Invented by Michael D. Hooven, Matthew J. Huddleston, David Stefanchik, Rowan CONVERSE, Kory GUNNERSON, James Marous, Phillip Schultz, Benjamin WEBB, Enable Injections Inc
One of the key factors driving the market growth is the rising prevalence of chronic diseases and the subsequent need for regular medication administration. Patients suffering from conditions like diabetes, cancer, and autoimmune disorders often require frequent injections of medication or fluids. The traditional methods of injection, such as syringes and needles, can be uncomfortable and inconvenient for patients. The medical fluid injection apparatus with a detachable patch provides a more comfortable and efficient alternative, allowing patients to receive their medication without the pain and hassle associated with traditional methods.
Moreover, the detachable patch feature of this apparatus offers added convenience and flexibility. The patch can be easily attached to the patient’s skin, allowing for continuous medication delivery over an extended period. This eliminates the need for repeated injections and ensures a consistent dosage, thereby improving treatment outcomes. Additionally, the detachable patch allows patients to move freely and engage in their daily activities without any disruption, enhancing their overall quality of life.
Furthermore, the integration of monitoring capabilities in the medical fluid injection apparatus adds another layer of value to this technology. The apparatus is equipped with sensors that can monitor vital signs, such as heart rate, blood pressure, and temperature. This real-time monitoring enables healthcare professionals to closely track the patient’s condition and make timely interventions if necessary. It also provides valuable data for healthcare providers to analyze and optimize treatment plans, leading to more personalized and effective care.
The market for medical fluid injection apparatus and method with detachable patch and monitoring is witnessing significant investments from both established healthcare companies and startups. These companies are focusing on research and development to enhance the functionality and usability of the apparatus. They are also collaborating with healthcare institutions and professionals to conduct clinical trials and gather real-world data to validate the benefits of this technology.
In terms of geographical distribution, North America and Europe are leading the market due to the presence of advanced healthcare infrastructure and a high adoption rate of innovative medical technologies. However, emerging economies in Asia Pacific and Latin America are also witnessing rapid growth in this market. The increasing healthcare expenditure, rising awareness about advanced treatment options, and improving healthcare infrastructure in these regions are driving the demand for medical fluid injection apparatus with detachable patch and monitoring.
In conclusion, the market for medical fluid injection apparatus and method with detachable patch and monitoring is experiencing robust growth due to its numerous advantages in terms of patient comfort, accurate dosage delivery, and real-time monitoring. This technology is revolutionizing the way healthcare professionals administer medication and monitor patients, leading to improved treatment outcomes and enhanced patient care. As the demand for advanced healthcare technologies continues to rise, this market is expected to witness further expansion in the coming years.
The Enable Injections Inc invention works as follows
Herein are provided systems and methods to monitor one or more physiological or health parameters of a subject. The systems and method may include a patch attached to an injector. The data can be sent to a remote server or mobile device, where it will be processed. The processed data can be used to inform the subject about a physiological or health condition.
Background for Medical Fluid Injection Apparatus and Method with Detachable Patch and Monitoring
Vials have a long history of clinical use and are a preferred container closure system for the pharmaceutical industry. This is due to the fact that they can be used with countless drugs. Vials are used to store pharmaceutical drugs, including biologics. The industry has also invested heavily in capital equipment to fill aseptic vials. Vials require that the drug be transferred from the vial into an injection device, such as an injector, autoinjector or infuser. For delivery to the patient. The introduction of new container closure systems, such as prefilled cartridges and syringes, allows the direct transfer of drug from the cartridge or syringe to the patient. These newer container closures have been used in injection devices like auto-injectors, pens and other auto-injectors. The pharmaceutical industry prefers devices that use standard container closures such as prefilled syringes, cartridges or vials because of the uncertainty of long-term stability of drugs and the existing manufacturing resources.
However vials, prefilled cartridges and syringes are not the optimal containers for a device that delivers drugs. This is particularly true for delivery devices that deliver high volumes of drug (2-50 cc), or drugs with high viscosity (15 cP up to 100 cP). Glass cylinders make up the majority of prefilled syringes and cartridges. This imposes constraints on design and geometry. The glass closures of syringes, auto-injectors and other syringes have a limit on the amount of viscosity that can flow through them. There are new injection devices, such as pumps that deliver insulin using custom-made container closures. However, these systems can be very expensive and cannot produce high pressures or forces. They are also typically refillable and reusable.
On-body injection devices are still being developed in an effort to create injection devices and methods which offer advantages such as comfort, less pain and effective subcutaneous injection.
It is recognized that there is a requirement for new or improved apparatuses, methods, and systems for the injection of drugs (e.g. from source vials) into and onto a subject. Also, apparatuses, methods, and systems are needed to monitor a health parameter or physiologic condition prior to, during and/or after injection of a drug into a patient. This apparatus or system could be used, for instance, in regulatory procedures and monitoring of patients.
The present disclosure describes apparatuses, methods, and systems that can be used to transfer medical fluid and inject it into a patient, as well as methods for administering medication (e.g.) and monitoring a patient’s physical attributes or parameters before, during, or after administration.
The present invention provides a system to measure a physiological or health parameter of a subject. This system comprises: (a), a patch having a first housing with a sensor configured to, (i), measure said physiological or health parameter of said person when said patch secures to the body of that person, (ii), provide one or multiple outputs corresponding with said physiological or health parameter of said person, said first housing comprising an opening, and an injector with a second housing with a cannula coupled in fluid communication to a fluid communication to a fluid communication to fluid with a fluid with a fluid with a fluid with a fluid with a fluid with fluid with fluid with fluid with fluid with fluid with fluid with fluid with fluid with fluid with fluid with fluid with fluid with fluid with fluidly communicating fluidly connected to fluid communication fluidly coupled to fluidly a fluidly communicated fluidly with fluidly a fluid communication to fluidly a fluidly a fluid with a fluid path.
In some embodiments, a pump is integrated with the tube, and the pump is configured for directing the substance into the subject via the tube. In certain embodiments, the tube is configured to either extend toward or retract from the subject’s body. In some embodiments the opening is a membrane that can be pierced. In some embodiments the pierceable membrane is punctured by the cannula in order to create the opening. In certain embodiments, a reservoir is attached to the injector. In certain embodiments, it is possible to remove the reservoir from the injector. In some embodiments the reservoir is a part of the injector. In some embodiments the substance is a drug. In some embodiments the medicament is used to treat one or more diseases from the group including cardiovascular, musculoskeletal and gastrointestinal disease, dermatology, immunology ophthalmology hematology neurology oncology endocrinology metabolic respiratory diseases. In some embodiments the injector includes the reservoir. The reservoir is configured for a formulation containing the substance. In some embodiments the first housing can be removed from the second housing. In certain embodiments, a patch includes a communication port for transmitting data related to physiologic or health parameters to an electronic gadget in communication with this port. In certain embodiments, a wireless interface is used as the communication interface. In certain embodiments, the interface is Wi-Fi. In certain embodiments, a near-field communication interface is used as the communication interface. In certain embodiments, the interface is Bluetooth. In certain embodiments, the interface for communication is an optical wireless interface. In some embodiments the communication interface is a digital or analog interface with direct electrical contact. In some embodiments an input transducer/sensor is selected from a group consisting a conductivity, impedance, capacitance, charge, humidity, temperature, interstitial, pressure, resistance, optical, distension, acoustic, vibration, blood pressure, color, chemical, and substance-tracking sensors. In some embodiments the system includes a second device sensor. The second sensor can be configured to measure any of a number of device parameters, including: the dosage of substance administered, the flow rate at which the substance is dispensed, the volume of substance administered, the occlusion or contact of cannula with the body. In some embodiments the patch or injector includes the second sensor. In certain embodiments, the patch also includes one or more transducers. In some embodiments the patch further comprises one or more transducers. The output signal may be a visual, audio, or vibration signal. In some embodiments an output transducer is selected from a group consisting of audio transducers, visual transducers, and transducers for direct electrical stimulation, such as a haptic (vibration) transmitter. transcutaneous electrical nerve stimulation/TENS).
The present invention discloses another method of measuring a plurality health or biological parameters in a subject. This includes: (a), providing: (i), a patch having a first housing with a plurality sensors, (ii), an injector with a second housing with a cannula, (iii), a reservoir with a substance, (iv) and a fluid path in fluid communications with the reservoir, (v) and (c) attaching the patch to the body of a
In some embodiments, a pump is integrated into the cannula and used to deliver the fluid from the fluid path directly into the subject via the cannula. In certain embodiments, a cannula may be configured to extend toward or retract away the body of a subject. In some embodiments the opening is a membrane that can be pierced. In some embodiments the cannula pierces the pierceable membrane to create the opening. In certain embodiments, the injector is attached to the reservoir. In certain embodiments, it is possible to remove the reservoir from the injector. In some embodiments the reservoir is a part of the injector. In some embodiments the substance is a drug. In some embodiments the medicament is used to treat one or more diseases from the group cardiovascular, musculoskeletal gastrointestinal, dermatology ophthalmology hematology neuroscience oncology endocrinology metabolic respiratory disease. In some embodiments the injector includes the reservoir. The reservoir is configured for a formulation containing the substance. In some embodiments the first housing can be removed from the second housing. In certain embodiments, a communication port is provided on the patch for the transmission of data related to the health parameters or physiological parameters. In some embodiments the communication interface is wireless. In some embodiments the communication interface is Wi-Fi. In some embodiments the communication interface can be a near-field communication interface. In certain embodiments, the interface for communication is Bluetooth. In some embodiments the communication interface is optical wireless. In some embodiments an input transducer/sensor is selected from a group consisting a conductivity/impedance sensor. impedance/capitance sensor. charge sensor. humidity/temperature sensor. heart rate sensor. interstitial pressure/resistance sensor. distension sensor. acoustic/vibration sensor. blood pressure sensor. color sensor. chemical sensor. In some embodiments an output transducer is selected from a group consisting haptic (vibration) sensor, audio transducer, visual transducers and direct electrical stimulation. transcutaneous electrical nerve stimulation/TENS).
In some embodiments, the second sensor is selected from a group including a temperature sensor (or humidity sensor), a flow rate sensor (or vibration sensor), an audible sensor or e.g.,,,,,,,,,,,,,,,.,,,,,,,,,,,,,, sensor, and,,,
The injector of this invention comprises: (a) A housing; and (b) A medicament reservoir in the housing. (c) An injection cannula that is movable within the house between a predispense and a dispensing position, in fluid communication with reservoir. (d) An injector sensor/transducer mounted on or in the housing. (e) A skin attachment layer attached the housing, with an adhesive to secure it to a users skin with a 1st holding force. (f
In some embodiments the second holding strength is greater than first holding force, and the patch can be removed from the skin attachment layer. Perforations are used in some embodiments to attach the patch to the skin-attachment layer. In certain embodiments, a magnet is used to secure the patch to the housing. In certain embodiments, the housing of an injector is equipped with a magnet and the patch has a metallic part that can be engaged by it. In some embodiments the skin attachment layer has an opening, and the patch is placed within the opening once it is attached to the injector housing. In some embodiments the opening is located centrally in the skin layer, and the injector’s injection cannula passes through both the opening and orifice in the patch in the dispensing position. In some embodiments the patch includes a portion that extends through the orifice, which is where the injector’s injection cannula passes in the dispensing position. The extension is configured to compress the skin of a user around the injection site. The patch may include a printed-circuit board on which the circuitry has been positioned, and to which both the sensor adhesive and patch transducer/sensor have been attached.
In some embodiments the extension has a generally conical shape. In some embodiments the patch is made up of a printed-circuit board, on which the circuitry has been positioned. The sensor adhesive layer as well as the patch sensor can be attached to the board. In some embodiments, the circuitry of the patch includes a microcontroller/microprocessor and a transmitter. In some embodiments the sensor of injector has a transmitter, and the circuitry patch also includes a wireless receiver that receives data from injector sensors/transducers and transmits data to the transducers. In some embodiments, the microcontroller/microprocessor, transmitter and receiver are combined into a single component. In some embodiments the injector also includes a wire connecting the transducers/sensors of the injector to the circuitry in the patch. The wire connection is designed to be disconnected when the injector or the patch are removed from the patient. In some embodiments, the microcontroller/microprocessor and the transmitter are combined into a single component. In some embodiments the transmitter is Bluetooth. In some embodiments the injector sensor has a number of input transducers/sensors as well as output transducers. In some embodiments the patch sensor has a number of input transducers/sensors as well as output transducers. In some embodiments the patch sensor has a plurality either of input transducers/sensors or output transducers.
The method of collecting data using an injector, a patient, and patch circuitry includes (a) attaching the injector, which has an injector-sensor, to the patient, (b) using the circuitry on the patch to receive data from both the injector-sensor and patch sensor; (c), transmitting the data received to a receiver remotely using the circuitry on the patch; (d), removing the injection from the patients; and (e) after removing the injector, receiving additional data using the circuit
In some embodiments the injector is attached to the patient at the same time as the patch. In some embodiments (a) comprises attaching the patches before the injector, and before attaching injectors to patients, the steps of receiving the data from the sensor patch using the circuitry patch, then transmitting it to a receiver remote using the circuitry patch. In some embodiments the data collected by the patient may include measurable attributes which can be affected by the injection of a drug by the injector or the injector itself. In some embodiments the data collected includes measurable characteristics that can affect or indicate the safety and/or effectiveness of a medication administered by an injector.
The method of monitoring the injection site for an injection reaction is described in another aspect. It includes the following steps: (a), attaching to the patient an injector with a patch that includes a temperature sensor/transducer and a color monitor, (b), receiving data using the circuitry of the patch; and (c), transmitting data received from the circuitry of the patch to a remote recipient using the circuitry of the patch.
The injector disclosed in another aspect comprises (a) housing, (b) a reservoir of medicament in the housing, (c) an injection tube moveable in the housing from a predispense to a dispense location in fluid communication with reservoir, (d) a sensor patch configured to receive data and transmit it, the sensor patch removably attached to housing with a holding force, (e) an attached layer to the sensor patch, the attached layer comprising an adhesive to secure the sensor patch to a skin
In some embodiments the skin is the body of the patient. In certain embodiments, data is received by the patch from the injector. In some embodiments the data is used for adjusting a device parameter on the patch or injector. In some embodiments the device parameter is one or more parameters that are selected from a group of injector parameters, such as a dosage, flow rate, and volume. In some embodiments the data is used for generating a notification that the subject receives via a transmitter. In some embodiments the notification includes one or more notifications chosen from the group consisting: of a vibration; a sound; direct electrical stimulation and a visible indicator.
The present subject matter includes several aspects that may be combined or embodied in the devices and system described below. These aspects can be used alone or in conjunction with other aspects described in this document. The description of these elements together does not preclude their use separately, or their claiming in different combinations.
The present subject matter comprises a transfer device or injector, of any appropriate detailed construction. However, transfer and injectors which are especially useful when combined with the apparatus described here are described in U.S. Pat. No. No.
In one aspect, the injector is comprised of a housing. The housing contains a medicament reservoir and the injection cannula moves within the housing from a predispense to a dispensing position, in fluid communication with reservoir. The housing may be mounted with an injector sensor. The housing is equipped with a skin attachment layer that includes an adhesive designed to attach the housing to the skin of a user using a first force. The housing is removable and a patch can be attached to it with a second force. A sensor adhesive layer secures the patch with a third force. The third holding pressure is greater than that of the second. The patch includes a patch and circuitry that is configured to receive data both from the injector and patch sensors and to transmit the data received to a distant receiver.
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