Medical fluid injection device and method with detachable patch and monitoring

Abstract

To provide systems and methods for monitoring one or more health or physiological parameters in a subject.SOLUTION: The systems and methods may comprise a patch 6701 coupled to an injector 6707. Data may be transmitted to a mobile device or remote server, where the data may be processed. Processed data may be used to inform a subject on a health or physiological condition.SELECTED DRAWING: Figure 67

Description

Technical Field

[0001] Cross-reference 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 Jan. 4, 2019, each of which is incorporated herein by reference.

Background Art

[0002] Vials are one of the preferred reservoir or container closure systems used in the pharmaceutical industry due to their extensive clinical track record and long-term stability with a wide variety of drugs. Pharmaceuticals, including biologics, are provided in standard containers such as vials. Further, the pharmaceutical industry has made significant capital investments for aseptic vial filling. However, vials require the contained drug to be transferred from the vial to an injection device (e.g., syringe, auto-injector, infuser, etc.) for delivery to a patient. New container closure systems such as prefilled syringes and cartridges that enable direct transfer of the drug from the syringe or cartridge to the patient have been introduced. Injection devices such as auto-injectors and auto pens have been developed to utilize these newer container closure forms. Due to uncertainty regarding long-term drug stability and the existing extensive manufacturing resources, devices incorporating standard container closure systems such as vials, prefilled syringes or cartridges are highly preferred in the pharmaceutical industry over devices that require custom forms of drug encapsulation.

[0003] However, vials, prefilled syringes, and cartridges are not always the most optimal containers for drug delivery devices. This is especially true for delivery devices that deliver relatively large volumes of drug (2 - 50 cc) or high viscosities (15 cP or greater, up to approximately 100 cP). Most vials, prefilled syringes, and cartridges are glass cylinders, which impose design constraints on force and geometry. Typical syringes and autoinjectors have limitations on the viscosity of the drug that can be delivered, as well as the force that can be applied to the glass container stopper system. New injection devices have been developed, including insulin delivery pumps that use custom stoppers, but these systems are very expensive, cannot generate large forces or pressures, and typically cannot be reused and / or refilled.

[0004] Wearable injection devices are being continuously developed to create injection devices and methods that provide effective subcutaneous injection while offering advantages such as increased comfort and reduced pain. SUMMARY OF THE INVENTION

[0005] There is a need herein recognized for new and / or improved devices, systems, and methods for injecting an agent (e.g., a drug) from a reservoir, such as a source vial or vial, to and into a subject. Further, there is a need herein recognized for devices, systems, and methods for monitoring health or physiological parameters before, during, and / or after injection of an agent into a subject. Such devices or systems may be useful, for example, in regulatory procedures and patient monitoring.

[0006] The present disclosure provides devices, systems, and methods that can be used for the transfer and injection of medical fluids, as well as methods for administering a substance (e.g., an agent) to a subject and monitoring the subject for one or more physical parameters or characteristics before, during, and / or after administration of the substance.

[0007] In one aspect, a system for measuring health or physiological parameters from a subject is provided herein, the system comprising: (a) a patch having a first housing with a sensor, the sensor configured to: (i) measure the 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 health or physiological parameters from the subject, wherein the first housing comprises 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 connected to the first housing such that the cannula is guided through the opening and contacts the subject's body when the patch is secured to the subject's body, the syringe 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.

[0008] In some embodiments, the system comprises a pump integrated with the cannula, where the pump is configured to direct a substance from a fluid flow path through the cannula to a subject. In some embodiments, the cannula is configured to extend towards or away from the subject's body. In some embodiments, the opening includes a pierce-able membrane. In some embodiments, the pierce-able membrane is pierced by the cannula to create an opening. In some embodiments, the reservoir is fixed to a 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 drug. In some embodiments, the drug is for treating one or more diseases selected from the group of cardiovascular, musculoskeletal, gastrointestinal, dermatological, immunological, ophthalmological, hematological, neurological, oncological, endocrinological, metabolic, and respiratory diseases. In some embodiments, the syringe comprises a reservoir, where the reservoir is configured to contain a formulation containing 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 in communication with the communication interface. In some embodiments, the communication interface includes a wireless communication interface. In some embodiments, the communication interface includes a Wi-Fi interface. In some embodiments, the communication interface includes a short-range wireless communication interface. In some embodiments, the communication interface includes a Bluetooth® interface. In some embodiments, the communication interface includes an optical wireless interface. In some embodiments, the communication interface includes a digital or analog interface of direct electrical contact.In some embodiments, the input transducers / sensors of the plurality of sensors are selected from the group consisting of conductivity sensors, impedance sensors, capacitance sensors, charge sensors, humidity sensors, temperature sensors, heart rate sensors, interstitial pressure sensors, resistance sensors, optical sensors, inflation sensors, acoustic sensors, vibration sensors, blood pressure sensors, color sensors, chemical sensors, and substance tracking sensors. 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 the dose of the administered substance, the flow rate of the dispensing of the substance, the volume of the administered substance, the occlusion of the cannula, and the 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, the one or more transducers are configured to generate an output signal, wherein the output signal includes a vibration signal, an audio signal, or a visual signal. In some embodiments, the output transducers of the plurality of transducers are selected from the group consisting of tactile (vibration) transducers, audio transducers, visual transducers, and direct electrical stimulation (e.g., transcutaneous electrical nerve stimulation / TENS).

[0009] In another aspect, a method for measuring a plurality of health or physiological parameters from a subject is disclosed herein, the method comprising: (a) providing: (i) a patch comprising a first housing having a plurality of sensors and an opening; and (ii) a syringe having a second housing with a cannula in fluid communication with a fluid flow path, wherein the second housing is coupled to the first housing of the patch, and the syringe comprises a reservoir comprising 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) direct the substance from the reservoir to the fluid flow path; and (ii) direct the substance from the fluid flow path through the cannula to the subject; and (d) using the plurality of sensors to: (i) measure a plurality of health or physiological parameters from the subject; and (ii) provide one or more outputs corresponding to the plurality of health or physiological parameters from the subject.

[0010] In some embodiments, the method further includes using a pump integrated into the cannula to direct a substance from a fluid flow path through the cannula to a subject. In some embodiments, the cannula is configured to extend towards or away from the body of the subject. In some embodiments, the opening comprises a penetrable membrane. In some embodiments, the penetrable membrane is penetrated by the cannula to create the opening. In some embodiments, the reservoir is fixed 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 drug. In some embodiments, the drug is for treating one or more diseases selected from the group of cardiovascular, musculoskeletal, gastrointestinal, dermatological, immunological, ophthalmological, hematological, neurological, oncological, endocrinological, metabolic, and respiratory diseases. In some embodiments, the syringe comprises a reservoir, wherein the reservoir is configured to contain a formulation containing the substance. In some embodiments, the first housing is removably connected 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 in communication 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 short-range wireless 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 of 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, an interstitial pressure sensor, a resistance sensor, a dilation 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 transducers of the plurality of transducers are selected from the group consisting of tactile (vibration) transducers, audio transducers, visual transducers, and direct electrical stimulation (e.g., transcutaneous electrical nerve stimulation / TENS).

[0011] 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 sensor, a button position sensor, a vibration sensor, an audible sensor, and a skin sensor.

[0012] In yet another aspect, a syringe is provided herein, the syringe comprising: (a) a housing; (b) a drug reservoir provided within 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 attached to or within the housing; (e) a skin attachment layer attached to the housing, the skin attachment layer including an adhesive configured to secure the housing to the user's skin with a first holding force; (f) a patch removably secured to the housing with a second holding force, the patch including a sensor adhesive layer configured to secure the patch to the user's skin with a third holding force, an input transducer / sensor of the patch, an output transducer, and a patch circuit configured to receive data from the transducer / sensor of the syringe and the transducer / sensor of the patch and transmit the received data to a remote receiver; wherein (g) the third holding force is greater than the second holding force.

[0013] In some embodiments, the second holding force is greater than the first holding 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 perforations. In some embodiments, the patch is removably fixed to the housing by a magnet. In some embodiments, the magnet is located within or on the housing of the syringe, and the patch comprises a metal portion configured to be engaged by the magnet. In some embodiments, the skin attachment layer comprises an opening, and the patch is located within the opening when removably fixed to the housing of the syringe. In some embodiments, the opening is disposed at 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 in the dispensing position. In some embodiments, the patch comprises an extension portion including an orifice through which the injection cannula of the syringe passes when in the dispensing position, and the extension portion is configured to compress the skin of the user around the injection site. In some embodiments, the patch comprises a printed circuit board on which the patch circuitry is located and to which the sensor adhesive layer and the patch transducer / sensor are attached, and the sensor adhesive layer comprises a central window through which the extension portion passes.

[0014] In some embodiments, the extension portion is generally conical. In some embodiments, the patch comprises a printed circuit board on which the patch circuit is located and to which the sensor adhesive layer and the patch sensor are attached. In some embodiments, the patch circuit comprises a microcontroller / microprocessor and a transmitter. In some embodiments, the syringe sensor comprises a transmitter, and the patch circuit further comprises a receiver configured to receive data wirelessly from the syringe transducer / sensor and to transmit the data wirelessly to the transducer. In some embodiments, the microcontroller / microprocessor, the transmitter, and the receiver are combined into a single component. In some embodiments, the syringe further comprises a wire connection between the syringe transducer / sensor and the patch circuit, the wire connection being configured to be severed when the syringe is removed from the patient or after removal. In some embodiments, the microcontroller / microprocessor and the transmitter are combined into a single component. In some embodiments, the transmitter is a Bluetooth transmitter. In some embodiments, the syringe sensor includes a plurality of input transducers / sensors and output transducers. In some embodiments, the patch sensor includes a plurality of input transducers / sensors and output transducers. In some embodiments, the patch sensor includes any of a plurality of input transducers / sensors and output transducers.

[0015] In yet another aspect, a method for collecting data from a syringe and a patient is provided herein, the method comprising: (a) attaching to the patient a syringe comprising a syringe sensor and a patch comprising a patch sensor, an output transducer, and a patch circuit; (b) using the patch circuit to receive data from the syringe sensor and the patch sensor; (c) using the patch circuit to transmit the received data to a remote receiver; (d) removing the syringe from the patient; (e) after removing the syringe from the patient, using the patch circuit to receive additional data from the syringe sensor; and (f) using the patch circuit to transmit the received additional data to the remote receiver.

[0016] In some embodiments, the syringe and the patch are attached to the patient simultaneously. In some embodiments, (a) includes attaching the patch before the syringe and before attaching the syringe to the patient, and further includes using the patch circuit to receive data from the patch sensor and using the patch circuit to transmit the received data to a remote receiver. In some embodiments, the data collected from the patient includes measurable characteristics that may be affected by the drug administered by the syringe and / or the injection of the drug using the syringe. In some embodiments, the data collected from the patient includes measurable characteristics that may be, or are indicators of, the safety and / or efficacy of the drug administered by the syringe and / or that may affect the use of the injection.

[0017] In yet other aspects, a method for monitoring a patient's injection site for injection site reactions is provided herein, the method comprising: (a) attaching to the patient a syringe comprising a patch sensor and a patch circuit, wherein the patch sensor comprises a surface temperature transducer / sensor and a skin color monitor; (b) using the patch circuit to receive data from the patch sensor; and (c) using the patch circuit to transmit the received data to a remote receiver, wherein the data includes an indication of a temperature increase or a change in skin color such that an injection site reaction can be identified.

[0018] In other aspects, a syringe is disclosed herein, the syringe comprising: (a) a housing; (b) a drug reservoir provided within 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, removably secured to the housing with a first holding force; (e) an adhesive layer attached to the patch sensor, the adhesive layer including an adhesive configured to secure the patch sensor to the user's skin with a second holding force; wherein (f) the second holding force is greater than the first holding force such that when the housing is removed from the patch sensor, the patch sensor remains attached to the user's skin.

[0019] In some embodiments, the body of the subject is the skin. In some embodiments, the patch is configured to receive data from the syringe. In some embodiments, the data is used to adjust device parameters of the patch or the 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 dispensing flow rate of the substance of the syringe, 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 the transducer. In some embodiments, the notification includes one or more notifications selected from the group consisting of vibration, sound, direct electrical stimulation, and visual indicators.

[0020] There are some aspects of the present subject matter that can be embodied individually or together in the devices and systems described and claimed below. These aspects may be used alone or in combination with other aspects of the subject matter described herein, and the description of these aspects is not intended to exclude the use of these aspects individually or the claiming of such aspects individually or in different combinations as set forth in the claims appended hereto.

[0021] The present subject matter includes transfer devices and / or syringes of any suitable detailed configuration, but transfer devices and syringes that are particularly useful in combination with the devices herein are described in U.S. Patent Application No. 9,925,333, the content of which is incorporated herein by reference.

[0022] In one aspect, the syringe includes a housing. A drug reservoir is provided within the housing, and an injection cannula is movable within the housing between a dispensing pre-position and a dispensing position in fluid communication with the drug 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 holding force. A patch is removably secured to the housing with a second holding force and includes a sensor adhesive layer configured to secure the patch to the user's skin with a third holding force. The third holding force is greater than the second holding force. The patch further includes a patch sensor and a patch circuit configured to receive data from the syringe sensor and the patch sensor and transmit the received data to a remote receiver.

[0023] In another aspect, a process for collecting data from a syringe and a patient is provided, the process comprising attaching a syringe equipped with a syringe sensor and a patch equipped with a patch sensor and a patch circuit to a patient; using the patch circuit to receive data from the syringe sensor and the patch sensor; using the patch circuit to transmit the received data to a remote receiver; removing the syringe from the patient; after removing the syringe from the patient, using the patch circuit to receive additional data from the syringe sensor; and using the patch circuit to transmit the received additional data to a remote receiver.

[0024] In yet another aspect, a process for monitoring a patient's injection site for injection site reactions comprises attaching to the patient a syringe equipped with a patch including a patch sensor and a patch circuit, wherein the patch sensor includes a surface temperature sensor and a skin color monitor; using the patch circuit to receive data from the patch sensor; and using the patch circuit to transmit the received data to a remote receiver, wherein the data includes an indication of a temperature increase or a change in skin color such that an injection site reaction is identified.

[0025] In yet another aspect, the syringe includes a housing having a drug reservoir provided therein. The injection cannula is movable within the housing between a dispensing pre-position and a dispensing position in fluid communication with the reservoir. A patch sensor configured to receive and transmit data is removably fixed to the housing with a first holding force. A skin attachment layer is attached to the patch sensor and configured to fix the patch sensor to the user's skin with a second holding force, where the second holding force is greater than the first holding force.

[0026] Another aspect of the present disclosure provides a non-transitory computer-readable medium including machine-executable code that, when executed by one or more computer processors, performs any of the methods described above or elsewhere in this specification.

[0027] Another aspect of the present disclosure provides a system including one or more computer processors and a computer memory connected thereto. The computer memory includes machine-executable code that, when executed by one or more computer processors, performs any of the methods described above or elsewhere in this specification.

[0028] Additional aspects and advantages of the present disclosure will be readily apparent to those of ordinary skill in the art from the following detailed description, which illustrates and describes only exemplary embodiments of the present disclosure. As will be understood, the present disclosure is capable of other and different embodiments, and its various details are capable of modifications 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 as restrictive.

[0029] Incorporation by reference All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. To the extent that the incorporated publications, patents, or patent applications conflict with the disclosure contained herein, this specification is intended to supersede and / or take precedence over such conflicting subject matter.

Brief Description of the Drawings

[0030] The novel features of the present invention are particularly set forth in the appended claims. The features and advantages of the present invention will be better understood by reference to the following detailed description which illustrates exemplary embodiments in which the principles of the present invention are used, and the following appended drawings (also referred to herein as "Figures").

[0031]

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DETAILED DESCRIPTION OF THE INVENTION

[0032] Although various 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 by way of example only. Numerous variations, changes, and substitutions may be contemplated by those skilled in the art without departing from the present invention. It should be understood that various alternatives to the embodiments of the present invention described herein may be utilized.

[0033] When terms such as "at least", "greater than", or "equal to or greater than" are prefixed to the first numerical value in a series of two or more numerical values, the terms "at least", "greater than", or "equal to or greater than" are always applied to each of the numerical values in the series of numerical values. For example, 1, 2, or 3 or more has the same meaning as 1 or more, 2 or more, or 3 or more.

[0034] When terms such as "no more than", "less than", or "less than or equal to" are prefixed to the first numerical value in a series of two or more numerical values, the terms "no more than", "less than", or "less than or equal to" are always applied to each of the numerical values in the series of numerical values. For example, 3, 2, or 1 or less has the same meaning as 3 or less, 2 or less, or 1 or less.

[0035] As used herein, the term "subject" generally refers to a user of the devices, systems, or methods of the present disclosure, or an individual on whom the devices, systems, or methods of the present disclosure are being used. The subject can be a patient (e.g., a patient being treated or monitored by a physician or healthcare provider). As an alternative, the subject may not be a patient. The subject may have a disease or disorder, or may be suspected of having a disease or disorder. As an alternative, the subject may be asymptomatic with respect to a disease or disorder. The subject may be a vertebrate, a mammal (e.g., a human or an animal), a non-human primate, etc. The subject may be an animal such as a rodent (e.g., a rat or a mouse), a canine (e.g., a dog), a feline (e.g., a cat), a bovine, or other animals.

[0036] As used herein, the term "agent" generally refers to a substance used to treat the health or physiological state or condition of a subject (e.g., a medical treatment). The agent may be a drug or a therapeutic agent. The agent may be an individual, a liquid, a gas, or a combination thereof. The agent may be an aerosol, a pill, a tablet, a capsule, a lozenge, an elixir, an emulsion, a foaming powder, a solution, a suspension, a tincture, a liquid, a gel, a dry powder, a vapor, a droplet, an ointment, or a combination or modification thereof. The agent may be used to treat a disease, illness, or disorder, or may be used as a dietary supplement (e.g., vitamins, minerals, probiotics, etc.).

[0037] The present disclosure provides devices, methods, and systems for delivering a substance (e.g., a drug) to a subject and for monitoring the subject before, during, and / or after delivery of the substance. The devices of the present disclosure can be syringes for delivering a drug. Alternatively, or in addition, the device may 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). As an alternative, the syringe and the patch may be part of a single device (e.g., not separable from each other).

[0038] syringe Referring to FIG. 1, the syringe (7) can be of any suitable configuration. As previously explained, the syringe can advantageously employ one or more of the features of the syringe described in U.S. Patent No. 9,925,333, the contents of which are incorporated herein by reference.

[0039] Referring to FIGS. 1-3, syringe (7) generally has a thin, disk-shaped outer housing (74) with an upper surface (75) and a lower surface (76). When actuated by a user, a cannula or needle projects through this housing. The upper surface (75) has an actuator or button (77) to initiate an injection and a portion (80) of the housing (74) that enables a subject or healthcare provider to view an expandable member (78) to confirm the amount of substance (79), such as an injectable fluid or drug, within the reservoir of the syringe (7). In this case, the portion (80) of the housing may comprise a transparent material, allowing the user to determine whether an injection has been initiated or completed. In some cases, the expandable member (78) and / or the portion (80) of the housing (74) are marked with graduations, such as by a line (127), enabling the subject or healthcare provider to visually determine the remaining amount of substance (79) with greater accuracy (e.g., about 50% complete or about 75% complete). Additionally, the expandable member (78) itself may include or interact with features on the outer housing (74) to indicate the remaining amount of substance (79) within the syringe reservoir. For example, when the syringe (7) is filled with substance (79), the transparent portion (80) may exhibit one color, such as green, although not limited thereto. When there is no substance (79) in the syringe (7), the transparent portion (80) may exhibit a different color, such as red, although not limited thereto. During dispensing, the transparent portion (80) can exhibit a combination of colors.

[0040] Referring to FIGS. 4-6, the lower surface (76) of syringe (7) includes a fill port (81) and a dispense port (82). The fill port (81) is an interface that enables a transfer device fill tube (83) to transfer substance (79) into the syringe (7), e.g., the syringe reservoir. The dispense port (82) also includes an internal passageway (84) between the substance (79) discharged from the expandable member (78) and the cannula (85). The fill port (81) and the dispense port (82) may be in direct fluid communication via an internal passageway (86) or may be combined into a single port.

[0041] Referring to FIGS. 4 to 6, the syringe may include a filling port (81) having a check valve (87) to prevent the pressurized substance (79) from leaking out of the syringe (7) when the syringe (7) is removed from the transfer device (6) and the filling port (81) is removed from the filling tube (83).

[0042] Referring to FIGS. 4 to 6, the syringe (7) may also have a filling port (81) configured to receive the insertion of the syringe. This syringe may be configured with a luer fitting or a cannula. With this configuration of the filling port (81), the user can manually fill the syringe. The transfer device (6) may still be used, but is not required in this configuration.

[0043] Referring to FIGS. 4 to 26, the syringe (7) may have a dispensing port (82) configured to connect directly to a cannula via an attached tubing or a standard cannula port.

[0044] Referring to FIGS. 4 to 6, the lower surface (76) of the syringe (7) carries an adhesive (88) for temporarily fixing the syringe (7) to the subject's body (e.g., skin) until the injection is completed. During removal of the syringe (7), the adhesive tape liner (89) is automatically removed, 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) may have a tab (90) that the user can pull to manually remove it before adhering the syringe (7) to the skin. Alternatively, this tab may be attached to the surface of the transfer device (4) so that the tape liner is automatically removed when the syringe (7) is removed.

[0045] Referring to FIGS. 4 - 6, the syringe (7) may have an adhesive tape flange (91) that extends beyond the lower surface base (76). This flange (91) of the adhesive tape (88) acts as a tension relief between the syringe (7) and the skin surface, and can reduce the risk of the syringe (7) being pulled off the skin. In other words, similar to the tapered tension relief for the wire entering the connector, the expanded adhesive flange (91) distributes the load on both sides of the connection point between the adhesive tape (88) and the lower surface base (76) of the syringe (7), and acts to reduce the stress concentration at the interface between the adhesive tape (88) and the skin.

[0046] Referring to FIGS. 4 - 6, the syringe (7) may be configured to have a tapered lower surface (98) that presses on the adhesive flange (91) to firmly attach the adhesive tape (88) to the skin when the user fixes the syringe (7) to the skin without further user intervention. When pressing the syringe (7) against the skin, by using the compliance of the human skin, the tapered lower surface (98) of the syringe (7) effectively presses the flange (91) of the adhesive tape (88) against the skin, but the exposed surface at the upper part of the flange (91) portion does not have an exposed adhesive, and thus cannot be attached to that portion of the tapered lower surface (98). The user does not need to move their finger around the flange (91) to fix the syringe (7) to the skin, which makes the method of attaching the adhesive tape (88) much simpler.

[0047] Referring to FIGS. 4 - 6, the syringe (7) may have a flexible or compliant lower surface (76) instead of rigidity so that attachment can be improved by adapting the syringe (7) to the skin during application.

[0048] Referring to FIGS. 7-9, after the syringe (7) is placed or adhered to the subject's body (e.g., skin) (99), the safety device or lockout mechanism is automatically released, and the syringe (7) is ready to fire (inject). In this case, the syringe (7) does not operate (is locked out) until it is placed against the skin. Alternatively, the user can manually remove a safety device (100) such as a safety pin, safety sleeve, tab, or collar to release the syringe and put it in a state where it can fire (inject, or guide the cannula into the subject through the opening). In some examples, the syringe (7) cannot fire until the safety device (100) is released. The safety device (100) may be passive or active and can be triggered manually by the user or automatically by the syringe (7).

[0049] Referring to FIGS. 7 - 9, after the syringe (7) is removed from the transfer device, an actuator or button (77) and a visual display (101) may be used in combination to indicate the parameters of the syringe (7). For example, if the button (77) is in the upper position and the display (101) has one color, such as but not limited to green, this may indicate that the syringe (7) is ready to start injection. Further, the button (77) may have a side wall (102) that is a different color from its upper part (103). When the button (77) is pressed down, the user cannot see the side wall (102) of the button (77); this may indicate that the syringe (7) is in use. When the injection of the drug is finished, the syringe (7) can give a warning to the user. This warning may be in the form of a visual display, an audible sound, a mechanical movement, or a combination. The button (77) is preferably designed to give audible, visual, and tactile feedback to the subject or user when the button (77) "pops up" to a locked position. The syringe (7) can indicate to the subject that the dispensing is complete and the full dose has been delivered to the patient when the button (77) is in the upper position and the display window (101) indicates that the syringe reservoir is empty. For example, if the button (77) is in the upper position and the display (101) shows a different color, such as but not limited to red, it may indicate that the syringe (7) has completed the injection.

[0050] Referring to FIGS. 10 - 12, syringe (7) may have an actuator or button (77) that a subject or user depresses to initiate an injection. Button (77) may be configured to be an on / off switch, i.e., having only two states of open and closed, such as a light switch. This can prevent a user from half - depressing button (77) and not activating syringe (7). Once activated, this “light switch” type of button (77) rapidly guides cannula (85) to skin (99) regardless of user operation of button (77). Alternatively, button (77) may have a continuous movement, whereby a user can slowly guide cannula (85) to skin (99). Button (77) may preferably be directly coupled to cannula (85) by using an adhesive (104) to form button (77) and cannula (85).

[0051] Referring to FIGS. 10 - 12, syringe (7) has a cannula (85) that, when the syringe (7) is attached to the skin and during operation, directs a substance from a reservoir into a fluid flow path in fluid communication with the reservoir, thereby allowing the substance to be directed from the reservoir to the skin (99). When the button (77) is actuated, as shown in FIG. 11, it first reaches a first position or depth, and then, as shown in FIG. 12, optionally automatically retracts slightly to a second position or depth. The first depth shown in FIG. 11 is achieved by the overtravel of the actuated button (77). The first depth can be controlled by a feature (105) on 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 injection. Alternatively, the final depth of the cannula (85) can be decreased for intradermal injection. Alternatively, the final depth of the cannula (85) can be increased for intramuscular injection. When the first depth is reached, the cannula (85) pulls away from the subject's body and returns to the second depth, as shown in FIG. 12. The distance the cannula retracts to the second depth ranges from 0.1 - 2 mm. This retraction feature is used to prevent, in some cases, the cannula (85) from being occluded by tissue during the initial insertion process. This tissue occlusion prevents the syringe (7) from delivering the drug and requires extremely high pressures to overcome. When the cannula (85) retracts from the first position to the second position, a pocket is created in front of the tip (107) of the cannula, which can reduce the pressure required to initiate the flow of drug from the cannula (85). This reduction in the pressure required to initiate the flow of drug from the cannula is, in some cases, necessary for the syringe (7) to maintain a relatively constant pressure and direct the substance through the cannula during injection.

[0052] Referring to FIGS. 10 - 12, syringe (7) may include a cannula (85) having a side opening (108). As shown in FIG. 12, when button (77) on syringe (7) is fully depressed, cannula (85) is fully inserted into skin (99) via dispensing port (82) and syringe (7) begins dispensing of the substance. Until button (77) is fully depressed, side holes (108), and thus the inner lumen of cannula (85), communicate with fluid channel (86) of dispensing port (82). Both side opening (108) and tip (107) of the cannula are held within septum (109). By holding side opening (108) and tip (107) of the cannula within septum (109), the entire drug pathway is kept sterile until use. When button (77) is fully depressed and cannula (85) is in the dispensing position, side opening (108) of cannula (85) communicates with fluid channel (86) of dispensing port (82) and injection of substance (e.g., injectable drug or fluid) is initiated.

[0053] Referring to FIGS. 10 - 12, the septum (109) provides the advantage of sealing the injection agent from the side opening (108) and the tip of the cannula (107) before and after dispensing. Sealing the tip of the cannula (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 the end of dispensing and / or after the syringe (7) has been removed from the skin surface. It also prevents contaminants from entering the hollow cannula before activation into the skin. The septum (109) may comprise a penetrable membrane made of any suitable material that can seal once the cannula (85) penetrates. The material composition of the septum (109), i.e., the penetrable membrane, may include silicone. Alternatively, the material composition of the septum (109), i.e., the penetrable membrane, 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. Alternatively, the fluid path (86) including the dispensing port (82) may include a rigid plastic with a silicone injection overmold to provide the septum described above.

[0054] Referring to FIGS. 10 - 12, the septum (109) at the dispensing port (82) protrudes slightly from the lower surface of the syringe (7) towards the skin surface (99) and can apply pressure to the skin surface (99) at the injection site. This pressure on the skin surface (99) by the dispensing port (82) after the cannula has retracted can eliminate the emergence of the substance from the injection site, commonly referred to as blowback.

[0055] Referring to FIGS. 10-12, syringe (7) may include a set of spring tabs (110) that interact with button (77) to perform a locking function. The spring tabs (110) are biased to lock into undercut (111) of button (77) to maintain button (77) in a first upper or pre-firing position, as shown in FIG. 10. The geometric shape of undercut (111) and spring tabs (110) serve to generate the light switch actuation force described above. This light switch actuation is achieved by the translational movement of button (77) relative to spring tabs (110) and the geometric shape of the mating undercut (111) surface.

[0056] Referring to FIGS. 10-12, syringe (7) may include spring tabs (112) that interact with button (77) of syringe (7) to perform a locking function, such that when button (77) is actuated to a first depth and slightly retracted to a second depth or dispensing position, undercut feature (113) of button (77) allows spring tabs (112) to hold button (77) in the dispensing position until syringe (7) completes dispensing.

[0057] Referring to FIGS. 13-14, syringe (7) may include a delivery completion indicator and an empty indicator (114) that senses when all of the substance (e.g., drug or injectable fluid) has been discharged from the expandable member (78) and the syringe (7) has completed dispensing. The empty indicator (114) may be configured with a slot or other opening (115) that slides over the expandable member (78) at the outlet port when the expandable member (78) is in a contracted state after all of the substance has been discharged. The empty indicator can have two states. As shown in FIG. 13, when the expandable member (78) is filled with the substance at that portion and not contained within the slot or opening (115), the empty indicator may be in a first position or deflected state. This first position is converted to a non-empty state of the expandable member (78) when the diameter of the expandable member (78) is greater than the minimum value due to the residual substance contained therein. As shown in FIG. 14, when the expandable member (78) is partially or fully contained within the slot or opening (115), the empty indicator (114) may be in a second position or deflected state. This second position is converted to an empty state of the expandable member (78) when the diameter is at the minimum value.

[0058] Referring to FIGS. 13-14, syringe (7) may include an automatic cannula retraction mechanism at the end of dispensing. This mechanism includes a direct connection between the spring tab (112) described above, the button undercut feature (113), and the air indicator (114). As shown in FIG. 14, when the expandable member (78) is filled with a substance (e.g., a drug or injectable fluid) and the button (77) is pushed down from a first pre-firing position to a second dispensing position, the undercut feature (113) of the button (77) allows the spring tab (112) to hold the button (77) in the dispensing position until the syringe (7) completes dispensing. This spring tab (112) may also be directly coupled to the air indicator (114) which is in its first position or deflected-out state. The movement of pushing the button (77) to the second or dispensing position causes the post feature (116) of the button (77) to bias or pre-tension onto the spring tab (112) and direct the air indicator (114) towards a second position or deflected-in state. However, the air indicator (114) cannot move to the second position or deflected state as the expandable member (78) is initially filled with the substance and has a large diameter as shown in FIG. 13. After the button (77) is pushed down, the substance begins to be discharged from the expandable member (78) through the cannula described above. Once the expandable member (78) has discharged all of the substance and reached its minimum diameter, as shown in FIG. 14, the air indicator (114) (under the pre-tension from the spring tab (112)) will move to the second position or deflected state. The spring tab (112) directly coupled to the air indicator (114) will also move with the air indicator (114). This movement releases the spring tab (112) from the undercut feature (113) of the button (77) and allows the button (77) (and the cannula) to move to a final or post-firing position after dispensing is complete as shown in FIG. 15.

[0059] Referring to FIG. 15, at the completion of injection, the button (77) is released and the lockout spring tab (117) interacts with the button (77) of the syringe (7) to perform a locking function such that the button (77) is pushed upward by the return spring (118) to its final upper or post - firing position. The height of the button (77) relative to the upper part of the syringe (7) in the final upper or post - firing position (shown in FIG. 15) may be higher than that in the pre - firing position (shown in FIG. 10). The end of the lockout spring tab (117) moves to the outer diameter surface (119) of the button (77) within the outer housing (74) to lock the button (77) in its final or post - firing position and prevent the button (77) from being actuated again.

[0060] Referring to FIG. 15, the syringe (7) may include a return spring (118) that interacts with the button (77) to bias the button (77) to a first upper or pre - firing position. When the button is actuated to a second depth or dispensing position, the return spring (118) is compressed, creating additional bias or pre - load. At the end of the dispensing period, the button (77) is unlocked from the second depth or dispensing position (shown in FIG. 12) and moves to its final or post - firing position after dispensing is complete, as described above. The upward push of the button (77) to its final or post - firing position is due to the bias of the return spring (118).

[0061] Referring to FIGS. 15 - 16, when the syringe (7) is removed from the skin (99), the syringe (7) is preferably locked out to prevent 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. This indication may be in the form of a visual display, an audible sound, a mechanical movement, or a combination thereof.

[0062] Referring to FIG. 16, when the syringe (7) is removed from the skin (35), the belt member (120) may be released from the syringe (7) and remain on the skin surface (35). This may be affected by using an adhesive that attaches the belt member more strongly to the skin than the adhesive that attaches the belt member to the syringe. Thus, as described in U.S. Patent No. 7,637,891 and U.S. Patent Application No. 12 / 630996 (which are incorporated herein by reference), when the housing is lifted from the skin, the belt member (120) remains in place over the injection site. The belt member (120) may include an opening (120b) (e.g., a hole or slit in the center of the belt member), as shown in FIG. 16B.

[0063] Referring to FIGS. 36 - 39, the syringe (7) may preferably include a manifold (121), which is assembled to both the expandable member (78) and the filling port (81) and the dispensing port (82), providing a 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) can be configured on the end and assembled to the expandable member (78) to have a larger diameter to facilitate the filling and discharging of all substances from the expandable member (78) as described above. The manifold (121) may preferably include an internal passage (122) that allows fluid flow to enter and exit the expandable member (78). The manifold (121) may be configured with a filter (123) in the path (122) of the injectable fluid to filter the substance and remove fine particles before and after being introduced into the expandable member (78). The filter (123) may be a membrane, depth filter, or other suitable filtration medium with a pore size or effective pore size small enough to remove undesirable fine particles, such as, but not limited to, undissolved substances in situations where the substance is reconstituted by a transfer device. The manifold (121) may also be configured with a filter (123) for removal or air. Such an air removal filter (123) may include a bubble trap, air gap, or other configuration in the path (122) of the injectable fluid that removes air from the path (122) of the injectable fluid before it is introduced into the expandable member (78). This air removal filter (123) may be composed of a hydrophobic filter or a combination of a hydrophobic filter and a hydrophilic filter. The hydrophobic filter discharges air from the transfer device but does not allow liquid to pass through. The hydrophilic filter allows liquid to pass through but does not allow fine particles or air to pass through. The air removal filter (123) may also have a check valve that can discharge the trapped air. Alternatively, the air remover or filter (123) may be disposed at any point in the fluid path from the filling port (81) to the cannula (85).For example, the most downstream point of the fluid path is the distal end (128) of the expandable member (78). The inner mandrel (124) may be connected to the distal end (128) of the expandable member (78). An air remover or filter (123) may be integrated at this downstream point to expel air trapped during filling of the syringe (7). Further, the mandrel (124) may include slots along its length, which communicate with the downstream filter (123) to assist in the expulsion of air during the filling process.

[0064] Referring to FIGS. 36 - 39, the syringe (7) may have an expandable member (78) such as an elastic elastomeric balloon or airbag. 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. Further, the expandable members (78) may be coated to improve their surface properties. The coating may include parylene, silicone, Teflon®, and treatment with fluorine gas. Alternatively, the expandable member (78) may be made from a thermoplastic elastomer.

[0065] Referring to FIGS. 36 - 39, the syringe (7) may include an elastic expandable member (78) through which the substance is transferred under pressure. Thereby, the expandable member (78) expands, and due to the elasticity of the expandable member (78), a pressure is created that tends to expel the substance. The pressure chamber of the aforementioned transfer device (or any other such pump or pressurizing means that may be utilized in the transfer device) transfers the substance to the syringe (7) under pressure. When the substance is introduced into the expandable member (78) under pressure, the expandable member (78) expands and elongates in both diameter and length. One example of this is inflating a long, slender balloon. The volume range of the syringe (7) can be from 0.5 to 30 milliliters. When expanded, the elastic expandable member (78) applies an ejection pressure in the range of 1 - 200 psi to the substance contained within the expandable member (78), such that when the syringe (7) is triggered by the user depressing a button, it is ready to automatically administer the substance. Thus, the transfer device described above not only transfers (and, if necessary, mixes, dilutes, and filters) a measured amount of the substance to the syringe (7), but also simultaneously operates to charge or provide a driving pressure to the syringe (7) (by expanding the elastic expandable member (78)), such that when the syringe (7) is actuated by the user, it is ready to automatically dispense the substance under the pressure applied by the elastic expandable member (78).

[0066] This aspect of the transfer device (transferring and charging simultaneously) is particularly useful. Activating the syringe (7), the above use shows the syringe (7) pre-filled or charged for injection of the substance (79), but in the present disclosure, the syringe (7) may remain empty and the expandable member (78) is intended to be in a relaxed, unfilled state, i.e., not charged or filled until the administration of the substance is required. Only in that case is the substance mixed and processed as needed, introduced into the syringe (7), and the expandable member (78) is expanded to a filled (charged) state. In the present disclosure, the drug is stored in the original container stopper (vial) until use. Since the substance is typically injected within seconds to hours after being transferred from the vial to the syringe (7), the quality retention period of the drug and the material compatibility with the materials in the fluid path within the syringe (7) are not critical issues. The difficulties and costs in designing the syringe (7) and selecting materials to extend the shelf life of the pre-filled syringe (7) are significantly reduced.

[0067] Referring to FIGS. 36 - 39, the present subject matter may use features of a syringe (7) as described in a patent application incorporated herein by reference above. However, the expandable member (78) utilized in the syringe (7) described herein may also preferably take the form of a deployed elongated balloon or airbag, for example, a planar helical or spiral configuration as illustrated. As described above, the syringe (7) includes an annular outer housing (74) that forms a helical slot or recess (125) therein. The elongated balloon or airbag (78) is stationary within the slot (125), one end being for communicating directly or indirectly with the injection cannula (85) via a fluid path (122), and the other end being for communicating directly or indirectly with the dispensing indicator (101). Due to the elongated helical configuration, the balloon or airbag (78) can have a significant volume for such an amount of substance (79) as may be desired while contributing to the thin profile of the syringe (7). In some cases, the use of an expandable member (78) with a relatively large length - to - diameter ratio can achieve very high pressures and volumes with minimal force. Additionally, the volume of the expandable member (78) can be changed by varying the filling length without significantly changing the pressure / volume curve of the expandable member (78).

[0068] Referring to FIGS. 36 - 39, one of the other aspects that may be utilized in the present subject matter is to use an insert or plug or mandrel (124) within the expandable member (78) to pre - stress the expandable member (78) to a slightly expanded position when not filled, so that when the expandable member (78) discharges the substance, as shown in FIGS. 38 and 39, the expandable member (78) still expands or contracts or collapses into a stressed state, continuing to apply pressure to any fluid therein. This ensures that all or substantially all of the substance is completely discharged from the syringe (7). Optionally, the mandrel or shaft (124) can be an expandable member filled with fluid. This allows for a variable - sized mandrel (124). Alternatively, when no stress is applied, the expandable member (78) may have a sufficiently small internal volume (small diameter) such that substantially all of the substance is discharged without the need for an internal mandrel or shaft (124). Further, the expandable member (78) can be flattened / elongated by "wrapping" around a surface within the syringe, such as the cylindrical wall (134). The pre - stress created in the expandable member (78) acts to expel the volume of residual fluid remaining therein.

[0069] There are a number of different ways to expand and / or contract the expandable member (78) in the aforementioned arcuate fashion. Referring again to FIG. 15, as one way, it is to design the expandable member (78) having a thicker wall cross-section (126) in a region around the periphery of the expandable member (78) that expands in an annular fashion. Alternatively, a separate element (126) may be fixed along the length of the expandable member (78) to stiffen the expandable member (78) at that portion of the periphery that effectively expands the expandable member (78) in an arcuate fashion. Referring again to FIG. 17, another way 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 an annular or helical path. These features (125) can interact with the expandable member (78) in a number of ways, the simplest being that the outer shape of the expandable member is constrained by the slot (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 smoothing the outer surface of the expandable member (78) or by inserting the expandable member (78) into a low spring rate spring that limits both the friction and the outer diameter of the expandable member (78), but not the length.

[0070] Referring to FIGS. 36 - 39, the elongate expandable member (78) can preferably be configured to expand along an arc having a predetermined tube diameter without the aid of a wall or a guide within the syringe. Referring again to FIG. 15, looking at the cross-section of the elongate expandable member (78), by adding a thicker wall region (126) in a small portion of the periphery of the expandable member (78), the elongate expandable member (78) can be expanded in an arcuate shape as described above. The arcuate expandable member (78) elongates in length due to the increase in pressure and volume therein; the thicker portion (126) is less deflected than the thinner portions.

[0071] Referring to FIG. 17, in order to orient the thick wall thickness region (126) or the region with less deflection inside the ring, the arcuate expandable member (78) will expand in length in an arc shape. As the wall thickness (126) of the expandable member (78) within the small region (126) around the periphery increases, the radius of the arc of the expandable member (78) will effectively continue to decrease. The increase in wall thickness (126) can be achieved by molding or extruding it into an arcuate expandable member (78), or by joining a piece of material to one side (126) of the expandable member and stretching that portion of its wall (126) at a low speed, thereby expanding the expandable member (78) in an arc shape as described above.

[0072] Referring to FIG. 18, the distal end of the expandable member (78) can be fixed to an element such as a display (101) and 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 or flattened around the inner annular diameter inside a syringe (7) such as a wall (134) so that the length of the expandable member does not change. Alternatively, a straight or curved mandrel (124) that is longer than the non-stressed expandable member can be used to stretch the expandable member into an annular shape within the syringe (7) before filling. Alternatively, the mandrel (124) can be used as a visual display to indicate the state of the syringe (7) and the progress of the injection. The mandrel (124) may be colored so that it can be easily observed through the housing.

[0073] Referring to FIGS. 36 - 39, a substance is injected by a transfer device into an expandable member (78), and the expandable member (78) is expanded to a specific outer diameter controlled by the configuration of the inner surface (125) of the housing (74). In this way, the entire length of the expandable member (78) is filled with a known volume of drug, and the outer diameter is known at each longitudinal position along the expandable member (78). It is desirable to fill and empty the expandable member (78) along its length from one end to the other in a controlled manner, encourage the expandable member (78) to be completely emptied, and enable easy and accurate measurement of the substance within the expandable member. To visually assist in determining how much substance is within the expandable member (78), markings with graduations, such as on a syringe, can be printed on the expandable member (78) to indicate the volume remaining in the expandable member (78). As described above, and referring to FIGS. 21 - 22, the expandable member (78) and the housing (74) can be transparent so that the user can see the volume remaining in the drug (74) and the syringe (7). Alternatively, graduated markings (127) may be printed on the housing (74) to indicate the volume remaining in the expandable member (78).

[0074] Referring to FIGS. 36 - 39, in accordance with this aspect of the above - described subject matter, a substance can be gradually discharged from the distal end (128) to the proximal end (129) of an elongatable member (78). The proximal end (129) of the elongatable member is adjacent to or in proximity to a dispensing cannula (82) or cannula. Thereby, a user can visually confirm or estimate the injection state either only by visual inspection or by using graduated markings (127), windows (80), or the elongatable member (78) on the injection housing (74). The gradual discharge can be achieved in various ways. For example, the substance exits the elongatable member (78) at a manifold (121) at the proximal outlet port portion (130) and is preferably disposed at the proximal end (129) of the elongatable member (e.g., a balloon or airbag). The wall thickness of the elongatable member (78) can vary and may increase uniformly or step - wise along its length from the distal end (128) to the proximal end (129). Due to the constraint by the wall of the helical channel (125) in which the elongatable member (78) is present, the elongatable member (78) expands to a substantially constant diameter along its length by the substance. However, the thicker wall at the distal end (128) of the elongatable member (78) exerts a greater contraction force on the substance than the thinner wall at the proximal end (129), and thus, initially, the diameter collapses or shrinks during the discharge of the substance. Thereafter, since the wall of the elongatable member (78) becomes thinner along its length in that direction, the elongatable member (78) gradually collapses from the distal end (128) towards the proximal end (129). Since the thickness of the elongatable member (78) preferably increases substantially uniformly from the proximal end (129) towards the distal or closed end (128), the contraction force of the wall of the elongatable member (78) when expanded increases substantially uniformly along the length of the elongatable member (78) from the proximal port end (129) to the distal or closed end (128). Thus, when the substance is discharged into the subject, the elongatable member (78) gradually collapses in diameter and shrinks in length, and this collapse of the diameter and shrinkage of the length are preferably visible to the user as described above.The distal end (128) of the elongate expandable member enables connection of a movable display component (101) within the syringe (7) that follows the contraction of the length of the elongate expandable member (78). This display (101) is preferably visible to the user through the outer housing (74) and indicates the state of the syringe (7) and the progress of the injection. Alternatively, the expandable member (78) is configured to have a constant wall thickness and, as described above, by pre-stressing the expandable member (78) during manufacture to bias the expandable member (78), it can be filled from the proximal end (129) to the distal end (128) and gradually collapse or empty from the distal end (128) to the proximal end (129).

[0075] Referring to FIGS. 36 - 39, the elongate expandable member (78) of the syringe (7) may be configured to have a portion (130) of the expandable member (7) adjacent to the proximal outlet port end (130) that first fills and last collapses during filling and discharging of the substance from the syringe (7). In other words, during filling of the syringe (7) by the transfer device, it is advantageous to have the most proximal outlet port portion (130) of the expandable member (79) that is first filled with the injectant. Additionally, during dispensing of the substance from the syringe (7), it is advantageous to have the last remaining volume of the substance contained within the most proximal outlet port portion (130) of the expandable member (79). There are several advantages to the above-described configuration. The proximal end portion (130) of the expandable member (78) may have a thin wall that keeps the expandable member (78) inflated under a lower pressure than the rest of the expandable member (78). This ensures that the portion (130) of the expandable member (78) continues to expand until all of the substance has been discharged from the rest of the expandable member (78). As described above, this portion (130) is directly coupled to the empty indicator to provide a fill or empty indication. Further, as described above, when the substance has been completely discharged, this portion (130) is mechanically connected to the empty indicator and automatic withdrawal of the button (77) and cannula (82) may be enabled.

[0076] Referring to FIGS. 36 - 39, instead of or in addition to changing the wall thickness (126) of the expandable member (78), the elongate internal mandrel or shaft (124) within the expandable member (78) can have its cross-sectional size gradually (linearly or stepwise) decreased along the length of the expandable member (78) from the proximal end (exit port end) (129) to the distal end (closed end) (128) of the expandable member (78). Further, the manifold (121) that enables attachment of the expandable member (78) of the syringe (7) may be configured to have a large diameter portion (130) at the proximal end (129) of the expandable member (78). The large diameter portion (130) of the mandrel (124) or the manifold (121) at the proximal end exit port (129) of the expandable member (78) ensures that the expandable member (78) is first filled with material in this region (129). In other words, the expandable member (78) is held at approximately the fill diameter at the proximal end exit port (129) by the large diameter portion (130) of the mandrel (120) or the manifold (121). The material first begins to fill the expandable member (78), and the expandable member (78) first reaches the fill diameter at the large diameter portion (130) and then gradually fills along the length of the expandable member (78) from the proximal end (129) to the distal end (128) as described above.

[0077] Referring to FIGS. 36 - 39, as described above, while dispensing material from the expandable member (78), the diameter of the expandable member (78) at its distal end gradually collapses from its distal (128) to its proximal end (129) (similar to squeezing a long balloon) until all of the fluid has been discharged from the expandable member (78). The large diameter portion (130) of the mandrel (124) or manifold (121) at the proximal end outlet port (129) of the expandable member (78) provides the same advantages (described above for filling) during material dispensing. This large diameter portion (130) contains the material that remains in the expandable member (78) last and ensures that it is dispensed from this region (130). As described above, this portion (130) can be directly coupled to the empty indicator to provide a fill or empty indication, as well as automatic retraction of the button (77) or cannula (82) when the material has been completely discharged.

[0078] Referring to FIG. 21, the user attaches the syringe (7) to his or her skin (99). There may be an adhesive on the bottom of the syringe (7) that enables adhesion to the surface of the skin (99) and hands - free operation. The adhesive extends beyond the outline of the syringe and enables the user to firmly tape the skin. Alternatively, the user can hold the syringe (7) against the skin (99) during injection.

[0079] Referring to FIGS. 21-23, to initiate an injection, the user removes the safety device (100) and depresses the button (77) on the syringe (7). Once the button (77) on the syringe (7) is fully depressed, it locks in place, the cannula is fully inserted into the patient, and the syringe (7) begins to dispense injectable drug. The syringe (7) can inform the user that the injection of the drug has started. This warning may be in the form of a visual display, an audible sound, a mechanical movement, or a combination. The injection time can range from a few seconds to several hours. The syringe (7) indicates to the user that it is dispensing while the button (77) is locked in the downward position, and the display window (101) indicates that the syringe (7) is less than full. The syringe (7) preferably has a transparent portion (80) that enables the user to easily determine the amount of drug remaining in the syringe (7).

[0080] Referring to FIG. 24, the user receives a warning when the injection of the drug is complete. This warning may be in the form of a visual display, an audible sound, a mechanical movement, or a combination. The syringe (7) moves to the upward locked position of the button (77), and the tactile and audible sound and the display window (101) indicating that the syringe is empty indicate to the user that the dispensing is complete. At the end of the dispensing, the cannula automatically retracts to the locked position within the syringe (7).

[0081] Referring to FIG. 21, when the syringe (7) is removed from the skin (99), the strap (120) is released from the syringe (7) and remains on the skin surface (99). Upon removal from the skin (99), the syringe (7) is preferably locked out to prevent 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. This indication may be in the form of a visual display, an audible sound, a mechanical movement, or a combination.

[0082] According to further aspects of the present subject matter, when administering an injection using a syringe and cannula intended for subcutaneous injection, it is desirable to know whether the cannula is properly positioned within the skin or is improperly positioned within a blood vessel. It is common for users performing intradermal (ID), subcutaneous (SC), or intramuscular (IM) injections to pull the plunger to aspirate the syringe, reducing the pressure within the syringe, and check to see if visible blood rises into the syringe from the cannula. If blood is visible, it means that the tip of the cannula is within a blood vessel. For many injectable drugs intended for subcutaneous injection, it is specifically indicated not to inject into a blood vessel. Blood aspiration using a syringe and cannula is a common technique and can be performed by anyone with appropriate training. In some cases, an autoinjector may be used, and the autoinjector may include a mechanism for determining whether the autoinjector is properly positioned.

[0083] Referring to FIGS. 25-26, the syringe (7) may comprise a cannula (85) having a side opening (e.g., a hole) (108) that operably engages a button (77) slidable within a septum (109) advancing into the skin (99). The button (77) may have an observation window (160) on a button top (103) that is in fluid communication with the proximal end (161) of the cannula (85). The button top (103) may have a cavity (162) in which blood (159) accumulates and can be seen by the user through the button window (160). The cavity (162) may include a central hole (163) that allows fluid communication with the proximal end (161) of the cannula (85) via the cannula lumen (165). The outer wall (164) of the cavity (162) is formed by the button top (103). Further, a portion of the outer wall (164) may include a hydrophobic filter (166). In this configuration, the proximal end (161) of the cannula (85) is at atmospheric pressure. When fluid (14) or blood (159) rises in the inner lumen (165) of the cannula (85), the fluid (14) or blood (159) exits the proximal end (161) of the cannula (85) and fills the cavity (162). The air (167) in the cavity (162) easily moves through the hydrophobic filter (166) until all of the air (167) has moved out of the cavity (162) and the cavity (162) is filled with fluid (14) or blood (159). At this point, since the fluid (14) or blood (159) cannot penetrate the hydrophobic filter (166), the flow of the fluid (14) or blood (159) stops and can be easily observed by the user through the button window (160) of the button top (103), thus providing a way to determine whether the cannula (85) of the syringe (7) is within a blood vessel (158).

[0084] Referring to FIG. 27, the insertion of the cannula into the tissue can generally be divided into four stages. These stages include non-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 area deflects under the influence of the load applied by the tip of the cannula, but the tip of the cannula does not penetrate the tissue. When the tip of the cannula begins to penetrate the skin, the skin boundary follows the tip of the cannula to the boundary displacement point in the contact area. After the tip of the cannula penetrates the skin, the shaft is inserted into the tissue. Even after the insertion of the tip and the shaft, the boundary of the skin surface in the contact area does not return to its original non-contact state and remains displaced by a distance x. The amount of boundary displacement x is a function of several parameters including, but not limited to, the diameter of the cannula, the geometric shape of the tip of the cannula, the friction of the shaft of the cannula, the insertion speed of the cannula, and the physical skin properties. The boundary displacement x of the skin in the contact area is characterized by a cannula-based syringe. This is because it affects how much the cannula penetrates the skin and thus reduces the actual cannula penetration depth by the amount of boundary displacement x. If boundary displacement x can be intentionally induced by stretching or preloading, such as by pushing the skin at the contact site before the insertion of the tip of the cannula, there will be no additional boundary displacement by the tip or shaft of the cannula during insertion, and the depth of the tip of the cannula can be defined as expected. The advantage of this intentional displacement is that the amount by which the cannula penetrates the tissue is not affected by variations in boundary conversion x. Without intentionally inducing boundary displacement on the skin surface before the insertion of the tip of the cannula, the actual cannula penetration depth into the skin is not specifically known. As shown in FIG. 27, a portion of the cannula length (depending on the above parameters) is outside the skin due to the naturally occurring boundary displacement x. On the other hand, if the maximum boundary displacement can be induced at the contact site, the actual cannula penetration depth does not change due to variations in the above parameters including the diameter of the cannula, the geometric shape of the tip of the cannula, the friction of the shaft of the cannula, the insertion speed of the cannula, and the physical skin properties.

[0085] Referring to FIG. 28, the syringe (7) may have an extension or structure of the boundary displacement of the skin, such as a lower surface (76) including an extension part (138), at or around the dispensing port (82), or as part of the dispensing port (82). The extension part extends substantially perpendicular to the plane of the tissue at the time of cannula insertion. When the syringe (7) is attached to the skin (99), the extension part (138) protrudes with respect to the surface of the skin (99), and as a result, displacement or compression of the skin (99) occurs in this contact area (139). Compression of the skin helps to reduce or eliminate the "tenting" of the tissue surface during cannula insertion. In other words, due to the "preloading" of the tissue by compression, the extension part (138) helps to eliminate further tissue detachment or tenting, or as a result, to reduce the amount of deflection or tenting of the skin surface more reproducibly. During actuation of the button (77) from the pre-firing state to the first position, the cannula (85) exits the syringe (7) and advances through the dispensing port (82) and / or the extension part (138) to the skin (99) to start drug dispensing. For the reasons described above, when the cannula (85) exits the syringe (7) and advances, the tip of the cannula (107) does not create additional boundary displacement (141) in the skin (99) at the contact area (139) (already intentionally induced by the extension part (138)). Therefore, the actual penetration depth (140) of the cannula into the skin (99) is better characterized and controlled. Also, the extension part through which the cannula passes compresses the tissue immediately around the cannula, which has several advantages. During injection, compression of the tissue by the extension part (138) in the contact area (139) increases the local density of the tissue compared to the surrounding adjacent tissue (99), thus creating a higher pressure area. When the injectate enters the skin (99), the fluid moves from this high pressure area (139) of the skin (99) to a lower pressure area, which helps to prevent the injected fluid or drug from flowing into or moving immediately around the cannula / skin puncture site, and acts to reduce or minimize fluid leakage (backflow) and / or bleeding from the puncture site. This higher pressure area also effectively provides the advantage that the injection cannula is much longer.For example, in ultrasonic evaluation, when comparing the subcutaneous deposition depth of a 10 mL fluid bolus (saline) using a syringe (7) with a needle depth of 5 mm and using a ready-made infusion pump (Freedom 60, RMS) with a winged needle extension set (needle depth of 9 mm), the results showed that the subcutaneous depth of the 10 mL bolus after injection was equivalent between the syringe (7) of the pump with a 5 mm needle length and the pump with a 9 mm needle length. In all results, the bolus position is characterized by the distance (Zd) from the skin surface to the upper end of the bolus. Figure 47 shows the upper end of a 10 mL subcutaneous bolus using a pump with a cannula length of 9 mm. The Zd distance is measured to be 0.44 cm. Figure 48 shows the upper end of a 10 mL subcutaneous bolus using a syringe (7) with a cannula length of 5 mm. The Zd distance is measured to be 0.42 cm. Thus, a similar bolus depth is achieved with a cannula depth (5 mm) and a tissue displacement structure that is more than 40% shorter than other test cannulas (9 mm) without a tissue displacement structure.

[0086] Another advantage of the extension portion (138) is the compression of the tissue in the contact area (139) after the injection is completed. In the post-firing state, the button (77) pops up, informing the user that the syringe (7) is complete. The cannula (85) is fully retracted out of the puncture hole in the skin (99). The dwell time between when the syringe (7) completes dispensing and when it is removed by the user can be several minutes or more, depending on the environment in which the user is placed at the time of completion. For the same reasons described above, the compression of the tissue by the extension portion (138) in the contact area (139) increases the local density of the tissue and thus creates a higher pressure area compared to the surrounding adjacent tissue (99). Similar to the way a nurse can apply pressure to the injection site with the thumb after injection, this pressure helps to close the puncture hole, prevent the injected fluid or drug from flowing back into the injection site, and act to reduce or minimize fluid leakage and / or bleeding from the puncture site.

[0087] Referring to FIG. 29, there are two interfaces related to the adhesion of the syringe (7) to the skin (99). The first interface is the adhesive / device interface (173), and the second interface is the adhesive / skin interface (174).

[0088] Referring to FIG. 30, the adhesive (88) may be configured on the syringe (7) having at least two regions. The first region (175) includes a permanent bond between the adhesive (88) and the syringe (7) using mechanical or chemical means, and preferably may be located within the periphery of the syringe (7). The second region (176) may be removable from the syringe (7) or may be configured not to be attached, and preferably is adjacent to or on the outside (e.g., radially outside) of the first region.

[0089] Referring to FIG. 31, when the adhesive (88) is fully attached to the bottom (76) of the device (7), during the occurrence of tissue swelling (177), the adhesive (88) at the adhesive / skin interface (174) will begin to peel off from the skin (99). This is because this interface (174) is weaker than the adhesive / device interface (173). This is shown in the bulging surface of FIG. 31. As a result, the syringe (7) may come off the skin surface (99) and fall from the patient.

[0090] Referring to FIGS. 30 and 32, instead of permanently attaching the adhesive (88) to the bottom (76) of the syringe (7) as shown in FIG. 31, the adhesive (88) may be configured on the syringe (7) with the above-mentioned regions (175)(176). During the tissue swelling event (177) in this configuration, the adhesive (88) in the second region (176) separates from the syringe (7) and firmly attaches to the skin surface (99) at the adhesive / skin interface (174). Thereby, the peeling edge (178) can be moved from the adhesive / skin interface (174) to the adhesive / device interface (173), and tension relaxation can be efficiently generated at the adhesive / skin interface. The adhesive / device interface (173) can be designed to be stronger and prevent the syringe (7) from coming off the skin surface (99).

[0091] When performing self-injection with an auto-injector, a beneficial requirement of the present device is to prevent the cannula from accidentally stabbing the user. Usually, the cannula can be retracted into the device before and after use, thus preventing the user from approaching the cannula. However, during injection, the cannula may extend outside the device. In some examples, the auto-injector is equipped with a skin detachment sensor that automatically retracts the cannula when the device detaches from the skin during injection.

[0092] Referring to FIGS. 33-35, the skin detachment sensor (179) may be in an operable engagement with the flexible latch (181) of the button (77) and slidable within the lower housing (180) of the syringe (7). Referring to FIG. 34, when the syringe (7) is attached to the skin surface (99), the skin detachment sensor (179) is pushed to the first or upper position (182) inside the syringe (7). When the button (77) is actuated to the firing state, the second position, or the dispensing position (exposing the cannula (85)), the flexible latch (181) is pushed to the locking position (187) by the skin detachment sensor (179) under the latch board (183). The latch board (183) holds the button (77) downward on the latch board surface (184) of the button (77) in the firing state or the dispensing position until dispensing is completed. At the end of dispensing, the latch board (183) moves away from the latch board surface (184) on the button (77), and the button (77) and the cannula (85) can be retracted to the post-firing position where the cannula (85) is contained within the syringe (7). Referring to FIG. 35, when the syringe (7) detaches from the skin surface (99) during injection, the skin detachment sensor (179) extends from the syringe (7) to the second or lower position (185). As a result, the flexible latch (181) bounces back to the unlocking position and can disengage from the latch board (183). Further, the button (77) and the cannula (85) can be retracted to the post-firing position, where the cannula (85) is contained within the syringe (7).

[0093] When performing self-injection with a syringe and a cannula, the user may need to temporarily stop or discontinue the injection due to sudden pain or irritation at the injection site. The cessation of the flow of the injection substance into the injection site is achieved by removing the pressure on the plunger rod of the syringe, and by allowing the parked fluid bolus to diffuse into the surrounding tissue for a longer time to relieve local compression and the associated pain and irritation, which helps relieve pain at the injection site. In some examples, the syringe comprises a mechanism for stopping the injection automatically or manually, for example.

[0094] Referring to FIGS. 36-37, when the button (77) is actuated, the cannula (85) and the button (77) move to a first position or depth as shown in FIG. 36. At this first position or depth, since the side holes (108) are covered by the partition wall (109), the lumen (165) of the cannula (85) is not in communication with the fluid channel (86) of the dispensing port (82). The button (77) may be intentionally held in this first position or depth to prevent the injection substance (14) from flowing from the fluid channel (86) through the side holes (108) of the cannula (85) and into the skin (99). As shown in FIG. 37, when the button (77) is released, the cannula (85) and the button (77) return to a second position or dispensing position, where the side holes (108) are in contact with the fluid channel (86), allowing the injection substance (14) to flow from the fluid channel (86) through the side holes (108) of the cannula (85) and into the skin (99) until the injection is complete. The act of pressing the button (77) to this first position or depth may be performed a number of times as necessary throughout the injection.

[0095] Referring to FIGS. 38 - 39, the actuating force (186) of the button (77) is the transition load applied to the button (77) necessary to initiate the displacement of the button (77) and the cannula (85) from the pre - firing position to the firing or dispensing position. Until this transition load is met, the force (186) applied to the button (77) moves directly to the syringe (7). Specifically, this load (186) may be transferred to the adhesive - skin interface (174) and / or the adhesive - device interface (173), whereby the syringe (7) is well fixed to the skin surface (99) before actuation.

[0096] Referring to FIGS. 40 - 41, the arcuate expandable member (78) is positioned and / or preferably, extends in an arcuate shape. In the illustrated embodiment, this arcuate shape is introduced by providing a less - elastic region, for example, a relatively thick and heavier wall - thickness region (126), whereby the deflection of the expandable member in said region is reduced and an expanded arcuate shape is formed. This heavy wall - thickness region (126) may be configured in any shape that allows the arcuate shape of the expandable member (78) during expansion. A preferred configuration of the heavy wall - thickness region (126) is to minimize its thickness or attachment portion (150) in the circumferential direction on the wall of the expandable member (78) and to maximize the radial thickness or protrusion (151) away from the expandable member (78). This not only functions to encourage the expandable member (78) to expand in an arcuate shape but also maximizes the amount of material along the periphery that is not affected by the heavy wall - thickness region (126) for expansion. To assist in encouraging the expandable member (78) into an arcuate shape, additional features including but not limited to a T - shape may be configured at the ends of the radial protrusions (152).

[0097] Referring to FIG. 42, a safety such as a safety pin or safety sleeve (100) may be configured to allow removal of the syringe (7) in any direction that releases the syringe (7) to the firing (injecting) state.

[0098] Referring to FIG. 43, the syringe (7) includes a cannula (85) with a side hole (108) that enables fluid communication between the fluid channel (86) and the skin (99) once the button (77) is fully depressed within the syringe (7). This initiates the dispensing of the injectable substance (14). The inner diameter (165) of the cannula (85) is important for controlling the dispensing rate from the syringe (7). Referring to the Hagen-Poiseuille's equation for fluid flowing through a pipe, the flow velocity through the pipe is directly proportional to the radius of the pipe to the fourth power. Thus, a small variation in the inner diameter (165) of the cannula (85), specifically when the inner diameter (165) becomes smaller, results in a large variation in the flow through the cannula (85). The cannula (85) of the syringe (7) may be of various wall thickness configurations and may be in the range of 21G to 34G (Stubs Iron Wire Gauge System). This range corresponds to an inner diameter (165) range of 0.021” to 0.003”, and it is recognized that manufacturing variations or tolerances exist for the cannula inner diameter (165) at a given cannula size. This is based on the cannula size and there can be an inner diameter variation of up to ±0.00075. To limit the range of the inner diameter (165) within a given cannula size and the resulting flow variations, the cannula (85) may be modified and then assembled into the syringe (7). Such modification can include crimping, flattening, or rolling the cannula from a circular shape to a non-circular shape to a newly defined effective inner diameter (165) over the length portion of the cannula (85). This has the advantage of enabling specific delivery rate adjustment from the syringe (7).

[0099] Monitoring of Radio Frequency Compliance In some examples, the syringe includes a mechanism to alert the subject, prescriber, healthcare provider, or another third party when non-compliance or non-adherence occurs.

[0100] In accordance with a further aspect of the invention identification matter of the present invention, when performing an injection with an auto-injector, it is desirable to know when the prescription drug for the syringe was first filled or refilled, and in addition whether the syringe was used properly and on time. Many prescription drugs are tracked by the patient as to the time of filling using specialized labels, but the options for verifying whether the patient actually took the drug are limited. Since more drugs are present in the syringe, the ability to automatically track the start of the prescription is currently limited in use. Furthermore, there is no ability to automatically track whether the syringe was used properly.

[0101] As described herein, automatic tracking of both adherence and compliance can be achieved wirelessly by RF (radio frequency) technology products installed in or cooperating with the transfer and / or syringe described herein. In the current art, the use of radio frequency identification (RFID) for transferring data is possible for the purpose of automatically recognizing and tracking tags or ultra-small circuit chips attached to an object. As used herein, RF, RFID, RF tag, or RF chip are used inclusively and interchangeably, and are intended to include radio electronic tags or chips for transmitting data / information using any suitable wireless communication protocol or technology product, such as wireless technology products such as Bluetooth (for example, wireless LAN, wireless PAN, or other wireless technology products described in the Institute of Electrical and Electronics Engineers (IEEE) 802 standards).

[0102] The RF tag or chip may be active or passive. In both types, RF energy is used between the tag or transponder and the reader, but 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 circuit, while passive RFID relies on RF energy that moves from the reader to the tag to power the tag. In the present invention, the package of the syringe or transporter may include an RFID tag, optionally include a power source for the tag, or may be read or received by an external reader. In one embodiment, the RF tag or chip is removably associated with the syringe so as to be physically removable from the syringe during use of the syringe. Thereby, the syringe can be discarded later without the limitations or restrictions that may apply if the tag or chip remains as part of the syringe after use.

[0103] Referring to FIGS. 44 - 45, the syringe (210) may include an electronic RF tag or chip (211) for monitoring the state of the syringe (210). For example, the RF tag (211) may broadcast (in the case of active) to an external reader (212), or provide information or status such as "the syringe (210) was prescribed", "the syringe (210) was removed from the package", "the syringe (210) was activated", and / or "the syringe (210) completed administration" (in the case of passive, read by the external reader (212)). The RF tag reader may further be associated with or in communication with an on - site or off - site data collection facility, such as by a wireless connection or a hard - wired connection, to enable recording and editing of compliance - related information.

[0104] Referring to FIGS. 44 - 45, the RF tag (211) may be used to monitor whether the syringe (210) has been actuated, administration has been started, or administration has been completed. The syringe (210) may be equipped with an active or passive radio frequency (RF) tag or chip (211) at any suitable location. As shown below, when the RF tag or chip (211) is used inside the syringe, it is attached to the button (213) and may be in a slidable communication state with the spring tab (214) between the first and second positions of the button (213). While the RF tag (211) is in a slidable communication state with the spring tab (214), the RF tag (211) may be broadcast (in the case of active) or may provide a first state including an unused state (in the case of passive, read by an external reader (212)). When the syringe (210) is actuated, the button (213) is pushed down to the dispensing position. At the end of the dispensing period, the button (213) is unlocked from the second depth or dispensing position (shown in FIG. 45) and lifted to the final or post - firing position. In this post - firing position, since the RF tag (211) is not in contact with the spring tab (214), a change in the state (second state) of the RF tag (211) becomes possible. In this second state, the RF tag (211) may be broadcast (in the case of active) or may provide a second state including a used state (in the case of passive, read by an external reader (212)). Alternatively, the RF tag (211) may be deformed or modified when using the syringe such that the RF tag (211) indicates a "used" signature upon invocation. For example, if the RF tag consists of two coils coupled by a conductor, the first signature of the tag (211) will be a "dual - coil" signature. Once the tag (211) has been used, if the conductor connecting the two coils is broken, the two independent coils will create different signatures.

[0105] For adjustment and / or disposable reasons, it is desirable for the location of the RF tab or chip to be outside the syringe. For example, the RF tag or chip (211) may further be associated with the transfer device and / or at a selected time during operation of the syringe to activate the tag or chip, or may be associated with other parts of the system, such as a safety sleeve or pull tab (100) (see Figure 42). The active RF tag or chip can be placed, for example, on the safety sleeve and configured to close the contact between the long-life battery and the tag or chip transmitter by removing the safety sleeve to initiate the injection process.

[0106] Referring to FIGS. 52-55, the RF chip or tag (211) within the syringe (210) may have two states, namely a standby or off state and an active or transmission state. Referring to FIGS. 52 and 54, this state may be changed by causing or breaking the contact between the battery (262) and the contact portion (263). As illustrated in FIG. 54, this can be achieved, for example, by configuring the safety release or pull tab (100) to prevent electrical contact between the battery (262) and the contact portion (263) by spatial separation when the pull tab (100) is in place on the syringe (210). As illustrated in FIG. 55, upon removal of the pull tab (100), the battery (262) and the contact portion (263) come into contact with each other, causing electrical contact. As a result, the RF tag begins to function. Further, various operations associated with the use of the transfer device and / or syringe can be utilized to cause or break contact. For example, when one operation is taken, such as the vial being inserted into the transfer device and becoming inactive by another operation, such as breaking contact after syringe use, a previously inactive RF tag or chip may be activated by closing the contact between the battery and the chip or tag transmitter.

[0107] The RF tag or chip (211) can transmit or communicate data related to the transporter or syringe in addition to usage information. For example, the tag or chip may be configured with a memory storage capacity to convey the type of syringe, lot number, amount of fluid administered, drug recognition, and other relevant information. FIG. 46 illustratively shows a system available for the invention particulars of the present invention. As shown in this figure, the RF tag or chip (250) may be of an active type and, when activated actively, transmits related information to a local patient module (252) located near the patient and the syringe. For example, this patient module may be a wall-mounted device or a desktop device in the patient's home to receive monitoring information transmitted by an RF tag or chip associated with the syringe and / or the transfer device. The patient module may also be a mobile phone or the like.

[0108] The patient module can be provided with a memory for maintaining data such as patient recognition and related information. The patient module communicates with a data manager (254) in an appropriate manner such as WIFI, mobile communication, telephone, hardwired link, etc. The data manager may be any data network or cloud storage configuration suitable for receiving and / or storing data received from the patient module indicating the status and / or use of the syringe related to specific patient recognition information. The data manager is accessible by medical personnel responsible for monitoring the use of the patient's syringe and the patient's compliance with any injection prescription regimen. The data manager can further be configured to automatically convey patient compliance information to appropriate medical personnel such as a specific physician or clinic (256).

[0109] Devices, systems, and methods for monitoring compliance, and other aspects of use with the syringes described herein, are shown in FIGS. 49 - 58. As illustrated in these figures, the system may include a wireless communication source, such as Bluetooth, such as a battery - powered transmission unit, such as a microchip shown as (262) in FIG. 59. This transmission unit can be attached in a suitable location and associated with or attached to a part of the syringe (and / or transfer device) in such a way that it can be removed from the syringe or transfer device at the time of disposal. Thereby, since the electronic circuit and the electronic chip are not usually reusable in the same way, most of the syringe or transfer device structure can be reused.

[0110] In some embodiments, a contact ring is provided on the upper part of the syringe housing and is prevented from contacting a sensing lead (attached to the syringe button) when the safety strip is installed. When the safety strip is removed, the contact ring on the housing contacts the sensing lead of the button. Thereafter, various sequences of the injection process may be tracked based on the connection state of the contact ring and the sensing lead (the position of the contact ring relative to the sensing lead). For example, an infrared sensor may also be embedded in the syringe to optically track the progress of delivery, such as by monitoring the position of the expandable member of the syringe or the amount of injectable fluid therein.

[0111] Referring to FIGS. 52 and 53, an embodiment of the RF tag or chip (211) comprises a battery (262), a contact portion (263), a Bluetooth module with a microcontroller / microprocessor (265), a button sensor (267), and an antenna (269). The battery (262) provides the stored energy to power the system. This battery may be a coin cell battery or its equivalent with a voltage range of 1.5 - 3V and a power output of 5 - 100 mAh. As described above, the contact portion (263) provides an electrical connection between the battery (262) and the RF tag or chip (211). The contact portion (263) is configured to not enable electrical contact until the user removes the pull tab (100) during use by interacting with the pull tab (100). The Bluetooth module (265) has an integrated microcontroller / microprocessor. An example of a suitable Bluetooth module is Dialog Semiconductor part number DA14580 - 01UNA. In an alternative embodiment, the Bluetooth module may be separated from the microcontroller / microprocessor.

[0112] A button position sensing system of one embodiment of the device is shown in FIGS. 56 and 57. The sensing system can use a combination of an infrared emitter and a receiver sensor (267). The RF chip (211) is mounted on the lower surface of a device button (177) with a downward-facing sensor (267). A reflecting member (112) is fixedly mounted at the bottom of the syringe. When the device button is actuated to move from the upward, raised, or extended position shown in FIG. 56 to the downward, lowered, or retracted position shown in FIG. 57, the sensor (267) detects a decrease in the distance from the reflecting member (112). Conversely, when the button is released to move from the position in FIG. 57 to the position in FIG. 56 after drug delivery, the sensor (267) detects an increase in the distance from the reflecting member (112). The sensor (267) transmits this button position information to the microcontroller / microprocessor module (265).

[0113] In one embodiment of the device, the processing executed by the microcontroller / microprocessor module (265) is shown in FIG. 58. When the microcontroller / microprocessor is activated, such as by removing the safety tab (100) as described above in connection with FIGS. 54 and 55, the start timer shown in block (302) starts. Thereafter, the mode or state of the device is set to "Ready to Fire" (dispensing preparation) as shown in block (304), and the Bluetooth packet indicating this device mode is transmitted to a Bluetooth-compatible remote reader or receiver (such as (212) in FIGS. 44 to 45). This remote reader or receiver may be, by way of example only, a smartphone or a computer system. The said mode is displayed to the user on the remote receiver.

[0114] Next, the process of block (308a) is performed to save the battery life of the device and calculate the timing of the device.

[0115] Thereafter, using an IR sensor as described above in connection with FIGS. 56 and 57, for example, the microcontroller / microprocessor checks the position of the device button (177 in FIGS. 56 and 57) as shown in block (312). If the device button has not been pressed to the downward position as shown in (314), the above process is repeated. If the device button has been pressed, the delivery start time of the injection substance is recorded as shown in block (316), and the device mode is set to "Dispensing" as shown in block (318). This mode is transmitted to the remote receiver as shown in block (322), where the mode is displayed to the user.

[0116] Next, the process of block (308b) is performed to save the battery life of the device, intermittently or alternately put the processor into a low-energy sleep mode, and then calculate the timing of the device by waking up the processor at 1-second intervals (or other appropriate times).

[0117] Next, as shown by block (324), the microcontroller / microprocessor checks the position of the device button. If, as shown in (326), the device button has not returned to the raised or upper position, the above process starting from block (322) is repeated. If the device button has moved to the upper position, the delivery end time of the injection substance is recorded as shown by block (332), and the device mode is set to "Completed" as shown by block (334). This mode is transmitted to the remote receiver as shown by block (336), where the mode is displayed to the user.

[0118] Next, the process of block (308c) is performed to save the battery life of the device and calculate the timing of the device, and then the device in the "Completed" state is transmitted to the remote receiver again (block (336)).

[0119] Embodiments of the present disclosure can provide a "smart" connected device that enables a patient's freedom and mobility by allowing the self - administration of high - volume / viscosity drugs by the patient. In multiple embodiments, a safe, simple, and personalized drug delivery experience can be provided to the user.

[0120] Embodiments of the present disclosure may provide a smart device system to provide three pieces of information regarding the operation of a drug delivery system: 1) the time when the device is powered on, 2) the start time of delivery by the device, and 3) the delivery completion time. In some embodiments, user interaction may include the deployment of a mobile application on those devices as otherwise described herein, and the smart device performs the rest of the operations without requiring additional operations from the subject or user.

[0121] Embodiments of the present disclosure can provide advantages such as a small board footprint. That is, the entire electronic device package fits inside an existing button and is less than 3 / 8 inch (9.5 mm) in diameter. This allows for easy removal of the electronics component (button) for disposal and reuse of the electronics.

[0122] Embodiments of the present disclosure may include smart device technology products in the transfer device. For example, the transfer device may include an electronics component that tracks its use. The electronics component in the transfer device can communicate directly with an external receiving device and / or with the electronics component of the patch / syringe. The transducer / sensor in the transfer device can provide information including, but not limited to, environmental conditions, opening of an external box or package, removal of the transfer device from the external package, orientation of the transfer device (tilt sensing), location of the device (e.g., using a global positioning system i.e., GPS), whether the transfer device is on a flat surface, vial insertion, plunger release (venting), and / or removal of the syringe from the transfer device. The electronics component in the transfer device can determine whether the correct vial has been inserted based on the electronics component in the vial or barcode / QRG code reading. Activation of the electronics component occurs when the external box or package is opened and the transfer device is removed. Additional electronics components can be added to vibrate or make a sound if the device is not placed on a table or at a certain angle. The electronics component that collaborates with the external receiver can provide voice commands to assist or instruct the user during use of the device if something is being done incorrectly.

[0123] In certain embodiments of the present disclosure, the syringe can utilize Bluetooth communication to provide data to the user. Additionally, in multiple embodiments, Bluetooth Low Energy (BLE) may be integrated into the device. BLE can be designed for low-power and low-cost applications that require lower data throughput speeds than conventional Bluetooth connections such as audio streaming or hands-free phone connections.

[0124] As two main types of connections defined by the Bluetooth standard, there are the standard (bonded) mode and the broadcast (also known as "beacon") mode. In a standard connection or bonded connection, the host (a smartphone with an application installed) creates a persistent connection with a peripheral device (a smart device). In this scenario, through the pairing process, both the host and the peripheral device share data to create a persistent connection that enables sharing between one host and one peripheral device. This method has the advantage of a strong connection that allows for the exchange of encrypted information that cannot be decoded without an encryption key.

[0125] In broadcast mode (also called "beacon"), the peripheral device sends out data at regular intervals that can be read by nearby hosts. In this scenario, only the peripheral device broadcasts data. However, the data is never received. This mode has various advantages, such as a reduction in power consumption. In some examples, further power savings can be achieved through a low-power "sleep" mode that is activated only when a new data broadcast is required.

[0126] In addition, since the peripheral device is configured to be a transmission-only device, security is improved so that the hardware cannot be "hijacked" or malicious software cannot be loaded. This reduces or eliminates the risk of the device being remotely controlled without permission. This software is loaded onto the device at the factory and once deployed, prevents unauthorized changes.

[0127] In some examples, the installation of an application can be used to ensure data confidentiality as described elsewhere in this specification. For example, without a proper application installation, the data can simply consist of an enumeration of unreadable binary numbers and lack text or other readable identifiers. Thus, confidential user information is not exposed even in the absence of an encrypted connection. The data may further exclude patient information that may be related to a particular individual, such as a name or identification number (and thus comply with HIPAA).

[0128] An important characteristic of a related healthcare implementation within embodiments of the present disclosure may be that it does not affect the performance functions essential to a drug delivery device. In some embodiments, the characteristics of this device only report the state of the device and never modify the functionality of the drug delivery device. If there are critical defects in a Bluetooth component such as a battery, some embodiments of the device complete drug delivery and provide the user with visual feedback regarding the device state.

[0129] By utilizing Bluetooth Low Energy broadcasts and decoding an electronic chip in a button of a device, some embodiments of the present disclosure can deliver real-time device performance information in a low-cost and convenient small package.

[0130] Syringe with patch In one aspect, the present disclosure provides a system for measuring a plurality of health or physiological parameters from a subject. The system may comprise a patch having a first housing with a plurality of sensors, the sensors being configured to (i) measure a plurality of health or physiological parameters of the subject when the patch is secured to the subject's body, and (ii) provide one or more outputs corresponding to the plurality of health or physiological parameters of the subject. The first housing may comprise an opening. The system may further comprise a syringe having a second housing including a cannula in fluid communication with a fluid flow path. The second housing may be coupled to the first housing such that when the patch is secured to the body, the cannula is in contact with the subject's body through the opening. The syringe may be configured to (i) direct a substance from a reservoir to a fluid flow path in fluid communication with the reservoir, and (ii) direct the substance from the fluid flow path to the subject through the cannula.

[0131] The cannula may be configured to extend towards or retract from the subject's body. In some examples, the cannula extends towards the subject's body (e.g., across the subject's skin) to deliver a substance to the subject's body. After delivery of the substance, the cannula may be retracted from the subject's body. The cannula may be connected to the reservoir via the fluid flow path. The cannula may be extended and / or retracted from the body using various mechanisms, such as mechanical or electrical mechanisms. Means for extending and retracting the cannula may include a pump, a spring, a gear, a diaphragm, a screw, or other means for moving the cannula, or variations or combinations thereof.

[0132] The syringe may be detachable from the patch. The patch includes a first housing, the syringe includes a second housing, and the first and second housings may be movably coupled. In one example, the first housing of the patch may be mechanically coupled to the second housing of the syringe using one or more fixing mechanisms. Optionally, the first housing and / or the second housing may include magnets to enable a detachable connection as described elsewhere herein. In another example, the first housing and the second housing may be adhered, for example, using adhesive tape. The adhesive force between the first housing and the second housing can be adjusted based on the desired characteristics. For example, it may be desirable to remove the syringe while maintaining the patch on the subject's body. In such an example, an adhesive layer can be added to the patch, thereby facilitating fixing the patch to the subject's body. In this adhesive layer that adheres to the body, the adhesive force between the patch and the subject's body may be stronger than the adhesive force between the patch and the syringe. In yet another example, the first housing and the second housing can be mechanically coupled using, for example, geometric shapes where the first housing and the second housing interlock with each other. For example, the first housing may include a screw (such as a thread, female thread, etc.), and the second housing may include a complementary screw engageable with the screw of the first housing. Simultaneously or alternatively, the first housing and / or the second housing may include snap-fit joints (such as cantilever snap-fits, annular snap-fits, etc.) that enable the first housing and the second housing to interlock with each other. Alternatively or simultaneously, the first housing and / or the second housing may include components that enable interference fits, press fits, shrink fits, position fits, etc.Examples of other fastening mechanisms include body - conforming pairs, hooks, loops, latches, screws, bolts, staples, clips, clamps, prongs, rings, brads, rubber bands, rivets, grommets, pins, ties, snaps, Velcro®, adhesives (such as glue), tapes, vacuums, seals, combinations thereof, or other types of fastening mechanisms, but are not limited thereto. Alternatively, the syringe can be permanently attached to the patch. For example, the first housing may be connected to or integrally incorporated into the second housing.

[0133] In some examples, the patch and the syringe can be fixed 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 form a body - conforming pair. The patch may have a male part that conforms to the body, and the syringe may have a female part that conforms to the body, and vice versa. In some examples, the outer diameter of the protruding fastening unit of the patch may be approximately equal to the inner diameter of the recessed fastening unit of the syringe to form an interference fit, and vice versa. Alternatively or additionally, the patch and the syringe may be provided with other types of complementary units or structures that can be integrally fixed (such as hooks, loops, latches, snap - ons, buttons, nuts, bolts, magnets, etc.). Alternatively or additionally, the patch and the syringe can be fixed using other fastening mechanisms, such as staples, clips, clamps, prongs, brads, rubber bands, grommets, pins, ties, snaps, Velcro®, adhesives (such as glue), magnets, magnetic fields, tapes, combinations thereof, or other types of fastening mechanisms, but are not limited thereto.

[0134] In some examples, the patch and the syringe can be fixed to each other via an intermediate structure. In some examples, the intermediate structure can be fixed to either or both of the patch and the syringe by any one or more of the fixing mechanisms described herein. The intermediate structure may include a solid material, a semi-solid material, a liquid material (e.g., a resin configured to solidify), or a plurality of types of materials. In some examples, the intermediate structure may undergo a phase transition (e.g., from liquid to solid in an adhesive). For example, the intermediate structure may include a fluid adhesive that solidifies to achieve fixation. In some examples, the intermediate structure can transition from a first phase to a second phase, such as from liquid to solid or from solid to liquid, when subjected to a stimulus (e.g., a change in temperature, pH, pressure, applied force, etc.) to achieve fixation or release (or both). In some examples, the patch and / or the syringe may be provided with an intermediate structure. For example, the intermediate structure may be integrated into the patch and / or the syringe.

[0135] The fastener between the patch and the syringe can be temporary, such as enabling subsequent fixing and releasing of the patch and syringe without causing damage to the patch or syringe (e.g., plastic deformation, shear deformation, wear, compression deformation, etc.). Alternatively, this fastener may be permanent, such as enabling subsequent release of two patches from the syringe. In some cases, it may be desirable to deform either the patch or the syringe, and the patch or syringe may be temporarily or permanently deformed (e.g., stretched, compressed, etc.) and / or have its appearance changed (e.g., curved, bent, wrinkled, etc.) or be otherwise manipulated when fixed to the syringe or patch. The opening may include a penetrable membrane. The penetrable membrane can be penetrated by a cannula to create the opening. This penetrable membrane may be formed of one polymeric material or multiple polymeric materials. The polymeric material may be natural or synthetic. Non-limiting examples of polymeric materials include polyvinyl chloride (PVC), polyethylene, and polyurethane. Optionally, the penetrable membrane may further include an adhesive layer (e.g., acrylate, methacrylate, epoxy diacrylate, or other vinyl resins, etc.). Optionally, the penetrable membrane may include a self-healing polymer or elastomer material such that the opening introduced by the cannula closes, for example, after the cannula is withdrawn. In this case, the penetrable membrane may include holes or slits configured to form a seal even when there is no cannula oriented through the opening. In some examples, the penetrable membrane may include openings not configured to seal even when there is no cannula oriented through the opening. Alternatively, the opening may be configured to be in direct line of sight of the subject's body without including a penetrable membrane. The opening may be of any suitable shape, such as a slit, triangle, square, rectangle, rhombus, pentagon, hexagon, heptagon, octagon, polygon, ellipsoid, annular, circular, etc. Optionally, the penetrable membrane may include an absorbent material, such as cotton, rayon, nylon, polymer, polymer blend, etc.In this case, the penetrable membrane may be used as a bandage and can collect body fluids (such as sweat, blood, etc.) from the body of the subject. In some examples, the penetrable membrane may include an oxygen-permeable material, and this material can expose the body of the subject or a part thereof to the surrounding air. Optionally, the penetrable membrane may include a drug (such as an analgesic or a drug for pain treatment).

[0136] The reservoir may be fixed to the syringe. Optionally, the reservoir is removable from the syringe. For example, the reservoir may include a container or be part of a container. The reservoir container may be removably coupled to the syringe (e.g., detachment to the housing of the syringe). The housing may be provided with a fastener for fixing the reservoir. Alternatively, the geometric shape of the syringe may be designed to fit the reservoir or reservoir container. In other cases, the reservoir may be part of the syringe (not removable). In one example, a drug reservoir may be provided in the housing, and the drug reservoir may be in fluid communication with the injection cannula. For example, the injection cannula may be movable within the housing that is between the dispensing pre-position and the dispensing position and in fluid communication with the reservoir. The reservoir may be configured to contain a formulation having a substance.

[0137] The substance may include a drug. The drug may be a solution or a mixture. The drug may be used to treat a disease within the scope of the therapeutic field. Examples of the field include, but are not limited to, the cardiovascular system, musculoskeletal system, gastrointestinal tract system, dermatology, immunology, ophthalmology, hematology, neuroscience, oncology, endocrinology / metabolism, and respiratory system. The drug may be used to treat discomfort or pain in the subject. For example, the drug may include an analgesic, a non-steroidal anti-inflammatory drug (NSAID), or other substances for pain management such as pain reduction and pain relief.

[0138] The patch housing and / or the syringe housing may include one or more polymer or plastic materials. Non-limiting examples of polymers include polyamide, polycarbonate, polyester, polyethylene, polypropylene, polystyrene, polyurethane, polyvinyl chloride, polyvinylidene chloride, acrylonitrile butadiene styrene, polymethacrylate, polytetrafluoroethylene, polyimide, polylactic acid, phenolic resin, polyether ether ketone, or derivatives thereof (e.g., highly cross-linked, high density, etc.). The patch housing and / or the syringe housing may include a single polymer type (e.g., homopolymer) or more than one polymer type (e.g., copolymer), and may include a random or ordered arrangement of monomers. For example, the polymer may be a block copolymer, alternating copolymer, periodic copolymer, statistical copolymer, stereoblock copolymer, gradient copolymer, branched copolymer, graft copolymer, etc.

[0139] The sensor and / or transducer may include one or more sensors or transducers that enable the measurement or monitoring of one or more health or physiological parameters, or the display of device functionality to a subject. Alternatively or concurrently, it may be possible to measure the parameters of a patch or syringe with one or more sensors. Non-limiting examples of parameters of a patch or syringe include whether the patch is fixed (e.g., to the body of the subject), whether the patch or syringe is in communication with a communication interface, whether the cannula is in fluid communication with a reservoir, occlusion of the cannula, whether the patch and syringe are properly coupled, the flow rate of a substance through the cannula, and the like. The sensors of the plurality of input transducers / sensors may be selected from the group consisting of conductivity sensors, impedance sensors, capacitance sensors, charge sensors, humidity and / or moisture sensors, temperature sensors, heart rate sensors, interstitial pressure sensors, resistance sensors, dilation sensors, acoustic sensors, vibration sensors, blood pressure sensors, optical sensors (e.g., color sensors, light sensors, wavelength sensors), chemical sensors, motion and / or activity sensors, and substance tracking sensors. The sensors of the plurality of output transducers may be selected from the group consisting of tactile (vibration) transducers, acoustic transducers, or visual transducers. Such sensors may be used, for non-limiting examples, to detect environmental conditions in which the subject is using a syringe, the subject's body temperature, heart rate, blood pressure, interstitial pressure, tissue density, skin dilation, bleeding (e.g., internal or external bleeding), drug delivery, the dose of a drug delivered to and / or by the subject, the amount of the subject's sweat, and the measurement of a plurality of analytes of the subject (e.g., blood glucose, blood oxygen, etc.). One or more measurements may be made or monitored before, simultaneously with, or after the fixation of the patch. For example, the patch may be configured to measure one or more health or physiological parameters prior to injection to establish reference values and / or calibration measurements for one or more health or physiological parameters. The patch may be separated from the syringe and fixed to the body of the subject. For example, the patch may be fixed to the body of the subject and one or more measurements may be collected.By subsequently attaching the syringe (e.g., to a patch and / or the user's body), it becomes possible to introduce the substance into the subject.

[0140] The transducer may comprise any useful component parts, such as a solenoid, a motor, a microelectromechanical system (MEMS) actuator. In this case, the housing of the syringe or patch may include conductive contacts that provide mechanical attachment and electrical contact of the transducer or sensor, for example, within an electronic subsystem housed in the syringe.

[0141] The patch and / or syringe may include a communication interface that enables transmission and reception of data corresponding to a plurality of health or physiological parameters of the subject and / or parameters of the patch or syringe. The data can be transmitted to an electronic device in communication with the communication interface. The communication interface may be a wireless communication interface, a Wi-Fi interface, a short-range wireless communication interface, or a Bluetooth interface as described herein. The electronic device may be a device capable of communicating with the communication interface, such as a mobile device (e.g., a smartphone, a tablet, a laptop, 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 power supply for connecting to an electronic device (e.g., a universal serial bus (USB), a type-C USB, etc.). The patch and / or syringe may include an RFID tag that enables carrying and optionally recording information including but not limited to information about the drug. Thereby, information about the device and the drug can be included in the data transmitted regarding the injection.

[0142] Optionally, the patch, syringe, and / or electronic device may include a method of performing 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 a subject after injection and generate data based on these parameters. This data can be transmitted to an electronic device (e.g., a mobile device) via a communication interface. Optionally, the mobile device may include a method of processing and / or storing data (e.g., in a computer-readable memory). Examples of processing include measuring analyte concentration, recognizing the analyte, comparing the analyte concentration with a standard concentration, calibrating the measurement, aggregating collected information, statistical calculations, trend determination, etc. Subsequently, the processed data can be used to adjust one or more parameters of the patch or syringe, for example, within a feedback loop. The processed data may also be directly transmitted to a third party for detailed evaluation. For example, in the measurement of physiological parameters, the concentration of an analyte or substance (e.g., a drug or agent) can be measured. The data may be transmitted to an electronic device, and this electronic device may further process the data (e.g., calibrating the concentration, comparing with a standard, determining whether a dosage change is necessary, etc.). Thus, the processed data can be used to change device parameters, such as the dosage of the substance to be administered, the dispensing flow rate of the substance, etc. Subsequently, the data, processed data, or other signals may be sent back to the patch or syringe so that subsequent syringe injections are adjusted (e.g., increasing or decreasing the next dosage). In another example, in the measurement of physiological parameters, patient bleeding (e.g., colorimetric quantification, measurement of heme iron in blood, etc.) can be measured. Detection of bleeding or substance leakage from a body site can be used to adjust subsequent administration rates or injections (e.g., within a feedback loop). In such an example, the presence of bleeding in the patient can make it possible to delay subsequent injections or change parameters of cannula extension into the subject's body (e.g., injection force, injection speed, etc.).In some cases, an electronic device may not be required and the patch may be able to communicate directly with the syringe or via a communication interface. In this case, the patch and / or syringe may measure the subject's device and / or physiological parameters and subsequently use the measurements to adjust the parameters of the syringe or patch. In a non-limiting example, measurement of a parameter (e.g., a patient's blood glucose) can be used to adjust the subsequent injection dose of the syringe.

[0143] In another example, the patch can monitor one or more parameters of the syringe and / or the patch and generate data based on this parameter. This data can be transmitted to an electronic device (e.g., a mobile device) via a communication interface. Optionally, the mobile device may include a way to process the data. Examples of processing include determining whether the device is properly fixed (e.g., whether the force with which the patch adheres to the subject's body is above or below a threshold), whether the patch is properly connected to the syringe, etc. Then, the processed data can be used to adjust one or more parameters of the patch or syringe, for example, within a feedback loop. For example, the force with which the patch adheres to the subject can be measured. The data may be transmitted to an electronic device, and this electronic device may further process the data (e.g., determine insufficient adhesion). Thus, the processed data can be used to change device parameters as described herein, such as triggering a notification to a user, such as a subject. Thereafter, the data, processed data, or other signals may be sent back to the patch or syringe such that the parameters of the patch or syringe are adjusted or require adjustment before proceeding with reinjection (e.g., administering another dose of a substance). Optionally, no electronic device is required, and the patch may be able to communicate directly with the syringe or via a communication interface. In this case, the patch and / or syringe may measure the parameters of the patch and / or syringe and subsequently use the measurements to adjust the said parameters or other parameters of the syringe or patch. In a non-limiting example, measuring insufficient adhesion of the patch can, in a feedback loop, prevent subsequent injection of the syringe until the patch is measured to be sufficiently adhered to the subject's body.

[0144] The patch and / or syringe can further be in communication with, or be capable of communicating with, the subject or other user. Optionally, the communication with the subject or other user may include a feedback system or loop. Alternatively or simultaneously, the patch or syringe can notify the subject or other user (e.g., a physician, nurse, healthcare worker, clinician, etc.) of device parameters, health or physiological parameters, or both. For example, the patch or syringe can make a sound, produce a movement (e.g., vibration), or include a visual indicator such as light (e.g., a light-emitting diode), a screen or display (e.g., a liquid crystal display (LCD), an organic light-emitting diode, a quantum dot display, or a variation or derivative thereof), or other visual indicators (e.g., to indicate a direction to the subject or other user). Alternatively or simultaneously, the patch or syringe may include a user interface module. In such examples, the subject or other user can interact with the patch and / or syringe. In one such example, the patch or syringe may include a screen or display capable of generating a series of characters or sounds used to prompt the subject or other user to respond to a command. In another example, the patch or syringe may include a screen or display capable of generating a series of characters or sounds used to display the output of results such as the measurement results of physiological parameters. Subsequently, the subject or other user can input a response or command, for example, by a microphone in the housing of the patch and / or syringe, or by a button on the housing of the patch or syringe with which the subject can interact. Optionally, when the subject inputs to the patch or syringe, the parameters of the patch or syringe can be adjusted. Optionally, the subject or other user can input parameters that are not easily measurable or accessible from the patch or syringe, such as pain, discomfort, etc. These parameters may then be communicated, for example, via the communication interface of an external device (e.g., a mobile device).Optionally, the patch and / or syringe may include a feedback system that allows input from the subject or other user to adjust the parameters of the patch or syringe. For example, entering a pain parameter can adjust the flow rate of the substance through the cannula or the frequency of substance administration.

[0145] The patch and / or syringe can further be configured to communicate with a remote system. In some examples, the patch and / or syringe can measure one or more physiological parameters of the subject or one or more parameters of the patch and / or syringe and generate data based on these parameters. The data can be transmitted to a remote server, a distributed computing network (e.g., for cloud computing). Thereafter, the processing of the data can be performed separately from the patch and / or syringe. Optionally, the processed data may then be transmitted to an electronic device (e.g., a mobile device). In other cases, the processed data may then be transmitted to the patch and / or syringe to adjust the parameters of the patch and / or syringe. When data is transmitted to the remote server and / or the electronic device, the subject can monitor one or more physiological parameters, and / or alternatively, a physician or caregiver can also monitor one or more physiological parameters of the subject.

[0146] In another aspect, the present specification provides a method for measuring a plurality of health or physiological parameters of a subject. The method includes the steps of: (a) providing (i) a patch including a first housing having a plurality of sensors and an opening, and (ii) a syringe having a second housing including a cannula in fluid communication with a fluid flow path, wherein the second housing is attachable to the first housing of the patch, the syringe includes a reservoir including a substance and the fluid flow path, and the fluid flow path is in fluid communication with the reservoir; (b) securing the patch to the body of the subject; (c) when securing the patch to the body of the subject, guiding (i) the substance from the reservoir to the fluid flow path and (ii) the cannula through the opening to guide the substance from the fluid flow path through the cannula to the subject; and (d) using the plurality of sensors to (i) measure a plurality of health or physiological parameters of the subject and (ii) provide one or more outputs corresponding to the plurality of health or physiological parameters of the subject.

[0147] Using embodiments of the present disclosure, a person having any physical and / or mental disorder treatable with a drug administered by a syringe such as the device described above can be monitored to confirm that the combination therapy (drug and syringe) is safe and effective. The data collected during monitoring of the characteristics of the patient and the syringe can be used by the aforementioned parties to provide feedback including confirmation of requests / results to any of the patient, caregiver, healthcare provider, payer, drug / device manufacturer, and to enable manual and / or automatic intervention by the patient and / or the device to improve the safety and effectiveness of the treatment.

[0148] In one embodiment, FIGS. 59 and 60 show an overall syringe of the type described above at (402). The device includes a housing with a circular base (404). An annular skin attachment layer (406) is fixed to the base of the syringe by an adhesive and features a pull tab (408). Below the attachment layer (visible in FIGS. 59 and 60) is provided an adhesive that provides a lower holding force than the adhesive that secures the attachment layer of the syringe (406). As a result, the syringe (404) can be removed from the subject's body (e.g., skin) by pulling the tab (408) away from the subject's skin.

[0149] In addition to the skin attachment layer (406), a patch, generally shown at (412) in the exploded views of FIGS. 59 and 60, is attached to the bottom of the syringe by a magnetic fixation arrangement as will be described in more detail below. Instead of magnetic attachment, the patch can be attached to the syringe by an adhesive or other mechanical means.

[0150] The patch and the skin attachment layer are shown as having a circular contour, although alternative shapes may be used.

[0151] An overall conical skin boundary replacement extension (414) extends from the bottom of the patch (412) and compresses the skin to assist in reducing tissue deflection or "tenting" during cannula insertion, as described above. The extension (414) features a central orifice (416) that is aligned with the dispensing portion of the syringe.

[0152] In an alternative embodiment, as described in the above embodiment, the skin boundary replacement extension may be part of the base (404) of the syringe itself or extend from the base. In such an embodiment, a central hole may be provided in the center of the patch, the diameter of which is smaller than the diameter of the base of the extension. When the syringe is positioned in the skin attachment layer to fix the device to the skin, the extension expands the hole in the patch to provide a path for the syringe cannula to enter the skin when the device operates or "fires" as described above. Since the cannula does not pass directly through the material, it does not provide an opportunity to clog the cannula or inject foreign material from the cannula into the skin. Refer to Figure 16B. When the syringe is removed from the skin, the central hole in the expanded patch closes and returns to its original smaller size. Optionally, an absorbent material may be placed near the central hole of the patch to absorb any blood or leakage. In this way, the patch acts as a "band aid" after injection.

[0153] As shown in FIGS. 59 and 60, the skin attachment layer (406) features a central opening (418) sized to receive the patch (412). The embodiments of FIGS. 59 and 60 illustrate the patch (412) separated from the skin attachment layer (406), but in an alternative embodiment, the patch may be peripherally bonded to the skin attachment layer by a perforated arrangement. As a further alternative, the patch (412) may be fixed to the skin attachment layer via tabs spaced around the perimeter of the patch.

[0154] As shown in FIG. 60, the patch (412) includes a sensor (422), a printed circuit board (PCB) chip (424), and a sensor adhesive layer (426). The PCB chip (424) and the sensor adhesive layer (426) are fixed to the sensor (422) by an adhesive or other fixing mechanism. As shown in FIG. 59, the sensor adhesive layer (426) includes a central window (428) through which the extension (414) protrudes after assembly. To fix the patch to the user's skin, an adhesive is provided on the surface (430) facing downward below the sensor adhesive layer (426).

[0155] The syringe (402) and the patch (412) are configured to be applied to the body (e.g., skin, finger) of a subject (e.g., user) when the syringe is attached. Further, after removing the syringe (402), the patch (212) remains. More specifically, as shown in FIG. 60, a number of permanent magnets (432) are positioned and fixed within the housing of the syringe (402). By way of example only, as described elsewhere herein, the magnets may be fixed within corresponding recesses (434) formed within the syringe housing by adhesive, interference fit, or other attachment arrangements. The upper side of the sensor (422) features a metal disc portion (436) (FIGS. 59 and 60) such that the patch is fixed to the bottom of the syringe by magnetic force. 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 that holds the patch to the syringe. Instead of making the metal disc portion (436) of metal, a metal portion corresponding to and attracting the magnet of the syringe, as illustrated in perspective at (437) of FIG. 59, may be provided on the disc portion. In alternative embodiments, other shapes may be provided for the metal portion of the patch. It is also possible to use one annular metal portion.

[0156] By using a magnet to fix the patch to the syringe, there is an advantage that when the patch remains on the patient, no adhesive remains exposed thereon. Additionally, this magnet can be placed precisely on the syringe and a corresponding metal portion can be placed on the patch, and by doing so, the amount of force that "pulls" the patch when the syringe is removed can be adjusted. Instead of placing the metal portion on the syringe, a magnet may be used. In alternative embodiments, the magnet may be placed on the patch and a corresponding metal portion may be placed on the syringe.

[0157] In alternative embodiments, the patch (412) may be fixed to the bottom of the syringe by an adhesive (such as above the sensor (422)) that has less holding force than the adhesive that engages the skin on the surface (430) of the sensor adhesive layer (426).

[0158] In another alternative embodiment, the patch (412) may be fixed to the bottom of the syringe using mechanical features incorporated into the patch, syringe, or both, that have less holding power than the adhesive that engages the skin on the surface (430) of the sensor adhesive layer (426). In such an embodiment, the skin attachment layers (406) of FIGS. 59 and 60 may be excluded such that the syringe is fixed to the patient only via the connection between the syringe housing and the patch. In such an embodiment, both the syringe and the patch are fixed to the patient only by the sensor adhesive layer. There may also be a further connection between the syringe housing and the sensor adhesive layer (426) (in addition to the connection of the syringe to the sensor adhesive layer via the patch, as described elsewhere herein).

[0159] As shown in FIGS. 61 and 62, the PCB chip (424) features a circuit including a Bluetooth module with a microcontroller / microprocessor (444) connected to a battery (442) and an antenna (448). Additionally, the Bluetooth module (444) is attached to the sensor (422). The battery (442) provides stored energy to power the system. The Bluetooth module (444) has an integrated microcontroller / microprocessor. An example of a suitable Bluetooth module is Dialog Semiconductor part number DA14580-01UNA. In an alternative embodiment, the Bluetooth module may be separated from the microcontroller / microprocessor. In some embodiments, direct communication to the cloud may be used via, for example, cellular communication or other communication techniques.

[0160] As shown in FIG. 63, the syringe (402) may be provided with one or more sensors (450a) and (450b) that communicate with a Bluetooth module (444) via Bluetooth. The sensors (450a) and (450b) include transmitters and can 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 further be passive sensors that do not require battery power. The sensors (450a) and (450b) can be selected to provide various alternative functions as detailed below.

[0161] In an alternative embodiment, communication between the syringe sensors (450a) and (450b) and the module (444) of the patch's PCB chip (424) can be achieved by alternative wireless communication arrangements known in the art. In a further alternative embodiment, the sensors (450a) and (450b) can communicate with the module (444) of the PCB chip (424) via a wire connection that automatically disconnects when the syringe is removed from the patch and the patient.

[0162] Of course, the number of sensors (436), (450a), and (450b) may differ from that shown in FIGS. 61 to 63.

[0163] The Bluetooth module (444) further 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, a network, or the cloud. This remote receiver can collect the received data in a database and build the database.

[0164] In use, initially, the syringe is characterized by a patch attached (via the magnet arrangement described above) as shown in FIG. 59. The protective backing sheet is removed from the skin attachment layer (406) so that the adhesive on the surface facing away from the syringe is exposed. This backing sheet further removably covers the adhesive on the surface (430) of the patch. Thereafter, the exposed adhesive surfaces of the skin attachment layer (406) and the sensor adhesive layer (426) of the syringe are pressed against the user's skin so that the syringe and the patch are attached.

[0165] In the illustrated embodiment, the patch (412) has multiple functions. First, the patch senses the state of the syringe and transmits this to a remote receiver (a personal data device such as a smartphone, a computer network, the cloud, etc.). The state of the syringe is, namely, that the syringe is operating as if an injection is being made, or the state where the injection is complete. Next, the patch transmits the patient's state to the remote receiver via the data collected from the sensors. This can be done before, during, or after the injection and before, during, or after the attachment and / or removal of the syringe. For example, the skin temperature and the "color" of the skin at the injection site can be detected via a simple temperature monitor combined with an LED / phototransistor circuit included in the sensor (422) to transmit the temperature and color of the tissue during and after the injection. This feature is useful for warning the staff whether there is an injection site reaction (ISR) during a clinical trial and for quantifying the ISR based on the temperature and color of the tissue. Finally, the patch can directly interact with the syringe based on the data collected from the syringe, the data collected from the patient, and / or the data collected from the patch itself. The patch interacts with the syringe as an adjustment mechanism including adjusting the flow rate (fast, slow, or stopped), vibrates for user notification and / or pain management, generates an audible sound to provide a direction or notification to the user, provides changes, warnings, notifications, or information to the user via a visual display, and can cause a change in the state of the syringe including, but not limited to, pulling in a button to stop delivery in the case of patient data (such as pain) or device data (such as early removal or detachment) via a mechanical command.

[0166] A heart rate sensor can also be included in the sensor (422) to obtain a patient EKG signal when useful, and / or a strain gauge sensor may be provided to detect the skin pressure exerted by the extensions (414) of FIGS. 59 and 60. Data on the patient's mobility, position, and location can be collected by corresponding sensors (such as accelerometers, GPS sensors, etc.) incorporated in the sensor (422). In addition, a set of electrodes in contact with the skin (included in the sensor (422)) can detect skin impedance to detect leakage or detachment. Further, the skin contact electrodes can detect premature removal of the device, i.e., removal before the device completes a cycle.

[0167] Upon completion of the injection, the syringe can be removed from the patient's skin by pulling the tab (408) (FIGS. 59 and 60) to the opposite side of the patient's skin. When this is done, the patch detaches from the syringe and only the patch can be adhered to the patient. Due to the detachable nature of the monitoring patch, a doctor or the like can continuously monitor the patient during the injection.

[0168] Alternatively, the patch can first be removed from the syringe and placed on the patient, and monitoring can be performed before the start of drug administration / injection. Thereby, baseline data regarding the patient can be obtained before administration / injection.

[0169] Alternatively, the patch can be applied independently of the syringe and placed on the patient, and monitoring of baseline conditions (such as baseline physiological parameters) can be performed before the start of drug administration / injection. Then, the syringe can be coupled to the patch before the start of the injection.

[0170] Figures 64 - 65 illustrate an exploded view of another embodiment of a patch and a syringe. The patch (6401) includes an adhesive layer (6403) and a sensor (6405), which may include a PCB chip. In this embodiment, and in further embodiments described hereinafter, as described in the previous embodiments, the patch and / or syringe may each include one or more sensors. The sensor (6405) can be adhered to the adhesive layer (6403) and used to secure the patch (6401) to the subject's body. The syringe (6407) and the patch (6401) can be configured such that the patch is applied to the subject's body when the syringe (6407) is attached. Alternatively or additionally, the syringe (6407) and the patch (6401) may be coupled before securing the patch (6401) and the syringe (6407) to the subject's body.

[0171] The patch (6401) can be coupled to the syringe (6407) using an interlocking bayonet mechanism. For example, the syringe (6407) may include a protruding element (6409) that can be coupled to a detent (6411) within the patch (6401). The detent (6411) can prevent free rotation of the patch (6401) and the protruding element (6409) in a first configuration. When the patch (6401) or the syringe (6407) is twisted, the syringe (6407) can move to a second configuration where the protruding portion (6409) no longer engages the detent (6411), such that the syringe (6407) may be decoupled or removed from the patch (6401) (e.g., after the patch is secured to the subject's body and the drug is delivered).

[0172] Figure 66 illustrates an exploded view of another embodiment of a patch and a syringe. The patch (6601) includes an adhesive layer (6603) and a sensor (6605), which may include a PCB chip. The sensor (6605) can be adhered to the adhesive layer (6603) and used to fix the patch (6601) to the subject's body. The syringe (6607) and the patch (6601) can be configured such that the patch is applied to the subject's body when the syringe (6607) is attached. Alternatively or additionally, the syringe (6607) and the patch (6601) may be coupled before fixing the patch (6601) and the syringe (6607) to the subject's body.

[0173] The patch (6601) can be coupled to the syringe (6607) by joining or pairing portions (6609) and (6611). The portion (6609) may be coupled to the syringe (6607) (e.g., a recess (6613)), while the portion (6611) may be coupled to the patch (6601). The portions (6609) and (6611) can be fixed to the syringe (6607) and the recess (6613) of the patch (6601) via an adhesive, interference fit, or other attachment arrangement, respectively. The adhesive layer (6603) can provide a holding force to the subject's body (e.g., skin) that is greater than the magnetic force that holds the patch to the syringe.

[0174] Figure 67 illustrates another embodiment of a patch and a syringe. The patch (6701) includes an adhesive layer (6703) and a sensor (6705), which may include a PCB chip. The sensor (6705) can be adhered to the adhesive layer (6703) and used to fix the patch (6701) to the subject's body. The syringe (6707) and the patch (6701) can be configured such that the patch is applied to the subject's body when the syringe (6707) is attached. Alternatively or additionally, the syringe (6707) and the patch (6701) may be coupled before fixing the patch (6701) and the syringe (6707) to the subject's body.

[0175] The patch (6701) may be coupled to a syringe (6707). For example, the sensor (6705) may be configured to couple to the syringe (6707) by fitting into a recess (6713). The syringe may 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 that holds the patch to the syringe.

[0176] FIG. 68 shows a cross-sectional view of the combined syringe and patch of FIG. 67. The syringe may include a latch (6717) connected to a spring (e.g., a torsion spring) (6715). In panel A, the patch and syringe are in a first configuration (“ready position”), where the device is locked and the patch remains attached to the syringe. The button (6719) is usable to orient the cannula to the subject upon pressing, is in the start or ready position, and is ready for activation. In panel B, the syringe may be deformed (e.g., via rotation, removal of the safety tab (6801), or both) to a second configuration (“lockout position”). In the second configuration, the torsion spring may be loosened, thereby moving the latch (6717) to a different position. In such a configuration, the syringe is removable from the patch, and the button (6719) can prevent the cannula from recessing from the syringe at the raised position shown in panel B.

[0177] FIG. 69 illustrates another embodiment of a patch and a syringe. The patch (6901) includes an adhesive layer (6903), a sensor (6905), and an attachment module (6911), and the adhesive layer and the sensor may include a PCB chip. The attachment module (6911) may include an adhesive mechanism or other fixing mechanism for adhering the patch (6901) to the syringe (6907). The sensor (6905) can be adhered to the adhesive layer (6903), and this can be used to fix the patch (6901) to the body of a subject. The syringe (6907) and the patch (6901) can be configured such that the patch is applied to the body of the subject when the syringe (6907) is attached. Alternatively or additionally, the syringe (6907) and the patch (6901) may be coupled before fixing the patch (6901) and the syringe (6907) to the body of the subject. The patch (6901) may further include an outer layer including a perforation (6921). For example, the outer layer may include plastic, a polymer (such as a heat-sensitive polymer, such as shrink wrap), or other materials. The outer layer can be configured to be removed before use of the patch and the syringe. When the device is in a usable state, the outer layer can be removed by pulling the pull tab (6923), and thus the outer layer is removed through the perforation (6921), thereby enabling removal of the outer layer.

[0178] FIG. 70 shows a cross-sectional view of the combined syringe and patch in FIG. 69. The dimensions of the patch (such as width or diameter) may be substantially the same as the diameter of the syringe.

[0179] Figure 71 illustrates another embodiment of a patch and a syringe. The patch (7101) includes an adhesive layer (7103) and a sensor (7105), which may include a PCB chip. The sensor (7105) can be adhered to the adhesive layer (7103) and used to fix the patch (7101) to the subject's body. The syringe (7107) and the patch (7101) can be configured such that the patch is applied to the subject's body when the syringe (7107) is attached. Alternatively or additionally, the syringe (7107) and the patch (7101) may be coupled before fixing the patch (7101) and the syringe (7107) to the subject's body. The patch (7101) may be coupled to the syringe (7107) via a latch (7113). The latch (7113) can be coupled to the syringe (7101) using a press-fit mechanism, and then the patch (7101) can be separated from the syringe (7107) by applying force by pressing the latch (7113). Alternatively or additionally, the latch (7113) may include a hook that can be adhered to the housing of the syringe (7107). The latch can then be actuated by applying force by pressing the latch (7113) and pulling the latch away from the housing of the syringe (7107). In this way, the patch (7101) can be separated from the syringe (7107).

[0180] Figure 72 shows a cross-sectional view of the combined syringe and patch in Figure 71. The latch (7113) includes a hook for adhering to the housing of the syringe. By applying a force (7115) to the latch, the hook is released, thereby allowing the patch to be removed or separated from the syringe.

[0181] Figure 73 illustrates another embodiment of a patch and a syringe. The patch (7301) includes an adhesive layer (7303) and a sensor (7305), which may include a PCB chip. The sensor (7305) can be adhered to the adhesive layer (7303) and used to fix the patch (7301) to the subject's body. The syringe (7307) and the patch (7301) can be configured such that the patch is applied to the subject's body when the syringe (7307) is attached. Alternatively or additionally, the syringe (7307) and the patch (7301) may be coupled before fixing the patch (7301) and the syringe (7307) to the subject's body. The patch (7301) can be coupled to the syringe (7307) via a flange (7311) and a ring (7313). The ring (7313) may include rubber or other elastic material. The ring (7313) can be coupled to the syringe (7307) by fitting into the grooves of the flange (7311) and (7321). The flange (7311) may be complementary to the flange (7321) of the patch (7301).

[0182] Figure 74 shows a cross-sectional view of the combined syringe and patch in Figure 73. The flange (7321) of the patch may fit complementarily into the flange (7311) of the syringe. By applying a force (7415) to the flange (7321), the patch can be separated from the syringe.

[0183] Figure 75 illustrates another embodiment of a patch and a syringe. As shown in Panel A, the patch (7501) includes an adhesive layer (7503) and a sensor (7505), which may include a PCB chip. The sensor (7505) can be adhered to the adhesive layer (7503) and used to fix the patch (7501) to the subject's body. The syringe (7507) and the patch (7501) can be configured such that the patch is applied to the subject's body when the syringe (7507) is attached. As shown in Panel B, alternatively or additionally, the syringe (7507) and the patch (7501) may be coupled before fixing the patch (7501) and the syringe (7507) to the subject's body. The housing of the patch (7501) and the sensor (7505) may partially surround the housing of the syringe (7507). The patch may further include a winged feature (7513). The winged feature (7513) enables better gripping of the subject or positioning of the device.

[0184] Figure 76 illustrates another embodiment of a patch and a syringe. In Panel A, the patch (7601) includes an adhesive layer (7603) and a sensor (7605), which may include a PCB chip. The sensor (7605) can be adhered to the adhesive layer (7603) and used to fix the patch (7601) to the subject's body. The syringe (7607) and the patch (7601) can be configured such that the patch is applied to the subject's body when the syringe (7607) is attached. As shown in Panel B, alternatively or additionally, the syringe (7607) and the patch (7601) may be coupled before fixing the patch (7601) and the syringe (7607) to the subject's body. The patch (7601) is coupled to the syringe (7601) via a latch (7613) and can thus be fixed to the protrusion (7611) of the syringe (7611). The latch may be rotatable such that in a particular configuration, the latch (7613) does not rest on the protrusion (7611), thereby enabling the patch (7601) to be separated from the syringe (7607).

[0185] FIG. 77 illustrates another embodiment of a patch and a syringe. In panel A, the patch (7701) includes an adhesive layer (7703) and a sensor (7705), which may include a PCB chip. The sensor (7705) can be adhered to the adhesive layer (7703) and used to secure the patch (7701) to the subject's body. The syringe (7707) and the patch (7701) can be configured such that the patch is applied to the subject's body when the syringe (7707) is attached. As shown in panel B, alternatively or additionally, the syringe (7707) and the patch (7701) may be coupled before securing the patch (7701) and the syringe (7707) to the subject's body. The patch (7701) may be coupled to the syringe (7707) via an adhesive (e.g., at the interface between the patch (7701) and the syringe (7707)). The patch may further comprise a protruding feature (7713), for example, on the adhesive layer (7703). This protruding feature allows the patch (7701) to be separated from the syringe (7707) when the subject pushes or pulls on the feature (7713).

[0186] FIG. 78 shows a cross-sectional view of the combined syringe and patch of FIG. 77. The protruding feature (7713) may be used to pull the patch from the syringe.

[0187] FIG. 79 illustrates another embodiment of a patch and a syringe. In panel A, the patch (7901) includes an adhesive layer (7903) and a sensor (7905), which may include a PCB chip. The sensor (7905) can be adhered to the adhesive layer (7903) and used to secure the patch (7901) to the subject's body. The syringe (7907) and the patch (7901) can be configured such that the patch is applied to the subject's body when the syringe (7907) is attached. As shown in panel B, alternatively or additionally, the syringe (7907) and the patch (7901) may be coupled before securing the patch (7901) and the syringe (7907) to the subject's body. The patch (7901) may be coupled to the syringe (7907) via a flange (7913) on the patch and a protrusion (7911) on the syringe (7907). The flange (7913) may be hooked or suspended over the protrusion (7911). When the flange (7913) is locked in a first configuration and a second configuration, the flange (7913) is released and the patch (7901) can be separated from the syringe (7907).

[0188] Figure 80 illustrates another embodiment of a patch and a syringe. The patch (8001) includes an adhesive layer (8003) and a sensor (8005), which may include a PCB chip. The sensor (8005) can be adhered to the adhesive layer (8003) and used to fix the patch (8001) to the subject's body. The syringe (8007) and the patch (8001) can be configured such that the patch is applied to the subject's body when the syringe (8007) is attached. Alternatively or additionally, the syringe (8007) and the patch (8001) may be coupled before fixing the patch (8001) and the syringe (8007) to the subject's body. The patch (8001) may be coupled to the syringe (8007) via a screw feature (8013) on the patch (8001) and a complementary screw (not shown) on the syringe (8007). The screw feature (8013) can be screwed onto the complementary screw of the syringe (8007). Detachment of the patch (8001) from the syringe (8007) can be achieved by twisting the patch (8001) or the syringe (8007).

[0189] Figure 81 shows a cross-sectional view of the combined syringe and patch in FIG. 80. The screw (8013) of the patch may be complementary to the screw of the syringe. Twisting the syringe counterclockwise can release the patch from the syringe.

[0190] FIG. 82 illustrates another embodiment of a patch and a syringe. The patch (8201) includes an adhesive layer (8203), a sensor (8205), and a deformable surface (8213), and the adhesive layer and the sensor may include a PCB chip. The sensor (8205) can be adhered to the adhesive layer (8203), and this can be used to fix the patch (8201) to the body of a subject. The syringe (8207) and the patch (8201) can be configured such that the patch is applied to the body of the subject when the syringe (8207) is attached. Alternatively or additionally, the syringe (8207) and the patch (8201) may be coupled before fixing the patch (8201) and the syringe (8207) to the body of the subject. The patch (8201) may be coupled to the syringe (8207) via the deformable surface (8213). In a first configuration, the deformable surface (8213) may include a gradated hole (8215) that can be used to secure a screw or pin (8217) of the syringe (8207) to the patch (8201). When the two ends of the deformable surface (8213) are pressed towards each other, the deformable surface can assume a second configuration, where the gradated hole (8215) is sized such that the screw or pin (8217) can be separated from the deformable substrate (8213) of the patch (8201), thereby allowing the patch (8201) to be separated from the syringe (8207).

[0191] FIG. 83 shows a cross-sectional view of the combined syringe and patch of FIG. 82. In this configuration, the deformable substrate (8213) is locked onto the syringe. By pressing the two ends of the deformable substrate (8213) together, the gradated hole is moved such that the pin (8217) of the syringe lifts the deformable substrate and the patch, separating the patch from the syringe.

[0192] Figure 84 illustrates another embodiment of a patch and a syringe. The patch (8401) includes an adhesive layer (8403) and a sensor (8405), which may include a PCB chip. The sensor (8405) can be adhered to the adhesive layer (8403) and used to fix the patch (8401) to the subject's body. The syringe (8407) and the patch (8401) can be configured such that the patch is applied to the subject's body when the syringe (8407) is attached. Alternatively or additionally, the syringe (8407) and the patch (8401) may be coupled before fixing the patch (8401) and the syringe (8407) to the subject's body. The patch (8401) may be coupled to the syringe (8407) via a raised portion (8413) on the patch (8401), and this raised portion can be used to fix the patch (8401) to the syringe (8407) via a snap fit or a press fit. The syringe (8407) may further include complementary features that can be fixed to the raised portion (8413). Separation of the patch (8401) from the syringe (8407) can be achieved by twisting the patch (8401) or the syringe (8407), or by pulling the patch (8401) away from the syringe (8407).

[0193] Figure 85 shows a cross-sectional view of the combined syringe and patch in Figure 84. The raised portion (8413) of the patch can be configured to couple to complementary features (8513) (such as protrusions, ridges, cavities) of the syringe. Separation of the patch and the syringe can be achieved by applying a force sufficient to pull the raised portion (8413) and the complementary features (8513) apart.

[0194] Figure 86 illustrates another embodiment of a patch and a syringe. The patch (8601) includes an adhesive layer (8603) and a sensor (8605), which may include a PCB chip. The sensor (8605) can be adhered to the adhesive layer (8603) and used to fix the patch (8601) to the subject's body. The syringe (8607) and the patch (8601) can be configured such that the patch is applied to the subject's body when the syringe (8607) is attached. Alternatively or additionally, the syringe (8607) and the patch (8601) may be coupled before fixing the patch (8601) and the syringe (8607) to the subject's body. The patch (8601) can be coupled to the syringe (8607) by joining or pairing portions (8609) and (8611). Portion (8609) may be coupled to the syringe (8607) (e.g., recess (8613)), while portion (8611) may be coupled to the patch (8601). Portions (8609) and (8611) include magnets and can be fixed to the recess (8613) of the syringe (8607) and the patch (8601) via an adhesive, interference fit, or other attachment arrangement.

[0195] Figure 87 shows a cross-sectional view of the combined syringe and patch in Figure 86. The magnet (8611) of the patch can be configured to couple to the magnet (8609) of the syringe. Separation of the patch and the syringe can be achieved by applying a force sufficient to separate the magnet of the patch from the magnet of the syringe.

[0196] In some examples, it may be useful to fix both the patch and the syringe to the subject's body. In this case, the syringe may further comprise features configurable to couple the housing of the syringe to the subject's body. For example, the syringe may comprise an adhesive layer. The adhesive layer of the syringe may be separated from the mechanism used to fix the patch to the subject's body.

[0197] Figure 88 illustrates another embodiment of a patch and a syringe, where both the patch and the syringe are configured to couple to a subject's body. In panel A, the patch (8801) includes an adhesive layer (8803) and a sensor (8805), which may include a PCB chip. The sensor (8805) can adhere to the adhesive layer (8803) and can be used to secure the patch (8801) to the subject's body. The patch (8801) can be configured such that the patch (8801) is applied to the subject's body and secured separately from the syringe (8807) and can further include an adhesive layer (8813). As shown in panel B, alternatively or additionally, the syringe (8807) and the patch (8801) may be coupled before securing the patch (8801) and the syringe (8807) to the subject's body. As otherwise noted herein, the patch (8801) can be coupled to the syringe (8807) by joining or pairing a plurality of portions. The adhesive layer (8803) of the patch (8801) may include a feature (8811) by which the adhesive layer (8803) of the patch (8801) can be separated from the adhesive layer (8813) of the syringe (8807). In such an example, the patch (8801) may be secured to the subject's body and may not be removable from the subject until the syringe (8807) is removed. In some examples, the force to attach or adhere the patch adhesive layer (8803) to the subject's body (e.g., skin) may be greater than the force to attach or adhere the syringe (8807) to the subject's body (e.g., skin). In some examples, the force to attach or adhere the patch adhesive layer (8803) to the subject's body may be greater than the attachment or adhesion force of the syringe (8807) coupled to the subject's body.

[0198] Figure 89 shows a cross-sectional view of the combined syringe and patch of FIG. 88. Both the patch and the syringe may include an adhesive layer. The adhesive layer (8813) of the syringe can be configured to secure the syringe to the subject's body.

[0199] Optionally, the patch or its opening may comprise a permeable membrane. This permeable membrane may comprise an opening (e.g., a slit, a hole) through which the cannula of the syringe can pass when the cannula of the syringe is oriented from the syringe to the body of the subject. In some examples, the permeable membrane can be adhered or otherwise fixed to the body of the subject. In this case, the permeable membrane may include, for example, an absorbent material for absorbing body fluids (e.g., blood, sweat, etc.) from the subject. It should be understood that any of the above-described embodiments may comprise a patch that includes a sensor (e.g., on a PCB chip), and alternatively or additionally, the patch may comprise a permeable membrane, which may include an absorbent material.

[0200] Figure 90 shows an example of a patch or a part thereof having a penetrable membrane coupled to the adhesive layer of a syringe. In Panel A, the patch (9001) has an adhesive layer (9003). The patch may further comprise a sensor (not shown) that can be adhered to the adhesive layer (9003). The adhesive layer (9003) may be used to fix the patch (9001) to the subject's body. The patch (9001) can be configured such that when the patch (9001) is applied to the subject's body and fixed separately from the syringe (9007), it can further comprise an adhesive layer (9013). As shown in Panel B, alternatively or additionally, the syringe (not shown) and the patch (9001) may be coupled before fixing the patch (9001) and the syringe to the subject's body. The patch may further comprise an opening (9021), which may comprise a penetrable membrane (9023). Optionally, the opening (9021) is a slit, and the material of the penetrable membrane (9023) comprises a self-healing elastomer (the opening closes after the cannula is withdrawn from the subject's body). The adhesive layer (9003) of the patch (9001) may comprise a feature (9011) (e.g., a tab), by which the adhesive layer (9003) of the patch (9001) can be separated from the adhesive layer (9013) of the syringe (9007). Figure 91 shows a bottom cross-sectional view of the patch of Figure 90. The patch has an opening (9021), which is an opening of a penetrable membrane (9023). Optionally, the opening (9021) is a slit, and the material of the penetrable membrane (9023) comprises a self-healing elastomer and / or an absorbent material. The adhesive layer (9003) of the patch may comprise a feature (9011) (e.g., a tab), by which the adhesive layer (9003) of the patch can be separated from the adhesive layer of the syringe.

[0201] Figure 92 shows an exploded view of the adhesive layer of the patch and the syringe in Figure 90. The patch (9001) includes a permeable membrane (9023), which may include an opening (9021). The permeable membrane (9023) can be separated from the patch and can be continuously fixed to the subject's body (for example, as a bandage). Optionally, the opening (9021) is a slit, and the material of the permeable membrane (9023) includes an absorbent material in addition to a self-healing elastomer. The adhesive layer (9003) of the patch (9001) may include a feature (9011) (for example, a tab), by which the adhesive layer (9003) of the patch can be separated from the adhesive layer (9013) of the syringe.

[0202] In some examples, the patch can be configured to be coupled to an auto-injector. FIG. 93 shows an example of a patch with a penetrable membrane coupled to an auto-injector (9307). In Panel A, the patch (9301) includes an adhesive layer (9303). The patch may further include a sensor (not shown) that can be adhered to the adhesive layer (9303). The adhesive layer (9303) may be used to fix the patch (9301) to the subject's body, and in some cases, the adhesive layer (9303) may be fixed to the subject's body. In this case, the adhesive layer (9303) includes an absorbent material (e.g., a belt pad) and remains on the subject's body after injection. The patch (9301) can be fixed separately from the auto-injector (9307) when the patch (9301) is applied to the subject's body. As shown in Panel B, alternatively or additionally, the auto-injector (9307) and the patch (9301) may be coupled before the patch (9301) is fixed to the subject's body. The patch may further include an opening (9321), which may be part of a penetrable membrane (9323). Optionally, the opening (9321) is a slit, and the material of the penetrable membrane (9323) includes a self-healing elastomer (the opening closes after the cannula is withdrawn from the subject's body). The adhesive layer (9303) of the patch (9301) may include a feature (9311) (e.g., a tab) by which the adhesive layer (9303) of the patch (9301) can be separated from the auto-injector. In some examples, the patch (9301) further includes a sensor unit (9305), which may include a PCB chip.

[0203] Embodiments of the present disclosure provide a combination that informs the state of both the syringe and the patient during and after injection. The patch, and associated battery and circuitry, are first physically coupled to the syringe. In an alternative embodiment, the patch can be applied to enable connection of one or more syringes. The patch circuitry can communicate one or more parameters of the syringe to a receiver, for example via a communication interface, prior to fixation to the subject. Once the patch / syringe is fixed to the patient, the patch communicates the state of both the patient and the syringe. When the syringe is removed, the patch remains directly at the injection site of the patient and transmits the state of the injection site. The patch can remain in place for several hours if there is sufficient time to ensure a reaction does not occur, or until the next syringe / patch is applied. That is, upon completion of the injection, the patient can remove the syringe and leave the patch attached. This patch can continue to provide data until the next administration (for up to several days) if it is replaced.

[0204] There are a number of situations where a physician does not want a patient to self-administer at home due to the potential for adverse reactions. If the patch were able to monitor for the possibility of any complications (ISR, heart rate, respiration, temperature, etc.) and send a signal to the physician in the event of an abnormality, it could give the physician confidence to send the patient home for the injection. In an outcomes-based healthcare model, there is a significant benefit to a system that can determine that a patient is improving through treatment with quantitative data as evidence. In cases where a patient's health is changing acutely (or over a long period), there is a long-term benefit to the patient and overall outcomes in that the attending physician can be involved and intervene early through notifications based on trends in continuously accumulating data.

[0205] This type of "detachable" monitoring patch can also be extremely useful in clinical trials. During clinical trials, it is possible to monitor various patient parameters that can improve and reduce compliance and enable early enrollment. For example, if a patient is required to stay in the hospital for 4 hours after each injection to monitor ISR, the patient can avoid this waiting period through patch monitoring, thereby improving mobilization. Furthermore, such devices enable longitudinal studies that can measure patient compliance and improve the accuracy of data transmission (e.g., by eliminating the need for handwritten recording of data).

[0206] The patch concept is not limited to the above-described syringe. Patches with and / or without electronic devices can also be adapted to other syringes. These devices may be equipped with an autoinjector. From the above perspective, embodiments of the present disclosure can provide patches that can include, for example, an electronic device or only a belt material (see, for example, FIGS. 90-93). In some examples, the patch can be connected to the syringe, and the patch and the syringe can be fixed by applying force to the patch and the syringe, thereby eliminating the need to apply a separate patch. Alternatively, the patch may be applied directly to the injection site by the syringe and can cover the cannula inlet with an expandable / contractible element. As otherwise noted herein, the patch may be magnetically connected to the syringe. In some examples, the patch can be mechanically connected to a syringe equipped with a release mechanism intended for the user. Optionally, the patch may be smaller than the entire adhesive patch used for syringe adhesion. The patch may be provided with an adhesive pad having the same or smaller size as the patch dimensions. In some examples, the patch can transmit syringe data before application to the patient, transmit data for both the syringe and the patient after application to the patient, and / or transmit patient data after removal of the syringe.

[0207] Examples of Application / Use As shown in FIG. 94, the patch sensor (9401) may be customized in response to patient or physician requests to measure specific device and / or patient characteristics or physiological parameters.

[0208] One or more sensors may be used to measure device and / or patient characteristics 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 (BP in FIG. 94), color or other light sensors, moisture sensors, chemical sensors (e.g., those that sense, measure, or detect drug concentration, histamine, oxygen, etc.).

[0209] One or more sensors may be used to measure the characteristics of one or more devices, such as the presence of skin, tracking of substance delivery, and / or occlusion of a device (e.g., the cannula of a syringe).

[0210] As shown in FIG. 95, the sensor may alternatively be incorporated into a sensor adhesive layer (9501). As described above, any useful combination of a patient's sensing characteristics can provide significant evidence of a conclusion or outcome. For example, a site reaction can be detected using temperature measurement, skin resistance and / or impedance measurement, and color measurement, or a combination thereof. In another example of pain correlated with a measured site reaction, temperature measurement, skin resistance or impedance measurement, color measurement, skin dilation measurement, or interstitial pressure measurement, or any combination thereof can be used. In yet another example of monitoring a contraindicated activity during treatment, moisture measurement, heart rate measurement, and / or humidity measurement (e.g., indicating the amount of sweat), or a combination thereof can be used. In another example, monitoring of a wet injection may involve moisture measurement. Another example of a subject's outcome may involve monitoring poor bioabsorption by measurement of interstitial pressure, tissue density, temperature, skin resistance / impedance, color, and / or skin dilation. In yet another example of monitoring a systemic adverse reaction, moisture (sweat) measurement, EMG / ECG, vibration (e.g., instead of restlessness), loud sound (e.g., instead of the amount of gas in the stomach or intestine), or any combination thereof may be used.

[0211] FIG. 96 shows another embodiment of a sensor unit. This 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 / temperature sensor (9607), a 3D accelerometer / gyroscope (9608), a reed switch (9609), and a low power core processor (9610). The sensor may include more than one layer, and various sensors, batteries, and other components may be distributed among each layer or separate layers.

[0212] The patch can be used for various functions after injection and after removal of the syringe. In non-limiting examples, the patch can be used to prevent bleeding by closing the injection site, detect leakage / bleeding at the injection site by moisture detection, monitor skin temperature, color, pressure to detect ISR, monitor heart rate / EKG, monitor whether the patient's position is upright or lying down, and / or monitor the chemical properties / sweat of the skin.

[0213] In some embodiments, the patch can communicate with the patient to remind the patient of the next injection time and sound an alarm if there is a reaction or leakage, temperature increase, color change, heart rate increase, etc. at the injection site. The communication between the patch and the patient can be visual, auditory, or tactile.

[0214] Embodiments of the patch can be used during monitoring of the syringe state to determine, for example, whether the syringe is full, whether the amount or mass of a substance (e.g., drug or agent) fills the syringe, whether the syringe is removed from the storage or transport device base, whether the syringe is placed on the skin, whether the safety strip is removed, whether a button is pressed, whether injection has started, whether the position of the gas meter includes delivery tracking, whether the stop button is pressed, whether the button is retracting the cannula, whether injection is complete, whether the syringe is removed from the skin, or whether post-injection syringe parameters are relevant to the measurement of the aforementioned patient physiological parameters.

[0215] Additional Features / Embodiments In alternative embodiments, the sensor can detect whether another patch is transmitting or whether an existing patch has been removed. The patch may be transparent so that the patient can view the injection site and be as unobtrusive as possible so that the patient can continue with daily activities (such as showering, swimming, etc.) while wearing the patch.

[0216] In further alternative embodiments, sensing elements may be provided that can measure device characteristics including the presence of skin (sensing retraction or detachment of the cannula), delivery metric tracking (including filling and dispensing), occlusion detection, drug temperature, device status (On / Off moving base, On / Off patient, button status, stop events, etc.), flow rate, syringe internal pressure / injection pressure, and adhesiveness.

[0217] Further embodiments may incorporate patient-device sensing elements to enable manual and / or automated intervention (management) of the syringe. For example, the flow rate of the syringe can be adjusted (e.g., increased, decreased, stopped) based on site reaction sensing information (automated), patient pain information (manual), bioabsorption rate (automated), or any combination thereof.

[0218] In further embodiments, i.e., vibration elements in the syringe and / or patch, can vibrate based on site reaction sensing information, patient pain information (manual) or pain sensing information, interstitial pressure / site distension information (automated), or any combination thereof (for pain management or notification to the user).

[0219] In further embodiments, sound, i.e., sound elements in the syringe and / or patch, may be provided (e.g., for notification and / or information transmission to the user) and can operate based on patient sensing information, device sensing elements (occlusion, drug temperature (temp), delivery metrics, etc.), or combinations or variations thereof.

[0220] In further embodiments, visual indicators, i.e., LEDs or their equivalents in the syringe and / or patch, may be provided (e.g., for indication of change, notification and / or information transmission to the user) and can operate based on patient sensing information, device sensing elements, e.g., the position of the retraction button that detects premature removal / detachment, syringe sensing information (skin sensing, etc.), patient sensing information (high pressure, high temperature, etc.), or combinations or variations thereof.

[0221] In a further embodiment, a lockout against depression of the syringe button (e.g., for safety or prevention of drug misuse) may be provided and may be actuated based on sensed information of the syringe (such as drug temperature), sensed information of the patient (such as skin sensing), sensed information of the mobile application (e.g., time since last injection, user authentication), or variations or combinations thereof.

[0222] In a further embodiment, transcutaneous electrical nerve stimulation (TENS) (e.g., for pain management or bioabsorption) may be provided. In this case, electrode elements in the cannula and / or patch may be actuated based on site response sensed information, patient pain information (manual) or pain sensed information, interstitial pressure / site distension information (automatic), or variations or combinations thereof.

[0223] A further embodiment can predict the remaining injection time based on, for example, sensed flow rate and fill volume, sensed device pressure and back pressure, drug temperature, body temperature, and fill volume.

[0224] Further features that may exist in yet further embodiments include a patch that senses whether another patch is applied, a patch that is transparent enough to enable visualization of the underlying tissue, a patch that communicates directly with the user / patient, an audible signal (e.g., "hey-time for your next injection" or "Call the doctor-you have an ISR"), and / or other tactile options of a patch that regularly communicates data directly to a receiver or the cloud or broadcasts data intermittently, vibration, electrical stimulation, visual options, light-emitting diodes.

[0225] Mobile application In another aspect, the present specification discloses a system and method for generating a mobile application for monitoring one or more health or physiological parameters. The mobile application can be generated using various methods, such as an application programming interface (API). This mobile application may include a plurality of useful features and can be configured to interact with other mobile applications. Optionally, the mobile application can be configured to display measurements of one or more physiological parameters or parameters of a patch and / or syringe from a subject. The mobile application may include a feedback system that enables subject or other user input, thereby allowing adjustment of the patch and / or syringe (e.g., the amount of substance dispensed). The mobile application can further communicate with a remote server, for example, via a communication interface. Optionally, the remote server can be part of or communicate with a separate electronic device (e.g., a mobile device, a laptop), thereby enabling a clinician or physician to monitor a subject's physiological parameters. Optionally, the mobile application can allow a subject to input parameters that are not measurable (e.g., pain, discomfort, etc.). The mobile application may further include software for data processing. Non-limiting examples of data processing can include statistical analysis of data, trend plotting and analysis, and graphical display of data. Optionally, the mobile application can interact with or be combined with a lifestyle tracking application (e.g., one that monitors diet and activity), or other useful mobile applications, such as location tracking, accelerometer, calendar (e.g., one that sends reminders), etc.

[0226] FIG. 97 schematically shows an example of a workflow of a mobile application for monitoring one or more health or physiological parameters. The mobile device (9700) may be a laptop, a tablet, a phone, or other electronic device (e.g., a portable electronic device). When opening or selecting an application on the mobile device (9700), a loading screen (9710) may be presented, followed by a menu screen (9720). The menu screen (9720) can provide a plurality of functions (9730). Non-limiting examples of the functions (9730) can include starting a new infusion, infusion history, training video, additional information, and patient profile. When selecting a function (9730) (e.g., infusion history), a second screen (9740) regarding the function may be presented. In such an example, a calendar can be presented to the subject. In the process (9750), the subject can select a second function on the second screen (9740) that presents a third screen (9760). The third screen can display one or more health or physiological parameters (e.g., prescription, time, day of the week, regimen, reminder to the patient, alarm, vibration, etc.) regarding the subject, the device, or the delivery of a substance to the subject. In an example of the third screen (9980), the calendar may include selectable dates that provide information on one or more health or physiological parameters of the subject for each selected date. In an example of the fourth screen (9990), the calendar of the mobile application can display additional information, for example, when the subject forgets an infusion. In an example of the fifth screen (9790), the calendar of the mobile application can display additional information, for example, when the subject receives an infusion.

[0227] FIG. 98 schematically illustrates an example of a workflow of a mobile application for monitoring one or more health or physiological parameters, which can be used in conjunction with one or more workflows of the mobile application. When selecting a function (9730) (e.g., starting a new infusion, see FIG. 97) from a menu screen (9720) (see FIG. 97), a screen (9810) may appear. The mobile application enables the detection of substances or drugs, for example, by scanning barcodes or quick response codes (QR codes (registered trademarks)). The mobile application is integrated with another application on a mobile device such as a camera, and the camera can be displayed on the screen (9820). Screen (9830) shows an example of a screen of a scanned QR code (registered trademark), on which information regarding the substance or device can be presented. Subsequently, the mobile application can verify drug and device compatibility, and / or other parameters of the drug / device, such as expiration date and dosage. If the drug or device is inappropriate for the subject (e.g., the subject spits out the drug), screen (9842) or (9844) may appear, which notifies the subject of the inappropriateness of the drug or device. If the drug or device is appropriate for the subject, screen (9850) may appear, which can provide guidance, instructions, or directions to the subject. As illustrated in screen (9852), instructions may be presented in the form of continuous scrolling. Thereafter, the mobile application can be paired with the device. In an example screen (9860), additional guidance may be provided to the subject. Safety features can be included in the present application. For example, if safety measures (e.g., a safety tab) have not been performed by the subject, the mobile application can notify the subject. Screen (9870) can display one or more device parameters (e.g., infusion status, cannula injection into the subject's body, etc.).Incomplete injections are presented on screen (9872), which can indicate the injection status and include other indicators of device parameters (e.g., "device stop"). Upon completion of the delivery of the substance or drug, screen (9880) is displayed, where the injection status can be indicated. Optionally, (9880) can provide the subject with the option to rate the injection experience. Multiple steps in this process may further include communication steps (9854) (e.g., via Bluetooth, Wi-Fi) to separate devices, cloud computing, clinician servers, etc.

[0228] FIG. 99 illustrates another example of a workflow of a mobile application for monitoring one or more health or physiological parameters, which can be used in conjunction with one or more workflows of the mobile application. When selecting a function (9730) (e.g., training video, see FIG. 97) from the menu screen (9720) (see FIG. 97), a screen (9900) may appear. The mobile application may include various tutorials or training information for the subject. FIG. 99A schematically demonstrates a plurality of devices or systems that can be integrated into the mobile application. When 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, and this screen may include a video demonstrating a tutorial or method regarding the use of the device or system. FIG. 99B schematically illustrates another example of a workflow of a mobile application for monitoring one or more health or physiological parameters, which can be used in conjunction with one or more workflows of the mobile application. When selecting a function (9730) (e.g., additional information, see FIG. 97) from the menu screen (9720) (see FIG. 97), a screen (9925) may appear, and this screen may be provided with a menu for displaying one or more health or physiological parameters or one or more device parameters. Additional information (e.g., prescription information, device information, etc.) may be available to the subject. When selecting a function in the menu, screens (9930) or (9945) may appear, and this screen may further be provided with options for displaying additional information, such as safety information (e.g., screens (9935) or (9950)) or Q&A (e.g., screens (9940) or (9955)).FIG. 99C schematically illustrates another example of a workflow of a mobile application for monitoring one or more health or physiological parameters, which can be used in conjunction with one or more workflows of the mobile application. When selecting a function (9730) (e.g., patient profile, see FIG. 97) from the menu screen (9720) (see FIG. 97), a screen (9970) may appear, and this screen may have a menu. The menu may include options for the subject to view and / or enter patient information (e.g., gender, height, weight, activity value). Additional settings such as alarms, alerts, emails, notifications, etc. can also be implemented in the mobile application.

[0229] Computer system The present disclosure provides a computer system programmed to implement the methods of the present disclosure. FIG. 100 shows a computer system (10001) programmed or otherwise configured to transmit and receive data and process data. The computer system (10001) can regulate various aspects of the present disclosure, such as, for example, methods of data analysis, subject monitoring, measurement of physiological or health parameters, and provision of outputs of the physiological or health parameters. The computer system (10001) is an electronic device of a user or a computer system, and this user or computer system is located remotely with respect to the electronic device. The electronic device may be a mobile electronic device.

[0230] A computer system (10001) includes a central processing unit (CPU, also referred to herein as "processor" and "computer processor") (10005), which may be a single-core or multi-core processor, or multiple processors for parallel processing. The computer system (10001) further includes a memory or storage location (10010) (e.g., random access memory, read-only memory, flash memory), an electronic storage device (10015) (e.g., hard disk), a communication interface (10020) (e.g., network adapter) for communicating with one or more other systems, and peripheral devices (10025) such as a cache, other memory, data storage, and / or an electronic display adapter. The memory (10010), storage device (10015), interface (10020), and peripheral devices (10025) communicate with the CPU (10005) via a communication bus (solid line) such as a motherboard. The storage device (10015) may be a data storage device (or data repository) for storing data. The computer system (10001) can be operably coupled to a computer network ("network") (10030) with the assistance of the communication interface (10020). The network (10030) may be the Internet and / or an extranet, or an intranet and / or an extranet in communication with the Internet. Optionally, the network (10030) is a telecommunications and / or data network. The network (10030) may include one or more computer servers, enabling distributed computing such as cloud computing. The network (10030) can optionally implement a peer-to-peer network with the assistance of the computer system (10001), enabling devices connected to the computer system (10001) to act as clients or servers.

[0231] The CPU (10005) can execute a series of machine-readable instructions, which may be embedded in a program or software. The instructions may be stored in a storage location such as the memory (10010). The instructions can be directed to the CPU (10005), which can later program the CPU (10005) or configure it in other ways to implement the method of the present disclosure. Examples of operations performed by the CPU (10005) can include fetch, decode, execute, and write-back.

[0232] The CPU (10005) may be part of a circuit such as an integrated circuit. One or more other components of the system (10001) can be included in the circuit. Optionally, the circuit is an application-specific integrated circuit (ASIC).

[0233] The storage device (10015) can store files such as drivers, libraries, and saved programs. The storage device (10015) can store user data, such as user preferences and user programs. The computer system (10001) may optionally include one or more additional data storage devices outside the computer system (10001), such as being located on a remote server in communication with the computer system (10001) through an intranet or the Internet.

[0234] The computer system (10001) can communicate with one or more remote computer systems via a network (10030). For example, the computer system (10001) can communicate with a user's remote computer system (such as located in a clinic or a doctor's mobile device). Examples of remote computer systems include personal computers (such as portable PCs), slates or tablet PCs (such as Apple® iPad®, Samsung® Galaxy Tab), phones, smartphones (such as Apple® iPhone®, Android-enabled devices, Blackberry®), or personal digital assistants. The user can access the computer system (10001) via the network (10030).

[0235] The methods described herein can be executed as machine (such as a computer processor) - executable code stored in an electronic storage location of the computer system (10001), such as in a memory (10010) or an electronic storage device (10015). The machine - executable or machine - readable code can be provided in the form of software. During use, the code is executable by a processor (10005). Optionally, the code is retrieved from the electronic storage device (10015) and stored in the memory (10010) to enable easy access by the processor (10005). In some situations, the electronic storage device (10015) can be excluded, and the machine - executable instructions are stored in the memory (10010).

[0236] The code may be pre - compiled and configured for use with a machine having a processor adapted to execute the code, or may be compiled at runtime. The code may be provided in a programming language that can be selected such that the code is executable in a pre - compiled or as - compiled manner.

[0237] Aspects of the systems and methods provided herein, such as computer system (10001), can be embodied in programming. Various aspects of this technology may be considered as a "product" or "manufactured article" in the form of code and / or associated data that is executable by a machine (or processor) and that is typically carried on or embedded in a machine-readable medium. The machine-executable code can be stored in an electronic storage device such as a memory (e.g., read-only memory, random access memory, flash memory) or a hard disk. A "storage" type medium may include any or all of various semiconductor memories, tape drives, disk drives, etc., which are tangible memories of a computer or processor, or associated modules thereof, and which may at any time provide non-transitory storage for software programming. All or part of the software may sometimes be communicated via various electrical communication networks such as the Internet. Such communication may enable, for example, the loading of software from one computer or processor to another, such as from a management server or host computer to an application server computer platform. Thus, another type of medium that can carry software elements is one that includes light waves, radio waves, and electromagnetic waves that are used over physical interfaces between local devices over various air-links as well as over wired and optical terrestrial communication line networks. Physical elements that carry waves such as wired links, wireless links, optical links, etc., may also be considered media that carry software. As used herein, unless restricted to non-transitory and tangible "storage" media, terms such as computer or machine "readable media" refer to media that require a processor to be instructed for execution.

[0238] Thus, machine-readable media such as computer-executable code may take many forms, including but not limited to tangible storage media, carrier wave media, or physical transmission media. As non-volatile memory media, for example, optical disks or magnetic disks such as those that can be used to implement databases shown in figures, or any of the storage devices in a computer, etc. may be mentioned. As volatile memory media, dynamic memory such as the main memory of such a computer platform may be mentioned. As tangible transmission media, coaxial cables, copper wires, and optical fibers may be mentioned, and as an example, wires including buses within a computer system may be mentioned. Carrier wave transmission media may take the form of electrical signals, electromagnetic signals, sound waves, or light waves, such as those generated during radio frequency (RF) and infrared (IR) data communications. Therefore, common forms of computer-readable media include, for example, floppy disks, flexible disks, hard disks, magnetic tapes, other magnetic media, CD-ROMs, DVDs or DVD-ROMs, other optical media, punch cards, paper tapes, other physical storage media having patterns of holes, RAM, ROM, PROM, EPROM, FLASH (registered trademark)-EPROM, other memory chips or cartridges, carrier waves carrying data or instructions, cables or links transmitting such carrier waves, or other media readable by a computer for programming code and / or data. Many of these forms of computer-readable media may need to carry one or more sequences of one or more instructions to a processor for execution.

[0239] The computer system (10001) may include an electronic display (10035) having a user interface (UI) (10040), or may be in communication with the electronic display. Examples of UIs include, but are not limited to, graphical user interfaces (GUIs) and web-based user interfaces.

[0240] The methods and systems of the present disclosure are executable by one or more algorithms. The algorithms are executable by software after execution by a central processing unit (10005). The algorithms can, inter alia, process data, perform statistical analysis, plot or graph the data, and provide feedback to one or more systems (such as patches and / or syringes) disclosed herein.

[0241] Preferred embodiments of the invention have been shown and described herein, it being apparent to those skilled in the art that such embodiments are provided by way of example only. It is not intended that the invention be limited by the specific examples provided herein. While the invention has been described with reference to the foregoing specification, the descriptions and illustrations of the embodiments herein are not intended to be construed in a limiting sense. Numerous variations, modifications, and substitutions are presently contemplated by those skilled in the art without departing from the invention. Further, it is to be understood that all aspects of the invention are not limited to the specific depictions, configurations, or relative ratios described herein, which depend upon a variety of conditions and variables. It is to be understood that various alternatives to the embodiments of the invention described herein are available for use in practicing the invention. Therefore, the invention is considered to extend to any such alternatives, modifications, variations, or equivalents. The following claims define the scope of the invention, and it is intended that methods and structures within the scope of these claims and their equivalents be thereby included.

Claims

1. 1. A system for measuring a health or physiological parameter from a subject, the system comprising: a patch comprising a first housing having a sensor configured to (i) measure said health or physiological parameter from said subject when said patch is secured to a body of said subject, and (ii) provide one or more outputs corresponding to said health or physiological parameter from said subject, wherein said first housing comprises an opening; 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 contacts the body of the subject when the patch is secured to the body of the subject, and wherein the syringe is configured to (i) direct a substance from a reservoir to the fluid flow path, which is in fluid communication with the reservoir, and (ii) direct the substance from the fluid flow path through the cannula to the subject; A system comprising:

2. The system of claim 1 , further comprising a pump integrated into the cannula, wherein the pump is configured to direct the substance from the fluid flow pathway through the cannula to the subject.

3. The system of claim 1 , wherein the cannula is configured to extend toward or retract from the subject's body.

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 a cannula to create the opening.

6. The system of claim 1 , wherein the reservoir is fixed 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. 10. The system of claim 9, wherein the medicament is for treating one or more diseases selected from the group of cardiovascular, musculoskeletal, gastrointestinal, dermatological, immunological, ophthalmological, hematological, neurological, oncological, endocrinological, metabolic, 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 comprises a communication interface for transmitting data corresponding to the health or physiological parameter to an electronic device in communication with the communication interface.

14. 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 short-range wireless communication interface.

17. The system of claim 14 , wherein the communication interface includes 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. 10. The system of claim 1, 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, an interstitial 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.

21. 21. The system of claim 20, further comprising a second sensor configured to measure one or more device parameters selected from the group consisting of a dose of substance administered, a flow rate of substance dispensing, a volume of substance administered, occlusion of the cannula, and contact of the cannula with the subject's body.

22. The system of claim 21 , wherein the patch comprises the second sensor.

23. 22. The system of claim 21, wherein the syringe comprises the second sensor.

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

25. 25. The system of claim 24, 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.

26. The system of claim 1 , wherein the patch is configured to measure multiple health or physiological parameters, including the health or physiological parameter.

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

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

29. 1. A method for measuring a health or physiological parameter from a subject, the method comprising: (a) providing (i) a patch having a first housing having a sensor and including an opening; and (ii) a syringe having a second housing including a cannula in fluid communication with a fluid flow path, wherein the second housing couples to the first housing of the patch, and the syringe includes a reservoir including a substance and a fluid flow path in fluid communication with the reservoir; (b) securing the patch to the body of the subject; (c) once the patch is secured to the subject's body, (i) directing the substance from the reservoir into the fluid flow path, and (ii) directing the cannula through the opening to direct the substance from the fluid flow path through the cannula and into the subject; (d) (i) using the sensor to measure said health or physiological parameter from said subject, and (ii) providing one or more outputs corresponding to said health or physiological parameter from said subject; A method comprising:

30. 30. The method of claim 29, further comprising using a pump integrated into the cannula to direct the substance from the fluid flow path through the cannula to the subject.

31. 30. The method of claim 29, wherein the cannula is configured to extend toward or retract from the subject's body.

32. 30. The method of claim 29, wherein the opening comprises a pierceable membrane.

33. 33. The method of claim 32, wherein the pierceable membrane is pierced by a cannula to create the opening.

34. 30. The method of claim 29, wherein the reservoir is fixed to the syringe.

35. 35. The method of claim 34, wherein the reservoir is removable from the syringe.

36. 35. The method of claim 34, wherein the reservoir is part of the syringe.

37. 30. The method of claim 29, wherein the substance is a drug.

38. 38. The method of claim 37, wherein the medicament is used to treat one or more diseases selected from the group of cardiovascular, musculoskeletal, gastrointestinal, dermatological, immunological, ophthalmological, hematological, neurological, oncological, endocrinological, metabolic, and respiratory diseases.

39. 30. The method of claim 29, wherein the syringe comprises the reservoir, wherein the reservoir is configured to contain a formulation having the substance.

40. 30. The method of claim 29, wherein the first housing is removably coupled to the second housing.

41. 30. The method of claim 29, wherein the patch comprises a communications interface for transmitting data corresponding to the health or physiological parameter to an electronic device in communication with the communications interface.

42. 42. The method of claim 41, wherein the communication interface comprises a wireless communication interface.

43. 43. The method of claim 42, wherein the communication interface comprises a WiFi interface.

44. 43. The method of claim 42, wherein the communication interface comprises a short-range wireless communication interface.

45. 43. The method of claim 42, wherein the communications interface includes a Bluetooth interface.

46. 43. The method of claim 42, wherein the wireless communication interface comprises an optical wireless interface.

47. 42. The method of claim 41, wherein the communication interface is a wired communication interface.

48. 30. The method of claim 29, 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, an interstitial 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 tracing sensor.

49. 49. The method of claim 48, further comprising a second sensor, wherein the second sensor is selected from the group consisting of a temperature sensor, a humidity sensor, a flow sensor, a button position sensor, a vibration sensor, an audible sensor, and a skin sensor.

50. 50. The method of claim 49, wherein the patch comprises the second sensor.

51. 50. The method of claim 49, wherein the syringe comprises the second sensor.

52. 30. The method of claim 29, wherein the patch further comprises one or more transducers.

53. 53. The method of claim 52, 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.

54. 30. The method of claim 29, wherein the patch is configured to measure multiple health or physiological parameters, including the health or physiological parameter.

55. 30. The method of claim 29, wherein the body is skin.

56. 30. The method of claim 29, wherein the patch is configured to receive data from the syringe.

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

58. 58. The syringe of claim 57, wherein the second retention force is greater than the first retention force, and the patch is removably attached to the skin attachment layer.

59. 59. The syringe of claim 58, wherein the patch is removably attached to the skin attachment layer by perforations.

60. 58. The syringe of claim 57, wherein the patch is removably secured to the housing by a magnet.

61. 61. The syringe of claim 60, wherein a magnet is located within or on the housing of the syringe, and the patch comprises a metallic portion configured to be engaged by the magnet.

62. 58. The syringe of claim 57, wherein the skin attachment layer includes an opening, and wherein the patch is located within the opening when removably secured to the housing of the syringe.

63. 63. The syringe of claim 62, wherein the opening is centrally disposed in the skin-attachment layer, and the injection cannula of the syringe passes through the opening in the skin-attachment layer and through the orifice of the patch when in the dispensing position.

64. 64. The syringe of claim 63, wherein the patch comprises an extension that includes the orifice through which the injection cannula of the syringe passes when in the dispensing position, the extension configured to compress the user's skin around an injection site.

65. 64. The syringe of claim 63, wherein the patch comprises a printed circuit board on which the patch circuit is located and to which the sensor adhesive layer and the patch sensor are attached, the sensor adhesive layer comprising a central window through which the extension passes.

66. 66. The syringe of claim 65, wherein the extension is generally conical in shape.

67. 58. The syringe of claim 57, wherein the patch comprises a printed circuit board on which the patch circuit is located and on which the sensor adhesive layer and the patch sensor are attached.

68. 58. The syringe of claim 57, wherein the patch circuit of the patch comprises a microcontroller, a microprocessor, or a transmitter.

69. 69. The syringe of claim 68, wherein the syringe sensor comprises a transmitter, and the patch circuit further comprises a receiver by which data is received from the syringe sensor by wireless transmission.

70. 70. The syringe of claim 69, wherein the microcontroller or microprocessor and the transmitter and receiver are combined into a single component.

71. 69. The syringe of claim 68, further comprising a wire connection between the syringe sensor and the patch circuit, the wire connection configured to be disconnected when or after the syringe is removed from the patient.

72. 69. The syringe of claim 68, wherein the microcontroller or microprocessor and the transmitter are combined into a single component.

73. 51. The syringe of claim 50, wherein the transmitter is a Bluetooth transmitter.

74. 58. The syringe of claim 57, wherein the syringe sensor comprises a plurality of sensors.

75. 58. The syringe of claim 57, wherein the patch sensor comprises a plurality of sensors.

76. 1. A method for collecting data from a syringe and a patient, the method comprising: (a) attaching to the patient a syringe having a syringe sensor and a patch having a patch sensor and a patch circuit; (b) receiving data from the syringe sensor and the patch sensor using the patch circuitry; (c) transmitting the received data to a remote receiver using the patch circuit; (e) removing the syringe from the patient; (f) receiving additional data from the syringe sensor using the patch circuit after removing the syringe from the patient; (g) transmitting the received additional data to a remote receiver using said patch circuit.

77. 77. The method of claim 76, wherein the syringe and the patch are simultaneously attached to the patient.

78. 77. The method of claim 76, wherein step a includes attaching the patch before the syringe and before attaching the syringe to the patient, and further includes the steps of receiving data from the patch sensor using the patch circuitry, and transmitting received data to a remote receiver using the patch circuitry.

79. 77. The method of claim 76, wherein the data collected from the patient includes a drug administered by the syringe and / or a measurable attribute that may be affected by injection of a drug using the syringe.

80. 77. The method of claim 76, wherein the data collected from the patient includes measurable attributes that may affect or are indicative of the safety and / or efficacy of a drug administered by the syringe and / or use of the syringe.

81. 1. A method for monitoring an injection site of a patient for injection site reactions, the method comprising: (a) attaching to a patient a syringe having a patch including a patch sensor and a patch circuit, wherein the patch sensor includes a surface temperature sensor and a skin color monitor; (b) receiving data from a patch sensor using the patch circuit; (c) transmitting received data using said patch circuitry to a remote receiver, wherein said data includes an indication of temperature increase or change in skin color such that an injection site reaction can be identified; A method comprising:

82. A syringe comprising: (a) a housing; (b) a drug reservoir disposed within the housing; and (c) an injection cannula movable within the housing between a pre-dispense 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 retention force; and (e) an adhesive layer attached to the patch sensor, the adhesive layer including an adhesive configured to secure the patch sensor to a user's skin with a second retention force; and Equipped with (f) wherein the second retention force is greater than the first retention force such that the patch sensor remains attached to the user's skin when the housing is detached from the patch sensor. syringe.

83. 83. The syringe of claim 82, wherein the data is used to adjust device parameters of the patch or the syringe.

84. 84. The syringe of claim 83, wherein the device parameters include one or more device parameters selected from the group consisting of a dose of a substance administered by the syringe, a flow rate of the substance dispensed by the syringe, and a volume of the substance administered by the syringe.

85. 85. The syringe of claim 84, wherein the data is used to generate a notification to the subject.

86. 86. The syringe of claim 85, wherein the notification comprises one or more notifications selected from the group consisting of vibration, audio, and visual indication.

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