Patent Application
20250018115
The present disclosure is directed to an autoinjector medical device, and more particularly it is directed to bio-electrical sensing in an autoinjector medical device.
An autoinjector medical device is a device that is configured to deliver a dose of a particular drug or medication into a user. Autoinjectors were designed to overcome the hesitation associated with self-administration of needle-based drug delivery. Most autoinjectors utilize one-use, disposable syringes that are prefilled with the drug to be delivered. After the drug has been administered, the syringe can be disposed of and a new prefilled syringe can be inserted into the autoinjector for the next drug delivery. Real-time monitoring of physiological parameters of a user or patient at the point of care is currently one of the major trends in the healthcare industry. It represents an opportunity for innovation in portable medical devices, particularly in the drug delivery sector. As such, there is a desire to incorporate real-time monitoring of physiological parameters of a user or patient into an autoinjector medical device.
According to one aspect, an autoinjector medical device is disclosed. The autoinjector medical device can include a cover including: an engaging surface including a needle outlet, and a handle formed in the cover at an opposite end of the cover as the engaging surface. Further, the autoinjector medical device can include a needle configured to translate through the needle outlet, a first sensor electrode disposed on the engaging surface and adjacent the needle outlet, and a second sensor electrode disposed on the handle.
In one aspect, the autoinjector medical device can further include a third electrode disposed on the handle.
In one aspect, the third electrode is positioned on an opposite side of the handle as the second sensor electrode.
In one aspect, the third electrode is a right-leg drive electrode configured to implement common-mode powerline interference suppression.
In one aspect, the first sensor electrode and the second sensor electrode are each electrode sensors configured to measure and record electrical signals produced by a heart or body of a user.
In one aspect, the first sensor electrode and the second sensor electrode are configured to measure and record electrical signals produced by the heart of the user before, during, or after insertion of the needle into the user.
In one aspect, the first sensor electrode and the second sensor electrode are configured to measure and record one or more of heart rate, heart rate variability, physiological stress, energy expenditure, atrial fibrillation, arrhythmia, body composition (e.g., body fat mass), and hydration level (i.e., body water) in the user.
In one aspect, the autoinjector medical device can further include an alarm configured to alert the user when the measured and record electrical signals exceed a pre-defined threshold limit.
In one aspect, the first sensor electrode and the second sensor electrode can further be configured for at least one of biometric authentication and bio-impedance analysis of the user.
In one aspect, the autoinjector medical device can further include an analog front-end stage configured to precondition the electrical signals measured and recorded by the first sensor electrode and the second sensor electrode before processing and outputting results regarding the electrical signals.
In one aspect, the autoinjector medical device is an electro-mechanical autoinjector medical device including a power source configured to supply electrical energy to an actuator, the actuator being coupled to the needle and the actuator being configured to cause the needle to translate through the needle outlet.
In one aspect, the autoinjector medical device can further include a display disposed on or coupled to the cover, the display being configured to provide a visual presentation of data collected by the autoinjector medical device.
In one aspect, the autoinjector medical device can further include an input-output device configured to transfer data collected by the autoinjector medical device to a device separate and remote from the autoinjector medical device.
In one aspect, the input-output device can transfer collected data through one or more of a wireless network protocol (Wi-Fi), a cellular signal, a Bluetooth standard, and a cloud-based data transfer service.
According to another aspect, a method of collecting electrical signals of a heart or body of a user with an autoinjector medical device is disclosed. The method can include grasping a handle of the autoinjector medical device with a hand on a first side of a user's body, wherein during the grasping a second sensor electrode of the autoinjector medical device directly contacts the hand of the user; pressing an engaging surface of the autoinjector medical device directly against a portion of the user's body on a second side of the user's body, wherein during the pressing a first sensor electrode of the autoinjector medical device directly contacts the portion of the second side of the user's body; and measuring and collecting, by the first sensor electrode and the second sensor electrode, electrical signals produced by the heart or body of the user.
In one aspect, the method can further include directly contacting the first sensor electrode and the second sensor electrode to skin surfaces of the user's body.
In one aspect, the first side of the user's body and the second side of the user's body are positioned on opposite sides of a sagittal plane of the user's body.
In one aspect, the method can further include processing, by an analog front-end stage of the autoinjector medical device, the measured and collected electrical signals, wherein the processing comprises filtering the electrical signals to remove common-mode powerline interferences.
In one aspect, the method can further include converting, by an analog to digital converter of the autoinjector medical device, the processed electrical signals into digital data; and processing and outputting, by a microprocessor of the autoinjector medical device, physiological parameters relating to the heart or body of the user.
In one aspect, the method can further include displaying the physiological parameters on a display of the autoinjector medical device; or communicating the physiological parameters through an input-output device of the autoinjector medical device to a device separate and remote from the autoinjector medical device.
According to another aspect, an autoinjector medical device is disclosed. The autoinjector medical device can include a cover including an engaging surface with a needle outlet, and a handle formed in the cover at an opposite end of the cover as the engaging surface. The autoinjector medical device can further include a needle configured to translate through the needle outlet, a first sensor electrode, and a second sensor electrode. The first and second sensor electrodes can each be disposed on the engaging surface and adjacent the needle outlet. Further, the first sensor electrode and the second sensor electrode can be adapted to measure a bio-electrical impedance of a body of a user.
The foregoing Summary as well as the following Detailed Description will be best understood when read in conjunction with the appended drawings, which illustrate a preferred embodiment of the disclosure. In the drawings:
Certain terminology is used in the following description for convenience only and is not limiting. The words “front”, “rear”, “upper”, and “lower” designate directions in the drawings to which reference is made. The words “inwardly” and “outwardly” refer to directions towards and away from parts referenced in the drawings. “Axially” refers to a direction along the axis of an axle, shaft, pin, or the like. A reference to a list of items that are cited as “at least one of a, b, or c” (where a, b, and c represent the items being listed) means any single one of the items a, b, or c, or combinations thereof are included. The terms “about” and “approximately” encompass +/−10% of an indicated value unless otherwise noted. The term “generally” in connection with a radial direction encompasses +/−25 degrees. The terminology includes the words specifically noted above, derivatives thereof, and words of similar import.
The device 10 is configured to deliver a dose of a particular drug or medication into a user, thereby making it easier to self-administer needle-based drugs and medication. Further, the device 10 utilizes one-use, disposable cassettes and syringes (not shown) that are prefilled with the drug or medication to be delivered. After the drug or medication has been administered, the cassette and the syringe can be disposed of and a new prefilled cassette and syringe can be inserted into the device 10 for the next drug delivery.
As illustrated in
The actuator 18 can be coupled, directly or indirectly, to the needle 14, and the actuator 18 can cause the needle 14 to translate in and out of the cover 12 to administer the drug. As will be appreciated by a person having ordinary skill in the art, the needle 14 is configured to be inserted into a user's body for delivery of the drug into the user's body. As such, in operation, a user can press a button or switch (not shown) to activate the power source 16 which transfers electrical energy to the actuator 18. In turn, this causes the needle 14 to translate out from within the cover 12 such that the needle 14 enters the user's body to administer and dispense the drug or medication from the syringe (not shown) within the device 10 into the user's body.
The cover 12 can include an engaging surface 20 disposed at or on a bottom surface of the cover 12 of the device 10. In other words, the engaging surface 20 is the surface of the cover 12 and/or the device 10 that is directly pressed against a user's body during the injection of the drug or medication. The engaging surface 20 can include a needle outlet 22 disposed on or extending through the engaging surface 20 of the cover 12. In some examples, the needle outlet 22 can be an aperture that extends through the engaging surface 20 of the cover 12, allowing the needle 14 to translate in and out of the cover 12 through the needle outlet 22.
In addition, the cover 12 can include a handle 24 that is formed in the cover 12. In some examples, the handle 24 can be formed integral with the cover 12. The handle 24 provides a narrowed portion/width of the cover 12 in which a user can grasp and hold onto during use of the device 10. As illustrated, the handle 24 is disposed at an opposite end of the cover 12 and the engaging surface 20. Therefore, a user can grasp the handle 24 at one end of the cover 12 and the device 10, and the user can press the engaging surface 20 directly onto a skin surface of the user at the opposite end of the cover 12 and the device 10. As illustrated best in
In some examples, the device 10 can include a first sensor electrode 28, a second sensor electrode 30, and a third electrode 32. In other examples, the device 10 may only include the first sensor electrode 28 and the second sensor electrode 30. The first sensor electrode 28 can be disposed on or adjacent the engaging surface 20, and the first sensor electrode 28 can be disposed adjacent the needle outlet 22. The second sensor electrode 30 can be disposed on or extend through the cover 12, and the second sensor electrode 30 can be disposed on the handle 24 of the cover 12. The first sensor electrode 28 and the second sensor electrode 30 can each be electrode sensors that are configured to measure and record electrical signals produced by a heart and/or the body of a user. More specifically, the first sensor electrode 28 and the second sensor electrode 30 can each be electrode sensors that are configured to measure and record electrical signals produced by the heart and/or body of a user before, during, and after insertion of the needle 14 and dispensing of the drug or medication into the user.
As such, the first sensor electrode 28 and the second sensor electrode 30 can be utilized for real-time monitoring of physiological parameters at or adjacent the point of care (i.e., needle 14 insertion), providing the patient and/or physician health related data regarding the health of the patient. More specifically, the first sensor electrode 28 and the second sensor electrode 30 of the device 10 can be utilized for electrocardiogram (ECG) sensing of the user/patient, and the ECG measurement data and physiological parameters measured and computed by the device 10 can be shared to the patient's physician for remote patient monitoring, discussed further below.
In some examples, the first sensor electrode 28 and the second sensor electrode 30 can be configured to measure and record one or more of heart rate, heart rate variability, physiological stress, energy expenditure, atrial fibrillation, and arrhythmia of the user before, during, and after insertion of the needle 14 and dispensing of the drug/medication into the user. In other examples, the first sensor electrode 28 and the second sensor electrode 30 can be configured for bio-electrical impedance sensing of the user, and the bio-impedance measurement data and physiological parameters measured and computed by the device 10 can be shared to a physician for remote patient monitoring. More specifically, the first sensor electrode 28 and the second sensor electrode 30 can be configured to perform bio-impedance analysis (BIA), estimate body composition (e.g., body fat mass), and hydration level (e.g., total body water) of the user.
The data collected by the first sensor electrode 28 and the second sensor electrode 30 of the device 10 can then be presented on the display 26 of the device 10 for the user to view. Further, the data collected by the device 10 can also be transmitted by the device 10 to the patient's physician or a device that is separate and remote from the device 10. More specifically, the device 10 can include an input-output device 34 that is positioned within the cover 12 of the device 10 and electrically coupled to the power source 16 of the device 10. The input-output device 34 can be configured to transfer data collected by the device 10 to a device separate and remote from the device 10, such as a device remotely accessible by the patient's physician. In some examples, the input-output device 34 can transfer data collected by the device 10 through one or more of a wireless network protocol (Wi-Fi), a cellular signal, a Bluetooth standard, and a cloud-based data transfer service, among other options not specifically listed.
Further, in some examples, the device 10 can include stored data relating to the identity or biometric authentication of the user. The first sensor electrode 28 and the second sensor electrode 30 can be utilized to compare sensed parameters of the user (or the person holding the device 10) to the stored identity or biometric authentication data of the intended user to verify the identity of the user before injecting the drug or medication into the user. The device 10 including biometric authentication can increase the safety of the device 10 and prevent a drug or medication from being injected into anyone other than the intended user. For example, biometric authentication of the device 10 can prevent a child from accidently injecting themselves with a drug or medication that was not intended for their use.
As discussed, in some examples the device 10 can include only the first sensor electrode 28 and the second sensor electrode 30. In other examples, the device 10 can include the first sensor electrode 28, the second sensor electrode 30, and the third electrode 32. As illustrated in
In either example, the third electrode 32 can be a right-leg drive electrode that is configured to implement common-mode powerline interference suppression. In other words, the third electrode 32 can be utilized to determine and then cancel out natural frequencies/signals that are produced by the human body, which can cause interference and incorrect measurements and/or data during collection of the ECG measurements. As such, the third electrode 32 is not required but is advantageous and desirable because it results in more accurate measurements of the physiological parameters of the user's heart and/or body by the device 10 during collection of the ECG measurements. More specifically, the first sensor electrode 28, the second sensor electrode 30, and the third electrode 32 can gather information and data related to the user (e.g., ECG measurements, natural frequencies/signals, etc.), and then the data can be processed by algorithms to produce accurate results relating to the many different properties/characteristics of the user's heart and overall health. In some examples, the algorithms can be stored within the device 10 for processing by the device 10. In other examples, the algorithms can be stored on a device that is separate from the device 10, such that the data is processed after being transferred from the device 10 to a separate and remote device/controller.
It is to be understood that in an embodiment in which the device 10 is utilized for bio-impedance measurements, the third electrode 32 may not be included in the device 10 and/or the third electrode 32 may not be activated or utilized during the bio-impedance measurements. The aforementioned is due to the fact that the right-leg drive electrode common-mode powerline interference suppression (facilitated by the third electrode 32) is not utilized during bio-impedance measurements, as will be appreciated by those skilled in the art.
As illustrated in
In some examples, the analog to digital converter 40 can also be an electrical component coupled to the circuit board 36 within the device 10. In other examples, the analog to digital converter 40 can be embedded directly into the microprocessor 42. In either example, the analog to digital converter 40 can be configured to sample the measured ECG and other electrical signals from the sensors 28, 30, and convert the signals into digital data so that the data can be processed by the microprocessor 42. The microprocessor 42 can be an electrical component coupled to the circuit board 36 within the device 10. The microprocessor 42 can be configured to implement additional filtering in the digital domain for higher signal-to-noise ratio, and configured to perform ECG digital signal processing to analyze the characteristics of the ECG waveform and compute the corresponding physiological parameters. In addition, the microprocessor 42 can also be utilized to determine when there is sufficient contact between the electrodes (sensor electrodes 28, 30, and third electrode 32) and the user's skin surface. This lead on/off information can be used by the microprocessor 42 to determine if input data samples received by the device 10 are valid before executing further processing.
The alarm 44 can be an electrical component coupled to the circuit board 36 within the device 10. The alarm 44 can be configured to alert the user when the measured and recorded electrical signals exceed a pre-defined threshold limit. More specifically, the device 10 can include stored pre-defined limits for specific physiological parameters of the heart of the user. The device 10 can compare the measured and recorded electrical signals of the heart to the pre-defined threshold limits, and if the measured and recorded electrical signals of the heart exceed the pre-defined threshold limits, the device 10 can prevent the insertion of the needle 14 and the dispensing of the drug into the user. In one example, a pre-defined threshold (maximum) heartrate can be stored within the device 10, and if the measured/recorded heartrate of the user exceeds the pre-defined threshold limit, the device 10 can prevent the insertion of the needle 14 and the dispensing of the drug into the user. In addition, the alarm 44 could be a visual notification that is displayed on the display 26, a light that turns on to indicate an issue, or an audio notification, among other options not specifically listed. The alarm 44 is a safety feature of the device 10 that is configured to prevent harm to the user of the device 10.
As discussed, the device 10 can include a display 26 and the display 26 can be utilized to visually present the user with real-time ECG waveform information and other bio-electrical information. In addition, the display 26 can visually present data related to other physiological parameters of the user's heart and/or body that were sensed by the sensor electrodes 28, 30 and computed by the microprocessor 42 and other components of the circuit board 36, such as bio-impedance analysis (BIA) data, estimated body composition (e.g., body fat content), hydration level, etc. The device 10 can be enabled to perform bio-electrical (ECG, BIA, etc.) measurements before, during, and after the occurrence of an injection of a drug or medication into the user. In addition, the bio-electrical measurements obtained by the device 10 can be utilized as a feature itself of the device 10, without necessarily having to be associated with the execution of an injection of a drug or medication into the user. As such, in some examples, the device 10 can be utilized to gather and obtain bio-electrical measurements of the user for monitoring the user's health without injecting a drug or medication into the user.
It is to be understood that the first side of the user's body and the second side of the user's body are positioned on opposite sides of a sagittal plane (i.e., a plane that divides the body into right and left sides) of the user's body. Further, it is to be understood that with the device 10 held in a hand on one side of the body, the engaging surface 20 must contact the other or opposite side of the body, such that the signal produced by the device 10 passes through the heart of the user 50 to gather information relating to the heart (ECG measurements). Therefore, if the device 10 is held within the right hand of the user 50, then the engaging surface 20 must directly contact a skin surface on the left side of the body (i.e., left side of the heart). If the device 10 is held within the left hand of the user 50, then the engaging surface 20 must directly contact a skin surface on the right side of the body (i.e. right side of the heart). The previously described use/orientation is necessary to gather the desired information about the heart of the user 50.
Next, the device 10 can utilize the first sensor electrode 28 and the second sensor electrode 30 to measure and collect electrical signals produced by the heart and/or body of the user 50. The analog front-end stage 38 can process the measured and collected electrical signals, with the processing including filtering the electrical signals to remove common-mode powerline interferences by leveraging the use of the third electrode 32 (for ECG measurements, but not for BIA measurements). The analog to digital converter 40 can then convert the processed electrical signals and output digital data that can be processed by the microprocessor 42. The microprocessor 42 can then output physiological parameters or ECG and BIA measurements relating to the heart and/or body of the user 50. The physiological parameters or ECG measurements can be one or more of heart rate, heart rate variability, physiological stress, energy expenditure, atrial fibrillation, and arrhythmia of the user, among other properties/characteristics not specifically disclosed. In addition, the physiological parameters can include sensed bio-impedance analysis (BIA) data, estimated body composition (e.g., body fat content), and hydration level of the user (e.g., total body water).
Then the device 10 can display the physiological parameters on the display 26 of the device 10. In addition, the device 10 can also communicate the physiological parameters of the user's heart and/or body through the input-output device 34 of the device 10 to a device/system that is separate and remote from the device 10, in which a physician can remotely access data to view and analyze the data collected by the device 10. As such, the device 10 can remotely gather data relating to a user's heart and/or body, and send the data to a physician for analysis, which can be utilized to identify potentially serious illness, check vital conditions, and/or the heart condition of the user or patient.
The device 10 of the present application provides many advantages that will be appreciated by a person having ordinary skill in the art. For example, home-therapies that require self-administration of drugs which may produce effects on the cardiac cycle could demand frequent monitoring of the patient's ECG signal. The integration of an ECG subsystem (first sensor electrode 28, second sensor electrode 30, circuit board 36, etc.) in the device 10 enables the patient to execute ECG measurements from home using the same device 10 that is used for injection, without necessarily having to seek assistance from professional personnel. The patient's physician could prescribe the patient to execute contextual ECG measurements during the therapy to monitor the physiological parameters of the patient in response to the injection-based treatment. In addition, the sensed bio-impedance analysis (BIA) data can be evaluated by a physician to aid in patient weight reduction and control due to the device 10 being capable of measuring bio-parameters such as body mass index (BMI), body fat content, hydration (water) level, etc. of the user. Convenient sensor electrodes (i.e., the first sensor electrode 28 and the second sensor electrode 30) placement along the device 10 eases and simplifies the measurement process for the patient.
In addition, the remotely connected device 10 enables remote patient monitoring to present the physician with additional datasets to obtain a clearer picture on the patient's general health. This allows the physician to deliver better quality of care for the patient. Although the device 10 of the present application does not produce the same amount of data as a twelve-lead ECG measurement device that is exclusive to a clinical setting, the device 10 provides many medical insights that can be extracted by dedicated data processing algorithms (within the device 10 or separate from the device 10). For example, the device 10 can measure and record heart rate, heart rate variability, physiological stress, energy expenditure, atrial fibrillation, arrhythmia of the patient, among other physiological parameters not specifically listed. In addition, the device 10 can be configured to perform bio-impedance analysis (BIA), estimate body composition (e.g., body fat content), and hydration level of the user. The patient's physician can use the real-time data to discover patterns and potentially identify early on possible chronic health conditions. As such, the device 10 of the present application provides many advantages that are not currently provided by traditional or standard autoinjector medical devices.
Step 102 can include grasping the handle 24 of the device 10 with a hand 52 on a first side of a user's body, wherein during the grasping the second sensor electrode 30 of the device 10 directly contacts the hand 52 of the user 50. Step 104 can include pressing the engaging surface 20 of the device 10 directly against a portion of the user's body on a second side of the user's body, wherein during the pressing the first sensor electrode 28 of the device 10 directly contacts the portion of the second side of the user's body. Step 106 can include measuring and collecting, by the first sensor electrode 28 and the second sensor electrode 30, electrical signals produced by the heart and/or body of the user 50. Step 108 can include processing, by the analog front-end stage 38 of the device 10, the measured and collected electrical signals, wherein the processing comprises filtering the electrical signals to remove common-mode powerline interferences. Step 110 can include converting, by the analog to digital converter 40 of the device 10, the processed electrical signals into digital data, and further processing and outputting, by the microprocessor 42 of the device 10, physiological parameters relating to the heart and/or body of the user 50. Step 112 can include displaying the physiological parameters on the display 26 of the device 10, and/or communicating the physiological parameters through the input-output device 34 of the device 10 to a device separate and remote from the autoinjector medical device 10. As discussed, in some examples the method 100 can include more or less than steps 102-112, previously discussed.
Having thus described the present embodiments in detail, it is to be appreciated and will be apparent to those skilled in the art that many physical changes, only a few of which are exemplified in the detailed description of the disclosure, could be made without altering the inventive concepts and principles embodied therein.
It is also to be appreciated that numerous embodiments incorporating only part of the preferred embodiment are possible which do not alter, with respect to those parts, the inventive concepts and principles embodied therein. The present embodiment and optional configurations are therefore to be considered in all respects as exemplary and/or illustrative and not restrictive, the scope of the disclosure being indicated by the appended claims rather than by the foregoing description, and all alternate embodiments and changes to this embodiment which come within the meaning and range of equivalency of said claims are therefore to be embraced therein.
| Number | Date | Country | |
|---|---|---|---|
| 63526530 | Jul 2023 | US |
