Universal Smart Cap for Pen Syringes

Abstract

A two-part cap (100) for an injection pen (106) is provided. The cap includes a static portion (102) that remains on the pen injector (106) and a removable portion (104). The static portion (102) includes a dose sensor (126) for sensing movement of a plunger (118) within a reservoir (114) of the pen injector (106). The dose to be delivered is calculated based on the detected plunger movement.

Description

[Technical Field]

[0001] The present invention relates generally to dosage measurement devices, and more particularly to a cap for a pen injector that directly detects plunger movement to measure the dose during injection. (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Application Ser. No. 35 U.S.C. 119, filed September 28, 2019, U.S. Patent Application No. 62 / 738,202, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] Diabetes is a group of diseases characterized by high blood sugar levels due to defects in insulin production, insulin action, or both. Diabetes can lead to serious health complications and premature death, but there are well-known products that can help people with diabetes control the disease and lower their risk of complications.

[0003] Treatment options for people with diabetes include special diets, oral medications, and / or insulin therapy. The primary goal of diabetes treatment is to control a patient's blood glucose (sugar) levels to increase the chances of a complication-free life. However, achieving good diabetes control while balancing other life demands and circumstances is not always easy.

[0004] Pen injectors have traditionally provided people requiring insulin therapy with a convenient and portable means of injecting insulin. However, successful diabetes management with insulin pens relies on patients following their healthcare provider's instructions to administer the medication and inject properly. To ensure proper absorption of insulin into the body, insulin pens must be held in place by the patient for a period of time immediately following injection. Healthcare providers also want to accurately record the amount and time of injection to assist in assessing the patient's diabetes management. Currently, these functions are performed manually. Patients are instructed to inject the medication and count to a specific number, such as 10, to ensure the entire dose of medication is absorbed into the skin and delivered to the patient. Similarly, after injection, patients are expected to record the amount of insulin injected and the time of injection. While there are a wide variety of existing pen injectors, they do not assist users with proper injection technique or record or communicate dose records to healthcare providers. Therefore, a device is needed to assist users in properly injecting insulin, record successful or unsuccessful doses, and communicate this information to the user and their healthcare provider. Summary of the Invention

[0005] One aspect of an exemplary embodiment of the present invention substantially addresses the above and other concerns by providing a replacement cap for an injection pen. The replacement cap includes a static portion that remains on the injection pen during injection and a removable cap that covers the distal end of the injection pen when not in use and is removed for use. The static portion of the cap includes electronics and sensors for detecting the position and movement of the plunger within a vial of medication and records a dose based on the detected movement.

[0006] Additional and / or other aspects and advantages of the invention will be set forth in the description that follows, or will be obvious from the description, or may be learned by practice of the invention. The invention includes methods or apparatus or systems having one or more of the above-described aspects and / or one or more of the features and combinations thereof. The invention may include, for example, one or more of the features and / or combinations of the above-described aspects as set forth in the appended claims. [Brief explanation of the drawings]

[0007] Various objects, advantages and novel features of illustrative embodiments of the present invention will be more readily understood from the following detailed description when read in conjunction with the accompanying drawings. [Figure 1] FIG. 1 is a side view of an exemplary embodiment of the present invention. [Figure 2] FIG. 1 is a side view of an exemplary embodiment of the present invention. [Figure 3] FIG. 1 is a side view of an exemplary embodiment of the present invention. [Figure 4] FIG. 1 is a block diagram of an exemplary embodiment of the present invention. [Figure 5A] 1 is a flowchart of a method according to an exemplary embodiment of the present invention. [Figure 5B] 1 is a flowchart of a method according to an exemplary embodiment of the present invention. [Figure 6] 10 is a screenshot of a user interface on a mobile device according to an exemplary embodiment of the present invention. [Figure 7] 10 is a screenshot of a user interface on a mobile device according to an exemplary embodiment of the present invention. [Figure 8] 10 is a screenshot of a user interface on a mobile device according to an exemplary embodiment of the present invention. [Figure 9] FIG. 1 is a system diagram of an exemplary embodiment of the present invention. [Figure 10] 1 is a perspective view of an exemplary embodiment of the present invention; [Figure 11]1A and 1B are front and cross-sectional views of a cap according to an exemplary embodiment of the present invention; [Figure 12] 1A and 1B are side and cross-sectional views of a cap according to an exemplary embodiment of the present invention;

[0008] Throughout the drawings, like reference numerals will be understood to refer to like features, elements and structures. DETAILED DESCRIPTION OF THE INVENTION

[0009] As will be appreciated by those skilled in the art, there are many ways of implementing examples, modifications, and arrangements of smart caps for pen injectors in accordance with the embodiments of the invention disclosed herein. Although reference will be made to the exemplary embodiments shown in the drawings and in 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 can be made and various combinations can be made without departing from the invention.

[0010] As shown in FIGURE 1, an exemplary embodiment of the present invention includes a two-part cap 100 for a pen injector. Cap 100 includes a static portion 102 and a removable portion 104. Cap 100 is attachable to a pen injector 106. The pen injector components include a pen injector body 108, a thumb button 110, a disposable pen needle 112, and a reservoir chamber 114. Reservoir chamber 114 also includes a plunger 118 that remains in a reservoir located in reservoir chamber 114, and a window 116 through which medication fluid 120 can be viewed.

[0011] Figure 2 shows the cap 100 attached to a pen injector 106. Figure 3 shows the removable portion 104 of the cap 100 being removed to expose the pen needle 112 to allow for an injection. The removable portion 104 preferably connects and disconnects to the stationary portion 102 by a friction fit, a snap fit, threads, or any other suitable mechanism.

[0012] In an exemplary embodiment of the invention, the static portion 102 of the cap 100 includes three sensors. There is a cap sensor 122 to sense the presence or absence of the removable portion 104 of the cap 100. There is also a proximity sensor 124 that senses whether the pen injector remains pressed against the user's skin during injection. The third sensor is a dose sensor 126 incorporated into the static portion 102 of the cap 100 and will be described in further detail below. The dose sensor 126 advantageously senses the position of the plunger and / or the fluid remaining in the reservoir optically or by any other suitable means. Because the static portion 102 of the cap 100 remains on the pen injector 106 during injection, the dose sensor 126 can track the movement of the plunger 118 in real time during injection.

[0013] 3, the removable portion 104 of the cap 100 can be sized to accommodate a pen needle 112. In other embodiments, the removable portion 104 of the cap 100 can be sized not to accommodate a pen needle, such that the pen needle is attached to and detached from the pen injector 106 after the removable portion 104 is removed and before the removable portion 104 is replaced.

[0014] 4 is a block diagram of the cap 100 and pen injector 106 described above. The cap 100 includes a static cap 102 and a removable pen needle cap 104. The static cap 102 houses the cap sensor 122, proximity sensor 124, and dose sensor 126, as described above. The static cap 102 also houses a wireless communication unit 128 for communicating with a remote device, such as a mobile unit, as discussed in further detail below. The static cap houses, among other functions, a power battery 130 and a microcontroller 132 for receiving signals from the sensors and controlling communication with the remote device via the wireless controller 128. The static cap 102 preferably includes mechanical connection features 134 for connecting the static cap to the body 108 of the pen injector 106.

[0015] FIG. 5 illustrates an exemplary method of using the cap 100 in conjunction with a pen injector 106. In step 500, the removable pen needle cap 104 is removed from the injector 106. In step 502, the cap detector 122 detects that the removable cap has been removed and wakes the static cap 102, which turns on, and preferably, in step 504, the static cap 102 establishes contact with a remote device, such as a mobile phone. In step 506, the user sterilizes the septum on the pen. In step 508, the pen needle 112 is attached to the pen injector body 108. In step 510, the user dials a priming dose, typically two units. In step 512, the user dispenses the priming dose. In step 514, the user determines whether the priming was successful. If the injection fails, the method continues at step 516, where the injection error is logged at step 518 and an alarm to check for a clogged needle is displayed to the user on the connected mobile device. If the injection is successful, the method proceeds to step 520, where the device records and logs the successful injection step as an event at step 522 and displays "Pen needle injected and ready to inject" on the mobile device. The user then dials the dose to be injected at step 524. The pen needle is inserted into the patient's skin at step 526. The proximity sensor 124 detects that the pen needle has been inserted into the skin and displays "Ready to inject" on the display of the connected mobile device at step 528. The user presses the button with their thumb to activate the pen and dispense the dose at step 530, and the dose sensor 126 senses that the dose has been activated at step 532, where the display displays a countdown timer, preferably for a minimum of 10 seconds, or longer for more doses. The dose sensor 126 preferably senses and records movement data corresponding to the movement of the plunger and records the calculated dose based on the movement of the plunger. In step 534, the device determines whether the full dose was successfully delivered.If the full dose was not delivered, the method proceeds to step 536, where in step 538 the dose delivery error is recorded in an electronic log and displays "Target dose not delivered." If the dose was successfully delivered, the method proceeds to step 540, where in step 542 the device records successful dose delivery and displays "x units of dose delivered" on the mobile device display. In step 544, the user removes the pen needle from the injector. In step 546, the user replaces the pen needle cap 104 on the pen injector 106 and stores it until next use. Preferably, at this point, in step 548, the electronics of the static cap 102 recognize that contact with the mobile device has been lost and record the event.

[0016] 6-8 are exemplary user interface displays on a mobile device 600 according to an exemplary embodiment of the present invention. Those skilled in the art should understand that the messages shown herein are merely exemplary and can be replaced with alternative messages or symbols conveying similar meanings. FIG. 6 shows an exemplary display for use when the injection step fails. The display reads, "Warning! Injection step failed. Check needle for clogged needle. Replace needle as needed. Repeat injection step." FIG. 7 shows an exemplary display for use when the injection step is successful. The display reads, "2 unit doses administered. Required needle attached. Ready to inject. Dial target dose." FIG. 8 shows an exemplary display for use during injection. The display displays a countdown timer, preferably counting down from 10 seconds. During this time, the user must hold the pen injector against the skin. A proximity sensor 124 ensures that the pen injector 106 is not prematurely removed and triggers an error if the pen injector 106 is prematurely removed.

[0017] FIG. 9 illustrates a system 900 according to an exemplary embodiment of the present invention. The system 900 includes a pen injector 106 with a cap 100 substantially as described above, a mobile device 904, and a remote server or cloud storage 906. The dose sensor 126 and proximity sensor 124 of the cap 100 preferably transmit signals to the mobile device 904 via a wireless communication link 908. In this manner, the mobile device can record and analyze events occurring in the add-on device and the pen injector 106, and can further provide feedback to the user on a display 910 of the mobile device 904. The mobile device 904, in turn, advantageously has a wireless communication link 912 to the remote server 906, such as cloud storage. The mobile device 904 preferably transmits information to the remote server so that the information can be accessed by a healthcare provider or other interested party. The information transmitted to the remote server 906 may be all of the data received by the mobile device 904 from the pen injector 106 and cap 100, or preferably a subset of the information, or the results and / or summary of the information received by the mobile device 904 and analyzed in accordance with program instructions installed on the mobile device 904.

[0018] FIG. 10 is a perspective view of one embodiment of the present invention. As shown, cap 100 includes an electronics housing 140. Electronics housing 140 houses an electronics board 142, as shown in FIG. 12, a side view. Cap 100 also includes a locking nut 144 for securing cap 100 to pen injector 106. FIG. 11 is a front view of cap 100, showing a collet or chuck clamping mechanism 146 interlocking with locking nut 144 for securing cap 100 to pen injector 106. FIG. 11 also shows a sensor array 148 on the interior surface of cap 100 for sensing plunger position and movement during injection. It will be understood that the sensor array may be any suitable sensor, including optical reflective emitters and sensors located on the same side of the pen injector 106 and the vial, or transmissive emitters and sensors located on opposite sides of the vial.

[0019] 10-12 also show examples of removable portion 104 sized such that pen needle 112 cannot be accommodated within removable portion 104 while removable portion 104 is attached to stationary portion 102.

[0020] 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 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 combination of a pen injector (106) and a dose measuring device (100) for use with said pen injector (106), comprising: a static cap portion (102) connected to the pen injector (106) body (108); and a removable cap (104) attached to the static cap portion (102) and removable from the static cap portion (102) to expose a pen needle (112) of the pen injector (106); the static cap portion (102) includes a cap sensor (122) for sensing when the removable cap (104) is removed from the static cap portion (102), a proximity sensor (124) for sensing when the pen injector (106) is in proximity to a user, and a dose sensor (126) for detecting movement of a plunger (118) within a medication reservoir (114) during injection, wherein a proximal end of the static cap portion (102) is removably connected to a distal end of the pen injector body (108) via a mechanical connection feature (134), and the static cap portion (102) remains on the pen injector (106) during injection to cover the medication reservoir (114) connected to the pen injector body (108).

2. 10. The combination of claim 1, wherein the static cap portion (102) further comprises a wireless communication unit for communicating dosage data to a remote device.

3. 3. The combination of claim 2, wherein the remote device is a mobile phone.

4. 10. The combination of claim 1, further comprising a microcontroller that receives input signals from the proximity sensor, the cap sensor, and the dose sensor.

5. 5. The combination of claim 4, wherein the microcontroller is further adapted to determine dosage information from the received signal and transmit the dosage information to a remote device.

6. 10. The combination of claim 1, wherein the dose sensor comprises a light source and at least one photodetector that receives light transmitted from the light source through a reservoir.

7. 10. The combination of claim 1, wherein the dose sensor comprises a light source and at least one photodetector that receives light transmitted from the light source and reflected from the plunger.

8. 1. A method for measuring a dose, comprising: connecting a cap to a pen injector (106) body (108), said cap including a static cap portion (102) and a removable cap portion (104) removably attached to said static cap portion (102), said static cap portion (102) including a dose sensor (126), a removable cap sensor (122), and a proximity sensor (124); detecting the removal of the removable cap portion (104) using the removable cap sensor (122); activating the static cap portion (102) when removal of the removable cap portion (104) is detected; sensing movement of a plunger (118) within said pen injector (106) during an injection; calculating a dose based on the detected movement of the plunger (118); transmitting the dosage information to a remote device; wherein a proximal end of the static cap portion (102) is removably connected to a distal end of the pen injector (106) body (108) via a mechanical connection feature (134), and the static cap portion (102) remains on the pen injector (106) during injection to cover a medication reservoir (114) connected to the pen injector (106) body (108).

9. 10. The method of claim 8, further comprising determining that a pen needle attached to the pen syringe is clogged based on the sensed movement of the plunger.

10. 10. The method of claim 9, further comprising the step of communicating an alert to the remote device if a clog is detected.

11. 10. The method of claim 8, further comprising the steps of: providing a countdown display to the remote device during injection; and determining whether the proximity sensor detects that the pen injector contacts the user's skin throughout the injection.

12. 10. The method of claim 8, further comprising transmitting dosage information from the remote device to a cloud storage device.

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