisting of: the dose of the substance administered by the syringe, the flow rate at which the syringe dispenses the substance, and the volume of the substance administered by the syringe. In some embodiments, the data is used to generate a notification to the subject via a transducer. In some embodiments, the notification includes one or more notifications selected from the group consisting of: a vibration indicator, an audible indicator, a direct electrical stimulation indicator, and a visual indicator.

[0021] Several aspects of the present subject matter may be implemented individually or together in the devices and systems described and claimed below. These aspects may be employed individually or in combination with other aspects of the subject matter described herein, and the description of these aspects together is not intended to exclude the use of these aspects alone or in separate claims for such aspects or in different combinations as set forth in the claims appended hereto.

[0022] The present subject matter encompasses delivery devices and / or syringes of any suitable detailed configuration, but particularly useful delivery devices and syringes when used in combination with the present apparatus are described in US Patent No. 9,925,333, the contents of which are incorporated herein by reference.

[0023] In one aspect, the syringe includes a housing. A drug reservoir is disposed in the housing and an injection cannula is movable within the housing between a pre-dispensing position and a dispensing position in fluid communication with the reservoir. A syringe sensor is mounted on or within the housing. A skin attachment layer is attached to the housing and includes an adhesive configured to secure the housing to the user's skin with a first retention force. The patch is removably secured to the housing with a second retention force and includes a sensor adhesive layer configured to secure the patch to the user's skin with a third retention force. The third retention force is greater than the second retention force. The patch also includes a patch sensor and a circuit configured to receive data from the syringe sensor and the patch sensor and transmit the received data to a remote receiver.

[0024] On the other hand, a method for collecting data from a syringe and a patient is provided, the method comprising the steps of: attaching a syringe including a syringe sensor and a patch including a patch sensor and a circuit to a patient; receiving data from the syringe sensor and the patch sensor using the patch circuit; transmitting the received data to a remote receiver using the patch circuit; removing the syringe from the patient; after removing the syringe from the patient, receiving additional data from the syringe sensor using the patch circuit; and transmitting the additional received data to the remote receiver using the patch circuit.

[0025] On the other hand, a method for monitoring an injection site reaction at an injection site of a patient includes the following steps: attaching a syringe including a patch to the patient, the patch including a patch sensor and a circuit, wherein the patch sensor includes a skin temperature sensor and a skin color monitor; receiving data from the patch sensor using the patch circuit; and transmitting the received data to a remote receiver using the patch circuit, wherein the data includes an indication of an increase in temperature or a change in skin color so that the injection site reaction can be identified.

[0026] In another aspect, an injector includes a housing having a drug reservoir disposed therein. An injection cannula is movable within the housing between a pre-dispensing position and a dispensing position in fluid communication with the reservoir. A patch sensor configured to receive and transmit data is removably secured to the housing with a first retaining force. A skin attachment layer is attached to the patch sensor and configured to secure the patch sensor to the user's skin with a second retaining force, wherein the second retaining force is greater than the first retaining force.

[0027] Another aspect of the present disclosure provides a non-transitory computer-readable medium containing machine-executable code that, when executed by one or more computer processors, implements any of the methods described above or elsewhere herein.

[0028] Another aspect of the present disclosure provides a system comprising one or more computer processors and a computer memory coupled thereto, wherein the computer memory comprises machine executable code that, when executed by the one or more computer processors, implements any of the methods described above or elsewhere herein.

[0029] Other aspects and advantages of the present disclosure will become readily apparent to those skilled in the art from the following detailed description, wherein only illustrative embodiments of the present disclosure are shown and described. As will be appreciated, the present disclosure is capable of other and different embodiments, and its several details may be modified in various obvious respects, all without departing from the present disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not restrictive.

[0030] Incorporated by Reference

[0031] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated as incorporated by reference. To the extent that publications and patents or patent applications incorporated by reference conflict with the disclosure contained in this specification, the specification is intended to supersede and / or take precedence over any such conflicting material. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The novel features of the present invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description and accompanying drawings (also referred to herein as "Figures"), which set forth illustrative embodiments utilizing the principles of the present invention, wherein:

[0033] Figure 1 A perspective view of the syringe is shown.

[0034] Figure 2 Shown is a top view of a filled syringe showing the delivery indicator in the full state.

[0035] Figure 3 Shown is a top view of a filled syringe showing the delivery indicator in an empty state.

[0036] Figure 4 A perspective view is shown showing the underside of the syringe with attachment tape and filling port.

[0037] Figure 5 A perspective view is shown showing the underside of the syringe with the tape removed and the filling and dispensing ports exposed.

[0038] Figure 6A cross section of a syringe on a delivery device is shown.

[0039] Figure 7 A perspective view of a syringe attached to the body (eg, skin) with a safety device installed is shown.

[0040] Figure 8 A perspective view of a syringe attached to the body (eg, skin) is shown with the safety device removed and the button up in a pre-fired state.

[0041] Figure 9 A perspective view of a syringe attached to the body (eg, skin) is shown with the safety device removed and the button down in a fired position.

[0042] Figure 10 A cross-sectional view of the syringe is shown attached to the body (eg, skin) with the button facing up in a pre-fired state.

[0043] Figure 11 A cross-sectional view of the syringe is shown attached to the body (eg, skin) with the button down in a first firing state.

[0044] Figure 12 A cross-sectional view of the syringe is shown attached to the body (eg, skin) with the button down in a dispensing state.

[0045] Figure 13 A cross-sectional view of the syringe attached to the body (eg, skin) is shown, showing the end-of-delivery indicator untriggered.

[0046] Figure 14 A cross-sectional view of the syringe attached to the body (eg, skin) is shown, showing the end-of-delivery indicator being triggered.

[0047] Figure 15 A cross-sectional view of the syringe is shown attached to the body (eg, skin) with the button locked in a fired state.

[0048] Figure 16A A perspective view of a syringe being removed from the body (eg, skin) is shown with a bandage remaining on the skin. Figure 16B A perspective view of a syringe being removed from the body (eg, skin) is shown, with a bandage containing an opening remaining on the skin.

[0049] Figure 17 A perspective view of the syringe is shown with the top housing removed in the filled state.

[0050] Figure 18 Shown Figure 17 A top view of the syringe is shown in FIG.

[0051] Figure 19 A perspective view of the syringe is shown with the top housing removed in an empty state.

[0052] Figure 20 Shown Figure 19 A top view of the syringe is shown in FIG.

[0053] Figure 21 A perspective view of a syringe placed on the body (eg, skin) with the safety device in place is shown.

[0054] Figure 22 A perspective view of a syringe placed on the body (eg, skin) with the safety device removed is shown.

[0055] Figure 23 A perspective view of a syringe is shown placed on the body (e.g., skin) and the button is pressed to fire to initiate an injection.

[0056] Figure 24 A perspective view of the syringe being removed from the body (eg, skin) after injection is shown, with the button in a locked position and the bandage remaining on the body (eg, skin).

[0057] Figure 25 A perspective view of the syringe is shown.

[0058] Figure 26 Shown Figure 25 Cross-section showing the syringe with the button in the first position.

[0059] Figure 27 A diagram is shown showing four stages of cannula penetration of tissue including a) no contact, b) boundary displacement, c) tip insertion, and d) shaft insertion (Dr. Van Gerwen's PhD thesis at Delft University of Technology, "Cannula-Tissue Interaction by Experiment," 2013. ISBN 978-94-6186-238-9, p. 11).

[0060] Figure 28 Shown Figure 25 , showing a cross section of the syringe with the button in the second or dispensing position.

[0061] Figure 29 Shown Figure 25 Cross-section showing the adhesive / device and adhesive / body (e.g., skin) interfaces.

[0062] Figure 30Shown is a perspective view of the bottom of the syringe showing the different zones of adhesive.

[0063] Figure 31 Shown Figure 25 A cross section showing raised tissue on a device with permanently attached adhesive.

[0064] Figure 32 Shown Figure 25 Cross-section showing raised tissue on a device with multi-zone attachment adhesive.

[0065] Figure 33 A perspective view of an alternative syringe top is shown.

[0066] Figure 34 Shown Figure 33 Cross-section showing the displacement sensor disengaged and the cannula locked in the dispense position.

[0067] Figure 35 Shown Figure 33 Cross-section showing the displacement sensor engaged and the cannula and button retracted to the post-fire position.

[0068] Figure 36 Shown Figure 25 , cross-section showing the syringe with the button in the first or pause position.

[0069] Figure 37 Shown Figure 25 , showing a cross section of the syringe with the button in the second or dispensing position.

[0070] Figure 38 Shown Figure 25 Cross-section of a syringe showing the syringe with the cannula retracted and the button in the up or pre-fired position.

[0071] Figure 39 Shown Figure 25 , showing a cross section of the syringe with the button in the second or dispensing position.

[0072] Figure 40 A perspective view of the syringe is shown.

[0073] Figure 41 A cross-sectional perspective view of the syringe is shown with the button in the second or dispense position.

[0074] Figure 42 Shown is a perspective view of a syringe with an attached safety sleeve.

[0075] Figure 43 A cross-sectional perspective view of the syringe is shown with the button in the second or dispense position.

[0076] Figure 44 Shown is a perspective view of a syringe including a radio frequency (RF) tag and a tag reader or interrogator.

[0077] Figure 45 Shows something like Figure 44 , but showing a cross section of the syringe.

[0078] Figure 46 A block diagram / flow chart is shown illustrating a system employing the present subject matter for monitoring patient compliance.

[0079] Figure 47 Shown is an ultrasound image illustrating the subcutaneous depth using a commercial infusion pump with a 9 mm subcutaneous cannula depth.

[0080] Figure 48 An ultrasound image is shown illustrating the depth of a bolus injection using a syringe 7 having a cannula depth of 5 mm.

[0081] Figure 49 Depicts the adherence monitoring system.

[0082] Figure 50 A compliance monitoring system is also depicted.

[0083] Figure 51 Further aspects of compliance monitoring with syringes of the type described herein are shown.

[0084] Figure 52 Shown is a top perspective view of the RF chip in an embodiment of the syringe of the present disclosure.

[0085] Figure 53 A bottom perspective view of an RF chip according to an embodiment of the present disclosure is shown.

[0086] Figure 54 A top perspective view of an embodiment of a syringe of the present disclosure is shown with a safety tab installed.

[0087] Figure 55 Shown is a top perspective view of the syringe with the safety label removed.

[0088] Figure 56 A cross-sectional view of the syringe is shown showing the button in a raised, extended or upward position.

[0089] Figure 57 A cross-sectional view of the syringe is shown showing the button in a lowered, retracted or down position.

[0090] Figure 58 A flow chart is shown illustrating the processing performed by the microcontroller / microprocessor in an embodiment of the syringe of the present disclosure.

[0091] Figure 59 Shown is a bottom perspective view of a syringe with a removable patch in an embodiment of the present disclosure.

[0092] Figure 60 Shown Figure 59 Exploded view of the syringe and patch.

[0093] Figure 61 Shown Figure 60 A top-side perspective view of a SMD printed circuit board (PCB) chip.

[0094] Figure 62 Shown Figure 60 A bottom-side perspective view of a SMD PCB chip.

[0095] Figure 63 Shown Figures 59 to 63 Schematic diagram of the syringe and patch.

[0096] Figure 64 A schematic diagram showing another example of a syringe coupled to a patch.

[0097] Figure 65 Shown Figure 64 Another view of the patch and syringe is shown in FIG.

[0098] Figure 66 A schematic diagram showing another example of a syringe coupled to a patch.

[0099] Figure 67 A schematic diagram showing another example of a syringe coupled to a patch.

[0100] Figure 68 Shown Figure 67 Cross-sectional view of the patch and syringe.

[0101] Figure 69 A schematic diagram showing another example of a syringe coupled to a patch.

[0102] Figure 70 Shown Figure 69 Cross-sectional view of the patch and syringe.

[0103] Figure 71 A schematic diagram showing another example of a syringe coupled to a patch.

[0104] Figure 72 Shown Figure 71 Cross-sectional view of the patch and syringe.

[0105] Figure 73 A schematic diagram showing another example of a syringe coupled to a patch.

[0106] Figure 74 Shown Figure 73 Cross-sectional view of the patch and syringe.

[0107] Figure 75 A schematic diagram showing another example of a syringe coupled to a patch.

[0108] Figure 76 A schematic diagram showing another example of a syringe coupled to a patch.

[0109] Figure 77 A schematic diagram showing another example of a syringe coupled to a patch.

[0110] Figure 78 Shown Figure 77 Cross-sectional view of the patch and syringe.

[0111] Figure 79 A schematic diagram showing another example of a syringe coupled to a patch.

[0112] Figure 80 A schematic diagram showing another example of a syringe coupled to a patch.

[0113] Figure 81 Shown Figure 80 Cross-sectional view of the patch and syringe.

[0114] Figure 82 A schematic diagram showing another example of a syringe coupled to a patch.

[0115] Figure 83 Shown Figure 82 Cross-sectional view of the patch and syringe.

[0116] Figure 84 A schematic diagram showing another example of a syringe coupled to a patch.

[0117] Figure 85 Shown Figure 84 Cross-sectional view of the patch and syringe.

[0118] Figure 86 A schematic diagram showing another example of a syringe coupled to a patch.

[0119] Figure 87 Shown Figure 86 Cross-sectional view of the patch and syringe.

[0120] Figure 88 A schematic diagram showing another example of a syringe coupled to a patch.

[0121] Figure 89Shown Figure 88 Cross-sectional view of the patch and syringe.

[0122] Figure 90 A schematic diagram of an example patch having a pierceable membrane configured to couple to a syringe is shown.

[0123] Figure 91 Shown Figure 90 Another view of the middle patch.

[0124] Figure 92 A schematic diagram of another example patch having a pierceable membrane configured to couple to a syringe is shown.

[0125] Figure 93 A schematic diagram of an example patch having a pierceable membrane configured to couple to an autoinjector is shown.

[0126] Figure 94 Shows the syringe patch sensor and Figures 59 to 93 Schematic diagram of an embodiment of any of the patches.

[0127] Figure 95 A schematic diagram showing the sensor adhesive layer of a patch in an alternative embodiment of the present disclosure is shown.

[0128] Figure 96 A schematic diagram showing the sensor adhesive layer of a patch in an embodiment of the present disclosure is shown.

[0129] Figure 97 An example workflow of a mobile application is schematically illustrated.

[0130] Figure 98 Another example workflow of a mobile application is schematically shown.

[0131] Figure 99 A to Figure 99 C schematically shows another example workflow of a mobile application.

[0132] Figure 100 A computer system is shown that is programmed or otherwise configured to implement the methods provided herein. DETAILED DESCRIPTION

[0133] Although various embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that these embodiments are provided by way of example only. Many variations, modifications, and substitutions may occur to those skilled in the art without departing from the present invention. It will be understood that various alternatives to the embodiments of the present invention described herein may be employed.

[0134] Whenever the term "at least," "greater than," or "greater than or equal to" precedes the first value in a series of two or more numerical values, the term "at least," "greater than," or "greater than or equal to" applies to each value in the series. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.

[0135] Whenever the term "not greater than," "less than," or "less than or equal to" precedes the first value in a series of two or more numerical values, the term "not greater than," "less than," or "less than or equal to" applies to every value in the series. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.

[0136] The term "subject" as used herein generally refers to a user of a device, system or method of the present invention, or an individual who is using a device, system or method of the present invention. The subject can be a patient (e.g., a patient being treated or monitored by a physician or healthcare provider). Alternatively, the subject may not be a patient. The subject may be suffering from or suspected of having a disease or condition. Alternatively, the subject may not have symptoms related to the disease or condition. The subject can be a vertebrate, a mammal (e.g., a human or animal), a non-human primate, etc. The subject can be an animal, such as a rodent (e.g., a rat or mouse), a canine (e.g., a dog), a feline (e.g., a cat), a cow or other animal.

[0137] As used herein, the term "drug" generally refers to a substance used to treat a subject's health or physiological state or condition (e.g., a medical treatment). A drug can be a medicament or a therapeutic agent. A drug can be a solid, liquid, gas, or a combination thereof. A drug can be an aerosol, pill, tablet, capsule, lozenge, elixir, emulsion, effervescent powder, solution, suspension, tincture, liquid, gel, dry powder, vapor, droplets, ointment, or combinations or variations thereof. A drug can be used to treat an ailment, ailment, or disease, or can be used as a health supplement (e.g., vitamins, minerals, probiotics, etc.).

[0138] The present disclosure provides for delivering a substance (e.g., a drug) to a subject and monitoring the device, method, and system for delivering the substance to the subject before, simultaneously, and / or after the substance is delivered. The device of the present disclosure can be a syringe for delivering the drug. Alternatively, or in addition thereto, the device can be a patch configured to monitor the subject and / or communicate with the syringe. In some examples, the syringe and the patch are separate devices (e.g., separable from each other). Alternatively, the syringe and the patch can be a part of a single device (e.g., inseparable from each other).

[0139] syringe

[0140] refer to Figure 1 , the syringe 7 can be of any suitable configuration. As previously described, the syringe can advantageously employ one or more features of the syringe described in US Pat. No. 9,925,333, the contents of which are hereby incorporated by reference.

[0141] refer to Figures 1 to 3 , the syringe 7 has a generally low-profile, disc-shaped outer shell 74 having an upper surface 75 and a lower surface 76 through which a cannula or needle protrudes when actuated by the user. The upper surface 75 has an actuator or button 77 for starting the injection and a section 80 of the housing 74 that allows a subject or medical professional to view the expandable member 78 to determine the amount of substance 79 (e.g., an injectable fluid or medication in the reservoir of the syringe 7). In such cases, the section 80 of the housing can comprise a transparent material, and the user can determine whether the injection has begun or ended. In some cases, the expandable member 78 and / or the section 80 of the housing 74 can be graduated, such as by a demarcation line 127, etc., so that the subject or medical professional can more accurately visually determine the amount of substance 79 remaining, such as, for example, about 50% complete or about 75% complete. Furthermore, the expandable member 78 itself can include features on the outer housing 74 or interact with features on the outer housing 74 to indicate the amount of substance 79 remaining in the syringe's reservoir. For example, when the syringe 7 is full of substance 79, the transparent section 80 can display one color, such as, but not limited to, green. When the syringe 7 is empty of substance 79, the transparent section 80 can display a different color, such as, but not limited to, red. In the middle of a dispense, the transparent section 80 can display a combination of colors.

[0142] refer to Figures 4 to 6 , the lower surface 76 of the syringe 7 includes a filling port 81 and a dispensing port 82. The filling port 81 is an interface that allows a delivery device filling tube 83 to deliver a substance 79 to the syringe 7 (e.g., a reservoir of the syringe). The dispensing port 82 also contains an internal path 84 between the substance 79 discharged from the expandable member 78 and the cannula 85. The filling port 81 and the dispensing port 82 can be in direct fluid communication via the internal path 86, or they can be combined into a single port.

[0143] refer to Figures 4 to 6 The syringe may include a fill port 81 including a check valve 87 to prevent the pressurized substance 79 from leaking outside the syringe 7 when the syringe 7 is removed from the delivery device 6 and the fill port 81 is removed from the fill tube 83 .

[0144] refer to Figures 4 to 6The syringe 7 may also have a filling port 81 configured to receive a syringe. The syringe may be configured with a Luer connector or a cannula. The configuration of the filling port 81 allows the user to manually fill the syringe. The transfer device 6 may still be used, but is no longer required in this configuration.

[0145] refer to Figures 4 to 26 The syringe 7 may also have a dispensing port 82 configured to attach directly to a cannula via attached tubing or a standard cannula port.

[0146] refer to Figures 4 to 6 , the lower surface 76 of the syringe 7 carries an adhesive 88 for temporarily securing the syringe 7 to the subject's body (e.g., skin) before the injection is completed. During removal of the syringe 7, the adhesive tape liner 89 can be automatically removed, thereby exposing the adhesive surface 88 on the lower surface 76 of the syringe 7, which can be used to adhere the syringe 7 to the patient's body (e.g., skin). Alternatively, the tape liner 89 can have a tab 90 that the user pulls to manually remove before adhering the syringe 7 to the skin. Alternatively, the tab can be attached to a surface of the delivery device 4 so that the tape liner is automatically removed when the syringe 7 is removed.

[0147] refer to Figures 4 to 6 , the syringe 7 can have an adhesive tape flange 91 that extends beyond the bottom surface base 76. This flange 91 of the adhesive tape 88 can act as a strain relief between the syringe 7 and the skin surface, thereby reducing the risk of the syringe 7 accidentally becoming detached from the skin. In other words, similar to the tapered strain relief on a wire entering a connector, the extended adhesive flange 91 serves to distribute the load on both sides of the connection point between the adhesive tape 88 and the bottom surface base 76 of the syringe 7 to reduce any strain rise at the adhesive tape 88 and skin interface.

[0148] refer to Figures 4 to 6 , the syringe 7 can be configured with a tapered underside surface 98 that presses against the adhesive flange 91 to securely attach the adhesive tape 88 to the skin without further user intervention when the user secures the syringe 7 to the skin. By taking advantage of the compliance of a person's skin when the syringe 7 is pressed against the skin, the tapered underside surface 98 of the syringe 7 effectively presses the flange 91 of the adhesive tape 88 against the skin, but the upper exposed surface of the portion of the flange 91 is free of exposed adhesive and, therefore, is not attached to that portion of the tapered underside surface 98. The user does not need to move their fingers around the flange 91 to secure the syringe 7 to the skin, making it a much simpler adhesive tape 88 attachment method.

[0149] refer to Figures 4 to 6 , the syringe 7 may have an underside surface 76 that is flexible or compliant, rather than rigid, to allow for improved attachment by conforming the syringe 7 to the skin during application.

[0150] refer to Figures 7 to 9 , after the syringe 7 is placed against the subject's body (e.g., skin) 99 or adhered to the subject's body (e.g., skin) 99, the safety mechanism or locking mechanism can be automatically released and the syringe 7 is ready to fire (inject). In such cases, the syringe 7 is prevented from being actuated (it is locked) until it is placed against the skin. Alternatively, the user can manually remove the safety device 100, such as a safety pin, a safety cannula, a lug or a collar, to release the syringe to be ready to fire (inject or guide the cannula through the opening into the subject). In some cases, the syringe 7 cannot be fired before the safety mechanism 100 is released. The safety mechanism 100 can be passive or active and manually triggered by the user or automatically triggered by the syringe 7.

[0151] refer to Figures 7 to 9 The syringe 7 may utilize a combination of an actuator or button 77 and a visual indicator 101 to indicate syringe 7 parameters after the syringe 7 is removed from the delivery device. For example, when the button 77 is in the upward position and the indicator 101 is a color (such as, but not limited to, green), this may indicate that the syringe 7 is ready to begin an injection. Furthermore, the button 77 may have a sidewall 102 that is a different color than its top 103. When the button 77 is pressed, the user cannot see the sidewall 102 of the button 77; this may indicate that the syringe 7 is in use. When the injection of the medicament is complete, the syringe 7 may alert the user. This alert may be in the form of a visual indicator, an audible sound, a mechanical movement, or a combination thereof. The button 77 is ideally designed to provide auditory, visual, and tactile feedback to the subject or user when the button 77 "pops up" into the locked position. The syringe 7 may indicate to the subject that it has completed dispensing and has delivered the entire dose to the patient with the button 77 in the upward position and the indicator window 101 showing that the syringe reservoir is empty. For example, when the button 77 is in the upward position and the indicator 101 displays a different color (such as, but not limited to, red), this may indicate that the syringe 7 has completed an injection.

[0152] refer to Figures 10 to 12, the syringe 7 can have an actuator or button 77, which the subject or user presses to start the injection. The button 77 can be configured as an on / off switch (such as a light switch), that is, it has only two states, open and closed. This prevents the user from pushing the button 77 halfway without actuating the syringe 7. Once activated, the "light switch" type button 77 will quickly guide the cannula 85 into the skin 99 independently of the user's manipulation of the button 77. Alternatively, the button 77 can have a continuous movement, allowing the user to slowly guide the cannula 85 into the skin 99. The button 77 and the cannula 85 can be formed by preferably directly coupling the button 77 to the cannula 85 using an adhesive 104.

[0153] refer to Figures 10 to 12 The syringe 7 may have a cannula 85 that, when the syringe 7 is coupled to the skin and when actuated, directs the substance from the reservoir to a fluid flow path in fluid communication with the reservoir, thereby directing the substance from the reservoir into the skin 99. When the button 77 is actuated, the button 77 initially reaches a position such as Figure 11 , and retracts slightly (in some cases automatically) to a second position or depth, as shown in FIG. Figure 12 As shown in . Figure 11 The first depth shown in FIG is achieved by overtravel of the button 77 during actuation. The first depth can be controlled by a feature 105 in the button 77 that is in direct contact with the base 106 of the syringe 7. The final depth of the cannula 85 is suitable for subcutaneous injections. Alternatively, for intradermal injections, the final depth of the cannula 85 can be reduced. Alternatively, for intramuscular injections, the final depth of the cannula 85 can be increased. When the first depth is reached, the cannula 85 is retracted away from the subject's body to a second depth, as shown in FIG. Figure 12 . The retraction distance of the cannula to the second depth is in the range of 0.1-2 mm. In such cases, the retraction feature serves to prevent the cannula 85 from becoming blocked by tissue during initial insertion. Such tissue blockage may require very high pressure to overcome and prevent the syringe 7 from delivering the medicament. Retraction of the cannula 85 from the first position to the second position creates an open area before the cannula tip 107, thereby allowing pressure to be reduced to initiate the flow of the medicament from the cannula 85. In some cases, the reduced pressure to initiate the flow of the medicament from the cannula is necessary to maintain a relatively constant pressure in the syringe 7 while the substance is being directed through the cannula during the injection.

[0154] refer to Figures 10 to 12 , the syringe 7 may include a cannula 85 having a side opening 108. Figure 12As shown in FIG, once the button 77 on the syringe 7 is fully depressed, the cannula 85 will be fully inserted into the skin 99 through the dispensing port 82 and the syringe 7 will begin to dispense the substance. Before the button 77 is fully depressed, the side opening 108 and therefore the lumen of the cannula 85 are not in communication with the fluid passage 86 of the dispensing port 82. Both the side opening 108 and the cannula tip 107 are retained within the septum 109. Because the side opening 108 and the cannula tip 107 are retained within the septum 109, the entire medication path remains sterile before use. When the button 77 is fully depressed and the cannula 85 is in the dispensing position, the side opening 108 in the cannula 85 is in communication with the fluid passage 86 of the dispensing port 82, and injection of the substance (e.g., injectable drug or fluid) begins.

[0155] refer to Figures 10 to 12 The septum 109 provides the advantage of sealing the cannula tip 107 and the side opening 108 from the injectable before and after dispensing. Sealing the cannula tip 107 and the side opening 108 of the cannula 85 at the end of the injection has the particular advantage of preventing the substance (e.g., injectable liquid) from dripping from the syringe 7 after dispensing and / or after removal from the skin surface. It also prevents contaminants from entering the hollow cannula before being actuated into the skin. The septum 109 can comprise a pierceable membrane that can be made of any suitable material to allow it to be sealed once the cannula 85 pierces it. The material composition of the septum 109 or the pierceable membrane can comprise silicone. Alternatively, the material composition of the septum 109 or the pierceable membrane can also be a mixture of different materials, including but not limited to bromobutyl, chlorobutyl, isoprene, polyisoprene, SBR, polybutadiene, EPDM, PTFE, natural rubber and silicone. Alternatively, the fluid path 86 thereof containing the dispensing port 82 may comprise a rigid plastic with an overmold of injected silicone to create the septum previously described.

[0156] refer to Figures 10 to 12 The septum 109 at the dispensing port 82 can protrude slightly from the lower surface into the skin surface 99 of the syringe 7 to provide pressure on the skin surface 99 at the injection site. After the cannula is retracted, the pressure exerted by the dispensing port 82 on the skin surface 99 can eliminate the outflow of substance from the injection site, which is commonly referred to as backflush.

[0157] refer to Figures 10 to 12 , the syringe 7 may include a set of spring tabs 110 that interface with the button 77 to perform a locking function. The spring tabs 110 are biased to lock into undercuts 111 in the button 77 to hold the button 77 in the first upward or pre-fired position, as shown. Figure 10The geometry of the undercut 111 and the spring tab 110 contributes to the generation of the previously described light switch actuation force. The light switch actuation is achieved by translation of the button 77 relative to the spring tab 110 and the geometry of the mating undercut 111 surface.

[0158] refer to Figures 10 to 12 , the syringe 7 may include a spring tab 112 that interacts with the button 77 in the syringe 7 to perform a locking feature such that when the button 77 is actuated to a first depth and slightly retracted to a second depth or dispensing position, an undercut feature 113 in the button 77 allows the spring tab 112 to hold the button 77 in the dispensing position until the syringe 7 has completed dispensing.

[0159] refer to Figures 13 and 14 , the syringe 7 may include an end-of-delivery indicator or empty indicator 114 to sense when all of the substance (e.g., medication or injectable fluid) has been expelled from the expandable member 78 and the syringe 7 has completed dispensing. The empty indicator 114 can be configured with a slot or other opening 115 to slide over the expandable member 78 at the outlet port when the expandable member 78 is in a deflated state after all of the substance has been expelled. The empty indicator can have two states. Figure 13 As shown in FIG, the empty indicator may be in a first position or deflected state when the expandable member 78 is filled with material in the section and is not contained within the slot or opening 115. The first position will transition to a non-empty state of the expandable member 78 when the diameter of the expandable member 78 is greater than its minimum value due to residual material contained therein. Figure 14 , the empty indicator 114 may be in a second position or deflected state when the expandable member 78 is partially or completely contained within the slot or opening 115. The second position transitions to an empty state of the expandable member 78 when the diameter is at a minimum.

[0160] refer to Figures 13 and 14 The syringe 7 may include an automatic cannula retraction mechanism at the end of dispensing. The mechanism includes a direct connection between the spring tab 112, the button undercut feature 113 and the empty indicator 114, all of which were mentioned previously. Figure 14As shown in , when the expandable member 78 is filled with a substance (e.g., a medication or injectable fluid) and the button 77 is pressed from the first, pre-fired position to the second, dispensing position, the undercut feature 113 in the button 77 allows the spring tab 112 to hold the button 77 in the dispensing position until the syringe 7 completes dispensing. The spring tab 112 can also be directly coupled to the empty indicator 114, which is naturally in the first position or deflected state. The action of pressing the button 77 to the second, or dispensing position allows the post feature 116 in the button 77 to provide a bias or pre-tension on the spring tab 112 to guide the empty indicator 114 to its second position or deflected state. However, because the expandable member 78 is initially filled with a substance of a large diameter, the empty indicator 114 cannot move to the second position or deflected state as shown in . Figure 13 After the button 77 is depressed, the material begins to be expelled from the expandable member 78 through the cannula as previously described. Once the expandable member 78 has been emptied of all material and is at its smallest diameter, the empty indicator 114 (under pre-tension from the spring tab 112) will move to the second position or deflected state, as shown in FIG. Figure 14 . The spring tab 112, which is directly coupled to the empty indicator 114, also moves with the empty indicator 114. This movement releases the spring tab 112 from the undercut feature 113 in the button 77 to allow the button 77 (and cannula) to move upward to the final or post-fire position after dispensing is complete, as shown. Figure 15 As shown in .

[0161] refer to Figure 15 The locking spring tab 117 can also interact with the button 77 in the syringe 7 to perform a locking function so that when the injection is completed, the button 77 is released and the button 77 is pushed upward by the return spring 118 to the final upward position or the post-fired position. Figure 15 ), the button height 77 relative to the top of the syringe 7 can be higher than the pre-fire position (as shown in Figure 10 ). The end of the locking spring tab 117 moves outwardly to the outer diameter surface 119 of the button 77 within the outer housing 74 to lock the button 77 in the upward or post-fire position and prevent the button 77 from being actuated again.

[0162] refer to Figure 15 , the syringe 7 may include a return spring 118 that interacts with the button 77 to bias the button 77 to a first upward position or pre-fired position. When the button is actuated downward to a second depth or dispensing position, the return spring 118 is compressed, resulting in a greater bias or preload. At the end of the dispensing cycle, the button 77 is released from the second depth or dispensing position (e.g., Figure 12) unlock to move upwards to final position or post-fire position after dispensing is completed, as previously described. It is the bias of return spring 118 that forces button 77 to rise to final position or post-fire position.

[0163] refer to Figure 15 to Figure 1 6. When the syringe 7 is removed from the skin 99, the syringe 7 will preferably be locked to protect non-destructive access to the cannula or reuse of the syringe 7. The syringe 7 can indicate to the user that the full dose has been delivered. The indication can be in the form of a visual indicator, an audible sound, a mechanical movement, or a combination thereof.

[0164] 16 , when the syringe 7 is removed from the skin 35, the bandage 120 can be released from the syringe 7 and remain on the skin surface 35. This can be achieved by using an adhesive on the bandage portion that attaches the bandage to the skin more securely than the adhesive that attaches the bandage to the syringe 7. Thus, when the housing is lifted from the skin, the bandage 120 remains in place over the injection site, as described in U.S. Patent No. 7,637,891 and U.S. Patent Application No. 12 / 630,996, both of which are incorporated herein by reference. Figure 16B As shown in FIG, bandage 120 can include an opening 120b (eg, a hole or slit in the center of the bandage).

[0165] refer to Figures 36 to 39, the syringe 7 may preferably include a manifold 121 that is assembled to both the expandable member 78 and the filling port 81 and the dispensing port 82, and provides direct fluid communication between the expandable member 78 and the filling port 81 and the dispensing port 82 of the syringe 7. The manifold 121 may be configured to have a larger diameter at the end assembled to the expandable member 78 to facilitate filling and discharging all substances to the outside of the expandable member 78 as discussed above. The manifold 121 may preferably include an internal passage 122 to allow fluid to flow into and out of the expandable member 78. The manifold 121 may be configured with a filter 123 in the injectable fluid path 122 for filtering the substance before and after it is introduced into the expandable member 78 to remove particles. The filter 123 may be a membrane, depth filter or other suitable filter medium having a sufficiently small pore size or an effective pore size to remove undesirable particles of undissolved substances that may include, but are not limited to, undissolved substances in the case where the substance is reconstituted by the delivery device. The manifold 121 may also be configured with a filter 123 for removing air. Such an air removal filter 123 may include a bubble trap, an air gap, or other configuration within the injectable fluid path 122 that removes air from the injectable fluid path 122 before it is introduced into the expandable member 78. The air removal filter 123 may be configured with a hydrophobic filter or a combination of a hydrophobic filter and a hydrophilic filter. A hydrophobic filter will allow air to escape from the delivery device but will not allow liquid to pass through. A hydrophilic filter will allow liquid to pass through but will not allow particles or air to pass through. The air removal filter 123 may also have a check valve to allow trapped air to escape. Alternatively, the air remover and filter 123 may be located at any point in the fluid path from the filling port 81 to the cannula 85. For example, the most downstream point in the fluid path is the distal end 128 of the expandable member 78. The internal mandrel 124 may be connected to the distal end 128 of the expandable member 78. The air remover or filter 123 may be integrated into such a downstream point to allow trapped air to escape during filling of the syringe 7. Additionally, the mandrel 124 may include slots along its length that communicate with the downstream filter 123 to help evacuate air during the filling process.

[0166] refer to Figures 36 to 39 , the syringe 7 may include an elastic expandable member 78, such as an elastic balloon or a sac-like container. The material composition of the expandable member 78 may preferably be silicone. Alternatively, the material composition of the expandable member 78 may also be a mixture of different materials, including but not limited to bromobutyl, chlorobutyl, isoprene, polyisoprene, SBR, polybutadiene, EPDM, PTFE, natural rubber and silicone. In addition, the expandable member 78 may be coated to improve their surface properties. The coating may include polyparaxylene, silicone, Teflon and fluorine treatment. Alternatively, the expandable member 78 may be made of thermoplastic elastomer.

[0167] refer to Figures 36 to 39 , the syringe 7 may include an elastic expandable member 78 to which a substance is transferred under pressure. This causes the expandable member 78 to expand and the elasticity of the expandable member 78 to form a pressure that tends to expel the substance. The pressure chamber of the previously described delivery device (or other pumps or pressurizing devices that can be used in the delivery device) transfers the substance to the syringe 7 under pressure. Introducing the substance into the expandable member 78 under pressure causes both its diameter and length to stretch and expand. An example of this is blowing up a long and thin balloon. The volume range of the syringe 7 can be 0.5 to 30 milliliters. When expanded, the elastic expandable member 78 applies a discharge pressure in the range of 1 to 200 psi to the substance contained in the expandable member 78, so that the syringe 7 is ready to automatically administer the substance when triggered by the user pressing a button as described above. Thus, the delivery device as described above not only operates to deliver a measured amount of substance (and, if necessary, mix, dilute and filter it) to the syringe 7, but also simultaneously fills or provides motive pressure to the syringe 7 (by expanding the elastic expandable member 78) so that the syringe 7 is ready to automatically dispense the substance under the pressure exerted by the elastic expandable member 78 when actuated by the user.

[0168] The aspects of the delivery device (simultaneous delivery and charging) are particularly beneficial. Although the above applications show the syringe 7 in a pre-filled or filled state for injecting the substance 79 when the syringe 7 is actuated, the present disclosure contemplates that the syringe 7 can remain empty and the expandable member 78 in a more relaxed and unfilled state, i.e., in an unfilled or unfilled state, until the substance needs to be administered. Only then is the substance mixed or processed as needed and introduced into the syringe 7, causing the expandable member 78 to expand to a filled (charged) state. In the present disclosure, the medicament is stored in its original container closure (vial) until use. Because the substance is typically injected within seconds to hours after being transferred from the vial to the syringe 7, the shelf life of the medicament and the compatibility of the medicament with the materials in the fluid channel within the syringe 7 are not significant issues. The challenges and expenses of designing the syringe 7 and selecting materials to extend the shelf life of the pre-filled syringe 7 are significantly reduced.

[0169] refer to Figures 36 to 39The present subject matter can utilize features of the syringe 7 described in the patent applications incorporated herein by reference, as previously described. However, the expandable member 78 employed in the syringe 7 may also preferably take the form of an elongated balloon or sac-like container, for example, arranged in a planar spiral or helical configuration, as shown. As previously described, the syringe 7 includes a circular outer housing 74 having a helical slot or recess 125 formed therein. The elongated balloon or sac-like container 78 rests in the slot 125, with one end configured to communicate directly or indirectly with the injection cannula 85 via a fluid path 122, and the other end configured to communicate directly or indirectly with the dispensing indicator 101. The elongated helical configuration allows the balloon or sac-like container 78 to have sufficient volume for such quantities of substance 79 as may be desired, while also contributing to the low-profile configuration of the syringe 7. In some cases, by utilizing a relatively long expandable member 78 with a large aspect ratio, very high pressures and volumes can be achieved with minimal required force. Additionally, the volume of expandable member 78 may be varied by changing the fill length without significantly altering the pressure / volume curve of expandable member 78 .

[0170] refer to Figures 36 to 39 One of the other aspects that may be employed in the present subject matter is the use of an insert or plunger or mandrel 124 within the expandable member 78 to pre-stress the expandable member 78 to a slightly expanded position when unfilled so that when the expandable member 78 is emptied of material, it will contract or collapse to a still stretched or stressed state and continue to exert pressure on any fluid within it, such as Figure 38 and Figure 39 . This better ensures that all or substantially all of the substance is completely expelled from the syringe 7. If desired, the mandrel or shaft 124 can be an expandable member filled with fluid. This would allow for a mandrel 124 of variable size. Alternatively, when unstressed, the expandable member 78 can have a small enough internal volume (small diameter) so that substantially all of the substance is expelled without the need for an internal mandrel or shaft 124. Additionally, the expandable member 78 can be flattened / stretched by "wrapping" it around a surface within the syringe (such as cylindrical wall 134). The prestress developed in the expandable member 78 will serve to eliminate any residual fluid volume retained therein.

[0171] As previously described, there are a number of different ways to cause the expandable member 78 to expand and / or contract in an arcuate manner. Figure 15One way to do this is to design the expandable member 78 with a thicker wall cross section 126 in one area around the circumference of the expandable member 78, which will cause the expandable member 78 to expand in a circular manner. Alternatively, separate elements 126 can be fixed along the length of the expandable member 78 to effectively reinforce that portion of the circumference of the expandable member 78, which will cause the expandable member 78 to expand in an arcuate manner. Referring again to Figure 17 Another approach is to use internal features, such as slots or recesses 125 in the housing 74 of the syringe 7, to guide the expandable member 78 around a circular or spiral path. These features 125 can interact with the expandable member 78 in a variety of ways, the simplest of which is that the outer shape of the expandable member is constrained by the slots 125 in the housing 74 of the syringe 7. The friction between the expandable member 78 and the inner surface 125 of the housing 74 can be reduced by lubricating the outer surface of the expandable member 78, or by inserting the expandable member 78 into a low spring rate spring that will limit both the friction and outer diameter of the expandable member 78 without constraining the length.

[0172] refer to Figures 36 to 39 , the elongated expandable member 78 can preferably be configured to expand along an arc having a predetermined tubular diameter without the aid of walls or guides within the syringe. Referring again to Figure 15 , looking at the cross-section of the elongated expandable member 78, a thicker wall region 126 can be added to a small portion of the circumference of the expandable member 78 to allow the elongated expandable member 78 to expand in an arc as previously described. The arcuate expandable member 78 increases in length due to the increase in pressure and volume within it; the thicker section 126 deflects less than the thinner section.

[0173] refer to Figure 17 , the arcuate expandable member 78 will expand in an arcuate shape over its length, thereby orienting its thick wall thickness region 126 or less deflection region toward the interior of the circle. Increasing the wall thickness 126 of the expandable member 78 within the small region 126 around the circumference will effectively continue to decrease the arc radius of the expandable member 78. The increase in wall thickness 126 can be achieved by molding or extruding it into the arcuate expandable member 78, or by bonding a strip of material to one side 126 of the expandable member so that that portion of the wall 126 lengthens at a slower rate, thereby causing the expandable member 78 to expand in an arcuate shape as previously discussed.

[0174] refer to Figure 18, the distal end of the expandable member 78 can be fixed with an element such as an indicator 101 that is constrained to follow a guide path within the inner surface 125 of the housing 74. Alternatively, the expandable member 78 can be pre-stretched and flattened around a circular diameter (such as wall 134) within the syringe 7 so that the length of the expandable member does not change. Alternatively, a straight or curved mandrel 124 that is longer than the unstressed expandable member can be used to stretch the expandable member into a circle within the syringe 7 before filling. Alternatively, the mandrel 124 can be used as a visual indicator to show the status of the syringe 7 and the progress of the injection. The mandrel 124 can be colored to allow it to be easily seen through the housing.

[0175] refer to Figures 36 to 39 , a substance is injected into the expandable member 78 by a delivery device, and the expandable member 78 expands to a specific outer diameter controlled by the configuration of the inner surface 125 of the shell 74. In this manner, the entire length of the expandable member 78 can be filled with a known volume of the medicament, and the outer diameter at each longitudinal position along the expandable member 78 is known. It is desirable to have the expandable member 78 fill and empty along its length from one end to the other in a controlled manner to promote complete emptying of the expandable member 78 and to allow easy and accurate measurement of the substance in the expandable member. To visually assist in determining how much substance is in the expandable member 78, graduated markings (similar to a syringe) may be printed on the expandable member 78 to indicate the volume remaining in the expandable member 78. As previously described and with reference to Figures 21 to 22 , the expandable member 78 and the housing 74 can be transparent to allow the user to see the medicament 74 and the volume remaining in the syringe 7. Alternatively, graduated markings 127 can be printed on the housing 74 to indicate the volume remaining in the expandable member 78.

[0176] refer to Figures 36 to 39According to one aspect of the above-mentioned subject matter, the substance can be gradually discharged from the distal end 128 of the elongated expandable member 78 toward the proximal end 129. The proximal end 129 of the expandable member is closest to the distribution cannula 82 or cannula. This allows the user to visually determine or approach the injection state alone or with the help of the scale mark 127 on the injection housing 74, the window 80 or the expandable member 78. Gradual expulsion can be achieved in a variety of ways. For example, the substance leaves the expandable member 78 at the manifold 121 at the proximal end outlet port section 130 and is preferably located at the proximal end 129 of the elongated expandable member (e.g., a balloon or sac-like container). The thickness of the wall of the expandable member 78 can vary uniformly or gradually along its length from the distal end 128 toward the proximal end 129. Due to the limitation of the wall of the spiral channel 125 in which the expandable member 78 is located, the expandable member 78 will be expanded to a substantially uniform diameter along its length by the substance. 129 and will collapse or contract in diameter initially during expulsion of the material. As the walls of the expandable member 78 thin in that direction along its length, the expandable member 78 will then gradually collapse from the distal end 128 toward the proximal end 129. Because the thickness of the expandable member 78 preferably increases substantially uniformly from the proximal end 129 toward the distal or closed end 128, the contractile forces of the expandable member 78 walls will increase substantially uniformly along the length of the elongated expandable member 78 from the proximal end port end 129 toward the distal or closed end 128 when expanded. Thus, as the material is expelled into the subject, the expandable member 78 will gradually collapse in diameter and also gradually contract in length, with the diameter collapse and length contraction preferably being visible to the user as described above. The distal end 128 of the elongated expandable member can allow for the connection of a movable indicator component 101 in the syringe 7, which will follow the contraction of the length of the elongated expandable member 78. The indicator 101 is preferably visible to the user through the outer housing 74 and indicates the status of the syringe 7 and the progress of the injection. Alternatively, the expandable member 78 is configured to have a constant wall thickness and can be pre-stressed during manufacturing to bias it to fill from the proximal end 129 to the distal end 128 and collapse or empty in a progressive manner from the distal end 128 to the proximal end 129 as previously discussed.

[0177] refer to Figures 36 to 39The elongated expandable member 78 of the syringe 7 can be configured to have a section 130 of the expandable member 7 adjacent the proximal outlet port end 130 that fills first and collapses last during filling and expelling of the substance from the syringe 7. In other words, during filling of the syringe 7 via the delivery device, it is advantageous to have the proximal outlet port section 130 of the expandable member 79 fill with the injectable first. Furthermore, during dispensing of the substance from the syringe 7, it is advantageous to contain the last remaining volume of the substance within the proximal outlet port section 130 of the expandable member 79. This configuration has several advantages. The proximal end section 130 of the expandable member 78 can have thin walls, which will allow it to remain inflated at a lower pressure than the remaining section of the expandable member 78. This ensures that the section 130 of the expandable member 78 will remain inflated until all the substance has been expelled from the remaining section of the expandable member 78. As previously discussed, the section 130 can be directly coupled to an empty indicator to provide a full or empty indication. Furthermore, as previously described, the section 130 may be mechanically coupled to an empty indicator to allow for automatic withdrawal of the button 77 and cannula 82 upon complete expulsion of the substance.

[0178] refer to Figures 36 to 39 Alternatively or in addition to varying the wall thickness 126 of the expandable member 78, the elongated internal mandrel or shaft 124 within the expandable member 78 can gradually (linearly or stepwise) decrease in cross-sectional size along the length of the expandable member 78 from the proximal end (outlet port end) 129 of the expandable member 78 toward the distal end (closed end) 128. Additionally, the manifold 121 that allows the expandable member 78 to be attached to the syringe 7 can also be configured to have a large diameter section 130 at the proximal end 129 of the expandable member 78. The large diameter section 130 of the mandrel 124 or manifold 121 at the proximal end outlet port 129 of the expandable member 78 ensures that the expandable member 78 will be filled first with material in that region 129. In other words, the expandable member 78 is held close to the fill diameter at the proximal end outlet port 129 by the large diameter section 130 of the mandrel 120 or manifold 121. When the substance first begins to fill the expandable member 78, it first reaches the fill diameter in the large diameter section 130 and then gradually fills along the length of the expandable member 78 from the proximal end 129 to the distal end 128 as previously discussed.

[0179] refer to Figures 36 to 39As previously discussed, during the dispensing of material from the expandable member 78, the diameter of the expandable member 78 at its distal end continues to collapse in a progressive manner (similar to deflating an elongated balloon) from its distal end 128 to its proximal end 129 until all fluid is expelled from the expandable member 78. The large diameter section 130 of the mandrel 124 or manifold 121 provides the same benefits during the dispensing of material (as previously described for filling) at the proximal end outlet port 129 of the expandable member 78. The large diameter section 130 ensures that the last remaining material in the expandable member 78 will be contained and dispensed from the section 130. As previously discussed, the section 130 can be directly coupled to an empty indicator to provide a full or empty indication, as well as automatically withdraw the button 77 and cannula 82 when the material is completely expelled.

[0180] refer to Figure 21 , the user attaches the syringe 7 to their skin 99. There may be an adhesive on the bottom of the syringe 7 that allows for adhesion to the surface of the skin 99 and hands-free operation. The adhesive may extend beyond the contours of the syringe to allow the user to securely adhere the tape to the skin. Alternatively, the user may hold the syringe 7 against the skin 99 during the injection.

[0181] refer to Figures 21 to 23 , the user removes the safety device 100 and presses the button 77 on the syringe 7 to start the injection. Once the button 77 on the syringe 7 is fully pressed, it is locked in place, the cannula will be fully inserted into the patient, and the syringe 7 will begin to dispense the injectable medicament. The syringe 7 can remind the user that the injection of the medicament has begun. The reminder can be in the form of a visual indicator, an audible sound, a mechanical movement, or a combination thereof. The time of the injection can range from a few seconds to several hours. The syringe 7 can indicate to the user that it is dispensing with the button 77 locked in the down position and an indicator window 101 showing that the syringe 7 is not full. The syringe 7 preferably has a transparent section 80 that allows the user to easily determine the amount of medicament remaining in the syringe 7.

[0182] refer to Figure 24 When the injection of the medicament is complete, the user will be notified. The notification can be in the form of a visual indicator, an audible sound, a mechanical movement, or a combination thereof. The syringe 7 can indicate to the user that the dispensing is complete through a tactile and audible sound of the button 77 moving to the locked position and an indicator window 101 showing that the syringe is empty. At the end of the dispensing, the cannula will automatically retract into the locked position within the syringe 7.

[0183] refer to Figure 21When the syringe 7 is removed from the skin 99, the bandage 120 can be released from the syringe 7 and remain on the skin surface 99. When removed from the skin 99, the syringe 7 will preferably be locked to protect non-destructive access to the cannula or reuse of the syringe 7. The syringe 7 can indicate to the user that the full dose has been delivered. The indication can be in the form of a visual indicator, an audible sound, a mechanical movement, or a combination thereof.

[0184] According to other aspects of this theme, when utilizing the syringe and cannula of intention subcutaneous infusion to infuse, it is desirable to know whether the cannula is correctly placed in the skin or incorrectly placed in the blood vessel. The user performing intradermal (ID) injection, subcutaneous (SC) injection or intramuscular (IM) injection usually aspirates the syringe by pulling back the plunger to form a pressure drop in the syringe to see whether there is any visible blood entering the syringe from the cannula. If blood is visualized, this means that the tip of the cannula is in the blood vessel. A variety of injectable medicaments for subcutaneous injection are specifically instructed not to be infused into the blood vessel. Using a syringe and cannula to perform blood aspiration is a common technique that can be performed by anyone who has been fully trained. In some cases, an automatic syringe can be used, and the automatic syringe can include a mechanism for determining whether the automatic syringe is correctly placed.

[0185] refer to Figures 25 to 26 , the syringe 7 can have a cannula 85 having a side opening (e.g., a hole) 108 that operably engages a button 77 that can slide within a septum 109 that is advanced into the skin 99. The button 77 can have a viewing window 160 on the button top 103 that is in fluid communication with the proximal end 161 of the cannula 85. The button top 103 can include a cavity 162 for blood 159 to accumulate and be viewed by the user through the button window 160. The cavity 162 can include a central hole 163 that allows fluid communication with the proximal end 161 of the cannula 85 via the cannula cavity 165. The outer wall 164 of the cavity 162 is formed by the button top 103. In addition, a portion of the outer wall 164 can include a hydrophobic filter 166. In the described configuration, the proximal end 161 of the cannula 85 is at atmospheric pressure. If fluid 14 or blood 159 travels up the lumen 165 of the cannula 85, it exits the proximal end 161 of the cannula 85 and fills the lumen 162. Air 167 in the lumen 162 is easily displaced through the hydrophobic filter 166 until all of the air 167 is expelled from the lumen 162 and the lumen 162 is filled with fluid 14 or blood 159. At this point, the flow of fluid 14 or blood 159 ceases because the fluid 14 or blood 159 cannot penetrate the hydrophobic filter 166 and can be easily viewed by the user through the window 160 of the button top 103, thus providing a method for determining whether the cannula 85 of the syringe 7 is in the blood vessel 158.

[0186] See also Figure 27 , cannula insertion into tissue can be broadly divided into four stages. These include no contact (panel a), boundary displacement (panel b), tip insertion (panel c), and shaft insertion (panel d). During boundary displacement, the tissue boundary in the contact region deflects under the influence of the load applied by the cannula tip, but the cannula tip does not penetrate the tissue. As the cannula tip begins to penetrate the skin, the boundary of the skin follows the cannula tip until the point of maximum boundary displacement in the contact region. After the cannula tip penetrates the skin, the shaft is inserted into the tissue. Even after the tip and shaft are inserted, the boundary of the skin surface in the contact region does not return to its original no-contact state, but remains displaced a distance x. The amount of boundary displacement x is a function of several parameters (including but not limited to cannula diameter, cannula tip geometry, cannula shaft friction, cannula insertion speed, and physical skin properties). The boundary displacement x of the skin in the contact region is characteristic of cannula-based syringes because it affects the extent to which the cannula penetrates the skin and therefore reduces the actual cannula penetration depth by the amount of boundary displacement x. If the boundary displacement x can be intentionally induced by stretching or preloading (such as by pushing the skin out at the contact site before the cannula tip is inserted), there will be no additional boundary displacement of the cannula tip or shaft during insertion, and the cannula tip depth can be predictably defined. The advantage of such intentional displacement is that the amount of tissue penetration by the cannula is not affected by changes in the boundary displacement x. Without intentionally inducing a boundary displacement at the skin surface before the cannula tip is inserted, the actual depth of cannula penetration into the skin is not specifically known because of the Figure 27 The naturally occurring boundary displacement x shown in FIG, with some cannula length (depending on the above parameters) outside the skin. On the other hand, if the maximum boundary displacement can be induced at the contact site, the actual cannula penetration depth will not change with changes in the above parameters (including cannula diameter, cannula tip geometry, cannula shaft friction, cannula insertion speed, and physical skin properties).

[0187] refer to Figure 28In one embodiment, the syringe 7 may include a skin boundary displacement extension or structure (such as the underside surface 76) comprising an extension 138 at or around the dispensing port 82 or as part of the dispensing port 82. The extension extends substantially perpendicular to the tissue plane at the cannula insertion point. When the syringe 7 is attached to the skin 99, the extension 138 will protrude against the surface of the skin 99, causing displacement or compression of the skin 99 in the contact area 139. The compression of the skin helps to reduce or eliminate "bulging" of the tissue surface upon cannula insertion. In other words, by compressing the tissue to "preload" it, the extension 138 serves to eliminate further tissue loss or bulging, or to cause more reproducible and lesser deflection or bulging of the skin surface. During actuation of the button 77 from the pre-fired state to the first position, the cannula 85 advances through the dispensing port 82 and / or the extension 138 out of the syringe 7 and into the skin 99 to begin dispensing the medicament. For the reasons described above, as the cannula 85 advances outside the syringe 7, the tip of the cannula 107 does not produce an additional boundary displacement 141 in the skin 99 at the contact area 139 (already intentionally caused by the extension 138). Consequently, the actual cannula penetration depth 140 into the skin 99 is better characterized and controlled. Furthermore, the extension through which the cannula passes directly compresses the tissue surrounding the cannula, which has several advantages. During injection, the compression of the tissue by the extension 138 in the contact area 139 increases the local density of the tissue, thereby creating a higher pressure zone compared to the surrounding adjacent tissue 99. As the injectable enters the skin 99, fluid will migrate from the high-pressure zone 139 to a low-pressure zone in the skin 99, which helps prevent the injected fluid or medicament from flowing into or migrating into the immediate area surrounding the cannula / skin puncture site and serves to reduce or minimize fluid leakage (backflow) and / or bleeding at the puncture site. The high-pressure zone also effectively provides the benefits of a longer injection cannula. For example, in an ultrasound evaluation comparing the subcutaneous deposition depth of a 10 mL fluid bolus (saline) using a syringe 7 with a 5 mm needle depth and an off-the-shelf infusion pump (Freedom 60, RMS) with a butterfly needle extension assembly (9 mm needle depth), the results showed that the subcutaneous depth after injection of the 10 mL bolus was equivalent between the syringe 7 with a 5 mm needle length and the pump with a 9 mm needle length. In all results, the bolus location was characterized by the distance from the skin surface to the top edge of the bolus (Zd). Figure 47 Shown is the top edge of a 10 mL subcutaneous bolus using a pump with a 9 mm cannula length. The Zd distance is measured at 0.44 cm. Figure 48 The top edge of a 10 mL subcutaneous bolus injection using a syringe 7 with a 5 mm cannula length is shown. The Zd distance was measured at 0.42 cm. Thus, a bolus injection of similar depth had a cannula depth (5 mm) and a tissue displacement feature that was more than 40% shorter than another test cannula without the tissue displacement feature (9 mm).

[0188] Another advantage of the extension 138 is that it compresses the tissue in the contact area 139 after the injection is completed. In the post-fired state, the button 77 has popped up, alerting the user that the syringe 7 is complete. The cannula 85 is fully retracted outside the puncture hole in the skin 99. The dwell time between the syringe 7 completing the dispense and being removed by the user can be several minutes or longer, depending on the environment the user is in at the time of completion. For the same reasons described above, the compression of the tissue by the extension 138 in the contact area 139 increases the local density of the tissue, thereby creating a higher pressure area compared to the surrounding adjacent tissue 99. Similar to how a nurse may apply pressure to the injection site with their thumb after an injection, the pressure helps to seal the puncture hole and prevent the injected fluid or medicament from flowing back into the injection site, and acts to reduce or minimize fluid leakage and / or bleeding from the puncture site.

[0189] refer to Figure 29 , there are two interfaces associated with adhering the syringe 7 to the skin 99. The first is the adhesive / device interface 173, and the second is the adhesive / skin interface 174.

[0190] refer to Figure 30 , adhesive 88 can be configured to have at least two zones on syringe 7. A first zone 175 can include a permanent bond between adhesive 88 and syringe 7 using mechanical or chemical means and is preferably located within the periphery of syringe 7. A second zone 176 can be configured to be detachable or unattached from syringe 7 and is preferably adjacent to zone 1 and on the outside of zone 1 (e.g., radially outward).

[0191] refer to Figure 31 If the adhesive 88 is fully attached to the base 76 of the device 7, then during a tissue bulge 177 event, the adhesive 88 at the adhesive / skin interface 174 will begin to peel away from the skin 99 because the interface 174 is weaker than the adhesive / device interface 173. Figure 31 This may cause the syringe 7 to detach from the skin surface 99 and detach from the patient.

[0192] refer to Figure 30 and Figure 32 , the adhesive 88 can be configured on the syringe 7 having the above-mentioned areas 175, 176, rather than as Figure 317. The adhesive 88 is shown as being completely and permanently attached to the base 76 of the syringe 7. During a tissue bulging event 177 in this configuration, the adhesive 88 in the second region 176 will detach from the syringe 7 and be firmly attached to the skin 99 surface at the adhesive / skin interface 174. This will allow the peel edge 178 to pass from the adhesive skin interface 174 to the adhesive / device interface 173, effectively forming a strain relief at the adhesive / skin interface. The adhesive / device interface 173 can be designed to be more robust and prevent the syringe 7 from separating from the skin surface 99.

[0193] When using an autoinjector to perform a self-injection, protecting the user from accidental cannula sticks is a beneficial requirement for the device. Typically, the cannula is retracted into the device before and after use, preventing the user from accessing it. However, during injection, the cannula may extend outside the device. In some cases, autoinjectors incorporate a skin displacement sensor to automatically retract the cannula if the device is dislodged from the skin during an injection.

[0194] refer to Figures 33 to 35 , the skin displacement sensor 179 can be operably engaged with the flexible latch 181 of the button 77 and can slide within the lower housing 180 of the syringe 7. Figure 34 , when the syringe 7 is attached to the skin surface 99, the skin displacement sensor 179 is forced into a first or upward position 182 within the syringe 7. When the button 77 is actuated to the fired state or second position or dispensing position (exposing the cannula 85), the flexible latch 181 is forced into a locked position 187 by the skin displacement sensor 179 below the latch plate 183. In the downward fired state or dispensing position, the latch plate 183 holds the button 77 at the latch plate surface 184 on the button 77 until dispensing is completed. At the end of dispensing, the latch plate 183 translates away from the latch plate surface 184 on the button 77, allowing the button 77 and the cannula 85 to retract to the post-fired position, where the cannula 85 is housed within the syringe 7. Reference Figure 35 In the event that the syringe 7 is disengaged from the skin surface 99 during an injection, the skin disengagement sensor 179 extends to a second or downward position 185 outside of the syringe 7. This allows the flexible latch 181 to spring back to the unlocked position and disengage from the latch plate 183. This allows the button 77 and cannula 85 to retract to the post-fired position in which the cannula 85 is housed within the syringe 7.

[0195] When performing a self-injection using a syringe and cannula, the user may need to temporarily stop or pause the injection due to severe pain or irritation at the injection site. This pause in the flow of the injectable into the injection site is achieved by removing pressure from the syringe plunger rod, thereby reducing local pressure and associated pain and irritation by allowing the injectable bolus more time to diffuse into the surrounding tissue, and thereby helping to reduce pain at the injection site. In some cases, the syringe includes a mechanism for, for example, automatically or manually pausing the injection.

[0196] See also Figures 36 to 37 , when the button 77 is actuated, the cannula 85 and the button 77 travel to a first position or depth, as Figure 36 In the first position or depth, the side hole 108 is covered by the septum 109, and thus the lumen 165 of the cannula 85 is not in communication with the fluid channel 86 of the dispensing port 82. The button 77 can be intentionally maintained in the first position or depth to prevent the injectable 14 from flowing from the fluid channel 86 into the side hole 108 of the cannula 85 and into the skin 99. Figure 37 As shown in FIG, when the button 77 is released, the cannula 85 and the button 77 return to the second position or the dispensing position, in which the side hole 108 is exposed to the fluid channel 86, allowing the injectable 14 to flow from the fluid channel 86 into the side hole 108 of the cannula 85 and into the skin 99 until the injection is completed. The action of pushing the button 77 to the first position or depth can be performed as many times as needed during the entire injection period.

[0197] refer to Figures 38 to 39 , the actuation force 186 of the button 77 is a transition load applied to the button 77, which is required to initiate the displacement of the button 77 and the cannula 85 from the pre-fired position to the fired state or dispensed position. Before the transition load is satisfied, the force 186 applied to the button 77 is directly transmitted to the syringe 7. Specifically, the load 186 can be transmitted to the adhesive skin interface 174 and / or the adhesive device interface 173, thereby better securing the syringe 7 to the skin surface 99 before the syringe 7 is actuated.

[0198] refer to Figures 40 to 41, the arched expandable member 78 is positioned and / or preferably will expand in an arc shape over its length. In the illustrated embodiment, the arc shape is formed by providing a region of less elasticity, such as a thicker or relatively thicker wall thickness region 126, which will result in less deflection of the expandable member in the region and result in the formation of an expanded arc shape. The thick wall thickness region 126 can be configured to any shape that allows the expandable member 78 to assume an arc shape during expansion. The preferred configuration of the thick wall region 126 is to minimize its thickness or attachment 150 in the circumferential direction on the expandable member 78 wall and maximize the radial thickness or protrusion 151 away from the expandable member 78. This is used to encourage the expandable member 78 to expand in an arc shape, but also maximize the amount of material along the circumference without being affected by the thick wall thickness region 126 used for expansion. Additional features, including but not limited to T-shapes, can be configured to the ends of the radial protrusions 152 to help push the expandable member 78 into an arc shape.

[0199] refer to Figure 42 , a safety device such as a safety pin or safety sleeve 100 may be configured to allow removal from the syringe 7 in any direction to release the syringe 7 ready for firing (injection).

[0200] refer to Figure 43 The syringe 7 includes a cannula 85 with a side hole 108, which allows fluid communication between the fluid channel 86 and the skin 99 once the button 77 is fully depressed in the syringe 7. This initiates the dispensing of the injectable 14. The inner diameter 165 of the cannula 85 is important in controlling the dispensing rate from the syringe 7. Referring to the Hagen–Poiseuille equation for fluid flow in a pipe, the flow rate through a pipe is proportional to the fourth power of the pipe radius. Therefore, small changes in the inner diameter 165 of the cannula 85 result in large changes in the flow rate through the cannula 85, especially as the inner diameter 165 becomes smaller. The cannula 85 in the syringe 7 is available in various wall thickness configurations, ranging from 21G to 34G (short wire gauge system). This range corresponds to an inner diameter 165 range of 0.021" to 0.003", recognizing that within any given cannula size, there are manufacturing variations or tolerances in the cannula inner diameter 165. This is based on the cannula size and can have an inside diameter variation of up to ±0.00075". In order to limit the range of inside diameters 165 within any given cannula size and the resulting variation in flow rate, the cannula 85 may be modified prior to assembly into the syringe 7. Such modification may include crimping, flattening, or rolling the cannula 85 over a portion of its length from a circular shape to a non-circular shape to a new specified effective inside diameter 165. This has the advantage of allowing for specific delivery rate control from the syringe 7.

[0201] Radiofrequency compliance monitoring

[0202] In some cases, the syringe includes a mechanism to alert the subject, prescriber, healthcare provider, or another third party actor when non-compliance or non-adherence occurs.

[0203] According to other aspects of the present subject matter, when administering an injection with an auto-injector, it is desirable to know when the prescribed syringe was initially filled or refilled, and whether the syringe was used correctly and in a timely manner. Although many prescribed medications are tracked when the patient dispenses the medication using specialized labeling, there are limited options for confirming whether the patient has actually taken the medication. With the increasing number of medications available in syringes, the ability to automatically track prescribed activations currently has limited use. Furthermore, there is no ability to automatically track whether the syringe was used correctly.

[0204] As described herein, can use the RF (radio frequency) technology that is installed in transmission described herein and / or syringe or its collaborative association to realize the automatic tracking of both adhesion and compliance wirelessly.Current technology allows to use radio frequency identification (RFID) to transmit data, and purpose is to automatically identify and track the label or the microcircuit chip that is attached on the object.As used herein, RF or RFID or RF tag or RF chip are used comprehensively and interchangeably, and intention includes for using any suitable wireless communication protocol or technology (such as bluetooth or any other wireless technology (for example, other wireless technologies described in wireless local area network, wireless PAN or Institute of Electrical and Electronics Engineers (IEEE) 802 standards)) to transmit wireless electronic tag or the chip of data / information.

[0205] RF tags or chips can be active or passive. Although both types use RF energy to communicate between the tag or transponder and the reader, the method of powering the tag is different. Active RFID uses an internal power source (such as a battery) within or associated with the tag to continuously power the tag and its RF communication circuitry, while passive RFID relies on RF energy transferred from a reader to the tag to power the tag. In the present subject matter, a syringe or transport package can include an RFID tag, which can optionally include a power source for the tag, and be read or received by an external reader. In one embodiment, the RF tag or chip is removably associated with the syringe so that the RF tag or chip can be physically removed from the syringe when the syringe is used. If the tag or chip remains as part of the syringe after its use, this allows subsequent disposal of the syringe without restrictions or constraints that may apply.

[0206] refer to Figures 44 to 45, the syringe 210 may include an electronic RF tag or chip 211 to monitor the status of the syringe 210. For example, the RF tag 211 may broadcast (if active) or present (if passive, to be read by the external reader 212) information or status such as "the syringe 210 has been prescribed," "the syringe 210 has been removed from its packaging," "the syringe 210 has been actuated," and / or "the syringe 210 has completed its dose" to an external reader 212. The RF tag reader may also be associated with or communicate with an on-site or off-site data collection facility (such as through a wireless or hard-wired connection) to allow information about compliance to be recorded and compiled.

[0207] refer to Figures 44 to 45 , the RF tag 211 can be used to monitor whether the syringe 210 has been activated or has started or completed its dose. The syringe 210 may include an active or passive radio frequency (RF) tag or chip 211 in any suitable location. As shown below, when used inside the syringe, the RF tag or chip 211 can be attached to the button 213 and slidably communicate with the spring tab 214 during the first position and the second position of the button 213. When the RF tag 211 is slidably communicating with the spring tab 214, the RF tag 211 can broadcast (if active) or present (if passive, read by the external reader 212) a first state that includes an unused state. With the syringe 210 activated, the button 213 is pressed to the dispensing position. At the end of the dispensing cycle, the button 213 is pushed from the second depth or dispensing position (such as Figure 45 ) is unlocked to move upward to a final or post-fire position. In the post-fire position, the RF tag 211 may no longer be in contact with the spring tab 214, thereby allowing the state of the RF tag 211 (the second state) to change. In the second state, the RF tag 211 can broadcast (if active) or present (if passive, read by an external reader 212) a second state to include a use state. Alternatively, the RF tag 211 may be deformed or changed in such a manner when the syringe is used that the RF tag 211 presents a "used" signature when interrogated. For example, if the RF tag consists of two coils joined by a conductor, the initial signature of the tag 211 will be a "double coil" signature. Once the tag 211 is used, if the conductor joining the two coils is broken, the two independent coils produce different signatures.

[0208] For regulatory and / or disposability reasons, it may be desirable to place the RF tag or chip on the exterior of the syringe. For example, the RF tag or chip 211 may also be associated with another portion of the delivery device or system, such as, for example, a safety sleeve or pull tab 100 (see Figure 42) to activate the tag or chip at one or more selected points in the operation of the delivery device and / or injector. For example, the active RF tag or chip can be located on a safety sleeve and configured such that removal of the safety sleeve to initiate the injection process closes contact between the long-shelf-life battery and the tag or chip transmitter.

[0209] refer to Figures 52 to 55 , the RF chip or tag 211 within the syringe 210 can have two states, a standby or off state and an active or transmitting state. Figure 52 and Figure 54 , the state can be changed by connecting or disconnecting the contact between the battery 262 and the contact 263. Figure 54 As shown, this can be accomplished by, for example, configuring the safety release or pull tab 100 to prevent electrical contact between the battery 262 and the contacts 263 by spatial separation when the pull tab 100 is in place on the syringe 210. Figure 55 As shown, when the pull tab 100 is removed, the battery 262 and the contacts 263 come together to contact each other and form electrical contact. Thus, the RF tag becomes functional. In addition, different actions associated with the delivery and / or use of the syringe can be used to establish or break contact. For example, when one action is taken, such as when a vial is inserted into a delivery device, a previously inactive RF tag or chip can be activated by closing the contact between the battery and the chip or tag transmitter, and deactivated via another action (such as by breaking such contact after using the syringe).

[0210] In addition to usage information, the RF tag or chip 211 can also transmit or communicate data associated with the delivery or syringe. For example, the tag or chip can be configured with memory storage capacity to transmit the type of syringe, batch number, amount of fluid administered, medication identification, and other relevant information. Figure 46 A system that can be used with the present subject matter is schematically shown. As shown in the figure, the RF tag or chip 250 can be of an active type and, when activated, actively transmits relevant information to a local patient module 252 located within the vicinity of the patient and the syringe. For example, the patient module can be a wall-mounted or tabletop device located in the patient's home that receives monitoring information transmitted by the RF tag or chip associated with the syringe and / or delivery device. The patient module can also be a cellular phone, etc.

[0211] The patient module may include a memory that stores data such as patient identity and related information. The patient module then communicates with a data manager 254 in an appropriate manner (e.g., WIFI, cellular communication, telephone, hard-wired link or other means). The data manager 254 may be any appropriate data network or cloud storage device for receiving and / or storing data indicating the syringe status and / or use associated with specific identification patient information received from the patient module. The medical staff responsible for monitoring the patient's use of the syringe and the patient's compliance with any prescribed injection regimen may access the data manager. The data manager may also be configured to automatically forward patient compliance information to appropriate medical staff, such as a specific physician or clinic 256.

[0212] exist Figures 49 to 58 Other aspects of the compliance monitoring device, system and method described herein, and the use of a syringe are shown in FIG. As shown, the system may include a wireless (such as, Bluetooth) source, such as a battery powered transmitting unit, such as Figure 59 The sending unit may be mounted in any suitable location and may be associated with or attached to a portion of the syringe (and / or delivery device) in a manner such that it is detachable from the syringe or delivery device upon disposal, thereby allowing a substantial portion of the syringe or delivery device structure to be recovered, as electronic circuits and electronic chips are not typically similarly recoverable.

[0213] In some embodiments, a contactor ring is disposed on top of the syringe housing and, when the safety strip is installed, prevents the contactor ring from contacting the sensing lead (which is attached to the syringe button). When the safety strip is removed, the contact ring of the housing contacts the sensing lead of the button. Different sequences of the injection process can then be tracked based on the state of the connection between the contact ring and the sensing lead (i.e., the position of the contact ring relative to the sensing lead). An infrared sensor can also be embedded in the syringe to optically track the delivery process, such as by, for example, monitoring the position or amount of injectable fluid in the expandable member of the syringe.

[0214] refer to Figure 52 and Figure 53, an embodiment of the RF tag or chip 211 includes the following components: a battery 262, contacts 263, a Bluetooth module 265 with a microcontroller / microprocessor, a button sensor 267, and an antenna 269. The battery 262 provides stored energy to power the system. This can be a coin cell or equivalent battery in the voltage range of 1.5-3V with a power output of 5-100mAh. As previously described, the contacts 263 provide an electrical connection between the battery 262 and the RF tag or chip 211. The contacts 263 are configured to interact with the pull tab 100 to allow for no electrical contact until the user removes the pull tab 100 for use. The Bluetooth module 265 has an integrated microcontroller / microprocessor. An example of a suitable Bluetooth module is Dialog Semiconductor part number DA14580-01UNA. In alternative embodiments, the Bluetooth module can be separate from the microcontroller / microprocessor.

[0215] Figure 56 and Figure 57 The button position sensing system in an embodiment of the device is shown in FIG. The sensing system may use an infrared transmitter and receiver sensor combination 267. The RF chip 211 is mounted on the underside surface of the device button 177, with the sensor 267 facing downward. The reflective member 112 is fixedly mounted to the bottom of the syringe. When the device button is actuated to Figure 56 Move to the upward, raised or extended position shown Figure 57 In the downward, lowered or retracted position shown, the sensor 267 detects a decrease in the distance from the reflective member 112. Conversely, when the button is released after the drug is delivered, the sensor 267 detects a decrease in the distance from the reflective member 112. Figure 57 Move to the position Figure 56 When the button is in the position, the sensor 267 detects that the distance from the reflective member 112 increases. The sensor 267 transmits the button position information to the microcontroller / microprocessor module 265.

[0216] In an embodiment of the device, Figure 58 The processing performed by the microcontroller / microprocessor module 265 is presented in FIG. As shown at block 302, when the microcontroller / microprocessor is powered on, such as by the above reference Figure 54 and Figure 55 The start timer is initiated by removing the safety tab 100 as described. Then, as indicated by block 304, the mode or state of the device is set to "ready to fire" (i.e., ready to dispense), and a Bluetooth packet indicating the mode of the device is transmitted to a Bluetooth-enabled remote reader or receiver (e.g., Figures 44 to 45 212), by way of example only, the device may be a smartphone or a computer system. The mode is displayed to the user on a remote receiver.

[0217] The processing of block 308a may then be performed to conserve battery life of the device and calculate the timing of the device.

[0218] Then, as indicated at block 312, the microcontroller / microprocessor uses, for example, the Figure 56 and Figure 57 Description of the IR sensor check device button ( Figure 56 and Figure 57 177). If the device button is not pressed into the down position, as indicated at 314, the above process is repeated. If the device button has been pressed, the start time of delivering the injection is recorded, as indicated at block 316, and the device mode is set to "dispensing," as indicated at block 318. The mode is transmitted to the remote receiver, where it is displayed to the user, as indicated at block 322.

[0219] The process of block 308b is then performed to conserve device battery life and calculate device timing by intermittently or alternately placing the processor in a low power sleep mode and then waking the processor at one second (or other suitable time) intervals.

[0220] The microcontroller / microprocessor then checks the position of the device button, as indicated at block 324. If the device button has not returned to the raised or upward position, as indicated at 326, the above process starting at block 322 is repeated. If the device button has moved to the upward position, the end time of the injection delivery is recorded, as indicated at block 332, and the device mode is set to "complete," as indicated at block 334. As indicated at block 336, the mode is transmitted to the remote receiver, where it is displayed to the user.

[0221] The process of block 308c is then performed to conserve the device's battery life and calculate the device's timing, after which the device's "done" status is again transmitted to the remote receiver (block 336).

[0222] Embodiments of the present disclosure may provide a "smart" connected device that enables patients to self-administer high-volume / viscosity medications, thereby enabling and facilitating patient freedom and mobility. Implementations may provide users with a safe, simple, and discreet medication delivery experience.

[0223] Embodiments of the present disclosure can provide a smart device system to provide three pieces of information regarding the operation of a drug delivery system: 1) when the device is powered on, 2) when the device begins delivery, and 3) when delivery is complete. In some embodiments, user interaction can include opening a mobile app on their device, as described elsewhere herein, and the smart device will do the rest without requiring additional action by the subject or user.

[0224] Embodiments of the present disclosure may provide advantages such as: Small board footprint - the entire electronics package fits within an existing button and is less than 3 / 8 inch (9.5 mm) in diameter. This allows for easy removal of the electronics (button) for disposal and recycling of the electronics.

[0225] Embodiments of the present disclosure may include smart device technology in the delivery device. For example, the delivery device may include electronics to track the delivery device's use. The electronics in the delivery device may communicate directly with an external receiving device and / or electronics in the patch / syringe. Sensors / sensors within the delivery device electronics may provide information including, but not limited to, environmental conditions, opening of the outer box or packaging, removal of the delivery device from the outer packaging, delivery device orientation (tilt sensing), device location (e.g., using a global positioning system or GPS), whether the delivery device is positioned on a flat surface, vial insertion, plunger release (venting), and / or syringe removal from the delivery device. The electronics in the delivery device may determine whether the correct vial has been inserted based on reading electronics within the vial or a barcode / QRG code. The electronics may be activated when the outer box or packaging is opened or when the delivery device is removed. Additional electronics may be added to vibrate or emit a sound if the device is not placed on a table or is at an angle. The electronics, combined with the external receiver, may provide voice commands to help the user use the device or provide instructions when something is not done correctly.

[0226] In certain embodiments of the present disclosure, the injector may utilize Bluetooth communication to provide data to the user. In addition, embodiments may integrate Bluetooth Low Energy (BLE) into the device. BLE can be designed for low-power, low-cost applications that require lower data throughput rates than traditional Bluetooth connections (such as audio streaming or hands-free phone connections).

[0227] The Bluetooth standard defines two main connection types: standard (bonding) mode and broadcast (also known as "beacon") mode. In a standard or bonding connection, a host (a smartphone with an app installed) establishes a saved connection with a peripheral (i.e., a smart device). In this case, through a pairing process, both the host and the peripheral share data to form a permanent connection that only exists between one host and one peripheral. This method offers the advantage of a secure connection, allowing the exchange of encrypted information that cannot be decrypted without the encryption key.

[0228] In broadcast mode (also called "beaconing"), the peripheral device periodically sends data that can be read by any nearby host. In this case, the peripheral device only broadcasts data; the data is never received. This mode has several advantages, such as reduced power consumption. In some cases, further power savings can be achieved by using a low-power "sleep" mode, waking only when new data needs to be broadcast.

[0229] Furthermore, since peripheral devices can be configured as transmit-only devices, enhanced security is provided because the hardware cannot be "hijacked" or loaded with malware. This reduces or eliminates the risk of unauthorized remote control of the device. The software is loaded onto the device at the factory, preventing unauthorized changes once deployed.

[0230] In some cases, as described elsewhere herein, the installation of the application can be used to protect data privacy. For example, if the application is not installed correctly, the data may simply consist of an unusable list of binary numbers, lacking any text or other readable identifiers. Therefore, the lack of an encrypted connection will not expose any sensitive user information. The data may also not include patient information (such as name or social security number), which may be associated with a specific individual (thus complying with HIPAA).

[0231] Within embodiments of the present disclosure, an important attribute of connected healthcare implementations can be that they do not affect the basic performance functionality of the medication delivery device. In some embodiments, the device's features only report the device's status and in no way alter the functionality of the medication delivery device. Even in the event of a catastrophic failure of a Bluetooth component (such as a battery), some embodiments of the device will complete the delivery of medication and provide visual feedback to the user regarding the device's status.

[0232] Leveraging the Bluetooth low energy broadcast mode and through an electronic chip in a device button, some embodiments of the present disclosure can deliver real-time device performance information in a small, low-cost, convenient package.

[0233] Syringe with patch

[0234] In one aspect, the present disclosure provides a system for measuring multiple health or physiological parameters from a subject. The system may include a patch comprising a first housing having a plurality of sensors configured to (i) measure multiple health or physiological parameters from the subject when the patch is secured to the subject's body, and (ii) provide one or more outputs corresponding to the multiple health or physiological parameters from the subject. The first housing may include an opening. The system may also include a syringe having a second housing comprising a cannula in fluid communication with a fluid flow path. The second housing may be coupled to the first housing so that when the patch is secured to the body, the cannula is guided through the opening and into contact with the subject's body. The syringe may be configured to (i) guide a substance from a reservoir to a fluid flow path in fluid communication with the reservoir, and (ii) guide a substance from the fluid flow path through the cannula into the subject.

[0235] The cannula can be configured to extend toward the subject's body or retract away from the subject's body. In some examples, the cannula extends toward the subject's body to deliver a substance to the subject's body (e.g., through the subject's skin). After delivering the substance, the cannula can be retracted away from the subject's body. The cannula can be connected to a reservoir via a fluid flow path. The cannula can use a variety of mechanisms (e.g., mechanical, electrical, etc.) to extend into the body and / or retract from the body. The device for cannula extension and retraction can include a pump, a spring, a gear, a diaphragm, a screw or other devices for moving the cannula, or a variation or combination thereof.

[0236] The syringe can be detachable from the patch. The patch can include a first housing, and the syringe can include a second housing, and the first and second housings can be removably coupled. In one example, the first housing of the patch can be mechanically coupled to the second housing of the syringe using one or more fastening mechanisms. In some cases, the first housing and / or the second housing can include magnets that allow for removable coupling, as described elsewhere herein. In another example, the first and second housings can be bonded, for example, using adhesive tape. The adhesion between the first and second housings can be adjusted based on desired properties. For example, it may be desirable to maintain the patch on the subject's body while removing the syringe. In such examples, an adhesive layer can be added to the patch, which can facilitate securing the patch to the subject's body. The adhesion between the body-adhesive adhesive layer and the subject's body can be stronger than the adhesion between the patch and the syringe. In yet another example, the first and second housings can be mechanically coupled, for example, using interlocking geometric shapes of the first and second housings. For example, the first housing can include threads (e.g., threads, internal threads, etc.), and the second housing can include complementary threads that can engage with the threads of the first housing. In combination or alternatively, the first housing and / or the second housing can include a snap-fit ​​joint (e.g., a cantilever snap-fit, an annular snap-fit, etc.) that allows the first housing to interlock to the second housing. Alternatively or in combination, the first housing and / or the second housing can include components that allow interference fit, force fit, shrink fit, locating fit, etc. In a non-limiting example, other examples of fastening mechanisms can include, form fitting pairs, hooks and loops, latches, threads, screws, staples, clamps, clamps, forks, rings, friction pads, rubber bands, rivets, grommets, pins, laces, buckles, Velcro, adhesives (e.g., glue), tape, vacuum, seals, combinations thereof, or any other type of fastening mechanisms. Alternatively, the syringe can be permanently attached to the patch. For example, the first housing can be connected to the second housing, or can be integrally built into the second housing, or vice versa.

[0237] In some cases, the patch and the syringe can be fastened to each other via complementary fastening units. For example, the patch and the syringe, or the housing of the patch and the housing of the syringe, can complete a form-fitting pair. The patch can include a convex component that fits in form, and the syringe can include a concave component that fits in form, or vice versa. In some cases, the outer diameter of the protrusion type fastening unit of the patch can be substantially equal to the inner diameter of the recessed type fastening unit of the syringe, or vice versa, to form an interference fit. Alternatively or additionally, the patch and the syringe can include other types of complementary units or structures (for example, hooks and loops, latches, snaps, buttons, nuts and bolts, magnets, etc.) that can be fastened together. Alternatively or additionally, other fastening mechanisms may be used to fasten the patch and syringe, such as, but not limited to, staples, clamps, clamps, forks, rings, friction pads, rubber bands, rivets, grommets, pins, ties, snaps, Velcro, adhesives (e.g., glue), magnets or magnetic fields, tape, combinations thereof, or any other type of fastening mechanism.

[0238] In some cases, patch and syringe can be fastened to each other via intermediate structure.In some cases, intermediate structure can be fastened to one or both of patch and syringe by one or more in any fastening mechanism described herein.Intermediate structure can comprise solid material, semi-solid material, liquid material (for example, being configured to solidified resin) or multiple material types.In some cases, intermediate structure may experience phase change (for example, for adhesive, from liquid to solid).For example, intermediate structure can comprise solidification to realize the fluid adhesive of fastening.In some cases, when applying stimulation (for example, thermal change, pH change, pressure change, the force applied etc.), intermediate structure can be changed into second phase from first phase, such as changing into solid from liquid or changing into liquid from solid, to realize fastening or loosening (or both).In some cases, patch and / or syringe can comprise intermediate structure.For example, intermediate structure can be integrated with patch and / or syringe.

[0239] The fastening between the patch and the syringe can be temporary, such as allowing the subsequent fastening and loosening of the patch and the syringe when not damaging (for example, plastic deformation, shear deformation, wear, compression deformation, etc.) the patch or syringe. Alternatively, fastening can be permanent, such as allowing to loosen two patches from the syringe subsequently. In some cases, it may be desirable to deform the patch or syringe, and when fastened to the syringe or the patch, the patch or syringe can be temporarily or permanently deformed (for example, stretching, compression, etc.) and / or deformed (for example, bending, wrinkling, folding, wrinkling, etc.) or otherwise operated. The opening can include a pierceable film. The pierceable film can be pierced by the cannula to produce an opening. The pierceable film can be formed by a polymer material, or the pierceable film can be formed by a variety of polymer materials. The polymer material can be naturally occurring or can be synthetic. The non-limiting example of a polymer material includes polyvinyl chloride (PVC), polyethylene, polyurethane. In some cases, the pierceable film can also include an adhesive layer (for example, acrylate, methacrylate, epoxy diacrylate or other vinyl resins, etc.). In some cases, the pierceable film can include a self-repairing polymer or elastic material so that the opening introduced by the cannula can be closed, for example, after the cannula is retracted. In such cases, the pierceable film can include an opening (e.g., a hole or a slit) that is configured to form a seal when the cannula is not guided through the opening. In some examples, the pierceable film can include an opening that is not configured to seal when the cannula is not guided through the opening. Alternatively, the opening can not include the pierceable film and the opening can be configured to be in direct sight with the subject's body. The opening can be any suitable shape, for example, a slit, a triangle, a square, a rectangle, a rhombus, a pentagon, a hexagon, a heptagon, an octagon, a polygon, an ellipse, an annular, a circle, etc. In some cases, the pierceable film includes an absorbent material, for example, cotton, rayon, nylon, a polymer, a polymer mixture, etc. In such cases, the pierceable film can be used as a bandage, and body fluids (e.g., sweat, blood, etc.) can be collected from the subject's body. In some cases, the pierceable membrane can comprise an oxygen permeable material that can allow the subject's body or portion thereof to be exposed to ambient air. In some cases, the pierceable membrane can comprise a drug (e.g., an analgesic or a drug for treating pain).

[0240] The reservoir can be fixed to the syringe. In some cases, the reservoir can be removed from the syringe. For example, the reservoir can include a container or be part of a container. The reservoir container can be removably attached to the syringe (for example, attached to the housing of the syringe and removed from the housing of the syringe). The housing can accommodate fasteners to fix the reservoir. Alternatively, the geometry of the syringe can be designed to fit the reservoir or reservoir container. In other cases, the reservoir can be part of the syringe (i.e., non-removable). In one example, a drug reservoir can be arranged in the housing and can be in fluid communication with an injection cannula. For example, the injection cannula can move between a pre-dispensing position and a dispensing position in fluid communication with the reservoir within the housing. The reservoir can be configured to accommodate a preparation having the substance.

[0241] The substance may comprise a drug. The drug may be a solution or a mixture. The drug may be used to treat diseases in a range of therapeutic areas, including but not limited to cardiovascular, musculoskeletal, gastrointestinal, dermatological, immunological, ophthalmic, hematological, neurological, oncological, endocrine, metabolic, and respiratory diseases. The drug may be used to treat discomfort or pain in a subject. For example, the drug may comprise an analgesic, a nonsteroidal anti-inflammatory drug (NSAID), or other pain-relieving, pain-relieving, or other pain management substance.

[0242] The housing of patch and / or the housing of syringe can comprise one or more polymers or plastic materials.The non-limiting example of polymer comprises polyamide, polycarbonate, polyester, polyethylene, polypropylene, polystyrene, polyurethane, polyvinyl chloride, polyvinylidene chloride, acrylonitrile butadiene styrene, polymethyl methacrylate, polytetrafluoroethylene, polyimide, polylactic acid, phenolic resin, polyether ether ketone or its derivatives (for example, high cross-linked, high density etc.).The housing of patch and / or the housing of syringe can comprise single polymer type (for example, homopolymer) or more than one polymer type (for example, copolymer), and comprise the monomer organization of random or arrangement.For example, polymer can be block polymer, alternating copolymer, periodic copolymer, statistical copolymer, three-dimensional block copolymer, gradient copolymer, branched copolymer, graft copolymer etc.

[0243] The sensor and / or transducer may include one or more sensors or transducers that allow measurement or monitoring of a health or physiological parameter or multiple health or physiological parameters, or allow indication of device function to the subject. Alternatively or in combination, one or more sensors may allow measurement of patch or syringe parameters. Non-limiting examples of patch or syringe parameters include determining whether the patch is fixed (e.g., fixed to the subject's body), whether the patch or syringe communicates with the communication interface, whether the cannula is in fluid communication with the reservoir, the blockage of the cannula, whether the patch and syringe are correctly connected, the flow rate of the substance through the cannula, etc. The sensor in the multiple input transducers / sensors may be selected from the group consisting of: conductivity sensor, impedance sensor, capacitance sensor, charge sensor, humidity and / or moisture sensor, temperature sensor, heart rate sensor, gap pressure sensor, resistance sensor, expansion sensor, acoustic sensor, vibration sensor, blood pressure sensor, optical sensor (e.g., color sensor, light sensor, wavelength sensor), chemical sensor, movement and / or activity sensor, and substance tracking sensor. The sensor in multiple output transducers can be selected from the group consisting of: tactile (vibration) transducer, audio transducer or visual transducer. In a non-limiting example, these sensors can be used to detect the environmental conditions of the subject using the syringe, the subject's body temperature, heart rate, blood pressure, interstitial pressure, tissue density, skin expansion, bleeding (e.g., internal or external), the delivery of the drug, the delivery and / or the drug dosage delivered to the subject, the subject's sweat volume and / or the subject's multiple analyte measurements (e.g., blood sugar, blood oxygen, etc.). One or more measurements can be measured or monitored before, simultaneously or after the patch is fixed. For example, the patch can be configured to measure one or more health or physiological parameters before injection to establish a baseline and / or calibration measurement of one or more health or physiological parameters. The patch can be fixed to the subject's body separately from the syringe. For example, the patch can be fixed to the subject's body and one or more measurements can be collected. The subsequent attachment of the syringe (e.g., attached to the patch and / or the user's body) can then allow the substance to be guided to the subject.

[0244] The transducer may comprise any useful component, such as a solenoid, a motor, or a micro-electromechanical system (MEMS) actuator. In such cases, the housing of the syringe or patch may comprise conductive contacts that provide both mechanical attachment and electrical contact of the transducer or sensor, for example, in an electronic subsystem housed in the syringe.

[0245] The patch and / or syringe may include a communication interface that allows transmission and / or reception of data corresponding to multiple health or physiological parameters of the subject and / or parameters of the patch or syringe. Data may be transmitted to an electronic device that communicates with the communication interface. As described herein, the communication interface may be a wireless communication interface, a Wi-Fi interface, a near-field communication interface, or a Bluetooth interface. The electronic device may be a device that can communicate with the communication interface, such as a mobile device (e.g., a smart phone, a tablet computer, a laptop computer, etc.). Alternatively, the communication interface may be a wired communication interface. In some examples, the patch and / or syringe may include a port for communication and / or a power supply (e.g., a universal serial bus (USB), a USB-C type, etc.) for connecting to the electronic device. The patch and / or syringe may include an RFID tag that allows information to be transmitted to the syringe and / or patch, and optionally recorded by the syringe and / or patch, including but not limited to information about the medicament. This may allow the data about the injection transmitted to include information about the device and the medicament.

[0246] In some cases, the patch, syringe and / or electronic device can include methods for data processing, data storage and / or one or more feedback loops. In one such example, the patch can monitor one or more physiological parameters of the subject after injection to generate data about one or more physiological parameters of the subject. The data can be transmitted to an electronic device (e.g., a mobile device) via a communication interface. In some cases, the mobile device can include methods for processing data and / or storing data (e.g., in a computer-readable memory). The example of processing includes the measurement of analyte concentration, the identification of analyte, the comparison of analyte concentration with a standard, the calibration of measurement, the summary of collected information, statistical calculations, trend determination, etc. The processed data can then be used for adjustment, for example, in a feedback loop, to adjust one or more parameters of the patch or syringe. The processed data can also be directly sent to a third party for further evaluation. For example, the measurement of physiological parameters can measure the concentration of an analyte or a substance (e.g., a medicament or drug). The data can be transmitted to an electronic device, which can further process the data (e.g., calibrate concentration, compare with a standard, determine whether to change the dosage, etc.). In some embodiments, the data after treatment can be used to change device parameters, such as the dosage of the substance to be administered, the distribution flow rate of the substance, etc. The data, the data after treatment or other signals can be relayed back to the patch or syringe so that the subsequent injection of the syringe is adjusted (e.g., the next dosage is higher or lower). In another example, the measurement of physiological parameters can measure the patient's bleeding (e.g., colorimetry, the measurement of heme iron in the blood, etc.). The detection of bleeding or substance leakage from the position can be used to adjust (e.g., in a feedback loop) the subsequent application rate or injection. In such examples, the presence of patient bleeding can allow the subsequent injection to be delayed, or changes the parameter (e.g., injection force, injection speed, etc.) extending towards the cannula of the subject's body. In some cases, electronic device can be unnecessary, and the patch may be able to communicate with the syringe directly or through a communication interface. In such cases, the patch and / or syringe can measure the device and / or physiological parameters of the subject, and subsequently use the measurement to adjust the parameter of the syringe or patch. In a non-limiting example, the measured value of the parameter (e.g., the patient's blood sugar) can adjust the dosage of the subsequent injection of the syringe.

[0247] In another example, the patch can monitor one or more parameters of the patch and / or syringe to generate data about one or more parameters of the syringe and / or patch. The data can be transmitted to an electronic device (e.g., a mobile device) via a communication interface. In some cases, the mobile device can include a method for processing data. The example of processing includes determining whether the device is correctly fixed (e.g., whether the adhesion of the patch to the subject's body is higher or lower than a threshold), whether the patch is correctly connected to the syringe, etc. The processed data can then be used to, for example, adjust one or more parameters of the patch or syringe in a feedback loop. For example, the adhesion of the patch to the subject's body can be measured. The data can be transmitted to an electronic device, which can further process the data (e.g., determine that the adhesion is insufficient). Therefore, the processed data can be used to change device parameters, for example, to activate notifications to the subject or other users, as described herein. Then, the data, processed data or other signals can be relayed back to the patch or syringe so that before injecting again (e.g., administering another dose of the substance), the parameters of the patch or syringe are adjusted or need to be adjusted. In some cases, the electronic device may not be needed, and the patch may be able to communicate with the injector directly or through a communication interface. In such cases, the patch and / or injector can measure parameters of the patch and / or injector and subsequently use the measurements to adjust the parameters or different parameters of the injector or patch. In one non-limiting example, in a feedback loop, a measurement of insufficient adhesion to the patch can prevent subsequent injections from the injector until the patch is measured to be adequately adhered to the subject's body.

[0248] Patch and / or syringe can also communicate with experimenter or other user or can communicate with experimenter or other user.In some cases, feedback system or loop can be included with communication with experimenter or other user.Alternatively or in combination, patch or syringe may be able to notify experimenter or other user (for example, doctor, nurse, practitioner, clinician etc.) about device parameter, health or physiological parameter or both.For example, patch or syringe may be able to produce sound (for example, provide direction to experimenter or other user), produce motion (for example, vibration), or can include visual indicator, such as lamp (for example, light emitting diode), screen or display (for example, liquid crystal display (LCD), organic light emitting diode, quantum dot display, or its variant or derivative), or other visual indicator.Alternatively or in combination, patch or syringe can include user interface module.In such example, experimenter or other user may be able to interact with patch and / or syringe.In one of such example, patch or syringe can include screen or display, and described screen or display can produce character string or sound, and described character string or sound can be used for prompting experimenter or other user response command. In another example, patch or syringe can include screen or display, and described screen or display can produce character string or sound, and described character string or sound can be used for display output or result, such as the measurement result of physiological parameter.Then, experimenter or other user can, for example, by the microphone that can be in the housing of patch and / or syringe, or by the button on the housing of the patch or syringe that experimenter can interact with, input response or command.In some cases, experimenter may cause the adjustment of the parameter to patch or syringe to the input of patch or syringe.In some cases, experimenter or other user may be able to input parameter (for example, pain, discomfort etc.), and described parameter may not be easy to measure or obtain from patch or syringe.Then these parameters can be passed to external device (for example, mobile device) by communication interface, for example.In some cases, patch and / or syringe can include feedback system, so that the input from experimenter or other user can adjust the parameter of patch or syringe.For example, the input of pain parameter can cause the adjustment of material flow rate or material administration dosage frequency by cannula.

[0249] Patch and / or syringe can also be configured to communicate with remote system.In some examples, patch and / or syringe can measure one or more physiological parameters of experimenter or one or more parameters of patch and / or syringe, to produce the data about one or more physiological parameters of experimenter or one or more parameters of patch and / or syringe.Data can be transferred to remote server, distributed computing network (for example, for cloud computing).Then, the processing of data can be carried out separately with patch and / or syringe.In some cases, the data after processing can then be transferred to electronic device (for example, mobile device).In other cases, the data after processing can then be transferred to patch and / or syringe, for regulating the parameter of patch and / or syringe.Can allow experimenter to monitor one or more physiological parameters to remote server and / or electronic device transmission data, and / or can additionally or alternatively allow doctor or nursing staff also to monitor one or more physiological parameters of experimenter.

[0250] In another aspect, a method for measuring multiple health or physiological parameters of a subject is provided herein. The method may include (a) providing: (i) a patch comprising a first housing having a plurality of sensors and comprising an opening; and (ii) a syringe having a second housing comprising a cannula in fluid communication with a fluid flow path. The second housing may be coupled to the first housing of the patch, and the syringe may include a reservoir containing a substance and a fluid flow path in fluid communication with the reservoir. The method may also include: (b) securing the patch to the subject's body; (c) when the patch is secured to the subject's body, guiding the cannula through the opening to (i) guide the substance from the reservoir to the fluid flow path, and (ii) guide the substance from the fluid flow path through the cannula into the subject; and (d) using the plurality of sensors to (i) measure multiple health or physiological parameters from the subject, and (ii) provide one or more outputs corresponding to the multiple health or physiological parameters from the subject.

[0251] Using embodiments of the present disclosure, a person with any number of physical and / or psychiatric conditions that can be treated with a medication administered by a syringe (such as the device described above) can be monitored to ensure that the combined therapy (drug and syringe) is safe and effective. The data collected during monitoring of patient and syringe attributes can be used by the patient, caregiver, provider, payer, medication, and device manufacturers to provide feedback, including confirmation of statements / results, to any of the above, and to allow manual and / or automatic intervention by the patient and / or device to improve the safety and effectiveness of the treatment.

[0252] exist Figure 59 and Figure 60In one embodiment shown, a syringe of the type described above is generally indicated at 402. The device comprises a housing including a circular base 404. An annular skin attachment layer 406 is secured to the bottom of the syringe with adhesive and features a pull tab 408. The underside of the attachment layer (at Figure 59 and Figure 60 4 (seen in FIG) is provided with an adhesive that provides a lower holding force than the adhesive securing the attachment layer 406 to the syringe. Thus, the syringe 404 can be removed from the subject's body (e.g., skin) by pulling the tab 408 upwardly away from the subject's skin.

[0253] In addition to the skin attachment layer 406, Figure 59 The patch generally indicated at 412, such as Figure 60 As shown in the exploded view of FIG, the patch is attached to the base of the syringe by a magnetic fastening arrangement, which will be described in more detail below. As an alternative to magnetic attachment, the patch can be attached to the syringe with an adhesive or by other mechanical means.

[0254] Although the patch and skin attachment layer are shown as having circular profiles, alternative shapes may be used.

[0255] A generally conical skin boundary displacement extension 414 extends from the bottom of patch 412 and, as previously described, compresses the skin to help reduce tissue deflection or "bulging" upon cannula insertion. Extension 414 has a central aperture 416 that aligns with the dispensing port of a syringe.

[0256] In an alternative embodiment, as described in the embodiments presented above, the skin boundary displacement extension may be part of the base 404 of the syringe itself and extend therefrom. In such an embodiment, a central hole may be provided at the center of the patch, wherein the hole is smaller than the diameter of the base of the extension. When the syringe is positioned so that the skin attachment layer secures the device against the skin, the extension expands the hole in the patch and provides a path for the syringe cannula or cannula to enter the skin when the device is activated or "fired" in the manner described above. The cannula may not pass directly through the material and provide an opportunity for the cannula to become blocked or for foreign bandage material to be injected from the cannula into the skin, see Figure 16B When the syringe is removed from the skin, the expanded central hole of the patch closes to its original smaller size. Absorbent material can optionally be deposited around the central hole of the patch to absorb any blood or leakage. In this way, the patch acts as a "Band-Aid" after the injection.

[0257] like Figure 59 and Figure 60 As shown, the skin attachment layer 406 features a central opening 418 that is sized to receive the patch 412. Figure 59and Figure 60 The embodiment of the embodiment shows the patch 412 separate from the skin attachment layer 406, but in an alternative embodiment, the patch can be circumferentially attached to the skin attachment layer by a perforation device. As a further alternative, the patch 412 can be fastened to the skin attachment layer via convex tabs spaced circumferentially around the patch.

[0258] like Figure 60 As shown, patch 412 includes sensor 422, printed circuit board (PCB) chip 424 and sensor adhesive layer 426. PCB chip 424 and sensor adhesive layer 426 are fixed to sensor 422 by adhesive or other fastening mechanisms. Figure 59 As shown, the sensor adhesive layer 426 includes a central window 428 through which the extension 414 protrudes when assembled. A downwardly facing surface 430 of the sensor adhesive layer 426 is provided with an adhesive for securing the patch to the user's skin.

[0259] The syringe 402 and patch 412 are configured such that the patch is applied to the body (e.g., skin, finger) of a subject (e.g., user) when the syringe is attached. Furthermore, the patch 212 remains unchanged after the syringe 402 is removed. More specifically, as Figure 60 As shown, a plurality of permanent magnets 432 are positioned and secured within the housing of the syringe 402. By way of example only, the magnets may be secured within corresponding recesses 434 formed within the syringe housing by adhesive, interference fit, or other attachment means, as described elsewhere herein. The top side of the sensor 422 has a metal disk portion 436 ( Figure 59 and Figure 60 ), so that the patch is fixed to the bottom of the syringe via magnetic attraction. The adhesive on the surface 430 of the sensor adhesive layer 426 provides a holding force to the user's skin that is greater than the magnetic force holding the patch to the syringe. As an alternative to the disc portion 436 being metal, the disc portion can be provided with a metal portion, such as Figure 59 437, which corresponds to and attracts the magnet of the syringe. In alternative embodiments, the metal portion(s) of the patch may have other shapes. A single annular metal portion may also be used.

[0260] Using a magnet to secure the patch to the syringe offers the advantage that there is no exposed adhesive residue on the patch while the patch remains on the patient. Furthermore, the magnet can be precisely positioned on the syringe with the corresponding metal portion on the patch, allowing us to control the amount and location of the force "pulling" on the patch when the syringe is removed. As an alternative to the metal portion on the syringe, a magnet can be used. In an alternative embodiment, the magnet can be positioned on the patch and the corresponding metal portion can be positioned on the syringe.

[0261] In an alternative embodiment, patch 412 may be secured to the base of the syringe by an adhesive (such as on the top side of sensor 422 ) that has less holding force than the skin-engaging adhesive on surface 430 of sensor adhesive layer 426 .

[0262] In another alternative embodiment, mechanical features built into the patch, syringe, or both can be used to secure patch 412 to the base of the syringe using a holding force less than that of the skin engaging adhesive on surface 430 of sensor adhesive layer 426. In such an embodiment, Figure 59 and Figure 60 The skin attachment layer 406 can be removed so that the syringe is held to the patient solely via the attachment between the syringe housing and the patch. In such embodiments, both the syringe and the patch are secured to the patient solely via the sensor adhesive layer. There can also be an additional connection between the syringe housing and the sensor adhesive layer 426 (in addition to the syringe being connected to the sensor adhesive layer via the patch, as described elsewhere herein).

[0263] like Figure 61 and Figure 62 As shown, PCB chip 424 features circuitry that includes a Bluetooth module having a microcontroller / microprocessor 444 connected to a battery 442 and an antenna 448. In addition, Bluetooth module 444 is attached to sensor 422. Battery 442 provides stored energy to power the system. Bluetooth module 444 has an integrated microcontroller / microprocessor. An example of a suitable Bluetooth module is Dialog Semiconductor part number DA14580-01UNA. In alternative embodiments, the Bluetooth module can be separate from the microcontroller / microprocessor. In some embodiments, direct communication to the cloud can be used, such as, for example, via cellular or other communication technologies.

[0264] like Figure 63 As shown, the syringe 402 is provided with one or more sensors 450a and 450b, which communicate with the Bluetooth module 444 via Bluetooth. The sensors 450a and 450b may include a transmitter and receive power from a battery also located within the syringe housing. Alternatively, each sensor may have its own battery. The sensors 450a and 450b may also be passive sensors that do not require a battery power source. The sensors 450a and 450b may be selected to provide a variety of alternative functions, as described in more detail below.

[0265] In alternative embodiments, communication between the sensors 450a and 450b of the syringe and the module 444 of the PCB chip 424 of the patch may be accomplished by alternative wireless communication means known in the art. In other alternative embodiments, the sensors 450a and 450b may communicate with the module 444 of the PCB chip 424 via (one or more) wire connections that automatically disconnect when the syringe is removed from the patch and the patient.

[0266] Of course, the number of sensors 436, 450a and 450b may be different than Figures 61 to 63 The quantity shown in .

[0267] The Bluetooth module 444 also enables the patch to transmit data collected from the sensors 422, 450a and 450b to a remote receiver (such as a personal data device (such as a smartphone), a computer system or a network or cloud). The remote receiver can collect the received data in a database and build a database.

[0268] In use, such as Figure 59 As shown, the syringe initially features an attached patch (via the magnetic means described above). The protective backing sheet is removed from the skin attachment layer 406, exposing the adhesive on the surface facing away from the syringe. The backing sheet also removably covers the adhesive on the patch surface 430. The exposed adhesive surfaces of the syringe skin attachment layer 406 and the sensor adhesive layer 426 are then pressed against the user's skin, attaching the syringe and patch thereto.

[0269] In the illustrated embodiment, patch 412 has multiple functions. First, it senses the status of the injector and transmits this status to a remote receiver (such as a personal data device, such as a smartphone, a computer network, or the cloud), namely, whether the injector has been activated so that an injection is in progress or whether the injection has been completed. Second, the patch transmits the patient's status to the remote receiver via data collected from the sensor. This can occur before, during, or after the injection, as well as before, during, or after the injector is attached and / or removed. For example, skin temperature and skin "color" at the injection site can be detected via a simple temperature monitor combined with an LED / phototransistor circuit included in sensor 422 to transmit tissue temperature and color during and after the injection. This feature is very useful during clinical studies, alerting staff to the presence of an injection site reaction (ISR) and quantifying the ISR based on temperature and tissue color. Third, the patch can interact directly with the injector based on data received from the injector, data received from the patient, and / or data received from the patch itself. The patch can interact with the injector as a control mechanism, including adjusting the flow rate (faster, slower, or pause), vibrating for user notification and / or pain management, providing auditory sounds to provide directions or notifications to the user, visual indicators to indicate changes, reminders, notifications, or information to the user, or mechanical interactions to cause a change in the state of the injector, including but not limited to retracting a button to stop delivery in response to data from the patient (e.g., pain) or data from the device (e.g., premature removal or dislodgement).

[0270] If useful, a heart rate sensor may also be included in the sensor 422 to obtain the patient's EKG signal, and / or a strain gauge sensor may be provided to detect the patient's Figure 59 and Figure 60 The skin pressure applied by the extension 414 can be monitored. Patient mobility, position, and location data can be collected by corresponding sensors incorporated into the sensor 422 (such as accelerometers, GPS sensors, etc.). In addition, several electrodes in contact with the skin (included in the sensor 422) can detect skin impedance and detect leaks or removal. In addition, the skin contact electrodes can detect premature removal of the device, i.e., removal of the device before it has completed its cycle.

[0271] After the syringe is injected, the tab 408 ( Figure 59 and Figure 60 ) away from the patient's skin, the syringe can be removed from the patient's skin. When this is done, the patch is separated from the syringe, allowing only the patch to adhere to the patient. The detachable nature of the monitoring patch provides physicians and others with the ability to continuously monitor the patient between injections.

[0272] Alternatively, the patch can be initially separated from the syringe and placed on the patient for monitoring before commencing administration / injection of one or more medicaments. This can provide baseline data about the patient prior to administration / injection.

[0273] Alternatively, the patch can be applied independently of the syringe and placed on the patient to monitor baseline conditions (e.g., baseline physiological parameters) before starting administration / injection of one or more medicaments. The syringe can then be coupled to the patch before the injection begins.

[0274] Figures 64 to 65 An exploded view of another embodiment of a patch and a syringe is shown. Patch 6401 includes an adhesive layer 6403 and a sensor 6405, which may include a PCB chip. In the described embodiment, and in other embodiments described below, the patch and / or syringe may each include one or more sensors, as described in the previous embodiments. Sensor 6405 may adhere to adhesive layer 6403, which may be used to secure patch 6401 to the subject's body. Syringe 6407 and patch 6401 may be configured such that the patch is applied to the subject's body when syringe 6407 is attached. Alternatively, or in addition, syringe 6407 and patch 6401 may be coupled before patch 6401 and syringe 6407 are secured to the subject's body.

[0275] The patch 6401 can be coupled to the syringe 6407 using an interlocking bayonet mechanism. For example, the syringe 6407 can include a protruding element 6409 that can engage with a detent 6411 in the patch 6401. In a first configuration, the detent 6411 can prevent free rotation of the patch 6401 and the protruding element 6409. Upon twisting the patch 6401 or the syringe 6407, the syringe 6407 can be moved to a second configuration in which the protrusion 6409 is no longer coupled to the detent 6411, so that the syringe 6407 can be detached or removed from the patch 6401 (e.g., after the patch is secured to the subject's body and the drug has been delivered).

[0276] Figure 66An exploded view of another embodiment of a patch and syringe is shown. Patch 6601 includes an adhesive layer 6603 and a sensor 6605, which may include a PCB chip. Sensor 6605 may adhere to adhesive layer 6603, which may be used to secure patch 6601 to the subject's body. Syringe 6607 and patch 6601 may be configured such that the patch is applied to the subject's body when syringe 6607 is attached. Alternatively, or in addition, syringe 6607 and patch 6601 may be coupled before the patch 6601 and syringe 6607 are secured to the subject's body.

[0277] The patch 6601 can be coupled to the syringe 6607 by coupling or mating parts 6609 and 6611. Portion 6609 can be coupled to the syringe 6607 (e.g., in recess 6613), while portion 6611 can be coupled to the patch 6601. Parts 6609 and 6611 can be magnets and can be secured to the recess 6613 of the syringe 6607 and the patch 6601, respectively, via adhesive, interference fit, or other attachment means. The adhesive layer 6603 can provide a holding force to the subject's body (e.g., skin) that is greater than the magnetic force holding the patch to the syringe.

[0278] Figure 67 Another embodiment of a patch and syringe is shown. Patch 6701 includes an adhesive layer 6703 and a sensor 6705, which may include a PCB chip. Sensor 6705 may adhere to adhesive layer 6703, which may be used to secure patch 6701 to the subject's body. Syringe 6707 and patch 6701 may be configured such that the patch is applied to the subject's body when syringe 6707 is attached. Alternatively, or in addition, syringe 6707 and patch 6701 may be coupled before the patch 6701 and syringe 6707 are secured to the subject's body.

[0279] The patch 6701 can be coupled to the syringe 6707. For example, the sensor 6705 can be configured to be coupled to the syringe 6707 by being assembled into the recess 6713. The syringe can include a safety tab or strip. The adhesive layer 6703 can provide a holding force to the subject's body (e.g., skin) that is greater than the magnetic force holding the patch to the syringe.

[0280] Figure 68 Shown Figure 676717 is a cross-sectional view of a coupled syringe and patch. The syringe may include a latch 6717 connected to a spring (e.g., a torsion spring) 6715. In block A, the patch and syringe may be in a first configuration ("ready position"), in which the device is locked and the patch remains attached to the syringe. A button 6719 is in a start or ready position and is ready to actuate, and when pressed, the button 6719 can be used to guide the cannula toward the subject. In block B, the syringe can be converted (e.g., by rotating, removing the safety tab 6801, or both) into a second configuration ("locked position"). In the second configuration, the torsion spring can be released, thereby translating the latch 6717 to a different position. In such a configuration, the syringe can be removed from the patch, and the button 6719 can be in the raised position shown in block B, thereby preventing the cannula from being pressed out of the syringe.

[0281] Figure 69 Another embodiment of a patch and a syringe is shown. Patch 6901 includes an adhesive layer 6903, a sensor 6905 that may include a PCB chip, and an attachment module 6911. Attachment module 6911 may include an adhesive or other fastening mechanism to adhere patch 6901 to syringe 6907. Sensor 6905 may adhere to adhesive layer 6903, which may be used to secure patch 6901 to the subject's body. Syringe 6907 and patch 6901 may be configured such that the patch is applied to the subject's body when syringe 6907 is attached. Alternatively, or in addition, syringe 6907 and patch 6901 may be coupled before patch 6901 and syringe 6907 are secured to the subject's body. Patch 6901 may additionally include an outer layer including perforations 6921. For example, the outer layer may include plastic, polymer (e.g., a thermosensitive polymer, such as shrink wrap), or other material. The outer layer can be configured to be removed before using the patch and syringe.When the device is ready for use, the outer layer can be removed by pulling tab 6923, which can remove the outer layer via perforations 6921, allowing the outer layer to be removed.

[0282] Figure 70 Shown Figure 69 Cross-sectional view of a coupled syringe and patch. The size (eg, width or diameter) of the patch can be substantially similar to the diameter of the syringe.

[0283] Figure 71Another embodiment of a patch and syringe is shown. Patch 7101 includes an adhesive layer 7103 and a sensor 7105, which may include a PCB chip. Sensor 7105 may adhere to adhesive layer 7103, which may be used to secure patch 7101 to the subject's body. Syringe 7107 and patch 7101 may be configured so that the patch is applied to the subject's body when syringe 7107 is attached. Alternatively, or in addition, syringe 7107 and patch 7101 may be coupled before the patch 7101 and syringe 7107 are secured to the subject's body. Patch 7101 may be coupled to syringe 7107 via latch 7113. Latch 7113 may be coupled to syringe 7101 using a press-fit mechanism, and subsequently pushing or applying force to latch 7113 may cause patch 7101 to be removed from syringe 7107. Alternatively or in addition, the latch 7113 may comprise a hook that can adhere to the housing of the syringe 7107. The latch can then be actuated by pressing or applying force on the latch 7113 and pulling the latch away from the housing of the syringe 7107, allowing the patch 7101 to be detached from the syringe 7107.

[0284] Figure 72 Shown Figure 71 A cross-sectional view of a coupled syringe and patch. The latch 7113 comprises a hook that adheres to the housing of the syringe. By applying a force 7115 on the latch, the hook can be released, allowing the patch to be separated or removed from the syringe.

[0285] Figure 73 Another embodiment of a patch and syringe is shown. Patch 7301 includes an adhesive layer 7303 and a sensor 7305, which may include a PCB chip. Sensor 7305 may adhere to adhesive layer 7303, which may be used to secure patch 7301 to the subject's body. Syringe 7307 and patch 7301 may be configured such that the patch is applied to the subject's body when syringe 7307 is attached. Alternatively, or in addition, syringe 7307 and patch 7301 may be coupled before the patch 7301 and syringe 7307 are secured to the subject's body. Patch 7301 may be coupled to syringe 7307 via flange 7311 and ring 7313. Ring 7313 may include rubber or other elastic material. Ring 7313 may be coupled to syringe 7307 by being assembled into grooves in flanges 7311 and 7321. Flange 7311 can be complementary to flange 7321 of patch 7301.

[0286] Figure 74 Shown Figure 7373. A cross-sectional view of a coupled syringe and patch. The flange 7321 of the patch can complementarily mate with the flange 7311 of the syringe. The patch can be detached from the syringe by applying a force 7415 on the flange 7321.

[0287] Figure 75 Another embodiment of a patch and syringe is shown. As shown in block A, patch 7501 includes an adhesive layer 7503 and a sensor 7505, which may include a PCB chip. Sensor 7505 can adhere to adhesive layer 7503, which can be used to secure patch 7501 to the subject's body. Syringe 7507 and patch 7501 can be configured so that the patch is applied to the subject's body when syringe 7507 is attached. Alternatively, or in addition, syringe 7507 and patch 7501 can be coupled before the patch 7501 and syringe 7507 are secured to the subject's body, as shown in block B. The housings of patch 7501 and sensor 7505 can partially surround the housing of syringe 7507. The patch can also include wing-shaped features 7513. Features 7513 can allow the subject to better grip or be used to position the device.

[0288] Figure 76 Another embodiment of a patch and syringe is shown. In block A, patch 7601 includes an adhesive layer 7603 and a sensor 7605, which may include a PCB chip. Sensor 7605 can adhere to adhesive layer 7603, which can be used to secure patch 7601 to the subject's body. Syringe 7607 and patch 7601 can be configured so that the patch is applied to the subject's body when syringe 7607 is attached. Alternatively, or in addition, syringe 7607 and patch 7601 can be coupled before the patch 7601 and syringe 7607 are secured to the subject's body, as shown in block B. Patch 7601 can be coupled to syringe 7601 via latch 7613, which can be secured to protrusion 7611 of syringe 7611. The latch can be rotatable so that in certain configurations, the latch 7613 does not rest on the protrusion 7611, allowing the patch 7601 to be separated from the syringe 7607.

[0289] Figure 77Another embodiment of a patch and a syringe is shown. In block A, patch 7701 includes an adhesive layer 7703 and a sensor 7705, which may include a PCB chip. Sensor 7705 may adhere to adhesive layer 7703, which may be used to secure patch 7701 to the body of the subject. Syringe 7707 and patch 7701 may be configured so that the patch is applied to the body of the subject when syringe 7707 is attached. Alternatively, or in addition to this, syringe 7707 and patch 7701 may be coupled before the patch 7701 and syringe 7707 are secured to the body of the subject, as shown in block B. Patch 7701 may be coupled to syringe 7707 via an adhesive (e.g., at the interface between patch 7701 and syringe 7707). For example, the patch may also include a protruding feature 7713 on adhesive layer 7703. When the subject presses or pulls on feature 7713, the protruding feature can allow patch 7701 to separate from syringe 7707.

[0290] Figure 78 Shown Figure 77 Cross-sectional view of the coupled syringe and patch. Protruding feature 7713 can be used to pry the patch off the syringe.

[0291] Figure 79 Another embodiment of a patch and syringe is shown. In block A, patch 7901 includes an adhesive layer 7903 and a sensor 7905, which may include a PCB chip. Sensor 7905 can be adhered to adhesive layer 7903, which can be used to secure patch 7901 to the subject's body. Syringe 7907 and patch 7901 can be configured so that the patch is applied to the subject's body when syringe 7907 is attached. Alternatively, or in addition, syringe 7907 and patch 7901 can be coupled before the patch 7901 and syringe 7907 are secured to the subject's body, as shown in block B. Patch 7901 can be coupled to syringe 7907 via a flange 7913 on the patch and a complementary protrusion 7911 on syringe 7907. Flange 7913 can lock or hook onto protrusion 7911. In a first configuration, the flange 7913 can be locked, and in a second configuration, the flange 7913 can be released, such as to allow the patch 7901 to be separated from the syringe 7907.

[0292] Figure 80Another embodiment of a patch and a syringe is shown. Patch 8001 includes an adhesive layer 8003 and a sensor 8005, and the sensor 6405 can include a PCB chip. The sensor 8005 can adhere to the adhesive layer 8003, and the adhesive layer 6403 can be used to fix the patch 8001 to the body of the subject. The syringe 8007 and the patch 8001 can be configured so that the patch is applied to the body of the subject when the syringe 8007 is attached. Alternatively, or in addition to this, the syringe 8007 and the patch 8001 can be coupled together before the patch 8001 and the syringe 8007 are fixed to the body of the subject. The patch 8001 can be coupled to the syringe 8007 via a threaded feature 8013 on the patch 8001 and a complementary thread (not shown) on the syringe 8007. The threaded feature 8013 can be screwed onto the complementary thread of the syringe 8007. The coupling and detachment of the patch 8001 and the syringe 8007 can occur by twisting the patch 8001 or the syringe 8007.

[0293] Figure 81 Shown Figure 80 . The cross-sectional view of the coupled syringe and patch. The thread 8013 of the patch can be complementary to the thread of the syringe. When the syringe is rotated counterclockwise, the patch can be released from the syringe.

[0294] Figure 82 Another embodiment of a patch and syringe is shown. Patch 8201 includes an adhesive layer 8203, a sensor 8205, which may include a PCB chip, and a deformable surface 8213. Sensor 8205 can be adhered to adhesive layer 8203, which can be used to secure patch 8201 to the subject's body. Syringe 8207 and patch 8201 can be configured so that the patch is applied to the subject's body when syringe 8207 is attached. Alternatively, or in addition, syringe 8207 and patch 8201 can be coupled before the patch 8201 and syringe 8207 are secured to the subject's body. Patch 8201 can be coupled to syringe 8207 via deformable surface 8213. In a first configuration, deformable surface 8213 can include a tapered hole 8215, which can be used to secure a screw or pin 8217 of syringe 8207 to patch 8201. When the two ends of the deformable surface 8213 are pressed toward each other, the deformable surface can assume a second configuration in which the gradient hole 8215 is large enough so that the screw or pin 8217 can be removed from the deformable base 8213 of the patch 8201, thereby separating the patch 8201 from the syringe 8207.

[0295] Figure 83 Shown Figure 82A cross-sectional view of a coupled syringe and patch is shown. In this configuration, the deformable base 8213 is locked to the syringe. By pressing the ends of the deformable base 8213 together, the graduated aperture is displaced, allowing the syringe's pin 8217 to lift from the deformable base and patch, allowing the patch to be separated from the syringe.

[0296] Figure 84 Another embodiment of a patch and syringe is shown. Patch 8401 includes an adhesive layer 8403 and a sensor 8405, which may include a PCB chip. Sensor 8405 can be adhered to adhesive layer 8403, which can be used to secure patch 8401 to the subject's body. Syringe 8407 and patch 8401 can be configured so that the patch is applied to the subject's body when syringe 8407 is attached. Alternatively, or in addition, syringe 8407 and patch 8401 can be coupled before the patch 8401 and syringe 8407 are secured to the subject's body. Patch 8401 can be coupled to syringe 8407 via a ridge 8413 on patch 8401, which can be used to secure patch 8401 to syringe 8407 via a snap or press fit. Syringe 8407 can additionally include complementary features that can be secured to ridge 8413. Separation of the patch 8401 from the syringe 8407 may occur by twisting the patch 8401 or syringe 8407 or by pulling the patch 8401 away from the syringe 8407 .

[0297] Figure 85 Shown Figure 84 8413 of the patch can be configured to couple to a complementary feature 8513 (e.g., a protrusion, a ridge, a cavity) of the syringe. Separation of the patch and syringe can occur by applying sufficient force to pry apart the ridge 8413 and the complementary feature 8513.

[0298] Figure 86Another embodiment of a patch and syringe is shown. Patch 8601 includes an adhesive layer 8603 and a sensor 8605, which may include a PCB chip. Sensor 8605 can be adhered to adhesive layer 8603, which can be used to secure patch 8601 to the subject's body. Syringe 8607 and patch 8601 can be configured so that the patch is applied to the subject's body when syringe 8607 is attached. Alternatively, or in addition, syringe 8607 and patch 8601 can be coupled before the patch 8601 and syringe 8607 are secured to the subject's body. Patch 8601 can be coupled to syringe 8607 by coupling or mating parts 8609 and 8611. Portion 8609 can be coupled to syringe 8607 (e.g., in recess 8613), while portion 8611 can be coupled to patch 8601. Parts 8609 and 8611 may contain magnets and may be secured to the recess 8613 of the syringe 8607 and the patch 8601 via adhesive, interference fit, or other attachment means.

[0299] Figure 87 Shown Figure 86 86. A cross-sectional view of a coupled syringe and patch. The magnet 8611 of the patch can be configured to couple to the magnet 8609 of the syringe. Separation of the patch and syringe can occur by sufficiently separating the magnet of the patch from the magnet of the syringe.

[0300] In some cases, it may be useful to secure both the patch and the syringe to the subject's body. In such cases, the syringe may additionally include features configured to couple the syringe housing to the subject's body. For example, the syringe may include an adhesive layer. The syringe's adhesive layer may be separate from the mechanism for securing the patch to the subject's body.

[0301] Figure 88Another embodiment of a patch and a syringe is shown, wherein both the patch and the syringe are configured to be coupled to the body of a subject. In block A, patch 8801 includes an adhesive layer 8803 and a sensor 8805, which may include a PCB chip. Sensor 8805 may adhere to adhesive layer 8803, which may be used to secure patch 8801 to the body of a subject. Patch 8801 may be configured so that patch 8801 is applied to the body of a subject, and the patch 8801 may be secured separately from a syringe 8807, which may also include an adhesive layer 8813. Alternatively, or in addition, syringe 8807 and patch 8801 may be coupled before the patch 8801 and syringe 8807 are secured to the body of a subject, as shown in block B. Patch 8801 may be coupled to syringe 8807 by coupling or mating parts, as described elsewhere herein. The adhesive layer 8803 of the patch 8801 can include features 8811 that can allow the adhesive layer 8803 of the patch 8801 to be separated from the adhesive layer 8813 of the syringe 8807. In such examples, the patch 8801 can be secured to the subject's body and cannot be removed from the subject until the syringe 8807 is removed. In some cases, the adhesion or adhesive force of the patch adhesive layer 8803 to the subject's body (e.g., skin) can be greater than the adhesion or adhesive force of the syringe 8807 to the subject's body (e.g., skin). In some cases, the adhesion or adhesive force of the patch adhesive layer 8803 to the subject's body can be greater than the adhesion or adhesive force of the patch 8801 attached to the syringe 8807.

[0302] Figure 89 Shown Figure 88 Cross-sectional view of a coupled syringe and patch. Both the patch and the syringe may include an adhesive layer. The syringe's adhesive layer 8813 may be configured to secure the syringe to the subject's body.

[0303] In some cases, the opening of patch or patch can comprise pierceable film.Pierceable film can comprise opening (for example, slit, hole), and when cannula is guided to experimenter's health from syringe, the cannula of syringe can pass through described opening.In some cases, pierceable film can adhere to or otherwise be fixed to experimenter's health.In such case, pierceable film can comprise absorbent material, for example, to absorb body fluid (for example, blood, sweat etc.) from experimenter.Should be understood that any one in the above-mentioned embodiment can comprise patch, described patch comprises sensor (for example, on PCB chip), and alternatively or additionally, described patch can comprise pierceable film, and described pierceable film can comprise absorbent material.

[0304] Figure 90 An example patch or a portion thereof is shown, which includes a pierceable membrane coupled to an adhesive layer of a syringe. In block A, patch 9001 includes adhesive layer 9003. Patch can also include a sensor (not shown) that can adhere to adhesive layer 9003. Adhesive layer 9003 can be used to fix patch 9001 to the body of the subject. Patch 9001 can be configured so that patch 9001 is applied to the body of the subject, and the patch 8801 can be fixed separately from a syringe 9007, which can also include adhesive layer 9013. Alternatively, or in addition to this, a syringe (not shown) and patch 9001 can be coupled before patch 9001 and syringe are fixed to the body of the subject, as shown in block B. Patch can also include opening 9021, which can include pierceable membrane 9023. In some cases, the opening 9021 is a slit, and the material of the pierceable membrane 9023 comprises a self-healing elastomer (i.e., the opening closes after the cannula is retracted away from the subject's body). The adhesive layer 9003 of the patch 9001 can include features 9011 (e.g., tabs) that can allow the adhesive layer 9003 of the patch 9001 to separate from the adhesive layer 9013 of the syringe 9007. Figure 91 Shown Figure 90 9021 is an opening that is an opening in the pierceable membrane 9023. In some cases, the opening 9021 is a slit, and the material that can pierce the membrane 9023 comprises a self-healing elastomer and / or an absorbent material. The adhesive layer 9003 of the patch may include a feature 9011 (e.g., a tab) that may allow the adhesive layer 9003 of the patch to separate from the adhesive layer of the syringe.

[0305] Figure 92 Shown Figure 90 Exploded view of the adhesive layer of the patch and syringe. Patch 9001 includes a pierceable membrane 9023, which may include an opening 9021. The pierceable membrane 9023 can be separated from the patch and can remain fixed to the subject's body (e.g., as a bandage). In some cases, the opening 9021 is a slit, and the material of the pierceable membrane 9023 includes a self-healing elastomer and an absorbent material. The adhesive layer 9003 of the patch 9001 may include a feature 9011 (e.g., a tab) that allows the adhesive layer 9003 of the patch to be separated from the adhesive layer 9013 of the syringe.

[0306] In some examples, the patch can be configured to couple to an autoinjector. Figure 93Shown is an example patch comprising a pierceable membrane coupled to an automatic injector 9307. In block A, patch 9301 includes an adhesive layer 9303. The patch may also include a sensor (not shown) that may adhere to the adhesive layer 9303. The adhesive layer 9303 may be used to fix the patch 9301 to the body of the subject, and in some cases, the adhesive layer 9303 may be fixed to the body of the subject. In such cases, the adhesive layer 9303 includes an absorbent material (e.g., a bandage pad) and will remain on the body of the subject after injection. The patch 9301 may be configured so that the patch 9301 is applied to the body of the subject, and the patch 9301 may be fixed separately from the automatic injector 9307. Alternatively, or in addition to this, the automatic injector 9307 and the patch 9301 may be coupled before the patch 9301 is fixed to the body of the subject, as shown in block B. The patch may also include an opening 9321, which may be a part of a pierceable membrane 9323. In some cases, the opening 9321 is a slit, and the material of the pierceable membrane 9323 comprises a self-healing elastomer (i.e., the opening closes after the cannula is retracted away from the subject's body). The adhesive layer 9303 of the patch 9301 can include a feature 9311 (e.g., a tab) that can allow the adhesive layer 9303 of the patch 9301 to be separated from the autoinjector. In some cases, the patch 9301 can also include a sensor unit 9305, which can include a PCB chip.

[0307] Embodiments of the present disclosure provide a combination of reporting syringe and patient status during and after an injection. The patch and associated battery and circuitry are initially physically coupled to the syringe. In alternative embodiments, the patch can be applied and allow connection of one or more syringes. The patch circuit can, for example, transmit one or more parameters of the syringe to a receiver via a communication interface before being fixed to the patient. Once the patch / syringe is fixed to the patient, the patch transmits the status of both the patient and the syringe. When the syringe is removed, the patch remains directly on the patient's injection site to transmit the status of the injection site. If there is enough time to ensure that no reaction occurs, the patch can stay there for several hours, or the patch can remain until the next syringe / patch is applied. That is, after the injection is completed, the patient can remove the syringe and keep the patch on it. The patch can continue to provide data (up to several days) until the next patch is replaced.

[0308] In many cases, physicians may be reluctant to have patients self-administer the medication at home due to potential adverse reactions. If the patch is able to monitor any potential complications (ISR, heart rate, respiration, temperature, etc.) and transmit a signal to the physician if anything is abnormal, this may give the physician the confidence to send the patient home for the injection. In an outcomes-based healthcare model, knowing that the patient is improving with treatment evidenced by quantitative data has significant benefits to the system. In the event that a patient's health status changes dramatically (or over the long term), the ability of the treating physician to intervene earlier and intervene based on notifications based on ongoing accumulated data trends has long-term benefits to the patient and overall outcomes.

[0309] This type of "detachable" monitoring patch is also very useful in clinical research. During the study, a variety of patient parameters can be monitored, which can increase compliance, reduce complications, and even make enrollment easier. For example, if patients are required to remain in the physician's office for 4 hours after each injection to monitor ISR, they may be able to eliminate the wait with patch monitoring, which may result in improved enrollment. Moreover, such devices can allow longitudinal studies to measure patient compliance and provide increased accuracy of data transmission (e.g., by eliminating the need to manually record data).

[0310] The patch concept is not limited to the above-mentioned syringes. The patch with and / or without electronic devices can also be applied to other syringes. These devices can include automatic injectors. In view of the above, embodiments of the present disclosure can provide, for example, a patch that can include an electronic device or only contain bandage material (for example, see Figures 90 to 93 ). In some examples, the patch can be connected to the syringe, and fixation of the patch and syringe can occur via force applied to the patch and syringe, thereby eliminating the need for separate patch application. Alternatively, the patch can be applied directly to the injection site by the syringe, and the cannula entry point can be covered with an expandable / contractible element. As described elsewhere in this document, the patch can be magnetically coupled to the syringe. In some examples, the patch can be mechanically coupled to the syringe by a release mechanism desired by the user. In some cases, the patch can be smaller than the entire adhesive patch used to adhere to the syringe. The patch can include an adhesive pad that is the same size as the patch or smaller than the size of the patch. In some examples, the patch can transmit syringe data before being applied to the patient, transmit syringe and patient data after being applied to the patient, and / or transmit patient data after removing the syringe.

[0311] Example applications / uses

[0312] like Figure 94As shown, the patch's sensor 9401 can be customized to measure specific device and / or patient attributes or physiological parameters as specified by the patient or physician.

[0313] One or more sensors may be used to measure device and / or patient attributes or physiological parameters. Non-limiting examples of sensor types include temperature sensors, interstitial pressure sensors, skin resistance sensors, skin expansion sensors, acoustic sensors, vibration sensors, heart rate sensors, blood pressure sensors ( Figure 94 BP in), color or other optical sensors, moisture sensors, chemical sensors (e.g., sensing, measuring or detecting drug concentration, histamine, oxygen, etc.).

[0314] One or more sensors may be used to measure one or more device properties, such as the presence of skin, tracking of substance delivery, and / or occlusion of the device (eg, the cannula of a syringe).

[0315] like Figure 95 As shown, the sensor can alternatively be incorporated into the sensor adhesive layer 9501. As previously described, any useful combination of patient-perceived attributes can provide meaningful conclusions or evidence of results. For example, temperature measurement, skin resistance and / or impedance measurement, and color measurement, or any combination thereof, can be used to detect site reactions. In another example of correlating pain with measured site reactions, temperature measurement, skin resistance or impedance measurement, color measurement, skin turgor measurement, or interstitial pressure measurement, or any combination thereof, can be used. In yet another example of monitoring contraindicated activity during treatment, vibration measurement, heart rate measurement, and / or moisture measurement (e.g., to indicate sweat levels), or a combination thereof, can be used. In another example, monitoring for wet injections can use moisture measurement. Another example of a subject outcome can include monitoring for poor bioabsorption by measuring interstitial pressure, tissue density, temperature, skin resistance / impedance, color, and / or skin turgor. In another example of monitoring for systemic adverse reactions, moisture (sweat) measurement, EMG / ECG, vibration (e.g., to indicate agitation), increased sound (e.g., to indicate gastric or intestinal gas levels), or any combination thereof, can be used.

[0316] Figure 96 96 shows another embodiment of a sensor unit. The sensor unit may include, for example, a PCB 9601, a Hall effect sensor 9602, a coin cell battery 9603, a buzzer 9604, a tactile vibration sensor 9605, a skin presence sensor 9606, a humidity and temperature sensor 9607, a 3D accelerometer and gyroscope 9608, a reed switch 9609, and a low-power core processor 9610. The sensor may include more than one layer, with different sensors, batteries, and other components distributed within each layer or across different layers.

[0317] The patch can be used for a variety of functions after the injection and after the syringe is removed. In non-limiting examples, the patch can be used to seal the injection site to prevent bleeding, use moisture detection to detect any injection site leakage / bleeding, monitor skin temperature and color and pressure to detect ISRs, monitor heart rate / EKG, monitor patient position - upright or lying down, and / or monitor skin chemistry / sweat.

[0318] In some embodiments, the patch can communicate with the patient to remind him or her when the next injection is due, provide an alert if there is an injection site reaction or leakage, increase in temperature, color, heart rate, etc.

[0319] Embodiments of the patch can be used to monitor the status of a syringe / syringes during an injection to determine, for example, whether the syringe is filled, the volume or amount of substance (e.g., a medicament or drug) that has been filled into the syringe, whether the syringe has been removed from a storage or delivery device base, whether the syringe has been placed on the skin, whether the safety strip has been removed, whether a button has been pressed, whether an injection has been started, the manometer position (including delivery tracking), button press to pause, button retracts the cannula, injection is complete (if the syringe has been removed from the skin), or any post-injection parameter associated with the measurement of patient physiological parameters discussed previously.

[0320] Additional Features / Implementations

[0321] In an alternative embodiment, the sensor can detect whether another patch is transmitting, or if an existing patch is removed. The patch can be transparent to allow the patient to see the injection site, and it will be as unobtrusive as possible so that the patient can wear the patch and continue with their daily activities (showering, swimming, etc.).

[0322] In other alternative embodiments, sensing elements may be provided that can measure device properties including: presence of skin (cannula retraction or detachment sensing), delivery indicator tracking (including fill and dispense), occlusion detection, medication temperature, device status (on / off delivery base, on / off patient, button status, pause event, etc.), flow rate, internal syringe pressure / injection pressure, adhesive adhesion.

[0323] Other embodiments may incorporate patient and device sensing elements to allow manual and / or automatic intervention (management) of the injector. For example, the injector flow rate may be adjusted (e.g., faster, slower, stopped / paused) based on site reaction sensing information (automatic), pain information from the patient (manual), bioabsorption rate (automatic), or any combination or variation thereof.

[0324] Other embodiments may vibrate (for pain management or user notification) a vibrating element in the syringe and / or patch based on site response sensing information, pain information from the patient (manual) or pain sensing information, gap pressure / site expansion information (automatic), or any combination or variation thereof.

[0325] In other embodiments, sound (e.g., for notification and / or communication to the user) can be provided by a sound element in the syringe and / or patch and activated based on sensory information from the patient, device sensing elements (occlusion, medication temperature, delivery indication, etc.), or a combination or change thereof.

[0326] In other embodiments, a visual indicator (e.g., indicating a change for notifying and / or conveying information to the user) may be provided on the syringe and / or patch - based on sensory information from the patient, device sensing elements, position of the retraction button - for example, a light emitting diode or equivalent that is activated and activated to detect premature removal / dislodgement, sensory information from the syringe (skin sensing, etc.), sensory information from the patient (high pressure, temperature, etc.), or a combination or change thereof.

[0327] In other embodiments, a lock for syringe button presses (e.g., for safety or to prevent misuse of medication) can be provided and activated based on sensory information from the syringe (temperature of the medication, etc.), sensory information from the patient (skin sensing, etc.), sensory information from the mobile application (e.g., time since last injection, user authentication), or variations or combinations thereof.

[0328] In other embodiments, subcutaneous / transcutaneous electrical nerve stimulation (TENS) can be provided (e.g., for pain management or bioabsorption). In such cases, electrode elements in the cannula and / or patch can be activated based on site response sensing information, pain information from the patient (manually), or pain sensing information, gap pressure / site expansion information (automatically), or a variation or combination thereof.

[0329] Other embodiments may predict remaining infusion time based on, for example, sensing flow rate and fill volume, sensing device pressure and back pressure, medicament temperature, body temperature, and fill volume.

[0330] In addition, potential features of other embodiments may also include: the patch sensing whether another patch has been applied, the patch being transparent to allow visualization of underlying tissue, the patch communicating directly with the user / patient, auditory signals (e.g., "Hey - it's time for your next injection" or "Call the doctor - you have an ISR"), and / or other tactile options, vibration, electrical stimulation, visual options, light emitting diodes, the patch transmitting data periodically to a receiver or directly to the cloud or intermittent data broadcasts.

[0331] Mobile App

[0332] On the other hand, this paper discloses a system and method for generating a mobile application to monitor one or more health or physiological parameters. The mobile application can be generated using a variety of methods (e.g., application programming interface (API)). The mobile application can include multiple useful features and can be configured to interact with other mobile applications. In some cases, the mobile application can be configured to display the measured values ​​of one or more physiological parameters from the subject or the parameters of the patch and / or syringe. The mobile application can include a feedback system that allows the subject or other user input, and the feedback system can allow the patch and / or syringe to be adjusted (e.g., the amount of substance dispensed). The mobile application can also communicate with a remote server, for example, via a communication interface. In some cases, the remote server can be part of or communicate with a separate electronic device (e.g., a mobile device, a laptop computer), which can allow a clinician or physician to monitor the physiological parameters of the subject. In some cases, the mobile application can allow the input of unmeasurable parameters (e.g., pain, discomfort, etc.) from the subject. The mobile application can also include software for data processing. In a non-limiting example, data processing can include statistical analysis of the data, trend plotting and analysis, and graphical representation of the data. In some cases, the mobile application can interface or combine with other mobile applications, such as lifestyle tracking applications (e.g., monitoring diet and activity), or other useful mobile applications, such as location tracking, accelerometers, calendars (e.g., sending reminders), etc.

[0333] Figure 97Schematically illustrates an example workflow for a mobile application for monitoring one or more health or physiological parameters. Mobile device 9700 may be a laptop, tablet, phone, or other electronic device (e.g., a portable electronic device). When an application is opened or selected on mobile device 9700, a loading screen 9710 may be presented, followed by a menu screen 9720. Menu screen 9720 may provide multiple functions 9730. Non-limiting examples of functions 9730 may include starting a new infusion, infusion history, training videos, additional information, and a patient profile. When function 9730 (e.g., infusion history) is selected, a second screen 9740 related to the function may be presented. In such an example, a calendar may be presented to the subject. In process 9750, the subject may select a second function on second screen 9740, which then presents a third screen 9760. The third screen may display one or more health or physiological parameters of the subject, the device, or the substance being delivered to the subject (e.g., a schedule, time, day of the week, group, reminders to the patient, alarms, vibrations, etc.). In the example third screen 9980, the calendar may include selectable dates that provide information about one or more health or physiological parameters of the subject on each selected date. In the example fourth screen 9990, the mobile application's calendar may display additional information, such as when the subject has missed an infusion. In the example fifth screen 9790, the mobile application's calendar may display additional information, such as when the subject has already received an infusion.

[0334] Figure 98 Schematically illustrates an example workflow for a mobile application for monitoring one or more health or physiological parameters, which can be used in conjunction with one or more workflows for a mobile application. Figure 97 ) Select function 9730 (e.g., start a new infusion, see Figure 97), screen 9810 may appear. The mobile application can allow the detection of substances or drugs, for example, by scanning a barcode or a quick response code (QR code). The mobile application can be integrated with another application on the mobile device (such as a camera) and display the camera on screen 9820. Screen 9830 shows an example screen of a scanned QR code, which can present information about the substance or device. The mobile application can then verify the compatibility of the drug and the device and / or other parameters of the drug / device, such as expiration date, dosage, etc. In the case where the drug or device is not suitable for the subject (for example, an expired drug), screen 9842 or 9844 may appear, which notifies the subject that the drug or device is not suitable. In the case where the drug or device is suitable for the subject, screen 9850 may appear, which can provide guidance, instructions or instructions to the subject. The instructions can be presented in a continuous scrolling format, as illustrated by screen 9852. The mobile application can then be paired with the device. On example screen 9860, additional guidance can be provided to the subject. Safety features can be included in the application, for example, if the subject does not perform safety measures (e.g., safety tags), the mobile application can notify the subject. Screen 9870 can display one or more device parameters (e.g., infusion status, injection of the cannula into the subject's body, etc.). An incomplete infusion can present screen 9872, which can indicate the status of the infusion and can include other indications of device parameters (e.g., "device paused"). After the delivery of the substance or medicament is completed, screen 9880 can be displayed, which can indicate the status of the infusion. In some cases, 9880 can provide the subject with options to rank the infusion experience. Multiple steps in the process can also include communication steps 9854 (e.g., via Bluetooth, Wi-Fi) with independent devices, cloud computing, clinician servers, etc.

[0335] Figure 99 Another example workflow of a mobile application for monitoring one or more health or physiological parameters is shown, which can be used in conjunction with one or more workflows of a mobile application. Figure 97 ) Select function 9730 (e.g., training video, see Figure 97 ), screen 9900 may appear. The mobile application may contain a variety of tutorials or training information for the subject. Figure 99A schematically illustrates multiple devices or systems that can be integrated with the mobile application. Upon selecting a device or system (e.g., syringe delivery system, handheld system, vial delivery system, reconstitution system), screens 9905, 9910, 9915, or 9920 may appear, which may include a video demonstrating a tutorial or method of using the device or system. Figure 99 B schematically illustrates another example workflow of a mobile application for monitoring one or more health or physiological parameters, which may be used in conjunction with one or more workflows of a mobile application. Figure 97 ) Select function 9730 (e.g., for additional information, see Figure 97 ), screen 9925 may appear, which may include a menu displaying one or more physiological health parameters or one or more device parameters. Additional information (e.g., regulatory information, device information, etc.) may be available to the subject. When a function in the menu is selected, screen 9930 or 9945 may appear, which may also include options to display other information, such as safety information (e.g., screen 9935 or 9950) or questions and answers (e.g., screen 9940 or 9955). Figure 99 C schematically illustrates another example workflow of a mobile application for monitoring one or more health or physiological parameters, which may be used in conjunction with one or more workflows of a mobile application. Figure 97 ) Select function 9730 (e.g., patient profile, see Figure 97 ), screen 9970 may appear, which may include a menu. The menu may include options for the subject to view and / or enter patient information (e.g., gender, height, weight, activity level). Additional settings such as alarms, reminders, emails, notifications, etc. may be implemented in the mobile application.

[0336] Computer system

[0337] The present disclosure provides computer systems programmed to implement the methods of the present disclosure. Figure 100 A computer system 10001 is shown that is programmed or otherwise configured to transmit and / or receive data and process data. The computer system 10001 can facilitate various aspects of the present disclosure, such as, for example, methods for data analysis, subject monitoring, and measurement of physiological or health parameters, and providing output of physiological or health parameters. The computer system 10001 can be a user's electronic device or a computer system remotely located relative to the electronic device. The electronic device can be a mobile electronic device.

[0338] Computer system 10001 includes a central processing unit (CPU, also referred to herein as a "processor" and "computer processor") 10005, which can be a single-core or multi-core processor, or multiple processors for parallel processing. Computer system 10001 also includes a memory or storage unit 10010 (e.g., random access memory, read-only memory, flash memory), an electronic storage unit 10015 (e.g., a hard disk), a communication interface 10020 (e.g., a network adapter) for communicating with one or more other systems, and peripheral devices 10025, such as cache, other memory, data storage, and / or an electronic display adapter. Memory 10010, storage unit 10015, interface 10020, and peripheral devices 10025 communicate with CPU 10005 via a communication bus (solid line), such as a motherboard. Memory unit 10015 can be a data storage unit (or data repository) for storing data. Computer system 10001 can be operatively coupled to a computer network ("network") 10030 via communication interface 10020. Network 10030 can be the Internet, an internetwork and / or an extranet, or an intranet and / or an extranet in communication with the Internet. In some cases, network 10030 is a telecommunications and / or data network. Network 10030 can include one or more computer servers that can implement distributed computing, such as cloud computing. In some cases, network 10030 can implement a peer-to-peer network via computer system 10001, which can enable devices coupled to computer system 10001 to behave as either clients or servers.

[0339] The CPU 10005 can execute a series of machine-readable instructions, which can be implemented in a program or software. The instructions can be stored in a memory location (such as memory 10010). The instructions can be directed to the CPU 10005, which can then program or otherwise configure the CPU 10005 to implement the methods of the present disclosure. Examples of operations performed by the CPU 10005 can include fetching, decoding, executing, and writing back.

[0340] CPU 10005 may be part of a circuit, such as an integrated circuit, that may include one or more other components of system 10001. In some cases, the circuit is an application-specific integrated circuit (ASIC).

[0341] The storage unit 10015 can store files (such as drivers, libraries, and saved programs). The storage unit 10015 can store user data, such as user preferences and user programs. In some cases, the computer system 10001 may include one or more additional data storage units external to the computer system 10001, such as located on a remote server that communicates with the computer system 10001 via an intranet or the Internet.

[0342] Computer system 10001 can communicate with one or more remote computer systems via network 10030. For example, computer system 10001 can communicate with a user's remote computer system (e.g., located in a physician's office or on a physician's mobile device). Examples of remote computer systems include personal computers (e.g., portable PCs), tablets or tablet computers (e.g., iPad, Galaxy Tab), phones, smartphones (e.g. iPhone, Android-supported devices, ) or personal digital assistant. Users can access computer system 10001 via network 10030.

[0343] The methods described herein can be implemented by machine (e.g., computer processor) executable code stored in an electronic storage location of the computer system 10001, such as, for example, stored in the memory 10010 or on the electronic storage unit 10015. The machine executable or machine readable code can be provided in the form of software. During use, the code can be executed by the processor 10005. In some cases, the code can be retrieved from the storage unit 10015 and stored on the memory 10010 for ready access by the processor 10005. In some cases, the electronic storage unit 10015 can be eliminated, and the machine executable instructions can be stored on the memory 10010.

[0344] The code may be precompiled and configured for use with a machine having a processor suitable for executing the code, or may be compiled during runtime. The code may be supplied in a programming language that may be selected to enable the code to be executed in a precompiled or compiled manner.

[0345] Aspects of the systems and methods provided herein, such as computer system 10001, can be implemented in programming. Various aspects of the technology can be considered to be "products" or "articles" in the form of machine (or processor) executable code and / or associated data, which are typically carried or implemented in a type of machine-readable medium. Machine executable code can be stored on an electronic storage unit, such as a memory (e.g., read-only memory, random access memory, flash memory) or a hard disk. "Storage" type media can include any or all tangible memories of a computer, processor, etc., or its associated modules, such as various semiconductor memories, tape drives, disk drives, etc., which can provide non-transitory storage for software programming at any time. All or part of the software can sometimes be communicated via the Internet or various other telecommunications networks. For example, such communication can enable software to be loaded from one computer or processor to another, for example, from a management server or host computer to an application server's computer platform. Therefore, another type of medium that can carry software elements includes light waves, radio waves, and electromagnetic waves used on physical interfaces between local devices, such as over wired and optical land lines on a network and various air links. The physical elements that carry such waves (such as wired or wireless links, optical links, etc.) can also be considered to be the medium that carries the software. As used herein, unless restricted to non-transitory, tangible "storage" media, terms such as computer or machine "readable medium" refer to any medium that participates in providing instructions to a processor for execution.

[0346] Thus, a machine-readable medium such as computer executable code may take many forms, including but not limited to tangible storage media, carrier media, or physical transmission media. Non-volatile storage media include any storage device such as an optical or magnetic disk, such as in any computer(s), etc., such as may be used to implement the databases shown in the accompanying drawings. Volatile storage media include dynamic memory, such as the main memory of such a computer platform. Tangible transmission media include coaxial cables, copper wire, and optical fiber, including the wires that comprise a bus within a computer system. Carrier transmission media may take the form of electrical or electromagnetic signals, or acoustic or light waves, such as those generated during radio frequency (RF) and infrared (IR) data communications. Thus, common forms of computer-readable media include, for example: a floppy disk, a diskette, a hard disk, magnetic tape, any other magnetic medium, a CD-ROM, a DVD or DVD-ROM, any other optical medium, punched card stock tape, any other physical storage medium with a pattern of holes, a RAM, a ROM, a PROM and EPROM, a FLASH-EPROM, any other memory chip or cartridge, a carrier wave that transports data or instructions, a cable or link that transports such a carrier wave, or any other medium from which a computer can read programming code and / or data. Many of these forms of computer-readable media may be involved in carrying one or more sequences of one or more instructions to a processor for execution.

[0347] The computer system 10001 may include or be in communication with an electronic display 10035 that includes a user interface (UI) 10040. Examples of a UI include, but are not limited to, a graphical user interface (GUI) and a web-based user interface.

[0348] The methods and systems of the present disclosure can be implemented by one or more algorithms. The algorithms can be implemented by software when executed by the central processing unit 10005. The algorithms can, for example, process data, perform statistical analysis, plot or graphically represent data, and provide feedback to one or more systems disclosed herein (e.g., patches and / or injectors).

[0349] Although preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided as examples only. The present invention is not intended to be limited to the specific examples provided in the specification. Although the present invention has been described with reference to the foregoing description, the description and illustration of the embodiments herein are not meant to be interpreted in a restrictive sense. Without departing from the present invention, many variations, changes, and substitutions will now occur to those skilled in the art. In addition, it will be understood that all aspects of the present invention are not limited to the specific depictions, configurations, or relative proportions set forth herein based on a variety of conditions and variables. It will be understood that in practicing the present invention, various alternatives to the embodiments of the present invention described herein may be adopted. Therefore, it is contemplated that the present invention will also cover any such substitutions, modifications, variations, or equivalents. The following claims are intended to define the scope of the present invention and thus cover methods and structures within the scope of these claims and their equivalents.

Claims

1. A system for measuring a health or physiological parameter of a subject, comprising: a patch comprising a first housing having a sensor configured to: (i) measure the health or physiological parameter from the subject when the patch is secured to the subject's body, and (ii) provide one or more outputs corresponding to the health or physiological parameter from the subject, wherein the first housing includes an opening; and a syringe having a second housing including a cannula in fluid communication with a fluid flow path, wherein the second housing is coupled to the first housing such that the cannula is directed through the opening and into contact with the body of the subject when the patch is secured to the body, wherein the syringe is configured to (i) direct a substance from a reservoir to the fluid flow path in fluid communication with the reservoir, and (ii) direct the substance from the fluid flow path through the cannula to the subject, wherein the sensor is selected from the group consisting of: a conductivity sensor, an impedance sensor, a capacitance sensor, a charge sensor, a humidity sensor, a temperature sensor, a heart rate sensor, a gap pressure sensor, a resistance sensor, an optical sensor, an expansion sensor, an acoustic sensor, a vibration sensor, a blood pressure sensor, a color sensor, a chemical sensor, and a substance tracking sensor, and, wherein the system further comprises an additional sensor, wherein the additional sensor is configured to measure one or more device parameters selected from the group consisting of: a dose of the substance administered, a dispensing flow rate of the substance, a volume of the substance administered, obstruction of the cannula, and contact of the cannula with the body of the subject. 2 . The system of claim 1 , further comprising a pump integrated with the cannula, wherein the pump is configured to direct the substance from the fluid flow path through the cannula to the subject. 3 . The system of claim 1 , wherein the cannula is configured to extend toward or retract away from the body of the subject.

4. The system of claim 1, wherein the opening comprises a pierceable membrane.

5. The system of claim 4, wherein the pierceable membrane is pierced by the cannula to create the opening.

6. The system of claim 1, wherein the reservoir is secured to the syringe.

7. The system of claim 6, wherein the reservoir is removable from the syringe.

8. The system of claim 6, wherein the reservoir is part of the syringe.

9. The system of claim 1, wherein the substance is a drug.

10. The system of claim 9, wherein the drug is used to treat one or more diseases selected from the group consisting of cardiovascular diseases, musculoskeletal diseases, gastrointestinal diseases, skin diseases, immune diseases, ophthalmic diseases, blood diseases, neurological diseases, oncological diseases, endocrine diseases, metabolic diseases, and respiratory diseases.

11. The system of claim 1, wherein the syringe comprises the reservoir, wherein the reservoir is configured to contain a formulation having the substance.

12. The system of claim 1, wherein the first housing is removably coupled to the second housing.

13. The system of claim 1, wherein the patch includes a communication interface for transmitting data corresponding to the health or physiological parameter to an electronic device in communication with the communication interface. The system of claim 13 , wherein the communication interface comprises a wireless communication interface.

15. The system of claim 14, wherein the communication interface comprises a WiFi interface.

16. The system of claim 14, wherein the communication interface comprises a near field communication interface.

17. The system of claim 14, wherein the communication interface comprises a Bluetooth interface.

18. The system of claim 14, wherein the wireless communication interface comprises an optical wireless interface.

19. The system of claim 13, wherein the communication interface comprises a wired communication interface.

20. The system of claim 1, wherein the patch comprises the additional sensor.

21. The system of claim 1, wherein the syringe comprises the additional sensor.

22. The system of claim 1, wherein the patch further comprises one or more transducers.

23. The system of claim 22, wherein the one or more transducers are configured to generate an output signal, wherein the output signal comprises a vibration signal, an audio signal, an electrical signal, or a visual signal.

24. The system of claim 1, wherein the patch is configured to measure a plurality of health or physiological parameters.

25. The system of claim 1, wherein the body is skin.

26. The system of claim 1, wherein the patch is configured to receive data from the syringe.

27. The system of claim 1, wherein the health or physiological parameter comprises an injection site reaction on the body of the subject.

28. A syringe comprising: (a) Housing; (b) a drug reservoir disposed in the housing; (c) an injection cannula movable within the housing between a pre-dispensing position and a dispensing position in fluid communication with the reservoir; (d) a syringe sensor mounted on or within the housing; (e) a skin attachment layer attached to the housing, the skin attachment layer comprising an adhesive configured to secure the housing to the user's skin with a first retention force; (f) a patch removably secured to the housing with a second retention force, the patch comprising: a sensor adhesive layer configured to secure the patch to the user's skin with a third retention force; a patch sensor; and circuitry configured to receive data from the syringe sensor and the patch sensor and transmit the received data to a remote receiver; (g) wherein the third retaining force is greater than the second retaining force.

29. The syringe of claim 28, wherein the second retention force is greater than the first retention force and the patch is removably attached to the skin attachment layer.

30. The syringe of claim 29, wherein the patch is removably attached to the skin attachment layer by a perforation.

31. The syringe of claim 28, wherein the patch is removably secured to the housing by a magnet.

32. The syringe of claim 31 , wherein the magnet is positioned within or on the housing of the syringe and the patch comprises a metal portion configured to engage with the magnet.

33. The syringe of claim 28, wherein the skin attachment layer includes an opening, and the patch is positioned within the opening when the patch is removably secured to the housing of the syringe.

34. The syringe of claim 33, wherein the opening is located in the center of the skin attachment layer and the injection cannula of the syringe passes through the opening of the skin attachment layer and the orifice of the patch when the injection cannula of the syringe is in the dispensing position.

35. The syringe of claim 34, wherein the patch includes an extension including the orifice through which the injection cannula of the syringe passes when the injection cannula of the syringe is in the dispensing position, the extension being configured to compress the user's skin around an injection site.

36. The syringe of claim 35 wherein the patch comprises a printed circuit board, the circuit being positioned on the printed circuit board, and the sensor adhesive layer and the patch sensor being attached to the printed circuit board, the sensor adhesive layer including a central window through which the extension passes.

37. The syringe of claim 35, wherein the extension is tapered.

38. The syringe of claim 28, wherein the circuitry of the patch comprises a microcontroller, a microprocessor, or a transmitter.

39. The syringe of claim 38, wherein the syringe sensor comprises a transmitter and the circuit of the patch further comprises a receiver, by which data is received from the syringe sensor via wireless transmission.

40. The syringe of claim 39, wherein the microcontroller or microprocessor and the transmitter and receiver are combined into a single component.

41. The syringe of claim 38, further comprising a wire connection between the syringe sensor and the circuitry of the patch, the wire connection being configured to disconnect upon or after the syringe is removed from the user.

42. The syringe of claim 38, wherein the microcontroller or microprocessor and the transmitter are combined into a single component.

43. The syringe of claim 40, wherein the transmitter is a Bluetooth transmitter.

44. The syringe of claim 28, wherein the syringe sensor comprises a plurality of sensors.

45. The syringe of claim 28, wherein the patch sensor comprises a plurality of sensors.

46. ​​A system for collecting data from a syringe and a patient, the system comprising: a syringe including a syringe sensor; A patch including a patch sensor and circuit; The circuit configuration is: (i) receiving data from the syringe sensor and the patch sensor when the syringe sensor is attached to the patient; (ii) transmitting the received data to a remote receiver; (iii) receiving additional data from the syringe sensor after the syringe is removed from the patient; as well as (iv) transmitting the received further data to the remote receiver.

47. The system of claim 46, wherein the syringe and the patch are attached to the patient simultaneously.

48. The system of claim 46, wherein the data collected from the patient includes a measurable attribute that is affected by a medicament administered by the syringe.

49. The system of claim 46, wherein the data collected from the patient includes a measurable attribute that affects or indicates the safety and / or effectiveness of a medicament administered by the injector.

50. A syringe comprising: (a) Housing; (b) a drug reservoir disposed in the housing; (c) an injection cannula movable within the housing between a pre-dispensing position and a dispensing position in fluid communication with the reservoir; (d) a patch sensor configured to receive and transmit data, the patch sensor being removably secured to the housing with a first retaining force; (e) an attachment layer attached to the patch sensor, the attachment layer comprising an adhesive configured to secure the patch sensor to the user's skin with a second retention force; (f) wherein the second retaining force is greater than the first retaining force such that the patch sensor remains attached to the user's skin when the housing is removed from the patch sensor.

51. The injector of claim 50, wherein the data is used to adjust a device parameter of the patch or the injector.

52. The syringe of claim 51 , wherein the device parameters comprise one or more device parameters selected from the group consisting of: a dose of a substance administered by the syringe, a flow rate at which the syringe dispenses the substance, and a volume of the substance administered by the syringe.

53. The syringe of claim 52, wherein the data is used to generate a notification to the user.

54. The syringe of claim 53, wherein the notification comprises one or more notifications selected from the group consisting of: a vibration indicator, an audio indicator, and a visual indicator.

Images