A universal coupling device for pen injectors.

Abstract

To provide universal add-on for an injection pen.SOLUTION: A static portion (110) has opposing gripping members to grip a body (112) of the injection pen. A moving portion (106) has opposing gripping members to grip an actuator (114) of the injection pen. Displacement measurement devices (102) measure relative linear and rotational movement of the actuator relative to the injection pen body (112). Doses are determined and recorded based on relative movement of the static portion (110) and moving portion (106), and the dose data is transmitted wirelessly to a mobile device. The device is easily installed on injection pens by pressing opposing buttons to relieve gripping pressure imparted by the gripping members.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] This application claims the benefit under 35 U.S.C. §119 of Provisional Application Nos. 62 / 730,506 and 62 / 746,855, filed September 12, 2018 and October 17, 2018, respectively, the entire contents of each of which are incorporated herein by reference.

[0002] The present invention relates generally to drug dosage measurement devices, and more particularly to an accessory for a pen injector that detects actuator movement and records a dose based thereon. [Background technology]

[0003] Diabetes is a group of diseases characterized by high levels of blood glucose due to defects in insulin production, insulin action, or both. Although diabetes can lead to serious health complications and premature death, there are well-known products available to people with diabetes that can help control the disease and reduce the risk of complications.

[0004] Treatment options for people with diabetes include special diets, oral medications, and / or insulin therapy. The main goal of diabetes treatment is to control a patient's blood glucose (sugar) levels to improve the chances of a complication-free life. However, achieving good diabetes control while balancing other life demands and circumstances is not always easy. Summary of the Invention [Problem to be solved by the invention]

[0005] Pen injectors have traditionally provided people who require insulin therapy with a convenient, portable means of injecting insulin. However, for diabetes management with insulin pens to be successful, it is important that the patient administers the doses of medication as instructed by the healthcare provider and also injects them properly. The insulin pen should be held in the same position by the patient for a period of time immediately following injection so that the insulin is properly absorbed by the body. Healthcare providers also want to have an accurate record of the amount and time of injection to assist them in assessing the patient's diabetes management. Currently, these functions are performed manually. The patient is instructed to inject the medication and count to a specific number, for example, 10, to ensure that the entire dose of medication is absorbed into the skin and delivered to the patient. Similarly, after injection, the patient is expected to record the amount of insulin injected and the time of injection. Existing pen injectors are plentiful, but do not assist the user with proper injection technique, record, or communicate the dose record to the healthcare provider. Thus, a need exists for a device to assist a user in properly injecting insulin, record successful or unsuccessful doses, and communicate that information to the user and their health care provider. [Means for solving the problem]

[0006] One aspect of an exemplary embodiment of the present invention substantially addresses the above and other concerns and provides a removable device that is universally attachable to insulin pens. The device grips the pen body and actuator and measures the linear and rotational displacement of the actuator. Primes and doses are preferably recorded and transmitted to a mobile device. A display on the mobile device provides hold times to the patient during injection.

[0007] A further aspect of an exemplary embodiment of the present invention is to provide a method of injection that includes installing a universal add-on to a pen injector and then measuring the relative movement of the pen injector actuator and recording data regarding the movement, such as the dose and time of administration.

[0008] Another aspect of an exemplary embodiment of the present invention is to provide a universal add-on for a pen injector that includes gripping members for releasably gripping the body and actuator of the pen injector, the gripping members being attached and released by pressing opposing buttons biased toward each other and connected to the opposing gripping members.

[0009] Additional and / or other aspects and advantages of the invention will be set forth in the following description, will be apparent from the description, or may be learned by the practice of the invention. The invention may include a method or apparatus or system having one or more of the above-described aspects and / or one or more features and combinations thereof. The invention may include one or more features and / or combinations of the above-described aspects, for example, as set forth in the appended claims.

[0010] Various objects, advantages and novel features of the illustrative embodiments of the present invention will be more readily understood from the following detailed description when read in conjunction with the accompanying drawings. [Brief description of the drawings]

[0011] [Figure 1] FIG. 1 is a block diagram of an exemplary embodiment of the present invention. [Diagram 2] FIG. 1 is a block diagram of an exemplary embodiment of the present invention. [Diagram 3] FIG. 1 is an isometric view of an exemplary embodiment of the present invention mounted on a pen injector. [Figure 4A] 1A-1D are isometric views of an embodiment of the present invention in different linear extension positions. [Figure 4B] 1A-1D are isometric views of an embodiment of the present invention in different linear extension positions. [Figure 4C] 1A-1D are isometric views of an embodiment of the present invention in different linear extension positions. [Figure 5A] 2A-2C are different views of an exemplary embodiment of the present invention in different rotational positions. [Figure 5B] 2A-2C are different views of an exemplary embodiment of the present invention in different rotational positions. [Figure 5C] 2A-2C are different views of an exemplary embodiment of the present invention in different rotational positions. [Figure 6] FIG. 1 is a front view of an exemplary embodiment of the present invention mounted on a pen injector. [Figure 7] FIG. 7 is a cross-sectional view of the combination of FIG. [Figure 8] FIG. 8 is an enlarged cross-sectional view of the embodiment shown in FIG. [Figure 9] FIG. 1 is a side view of one embodiment of the present invention attached to a pen injector. [Figure 10] FIG. 1 is a cross-sectional view of the device attached to a pen injector. [Figure 11] FIG. [Figure 12] FIG. 2 is a top view of an exemplary embodiment of the present invention. [Figure 13] FIG. 13 is a cross-sectional view of the embodiment of FIG. [Figure 14] 13 is another cross-sectional view of the embodiment of FIG. 12. [Figure 15] FIG. 13 is another cross-sectional view of the embodiment of FIG. [Figure 16] FIG. 1 is a cross-sectional view of an embodiment of the present invention. [Figure 17] FIG. 2 is an alternative cross-sectional view of an embodiment of the present invention. [Figure 18] 1 is a flow chart of an exemplary method according to an exemplary method of using the devices described herein. [Figure 18A] 1 is a flow chart of an exemplary method according to an exemplary method of using the devices described herein. [Figure 18B] 1 is a flow chart of an exemplary method according to an exemplary method of using the devices described herein. [Figure 19] 1 is a system diagram of a system in accordance with an exemplary embodiment of the present invention. [Figure 20A] 1 is an exemplary display on a mobile device, according to an exemplary embodiment of the present invention. [Figure 20B] 1 is an exemplary display on a mobile device, according to an exemplary embodiment of the present invention. [Figure 20C] 1 is an exemplary display on a mobile device, according to an exemplary embodiment of the present invention. [Figure 20D] 1 is an exemplary display on a mobile device, according to an exemplary embodiment of the present invention. [Figure 21] 1 is a system diagram of a system in accordance with an exemplary embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] Throughout the drawings, like reference numbers will be understood to refer to like features, elements and structures.

[0013] As will be appreciated by those skilled in the art, there are many ways of implementing the implementations, modifications, and configurations of the weighing system in accordance with the embodiments of the invention disclosed herein. Although reference will be made to the exemplary embodiments shown in the drawings and the following description, the embodiments disclosed herein are not meant to be exhaustive of the various alternative designs and embodiments encompassed by the disclosed invention, and those skilled in the art will readily appreciate that various modifications may be made and various combinations may be made without departing from the invention.

[0014] As shown in FIG. 1, an exemplary embodiment of the present invention includes a pen injector 100 with a displacement measuring device 102, which preferably includes a moving portion and a stationary portion. The moving portion includes a moving portion holder 104 and a moving portion 106. The stationary portion includes a stationary portion holder 108 and a stationary portion 110. As shown, the stationary portion holder 108 is attached to a body 112 of the pen injector and supports the stationary portion 110. The caliper moving portion holder 104 is attached to an actuator element 114 of the pen injector 100 and supports the caliper moving portion 106. As shown, the moving portion 106 and the stationary portion 110 are disposed adjacent to one another such that the relative displacement of the actuator portion 114 can be detected by the relative movement of the caliper moving portion 106 and the caliper stationary portion 110. The actuator element 114 is preferably a setting knob of the pen injector. The displacement measuring device 102 is preferably capable of measuring both linear and rotational displacement of the setting knob. Electronics are preferably included so that the injection volume can be calculated from the measured displacement. Further electronics are preferably provided so that the calculated injection volume can then be sent to the user. The inclusion of the displacement measuring device 102 in the pen injector provides many advantages. Visual feedback can be provided to the user to confirm successful dose delivery in real time. Visual feedback can be provided such as on a mobile device that receives data from the device 102. As described in more detail below, the device 102 preferably has a universal fit for common insulin pens. The device 102 allows communication and tracking of dose delivery to patients and their medical caregivers, records the use of the pen injector and displays the same via a connected mobile device. It may also provide a visual guide of the hold time required for effective injection. This may take the form of a countdown timer or stopwatch display to the user, triggered by actuation of the thumb press on the injector, which signals the start of administration of the selected dose.

[0015] As described above, the displacement measurement device is preferably an add-on device that can be utilized with many existing pen injectors. FIG. 2 is a block diagram illustrating an exemplary embodiment of the present invention. As shown, the pen injector 100 typically includes a body 112, a setting knob 114, and a vial cap 116. The displacement measurement device 102, which may also be referred to as a universal add-on to the pen injector, includes a stationary caliper 118 and a movable caliper 120. The stationary caliper 118 includes a microcontroller 122 that is powered by a battery 124 and receives inputs from a linear displacement detector 126 and a rotational displacement detector 128. The microcontroller 122 is also coupled to a wireless communication unit 130 to enable communication to a remote device, such as a connected mobile device. The movable caliper 120 further includes a rotary encoder 132 and a linear encoder 134. The stationary caliper 118 and the movable caliper 120 also include respective pairs of buttons 136 , 138 that allow general purpose add-ons to be attached to the body 112 and knob 114 of the pen injector 100 , respectively.

[0016] 3 shows an isometric view of a generic add-on 102 attached to a pen injector 100. The generic add-on device 102 preferably includes spring-loaded mechanisms that allow the device 102 to be attached to the pen injector 100 and grip the pen injector 100 in a spring-like manner. Buttons 136 and 138 enable the release of these mechanisms, which results in the device 102 being attached to the pen injector 100 by the gripping force of the opposing gripping members. As can be seen from FIG. 3, the caliper moving portion 134 and the caliper stationary portion 135 interact to allow the device 102 to detect the linear displacement of the button / knob 114 relative to the body 112 of the pen injector 100. Although a pair of buttons is described herein as the mechanism that enables the gripping member to grip the pen injector body, those skilled in the art will recognize that other mechanisms, i.e., any resilient engagement such as a button, a clasp, a band, or the like, a rotating threaded engagement such as a chuck, and an interference or snap-on fit, etc., may be readily substituted.

[0017] Figures 4A to 4C show linear displacements detected by the device 102. The caliper moving part 106 is fully inserted into the caliper stationary part 110 in Figure 4A. The caliper moving part 106 is partially moved from the caliper stationary part 110 in Figure 4B. The caliper moving part 106 is fully extended from the caliper stationary part 110 as shown in Figure 4C.

[0018] Figures 5A to 5C show rotational measurements according to an exemplary embodiment of the invention. The dose knob grip 140 is preferably free to rotate and includes a rotation detector, such as an encoder and detector. Figure 5A shows the dose knob grip in a first rotational position, Figure 5B shows the dose knob grip 140 in a second rotational position, and Figure 5C shows the dose knob grip in a third rotational position.

[0019] FIG. 6 shows a side view of device 102 attached to pen injector 100. FIG. 7 is a cross-sectional view of the pen injector and device 102 combination shown in FIG. 6. FIG. 8 is an enlarged view of the cross-sectional view of FIG. 7, specifically showing a portion of device 102. As shown, a series of spring channels 150 are provided within the body of the components that make up device 102 to provide a gripping force to pen injector 100. FIG. 9 is a side view of the device 102 and pen injector 100 combination rotated 90° from FIG. 6. In this view, caliper station 110 is clearly visible. Preferably, caliper station 110 also forms a housing for housing electronics and wireless communication devices, as described above. FIG. 10 is a cross-sectional view of the pen injector 100 and device 102 combination of FIG. 9. FIG. 11 is an enlarged view of a portion of the pen injector and device 102. Shown is an electronics area 152 within the caliper stationary portion 110, as well as an exemplary rotary photointerrupter 154 that allows the device 102 to detect rotational movement of the rotating portion.

[0020] FIG. 12 is a top view of the device 102 mounted on the pen injector 100. FIGS. 13 and 14 are cross-sectional top views showing the spring channel 150. A spring in the spring channel tends to force two opposing gripping members 154, 156 apart. The opposing gripping members 158, 160 grip the outer surface of the pen injector 100 under the spring force of the spring mounted in the spring channel 150. FIG. 15 shows an encoder disk 162, which forms part of the rotating portion of the device 102 that allows detection of rotational movement of the pen knob. FIGS. 16 and 17 are alternative cross-sectional views from the isometric view showing the rotating photointerrupter 162 and the gripping members 158 and 160.

[0021] FIG. 18 illustrates an exemplary method of using the device 102 in conjunction with the pen injector 100. The method includes primary user actions 1802, results 1804, and communication or response 1806 with or from an interface device, such as a mobile unit. In step 1808, the device 102 is attached to the pen injector 100. This step is only required once per pen injector. After step 1808, the device 102 is attached to the pen injector 100 and is ready to take a measurement (step 1810). In step 1812, the user disinfects a septum on the pen injector 100. In step 1814, the user attaches the pen needle to the pen injector body. In step 1816, the user dials in a priming dose, which is typically 2 units. As the dial on the pen injector is rotated, the device 102 senses the rotation and sends a signal to the connected mobile device. This establishes a communication connection between the device and the mobile device, and the mobile device displays "Priming dose dialed" at step 1818. At step 1820, the user delivers the priming dose, and at step 1822, the movement is detected by the device and a signal is sent to the mobile device. The measured movement is compared to the expected movement. At step 1824, the method determines if priming was successful. If priming is unsuccessful (step 1826), a signal is sent to the mobile device indicating unsuccessful priming, and an error is logged at step 1828. The display of the mobile device displays the message "CHECK FOR NEEDLE STICK". If priming is successful, the priming dose is dispensed at step 1830, and a signal is sent to the mobile device. At step 1832, a signal is sent to the mobile device, a successful priming event is logged by the mobile device, and the message "Pen needle primed, ready to inject" is displayed on the mobile device. At step 1834, the user dials the injection dose on the pen injector 100. At step 1836, a signal is sent to the mobile device and "Dose dialed in X units" is displayed on the mobile device.In step 1838, the user inserts the pen needle into the skin. In step 1838, the user activates the thumb button of the pen injector to inject the dose. In step 1840, a signal is sent to the mobile device and measurements of the device's rotational and linear motion detectors are used to detect the start and end of dosing. During this time, a countdown timer, such as a 10 second countdown, is displayed on the mobile device to assist the user in maintaining the injector against the injection site for the appropriate amount of time and ensure that the user does not prematurely withdraw the injector from the injection site. In step 1842, the method determines whether the full dose was delivered successfully. If the full dose was not delivered due to incomplete movement of one or more motion detectors (step 1844), then in step 1846, a signal is sent to the mobile device and an error is recorded. The mobile device displays "Target Dose Not Reached". If the full dose was delivered successfully (step 1848), a signal is sent to the mobile device and successful dose delivery is recorded in step 1850. The mobile device displays "X units of dose delivered." At step 1852, the user removes the pen needle from the injector. At step 1854, the user replaces the pen injector cap, and at step 1856, after a period of inactivity, communication between the pen injector and the mobile device is interrupted.

[0022] 19 illustrates a system according to an exemplary embodiment of the invention. The system includes a pen injector 1900 with an attached device 1902 and a mobile device 1904 in communication with the device 1902. The system includes the elements required for a user to carry out the injection method described above.

[0023] 20A-20D are exemplary user interface displays on a mobile device 1904 according to an exemplary embodiment of the present invention. FIG. 20A shows an exemplary display for use when a user sets a priming dose. The display displays "2 unit dose prime complete", "Pen needle attached", and "Ready to complete priming step". FIG. 20B shows an exemplary display for use when a priming step fails. The display displays "Warning!! Priming step unsuccessful", "Check for needle clog", "Replace needle if necessary", and "Repeat priming step". FIG. 20C shows an exemplary display for use when a user successfully primes the injector. The display displays "2 unit dose delivered", "Pen needle prime complete", "Ready to inject", and "Dial target dose". FIG. 20D shows an exemplary display for use when a user sets an injection dose, inserts the pen needle, and presses the thumb button. The display preferably displays a countdown timer that counts down from 10 seconds to zero so the user knows how long they have held the injector in place. Either singly or incrementally, the mobile device is also preferably programmed to provide an audible countdown or a series of audible indications to aid the user in other sensory perception of the elapsed time. In embodiments in which the device 1902 includes a display, it should be understood that some or all of the aforementioned displays may be provided on the display of the attachment device rather than the mobile device display.

[0024] FIG. 21 illustrates a system 2100 according to an exemplary embodiment of the present invention. The system 2100 comprises a pen injector with a measurement add-on device 2102 substantially as described above, a mobile device 2104, and a remote server or cloud storage 2106. The linear and rotational motion measurement devices of the add-on device preferably transmit signals to the mobile device via a wireless communication link 2108. In this way, the mobile device can record and analyze events occurring in the add-on device and the pen injector 2102, and further provide feedback to the user on the display 2110 of the mobile device 2104. The mobile device then advantageously has a wireless communication link to the remote server 2106, which may be a cloud storage or the like. The mobile device preferably transmits information to the remote server, where it can be accessed by a healthcare provider or other interested party. The information transmitted to the remote server 2106 may be all of the data received by the mobile device 2104 from the pen injector and add-on devices 2102, or, preferably, a subset of the information, or a result and / or summary of the information received by the mobile device 2104 and analyzed in accordance with program instructions installed on the mobile device 2104.

[0025] Although only a few exemplary embodiments of the present invention have been described in detail above, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments, and various combinations of the exemplary embodiments are possible without substantially departing from the novel teachings and advantages of the present invention, and therefore, all such modifications are intended to be included within the scope of the present invention.

Claims

1. A displacement measurement device (102) for use with a pen injector (100), comprising: a stationary portion (110) adapted to be removably attached to a body (112) of a pen injector; a movable portion (106) adapted to be removably attached to an actuator (114) of a pen injector; a displacement measuring device for measuring a displacement between the stationary part (110) and the movable part (106); the stationary portion (110) includes a stationary portion gripping mechanism for gripping the body (112) of the pen injector; the movable part (106) includes a movable part gripping mechanism for gripping the actuator (114) of the pen injector; The stationary portion gripping mechanism includes: opposing gripping members gripping an outer surface of the body of the pen injector from opposite directions, the opposing gripping members gripping the body of the pen injector when slide buttons respectively connected to the opposing gripping members are biased away from each other, and releasing the body of the pen injector when the slide buttons are pressed toward each other; at least one spring disposed in a spring channel of the body of the pen injector, the spring biasing the slide buttons apart such that the opposing gripping members grip the body of the pen injector; and A displacement measuring device (102) comprising:

2. 2. The displacement measuring device according to claim 1, characterized in that the displacement measuring device includes a linear displacement measuring device that measures linear displacement between the stationary part and the movable part, and a rotational displacement measuring device that measures rotational displacement between two elements of the movable part.

3. 2. The displacement measuring device according to claim 1, further comprising an encoder.

4. 2. The displacement measuring device of claim 1, wherein the gripping member is shaped to correspond to the body of the pen injector.

5. 2. The displacement measuring device of claim 1, further comprising electronics for receiving signals from the displacement measuring device and recording displacement data based on the signals, and a wireless transceiver for transmitting the data to a remote device.

6. 6. The displacement measuring device of claim 5, wherein the stationary portion includes a housing for the electronic device.

7. 2. The displacement measuring device of claim 1, further comprising a controller in communication with the displacement measuring device, the controller determining that a dose has not been reached based on a signal received from the displacement measuring device.

8. 8. The displacement measuring device of claim 7 further comprising an audible or visual indicator to indicate a detected occlusion.

9. 10. The displacement measuring device of claim 1, further comprising a countdown timer adapted to provide audible or visual feedback to a user of the elapsed time of an injection.

10. 2. The displacement measuring device of claim 1, further comprising: a mobile device connected to the displacement measuring device by a wireless communication link; and a remote server connected to the mobile device by a communication link, wherein the displacement measuring device provides displacement-related data to the mobile device, and the mobile device communicates at least a portion of the data to the remote server.

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