Smart wearable injection and / or infusion device

Abstract

A delivery device for delivering a medical fluid to a patient has a housing configured to house a container at least partially filled with the medical fluid. The delivery device also has a drive mechanism associated with the housing configured to deliver the medical fluid from the container to the patient during an administration procedure. The delivery device also has a module configured to detect at least one of a property of the administration procedure and a property of the medical fluid. The module has at least one dose detection sensor configured to detect a start, progress, and completion of the administration procedure based on a position of an obstruction within the container. The module also has at least one temperature sensor configured to measure a temperature of the medical fluid within the container based on a temperature of the container.

Description

[0001] This application is a divisional application of Chinese patent application No. PCT / US2018 / 025657, Chinese application No. 201880031847.2, filed on April 2, 2018, entitled "Intelligent Wearable Injection and / or Infusion Device".

[0002] Cross-reference to related applications

[0003] This application claims priority to U.S. Provisional Application No. 62 / 479,742, filed March 31, 2017, entitled “Smart Wearable Injection and / or Infusion Device,” the entire disclosure of which is incorporated herein by reference. Technical Field

[0004] The present invention generally relates to wearable injection and / or infusion devices, and more particularly to wearable injection and / or infusion devices for administering therapeutic agents to patients. Background Technology

[0005] Various types of automated injection devices have been developed to allow drug solutions and other liquid therapeutic preparations to be administered or self-injected by untrained personnel. Typically, these devices include a reservoir pre-filled with the liquid therapeutic preparation and some types of automated needle injection mechanisms that can be triggered by the user. When the amount of fluid or drug to be administered is generally less than a certain amount (e.g., 1 mL), an automated injector is generally used, which typically has an injection time of about 10 to 15 seconds. When the amount of fluid or drug to be administered is greater than 1 mL, the injection time usually becomes longer, making it difficult for the patient to maintain contact between the device and the target area of ​​the patient's skin. Furthermore, when the amount of drug to be administered is larger, it is desirable to increase the time period used for injection. The traditional method of slowly injecting drugs into a patient is to initiate an intravenous infusion and slowly inject the drug into the patient. This procedure is typically performed in hospitals or outpatient clinics.

[0006] Some devices allow for self-injection or self-infusion in a home setting and are capable of gradually injecting liquid therapeutic preparations into a patient's skin. In some cases, these devices are small enough (both in height and overall size) to be "worn" by the patient while the liquid therapeutic preparation is being injected. These wearable injection and / or infusion devices typically include a pump or other type of discharge mechanism to force the liquid therapeutic preparation out of the reservoir and into the injection needle. Such devices often also include: a valve or flow control mechanism to initiate the flow of the liquid therapeutic preparation at the appropriate time; and a triggering mechanism to initiate the injection.

[0007] Although various wearable injection and / or infusion devices exist in the art, there is a need in the art for improved wearable injection and / or infusion devices. Summary of the Invention

[0008] In general, an improved wearable injection and / or infusion device is provided, configured for administering a therapeutic agent to a patient. In some examples, the wearable injection and / or infusion device may be configured for continuously monitoring the dosing process. In other examples, the wearable injection and / or infusion device may be configured to detect pauses in the dosing process based on a detected delivery rate. In other examples, the wearable injection and / or infusion device may be configured to detect the temperature of the therapeutic agent and adjust at least one dosing process protocol based on the detected temperature. In other examples, the wearable injection and / or infusion device may be configured to enable external data communication to a remote device. In other examples, the wearable injection and / or infusion device may include an enhanced visual indicator regarding the device status.

[0009] In some examples of this disclosure, a delivery device for delivering medical fluid to a patient may have a housing configured to receive a container at least partially filled with medical fluid. The delivery device may also have a drive mechanism associated with the housing configured to deliver the medical fluid from the container to the patient during a drug administration procedure. The delivery device may also have a module configured to detect at least one of the nature of the drug administration procedure and the nature of the medical fluid. The module may have at least one dose detection sensor configured to detect the start, progress, and completion of the drug administration procedure based on the location of an obstruction within the container. The module may also have at least one temperature sensor configured to measure the temperature of the medical fluid within the container based on the temperature of the container.

[0010] In other examples of this disclosure, the at least one dose detection sensor may be configured to measure the delivery rate of medical fluid to a patient based on a change in the detected location of an obstruction over time. The module may be configured to stop the drive mechanism if the delivery rate of the medical fluid measured by the at least one dose detection sensor is below a minimum threshold or above a maximum threshold. The output of the at least one dose detection sensor may be a function of the output of the at least one temperature sensor. The at least one dose detection sensor may be an optical sensor array configured to detect the actual amount of medical fluid in the container or to estimate the amount of medical fluid in the container based on the location of an obstruction within the container. The optical sensor array may have one or more infrared emitters configured to emit electromagnetic energy in the infrared spectrum and one or more infrared detectors configured to detect electromagnetic energy in the infrared spectrum.

[0011] In other examples of this disclosure, the temperature of the medical fluid can be a function of the ambient temperature outside the housing of the delivery device and the local temperature inside the housing of the delivery device. The module can be configured to prevent activation of the drive mechanism if the temperature of the medical fluid within the container is below a minimum threshold or above a maximum threshold.

[0012] In other examples of this disclosure, the module may further include: at least one start detection switch configured to detect the start of a drug administration procedure; and at least one completion detection switch configured to detect the completion of the drug administration procedure. The at least one start detection switch may be configured to detect at least one of the position and velocity of at least one component of the drive mechanism, and the at least one completion detection switch may be configured to detect at least one of the position and velocity of at least one component of the drive mechanism. The at least one start detection switch may be a mechanical sensor in direct physical contact with at least one component of the drive mechanism or an optical sensor not in direct physical contact with at least one component of the drive mechanism. The at least one completion detection switch may be a mechanical sensor in direct physical contact with at least one component of the drive mechanism or an optical sensor not in direct physical contact with at least one component of the drive mechanism.

[0013] In other examples of this disclosure, the module may also have a communication element configured to externally communicate with a remote device via a wired connection, a wireless connection, or a combination of wired and wireless connections. The communication element may be a unidirectional communication element configured to send or receive information from a remote device, or a bidirectional communication element configured to send and receive information from a remote device. The remote device may be configured to provide at least one of the following: contextual instructions for using the delivery device, safety protocol information regarding the drug delivery procedure, and status indications for at least one stage of the drug delivery procedure.

[0014] In other examples of this disclosure, the module may also have one or more indicators configured to provide the user with at least one of operating instructions and information regarding the status of the drug delivery procedure. The one or more indicators may have at least one visual indicator with at least one light. The at least one light is a monochromatic or multicolor light-emitting diode configured for at least one of steady-state operation and flashing operation. The one or more indicators may have at least one audible indicator configured to deliver an audible message to the user. The delivery device may have a cover removably attachable to a housing, with the module attached to the cover.

[0015] Other examples or aspects of this disclosure are characterized in the following numbered clauses.

[0016] Clause 1. A delivery device for delivering a medical fluid to a patient, the delivery device comprising: a housing configured to receive a container at least partially filled with the medical fluid; a drive mechanism associated with the housing, the drive mechanism configured to deliver the medical fluid from the container to the patient in a drug administration procedure; and a module configured to detect at least one of the nature of the drug administration procedure and the nature of the medical fluid, the module comprising: at least one dose detection sensor configured to detect the start, progress, and completion of the drug administration procedure based on the location of an obstruction within the container; and at least one temperature sensor configured to measure the temperature of the medical fluid within the container based on the temperature of the container.

[0017] Clause 2. The delivery device according to Clause 1, wherein the at least one dose detection sensor is configured to measure the delivery rate of the medical fluid to the patient based on the detection of a change in the position of the obstruction over time.

[0018] Clause 3. The delivery device according to Clause 1 or Clause 2, wherein the module is configured to stop the drive mechanism when the delivery rate of the medical fluid, as measured by the at least one dose detection sensor, is below a minimum threshold or above a maximum threshold.

[0019] Clause 4. A delivery device according to any one of Clauses 1-3, wherein the output of the at least one dose detection sensor is a function of the output of at least one temperature sensor.

[0020] Clause 5. The delivery device according to any one of Clauses 1-4, wherein the at least one dose detection sensor is an optical sensor array configured to detect the actual amount of medical fluid in the container or to estimate the amount of medical fluid in the container based on the location of an obstruction within the container.

[0021] Clause 6. The delivery device according to any one of Clauses 1-5, wherein the optical sensor array comprises: one or more infrared emitters configured to emit electromagnetic energy in the infrared spectrum; and one or more infrared detectors configured to detect electromagnetic energy in the infrared spectrum.

[0022] Clause 7. The delivery device according to any one of Clauses 1-6, wherein the temperature of the medical fluid is a function of the ambient temperature outside the housing of the delivery device and the local temperature inside the housing of the delivery device.

[0023] Clause 8. The delivery device according to any one of Clauses 1-7, wherein the module is configured to prevent activation of the drive mechanism if the temperature of the medical fluid within the container is below a minimum threshold or above a maximum threshold.

[0024] Clause 9. The delivery device according to any one of Clauses 1-8, wherein the module further comprises: at least one start detection switch configured to detect the start of the drug administration procedure; and at least one completion detection switch configured to detect the completion of the drug administration procedure.

[0025] Clause 10. The conveying device according to any one of Clauses 1-9, wherein the at least one start detection switch is configured to detect at least one of the position and speed of at least one component of the drive mechanism, and wherein the at least one finish detection switch is configured to detect at least one of the position and speed of at least one component of the drive mechanism.

[0026] Clause 11. The conveying device according to any one of Clauses 1-10, wherein the at least one start detection switch is a mechanical sensor in direct physical contact with at least one component of the drive mechanism or an optical sensor not in direct physical contact with at least one component of the drive mechanism.

[0027] Clause 12. The conveying device according to any one of Clauses 1-11, wherein the at least one completion detection switch is a mechanical sensor in direct physical contact with at least one component of the drive mechanism or an optical sensor not in direct physical contact with at least one component of the drive mechanism.

[0028] Clause 13. The conveying device according to any one of Clauses 1-12, wherein the module further includes a communication element configured to communicate externally with a remote device via a wired connection, a wireless connection, or a combination of the wired connection and the wireless connection.

[0029] Clause 14. A conveying device according to any one of Clauses 1-13, wherein the communication element is a unidirectional communication element configured to send information to or receive information from the remote device, or the communication element is a bidirectional communication element configured to send information to or receive information from the remote device.

[0030] Clause 15. The delivery device according to any one of Clauses 1-14, wherein the remote device is configured to provide at least one of situational instructions for using the delivery device, safety protocol information regarding the drug administration procedure, and status indications regarding at least one stage of the drug administration procedure.

[0031] Clause 16. The delivery device according to any one of Clauses 1-15, wherein the module further includes one or more indicators configured to provide the user with at least one of operating instructions and information about the status of the drug delivery procedure.

[0032] Clause 17. The conveying device according to any one of Clauses 1-16, wherein the one or more indicators include at least one visual indicator having at least one light.

[0033] Clause 18. The conveying device according to any one of Clauses 1-17, wherein the at least one lamp is a monochromatic or multicolor light-emitting diode configured for at least one of steady-state operation and flashing operation.

[0034] Clause 19. The delivery device according to any one of Clauses 1-18, wherein the one or more indicators include at least one audible indicator configured to deliver an audible message to a user.

[0035] Clause 20. The conveying device according to any one of Clauses 1-19 further includes a cover removably connected to the housing, wherein the module is connected to the cover.

[0036] These and other features and characteristics of this disclosure, as well as the methods of operation and function of related elements or structures, and the economics of parts and manufacture, will become more apparent after considering the following description with reference to the accompanying drawings, which form a part of this specification. However, it should be clearly understood that the drawings are for illustrative and descriptive purposes only and are not intended to be construed as limiting the invention. Attached Figure Description

[0037] Figure 1 This is a front perspective view based on an example of a smart wearable injection and / or infusion device;

[0038] Figure 2 yes Figure 1 A schematic top view of a smart wearable injection and / or infusion device, showing the various components of the device;

[0039] Figure 3 yes Figure 1 Side perspective view of the intelligent wearable injection and / or infusion device shown;

[0040] Figure 4 yes Figure 3 An exploded view of the smart wearable injection and / or infusion device shown, which illustrates a cap separate from the smart wearable injection and / or infusion device;

[0041] Figure 5 It is a detailed perspective view of the control element for use with smart wearable injection and / or infusion devices;

[0042] Figure 6 This is a front perspective view based on another example of a smart wearable injection and / or infusion device;

[0043] Figure 7 yes Figure 6 An exploded perspective view of the intelligent wearable injection and / or infusion device shown.

[0044] Figure 8 yes Figure 6 Rear perspective view of the smart wearable injection and / or infusion device shown;

[0045] Figure 9 yes Figure 8 An exploded perspective view of the intelligent wearable injection and / or infusion device shown.

[0046] Figure 10 yes Figure 6 A perspective view of the inner surface of the cap of the smart wearable injection and / or infusion device shown.

[0047] Figure 11 This is a front perspective view of a smart wearable injection and / or infusion device, showing various states of the indicators;

[0048] Figure 12 Cross-sectional views of various cap designs for use with smart wearable injection and / or infusion devices are shown;

[0049] Figure 13 -14 illustrates a smart wearable injection and / or infusion device configured to communicate wirelessly with a remote device;

[0050] Figure 15 It is a screenshot of the graphical user interface of a mobile device application configured for use with smart wearable injection and / or infusion devices.

[0051] Figure 16 This is a detailed view of an optical sensing array used with smart wearable injection and / or infusion devices;

[0052] Figure 17-20 shows the variation of various performance parameters of the smart wearable injection and / or infusion device over time;

[0053] Figure 21 -22 shows the spectral distribution as a function of wavelength for various types of lighting devices;

[0054] Figure 23 This is a schematic diagram of the various components of a smart wearable injection and / or infusion device; and

[0055] Figure 24 This is a schematic diagram of temperature detection and estimation for a smart wearable injection and / or infusion device.

[0056] exist Figure 1 In -24, unless otherwise stated, the same character refers to the same part and element as appropriate. Detailed Implementation

[0057] As used herein, unless the context clearly indicates otherwise, the singular forms of “a,” “one,” and “the” include plural indicators.

[0058] Spatial or directional terms, such as “left,” “right,” “inner,” “outer,” “above,” “below,” etc., are relevant to the invention shown in the accompanying drawings and should not be considered limiting, as the invention can take various alternative orientations.

[0059] In all cases, all figures and ranges used in the specification and claims should be understood to be modified by the term "about". "About" means plus or minus twenty-five percent of the value, for example, plus or minus ten percent of the value. However, this should not be regarded as a limitation on any analysis of the values ​​under the equivalence principle.

[0060] Unless otherwise stated, all ranges or ratios disclosed herein should be understood to encompass start and end values, as well as any and all subranges or subratios contained therein. For example, the specified range or ratio “1 to 10” should be considered to include any and all subranges or subratios between the minimum value of 1 and the maximum value of 10 (inclusive); that is, all subranges or subratios begin with a minimum value of 1 or greater and end with a maximum value of 10 or less. The ranges and / or ratios disclosed herein represent the average of the specified ranges and / or ratios.

[0061] The terms “first,” “second,” etc., are not intended to refer to any particular order or chronology, but rather to different conditions, characteristics, or elements.

[0062] The term "at least" is synonymous with "greater than or equal to".

[0063] The term "not greater than" is synonymous with "less than or equal to".

[0064] As used herein, “at least one” is synonymous with “one or more”. For example, the phrase “at least one of A, B, and C” means any one of A, B, or C, or any two or more of A, B, or C. For example, “at least one of A, B, and C” includes: only A; or only B; or only C; or A and B; or A and C; or B and C; or all of A, B, and C.

[0065] The terms "include" and "contain" are synonymous.

[0066] The discussion of this invention may describe certain features as “particularly” or “preferred” within certain limitations (e.g., “preferred,” “more preferred,” or “even more preferred” within certain limitations). It should be understood that the invention is not limited to these particular or preferred limitations, but covers the entire scope of this disclosure.

[0067] In various non-limiting examples or aspects and referring to Figure 1 This disclosure relates to a wearable injection and / or infusion device configured for continuous monitoring of dosing progression. In other examples, the wearable injection and / or infusion device may be configured to detect pauses in the dosing progression based on a detected delivery rate. In other examples, the wearable injection and / or infusion device may be configured to detect the temperature of a therapeutic agent and adjust at least one dosing progression scheme based on the detected temperature. In other examples, the wearable injection and / or infusion device may be configured to enable external data communication to a remote device. In other examples, the wearable injection and / or infusion device may include enhanced visual indicators regarding the device status.

[0068] Wearable injection and / or infusion devices

[0069] Reference Figure 1 -2. A wearable injection and / or infusion device 100 is illustrated according to one example. The wearable injection and / or infusion device 100 is configured to connect to a patient's skin to deliver a therapeutically effective amount of a therapeutic agent at a predetermined delivery rate. For example, the therapeutic agent can be any type of drug, chemical substance, biological substance, or biochemical substance that, when delivered in a therapeutically effective amount, can achieve the desired therapeutic effect. The wearable injection and / or infusion device 100 has a housing 102 for encapsulating a syringe assembly 103. Figure 7 As shown), the syringe assembly is connected to a container 104 filled with a therapeutic agent. Figure 7 (As shown) fluid communication. The wearable injection and / or infusion device 100 is operable to deliver a therapeutic agent from a container 104 to a patient using a syringe assembly 103.

[0070] Reference Figure 6 -7. The housing 102 of the wearable injection and / or infusion device 100 has a cover 106 that can be removably attached to the housing. The cover 106 may have a module 150 ( Figure 10 As shown, the module includes multiple components configured for dosing progression, pause detection, temperature measurement, and external communication. As discussed herein, module 150 may include one or more sensors, such as environmental sensors (e.g., temperature), to improve the dosing detection algorithm (e.g., fluid viscosity-temperature effect) and provide feedback to the user (e.g., the drug for injection is too cold). Module 150 may additionally include one or more indicators (e.g., auditory, visual, tactile) to provide feedback or instructions to the user. Module 150 may also include the ability to transmit device data to external devices (e.g., smartphones). Module 150 is integrated with cap 106 such that when cap 106 is attached to housing 102, module 150 does not interfere with the basic functionality of the wearable injection and / or infusion device 100. Module 150 may include additional sensors to detect mechanical movements associated with syringe operation (e.g., switches for detecting actuation, completion, needle insertion / withdrawal, or other device events and states). Module 150 may have one or more additional sensors to continuously monitor dose delivery, such as an optical sensor array, a capacitive sensor array, an inductive sensor array, etc.

[0071] In some examples, a cap 106 including module 150 may be provided as an alternative to the cap of an existing wearable injection and / or infusion device (not shown). In such examples, cap 106 and module 150 may be integrated with the wearable injection and / or infusion device to provide the additional functionality given to the wearable injection and / or infusion device by module 150. For example, cap 106 may be a device used with a wearable injection and / or infusion device disclosed in International Patent Application No. PCT / US2016 / 013444 (published as WO / 2016 / 115372), the disclosure of which is incorporated herein by reference in its entirety.

[0072] The cap 106 has an observation window 108 for observing the contents of the container 104, such as the filling level of the container 104. A filter (not shown) may be provided on the observation window 108 to filter ambient light passing through the observation window 108. The housing 102 also has an indicator 110 for indicating the status of the wearable injection and / or infusion device 100.

[0073] Reference Figure 2The wearable injection and / or infusion device 100 also has a start detection switch 112 and a completion detection switch 114 for detecting the start / completion of the drug administration procedure. The wearable injection and / or infusion device 100 also has a start detection button switch 117 to detect the start button 115 of the syringe. Figure 1 (As shown in the diagram). The wearable injection and / or infusion device 100 also includes: a wireless communication element 116 for communicating with a remote device, an on / off switch 118 for powering the device 100 on / off, and a charging port 120 for charging the battery 122. The wearable injection and / or infusion device 100 also includes an auditory indicator 124, one or more temperature sensors 126, and a dose detection array 128.

[0074] Reference Figure 23 A controller 140 may be provided for controlling one or more components of the wearable injection and / or infusion device 100. In some examples, the controller 140 includes a processor 142, a memory 144, a storage component 146, and a bus 148 for communicating with the various components of the wearable injection and / or infusion device 100. The bus 148 includes components that allow communication between the components of the wearable injection and / or infusion device 100. In some non-limiting embodiments, the processor 142 is implemented in hardware, firmware, or a combination of hardware and software. For example, the processor 142 includes a processor (e.g., a central processing unit (CPU), a graphics processing unit (GPU), an accelerated processing unit (APU), etc.), a microprocessor, a digital signal processor (DSP), and / or any processing component that can be programmed to perform functions (e.g., a field-programmable gate array (FPGA), an application-specific integrated circuit (ASIC), etc.). The memory 144 includes random access memory (RAM), read-only memory (ROM), and / or other types of dynamic or static storage devices (e.g., flash memory, magnetic memory, optical memory, etc.) for storing information and / or instructions for use by the processor 142.

[0075] Storage component 146 stores information and / or software related to the operation and use of the wearable injection and / or infusion device 100. For example, storage component 146 includes hard disks (e.g., magnetic disks, optical disks, magneto-optical disks, solid-state disks, etc.), cassettes, magnetic tapes, and / or other types of computer-readable media and corresponding drives. Computer-readable media (e.g., non-transitory computer-readable media) are defined herein as non-transitory storage devices. Storage devices include storage space located within a single physical storage device or storage space distributed across multiple physical storage devices.

[0076] Wearable injection and / or infusion device 100 can perform one or more of the processes described herein. These processes can be performed by processor 142 executing software instructions stored in a computer-readable medium (e.g., memory 144 and / or storage unit 146). The software instructions can be read into memory 144 and / or storage unit 146 via bus 148 from another computer-readable medium or another device. When executed, the software instructions stored in memory 144 and / or storage unit 146 cause processor 142 to perform one or more of the described processes. Alternatively or additionally, hardwired circuitry may be used in place of or in combination with the software instructions to perform one or more of the processes described herein. Therefore, the examples described herein are not limited to any particular combination of hardware circuitry and software.

[0077] supply Figure 23 The number and arrangement of the components shown are for illustrative purposes. In some non-limiting examples, with... Figure 23 Compared to those shown, controller 140 includes additional components, fewer components, different components, or components arranged differently. Additionally or alternatively, a set of components (e.g., one or more components) of controller 140 may perform one or more functions described as being performed by another set of components of wearable injection and / or infusion device 100.

[0078] Device status monitoring

[0079] In some examples, cap 106 and module 150 may be configured to track the mechanical state of an underlying component of the wearable injection and / or infusion device 100. For example, detection switches 112, 114 within module 150 may be configured to detect at least one characteristic of at least one component of the wearable injection and / or infusion device 100, such as position, velocity, and / or a change in the state of the component from a first state to a second state. For example, detection switches 112, 114 within module 150 may be configured to detect mechanical movements associated with changes in syringe state, such as needle sheath removal, syringe unlocking, start button pressing, injection initiation, and injection completion. In some examples, detection switches 112, 114 may be mechanical components that directly mechanically interact with the underlying component. In other examples, detection switches 112, 114 may be infrared-based optical sensors (e.g., reflectivity or light interruptor sensors) to allow for non-contact detection. The transition of device state can be used as a trigger to start or stop other system measurements, such as temperature or dosage processes.

[0080] Dosing progression and pause detection

[0081] In some examples, the wearable injection and / or infusion device 100 may be configured to use module 150 to detect the dosing progress and detect pauses in the dosing progress. For example, the dose detection array 128 of module 150 may be an array of optical sensors for tracking the dispensing chain. The dose detection array 128 may be configured to use algorithms to detect or estimate the amount of therapeutic agent delivered to the patient. The dose detection array 128 may be configured not to contact any parts of the wearable injection and / or infusion device and therefore not to affect the delivery of the therapeutic agent. For example, the dose detection array 128 may be positioned on the side of container 104. The dose detection array 128 may be configured to detect the movement of an obstruction along the longitudinal direction of container 104 and to correlate the position of the obstruction with the amount of therapeutic agent already delivered and / or the amount of therapeutic dose still retained in container 104. In some examples, the dose detection array 128 may be an optical system with one or more emitters that emit electromagnetic energy (e.g., visible or infrared light) reflected by the obstruction and container 104 and received by one or more detectors. The reflective properties of the dose detection array 128 allow the components to be placed on one side of the container 104. This makes the system more compact and easier to manufacture compared to an arrangement in which the transmitter and detector are positioned relative to each other.

[0082] In some examples, such as in Figure 10 In this configuration, the dose detection array 128 may be an infrared-based optical sensor array comprising one or more infrared emitters 130 (e.g., IR LEDs, phototransistors, or photodiodes) configured to emit electromagnetic energy in the infrared spectrum and one or more infrared detectors 132 configured to detect electromagnetic energy in the infrared spectrum. The dose detection array 128 may be integrated with the cover 106 such that removing the cover 106 from the housing 102 also removes the dose detection array 128 from the housing 102.

[0083] Continue to refer to Figure 10 The transmitter 130 and detector 132 can be interleaved on a shared circuit board. The number of transmitters 130 can be the same as or different from the number of detectors 132. In some examples, the transmitters 130 and detectors 132 can be arranged in an alternating pattern, with each transmitter / detector located between a pair of detectors / transmitters. The dose detection array 128 can communicate electronically with a controller for controlling the optics and processing the detector output to establish the location of the obstruction. The wearable injection and / or infusion device 100 may also have other electronics to connect the controller to the dose detection array 128 (e.g., multiplexer, amplifier, A / D converter, etc.). Infrared spectroscopy provides improved immunity to external noise sources, such as visible light sources. The infrared light emitted from the transmitter is also invisible to the user.

[0084] In use, a single transmitter 130 can be activated to emit infrared light, while one or more detectors 132 detect the infrared light reflected from the container 104. This sequence can be repeated iteratively between different transmitter / detector combinations. Sampling of all detectors 132 can be performed simultaneously or sequentially. In some examples, the transmitter 130 may remain active for less than 200 microseconds (0.02% duty cycle) per measurement. Detector measurements are compared to a pre-existing set of reference measurements and matched against the most probable reference point associated with the obstruction / plunger location. The number of reference measurement points can be greater than the number of detectors 132 to improve positional resolution (e.g., 200 reference points using 6 detectors). In this way, the dose detection array 128 functions similarly to a multistep encoder (e.g., a 200-step absolute position encoder). The method of matching the acquired values ​​with reference values ​​minimizes the error between the collected data and the reference values. Weighting methods can be used to selectively favor certain transmitter / detector combinations at different times or locations during injection. Additional filtering can be employed to preprocess the data, such as minimizing the influence of ambient light. In some examples, the dose detection array 128 can have a step resolution of approximately 160 μm. To minimize the influence of ambient infrared energy, numerous background measurements can be performed when the transmitter is not powered on to establish a detector baseline. This baseline value can then be subtracted from the detector measurements when the transmitter is powered on. Synchronous modulation techniques can also be used to isolate the target measurements from the background energy level.

[0085] In some examples, feature recognition methods can be used to process signal measurements to identify known signal features (e.g., local maxima or minima) corresponding to a specific obstruction / plunger location, thereby mitigating or minimizing reliance on a pre-existing set of reference measurements. Feature recognition methods can include fuzzy logic and machine learning-based techniques.

[0086] The determination of the dosing process can rely on a position-based algorithm from which the amount of dose delivered can be calculated. The change in the position of the obstruction over time can be used to calculate the obstruction velocity, and thus the delivery rate of the therapeutic agent. This algorithm can compensate for known variations in the fluid delivery components, such as variations in the diameter and length of container 104. Obstruction / pump velocity data can be used to determine if the dosing procedure has been interrupted. For example, a minimum threshold (interruption condition) can correspond to a minimum obstruction / pump velocity and any error sources (noise, ambient IR, etc.). For example, the interruption detection time can be indicated by the slowest acceptable delivery rate (e.g., 4 μl / s). Figure 17 -20 shows how various performance parameters change over time.

[0087] Since the optical components are known to be temperature-sensitive, temperature compensation can be applied using measurements from a temperature sensor to continuously correct temperature-related measurement errors. (Reference) Figure 24 Inputs from one or more temperature sensors can be filtered through one or more filters to compensate for any temperature-related measurement errors.

[0088] In an injection system where the container 104 must first be translated a fixed distance to puncture the diaphragm, a dose detection array can also be used to detect the position of the entire container 104 (including the plunger). The position of the entire container 104 can be determined using a separate set of reference measurements. Once the container is detected to be punctured, the algorithm can switch to the set of reference measurements used to detect the plunger position.

[0089] Premature removal of detection

[0090] In some examples, the calculated position and velocity data can be used to determine whether the device has been prematurely removed from the injection site. For instance, a maximum velocity threshold could correspond to the maximum expected obstruction / pump velocity when injected into the body (i.e., a high-pressure site). Velocities above this threshold could correspond to the injection of air (i.e., a low-pressure site). Therefore, a sudden, large, unexpected change in position or velocity can be used to indicate an undesirable change at the injection site (e.g., premature needle removal or withdrawal).

[0091] Temperature measurement

[0092] In some examples, the wearable injection and / or infusion device 100 may be configured to measure temperatures, such as the temperature of a therapeutic agent inside container 104. For example, one or more temperature sensors 126 may be used to detect the temperature of container 104. Using this temperature data, the temperature of the therapeutic agent inside container 104 can be predicted based on at least one of several factors, such as: the temperature at one or more locations within the syringe relative to the container temperature, the spatial temperature gradient within the syringe, and the rate of temperature change (i.e., the time gradient) at the measurement location within the container. The temperature sensor data can be used to predict or estimate the ambient temperature under transient temperature conditions. By estimating the ambient temperature and comparing it with the local temperature within the device, the temperature of the therapeutic agent inside the container can be better predicted over time. The temperature data can be used to indicate whether the wearable injection and / or infusion device 100 is ready to perform a drug delivery procedure. For example, some therapeutic agents can only be delivered when they are at a predetermined temperature (or temperature range). If the therapeutic agent is above / below the predetermined temperature (or temperature range), the wearable injection and / or infusion device 100 may prevent the delivery of the therapeutic agent. In some examples, the wearable injection and / or infusion device 100 may allow the use of an increased drug delivery procedure (e.g., increased or decreased delivery rate) to deliver therapeutic agents outside a predetermined temperature (or temperature range).

[0093] Temperature data can also be combined with dosing progression data to detect or estimate whether an abnormal delivery rate (or dosing progression pause) is caused by a temperature-related change in the viscosity of the therapeutic agent (e.g., a pause due to increased viscosity at low temperatures). In these cases, changes in temperature data can be used to indicate whether the abnormal delivery condition can be resolved (e.g., the injection has currently paused but may resume due to a rise in temperature) to prevent premature removal due to temporary delivery interruptions.

[0094] external communication

[0095] In some examples, the wearable injection and / or infusion device 100 can be configured for external communication with a remote device 119 via a network, such as Figure 13 As shown in –14. This communication can be unidirectional, where the wearable injection and / or infusion device 100 is configured to send information to or receive information from the remote device 119 only. In other examples, the wearable injection and / or infusion device 100 can be configured to communicate bidirectionally with the remote device 119, where the wearable injection and / or infusion device 100 is configured to both send and receive information from the remote device 119. In some examples, the wearable injection and / or infusion device 100 may have transceiver-like components (e.g., transceiver, separate receiver and transmitter, etc.) that enable the wearable injection and / or infusion device 100 to communicate with the remote device 119, for example, via a wired connection, a wireless connection, or a combination of wired and wireless connections. The transceiver-like components can allow the wearable injection and / or infusion device 100 to receive information from and / or provide information to the remote device 119.

[0096] In some examples, a network may include one or more wired and / or wireless networks. For example, a network may include cellular networks (e.g., Long Term Evolution (LTE) networks, third-generation (3G) networks, fourth-generation (4G) networks, Code Division Multiple Access (CDMA) networks, etc.), Public Land Mobile Networks (PLMNs), Local Area Networks (LANs), Wide Area Networks (WANs), Metropolitan Area Networks (MANs), Telephone Networks (e.g., Public Switched Telephone Networks (PSTN)), Private Networks, Ad Hoc Networks, Intranets, the Internet, Fiber-based Networks, Cloud Computing Networks, and / or similar entities, and / or combinations of these or other types of networks.

[0097] In some examples, the wearable injection and / or infusion device 100 may be configured to wirelessly communicate with an application 121 (e.g., a tablet or mobile phone or a server-based application) on a remote device 119 using Bluetooth, Wi-Fi, or cellular communication protocols. The application 121 on the remote device 119 may be configured to display real-time data regarding the performance of the wearable injection and / or infusion device 100. In some examples, the application 121 on the remote device 119 may be configured to display any data related to the wearable injection and / or infusion device 100. Figure 15 In some examples, the wearable injection and / or infusion device 100 may have a BLE / MCU radio for wireless external communication with remote devices.

[0098] The remote device can be configured to provide contextual instructions to the patient during use of the wearable injection and / or infusion device 100. For example, the remote device can provide instructions to the patient on how to establish and initiate a drug administration procedure using the wearable injection and / or infusion device 100. In some examples, the remote device can indicate to the patient that the drug administration procedure is in progress and provide status indications for each stage of the procedure. In other examples, the remote device can provide instructions to the patient on the procedure to follow in case of an abnormal event (e.g., in the event that the drug administration procedure may be interrupted). The wearable injection and / or infusion device 100 can be configured to use the remote device to send information about the time, date, and amount of the therapeutic agent delivered to the patient to a third party (such as the patient's healthcare provider or health insurance company). In the event of an exceptional event, the wearable injection and / or infusion device 100 can contact the third party, for example, by sending a text alert or dialing the third party's telephone number.

[0099] Data from the wearable injection and / or infusion device 100 can be transmitted in real time to a remote device and / or stored in a remote database for post-delivery use. In some examples, a safety protocol can be run using a remote device before the wearable injection and / or infusion device 100 initiates a drug delivery procedure. For example, the remote device can check for drug recalls, verify that the correct therapeutic agent was used, and / or verify the time and amount of the last drug delivery procedure. Depending on whether the safety protocol running on the remote device detects any anomalies, the wearable injection and / or infusion device 100 can be prevented from initiating a new drug delivery procedure.

[0100] Enhanced visual indicators

[0101] In some examples, the wearable injection and / or infusion device 100 may have one or more enhanced electronic indicators. For example, the wearable injection and / or infusion device 100 may have one or more visual indicators, such as LED-based indicators with three colors (blue, red, and white). Alternatively or additionally, the wearable injection and / or infusion device 100 may have one or more audible indicators, such as piezoelectric-based buzzers with chiming / beep sounds.

[0102] A visual indicator can be used to convey a range of visual messages to the user regarding the status and performance of the wearable injection and / or infusion device. For example, the color of the visual indicator can be used to indicate the status of the wearable injection and / or infusion device 100, such as whether the device is powered on or whether a drug delivery procedure is in progress. Alternatively or additionally, the visual indicator can operate between steady-state and flashing modes to indicate the status of the wearable injection and / or infusion device 100. A speaker port can be located within the housing of the wearable injection and / or infusion device 100 for conveying audio messages to the user.

[0103] Although the invention has been described in detail for illustrative purposes based on examples currently considered to be the most practical and preferred, it should be understood that such detail is for that purpose only, and the invention is not limited to the disclosed examples, but rather intended to cover modifications and equivalent arrangements within the spirit and scope of this disclosure. For example, it should be understood that the invention contemplates that, to the extent possible, one or more features of any example may be combined with one or more features of any other example.

Claims

1. A delivery device for delivering medical fluid to a patient, the delivery device comprising: A housing configured to receive a container at least partially filled with the medical fluid; A cover that can be removably attached to the housing; A drive mechanism associated with the housing, the drive mechanism being configured to deliver the medical fluid from the container to the patient during a drug administration procedure; and A module configured to detect at least one of the properties of the drug delivery procedure and the properties of the medical fluid, the module including a dose detection array configured to detect the start, progress, and completion of the drug delivery procedure based on the location of an obstruction within the container; The dose detection array includes an optical sensor array integrated with the cover, such that removing the cover from the housing causes the optical sensor array to be removed from the housing. The optical sensor array includes: a plurality of infrared emitters configured to emit electromagnetic energy in the infrared spectrum; and a plurality of infrared detectors configured to detect electromagnetic energy in the infrared spectrum, wherein the plurality of infrared emitters and the plurality of infrared detectors are arranged on a circuit board such that the plurality of infrared emitters and the plurality of infrared detectors are all located on one side of the container; The detector measurements of the plurality of infrared detectors are compared with reference measurements of a pre-existing set of reference measurement points and matched with the most probable reference point associated with the location of the obstruction, wherein the number of reference measurement points is greater than the number of infrared detectors, and wherein, when comparing the detector measurements with reference measurements of a pre-existing set of reference measurement points and matching the detector measurements with the most probable reference point associated with the location of the obstruction, one or more transmitter / detector combinations at different times or locations during injection are selectively weighted; The module further includes at least one temperature sensor configured to measure the temperature of the medical fluid within the container based on the temperature of the container, and wherein the output of the dose detection array is a function of the output of the at least one temperature sensor.

2. The conveying device according to claim 1, wherein, Based on the detected change in the location of the obstruction over time, the dose detection array is configured to measure the delivery rate of the medical fluid to the patient.

3. The conveying device according to claim 1, wherein, The module is configured to stop the drive mechanism if the delivery rate of the medical fluid, as measured by the dose detection array, is below a minimum threshold or above a maximum threshold.

4. The conveying device according to claim 1, wherein, The optical sensor array is configured to detect the actual amount of medical fluid in the container, or to estimate the amount of medical fluid in the container based on the location of any obstructions within the container.

5. The conveying device according to claim 1, wherein, The temperature of the medical fluid is a function of the ambient temperature outside the housing of the delivery device and the local temperature inside the housing of the delivery device.

6. The conveying device according to claim 1, wherein, The module is configured to prevent the actuation of the drive mechanism if the temperature of the medical fluid within the container is below a minimum threshold or above a maximum threshold.

7. The conveying device according to claim 1, wherein, The module further includes: at least one start detection switch configured to detect the start of the dosing procedure; and at least one completion detection switch configured to detect the completion of the dosing procedure.

8. The conveying device according to claim 7, wherein, The at least one start detection switch is configured to detect at least one of the position and speed of at least one component of the drive mechanism, and wherein the at least one finish detection switch is configured to detect at least one of the position and speed of at least one component of the drive mechanism.

9. The conveying device according to claim 7, wherein, The at least one start detection switch is a mechanical sensor that is in direct physical contact with at least one component of the drive mechanism or an optical sensor that is not in direct physical contact with at least one component of the drive mechanism.

10. The conveying device according to claim 7, wherein, The at least one completion detection switch is a mechanical sensor that is in direct physical contact with at least one component of the drive mechanism or an optical sensor that is not in direct physical contact with at least one component of the drive mechanism.

11. The conveying device according to claim 1, wherein, The module also includes a communication element configured to communicate externally with a remote device via a wired connection, a wireless connection, or a combination of the wired and wireless connections.

12. The conveying device according to claim 11, wherein, The communication element is either a unidirectional communication element configured to send information to or receive information from the remote device, or a bidirectional communication element configured to send information to or receive information from the remote device.

13. The conveying device according to claim 11, wherein, The remote device is configured to provide at least one of the following: contextual instructions for using the delivery device, safety protocol information regarding the drug administration procedure, and status indications for at least one stage of the drug administration procedure.

14. The conveying device according to claim 1, wherein, The module also includes one or more indicators configured to provide the user with at least one of operating instructions and information about the status of the drug administration procedure.

15. The conveying device according to claim 14, wherein, The one or more indicators include at least one visual indicator having at least one light.

16. The conveying device according to claim 15, wherein, The at least one lamp is a monochromatic or multicolor light-emitting diode configured for at least one of steady-state operation and flashing operation.

17. The conveying device according to claim 14, wherein, The one or more indicators include at least one audible indicator configured to deliver an audible message to a user.

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