High performance wearable injection and / or infusion devices

Abstract

To provide an improved wearable injection and / or infusion device configured to administer a therapeutic drug to a patient.SOLUTION: A delivery device for delivering a medical fluid to a patient has a housing configured to receive a container at least partially filled with the medical fluid. The delivery device further has a drive mechanism associated with the housing configured to deliver the medical fluid from the container to the patient in a dosing procedure. The delivery device further has a module configured to detect at least one of a property of the dosing procedure and a property of the medical fluid. The module has at least one dose detection sensor configured to detect initiation, progression, and completion of the dosing procedure on the basis of a position of a stopper within the container. The module further has at least one temperature sensor configured to measure a temperature of the medical fluid within the container on the basis of a temperature of the container.SELECTED DRAWING: Figure 6

Description

[Technical Field]

[0001] The present invention relates generally to wearable injection and / or infusion devices, and more particularly to wearable injection and / or infusion devices for administering therapeutic agents to a patient. [Background technology]

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 479,742, filed March 31, 2017, entitled "Smart Wearable Injection and / or Infusion Device," the disclosure of which is incorporated herein by reference in its entirety.

[0003] Various types of automatic injection devices have been developed to allow untrained individuals to administer or self-inject drug solutions and other liquid therapeutic formulations. These devices generally include a reservoir prefilled with the liquid therapeutic formulation and some type of automatic needle injection mechanism that can be triggered by the user. When the volume of fluid or drug to be administered is generally below a certain volume, such as 1 mL, automatic injectors with an injection time of approximately 10 to 15 seconds are commonly used. When the volume of fluid or drug to be administered is greater than 1 mL, the injection time becomes longer overall, making it more difficult for the patient to maintain contact between the device and the target area of ​​the patient's skin. Furthermore, as the volume of drug administered increases, it becomes desirable to increase the duration of the injection. The conventional method for slowly injecting a drug into a patient is to start an IV and slowly inject the drug into the patient's body. Such procedures are typically performed in a hospital or outpatient facility.

[0004] Certain devices allow for self-injection or self-infusion in the home, gradually injecting a liquid therapeutic formulation into a patient's skin. In some cases, these devices are small enough (both in height and overall size) to allow them to be "worn" by the patient while the liquid therapeutic formulation is being injected into the patient. These wearable injection and / or infusion devices typically include a pump or other type of discharge mechanism to flow the liquid therapeutic formulation from a reservoir and into the injection needle. Such devices also typically include a valve or flow control mechanism to ensure the liquid therapeutic formulation begins to flow at the appropriate time, and a trigger mechanism to initiate the injection. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] International patent application PCT / US2016 / 013444 [Patent Document 2] International Publication No. 2016 / 115372 Brochure Summary of the Invention [Problem to be solved by the invention]

[0006] While 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. [Means for solving the problem]

[0007] Generally, improved wearable injection and / or infusion devices configured to administer a therapeutic agent to a patient are provided. In some examples, the wearable injection and / or infusion device may be configured to continuously monitor dose progression. In other examples, the wearable injection and / or infusion device may be configured to detect a stall in dose progression based on a detected delivery rate. In a further example, the wearable injection and / or infusion device may be configured to detect the temperature of the therapeutic agent and adjust at least one dose progression protocol based on the detected temperature. In other examples, the wearable injection and / or infusion device may be configured to enable external communication of data to a remote device. In a further example, the wearable injection and / or infusion device may incorporate enhanced visual indicators of the device's status.

[0008] In some examples of the present disclosure, a delivery device for delivering a medical fluid to a patient may have a housing configured to receive a container at least partially filled with the medical fluid. The delivery device may further have a drive mechanism associated with the housing configured to deliver the medical fluid from the container to the patient in a dispensing procedure. The delivery device may further have a module configured to detect at least one of a characteristic of the dispensing procedure and a characteristic of the medical fluid. The module may have at least one dose detection sensor configured to detect the initiation, progress, and completion of the dispensing procedure based on the position of a stopper in the container. The module may further have at least one temperature sensor configured to measure the temperature of the medical fluid in the container based on the temperature of the container.

[0009] In another example of the present disclosure, the at least one dose detection sensor may be configured to measure a delivery rate of the medical fluid to the patient based on detecting a change in the position of the stopper as a function of time. The module may be configured to stop the drive mechanism when the delivery rate of the medical fluid measured by the at least one dose detection sensor falls below a minimum threshold or exceeds 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 an actual volume of the medical fluid in the container or estimate the volume of the medical fluid in the container based on the position of the stopper in the container. The optical sensor array may include 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.

[0010] In other examples of the present disclosure, the temperature of the medical fluid can be a function of the ambient environment temperature outside the housing of the delivery device and the local temperature within the housing of the delivery device. The module can be configured to prevent actuation of the drive mechanism when the temperature of the medical fluid within the container is below a minimum threshold or above a maximum threshold.

[0011] In another example of the present disclosure, the module may further include at least one activation detection switch configured to detect the start of a dispensing procedure and at least one completion detection switch configured to detect the completion of a dispensing procedure. The at least one activation detection switch may be configured to detect at least one of a position and a 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 a position and a velocity of at least one component of the drive mechanism. The at least one activation 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.

[0012] In other examples of the present disclosure, the module can further include a communication element configured to communicate externally with a remote device via a wired connection, a wireless connection, or a combination of wired and wireless connections. The communication element can be a one-way communication element configured to send information to or receive information from the remote device, or a two-way communication element configured to send information to and receive information from the remote device. The remote device can be configured to provide at least one of contextual instructions for using the delivery device, safety protocol information for the administration procedure, and a status indication of at least one stage of the administration procedure.

[0013] In another example of the present disclosure, the module may further include one or more indicators configured to provide the user with at least one of information about the status of the medication procedure and activation instructions. The one or more indicators may include at least one visual indicator having at least one light, the at least one light being a monochromatic or multicolor light-emitting diode configured for at least one of steady state and flashing activation. The one or more indicators may include at least one audible indicator configured to deliver an audible message to the user. The delivery device may have a cover removably connectable to the housing, the module being connected to the cover.

[0014] Further examples or aspects of the present disclosure are characterized in the following numbered paragraphs:

[0015] Item 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 pre-filled with a medical fluid; a drive mechanism associated with the housing configured to deliver the medical fluid from the container to the patient in a dispensing procedure; and a module configured to detect at least one characteristic of the dispensing procedure and a characteristic of the medical fluid, the module comprising at least one dose detection sensor configured to detect the initiation, progress, and completion of the dispensing procedure based on the position of a stopper in the container; and at least one temperature sensor configured to measure the temperature of the medical fluid in the container based on the temperature of the container.

[0016] 2. The delivery device of claim 1, wherein the at least one dose detection sensor is configured to measure a delivery rate of the medical fluid to the patient based on detecting a change in position of the stopper as a function of time.

[0017] Item 3. The delivery device of paragraph 1 or 2, wherein the module is configured to stop the drive mechanism when the delivery rate of the medical fluid measured by the at least one dose detection sensor falls below a minimum threshold or exceeds a maximum threshold.

[0018] Item 4. The delivery device of any of items 1-3, wherein the output of the at least one dose detection sensor is a function of the output of the at least one temperature sensor.

[0019] Item 5. The delivery device of any of items 1-4, wherein the at least one dose detection sensor is an optical sensor array configured to detect the actual volume of medical fluid in the container or estimate the volume of medical fluid in the container based on the position of the stopper in the container.

[0020] Clause 6. The delivery device of any of clauses 1 through 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.

[0021] Clause 7. The delivery device of any of clauses 1-6, wherein the temperature of the medical fluid is a function of the ambient environment temperature outside the housing of the delivery device and the local temperature within the housing of the delivery device.

[0022] Clause 8. The delivery device of any of clauses 1-7, wherein the module is configured to prevent actuation of the drive mechanism when the temperature of the medical fluid in the container is below a minimum threshold or above a maximum threshold.

[0023] Clause 9. The delivery device of any of clauses 1-8, wherein the module further comprises at least one activation detection switch configured to detect the start of a medication procedure and at least one completion detection switch configured to detect the completion of a medication procedure.

[0024] Clause 10: The delivery device of any of clauses 1 to 9, wherein the at least one activation detection switch is configured to detect at least one of a position and a velocity of at least one component of the drive mechanism, and the at least one completion detection switch is configured to detect at least one of a position and a velocity of at least one component of the drive mechanism.

[0025] Clause 11: The delivery device of any of clauses 1 to 10, wherein the at least one activation 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.

[0026] Clause 12: The delivery device of any of clauses 1 to 11, 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.

[0027] Clause 13. The delivery device of any of clauses 1-12, wherein the module further comprises a communication element configured for external communication with a remote device via a wired connection, a wireless connection, or a combination of wired and wireless connections.

[0028] Clause 14. The delivery device of any of clauses 1 through 13, wherein the communication element is a one-way communication element configured to send information to or accept information from a remote device, or a two-way communication element configured to send information to and accept information from a remote device.

[0029] Clause 15. The delivery device of any of clauses 1-14, wherein the remote device is configured to provide at least one of contextual instructions for using the delivery device, safety protocol information about the administration procedure, and a status indication of at least one stage of the administration procedure.

[0030] Clause 16. The delivery device of any of clauses 1-15, wherein the module further comprises one or more indicators configured to provide the user with at least one of information about the status of the medication procedure and activation instructions.

[0031] Clause 17. The delivery device of any of clauses 1-16, wherein the one or more indicators comprise at least one visual indicator having at least one light.

[0032] Clause 18. The delivery device of any of clauses 1-17, wherein at least one light is a monochromatic or multicolored light emitting diode configured for at least one of steady state and flashing operation.

[0033] Clause 19. The delivery device of any of clauses 1-18, wherein the one or more indicators comprise at least one audible indicator configured to deliver an audible message to the user.

[0034] Clause 20. The delivery device of any of clauses 1-19, further comprising a cover removably connectable to the housing, the module being connected to the cover.

[0035] These and other features and characteristics of the present disclosure, as well as the method of operation and function of the associated elements or structures and combinations of parts and economies of manufacture, will become more apparent from a consideration of the following description with reference to the accompanying drawings, all of which form a part of this specification, but it is to be expressly understood that the drawings are for purposes of illustration and description only and are not intended to define the limits of the invention. [Brief explanation of the drawings]

[0036] [Figure 1] FIG. 1 is a front perspective view of a smart wearable injection and / or infusion device, according to one example. [Figure 2]FIG. 2 is a schematic top view of the smart wearable injection and / or infusion device of FIG. 1 showing the various components of the device. [Figure 3] FIG. 2 is a side perspective view of the smart wearable injection and / or infusion device shown in FIG. 1. [Figure 4] FIG. 4 is an exploded view of the smart wearable injection and / or infusion device shown in FIG. 3, showing the cover separated from the smart wearable injection and / or infusion device. [Figure 5] FIG. 13 is a detailed perspective view of a control element for use with a smart wearable injection and / or infusion device. [Figure 6] FIG. 10 is a front perspective view of another example of a smart wearable injection and / or infusion device. [Figure 7] FIG. 7 is an exploded perspective view of the smart wearable injection and / or infusion device shown in FIG. [Figure 8] FIG. 7 is a rear perspective view of the smart wearable injection and / or infusion device shown in FIG. 6. [Figure 9] FIG. 9 is an exploded perspective view of the smart wearable injection and / or infusion device shown in FIG. 8. [Figure 10] FIG. 7 is a perspective view of the inner surface of the cover of the smart wearable injection and / or infusion device shown in FIG. 6. [Figure 11] 1A-1C are front perspective views of a smart wearable injection and / or infusion device showing various states of an indicator. [Figure 12] 10A-10C are cross-sectional views of various designs of covers for use with smart wearable injection and / or infusion devices. [Figure 13] FIG. 1 illustrates a smart wearable injection and / or infusion device configured for wireless communication with a remote device. [Figure 14] FIG. 10 is another diagram illustrating a smart wearable injection and / or infusion device configured for wireless communication with a remote device. [Figure 15]FIG. 10 is a screenshot of a graphical user interface of a mobile device application configured for use with the smart wearable injection and / or infusion device. [Figure 16] FIG. 12 is a detailed view of an optical sensing array for use with a smart wearable injection and / or infusion device. [Figure 17] FIG. 1 illustrates certain performance parameters of a smart wearable injection and / or infusion device as a function of time. [Figure 18] FIG. 10 is another diagram illustrating another performance parameter of the smart wearable injection and / or infusion device as a function of time. [Figure 19] FIG. 10 is another diagram showing additional performance parameters of the smart wearable injection and / or infusion device as a function of time. [Figure 20] FIG. 10 is another diagram illustrating further performance parameters of the smart wearable injection and / or infusion device as a function of time. [Figure 21] FIG. 1 illustrates the spectral distribution of a type of illumination as a function of wavelength. [Figure 22] FIG. 10 is another diagram illustrating the spectral distribution as a function of wavelength for another type of illumination. [Figure 23] 1 is a schematic diagram of various components of a smart wearable injection and / or infusion device. [Figure 24] FIG. 1 is a schematic diagram of a smart wearable injection and / or infusion device for temperature detection and estimation. DETAILED DESCRIPTION OF THE INVENTION

[0037] In Figures 1-24, wherever applicable, like symbols refer to the same components and elements unless otherwise noted.

[0038] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0039] Spatial or directional terms such as "left," "right," "inner," "outer," "upper," "lower," etc. relate to the present invention as shown in the figures and are not to be considered limiting as the present invention may assume various alternative orientations.

[0040] All numerical values ​​and ranges used in the specification and claims are understood to be modified in all instances by the term "about." "About" means plus or minus 25 percent of the stated value, such as plus or minus 10 percent of the stated value. However, this should not be considered as a limitation on any analysis of values ​​under the doctrine of equivalents.

[0041] Unless otherwise indicated, all ranges or ratios disclosed herein are to be understood to encompass the starting and ending values, and any and all subranges and subratios therein. For example, a stated range or ratio of "1 to 10" should be considered to include any and all subranges or subratios from a minimum value of 1 to a maximum value of 10, inclusive, i.e., all subranges or subratios beginning with a minimum value of 1 or more and ending with a maximum value of 10 or less. Ranges and / or ratios disclosed herein represent average values ​​across the stated range and / or ratio.

[0042] Terms such as "first," "second," etc. are not intended to refer to any particular order or chronology, but rather to various states, properties, or elements.

[0043] The term "at least" is synonymous with "greater than or equal to."

[0044] The term "less than or equal to" is synonymous with "less than or equal to."

[0045] 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 combination of any two or more of A, B, or C. For example, "at least one of A, B, and C" includes A alone, or B alone, or C alone, or A and B, or A and C, or B and C, or all of A, B, and C.

[0046] The term "including" is synonymous with "comprises."

[0047] The discussion of the present invention may describe certain features as "particularly" or "preferably" within certain limits (e.g., "preferably," "more preferably," or "even more preferably" within certain limits). It is to be understood that the invention is not limited to these particular or preferred limits, but encompasses the full scope of the present disclosure.

[0048] In various non-limiting examples or embodiments, with reference to FIG. 1 , the present disclosure is directed to a wearable injection and / or infusion device that can be configured to continuously monitor dose progression. In other examples, the wearable injection and / or infusion device can be configured to detect a stall in dose progression based on a detected delivery rate. In further examples, the wearable injection and / or infusion device can be configured to detect the temperature of the therapeutic agent and adjust at least one dose progression protocol based on the detected temperature. In other examples, the wearable injection and / or infusion device can be configured to allow external communication of data to a remote device. In further examples, the wearable injection and / or infusion device can incorporate enhanced visual indicators of the device's status.

[0049] Wearable injection and / or infusion devices 1-2, a wearable injection and / or infusion device 100 is shown by way of example. The wearable injection and / or infusion device 100 can be configured to couple to a patient's skin and deliver a therapeutically effective dose of a therapeutic agent at a predetermined delivery rate. For example, the therapeutic agent can be any type of drug, chemical, biological, or biochemical substance that, when delivered in a therapeutically effective amount, achieves a desired therapeutic effect. The wearable injection and infusion device 100 has a housing 102 for enclosing a syringe assembly 103 (shown in FIG. 7) in fluid communication with a container 104 (shown in FIG. 7) filled with a therapeutic agent. The wearable injection and infusion device 100 is operable to deliver the therapeutic agent from the container 104 to the patient using the syringe assembly 103.

[0050] 6-7 , the housing 102 of the wearable injection and / or infusion device 100 has a cover 106 that can be removably coupled to the housing. The cover 106 can have a module 150 (shown in FIG. 10 ) that includes multiple components configured for dose progression, stall detection, temperature measurement, and external communication. As discussed herein, the module 150 can include one or more sensors, such as an environmental sensor (e.g., temperature), to refine the dose detection algorithm (e.g., fluid viscosity temperature effects) and provide feedback to the user (e.g., the medication is too cold for injection). The module 150 can additionally include one or more indicators (e.g., audible, visual, or tactile) to provide feedback or instructions to the user. The module 150 can also include communication capabilities to transmit device data to an external device (e.g., a smartphone). The module 150 is integrated with the cover 106, such that when the cover 106 is coupled to the housing 102, the module 150 does not interfere with the underlying functionality of the wearable injection and / or infusion device 100. Module 150 may include additional sensors to detect mechanical actions associated with syringe actuation (e.g., switches to detect activation, completion, needle insertion / retraction, or other device events or states). Module 150 may have one or more additional sensors, such as an optical sensor array, a capacitive sensor array, an inductive sensor array, etc., to continuously monitor dose delivery.

[0051] In some examples, cover 106 including module 150 may be provided as a replacement for an existing cover of an existing wearable injection and / or infusion device (not shown). In such examples, cover 106 and module 150 may be integrated with the wearable injection and / or infusion device to provide additional functionality to the wearable injection and / or infusion device provided by module 150. For example, cover 106 may be used with the wearable injection and / or infusion device disclosed in U.S. Patent No. 6,223,999 (published as U.S. Patent No. 6,223,999), the disclosure of which is incorporated herein by reference in its entirety.

[0052] The cover 106 has an observation window 108 for viewing the contents of the container 104, such as viewing the fill volume of the container 104. A filter (not shown) may be provided over the observation window 108 to filter ambient light passing through the window 108. The housing 102 further has an indicator 110 for indicating the status of the wearable injection and / or infusion device 100.

[0053] 2, the wearable injection and / or infusion device 100 further has an activation detection switch 112 and a completion detection switch 114 for detecting activation / completion of a medication procedure. The wearable injection and / or infusion device 100 further has an activation detection button switch 117 for detecting the state of the injector activation button 115 (shown in FIG. 1). The wearable injection and / or infusion device 100 further has a wireless communication element 116 for communication with a remote device, an on / off switch 118 for turning power to the device 100 on / off, and a charging port 120 for recharging the battery 122. The wearable injection and / or infusion device 100 further has an audible indicator 124, one or more temperature sensors 126, and a dose detection array 128.

[0054] 23 , a controller 140 may be provided to control one or more of the 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 enable communication among 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 (e.g., a field programmable gate array (FPGA), an application specific integrated circuit (ASIC) that can be programmed to perform a function, etc.). The memory 144 may include random access memory (RAM), read-only memory (ROM), and / or another type of dynamic or static storage device (e.g., flash memory, magnetic memory, optical memory, etc.) that stores information and / or instructions for use by the processor 142.

[0055] The 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, the storage component 146 includes a hard disk (e.g., a magnetic disk, an optical disk, a magneto-optical disk, a solid-state disk, etc.), a cartridge, a magnetic tape, and / or another type of computer-readable medium along with a corresponding drive. A computer-readable medium (e.g., a non-removable computer-readable medium) is defined herein as a non-removable memory device. A memory device includes memory space located within a single physical storage device or memory space spread across multiple physical storage devices.

[0056] The wearable injection and / or infusion device 100 can perform one or more processes described herein. The wearable injection and / or infusion device 100 can perform these processes based on the processor 142 executing software instructions stored by a computer-readable medium, such as the memory 144 and / or storage component 146. The software instructions may be loaded into the memory 144 and / or storage component 146 from another computer-readable medium or another device via the bus 148. When executed, the software instructions stored in the memory 144 and / or storage component 146 cause the processor 142 to perform one or more processes described herein. Additionally or alternatively, hardwired circuitry can be used in place of or in combination with software instructions to perform one or more processes described herein. Thus, the examples described herein are not limited to any specific combination of hardware circuitry and software.

[0057] The number and arrangement of components shown in Figure 23 is provided as an example. In some non-limiting examples, controller 140 includes additional, fewer, different, or differently arranged components than those shown in Figure 23. Additionally or alternatively, a set of components (e.g., one or more components) of controller 140 can perform one or more functions described as being performed by another set of components of wearable injection and / or infusion device 100.

[0058] Device State Detection In some examples, the cover 106 and the module 150 may be configured to track the mechanical state of the underlying components of the wearable injection and / or injection device 100. For example, the detection switches 112, 114 in the module 150 may be configured to detect at least one characteristic of at least one component of the wearable injection and / or injection device 100, such as the component's position, velocity, and / or a state change from a first state to a second state. For example, the detection switches 112, 114 in the module 150 may be configured to detect mechanical actions associated with changes in syringe state, such as needle shield removal, syringe unlocking, activation button depression, injection activation, and injection completion. In some examples, the detection switches 112, 114 may be mechanical components that have direct mechanical interaction with the underlying components. In other examples, the detection switches 112, 114 may be infrared-based optical sensors (e.g., reflectance or photointerrupter sensors) that enable contactless detection. Transitions in device state can be used as triggers to start or stop other system measurements such as temperature or dose progression.

[0059] Dose progression and stall detection In some examples, the wearable injection and / or infusion device 100 can be configured to monitor dose progression and detect dose progression stall events using the module 150. For example, the dose detection array 128 of the module 150 can be an optical sensor array for tracking the dispense chain. The dose detection array 128 can be configured to detect or algorithmically estimate the volume of therapeutic agent delivered to the patient. The dose detection array 128 can be configured to avoid contact with components of the wearable injection and / or infusion device and therefore not affect the delivery of the therapeutic agent. For example, the dose detection array 128 can be positioned on a lateral side of the container 104. The dose detection array 128 can be configured to detect the progression of a stopper along the length of the container 104 and can correlate the position of the stopper with the volume of therapeutic agent delivered and / or the volume of therapeutic agent remaining in the container 104. In some examples, the dose detection array 128 may be an optical system having one or more emitters that emit electromagnetic energy, such as visible or infrared light, that is reflected from the stopper and container 104 and received by one or more detectors. The reflective nature of the dose detection array 128 allows the components to be located on one side of the container 104, making the system more compact and easier to manufacture than an arrangement in which the emitters and detectors are positioned opposite each other.

[0060] 10 , the dose detection array 128 may be an infrared-based optical sensor array that includes one or more infrared emitters 130 (e.g., IR LEDs, and 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 removal of the cover 106 from the housing 102 also removes the dose detection array 128 from the housing 102.

[0061] Continuing with reference to FIG. 10 , the emitters 130 and detectors 132 may be interleaved on a common circuit board. The number of emitters 130 may be the same as or different from the number of detectors 132. In some examples, the emitters 130 and detectors 132 may be arranged in an alternating pattern, where each emitter / detector is positioned between a detector / emitter pair. The dose detection array 128 may be in electronic communication with a controller for controlling the optical components and processing the detector output to establish the location of the stopper. The wearable injection and / or infusion device 100 may further include other electronic devices (e.g., multiplexers, amplifiers, A / Ds, etc.) to connect the controller to the dose detection array 128. The infrared spectrum provides improved noise immunity against external noise sources, such as visible light sources. The infrared light emitted from the emitters is also invisible to the user.

[0062] In use, a single emitter 130 can be activated to emit infrared light while one or more detectors 132 detect infrared light reflected from the container 104. This sequence can be repeated repeatedly between different emitter / detector combinations. Sampling of all detectors 132 can occur simultaneously or sequentially. In some examples, the emitters 130 can be active for less than 200 μs per measurement (0.02% duty cycle). Detector measurements are compared against an existing set of reference measurements and aligned to the nearest reference point correlated to the stopper / plunger position. The number of reference measurement points can be greater than the number of detectors 132, thereby improving position resolution (e.g., 200 reference points using six detectors). In this way, the dose detection array 128 functions similarly to a multi-step encoder, such as a 200-step absolute position encoder. Aligning acquired values ​​to a reference value minimizes errors between the collected data and the reference value. Weighting methods can be used to selectively prioritize specific emitter / detector combinations at different times or locations during an injection. Additional filtering can be employed to pre-process the data, such as to minimize the effects of ambient light. In some examples, the dose detection array 128 can have a 160 μm step resolution. To minimize the effects of ambient infrared energy, several background measurements can be taken when the emitter is not energized to establish a detector baseline. This baseline value can then be subtracted from the detector measurements when the emitter is energized. Synchronous modulation techniques can also be utilized to separate the target measurements from the background energy levels.

[0063] In some examples, the signal measurements can be processed using feature recognition methods to identify known signal features (e.g., local maxima or minima) that correspond to unique stopper / plunger positions, thus reducing or minimizing reliance on an existing set of reference measurements. Feature recognition methods can include fuzzy logic and machine learning-based techniques.

[0064] The determination of dose progression can be found in a position-based algorithm, i.e., an algorithm from which the delivered dose volume can be calculated. The change in stopper position as a function of time can be used to calculate the stopper velocity and therefore the therapeutic drug delivery rate. The algorithm can compensate for known variations in fluid delivery components, such as variability in the diameter and length of the container 104. Stopper / plunger velocity data can be used to determine whether the dosing procedure is stalled. For example, a minimum threshold (stall condition) can correspond to the minimum stopper / plunger velocity combined with any error sources (e.g., noise, ambient IR, etc.). For example, the stall detection time can be determined by the slowest allowable delivery rate, such as 4 μl / s. Figures 17-20 show various performance parameters as a function of time.

[0065] Optical components are known to be temperature sensitive, so measurements from temperature sensors can be used to apply temperature compensation to continuously correct for temperature-related measurement errors. Referring to Figure 24, inputs from one or more temperature sensors can be passed through one or more filters to compensate for any temperature-related measurement errors.

[0066] In injection systems where the container 104 must first translate a fixed distance to pierce the septum, the dose detection array can also be used to detect the position of the entire container 104 (including the plunger). A separate reference measurement set can be utilized to determine the position of the entire container 104. Once the container is detected to be in a pierced state, the algorithm can switch to the reference set used to detect the plunger position.

[0067] Premature removal detection 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 example, a maximum velocity threshold can correspond to the maximum expected stopper / plunger velocity when injected into the body (i.e., a high-pressure site). Velocities above this threshold can correspond to injection in air (i.e., a low-pressure site). Large, sudden, and unexpected changes in position or velocity can thus be used to indicate undesirable changes at the injection site (e.g., premature removal or needle retraction).

[0068] temperature measurement In some examples, the wearable injection and / or infusion device 100 may be configured to measure a temperature, such as the temperature of a therapeutic agent inside the container 104. For example, one or more temperature sensors 126 may be used to detect the temperature of the container 104. This temperature data may be used to predict the temperature of the therapeutic agent inside the container 104 based on at least one of several factors, such as the temperature at one or more locations within the syringe relative to the temperature of the container, spatial temperature gradients within the syringe, and the rate of temperature change at the measured locations on the container (i.e., the temperature gradient). The temperature sensor data may be used to predict or estimate the ambient environment temperature during transient temperature conditions. By estimating the ambient environment temperature relative to the local temperature within the device, the temperature of the therapeutic agent inside the container may be better predicted over time. The temperature data may be used to indicate whether the wearable injection and / or infusion device 100 is ready to perform a medication procedure. For example, certain therapeutic agents may be delivered only if they are at a predetermined temperature (or temperature range). The wearable injection and / or infusion device 100 can prevent delivery of the therapeutic agent if the therapeutic agent is above / below such a predetermined temperature (or temperature range). In some examples, the wearable injection and / or infusion device 100 can allow delivery of the therapeutic agent that is outside of the predetermined temperature (or temperature range) using an extended dosing protocol, such as an increased or decreased delivery rate.

[0069] Temperature data can also be combined with dose progression data to detect or estimate whether an abnormal delivery rate (or stall in dose progression) is likely caused by a temperature-related change in the viscosity of the therapeutic agent (e.g., stall due to increased viscosity at low temperatures). In these scenarios, changes in temperature data can be used to indicate whether resolution of the abnormal delivery condition is expected (e.g., the injection is currently stalled but is likely to recover due to increased temperature), thereby preventing premature removal, for example, due to a temporary interruption in delivery.

[0070] External Communications In some examples, the wearable injection and / or infusion device 100 may be configured to communicate externally with a remote device 119 over a network, as shown in FIGS. 13-14 . The communication may be one-way, in which case the wearable injection and / or infusion device 100 is configured to only send information to or only accept information from the remote device 119. In other examples, the wearable injection and / or infusion device 100 may be configured for two-way communication with the remote device 119, in which case the wearable injection and / or infusion device 100 is configured to both send information to and accept information from the remote device 119. In some examples, the wearable injection and / or infusion device 100 may have transceiver-like components (e.g., a transceiver, a separate receiver and transmitter, etc.) that enable the wearable injection and / or infusion device 100 to communicate with the remote device 119, such as via a wired connection, a wireless connection, or a combination of wired and wireless connections. The transceiver-like component may enable the wearable injection and / or infusion device 100 to accept information from and / or provide information to the remote device 119.

[0071] In some examples, the network may include one or more wired and / or wireless networks. For example, the network may include a cellular network (e.g., a Long Term Evolution (LTE) network, a Third Generation (3G) network, a Fourth Generation (4G) network, a Code Division Multiple Access (CDMA) network, etc.), a Public Land Mobile Network (PLMN), a Local Area Network (LAN), a Wide Area Network (WAN), a Metropolitan Area Network (MAN), a telephone network (e.g., a Public Switched Telephone Network (PSTN)), a private network, an ad hoc network, an intranet, the Internet, an optical fiber-based network, a cloud computing network, etc., and / or a combination of these or other types of networks.

[0072] In some examples, the wearable injection and / or infusion device 100 may be configured to communicate externally wirelessly using Bluetooth or Wi-Fi or cellular communication protocols, etc., with an application 121 on a remote device 119, such as a tablet or cell phone, or a server-based application. 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 associated with the wearable injection and / or infusion device 100 (FIG. 15). In some examples, the wearable injection and / or infusion device 100 may have a BLE / MCU radio for wireless external communication with the remote device.

[0073] The remote device may 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 may provide instructions to the patient regarding how to set up and initiate a medication procedure using the wearable injection and / or infusion device 100. In some examples, the remote device may display to the patient that the medication procedure is progressing and provide a status indication of various stages of the medication procedure. In further examples, the remote device may provide instructions to the patient regarding procedures to follow in an abnormal event, such as when a medication procedure may stall. The wearable injection and / or infusion device 100 may be configured to send information about the time, date, and volume of therapeutic agent delivered to the patient to a third party, such as the patient's healthcare provider or health insurance company, using the remote device. The wearable injection and / or infusion device 100 may contact such a third party in the event of an abnormal event, such as by sending a text alert or dialing a third party's phone number.

[0074] Data from the wearable injection and / or infusion device 100 may be transmitted to a remote device in real time, and / or the data may be stored in a remote database for use after delivery. In some examples, the remote device may be used to execute safety protocols before the wearable injection and / or infusion device 100 begins a medication procedure. For example, the remote device may check for drug recalls, verify that the correct therapeutic agent is being used, and / or verify the time and volume of the last medication procedure. The wearable injection and / or infusion device 100 may be prevented from starting a new medication procedure depending on whether a safety protocol executed on the remote device detects an anomaly.

[0075] Enhanced Visual Indicators In some examples, the wearable injection and / or infusion device 100 can have one or more enhanced electronic indicators. For example, the wearable injection and / or infusion device 100 can have one or more visual indicators, such as an LED-based indicator with three colors (blue, red, and white). Alternatively, or in addition, the wearable injection and / or infusion device 100 can have one or more audible indicators, such as a piezoelectric-based buzzer with a chime / beep.

[0076] The visual indicator can be used to deliver a range of visual messages to the user regarding the status of the wearable injection and / or infusion device and its performance. For example, the color of the visual indicator can be used to indicate the state of the wearable injection and / or infusion device 100, such as whether the device is powered, whether a dosing procedure is progressing, etc. Alternatively, or in addition, the visual indicator can be activated between a steady state and a flushing activation to indicate the status of the wearable injection and / or infusion device 100. A speaker port can be provided within the housing of the wearable injection and / or infusion device 100 to deliver audible messages to the user.

[0077] While the present invention has been described in detail for purposes of illustration, based on what are presently considered to be the most practical and preferred embodiments, it should be understood that such detail is for this purpose only, and that the invention is not limited to the disclosed embodiments, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the present disclosure. For example, it should be understood that the present invention contemplates combining, to the extent possible, one or more features of any embodiment with one or more features of any other embodiment.

Claims

1. 1. A delivery device for delivering a medical fluid to a patient, comprising: a housing configured to receive a container at least partially filled with the medical fluid; a drive mechanism associated with the housing configured to deliver the medical fluid from the container to the patient during a medication procedure; a module configured to detect at least one of a characteristic of the medication procedure and a characteristic of the medical fluid, at least one dose detection sensor configured to detect the initiation, progress, and completion of the dispensing procedure based on the position of a stopper within the container; at least one activation detection switch configured to detect the initiation of the dispensing procedure; at least one completion detection switch separate from the at least one activation detection switch and configured to detect the completion of the medication sequence; a module comprising: Equipped with the at least one start detection switch is configured to detect at least one of a position and a velocity of at least one component of the drive mechanism, and the at least one completion detection switch is configured to detect at least one of a position and a velocity of at least one component of the drive mechanism; A delivery device wherein the at least one activation detection switch is a mechanical sensor in direct physical contact with at least one component of the drive mechanism or an optical sensor that does not directly contact at least one component of the drive mechanism, and the at least one activation detection switch and / or the at least one completion detection switch detect the start of an administration procedure and / or the completion of an administration procedure and trigger the start and / or stop of detection of the administration procedure by the at least one dose detection sensor.

2. The delivery device of claim 1 , wherein the at least one dose detection sensor is configured to measure a delivery rate of the medical fluid to the patient based on detecting a change in the position of the stopper as a function of time.

3. 10. The delivery device of claim 1, wherein the module is configured to stop the drive mechanism when the delivery rate of the medical fluid measured by the at least one dose detection sensor falls below a minimum threshold or exceeds a maximum threshold.

4. the module comprising at least one temperature sensor configured to measure a temperature of the medical fluid in the container based on a temperature of the container; The delivery device of claim 1 , wherein the output of the at least one dose detection sensor is a function of the output of the at least one temperature sensor.

5. The delivery device of claim 4 , 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 within the housing of the delivery device.

6. The delivery device of claim 4 , wherein the module is configured to prevent actuation of the drive mechanism when the temperature of the medical fluid in the container is below a minimum threshold or above a maximum threshold.

7. the at least one dose detection sensor is an optical sensor array configured to detect an actual volume of the medical fluid in the container or to estimate the volume of the medical fluid in the container based on the position of the stopper in the container; 10. The delivery device of claim 1, 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.

8. The delivery device of claim 1 , wherein the module further comprises a communication element configured for external communication with a remote device via a wired connection, a wireless connection, or a combination of the wired connection and the wireless connection.

9. 9. The delivery device of claim 8, wherein the communication element is a one-way communication element configured to send information to or accept information from the remote device, or a two-way communication element configured to send information to and accept information from the remote device.

10. 10. The delivery device of claim 8, wherein the remote device is configured to provide at least one of contextual instructions for using the delivery device, safety protocol information about the medication procedure, and a status indication of at least one stage of the medication procedure.

11. The delivery device of claim 1 , wherein the module further comprises one or more indicators configured to provide a user with at least one of information about the status of the medication procedure and activation instructions.

12. the one or more indicators comprise at least one visual indicator having at least one light; 12. The delivery device of claim 11, wherein the at least one light is a monochromatic or multi-colored light emitting diode configured for at least one of steady state and flashing operation.

13. The delivery device of claim 11 , wherein the one or more indicators comprise at least one audible indicator configured to deliver an audible message to a user.

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