Medical fluid injection device and method with reusable patch

Abstract

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

Description

[0001] Cross-referencing

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 047,471, filed July 2, 2020, the entire contents of which are incorporated herein by reference. Background Technology

[0003] Medical syringes can be used to deliver drugs to subjects, and injection devices on the body have become a subject of ongoing development in an effort to develop injection devices and methods that provide benefits such as greater comfort and less pain while delivering effective subcutaneous injections.

[0004] A variety of methods can be used to monitor the health or physiological parameters of subjects receiving treatment for diseases or health conditions, such as collecting biological samples and processing samples for analyte testing. Summary of the Invention

[0005] This article recognizes the need for new and / or improved devices, systems, and methods for injecting and delivering medications (e.g., pharmaceutical agents) from reservoirs (e.g., one or more source vials) into subjects. Furthermore, this article recognizes the need for devices, systems, and methods for monitoring health or physiological parameters before, during, and / or after the injection of medication into subjects. Such devices or systems may be useful, for example, in regulatory procedures and patient monitoring.

[0006] This disclosure provides devices, systems, and methods for medical fluid delivery and injection, as well as methods for administering a substance (e.g., a drug) to a subject and monitoring one or more physical parameters or properties of the subject before, during, and / or after the administration of the substance.

[0007] In one aspect, this document discloses a method for measuring a health or physiological parameter of a subject, the method comprising: (a) providing (i) a reusable patch including a first housing having a sensor, and (ii) a syringe having a second housing including a cannula in fluid communication with a fluid flow path and a reservoir containing a substance, wherein the second housing is coupled to the first housing of the reusable patch, the patch being attached to the body of the subject; and (b) using the sensor (i) to measure the health or physiological parameter from the subject, and (ii) providing one or more outputs corresponding to the health or physiological parameter from the subject.

[0008] In some embodiments, the syringe includes the reservoir and the fluid flow path. In some embodiments, the syringe is configured to administer a dose of the substance to the subject from the reservoir via the fluid flow path and the cannula. In some embodiments, the reusable patch includes a second sensor configured to measure one or more device parameters selected from: the dose of the administered substance, the flow rate of the administered substance, the volume of the administered substance, the obstruction of the cannula, the duration of contact between the cannula and the subject's body, and the contact between the cannula and the subject's body. In some embodiments, the second housing is removably coupled to the first housing of the reusable patch. In some embodiments, the method further includes sterilizing or cleaning the reusable patch after (b). In some embodiments, the method further includes providing a charging station configured to be coupled to the reusable patch. In some embodiments, the reusable patch includes a rechargeable battery. In some embodiments, the reusable patch is secured to the subject's body using an adhesive. In some embodiments, the health or physiological parameter includes a selection from temperature, tissue thickness, heart rate, blood pressure, interstitial pressure, tissue density, skin swelling, bleeding, sweat volume, and analyte measurements. In some embodiments, the analyte is obtained from the subject's blood. In some embodiments, the health or physiological parameter includes fat or adipose tissue thickness. In some embodiments, the sensor includes an ultrasound transmitter and an ultrasound receiver, and wherein (b) includes transmitting an ultrasound signal from the ultrasound transmitter to a location within the subject's body and using the ultrasound receiver to receive a signal from the location, and wherein at least the signal is received by the ultrasound receiver and used to measure the health or physiological parameter. In some embodiments, the reusable patch includes a membrane with an opening. In some embodiments, the membrane is puncturable. In some embodiments, the opening of the membrane is pre-formed. In some embodiments, the reusable patch includes a bandage. In some embodiments, the method further includes placing the bandage on the subject's body. In some embodiments, the reusable patch includes a communication interface. In some embodiments, the communication interface is configured to transmit data corresponding to the health or physiological parameter to an electronic device communicating with the communication interface. In some embodiments, the electronic device includes a mobile device. In some embodiments, the method further includes using a mobile application implemented on the mobile device to monitor the health or physiological parameter over a period of time. In some embodiments, the communication interface communicates with an additional communication interface of the syringe.In some embodiments, the communication interface and the additional communication interface are used to position the patch or the syringe. In some embodiments, the one or more outputs include output signals, wherein the output signals include one or more members selected from vibration signals, audio signals, visual signals, tactile signals, and electrical signals. In some embodiments, the method further includes, after (b), administering a dose of the substance from the reservoir to the subject using the syringe through the fluid flow path and the cannula.

[0009] In another aspect of this disclosure, a system for measuring a health or physiological parameter of a subject is provided, the system comprising: a reusable patch including a first housing having a sensor, the patch being configured to be attached to the body of the subject; and a syringe having a second housing including a cannula in fluid communication with a fluid flow path and a reservoir containing a substance, wherein the second housing is configured to be coupled to the first housing of the reusable patch, wherein the sensor is configured to (i) measure the health or physiological parameter from the subject, and (ii) provide one or more outputs corresponding to the health or physiological parameter from the subject.

[0010] In some embodiments, the syringe includes the reservoir and the fluid flow path. In some embodiments, the syringe is configured to administer a dose of the substance to the subject from the reservoir via the fluid flow path and the cannula. In some embodiments, the reusable patch includes a second sensor configured to measure one or more device parameters selected from: the dose of the administered substance, the flow rate of the administered substance, the volume of the administered substance, the obstruction of the cannula, the duration of contact between the cannula and the subject's body, and the contact between the cannula and the subject's body. In some embodiments, a second housing is removably coupled to a first housing of the reusable patch. In some embodiments, the system further includes a charging station configured to be coupled to the reusable patch. In some embodiments, the reusable patch includes a rechargeable battery. In some embodiments, the reusable patch is secured to the subject's body using an adhesive. In some embodiments, the health or physiological parameter includes a selection of temperature, tissue thickness, heart rate, blood pressure, interstitial pressure, tissue density, skin swelling, bleeding, sweat volume, and analyte measurements. In some embodiments, the analyte is obtained from the subject's blood. In some embodiments, the health or physiological parameter includes fat or adipose tissue thickness. In some embodiments, the sensor includes an ultrasound transmitter and an ultrasound receiver. In some embodiments, the reusable patch includes a membrane with an opening. In some embodiments, the membrane is puncturable. In some embodiments, the opening of the membrane is pre-formed. In some embodiments, the reusable patch includes a bandage. In some embodiments, the bandage is configured to be placed on the subject's body. In some embodiments, the reusable patch includes a communication interface. In some embodiments, the communication interface is configured to transmit data corresponding to the health or physiological parameter to an electronic device communicating with the communication interface. In some embodiments, the electronic device includes a mobile device. In some embodiments, the mobile device includes a computer-implemented mobile application configured to monitor the health or physiological parameter over a period of time. In some embodiments, the communication interface communicates with an additional communication interface of the syringe. In some embodiments, the communication interface and the additional communication interface are used to position the patch or the syringe. In some embodiments, the one or more outputs include output signals, wherein the output signals include one or more members selected from vibration signals, audio signals, visual signals, tactile signals, and electrical signals.

[0011] On the other hand, this document provides a system for measuring a health or physiological parameter of a subject, the system comprising: (a) a patch including a first housing having a sensor, the patch being configured to: (i) measure the health or physiological parameter from the subject when the patch is attached to the subject's body, and (ii) provide one or more outputs corresponding to the health or physiological parameter from the subject, wherein the first housing includes an opening; and a syringe having a second housing including a second housing in fluid communication with a fluid flow path, wherein the second housing is coupled to the first housing such that when the patch is attached to the body, a cannula is guided through the opening and into contact with the subject's body, wherein the syringe is configured to: (i) guide a substance from a reservoir into the fluid flow path in fluid communication with the reservoir, and (ii) guide the substance from the fluid flow path through the cannula into the subject.

[0012] In some embodiments, the system further includes a pump integrated with a cannula, wherein the pump is configured to guide a substance from a fluid flow path through the cannula into the subject. In some embodiments, the cannula is configured to extend toward or retract away from the subject's body. In some embodiments, the opening includes a puncturable membrane. In some embodiments, the puncturable membrane is punctured by the cannula to create an opening. In some embodiments, a reservoir is attached 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 used to treat one or more diseases selected from: cardiovascular diseases, musculoskeletal diseases, gastrointestinal diseases, skin diseases, immune diseases, ophthalmic diseases, blood diseases, neurological diseases, oncological diseases, endocrine diseases, metabolic diseases, and respiratory diseases. In some embodiments, the syringe includes a reservoir configured to contain a formulation having the substance. In some embodiments, a first housing is removably coupled to a second housing. In some embodiments, the patch includes a communication interface for transmitting data corresponding to multiple health or physiological parameters to an electronic device communicating 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 near-field 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 direct electrical contact digital or analog interface. In some embodiments, the input transducer / sensor among the plurality of sensors is selected from: conductivity sensors, impedance sensors, capacitance sensors, charge sensors, humidity sensors, temperature sensors, heart rate sensors, interstitial pressure sensors, resistance sensors, optical sensors, expansion sensors, acoustic sensors, vibration sensors, blood pressure sensors, color sensors, chemical sensors, and substance tracking sensors. In some embodiments, the system further includes a second sensor, wherein the second sensor is configured to measure one or more device parameters selected from: the dose of the administered substance, the flow rate of the dispensed substance, the volume of the administered substance, the obstruction of the cannula, and the contact between the cannula and the subject's body. In some embodiments, a patch or syringe includes a second sensor. In some embodiments, the patch also includes one or more transducers. In some embodiments, one or more transducers are configured to generate an output signal, wherein the output signal comprises a vibration signal, an audio signal, or a visual signal. In some embodiments, the output transducer among the plurality of transducers is selected from: tactile (vibration) transducers, audio transducers, visual transducers, and direct electrical stimulation (e.g., transcutaneous electroneuropathy / TENS).

[0013] On the other hand, this document discloses a method for measuring multiple health or physiological parameters of a subject, the method comprising: (a) providing: (i) a patch including a first housing having multiple sensors 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 is coupled to the first housing of the patch, and wherein the syringe includes a reservoir containing a substance and a fluid flow path in fluid communication with the reservoir; (b) attaching the patch to the body of the subject; (c) while the patch is attached to the body of the subject, guiding the cannula through the opening to (i) guide the substance from the reservoir to the fluid flow path, and (ii) guide the substance from the fluid flow path through the cannula into the subject; and (d) using the multiple sensors to (i) measure multiple health or physiological parameters from the subject, and (ii) provide one or more outputs corresponding to the multiple health or physiological parameters from the subject.

[0014] In some embodiments, the method further includes using a pump integrated with the cannula to guide a substance from a fluid flow path through the cannula into the subject. In some embodiments, the cannula is configured to extend toward or retract away from the subject's body. In some embodiments, the opening includes a puncturable membrane. In some embodiments, the puncturable membrane is punctured by the cannula to create the opening. In some embodiments, a reservoir is attached to a syringe. In some embodiments, the reservoir can be removed 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 used to treat one or more diseases selected from: cardiovascular diseases, musculoskeletal diseases, gastrointestinal diseases, skin diseases, immune diseases, ophthalmic diseases, blood diseases, neurological diseases, oncological diseases, endocrine diseases, metabolic diseases, and respiratory diseases. In some embodiments, the syringe includes a reservoir configured to contain a formulation having the substance. In some embodiments, a first housing is removably coupled to a second housing. In some embodiments, the patch includes a communication interface for transmitting data corresponding to multiple health or physiological parameters to an electronic device communicating with the communication interface. In some embodiments, the communication interface is a wireless communication interface. In some embodiments, the communication interface is a Wi-Fi interface. In some embodiments, the communication interface is a near-field communication interface. In some embodiments, the communication interface is a Bluetooth interface. In some embodiments, the communication interface is an optical wireless interface. In some embodiments, the input transducer / sensor among the multiple sensors is selected from: conductivity sensors, impedance sensors, capacitance sensors, charge sensors, humidity sensors, temperature sensors, heart rate sensors, interstitial pressure sensors, resistance sensors, expansion sensors, acoustic sensors, vibration sensors, blood pressure sensors, color sensors, chemical sensors, and material tracking sensors. In some embodiments, the output transducer among the multiple transducers is selected from: tactile (vibration) transducers, audio transducers, visual transducers, and direct electrical stimulation (e.g., transcutaneous electroneuropathy stimulation / TENS).

[0015] In some implementations, the second sensor among a plurality of sensors is selected from the following: temperature sensor, humidity sensor, flow rate sensor, button position sensor, vibration sensor, hearing sensor, and skin sensor.

[0016] In another aspect, this document provides a syringe comprising: (a) a housing; (b) a drug reservoir disposed 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 mounted on or within the housing; (e) a skin attachment layer attached to the housing, the skin attachment layer comprising an adhesive configured to hold the housing to a user's skin with a first holding force; (f) a patch removably attached to the housing with a second holding force, the patch comprising: a sensor adhesive layer configured to hold the patch to a user's skin with a third holding force; a patch input transducer / sensor; an output transducer; and circuitry configured to receive data from the syringe transducer / sensor and the patch transducer / sensor and to transmit the received data to a remote receiver; (g) wherein the third holding force is greater than the second holding force.

[0017] 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 through perforations. In some embodiments, the patch is removably secured to the housing by a magnet. In some embodiments, the magnet is positioned within or on the housing of the syringe, and the patch includes a metal portion configured to engage with the magnet. In some embodiments, the skin attachment layer includes an opening, and the patch is positioned within the opening when the patch is removably secured to the syringe housing. In some embodiments, the opening is located at the center of the skin attachment layer, and when in the dispensing position, the syringe cannula passes through the opening of the skin attachment layer and the orifice of the patch. In some embodiments, the patch includes an extension that includes an orifice through which the syringe cannula passes when in the dispensing position, the extension being configured to compress the user's skin around the injection site. In some embodiments, the patch includes a printed circuit board on which the circuitry is positioned, and a sensor adhesive layer and a patch transducer / sensor are attached to the printed circuit board, the sensor adhesive layer including a central window through which an extension passes.

[0018] In some embodiments, the extension is generally tapered. In some embodiments, the patch includes a printed circuit board, circuitry is positioned on the printed circuit board, and a sensor adhesive layer and a patch sensor are attached to the printed circuit board. In some embodiments, the patch circuitry includes a microcontroller / microprocessor and a transmitter. In some embodiments, the syringe sensor includes a transmitter, and the patch circuitry also includes a receiver, through which data is received wirelessly from the syringe transducer / sensor and transmitted wirelessly to the transducer. In some embodiments, the microcontroller / microprocessor, transmitter, and receiver are combined into a single component. In some embodiments, the syringe also includes a wire connection between the syringe transducer / sensor and the patch circuitry, the wire connection being configured to disconnect when or after the syringe is removed from the patient. In some embodiments, the microcontroller / microprocessor and transmitter are combined into a single component. In some embodiments, the transmitter is a Bluetooth transmitter. In some embodiments, the syringe sensor includes multiple input transducers / sensors and an output transducer. In some embodiments, the patch sensor includes multiple input transducers / sensors and an output transducer. In some implementations, the patch sensor includes multiple input transducers / sensors and an output transducer.

[0019] In another aspect, this document provides a method for collecting data from a syringe and a patient, the method comprising (a) attaching a syringe including a syringe sensor and a patch including a patch sensor, an output transducer, and circuitry to a patient; (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 circuitry; (d) removing the syringe from the patient; (e) receiving additional data from the syringe sensor using the patch circuitry after removing the syringe from the patient; and (f) transmitting the additional received data to a remote receiver using the patch circuitry.

[0020] In some embodiments, the syringe and patch are simultaneously attached to the patient. In some embodiments, (a) includes attaching the patch before the syringe and before attaching the syringe to the patient, and further includes receiving data from a patch sensor using patch circuitry, and transmitting the received data to a remote receiver using patch circuitry. In some embodiments, the data collected from the patient includes measurable properties that may be affected by medication administered by the syringe and / or by injecting medication with the syringe. In some embodiments, the data collected from the patient includes measurable properties that may affect the safety and / or effectiveness of medication administered by the syringe and / or the use of the injection, or serve as an indicator thereof.

[0021] In another aspect, this article provides a method for monitoring injection site reactions in a patient, the method comprising the steps of: (a) attaching a syringe including a patch comprising a patch sensor and circuitry to a patient, wherein the patch sensor includes a skin temperature transducer / sensor and a skin color monitor; (b) receiving data from the patch sensor using the patch circuitry; and (c) transmitting the received data to a remote receiver using the patch circuitry, wherein the data includes indications of temperature rise or skin color change, enabling identification of injection site reactions.

[0022] In another aspect, this document discloses a syringe comprising (a) a housing; (b) a drug reservoir disposed 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, the patch sensor being removably attached to the housing with a first retaining force; (e) an attachment layer attached to the patch sensor, the attachment layer comprising an adhesive configured to secure the patch sensor to a user's skin using a second retaining force; and (f) wherein the second retaining force is greater than the first retaining force, such that the patch sensor remains attached to the user's skin when the housing is removed from the patch sensor.

[0023] In some embodiments, the subject's body is skin. In some embodiments, the patch is configured to receive data from a syringe. In some embodiments, the data is used to adjust device parameters of the patch or syringe. In some embodiments, the device parameters include one or more device parameters selected from: the dose of substance administered by the syringe, the flow rate of the substance dispensed by the syringe, and the volume of substance administered by the syringe. In some embodiments, the data is used to generate a notification to the subject via a transducer. In some embodiments, the notification includes one or more notifications selected from: a vibration indicator, an acoustic indicator, a direct electrical stimulation indicator, and a visual indicator.

[0024] Several aspects of this subject matter may be implemented individually or together in the apparatuses and systems described and claimed below. These aspects may be employed individually or in combination with other aspects of the subject matter described herein, and the description of these aspects together is not intended to exclude the individual use of these aspects or the individual claims of such aspects or the different combinations set forth in the appended claims.

[0025] This subject matter includes delivery devices and / or syringes of any suitable detailed construction, but U.S. Patent No. 9,925,333 describes delivery devices and syringes that are particularly useful when used in combination with the devices described herein, the contents of which are hereby incorporated by reference.

[0026] In one aspect, the syringe includes a housing. A drug reservoir is disposed within the housing, and an injection cannula is movable within the housing between a pre-dispensing position and a dispensing position in fluid communication with the reservoir. A syringe sensor is mounted on or within the housing. A skin attachment layer is attached to the housing and includes an adhesive configured to hold the housing to the user's skin with a first holding force. A patch is removably attached to the housing with a second holding force and includes a sensor adhesive layer configured to hold 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 also includes a patch sensor and circuitry configured to receive data from the syringe sensor and the patch sensor, and to transmit the received data to a remote receiver.

[0027] In another aspect, a method for collecting data from a syringe and a patient is provided, the method comprising the steps of: attaching a syringe including a syringe sensor and a patch including a patch sensor and circuitry to a patient; receiving data from the syringe sensor and the patch sensor using the patch circuitry; transmitting the received data to a remote receiver using the patch circuitry; removing the syringe from the patient; receiving additional data from the syringe sensor using the patch circuitry after removing the syringe from the patient; and transmitting the additionally received data to the remote receiver using the patch circuitry.

[0028] In another aspect, a method for monitoring injection site reactions in a patient includes the steps of: attaching a syringe comprising a patch including a patch sensor and circuitry to a patient, wherein the patch sensor includes a skin temperature sensor and a skin color monitor; receiving data from the patch sensor using the patch circuitry; and transmitting the received data to a remote receiver using the patch circuitry, wherein the data includes indications of temperature rise or skin color change, enabling the identification of injection site reactions.

[0029] On the other hand, the syringe includes a housing having a drug reservoir disposed within the housing. An injection cannula is movable within the housing between a pre-dispensing position and a dispensing position in fluid communication with the reservoir. A patch sensor configured to receive and transmit data is removably attached to the housing with a first holding force. A skin attachment layer is attached to the patch sensor and configured to secure the patch sensor to the user's skin using a second holding force, wherein the second holding force is greater than the first holding force.

[0030] Another aspect of this disclosure provides a non-transitory computer-readable medium containing machine-executable code that, when executed by one or more computer processors, implements any of the methods described above or elsewhere herein.

[0031] Another aspect of this disclosure provides a system comprising one or more computer processors and computer memory coupled thereto. The computer memory contains machine-executable code that, when executed by the one or more computer processors, implements any of the methods described above or elsewhere herein.

[0032] Other aspects and advantages of this disclosure will become readily apparent to those skilled in the art from the following detailed description (in which only illustrative embodiments of this disclosure are shown and described). As will be appreciated, this disclosure is capable of other and different embodiments, and modifications can be made to certain details in various obvious respects without departing from this disclosure. Therefore, the drawings and descriptions are to be considered illustrative in nature and not restrictive.

[0033] Incorporation

[0034] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference to the extent that each individual publication, patent, or patent application is specifically and individually indicated as incorporated by reference. Where a publication, patent, or patent application incorporated by reference contradicts the disclosure contained in this specification, the specification is intended to supersede and / or take precedence over any such contradictory material. Attached Figure Description

[0035] The novel features of the invention are specifically set forth in the appended claims. A better understanding of the features and advantages of the invention will be obtained by referring to the following detailed description and accompanying drawings (also referred to herein as “Figures”) illustrating illustrative embodiments in which the principles of the invention are utilized, in which:

[0036] Figure 1 A perspective view of the syringe is shown.

[0037] Figure 2 A top view of a filled syringe is shown, along with a delivery indicator indicating that it is full.

[0038] Figure 3 A top view of a filled syringe is shown, along with a delivery indicator when empty.

[0039] Figure 4 A perspective view is shown, illustrating the underside of the syringe with attachment tape and a filling port.

[0040] Figure 5 A perspective view is shown, illustrating the underside of the syringe with separation tape and exposed filling and dispensing ports.

[0041] Figure 6 A cross-section of a syringe on a delivery device is shown.

[0042] Figure 7 A perspective view of a syringe with a safety device attached to the body (e.g., skin) is shown.

[0043] Figure 8 A perspective view of a syringe attached to the body (e.g., skin) is shown, with the safety device removed and the button facing upward in the pre-firing position.

[0044] Figure 9 A perspective view of a syringe attached to the body (e.g., skin) is shown, with the safety device removed and the button facing down in the firing position.

[0045] Figure 10 A cross-sectional view of a syringe attached to the body (e.g., skin) is shown, with the button facing upwards in the pre-firing state.

[0046] Figure 11 A cross-sectional view of a syringe attached to the body (e.g., skin) is shown, with the button facing down in the first firing state.

[0047] Figure 12 A cross-sectional view of a syringe attached to the body (e.g., skin) is shown, with the button facing down in the dispensing state.

[0048] Figure 13 A cross-sectional view of a syringe attached to the body (e.g., skin) is shown, illustrating an untriggered delivery end indicator.

[0049] Figure 14 A cross-sectional view of a syringe attached to the body (e.g., skin) is shown, illustrating a triggered delivery end indicator.

[0050] Figure 15 A cross-sectional view of a syringe attached to the body (e.g., skin) is shown, with the button locked in the post-firing state.

[0051] Figure 16A A perspective view shows the syringe being removed from the body (e.g., the skin), with a bandage remaining on the skin. Figure 16B A perspective view shows the syringe being removed from the body (e.g., the skin), with the bandage containing an opening left in the skin.

[0052] Figure 17 This is a perspective view of a syringe in which the top shell has been removed while it is filled.

[0053] Figure 18 It shows Figure 17 The top view of the syringe is shown in the image.

[0054] Figure 19 This is a perspective view of a syringe in which the top shell has been removed in an empty state.

[0055] Figure 20 It shows Figure 19 The top view of the syringe is shown in the image.

[0056] Figure 21 A perspective view of a syringe placed on the body (e.g., skin) with a safety device in place is shown.

[0057] Figure 22 A perspective view of a syringe placed on the body (e.g., skin) with the safety device removed is shown.

[0058] Figure 23 A perspective view shows a syringe placed on the body (e.g., skin) and a button pressed to fire and begin an injection.

[0059] Figure 24 A perspective view shows the syringe being removed from the body (e.g., skin) after injection, with the button in the locked position and the bandage remaining on the body (e.g., skin).

[0060] Figure 25 A perspective view of the syringe is shown.

[0061] Figure 26 It shows Figure 25 The cross-section shows the syringe with the button in the first position.

[0062] Figure 27 The illustration shows four stages of cannulation through tissue, including a) no contact, b) boundary displacement, c) tip insertion, and d) axial insertion (Dr. Van Gerwen's PhD dissertation at Delft University of Technology, "Cannula-Tissue Interaction by Experiment", 2013. ISBN 978-94-6186-238-9, page 11).

[0063] Figure 28 It shows Figure 25 The cross-section shows the syringe with the button in the second position or the dispensing position.

[0064] Figure 29 It shows Figure 25 The cross-section shows the adhesive / device and adhesive / body (e.g., skin) interface.

[0065] Figure 30 A perspective view of the bottom of the syringe is shown, illustrating different areas of the adhesive.

[0066] Figure 31 It shows Figure 25 The cross-section shows the protruding tissue on the device with a permanently attached adhesive.

[0067] Figure 32 It shows Figure 25 The cross-section shows the protruding tissue on the device with multi-zone adhesive.

[0068] Figure 33 A perspective view of the top of the alternative syringe is shown.

[0069] Figure 34 It shows Figure 33 The cross-section shows the unengaged displacement sensor and the cannula locked in the dispensing position.

[0070] Figure 35 It shows Figure 33 The cross-section shows the displacement sensor engaged and the cannula and button retracted to the post-firing position.

[0071] Figure 36 It shows Figure 25 The cross-section shows the syringe with the button in the first or paused position.

[0072] Figure 37 It shows Figure 25 The cross-section shows the syringe with the button in the second position or the dispensing position.

[0073] Figure 38 It shows Figure 25 A cross-section of the syringe is shown, in which the cannula is retracted and the button is in the upward or pre-firing position.

[0074] Figure 39 It shows Figure 25 The cross-section shows the syringe with the button in the second position or the dispensing position.

[0075] Figure 40 A perspective view of the syringe is shown.

[0076] Figure 41 A cross-sectional perspective view of the syringe with the button in the second or dispensing position is shown.

[0077] Figure 42 A perspective view of a syringe with an attached safety cannula is shown.

[0078] Figure 43 A cross-sectional perspective view of the syringe with the button in the second or dispensing position is shown.

[0079] Figure 44A perspective view of a syringe including a radio frequency (RF) tag and a tag reader or interrogator is shown.

[0080] Figure 45 It shows something similar to Figure 44 However, a cross-section of the syringe is shown.

[0081] Figure 46 A block diagram / flowchart is shown, illustrating a system that uses this topic to monitor patient compliance.

[0082] Figure 47 An ultrasound image is shown, illustrating the subcutaneous injection depth using a commercial infusion pump with a 9 mm subcutaneous cannulation depth.

[0083] Figure 48 An ultrasound image is shown, illustrating the injection depth using a syringe 7 with a 5 mm cannula depth.

[0084] Figure 49 A compliance monitoring system was described.

[0085] Figure 50 It also describes a compliance monitoring system.

[0086] Figure 51 Another aspect of compliance monitoring with syringes of the type described herein is shown.

[0087] Figure 52 A top perspective view of the RF chip in an embodiment of the syringe of this disclosure is shown.

[0088] Figure 53 A bottom perspective view of an RF chip according to an embodiment of the present disclosure is shown.

[0089] Figure 54 A top perspective view shows an embodiment of the syringe of this disclosure with a safety tab installed.

[0090] Figure 55 A top perspective view of the syringe with the safety tab removed is shown.

[0091] Figure 56 A cross-sectional view of the syringe is shown, illustrating the buttons in the raised, extended, or upward position.

[0092] Figure 57 A cross-sectional view of the syringe is shown, illustrating the button in the lowered, retracted, or downward position.

[0093] Figure 58 A flowchart is shown illustrating the processes performed by a microcontroller / microprocessor in an embodiment of the syringe disclosed herein.

[0094] Figure 59 A bottom perspective view of a syringe with a removable patch according to an embodiment of this disclosure is shown.

[0095] Figure 60 It shows Figure 59 Exploded view of the syringe and patch.

[0096] Figure 61 It shows Figure 60 Top-side perspective view of a surface-mount printed circuit board (PCB) chip.

[0097] Figure 62 It shows Figure 60 Bottom perspective view of the surface-mount PCB chip.

[0098] Figure 63 It shows Figures 59 to 63 A schematic diagram of the syringe and patch.

[0099] Figure 64 A schematic diagram of another example of a syringe coupled to a patch is shown.

[0100] Figure 65 It shows Figure 64 Another view of the patch and syringe shown in the image.

[0101] Figure 66 A schematic diagram of another example of a syringe coupled to a patch is shown.

[0102] Figure 67 A schematic diagram of another example of a syringe coupled to a patch is shown.

[0103] Figure 68 It shows Figure 67 Cross-sectional view of the patch and syringe.

[0104] Figure 69 A schematic diagram of another example of a syringe coupled to a patch is shown.

[0105] Figure 70 It shows Figure 69 Cross-sectional view of the patch and syringe.

[0106] Figure 71 A schematic diagram of another example of a syringe coupled to a patch is shown.

[0107] Figure 72 It shows Figure 71 Cross-sectional view of the patch and syringe.

[0108] Figure 73 A schematic diagram of another example of a syringe coupled to a patch is shown.

[0109] Figure 74 It shows Figure 73 Cross-sectional view of the patch and syringe.

[0110] Figure 75 A schematic diagram of another example of a syringe coupled to a patch is shown.

[0111] Figure 76 A schematic diagram of another example of a syringe coupled to a patch is shown.

[0112] Figure 77 A schematic diagram of another example of a syringe coupled to a patch is shown.

[0113] Figure 78 It shows Figure 77 Cross-sectional view of the patch and syringe.

[0114] Figure 79 A schematic diagram of another example of a syringe coupled to a patch is shown.

[0115] Figure 80 A schematic diagram of another example of a syringe coupled to a patch is shown.

[0116] Figure 81 It shows Figure 80 Cross-sectional view of the patch and syringe.

[0117] Figure 82 A schematic diagram of another example of a syringe coupled to a patch is shown.

[0118] Figure 83 It shows Figure 82 Cross-sectional view of the patch and syringe.

[0119] Figure 84 A schematic diagram of another example of a syringe coupled to a patch is shown.

[0120] Figure 85 It shows Figure 84 Cross-sectional view of the patch and syringe.

[0121] Figure 86 A schematic diagram of another example of a syringe coupled to a patch is shown.

[0122] Figure 87 It shows Figure 86 Cross-sectional view of the patch and syringe.

[0123] Figure 88 A schematic diagram of another example of a syringe coupled to a patch is shown.

[0124] Figure 89 It shows Figure 88Cross-sectional view of the patch and syringe.

[0125] Figure 90 A schematic diagram of an example patch having a punctureable membrane configured to be coupled to a syringe is shown.

[0126] Figure 91 It shows Figure 90 Another view of the patch.

[0127] Figure 92 A schematic diagram of another example patch with a puncture-resistant membrane configured to be coupled to a syringe is shown.

[0128] Figure 93 A schematic diagram of an example patch having a punctureable membrane configured to be coupled to an autoinjector is shown.

[0129] Figure 94 The syringe's patch sensor and Figures 59 to 93 A schematic diagram illustrating an implementation of any one of the patches.

[0130] Figure 95 A schematic diagram of the sensor adhesive layer of the patch in an alternative embodiment of this disclosure is shown.

[0131] Figure 96 A schematic diagram of the sensor adhesive layer of the patch in an embodiment of this disclosure is shown.

[0132] Figure 97 This schematically illustrates an example workflow for a mobile application.

[0133] Figure 98 This schematically illustrates another example workflow of a mobile application.

[0134] Figure 99 A to Figure 99 C schematically illustrates another example workflow of a mobile application.

[0135] Figure 100 A computer system is shown that is programmed or otherwise configured to implement the methods provided herein.

[0136] Figure 101 Examples of patches and syringes with membranes are shown schematically.

[0137] Figure 102 Another example of a reusable patch and a syringe with a membrane is illustrated. Detailed Implementation

[0138] Although various embodiments of the invention have been shown and described herein, it will be apparent to those skilled in the art that these embodiments are provided merely as examples. Many variations, modifications, and substitutions will occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed.

[0139] Whenever the term "at least," "greater than," or "greater than or equal to" precedes the first value in two or more numerical series, the term "at least," "greater than," or "greater than or equal to" applies to each value in the numerical series. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.

[0140] Whenever the terms "not greater than", "less than", or "less than or equal to" precede the first value in two or more numerical series, the terms "not greater than", "less than", or "less than or equal to" apply to each value in the numerical series. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.

[0141] As used herein, the term "subject" generally refers to a user of the apparatus, system, or method of this disclosure, or an individual using the apparatus, system, or method of this disclosure. A subject may be a patient (e.g., a patient being treated or monitored by a physician or healthcare provider). Alternatively, a subject may not be a patient. A subject may have or be suspected of having a disease or condition. Alternatively, a subject may not have symptoms of a disease or condition. A subject may be a vertebrate, mammal (e.g., a human or animal), non-human primate, etc. A subject may be an animal, such as a rodent (e.g., a rat or mouse), a canine (e.g., a dog), a feline (e.g., a cat), a cow, or another animal.

[0142] As used herein, the term "medicine" generally refers to a substance intended to treat a subject's health or physiological state or condition (e.g., medical treatment). A medicine can be a pharmaceutical preparation or a therapeutic agent. A medicine can be a solid, liquid, gas, or a combination thereof. A medicine can be an aerosol, pill, tablet, capsule, lozenge, elixir, emulsion, effervescent powder, solution, suspension, tincture, liquid, gel, dry powder, vapor, droplets, ointment, or a combination or variation thereof. A medicine can be used to treat ailments, minor illnesses, or diseases, or can be used as a health supplement (e.g., vitamins, minerals, probiotics, etc.).

[0143] As used herein, the term "reusable" generally refers to an item that can be used multiple times. The item can be reused for the same purpose or for different purposes. The item can be disposed of after use and then reused. The item can be reused at least once, at least twice, at least three times, at least four times, at least five times, at least six times, at least seven times, at least eight times, at least nine times, at least ten times, at least twenty times, at least thirty times, at least four hundred times, at least fifty times, at least six hundred times, at least seventy times, at least eighty times, at least ninety times, at least one hundred times, at least two hundred times, at least three hundred times, at least four hundred times, at least five hundred times, at least six hundred times, at least seven hundred times, at least eight hundred times, at least nine hundred times, at least one hundred thousand times, at least one hundred thousand times, or more.

[0144] This disclosure provides apparatus, methods, and systems for delivering a substance (e.g., a drug) to a subject and monitoring the subject before, during, and / or after delivery of the substance. The apparatus of this disclosure may be a syringe for delivering the drug. Alternatively, or otherwise, the apparatus may be a patch configured to monitor the subject and / or communicate with the syringe. In some examples, the syringe and patch are separate devices (e.g., separable from each other). Alternatively, the syringe and patch may be part of a single device (e.g., inseparable from each other).

[0145] syringe

[0146] refer to Figure 1 The syringe 7 can be any suitable configuration. As previously described, the syringe can advantageously employ one or more features of the syringe described in U.S. Patent No. 9,925,333, the contents of which are hereby incorporated herein by reference.

[0147] refer to Figures 1 to 3The syringe 7 has a generally low-profile, disc-shaped housing 74 with an upper surface 75 and a lower surface 76 through which a cannula or needle protrudes when actuated by a user. The upper surface 75 has an actuator or button 77 for initiating injection, and a section 80 of the housing 74 that allows the subject or medical professional to observe the expandable member 78 to determine the amount of substance 79 (e.g., injectable fluid or drug in the reservoir of the syringe 7). In such cases, the section 80 of the housing may contain a transparent material, and the user can determine whether injection has begun or ended. In some cases, the expandable member 78 and / or the section 80 of the housing 74 may be graded, such as by a dividing line 127, allowing the subject or medical professional to more accurately visually determine the amount of remaining substance 79, such as, for example, about 50% complete or about 75% complete. Furthermore, the expandable member 78 itself may include features on or interact with features on the housing 74 to indicate the amount of substance 79 remaining in the syringe's reservoir. For example, when the syringe 7 is full of substance 79, the transparent section 80 may display a color, such as, but not limited to, green. When the syringe 7 is empty of substance 79, the transparent section 80 may display a different color, such as, but not limited to, red. During dispensing, the transparent section 80 may display a combination of colors.

[0148] refer to Figures 4 to 6 The lower surface 76 of the syringe 7 includes a filling port 81 and a dispensing port 82. The filling port 81 is an interface that allows the delivery device filling tube 83 to deliver substance 79 to the syringe 7 (e.g., a reservoir of the syringe). The dispensing port 82 also includes an internal path 84 between the substance 79 discharged from the expandable member 78 and the cannula 85. The filling port 81 and the dispensing port 82 can be in direct fluid communication through the internal path 86, or they can be combined into a single port.

[0149] refer to Figures 4 to 6 The syringe may include a filling port 81, which includes a check valve 87 to prevent pressurized material 79 from leaking to the outside of the syringe 7 when the syringe 7 is removed from the delivery device 6 and the filling port 81 is removed from the filling tube 83.

[0150] refer to Figures 4 to 6 The syringe 7 may also have a filling port 81 configured to accept insertion of a syringe. The syringe may be configured to have a Luer connector or a cannula. The configuration of the filling port 81 allows the user to manually fill the syringe. The delivery device 6 can still be used, but it will no longer be needed in this configuration.

[0151] refer to Figures 4 to 26The syringe 7 may also have a dispensing port 82, which is configured to be directly connected to the cannula via an attached tubing or standard cannula port.

[0152] refer to Figures 4 to 6 The lower surface 76 of the syringe 7 carries an adhesive 88 for temporarily securing the syringe 7 to the subject's body (e.g., skin) before injection is completed. During removal of the syringe 7, the adhesive tape pad 89 can be 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 pad 89 may have a tab 90 that the user pulls to manually remove before adhering the syringe 7 to the skin. Alternatively, the tab may be attached to the surface of the delivery device 4 such that the tape pad is automatically removed when the syringe 7 is removed.

[0153] refer to Figures 4 to 6 The syringe 7 may have an adhesive tape flange 91 extending beyond the lower surface base 76. The flange 91 of the adhesive tape 88 serves as a strain relief element between the syringe 7 and the skin surface, thereby reducing the risk of accidental detachment of the syringe 7 from the skin. In other words, similar to a tapered strain relief element on a wire entering a connector, the extended 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 to reduce any stress rise at the interface between the adhesive tape 88 and the skin.

[0154] refer to Figures 4 to 6 The syringe 7 can be configured to have a tapered underside surface 98 that presses against the adhesive flange 91 to securely attach the adhesive tape 88 to the skin without additional user intervention when the user holds the syringe 7 against the skin. By utilizing the compliance of the skin when the syringe 7 is pressed against it, the tapered underside surface 98 of the syringe 7 effectively presses the flange 91 of the adhesive tape 88 against the skin, but the upper exposed surface of the flange 91 portion is not exposed to adhesive and therefore not attached to said portion of the tapered underside surface 98. The user does not need to move their fingers around the flange 91 to hold the syringe 7 to the skin, making it a much simpler method of attaching the adhesive tape 88.

[0155] refer to Figures 4 to 6 The syringe 7 may have a lower surface 76, which is flexible or compliant rather than rigid, to allow for improved adhesion during application by conforming the syringe 7 to the skin.

[0156] refer to Figures 7 to 9After the syringe 7 is placed against or adhered to the subject's body (e.g., skin) 99, the safety mechanism or locking mechanism can be automatically released, and the syringe 7 is ready to fire (injection). In such cases, the syringe 7 is prevented from being actuated (locked) until it is placed against the skin. Alternatively, the user can manually remove the safety device 100, such as a safety pin, safety sleeve, tab, or collar, to release the syringe to prepare for firing (injection or guiding cannula through the opening into the subject). In some cases, the syringe 7 cannot be fired until the safety mechanism 100 is released. The safety mechanism 100 can be passive or active and can be manually triggered by the user or automatically triggered by the syringe 7.

[0157] refer to Figures 7 to 9 The syringe 7 can be used in combination with an actuator or button 77 and a visual indicator 101 to indicate the parameters of the syringe 7 after it has been removed from the delivery device. For example, when the button 77 is in the upward position and the indicator 101 has a color (such as, but not limited to, green), this can indicate that the syringe 7 is ready to begin injection. Furthermore, the button 77 can have a sidewall 102 that is a different color from its top 103. When the button 77 is pressed, the user cannot see the sidewall 102 of the button 77; this can indicate that the syringe 7 is in use. When the injection of the medication is complete, the syringe 7 can alert the user. The alert can be in the form of a visual indicator, an auditory sound, a mechanical movement, or a combination thereof. The button 77 is ideally designed to provide auditory, visual, and tactile feedback to the subject or user when the button 77 “pops up” to the locked position. The syringe 7 can indicate to the subject that it has completed dispensing and that the full dose has been delivered to the patient, with the button 77 in the upward position and the indicator window 101 showing that the syringe reservoir is empty. For example, when button 77 is in the up position and indicator 101 displays a different color (such as, but not limited to, red), this can indicate that syringe 7 has finished injecting.

[0158] refer to Figures 10 to 12 The syringe 7 may have an actuator or button 77, which is pressed by the subject or user to initiate injection. The button 77 may be configured as an on / off switch (e.g., a light switch), i.e., having only two states: open and closed. This prevents the user from pushing the button 77 halfway without actuating the syringe 7. Once activated, the "light switch" type button 77 will rapidly guide the cannula 85 into the skin 99 independently of user manipulation of the button 77. Alternatively, the button 77 may have continuous motion, allowing the user to slowly guide the cannula 85 into the skin 99. The button 77 and the cannula 85 can be formed by preferably directly coupling the button 77 to the cannula 85 using an adhesive 104.

[0159] refer to Figures 10 to 12 The syringe 7 may have a cannula 85, which, when coupled to the skin and actuated, guides substance from the reservoir into a fluid flow path in fluid communication with the reservoir, thereby guiding the substance from the reservoir into the skin 99. When the button 77 is actuated, the button 77 initially reaches as... Figure 11 The first position or depth is shown, and it is slightly recessed to a second position or depth (automatically in some cases), such as... Figure 12 As shown in the image. Figure 11 The first depth shown is achieved by the overtravel of button 77 during actuation. The first depth can be controlled by feature 105 in button 77 that directly contacts the base 106 of syringe 7. The final depth of cannula 85 is suitable for subcutaneous injection. Alternatively, for intradermal injection, the final depth of cannula 85 can be decreased. Alternatively, for intramuscular injection, the final depth of cannula 85 can be increased. Upon reaching the first depth, cannula 85 retracts away from the subject's body to a second depth, such as... Figure 12 As shown in the diagram, the retraction distance of the cannula to the second depth is in the range of 0.1-2 mm. In such cases, the retraction feature serves to prevent the cannula 85 from being blocked by tissue during the initial insertion process. Such tissue blockage may require very high pressure to overcome and prevent the syringe 7 from delivering the medication. The cannula 85 retracts from the first position to the second position, creating an open area before the cannula tip 107, thereby allowing pressure reduction to initiate the flow of medication from the cannula 85. In some cases, in order to maintain a relatively constant pressure in the syringe 7, the decompression used to guide the substance through the cannula during injection to initiate the flow of medication from the cannula is necessary.

[0160] refer to Figures 10 to 12 The syringe 7 may include a cannula 85 having a side opening 108. For example... Figure 12 As shown, once the button 77 on the syringe 7 is fully pressed, the cannula 85 is fully inserted into the skin 99 through the dispensing port 82 and the syringe 7 begins dispensing the substance. Before the button 77 is fully pressed, the side opening 108, and therefore the lumen of the cannula 85, is not in communication with the fluid passage 86 of the dispensing port 82. Both the side opening 108 and the cannula tip 107 remain within the septum 109. Because the side opening 108 and the cannula tip 107 remain within the septum 109, the entire drug pathway remains sterile before use. When the button 77 is fully pressed and the cannula 85 is in the dispensing position, the side opening 108 in the cannula 85 communicates with the fluid passage 86 of the dispensing port 82, and the injection of the substance (e.g., an injectable drug or fluid) begins.

[0161] refer to Figures 10 to 12The diaphragm 109 provides the advantage of sealing the cannula tip 107 and the side opening 108 with the injected material before and after dispensing. Sealing the cannula tip 107 and the side opening 108 of the cannula 85 at the end of the injection has the particular advantage of preventing substances (e.g., injectable fluids) from dripping from the syringe 7 after dispensing and / or removal from the skin surface. It also prevents contaminants from entering the hollow cannula before it is actuated into the skin. The diaphragm 109 may comprise a puncture-resistant membrane, which may be made of any suitable material to allow for sealing once the cannula 85 is punctured. The material composition of the diaphragm 109 or the puncture-resistant membrane may comprise silicone. Alternatively, the material composition of the diaphragm 109 or the puncture-resistant 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 having an overmolded silicone resin to produce the diaphragm described previously.

[0162] refer to Figures 10 to 12 The diaphragm 109 at the dispensing port 82 can protrude slightly from its lower surface into the skin surface 99 of the syringe 7 to provide pressure on the skin surface 99 at the injection site. After the cannula is retracted, the pressure on the skin surface 99 by the dispensing port 82 can prevent the substance from flowing out of the injection site, commonly referred to as backflush.

[0163] refer to Figures 10 to 12 The syringe 7 may include a set of spring tabs 110 that interact with the button 77 to perform a locking function. The spring tabs 110 are biased to lock in an undercut 111 within the button 77 to hold the button 77 in a first upward position or pre-firing position, such as... Figure 10 As shown in the diagram, the geometry of the undercut 111 and the spring tab 110 contributes to the previously described actuation force of the lamp switch. The lamp switch actuation is achieved by the translation of the button 77 relative to the spring tab 110 and its engagement with the geometry of the undercut 111 surface.

[0164] refer to Figures 10 to 12 The syringe 7 may include a spring tab 112 that interacts with a button 77 in the syringe 7 to perform a locking function, such that when the button 77 is actuated to a first depth and slightly retracted to a second depth or dispensing position, the undercut feature 113 in the button 77 allows the spring tab 112 to hold the button 77 in the dispensing position until the syringe 7 has finished dispensing.

[0165] refer to Figures 13 to 14The syringe 7 may include a delivery end indicator or an empty indicator 114 to sense when all material (e.g., a drug or injectable fluid) has been expelled from the expandable member 78 and the syringe 7 has completed dispensing. The empty indicator 114 may be configured to have a slot or other opening 115 to slide across the expandable member 78 at the outlet port when the expandable member 78 is in a deflated state after all material has been expelled. The empty indicator may have two states. Figure 13 As shown, when the expandable member 78 is filled with material in the section and not contained within the slot or opening 115, the empty indicator can be in a first position or a deflected state. When the diameter of the expandable member 78 exceeds its minimum value due to residual material contained therein, the first position will transition to a non-empty state of the expandable member 78. Figure 14 As shown, when the expandable member 78 is partially or completely contained within the slot or opening 115, the empty indicator 114 can be in a second position or deflected state. When the diameter is at its minimum, the second position will transition to the empty state of the expandable member 78.

[0166] refer to Figures 13 to 14 The syringe 7 may include an automatic cannula retraction mechanism at the end of dispensing. This mechanism includes a direct coupling between a spring tab 112, a button undercut feature 113, and an empty indicator 114, all of which have been previously mentioned. Figure 14 As shown, when the expandable member 78 is filled with a substance (e.g., a drug or injectable fluid) and the button 77 is pressed from the first pre-firing position to the second dispensing position, the undercut feature 113 in the button 77 allows the spring tab 112 to hold the button 77 in the dispensing position until the syringe 7 has finished dispensing. The spring tab 112 can also be directly coupled to the empty indicator 114, which is naturally in the first position or deflected state. The action of pressing the button 77 to the second position or dispensing position allows the post feature 116 in the button 77 to provide bias or pretension on the spring tab 112 to guide the empty indicator 114 to its second position or deflected state. However, because the expandable member 78 is initially filled with a large-diameter substance, the empty indicator 114 cannot move as... Figure 13 The second position or deflection state is shown in the diagram. After button 77 is pressed, material begins to be discharged from the expandable member 78 through the cannula, as previously described. Once the expandable member 78 has discharged all material and is at its minimum diameter, the empty indicator 114 (under pretension from the spring tab 112) will move to the second position or deflection state, as shown in the diagram. Figure 14As shown in the diagram, the spring tab 112, directly coupled to the empty indicator 114, also moves with the empty indicator 114. This movement releases the spring tab 112 from the undercut feature 113 in the button 77, allowing the button 77 (and the cannula) to move upwards to the final position or the post-firing position after dispensing, as shown in the diagram. Figure 15 As shown in the image.

[0167] refer to Figure 15 The locking spring tab 117 can also interact with the button 77 in the syringe 7 to perform a locking function, such that when the injection is complete, the button 77 is released and pushed upward by the return spring 118 to the final upward position or the post-firing position. In the final upward position or the post-firing position (e.g....) Figure 15 As shown in the figure, the button height 77 relative to the top of the syringe 7 can be higher than the pre-firing position (as shown in the figure). Figure 10 (As shown in the figure). The end of the locking spring tab 117 moves outward to the outer diameter surface 119 of the button 77 within the housing 74 to lock the button 77 in the up position or the post-fired position and to prevent the button 77 from being actuated again.

[0168] refer to Figure 15 The syringe 7 may include a return spring 118 that interacts with a button 77 to bias the button 77 to a first upward position or pre-firing position. When the button is actuated downward to a second depth or dispensing position, the return spring 118 is compressed, resulting in a greater bias or preload. At the end of the dispensing cycle, the button 77 is released from the second depth or dispensing position (e.g., Figure 12 (As shown) the button 77 is unlocked to move upwards to the final or post-fired position after assignment is complete, as previously described. It is the bias of the reset spring 118 that forces the button 77 to rise to the final or post-fired position.

[0169] refer to Figures 15 to 1 6. When syringe 7 is removed from the skin 99, syringe 7 will preferably be locked to protect against non-destructive access to the cannula or reuse of syringe 7. Syringe 7 can indicate to the user that the full dose has been delivered. The indication may be in the form of a visual indicator, audible sound, mechanical movement, or a combination thereof.

[0170] Referring to Figure 16, when the syringe 7 is removed from the skin 35, the bandage 120 can be released from the syringe 7 and remains on the skin surface 35. This can be achieved by using an adhesive on the bandage portion that is more securely attached to the skin than the adhesive used to attach the bandage to the syringe 7. Thus, when the casing is lifted from the skin, the bandage 120 remains in the appropriate position above the injection site, as described in U.S. Patent No. 7,637,891 and U.S. Patent Application No. 12 / 630996, both of which are incorporated herein by reference. Figure 16B As shown, the bandage 120 may include an opening 120b (e.g., a hole or slit in the center of the bandage).

[0171] refer to Figures 36 to 39 The syringe 7 may preferably include a manifold 121 assembled to both the expandable member 78 and the filling port 81 and dispensing port 82, providing direct fluid communication between the expandable member 78 and the filling port 81 and dispensing port 82 of the syringe 7. The manifold 121 may be configured with a larger diameter at the end assembled to the expandable member 78 to facilitate the filling and dispensing of all material to the outside of the expandable member 78 as previously discussed. The manifold 121 may preferably include an internal passage 122 to allow fluid to flow into and out of the expandable member 78. The manifold 121 may be configured with a filter 123 in the injectable fluid path 122 for filtering the material before and after introduction into the expandable member 78 to remove particles. The filter 123 may be a membrane, depth filter, or other suitable filter media having a sufficiently small or effective pore size to remove undissolved material particles, including but not limited to, in the event of material reconfiguration by the delivery device. The manifold 121 may also be configured with the filter 123 for removing air. Such an air removal filter 123 may include a bubble trap, air gap, or other configuration in the injectable fluid path 122 to remove air from the injectable fluid path 122 before air is introduced into the expandable member 78. The air removal filter 123 may be configured to have a hydrophobic filter or a combination of a hydrophobic and a hydrophilic filter. The hydrophobic filter will allow air to escape from the delivery device but will not allow liquid to pass through. The hydrophilic filter will allow liquid to pass through but will not allow particles or air to pass through. The air removal filter 123 may also have a check valve to allow the venting of trapped air. Alternatively, the air remover and filter 123 may be located at any point in the fluid path from the filling port 81 to the cannula 85. For example, the most downstream point in the fluid path is the distal end 128 of the expandable member 78. An internal mandrel 124 may be connected to the distal end 128 of the expandable member 78. The air remover or filter 123 may be integrated into said downstream point to allow the venting of trapped air during the filling of the syringe 7. In addition, the spindle 124 may include a slot along its length that communicates with a downstream filter 123 to help vent air during the filling process.

[0172] refer to Figures 36 to 39The syringe 7 may include an elastic expandable member 78, such as an elastic balloon or sac-like container. The material composition of the expandable member 78 may preferably be silicone resin. 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 resin. Furthermore, the expandable member 78 may be coated to improve its surface properties. The coating may include parylene, silicone resin, Teflon, and fluorine treatment. Alternatively, the expandable member 78 may be made of a thermoplastic elastomer.

[0173] refer to Figures 36 to 39 The syringe 7 may include a resilient expandable member 78 to which a substance is delivered under pressure. This causes the expandable member 78 to expand, and the elasticity of the expandable member 78 tends to displace the pressure of the substance. The pressure chamber of the previously described delivery device (or other pumps or pressurizing devices that may be used in the delivery device) delivers the substance to the syringe 7 under pressure. Introducing the substance into the expandable member 78 under pressure causes both its diameter and length to stretch and expand. An example of this is inflating a long, thin balloon. The volume of the syringe 7 may range from 0.5 to 30 ml. When expanded, the resilient expandable member 78 applies a displacement pressure in the range of 1 to 200 psi to the substance contained within the expandable member 78, thus preparing the syringe 7 to automatically dispense the substance upon user-triggered button press as previously described. Therefore, the delivery device described above not only operates to deliver a measured amount of substance (and, if necessary, mix, dilute and filter it) to the syringe 7, but also simultaneously fills or provides motion pressure to the syringe 7 (by expanding the elastic expandable member 78), so that the syringe 7 is ready to automatically dispense the substance under the pressure applied by the elastic expandable member 78 when actuated by the user.

[0174] The aforementioned aspects of the delivery device (simultaneous delivery and charging) are particularly advantageous. Although the aforementioned applications show the syringe 7 in a pre-filled or charged state for injecting substance 79 when the syringe 7 is actuated, this disclosure envisions that the syringe 7 could remain empty, and the expandable member 78 in a more relaxed and unfilled state, i.e., uncharged or unfilled, until the substance needs to be administered. Only then is the substance mixed or processed as needed and introduced into the syringe 7, causing the expandable member 78 to expand into a filled (charged) state. In this disclosure, the agent is stored in its original container closure (vial) until use. Because the substance is typically injected within seconds to hours after being transferred from the vial to the syringe 7, the shelf life of the agent and the compatibility of the agent with the materials in the fluid channels within the syringe 7 are not critical issues. This significantly reduces the challenges and costs of designing the syringe 7 and selecting materials to extend the shelf life of the pre-filled syringe 7.

[0175] refer to Figures 36 to 39 This subject matter may utilize the features of the syringe 7 described above, which are incorporated herein by reference. However, the expandable member 78 employed in the syringe 7 may also preferably take the form of an elongated balloon or sac-like container, for example, arranged in a planar spiral or helical configuration as shown. As previously described, the syringe 7 includes a circular outer shell 74 in which a helical slot or recess 125 is formed. The elongated balloon or sac-like container 78 rests in the slot 125, one end for direct or indirect communication with the injection cannula 85 via a fluid path 122, and the other end for direct or indirect communication with the dispensing indicator 101. The elongated helical configuration allows the balloon or sac-like container 78 to have sufficient volume for such an amount of substance 79 as may be desired, while also contributing to a low-profile configuration of the syringe 7. In some cases, by utilizing a relatively long expandable member 78 with a large aspect ratio, very high pressure and volume can be achieved with minimal required force. In addition, the volume of the expandable member 78 can be changed by altering the filling length without significantly changing the pressure / volume curve of the expandable member 78.

[0176] refer to Figures 36 to 39 One other aspect that can be employed in this subject is to use an insert, plunger, or mandrel 124 within the expandable member 78 to prestress the expandable member 78 to a slightly expanded position when unfilled, such that when the expandable member 78 discharges material, it will contract or collapse to a state still stretched or stressed, and continue to exert pressure on any fluid within it, such as Figure 38 and Figure 39As shown in the diagram. This better ensures that all or substantially all material is completely expelled from the syringe 7. If desired, the mandrel or shaft 124 can be an expandable member filled with fluid. This would allow for a variable-size mandrel 124. Alternatively, when unstressed, the expandable member 78 can have a sufficiently small internal volume (small diameter) such that almost all material is expelled without the need for an internal mandrel or shaft 124. Furthermore, the expandable member 78 can be flattened / stretched around a surface within the syringe (such as the cylindrical wall 134). The prestress formed in the expandable member 78 will be used to eliminate any residual fluid volume retained therein.

[0177] As described above, there are several different ways to cause the expandable member 78 to expand and / or contract in an arcuate manner. (Return to Reference) Figure 15 One approach is to design an expandable member 78 with a thicker wall cross-section 126 in a region around its circumference, which would cause the expandable member 78 to expand in a circular manner. Alternatively, individual elements 126 can be fixed along the length of the expandable member 78 to effectively reinforce that portion of the circumference of the expandable member 78, which would cause the expandable member 78 to expand in an arcuate manner. (Return to Reference) Figure 17 Another approach is to use internal features, such as slots or recesses 125 in the housing 74 of the syringe 7, to guide the expandable member 78 around a circular or spiral path. These features 125 can interact with the expandable member 78 in various ways, the simplest being that the external shape of the expandable member is constrained by the slots 125 in the housing 74 of the syringe 7. Friction between the expandable member 78 and the inner surface 125 of the housing 74 can be reduced by lubricating the outer surface of the expandable member 78, or by inserting the expandable member 78 into a low-stiffness spring that limits both the friction and outer diameter of the expandable member 78 without constraining its length.

[0178] refer to Figures 36 to 39 The elongated expandable member 78 can preferably be configured to expand along an arc having a predetermined tube diameter without the aid of the syringe wall or guide. (Return to Reference) Figure 15 By observing the cross-section of the elongated expandable member 78, a thicker wall region 126 can be added to a small portion of the circumference of the expandable member 78 so that the elongated expandable member 78 expands in an arc shape as previously described. The arc-shaped expandable member 78 increases in length due to the increase in its internal pressure and volume; the deflection of the thicker section 126 is less than that of the thinner section.

[0179] refer to Figure 17The arc-shaped expandable member 78 will expand in an arc shape along its length, thereby orienting its thickest wall thickness region 126, or smaller deflection region, towards the interior of the circle. Increasing the wall thickness 126 of the expandable member 78 within the small area 126 around the circumference will effectively continue to reduce the arc radius of the expandable member 78. The increase in wall thickness 126 can be achieved by molding or extruding it into the arc-shaped expandable member 78, or by bonding a strip of material to one side 126 of the expandable member, so that said portion of the wall 126 lengthens at a slower rate, thereby allowing the expandable member 78 to expand in the arc shape as discussed above.

[0180] refer to Figure 18 The distal end of the expandable member 78 may be secured with an element such as an indicator 101, which is constrained to follow a guide path within the inner surface 125 of the housing 74. Alternatively, the expandable member 78 may be pre-stretched and flattened around a circular diameter (such as wall 134) within the syringe 7, such that the length of the expandable member remains unchanged. Alternatively, a straight or curved mandrel 124, longer than the unstressed expandable member, may be used to stretch the expandable member into a circular shape within the syringe 7 prior to filling. Alternatively, the mandrel 124 may serve as a visual indicator to show the status of the syringe 7 and the progress of injection. The mandrel 124 may be colored to allow it to be easily seen through the housing.

[0181] refer to Figures 36 to 39 The substance is injected into the expandable member 78 via a delivery device, and the expandable member 78 expands to a specific outer diameter controlled by the configuration of the inner surface 125 of the housing 74. In this manner, the entire length of the expandable member 78 can be filled with a known volume of the agent, and the outer diameter at each longitudinal position along the expandable member 78 is known. It is desirable to allow the expandable member 78 to be filled and emptied in a controlled manner along its length from one end to the other to facilitate complete emptying of the expandable member 78 and to allow easy and accurate measurement of the substance in the expandable member. To visually aid in determining how much substance is in the expandable member 78, graduations (similar to those on a syringe) can be printed on the expandable member 78 to indicate the remaining volume. As previously described and referenced... Figures 21 to 22 The expandable member 78 and the housing 74 may be transparent to allow the user to see the remaining volume in the drug 74 and the syringe 7. Alternatively, scale markings 127 may be printed on the housing 74 to indicate the remaining volume in the expandable member 78.

[0182] refer to Figures 36 to 39According to one aspect of the above subject matter, material can be gradually expelled from the distal end 128 of the elongated expandable member 78 toward the proximal end 129. The proximal end 129 of the expandable member is closest to the dispensing cannula 82 or cannula. This allows the user to visually determine or approach the injection state, either alone or by means of the injection housing 74, window 80, or scale markings 127 on the expandable member 78. Gradual expulsion can be achieved in various ways. For example, the material exits the expandable member 78 at a manifold 121 at the proximal outlet port segment 130, and preferably at the proximal end 129 of the elongated expandable member (e.g., a balloon or sac-like container). The thickness of the wall of the expandable member 78 can vary uniformly or gradually along its length from the distal end 128 toward the proximal end 129. Due to the constraint of the wall of the helical channel 125 in which the expandable member 78 is located, the expandable member 78 will be expanded along its length by the material to a substantially uniform diameter. However, the thicker wall at the distal end 128 of the expandable member 78 will exert a greater contractile force on the material than the thinner wall at the proximal end 129, and thus will first collapse or shrink in diameter during material discharge. As the wall of the expandable member 78 thins along its length in that direction, the expandable member 78 will then gradually collapse from the distal end 128 toward the proximal end 129. Because the thickness of the expandable member 78 preferably increases substantially uniformly from the proximal end 129 toward the distal or closed end 128, the contractile force of the wall of the expandable member 78 will increase substantially uniformly along the length of the elongated expandable member 78 from the proximal port end 129 toward the distal or closed end 128 during expansion. Therefore, when material is discharged into the subject, the diameter of the expandable member 78 will gradually collapse and the length will also gradually shrink, as described above, and this diameter collapse and length shrinkage are preferably visible to the user. The distal end 128 of the elongated expandable member allows for the connection of a movable indicator component 101 in the syringe 7, which retracts along the length of the elongated expandable member 78. The indicator 101 is preferably visible to the user through the housing 74 and indicates the status of the syringe 7 and the progress of injection. Alternatively, the expandable member 78 is configured to have a constant wall thickness and may be prestressed during manufacturing to bias it, thereby filling from the proximal end 129 to the distal end 128 and, as previously discussed, collapsing or emptying from the distal end 128 to the proximal end 129 in a progressive manner.

[0183] refer to Figures 36 to 39The elongated expandable member 78 of the syringe 7 can be configured to have a segment 130 of the expandable member 7 adjacent to the proximal outlet port end 130, which is filled first and collapsed last during the filling and discharging of material from the syringe 7. In other words, during the filling of the syringe 7 via the delivery device, it is advantageous to fill the injectable material first at the proximal outlet port segment 130 of the expandable member 79. Furthermore, during the dispensing of material from the syringe 7, it is advantageous to contain the last remaining volume of material within the proximal outlet port segment 130 of the expandable member 79. The above configuration has several advantages. The proximal end segment 130 of the expandable member 78 can have thin walls, which will allow it to remain expanded at a lower pressure than the remaining segments of the expandable member 78. This will ensure that the segment 130 of the expandable member 78 will remain expanded until all material has been discharged from the remaining segments of the expandable member 78. As discussed above, the segment 130 can be directly coupled to an empty indicator to provide indication of full or empty status. Furthermore, as previously mentioned, the segment 130 may be mechanically coupled to an empty indicator to allow automatic withdrawal of the button 77 and the cannula 82 when the substance has been completely expelled.

[0184] refer to Figures 36 to 39 Alternatively, or in addition to changing the wall thickness 126 of the expandable member 78, the elongated internal mandrel or shaft 124 within the expandable member 78 can gradually (linearly or progressively) decrease in cross-sectional size along the length of the expandable member 78 from the proximal end (outlet port end) 129 toward the distal end (closed end) 128. Furthermore, the manifold 121 that allows the expandable member 78 to be attached to the syringe 7 can also be configured to have a large-diameter section 130 at the proximal end 129 of the expandable member 78. The large-diameter section 130 of the mandrel 124 or manifold 121 at the proximal end outlet port 129 of the expandable member 78 ensures that the expandable member 78 will first fill the material in said region 129. In other words, the expandable member 78 is held at the proximal end outlet port 129 by the large-diameter section 130 of the mandrel 120 or manifold 121 near the filling diameter. When the material first begins to fill the expandable member 78, it first reaches the filling diameter in the large diameter section 130, and then gradually fills along the length of the expandable member 78 from the proximal end 129 to the distal end 128 as previously discussed.

[0185] refer to Figures 36 to 39As discussed previously, during the dispensing of material from the expandable member 78, the diameter of the expandable member 78 at its distal end collapses progressively (similar to deflating an elongated airbag) from its distal end 128 to its proximal end 129 until all fluid is expelled from the expandable member 78. A large-diameter section 130 of the spindle 124 or manifold 121 at the proximal end outlet port 129 of the expandable member 78 provides the same benefit during material dispensing (as previously described for filling). The large-diameter section 130 ensures that any remaining material in the expandable member 78 is contained and dispensed from the region 130. As discussed previously, the section 130 can be directly coupled to an empty indicator to provide indication of fullness or emptiness, and to automatically withdraw the button 77 and cannula 82 upon complete material expulsion.

[0186] refer to Figure 21 The user attaches syringe 7 to their skin 99. An adhesive may be present at the bottom of syringe 7, allowing adhesion to the skin 99 surface and hands-free operation. The adhesive may extend beyond the contour of the syringe to allow the user to firmly adhere the tape to the skin. Alternatively, the user may hold syringe 7 against the skin 99 during injection.

[0187] refer to Figures 21 to 23 The user removes the safety device 100 and presses button 77 on syringe 7 to begin injection. Once button 77 on syringe 7 is fully pressed, it locks in place, the cannula is fully inserted into the patient, and syringe 7 begins dispensing the injectable medication. Syringe 7 can alert the user that the injection has begun. The alert can be in the form of a visual indicator, audible sound, mechanical movement, or a combination thereof. The injection time can range from a few seconds to several hours. Syringe 7 can indicate to the user that it is dispensing the button 77 locked in the downward position and displays an indicator window 101 showing that syringe 7 is not full. Syringe 7 preferably has a transparent section 80 that allows the user to easily determine the remaining dose of medication in syringe 7.

[0188] refer to Figure 24 When the injection of the medication is complete, the user will be alerted. The alert may be in the form of a visual indicator, an audible sound, a mechanical movement, or a combination thereof. The syringe 7 can indicate to the user that it has been dispensed by a tactile and audible sound indicating that the syringe is empty, and by an indicator window 101 showing that the syringe is empty, when the injection is moved to the locked position via button 77. At the end of the dispensing, the cannula will automatically retract into the locked position within the syringe 7.

[0189] refer to Figure 21When the syringe 7 is removed from the skin 99, the bandage 120 can be released from the syringe 7 and remains on the skin surface 99. The syringe 7 is preferably locked upon removal from the skin 99 to protect against 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 can be in the form of a visual indicator, audible sound, mechanical movement, or a combination thereof.

[0190] As with other aspects of this topic, when administering an injection using a syringe and cannula intended for subcutaneous infusion, it is desirable to know whether the cannula is correctly positioned inside the skin or incorrectly inside the blood vessel. Users performing intradermal (ID), subcutaneous (SC), or intramuscular (IM) injections typically aspirate the syringe by pulling back the plunger to create a pressure drop within the syringe, allowing them to see if any visible blood is entering the syringe from the cannula. If blood is visible, this means the tip of the cannula is in the blood vessel. Many injectable medications intended for subcutaneous injection are specifically instructed not to be infused into a blood vessel. Performing blood aspiration using a syringe and cannula is a common technique that can be performed by anyone who is adequately trained. In some cases, an autoinjector may be used, and the autoinjector may include a mechanism for determining whether the autoinjector is correctly positioned.

[0191] refer to Figures 25 to 26 The syringe 7 may have a cannula 85 with a side opening (e.g., an orifice) 108 operatively engaged with a button 77, which is slidable within a septum 109 advanced into the skin 99. The button 77 may have an observation window 160 on a button top 103 in fluid communication with the proximal end 161 of the cannula 85. The button top 103 may include a cavity 162 for blood 159 to accumulate and be visible to the user through the button window 160. The cavity 162 may include a central orifice 163 allowing fluid communication with the proximal end 161 of the cannula 85 via the cannula cavity 165. An outer wall 164 of the cavity 162 is formed by the button top 103. Furthermore, 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. If fluid 14 or blood 159 travels upward along the internal cavity 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. Air 167 in the cavity 162 is easily displaced by the hydrophobic filter 166 until all the air 167 is expelled from the cavity 162 and the cavity is filled with fluid 14 or blood 159. At this point, the flow of fluid 14 or blood 159 stops because fluid 14 or blood 159 cannot penetrate the hydrophobic filter 166 and can be easily seen by the user through the window 160 on the top of the button 103, thus providing a method for determining whether the cannula 85 of the syringe 7 is in the blood vessel 158.

[0192] refer to Figure 27 The insertion of a cannula into tissue can be broadly divided into four stages. These include no contact (panel a), boundary displacement (panel b), tip insertion (panel c), and shaft insertion (panel d). During boundary displacement, the tissue boundary in the contact area is deflected under the load applied by the cannula tip, but the cannula tip does not penetrate the tissue. As the cannula tip begins to penetrate the skin, the skin boundary follows the cannula tip until the point of maximum boundary displacement in the contact area. After the cannula tip penetrates the skin, the shaft is inserted into the tissue. Even after tip and shaft insertion, the boundary of the skin surface in the contact area does not return to its original no-contact state but retains a displacement distance x. The boundary displacement x is a function of several parameters, including but not limited to cannula diameter, cannula tip geometry, cannula shaft friction, cannula insertion speed, and physical skin properties. The boundary displacement x of the skin in the contact area is characterized by the syringe based on the cannula, as it affects the extent to which the cannula penetrates the skin and thus reduces the actual cannula penetration depth by the amount of boundary displacement x. If the boundary displacement x can be intentionally induced by stretching or preloading (such as pushing the skin out at the contact site before insertion of the cannula tip), there will be no additional boundary displacement of the cannula tip or axis during insertion, and the cannula tip depth can be predictably defined. The advantage of this intentional displacement is that the amount of tissue penetrated by the cannula is not affected by changes in the boundary displacement x. Since no boundary displacement is intentionally induced on the skin surface before cannula tip insertion, the actual depth of skin penetration is not specifically known because... Figure 27 The figure shows a naturally occurring boundary displacement x, with some cannula length (depending on the parameters mentioned above) extending beyond the skin. On the other hand, if the maximum boundary displacement can be induced at the contact site, the actual cannula penetration depth will not change with variations in the parameters mentioned above (including cannula diameter, cannula tip geometry, cannula axial friction, cannula insertion speed, and physical skin properties).

[0193] refer to Figure 28The syringe 7 may have a skin boundary displacement extension or structure (such as a lower surface 76) including an extension 138 at or around the dispensing port 82 or as part of the dispensing port 82. The extension extends substantially perpendicular to the tissue plane at the cannula insertion point. When the syringe 7 is attached to the skin 99, the extension 138 protrudes against the surface of the skin 99, causing displacement or compression of the skin 99 in the contact area 139. This compression of the skin helps to reduce or eliminate “bulges” on the tissue surface during cannula insertion. In other words, by “preloading” the tissue through tissue compression, the extension 138 serves to eliminate further tissue defects or bulges, or result in more reproducible and less skin surface deflection or bulge. During the actuation of button 77 from a pre-firing state to a first position, the cannula 85 advances beyond the syringe 7 into the skin 99 through the dispensing port 82 and / or the extension 138 to begin dispensing the medication. For the reasons stated above, when the cannula 85 advances outside the syringe 7, the tip of the cannula 107 does not generate additional boundary displacement 141 in the skin 99 at the contact area 139 (intentionally caused by the extension 138). Therefore, the actual cannula penetration depth 140 into the skin 99 is better characterized and controlled. Furthermore, the extension through which the cannula passes directly compresses the tissue surrounding the cannula, which has several advantages. During injection, the compression of the tissue by the extension 138 in the contact area 139 increases the local density of the tissue, thus creating a higher pressure zone compared to the surrounding adjacent tissue 99. As the injected substance enters the skin 99, fluid migrates from the high-pressure zone 139 to the low-pressure zone within the skin 99, which helps prevent injected fluid or medication from flowing into or migrating into the immediate area around the cannula / skin puncture site and reduces or minimizes fluid leakage (backflow) and / or bleeding at the puncture site. The high-pressure zone also effectively provides the benefit of a longer injection cannula. For example, in an ultrasound evaluation comparing the subcutaneous deposition depth of a 10 mL fluid pill (saline) using a syringe 7 with a 5 mm needle depth and an off-the-shelf infusion pump (Freedom 60, RMS) with a butterfly needle extension assembly (9 mm needle depth), the results showed that the subcutaneous depth after injection of the 10 mL pill was equal between the syringe 7 with a 5 mm needle length and the pump with a 9 mm needle length. In all results, the injection site was characterized by the distance (Zd) from the skin surface to the top edge of the injection site. Figure 47 The top edge of a 10 mL subcutaneous bolus is shown using a pump with a 9 mm cannula length. The Zd distance was measured at 0.44 cm. Figure 48 The top edge of a 10 mL subcutaneous injection using a syringe 7 with a 5 mm cannula length is shown. The Zd distance was measured at 0.42 cm. Therefore, an injection of similar depth has a cannula depth (5 mm) and a tissue displacement structure that is more than 40% shorter than another test cannula (9 mm) without tissue displacement structure.

[0194] Another advantage of the extension 138 is its ability to compress the tissue in the contact area 139 after injection. In the post-firing state, the button 77 has popped up, alerting the user that the syringe 7 has been dispensed. The cannula 85 is fully retracted outside the puncture site in the skin 99. The dwell time between the dispensing of the syringe 7 and its removal by the user can be several minutes or longer, depending on the user's environment at the time of dispensing. For the same reasons described above, the compression of the tissue by the extension 138 in the contact area 139 increases the local density of the tissue, thus creating a higher pressure zone compared to the surrounding adjacent tissue 99. Similar to a nurse applying pressure to the injection site with their thumb after an injection, this pressure helps to seal the puncture site and prevent the injected fluid or medication from flowing back to the injection site, and also helps to reduce or minimize fluid leakage and / or bleeding from the puncture site.

[0195] refer to Figure 29 There are two interfaces associated with adhering the syringe 7 to the skin 99. The first is the adhesive / device interface 173, and the second is the adhesive / skin interface 174.

[0196] refer to Figure 30 The adhesive 88 can be configured on the syringe 7 to have at least two regions. The first region 175 can include a permanent bond between the adhesive 88 and the syringe 7 using a mechanical or chemical means, and is preferably located within the outer periphery of the syringe 7. The second region 176 can be configured to be detachable from or not attached to the syringe 7, and is preferably adjacent to region 1 and on the outside of region 1 (e.g., radially outward).

[0197] refer to Figure 31 If adhesive 88 is fully attached to the bottom 76 of device 7, then during the tissue protrusion 177 event, because the interface 174 is weaker than the adhesive / device interface 173, the adhesive 88 at the adhesive / skin interface 174 will begin to peel off from the skin 99. This is in Figure 31 This was demonstrated on the raised surface. This could cause the syringe 7 to detach from the skin surface and from the patient.

[0198] refer to Figure 30 and Figure 32 Adhesive 88 can be configured on syringe 7 having the aforementioned regions 175, 176, instead of as... Figure 31The image shows adhesive 88 being permanently attached to the bottom 76 of syringe 7. During a tissue protrusion event 177 in this configuration, adhesive 88 in the second zone 176 is detached from syringe 7 and firmly attached to the skin 99 surface at adhesive / skin interface 174. This allows the peeling edge 178 to be transferred from adhesive / skin interface 174 to adhesive / device interface 173, effectively forming a strain relief element at the adhesive / skin interface. Adhesive / device interface 173 can be designed to be more robust and prevent syringe 7 from separating from the skin surface 99.

[0199] When using an autoinjector for self-injection, protecting the user from accidental cannula puncture is a beneficial requirement for the device. Typically, the cannula retracts into the device before and after use to prevent the user from touching it. However, during injection, the cannula may extend outside the device. In some cases, the autoinjector includes a skin displacement sensor so that the cannula automatically retracts if the device displaces from the skin during injection.

[0200] refer to Figures 33 to 35 The skin displacement sensor 179 can be operatively engaged with the flexible latch 181 of the button 77 and can slide within the lower housing 180 of the syringe 7. (Reference) Figure 34 When syringe 7 is attached to skin surface 99, skin displacement sensor 179 is forced into a first or upward position 182 within syringe 7. When button 77 is actuated to the firing state, second position, or dispensing position (exposing cannula 85), flexible latch 181 is forced into a locked position 187 by skin displacement sensor 179 below latch plate 183. In the firing state or dispensing position, latch plate 183 holds button 77 downward at latch plate surface 184 on button 77 until dispensing is complete. At the end of dispensing, latch plate 183 translates away from latch plate surface 184 on button 77, allowing button 77 and cannula 85 to retract to the post-firing position, where cannula 85 is accommodated within syringe 7. Reference Figure 35 In the event that the syringe 7 displaces from the skin surface 99 during injection, the skin displacement sensor 179 extends beyond the syringe 7 to a second or downward position 185. This allows the flexible latch 181 to spring back to the unlocked position and disengage from the latch plate 183. This allows the button 77 and the cannula 85 to retract to the post-firing position, in which the cannula 85 is housed within the syringe 7.

[0201] When performing self-injection using a syringe and cannula, the user may need to temporarily stop or pause the injection due to severe pain or irritation at the injection site. This pause in the flow of the injectable to the injection site is achieved by eliminating pressure on the syringe plunger, allowing the injectable pellet more time to diffuse into the surrounding tissue, thereby reducing local pressure and associated pain and irritation, and thus helping to reduce pain at the injection site. In some cases, the syringe includes a mechanism for, for example, automatically or manually pausing the injection.

[0202] refer to Figures 36 to 37 When button 77 is actuated, cannula 85 and button 77 travel to the first position or depth, such as Figure 36 As shown in the diagram. At the first position or depth, the side hole 108 is covered by the diaphragm 109, and therefore the internal cavity 165 of the cannula 85 is not in communication with the fluid channel 86 of the dispensing port 82. The button 77 can be intentionally held at the first position or depth to prevent the injection fluid 14 from flowing from the fluid channel 86 into the side hole 108 of the cannula 85 and into the skin 99. Figure 37 As shown, when button 77 is released, cannula 85 and button 77 return to the second or dispensing position, in which side hole 108 is exposed to fluid channel 86, allowing injectable agent 14 to flow from fluid channel 86 into side hole 108 of cannula 85 and into skin 99 until the injection is completed. The action of pushing button 77 to the first position or depth can be performed multiple times as needed throughout the injection.

[0203] refer to Figures 38 to 39 The actuating force 186 of button 77 is a transitional load applied to button 77, which is required to move button 77 and cannula 85 from the pre-firing position to the firing state or dispensing position. Before the transitional load is satisfied, the force 186 applied to button 77 is directly transmitted to syringe 7. Specifically, the load 186 may be transmitted to adhesive skin interface 174 and / or adhesive device interface 173, thereby better securing syringe 7 to skin surface 99 before actuation of syringe 7.

[0204] refer to Figures 40 to 41The arcuate expandable member 78 is positioned and / or preferably expands in an arcuate shape along its length. In the illustrated embodiment, the arcuate shape is formed by providing a region with less elasticity, such as a thicker or relatively thicker wall thickness region 126, which results in less deflection of the expandable member in said region and leads to the formation of the expanding arcuate shape. The thick wall thickness region 126 can be configured to any shape that allows the expandable member 78 to take on an arcuate shape during expansion. A preferred configuration of the thick wall thickness region 126 is to minimize its thickness or attachment 150 in the circumferential direction on the wall of the expandable member 78 and to maximize its radial thickness or protrusion 151 away from the expandable member 78. This serves to induce the expandable member 78 to expand in an arcuate shape, but also maximizes the amount of material along the circumference, regardless of the thickness of the wall thickness region 126 used for expansion. Additional features, including but not limited to T-shapes, can be configured at the ends of the radial protrusions 152 to help push the expandable member 78 into an arcuate shape.

[0205] refer to Figure 42 Safety devices such as safety pins or safety sleeves 100 can be configured to allow removal from syringe 7 in any direction to release syringe 7 in preparation for firing (injection).

[0206] refer to Figure 43 The syringe 7 includes a cannula 85 with side holes 108, which allows fluid communication between the fluid passage 86 and the skin 99 once the button 77 is fully pressed in the syringe 7. This initiates the dispensing of the injection 14. The inner diameter 165 of the cannula 85 is important in controlling the dispensing rate from the syringe 7. Referring to the Hagen–Poiseuille equation for fluid flow in a conduit, the flow velocity through a conduit is proportional to the fourth power of the conduit radius. Therefore, especially when the inner diameter 165 becomes smaller, a small change in the inner diameter 165 of the cannula 85 results in a large change in the flow rate through the cannula 85. The cannula 85 in the syringe 7 can range from 21G to 34G (short wire gauge system) in various wall thickness configurations. This range corresponds to an inner diameter 165 range of 0.021” to 0.003”, recognizing that there are manufacturing deviations or tolerances in the inner diameter 165 of the cannula at any given cannula size. This is based on the cannula size and can have an inner diameter variation of up to ±0.00075”. To limit the range of the inner diameter 165 within any given cannula size and to result in variations in flow rate, the cannula 85 can be modified before assembly into the syringe 7. Such modifications may include coiling, flattening, or rolling the cannula 85 along a length from a circular shape to a non-circular shape to a new, specified effective inner diameter 165. This has the advantage of allowing for specific delivery rate control from the syringe 7.

[0207] Radiofrequency compliance monitoring

[0208] In some cases, the syringe is contained within the institution that alerts the subject, prescriber, healthcare provider, or another third-party participant when non-compliance or non-adhesion occurs.

[0209] Based on other aspects of this topic, when administering injections with an auto-injector, it is desirable to know when the prescribed dosage was initially filled or refilled, and whether the syringe was used correctly and in a timely manner. While many prescribed medications are tracked when patients use specially labeled dispensing kits, options for confirming whether a patient has actually taken the medication are limited. With an increasing number of medications being dispensed into syringes, the ability to automatically track dosage initiation is currently of limited use. Furthermore, there is no capability to automatically track whether the syringe has been used correctly.

[0210] As described herein, automated tracking of both adhesion and compliance can be achieved wirelessly using RF (radio frequency) technology installed within or associated with the delivery and / or syringe described herein. Current technology allows the use of radio frequency identification (RFID) to transmit data for the purpose of automatically identifying and tracking tags or microcircuit chips attached to the subject. As used herein, RF or RFID or RF tags or RF chips are used comprehensively and interchangeably, and are intended to include wireless electronic tags or chips used to transmit data / information using any suitable wireless communication protocol or technology, such as Bluetooth or any other wireless technology (e.g., wireless LAN, wireless PAN, or other wireless technologies described in the IEEE 802 standard)).

[0211] RF tags or chips can be active or passive. While both types use RF energy to communicate between the tag or transponder and the reader, the methods of powering the tag differ. Active RFID uses an internal power source (such as a battery) within or associated with the tag to continuously power the tag and its RF communication circuitry, while passive RFID relies on RF energy delivered from the reader to the tag to power it. In this context, a syringe or delivery package may include an RFID tag, optionally including a power source for the tag, and be read or received by an external reader. In one embodiment, the RF tag or chip is removably associated with the syringe such that it can be physically removed from the syringe when the syringe is used. This allows for subsequent disposal of the syringe without any applicable limitations or constraints if the tag or chip remains part of the syringe after its use.

[0212] refer to Figures 44 to 45The syringe 210 may include an electronic RF tag or chip 211 to monitor the status of the syringe 210. For example, the RF tag 211 may broadcast (if active) or present (if passive, read by the external reader 212) information or status such as “syringe 210 has been prescribed,” “syringe 210 has been removed from its packaging,” “syringe 210 has been actuated,” and / or “syringe 210 has completed its dosage.” The RF tag reader may also be associated with or communicate with (e.g., via wireless or hardwired connection) field or off-site data collection facilities to allow for the recording and editing of information regarding compliance.

[0213] refer to Figures 44 to 45 The RF tag 211 can be used to monitor whether the syringe 210 has been activated or has started or completed its dosage. The syringe 210 may include an active or passive radio frequency (RF) tag or chip 211 at any suitable location. As shown below, when used inside the syringe, the RF tag or chip 211 may be attached to button 213 and slidably communicate with a spring tab 214 during a first and second position of button 213. When the RF tag 211 is slidably communicating with the spring tab 214, the RF tag 211 may broadcast (if active) or present (if passive, read by an external reader 212) a first state including an unused state. When the syringe 210 is activated, button 213 is pressed to the dispensing position. At the end of the dispensing cycle, button 213 is released from the second depth or dispensing position (e.g., Figure 45 (As shown) unlocking to move upwards to the final position or the post-firing position. In the post-firing position, the RF tag 211 may no longer be in contact with the spring tab 214, thus allowing a change in the state (second state) of the RF tag 211. In the second state, the RF tag 211 may broadcast (if active) or present (if passive, read by an external reader 212) the second state to include the used state. Alternatively, the RF tag 211 may be deformed or altered in such a manner when the syringe is used, such that, upon inquiry, the RF tag 211 presents a "used" signature. For example, if the RF tag consists of two coils joined by a conductor, the initial signature of the tag 211 would be a "dual-coil" signature. Once the tag 211 has been used, if the conductor joining the two coils breaks, the two separate coils will produce different signatures.

[0214] For regulatory and / or disposability reasons, it may be necessary to place the RF tag or chip outside the syringe. For example, the RF tag or chip 211 may also be associated with another part of the delivery device or system, such as, for example, a safety sleeve or pull tab 100 (see...). Figure 42This allows for the activation of a tag or chip at one or more selected points during the operation of the delivery device and / or syringe. For example, an active RF tag or chip may be located on a safety sleeve, and the active RF tag or chip is configured such that removing the safety sleeve to initiate the injection process closes the contact between the long-life battery and the tag or chip transmitter.

[0215] refer to Figures 52 to 55 The RF chip or tag 211 within the syringe 210 can have two states: a standby or off state and an active or transmitting state. (See reference) Figure 52 and Figure 54 The state can be changed by connecting or disconnecting the contact between battery 262 and contact 263. For example... Figure 54 As shown, 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 263 by spatial separation when the pull tab 100 is in the appropriate position on the syringe 210. Figure 55 As shown, when the pull tab 100 is removed, the battery 262 and contact 263 come together to contact each other and form an electrical contact. Therefore, the RF tag begins to function. Furthermore, different actions associated with the use of delivery and / or the syringe can be employed to establish or break the contact. For example, when one action is taken, such as when the vial is inserted into the delivery device, a previously inactive RF tag or chip can be activated by closing the contact between the battery and the chip or tag transmitter, and the tag or chip can be deactivated via another action, such as by breaking such contact after using the syringe.

[0216] In addition to usage information, the RF tag or chip 211 can also transmit or deliver data associated with delivery or the syringe. For example, the tag or chip can be configured to have memory storage capacity to transmit the syringe type, batch number, volume of fluid administered, drug identification, and other relevant information. Figure 46 A system that can be used in conjunction with this topic is illustrated schematically. As shown in the figure, the RF tag or chip 250 can be active and, when activated, actively transmits relevant information to a local patient module 252 located near the patient and the syringe. For example, the patient module can be a wall-mounted or tabletop device located in the patient's home for receiving monitoring information transmitted by the RF tag or chip associated with the syringe and / or delivery device. The patient module can also be a cellular phone, etc.

[0217] The patient module may include a memory that stores data such as patient identity and related information. The patient module then communicates with a data manager 254 in an appropriate manner (e.g., Wi-Fi, cellular communication, telephone, hardwired link, or other means). The data manager 254 may be any suitable data network or cloud storage device for receiving and / or storing data received from the patient module indicating the status and / or use of syringes associated with specific identified patient information. Healthcare professionals responsible for monitoring patient syringe use and patient adherence to any prescribed injection protocol can access the data manager. The data manager may also be configured to automatically forward patient adherence information to appropriate healthcare professionals, such as a specific physician or clinic 256.

[0218] exist Figures 49 to 58 Other aspects of compliance monitoring devices, systems, and methods, such as those described herein, and the use of a syringe are illustrated. As shown, the system may include a wireless (e.g., Bluetooth) source, a battery-powered transmitting unit, and other components. Figure 59 The microchip indicated at point 262. The delivery unit can be mounted in any suitable location and can be associated with or attached to a portion of the syringe (and / or delivery device) in such a way that it can be detached from the syringe or delivery device upon disposal, thereby allowing a large portion of the syringe or delivery device structure to be recycled, since electronic circuitry and electronic chips are generally not similarly recyclable.

[0219] In some embodiments, a contactor ring is positioned on top of the syringe housing and, when the safety strip is attached, prevents the contactor ring from contacting the sensing lead (attached to the syringe button). When the safety strip is removed, the contactor ring of the housing contacts the sensing lead of the button. Different sequences of the injection process can then be tracked based on the connection state between the contactor ring and the sensing lead (i.e., the position of the contactor ring relative to the sensing lead). Infrared sensors can also be embedded in the syringe to optically track the delivery process, such as by monitoring, for example, the position or amount of injectable fluid in the expandable member of the syringe.

[0220] refer to Figure 52 and Figure 53The implementation of the RF tag or chip 211 includes the following components: a battery 262, contacts 263, a Bluetooth module 265 with a microcontroller / microprocessor, a button sensor 267, and an antenna 269. The battery 262 provides stored energy to power the system. This can be a coin cell battery or equivalent with a power output in the 1.5-3V voltage range of 5-100mAh. As previously mentioned, contacts 263 provide an electrical connection between the battery 262 and the RF tag or chip 211. Contacts 263 are configured to interact with the pull tab 100 to allow no electrical contact before the user removes the pull tab 100 during use. The Bluetooth module 265 has an integrated microcontroller / microprocessor. An example of a suitable Bluetooth module is Dialog Semiconductor part number DA14580-01UNA. In alternative implementations, the Bluetooth module may be separate from the microcontroller / microprocessor.

[0221] Figure 56 and Figure 57 The diagram illustrates a button position sensing system in an embodiment of the device. The sensing system may utilize an infrared transmitter and receiver sensor combination 267. An RF chip 211 is mounted on the lower surface of the device button 177, with the sensor 267 facing downwards. A reflective member 112 is fixedly mounted to the bottom of the syringe. When the device button is actuated to... Figure 56 Move to the indicated upward, elevated, or extended position. Figure 57 When the button is in the downward, lowered, or retracted position as shown, sensor 267 detects a decrease in the distance from reflective member 112. Conversely, when the button is released after the drug delivery, the distance from the reflective member 112 decreases. Figure 57 Move the position to Figure 56 When the button is positioned, sensor 267 detects an increase in distance from reflective member 112. Sensor 267 transmits the button position information to microcontroller / microprocessor module 265.

[0222] In an embodiment of the device, in Figure 58 The diagram illustrates the processing performed by the microcontroller / microprocessor module 265. As shown in box 302, when the microcontroller / microprocessor is powered on, such as via the above reference... Figure 54 and Figure 55 The described removal of the safety tab 100 initiates a start timer. Then, as indicated in box 304, the device's mode or state is set to "Ready to Fire" (i.e., Ready to Assign), and a Bluetooth packet indicating the device's mode is transmitted to a Bluetooth-enabled remote reader or receiver (e.g., Figures 44 to 45 (212), by way of example only, the device may be a smartphone or a computer system. The mode is displayed to the user on a remote receiver.

[0223] Then the processing in box 308a can be performed to save the device's battery life and calculate the device's timing.

[0224] Then, as indicated in box 312, the microcontroller / microprocessor uses, for example, the reference above. Figure 56 and Figure 57 Description of the IR sensor inspection device button ( Figure 56 and Figure 57 Position 177 in the diagram. As indicated in 314, if the device button is not pressed into the down position, the above process is repeated. If the device button has been pressed, as indicated in box 316, the start time of the injection is recorded, and as indicated in box 318, the device mode is set to "Dispensing". As indicated in box 322, the mode is transmitted to a remote receiver, where it is displayed to the user.

[0225] Then, the processing of box 308b is performed to save device battery life and calculate device timing by intermittently or alternately putting the processor into a low-power sleep mode and then waking the processor at intervals of one second (or other suitable time).

[0226] The microcontroller / microprocessor then checks the position of the device button, as indicated in box 324. As indicated in box 326, if the device button has not returned to the raised or up position, the above process starting from box 322 is repeated. If the device button has been moved to the up position, the end time of the injection delivery is recorded, as indicated in box 332, and the device mode is set to "Completed," as indicated in box 334. As indicated in box 336, this mode is transmitted to a remote receiver, where it is displayed to the user.

[0227] Then the processing in box 308c is performed to conserve the device's battery life and calculate the device's timing, after which the device's "complete" status is transmitted again to the remote receiver (box 336).

[0228] Embodiments of this disclosure can provide a “smart” connected device that enables patients to self-administer high-volume / viscosity medications, thereby enabling and facilitating patient freedom and mobility. The implementation provides users with a safe, simple, and discreet medication delivery experience.

[0229] Embodiments of this disclosure may provide an intelligent device system to provide three pieces of information regarding the operation of the drug delivery system: 1) when the device is powered on, 2) when delivery begins, and 3) when delivery is complete. In some embodiments, user interaction may involve opening a mobile application on their device, as described elsewhere herein, and the intelligent device will complete the remainder without requiring further action from the subject or user.

[0230] The embodiments disclosed herein can provide advantages such as: small board coverage area – the entire electronic package fits within an existing button and has a diameter of less than 3 / 8 inch (9.5 mm). This allows for easy removal of the electronic device (button) for disposal and recycling.

[0231] Embodiments of this disclosure may incorporate smart device technology into the delivery device. For example, the delivery device may include electronics to track the use of the delivery device. The electronics in the delivery device may communicate directly with an external receiving device and / or electronics in the patch / syringe. Transducers / sensors within the electronics of the delivery device may provide information, including but not limited to environmental conditions, opening of the outer box or packaging, removal of the delivery device from the outer packaging, orientation of the delivery device (tilt sensing), device position (e.g., using a Global Positioning System or GPS), whether the delivery device is on a flat surface, vial insertion, plunger release (venting), and / or removal of the syringe from the delivery device. The electronics in the delivery device may determine whether the correct vial has been inserted based on the electronics within the vial or the reading of a barcode / QRG code. The electronics may be activated when the outer box or packaging is opened or when the delivery device is removed. If the device is not placed on a table or at an angle, additional electronics may be added to vibrate or emit sound. Electronics combined with an external receiver may provide voice commands to assist the user in using the device or to provide instructions when something is done incorrectly.

[0232] In some embodiments of this disclosure, the syringe can utilize Bluetooth communication to provide data to a user. Furthermore, embodiments can integrate Bluetooth Low Energy (BLE) into the device. BLE can be designed for low-power, low-cost applications that require lower data throughput than traditional Bluetooth connections (such as audio streaming or hands-free phone connections).

[0233] The Bluetooth standard defines two main connection types: Standard (Paired) mode and Broadcast (also known as "Beacon") mode. In a Standard or Paired connection, the host (a smartphone with the app installed) establishes a pre-existing connection with a peripheral device (i.e., the smart device). In this case, through a pairing process, both the host and the peripheral device share data to form a permanent connection, which can be shared only between one host and one peripheral device. This method has the advantage of a secure connection, allowing the exchange of encrypted information that cannot be decoded without an encryption key.

[0234] In broadcast mode (also known as "beacon"), the peripheral device periodically sends data that can be read by any nearby host. In this case, the peripheral device only broadcasts data; the data is never received. This mode has several advantages, such as reduced power consumption. In some cases, further energy savings can be achieved through a low-power "sleep" mode, which wakes the device only when new data needs to be broadcast.

[0235] Furthermore, enhanced security is provided because the peripheral device can be configured as a transmission-only device, preventing the hardware from being "hijacked" or loaded with malware. This reduces or eliminates the risk of unauthorized remote control of the device. The software is loaded onto the device at the factory, thus preventing unauthorized modifications once deployed.

[0236] In some cases, as described elsewhere in this document, app installation can be used to protect data privacy. For example, if an app is not installed correctly, the data may simply consist of a list of unusable binary numbers, lacking any text or other readable identifiers. Therefore, the absence of an encrypted connection would not expose any sensitive user information. The data may also not include patient information (such as names or ID numbers) that might be associated with a specific individual (and thus comply with HIPAA compliance).

[0237] Within the embodiments of this disclosure, an important attribute of the connected healthcare implementation is that it does not affect the basic performance functions of the medication delivery device. In some embodiments, the features of the device merely report the status of the device and never alter the functionality of the medication delivery device. Even in the event of a serious failure of Bluetooth components (such as batteries), some embodiments of the device will still complete medication delivery and provide the user with visual feedback regarding the device's status.

[0238] By utilizing Bluetooth Low Energy Broadcast mode and through an electronic chip in the device button, some embodiments of this disclosure can deliver real-time device performance information in a small, low-cost, and convenient package.

[0239] syringe with patch

[0240] In one aspect, this disclosure provides a system for measuring health or physiological parameters from a subject. The system may include a patch comprising a first housing having one or more sensors configured to (i) measure health or physiological parameters from the subject when the patch is attached to the subject's body, and (ii) provide one or more outputs corresponding to the health or physiological parameters from the subject. The first housing may include an opening. The system may also include a syringe having a second housing containing 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 attached to the body, the cannula is guided through the opening and into contact with the subject's body. The syringe may be configured to (i) guide a substance from a reservoir to a fluid flow path in fluid communication with the reservoir, and (ii) guide a substance from the fluid flow path through the cannula into the subject. The syringe may be configured to administer a dose of the substance from the reservoir to the subject via the fluid flow path and the cannula.

[0241] The cannula can be configured to extend toward or retract away from the subject's body. In some examples, the cannula extends toward the subject's body to deliver a substance into the subject's body (e.g., through the subject's skin). After delivery of the substance, the cannula can retract away from the subject's body. The cannula can be connected to a reservoir via a fluid flow path. The cannula can be extended into and / or retracted from the body using a variety of mechanisms (e.g., mechanical, electrical, etc.). The means for cannula extension and retraction can include pumps, springs, gears, diaphragms, screws, or other means for moving the cannula, or variations or combinations thereof.

[0242] The syringe can be detachably attached to the patch. The patch may include a first housing, and the syringe may include a second housing, and the first and second housings may be removably 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 fastening mechanisms. In some cases, the first and / or second housings may include magnets that allow for removable coupling, as described elsewhere herein. In another example, the first and second housings may be bonded, for example, using adhesive tape. The adhesive force of the first and second housings may be adjusted based on desired characteristics. For example, it may be desirable to maintain the patch on the subject's body while removing the syringe. In such examples, an adhesive layer may be added to the patch, which facilitates securing the patch to the subject's body. The adhesive force of the body-adhesive layer 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 and second housings may be mechanically coupled, for example, using interlocking geometries of the first and second housings. For example, the first housing may include threads (e.g., internal threads, etc.), and the second housing may include complementary threads that can engage with the threads of the first housing. Alternatively or in combination, the first housing and / or the second housing may include snap-fit ​​joints (e.g., cantilever snap-fit ​​joints, annular snap-fit ​​joints, etc.) that allow the first housing to interlock to the second housing. Alternatively or in combination, the first housing and / or the second housing may include components that allow interference fits, force fits, contraction fits, positioning fits, etc. In non-limiting examples, other examples of fastening mechanisms may include form-fit pairs, hooks and rings, latches, threads, screws, clips, clamps, clamps, forks, rings, friction plates, rubber bands, rivets, lanyards, pins, ties, snaps, Velcro, adhesives (e.g., glue), tapes, vacuum, seals, combinations thereof, or any other type of fastening mechanism. Alternatively, the syringe may be permanently attached to the patch. For example, the first housing may be attached to the second housing, or may be integrally constructed into the second housing, or vice versa.

[0243] In some cases, the patch and syringe can be fastened to each other via complementary fastening units. For example, the patch and syringe, or the housing of the patch and the housing of the syringe, can form a form-fit pair. The patch may include a form-fitting convex component, and the syringe may include a form-fitting concave component, or vice versa. In some cases, the outer diameter of the protruding fastening unit of the patch may be substantially equal to the inner diameter of the concave fastening unit of the syringe, or vice versa, to form an interference fit. Alternatively or additionally, the patch and syringe may include other types of complementary units or structures that can be fastened together (e.g., hooks and rings, latches, snaps, buttons, nuts and bolts, magnets, etc.). Alternatively or additionally, other fastening mechanisms (such as, but not limited to, nails, clamps, forks, rings, friction plates, rubber bands, rivets, grommets, pins, straps, buckles, Velcro, adhesives (e.g., glue), magnets or magnetic fields, tapes, combinations thereof, or any other type of fastening mechanism) may be used to fasten the patch and syringe.

[0244] In some cases, the patch and syringe can be fastened to each other via an intermediate structure. In some cases, the intermediate structure can be fastened to one or both of the patch and syringe via one or more of any of the fastening mechanisms described herein. The intermediate structure can comprise a solid material, a semi-solid material, a liquid material (e.g., a resin configured to cure), or a combination of material types. In some cases, the intermediate structure may undergo a phase change (e.g., from liquid to solid for adhesives). For example, the intermediate structure can comprise a fluid adhesive that cures to achieve fastening. In some cases, upon application of a stimulus (e.g., thermal change, pH change, pressure change, applied force, etc.), the intermediate structure can transform from a first phase to a second phase, such as from liquid to solid or from solid to liquid, to achieve fastening or loosening (or both). In some cases, the patch and / or syringe can incorporate the intermediate structure. For example, the intermediate structure can be integral with the patch and / or syringe.

[0245] The fastening between the patch and the syringe can be temporary, such as allowing subsequent fastening and loosening of the patch and syringe without damaging (e.g., plastic deformation, shear deformation, abrasion, compression deformation, etc.) the patch or syringe. Alternatively, the fastening can be permanent, such as allowing subsequent release of the two patches from the syringe. In some cases, it may be desirable to deform the patch or syringe, and when fastened to the syringe or patch, the patch or syringe may be temporarily or permanently deformed (e.g., stretched, compressed, etc.) and / or deformed (e.g., bent, wrinkled, folded, creased, etc.) or otherwise operated.

[0246] The opening may comprise a puncturable membrane. The puncturable membrane can be punctured by a cannula to create the opening. The puncturable membrane may be formed of a polymeric material, or a combination of polymeric materials. The polymeric material may be naturally occurring or synthetic. Non-limiting examples of polymeric materials include polyvinyl chloride (PVC), polyethylene, and polyurethane. In some cases, the puncturable membrane may also comprise an adhesive layer (e.g., acrylate, methacrylate, epoxy diacrylate, or other vinyl resins). In some cases, the puncturable membrane may comprise a self-healing polymer or elastic material such that the opening introduced by the cannula can close, for example, after the cannula is retracted. In such cases, the puncturable membrane may comprise an opening (e.g., a hole or slit) configured to form a seal without a cannula being guided through it. In some examples, the puncturable membrane may comprise an opening not configured to seal without a cannula being guided through it. Alternatively, the opening may not comprise a puncturable membrane and may be configured to be in direct line of sight to the subject's body. The opening can be any suitable shape, such as a slit, triangle, square, rectangle, rhombus, pentagon, hexagon, heptagon, octagon, polygon, ellipse, ring, circle, etc. In some cases, the punctureable membrane contains absorbent materials, such as cotton, rayon, nylon, polymers, polymer blends, etc. In such cases, the punctureable membrane can be used as a bandage and can collect bodily fluids (e.g., sweat, blood, etc.) from the subject's body. In some cases, the punctureable membrane may contain an oxygen-permeable material that allows the subject's body or parts thereof to be exposed to ambient air. In some cases, the punctureable membrane may contain a medication (e.g., analgesics or drugs for treating pain).

[0247] In some cases, the patch includes a membrane that is not punctured during injection. The membrane may include an opening (e.g., a slit, a hole) through which the syringe can pass when the cannula is guided from the syringe into the subject's body, and the opening may close after the cannula retracts. The opening of the membrane may be pre-formed, or the opening may be generated (e.g., by puncture of the membrane). For example, the membrane may be provided in an "open" configuration, wherein the membrane is stretched and provides the opening by a mechanism (e.g., a "tissue tent" structure) on the patch. When the syringe is separated from the patch, the mechanism may switch to a "closed" configuration (e.g., by removing the "tissue tent" structure from the patch, thereby biasing the membrane to the closed configuration), and the membrane may return to its state before stretching. In some cases, the membrane may adhere to or otherwise attach to the subject's body. In such cases, the membrane may include an absorbent material, for example, to absorb bodily fluids (e.g., blood, sweat, etc.) from the subject. It should be understood that any of the above embodiments may include a patch comprising one or more sensors (e.g., on a PCB chip), and alternatively or otherwise, the patch may include a film that may include an absorbent material.

[0248] In some cases, the patch includes a bandage that can be placed on the subject's body. The bandage can be placed before or after injection. The bandage can include one or more polymeric materials. The polymeric material can be naturally occurring or synthetic. Non-limiting examples of polymeric materials include polyvinyl chloride (PVC), polyethylene, and polyurethane. In some cases, the bandage may also include an adhesive layer (e.g., acrylate, methacrylate, epoxy diacrylate, or other vinyl resins). In some cases, the bandage includes a self-healing polymer or elastomeric material. In some cases, the bandage includes an opening, such as a hole or slit, configured to form a seal without a cannula being guided through the opening. In some examples, the bandage may include an opening that is not configured to seal without a cannula being guided through the opening. The opening can be any suitable shape, such as a slit, triangle, square, rectangle, rhombus, pentagon, hexagon, heptagon, octagon, polygon, ellipse, ring, circle, etc. In some cases, the bandage includes an absorbent material, such as cotton, rayon, nylon, polymer, polymer blend, etc. In this context, the bandage can collect bodily fluids (e.g., sweat, blood, etc.) from the subject's body. In some cases, the bandage may contain oxygen-permeable materials, allowing the subject's body or parts thereof to be exposed to ambient air. In others, the bandage may include medications (e.g., analgesics or drugs used to treat pain).

[0249] The reservoir can be attached to the syringe. In some cases, the reservoir can be removed from the syringe. For example, the reservoir may comprise a container or be part of a container. The reservoir container may be removably coupled to the syringe (e.g., attached to and detached from the syringe housing). The housing may house fasteners to secure the reservoir. Alternatively, the geometry of the syringe may be designed to fit the reservoir or reservoir container. In other cases, the reservoir may be part of the syringe (i.e., non-removable). In one example, a drug reservoir may be disposed within the housing and may be in fluid communication with an injection cannula. For example, the injection cannula may be movable within the housing between a pre-dispensing position and a dispensing position in fluid communication with the reservoir. The reservoir may be configured to contain a formulation containing the substance.

[0250] The substance may contain a drug. The drug may be a solution or a mixture. The drug may be used to treat conditions in a range of therapeutic areas, including but not limited to cardiovascular, musculoskeletal, gastrointestinal, dermatological, immunological, ophthalmic, hematological, neuroscience, oncological, endocrine / metabolic, and respiratory systems. The drug may be used to treat discomfort or pain in a subject. For example, the drug may contain analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), or other pain-relieving, pain-managing substances.

[0251] The housing of the patch and / or the housing of the syringe may comprise one or more polymeric or plastic materials. Non-limiting examples of polymers include polyamide, polycarbonate, polyester, polyethylene, polypropylene, polystyrene, polyurethane, polyvinyl chloride, polyvinylidene chloride, acrylonitrile butadiene styrene, polymethyl methacrylate, polytetrafluoroethylene, polyimide, polylactic acid, phenolic resin, polyetheretherketone, or derivatives thereof (e.g., highly crosslinked, high-density, etc.). The housing of the patch and / or the housing of the syringe may comprise a single polymer type (e.g., homopolymer) or more than one polymer type (e.g., copolymer), and contain a random or arranged monomer structure. For example, the polymer may be a block polymer, alternating copolymer, periodic copolymer, statistical copolymer, stereoblock copolymer, gradient copolymer, branched copolymer, graft copolymer, etc.

[0252] The patch or portions thereof (e.g., sensors, removably coupled housings, etc.) may be reusable. Reusable patches or portions thereof may be sterilized or cleaned before and / or after use. For example, subjects or users (e.g., subjects, healthcare providers, clinicians, etc.) may sterilize or clean the patch or portions thereof. In non-limiting examples, the patch or portions thereof may be sterilized using chemical sterilization (e.g., using bleach, alcohol, hydrogen peroxide, acids, alkalis, or other chemical reagents), radiation treatment (e.g., gamma or ultraviolet irradiation), heat (e.g., autoclave, microwave, etc.), or combinations thereof.

[0253] The patch, syringe, or both may include reusable components and can be configured to couple to a docking station or charging station. For example, the patch or a portion thereof may be reusable, and the patch may include a rechargeable battery. The rechargeable battery can be removed from the patch's housing and coupled to a docking station or charging station that can be used to charge the battery. In other cases, the entire patch may be coupled to a docking station or charging station. In some cases, the docking station or charging station includes a communication interface that can be used, for example, to transmit or upload data from the patch, syringe, or both. The docking station can also be used to provide software updates to the patch, syringe, or both. In some cases, the docking station may be configured to couple to multiple patches or syringes to facilitate use or avoid waiting times or delays (e.g., due to charging duration), or to streamline the workflow of the subject or user.

[0254] Sensors and / or transducers may include one or more sensors or transducers that allow the measurement or monitoring of one or more health or physiological parameters, or allow the instruction of a device to a subject. Alternatively or additionally, one or more sensors may allow the measurement of patch or syringe parameters. Non-limiting examples of patch or syringe parameters include determining whether a patch is secured (e.g., secured to a subject's body), whether a patch or syringe is in communication with a communication interface, whether a cannula is in fluid communication with a reservoir, cannula obstruction, whether the patch and syringe are properly coupled, the flow rate of substance through the cannula, etc. Sensors may be configured to measure the dose of substance administered to the subject, the duration of substance administration or injection (e.g., by measuring the duration of cannula contact with the body or by measuring the volume of substance in the reservoir), cannula contact with the subject's body, or any combination thereof.

[0255] The sensors in the multiple input transducers / sensors can be selected from the following: conductivity sensors, impedance sensors, capacitance sensors, charge sensors, humidity and / or moisture sensors, temperature sensors, heart rate sensors, interstitial pressure sensors, resistance sensors, expansion 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 material tracking sensors. The sensors in the multiple output transducers can be selected from the following: tactile (vibration) transducers, audio transducers, or visual transducers. The output may include an output signal, which may include vibration signals, audio signals, visual signals, tactile signals, electrical signals, or combinations thereof. In non-limiting examples, these sensors can be used to detect environmental conditions of the subject's use of a syringe, the subject's body temperature, heart rate, blood pressure, interstitial pressure, tissue density, tissue thickness (e.g., skin, fat, or adipose tissue thickness), skin swelling, bleeding (e.g., internal or external), drug delivery, the dose of drug delivered and / or delivered to the subject, the subject's sweating and / or multiple analyte measurements (e.g., blood glucose, blood oxygen, etc.) or sleep quality measurements. In some cases, the sensor includes an ultrasound transmitter and an ultrasound receiver. In this case, the method for measuring health or physiological parameters may include transmitting an ultrasound signal from the ultrasound transmitter to a location within the subject's body and receiving the signal from the same or different locations using the ultrasound receiver. This signal can be received by the ultrasound receiver and used to measure health or physiological parameters (e.g., tissue depth, thickness, etc.).

[0256] One or more measurements can be measured or monitored before, during, or after the patch is attached to a subject. For example, the patch can be configured to measure one or more health or physiological parameters prior to injection to establish baseline and / or calibrate measurements for one or more health or physiological parameters. The patch can be attached to the subject's body separately from the syringe. For example, the patch can be attached to the subject's body and one or more measurements can be collected. Subsequent attachment of the syringe (e.g., to the patch and / or the user's body) can then allow the delivery of the substance to the subject.

[0257] The transducer can contain any useful component, such as a solenoid, motor, or microelectromechanical system (MEMS) actuator. In such cases, the housing of the syringe or patch can contain conductive contacts that provide both mechanical attachment and electrical contact for the transducer or sensor, for example, in an electronic subsystem housed within a syringe.

[0258] The patch and / or syringe may include a communication interface that allows the transmission and / or reception of data corresponding to multiple health or physiological parameters of the subject and / or parameters of the patch or syringe. The data may be transmitted to an electronic device that communicates with the communication interface. As described herein, the communication interface may be a wireless communication interface, a Wi-Fi interface, a near-field communication interface, or a Bluetooth interface. The electronic device may be a device capable of communicating with the communication interface, such as a mobile device (e.g., a smartphone, tablet computer, laptop computer, etc.). Alternatively, the communication interface may be a wired communication interface. In some examples, the patch and / or syringe may include a port for communication and / or a power source for connecting to the electronic device (e.g., Universal Serial Bus (USB), USB-C, etc.). The patch and / or syringe may include an RFID tag that allows information to be transmitted to the syringe and / or patch and optionally recorded by the syringe and / or patch, including but not limited to information about the medication. This may allow the transmitted data about the injection to include information about the device and the medication. In some cases, the patch includes a communication interface and the syringe includes an additional communication interface, and the communication interface may be used to provide information about the other communication interface. For example, the patch's communication interface might be able to determine the syringe's parameters (e.g., via an additional communication interface). For instance, the communication interface could be used to determine the location of the syringe or patch and provide one or more outputs (e.g., audio, vibration, or visual signals). In this scenario, if a subject misplaces a syringe or patch, the patch or syringe (or an electronic device communicating with the patch and / or syringe) can be used to track the misplaced item.

[0259] In some cases, patches, syringes, and / or electronic devices may include methods for data processing, data storage, and / or one or more feedback loops. In one such example, a patch may monitor one or more physiological parameters of a subject after injection to generate data about one or more physiological parameters of the subject. The data may be transmitted to an electronic device (e.g., a mobile device) via a communication interface. In some cases, the mobile device may include methods for processing and / or storing the data (e.g., in a computer-readable storage device). Examples of processing include the measurement of analyte concentration, identification of the analyte, comparison of the analyte concentration with a standard, calibration of the measurement, summarization of collected information, statistical calculation, trend determination, etc. The processed data may then be used for adjustment, for example, adjusting one or more parameters of the patch or syringe in a feedback loop. The processed data may also be sent directly to a third party for further evaluation. For example, the measurement of physiological parameters may measure the concentration of an analyte or substance (e.g., a drug or pharmaceutical agent). The data may be transmitted to an electronic device that may further process the data (e.g., calibrate the concentration, compare it with a standard, determine if a dose change is needed, etc.). Therefore, the processed data can be used to modify device parameters, such as the dosage of the substance to be administered, the dispensing flow rate of the substance, etc. The data, processed data, or other signals can then be relayed back to the patch or syringe, allowing subsequent injections to be adjusted (e.g., higher or lower dose for the next injection). In another example, the measurement of physiological parameters can measure patient bleeding (e.g., colorimetric measurements, measurements of heme iron in the blood, etc.). Detection of bleeding or leakage of the substance from the site can be used to adjust (e.g., in a feedback loop) the subsequent administration rate or injection. In such examples, the presence of patient bleeding can allow for a delay in subsequent injections or a change in parameters of the cannula extension toward the subject's body (e.g., injection force, injection speed, etc.). In some cases, electronic devices may not be required, and the patch may be able to communicate directly with the syringe or via a communication interface. In such cases, the patch and / or syringe can measure the subject's device and / or physiological parameters, and subsequently use said measurements to adjust the parameters of the syringe or patch. In a non-limiting example, the measurement of a parameter (e.g., the patient's blood glucose) can adjust the dose of subsequent injections with the syringe.

[0260] In another example, the patch can monitor one or more parameters of the patch and / or syringe to generate data about one or more parameters of the syringe and / or patch. The data can be transmitted to an electronic device (e.g., a mobile device) via a communication interface. In some cases, the mobile device may include methods for processing the data. Examples of processing include determining whether the device is properly secured (e.g., whether the patch's adhesion to the subject's body is above or below a threshold), whether the patch is properly attached to the syringe, etc. The processed data can then be used, for example, to adjust one or more parameters of the patch or syringe in a feedback loop. For example, the adhesion of the patch to the subject's body can be measured. The data can be transmitted to an electronic device that can further process the data (e.g., determine insufficient adhesion). Thus, the processed data can be used to change device parameters, for example, to activate a notification to the subject or other user, as described herein. The data, processed data, or other signals can then be relayed back to the patch or syringe so that the parameters of the patch or syringe are adjusted or need to be adjusted before another injection (e.g., administration of another dose of a substance). In some cases, electronic devices may not be required, and the patch may be able to communicate with the syringe directly or via a communication interface. In such cases, the patch and / or syringe can measure parameters of the patch and / or syringe, and these measurements can then be used to adjust the parameters or different parameters of the syringe or patch. In a non-limiting example, in a feedback loop, a measurement of insufficient adhesion of the patch can prevent subsequent injections from the syringe until the patch is measured to be sufficiently adhered to the subject's body.

[0261] The patch and / or syringe may also communicate with or be able to communicate with a subject or other user. In some cases, communication with the subject or other user may include a feedback system or loop. Alternatively or in combination, the patch or syringe may be able to inform the subject or other user (e.g., physician, nurse, medical practitioner, clinician, etc.) about device parameters, health or physiological parameters, or both. For example, the patch or syringe may be able to generate sound (e.g., to provide direction to the subject or other user), generate motion (e.g., vibration), or may include visual indicators such as lights (e.g., light-emitting diodes), screens or displays (e.g., liquid crystal displays (LCDs), organic light-emitting diodes, quantum dot displays, or variations or derivatives thereof), or other visual indicators. Alternatively or in combination, the patch or syringe may include a user interface module. In such examples, the subject or other user may be able to interact with the patch and / or syringe. In one of such examples, the patch or syringe may include a screen or display that can generate strings or sounds that can be used to prompt the subject or other user in response to commands. In another example, the patch or syringe may include a screen or display that can generate strings or sounds that can be used to display outputs or results, such as measurements of physiological parameters. The subject or other user may then be able to input a response or command, for example, via a microphone that may be in the housing of the patch and / or syringe, or via buttons on the housing of the patch or syringe that the subject can interact with. In some cases, the subject's input to the patch or syringe may result in adjustment of the parameters of the patch or syringe. In some cases, the subject or other user may be able to input parameters (e.g., pain, discomfort, etc.) that may not be easily measured or obtained from the patch or syringe. These parameters may then be transmitted, for example, via a communication interface to an external device (e.g., a mobile device). In some cases, 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, input of pain parameters may result in adjustment of the flow rate of a substance through a cannula or the frequency of substance administration.

[0262] The patch and / or syringe can also 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 to generate data about one or more physiological parameters of the subject or one or more parameters of the patch and / or syringe. The data can be transmitted to a remote server, a distributed computing network (e.g., for cloud computing). The processing of the data can then be performed separately from the patch and / or syringe. In some cases, the processed data can then be transmitted to an electronic device (e.g., a mobile device). In other cases, the processed data can then be transmitted to the patch and / or syringe for adjusting the parameters of the patch and / or syringe. Transmitting data to a remote server and / or electronic device can allow the subject to monitor one or more physiological parameters, and / or can additionally or alternatively allow a physician or caregiver to also monitor one or more physiological parameters of the subject.

[0263] On the other hand, this document provides a method for measuring one or more health or physiological parameters of a subject. The method may include (a) providing: (i) a patch including 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. The second housing may be coupled to the first housing of the patch, and the syringe may include a reservoir containing a substance and a fluid flow path in fluid communication with the reservoir. The method may further include: (b) attaching the patch to the body of a subject; (c) while the patch is attached to the body of the subject, guiding the cannula through the opening to (i) guide the substance from the reservoir to the fluid flow path, and (ii) guide the substance from the fluid flow path through the cannula into the subject; and (d) using the sensor to (i) measure one or more health or physiological parameters from the subject, and (ii) provide one or more outputs corresponding to the one or more health or physiological parameters from the subject.

[0264] On the other hand, this document provides a system for performing one or more processes or methods described herein. The system may include a patch comprising a first housing having a sensor and including an opening, and 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 of the patch, and the syringe may include a reservoir containing a substance and a fluid flow path in fluid communication with the reservoir. The patch may be configured to be coupled or secured to the body of a subject. The syringe may be configured to guide the cannula through the opening to guide the substance from the reservoir to the fluid flow path and to guide the substance from the fluid flow path through the cannula into the subject. The sensor may be configured to (i) measure one or more health or physiological parameters from the subject, and (ii) provide one or more outputs corresponding to one or more health or physiological parameters from the subject.

[0265] On the other hand, this document discloses a method for measuring a subject's health or physiological parameters, the method comprising: (a) providing (i) a reusable patch including a first housing having a sensor, and (ii) a syringe having a second housing including a cannula in fluid communication with a fluid flow path and a reservoir containing a substance, wherein the second housing is coupled to the first housing of the reusable patch, the patch being secured to the subject's body. The method may further include using the sensor to (i) measure the health or physiological parameters from the subject and (ii) provide one or more outputs corresponding to the health or physiological parameters from the subject.

[0266] In other aspects of this disclosure, a system is provided that can be used to perform one or more methods or processes disclosed herein. The system can be used to measure health or physiological parameters from a subject and may include: a reusable patch including a first housing having a sensor, the patch being configured to be attached to the subject's body; and a syringe having a second housing including a cannula in fluid communication with a fluid flow path and a reservoir containing a substance, wherein the second housing is configured to be coupled to the first housing of the reusable patch. The sensor may be configured to measure health or physiological parameters from the subject and provide one or more outputs corresponding to the health or physiological parameters from the subject.

[0267] Using embodiments of this disclosure, individuals with any number of physical and / or psychotic symptoms that can be treated with medications administered via syringes (such as the device described above) can be monitored to ensure the safety and effectiveness of combination therapies (medication and syringes). Data collected during monitoring of patient and syringe attributes can be used by patients, caregivers, providers, payers, and manufacturers of the medications and devices to provide feedback, including confirmation statements / outcomes, to any of these parties, and allows for manual and / or automated intervention by the patient and / or device to improve the safety and effectiveness of treatment.

[0268] exist Figure 59 and Figure 60 In one embodiment shown, the syringe of the above type is generally indicated by 402. The device includes a housing comprising a circular base 404. An annular skin attachment layer 406 is secured to the bottom of the syringe with adhesive and features a pull tab 408. The underside of the attachment layer (in...) Figure 59 and Figure 60 (As can be seen) An adhesive is provided that provides a lower holding force than the adhesive that secures the attachment layer 406 to the syringe. Therefore, the syringe 404 can be removed from the subject's body (e.g., skin) by pulling the tab 408 upward away from the subject's skin.

[0269] In addition to the 406 skin adhesion layer, in Figure 59 The patch is generally indicated by 412, such as Figure 60 As shown in the exploded diagram, the patch is attached to the bottom of the syringe via a magnetic fastening device, which will be explained in more detail below. As an alternative to magnetic attachment, the patch can be attached to the syringe using adhesive or other mechanical means.

[0270] Although the patch and skin attachment layer are shown with a circular outline, alternative shapes can also be used.

[0271] A generally tapered skin boundary displacement extension 414 extends from the bottom of the patch 412 and, as previously described, compresses the skin to help reduce tissue deflection or “bulge” during cannulation. The extension 414 has a central aperture 416 aligned with the dispensing port of the syringe.

[0272] In an alternative embodiment, as described in the embodiments presented above, the skin boundary displacement extension may be part of and extend from the base 404 of the syringe itself. In such embodiments, a central hole may be provided at the center of the patch, wherein the hole is smaller than the diameter of the base of the extension. When the syringe is positioned to hold the device against the skin with the skin adhesion layer, the extension dilates the hole in the patch and provides a path for the syringe cannula or insert to enter the skin when the device is activated or “fired” in the manner described above. The cannula may not pass directly through the material and provides the opportunity to block the cannula or inject foreign bandage material into the skin from the cannula, see [reference needed]. Figure 16B When the syringe is removed from the skin, the expanded central hole of the patch closes to its original smaller size. Absorbent material may optionally be deposited around the central hole of the patch to absorb any blood or leakage. In this way, the patch acts as a "band-aid" after injection.

[0273] like Figure 59 and Figure 60 As shown, the skin attachment layer 406 has a central opening 418, which is sized to receive the patch 412. Although Figure 59 and Figure 60 The embodiment shows the patch 412 separated from the skin attachment layer 406, but in an alternative embodiment, the patch can be circumferentially attached to the skin attachment layer via a perforation device. As yet another alternative, the patch 412 can be secured to the skin attachment layer via tabs spaced circumferentially around the patch.

[0274] like Figure 60 As shown, patch 412 includes sensor 422, printed circuit board (PCB) chip 424, and sensor adhesive layer 426. The PCB chip 424 and sensor adhesive layer 426 are secured to sensor 422 by adhesive or other fastening mechanisms. Figure 59 As shown, the sensor adhesive layer 426 includes a central window 428 through which, after assembly, an extension 414 protrudes when the sensor adhesive layer 426 is in place. The downward-facing surface 430 of the sensor adhesive layer 426 is provided with adhesive for securing the patch to the user's skin.

[0275] The syringe 402 and patch 412 are configured such that when the syringe is attached, the patch is applied to the body (e.g., skin, finger) of the subject (e.g., user). Furthermore, after the syringe 402 is removed, the patch 412 remains unchanged. More specifically, as... Figure 60As shown, a plurality of permanent magnets 432 are positioned and secured within the housing of syringe 402. By way of example only, the magnets may be secured within corresponding recesses 434 formed within the syringe housing by adhesives, interference fits, or other attachment methods, as described elsewhere herein. The top side of sensor 422 has a metal disk portion 436 ( Figure 59 and Figure 60 This allows the patch to be magnetically attached to the bottom of the syringe. 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 required to hold the patch to the syringe. As an alternative to metal, the disc portion 436 can be provided with a metal portion, such as... Figure 59 As shown by the dashed line at point 437, this corresponds to and attracts the magnet of the syringe. In alternative embodiments, the patch(s) may have other shapes. A single annular metal portion may also be used.

[0276] The advantage of using a magnet to attach the patch to the syringe is that no adhesive residue is exposed on the patch when it remains on the patient. Furthermore, the magnet can be precisely positioned on the syringe, with the corresponding metal portion on the patch, allowing control over the magnitude and location of the "pulling" force applied to the patch when the syringe is removed. A magnet can be used as an alternative to the metal portion on the syringe. In an alternative implementation, the magnet can be located on the patch and the corresponding metal portion can be located on the syringe.

[0277] In an alternative embodiment, patch 412 may be secured to the bottom of the syringe with an adhesive (such as on the top side of sensor 422) having a smaller holding force than the skin-adhesive adhesive on the surface 430 of sensor adhesive layer 426.

[0278] In another alternative embodiment, a mechanical feature built into the patch, syringe, or both can be used to secure the patch 412 to the bottom of the syringe using the retaining force of the skin-adhesive adhesive on the surface 430 of the sensor adhesive layer 426. In such embodiments, Figure 59 and Figure 60 The skin attachment layer 406 can be removed, so that the syringe is held to the patient solely via a connector between the syringe housing and the patch. In such embodiments, both the syringe and the patch are secured to the patient solely via the sensor adhesive layer. Additional connectors may also exist between the syringe housing and the sensor adhesive layer 426 (in addition to the syringe being connected to the sensor adhesive layer via the patch, as described elsewhere herein).

[0279] like Figure 61 and Figure 62As shown, PCB chip 424 has circuitry including a Bluetooth module, which has a microcontroller / microprocessor 444 connected to a battery 442 and an antenna 448. Furthermore, Bluetooth module 444 is attached to sensor 422. Battery 442 provides stored energy to power the system. Bluetooth module 444 has an integrated microcontroller / microprocessor. An example of a suitable Bluetooth module is Dialog Semiconductor part number DA14580-01UNA. In alternative embodiments, the Bluetooth module may be separate from the microcontroller / microprocessor. In some embodiments, direct communication to the cloud may be used, such as, for example, via cellular or other communication technologies.

[0280] like Figure 63 As shown, syringe 402 is provided with one or more sensors 450a and 450b, which communicate with Bluetooth module 444 via Bluetooth. Sensors 450a and 450b may include transmitters and may receive power from a battery also located within the syringe housing. Alternatively, each sensor may have its own battery. Sensors 450a and 450b may also be passive sensors that do not require battery power. Sensors 450a and 450b can be selected to provide a variety of alternative functions, as described in more detail below.

[0281] 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 using alternative wireless communication devices known in the art. In other alternative embodiments, sensors 450a and 450b can communicate with the module 444 of the PCB chip 424 via one or more wire connectors that automatically disconnect when the syringe is removed from the patch and the patient.

[0282] Of course, the number of sensors 436, 450a, and 450b can differ. Figures 61 to 63 The quantities shown.

[0283] The Bluetooth module 444 also enables the patch to transmit data collected from sensors 422, 450a, and 450b to a remote receiver (such as a personal data device, such as a smartphone, computer system, or network or cloud). The remote receiver can collect the received data in a database and build a database.

[0284] In use, such as Figure 59As shown, the syringe initially has an attached patch (via the aforementioned magnetic device). A protective backing sheet is removed from the skin attachment layer 406, exposing the adhesive on the surface away from the syringe. The backing sheet can also removably cover the adhesive on the patch surface 430. The exposed adhesive surfaces of the syringe skin attachment layer 406 and the sensor adhesive layer 426 are then pressed against the user's skin, attaching the syringe and patch there.

[0285] In the illustrated embodiment, patch 412 has several functions. First, it senses the status of the syringe and transmits this status to a remote receiver (such as a personal data device, like a smartphone, computer network, or cloud), indicating that the syringe has been activated, injection is in progress, or injection has been completed. Second, the patch transmits the patient's status to the remote receiver via data collected from the sensor. This can be done before, during, or after injection, and before, during, or after attaching and / or removing the syringe. For example, skin temperature and skin "color" at the injection site can be detected via a simple temperature monitor combined with LED / phototransistor circuitry included in sensor 422 for transmitting tissue temperature and color during and after injection. These features are very useful during clinical studies, alerting staff to the presence of an injection site reaction (ISR) and quantifying the ISR based on temperature and tissue color. Third, the patch can interact directly with the syringe based on data received from the syringe and / or from the patient and / or from itself. The patch can interact with the syringe as a control mechanism, including adjusting the flow rate (faster, slower, or paused), vibrating for user notification and / or pain management, providing audible sounds to provide direction or notification to the user, visual indicators to indicate changes, reminders, notifications, or information to the user, or mechanical interactions to cause changes in the syringe state, including but not limited to retracting a button to stop delivery in response to data from the patient (e.g., pain) or data from the device (e.g., premature removal or detachment).

[0286] If useful, sensor 422 may also include a heart rate sensor to obtain the patient's EKG signal, and / or may provide a strain gauge sensor to detect the EKG signal. Figure 59 and Figure 60 The extension 414 applies skin pressure. Patient mobility, location, and position data can be collected by corresponding sensors (such as accelerometers, GPS sensors, etc.) incorporated in sensor 422. Furthermore, several electrodes in contact with the skin (included in sensor 422) can detect skin impedance and detect leakage or disassembly. Additionally, the skin-contact electrodes can detect premature removal of the device, i.e., removal of the device before it has completed its cycle.

[0287] After the syringe injection is completed, by using the convex plate 408 ( Figure 59 and Figure 60 By pulling away from the patient's skin, the syringe can be removed from the patient's skin. When done in this way, the patch separates from the syringe, allowing only the patch to adhere to the patient. The removable nature of the monitoring patch provides physicians and others with the ability to continuously monitor the patient between injections.

[0288] Alternatively or additionally, the patch may initially be detached from the syringe and placed on the patient for monitoring before the administration / injection of one or more medications. This provides baseline data about the patient prior to administration / injection.

[0289] Alternatively or additionally, the patch can be applied independently of the syringe and placed on the patient to monitor baseline status (e.g., baseline physiological parameters) before the administration / injection of one or more medications. The syringe can then be coupled to the patch before the injection begins.

[0290] Alternatively or additionally, the patch may be provided separately from the syringe, and in some cases, the patch or a portion thereof is reusable. In this case, an adhesive may be used to attach the patch to the subject's body (e.g., skin), and the adhesive may be single-use or reusable. In some cases, the patch or a portion thereof is reusable and may be sterilized or cleaned before or after use. For example, the subject or user (e.g., subject, healthcare provider, clinician, etc.) may sterilize or clean the patch or a portion thereof. An adhesive may be applied or attached to the patch, and then the patch may be used to secure it to the subject's body. As described herein, the patch may be used to monitor health or physiological parameters and may provide or monitor baseline conditions prior to injection.

[0291] During the injection or administration of a substance, the subject or user may attach a syringe to the patch. After the administration or injection of the substance is complete, the subject or user may remove the syringe and attach the patch to the subject's body. The patch can then continue to monitor health or physiological parameters following administration or injection. The subject or user may remove the patch at any convenient or useful time (e.g., after health or physiological parameters have been monitored for a certain duration or frequency following injection or administration).

[0292] Where the patch is reusable, the patch or a portion thereof can be removed from the subject's body and can be cleaned or sterilized. For example, the patch or a portion thereof (e.g., a sensor) can be removed from the subject or the patch's housing. Then, in non-limiting instances, the patch or a portion thereof can be sterilized using chemical sterilization (e.g., using bleach, alcohol, acid, alkali, or other chemical reagents), radiation treatment (e.g., gamma radiation), heat (e.g., autoclave, microwave oven, hot water, etc.) or a combination thereof.

[0293] The patch or syringe can be configured to couple to a docking station or charging station. In this case, the patch or a portion thereof can be reused and may include a rechargeable battery. The rechargeable battery (contained in the patch or a portion thereof and / or the syringe) can be coupled to the docking station or charging station, which can be used to charge one or more batteries. In some cases, the docking station or charging station includes a communication interface that can be used, for example, to transmit or upload data from the patch, syringe, or both. The docking station can also be used to provide software updates for the patch, syringe, or both. In some cases, the docking station can be configured to couple to multiple patches or syringes to facilitate use or avoid waiting times or delays (e.g., due to charging duration), or to simplify the workflow of the subject or user.

[0294] Figures 64 to 65 An exploded view of another embodiment of the patch and syringe is shown. Patch 6401 includes an adhesive layer 6403 and a sensor 6405, which may include a PCB chip. In this embodiment, and in other embodiments described below, the patch and / or syringe may each include one or more sensors, as described in the preceding embodiments. Sensor 6405 may adhere to adhesive layer 6403, which may be used to secure patch 6401 to a subject's body. Syringe 6407 and patch 6401 may be configured such that the patch is applied to the subject's body when syringe 6407 is attached. Alternatively, or otherwise, syringe 6407 and patch 6401 may be coupled together before securing patch 6401 and syringe 6407 to the subject's body.

[0295] An interlocking bayonet mechanism can be used to couple the patch 6401 to the syringe 6407. For example, the syringe 6407 may include a protruding element 6409 that can engage a pawl 6411 in the patch 6401. In a first configuration, the pawl 6411 prevents free rotation of the patch 6401 and the protruding element 6409. When twisting the patch 6401 or the syringe 6407, the syringe 6407 can be moved to a second configuration where the protruding element 6409 is no longer coupled to the pawl 6411, thus allowing the syringe 6407 to be detached from or removed from the patch 6401 (e.g., after the patch has been attached to the subject's body and the medication has been delivered).

[0296] Figure 66An exploded view of another embodiment of the patch and syringe is shown. Patch 6601 includes an adhesive layer 6603 and a sensor 6605, which may include a PCB chip. Sensor 6605 can adhere to adhesive layer 6603, which can be used to secure patch 6601 to a subject's body. Syringe 6607 and patch 6601 can be configured such that the patch is applied to the subject's body when syringe 6607 is attached. Alternatively, or otherwise, syringe 6607 and patch 6601 may be coupled together before being secured to the subject's body.

[0297] The patch 6601 can be coupled to the syringe 6607 via coupling or mating parts 6609 and 6611. Part 6609 can be coupled to the syringe 6607 (e.g., in the recess 6613), while part 6611 can be coupled to the patch 6601. Parts 6609 and 6611 can be magnets and can be correspondingly secured to the recess 6613 of the syringe 6607 and the patch 6601 via adhesive, interference fit, or other attachment means. The adhesive layer 6603 can provide a holding force to the subject's body (e.g., skin) greater than the magnetic force required to hold the patch to the syringe.

[0298] Figure 67 Another embodiment of the patch and syringe is shown. Patch 6701 includes an adhesive layer 6703 and a sensor 6705, which may include a PCB chip. Sensor 6705 can adhere to adhesive layer 6703, which can be used to secure patch 6701 to a subject's body. Syringe 6707 and patch 6701 can be configured such that the patch is applied to the subject's body when syringe 6707 is attached. Alternatively, or otherwise, syringe 6707 and patch 6701 can be coupled together before being secured to the subject's body.

[0299] The patch 6701 can be coupled to the syringe 6707. For example, the sensor 6705 can be configured to be coupled to the syringe 6707 by being assembled into the recess 6713. The syringe may include a safety tab or strip. The adhesive layer 6703 can provide a holding force to the subject's body (e.g., skin) greater than the magnetic force required to hold the patch to the syringe.

[0300] Figure 68 It shows Figure 67A cross-sectional view of the coupled syringe and patch. The syringe may include a latch 6717 connected to a spring (e.g., a torsion spring) 6715. In block A, the patch and syringe may be in a first configuration (“ready position”), where the device is locked and the patch remains attached to the syringe. Button 6719 is in the start or ready position and is ready to actuate; when pressed, button 6719 can be used to guide the cannula toward the subject. In block B, the syringe may be switched (e.g., via rotation, removal of safety tab 6801, or both) to a second configuration (“locked position”). In the second configuration, the torsion spring may be released, thereby translating latch 6717 to a different position. In this configuration, the syringe can be removed from the patch, and button 6719 may be in the raised position shown in block B, thereby preventing the cannula from being expelled from the syringe.

[0301] Figure 69 Another embodiment of the patch and syringe is shown. Patch 6901 includes an adhesive layer 6903, a sensor 6905 which may contain a PCB chip, and an attachment module 6911. Attachment module 6911 may include an adhesive or other fastening mechanism to adhere patch 6901 to syringe 6907. Sensor 6905 may be adhered to adhesive layer 6903, which may be used to secure patch 6901 to a subject's body. Syringe 6907 and patch 6901 may be configured such that the patch is applied to the subject's body when syringe 6907 is attached. Alternatively, or otherwise, syringe 6907 and patch 6901 may be coupled together before being secured to the subject's body. Patch 6901 may additionally include an outer layer containing perforations 6921. For example, the outer layer may comprise plastic, polymer (e.g., a thermosensitive polymer, such as a shrink wrap), or other materials. The outer layer can be configured to be removed before the patch and syringe are used. When the device is ready for use, the outer layer can be removed by pulling tab 6923, which can remove the outer layer through perforation 6921, thus allowing the removal of the outer layer.

[0302] Figure 70 It shows Figure 69 A cross-sectional view of the coupled syringe and patch. The dimensions of the patch (e.g., width or diameter) can be substantially similar to the diameter of the syringe.

[0303] Figure 71Another embodiment of the patch and syringe is shown. The patch 7101 includes an adhesive layer 7103 and a sensor 7105, which may include a PCB chip. The sensor 7105 can adhere to the adhesive layer 7103, which can be used to secure the patch 7101 to a subject's body. The syringe 7107 and patch 7101 can be configured such that the patch is applied to the subject's body when the syringe 7107 is attached. Alternatively, or otherwise, the syringe 7107 and patch 7101 can be coupled together before being secured to the subject's body. The patch 7101 can 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 subsequent pushing or applying force to the latch 7113 can cause the patch 7101 to detach from the syringe 7107. Alternatively or otherwise, latch 7113 may include a hook capable of adhering to the housing of syringe 7107. The latch can then be actuated by pressing or applying force to latch 7113 and pulling the latch away from the housing of syringe 7107, which allows patch 7101 to be detached from syringe 7107.

[0304] Figure 72 It shows Figure 71 A cross-sectional view of the coupled syringe and patch. Latch 7113 includes a hook that adheres to the syringe housing. By applying force 7115 to the latch, the hook can be released, allowing the patch to be separated from or removed from the syringe.

[0305] Figure 73 Another embodiment of the patch and syringe is shown. The patch 7301 includes an adhesive layer 7303 and a sensor 7305, which may include a PCB chip. The sensor 7305 can adhere to the adhesive layer 7303, which can be used to secure the patch 7301 to a subject's body. The syringe 7307 and patch 7301 can be configured such that the patch is applied to the subject's body when the syringe 7307 is attached. Alternatively, or otherwise, the syringe 7307 and patch 7301 can be coupled together before being secured 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 comprise rubber or other elastic material. The ring 7313 can be coupled to the syringe 7307 by being assembled into grooves in the flanges 7311 and 7321. Flange 7311 can be complementary to flange 7321 of patch 7301.

[0306] Figure 74 It shows Figure 73A cross-sectional view of the coupled syringe and patch. The flange 7321 of the patch can complementarily mate with the flange 7311 of the syringe. The patch can be detached from the syringe by applying a force 7415 to the flange 7321.

[0307] Figure 75 Another embodiment of the patch and syringe is illustrated. As shown in block A, patch 7501 includes an adhesive layer 7503 and a sensor 7505, which may contain a PCB chip. Sensor 7505 can adhere to adhesive layer 7503, which can be used to secure patch 7501 to a subject's body. Syringe 7507 and patch 7501 can be configured such that the patch is applied to the subject's body when syringe 7507 is attached. Alternatively, or otherwise, syringe 7507 and patch 7501 can be coupled together before being secured to the subject's body, as shown in block B. The housings of patch 7501 and sensor 7505 may partially surround the housing of syringe 7507. Patch may also include wing-shaped features 7513. Features 7513 may allow for better gripping by the subject or be used for positioning the device.

[0308] Figure 76 Another embodiment of the patch and syringe is illustrated. In block A, patch 7601 includes an adhesive layer 7603 and a sensor 7605, which may include a PCB chip. Sensor 7605 may adhere to adhesive layer 7603, which may be used to secure patch 7601 to a subject's body. Syringe 7607 and patch 7601 may be configured such that patch is applied to subject's body when syringe 7607 is attached. Alternatively, or otherwise, syringe 7607 and patch 7601 may be coupled together before being secured to subject's body, as shown in block B. Patch 7601 may be coupled to syringe 7601 via latch 7613, which may secure to protrusion 7611 of syringe 7601. The latch may be rotatable, such that in some configurations the latch 7613 does not rest on the protrusion 7611, thereby allowing the patch 7601 to be separated from the syringe 7607.

[0309] Figure 77Another embodiment of the patch and syringe is illustrated. In block A, patch 7701 includes an adhesive layer 7703 and a sensor 7705, which may include a PCB chip. Sensor 7705 can adhere to adhesive layer 7703, which can be used to secure patch 7701 to a subject's body. Syringe 7707 and patch 7701 can be configured such that the patch is applied to the subject's body when syringe 7707 is attached. Alternatively, or otherwise, syringe 7707 and patch 7701 can be coupled together before being secured to the subject's body, as shown in block B. Patch 7701 can be coupled to syringe 7707 via adhesive (e.g., at the interface between patch 7701 and syringe 7707). For example, patch may also include protruding features 7713 on adhesive layer 7703. When the subject presses or pulls feature 7713, the protruding feature allows patch 7701 to separate from syringe 7707.

[0310] Figure 78 It shows Figure 77 A cross-sectional view of the coupled syringe and patch. Highlighting feature 7713 allows the patch to be pried open from the syringe.

[0311] Figure 79 Another embodiment of the patch and syringe is illustrated. In block A, patch 7901 includes an adhesive layer 7903 and a sensor 7905, which may contain a PCB chip. Sensor 7905 can adhere to adhesive layer 7903, which can be used to secure patch 7901 to a subject's body. Syringe 7907 and patch 7901 can be configured such that the patch is applied to the subject's body when syringe 7907 is attached. Alternatively, or otherwise, syringe 7907 and patch 7901 can be coupled together before being secured to the subject's body, as shown in block B. Patch 7901 can be coupled to syringe 7907 via a flange 7913 on the patch and a complementary protrusion 7911 on syringe 7907. Flange 7913 can lock or hook onto protrusion 7911. In the first configuration, flange 7913 can be locked, and in the second configuration, flange 7913 can be released, such as to allow patch 7901 to separate from syringe 7907.

[0312] Figure 80Another embodiment of the patch and syringe is shown. The patch 8001 includes an adhesive layer 8003 and a sensor 8005, which may include a PCB chip. The sensor 8005 can adhere to the adhesive layer 8003, which can be used to secure the patch 8001 to the subject's body. The syringe 8007 and patch 8001 can be configured such that the patch is applied to the subject's body when the syringe 8007 is attached. Alternatively, or otherwise, the syringe 8007 and patch 8001 can be coupled together before securing the patch 8001 and syringe 8007 to the subject's body. The patch 8001 can be coupled to the syringe 8007 via a threaded feature 8013 on the patch 8001 and a complementary thread (not shown) on the syringe 8007. The threaded feature 8013 can be screwed onto the complementary thread of the syringe 8007. The coupling and disengagement of patch 8001 and syringe 8007 can occur by twisting patch 8001 or syringe 8007.

[0313] Figure 81 It shows Figure 80 A cross-sectional view of the coupled syringe and patch. The patch's thread 8013 is complementary to the syringe's thread. The patch can be released from the syringe by twisting the syringe counterclockwise.

[0314] Figure 82 Another embodiment of the patch and syringe is shown. The patch 8201 includes an adhesive layer 8203, a sensor 8205 that may contain a PCB chip, and a deformable surface 8213. The sensor 8205 can adhere to the adhesive layer 8203, which can be used to secure the patch 8201 to a subject's body. The syringe 8207 and patch 8201 can be configured such that the patch is applied to the subject's body when the syringe 8207 is attached. Alternatively, or otherwise, the syringe 8207 and patch 8201 can be coupled together before being secured to the subject's body. The patch 8201 can be coupled to the syringe 8207 via the deformable surface 8213. In a first configuration, the deformable surface 8213 may include a gradient hole 8215, which 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 together, the deformable surface can present a second configuration in which the gradient hole 8215 is large enough that the screw or pin 8217 can be removed from the deformable base 8213 of the patch 8201, thereby separating the patch 8201 from the syringe 8207.

[0315] Figure 83 It shows Figure 82A cross-sectional view of the coupled syringe and patch. In this configuration, the deformable substrate 8213 is locked onto the syringe. By pressing the ends of the deformable substrate 8213 together, the tapered hole is moved, allowing the syringe pin 8217 to be lifted from the deformable substrate and the patch, thereby separating the patch from the syringe.

[0316] Figure 84 Another embodiment of the patch and syringe is shown. The patch 8401 includes an adhesive layer 8403 and a sensor 8405, which may include a PCB chip. The sensor 8405 can adhere to the adhesive layer 8403, which can be used to secure the patch 8401 to the subject's body. The syringe 8407 and patch 8401 can be configured such that the patch is applied to the subject's body when the syringe 8407 is attached. Alternatively, or otherwise, the syringe 8407 and patch 8401 can be coupled together before being secured to the subject's body. The patch 8401 can be coupled to the syringe 8407 via a ridge 8413 on the patch 8401, which can be used to secure the patch 8401 to the syringe 8407 via a snap-fit ​​or press-fit. The syringe 8407 may additionally include complementary features that can be secured to the ridge 8413. The separation of patch 8401 from syringe 8407 can be achieved by twisting patch 8401 or syringe 8407 or by pulling patch 8401 away from syringe 8407.

[0317] Figure 85 It shows Figure 84 A cross-sectional view of the coupled syringe and patch. The ridge 8413 of the patch can be configured to couple to a complementary feature 8513 of the syringe (e.g., a bump, ridge, cavity). Separation of the patch and syringe can occur by applying sufficient force to pry open the ridge 8413 and the complementary feature 8513.

[0318] Figure 86Another embodiment of the patch and syringe is shown. Patch 8601 includes an adhesive layer 8603 and a sensor 8605, which may include a PCB chip. Sensor 8605 may adhere to adhesive layer 8603, which may be used to secure patch 8601 to a subject's body. Syringe 8607 and patch 8601 may be configured such that the patch is applied to the subject's body when syringe 8607 is attached. Alternatively, or otherwise, syringe 8607 and patch 8601 may be coupled together before being secured to the subject's body. Patch 8601 may be coupled to syringe 8607 by coupling or mating parts 8609 and 8611. Part 8609 may be coupled to syringe 8607 (e.g., in recess 8613), while part 8611 may be coupled to patch 8601. Components 8609 and 8611 may contain magnets and may be attached to the recess 8613 and patch 8601 of syringe 8607 by means of adhesive, interference fit or other attachment means.

[0319] Figure 87 It shows Figure 86 A cross-sectional view of the coupled syringe and patch. The patch magnet 8611 can be configured to be coupled to the syringe magnet 8609. Separation of the patch and syringe can occur by fully separating the patch magnet from the syringe magnet.

[0320] In some cases, it may be useful to attach both the patch and the syringe to the subject's body. In such cases, the syringe may additionally include features that can be configured to couple the syringe housing to the subject's body. For example, the syringe may include an adhesive layer. The adhesive layer of the syringe may be separate from the mechanism used to attach the patch to the subject's body.

[0321] Figure 88Another embodiment of the patch and syringe is shown, wherein both the patch and syringe are configured to be coupled to a subject's body. In block A, patch 8801 includes an adhesive layer 8803 and a sensor 8805, which may include a PCB chip. Sensor 8805 may adhere to adhesive layer 8803, which may be used to secure patch 8801 to the subject's body. Patch 8801 may be configured such that patch 8801 is applied to the subject's body, and patch 8801 may be secured separately from syringe 8807, which may also include adhesive layer 8813. Alternatively, or otherwise, syringe 8807 and patch 8801 may be coupled together before patch 8801 and syringe 8807 are secured to the subject's body, as shown in block B. Patch 8801 may be coupled to syringe 8807 by coupling or mating parts, as described elsewhere herein. The adhesive layer 8803 of patch 8801 may include a feature 8811 that allows the adhesive layer 8803 of patch 8801 to be separated from the adhesive layer 8813 of syringe 8807. In such examples, patch 8801 can be secured to the subject's body and cannot be removed from the subject until syringe 8807 is removed. In some cases, the adhesion or bonding force of patch adhesive layer 8803 to the subject's body (e.g., skin) may be greater than the adhesion or bonding force of syringe 8807 to the subject's body (e.g., skin). In some cases, the adhesion or bonding force of patch adhesive layer 8803 to the subject's body may be greater than the adhesion or bonding force of patch 8801 coupled to syringe 8807.

[0322] Figure 89 It shows Figure 88 A cross-sectional view of the coupled syringe and patch. Both the patch and the syringe may contain an adhesive layer. The adhesive layer 8813 of the syringe can be configured to secure the syringe to the subject's body.

[0323] In some cases, the patch or its opening may include a puncturable or flexible membrane. A puncturable membrane may include an opening (e.g., a slit, a hole) through which the syringe can pass when the cannula is guided from the syringe into the subject's body. In some cases, a flexible membrane includes an opening (e.g., a slit, a hole) through which the syringe can pass when the cannula is guided from the syringe into the body, and the opening may close after the cannula is retracted. For example, the membrane may be provided in an "open" configuration, wherein the membrane is stretched by a mechanism (e.g., a "tissue tent" structure) on the patch. When the syringe is separated from the patch, this mechanism may switch to a "closed" configuration (e.g., by removing the "tissue tent" structure from the patch, thereby biasing the membrane to the closed configuration), and the membrane may return to its state before stretching. In some cases, the puncturable membrane may adhere to or otherwise attach to the subject's body. In such cases, the puncturable membrane may include an absorbent material, for example, to absorb bodily fluids (e.g., blood, sweat, etc.) from the subject. It should be understood that any of the above embodiments may include a patch containing a sensor (e.g., on a PCB chip), and alternatively or otherwise, the patch may include a puncture-resistant membrane, which may include an absorbent material.

[0324] Figure 90 An example patch or a portion thereof is shown, comprising a punctureable membrane of an adhesive layer coupled to a syringe. In block A, patch 9001 includes an adhesive layer 9003. The patch may also include a sensor (not shown) that can adhere to the adhesive layer 9003. The adhesive layer 9003 can be used to secure patch 9001 to a subject's body. Patch 9001 can be configured such that patch 9001, when applied to a subject's body, can be secured separately from syringe 9007, which may also include adhesive layer 9013. Alternatively, or otherwise, syringe (not shown) and patch 9001 may be coupled prior to securing patch 9001 and syringe to the subject's body, as shown in block B. The patch may also include an opening 9021, which may include a punctureable membrane 9023. In some cases, the opening 9021 is a slit, and the material of the puncture-resistant membrane 9023 contains a self-healing elastomer (i.e., the opening closes after the cannula retracts away from the subject's body). The adhesive layer 9003 of the patch 9001 may include a feature 9011 (e.g., a tab) that allows the adhesive layer 9003 of the patch 9001 to separate from the adhesive layer 9013 of the syringe 9007. Figure 91 It shows Figure 90A bottom-up cross-sectional view of the patch. The patch includes an opening 9021, which is an opening to a puncture-resistant membrane 9023. In some cases, the opening 9021 is a slit, and the material of the puncture-resistant membrane 9023 comprises a self-healing elastomer and / or absorbent material. The adhesive layer 9003 of the patch may include a feature 9011 (e.g., a tab) that allows the adhesive layer 9003 of the patch to be separated from the adhesive layer of the syringe. In some cases, the housing of the patch may serve as an insulating barrier to protect the user or subject. The patch may include a flexible membrane comprising absorbent material and serving as a single-use component to allow attachment / removal / use of a reusable patch or portion thereof, as described herein (see, for example...). Figure 101 and 102 ).

[0325] Figure 92 It shows Figure 90 An exploded view of the adhesive layers of the patch and syringe. Patch 9001 includes a puncture-resistant membrane 9023, which may include an opening 9021. The puncture-resistant membrane 9023 can be separated from the patch and can remain attached to the subject's body (e.g., as a bandage). In some cases, the opening 9021 is a slit, and the material of the puncture-resistant membrane 9023 includes a self-healing elastomer as well as an absorbent material. The adhesive layer 9003 of patch 9001 may include a feature 9011 (e.g., a tab) that allows the adhesive layer 9003 of the patch to be separated from the adhesive layer 9013 of the syringe.

[0326] In some examples, the patch can be configured to couple to an autoinjector. Figure 93An example patch comprising a puncturable membrane coupled to an autoinjector 9307 is shown. In block A, patch 9301 includes an adhesive layer 9303. The patch may also include a sensor (not shown) that can adhere to the adhesive layer 9303. The adhesive layer 9303 can be used to secure patch 9301 to a subject's body, and in some cases, adhesive layer 9303 can be secured to the subject's body. In such cases, adhesive layer 9303 contains an absorbent material (e.g., a bandage pad) and will remain on the subject's body after injection. Patch 9301 can be configured such that patch 9301 can be applied to the subject's body and can be secured separately from the autoinjector 9307. Alternatively, or otherwise, the autoinjector 9307 and patch 9301 may be coupled prior to securing patch 9301 to the subject's body, as shown in block B. The patch may also include an opening 9321, which may be part of the puncturable membrane 9323. In some cases, the opening 9321 is a slit, and the material of the puncture-resistant membrane 9323 contains a self-healing elastomer (i.e., the opening closes after the cannula retracts away from the subject's body). The adhesive layer 9303 of the patch 9301 may include features 9311 (e.g., tabs) that allow the adhesive layer 9303 of the patch 9301 to separate from the autoinjector. In some cases, the patch 9301 may also include a sensor unit 9305, which may include a PCB chip.

[0327] Figure 101An example schematic diagram of a patch including a membrane with an absorbent material is provided. Patch 10150 may include a membrane 10125, which is flexible and may include or form openings. Patch 10150 may also include one or more sensors 10115, such as those described herein, and an adhesive layer 10120. The patch may be coupled to a syringe including a cannula 10105. In block A, the patch and syringe may be attached to a subject's body 10130 (e.g., skin, tissue). The surface of syringe 10100 may include a "tissue tent" structure 10110, which may facilitate the formation of openings in the membrane 10125 when coupled to patch 10150 (e.g., by pressing down the membrane). In block B, cannula 10105 may be guided through the openings toward the subject's body 10130 and into underlying tissue. In block C, cannula 10105 may be retracted. The syringe can then be removed or detached from the patch 10150, and the membrane 10125 can be in a “closed” configuration. Deposition of a substance or drug 10135 can be performed within or near the subject's body 10130. Block D shows a top-down schematic of the patch, including a sealable opening 10140, the membrane 10125, and the sensor 10115 in “open” and “closed” configurations (left and right, respectively), as described herein.

[0328] Figure 102 Another example schematic diagram of a reusable patch including a membrane with absorbent material is provided. The reusable patch may include a flexible membrane 10225 that may include or form openings. The patch may also include one or more sensors 10215, such as those described herein, and an adhesive layer 10220. In some cases, the patch portion 10250 including the sensor 10215 may be removed from the patch. In other cases, the entire patch may be removable and / or reusable, and the adhesive layer 10220 may be provided separately. For example, the patch portion 10250 may include a protective layer 10255, and the portion of the patch may be reusable. The sensor 10215 may be attached to the patch 10250 using, for example, the adhesive layer 10220, which may also be used to attach the patch or a portion thereof 10250 to a subject. The patch may be coupled to a syringe 10200 including a cannula 10205. In block A, the patch and syringe may be secured to the body (e.g., skin, tissue) of a subject (not shown). The surface of syringe 10200 may include a “tissue tent” structure (not shown) that, when coupled to patch 10250, can facilitate the formation of openings in membrane 10225 (e.g., by pressing down the membrane, see also). Figure 101The cannula 10205 can be guided through the opening toward the subject's body and into the underlying tissue. The cannula 10205 can be retracted. The syringe 10200 can then be removed or detached from the patch 10250, and the membrane 10125 can be presented in a "closed" configuration. Figure B shows a top-down schematic of the patch, including a removable or reusable portion 10250, a sealable or closable opening 10240, a membrane 10225, and a sensor 10215, all in a "closed" configuration as described herein. The reusable portion 10250 can be adhered to the patch and / or the subject's body using an adhesive layer 10210.

[0329] Embodiments of this disclosure provide a combination of reporting the status of both the syringe and the patient during and after injection. The patch and associated battery and circuitry are initially physically coupled to the syringe. In alternative embodiments, the patch can be applied and allow connection of one or more syringes. The patch circuitry can, for example, transmit one or more parameters of the syringe to a receiver before being attached to the patient, via a communication interface. Once the patch / syringe is attached to the patient, the patch transmits the status of both the patient and the syringe. When the syringe is removed, the patch remains directly on the patient's injection site to transmit the status of the injection site. If sufficient time is available to ensure no reaction has occurred, the patch may remain there for several hours, or the patch may be retained until the next application of the syringe / patch. That is, after injection, the patient can remove the syringe and leave the patch on. The patch can continue to provide data (up to several days) until the next patch replacement.

[0330] In many situations, physicians may be reluctant to have patients self-administer the patch at home due to potential adverse reactions. If the patch could monitor any potential complications (ISR, heart rate, respiration, temperature, etc.) and signal the physician if any abnormalities are detected, it could give the physician the confidence to send the patient home for injection. In outcome-based healthcare models, quantifying data as evidence allows the system to know that the patient is improving their treatment, which is highly beneficial. In cases of rapid (or long-term) changes in a patient's health, the ability of treating physicians to intervene earlier and make interventions based on notifications of continuously accumulating data trends offers long-term benefits to both the patient and overall outcomes.

[0331] This type of "removable" monitoring patch is also very useful in clinical research. During the study, multiple patient parameters can be monitored, which can increase adherence, reduce complications, and even make enrollment easier. For example, if patients are required to remain in the physician's office for 4 hours after each injection to monitor ISR, they may be able to eliminate that wait with patch monitoring, potentially leading to improved enrollment. Furthermore, such devices can allow for longitudinal studies measuring patient adherence and provide increased accuracy in data transmission (e.g., by eliminating the need for manual data recording).

[0332] The patch concept is not limited to the syringes described above. Patches with and / or without electronic devices can also be applied to other syringes. These devices may include autoinjectors. In view of the foregoing, embodiments of this disclosure may provide, for example, patches that may include electronic devices or simply contain bandage material (e.g., see...). Figures 90 to 93 In some examples, the patch can be attached to the syringe, and the patch and syringe can be secured via forces applied to both, eliminating the need for separate patch application. Alternatively, the patch can be applied directly to the injection site by the syringe, and the cannula entry point can be covered with an expandable / contractable element. As described elsewhere herein, the patch can be magnetically coupled to the syringe. In some examples, the patch can be mechanically coupled to the syringe via a release mechanism desired by the user. In some cases, the patch can be smaller than the entire adhesive patch used to adhere the syringe. The patch can contain an adhesive pad that is the same size as or smaller than the patch size. In some examples, the patch can transmit syringe data before application to the patient, both syringe and patient data after application to the patient, and / or patient data after removal of the syringe.

[0333] Example applications / uses

[0334] like Figure 94 As shown, the patch sensor 9401 can be customized according to the patient's or physician's requirements to measure specific device and / or patient attributes or physiological parameters.

[0335] One or more sensors can be used to measure device and / or patient attributes or physiological parameters. Non-limiting examples of sensor types include temperature sensors, interstitial pressure sensors, skin resistance sensors, skin expansion sensors, acoustic sensors, vibration sensors, heart rate sensors, and blood pressure sensors. Figure 94 (BP), color or other optical sensors, moisture sensors, chemical sensors (e.g., sensing, measuring or detecting drug concentrations, histamine, oxygen, etc.).

[0336] One or more sensors can be used to measure one or more device properties, such as the presence of skin, tracking of substance delivery, and / or occlusion of a device (e.g., the cannula of a syringe).

[0337] like Figure 95 As shown, the sensor can alternatively be incorporated into the sensor adhesive layer 9501. As previously described, any useful combination of patient-perceived attributes can provide meaningful conclusions or evidence of outcome. For example, site responses can be detected using temperature measurements, skin resistance and / or impedance measurements, and color measurements, or any combination thereof. In another example of correlating pain with measured site responses, temperature measurements, skin resistance or impedance measurements, color measurements, skin swelling measurements, or interstitial pressure measurements, or any combination thereof, can be used. In yet another example of monitoring contraindicated activities during treatment, vibration measurements, heart rate measurements, and / or hydration measurements (e.g., to indicate sweating levels) or combinations thereof can be used. In another example, monitoring of wet injections can be performed using hydration measurements. Another example of subject outcomes may include monitoring adverse bioabsorption by measuring interstitial pressure, tissue density, temperature, skin resistance / impedance, color, and / or skin swelling. In another example of monitoring systemic adverse reactions, hydration (sweat) measurements, EMG / ECG, vibration (e.g., representing agitation), increased sound (e.g., representing gastric or intestinal gas levels), or any combination thereof, can be used.

[0338] Figure 96 Another embodiment of the sensor unit is shown. The sensor unit may include, for example, a PCB 9601, a Hall effect sensor 9602, a coin cell battery 9603, a buzzer 9604, a tactile vibration sensor 9605, a skin presence sensor 9606, a humidity and temperature sensor 9607, a 3D accelerometer and gyroscope 9608, a reed switch 9609, and a low-power core processor 9610. The sensor may comprise more than one layer, with different sensors, batteries, and other components distributed in each or different layers.

[0339] The patch can be used for a variety of functions after injection and after syringe removal. In non-limiting examples, the patch can be used to seal the injection site to prevent bleeding, use moisture detection to detect any leakage / bleeding at the injection site, monitor skin temperature and color as well as pressure to detect ISR, monitor heart rate / EKG, monitor patient position - upright or supine, and / or monitor skin chemistry / sweat.

[0340] In some implementations, the patch can communicate with the patient to remind him or her of the next injection time, and provide alerts if there is an increase in injection site reaction or leakage, temperature, color, heart rate, etc. Communication between the patch and the patient can be visual, auditory, or tactile.

[0341] The patch can be implemented to monitor the status of the syringe / multiple syringes during injection to determine, for example, whether the syringe is filled, the volume or quantity of the substance (e.g., a drug or medication) already filled into the syringe, whether the syringe is removed from the storage or delivery device base, whether the syringe is placed on the skin, whether the safety strip is removed, whether the button is pressed, whether the injection has started, the barometer position (including delivery tracking), whether the button is pressed to pause, whether the button retracts the cannula, whether the injection is completed (if the syringe is removed from the skin), or any post-injection parameters associated with the patient physiological parameter measurements discussed above.

[0342] Additional features / implementation methods

[0343] In an alternative implementation, the sensor can detect whether another patch is being transferred or whether an existing patch has been removed. The patch can be transparent to allow the patient to see the injection site, and it will be as inconspicuous as possible so that the patient can wear the patch and continue with daily activities (showering, swimming, etc.).

[0344] In other alternative implementations, sensing elements may be provided that can measure device properties including: skin presence (cannula retraction or dislodgement sensing), delivery indicator tracking (including filling and dispensing), obstruction detection, drug temperature, device status (on / off delivery base, on / off patient, button status, pause event, etc.), flow rate, internal syringe pressure / injection pressure, and adhesive adhesion.

[0345] Other implementations may incorporate patient and device sensing elements to allow for manual and / or automatic intervention (management) of the syringe. For example, the syringe flow rate (e.g., faster, slower, stop / pause) may be adjusted based on site response sensing information (automatic), pain information from the patient (manual), bioabsorption rate (automatic), or any combination or variation thereof.

[0346] Other implementations may be based on site response sensing information, pain information from the patient (manual) or pain sensing information, interstitial pressure / site expansion information (automatic) or any combination or variation thereof, vibrating (for pain management or to notify the user) a vibrating element in the syringe and / or patch.

[0347] In other implementations, sound (e.g., for notifying and / or conveying information to the user) may be provided—an acoustic element in the syringe and / or patch—and activated based on sensing information from the patient, device sensing elements (blockage, drug temperature, delivery indication, etc.) or a combination or change thereof.

[0348] In other implementations, a visual indicator (e.g., indicating a change, for notifying and / or conveying information to the user) may be provided – an LED or equivalent on the syringe and / or patch, and activated based on sensing information from the patient, the device sensing element, the position of the retraction button – for example, detecting premature removal / detachment, sensing information from the syringe (skin sensing, etc.), sensing information from the patient (high pressure, temperature, etc.), or a combination or change thereof.

[0349] In other implementations, a lock for pressing the syringe button can be provided and activated based on sensing information from the syringe (medication temperature, etc.), sensing information from the patient (skin sensing, etc.), sensing information from the mobile application (e.g., time since the last injection, user authentication), or variations or combinations thereof (e.g., for security or to prevent medication misuse).

[0350] In other embodiments, subcutaneous / transcutaneous electrical nerve stimulation (TENS) may be provided (e.g., for pain management or bioresorption). In such cases, the electrode elements in the cannula and / or patch may be activated based on site response sensing information, pain information from the patient (manual) or pain sensing information, interstitial pressure / site expansion information (automatic), or variations or combinations thereof.

[0351] Other implementations may predict the remaining injection time based on, for example, sensing flow rate and fill volume, sensing device pressure and back pressure, drug temperature, body temperature, and fill volume.

[0352] Other potential features of other implementations may include: patch sensing whether another patch has been applied; the patch being transparent to allow visualization of underlying tissues; the patch communicating directly with the user / patient; auditory signals (e.g., “Hey - when is your next injection?” or “Call your doctor - you have an ISR”); and / or other tactile options; vibration; electrical stimulation; visual options; light-emitting diodes; and the patch periodically transmitting data to a receiver or directly to the cloud or intermittent data broadcast.

[0353] Mobile application

[0354] On the other hand, this document discloses systems and methods for generating mobile applications to monitor one or more health or physiological parameters. The mobile application can be generated using various methods, such as application programming interfaces (APIs). The mobile application can include multiple useful features and can be configured to interact with other mobile applications. In some cases, the mobile application can be configured to display measurements of one or more physiological parameters from a subject, or parameters of a patch and / or syringe. The mobile application can include a feedback system that allows input from the subject or other users, which can allow adjustment of the patch and / or syringe (e.g., the amount of substance dispensed). The mobile application can also communicate with a remote server, for example, via a communication interface. In some cases, the remote server can be part of or communicate with a separate electronic device (e.g., a mobile device, a laptop computer), which can allow a clinician or physician to monitor the subject's physiological parameters. In some cases, the mobile application can allow input of non-measurable parameters from the subject (e.g., pain, discomfort, etc.). The mobile application can also include software for data processing. In non-limiting examples, data processing can include statistical analysis, trend plotting and analysis, and graphical representation of the data. In some cases, mobile applications may be able to interact with or combine with other mobile applications, such as lifestyle tracking applications (e.g., monitoring diet and activity) or other useful mobile applications, such as location tracking, accelerometers, calendars (e.g., sending reminders), etc.

[0355] Figure 97An example workflow for a mobile application used to monitor one or more health or physiological parameters is illustrated schematically. The mobile device 9700 may be a laptop computer, tablet computer, telephone, or other electronic device (e.g., a portable electronic device). When the application is opened or selected on the mobile device 9700, a loading screen 9710 may be presented, followed by a menu screen 9720. The menu screen 9720 may provide multiple functions 9730. Non-limiting examples of functions 9730 may include starting a new infusion, infusion history, training videos, additional information, and patient profiles. When a function 9730 (e.g., infusion history) is selected, a second screen 9740 associated with said function may be presented. In such examples, a calendar may be presented to the subject. In process 9750, the subject may select a second function on the second screen 9740, which presents a third screen 9760. The third screen may display one or more health or physiological parameters of the subject, the device, or substances delivered to the subject (e.g., schedule, time, day of the week, group, reminders for the patient, alarms, vibrations, etc.). In example third screen 9980, the calendar may include selectable dates, each of which provides information about one or more health or physiological parameters of the subject. In example fourth screen 9990, the mobile application's calendar may display additional information, such as when the subject misses an infusion. In example fifth screen 9790, the mobile application's calendar may display additional information, such as when the subject has received an infusion.

[0356] Figure 98 An example workflow of a mobile application for monitoring one or more health or physiological parameters is illustrated schematically. This example workflow can be used in conjunction with one or more other workflows of the mobile application. When viewed from menu screen 9720 (see...) Figure 97 Select function 9730 (e.g., start a new infusion, see [link]). Figure 97When the subject is in a suitable condition, screen 9810 may appear. The mobile application may allow detection of the substance or drug, for example, by scanning a barcode or quick response code (QR code). The mobile application may integrate with another application on the mobile device (such as the camera) and display the camera on screen 9820. Screen 9830 shows an example screen of a scanned QR code, which may present information about the substance or device. The mobile application may then verify the compatibility of the drug and device and / or other parameters of the drug / device, such as expiration date, dosage, etc. If the drug or device is not suitable for the subject (e.g., expired drug), screen 9842 or 9844 may appear, notifying the subject that the drug or device is unsuitable. If the drug or device is suitable for the subject, screen 9850 may appear, which may provide guidance, instructions, or directions to the subject. Instructions may be presented in a continuously scrolling format, as illustrated in screen 9852. The mobile application may then pair with the device. Additional guidance may be provided to the subject on example screen 9860. Safety features may be included in the application; for example, the mobile application may notify the subject if they fail to take safety precautions (e.g., a safety tab). Screen 9870 may display one or more device parameters (e.g., infusion status, insertion of the cannula into the subject's body, etc.). Incomplete infusion may present screen 9872, which may indicate the infusion status and may include other indications of device parameters (e.g., "device paused"). After the delivery of the substance or agent is complete, screen 9880 may be displayed, which may indicate the infusion status. In some cases, 9880 may present the subject with options to rank the infusion experience. Multiple steps in the process may also include communication steps 9854 (e.g., via Bluetooth, Wi-Fi) with stand-alone devices, cloud computing, clinician servers, etc.

[0357] Figure 99 Another example workflow for a mobile application used to monitor one or more health or physiological parameters is shown, which can be used in conjunction with one or more other workflows of the mobile application. When viewed from menu screen 9720 (see...) Figure 97 Select function 9730 (e.g., training video, see...) Figure 97 At this time, screen 9900 may appear. The mobile application may contain various tutorials or training information for the subject. Figure 99A schematically illustrates multiple devices or systems that can be integrated with a mobile application. When selecting a device or system (e.g., a syringe delivery system, a handheld system, a vial delivery system, a reconfiguration system), screens 9905, 9910, 9915, or 9920 may appear, and these screens may contain videos demonstrating tutorials or methods for using the device or system. Figure 99 B schematically illustrates another example workflow of a mobile application for monitoring one or more health or physiological parameters, which can be used in conjunction with one or more other workflows of the mobile application. From menu screen 9720 (see...) Figure 97 Select function 9730 (for example, see additional information). Figure 97 When a function is selected from the menu, screen 9925 may appear, and screen 9925 may contain a menu displaying one or more physiological health parameters or one or more device parameters. Additional information (e.g., specification information, device information, etc.) may be available to the subject. When a function is selected from the menu, screen 9930 or 9945 may appear, and screen 9930 or 9945 may also contain options to display other information, such as safety information (e.g., screen 9935 or 9950) or questions and answers (e.g., screen 9940 or 9955). Figure 99 C schematically illustrates another example workflow of a mobile application for monitoring one or more health or physiological parameters, which can be used in conjunction with one or more other workflows of the mobile application. When viewed from menu screen 9720 (see...) Figure 97 Select function 9730 (e.g., patient profile, see...) Figure 97 When [the subject is present], screen 9970 may appear, and screen 9970 may contain a menu. The menu may include options for the subject to view and / or enter patient information (e.g., gender, height, weight, activity level). Additional settings, such as alarms, reminders, emails, notifications, etc., can be implemented in the mobile application.

[0358] Examples of mobile application usage

[0359] In this example, the subject (e.g., a patient) can complete the injection using the patch and syringe system, remove the syringe, and continue wearing the patch. Information from the patch can be automatically transmitted via a mobile application to another individual (e.g., a clinician, healthcare provider) or directly to the cloud via a communication interface (e.g., Bluetooth connection) with an electronic device (e.g., a mobile device such as a phone, laptop, or tablet). In this example, the subject may undergo an injection lasting approximately one minute. In addition to one or more health or physiological parameters, the patch sensor can also indicate device parameters, such as the level or volume of medication in the syringe's reservoir. In one example, the patch sensor may indicate that the reservoir is full and that the subject's temperature rises and reddens at the injection site. In such an example, the mobile application can alert the user to contact a healthcare provider immediately. The mobile application can allow for direct telemedicine connections with healthcare providers. In some cases, all necessary and relevant information about the patient can be provided to the healthcare professional before or at the start of a call, such as, but not limited to, updated information about the injection and health or physiological parameters. Healthcare professionals and patients can conduct telemedicine conversations to determine how the subject is feeling, view the injection site via a camera on the mobile device, and recommend additional medication or in-person visits. The patch can be used to measure the subject's temperature or blood pressure. In emergency situations, if any measured health or physiological parameters indicate a pathological condition (e.g., abnormal breathing, pulse, blood pressure, presence of an acute event such as sudden acceleration or change of position during a fall), the mobile application can be configured to automatically connect the subject to a designated caregiver or make an emergency call (e.g., 911 in the United States).

[0360] In some cases, the patch can be used to monitor subjects during sleep. In such situations, if a subject experiences complications, the patch can provide output to the subject (e.g., via audio, tactile, vibrational, electrical, or tactile signals), or the patch can alert a designated caregiver or healthcare professional. In emergencies, a mobile application communicating with the patch can dial emergency numbers (e.g., 911 in the United States). In some cases, the patch can monitor or measure a subject's health or physiological parameters while the subject is asleep, which may help obtain consistent or continuous data, or help eliminate physiological variables that occur while the subject is asleep.

[0361] As described herein, healthcare providers may have access to aggregated data (e.g., several measurements of a subject's health or physiological parameters collected). In some cases, the data may be stored in a database or library. A database or library may include compartments or structures for storing data specific to subjects using the same medication. For example, a database may store information about multiple subjects, including ISR frequency, injection comfort, safety information, efficacy information, which may be specific to the administered medication. Alternatively or in addition, ancillary data, such as activity, location, mobile application history (e.g., its usage), questionnaire responses, etc., may be collected and used to monitor the safety or efficacy of treatment. For example, if a subject is taking a rheumatoid arthritis medication and exhibits low levels of activity and indicates mild pain via a mobile application, the healthcare provider may decide to change the treatment. If the subject's condition improves (e.g., the subject reports higher activity and reduced pain), the treatment change can be flagged as an improvement.

[0362] In some cases, mobile applications may include additional features that allow subjects to interact or communicate with a subject community. For example, subjects may be electronically connected to multiple subjects using the same treatment and syringe and patch system. Mobile applications may include forums or group chats that allow subjects or users to reply to each other, answer questions, or post questions, answers, comments, etc. In some cases, subject interactions may be publicly available, for example, so that drug manufacturers or device manufacturers can review and investigate them.

[0363] Additional systems and methods for measuring health or physiological parameters using, for example, patch and syringe systems may include those disclosed in U.S. Patent Application No. 16 / 785,408, filed February 7, 2020, and International Patent Application No. PCT / US2019 / 069142, filed December 31, 2019, each of which is incorporated herein by reference in its entirety.

[0364] Computer System

[0365] This disclosure provides computer systems programmed to implement the methods of this disclosure. Figure 100 A computer system 10001 is illustrated, which is programmed or otherwise configured to transmit and / or receive data and process data. The computer system 10001 can be adapted to various aspects of this disclosure, such as, for example, methods for data analysis, subject monitoring, and measurement of physiological or health parameters, and for providing outputs of physiological or health parameters. The computer system 10001 can be a user's electronic device or a computer system remotely located relative to an electronic device. The electronic device can be a mobile electronic device.

[0366] Computer system 10001 includes a central processing unit (CPU, also referred to herein as a "processor" and "computer processor") 10005, which may be a single-core or multi-core processor, or multiple processors for parallel processing. Computer system 10001 also includes memory or storage units 10010 (e.g., random access memory, read-only memory, flash memory), electronic storage units 10015 (e.g., hard disk), a communication interface 10020 for communicating with one or more other systems (e.g., a network adapter), and peripheral devices 10025, such as cache, other memory, data memory, and / or electronic display adapters. Memory 10010, storage units 10015, interface 10020, and peripheral devices 10025 communicate with CPU 10005 via a communication bus (solid line) such as a motherboard. Storage unit 10015 may be a data storage unit (or data repository) for storing data. With the aid of communication interface 10020, computer system 10001 can be operatively coupled to computer network (“network”) 10030. Network 10030 may be the Internet, an intranet and / or extranet, or an intranet and / or extranet communicating with the Internet. In some cases, network 10030 is a telecommunications and / or data network. Network 10030 may include one or more computer servers that can implement distributed computing, such as cloud computing. In some cases, with the aid of computer system 10001, network 10030 can implement a peer-to-peer network, which allows devices coupled to computer system 10001 to act as clients or servers.

[0367] CPU 10005 can execute a series of machine-readable instructions, which can be implemented in a program or software. The instructions can be stored in a memory location (such as memory 10010). The instructions can be directed to CPU 10005, which can then be programmed or otherwise configured to implement the methods of this disclosure. Examples of operations performed by CPU 10005 may include fetching, decoding, executing, and writing back.

[0368] CPU 10005 may be part of a circuit (such as an integrated circuit). The circuit may include one or more other components of system 10001. In some cases, the circuit is an application-specific integrated circuit (ASIC).

[0369] Storage unit 10015 may store files (such as drivers, libraries, and saved programs). Storage unit 10015 may store user data, such as user preferences and user programs. In some cases, computer system 10001 may include one or more additional data storage units external to computer system 10001, such as those located on a remote server communicating with computer system 10001 via an intranet or the Internet.

[0370] Computer system 10001 can communicate with one or more remote computer systems via network 10030. For example, computer system 10001 can communicate with a user's remote computer system (e.g., located in a physician's office or a physician's mobile device). Examples of remote computer systems include personal computers (e.g., portable PCs), tablets, or tablet PCs (e.g., [missing information]). iPad Galaxy Tab), telephone, smartphone (e.g., Apple) Android-enabled devices (or personal digital assistant). Users can access computer system 10001 via network 10030.

[0371] The method described herein can be implemented using machine-executable code (e.g., a computer processor) stored in an electronic storage location (such as, for example, on memory 10010 or electronic storage unit 10015) of computer system 10001. The machine-executable or machine-readable code can be provided in software form. During use, the code can be executed by processor 10005. In some cases, the code can be retrieved from storage unit 10015 and stored on memory 10010 for access by processor 10005 at any time. In some cases, electronic storage unit 10015 can be excluded, and machine-executable instructions are stored on memory 10010.

[0372] The code can be pre-compiled and configured for use with a machine having a processor suitable for executing the code, or it can be compiled during runtime. The code can be supplied in a programming language, which can be selected to enable the code to execute in a pre-compiled or compiled manner.

[0373] Aspects of the systems and methods provided herein, such as computer system 10001, can be implemented in a programmable manner. The various aspects of the technology can be considered as “products” or “articles of art” typically carried or implemented in a type of machine-readable medium in the form of machine (or processor) executable code and / or associated data. Machine-executable code can be stored on electronic storage units, such as memory (e.g., read-only memory, random access memory, flash memory) or hard disks. “Storage” media can include any or all tangible memory, such as various semiconductor memories, tape drives, disk drives, etc., of computers, processors, etc., or associated modules thereof, which can provide non-transitory storage for software programming at any time. All or part of the software can sometimes be communicated via the Internet or various other telecommunications networks. For example, such communication can enable the loading of software from one computer or processor into another computer or processor, for example, from a management server or host computer into a computer platform for an application server. Therefore, another type of medium that can carry software elements includes optical, electrical, and electromagnetic waves, used, for example, through physical interfaces between local devices, through wired and optical ground networks, and through various air links. Physical elements carrying such waves (such as wired or wireless links, optical links, etc.) can also be considered as media carrying software. As used herein, unless limited to non-transitory, tangible "storage" media, the term "readable medium" for a computer or machine refers to any medium involved in providing instructions to a processor for execution.

[0374] Therefore, machine-readable media, such as computer-executable code, can take many forms, including but not limited to tangible storage media, carrier media, or physical transmission media. Non-volatile storage media include optical discs or disks, any storage device such as any computer(s), such as a database that can be used to implement the figures shown. Volatile storage media include dynamic memory, such as the main memory of a computer platform. Tangible transmission media include coaxial cables, copper wires, and optical fibers, including wires that contain the bus within a computer system. Carrier transmission media can take the form of electrical or electromagnetic signals, or sound 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, hard disks, magnetic tapes, any other magnetic media, CD-ROMs, DVDs or DVD-ROMs, any other optical media, punched card tapes, any other physical storage media with a perforated pattern, RAM, ROM, PROM and EPROM, FLASH-EPROM, any other memory chips or cassette tapes, carrier waves for transmitting data or instructions, cables or links for transmitting such carrier waves, or any other medium from which a computer can read programming code and / or data. Many of these forms of computer-readable media may involve transmitting one or more sequences of one or more instructions to a processor for execution.

[0375] Computer system 10001 may include or communicate with an electronic display 10035, the electronic display 10035 including a user interface (UI) 10040. Examples of UIs include, but are not limited to, graphical user interfaces (GUIs) and web-based user interfaces.

[0376] The methods and systems disclosed herein can be implemented by one or more algorithms. The algorithms can be implemented in software when executed by the central processing unit 10005. The algorithms can, for example, process data, perform statistical analysis, plot or graphically represent data, and provide feedback to one or more systems disclosed herein (e.g., patches and / or syringes).

[0377] Although preferred embodiments of the invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided merely as examples. The invention is not intended to be limited to the specific examples provided in the specification. While the invention has been described with reference to the foregoing description, the description and illustration of embodiments herein are not intended to be construed as limiting. Many variations, alterations, and substitutions will now occur to those skilled in the art without departing from the invention. Furthermore, it should be understood that all aspects of the invention are not limited to the specific depictions, configurations, or relative proportions set forth herein according to various conditions and variables. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in the practice of the invention. Therefore, the following claims are contemplated to define the scope of the invention, and the methods and structures within the scope of these claims and their equivalents are thereby covered.

Claims

1. A system for measuring physiological parameters of a subject, the system comprising: A reusable patch, the reusable patch including a first housing having a sensor, the reusable patch being configured to be attached to the body of the subject; and A syringe having a second housing including a cannula in fluid communication with a fluid flow path and a reservoir containing a substance, wherein the second housing is configured to be coupled to the first housing of the reusable patch; The sensor is configured to (i) measure the physiological parameters from the subject, and (ii) provide one or more outputs corresponding to the physiological parameters from the subject. The reusable patch includes a puncture-resistant membrane with an opening, wherein the opening is in a closed configuration before the second housing is coupled to the first housing, and is in an open configuration when the second housing is coupled to the first housing. The syringe is configured to (a) insert the cannula through the opening in the puncturable membrane and into the body of the subject, and (b) retract the cannula from the body of the subject and through the puncturable membrane. The opening in the puncturable membrane is configured to return to the closed configuration after the second housing separates from the first housing.

2. The system of claim 1, wherein the syringe includes the reservoir and the fluid flow path.

3. The system of claim 2, wherein the syringe is configured to administer a dose of the substance to the subject from the reservoir via the fluid flow path and the cannula.

4. The system of claim 1, wherein the reusable patch includes a second sensor, wherein the second sensor is configured to measure one or more device parameters selected from: the dose of the administered substance, the flow rate of the administered substance, the volume of the administered substance, the obstruction of the cannula, the duration of contact between the cannula and the subject's body, and the contact between the cannula and the subject's body.

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

6. The system of claim 1, further comprising a charging station configured to be coupled to the reusable patch.

7. The system of claim 1, wherein the reusable patch comprises a rechargeable battery.

8. The system of claim 1, wherein the reusable patch is attached to the subject's body using an adhesive.

9. The system of claim 1, wherein the physiological parameters include those selected from temperature, tissue thickness, heart rate, blood pressure, interstitial pressure, tissue density, skin swelling, bleeding, sweat volume, and analyte measurements.

10. The system of claim 9, wherein the analyte is obtained from the blood of the subject.

11. The system of claim 9, wherein the physiological parameter includes adipose tissue thickness.

12. The system of claim 1, wherein the sensor comprises an ultrasound transmitter and an ultrasound receiver configured to measure tissue depth or thickness.

13. The system of claim 1, wherein the opening of the membrane is pre-formed.

14. The system of claim 1, wherein the reusable patch comprises a bandage.

15. The system of claim 14, wherein the bandage is configured to be placed on the body of the subject.

16. The system of claim 1, wherein the reusable patch includes a communication interface.

17. The system of claim 16, wherein the communication interface is configured to transmit data corresponding to the physiological parameters to an electronic device communicating with the communication interface.

18. The system of claim 17, wherein the electronic device includes a mobile device.

19. The system of claim 18, wherein the mobile device includes a computer-implemented mobile application configured to monitor the physiological parameters over a period of time.

20. The system of claim 16, wherein the communication interface communicates with an additional communication interface of the syringe.

21. The system of claim 20, wherein the communication interface and the additional communication interface are used for positioning the patch or the syringe.

22. The system of claim 1, wherein the one or more outputs include an output signal, wherein the output signal includes one or more members selected from vibration signals, audio signals, visual signals, tactile signals, and electrical signals.

23. The system of claim 1, wherein the second housing further includes a protrusion structure configured to: when the second housing is coupled to the first housing, change the opening from the closed configuration to the open configuration.

24. The system of claim 1, wherein the puncturable membrane further comprises an absorbent material configured to absorb bodily fluids from the subject.

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