Tactile Feedback of Electronic Medical Devices

Abstract

Implementations of the present disclosure are directed to a medical handheld device that includes an actuation function configured to generate a trigger signal, a sensor configured to detect functionality of the medical handheld device in response to the trigger signal, and a tactile source configured to generate a tactile signal that includes information associated with the functionality of the medical handheld device.

Description

Technical Field

[0001] Many electronic medical devices, such as injection devices, do not require continuous management by medical staff and enable patients to safely monitor physiological parameters and receive treatments. Electronic medical devices often include a display, which is configured to provide information about one or more functions or features of the electronic medical device. However, during the use of an electronic medical device, the user's visual focus may be away from the display of the electronic medical device. For example, a user may focus on the injection spot during injection while using an electronic injection device. Additionally, some users have visual impairments, which limit their ability to use the visual display of an electronic medical device.

Summary of the Invention

Means for Solving the Problems

[0002] Implementations of the present disclosure include a handheld medical device configured to provide tactile feedback regarding the configuration and / or use of a medical device. According to one aspect of the invention, a medical handheld device includes an actuator configured to generate a trigger signal, a sensor configured to detect the functionality of the medical handheld device in response to the trigger signal, and a tactile source configured to generate a tactile signal including information associated with the functionality of the medical handheld device. Mechanism and, in response to the trigger signal, a sensor configured to detect the functionality of the medical handheld device, and a tactile source configured to generate a tactile signal including information associated with the functionality of the medical handheld device.

[0003] In some implementations, the tactile source includes a vibration element. The vibration element includes at least one of a vibration motor, a vibration battery, and a speaker with a vibrating diaphragm. The tactile source is enclosed within the medical handheld device. The tactile source is fixed at a position configured to improve the transmission of the tactile signal. The tactile source is integrated with the activation button. The medical handheld device can include a second sensor configured to detect the patient's physiological parameters. Actuator Mechanismis configured to generate a trigger signal in response to the detection of physiological parameters. The medical handheld device can include a drug reservoir configured to store a drug to be discharged by the medical handheld device. The tactile signal includes information associated with the discharge of the drug stored in the drug reservoir. The vibration element is included in the electric drive device. At least a part of the electric drive device is connected to a plunger rod configured to be moved to discharge the drug. The tactile source is integrated into at least one of an injection button, an input button, a dose knob, and a dial grip. The medical handheld device can further include a motor including a first axis configured to discharge the drug and a second axis configured to generate a tactile signal.

[0004] According to another aspect of the present invention, a medical system includes a medical handheld device and an external device including components monitored by the medical handheld device.

[0005] It should be understood that the systems according to the present disclosure can include any combination of the aspects and configurations described herein. That is, the methods according to the present disclosure are not limited to the combinations of aspects and configurations specifically described herein, but also include any combination of the provided aspects and configurations.

[0006] Details of one or more implementations of the present disclosure are described in the accompanying drawings and the following description. Other configurations and advantages of the present disclosure will become apparent from the description, the drawings, and the claims.

Brief Description of the Drawings

[0007]

Figure 1A

Figure 1B

Figure 2

Figure 3

Figure 4

Figure 5

Best Mode for Carrying Out the Invention

[0008] Like reference numerals in the various drawings indicate like elements.

[0009] Embodiments of the present disclosure generally relate to the generation of tactile (vibratory) signals associated with the operation of medical handheld devices. More particularly, embodiments of the present disclosure are directed to generating and transmitting tactile signals that indicate the condition of an electronic medical device to the user of the medical device. This condition can include critical conditions of the medical device, such as the detection of an abnormal condition associated with a function, parameter, method of operation, or mechanism (e.g., a blocked needle, an occlusion of the injection mechanism, and out-of-range temperature). The tactile signal can also indicate non-critical conditions, such as method of operation conditions (e.g., completion of an injection, completion of a waiting time, and a holding time).

[0010] An electronic medical device can be configured to provide tactile feedback in response to the analysis of critical parameters detectable by a sensor of the electronic medical device. For example, the tactile feedback can be provided to correct a medical procedure and to prevent usage errors. In some implementations, the tactile feedback can be a distinct signal that is used in place of acoustic feedback while using the electronic medical device in a public environment. The electronic medical device can be configured to maximize the delivery of tactile feedback to a user of the electronic medical device. The tactile feedback can be generated by tactile elements that can be included in any type of handheld medical device, such as the devices described with reference to FIGS. 1-4 (but not limited to). These tactile elements can include any system capable of generating a tactile signal, such as the implementations described with reference to FIGS. 1-4 (but not limited to).

[0011] FIGS. 1A and 1B illustrate a system 100 configured to provide tactile feedback according to one implementation of the present disclosure. System 100 includes an exploded view in an example of an injection device (medical handheld device) 102. Injection device 102 includes one or more tactile elements 120a, 120b that can be used to provide feedback regarding the function or use of injection device 102. In some examples, injection device 102 can be a pen-type device that uses a replaceable drug reservoir (cartridge) 106. The pen-type device can be a pre-filled injection pen or a reusable injection pen. Injection device 102 includes a housing 104, a drug reservoir 106 (e.g., a drug container or cartridge), a plunger 108, an injection button 110, a dose knob 112, and a dose window 114.

[0012] The housing 104 can be configured to define a medicament container or to include a reservoir 106 capable of containing an amount of medicament. The outer shape and the composition material can be configured to optimize the transmission of tactile signals. For example, the reservoir 106 can include a COC material or glass that provides high purity, a high moisture barrier, excellent tactile signal transmission, breakage prevention, and low density. The reservoir 106 (e.g., a container) can be configured to contain a liquid medicament. This medicament can include a pharmaceutical formulation that includes at least one pharmaceutically active compound. This medicament can include an insulin analogue, an insulin derivative, an analgesic, a hormonal agent, a beta-acting agent, a corticosteroid, or a combination of any of the aforementioned drugs.

[0013] The plunger 108 can be configured to expel a portion of the medicament contained within the reservoir 106. The plunger 108 can include a plunger rod 108a and a plunger head 108b configured to push a stopper 109. The stopper 109 can be configured to expel a portion of the medicament contained within the reservoir 106 by moving in the direction from the distal end 116a to the proximal end 116b within the tubular wall 115 of the reservoir 106, whereby the position of the stopper 109 indicates the amount of medicament within the reservoir 106. The terms "distal", "distally", and "distal end" refer to the end of the injection device towards which the needle is provided. The terms "proximal", "proximally", and "proximal end" refer to the opposite end of the injection device towards which the injection button or dose knob is provided. Most (e.g., at least 90%) of the surface of the stopper 109 that contacts the medicament can be configured to be flat in order to minimize the dead volume of filling in the injection device 102. The position of the stopper 109 can be associated with the amount of medicament within the injection device 102.

[0014] The injection device can include an electric drive device 111 for automatically discharging the drug in response to activation of the injection button 110. The injection button 110 is configured to enable injection of the drug into the patient's body and to generate a trigger signal. The dose knob 112 is configured to enable selection of the dose of the drug to be extruded from the injection device 102 and to generate a trigger signal. For example, a specific dose (volume) of the included drug can be set and extruded from the injection device 102 by turning the dose knob 112. By turning the dose knob 112, the tactile element 120a can provide tactile feedback to the user. The dose window 114 is configured to display the selected dose. The selected dose can be displayed as a multiple of the so-called international unit (IU). One IU is approximately 45.5 micrograms of the biological equivalence of the pure crystalline drug (1 / 22 mg). An example of the selected dose displayed in the dose window 114 can be, for example, 30 IU, as shown in FIGS. 1A and 1B. The numbers displayed in the dose window 114 can be printed on the sleeve. This sleeve is included in the housing 104 and mechanically interacts with the plunger 108 in the reservoir 106. In some implementations, the dose window 114 is an electronic display. This electronic display is configured to display a plurality of information regarding the injection device 102, including any of the available drug amount, the selected dose, the extruded dose, the battery life, the expiration date of the drug, the storage temperature, and the pre-stored data.

[0015] The threaded interface (nose piece) 118 of the housing 104 can be attached to the needle hub 123. The needle hub 123 includes a needle 122 and a handle 124. The needle 122 is protected by an inner needle cap 126 and an outer needle cap 128, which may then be covered by a cap 130. When the needle 122 can be inserted into the patient's skin portion, the injection button 110 is depressed, the drug dosage displayed on the display window 114 is extruded from the injection device 102, and at least one of the tactile elements 120a, 120b, 120c generates a tactile signal.

[0016] Tactile signals can be characterized by a specific tactile pattern. The tactile pattern includes a combination of signal durations at specific signal frequencies and pressures. The tactile pattern can include intermittent vibration, continuous vibration, and vibration patterns. Vibration patterns can include: (i) long vibrations (e.g., about several seconds) with short interruptions (e.g., about several milliseconds) perceptible to humans, (ii) short vibrations (e.g., less than about 1 second) with long interruptions (e.g., about several seconds), (iii) interruptions with increasing durations, (iv) interruptions with decreasing durations, (v) single / double / triple short vibrations; (vi) soft vibrations (e.g., with amplitudes of about 10 to about 50 micrometers), (vii) strong vibrations (e.g., with amplitudes of about 100 to about 500 micrometers). In some implementations, a short (e.g., less than about 3 seconds) tactile signal having a simple tactile pattern (e.g., a single constant frequency below about 220 Hz, or a pair of low and high frequencies) can be used to provide positive feedback. In some implementations, a long (e.g., longer than about 3 seconds) tactile signal having a simple tactile pattern (e.g., a single constant frequency, or a pair of low and high frequencies), or a complex tactile pattern (e.g., a combination of multiple frequencies, or a strong signal with a high frequency) can be used to provide indication of critical conditions. Long vibrations or pulses are generally in the range of about 0.1 Hz to about 5 Hz, preferably in the range of about 1 Hz to about 3 Hz. Short vibrations or pulses are generally in the range of about 5 Hz to about 30 Hz, preferably in the range of about 5 Hz to about 12 Hz. Similar intervals apply to short and long interruptions respectively.

[0017] For example, when the needle 122 of the injection device 102 remains in contact with a part of the skin for a specific period of time (e.g., 10 seconds) after the injection button 110 is pressed, a high percentage (e.g., more than 98%) of the dose is actually injected into the patient's body. In response to the completion of the extrusion of the drug, at least one of the tactile elements 120a, 120b, 120c can generate an additional tactile signal. It may be different from the tactile signal generated before the drug is extruded (e.g., it may have a different tactile pattern). The injection device 102 can be used for several injection processes until either the drug reservoir 106 becomes empty or the expiration date of the injection device 102 is reached (e.g., 28 days after the first use). It may be necessary to perform a so-called "prime shot" to discharge air from the drug reservoir 106 and the needle 122 before using the injection device 102 for the first time. This is performed, for example, by selecting two units of the drug and pressing the injection button 110 while holding the injection device 102 with the needle 122 facing upward.

[0018] The tactile elements 120a, 120b (illustrated in FIG. 1A), 120c (illustrated in FIG. 1B) can be configured to generate a tactile signal in response to the reception of a trigger signal. The tactile elements 120a, 120b, 120c can be included in any member of the injection device 102. The tactile elements 120a, 120b, 120c can be fixed through the housing 104 to a position that enables maximum transmission of the tactile signal, such as proximal to the injection button 110 or around an intermediate section of the housing 104 proximal to the wall of the housing 104. In some implementations, the tactile elements 120a, 120b, 120c are in direct contact with the housing 104 to maximize the transmission of the tactile signal through the housing 104. In some implementations, the composition, outer shape, and structure of the housing 104 can be configured such that the tactile signal is maximally perceived near the tactile elements 120a, 120b, 120c and is perceivable across the entire surface of the housing 104. For example, the configuration of the housing 104 and the tactile elements 120a, 120b, 120c can enable the transmission of the tactile signal to a user holding the injection device 102, regardless of the holding configuration.

[0019] As illustrated in FIG. 1A, the haptic elements 120a, 120b can include a piston rod 132, a shaft 134 with a clutch 134a for clockwise rotation, a motor 136, a shaft 138 with a clutch 138a for counterclockwise rotation, and an imbalance disk 140. The shaft 134 is configured to drive a drug drive train. The shaft 138 is configured to generate a haptic signal. For example, the piston rod 132 can be attached to the plunger rod 108a, thereby associating the haptic signal with the movement of the plunger rod 108a. The haptic signal is generated in response to a trigger signal by the imbalance disk 140 when activated by the motor 136 and transmitted by the shaft 138. The trigger signal can include a mechanical signal (e.g., movement of the plunger rod 108a) or an electrical signal (e.g., detection that the battery life of the injection device 102 is at a critical level). The haptic elements 120a, 120b, 120c can include one or more clutches 138a (e.g., drive plates) to disengage the imbalance disk 140 when the injection device 102 injects a dose (by clockwise rotation) and to engage the imbalance disk 140 by counterclockwise rotation. The clutch 138a can be a movable (e.g., counterclockwise rotation) or fixed clutch. The counterclockwise clutch 138a can have a centrifugal clutch unit to slowly retract the piston rod 132 without generating a haptic (vibration) signal (when the cartridge is being replaced). The haptic signal can be generated by rotation of the motor 136 that activates a rapid counterclockwise rotation of the shaft 138.

[0020] As illustrated in FIG. 1B, the tactile element 120c can be configured to generate a tactile signal for a user of the device 102. The tactile element 120c can include a vibrating battery or a vibration drive train. The tactile element 120c includes a housing 143 configured to cover the internal elements of the tactile element 120c and a basket 145 configured to support the internal elements of the tactile element 120c. In some implementations, the tactile element 120c can be a speaker with a diaphragm, as illustrated in FIG. 1B. The diaphragm can include a material having a specific elastic modulus, which enables vibrations of an optimal frequency and amplitude for transmission through the housing 104. For example, the diaphragm can include a thin film of polymer. The tactile element 120c can include a magnet 147, a spider 149, a voice coil 150, a diaphragm 152, and a suspension 154.

[0021] In some implementations, the injection device 102 can include a detection module 142. The detection module 142 can be configured to determine the functionality of the injection device 102 and the amount of drug stored within the drug reservoir 106. For example, the detection module 142 can be configured to monitor and identify a critical value of the amount of drug contained within the injection device 102 or to be set to be delivered by the injection device 102.

[0022] The detection module 142 can include a power source 144, a sensor 146, and a processor 148. The power source 144 can be an integrated battery or a supercapacitor. In some implementations, the power source 144 can include an energy harvester. The energy harvester is configured to collect energy from an external device or a calling signal generated by mechanical energy generated by an interaction between the user and the injection device 102. The power source 144 can be configured to supply energy to the components of the detection module 142 continuously or under specific conditions (e.g., in response to activation of the injection button 110).

[0023] Sensor 146 can include a plurality of sensors. Sensor 146 can include a mechanical sensor, an electrical sensor, an optical sensor, an acoustic sensor, or a combination thereof. Sensor 146 can be configured to detect values associated with a plurality of components of injection device 102. For example, sensor 146 can be configured to detect the status of power source 144, the position of stopper 109 for each injection, and the amount of medicine remaining in medicine reservoir 106. For example, sensor 146 can be configured to detect the status of power source 144 (e.g., low power of power source 144), the position of stopper 109 for each injection (e.g., the position of stopper 109 relative to a specific stopper position), a low temperature or a high temperature (e.g., a temperature outside a specific temperature interval such as 0°C to 15°C), a malfunction in the method of operation, and the amount of medicine remaining in injection device 102. Examples of malfunctions in the method of operation detectable by sensor 146 include premature termination of an injection due to stoppage and / or clogging of needle 122, a malfunction in cap removal, an incorrect device orientation (e.g., the longitudinal axis of the device forms an angle of less than 80° with respect to the patient's skin). Another situation may be associated with the amount of medicine in medicine reservoir 106 (e.g., empty or insufficient medicine for an injection). Can the amount of medicine be compared with the dose set by the user of injection device 102 (e.g., the user selects to inject 23 units but only 16 units remain in the container), or with a statistically determined dose (e.g., the average of the doses injected within a predetermined time interval). The electronics of injection device 102 can be configured to continuously track the medicine dose history and thus have information on the current available amount of medicine in the container.

[0024] The processor 148 can be configured to determine the amount of drug within the injection device based on at least a portion of the electrical signal and to communicate data including the amount of drug to the display 114. The processor 148 can be configured to compare the value detected by the sensor 146 with a corresponding threshold or reference value and generate a trigger signal in response to the identification of a critical operating method or an abnormal condition. The processor 148 can be configured to communicate the trigger signal to one or more tactile elements 120a, 120b, 120c to generate a tactile signal to alert the user of the injection device 102 of a critical condition. In some examples, the processor 148 includes a controller configured to correct a critical condition (such as moving the position of the stopper 109 to a standard predetermined position) and to generate an additional trigger signal to indicate the correction of the critical condition. The processor 148 can be configured to determine information / data and generate trigger signals over the useful life of the drug reservoir 106 and / or the injection device 102. FIG. 2 illustrates an example of an injection device 200 configured to provide tactile feedback according to one implementation of the present disclosure. The injection device 200 includes a drug cartridge holder 202, a needle hub / tip 204, a drug reservoir 206 (such as a drug cartridge), a plunger 208, an injection button 210, a display 212, a control panel 214, a speaker 216, a battery 218, a tactile element 220, and a charging port 222.

[0025] The drug cartridge holder 202 is configured to hold the drug cartridge 206. In some implementations, the cartridge holder 202 is held in a predetermined position by a latch 203. The injection device 200 includes a discharge mechanism configured to extrude a portion of the drug from the drug cartridge 206 through the needle hub / tip 204 in response to an activation signal. The drug cartridge 206 is a disposable and replaceable member of the injection device 200. The drug cartridge 206 can be inserted into and removed from the drug cartridge holder 202. The drug cartridge 206 contains the drug.

[0026] The discharge mechanism can include a plunger 208 and a stopper. The plunger 208 can be configured to discharge a portion of the drug contained within the drug cartridge 206. The plunger 208 can include a plunger rod and a plunger head configured to push the stopper 209. The stopper 209 can be configured to discharge a portion of the drug stored within the drug cartridge 206, whereby the position of the stopper 209 indicates the amount of drug within the drug cartridge 206. In some implementations, the plunger 208 is held within the dovetail guide slit 230 in the injection device 200. The discharge mechanism includes a belt drive 242 that drives the plunger 208. A motor 236 drives the belt drive 242. The guiding portion of the piston rod in the rotational direction uses the dovetail guide slit 230 and is provided via the housing.

[0027] The haptic element 220 can include a piston rod 232, a shaft 234 with a clutch 234a for clockwise rotation, a motor 236, a shaft 238 with a clutch 238a for counterclockwise rotation, and an imbalance disk 240. The shaft 234 is configured to drive a drug drive train. The shaft 238 is configured to generate a haptic signal. For example, the piston rod 232 can be attached to the plunger rod 208a, thereby associating the haptic signal with the movement of the plunger rod 208a. The haptic signal is generated in response to a trigger signal from the imbalance disk 240 when activated by the motor 236 and transmitted by the shaft 238. The motor 236 can include an absolute rotation sensor and / or a stepper motor to control the rotation speed of the motor 236. The piston position of the plunger 208 relative to the drug cartridge 206 can be determined from the rotation speed of the motor 236 in some implementations. In some implementations, the absolute position of the plunger 208 is determined by the sensor 246 relative to a reference position measured after the drug cartridge 206 is inserted. In some implementations, the scanner unit 246 determines the corresponding plunger stroke by measuring the drug level in the drug cartridge 206. The motor 236 can use the corresponding plunger stroke to provide a rotation speed that can provide that plunger stroke, thereby reaching the corresponding plunger position in the drug cartridge 206. The motor 236 is also provided with the absolute value of the distance between the plunger 208 and the stopper 209 before the injection device is first used. The distance from the plunger to the stopper helps ensure that the motor 236 moves the plunger 208 by an accurate distance to discharge a selected amount of drug and prevents an inaccurate amount of drug from being discharged.

[0028] The clutches 234a, 238a (e.g., drive plates) can be configured to disengage the imbalance disk 240 when the injection device 200 injects a dose (by clockwise rotation), and to engage the imbalance disk 240 by counterclockwise rotation. The clutch 238a can be a movable (e.g., counterclockwise rotation) or fixed clutch. The counterclockwise clutch 238a can have a centrifugal clutch unit so that the piston rod 232 can be slowly withdrawn without generating a tactile (vibration) signal (when the cartridge is being replaced). The tactile signal can be generated by the rotation of a motor 236 that activates a rapid counterclockwise rotation of the shaft 238.

[0029] The injection button 210 can be used to provide an activation signal to start the discharge of the drug from the drug cartridge 206 by the discharge mechanism. In some implementations, the injection button 210 is attached to a tactile element 220, whereby activating the injection button 210 can cause the tactile element 220 to provide tactile feedback to the user of the injection device 200.

[0030] The display 212 can include a touchscreen function. The display 212 can provide a visual indication of the situation in the injection device 200, such as the mode of the injection device 200, the battery status, and / or whether the power supply is connected to the injection device 200. In some implementations, the display 212 is synchronized with the tactile element 220, so that each visual indication can correspond to a specific tactile signal with a unique pattern. The display 212 can also be used to communicate messages to the user. The display 212 can include a liquid crystal display (LCD), or a light emitting diode (LED) or OLED screen, etc. In some implementations, the display 212 includes a touchscreen function and can enable the display to receive user input. The touchscreen function can be used to assist with setting and troubleshooting procedures. Alternatively or additionally, the display 212 can be accompanied by one or more push buttons or keys in the vicinity of the display, and the user can interact with the injection device 200, for example, by operating a cursor via a series of menus and options on the display 212.

[0031] The control panel 214 can include one or more of: a power switch (on / off switch), a release switch for the cartridge holder 202, a dose setting button, and a control device for the display 212. In some implementations, the control panel 214 is attached to the tactile element 220, so that activating the control panel 214 can cause the tactile element 220 to provide tactile feedback to the user of the injection device 200.

[0032] The speaker 216 can be configured to transmit an audio signal in acoustic form to the user of the injection device 200. The injection device 200 can include a microphone (not shown) for receiving user input including an acoustic signal. In some implementations, the acoustic signal can be used as a trigger signal for the tactile element 220.

[0033] The injection device 200 can be powered by a battery 218. The battery 218 can include a rechargeable battery. A power port 222 can be included in the injection device 200 to charge the injection device 200. In some implementations, the battery 218 can also be recharged using the power port 222. In some implementations, the battery 218 and / or the power port 222 can be attached to a tactile element 220, whereby the status of the battery 218 can cause the tactile element 220 to provide tactile feedback to the user of the injection device 200.

[0034] In some implementations, the injection device 200 can include a network interface 244 configured to connect the injection device 200 to a network. The network interface 244 can include one or more of: a WiFi interface; an Ethernet interface; a Bluetooth receiver; and / or a USB interface. The injection device 200 can be connected to a local area network (LAN) and / or the Internet via the network interface 244, enabling the injection device 200 to exchange data with other devices connected to the network. The injection device 200 can also use the network interface 244 to directly connect to additional devices, for example using a Bluetooth connection. The injection device 200 can be connected to a data server via the network interface 244. Through this connection, the device can share data bi-directionally using the data server. The data server can be located remotely from the injection device 200, for example in a data center controlled by a drug supplier or device manufacturer. In some implementations, the data center can be part of a distributed computer system. For example, the computer system can be a "cloud" based system. In some implementations, the data server is located near the device in the same local area network.

[0035] In some implementations, the injection device 200 can include a sensor 246. The sensor 246 can include an optical CCDM unit. The sensor 246 is configured to monitor an optical code in the drug cartridge 206 to register an individual drug cartridge 206. For example, the sensor 246 can record a drug identifier of the drug cartridge 206. In some implementations, the sensor 246 can be used to monitor one or more of the color of the drug and the drug level in the drug cartridge 206. In some implementations, the sensor 246 can be attached to the haptic element 220, whereby the value measured by the sensor 246 can cause the haptic element 220 to provide haptic feedback to the user of the injection device 200. FIG. 3 is a schematic diagram of an example of an auxiliary device (medical handheld device) 300 and an example of a medical system 301 that includes an injection device 302. The auxiliary device 300 can be configured to provide haptic feedback according to an implementation of the present disclosure. The auxiliary device 300 can be releasably attached to the injection device 302 (e.g., the injection device 300 in FIG. 3). The auxiliary device 300 includes a housing 304 with a fitting unit. This fitting unit is configured to surround the housing 310 of the injection device 302 so that the auxiliary device 300 fits snugly into the housing 310 of the injection device 302. The housing 304 can be configured to allow the auxiliary device 300 to be removed from the injection device 302, for example, when the injection device 302 needs to be emptied and replaced.

[0036] The auxiliary device 300 can include one or more tactile elements 320 and a plurality (e.g., three) of user input buttons schematically illustrated as buttons 322, for example. The tactile element 320 can be fixed at a position where a tactile signal can be transmitted through the housing 310. For example, the tactile element 320 can be positioned near any one of the buttons 322, 324, 326. The tactile element 320 can be configured to generate a tactile signal for the user of the auxiliary device 300. The tactile element 320 can be a vibration motor of a micro drive. For example, the tactile element 320 can include a counterweight 330 of an eccentric mass, a race bearing 332, a front cap 334, and a motor 336.

[0037] The buttons 322, 324, 326 can include a mechanical switch or an electrical coupling. The first button 322 can be an input button. The input button 322 can be configured such that the user can turn the auxiliary device 300 on or off or confirm an operation (e.g., to enable an operation such as connecting to or pairing with another device and / or triggering the transmission of information from the auxiliary device 300 to another device). The second button 324 can be a communication button. The third button 326 can be a confirmation button (e.g., an OK button). The auxiliary device 300 can include a detection module 342 for recovering information (e.g., the amount of drug in the drug reservoir 306) from the injection device 302. The display unit 321 of the auxiliary device 300 can be configured to display the information obtained by the detection module 342. The dose window of the injection device 302 can be blocked by the auxiliary device 300 when the auxiliary device 300 is attached to the injection device 302.

[0038] The detection module 342 can include a power source 344, a sensor 346, and a processor 348. The power source 344 can be an integrated battery or a supercapacitor. In some implementations, the power source 344 can include an energy harvester. The energy harvester is configured to collect energy from an external device or a call signal generated by mechanical energy generated by the interaction between the user and the auxiliary device 300. The power source 344 can be configured to supply energy to the components of the detection module 342 and the tactile element 320 continuously or under specific conditions (e.g., in response to the activation of one of the buttons 312, 322, 324, 326).

[0039] The sensor 346 can be configured to detect values associated with a plurality of configurations of the injection device 302. The sensor 346 can include a plurality of sensors. The sensor 346 can include a mechanical sensor, an electrical sensor, an optical sensor, an acoustic sensor, or a combination thereof. For example, the sensor 346 can be configured to detect the amount of drug in the drug reservoir 306, the status of the power source 344 (e.g., low power of the power source 344), the position of each injection stopper 309 (e.g., the position of the stopper 309 relative to a specific stopper position), low or high temperature (e.g., a temperature outside a specific temperature interval such as 0°C to 35°C), malfunction of the operation method, and the amount of medicine remaining in the injection device 302.

[0040] The processor 348 can be configured to compare the values detected by the sensor 346 with corresponding threshold or reference values and generate a trigger signal in response to the identification of a critical operating method or an unusual condition (such as the battery life decreasing to a minimum operating method level). The processor 348 can be configured to transmit the trigger signal to the tactile element 320, generate a tactile signal, and warn the user of the auxiliary device 300 of a critical condition. In some examples, the processor 348 is configured to correct a critical condition (such as interfering with the delivery of a drug under critical conditions) and generate an additional trigger signal to indicate whether the critical condition has been corrected (such as whether the battery has been replaced or recharged). The processor 348 can be configured to determine information / data and generate trigger signals over the useful life of the auxiliary device 300 and / or the injection device 302.

[0041] FIG. 4 shows a health monitoring device (medical handheld device) 400 configured to provide tactile feedback according to one implementation of the present disclosure. The health monitoring device 400 includes a housing 402, a display unit 404, a plurality of input buttons 406, a tactile element 420, and a detection module 442. The display unit 404 and the plurality of input buttons 406 are positioned to be accessible through the housing 402. The plurality of input buttons 406 are configured to enable a user of the health monitoring device 400 to provide input data or enter data or relevant information associated with the operating method of the health monitoring device 400. For example, a user of the health monitoring device 400 can operate one or more of the input buttons 406 to enter a calibration code. This calibration code is associated with the means for receiving test strips or other fluid samples for use with the health monitoring device 400.

[0042] In some implementations, the health monitoring device 400 can include a blood glucose meter with a bolus calculation function. This bolus calculation function is configured to calculate a single bolus dose of a pharmaceutical, such as long-acting, rapid-acting, or immediate-acting insulin. Additionally, the user can operate one or more input buttons 406 to adjust time and / or date information, as well as other configurations or settings associated with the operation of the health monitoring device 400.

[0043] In some implementations, a strip port for receiving a test strip can be integrated with the housing of the health monitoring device 400, or alternatively, a strip port for receiving a test strip can be provided in a separate housing or as a separate component that can be physically or electrically coupled to the health monitoring device 400. For example, a component including the strip port can be provided in a separate snap-fit housing that physically snaps onto the housing 402 of the health monitoring device 400.

[0044] In some implementations, the health monitoring device 400 can be configured to automatically enter a pharmaceutical dose calculation mode, estimate a pharmaceutical dose based on information stored in the health monitoring device 400 (such as the patient's insulin sensitivity), and / or prompt the patient to provide additional information, such as the amount of carbohydrates consumed by the patient, in order to determine, for example, a carbohydrate bolus dose. The patient can operate the input buttons 406 in conjunction with a user interface menu provided on the display unit 404 to provide additional user information.

[0045] In some implementations, after the display of the analysis level determined from the test strip, the health monitoring device 400 can be configured to prompt the patient to select whether to administer a predetermined or pre-programmed dose of a medicament, such as a correction bolus or a carbohydrate bolus. The health monitoring device 400 can be configured to automatically prompt the user or patient to select whether the determined dose of the medicament is desirable after an analyte test using the test strip. In some implementations, the prompting is provided as a display on the display unit 404 and as a tactile signal generated by the tactile element 420.

[0046] The tactile element 420 can include a vibrating battery. The tactile element 420 can include a housing 410, a base member 412, one or more plates 414, one or more piezoelectric elements 416, a connecting member 418, a vibration amplifying member 422, and a circuit board 424. The housing 410 can have an internal space and can form the appearance of the tactile element 420. For example, the housing 410 can have a coin-like shape, a flat rectangular shape, or a thin curved shape that conforms to the curvature of the housing 402. The base member 412, the plates 414, the piezoelectric elements 416, the connecting member 418, the vibration amplifying member 422, and the circuit board 424 can be disposed in the internal space of the housing 410.

[0047] In some implementations, the user input, one or more operating methods of the health monitoring device 400, and one or more parameters measured by the health monitoring device 400 are processed by the detection module 442. The detection module 442 can include a power source 444, a sensor 446, and a processor 448. The power source 444 can be an integrated battery or a supercapacitor. In some implementations, the power source 444 can include an energy harvester. The energy harvester is configured to collect energy from an external device or a call signal generated by mechanical energy generated by the interaction between the user and the health monitoring device 400. The power source 444 can be configured to supply energy to the components of the detection module 442 and other components of the health monitoring device 400 continuously or under specific conditions (e.g., in response to the activation of one of the buttons 406).

[0048] The sensor 446 can be configured to detect values associated with a plurality of parameters of the health monitoring device 400. The sensor 446 can include a digital sensor. For example, the sensor 446 can be configured to detect the status of the power source 444, the result of an analyte test, and the amount of medicine remaining in the health monitoring device 400.

[0049] The processor 448 can be configured to compare the values detected by the sensor 446 with corresponding threshold or reference values and generate a trigger signal in response to the identification of a critical operating method or an abnormal condition. The processor 448 can be configured to transmit the trigger signal to activate the tactile element 420, generate a tactile signal, and warn the user of the health monitoring device 400 of a critical condition. In some examples, the processor 448 includes a controller configured to generate an additional trigger signal to indicate the correction of a critical condition. The processor 448 can be configured to determine information / data and generate a trigger signal over the useful life of the health monitoring device 400.

[0050] FIG. 5 is a flowchart illustrating an example of a process 500 that can be implemented to generate a tactile signal to assist in the functionality of a medical device. The process 500 can be implemented by the devices and systems described with reference to FIGS. 1-4. The process 500 illustrated in FIG. 5 begins upon receipt of a trigger signal (502). The trigger signal can be generated in response to the receipt of an input, such as by an actuation Mechanism (e.g., a button of a medical device) or by a sensor included in a handheld electronic medical device. The handheld electronic medical device can include an injection device and an auxiliary device that is releasably attachable to a medical device or a health monitoring device (e.g., a blood glucose monitor). In some implementations, the trigger signal can be generated in response to a critical physiological parameter of a patient measured by the electronic medical device. In some implementations, the trigger signal can be generated in response to user input (e.g., an injection actuation method or an input provided using a graphical user interface) in the handheld medical device. Examples of injection actuation methods implemented with an injection device include selecting a specific number of units of a drug (e.g., 1 or 2) and pressing an injection button while holding the injection device with the needle pointing upward. Another example of an injection actuation method for a medical device includes pressing an injection button or an on / off button of the medical device configured as an electrical switch. The trigger signal can include at least one of a mechanical signal and an electrical signal. In some implementations, the trigger signal can include an on-switch signal, which is generated for a specific period (e.g., a given number of seconds, or 1-2 minutes). The trigger signal can include an instruction to generate a confirmation of the operating method conditions and parameters of the medical device.

[0051] One or more operating method conditions of a medical device, parameters of the medical device, and / or physiological parameters of a patient are compared to standard values to distinguish between standard (normal) values and abnormal (critical) operating methods (504). Any condition or configuration of a medical device or a drug housed in a medical device that may affect what is defined as a standard injection of a predicted drug amount can be analyzed. The operating method conditions or configurations of a medical device can include the battery life of the medical device, the amount of drug to be extruded, the amount of drug available in the drug container, the current date, the identifier of the drug, and the drug characteristics.

[0052] The operating method conditions or configurations of a medical device can be based on the measurement of an electrical signal, the scanning of an identifier specific to the injection device, the optical measurement of drug characteristics (such as the sedimentation rate, density, light absorption coefficient, and / or drug temperature within the drug), the measured temperature (such as the drug temperature), and the internal clock measurement (such as the timestamp of ultrasonic signal reception). The drug temperature can be determined for drugs containing additives or sediments based on the optical signal detected by the receiver and the known sedimentation rate. The amount of drug within the injection device can be determined based on one or more characteristics of the optical signal detected by the receiver. For example, the stopper position of the injection device can be determined based on the phase of the reflected optical signal using a specific detection method. The detection method can include a distance detection method by interferometry and / or a phase modulation method combined with known geometric features (such as cross-sectional area) in the injection device and the drug reservoir. In some implementations, the amount of drug within the injection device can be determined based on a differential measurement associated with the initial position of the plunger (before drug administration) and the final position of the plunger (after drug administration).

[0053] In some implementations, this comparison includes an evaluation of a preset threshold value (e.g., the minimum percentage of battery life, the minimum number of days until expiration, the selected dosage of the drug to be discharged, and the minimum amount of drug in the drug reservoir relative to the expected amount of drug). The accurate insertion of the drug in the injection device can be determined based on a comparison between the optical signal detected by the receiver and the determined optical absorption coefficient of the drug and the known optical absorption coefficient of the drug. The compatibility between the drug volume and the available drug volume can be determined based on the optical signal detected by the receiver and the optical absorption coefficient of the drug with respect to air. The compatibility between the drug volume and the available drug volume can be used to check whether the drug reservoir is empty or partially empty. The drug temperature can be compared with the threshold value of the storage temperature of the drug containing additives or precipitates based on the optical signal detected by the receiver and the known precipitation rate of the precipitate. The dosage of the drug selected by the user scheduled to be discharged by the injection device can be compared with the expected dosage of the drug (the average dosage of the drug discharged during the analyzed time interval) and the dosage of the drug stored in the drug reservoir. If the dosage of the drug selected by the user scheduled to be discharged by the injection device is more (by a specific preselected percentage) than the expected dosage of the drug or more than the dosage of the drug stored in the drug reservoir, the comparison result indicates a critical condition.

[0054] In response to a determination that the comparison result indicates normal (non-critical) operating method conditions, the function of the medical device is executed (506). For example, the selected drug dose is dispensed by the injection device. In response to a determination that the comparison result indicates critical (non-standard) operating method conditions, a tactile signal is generated (508). This tactile signal can include mechanical vibrations that are transmitted through the housing of the medical device. The tactile signal can have a plurality of characteristics corresponding to the type of critical condition determined. The tactile signal can be characterized by a specific tactile pattern. The tactile pattern includes a combination of a specific signal frequency and a signal duration of a specific frequency at a specific pressure. The tactile pattern can include intermittent vibrations, continuous vibrations, and vibration patterns. Examples of vibration patterns are included in Tables 1 to 3.

[0055] [Table 1]

[0056] [Table 2]

[0057] [Table 3]

[0058] For example, the characteristics of the tactile signal can distinguish between a battery with a short service life and critical conditions regarding the drug. The tactile signal can be generated by a tactile element including at least one of a vibration motor, a vibration battery, and a speaker with a vibrating diaphragm: (i) a long vibration (e.g., about several seconds) with a short interruption (e.g., about several milliseconds) perceptible to humans, (ii) a short vibration (e.g., less than about 1 second) with a long interruption (e.g., about several seconds), (iii) an interruption with an increasing duration, (iv) an interruption with a decreasing duration, (v) single / double / triple short vibrations; (vi) soft (e.g., low-pressure) vibrations, (vii) strong (e.g., high-pressure) vibrations. In some implementations, positive feedback can be provided using a short (e.g., less than about 3 seconds) tactile signal having a simple tactile pattern (e.g., a single constant frequency, or a pair of low and high frequencies). In some implementations, a long (e.g., longer than about 3 seconds) tactile signal having a simple tactile pattern (e.g., a single constant frequency, or a pair of low and high frequencies), or a complex tactile pattern (e.g., a combination of multiple frequencies, or a strong signal with a high frequency) can be used to provide an indication of critical conditions.

[0059] In some implementations, in response to a successful transmission of a tactile signal, the medical device can reset a critical function (510) or initiate a sleep mode to conserve power. In some implementations, the medical device is configured to periodically restart a process based on a preset time interval. The described configurations can be implemented in digital electronic circuitry, or in computer hardware, firmware, software, or combinations thereof. The apparatus can be implemented as a computer program product tangibly embodied in an information medium, e.g., a machine-readable storage device, for execution by a programmable processor; the method steps can be performed by a programmable processor executing a program of instructions to perform functions of the described implementations by operations on input data and generation of output. The described configurations can advantageously be implemented in one or more computer programs. These computer programs are executable on a programmable system that includes at least one programmable processor coupled to receive data and instructions from, and to transmit data and instructions to, a data storage system, at least one input device, and at least one output device. A computer program is a set of instructions that can be used, directly or indirectly, by a computer to perform a particular operation or to cause a particular result. A computer program can be written in any form of programming language, including compiled or interpreted languages, and it can be deployed in any form, including as a stand-alone program, or as a module, component, subroutine, or other unit suitable for use in a computing environment.

[0060] Examples of processors suitable for executing command programs include both general-purpose and special-purpose microprocessors, and one of a single processor or multiple processors in any type of computer. Generally, a processor receives instructions and data from a read-only memory, a random access memory, or both. The basic elements of a computer are a processor for executing instructions and one or more memories for storing instructions and data. Generally, a computer also includes or is operatively coupled for communicating with one or more mass storage devices for storing data files; such devices include magnetic disks such as internal hard disks and removable disks; magneto-optical disks; and optical disks. Storage devices suitable for actually embodying the instructions and data of a computer program include non-volatile memories including semiconductor memory devices such as EPROM, EEPROM, and flash memory devices; magnetic disks such as internal hard disks and removable disks; magneto-optical disks; and all forms of CD-ROM and DVD-ROM disks. The processor and memory can be complemented or incorporated by an ASIC (application specific integrated circuit).

[0061] To provide interaction with a user, these configurations can be implemented on a computer having a display device such as a CRT (cathode ray tube) or LCD (liquid crystal display) monitor for displaying information to the user, a keyboard for the user to provide input to the computer, and a pointing device such as a mouse or a trackball.

[0062] The configuration can be implemented in a computer system that includes backend components such as a data server, or includes middleware components such as an application server or an Internet server, or includes frontend components such as a client computer having a graphical user interface or an Internet browser, or any combination thereof. The components of the system can be connected by any form or medium in digital data communication such as a communication network. Examples of communication networks include, for example, LAN, WAN, and the computers and networks that form the Internet.

[0063] The computer system can include clients and servers. The clients and servers are generally separated from each other and usually interact via a network such as described. The client-server relationship is created by computer programs that operate on each computer and have a client-server relationship with each other.

[0064] Additionally, the logical flow shown in the figures does not require the specific order, or sequential order, shown to achieve the desired result. Additionally, other steps can be provided or removed from the flow described, and other components can be added to or removed from the system described. Accordingly, other implementations are within the scope of the following claims.

[0065] Some implementations of the present disclosure have been described. However, it should be understood that various changes can be made without departing from the spirit and scope of the present disclosure. Accordingly, other implementations are within the scope of the following claims.

Description of the Reference Numerals

[0066] 100 Exploded view of the injection device 102, 200 Injection device 104 Housing 106, 206, 304 Drug Reservoirs (Cartridges) 108, 208 Plungers 108a Plunger Rod 108b Plunger Head 109, 209 Stoppers 110, 210 Injection Buttons 111 Electric Drive Device 112 Dose Knob 114 Dose Window 115 Tubular Wall 116a Distal End of the Injection Device 116b Proximal End of the Injection Device 118 Threaded Interface 120a, 120b, 120c, 220 Tactile Elements 122 Needle 123 Needle Hub 124 Handle 126 Needle Cap 128 Outer Needle Cap 130 Cap of the Injection Device 132, 232 Piston Rods 134, 138, 234, 238 Shafts 134a, 138a, 234a, 238a, 308a Clutches 136, 236 Motors 140, 240 Unbalance Disks 142 Detection Module 143 Housing 144, 244, 344 Power Supplies 145 Basket 146, 246, 346, 446 Sensors 147 Magnet 148, 348, 448 Processors 149 Spider 150 Voice Coil 152 Diaphragm 154 Suspension 202 Cartridge Holder 204 Needle Hub / Chip 212 Display 214 Control Panel 216 Speaker 218 Battery 222 Power Port 230 Slit 242 Belt Drive 244 Network Interface 300 Auxiliary Device 304 Housing of Auxiliary Device 310 Housing of Injection Device 312 Button 320 Tactile Element 331 Display Unit 322 Input Button 324 Communication Button 326 Confirmation Button 330 Counterweight of Eccentric Mass 332 Race Bearing 334 Front Cap 342 Detection Module 348 Processor 400 Health Monitoring Device 402 Housing 404 Display Unit 406 Input Button 410 Housing 412 Base Member 414 Plate 416 Piezoelectric Element 418 Connecting Member 420 Tactile Element 422 Amplifying Member 424 Circuit Board 442 Detection Module 444 Power Supply

Claims

**Claim 1** A medical handheld device (102, 200, 300, 400), comprising: An actuating mechanism (110, 210, 312, 322, 324, 326) configured to generate a trigger signal; A sensor (146, 246, 346, 446) configured to detect the functionality of the medical handheld device (102, 200, 300, 400) in response to the trigger signal; A processor (148, 348, 448) configured to determine the situation of the medical handheld device; A tactile source (120a, 120b, 120c, 220, 320, 420) configured to generate a tactile signal including information about the medical handheld device (102, 200, 300, 400); wherein the tactile source (120a, 120b, 120c, 220, 320, 420) is coupled to a housing (104); the housing (104) is configured to define a drug container or to include a reservoir (106) capable of storing a certain amount of drug; the drug container or reservoir (106) includes a COC (cyclic olefin copolymer) material or glass to improve the transmission of the tactile signal; the medical handheld device. **Claim 2** A medical handheld device (102, 200, 300, 400), comprising: An actuating mechanism (110, 210, 312, 322, 324, 326) configured to generate a trigger signal; A sensor (146, 246, 346, 446) configured to detect the functionality of the medical handheld device (102, 200, 300, 400) in response to the trigger signal; A processor (148, 348, 448) configured to determine the situation of the medical handheld device; A tactile source (120a, 120b, 120c, 220, 320, 420) configured to generate a tactile signal including information about the medical handheld device (102, 200, 300, 400); A motor (136) including a first shaft (134) configured to discharge a drug and a second shaft (138) configured to generate the tactile signal; wherein the tactile signal includes a pattern about the medical handheld device (102, 200, 300, 400); the medical handheld device. **Claim 3** The tactile source (120a, 120b, 120c, 220, 320, 420) includes a vibration element (120a, 120b, 120c, 220, 320, 420), and is the medical handheld device (102, 200, 300, 400) according to claim 1 or 2.

4. The vibration element (120a, 120b, 120c, 220, 320, 420) includes at least one of a vibration motor (136), a vibration battery (152), and a speaker (216) with a vibration diaphragm (338), and is the medical handheld device (102, 200, 300, 400) according to claim 3.

5. The tactile source (120a, 120b, 120c, 220, 320, 420) is enclosed within the medical handheld device (102, 200, 300, 400), and is the medical handheld device (102, 200, 300, 400) according to any one of claims 1 to 3.

6. The tactile source (120a, 120b, 120c, 220, 320, 420) is integrated with an activation button (110, 112, 212, 222, 224, 226, 374), and is the medical handheld device (102, 200, 300, 400) according to any one of claims 1, 3 to 5.

7. The medical handheld device (102, 200, 300, 400) according to claim 1 further includes a second sensor configured to detect a patient's physiological parameter.

8. The actuating mechanism (110, 210, 312, 322, 324, 326) is configured to generate a trigger signal in response to the detection of a physiological parameter, and is the medical handheld device (102, 200, 300, 400) according to claim 7.

9. The tactile source (120a, 120b, 120c, 220, 320, 420) is included in an electric drive device (111), and is the medical handheld device (102, 200, 300, 400) according to any one of claims 1 to 8.

10. At least a part of the electric drive device (111) is attached to a plunger rod (108a) configured to be moved to discharge a drug, and is the medical handheld device (102, 200, 300, 400) according to claim 9.

11. The tactile source (120a, 120b, 120c, 220, 320, 420) is an injection button ( The medical hand-held device (102, 200, 300, 400) according to claim 10, integrated with at least one of (110), an input button (406), a dosage knob (112), and a dial grip (371).

12. A medical system (201) comprising: a medical hand-held device (200) according to any one of claims 1 to 11; an external device (202) including components (209, 212) monitored by the medical hand-held device (200) The medical system as described above.

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